Filed Pursuant to Rule 424(b)(4)

Registration No. 333-269483

 

1,415,095 Units

Each Unit Consisting of

One Share of Common Stock,

One Warrant to Purchase One share of Common Stock, and

One Non-tradeable Warrant to Purchase One Share of Common Stock

and the 2,830,190 Shares of Common Stock underlying such Warrants

 

 

60 Degrees Pharmaceuticals, Inc.

 

This is a firm commitment initial public offering of 1,415,095 units (each, a “Unit,” collectively, the “Units”) of 60 Degrees Pharmaceuticals, Inc. (the “Company,” “we,” “us” or “our”). The initial public offering price of our Units is $5.30 per Unit. Each Unit consists of one share of our common stock, one tradeable warrant (each, a “Tradeable Warrant,” collectively, the “Tradeable Warrants”) to purchase one share of common stock at an exercise price of $6.095 per share, and one non-tradeable warrant (each, a “Non-tradeable Warrant,” collectively, the “Non-tradeable Warrants”; together with the Tradeable Warrants, each, a “Warrant,” collectively, the “Warrants”) to purchase one share of our common stock at an exercise price of $6.36 per share. The Units have no stand-alone rights and will not be certificated or issued as stand-alone securities. The shares of common stock and the Warrants underlying the Units are immediately separable and will be issued separately in this offering. Each Warrant offered as part of this offering is immediately exercisable on the date of issuance and will expire five years from the date of issuance.

 

The Warrants will be issued in book-entry form pursuant to a warrant agent agreement (the “Warrant Agent Agreement”) between us and Equity Stock Transfer, LLC, who will be acting as the warrant agent (the “Warrant Agent”).

 

Prior to this offering, there has been no public market for our common stock or Tradeable Warrants. Our common stock and Tradeable Warrants have been approved for listing on The Nasdaq Capital Market under the symbols “SXTP” and “SXTPW,” respectively. We have not and do not intend to apply for listing of the Non-tradeable Warrants on any exchange or market.

 

We intend to use the proceeds from this offering for general corporate purposes, including working capital. See “Use of Proceeds.”

 

In addition, the selling stockholders (the “Selling Stockholders”) are offering an aggregate of 2,224,763 shares of common stock to be sold pursuant to a separate resale prospectus (the “Resale Prospectus”), consisting of (i) 10,482 shares of common stock to be issued upon conversion of a convertible note immediately prior to the consummation of the initial public offering, (ii) 373,426 shares of common stock to be issued in conjunction with the conversion or extinguishment of interim financing notes on the date of the effectiveness of the registration statement of which this prospectus forms a part, (iii) 1,608,938 shares of common stock held by certain of the Selling Stockholders and (iv) 231,917 shares of common stock issuable upon the exercise of warrants that are to be issued on the date of effectiveness of the registration statement of which the Resale Prospectus forms a part. We will not receive any proceeds from the sale or other disposition of shares by the Selling Stockholders. The Selling Stockholders will bear all commissions and discounts, if any, attributable to the sale or other disposition of the shares. We will bear all costs, expenses and fees in connection with the registration of the Selling Stockholders’ shares. The Selling Stockholders may not offer or sell shares prior to the closing of the initial public offering.

 

In order to meet The Nasdaq Stock Market LLC’s (“Nasdaq”) public float requirement of $15,000,000, we are partly relying on the registration of shares of common stock held by the Selling Stockholders. The per share value of the common stock included in each Unit is $5.05, and the value of the tradeable warrant included in each Unit is $0.125, which requires us to have, at a minimum, 1,483,456 issued and outstanding public float shares. Since the number of shares of common stock being registered pursuant to the registration statement of which the Resale Prospectus forms a part that are not subject to transfer restrictions is 1,608,938, which is greater than 1,483,456, we will be able to meet Nasdaq’s public float requirement of $15,000,000.

 

Investing in our securities involves a high degree of risk. See “Risk Factors” beginning on page 20 of this prospectus for a discussion of information that should be considered in connection with an investment in our securities.

 

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

We are an “emerging growth company” and a “smaller reporting company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and have elected to comply with certain reduced public company reporting requirements. See “Summary—Implications of Being an Emerging Growth Company and Smaller Reporting Company.”

 

   Per Unit   Total 
Initial public offering price  $5.30   $7,500,000 
Underwriting discounts and commissions(1)(2)  $0.424   $600,000 
Proceeds, before expenses, to us  $4.876   $6,900,000 

 

(1)Represents underwriting discount and commissions equal to $0.424 per Unit.

 

(2)Does not include a non-accountable expense allowance equal to 1.5% of the gross proceeds of this offering, payable to WallachBeth Capital LLC, as representative of the underwriters (the “Representative”), or the reimbursement of certain expenses of the underwriters. See “Underwriting” beginning on page 120 of this prospectus for additional information regarding underwriting compensation.

 

In addition to the underwriting discounts listed above and the non-accountable expense allowance described in the footnote, we have agreed to issue upon the closing of this offering to the Representative, warrants that will expire on the fifth anniversary of the effective date of the registration statement of which this prospectus is a part, entitling the Representative to purchase 6% of the number of shares of common stock sold in this offering (excluding shares of common stock sold to cover over-allotments, if any) (the “Representative Warrants”). The registration statement of which this prospectus is a part also covers the Representative Warrants and the shares of common stock issuable upon the exercise thereof. For additional information regarding our arrangement with the underwriters, please see “Underwriting” beginning on page 120. 

 

We have also granted the Representative an option to purchase from us, at the public offering price, up to 212,265 additional shares of common stock and/or 212,265 Tradeable Warrants and/or 212,265 Non-tradeable Warrants, less the underwriting discounts and commissions, within 45 days from the date of this prospectus to cover over-allotments, if any. If the Representative exercises the option in full, the total underwriting discounts and commissions payable will be approximately $690,000 and the total proceeds to us, before expenses, will be approximately $7,935,000.

 

The underwriters expect to deliver the securities against payment on or about July 14, 2023.

 

Sole Book-Running Manager

 

WallachBeth Capital LLC

 

Prospectus dated July 12, 2023

 

   

 

  

TABLE OF CONTENTS

 

ABOUT THIS PROSPECTUS 1
TRADEMARKS 1
GLOSSARY OF SELECTED TERMS 2
MARKET DATA 3
PROSPECTUS SUMMARY 4
SUMMARY OF THE OFFERING 18
SUMMARY FINANCIAL DATA 19
RISK FACTORS 20
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 55
USE OF PROCEEDS 56
DIVIDEND POLICY 57
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 57
CAPITALIZATION 57
DILUTION 59
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 60
BUSINESS 74
MANAGEMENT 103
EXECUTIVE COMPENSATION 108
PRINCIPAL STOCKHOLDERS 113
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS 114
DESCRIPTION OF SECURITIES 114
Shares Eligible for Future Sale 119
UNDERWRITING 120
EXPERTS 124
LEGAL MATTERS 124
WHERE YOU CAN FIND MORE INFORMATION 124
INDEX TO FINANCIAL STATEMENTS F-1

 

Through and including August 26, 2023 (the 25th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

 

You should rely only on the information contained in this prospectus or any prospectus supplement or amendment. Neither we, nor the underwriters, have authorized any other person to provide you with information that is different from, or adds to, that contained in this prospectus. If anyone provides you with different or inconsistent information, you should not rely on it. Neither we nor the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. You should assume that the information contained in this prospectus or any free writing prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date. We are not making an offer of any securities in any jurisdiction in which such offer is unlawful.

 

No action is being taken in any jurisdiction outside the United States to permit a public offering of our securities or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this public offering and the distribution of this prospectus applicable to that jurisdiction.

 

   

 

  

ABOUT THIS PROSPECTUS

 

Throughout this prospectus, unless otherwise designated or the context suggests otherwise,

 

all references to the “Company,” “60P,” the “registrant,” “we,” “our,” or “us” in this prospectus mean 60 Degrees Pharmaceuticals, Inc., a Delaware corporation, and 60P Australia Pty Ltd, an Australian proprietary company limited by shares, our subsidiary;

 

“year” or “fiscal year” means the year ending December 31; and

 

all dollar or $ references, when used in this prospectus, refer to United States dollars.

 

Except as otherwise indicated, all information in this prospectus assumes that:

 

no shares of common stock have been issued pursuant to (i) the conversion of certain of our outstanding debt and (ii) certain consultant agreements;

 

no shares of common stock have been issued pursuant to any warrants;

 

no shares of common stock have been issued pursuant to the Representative’s over-allotment option; and

 

no shares of common stock have been issued pursuant to the Representative Warrants.

 

TRADEMARKS

 

Solely for convenience, our trademarks and tradenames referred to in this prospectus, may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and tradenames. All other trademarks, service marks and trade names included or incorporated by reference into this prospectus or the accompanying prospectus are the property of their respective owners.

 

 1 

 

  

GLOSSARY OF SELECTED TERMS

 

The following are definitions of certain terms that are commonly used in the medical industry and in this prospectus:

 

“8-aminoquinoline” refers to the structural class of antimalarials to which Tafenoquine and Primaquine belong. 8-aminoquinolines are characterized by the presence of an 8-amino substitution on their core quinoline ring, which confers their unique properties including an oxidative Mode of Action and activity against the relapsing liver forms of Plasmodium vivax.

 

“API” means active pharmaceutical ingredient, the active molecule contained in a pharmaceutical product.

 

“Arakoda” means ARAKODA®, the 60P-owned and FDA-approved product to prevent malaria in travelers, which contains as its active pharmaceutical ingredient, Tafenoquine succinate.

 

“Broad Spectrum of Activity” refers to a molecule or drug that is active against a range of different pathogens.

  

“CAR-T” means chimeric antigen receptor therapy.

 

“CLIA” means The Clinical Laboratory Improvements Amendment of 1988.

 

“Dengue” means a mosquito-borne viral disease occurring in tropical and subtropical areas.

  

“Ethics Committee” a stand-alone or institutional committee responsible for ensuring clinical trials are conducted ethically, and from whom permission is required for a clinical trial to proceed. 

 

“EUA” means Emergency Use Authorization.

 

“FDA” refers to the U.S. Food and Drug Administration.

 

“G6PD” means glucose-6-phosphate dehydrogenase.

 

“GMP” means Good Manufacturing Practices.

 

“IND” means investigational new drug application.

 

“Kodatef” is the brand name of Arakoda outside the United States. Kodatef has been approved for use in Australia by the Therapeutic Goods Administration.

 

“Legacy Studies” is a reference to the collection of clinical and non-clinical studies involving Tafenoquine, which were conducted by the U.S. Army prior to 2014, and which were included in the new drug application submitted by 60P to the FDA in 2018. Some of those Legacy Studies are described in the account of the Army development program published by Zottig et. al.

 

“Mode of Action” is the process by which an anti-infective or other pharmaceutical product is known or suspected to affect a disease process. This process is different for each drug and may or may not be known at the time of FDA approval.

 

“Named-patient” use of a drug refers to the prescription by a physician of a drug to one of their patients in a jurisdiction in which the prescribed drug has not received marketing authorization, but is believed by said physician to be safe and medically necessary. Also, sometimes referred to as “compassionate use.”

 

“NIH” means the National Institutes of Health.

 

“PDUFA” means The Prescription Drug User Fee Act.

 

“PMA” means Premarket Approval by the FDA.

 

 2 

 

  

“Primaquine” is the FDA-approved antimalarial from which Tafenoquine is chemically derived.

 

P. vivax” is an abbreviation for Plasmodium vivax, one of the two most important malaria parasites, characterized by its ability to relapse utilizing a dormant life cycle stage that persists in the human liver following a bite from an infected mosquito.

 

“RSV” means respiratory syncytial virus, which is a common respiratory virus that usually causes cold-like symptoms.

 

“Repositioned Molecule” is one which was approved by the FDA or other regulatory authorities to treat one disease, and is being developed for a new disease.

 

“Tafenoquine” is the shortened name of the active ingredient of Arakoda and Kodatef, tafenoquine succinate.

 

“TGA” is the Therapeutic Goods Administration, the Australian equivalent of the FDA.

 

“TMPRSS2” means transmembrane protease, serine 2, which is an enzyme that in humans is encoded by the TMPRSS2 gene, and belongs to the TMPRSS family of proteins, whose members are transmembrane proteins which have a serine protease activity.

 

In connection with presentation of scientific data, this prospectus references “P-values” at various points. These values are provided to convey the likelihood of a particular set of data occurring by chance. For example, a P-value of 0.12 associated with a stand-alone, pre-conceived hypothesis is generally understood to mean that the likelihood of that particular outcome occurring purely by chance is 12%. It is scientific convention that a particular observation is “proven” if its associated P value is lower than 0.05 (i.e., associated with a likelihood of occurring by chance of < 5%). However, clinical observations of interest are routinely reported in the peer-reviewed scientific literature even if their associated P-values are > 0.05, because they may represent important therapeutic signals, and motivate additional research. With the exception of the data reported in Figure B, the efficacy data described herein related to our COVID-19 program and Arakoda have been published in a peer-reviewed scientific journal.1 P-values presented herein are not corrected for multiple comparison error, and represent the outcomes of both pre-conceived, and post-hoc, analyses.

 

USE of PRODUCT VERSUS GENERIC NAMES

 

This prospectus makes reference to two commercial products owned/manufactured by 60P, Arakoda and Kodatef, which are approved by regulators in the United States and Australia, respectively, for the prevention of malaria. The active molecule in those products is tafenoquine succinate (Tafenoquine for short), which we are repositioning for other indications using either (i) the same dosing regimen employed in the commercial Arakoda product (in which case reference is made to the “Arakoda regimen of tafenoquine” or (ii) different dosing regimens (in which case reference is made to “Tafenoquine”). We also utilize the molecular name (Tafenoquine), where the active ingredient of Arakoda and Kodatef was tested in cell culture or animal models. These different usages have been employed both for convenience and to avoid any assertions that Arakoda or Kodatef have been granted marketing authorization by regulators for uses other than the prevention of malaria.

 

MARKET DATA

 

Market data and certain industry data and forecasts used throughout this prospectus were obtained from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. To our knowledge, certain third-party industry data that includes projections for future periods does not take into account the effects of the worldwide coronavirus (COVID-19) pandemic. Accordingly, those third-party projections may be overstated and should not be given undue weight. Forecasts are particularly likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general economic growth were used in preparing the forecasts we cite. Statements regarding our market position are based on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this prospectus, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus.

 

 

1 Dow and Smith, New Microbe and New Infect 2022; 47:100986.

 

 3 

 

  

PROSPECTUS SUMMARY

 

This summary provides a brief overview of the key aspects of our business and our securities. The reader should read the entire prospectus carefully, especially the risks of investing in our securities discussed under “Risk Factors.” Some of the statements contained in this prospectus, including statements under “Summary” and “Risk Factors” as well as those noted in the documents incorporated herein by reference, are forward-looking statements and may involve a number of risks and uncertainties. Our actual results and future events may differ significantly based upon a number of factors. The reader should not put undue reliance on the forward-looking statements in this document, which speak only as of the date on the cover of this prospectus.

 

Unless the context otherwise requires, references in this prospectus to “60P,” the “Company,” “we,” “us” and “our” refer to 60 Degrees Pharmaceuticals, Inc., a Delaware corporation, and 60P Australia Pty Ltd, an Australian proprietary company limited by shares, our majority-owned subsidiary.

 

Overview

 

We are a growth-oriented specialty pharmaceutical company with a goal of using cutting-edge biological science and applied research to further develop and commercialize new therapies for the prevention and treatment of infectious diseases. We have successfully achieved regulatory approval of Arakoda, a malaria preventative treatment that has been on the market since late 2019. Currently, 60P’s pipeline under development covers development programs for COVID-19, fungal, tick-borne, and other viral diseases utilizing three of the Company’s future products: (i) new products that contain the Arakoda regimen of Tafenoquine; (ii) new products that contain Tafenoquine; and (iii) Celgosivir.

 

Mission

 

Our mission is to address the unmet medical need associated with infectious diseases, through the development and commercialization of new small molecule therapeutics, focusing on synthetic drugs (made by chemists in labs, excluding biologics) with good safety profiles based on prior clinical studies, in order to reduce cost, risk, and capitalize on existing research. We are seeking to expand Arakoda’s use for malaria prevention and to demonstrate clinical benefit for other disease indications. We are further testing the viability of another product (Celgosivir) to determine whether to advance it into further clinical development, and may seek to develop and license other molecules in the future. Celgosivir is being developed for COVID-19, RSV and Dengue.

 

Market Opportunity

 

In 2018, the FDA approved Arakoda for malaria prevention in individuals 18 years and older, an indication for which there has historically been approximately 550,000 prescriptions (one prescription per three weeks of travel) in the United States each year for the current market-leading product (atovaquone-proguanil). Arakoda entered the U.S. supply chain in the third quarter of 2019, just prior to the COVID-19 pandemic. As the approved indication is for travel medicine, and international travel was substantially impacted by the pandemic, we did not undertake any active marketing efforts for Arakoda. Targeted marketing efforts will commence in the second half of 2023 to promote the malaria indication as resources permit, although we expect our primary efforts to be developing Arakoda for other applications.

 

We are repositioning the Arakoda regimen of Tafenoquine for new indications to address several therapeutic indications that have substantial U.S. caseloads, as further described below:

 

  Treatment of COVID-19. According to The New York Times, the lowest daily case rate for the COVID-19 virus since March 2020 based on a seven-day average has not typically been below 11,000 cases. Assuming this trend continues, this dynamic translates into a potential market size of at least 4,000,000 cases per year in 2023 and future years. Paxlovid and molnupiravir have received emergency use authorization for the prevention of death and hospitalization in individuals with high risk of disease progression and their use for those purposes continues to be recommended by public health experts. However, to our knowledge, there is not published evidence from randomized controlled clinical trials that either drug reduces the time to sustained clinical recovery for four or more days in standard risk patients infected with contemporary viral strains, and Pfizer has formally abandoned efforts related to this endpoint for paxlovid.2 Additionally molnupiravir and paxlovid are not approved by FDA for use in patients without risk factors for disease progression, and that excluded lower risk population comprises about 25% of the U.S. population.3 The economic value of that unsatisfied market may be a multi-billion-dollar opportunity, given that the value of paxlovid and molnupiravir in the 75% of the population in which they can be used was ~ $12 billion in 2022.4 If proven effective for early relief of COVID-19 symptoms in standard risk COVID-19 patients, Tafenoquine (Arakoda regimen) could fulfill a patient’s need unmet by the approved antivirals.

 

 

2 Press release: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supporting.

3 See the Paxlovid (www.paxlovid.com) and Lagevrio (www.lagevrio.com) prescribing information and epidemiology data described by Ajufo et al Am J Preventive Cardiol 2021;6:101156.

4 See 2022 revenue data for Paxlovid in Pfizer (https://investors.pfizer.com/Investors/Financials/SEC-Filings/SEC-Filings-Details/default.aspx?FilingId=16428097) and Lagevrio (https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/b390be48-92bf-4595-96da-ac5cd7c3d92e.pdf) in Merck financial reports.

 

 4 

 

 

Treatment and Post-Exposure Prevention of Tick-Borne Diseases. There are at least 47,000 cases of babesiosis (red blood cell infections caused by deer tick bites) in the United States each year. This estimate is based on the observations of Krugeler who reported that 476,000 cases of Lyme disease occur in U.S. states where babesiosis is endemic and Krause et. al. who reported that 10% of Lyme disease patients are co-infected with babesiosis (thus 476,000*10% = 47,600 cases of babesiosis per year).5 Furthermore, post-exposure prophylaxis following a tick-bite is a recognized indication to prevent Lyme disease, and it is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis. There may be more than 400,000 tick bites in the United States requiring medical treatment each year. This estimate is based on the observation that approximately 50,000 tick bites are treated in U.S. hospital emergency rooms each year but this calculation represents only about 12% of actual treated tick bites based on observations from comparable ex-U.S health systems.6 Arakoda has the potential to be added to the existing standard of care for treatment of babesiosis, and to be a market leading product for pre- and post-exposure prophylaxis of babesiosis.

 

 

Prevention of fungal pneumonias. There are up to ~ 91-92,000 new medical conditions each year in the United States including acute lymphoblastic leukemia (up to 6.540 cases) and large B-cell lymphoma (up to 18,000 cases) patients receiving CAR-T therapy, solid organ transplant patients (up to 42,887 cases), allogeneic (~ 9,000 cases) and autologous (~ 15,000 cases) hematopoietic stem cell transplant patients for whom the use of antifungal prophylaxis is recommended.7 Despite the availability and use of antifungal prophylaxis, the risk of some patient groups contracting fungal pneumonia exceeds the risk of contracting malaria during travel to West Africa.6 Arakoda has the potential to be added to existing standard of care regimens for the prevention of fungal pneumonias.

 

  Treatment of Candida infections. According to the Centers for Diseases Control (CDC), there are 50,000 cases of candidiasis (a type of fungal infection) each year in the United States and up to 1,900 clinical cases of C. auris, for which there are few available treatments, have been reported to date9 Arakoda has the potential to be a market leading therapy for treatment/prevention of C. auris, and to be added to the standard of care regimens for other Candida infections.

 

Dengue and RSV, both afflictions against which 60P’s early clinical candidates (e.g., Celgosivir) show potential in non-clinical studies, are associated with at least 4.1 million cases globally according to the European CDC (Dengue) 10 and up to 240,000 hospitalizations (RSV) in children less than five years of age and adults greater than 65 years of age in the United States each year according to the CDC.11

 

More information about our products is provided in the next section, and the status of various development efforts for the above-mentioned diseases is outlined in Figure A, below.

 

 

5 Krause et al JAMA 1996;275:1657-16602. Krugeler et al Emerg Infect Dis 2021;27:616-619

6 Marx et. al., MMWR 2021;70:612-616.

7 See statistics for solid organ transplants at the Organ Transplant and Procurement Network at: National data - OPTN (hrsa.gov); See statistics for hematopoietic stem cell transplant in Dsouza et al Biology of Blood and Bone Marrow Transplantation 202;26: e177-e182; See statistics for acute lymphoblastic leukemia at: Key Statistics for Acute Lymphocytic Leukemia (ALL) (cancer.org); See statistics for large cell large B-cell lymphoma at; Diffuse Large B-Cell Lymphoma - Lymphoma Research Foundation; Treatment guidelines recommending antifungal prophylaxis for these diseases can be reviewed in (i) Fishman et al Clinical Transplantation. 2019;33:e13587, (ii) Hematopoietic Cell Transplantation (cancernetwork.com), (iii) Cooper et al Journal of the National Comprehensive Cancer Network 2016;14:882-913 and (iv) Los Arcos et al Infection (2021) 49:215–231.

8 Aguilar-Guisado et al Clin Transplant 2011;25:E629–38; Mace et al MMWR 202;70:1–35

9 https://www.cdc.gov/fungal/diseases/candidiasis/invasive/statistics.html.; https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html.

10https://www.ecdc.europa.eu/en/dengue-monthly#:~:text=This%20is%20an%20increase%20of%2032%20653%20cases%20and%2032,853%20deaths%20have%20been%20reported.

11https://www.cdc.gov/rsv/research/index.html#:~:text=Each%20year%20in%20the%20United,younger%20than%205%20years%20old.&text=58%2C000-80%2C000%20hospitalizations%20among%20children%20younger%20than%205%20years%20old.&text=60%2C000-120%2C000%20hospitalizations%20among%20adults%2065%20years%20and%20older.

 

Figure A

  

 

 5 

 

  

Products

 

Arakoda (Tafenoquine) for malaria prevention

 

We entered into a cooperative research and development agreement with the United States Army in 2014 to complete development of Arakoda for prevention of malaria.12 With the U.S. Army, and other private sector entities as partners, we coordinated the execution of two clinical trials, development of a full manufacturing package, gap-filling non-clinical studies, compilation of a full regulatory dossier, successful defense of our program at an FDA advisory committee meeting, and submitted a new drug application (“NDA”) to the FDA in 2018. The history of that collaboration has been publicly communicated by the U.S. Army.13

 

The FDA and Australia’s medicinal regulatory agency, Therapeutic Goods Administration, subsequently approved Arakoda and Kodatef (brand name in Australia), respectively, for prevention of malaria in travelers in 2018. Prescribing information and guidance for patients can be found at www.arakoda.com. The features and benefits of Tafenoquine for malaria prophylaxis (marketed as Arakoda in the United States), some of which have been noted by third-party experts, include: convenient once weekly dosing following a three day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species (Plasmodium vivax and Plasmodium falciparum); absence of any black-box safety warnings; good tolerability including in women and individuals with prior psychiatric medical history, and a comparable adverse event rate to placebo with up to 12 months continuous dosing.14 Tafenoquine entered the commercial supply chains in the U.S. (as Arakoda) and Australia (as Kodatef) in the third quarter of 2019.

 

The only limitation of Arakoda is the requirement for a G6PD test prior to administration.15 The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic anemia in individuals with G6PD deficiency.16 G6PD is one of the most common enzyme deficiencies and is implicated in hemolysis following administration/ingestion of a variety of oxidant drugs/food. G6PD must also be ruled out as a possible cause when diagnosing neonatal jaundice. As a consequence, G6PD testing is widely available in the United States through commercial pathology service providers (e.g., Labcorp, Quest Diagnostics, etc.). Although these tests have a turn-around time of up to 72 hours, the test needs only to be administered once. Thus, existing U.S. testing infrastructure is sufficient to support the FDA-approved use of the product (malaria prevention) by members of the armed forces (who automatically have a G6PD test when they enlist), civilian travelers with a long planning horizon or repeat travelers.

 

Tafenoquine (Arakoda regimen) for COVID-19

 

During the COVID-19 pandemic, since our commercial opportunities were limited, we embarked upon an exploratory research and development campaign to identify new indications for the Arakoda dosing regimen of Tafenoquine. In the second quarter and third quarter of 2020, we commissioned cell culture studies that showed that Tafenoquine, the active ingredient in Arakoda, inhibited replication of SARS-CoV-2 (the virus that causes COVID-19).17 Then, we commissioned computer simulations, which showed that the predicted concentration of Tafenoquine in the lungs of COVID-19 patients following administration of the first four doses of the approved antimalarial prophylactic regimen of Arakoda exceeded those inhibiting the virus in cell culture. The foregoing provided the rationale for seeking approval from the FDA to conduct a Phase II clinical trial in patients with the COVID-19 disease, for which the FDA granted clearance to proceed in October 2020.

 

In 2021, with financial support from the U.S. Army16, we conducted a Phase II clinical investigation of the safety and efficacy of Tafenoquine using the Arakoda regimen in outpatients with mild-moderate COVID-19 disease (assumed to be mostly caused by the delta variant of SARS-COV-2). In summary, safety and efficacy of Tafenoquine administered at the approved dose for malaria prevention (200 mg dose once per day on days 1, 2, 3, and 10) was evaluated over a 28-day period in mild-moderate COVID-19 patients. The primary endpoint was day 14 clinical recovery from COVID-19 symptoms, defined as cough mild or absent, respiratory rate < 24 bpm, and no shortness of breath or fever. From March 2021 through September 2021, this study enrolled 87 of the originally planned 275 patients. In October 2021, a data safety monitoring board, after conducting a futility analysis for the primary endpoint and reviewing adverse event data, recommended that the study be continued as planned. However, at the time of the unblinding of this study, topline results from Phase III studies for three oral COVID-19 therapeutics in at risk patients with mild-moderate COVID-19 disease had been announced: Fluvoxamine, molnupiravir, and paxlovid reduced the risk of hospitalization by approximately 30%, 50% (in the first public announcement) and 90%, respectively.19 As reported in our publication18, an informal survey of potential funding/commercialization partners for a follow-on program suggested it would be important to know the magnitude of possible benefit prior to initiating such an effort. Primarily for the above reasons, the study was terminated and unblinded early.

 

The results of the study were accepted for peer-reviewed publication in May 2022.21 For the primary endpoint, the proportion of patients not recovered on Day 14 was numerically decreased by 27% in the intent to treat population (8/45 v 10/42 not recovered in the Tafenoquine and placebo arms, P = 0.60) and 47% in the per protocol population (5/42 v 9/41, P = 0.25). Amongst individuals who recorded responses in an electronic diary on day 28, all Tafenoquine patients were recovered, whereas up to 12% of placebo patients exhibited lingering shortness of breath. Analysis of secondary/exploratory endpoints suggested Arakoda reduced time to clinical recovery from shortness of breath, cough and fever (P < 0.02) and numerically improved aggregate symptom scores five days after treatment (P < 0.1).22 The risk of COVID-19-related hospitalization was numerically reduced in the Arakoda arm (by approximately 50%; two instances for placebo versus one for Arakoda). Mild, drug related adverse events occurred in 8.4% of individuals in the Tafenoquine arm (v 2.4% in the placebo). We plan to confirm that Arakoda accelerates sustained recovery from COVID-19 symptoms in our next study (described in “Prospectus Summary—Strategy” beginning on page 4).

 

 

12 In 2014, we signed a cooperative research and development agreement with the United States Army Medical and Materiel Development Activity (Agreement W81XWH-14-0313). Under this agreement, we agreed to submit an NDA for Tafenoquine to the FDA (as Arakoda), while the US Army agreed to finance the bulk of the necessary development activities in support of that goal.

13 Zottig et al Military Medicine 2020; 185 (S1): 687.

14 Tan and Hwang Journal of Travel Medicine, 2018, 1–2; Baird Journal of Travel Medicine 2018:, 1–13; Schlagenhauf et al Travel Medicine and Infectious Disease 2022; 46:102268; See Arakoda prescribing information at www.arakoda.com; McCarthy et al CID 2019:69:480-486; Dow et al. Malar J (2015) 14:473; Dow et al. Malaria Journal 2014, 13:49; Novitt-Moreno et al Travel Med Infect Dis 2022 Jan-Feb;45:102211.

15 See prescribing information at www.arakoda.com.

16 See prescribing information at www.arakoda.com.

17 U.S. Patent application # 17/189,544, Dow et. al. bioRxiv 2020.07.12.199059; doi: https://doi.org/10.1101/2020.07.12.199059.

18 Financial support was obtained from Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (which may be referred to as “JPEO”) or JPEO via other transactional authority agreement #W911QY-21-9-0011.

19 Reis et al Lancet Global Health 2022;10:e42-51, Bernal et al New Eng J Med 2021; https://doi.org/10.1056/NEJMoa2116044; Pfizer Inc. Press release (November 5, 2021) – Pfizer’s novel COVID 19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of Phase 2/3 EPIC-HR study. Accessible at: Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study | Pfizer.

20 Dow and Smith, New Microbe and New Infect 2022; 47:100986.

21 Dow and Smith, New Microbe and New Infect 2022; 47:100986.

22 Dow and Smith, New Microbe and New Infect 2022; 47:100986.

 

 6 

 

  

In 2022, we conducted additional analyses of laboratory endpoint data from the clinical study described above and are preparing a manuscript for publication. That analysis and the scientific literature suggest two possible modes of action for Arakoda: (i) down-regulation of cytokines (immune system inflammatory proteins) associated with severe COVID-19 and a greater risk of hospitalization or death and/or (ii) inhibition of viral entry in the lung or elsewhere in the body, perhaps through inhibition of a host enzyme called TMPRSS2 (which facilitates entry of the virus that causes COVID-19, SARS-CoV-2, into human cells).

 

Assuming the efficacy of Tafenoquine in COVID-19 disease is proven in our next study, some of the features of the Arakoda regimen that make it ideal for malaria prophylaxis might also make it very useful for COVID-19 related indications. Tafenoquine is slowly metabolized and has few important drug-drug interactions, so it might be an ideal partner for standard of care oral COVID-19 therapeutics that reduce hospitalization but have no demonstrated effect on the time to clinical recovery in non-hospitalized patients. The Arakoda regimen requires fewer tablets (8 in the first ten days versus 30 or 40 for paxlovid and molnupiravir) which should make compliance with medication easier for patients. This is an important consideration in the attractiveness of a regimen in standard risk patients at lower risk of hospitalization, and who may be interested in taking a COVID-19 therapeutic primarily to treat early symptoms and accelerate recovery. The potential for better compliance may also suggest suitability for outbreak control in some settings (including, for example, nursing homes).

 

Tafenoquine for other infectious diseases

 

During the pandemic, we also worked with NIH to evaluate the utility of Tafenoquine as an antifungal. We, and the NIH, found that Tafenoquine exhibits a Broad Spectrum of Activity in cell culture against Candida and other yeast strains via a different Mode of Action than traditional antifungals and also exhibits antifungal activity against some fungal strains at clinically relevant doses in animal models.23 Our work followed Legacy Studies that show Tafenoquine is effective for treatment and prevention of Pneumocystis pneumonia in animal models.24 We believe that if added to the standard of care for anti-fungal and yeast infection treatments for general use, Tafenoquine has the potential to improve patient outcomes in terms of recovery from yeast infections, and prevention of fungal pneumonias in immunosuppressed patients. There are limited treatment options available for these indications, and Tafenoquine’s novel mechanism of action might also mitigate problems of resistance. Clinical trial(s) to prove safety and efficacy, and approval by the FDA and other regulators, would be required before Tafenoquine could be marketed for these indications.

 

Tafenoquine is effective in animal models of babesiosis (tick borne red blood cell infections). In two of three recent clinical case studies, Tafenoquine administered after failure of conventional antibiotics in immunosuppressed babesiosis patients resulted in cures.25 Consequently, we believe that (i) if combined with standard of care products, Tafenoquine has the potential to reduce the duration of treatment with antibiotic therapy in immunosuppressed patients and the time to parasite clearance in non-immunosuppressed patients and (ii) that once appropriate clinical studies have been conducted, it is likely that Tafenoquine would be quickly embraced for post-exposure prophylaxis of babesiosis in patients with tick bites and suspected of being co-infected with Lyme disease. Clinical trial(s) to prove safety and efficacy, and approval by FDA and other regulators, would be required before Tafenoquine could be marketed for these indications.

 

Celgosivir

 

Celgosivir is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C.26 The sponsors abandoned Celgosivir after completion of Phase II clinical trials involving 700+ patients, because other antivirals in development at the time had superior activity. The National University of Singapore initiated development of Celgosivir independently for Dengue fever. A clinical study, conducted in Singapore, and the results of which were accepted for publication in the peer-reviewed journal Lancet Infectious Diseases, confirmed its safety but the observed reduction in viral load was lower than what the study was powered to detect.27 Celgosivir (as with other Dengue antivirals) exhibits greater capacity to cure Dengue infections in animal models when administered prior to symptom onset compared to post-symptom onset. In animal models, this problem can be addressed for Celgosivir, by administering the same dose of drug split into four doses per day rather than two doses per day (as was the case in the Singaporean clinical trial).28 This observation led to the filing and approval of a patent related to Dengue, which we licensed from the National University of Singapore.

 

 

23 Dow and Smith, New Microbe and New Infect 2022; 45: 100964.

24 Queener et al Journal of Infectious Diseases 1992;165:764-8).

25 Liu et al. Antimicrobial Agents Chemo 2021;65:e00204-21, Marcos et al. IDCases 2022;27:e01460; Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:1015.

26 Sorbera et al, Drugs of the Future 2005; 30:545-552.

27 Low et. al., Lancet ID 2014; 14:706-715.

28 Watanabe et al, Antiviral Research 2016; 10:e19.

 

 7 

 

  

Additional clinical studies would be required to prove that such a 4x daily dosing regimen would be safe and effective in Dengue patients to regulators’ satisfaction. To that end, earlier in our history, we, in partnership with the National University of Singapore, and Singapore General Hospital, successfully secured a grant from the government of Singapore for a follow-on clinical trial, but were unable at that time to raise matching private sector funding. We concluded as a result that development of Repositioned Molecules for Dengue, solely and without simultaneous development for other therapeutic use, despite substantial morbidity and mortality in tropical countries, was an effort best suited for philanthropic entities. Accordingly, during the pandemic, we undertook an effort (in partnership with NIH’s Division of Microbiology and Infectious Diseases program and Florida State University) to determine whether Celgosivir might be more broadly useful for respiratory diseases that have impact in both tropical and temperate countries. Preliminary data suggest Celgosivir inhibits the replication of the virus that causes COVID-19 (SARS-CoV-2) in cell culture, and the RSV virus in cell culture and provides benefits in animals. We have filed and/or licensed patents in relation to Celgosivir for these other viruses as we believe there is potential applications to fight respiratory diseases that might have more commercial viability than historical development of Celgosivir to combat Dengue fever.

 

Competitive Strengths

 

Our main competitive strength has been our ability to achieve important clinical milestones inexpensively in therapeutic areas that other entities have found extremely challenging. With a small virtual management team, we have successfully built productive research partnerships with public and academic entities, and licensed products with well characterized safety profiles in prior clinical studies, thereby reducing the cost and risk of clinical development. This business and product model enabled Arakoda to be approved in 2018, with a total operating expense of < $10 million. We plan to focus in the future on generating proof of concept clinical data sets for the approved Arakoda regimen of Tafenoquine in other therapeutic areas, all of which is expected to foster and continue our existing tradition of inexpensive product development.

 

Strategy

 

Our general strategy is to demonstrate clinical proof of concept that the FDA-approved Arakoda regimen of Tafenoquine provides clinical benefits in non-malaria therapeutic areas. Our initial focus is on COVID-19, but additional indications have been identified for development, namely babesiosis and fungal infections, pending further data generation. Upon demonstration of clinical proof of concept, we plan to enter into a strategic partnership with a larger entity with commercialization capacity, or raise additional capital to facilitate commercialization of Arakoda, and any additional clinical studies that may be required by regulators, for both travel medicine and broad infectious disease indications. We will continue to develop our portfolio products as resources permit.

 

Beginning in the second half of 2023, we plan to execute a Phase IIB, randomized, placebo-controlled double blind clinical study powered (at 80%) to prove that the Arakoda regimen of Tafenoquine accelerates time to sustained clinical recovery in patients with mild-moderate disease with low risk for disease progression. This trial will utilize the bulk of proceeds raised in this offering. Based on an analysis of unpublished data from our earlier COVID-19 clinical trial,29 we believe that the Arakoda regimen of Tafenoquine has the potential to reduce the time to sustained clinical recovery by about three days (see Figure B, below). The study will be conducted in out-patient clinics in the United States. The study will utilize the majority of the proceeds of the offering reserved for research and development activities for this purpose. As of the date of this prospectus, we have completed a clinical study synopsis. Submission of the full protocol to the Ethics Committees and to U.S. regulators, and posting of the trial at clinicaltrials.gov will follow this initial public offering.

 

Figure B

 

 

 

Figure B: Survival curve for sustained clinical recovery in outpatients with mild-moderate COVID-19 disease randomized to receive Tafenoquine (Arakoda regimen) or placebo. Sustained clinical recovery was defined as the first instance of patient reported symptoms scores being < 3 for four or more days, with symptoms scores assessed according to FDA guidance.30 This analysis utilized unpublished data from our earlier Phase II clinical trial.31 The analysis excludes individuals hospitalized or loss to follow-up and with a symptom score on the days of dosing < 3. This analysis represents a post-hoc analysis of our Phase II clinical trial data. If this were a formal, pre-conceived primary study endpoint, the P value of 0.1209 would imply the associated difference between Tafenoquine (Arakoda regimen) and placebo has a 12.09% chance of occurring by chance.

 

 8 

 

 

We intend to design the study, subject to approval by the FDA and Ethics Committee(s) as appropriate, to include two interim endpoints to manage risk. The first will be an optional futility analysis at the earlier of 33% enrollment or six months following the first patient enrolled, which would allow early termination of the study if the conditional power of proving the intended hypothesis is < 20%. The second, mandatory interim analysis will occur at 75% enrollment and follow a step-wise (sponsor-blinded) process involving testing for futility, statistical significance, and sample-size reassessment if required. The test for statistical significance would allow early termination of the study if results are unexpectedly positive and the sample size reassessment would allow the study to enroll more patients within pre-specified limits if variability is more, and/or the magnitude of the expected treatment effect is less, than expected.

 

We plan to conduct additional non-clinical studies to clarify the process by which Tafenoquine alters the course of COVID-19 illness. Specifically, such studies will attempt to determine whether Tafenoquine acts as an immunomodulator (by decreasing the production of immune system molecules that cause inflammation) and/or exhibits an antiviral effect via inhibition of the host protease TMPRSS2. Antivirals are generally utilized earlier, and immunomodulators later, in treating patients with COVID-19 disease. However, the clinical hypothesis of our planned study will be that Arakoda accelerates clinical recovery by three days in individuals who have experienced symptoms for fewer than seven days, thereby confirming observations from our earlier clinical study (see Figure B). Since the potential clinical benefit is already known, the primary purpose of clarifying the manner in which Arakoda works is to (i) address anticipated regulatory questions and (ii) ascertain whether other indications, such as relief of COVID-19 symptoms during vaccination, treatment of long COVID-19 patients, or use during hospitalization, might be plausible.

 

Following completion of our planned COVID-19 clinical study, if warranted based on the data generated, we intend to request a change in prescribing information to facilitate an expansion of use of Arakoda for malaria prevention from six to twelve months (mirroring our recently published post-marketing safety study) and to include reference to the recently generated COVID-19 treatment data. Prior to doing so, we plan to discuss with the FDA additional labeling related to COVID-19 which might be acceptable.

 

We intend to design and conduct feasibility assessments for one or more additional studies in the same type of patients as the planned study and/or for a COVID 19-related indication different from that targeted by our clinical study in 2023. One of these additional studies would be conducted in Australia, and would be a requirement to secure tax rebates for the overall COVID-19 program (see next paragraph). A second study is likely to be required by regulators which may or may not be the same as the study conducted in Australia. The value of conducting additional studies, in addition to securing tax credits or for regulatory approvals, would be (i) independently confirming the therapeutic modality/clinical mode of action of Arakoda (i.e. that it accelerates clinical recovery from COVID-19 symptoms and/or acts as an antiviral or disease modulator) and (ii) broadening the COVID-19 indication beyond treatment of lower risk patients (i.e. potentially increasing the volume of annual prescriptions). Thus, possible study designs could be (i) a simple repetition of the planned study with a larger sample size, (ii) a treatment study in higher risk patients or (iii) a pre-treatment loading study in individuals known to be exposed to the virus that causes COVID-19, and/or (iv) amelioration of COVID-19 disease-like symptoms in individuals receiving mRNA COVID-19 vaccines (if it turns out Arakoda is an immunomodulator).

 

We plan to license ex-U.S. rights to COVID-19 indications to our Australian subsidiary, 60P Australia Pty Ltd. This will facilitate claiming the Australian government’s research tax credit for any of our COVID-19-related research activities conducted in Australia. 60P Australia has been successful in securing research tax credits for malaria and Dengue-related research since 2013. Since conducting our planned COVID-19 study in Australia is likely to be unfeasible and must be conducted in the U.S., we plan to apply for an overseas finding to the Australian Tax Office in the second quarter of 2023 to request an overseas finding for the U.S. study. Should such a finding be awarded, it would allow a tax rebate of 43.5% on research and development costs associated with the planned U.S. COVID-19 study to be claimed, but commit the Company to conduct COVID-19 research activities in Australia of a value at least as much as the cost of the planned U.S. clinical study.

 

 

29 Dow and Smith, New Microbe and New Infect 2022; 45: 100964.

30 FDA 2020 Guidance on Assessing COVID-19 Symptoms-14 Common COVID-19 Symptoms Severity Scale.

31 Dow and Smith, New Microbe and New Infect 2022; 45: 100964.

 

 9 

 

  

We are planning several commercial initiatives for the malaria market in parallel with further clinical development activities. Three routes exist for commercialization of Arakoda for the malaria prevention market are: (i) U.S. civilian travel clinics, travel prescribing centers, and large private sector entities with employees deployed overseas (e.g., mining companies), (ii) the prospect of additional U.S. Department of Defense (“DoD”) and government agency procurement in the future (noting that as described on page 60 our existing contract with DoD has been fulfilled and has not been extended or modified) and (iii) ex U.S. sales strategy where we currently (or in the future) have exclusive distribution arrangements in overseas markets.

 

As of the date of this prospectus, we did not have plans to hire a U.S. field sales force, but are exploring possible commercial arrangements with contract sales organizations to target U.S. travel clinics for malaria prophylaxis. We may consummate a contract with a lobbying firm/contract sales organization to attempt to improve the position of Arakoda in the DoD formulary and to raise awareness of Arakoda amongst other U.S. government agencies. For such agencies, the product is expected to meet many of the requirements for occupational malaria prevention identified by the independent parties that have endorsed the product. We have been successful in securing procurement contracts with U.S. government agencies for Arakoda, and anticipate continued success in the future. In the third quarter of 2022, we made our first sale to our European distributor, and made additional sales to our Australian distributor in the second quarter of 2022. We are actively exploring the possibility of named-patient sales in jurisdictions outside Australia, Europe, and the United States. We plan to undertake a focused marketing campaign for Arakoda for malaria prevention in the second half of 2023. This will consist of promotion at relevant conferences, email promotion to prescribers, and target print and electronic advertisements.

 

It is expected that a point of care G6PD test might be required to maximize the economic potential of a COVID-19 indication for Tafenoquine (regardless of regimen). We do not intend to pursue independent development of such a test as there are well resourced development efforts already underway (see “Risk Factors—Any future clinical trial for Arakoda will require screening for G6PD deficiency in order to safely administer the product. In the United States, G6PD testing can obtained through commercial pathology services which is associated with delays. The use of a third-party diagnostic provider of point of care testing may be required and we may not directly control the timing, conduct and expense of such testing” beginning on page 18). However, we will continue to monitor the progress of development and U.S. commercialization of G6PD tests. We will seek to pursue collaborative commercial partnerships with the companies involved in commercialization efforts, if such activities can be conducted through resource sharing efforts.

 

We plan to generate additional validation data for our portfolio products if resources permit. Specifically, we will evaluate whether Celgosivir provides therapeutic benefit in a COVID-19 animal model, and complete critical activities related to confirming GMP process feasibility.

 

We may elect, as resources permit, to undertake a clinical study of Tafenoquine in combination with standard of care for hospitalized patients with babesiosis. We have developed such a protocol concept in partnership with academic collaborators and are planning to submit an investigational new drug application (“IND”) to the FDA and pursue public and philanthropic funding to support our execution. We plan to seek public funding to support additional non-clinical studies to validate the mechanism of action of Tafenoquine against Candida spp. and further assess our utility in combination with standard of care agents in cell culture and animal studies.

 

Most new antimalarial treatment products are developed as drug combinations to proactively combat drug resistance. Tafenoquine, due to its long half-life and activity against all parasite species and strains, would be ideal partner in a drug combination. In the second half of 2023, we will actively seek out a potential partner antimalarial drug for Arakoda, with the goal of pursuing licensure of a new drug combination. We will only enter into a partnership to develop such a drug combination, if clear legal guidance can be obtained that such a combination if developed would have a high probability of securing a priority review voucher upon FDA approval.

 

There are currently efforts underway, in malaria-endemic countries outside the U.S., to generate datasets supporting the use of Tafenoquine for mass drug administration in asymptomatic individuals to prevent malaria transmission. We believe that such efforts are important to promote community acceptance of Tafenoquine and may eventually support World Health Organization pre-qualification of Tafenoquine for malaria eradication efforts. To that end, we intend to support, on a case-by-case basis, clinical studies sponsored by others, by providing commercial Arakoda and/or Kodatef for research use (provided such product would not otherwise have been commercially salable, and the study sponsor covers shipping costs). We have previously provided Tafenoquine for such efforts on a limited basis.

 

We have a post-marketing requirement to conduct a malaria prophylaxis study of Arakoda in pediatric and adolescent subjects. We proposed to the FDA, in late 2021, that this might not be safe to execute given that malaria prevention is administered to asymptomatic individuals and that methemoglobinemia (damage to the hemoglobin in blood that carries oxygen) occurred in 5% of patients, and exceeded a level of 10% in 3% of individuals in a study conducted by another sponsor in pediatric subjects with symptomatic vivax malaria.32 The FDA has asked us to propose an alternate design, for which we submitted a concept protocol in the fourth quarter of 2022, and plan to submit a full protocol by the end of the second quarter of 2023. We estimate the cost of conducting the study proposed by the FDA, if conducted in the manner suggested by the FDA, would be $2 million, and, due to the time periods required to secure protocol approvals from the FDA and Ethics Committees, could not be initiated any earlier than the third quarter of 2024. The funds from this offering to be expended on such a pediatric study will be limited to the minimum required to support protocol preparation and regulatory interactions with the FDA.

 

 

32 Velez et al 2021 - Lancet Child Adolesc Health 2022; 6: 86–95.

 

 10 

 

 

Intellectual Property 

 

We are co-owners, with the U.S. Army, of patents in the United States and certain foreign jurisdictions directed toward use of Tafenoquine for malaria and have obtained an exclusive worldwide license from the U.S. Army to practice these inventions. We also have an exclusive worldwide license to use manufacturing information and non-clinical and clinical data that the U.S. Army possesses relating to use of Tafenoquine for all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria. We have submitted patent applications in the United States and certain foreign jurisdictions for use of Tafenoquine for COVID-19, fungal lung infections, tick-borne diseases, and other infectious and non-infectious diseases in which induction of host cytokines/inflammation is a component of the disease process. The United States Patent and Trademark Office (“USPTO”) recently allowed our first COVID-19 patent for Tafenoquine. We have optioned or licensed patents involving Celgosivir for the treatment and prevention of Dengue (from the National University of Singapore), COVID-19 & Zika (Florida State University), and have submitted provisional patent applications related to Celgosivir for RSV. We have optioned or own manufacturing methods related to Celgosivir. A detailed list of our intellectual property is as follows:

 

Patents

 

Title   Patent No.   Country   Status   US Patent Date   Application No.   Estimated/
Anticipated
Expiration
Date
 
Dosing Regimen For Use Of Celgosivir As An Antiviral Therapeutic For Dengue Virus Infections   2013203400   Australia           2013203400+   10-April-2033*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   2014228035   Australia           2014228035   14-Mar-2034*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   MY-170991-A   Malaysia           PI2015002372   14-Mar-2034*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   378015   Mexico           MX/a/2015/013115   14-Mar-2034*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   11201507254V   Singapore           11201507254V   14-Mar-2034*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   Pending   Singapore   Pending       10201908089V   14-Mar-2034*  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   9763921   US       9/19/2017   14/772,873   14-Mar-2034^  
Novel Dosing Regimens Of Celgosivir For The Treatment Of Dengue   10517854   US       12/31/2019   15/706,845   14-Mar-2034^  
Dosing Regimens Of Celgosivir For The Treatment Of Dengue   11219616   US       1/11/2022   16/725,387   14-Mar-2034^  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   2015358566   Australia           2015358566   02-Dec-2035*  
Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   Pending   Canada   Pending       2968694   02-Dec-2035*  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   10342791   US       7/9/2019   15/532,280   02-Dec-2035^  
Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naive Subjects   10888558   US       1/12/2021   16/504,533   02-Dec-2035^  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   Pending   Singapore   Pending       10201904908Q   02-Dec-2035*  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   Pending   EP   Pending       15865264.4   02-Dec-2035*  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   Pending   Hong Kong   Pending       18103081.4   02-Dec-2035*  
Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naive Subjects   Pending   US   Pending       17/145,530   02-Dec-2035^  
Novel Regimens Of Tafenoquine For Prevention Of Malaria In Malaria-Naïve Subjects   Pending   New Zealand   Pending       731813   02-Dec-2035*  
Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue   2016368580   Australia           2016368580   09-Dec-2036*  
Novel Dosing Regimens Of Celgosivir For The Prevention Of Dengue   Pending   Singapore   Pending       10201912141Y   09-Dec-2036*  
Dosing Regimens Of Celgosivir For The Prevention Of Dengue   11000516   US        5/11/2011   16/060,945   09-Dec-2036^  
Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine   Pending   EP   Pending       21764438.4   02-Mar-2041*  
Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine   Pending   China   Pending        202180029643.7   02-Mar-2041*  
Methods For The Treatment And Prevention Of Lung Infections By Administration Of Tafenoquine   Pending   Australia   Pending       2021231743   02-Mar-2041*  
Methods For The Treatment And Prevention Of Lung Infections Caused By Gram-Positive Bacteria, Fungus, Or Virus By Administration Of Tafenoquine   Pending   US   Pending       17/189,544   02-Mar-2041^  
Methods For The Treatment And Prevention Of Lung Infections Caused By Fungus By Administration Of Tafenoquine   Pending   US   Pending       17/683,679   02-Mar-2041^  
Methods For The Treatment And Prevention Of Lung Infections Caused By Sars-Cov-2 Virus By Administration Of Tafenoquine   Pending   US   Pending       17/683,718   02-Mar-2041^  
Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors   11369592   US        6/28/2022   17/180,140#   19-Feb-2041^  
Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors   Pending   US   Pending       17/664,693#   19-Feb-2041^  
Treatment Of Human Coronavirus Infections Using Alpha-Glucosidase Glycoprotein Processing Inhibitors   Pending   EP   Pending       2021757552#   19-Feb-2041*  
Methods For The Treatment And Prevention Of Non-Viral Tick-Borne Diseases And Symptoms Thereof   Provisional   US   Provisional       63/461,060   ~21-Apr-2044&  
Methods To Treat Respiratory Infection Utilizing Castanospermine Analogs   Provisional   US   Provisional       63/358,341   ~05-Jul-2043&  
Methods For The Treatment And Prevention Of Diseases Or Infections With Mcp-1 Involvement By Administration Of Tafenoquine   Provisional   US   Provisional       63/411,654   ~30-Sep-2043&  
Treatment Of Zika Virus Infections Using Alpha Glucosidase Inhibitors   10,328,061+   US        6-25-2019   15/584,952+   2-May-37  
Treatment Of Zika Virus Infections Using Alpha Glucosidase Inhibitors   10,561,642+   US        2-18-2020   15/856,377+   2-May-37  

 

* =For foreign patents and applications, the estimated and/or anticipated patent expiration is the date that is twenty years from the PCT filing date. For all issued Australian patents, this estimated date was also confirmed through the Australian patent office web database.
   
^ = For issued U.S. patents, the estimated patent expiration was calculated using information from the front cover of the patent, i.e., 20 years from the date of the nonprovisional filing plus any listed Patent Term Adjustment less any time disclaimed through a Terminal Disclaimer. For pending U.S. applications, the anticipated patent expiration is the date twenty years from the earliest nonprovisional filing date and does not account for possible Patent Term Adjustment (PTA), Patent Term Extension (PTE), or Terminal Disclaimers.
   
& =For U.S. provisional applications that are not yet the subject of a nonprovisional or PCT application, the anticipated patent expiration was determined using the assumption that a non-provisional application or PCT will be filed one year after filing the provisional application with a term lasting twenty years from the date of that nonprovisional or PCT filing. This does not account for possible Patent Term Adjustment (PTA), Patent Term Extension (PTE), or Terminal Disclaimers.
   
+ = 60 Degrees Pharmaceuticals, Inc. is not a listed Applicant and Geoffrey S. Dow, Ph.D. is not a listed inventor.
   
# =60 Degrees Pharmaceuticals, Inc. is not a listed Applicant, but Geoffrey S. Dow, Ph.D. is a listed inventor.

 

All patents not designated with a “+” list Geoffrey S. Dow, Ph.D. as an inventor.

All patents not designated with a “+” or a “#” list 60 Degrees Pharmaceuticals, Inc. as an applicant.

All estimated patent expiration dates and anticipated patent expiration assume payment of any maintenance/annuity fees during the patent term.

 

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Trademarks

 

Country   Mark   Status   Application Number   Date Filed   Registration Date   Registration Number   BIR Ref Number   Due Date   Due Date Description
Australia   KODATEF   Registered   1774631   2-Jun-16   6/2/2016   1774631   0081716-000029   2-Jun-26   Renewal Due
                                     
Canada   KODATEF   Registered   1785098   1-Jun-16   11/26/2019   TMA1,064,371   0081716-000028   26-Nov-29   Renewal Due
Canada   ARAKODA   Registered   1899317   15-May-18   8/20/2020   TMA1,081,180   0081716-000053   20-Aug-30   Renewal Due
                                     
China   KODATEF   Registered   20842242   2-Aug-16   9/28/2017   20842242   0081716-000035   27-Sep-27   Renewal Due
                                     
European Union   KODATEF   Registered   15508872   3-Jun-16   9/21/2016   15508872   0081716-000034   3-Jun-26   Renewal Due
European Union   ARAKODA   Registered   17900852   16-May-18   9/20/2018   17900852   0081716-000054   16-May-28   Renewal Due
                                     
Israel   KODATEF   Registered   285476   6-Jun-16   6/6/2016   285476   0081716-000033   6-Jun-26   Renewal Due
                                     
New Zealand   KODATEF   Registered   1044407   7-Jun-16   12/8/2016   1044407   0081716-000031   6-May-26   Renewal Due
                                     
Russian Federation   KODATEF   Registered   2016720181   6-Jun-16   7/10/2017   623174   0081716-000032   6-Jun-26   Renewal Due
                                     
Singapore   KODATEF   Registered   40201707950V   2-May-17   11/8/2017   40201707950V   0081716-000040   2-May-27   Renewal Due
                                     
United Kingdom   ARAKODA   Registered   17900852   16-May-18   9/20/2018   UK00917900852   0081716-000054   16-May-28   Renewal Due
United Kingdom   KODATEF   Registered   15508872   3-Jun-16   9/21/2016   UK009015508872   0081716-000072   3-Jun-26   Renewal Due
                                     
United States of America   TQ 100 & TABLET DESIGN   Registered   87608493   14-Sep-17   9/11/2018   5562900   0081716-000037   11-Sep-24   Section 8 & 15 Due
United States of America   ARAKODA   Registered   87688137   16-Nov-17   12/31/2019   5950691   0081716-000050   31-Dec-25   Section 8 & 15 Due
United States of America   KODATEF   Allowed -  02/16/2021   90072885   24-Jul-20           0081716-000069   16-Aug-23   Statement of Use/3rd Extension of Time Due

 

Key Relationships & Licenses

 

On May 30, 2014, we entered into the Exclusive License Agreement (the “2014 NUS-SHS Agreement”) with National University of Singapore (“NUS”) and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Dosing Regimen for Use of Celgosivir as an Antiviral Therapeutic for Dengue Virus Infection” to develop, market and sell licensed products. The 2014 NUS-SHS Agreement continues in force until the expiration of the last to expire of any patents under the patent rights unless terminated earlier in accordance with the 2014 NUS-SHS Agreement. We are obligated to pay at the rate of 1.5% of gross sales.

 

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On July 15, 2015, we entered into the Exclusive License Agreement with the U.S. Army Medical Materiel Development Activity (the “U.S. Army”), which was subsequently amended (the “U.S. Army Agreement”), in which we obtained a license to develop and commercialize the licensed technology with respect to all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria. This exclusion does not impact our ability to market Arakoda for the FDA-approved use, which is the prevention of malaria utilizing the indicated dose in asymptomatic individuals traveling to high-malaria or malaria-prone regions (whereas the license exclusion relates to its use to treat symptomatic vivax malaria in a patient already presenting with that disease). The term of the U.S. Army Agreement will continue until the expiration of the last to expire of the patent application or valid claim of the licensed technology, or 20 years from the start date of the U.S. Army Agreement, unless terminated earlier by the parties. We will be required to make a minimum annual royalty payment of 3% of net sales for net sales < $35 million, and 5% of net sales greater than $35 million, with US government sales excluded from the definition of net sales. In addition, we must pay a milestone fee of $75,000 once cumulative net sales from all sources exceeds $6 million, $100,000 if we are acquired or merge, and regulatory approval milestone payments once marketing authorizations are achieved in Canada ($5,000) and Europe ($5,000). Also, we will be required to obtain the U.S. Army Medical Materiel Development Activity’s consent prior to a change of control of the Company, which consent was obtained on September 2, 2022.

 

On September 15, 2016, we entered into the Exclusive License Agreement (the “2016 NUS-SHS Agreement”) with National University of Singapore and Singapore Health Services Pte Ltd (“SHS”) in which we were granted a license from NUS and SHS with respect to their share of patent rights regarding “Novel Dosing Regimens of Celgosivir for The Prevention of Dengue” to develop, market and sell licensed products. The 2016 NUS-SHS Agreement continues in force until the expiration of the last to expire of any patents under the patent rights unless terminated earlier in accordance with the 2016 NUS-SHS Agreement. We are obligated to pay at the rate of 1.5% of gross sales or minimum annual royalty ($5,000 in 2022 and $15,000 in 2023). In July 2022, we renegotiated the timing of a license fee of $85,000 Singapore Dollars, payable to NUS, such that payment would be due at the earlier of (i) enrollment of a patient in a Phase II clinical trial involving Celgosivir, (ii) two years from the agreement date and (iii) an initial public offering.

 

On December 4, 2020, we entered into the Other Transaction Authority for Prototype Agreement (“OTAP Agreement”) with the Natick Contracting Division of the U.S. government in which we will, among other things, conduct activities for a Phase II clinical trial to assess the safety and efficacy of Tafenoquine for the treatment of mild to moderate COVID-19 disease, with the goal of delivering Tafenoquine with an FDA Emergency Use Authorization (“EUA”) approved as a countermeasure against COVID-19. The total amount of the OTAP Agreement is $4,999,814. The term of the OTAP Agreement commences on December 4, 2020 and was completed in the third quarter of 2022. Pursuant to the OTAP Agreement, we will not offer, sell or otherwise provide the EUA or licensed version of the prototype (Tafenoquine) that is FDA approved for COVID-19 or any like product to any entity at a price lower than that offered to the DoD, which applies only to products sold in the U.S., European Union and Canada related to COVID-19.

 

On February 15, 2021, we entered into the Inter-Institutional Agreement (the “FSURF Agreement”) with the Florida State University Research Foundation (“FSURF”) in which FUSRF granted us the right to manage the licensing of intellectual property created at FSURF. The term of the FSURF Agreement expires five years from February 15, 2021. After deduction of a 5% administrative fee by FSURF, capped at $15,000 annually, and reimbursement of patent prosecution expenses, we will receive 20% of license income and FSURF will receive 80% of license income. Payments of license income shall be paid in U.S. dollars quarterly each year. On February 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, that collectively granted an option, effective through August 19, 2023, to us to license methods for purifying castanospermine and its use for the treatment of COVID-19. On August 19, 2021, we entered into an agreement with FSURF, subsequently amended on February 15, 2023, that collectively granted an option, effective through August 19, 2023, to us to license a patent relating to the use of alpha glucosidase inhibitors (including castanospermine and Celgosivir) for treatment of Zika infections.

 

Pursuant to the Knight Debt Conversion Agreement, for a period commencing on January 1, 2022 and ending upon the earlier of ten years after the closing date of this offering or the conversion or redemption in full of all of the shares of Series A Preferred Stock owned by Knight, we will pay Knight a royalty equal to 3.5% of our net sales, where “net sales” has the same meaning as in our license agreement with the U.S. Army for Tafenoquine. Upon closing the qualified initial public offering (“IPO”), at the end of the first quarter (or portion thereof) and each subsequent quarter thereafter the royalty will be calculated, and payment will be made within fifteen days.

 

Corporate Structure

 

60 Degrees Pharmaceuticals, Inc. is a Delaware corporation that was incorporated on June 1, 2022.

 

On June 1, 2022, 60 Degrees Pharmaceuticals, LLC, a District of Columbia limited liability company (“60P LLC”), entered into the Agreement and Plan of Merger with 60 Degrees Pharmaceuticals, Inc., pursuant to which 60P LLC merged into 60 Degrees Pharmaceuticals, Inc. The value of each outstanding member’s membership interest in 60P LLC was correspondingly converted into common stock of 60 Degrees Pharmaceuticals, Inc., par value $0.0001 per share, with a cost-basis equal to $5.00 per share.

 

Our majority-owned subsidiary, 60P Australia Pty Ltd, an Australian proprietary company limited by shares (“60P Australia”), was formed and registered in Queensland on December 3, 2013, and conducts operations in Australia.

 

60P Australia previously solely owned a Singaporean subsidiary company, 60P Singapore Pte. Ltd., which dissolved at our election in the second quarter of 2022.

 

Going Concern

 

Our independent auditors have issued a report raising substantial doubt of our ability to continue as a going concern. We anticipate that we will require additional capital to continue as a going concern and expand our operations in accordance with our current business plan.

 

Suppliers

 

We have quality and contract manufacturing agreements relating to Arakoda in place with Piramal Enterprises Limited (API, tablets) and PCI Pharma Services (secondary packaging) (“PCI”) and supply/quality/pharmacovigilance agreements in place with Biocelect Pty Ltd, Scandinavian Biopharma, and Knight Therapeutics Inc. (to allow supply of Arakoda/Kodatef to Australia, Europe and Canada/Israel/Latin America and Russia, respectively). As of the date of this prospectus, we have not supplied any of our products to Russia nor do we anticipate supplying any of our products to Russia in the near future.

 

Recent Developments

 

Effects of COVID-19 Outbreak. In December 2019, a novel strain of coronavirus was reported to have surfaced in Wuhan, China, which has and is continuing to spread throughout China and other parts of the world, including the United States. On January 30, 2020, the World Health Organization declared the outbreak of COVID-19 a “Public Health Emergency of International Concern.” On January 31, 2020, U.S. Health and Human Services Secretary Alex M. Azar II declared a public health emergency for the United States to aid the U.S. healthcare community in responding to COVID-19, and on March 11, 2020, the World Health Organization characterized the outbreak as a “pandemic.” A significant outbreak of COVID-19 and other infectious diseases could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide.

 

We are monitoring the global outbreak and spread of COVID-19 and taking steps in an effort to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and the governmental and community reactions thereto. The current outbreak of COVID-19 has globally resulted in loss of life, business closures, restrictions on travel, and widespread cancellation of social gatherings. The extent to which the COVID-19 pandemic impacts our business will depend on future developments, which are highly uncertain and cannot be predicted at this time, including:

 

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new information which may emerge concerning the severity of the disease;

 

the duration and spread of the outbreak;

 

the severity of travel restrictions imposed by geographic areas in which we operate, mandatory or voluntary business closures;

 

regulatory actions taken in response to the pandemic, which may impact our product offerings;

 

other business disruptions that affect our workforce and supply chain;

 

the impact on capital and financial markets; and

 

actions taken throughout the world, including in markets in which we operate, to contain the COVID-19 outbreak or treat its impact.

 

In addition, the current outbreak of COVID-19 has resulted in a widespread global health crisis and adversely affected global economies and financial markets, and similar public health threats could do so in the future. Such events have impacted, and could in the future impact, demand for our products, which in turn could adversely affect our revenue and results of operations.

 

The spread of COVID-19 has caused us to modify our business practices, including employee travel, employee work locations in certain cases, and cancellation of physical participation in certain meetings, events and conferences and further actions may be taken as required or recommended by government authorities or as we determine are in the best interests of our employees, customers and other business partners. We are monitoring the global outbreak of the pandemic and are taking steps in an effort to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and the governmental and community reactions thereto. See “Risk Factors—Our financial condition and results of operations may be adversely affected by the COVID-19 pandemic.”

 

2023 Financings

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Cyberbahn Federal Solutions, LLC with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Cyberbahn Federal Solutions, LLC shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Ariana Bakery Inc with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Ariana Bakery Inc shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $333,333.30 to Sabby Volatility Warrant Master Fund, Ltd. with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Sabby Volatility Warrant Master Fund, Ltd. shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $55,555.55 to Steel Anderson with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Steel Anderson shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Bixi Gao & Ling Ling Wang with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Bixi Gao & Ling Ling Wang shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

Our Resale Offering

 

Certain of our stockholders will be selling through the Resale Prospectus a total of 2,224,763 shares of common stock, consisting of (i) 10,482 shares of common stock to be issued upon conversion of a convertible note immediately prior to the consummation of the initial public offering, (ii) 373,426 shares of common stock to be issued in conjunction with the conversion or extinguishment of interim financing notes on the date of the effectiveness of the registration statement of which this prospectus forms a part, (iii) 1,608,938 shares of common stock held by certain of the Selling Stockholders and (iv) 231,917 shares of common stock issuable upon the exercise of warrants that are to be issued on the date of effectiveness of the registration statement of which the Resale Prospectus forms a part. We will not receive any proceeds from the sales by the Selling Stockholders of the securities set forth in the Resale Prospectus.

 

The Resale Prospectus is substantively identical to the Public Offering Prospectus, except for the following principal points:

 

they contain different outside and inside front covers and back covers;

 

they contain different “Offering” sections in the “Prospectus Summary” section beginning on page Alt-1;

 

they contain different “Use of Proceeds” sections on page Alt-16;

 

the “Capitalization” and “Dilution” sections from the Public Offering Prospectus are deleted from the Resale Prospectus;

 

a “Selling Stockholders” section is included in the Resale Prospectus;

 

the “Underwriting” section from the Public Offering Prospectus is deleted from the Resale Prospectus and a “Selling Stockholder Plan of Distribution” is inserted in its place in the Resale Prospectus; and

 

the “Legal Matters” section in the Resale Prospectus on page Alt-19 deletes the reference to counsel for the underwriters.

 

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Summary Risk Factors

 

Our business is subject to a number of risks. You should be aware of these risks before making an investment decision. These risks are discussed more fully in the section of this prospectus titled “Risk Factors,” which begins on page 18 of this prospectus. These risks include, among others, that:

 

Our financial statements have been prepared on a going-concern basis and our continued operations are in doubt;

  

We have incurred net losses since our inception and if we continue to incur net losses in the foreseeable future, the market price of our common stock may decline;

 

There is no assurance that we will be profitable;

 

 

There is no assurance that we will be eligible for Australian government research and development tax rebates;

 

Our financial condition and results of operations may be adversely affected by the COVID-19 pandemic;

 

If we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for Tafenoquine (Arakoda or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations;

 

Our clinical trials for our product candidates may not yield results that will enable us to further develop our products and obtain regulatory approvals necessary to sell them;

  

The mechanisms of actions of some of our products, and interactions with other antiviral products are not known, which may restrict regulatory label claims;

 

We expect to depend on existing and future collaborations with third parties for the development of some of our product candidates. If those collaborations are not successful, we may not be able to complete the development of these product candidates;

 

Even if one of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable;

 

Any future clinical trial for Arakoda will require screening for G6PD deficiency in order to safely administer the product. In the United States, G6PD testing can obtained through commercial pathology services which is associated with delays. The use of a third-party diagnostic provider of point of care testing may be required and we do not directly control the timing, conduct, expense of such testing or the timing of market entry into the US;

 

Our product candidates are subject to extensive regulation, which can be costly and time-consuming, and unsuccessful or delayed regulatory approvals could increase our future development costs or impair our future revenue;

 

If our product candidates receive regulatory approval, we would be subject to ongoing regulatory obligations and restrictions, which will continue to change, and which may result in significant expenses and limit our ability to develop and commercialize other potential products;

 

We have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market;

 

We rely on relationships with third-party contract manufacturers and raw material suppliers, which limits our ability to control the availability of, and manufacturing costs for, our product candidates;

 

Our future growth depends on our ability to successfully commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and our other product candidates, and we can provide no assurance that we will successfully commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and other product candidates;

 

Health care reform measures could materially and adversely affect our business;

 

Our competitors may be better positioned in the marketplace and thereby may be more successful than us at developing, manufacturing and marketing approved products;

 

We compete in an industry characterized by extensive research and development efforts and rapid technological progress. New discoveries or commercial developments by our competitors could render our potential products obsolete or non-competitive;

 

We would be subject to applicable regulatory approval requirements of the foreign countries in which we market our products, which are costly and may prevent or delay us from marketing our products in those countries;

 

Defending against claims relating to improper handling, storage or disposal of hazardous chemicals, radioactive or biological materials could be time consuming and expensive;

 

Geopolitical conditions, including direct or indirect acts of war or terrorism could have an adverse effect on our operations and financial results;

 

If product liability lawsuits are successfully brought against us, then we will incur substantial liabilities and may be required to limit commercialization of Arakoda, Celgosivir or other product candidates;

 

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Our intellectual property rights may not preclude competitors from developing competing products and our business may suffer;

 

If the manufacture, use or sale of our products infringe on the intellectual property rights of others, we could face costly litigation, which could cause us to pay substantial damages or licensing fees and limit our ability to sell some or all of our products;

 

We may not be able to protect our intellectual property rights throughout the world;

 

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time;
   
 

The earliest Paragraph IV certification date for Arakoda has passed. Generic companies may file an ANDA at any time, and successful challenge of our malaria use patents would negatively impact our business;

 

There has been no public market for our common stock prior to this offering, and we cannot assure you that an active trading market will develop in the near future. An active market in which investors can resell their shares may not develop. If there is no viable public market for our common stock, you may be unable to sell your shares at or above the initial public offering price;

 

We may not be able to satisfy listing requirements of Nasdaq to maintain a listing of our common stock or Tradeable Warrants;

 

There is no public market for the Non-tradeable Warrants being offered in this offering;

 

The warrants may have an adverse effect on the market price of our common stock and make it more difficult to effect a business combination;

 

Any failure to maintain effective internal controls over financial reporting could have an adverse impact on us; and

 

We are an “emerging growth company” and a “smaller reporting company” under the JOBS Act, and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

 

Information Regarding our Capitalization

 

As of July 10, 2023, we had 2,378,009 shares of common stock issued and outstanding. Additional information regarding our issued and outstanding securities may be found under “Market for Common Equity and Related Stockholder Matters” and “Description of Securities.”

 

Unless otherwise specifically stated, information throughout this prospectus does not assume the exercise of outstanding options or warrants to purchase shares of our common stock.

 

Corporate Information

 

Our principal executive offices are located at 1025 Connecticut Avenue NW Suite 1000, Washington, D.C. 20036. Our corporate website address is 60degreespharma.com. Our telephone number is (202) 327-5422. The information included on our website is not part of this prospectus.

 

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

 

We are an “emerging growth company,” as defined in the JOBS Act. We will remain an emerging growth company until the earlier of (i) the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act; (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under applicable SEC rules. We expect that we will remain an emerging growth company for the foreseeable future, but cannot retain our emerging growth company status indefinitely and will no longer qualify as an emerging growth company on or before the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from specified disclosure requirements that are applicable to other public companies that are not emerging growth companies.

 

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These exemptions include:

 

being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

 

not being required to comply with the requirement of auditor attestation of our internal controls over financial reporting;

 

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

 

reduced disclosure obligations regarding executive compensation; and

 

not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

 

An emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act to comply with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period and, as a result, we will not be required to adopt new or revised accounting standards on the dates on which adoption of such standards is required for other public reporting companies.

 

We are also a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies. We will remain a smaller reporting company until the end of the fiscal year in which (1) we have a public common equity float of more than $250 million, or (2) we have annual revenues for the most recently completed fiscal year of more than $100 million and a public common equity float or public float of more than $700 million. We also would not be eligible for status as a smaller reporting company if we become an investment company, an asset-backed issuer or a majority-owned subsidiary of a parent company that is not a smaller reporting company.

 

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different from what you might receive from other public reporting companies in which you hold equity interests.

 

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SUMMARY OF THE OFFERING

 

Issuer 60 Degrees Pharmaceuticals, Inc.
   
Units offered by us

1,415,095 Units, each Unit consisting of one share of common stock, one Tradeable Warrant to purchase one share of common stock and one Non-tradeable Warrant to purchase one share of common stock.

 

The Units will not be certificated or issued in stand-alone form. The shares of our common stock and the warrants comprising the Units are immediately separable upon issuance and will be issued separately in this offering.

   
Common stock outstanding
prior to the offering(1)
2,378,009 shares
   
Common stock to be outstanding
after the offering(2)(3)

5,569,528 shares (5,781,793 shares if the underwriters exercise their option to purchase additional shares in full).

   
Over-allotment option

We have granted the underwriters a 45-day option to purchase up to an aggregate of 212,265 additional shares of common stock and/or 212,265 Tradeable Warrants and/or 212,265 Non-tradeable Warrants at the public offering price per share of common stock and per warrant, respectively, less, in each case, underwriting discounts and commissions, on the same terms as set forth in this prospectus, solely to cover over-allotments, if any.

   
Description of the Warrants

The Tradeable Warrants will be exercisable from the date of issuance until the fifth anniversary date of issuance date for $4.945 and $7.245 per share (115% of the public offering price of one Unit), subject to adjustment in the event of stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting our common stock as described herein.

 

The Non-tradeable Warrants will be exercisable from the date of issuance until the fifth anniversary date of issuance date for $5.16 and $7.56 per share (120% of the public offering price of one Unit), subject to adjustment in the event of stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting our common stock as described herein.

 

A holder may not exercise any portion of a warrant to the extent that the holder, together with its affiliates and any other person or entity acting as a group, would own more than 4.99% of the outstanding common stock after exercise, as such percentage ownership is determined in accordance with the terms of the warrants, except that upon notice from the holder to us, the holder may waive such limitation up to a percentage, not in excess of 9.99%.

 

The terms of the warrants will be governed by the Warrant Agent Agreement. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants. See “Description of Securities–Warrants.”

   
Use of Proceeds The principal purposes of this offering are to fund the development of new indications for our products with a focus on executing a COVID-19 clinical trial involving Arakoda, to repay debt associated with prior financing, increase our capitalization and financial flexibility, increase our visibility in the marketplace and create a public market for our common stock. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. However, we currently intend to use the net proceeds to us from this offering for debt repayment and research and general corporate purposes, including working capital. See “Use of Proceeds” beginning on page 54.
   
Proposed Listing

Our common stock and Tradeable Warrants have been approved for listing on The Nasdaq Capital Market under the symbols “SXTP” and “SXTPW,” respectively. We do not intend to apply for listing of the Non-tradeable Warrants on any exchange or market.

   
Representative Warrants Upon the closing of this offering, we have agreed to issue to the Representative, warrants that will expire on the fifth anniversary of the commencement date of sales in this offering, entitling the Representative to purchase 6% of the number of shares of common stock sold in this offering. The registration statement of which this prospectus is a part also covers the Representative Warrants and the shares of common stock issuable upon the exercise thereof. For additional information regarding our arrangement with the underwriters, please see “Underwriting.”
   
Lock-up agreements Our executive officers and directors have agreed with the underwriters not to sell, transfer or dispose of any shares or similar securities for six months following the effective date of the registration statement for this offering without the prior written consent of WallachBeth Capital LLC. Any other holders of more than 5% of the outstanding shares of our common stock have also agreed with the underwriters not to sell, transfer or dispose of any shares or similar securities for six months following the effective date of the registration statement for this offering without the prior written consent of the underwriters. For additional information regarding our arrangement with the underwriters, please see “Underwriting.”
   
Knight Therapeutics Preferred Stock Knight will be granted 80,965 preferred shares (share price of $100, total value $8,096,500) in consideration for extinguishment of accumulated interest associated with their loans. The preferred shares are nonvoting, have a 6% cumulative dividend accumulating annually on March 31st, are not redeemable and are convertible into shares of common stock solely at the discretion of the Company, determined by (A) multiplying the number of shares of Series A Preferred Stock to be converted by $100, (B) adding to the result all accrued and accumulated and unpaid dividends on such shares to be converted, if any, and then (C) dividing the result by a price equal to the lower of (1) $100, (2) the price paid for the shares of common stock in this offering and (3) the 10-day volume weighted average share price immediately preceding our election to convert the shares of Series A Preferred Stock; provided that the conversion of the shares of Series A Preferred Stock does not result in the holder’s ownership of common stock exceeding 19.9%.
   
Transfer Agent Equity Stock Transfer, LLC.
   
Risk Factors You should carefully consider the information set forth in this prospectus and, in particular, the specific factors set forth in the “Risk Factors” section beginning on page 20 of this prospectus before deciding whether or not to invest in shares of our common stock.

 

 18 

 

  

  (1)

As of July 10, 2023 and excludes 238,601 shares of common stock reserved for issuance under our 2022 Equity Incentive Plan.

 

  (2)

Includes (i) 29,245 shares of our common stock issued to BioIntelect Pty Ltd (“BioIntelect”) pursuant to the Master Consultancy Agreement dated as of May 29, 2013 (the “BioIntelect Agreement”), which provides that in connection with our initial public offering, BioIntelect will be entitled to receive deferred equity compensation in the amount equal to $155,000 (or $245,000 if Australian VC Horizon Biotech participates in the offering), (ii) 1,108,337 shares of our common stock that are to be issued to Knight Therapeutics International S.A. (formerly known as Knight Therapeutics (Barbados) Inc.) (“Knight”) determined by dividing the outstanding principal amount as of March 31, 2022 of $10,770,037 by the public offering price discounted by 15%, up to 19.9% of our outstanding common stock after giving effect to the initial public offering, for a total value of common shares to be issued of $5,874,186 pursuant to the Debt Conversion Agreement dated as of January 9, 2023, as amended on January 19, 2023 and January 27, 2023 (the “Knight Debt Conversion Agreement”), (iii) 383,908 shares of our common stock that are to be issued prior to the closing of this offering as a result of either the conversion or extinguishment of our interim financing notes which had a carrying value at March 31, 2023 of $1,651,560 excluding the Xu Yu Equity Conversion Note, (iv) 214,934 shares of our common stock that are to be issued prior to the closing of this offering as a result of the conversion of certain debt totaling $1,164,190 pursuant to the Equity Conversion Note dated as of October 11, 2017, as amended on December 23, 2017 and December 11, 2022 (the “Xu Yu Equity Conversion Note”) entered into with Xu Yu and (v) 40,000 shares of our common stock valued at $5.00 per share that are to be issued to four of our directors on the date of effectiveness of the registration statement of which this prospectus forms a part.

 

  (3)

Does not include (i) 31,447 shares of our common stock underlying a warrant issued to Bigger Capital Fund, LP with an exercise price equal to 110% of the initial public offering price of the Units, (ii) 26,205 shares of our common stock underlying a warrant issued to Cavalry Investment Fund, LP with an exercise price equal to 110% of the initial public offering price of the Units, (iii) 26,205 shares of our common stock underlying a warrant issued to Walleye Opportunities Master Fund Ltd with an exercise price equal to 110% of the initial public offering price of the Units, (iv) 10,482 shares of our common stock underlying a warrant issued to Geoffrey Dow (in the form of his revocable grantor trust, the Geoffrey S. Dow Revocable Trust for which Mr. Dow is the sole trustee) with an exercise price equal to 110% of the initial public offering price of the Units, (v) 69,444 shares of our common stock underlying a warrant issued to Mountjoy Trust with an exercise price equal to 110% of the initial public offering price of the Units, (vi) 10,482 shares of our common stock underlying a warrant issued to Cyberbahn Federal Solutions, LLC with an exercise price equal to 110% of the initial public offering price of the Units, (vii) 10,482 shares of our common stock underlying a warrant issued to Ariana Bakery Inc with an exercise price equal to 110% of the initial public offering price of the Units, (viii) 31,447 shares of our common stock underlying a warrant issued to Sabby Volatility Warrant Master Fund, Ltd. with an exercise price equal to 110% of the initial public offering price of the Units, (ix) 5,241 shares of our common stock underlying a warrant issued to Steel Anderson with an exercise price equal to 110% of the initial public offering price of the Units, (x) 10,482 shares of our common stock underlying a warrant issued to Bixi Gao & Ling Ling Wang with an exercise price equal to 110% of the initial public offering price of the Units, (xi) 84,906 shares of our common stock issuable upon the exercise of the Representative Warrants with an exercise price equal to 110% of the initial public offering price of the Units, (xii) 238,601 shares of common stock reserved for issuance under our 2022 Equity Incentive Plan and (xiii) $40,000 in value of shares of our common stock, based on the 30 day average after the IPO, to be issued pursuant to the Red Chip services agreement.

 

Except as otherwise indicated, all information in this prospectus assumes that:

 

  no shares of common stock have been issued pursuant to the (i) conversion of certain of our outstanding debt owed to Knight, (ii) BioIntelect Agreement, (iii) conversion and extinguishment of our interim financing notes and (iv) Xu Yu Equity Conversion Note;
     
  no shares of common stock have been issued pursuant to any warrants or options; and

 

  no shares of common stock have been issued pursuant to the Representative’s over-allotment option;

 

  no shares of common stock have been issued pursuant to the Representative Warrants.

 

SUMMARY FINANCIAL DATA

 

The following tables summarize our financial data. We derived the summary financial statement data for the years ended December 31, 2022 and 2021 set forth below from our audited financial statements and related notes contained in this prospectus, and the summary financial statement data for the three months ended March 31, 2023 and March 31, 2022 set forth below from our unaudited financial statements and related notes contained in this prospectus. The unaudited interim financial statements were prepared on a basis consistent with our audited financial statements and include, in management’s opinion, all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair statement of the financial information set forth in those statements. Our historical results are not necessarily indicative of the results that may be expected in the future. You should read the information presented below together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our financial statements, the notes to those statements and the other financial information contained in this prospectus.

 

Summary of Operations in U.S. Dollars

 

    Year Ended     Three Months Ended  
    December 31,     March 31,  
    2022     2021     2023 (unaudited)     2022 (unaudited)  
Product revenues – net of discounts and rebates   $ 192,913     $ 1,078,440     $ 17,172     $ 47,024  
Service revenues     30,295       81,900       -       -  
Product and service revenues     223,208       1,160,340       17,172       47,024  
Cost of revenues     432,370       850,742       73,120       90,134  
Gross profit (loss)     (209,162 )     309,598       (55,948 )     (43,110 )
Research revenues     288,002       5,192,516       4,292       117,147  
Net revenue     78,840       5,502,114       (51,656 )     74,037  
Operating expenses:                                
Research & development     525,563       5,510,866       123,994       63,057  
General and administrative expenses     1,303,722       1,115,350       775,014       174,692  
Total operating expenses     1,829,285       6,626,216       899,008       237,749  
Loss from operations     (1,750,445 )     (1,124,102 )     (950,664 )     (163,712 )
Interest and other income (expense), net:                                
Interest expense     (3,989,359 )     (3,172,712 )     (1,141,429 )     (762,217 )
Derivative expense     (504,613 )     -       -       -  
Change in fair value of derivative liabilities     (10,312 )     -       (5,134 )     -  
Gain (loss) on debt extinguishment     120,683       -       (839,887 )     -  
Change in fair value of promissory note     -       -       339,052       -  
Other income (expense)     (43,238 )     37,515       591       18,732  
Total interest and other income (expense), net     (4,426,839 )     (3,135,197 )     (1,646,807 )     (743,485 )
Loss from operations before provision for income taxes     (6,177,284 )     (4,259,299 )     (2,597,471 )     (907,197 )
Provision for income taxes     500       1,000       63       250  
Net loss including noncontrolling interest   $ (6,177,784 )   $ (4,260,299 )   $ (2,597,534 )   $ (907,447 )

 

    As of December 31,     As of March 31,  
    2022     2021     2023
(unaudited)
 
Consolidated Balance Sheet Data:                        
Total assets   $ 1,297,206     $ 1,393,527     $ 7,586,974  
Total liabilities     25,446,266       19,548,011       27,119,858  
Total liabilities and members' equity (deficit)     -       1,393,527       -  
Total liabilities and stockholders' equity (deficit)   $ 1,297,206     $ -     $ 7,586,974  

  

 19 

 

  

RISK FACTORS

 

Our business is subject to many risks and uncertainties, which may affect our future financial performance. If any of the events or circumstances described below occur, our business and financial performance could be adversely affected, our actual results could differ materially from our expectations, and the price of our stock could decline. The risks and uncertainties discussed below are not the only ones we face. There may be additional risks and uncertainties not currently known to us or that we currently do not believe are material that may adversely affect our business and financial performance. You should carefully consider the risks described below, together with all other information included in this prospectus, including our financial statements and related notes, before making an investment decision. The statements contained in this prospectus that are not historic facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. If any of the following risks actually occurs, our business, financial condition or results of operations could be harmed. In that case, the trading price of our common stock could decline, and investors in our securities may lose all or part of their investment.

 

Risks Related to Our Business

 

Our financial statements have been prepared on a going-concern basis and our continued operations are in doubt.

 

The financial statements have been prepared on a going concern basis under which an entity is considered to be able to realize its assets and satisfy its liabilities in the ordinary course of business. Our future operations are dependent upon the identification and successful completion of equity or debt financing and the achievement of profitable operations at an indeterminate time in the future. There can be no assurances that we will be successful in completing an equity or debt financing or in achieving profitability.

 

We have incurred net losses since our inception and if we continue to incur net losses in the foreseeable future, the market price of our common stock may decline.

 

To date, we have financed our operations primarily through the issuance of equity, promissory notes and convertible notes. We incurred annual net losses of $6,177,784 in 2022 and $4,260,299 in 2021, respectively and operating losses were $1,750,445 in 2022 and $1,124,102 in 2021. We had an accumulated deficit of $28,815,148 as of December 31, 2022 ($22,633,428 as of December 31, 2021). For the quarterly period ending March 31, 2023, we incurred a net loss of $2,600,061 and an operating loss of $950,664 and now have accumulated losses of $31,415,209.

  

We may not achieve or maintain profitability in the future. In particular, we expect that our expenses relating to sales and marketing and product development and support, as well as our general and administrative costs, will increase, requiring us to increase sales in order to achieve and maintain profitability. If we do not achieve and maintain profitability, our financial condition will be materially and adversely affected. We would eventually be unable to continue our operations unless we were able to raise additional capital. We may not be able to raise any necessary capital on commercially reasonable terms or at all. If we fail to achieve or maintain profitability on a quarterly or annual basis within the timeframe expected by investors, the market price of our common stock may decline.

 

There is no assurance that we will be profitable.

 

There is no assurance that we will earn profits in the future, or that profitability will be sustained. There is no assurance that future revenues will be sufficient to generate the funds required to continue our business and product development and marketing activities. If we do not have sufficient capital to fund our operations, we may be required to reduce our sales and marketing efforts or forego certain business opportunities.

 

There is no assurance we will be eligible for Australian Government research and development tax credits and eligibility rules might change in a manner that jeopardizes our business.

 

There is no assurance that the Australian government will pay research and development rebates on our research activities conducted by our subsidiary, 60P Australia Pty Ltd, in Australia. There is no assurance that we will be able to demonstrate that our subsidiary will have < $20 million AUD in aggregate turnover amongst beneficial owners with > 40% beneficial interest. If any of these risks materialize, we might not be able to complete our planned COVID-19 clinical study, which would negatively impair our business.

 

Even if Australian government grants an overseas finding, if we could not raise additional financing to fund the linked Australian research and development activities. Also, it is possible depending on evolving interpretations by the Australian Tax Office of the legislation, that matching Australian core research might not be eligible for consideration when a determination of an overseas finding is made. Either of these scenarios if realized might require us to refund any rebates on the COVID-19 clinical study to the Australian government or result in us not being to obtain rebates, thereby negatively impairing our business.

 

We have limited revenues to date, and any potential revenues from commercial use may not materialize in the future.

 

We have earned limited revenues to date from Arakoda. Any potential revenues from the sale of current approved commercial use may not materialize in the future. There is no guarantee that we will be able to generate revenue in the future. No assurance can be given that our efforts from sale of current approved products for commercial use will be successful in the future.

 

 20 

 

  

Our financial condition and results of operations may be adversely affected by the COVID-19 pandemic.

 

A significant outbreak, epidemic or pandemic of contagious diseases in any geographic area in which we operate or plan to operate could result in a health crisis adversely affecting the economies, financial markets and overall demand for our services in such areas. In addition, any preventative or protective actions that governments implement or that we take in response to a health crisis, such as travel restrictions, quarantines, or site closures, may interfere with the ability of our employees, suppliers and customers to perform their responsibilities. Such results could have a material adverse effect on our business.

 

The continued global COVID-19 pandemic has created significant volatility, uncertainty and economic disruption. To date, this pandemic has affected nearly all regions around the world. In the United States, businesses as well as federal, state and local governments implemented significant actions to mitigate this public health crisis. While we cannot predict the duration or scope of the COVID-19 pandemic, it may negatively impact our business and such impact could be material to our financial results, condition and outlook related to:

 

disruption to our operations or the operations of our suppliers, through the effects of business and facilities closures, worker sickness and COVID-19 related inability to work, social, economic, political or labor instability in affected areas, transportation delays, difficulty in enrolling patients, travel restrictions and changes in operating procedures, including for additional cleaning and safety protocols;

 

increased volatility or significant disruption of global financial markets due in part to the COVID-19 pandemic, which could have a negative impact on our ability to access capital markets and other funding sources, on acceptable terms or at all and impede our ability to comply with debt covenants; and

 

the further spread of COVID-19, and the requirements to take action to mitigate the spread of the pandemic (e.g., vaccination requirements that have been and continue to be taken in response to the pandemic and enhanced health and hygiene requirements or social distancing or other measures), will impact our ability to carry out our business as usual and may materially adversely impact global economic conditions, our business, results of operations, cash flows and financial condition.

 

To the extent the COVID-19 pandemic or a similar public health threat has an impact on our business, it is likely to also have the effect of heightening many of the other risks described in this “Risk Factors” section.

 

If COVID-19 cases decline, it could jeopardize our business and make us less profitable.

 

Although the number of U.S. cases of COVID-19 remains high, it is possible that this may not be the case in the future. Since our major business objective is to conduct clinical trials to evaluate the use of the Arakoda regimen of Tafenoquine for treatment of COVID-19, a future decline in U.S cases would reduce our sales and profitability, and therefore harm our business.

 

U.S. public sector procurement of Arakoda might not materialize in the future, which could jeopardize our business.

 

Sales to the U.S. DoD were important to our revenue stream in the recent past. Although, as of the date of this prospectus, we were not in discussions with the DoD about additional/future procurement, we anticipate that this will be feasible in the future if one or more of the conditions/events described in this paragraph occur. First, the position of Arakoda in the DoD formulary (Tricare, deployed personnel) needs to be improved from second/third tier to at least equivalency with competing products (as is the case for civilian use as recommended by the CDC). Second, the shelf-life of the existing product requires extension, which is known to be technically possible as the shelf-life of Kodatef in Australia is 48 months, but appropriate data must be generated to meet FDA requirements. Finally, a change in the operational footprint of DoD deployments to areas with higher malaria attack rates (e.g., the Liberia deployment to manage the Ebola outbreak in 2014) may lead to a rapid reassessment by DoD of the position of Arakoda in the formulary (advancement of the last approved prophylactic antimalarial to co-equal standard of care took thirteen years). It is possible that none of these events would transpire, which would reduce our revenues and jeopardize our business.

  

Supply chain disruptions across the globe, including in the U.S., could jeopardize our business and harm our operations.

 

Global business interruptions may adversely impact our third-party relationships whom we rely upon in our business as well as manufacturers, suppliers, and makers of raw materials. If any such parties are adversely impacted by supply chain restrictions, or if they cannot obtain the necessary supplies, or if such third parties need to prioritize other products or customers over us, we may experience delays or disruptions in our supply chain, which could have a material and adverse impact on our business. Third-party manufacturers may also need to implement measures and changes, or deviate from typical requirements because of the COVID-19 pandemic that may otherwise adversely impact our supply chain or the quality of the resulting products or supplies. Depending on the change, we may need to obtain FDA approval or otherwise provide the FDA with a notification of the change. As a result, we may not be able to obtain sufficient quantities of certain items, which could impair our ability to commercialize our products and conduct the post-marketing studies requested by the FDA, in connection with the approval of our goods. In addition, if there are continued or future disruptions, our third-party manufacturers may not be able to supply our other potential product candidates, which would adversely affect our research and development activities.

  

We may lose the services of key management personnel and may not be able to attract and retain other necessary personnel.

  

Changes in our management could have an adverse effect on our business. This is especially an issue while our staff is small. We are dependent upon the active participation of several key management personnel, including Geoffrey Dow, our President and Chief Executive Officer. We also do not carry key person life insurance on any of our senior management or other key personnel. Hence, we may suffer if the services of our management were to become unavailable to us in the future.

 

 21 

 

  

We must hire highly skilled technical personnel as employees and as independent contractors in order to develop our products. As of the date of this prospectus, we have two full-time employees, and we rely on two independent contractors to provide us with skilled technical support. The competition for highly skilled technical, managerial and other personnel is intense and we may not be able to retain or recruit such personnel. Our recruiting and retention success is substantially dependent on our ability to offer competitive salaries and benefits to our employees and competitive compensation to contractors. We must compete with companies that possess greater financial and other resources than we do and that may be more attractive to potential employees and contractors. To be competitive, we may have to increase the compensation, bonuses, stock options and other fringe benefits offered to employees in order to attract and retain such personnel. The costs of retaining or attracting new personnel may have a material adverse effect on our business and operating results. If we fail to attract and retain the technical and managerial personnel needed to be successful, our business, operating results and financial condition could be materially adversely affected.

 

Cybersecurity risks could adversely affect our business and disrupt our operations.

 

The threats to network and data security are increasingly diverse and sophisticated. Despite our efforts and processes to prevent breaches, our devices, as well as our servers, computer systems, and those of third parties that we use in our operations are vulnerable to cybersecurity risks, including cyber-attacks such as viruses and worms, phishing attacks, denial-of-service attacks, physical or electronic break-ins, employee theft or misuse, and similar disruptions from unauthorized tampering with our servers and computer systems or those of third parties that we use in our operations, which could lead to interruptions, delays, loss of critical data, and unauthorized access to user data. In addition, we may be the target of email scams that attempt to acquire personal information or our assets. Despite our efforts to create security barriers to such threats, we may not be able to entirely mitigate these risks. Any cyber-attack that attempts to obtain our or our users’ data and assets, disrupt our service, or otherwise access our systems, or those of third parties we use, if successful, could adversely affect our business, operating results, and financial condition, be expensive to remedy, and damage our reputation. In addition, any such breaches may result in negative publicity, adversely affect our brand, decrease demand for our products and services, and adversely affect our operating results and financial condition.

 

The illegal sale or distribution by third parties of counterfeit versions of our products could have a negative impact on our business.

 

Pharmaceutical products are vulnerable to counterfeiting. Third parties may illegally produce and distribute counterfeit versions of our products that are below the various manufacturing and testing standards that our products undergo. Counterfeit products are often unsafe, ineffective and potentially life-threatening. As many counterfeit products may be visually indistinguishable from their authentic versions, the presence of counterfeit products could affect overall consumer confidence in the authentic product. A public loss of confidence in the integrity of pharmaceutical products in general or in any of our products in particular due to counterfeiting could have a material adverse effect on our business, prospects, financial condition and results of operations.

 

If we encounter difficulties enrolling patients in any future clinical trials, our future trials could be delayed or otherwise adversely affected. Furthermore, our current COVID-19 trials may not necessarily yield sufficient results or patient participants.

 

If we have difficulty enrolling a sufficient number of patients in any future clinical trial, including for COVID-19 studies for which the number of cases is unpredictable, we may need to delay or terminate our trial, which would impair our ability to develop marketable products, and have a negative impact on our business. Delays in enrolling patients in any future clinical trials would also adversely affect our ability to generate any product, milestone and royalty revenues under collaboration agreements, if any, and could impose significant additional costs on us or on any future collaborators.

 

 22 

 

  

Our clinical trials for our product candidates may not yield results that will enable us to further develop our products and obtain regulatory approvals necessary to sell them.

 

We will receive regulatory approval for our product candidates only if we can demonstrate in carefully designed and conducted clinical trials that the product candidate is safe and effective. We do not know whether any current or future clinical trials for Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir or any other product candidate will demonstrate sufficient safety and efficacy to obtain the requisite regulatory approvals or will result in marketable products.

 

Clinical trials are lengthy, complex and expensive processes with uncertain results. We have spent, and expect to continue to spend, significant amounts of time and money on the clinical development of our product candidates. The three clinical trials we conducted in the past were managed directly by us, but executed contract research organizations (“CROs”). While certain of our employees have experience in designing and administering clinical trials, our experience is limited to three clinical trials conducted by the management team.

 

The results we obtain in preclinical testing and early clinical trials may not be predictive of results that are obtained in later studies. We may suffer significant setbacks in advanced clinical trials, even after seeing promising results in earlier studies. Based on results at any stage of clinical trials, we may decide to repeat or redesign a trial or discontinue development of one or more of our product candidates. If we fail to adequately demonstrate the safety and efficacy of our products under development, we will not be able to obtain the required regulatory approvals to commercialize our product candidates, and our business, results of operations and financial condition would be materially adversely affected.

 

Administering our product candidates to humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical trials of our product candidates and could result in the FDA or other regulatory authorities denying approval of our product candidates for any or all targeted indications.

 

If clinical trials for a product candidate are unsuccessful, we will be unable to commercialize the product candidate. If one or more of our clinical trials are delayed, we will be unable to meet our anticipated development timelines. Either circumstance could cause the market price of our common stock to decline.

 

In planning for, and executing, clinical trials, the targeted standard of care in the United States or other jurisdictions for the therapeutic indication may change, necessitating changes to the design of such trials. Changes to such design trials will cause delays, and increase costs, thereby rendering us unable to meet development timelines or complete development programs. The clinical data generated from clinical trials may not be acceptable to regulatory agencies if changes to the standard of care occurred during trial execution, which may prevent regulatory approval, thereby damaging our business prospects.

 

Because patients with COVID-19 disease enrolled in our Phase II clinical study of Tafenoquine (Arakoda regimen) were presumed to be mostly infected with the SARS-CoV-2 delta variant, it is possible that the results of the study might not be representative of those of future studies of Tafenoquine (Arakoda regimen) that utilize patients infected with newer viral strains. If this risk materialized, our planned clinical trial might fail, thereby damaging our business prospects. It should be stated that, due to the changing nature of the pandemic, this risk is common to all COVID-19 therapeutics. It is possible this risk may be less likely to occur if the mechanism of Tafenoquine turns out not to be mediated via a direct antiviral effect.

 

Because our 2021 Phase II clinical study of Tafenoquine (Arakoda regimen) in COVID-19 patients was small, it is possible that the magnitude of clinical benefit implied in Figure B listed in “Prospectus Summary—Strategy” (a three-day acceleration of recovery in the Tafenoquine arm) may be an overestimate of the true therapeutic effect of Tafenoquine (Arakoda regimen). We have attempted to mitigate this risk in our planned Phase IIB clinical trial design by providing for an interim analysis at 75% patient enrollment which will include a sample size reanalysis, which would allow additional enrollment of patients if required without study termination. If additional patients did need to be enrolled, it would increase the overall cost of the study. This risk mitigation strategy would not work if the true therapeutic benefit of Tafenoquine (Arakoda regimen) is minimal or non-existent, or actual patient to patient variability is larger than assumed. Any of those outcomes might result in failure of the study.

 

We believe that the inclusion of a placebo arm in our planned Phase IIB study is ethical because there are not any FDA-approved orally administered medications available for patients with low risk of disease progression. However, because the standard of care for COVID-19 is evolving, it is possible that FDA or an Ethics Committee may not agree with our assessment that inclusion of a placebo arm in our Phase IIB study is ethical. If this risk was realized, it might result in (i) wasted expenditure on development of clinical sites if this was done aggressively in parallel with seeking FDA feedback (a typical approach in the industry), and/or (ii) necessitate conducting our trial outside the United States in jurisdictions without approved oral antivirals and accepting a greater risk of failing an FDA audit of the study in the future and/or (iii) replacement of the placebo control with an active control arm and accepting the greater cost associated with such a study design (because they require a higher number of patients). To mitigate against the first risk, we are planning to initiate preparations for the clinical trial at only a small number of sites in parallel with seeking FDA and Ethics Committee feedback. If either of the second or third risks materialized, our business might be irreparably harmed.

 

Because the number of COVID-19 cases is episodic, and the severity of the COVID-19 disease is generally perceived as being milder than it was earlier in the pandemic meaning patients seek out medical treatment less often, it is possible that that there may be fewer COVID-19 patients available to be enrolled than expected in our study. If this risk materialized, it would result in slower recruitment in our study than planned, forcing either a delay in the timeline for data being available, or increasing the overall cost in order to increase the number of study sites, or both. Either eventuality would harm our business.

 

The mechanisms of actions of some of our products, and interactions with other antiviral products are not known, which may restrict regulatory label claims.

 

The FDA has granted full or limited marketing authority for COVID-19 products based on the clinical benefit demonstrated in clinical trials, for products that have both antiviral and non-antiviral modes of action. However, the FDA may require specific additional evidence to grant a labeling claim of antiviral activity. We are planning to further develop Tafenoquine (Arakoda regimen) for treatment of COVID-19 based on the observation of trends towards accelerated recovery observed in the exploratory endpoints of a Phase II clinical trial we recently completed. We plan to undertake limited research activities to confirm whether Tafenoquine provides clinical benefit via an antiviral or other mechanism. However, we cannot guarantee such efforts will confirm a direct antiviral mechanism to the satisfaction of the FDA, or that any data generated will support regulatory claims of antiviral activity in additional to whatever claims related to clinical benefit in COVID-19 treatment that the FDA may allow. Relatedly, the FDA required warning language to be placed on the remdesivir label related to a theoretical drug-drug interaction with other antimalarials based on in vitro (not clinical) data. Although we have conducted in vitro drug interactions studies of Tafenoquine versus molnupiravir, remdesivir, and paxlovid, which do not suggest the possibility of clinically meaningful antagonism, we cannot guarantee these studies will discharge any theoretical risks or concerns regulators may have (including the need for disclaimers or warning labels).

 

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We will rely on contract research organizations to conduct substantial portions of our clinical trials, including any future clinical trial of Arakoda Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir, and as a result, we will be unable to directly control the timing, conduct and expense of all aspects of our clinical trials.

 

We do not currently have sufficient staff to conduct our clinical trials ourselves, and therefore, we will rely on third parties to conduct certain aspects of any future clinical trials. We previously contracted with a CRO to conduct components of our clinical trials and anticipate contracting with a CRO to conduct components of any future clinical trial for Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir or any future clinical trials for our other product candidates. As a result, we will have less control over many details and steps of any clinical trial, the timing and completion of any clinical trial, the required reporting of adverse events and the management of data developed through any clinical trial than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties, such as CROs, may have staffing difficulties, may undergo changes in priorities or may become financially distressed, adversely affecting their willingness or ability to conduct our clinical trial. We may experience unexpected cost increases that are beyond our control. Problems with the timeliness or quality of the work of a CRO may lead us to seek to terminate the relationship and use an alternative service provider. However, making any change may be costly and may delay ongoing trials, if any, and contractual restrictions may make such a change difficult or impossible. Additionally, it may be impossible to find a replacement organization that can conduct clinical trials in an acceptable manner and at an acceptable cost.

 

Even though we anticipate relying on CROs in the future, we will likely have to devote substantial resources and rely on the expertise of our employees to manage the work being done by the CROs. We and our management team have experience in managing clinical trials being executed on our behalf by CROs based on three clinical studies. Therefore, we cannot guarantee that our employees will manage such studies effectively in the future.

 

We expect to depend on existing and future collaborations with third parties for the development of some of our product candidates. If those collaborations are not successful, we may not be able to complete the development of these product candidates.

 

Collaborations involving our product candidates pose the following risks to us:

 

collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

 

collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;

 

collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

 

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

 

collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;

 

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collaborators may not comply with regulatory requirements and as a result their operations may be disrupted or ended until they resolve their regulatory issues with government officials;

 

disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources;

 

collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;

 

collaborators may elect to take over manufacturing rather than retain us as manufacturers and may encounter problems in starting up or gaining approval for their manufacturing facility and so be unable to continue development of product candidates;

 

we may be required to undertake the expenditure of substantial operational, financial and management resources in connection with any collaboration;

 

we may be required to issue equity securities to collaborators that would dilute our existing stockholders’ percentage ownership;

 

we may be required to assume substantial actual or contingent liabilities;

 

collaborators may not commit adequate resources to the marketing and distribution of our product candidates, limiting our potential revenues from these products; and

 

collaborators may experience financial difficulties.

 

We face a number of challenges in seeking additional collaborations. Collaborations are complex and any potential discussions may not result in a definitive agreement for many reasons. For example, whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of a number of factors, such as the design or results of our clinical trials, the potential market for our product candidates, the costs and complexities of manufacturing and delivering our product candidates to patients, the potential of competing products, the existence of uncertainty with respect to ownership or the coverage of our intellectual property, and industry and market conditions generally. If we were to determine that additional collaborations for our Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir development program are necessary and were unable to enter into such collaborations on acceptable terms, we might elect to delay or scale back the development or commercialization of Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir in order to preserve our financial resources or to allow us adequate time to develop the required physical resources and systems and expertise ourselves.

 

Collaboration agreements may not lead to development or commercialization of our product candidates in the most efficient manner, or at all. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. If a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

 

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Any future clinical trial for Tafenoquine (all regimens) will require screening for G6PD deficiency in order to safely administer the product. In the United States, G6PD testing can obtained through commercial pathology services which is associated with delays. The use of a third-party diagnostic provider of point of care testing may be required and we do not directly control the timing, conduct and expense of such testing.

 

According to prescribing information for Arakoda, administration of a test for G6PD deficiency is required before administration in order prevent the occurrence of hemolytic anemia that has been observed in some patients who have G6PD deficiency and were inadvertently administered Arakoda in clinical trials. Therefore, G6PD deficiency is an exclusion criteria in clinical trials involving Tafenoquine (all regimens).

 

For clinical trials administered in the United States, G6PD testing is provided through commercial pathology companies including Labcorp and Quest Diagnostics. Such testing, while usually available with 72-hour turnaround time, may sometimes take much longer. There is a single FDA-approved point of care test (Abbott’s Binax Now) but this requires administration in a CLIA-certified laboratory, which not all clinical trial sites have access to.

 

For many clinical trials, and in particular those involving viral diseases, rapid administration of the investigational agent is required to maximize efficacy. Therefore, we will attempt to import and utilize hand-held point of care tests approved elsewhere in the world in our clinical trials involving Tafenoquine (any regimen). We may not be successful in this process, which would compromise our ability to recruit patients or result in a lower-than-expected effect of Tafenoquine (any regimen) in such a trial.

 

Tafenoquine (all regimens) requires administration of a G6PD test. The lack of point of care tests may negatively impair sales of Arakoda or other drug regimens containing Tafenoquine.

 

A G6PD test need only be administered once and can be recorded in electronic health records for future reference. The commercial providers of G6PD testing in the United States will usually only commit to at best a 72-hour turn-around time for G6PD testing. Thus, while this does not present a problem in principle for the existing malaria indication for individuals who travel frequently, or for organizations with organized occupational health and safety programs where G6PD testing results are held on file, it may be a barrier to use of Arakoda by first time travelers or those planning to travel and hence be a barrier to use of Arakoda if prospective patients are unwilling or unable to take the G6PD test.

 

If it is confirmed that the Mode of Action of Tafenoquine in COVID-19 is via a direct antiviral mechanism, it is likely that, as with other antivirals, rapid administration of the product is important to maximize efficacy. Therefore, it is possible that the current lack of an FDA-approved, widely available point of care G6PD test will negatively impact sales of Tafenoquine (any regimen) for COVID-19, under the assumption that the FDA eventually approves Arakoda (or other) regimen of Tafenoquine for this indication and appropriate G6PD tests are never approved by FDA.

 

Several third-party diagnostic test companies are developing point of care G6PD tests (or platforms that would accommodate them) that utilize finger stick blood samples and which may be appropriate for use in the United States. One of these tests is approved in Brazil and Australia.33 Another is available for use in Europe and was recently approved by the FDA in the United States.34 A third test is being developed with the NIH grant support for the U.S. and ex U.S. markets and is in clinical development.35 There is no guarantee that tests will succeed in clinical development or ever become commercially available to the public. Having to take a test at all, or to go to a third-party lab in order to take the test, may be a hindrance to the use of Arakoda, which would negatively impact our sales.

 

Our product candidates are subject to extensive regulation, which can be costly and time-consuming, and unsuccessful or delayed regulatory approvals could increase our future development costs or impair our future revenue.

 

The preclinical and clinical development, testing, manufacture, safety, efficacy, labeling, storage, recordkeeping, and subsequent advertising, promotion, sale, marketing, and distribution, if approved, of our product candidates are subject to extensive regulation by the FDA and other regulatory authorities in the United States and elsewhere. These regulations also vary in important, meaningful ways from country to country. We are not permitted to market a potential new drug in the United States until we receive approval of an NDA from the FDA for such drug. We have received an NDA approval for Arakoda for malaria prevention, but have not received approval from the FDA for any non-malaria prevention indications for Tafenoquine (Arakoda regimen), Tafenoquine or any NDA approval from the FDA for Celgosivir or any of our other product candidates. There can be no guarantees with respect to our product candidates that clinical studies will adequately support an NDA, that the products will receive necessary regulatory approvals, or that they will prove to be commercially successful.

 

 

33 https://www.sdbiosensor.com/product/product_view?product_no=183.

34 Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform | Baebies.

35 https://ivd.solutions/grant/.

 

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To receive regulatory approval for the commercial sale of any product candidates, we must demonstrate safety and efficacy in humans to the satisfaction of regulatory authorities through preclinical studies and adequate and well-controlled clinical trials of the product candidates. This process is expensive and can take many years, and failure can occur at any stage of the testing. Our failure to adequately demonstrate the safety and efficacy of our product candidates will prevent regulatory approval and commercialization of such products.

 

In the event that we or our collaborators conduct preclinical studies that do not comply with Good Laboratory Practices (“GLP”), or incorrectly design or carry out human clinical trials in accordance with Good Clinical Practices (“GCP”), or those clinical trials fail to demonstrate clinical significance, it is unlikely that we will be able to obtain FDA approval for product development candidates. Our inability to successfully initiate and effectively complete clinical trials for any product candidate on schedule, or at all, will severely harm our business. Significant delays in clinical development could materially increase product development costs or allow our competitors to bring products to market before we do, impairing our ability to effectively commercialize any future product candidate. We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including:

 

delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

 

delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidates for use in trials;

 

delays or failures in reaching agreement on acceptable terms with prospective study sites;

 

delays or failures in obtaining approval of our clinical trial protocol from an Institutional Review Board (“IRB”) to conduct a clinical trial at a prospective study site;

 

delays in recruiting patients to participate in a clinical trial, which may be due to the size of the patient population, eligibility criteria, protocol design, perceived risks and benefits of the drug, availability of other approved and standard of care therapies or, availability of clinical trial sites;

 

other clinical trials seeking to enroll subjects with similar profile;

 

failure of our clinical trials and clinical investigators to be in compliance with GCP;

 

unforeseen safety issues, including negative results from ongoing preclinical studies;

 

inability to monitor patients adequately during or after treatment;

 

difficulty recruiting and monitoring multiple study sites; and

  

failure of our third-party contract research organizations, clinical site organizations and other clinical trial managers, to satisfy their contractual duties, comply with regulations or meet expected deadlines; and

 

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an insufficient number of patients who have, or are willing to have, a device implanted for monitoring and recording data.

 

In addition, any approvals we may obtain may not cover all of the clinical indications for which we seek approval or permit us to make claims of superiority over currently marketed competitive products. Also, an approval might contain significant limitations in the form of narrow indications, warnings, precautions or contraindications with respect to conditions of use. If the FDA determines that a risk evaluation and mitigation strategy (“REMS”) is necessary to ensure that the benefits of the drug outweigh the risks, we may be required to include as part of the NDA a proposed REMS that may include a package insert directed to patients, a plan for communication with healthcare providers, restrictions on a drug’s distribution, or a medication guide to provide better information to consumers about the drug’s risks and benefits. Finally, approval could be conditioned on our commitment to conduct further clinical trials, which we may not have the resources to conduct or which may negatively impact our financial situation.

 

The manufacture and tableting of Arakoda, Tafenoquine (all regimens) or Celgosivir is, or will be done, by third-party suppliers, who must also meet current Good Manufacturing Practices (“cGMP”) requirements and pass a pre-approval inspection of their facilities before we obtain marketing approval (now or in the future). All of our product candidates are prone to the risks of failure inherent in drug development. The results from preclinical animal testing and early human clinical trials may not be predictive of results obtained in later human clinical trials. Further, although a new product may show promising results in preclinical or early human clinical trials, it may subsequently prove unfeasible or impossible to generate sufficient safety and efficacy data to obtain necessary regulatory approvals. The data obtained from preclinical and clinical studies are susceptible to varying interpretations that may delay, limit or prevent regulatory approval, and the FDA and other regulatory authorities in the United States and elsewhere exercise substantial discretion in the drug approval process. The numbers, size and design of preclinical studies and clinical trials that will be required for FDA or other regulatory approval will vary depending on the product candidate, the disease or condition for which the product candidate is intended to be used and the regulations and guidance documents applicable to any particular product candidate. The FDA or other regulators can delay, limit or deny approval of any product candidate for many reasons, including, but not limited to:

 

side effects;

 

safety and efficacy;

 

defects in the design of clinical trials;

 

new understanding related to the pharmacology of other related drug products and their side effects;

 

the fact that the FDA or other regulatory officials may not approve our or our third-party manufacturer’s processes or facilities; or

 

the fact that new regulations may be enacted by the FDA or other regulators may change their approval policies or adopt new regulations requiring new or different evidence of safety and efficacy for the intended use of a product candidate.

 

In light of widely publicized events concerning the safety of certain drug products, regulatory authorities, members of Congress, the Government Accountability Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of certain drug products, revisions to certain drug labeling that further limit use of the drug products and establishment of risk management programs that may, for instance, restrict distribution of drug products. The increased attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials and approval. Data from clinical trials may receive greater scrutiny with respect to safety and the product’s risk/benefit profile, which may make the FDA or other regulatory authorities more likely to terminate clinical trials before completion, or require longer or additional clinical trials that may result in substantial additional expense, and a delay or failure in obtaining approval or approval for a more limited indication than originally sought. Aside from issues concerning the quality and sufficiency of submitted preclinical and clinical data, the FDA may be constrained by limited resources from reviewing and determining the approvability of an NDA or regulatory supplement for Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications or of a Celgosivir NDA in a timely manner.

 

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In pursuing clinical development of Tafenoquine (Arakoda or other regimen) for a non-malaria prevention indication or Celgosivir for other indications, we will be required to amend existing prescribing information, or prepare a new NDA as appropriate. The FDA could approve Tafenoquine (Arakoda or other regimen) or Celgosivir, but without including some or all of the prescribing information that we have requested. For instance, the FDA could approve Tafenoquine (Arakoda or other regimen) or Celgosivir in a more limited patient population or include additional warnings in the drug’s label. This, in turn, could substantially and detrimentally impact our ability to successfully commercialize Tafenoquine (Arakoda or other regimen) or Celgosivir and effectively protect our intellectual property rights in Tafenoquine (Arakoda or other regimen) or Celgosivir.

 

If we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for Tafenoquine (Arakoda or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations.

 

We currently have only a single product (Arakoda for malaria prevention) that has received regulatory approval for commercial sale. The process to develop, obtain regulatory approval for and commercialize potential product candidates is long, complex and costly. Any future development of Tafenoquine (Arakoda or other regimen for a non-malaria prevention indication) or Celgosivir, including initiating clinical trials, is dependent on obtaining additional financing, even if we enter into a strategic collaboration.

 

Failure to demonstrate that a product candidate, including Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or, in the future, Celgosivir, is safe and effective, or significant delays in demonstrating such safety and efficacy, would adversely affect our business. Failure to obtain marketing approval of Tafenoquine (Arakoda or other regimen for non-malaria prevention indications) or Celgosivir from appropriate regulatory authorities, or significant delays in obtaining such approval, would also adversely affect our business and could, among other things, preclude us from completing a strategic transaction or obtaining additional financing necessary to continue as a going concern.

 

Even if approved for sale, a product candidate must be successfully commercialized to generate value. Although we plan to undertake limited efforts through a contracts sales organization to begin commercialization activities for Arakoda for malaria prevention, we do not currently have the capital resources or management expertise to commercialize Tafenoquine (Arakoda other regimen for non-malaria prevention indications), or Celgosivir or any of our other product candidates and, as a result, will need to complete a strategic transaction, or, alternatively, raise substantial additional funds to enable commercialization of Arakoda, Tafenoquine (Arakoda or other regimen for non-malaria prevention indications) or Celgosivir or any of our other product candidates, if approved. Failure to successfully provide for the commercialization of Arakoda for its current malaria prevention application, or Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications or Celgosivir or any other product candidate, would damage our business.

 

If our product candidates receive regulatory approval, we would be subject to ongoing regulatory obligations and restrictions, and possible litigation exposure, which may result in significant expenses and limit our ability to develop and commercialize other potential products.

 

If a product candidate of ours is approved by the FDA or by another regulatory authority, we would be held to extensive regulatory requirements over product manufacturing, testing, distribution, labeling, packaging, adverse event reporting and other reporting to regulatory authorities, storage, advertising, marketing, promotion, distribution, and record keeping. Regulatory approvals may also be subject to significant limitations on the indicated uses or marketing of the product candidates. Potentially costly follow-up or post-marketing clinical studies may be required as a condition of approval to further substantiate safety or efficacy, or to investigate specific issues of interest to the regulatory authority. Previously unknown problems with the product candidate, including adverse events of unanticipated severity or frequency, may result in additional regulatory controls or restrictions on the marketing or use of the product or the need for post marketing studies, and could include suspension or withdrawal of the products from the market.

 

Furthermore, our third-party manufacturers and the manufacturing facilities that they use to make our product candidates are regulated by the FDA. Quality control and manufacturing procedures must continue to conform to cGMP after approval. Drug manufacturers and their subcontractors are required to register their facilities and products manufactured annually with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA, state and/or other foreign authorities. Any subsequent discovery of problems with a product, or a manufacturing or laboratory facility used by us or our collaborators, may result in restrictions on the product, or on the manufacturing or laboratory facility, including a withdrawal of the drug from the market or suspension of manufacturing. Any changes to an approved product, including the way it is manufactured or promoted, often require FDA approval before the product, as modified, can be marketed. We and our third-party manufacturers will also be subject to ongoing FDA requirements for submission of safety and other post-market information.

 

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The marketing and advertising of our drug products by our collaborators or us will be regulated by the FDA, certain state agencies or foreign regulatory authorities including the Federal Trade Commission (“FTC”). Violations of these laws and regulations, including promotion of our products for unapproved “off-label” uses or failing to disclose risk information, are punishable by criminal and civil sanctions and may result in the issuance of enforcement letters or other enforcement action by the FDA, U.S. Department of Justice, state agencies, or foreign regulatory authorities that could jeopardize our ability to market the product.

 

In addition to the FDA, state or foreign regulations, the marketing of our drug products by us or our collaborators will be regulated by federal, state or foreign laws pertaining to health care “fraud and abuse,” such as the federal anti-kickback law prohibiting bribes, kickbacks or other remuneration for the order or recommendation of items or services reimbursed by federal health care programs. Many states have similar laws applicable to items or services reimbursed by commercial insurers. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state health care programs, including the Medicare, Medicaid and Veterans Affairs healthcare programs. Because of the far-reaching nature of these laws, we may be required to discontinue one or more of our practices to be in compliance with these laws. Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. Any violations of these laws, or any action against us for violations of these laws, even if we successfully defend against it, could have a material adverse effect on our business, financial condition and results of operations.

 

If we, our collaborators or our third-party manufacturers fail to comply with applicable continuing regulatory requirements, our business could be seriously harmed because a regulatory agency may:

 

issue untitled or warning letters;

 

suspend or withdraw our regulatory approval for approved products;

 

seize or detain products or recommend a product recall of a drug or medical device, or issue a mandatory recall of a medical device;

 

refuse import or export of any of our drug products;

 

refuse to approve pending applications or supplements to approved applications filed by us;

 

suspend our ongoing clinical trials;

 

restrict our operations, including costly new manufacturing requirements, or restrict the sale, marketing and/or distribution of our products;

 

seek an injunction;

 

pursue criminal prosecutions;

 

close the facilities of our contract manufacturers; or

 

impose civil or criminal penalties.

 

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We could become subject to false claims litigation under federal statutes, which can lead to civil money penalties, restitution, criminal fines and imprisonment, and exclusion from participation in Medicare, Medicaid and other federal and state health care programs.

 

False claims statutes include the False Claims Act, which allows any person to bring a suit on behalf of the federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, under federal programs or contracts claims or other violations of the statute and to share in any amounts paid by the entity to the government in fines or settlement. These suits against pharmaceutical companies have increased significantly in volume and breadth in recent years. Some of these suits have been brought on the basis of certain sales practices promoting drug products for unapproved uses. This new growth in litigation has increased the risk that a pharmaceutical company will have to defend a false claim action, pay fines or restitution, or be excluded from the Medicare, Medicaid, Veterans Affairs and other federal and state healthcare programs as a result of an investigation arising out of such action. We may become subject to such litigation and, if we are not successful in defending against such actions, those actions may have a material adverse effect on our business, financial condition and results of operations.

 

We could also become subject to false claims litigation and consumer protection claims under state statutes, which also could lead to civil monetary penalties, restitution, criminal fines and imprisonment, and exclusion from participation in state health care programs. Of note, over the past few years there has been an increased focus on the sales and marketing practices of the pharmaceutical industry at both the federal and state level. Additionally, the law or regulatory policies governing pharmaceuticals may change. New statutory requirements may be enacted or additional regulations may be adopted that could prevent or delay regulatory approval of our product candidates or limit our ability to commercialize our products. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or elsewhere.

 

Failure to be included in formularies developed by MCOs and other organizations may impact the use of our products.

 

Managed Care Organizations (“MCOs”) and other third-party payers try to negotiate the pricing of medical services and products to control their costs. MCOs and pharmacy benefit managers typically develop formularies to reduce their cost for medications. These formularies can be based on the prices and therapeutic benefits of the available products. The breadth of the products covered by formularies varies considerably from one MCO to another, and many formularies include alternative and competitive products for treatment of particular medical conditions. Failure to be included in such formularies or to achieve favorable formulary status may negatively impact the use of our products. If our products are not included within an adequate number of formularies, additional coverage criteria are required or if the patient’s cost-sharing obligations are high, our market share and gross margins could be adversely impacted, which could have a material adverse effect on our business.

 

Even if we obtain regulatory approvals and market our products as planned, there is no guarantee of widespread market acceptance and the results of our efforts to commercialize our products are uncertain.

 

Even if we are able to obtain and maintain regulatory approvals for our products, the success of our products depends upon achieving and maintaining market acceptance. Commercializing products is time-consuming, expensive and unpredictable. Furthermore, the market for products that address unmet medical needs is highly speculative. If we overestimate the market opportunity for any of our products or candidates, or if we are unsuccessful in gaining market share, these factors could have a material adverse effect on our business. There can be no assurance that we will be able to successfully commercialize our products or gain market acceptance for such products, including in new markets. New product candidates that appear promising in development may fail to reach the market or may have only limited or no commercial success. If any of our products fail to gain, or lose, market acceptance, our revenues could be adversely impacted, which in turn could have a material adverse effect on our business.

 

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Levels of market acceptance for our products could be impacted by several factors, some of which are not within our control, including, among others:

 

safety, efficacy, convenience and cost-effectiveness of our products as compared to products of our competitors;

 

scope of approved uses and marketing approval;

 

availability of patent or regulatory exclusivity;

 

timing of market approvals and market entry;

 

availability of alternative products from our competitors;

 

acceptance of the price of our products;

 

the shelf life of our products;

 

effectiveness of our sales forces and promotional efforts;

 

the level of reimbursement of our products;

 

acceptance of our products on government and private formularies;

 

ability to market our products effectively at the retail level or in the appropriate setting of care; and

 

reputation of our products.

 

Unexpected safety, efficacy or other concerns, whether actual or perceived, about our products may arise which could have a material adverse effect on our business and operations.

 

Unexpected safety or efficacy concerns can arise with respect to our products, whether or not scientifically justified. These concerns are especially more likely to arise as our products are used or studied over longer periods of time or used by a wider group of patients, some of whom may be taking other medicines or have additional underlying health problems. Such developments can potentially result in product recalls, withdrawals and/or declining sales, as well as product liability, consumer fraud and/or other claims, any of which could have a material adverse effect on our business.

 

Any negative publicity about any of our products, such as the discovery of safety or efficacy issues, adverse events involving our products or even public rumors about such events, could have a material adverse effect on our business. In addition, the discovery of one or more significant problems with a product similar to one of our products that implicates (or are perceived to implicate) an entire class of products, or the withdrawal or recall of such similar products, could have an adverse effect on the sales of our products. New data about our products, or products similar to our products, could also cause us reputational harm and could negatively impact demand for our products (or result in product withdrawal), due to real or perceived side effects or uncertainty regarding safety or efficacy.

 

Reliance on third parties to commercialize Arakoda, Tafenoquine (Arakoda or other regimen) Celgosivir or our other product candidates could negatively impact our business. If we are required to establish a direct sales force in the United States and are unable to do so, our business may be harmed.

 

We have received FDA approval of Arakoda for malaria prevention. Arakoda entered the U.S. commercial supply chain in the third quarter of 2019. Sales have been limited due to the impact of the COVID-19 pandemic, and we accordingly suspended our efforts to build internal sales and marketing capability. Re-establishing such sales and marketing capability for the malaria indication would require substantial additional resources.

 

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Future commercialization of Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir or any other product candidate, if approved, particularly the establishment of a sales organization, will require substantial additional capital resources. We currently intend to pursue a strategic partnership alternative for the commercialization of Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir, if it is approved, and we have suspended our efforts to build internal sales, marketing and distribution capabilities. If we elect to rely on third parties to sell Arakoda, Tafenoquine (Arakoda or other regimen), or Celgosivir and any other products, then we may receive less revenue than if we sold such products directly. In addition, we may have little or no control over the sales efforts of those third parties. If we are unable to complete a strategic transaction, we would be unable to commercialize Arakoda, Tafenoquine (Arakoda or other regimen) or Celgosivir or any other product candidate without substantial additional capital. Even if such capital were secured, we would be required to rely on our existing distribution network in place through prime vendors for sales and marketing and capabilities, since we lack our own internal resources to directly sell and market Arakoda, Tafenoquine (Arakoda or other regimen) or Celgosivir in the United States. None of our current employees have experience in establishing and managing a sales force.

 

In the event we are unable to establish an effective sales channel for Arakoda, Tafenoquine (Arakoda or other regimen) or Celgosivir and other selected product candidates, either directly or through third parties via a strategic transaction, the commercialization of Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, or Celgosivir, if approved, may be delayed indefinitely and our revenues will be impaired.

 

We may explore new strategic collaborations that may never materialize or may fail.

 

We may, in the future, periodically explore a variety of new strategic collaborations in an effort to gain access to additional product candidates or resources. At the current time, we cannot predict what form such a strategic collaboration might take. We are likely to face significant competition in seeking appropriate strategic collaborators, and these strategic collaborations can be complicated and time-consuming to negotiate and document. We may not be able to negotiate strategic collaborations on acceptable terms, or at all. We are unable to predict when, if ever, we will enter into any additional strategic collaborations because of the numerous risks and uncertainties associated with establishing strategic collaborations.

 

We have no manufacturing capacity, which puts us at risk of lengthy and costly delays of bringing our products to market.

 

We do not currently operate manufacturing facilities for clinical or commercial production of our product candidates, including their API. We have no experience in drug formulation or manufacturing, and we lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. We do not intend to develop Company-owned facilities for the manufacture of product candidates for clinical trials or commercial purposes in the foreseeable future. We have contracted with Piramal to manufacture the API for Arakoda. For drug product, we previously contracted with Piramal to manufacture the Arakoda tablets (and placebos) for commercial and clinical use and with PCI in the United States for secondary packaging. In addition, we contracted with a separate service provider for packaging and distribution of our clinical trial materials. We may also need to contract with similar manufacturers for similar services in connection with any planned or future clinical trials of Arakoda and Celgosivir.

 

Our contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store and distribute our products. In addition, these manufacturers may have staffing difficulties, may not be able to manufacture our products on a timely basis or may become financially distressed. In the event of errors in forecasting production quantities required to meet demand, natural disaster, equipment malfunctions or failures, technology malfunctions, strikes, lock-outs or work stoppages, regional power outages, product tampering, war or terrorist activities, actions of regulatory authorities, business failure, strike or other difficulty, we may be unable to find an alternative third-party manufacturer in a timely manner and the production of our product candidates would be interrupted, resulting in delays and additional costs, which could impact our ability to commercialize and sell our product candidates. We or our contract manufacturers may also fail to achieve and maintain required manufacturing standards, which could result in patient injury or death, product recalls or withdrawals, an order by governmental authorities to halt production, delays or failures in product testing or delivery, stability testing failures, cost overruns or other problems that could seriously hurt our business.

 

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Contract manufacturers also often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages of qualified personnel. In addition, our contract manufacturers are subject to ongoing inspections and regulation by the FDA, the U.S. Drug Enforcement Agency and corresponding foreign and state agencies and they may fail to meet these agencies’ acceptable standards of compliance. If our contract manufacturers fail to comply with applicable governmental regulations, such as quality control, quality assurance and the maintenance of records and documentation, we may not be able to continue production of the API or finished product. If the safety of any API or product supplied is compromised due to failure to adhere to applicable laws or for other reasons, this may jeopardize our regulatory approval for Arakoda, or Celgosivir and other product candidates, and we may be held liable for any injuries sustained as a result. Upon the occurrence of one of the aforementioned events, the ability to switch manufacturers may be difficult for a number of reasons, including:

 

the number of potential manufacturers is limited and we may not be able to negotiate agreements with alternative manufacturers on commercially reasonable terms, if at all;

 

long lead times are often needed to manufacture drugs;

 

the manufacturing process is complex and may require a significant learning curve; and

 

the FDA must approve any replacement prior to manufacturing, which requires new testing and compliance inspections.

 

Our contract manufacturers are subject to significant regulation with respect to the manufacturing of our products.

 

All entities involved in the preparation of a product candidate for clinical trials or commercial sale, including our contract manufacturing organizations used for bulk product manufacturing and filling and finishing of our bulk product, are subject to extensive regulation. Components of a finished product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP. These regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of any regulatory approval of our product candidates. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted.

 

The regulatory authorities also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party contractors or raw material suppliers. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, the relevant regulatory authority may require remedial measures that may be costly and time-consuming to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Our third-party contractors or raw material suppliers may refuse to implement remedial measures required by regulatory authorities. Any failure to comply with applicable manufacturing regulations or failure to implement required remedial measures imposed upon third parties with whom we contract could materially harm our business.

 

We rely on relationships with third-party contract manufacturers and raw material suppliers, which limits our ability to control the availability of, and manufacturing costs for, our product candidates.

 

Problems with any of our contract manufacturers’ or raw material suppliers’ facilities or processes, could prevent or delay the production of adequate supplies of finished products. This could delay clinical trials or delay and reduce commercial sales and materially harm our business. Any prolonged delay or interruption in the operations of our collaborators’ facilities or contract manufacturers’ facilities could result in cancellation of shipments, loss of components in the process of being manufactured or a shortfall in availability of a product candidate or products. A number of factors could cause interruptions, including, but not limited to:

 

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the inability of a supplier to provide raw materials;

 

equipment malfunctions or failures at the facilities of our collaborators or suppliers;

 

high process failure rates;

 

damage to facilities due to natural or man-made disasters;

 

changes in regulatory requirements or standards that require modifications to our or our collaborators’ and suppliers’ manufacturing processes;

 

action by regulatory authorities or by us that results in the halting or slowdown of production of components or finished product at our facilities or the facilities of our collaborators or suppliers;

 

problems that delay or prevent manufacturing technology transfer to another facility, contract manufacturer or collaborator with subsequent delay or inability to start up a commercial facility;

 

a contract manufacturer or supplier going out of business, undergoing a capacity shortfall or otherwise failing to produce product as contractually required;

 

employee or contractor misconduct or negligence; and

 

shipping delays, losses or interruptions; and other similar factors.

 

Because manufacturing processes are complex and are subject to a lengthy regulatory approval process, alternative qualified production capacity and sufficiently trained or qualified personnel may not be available on a timely or cost-effective basis or at all. Difficulties or delays in our contract manufacturers' production of drug substances could delay our clinical trials, increase our costs, damage our reputation and cause us to lose revenue and market share if we are unable to timely meet market demand for any products that are approved for sale.

 

The manufacturing process for our product candidates has several components that are sourced from a single manufacturer. If we utilize an alternative manufacturer or alternative component, we may be required to demonstrate comparability of the drug product before releasing the product for clinical use and we may not be to find an alternative supplier.

 

Further, if our contract manufacturers are not in compliance with regulatory requirements at any stage, including post-marketing approval, we may be fined, forced to remove a product from the market and/or experience other adverse consequences, including delays, which could materially harm our business.

 

Even if one of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

 

Physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market. Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch therapies due to lack of reimbursement for existing therapies.

 

Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful. If any of our product candidates is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

 

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the efficacy and safety of the product;

 

the potential advantages of the product compared to competitive therapies;

 

the prevalence and severity of any side effects;

 

the clinical indications for which the product is approved;

 

whether the product is designated under physician treatment guidelines as a first-, second- or third-line therapy;

 

the product’s convenience and ease of administration compared to alternative treatments;

 

the willingness of the target patient population to try, and of physicians to prescribe, the product;

 

limitations or warnings, including distribution or use restrictions contained in the product’s approved labeling;

 

the approval of other new products for the same indications;

 

changes in the standard of care for the targeted indications for the product; and

 

availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.

 

Our future growth depends on our ability to successfully commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and our other product candidates, and we can provide no assurance that we will successfully commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and other product candidates.

 

Our future growth depends on our ability to successfully commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and our other product candidates, including our ability to:

 

  conduct additional clinical trials and develop and obtain regulatory approval for Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir or other product candidates;

 

  successfully partner a companion genetic test (if required by the FDA) with the commercialization of Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications and Celgosivir;

 

  pursue additional indications for Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications and Celgosivir and develop other product candidates, including other therapies; and

 

  obtain commercial quantities of Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications and Celgosivir or other product candidates at acceptable cost levels.

 

Any one of these or other factors could affect our ability to successfully commercialize products.

 

If approved by the FDA, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, and Celgosivir, will be entering a competitive marketplace and may not succeed.

 

Our commercial opportunity may be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications and Celgosivir. If products with any of these properties are developed, or any of the existing products are better marketed, then Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications and Celgosivir could be rendered obsolete and noncompetitive. Further, public announcements regarding the development of any such competing drugs could adversely affect the market price of our common stock and the value of our assets.

 

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State-specific regulatory activities may negatively affect our business.

 

In the United States, individual state governments regulate certain aspects of the pharmaceutical industry including price transparency, requirements in some cases to obtain state licenses, compliance with cGMPs, and for environmental stewardship/take-back programs. For distribution of Arakoda, we have employed a “title model” approach to distribution which limits the extent of state licenses required, and we have contracted with third-party organizations to ensure we are participating in appropriate stewardship/take programs, and have complied (or have a process in place to comply) with state licensing/price transparency requirements that we are aware of. However, we cannot guarantee that we will be compliant with all state regulations, or that we will become aware of and act on any new requirements (which are constantly changing) in time to ensure 100% compliance at all times. State compliance is expensive and new requirements may impose new costs we were not previously aware of.

 

Health care reform measures could materially and adversely affect our business.

 

The business and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of governmental and third-party payors to contain or reduce the costs of health care. The U.S. Congress has enacted legislation to reform the health care system. While we anticipate that this legislation may, over time, increase the number of patients who have insurance coverage for pharmaceutical products, it also imposes cost containment measures that may adversely affect the amount of reimbursement for pharmaceutical products. These measures include increasing the minimum rebates for products covered by Medicaid programs and extending such rebates to drugs dispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations as well as expansion of the 340(B) Public Health Services drug discount program. In addition, such legislation contains a number of provisions designed to generate the revenues necessary to fund the coverage expansion, including new fees or taxes on certain health-related industries, including medical device manufacturers. Each medical device manufacturer has to pay an excise tax (or sales tax) in an amount equal to 2.3% of the price for which such manufacturer sells its medical devices. Such excise taxes may impact any potential sales of the genetic test if it is approved for marketing. On January 22, 2018, legislation was enacted suspending the medical device tax in 2018 and 2019. In December 2019, a permanent repeal of the medical device tax was enacted. The Celgosivir test is likely to be subject to this tax if this tax is reinstated in the future. In foreign jurisdictions there have been, and we expect that there will continue to be, a number of legislative and regulatory proposals aimed at changing the health care system. For example, in some countries other than the United States, pricing of prescription drugs is subject to government control and we expect to see continued efforts to reduce healthcare costs in international markets.

 

In August 2022, the Inflation Reduction Act of 2022 was signed into law. This law requires the federal government to negotiate prices for a small number of high-cost drugs covered under Medicare, requires drug manufacturers to pay rebates to Medicare if they increase prices faster than inflation for drugs used by Medicare beneficiaries, and caps Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit. This legislation could create more demand for negotiated drug prices and further government control of prescription drug pricing. Future legal restrictions regarding our ability to price our drugs could affect our revenues and our business going forward.

 

Additionally, federal, state and local governments continue to consider legislation to limit the growth of healthcare costs, including the cost of prescription drugs and combination products. Since 2017, several states and local governments have either implemented or are considering implementation of price transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies. If adequate reimbursement levels are not maintained by government and other third-party payers for our products, our ability to sell our products may be limited and our ability to establish acceptable pricing levels may be impaired, thereby reducing anticipated revenues and profitability. Further, the pace of change and varying demands of state requirements may render it very difficult to comply with these various laws, and failure to comply with these regulations could expose us to substantial financial penalties and the potential for adverse publicity.

 

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Some states are also considering legislation that would control the prices of drugs, and state Medicaid programs are increasingly requesting manufacturers to pay supplemental rebates and requiring prior authorization by the state program for use of any drug for which supplemental rebates are not being paid. Managed care organizations continue to seek price discounts and, in some cases, to impose restrictions on the coverage of particular drugs. Government efforts to reduce Medicaid expenses may lead to increased use of managed care organizations by Medicaid programs. This may result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and reimbursement for drugs. It is likely that federal and state legislatures and health agencies will continue to focus on additional health care reform in the future although we are unable to predict what additional legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be enacted in the future or what effect such legislation or regulation would have on our business. We or any strategic partner’s ability to commercialize Celgosivir, or any other product candidates that we may seek to commercialize, is highly dependent on the extent to which coverage and reimbursement for these product candidates will be available from government payors, such as Medicare and Medicaid, private health insurers, including managed care organizations, and other third-party payors, and any change in reimbursement levels could materially and adversely affect our business. Further, the pendency or approval of future proposals or reforms could result in a decrease in our stock price or limit our ability to raise capital or to obtain strategic partnerships or licenses.

 

Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

 

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we have established, comply with federal and state health-care fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

 

Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal, and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.

 

Our competitors may be better positioned in the marketplace and thereby may be more successful than us at developing, manufacturing and marketing approved products.

 

Many of our competitors currently have significantly greater financial resources and expertise in conducting clinical trials, obtaining regulatory approvals, and managing manufacturing and marketing approved products than us. Other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. In addition, these third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring therapies and therapy licenses complementary to our programs or advantageous to our business. We expect that our ability to compete effectively will depend upon our ability to:

 

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successfully and rapidly complete clinical trials for any product candidates and obtain all requisite regulatory approvals in a cost-effective manner;

 

build an adequate sales and marketing infrastructure, raise additional funding, or enter into strategic transactions enabling the commercialization of our products;

 

develop competitive formulations of our product candidates;

 

attract and retain key personnel; and

 

identify and obtain other product candidates on commercially reasonable terms.

 

We compete in an industry characterized by extensive research and development efforts and rapid technological progress. New discoveries or commercial developments by our competitors could render our potential products obsolete or non-competitive.

 

New developments occur and are expected to continue to occur at a rapid pace in our industry, and there can be no assurance that discoveries or commercial developments by our competitors will not render some or all of our potential products obsolete or non-competitive, which could have a material adverse effect on our business, financial condition and results of operations. New data from commercial and clinical-stage products continue to emerge and it is possible that these data may alter current standards of care, completely precluding us from further developing our product candidates or preventing us from getting them approved by regulatory agencies. Further, it is possible that we may initiate a clinical trial or trials for our product candidates, only to find that data from competing products make it impossible for us to complete enrollment in these trials, resulting in our inability to file for marketing approval with regulatory agencies. Even if these products are approved for marketing in a particular indication or indications, they may have limited sales due to particularly intense competition in these markets.

 

We expect to compete with fully integrated and well-established pharmaceutical and biotechnology companies in the near- and long-term. Most of these companies have substantially greater financial, research and development, manufacturing and marketing experience and resources than we do and represent substantial long-term competition for us. Such companies may succeed in discovering and developing pharmaceutical products more rapidly than we do or pharmaceutical products that are safer, more effective or less costly than any that we may develop. Such companies also may be more successful than we are in manufacturing, sales and marketing. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and established biotechnology companies. Academic institutions, governmental agencies and other public and private research organizations also conduct clinical trials, seek patent protection and establish collaborative arrangements for the development of product candidates.

 

We expect competition among products will be based on product efficacy and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales capabilities, reimbursement coverage, price and patent position. There can be no assurance that our competitors will not develop safer and more effective products, commercialize products earlier than we do, or obtain patent protection or intellectual property rights that limit our ability to commercialize our products.

 

There can be no assurance that our issued patents or pending patent applications, if issued, will not be challenged, invalidated or circumvented or that the rights granted thereunder will provide us with proprietary protection or a competitive advantage.

 

We would be subject to applicable regulatory approval requirements of the foreign countries in which we market our products, which are costly and may prevent or delay us from marketing our products in those countries.

 

In addition to regulatory requirements in the United States, we would be subject to the regulatory approval requirements in each foreign country where we market our products. Also, we might be required to identify one or more collaborators in these foreign countries to develop, seek approval for and manufacture our products and any companion genetic test that may be required for Arakoda or Celgosivir. If we decide to pursue regulatory approvals and commercialization of our product candidates internationally, we may not be able to obtain the required foreign regulatory approvals on a timely basis, if at all, and any failure to do so may cause us to incur additional costs or prevent us from marketing our products in foreign countries, which may have a material adverse effect on our business, financial condition and results of operations.

 

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Failure to comply with data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

 

We and our partners may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws and regulations (e.g., Section 5 of the FTC Act of 1914), that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

 

In addition, the California Consumer Privacy Act, as amended (“CCPA”), became effective on January 1, 2020. The CCPA gives California residents expanded rights to access and delete their personal information (subject to certain exceptions), opt out of certain personal information sharing, correct inaccurate personal information that a business has about them and limit the use and disclosure of sensitive personal information collected about them and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information and the right not to be discriminated against for exercising these rights. The CCPA also gives consumers the right to request disclosure of information collected about them and whether that information has been sold or shared with others.

 

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Although there are limited exemptions for clinical trial data and the CCPA’s implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, the CCPA may increase our compliance costs and potential liability. Many similar privacy laws have been proposed at the federal level and in other states.

 

Foreign data protection laws, including, without limitation, the European Union Directive 95/46/EC, or the Directive, and the European Union’s General Data Protection Regulation (“GDPR”), that became effective in May 2018, and member state data protection legislation, may also apply to health-related and other personal information obtained outside of the United States. These laws impose strict obligations on the ability to process health-related and other personal information of data subjects in the European Union and the United Kingdom, including in relation to use, collection, analysis, and transfer (including cross-border transfer) of such personal information. These laws include several requirements relating to the consent of the individuals to whom the personal data relates, limitations on data processing, establishing a legal basis for processing, notification of data processing obligations or security incidents to appropriate data protection authorities or data subjects, the security and confidentiality of the personal data and various rights that data subjects may exercise.

 

The Directive and the GDPR prohibit, without an appropriate legal basis, the transfer of personal data to countries outside of the European Economic Area (“EEA”), such as the United States, which are not considered by the European Commission to provide an adequate level of data protection. Switzerland has adopted similar restrictions. Although there are legal mechanisms to allow for the transfer of personal data from the EEA and Switzerland to the United States, uncertainty about compliance with European Union data protection laws remains. For example, ongoing legal challenges in Europe to the mechanisms allowing companies to transfer personal data from the EEA to the United States could result in further limitations on the ability to transfer personal data across borders, particularly if governments are unable or unwilling to reach new or maintain existing agreements that support cross-border data transfers, such as the European Union-U.S. and Swiss-U.S. Privacy Shield framework. Additionally, other countries have passed or are considering passing laws requiring local data residency.

 

Under the GDPR, regulators may impose substantial fines and penalties for non-compliance. Companies that violate the GDPR can face fines of up to the greater of 20 million Euros or 4% of their worldwide annual turnover (revenue). The GDPR increases our responsibility and potential liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR and other EU and international data protection rules.

 

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Compliance with U.S. and foreign privacy and security laws, rules and regulations could require us to take on more onerous obligations in our contracts, require us to engage in costly compliance exercises, restrict our ability to collect, use and disclose data, or in some cases, impact our or our partners’ or suppliers’ ability to operate in certain jurisdictions. Each of these constantly evolving laws can be subject to varying interpretations. Failure to comply with U.S. and foreign data protection laws and regulations could result in government investigations and enforcement actions (which could include civil or criminal penalties), fines, private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, patients about whom we or our partners obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

 

Because we have multiple product candidates in our clinical pipeline and are considering a variety of target indications, we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

 

Because we have limited financial and managerial resources, we must focus our research and development efforts on those product candidates and specific indications that we believe are the most promising. As a result, we may forego or delay our pursuit of opportunities with other product candidates or other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. We may in the future spend our resources on other research programs and product candidates for specific indications that ultimately do not yield any commercially viable products. Furthermore, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights.

 

We must meet post-marketing requirements associated with the Arakoda NDA imposed by the FDA. Failure to complete such requirements, or delays due to lack of resources or other factors, may negatively impact our business.

 

When the FDA approved the Arakoda NDA in August 2018, it imposed post-marketing requirements on us, including associated timelines. We have made substantial progress in meeting all such requirements and recently published data from a clinical trial related to one of them. However, we have experienced delays in our ability to execute our observational and pediatric study requirements and are in discussion with the FDA regarding future plans relating to our pediatric program. We may experience new or additional delays in the future on one or more of its post-marketing requirements in the future. As of the date of this prospectus, we have not received acknowledgement from the FDA that any of the post-marketing requirements are completed nor been referred for enforcement action due to delays in our post-marketing studies. If we fail to meet FDA requirements, experiences additional delays or is referred for enforcement action, we might require diversion of managerial and capital resources from planned research and development to completion of post-marketing requirements, or the FDA might revoke the NDA for Arakoda, and therefore harm the business. In the future, regulators may impose additional post-marketing requirements for Arakoda for malaria or other indications, or in relation to our products. This situation would require expensive clinical or non-clinical studies that might damage our financial position.

 

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.

 

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

 

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Continued uncertain economic conditions, including inflation and the risk of a global recession could impair our ability to forecast and may harm our business, operating results, including our revenue growth and profitability, financial condition and cash flows.

 

The U.S. economy is experiencing the highest rates of inflation since the 1980s. Historically, we have not experienced significant inflation risk in our business. However, our ability to raise our product prices depends on market conditions and there may be periods during which we are unable to fully recover increases in our costs. In addition, the global economy suffers from slowing growth and rising interest rates, and many economists believe that a global recession may begin in the near future. If the global economy slows, our business would likely be adversely affected.

 

Also, the global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, increases in unemployment rates and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Our general business strategy may be adversely affected by any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions.

 

Geopolitical conditions, including direct or indirect acts of war or terrorism, could have an adverse effect on our operations and financial results.

 

Our operations could be disrupted by geopolitical conditions, political and social instability, acts of war, terrorist activity or other similar events. In February 2022, Russia initiated significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates, regional economies and the global economy. The situation remains uncertain, and while it is difficult to predict the impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs, disrupt our supply chain, reduce our sales and earnings, impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

 

We could be subject to lawsuits.

 

We may be party to lawsuits, settlement discussions, mediations, arbitrations and other disputes, including patent and product liability claims, whether brought by companies, individuals or governmental authorities. These matters may result in a loss of patent protection, reduced revenue, incurrence of significant liabilities and diversion of our management’s time, attention and resources. Our insurance coverage may not provide adequate protection against actual losses. In addition, we are subject to the risk that one or more of our insurers may become insolvent and become unable to pay claims that may be made in the future. Even if we maintain adequate insurance, claims could have a material adverse effect on our financial condition, liquidity and results of operations and on our ability to obtain suitable, adequate or cost-effective insurance in the future. Litigation and other disputes, including any adverse outcomes, may have an adverse impact on our business, operations or financial condition. Even claims without merit could subject us to adverse publicity and require us to incur significant legal fees.

 

We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation, the loss of such assets would have a severe negative affect on our operations and liquidity.

 

We may maintain our cash assets at certain financial institutions in the U.S. in amounts that may be in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $250,000. In the event of a failure of any financial institutions where we maintain our deposits or other assets, we may incur a loss to the extent such loss exceeds the FDIC insurance limitation, which could have a material adverse effect upon our liquidity, financial condition and our results of operations.

 

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Risks Related to Intellectual Property and Other Legal Matters

 

If product liability lawsuits are successfully brought against us, then we will incur substantial liabilities and may be required to limit commercialization of Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir or other product candidates.

 

We may face product liability exposure related to the testing of our product candidates in human clinical trials, and may face exposure to claims by an even greater number of persons once we begin marketing and distributing our products commercially. If we cannot successfully defend against product liability claims, then we will incur substantial liabilities.

 

Regardless of merit or eventual outcome, liability claims may result in:

 

decreased demand for our products and product candidates;

 

injury to our reputation;

 

withdrawal of clinical trial participants;

 

costs of related litigation;

 

substantial monetary awards to patients and others;

 

loss of revenues; and

 

the inability to commercialize our products and product candidates.

 

We have obtained limited product liability insurance coverage. Such coverage, however, may not be adequate or may not continue to be available to us in sufficient amounts or at an acceptable cost, or at all. We may not be able to obtain commercially reasonable product liability insurance for any product candidate.

 

Defending against claims relating to improper handling, storage or disposal of hazardous chemicals, radioactive or biological materials could be time consuming and expensive.

 

Our research and development of product candidates may involve the controlled use of hazardous materials, including chemicals, radioactive and biological materials. We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from the materials. Various laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. We may be sued or be required to pay fines for any injury or contamination that results from our use or the use by third parties of these materials. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development and production efforts.

 

Third parties may own or control patents or patent applications that we may be required to license to commercialize our product candidates or that could result in litigation that would be costly and time consuming.

 

Our or any strategic partner’s ability to commercialize Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir and other product candidates depends upon our ability to develop, manufacture, market and sell these drugs without infringing the proprietary rights of third parties. A number of pharmaceutical and biotechnology companies, universities and research institutions have or may be granted patents that cover technologies similar to the technologies owned by or licensed to us. We may choose to seek, or be required to seek, licenses under third-party patents, which would likely require the payment of license fees or royalties or both. We may also be unaware of existing patents that may be infringed by Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications or Celgosivir, the genetic testing we intend to use in connection with Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir or our other product candidates. Because patent applications can take many years to issue, there may be other currently pending applications that may later result in issued patents that are infringed by Arakoda, Tafenoquine (Arakoda or other regimen) for non-malaria prevention indications, Celgosivir or our other product candidates. Moreover, a license may not be available to us on commercially reasonable terms, or at all.

 

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There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a third-party claims that we are infringing on its technology, then our business and results of operations could be harmed by a number of factors, including:

 

infringement and other intellectual property claims, even if without merit, are expensive and time-consuming to litigate and can divert management’s attention from our core business;

 

monetary damage awards for past infringement can be substantial;

 

a court may prohibit us from selling or licensing product candidates unless the patent holder chooses to license the patent to us; and

 

if a license is available from a patent holder, we may have to pay substantial royalties.

 

We may also be forced to bring an infringement action if we believe that a competitor is infringing our protected intellectual property. Any such litigation will be costly, time-consuming and divert management’s attention, and the outcome of any such litigation may not be favorable to us.

 

Our intellectual property rights may not preclude competitors from developing competing products and our business may suffer.

 

Our competitive success will depend, in part, on our ability to obtain and maintain patent protection for our inventions, technologies and discoveries, including intellectual property that we license. The patent positions of biotechnology companies involve complex legal and factual questions, and we cannot be certain that our patents and licenses will successfully preclude others from using our technology. Consequently, we cannot be certain that any of our patents will provide significant market protection or will not be circumvented or challenged and found to be unenforceable or invalid. In some cases, patent applications in the United States and certain other jurisdictions are maintained in secrecy until patents issue, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain of the priority of inventions covered by pending patent applications. An adverse outcome could subject us to significant liabilities to third parties, require disputed rights to be licensed from third parties or require us to cease using such technology. Regardless of merit, the listing of patents in the FDA Orange Book for Arakoda, Celgosivir may be challenged as being improperly listed. We may have to defend against such claims and possible associated antitrust issues. We could also incur substantial costs in seeking to enforce our proprietary rights against infringement.

 

We may not be able to effectively protect our intellectual property rights in some foreign countries, as our patents are limited by jurisdiction and many countries do not offer the same level of legal protection for intellectual property as the United States.

 

We require our employees, consultants, business partners and members of our scientific advisory board to execute confidentiality agreements upon the commencement of employment, consulting or business relationships with us. These agreements provide that all confidential information developed or made known during the course of the relationship with us be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions resulting from work performed for us, utilizing the property or relating to our business and conceived or completed by the individual during employment shall be our exclusive property to the extent permitted by applicable law.

 

Third parties may breach these and other agreements with us regarding our intellectual property and we may not have adequate remedies for the breach. Third parties could also fail to take necessary steps to protect our licensed intellectual property, which could seriously harm our intellectual property position.

 

If we are not able to protect our proprietary technology, trade secrets and know-how, then our competitors may develop competing products. Any issued patent may not be sufficient to prevent others from competing with us. Further, we have trade secrets relating to Arakoda, Celgosivir, and such trade secrets may become known or independently discovered. Our issued patents and those that may issue in the future, or those licensed to us, may be challenged, opposed, invalidated or circumvented, which could allow competitors to market similar products or limit the patent protection term of our product candidates. All of these factors may affect our competitive position.

 

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If the manufacture, use or sale of our products infringe on the intellectual property rights of others, we could face costly litigation, which could cause us to pay substantial damages or licensing fees and limit our ability to sell some or all of our products.

 

Extensive litigation regarding patents and other intellectual property rights has been common in the biopharmaceutical industry. Litigation may be necessary to assert infringement claims, enforce patent rights, protect trade secrets or know-how and determine the enforceability, scope and validity of certain proprietary rights. Litigation may even be necessary to defend disputes of inventorship or ownership of proprietary rights. The defense and prosecution of intellectual property lawsuits, U.S. Patent and Trademark Office interference proceedings, and related legal and administrative proceedings (e.g., a re-examination, inter partes review, or post-grant review) in the United States and internationally involve complex legal and factual questions. As a result, such proceedings are costly and time-consuming to pursue, and their outcome is uncertain.

 

Regardless of merit or outcome, our involvement in any litigation, interference or other administrative proceedings could cause us to incur substantial expense and could significantly divert the efforts of our technical and management personnel. Any public announcements related to litigation or interference proceedings initiated or threatened against us could cause our stock price to decline. Adverse outcomes in patent litigation may potentially subject us to antitrust litigation which, regardless of the outcome, would adversely affect our business. An adverse determination may subject us to the loss of our proprietary position or to significant liabilities, or require us to seek licenses that may include substantial cost and ongoing royalties. Licenses may not be available from third parties, or may not be obtainable on satisfactory terms. An adverse determination or a failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling our products, if any. These outcomes could materially harm our business, financial condition and results of operations.

 

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

 

Changes in either the patent laws or interpretation of the patent laws in the United States and Ex-US could increase the uncertainties and costs. Recent patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), signed into law in the United States on September 16, 2011, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first inventor to file system in which, assuming that the other statutory requirements are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third-party was the first to invent the claimed invention. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

 

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The patent protection and patent prosecution for some of our product candidates is dependent or may be dependent in the future on third parties.

 

While we normally seek and gain the right to fully prosecute the patents relating to our product candidates, there may be times when platform technology patents or product-specific patents that relate to our product candidates are controlled by our licensors. In addition, our licensors and/or licensees may have back-up rights to prosecute patent applications in the event that we do not do so or choose not to do so, and our licensees may have the right to assume patent prosecution rights after certain milestones are reached. If any of our licensing collaborators fails to appropriately prosecute and maintain patent protection for patents covering any of our product candidates, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using and selling competing products.

 

We may not be able to protect our intellectual property rights throughout the world.

 

Patents are of national or regional effect, and filing, prosecuting and defending patents on all of our product candidates throughout the world would be prohibitively expensive. As such, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Further, the legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals or biologics, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. In addition, certain developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third-party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

 

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

 

Patent rights are of limited duration. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such product candidates are commercialized. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products. A patent term extension based on regulatory delay may be available in the U.S. However, only a single patent can be extended for each marketing approval, and any patent can be extended only once, for a single product. Moreover, the scope of protection during the period of the patent term extension does not extend to the full scope of the claim, but instead only to the scope of the product as approved. Laws governing analogous patent term extensions in foreign jurisdictions vary widely, as do laws governing the ability to obtain multiple patents from a single patent family. Additionally, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. If we are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product will be shortened and our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially.

 

The earliest Paragraph IV certification date for Arakoda has passed. Generic companies may file an ANDA at any time, and successful challenge of our malaria use patents would negatively impact our business.

 

The PDUFA date for Arakoda is August 8, 2018, and the beginning date for exclusivity associated with the product’s API is July 20, 2018. The five-year data exclusivity ending date for Arakoda is July 20, 2023. Therefore, the earliest date a generic company could file an ANDA, claiming such an application does not infringe our Orange Book listed patents was July 20, 2022. Any generic company filing such an abbreviated new drug application (“ANDA”) with FDA, must notify us within 20 calendar days of receiving acknowledgement from the FDA or receipt of such an ANDA. Thus, the earliest date we could receive such a notification was August 9, 2022.

 

As of the date of this prospectus, to the best of our knowledge, no such notice has been received by us. However, such a notice might be received at any time. Such a notice might require us to undertake expensive litigation to defend our patents related to Arakoda’s malaria indication, thereby diverting funds away from critical research and development efforts for Tafenoquine (Arakoda or other regimen) for other indications. This potential litigation and the related expenditure may harm our business. Additionally, the approval of any ANDA would increase competition and most likely drive down prices for Arakoda.

 

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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

 

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our product candidates, our competitive position would be adversely affected.

  

Risks Related to this Offering

 

Our management will have broad discretion over the use of any net proceeds from this offering and you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

 

Our management will have broad discretion as to the use of any net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering and in ways that do not necessarily improve our results of operations or enhance the value of our common stock. Accordingly, you will be relying on the judgment of our management with regard to the use of any proceeds from this offering and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return for you.

 

Investors in this offering may experience future dilution as a result of this and future equity offerings.

 

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock. Investors purchasing our shares or other securities in the future could have rights superior to existing common stockholders, and the price per share at which we sell additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price per Unit in this offering.

 

If we issue shares of preferred stock your rights as a holder of our common stock or warrants may be materially adversely affected.

  

As of the date of this prospectus, we are authorized to issue up to 1,000,000 shares of “blank check” preferred stock. Upon the consummation of this offering, we will have authorized shares of 80,965 Series A Preferred Stock, of which 80,965 shares of Series A Preferred Stock will be issued and outstanding. The designations, rights and preferences of our other preferred stock may be determined from time-to-time by our Board. Accordingly, our Board is empowered, without stockholder approval, to issue one or more series of preferred stock with dividend, liquidation, conversion, voting or other rights superior to those of the holders of our common stock. For example, an issuance of shares of preferred stock could:

 

adversely affect the voting power of the holders of our common stock;

 

  make it more difficult for a third-party to gain control of us;

 

discourage bids for our common stock;

 

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limit or eliminate any payments that the holders of our common stock could expect to receive upon our liquidation; or

 

adversely affect the market price of our common stock.

 

Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock.

 

Sales of a substantial number of shares of our common stock in the public markets could depress the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities. We cannot predict the effect that future sales of our common stock would have on the market price of our common stock. 

 

Existing stockholders may sell significant quantities of common stock.

 

The existing shareholders will own 74.6% of our common stock following the successful completion of this offering. Notwithstanding that certain of our officers and directors who are shareholders will be locked up for a period of six months, and any greater than 5% holders of our common stock will also be locked up for a period of six months, following the completion of this offering, our existing stockholders may have acquired their shares at a lower price than that of this offering. Accordingly, they may be incentivized to sell all or part of their holdings as soon as any applicable transfer restrictions have ended and such sales could have a negative impact on the market price of our common stock. In addition, large number of sales of our common stock by the selling stockholders named in the Resale Prospectus could depress the market price of our common stock and make it more difficult to sell your shares of our common stock.

 

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

 

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Several analysts may cover our stock. If one or more of those analysts downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

 

The requirements of being a public company.

 

As a public company, we will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act, (the “Dodd-Frank Act”) and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight may be required. As a result, management’s attention may be diverted from other business concerns, which could harm our business and operating results. We may need to hire more employees in the future to comply with these requirements, which will increase our costs and expenses.

 

In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

 

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We also expect that being a public company and these new rules and regulations will make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors (“Board”) and qualified executive officers.

 

As a result of disclosure of information in this prospectus and in filings required of a public company, our business and financial condition will become more visible, which we believe may result in increased threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and operating results could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business and operating results.

 

Risks Relating to Ownership of Our Securities

 

There has been no public market for our common stock or Tradeable Warrants prior to this offering, and we cannot assure you that an active trading market will develop in the near future.

 

Prior to this offering, there has been no public market for our common stock or Tradable Warrants. All investments in securities involve the risk of loss of capital. No guarantee or representation is made that an investor will receive a return of its capital. The value of our common stock or Tradeable Warrants can be adversely affected by a variety of factors, including development problems, regulatory issues, technical issues, commercial challenges, competition, legislation, government intervention, industry developments and trends, and general business and economic conditions. We cannot predict the extent to which an active market for our common stock or Tradeable Warrants will develop or be sustained after this offering, or how the development of such a market might affect the market price of our common stock.

 

The public price of our common stock may be volatile, and could, following a sale decline significantly and rapidly.

 

The initial public offering price for the Units will be determined by negotiations between us and the underwriters and may not be indicative of prices that will prevail in the open market following this offering. The market price of our common stock may decline below the initial offering price, and you may not be able to sell your shares of our common stock at or above the price you paid in the offering, or at all. Following this offering, the public price of our common stock in the secondary market will be determined by private buy and sell transaction orders collected from broker-dealers.

 

In addition, the stock market in general has experienced significant price and volume fluctuations that have often been unrelated or disproportionate to operating performance of individual companies, particularly following an initial public offering of a company with a small public float. There is the potential for rapid and substantial price volatility of our common stock following this offering. These broad market factors may seriously harm the market price of our common stock, regardless of our actual or expected operating performance and financial condition or prospects, which may make it difficult for investors to assess the rapidly changing value of our common stock. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A class action suit against us could result in significant liabilities and, regardless of the outcome, could result in substantial costs and the diversion of our management’s resources and attention.

 

Stock price run-ups followed by rapid price declines and stock price volatility may also be completely unrelated to company performance. Such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our stock.

 

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A possible “short squeeze” due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

 

Following this offering, investors may purchase our common stock to hedge existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders of our common stock. Those repurchases may in turn dramatically increase the price of our common stock until investors with short exposure are able to purchase additional shares of common stock to cover their short position. This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects of our Company and once investors purchase the shares of common stock necessary to cover their short position, the price of our common stock may decline.

 

We may not be able to satisfy listing requirements of Nasdaq to maintain a listing of our common stock or Tradeable Warrants.

 

If our common stock and Tradeable Warrants are listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain such listing. If we violate the maintenance requirements for continued listing of our common stock and Tradeable Warrants, our common stock and Tradeable Warrants may be delisted. Nasdaq requires us to have a minimum amount of shareholders’ equity of $5 million in order to maintain our listing. Currently, our adjusted, pro forma shareholders’ equity is $9,616,852. In January of 2023, we entered into service agreements with Kentucky Technology Inc., Florida State University Research Foundation, Inc., Trevally, LLC, and Carmel, Milazzo & Feil LLP in which these entities received 525,000, 405,000, 120,000 and 100,000 shares, respectively. As required by accounting guidance, since the services for which these shares were issued as consideration had not yet been performed, they were booked as prepaid assets with a value equivalent to the value of the shares issued. Since the value of the shares issued by us was estimated to be $5 per share, the to-be-provided services resulted in a relative change of shareholders’ equity of $5,750,000. As the services are performed, they will be recorded on our financial statements as expenses, and the value of the pre-paid research asset will decline, thereby reducing shareholders’ equity. Therefore, if all of these agreements for some reason were cancelled, or all of the services to be performed were performed ahead of schedule, we would be required to expense the cost of lost or completed services, thereby resulting in a decline in shareholders’ equity below that required for Nasdaq listing requirements, thereby potentially resulting in delisting. A delisting of our common stock or Tradeable Warrants from Nasdaq may materially impair our stockholders’ ability to buy and sell our common stock or Tradeable Warrants and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock and Tradeable Warrants. In addition, the delisting of our common stock or Tradeable Warrants could significantly impair our ability to raise capital. Also, our Board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. Although we expect our common stock and Tradeable Warrants will be approved for listing on Nasdaq and that we will satisfy maintenance requirements for the continued listing of our common stock and Tradeable Warrants in the near future, an active trading market for our shares or Tradeable Warrants may never develop or be sustained following this offering.

 

There is no public market for the Non-tradeable Warrants being offered in this offering.

 

There is no public trading market for the Non-tradeable Warrants offered by this prospectus, and we do not expect a market to develop. In addition, we do not intend to apply to list the Non-tradeable Warrants on any exchange or market. Without an active market, the liquidity of the Non-tradeable Warrants will be limited.

 

Warrants are speculative in nature.

 

The warrants offered in this offering do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of our common stock at a fixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the Tradeable Warrants may exercise their right to acquire the common stock and pay an exercise price of $6.095 per share (115% of the offering price per Unit), from time to time, until the fifth anniversary from the date of issuance, after which date any unexercised Tradeable Warrants will expire and have no further value. Also, commencing on the date of issuance, holders of the Non-tradeable Warrants may exercise their right to acquire the common stock and pay an exercise price of $6.36 per share (120% of the offering price per Unit), from time to time, until the fifth anniversary from the date of issuance, after which date any unexercised Non-tradeable Warrants will expire and have no further value. In addition, there is no established trading market for the Non-tradeable Warrants.

 

Since the warrants are executory contracts, they may have no value in a bankruptcy or reorganization proceeding.

 

In the event a bankruptcy or reorganization proceeding is commenced by or against us, a bankruptcy court may hold that any unexercised warrants are executory contracts that are subject to rejection by us with the approval of the bankruptcy court. As a result, holders of the warrants may, even if we have sufficient funds, not be entitled to receive any consideration for their warrants or may receive an amount less than they would be entitled to if they had exercised their warrants prior to the commencement of any such bankruptcy or reorganization proceeding.

 

Holders of our warrants will have no rights as a common stockholder until they acquire our common stock.

 

Until investors acquire shares of our common stock upon exercise of the warrants being offered in this offering, they will have no rights with respect to our common stock such as voting rights or the right to receive dividends. Upon exercise of such warrants, holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

 

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Provisions of the warrants offered by this prospectus could discourage an acquisition of us by a third-party.

 

Certain provisions of the warrants offered by this prospectus could make it more difficult or expensive for a third-party to acquire us. The warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the warrants. These and other provisions of the warrants offered by this prospectus could prevent or deter a third-party from acquiring us even where the acquisition could be beneficial to you.

 

If we do not file and maintain a current and effective prospectus relating to the common stock issuable upon exercise of the warrants, holders will only be able to exercise such warrants on a “cashless basis.”

 

If we do not file and maintain a current and effective registration statement relating to the common stock issuable upon exercise of the warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them on a “cashless basis” provided that an exemption from registration is available. As a result, the number of shares of common stock that holders will receive upon exercise of the warrants will be fewer than it would have been had such holder exercised his, her or its warrants for cash. Further, if an exemption from registration is not available, holders would not be able to exercise on a cashless basis and would only be able to exercise their warrants for cash if a current and effective registration statement relating to the common stock issuable upon exercise of the warrants is available. Under the terms of the underwriting agreement, we have agreed to use our best efforts to meet these conditions and to file and maintain a current and effective registration statement relating to the common stock issuable upon exercise of the warrants until the expiration of the warrants. However, we cannot assure you that we will be able to do so. If we are unable to do so, the potential “upside” of the holder’s investment in our Company may be reduced or the warrants may expire worthless.

  

We may amend the terms of the warrants in a way that may be adverse to holders with the approval by the holders of a majority of the then outstanding warrants.

 

The Warrant Agent Agreement provides that the terms of the warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision. All other modifications or amendments, including any amendment to increase the exercise price of the warrants or shorten the exercise period of the warrants, shall require the written consent of the registered holders of a majority of the then outstanding warrants which may be contrary to your interests.

 

The warrants may have an adverse effect on the market price of our common stock and make it more difficult to effect a business combination.

 

We will be issuing warrants to purchase shares of common stock as part of this offering. To the extent we issue shares of common stock to effect a future business combination, the potential for the issuance of a substantial number of additional shares upon exercise of the warrants could make us a less attractive acquisition vehicle in the eyes of a target business. Such warrants, when exercised, will increase the number of issued and outstanding shares of common stock and reduce the value of the shares issued to complete the business combination. Accordingly, the warrants may make it more difficult to effectuate a business combination or increase the cost of acquiring a target business. Additionally, the sale, or even the possibility of a sale, of the shares of common stock underlying the warrants could have an adverse effect on the market price for our securities or on our ability to obtain future financing. If and to the extent the warrants are exercised, you may experience dilution to your holdings.

 

Our Warrant Agent Agreement designate the courts of the State of New York or the United States District Court for the Southern District of New York as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of our warrants, which could limit the ability of warrant holders to obtain a favorable judicial forum for disputes with our Company.

 

Our Warrant Agent Agreement provides that, subject to applicable law, (i) any action, proceeding or claim against us arising out of or relating in any way to the Warrant Agent Agreement, including under the Securities Act, will be brought and enforced in the courts of the State of New York or the United States District Court for the Southern District of New York, and (ii) that we irrevocably submit to such jurisdiction, which jurisdiction shall be the exclusive forum for any such action, proceeding or claim. We will waive any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum.

 

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Notwithstanding the foregoing, these provisions of the Warrant Agent Agreement do not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal district courts of the United States of America are the sole and exclusive forum. Any person or entity purchasing or otherwise acquiring any interest in any of our warrants shall be deemed to have notice of and to have consented to the forum provisions in our Warrant Agent Agreement.

 

If any action, the subject matter of which is within the scope of the forum provisions of the Warrant Agent Agreement, is filed in a court other than courts of the State of New York or the United States District Court for the Southern District of New York (a “foreign action”) in the name of any holder of our warrants, such holder shall be deemed to have consented to: (x) the personal jurisdiction of the state and federal courts located in the State of New York in connection with any action brought in any such court to enforce the forum provisions (an “enforcement action”), and (y) having service of process made upon such warrant holder in any such enforcement action by service upon such warrant holder’s counsel in the foreign action as an agent for such warrant holder.

 

This choice-of-forum provision may limit a warrant holder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with our Company, which may discourage such lawsuits. Alternatively, if a court were to find this provision of our Warrant Agent Agreement inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely affect our business, financial condition and results of operations and result in a diversion of the time and resources of our management and Board.

 

We may be subject to securities litigation, which is expensive and could divert our management’s attention.

 

The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns.

 

Our failure to maintain effective internal controls over financial reporting could have an adverse impact on us.

 

We are required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment of our internal controls over financial reporting or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an adverse impact on the price of our common stock.

 

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. In addition, the design of a control system must reflect the fact that there are resource constraints and the benefit of controls must be relative to their costs. Because of the inherent limitations in all control systems, no system of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Further, controls can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.

 

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At present, we are executing a plan to improve existing internal controls by segregating accounting functions through outsourcing. For over 10 years, our Chief Executive Officer and Chief Financial Officer have worked together in a collaborative relationship using budgets to track finances with limited resources. Our management, including our President and Chief Executive Officer, cannot guarantee that our internal controls and disclosure controls that we have in place will prevent all possible errors, mistakes or fraud. If we fail to have effective controls and procedures for financial reporting in place, we could be unable to provide timely and accurate financial information and be subject to investigation by the SEC and civil or criminal sanctions.

 

Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm our stock price.

 

We require significant financial resources to maintain our public reporting status. We cannot assure you we will be able to maintain adequate resources to ensure that we will not have any future material weakness in our system of internal controls. The effectiveness of our controls and procedures may in the future be limited by a variety of factors including:

 

faulty human judgment and simple errors, omissions or mistakes;

 

fraudulent action of an individual or collusion of two or more people;

 

inappropriate management override of procedures; and

 

the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information.

 

Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States of America. Our internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.

 

Despite these controls, because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives. Furthermore, smaller reporting companies like us face additional limitations. Smaller reporting companies employ fewer individuals and can find it difficult to employ resources for complicated transactions and effective risk management. Additionally, smaller reporting companies tend to utilize general accounting software packages that lack a rigorous set of software controls.

 

Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.

 

Because of the exemptions from various reporting requirements provided to us as an “emerging growth company” and because we will have an extended transition period for complying with new or revised financial accounting standards, we may be less attractive to investors and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry. If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

 

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The elimination of personal liability against our directors and officers under Delaware law and the existence of indemnification rights held by our directors, officers and employees may result in substantial expenses.

 

Our certificate of incorporation, as corrected (“Certificate of Incorporation”), and our amended and restated bylaws (“Bylaws”) eliminate the personal liability of our directors and officers to us and our stockholders for damages for breach of fiduciary duty as a director or officer to the extent permissible under Delaware law. Further, our Certificate of Incorporation provides that we are obligated to indemnify each of our directors or officers to the fullest extent authorized by Delaware law. Those indemnification obligations could expose us to substantial expenditures to cover the cost of settlement or damage awards against our directors or officers, which we may be unable to afford. Further, those provisions and resulting costs may discourage us or our stockholders from bringing a lawsuit against any of our current or former directors or officers for breaches of their fiduciary duties, even if such actions might otherwise benefit our stockholders. Note that for liabilities arising under the Securities Act, we have been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

 

You should consult your own independent tax advisor regarding any tax matters arising with respect to the securities offered in connection with this offering.

 

Participation in this offering could result in various tax-related consequences for investors. All prospective purchasers of the resold securities are advised to consult their own independent tax advisors regarding the U.S. federal, state, local and non-U.S. tax consequences relevant to the purchase, ownership and disposition of the resold securities in their particular situations.

 

We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

 

We have never declared or paid cash dividends on our common stock since inception as this is not how an LLC returns capital to its members and do not anticipate paying any cash dividends on our common stock as a C-Corporation in the foreseeable future. Instead, we currently intend to retain any future earnings for working capital and to support the growth and development of our business. Our payment of any future dividends will be at the discretion of our Board after taking into account various factors, including, but not limited to, our earnings, capital requirements, financial condition, prospects, operating results, cash needs, growth plans, applicable Delaware law and any other factors which our Board may deem relevant. Our ability to pay dividends on our common stock may be limited by Delaware state law. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize a return on their investment. Investors seeking cash dividends should not purchase our common stock.

 

We are an “emerging growth company” and a “smaller reporting company” under the JOBS Act, and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.

 

We are an “emerging growth company” and a “smaller reporting company” as defined in the JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” and “smaller reporting companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

 

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition period for complying with new or revised accounting standards.

 

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We will remain an “emerging growth company” until the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act, although we will lose that status sooner if our revenues exceed $1.235 billion, if we issue more than $1 billion in non-convertible debt in a three year period, or if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last day of our most recently completed second fiscal quarter.

 

We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our common stock held by non-affiliates is equal to or less than $250 million as of the last business day of the most recently completed second fiscal quarter, and (ii) our annual revenues is equal to or less than $100 million during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is equal to or less than $700 million as of the last business day of the most recently completed second fiscal quarter.

 

We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. In addition, taking advantage of reduced disclosure obligations may make comparison of our financial statements with other public companies difficult or impossible. If investors are unable to compare our business with other companies in our industry, we may not be able to raise additional capital as and when we need it, which may materially and adversely affect our financial condition and results of operations. 

 

Our Certificate of Incorporation designates the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.

 

Our Certificate of Incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, employee or agent of the Company to the Company or the Company’s stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our Certificate of Incorporation or Bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine, in each case subject to said Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. However, our Certificate of Incorporation states that this exclusive forum provision does not apply to claims arising under federal securities laws. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock shall be deemed to have notice of and to have consented to the provisions of our Certificate of Incorporation as described above.

 

This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims. As such, stockholders of the Company seeking to bring a claim regarding the internal affairs of the Company may be subject to increased costs associated with litigating in Delaware as opposed to their home state or other forum, precluded from bringing such a claim in a forum they otherwise consider to be more favorable, and discouraged from bringing such claims as a result of the foregoing or other factors related to forum selection. Alternatively, if a court were to find the choice of forum provision contained in our Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.

  

We believe these provisions benefit us by providing increased consistency in the application of Delaware law by chancellors particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. However, the provision may have the effect of discouraging lawsuits against our directors, officers, employees and agents as it may limit any stockholder’s ability to bring a claim in a judicial forum that such stockholder finds favorable for disputes with us or our directors, officers, employees or agents. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court could find the choice of forum provisions contained in our Certificate of Incorporation to be inapplicable or unenforceable in such action. If a court were to find the choice of forum provision contained in our Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business, financial condition or results of operations.

 

IN ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT OUR BUSINESS OPERATIONS AND THE VALUE OF OUR SECURITIES.

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this prospectus, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this prospectus relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

 

  Our ability to effectively operate our business segments;

 

  Our ability to manage our research, development, expansion, growth and operating expenses;

 

  Our ability to evaluate and measure our business, prospects and performance metrics;

 

  Our ability to compete, directly and indirectly, and succeed in a highly competitive and evolving industry;

 

  Our ability to respond and adapt to changes in technology and customer behavior;

 

  Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and

 

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  other factors (including the risks contained in the section of this prospectus entitled “Risk Factors”) relating to our industry, our operations and results of operations.

 

Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

 

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

USE OF PROCEEDS

 

We will receive net proceeds of approximately $6,336,726 (or approximately $7,354,855 if the underwriters’ option to purchase additional shares is exercised in full) from the sale of the Units offered by us in this offering, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

The principal purposes of this offering are to increase our capitalization and financial flexibility, increase our visibility in the marketplace and create a public market for our common stock. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. However, we currently intend to use the majority of the net proceeds to us from this offering for executing clinical studies and trials.

 

Our strategic priority is to further develop, through clinical studies and related activities, additional/new indications for our products. Assuming the indicated amount of funds are raised, we anticipate up to $3.2 million ($2.0 million net after giving effect to anticipated research and development tax credits) will be dedicated to financing such efforts. If market conditions permit, the majority of the available funds will be utilized for the execution of a clinical trial to confirm that Arakoda accelerates recovery from COVID-19 symptoms. Other research activities may include new product research, trial design and opening of an IND for the babesiosis indication, protocol preparation for the pediatric post-marketing requirement, study feasibility for a second COVID-19 trial and mechanism of action studies. If market conditions are not conducive clinical trial activities may be postponed, but the activities mentioned in the aforementioned sentence will continue.

 

We plan, as resources permit, to conduct additional research and development activities including execution of animal studies to further evaluate the activities of Tafenoquine against Candida and Celgosivir against COVID-19. We may also conduct a targeted promotional campaign for Arakoda for the malaria indication in the United States.

 

We may also retire the following cash commitments to other parties associated with the public offering: $85,000 Singapore Dollars to the National University of Singapore as a license agreement milestone payment and $100,000 to Biointelect. Both payments are due upon the consummation of this offering and are non-interest bearing.

 

The table below sets forth the manner in which we expect to use the net proceeds we receive from this offering. All amounts included in the table below are estimates.

 

Description   Amount  
Working Capital and General Corporate Purposes   $ 2,411,726  
Debt Repayment   $ 1,925,000  
Research and Development (clinical trials and related activities)   $ 3,400,000  
Anticipated Research and Development Tax Credits   $ 1,400,000  
Total   $ 6,336,726  

 

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The foregoing information is an estimate based on our current business plan. We may find it necessary or advisable to re-allocate portions of the net proceeds reserved for one category to another, and we will have broad discretion in doing so. Pending these uses, we intend to invest the net proceeds of this offering in a money market or other interest-bearing account.

 

DIVIDEND POLICY

 

We have not declared any cash dividends since inception and we do not anticipate paying any dividends in the foreseeable future. Instead, we anticipate that all of our earnings will be used to provide working capital, to support our operations, and to finance the growth and development of our business. The payment of dividends is within the discretion of the Board and will depend on our earnings, capital requirements, financial condition, prospects, operating results, cash needs, growth plans, applicable Delaware law, which provides that dividends are only payable out of surplus or current net profits, and other factors our board might deem relevant. There are no restrictions that currently limit our ability to pay dividends on our common stock other than those generally imposed by applicable state law. 

 

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

 

Prior to this offering, our common stock and warrants have not been listed on any stock exchange or quoted on any over-the-counter market or quotation system and there has been no public market for our common stock or warrants. Our common stock and Tradeable Warrants have been approved for listing on The Nasdaq Capital Market under the symbols “SXTP” and “SXTPW,” respectively. We do not intend to apply for listing of the Non-tradeable Warrants on any exchange or market. For more information see the section “Risk Factors.”

 

As of July 10, 2023, 2,378,009 shares of our common stock were issued and outstanding and were held by fifteen stockholders of record.

 

CAPITALIZATION

 

The following table sets forth our consolidated cash and capitalization, as of March 31, 2023. Such information is set forth on the following basis:

 

on an actual basis;

 

  on a pro forma basis to reflect the (i) receipt of short-term advances from related parties totaling $50,000 after March 31, 2023 but prior to the date of this prospectus, (ii) repayment of the (A) $200,000 short-term advance from the Geoffrey S. Dow Revocable Trust contributed in March 2023, (B) $23,000 short term advance from the Geoffrey S. Dow Revocable Trust contributed in April 2023 and (C) $27,000 from Tyrone Miller contributed in May 2023, (iii) issuance of promissory notes in May 2023 for a total principal of $722,222 and a net carrying value of $555,000, (iv) issuance of 29,245 shares of our common stock and payment of $100,000 in cash to BioIntelect pursuant to the BioIntelect Agreement, (v) issuance of 1,108,337 shares of our common stock and 80,965 shares of our preferred stock to Knight as a result of the conversion of our outstanding debt owed to Knight pursuant to the Knight Debt Conversion Agreement, (vi) issuance of 383,908 shares of our common stock as a result of either the conversion or extinguishment of our interim financing notes excluding the Xu Yu Equity Conversion Note, (vii) issuance of 214,934 shares of our common stock pursuant to the Xu Yu Equity Conversion Note and (viii) issuance of 40,000 shares of our common stock that are to be issued to four of our directors on the date of effectiveness of the registration statement of which this prospectus forms a part; and

 

on a pro forma as adjusted basis to reflect the pro forma adjustments discussed in the prior bullet and our receipt of the net proceeds our sale and issuance of 1,415,095 Units in this offering at an initial public offering price of $5.30 per Unit, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and after the use of net proceeds therefrom.

 

You should read the following table in conjunction with “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included in this prospectus.

 

The pro forma as adjusted information set forth below is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

 

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     Actual(1)         Pro Forma(2)     Pro forma,
as
adjusted(3)
 
Cash   $ 29,993     $ 284,993     $ 6,621,723  
Total Assets   $ 7,586,974     $ 7,841,974     $ 14,178,704  
Total Current Liabilities     25,542,263       4,403,447       4,403,447  
Total Long-Term Liabilities   $ 1,577,595     $ 158,405     $ 158,405  
                         
Stockholders’ equity:                        
Common stock, $0.0001 par value, 150,000,000 shares authorized, 2,378,009 shares issued and outstanding, actual; 150,000,000 shares authorized, 4,154,433 shares issued and outstanding, pro forma; and 150,000,000 shares authorized, 5,569,528 shares issued and outstanding, pro forma as adjusted.     238       415       557  
Preferred stock, $0.0001 par value, 1,000,000 shares authorized, 0 shares issued and outstanding, actual; 1,000,000 shares authorized, 80,965 shares issued and outstanding, pro forma; and 1,000,000 shares authorized, 80,965 shares issued and outstanding, pro forma as adjusted.     -       8,096,500       8,096,500  
Additional paid-in capital     12,379,462       21,782,334       28,118,922  
Retained earnings (deficit)     (31,415,209 )     (26,101,752 )     (26,101,752 )
                         
Total stockholders’ equity     (19,532,884 )     3,280,122       9,616,852  
Total capitalization   $ 7,586,974     $ 7,841,974     $ 14,178,704  

  

(1)

As of March 31, 2023.

  

(2) The number of issued and outstanding shares as of March 31, 2023 on a pro forma basis includes (i) receipt of short-term advances from related parties totaling $50,000 after March 31, 2023 but prior to the date of this prospectus, (ii) repayment of the (A) $200,000 short-term advance from the Geoffrey S. Dow Revocable Trust contributed in March 2023, (B) $23,000 short term advance from the Geoffrey S. Dow Revocable Trust contributed in April 2023 and (C) $27,000 from Tyrone Miller contributed in May 2023, (iii) issuance of promissory notes in May 2023 for a total principal of $722,222 for a net carrying value of $555,000, (iv) 29,245 shares of our common stock to be issued to BioIntelect and payment of $100,000 in cash pursuant to the BioIntelect Agreement, which provides that in connection with our initial public offering, BioIntelect will be entitled to receive deferred equity compensation for a number of shares determined by dividing $155,000 by the public offering price (or $245,000 if Australian VC Horizon Biotech participates in the offering), (v) pursuant to the Knight Debt Conversion Agreement, (a) 1,108,337 shares of our common stock that are to be issued to Knight, determined by dividing the outstanding principal amount as of March 31, 2022 of $10,770,037 by the public offering price discounted by 15%, up to 19.9% of our outstanding common stock after giving effect to the initial public offering, for a total value of common shares to be issued of $5,874,186, (b) 80,965 shares of our preferred stock that are to be issued to Knight, determined by dividing the accumulated interest balance as of March 31, 2022 of $8,096,500 by $100.00, rounding up for fractional shares, for a total value of preferred stock to be issued of $8,096,486, (c) recognition of derivative liability in the amount of $1,964,658, relating to the fair value of the milestone payment to be due to Knight if, after the date of the initial public offering, we sell Arakoda or if a Change of Control occurs, (d) recognition of $5,548 of royalty liability due to Knight after the date of the initial public offering in the amount of 3.5% of net sales, and (e) recognition of a gain on the conversion of debt in the amount of $5,871,570, determined by the fair value of our cumulative outstanding Knight debt as of March 31, 2023 of $21,815,841 less the value of (a) through (d) herein, (vi) 383,908 shares of our common stock that are to be issued prior to the closing of this offering as a result of either the conversion or extinguishment of our interim financing notes, excluding the Xu Yu Equity Conversion Note, and a net loss on conversion of $383,152, which is determined based on the aggregate net carrying value of the convertible promissory notes as of March 31, 2023 of $1,651,560, less the total value of common shares to be issued of $2,034,712, (vii) 214,934 shares of our common stock that are to be issued pursuant to the Xu Yu Equity Conversion Note, and a net gain on conversion of $25,040, which is determined based on the aggregate net carrying value of the Xu Yu Equity Conversion Note as of March 31, 2023 of $1,164,190, less the total value of common shares to be issued of $1,139,150 and (viii) 40,000 shares of our common stock valued at $5.00 per share that are to be issued to four of our directors on the date of effectiveness of the registration statement of which this prospectus forms a part, and an offsetting charge of $200,000 recognized in compensation expense; and excludes 31,447 shares of our common stock underlying a warrant issued to Bigger Capital Fund, LP with an exercise price equal to 110% of the initial public offering price of the Units, 26,205 shares of our common stock underlying a warrant issued to Cavalry Investment Fund, LP with an exercise price equal to 110% of the initial public offering price of the Units, 26,205 shares of our common stock underlying a warrant issued to Walleye Opportunities Master Fund Ltd. with an exercise price equal to 110% of the initial public offering price of the Units, 10,482 shares of our common stock underlying a warrant issued to Geoffrey Dow with an exercise price equal to 110% of the initial public offering price of the Units, 69,444 shares of our common stock underlying a warrant issued to Mountjoy Trust with an exercise price equal to 110% of the initial public offering price of the Units, 10,482 shares of our common stock underlying a warrant issued to Cyberbahn Federal Solutions, LLC with an exercise price equal to 110% of the initial public offering price of the Units, 10,482 shares of our common stock underlying a warrant issued to Ariana Bakery Inc with an exercise price equal to 110% of the initial public offering price of the Units, 31,447 shares of our common stock underlying a warrant issued to Sabby Volatility Warrant Master Fund, Ltd. with an exercise price equal to 110% of the initial public offering price of the Units, 5,241 shares of our common stock underlying a warrant issued to Steel Anderson with an exercise price equal to 110% of the initial public offering price of the Units, 10,482 shares of our common stock underlying a warrant issued to Bixi Gao & Ling Ling Wang, 84,906 shares of our common stock issuable upon the exercise of the Representative Warrants with an exercise price equal to 110% of the initial public offering price of the Units and 238,601 shares of common stock reserved for issuance under our 2022 Equity Incentive Plan.

 

(3)

The number of issued and outstanding shares as of March 31, 2023 on a pro forma as adjusted basis reflects the pro forma adjustments discussed in footnote (2) above and our receipt of the net proceeds of approximately $6,336,726 resulting from our sale and issuance of 1,415,095 Units in this offering at an initial public offering price of $5.30 per Unit for total gross proceeds of $7,500,000, after deducting $1,163,274 of estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

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DILUTION

 

Purchasers of our common stock in this offering will experience an immediate and substantial dilution in the adjusted net tangible book value of their shares of common stock. Dilution in as adjusted net tangible book value represents the difference between the public offering price per share that is part of the Unit and the as adjusted net tangible book value per share of our common stock immediately after the offering.

 

The historical net tangible book value (deficit) of our common stock as of March 31, 2023, was ($19,727,151) or ($8.30) per share. Historical net tangible book value per share of our common stock represents our total tangible assets (total assets less intangible assets) less total liabilities divided by the number of shares of common stock outstanding as of that date. After giving effect to the (i) receipt of short-term advances from related parties totaling $50,000 after March 31, 2023 but prior to the date of this prospectus, (ii) repayment of the (A) $200,000 short-term advance from the Geoffrey S. Dow Revocable Trust contributed in March 2023, (B) $23,000 short term advance from the Geoffrey S. Dow Revocable Trust contributed in April 2023 and (C) $27,000 from Tyrone Miller contributed in May 2023, (iii) issuance of promissory notes in May 2023 for a total principal of $722,222 and a net carrying value of $555,000, (iv) issuance of 29,245 shares of our common stock and payment of $100,000 in cash to BioIntelect pursuant to the BioIntelect Agreement, (v) issuance of 1,108,337 shares of our common stock and 80,965 shares of our preferred stock to Knight as a result of the conversion of our outstanding debt owed to Knight pursuant to the Knight Debt Conversion Agreement, (vi) issuance of 383,908 shares of our common stock as a result of either the conversion or extinguishment of our interim financing notes excluding the Xu Yu Equity Conversion Note, (vii) issuance of 214,934 shares of our common stock pursuant to the Xu Yu Equity Conversion Note and (viii) issuance of 40,000 shares of our common stock that are to be issued to four of our directors on the date of effectiveness of the registration statement of which this prospectus forms a part, our pro forma net tangible book value as of March 31, 2023 would have been $3,085,855 or approximately $0.74 per share of our common stock.

 

After giving effect to the pro forma adjustments set forth above and the issuance of 1,415,095 shares that are part of the Units in this offering at an initial public offering price of $5.30 per Unit for net proceeds of approximately $6,336,726, our pro forma as adjusted net tangible book value as of March 31, 2023 would have been $9,422,585 or approximately $1.69 per share of our common stock. This represents an immediate increase in pro forma net tangible book value per share of $0.95 to the existing stockholders and an immediate dilution in pro forma net tangible book value per share of $3.61. The following table illustrates this per share dilution to new investors:

 

Public offering price per share         $ 5.30  
Historical net tangible book value (deficit) per share as of March 31, 2023   $

(8.30)

       
Pro forma increase in net tangible book value per share attributable to the adjustments    

9.04

       
Pro forma net tangible book value per share as of March 31, 2023     0.74        
Increase in pro forma net tangible book value per share after giving effect to the offering     0.95        
Pro forma as adjusted net tangible book value (deficit) per share as of March 31, 2023 after the offering           1.69  
Dilution in pro forma net tangible book value per share to new investors after giving effect to the offering         $ 3.61  

 

After completion of this offering, our existing stockholders would own approximately 74.6% and our new investors would own approximately 25.4% of the total number of shares of our common stock outstanding after this offering.

 

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To the extent that outstanding options or warrants, if any, are exercised, you will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities may result in further dilution to our stockholders.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the information presented in “Selected Historical Consolidated Financial Data” and our historical consolidated financial statements and the related notes included elsewhere in this prospectus. In addition to historical information, the following discussion contains forward-looking statements, such as statements regarding our expectation for future performance, liquidity and capital resources, that involve risks, uncertainties and assumptions that could cause actual results to differ materially from our expectations. Our actual results may differ materially from those contained in or implied by any forward-looking statements. Factors that could cause such differences include those identified below and those described in “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and “Audited Consolidated Financial Information.” We assume no obligation to update any of these forward-looking statements.

 

Overview

 

We specialize in the cost-effective development and commercialization of small molecule therapeutics for infectious diseases. We have a single FDA-approved product Arakoda, for malaria prevention in travelers. This product is revenue-generating in the United States and foreign markets, but not yet profitable, primarily due to the lack of an active marketing campaign following its introduction into the U.S. supply chain in late 2019. The COVID-19 pandemic curtailed foreign travel and therefore any ability to raise financing to support an active marketing effort.

 

We believe that the pathway to profitability lies through future investment in an active marketing program and recruitment of a direct sales force to support Arakoda. However, the return on investment for such an effort is likely to be much greater if it can be shown that the pool of potential prescriptions/patients is larger than that for malaria prevention alone. To that end, our primary operational goal is to demonstrate the clinical effectiveness of the already approved dosing regimen of Arakoda in other disease states. Thus, in the second half of 2023, our focus will be on executing a Phase II B clinical investigation of the efficacy of Arakoda in COVID-19 outpatients. Other supporting activities referenced below and elsewhere in this prospectus, such as improving technical specifications, limited marketing efforts, portfolio development, and observing the progress of foreign market growth, will be conducted as resources permit.

 

Key Factors Affecting our Performance

 

As a result of a number of factors, our historical results of operations may not be comparable to our results of operations in future periods, and our results of operations may not be directly comparable from period to period. Set forth below is a brief discussion of the key factors impacting our results of operations.

 

Known Trends and Uncertainties

 

Inflation

 

Inflation generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented.

 

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Supply Chain

 

Our approved product, Arakoda, is manufactured in India. During the audited period, our contract manufacturer experienced reduced capacity due to the COVID-19 pandemic, which in theory, but not in practice, could have disrupted continuity of U.S. supply of Arakoda.

 

Geopolitical Conditions

 

In February 2022, Russia initiated significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates, regional economies and the global economy. The situation remains uncertain, and while it is difficult to predict the impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs, reduce our sales and earnings, impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

  

Effects of the COVID-19 Pandemic

 

The current pandemic of COVID-19 has globally resulted in loss of life, business closures, restrictions on travel, and widespread cancellation of social gatherings. While the disruption is currently expected to be temporary, there is considerable uncertainty around the duration. Therefore, we expect this matter to negatively impact our operating results.

 

The extent to which the COVID-19 pandemic impacts our business will depend on future developments, which are highly uncertain and cannot be predicted at this time, including:

 

new information which may emerge concerning the severity of the disease;

 

the duration and spread of the outbreak;

 

the severity of travel restrictions imposed by geographic areas in which we operate, mandatory or voluntary business closures;

 

our ability to enroll patients;

 

regulatory actions taken in response to the pandemic, which may impact merchant operations, consumer and merchant pricing, and our product offerings;

 

other business disruptions that affect our workforce and supply chain;

 

the impact on capital and financial markets; and

 

actions taken throughout the world, including in markets in which we operate, to contain the COVID-19 outbreak or treat its impact.

 

In addition, the current pandemic of COVID-19 has resulted in a widespread global health crisis and adversely affected global economies and financial markets, and similar public health threats could do so in the future. Any potential impact to our results will depend on, to a large extent, future developments and new information that may emerge regarding the duration and severity of the COVID-19 pandemic and the actions taken by government authorities and other entities to contain the COVID-19 pandemic or treat its impact, almost all of which are beyond our control. If the disruptions posed by the COVID-19 pandemic or other matters of global concern continue for an extensive period of time, the operations of our business may be materially adversely affected.

 

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To the extent the COVID-19 pandemic or a similar public health threat has an impact on our business, it is likely to also have the effect of heightening many of the other risks described in the “Risk Factors” section.

 

Seasonality

 

Our business could be affected by seasonal variations. For instance, we expect to experience higher sales in the second and third quarters of the fiscal year. However, taken as a whole, seasonality does not have a material impact on our financial results.

 

Foreign Currency

 

Our reporting currency is the U.S. dollar and our operations in Australia and Singapore use their local currency as their functional currencies. We are subject to the effects of exchange rate fluctuations with respect to any of such currency. The income statements of some of our operations are translated into U.S. dollars at the average exchange rates in each applicable period. To the extent the U.S. dollar strengthens against foreign currencies, the translation of these foreign currencies denominated transactions results in reduced revenue, operating expenses and net income for our international operations. We are also exposed to foreign exchange rate fluctuations as we convert the financial statements of our foreign subsidiaries into U.S. dollars in consolidation.

 

Concentration of Revenues

 

We received the majority of our revenues from sales of our Arakoda product to the DoD. The DoD has historically been our largest customer. Upon fulfilment of the final purchase of product under the contract, which expired on August 31, 2022, the DoD has not issued any further contracts nor contract modifications to allow additional procurement. Further information is provided in the “Revenue” section below. Revenues remain concentrated. The following tables set forth our concentrations of revenues for the three months ended March 31, 2023 and 2022 and the twelve months ended December 31, 2022 and 2021.

 

Three Months Ended March 31, 2023, and 2022

 

Customers (Market)   3/31/2023     3/31/2022     $ Change     % Change  
Biocelect (Australia)   $ 36,438     $ -     $ 36,438       100 %
ICS AmerisourceBergen (US Commercial)     (19,266 )     47,024       (66,290 )     (141 )
Net Sales Revenue   $ 17,172     $ 47,024     $ (29,852 )     (63 )%

 

Twelve Months Ended December 31, 2022, and 2021

 

Customers (Market)   12/31/2022     12/31/2021     $ Change     % Change  
Biocelect (Australia)   $ 86,763     $ 37,046     $ 49,717       134 %
DoD (US Military)     30,295       1,150,650       (1,120,355 )     (97 )%
ICS AmerisourceBergen (US Commercial)     88,150       (27,356)       115,506       (422 )%
Scandinavian Biopharma Distribution AB (European Union)     18,000       -       18,000       NA %
Net Sales Revenue   $ 223,208     $ 1,160,340     $ (937,132 )     (81 )%

 

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Results of Operations

 

Three Months Ended March 31, 2023, and 2022

 

The following table sets forth our results of operations for the periods presented:

 

    Three Months Ended  
    March 31,  
Consolidated Statements of Operations Data:   2023     2022  
Product revenues – net of discounts and rebates   $ 17,172     $ 47,024  
Cost of revenues     73,120       90,134  
Gross loss     (55,948 )     (43,110 )
Research revenues     4,292       117,147  
Net revenue     (51,656 )     74,037  
Operating expenses:                
Research and development     123,994       63,057  
General and administrative expenses     775,014       174,692  
Total operating expenses     899,008       237,749  
Loss from operations     (950,664 )     (163,712 )
Interest and other income (expense), net:                
Interest expense     (1,141,429 )     (762,217 )
Change in fair value of derivative liabilities     (5,134 )     -  
Loss on debt extinguishment     (839,887 )     -  

Change in fair value of promissory note

   

339,052

      -  
Other income     591       18,732  
Total interest and other income (expense), net     (1,646,807 )     (743,485 )
Loss from operations before provision for income taxes     (2,597,471 )     (907,197 )
Provision for income taxes     63       250  
Net loss including noncontrolling interest     (2,597,534 )     (907,447 )
Net gain (loss) noncontrolling interest     2,527       4,835  
Net loss - attributed to 60 Degrees Pharmaceuticals Inc     (2,600,061 )     (912,282 )
                 
Comprehensive loss:                
Net loss    

(2,597,534

)     (907,447 )
Unrealized foreign currency translation gain (loss)     (1,290 )     96,556  
Total comprehensive loss     (2,598,824 )     (810,891 )
                 
Net gain (loss) – noncontrolling interest     2,527       4,835  
Unrealized foreign currency translation gain from noncontrolling interest     -       -  
Comprehensive loss - attributed to 60 Degrees Pharmaceuticals, Inc.   $ (2,601,351 )   $ (815,726 )

 

The following table sets forth our results of operations as a percentage of revenue:

 

    Three Months Ended  
    March 31,  
Consolidated Statements of Operations Data:   2023     2022  
Product revenues – net of discounts and rebates     100.00 %     100.00 %
Cost of revenues     425.81       191.68  
Gross loss     (325.81 )     (91.68 )
Research revenues     24.99       249.12  
Net revenue     (300.82 )     157.44  
Operating expenses:                
Research and development     722.07       134.10  
General and administrative expenses     4,513.24       371.50  
Total operating expenses     5,235.31       505.60  
Loss from operations     (5,536.13 )     (348.16 )
Interest and other income (expense), net:                
Interest expense     (6,647.04 )     (1,620.91 )
Change in fair value of derivative liabilities     (29.90 )     -  
Loss on debt extinguishment     (4,891.03 )     -  

Change in fair value of promissory note

   

1,947.45

      -  
Other income     3.44       39.83  
Total interest and other income (expense), net     (9,590.08 )     (1,581.08 )
Loss from operations before provision for income taxes     (15,126.21 )     (1,929.24 )
Provision for income taxes     0.37       0.53  
Net loss including noncontrolling interest     (15,126.58 )     (1,929.77 )
Net gain (loss) noncontrolling interest     14.72       10.28  
Net loss - attributed to 60 Degrees Pharmaceuticals Inc     (15,141.30 )     (1,940.05 )
                 
Comprehensive loss:                
Net loss     (15,126.58 )     (1,929.77 )
Unrealized foreign currency translation gain (loss)     (7.51 )     205.34  
Total comprehensive loss     (15,134.09 )     (1,724.43 )
                 
Net gain (loss) – noncontrolling interest     14.72       10.28  
Unrealized foreign currency translation gain from noncontrolling interest     0.00       0.00  
Comprehensive loss - attributed to 60 Degrees Pharmaceuticals, Inc.     (15,148.81 )     (1,734.71 )

 

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Comparison of the Three Months Ended March 31, 2023, and 2022

 

Product and Service Revenue, Discounts and Rebates, Net Sales Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin

 

   

Three Months Ended

March 31,

             
    2023     2022     $ Change     % Change  
Product revenues – net of discounts and rebates   $ 17,172     $ 47,024     $ (29,852 )     (63.48 )%
Cost of revenues     73,120       90,134       (17,014 )     (18.88 )
Gross loss   $ (55,948 )   $ (43,110 )   $ (12,838)       (29.78 )%
Gross margin     (325.81 )%     (91.68 )%                

 

Product Revenues – Net of Discounts and Rebates, Service Revenue and Net Product and Service Revenues

 

Our product revenues were $17,172 for the three months ended March 31, 2023, as compared to $47,024 for the three months ended March 31, 2022. As of March 31, 2023, our Australian distributor accounted for 212% (0% as of March 31, 2022), and our U.S. distributor accounted for (112%) of our total net product sales (100% as of March 31, 2022). While our sales volume increased over the same periods, the decrease in net product sales was impacted by the reduction of our wholesale acquisition cost of Arakoda™ (16 x 100 mg tablets) from $285 to $235 per box in January 2023, in addition to expiring inventory returns.

 

We offer discounts and rebates to the civilian U.S. supply chain distribution channel. We record sales when our third-party logistics (“3PL”) partner transfers boxes into their title model. Discounts and rebates are offered to our 3PL partner amounting to 2%. Then product is transferred normally to one of the three large U.S. pharmaceutical distributors where rebates range form 10-15%. Lastly, we have relationships with several large pharmacy benefit managers (“PBMs”) that allows patients to purchase Arakoda at a discount. The rebate associated with PBMs ranges from 15% to 39.75% depending on the amount of coverage provided. For the three months ending March 31, 2023, discounts and rebates were $25,499 compared to 13,396 for the three months ending March 31, 2022.

 

Although, as of the date of this prospectus, we were not in discussions with the DoD about additional/future procurement, we anticipate that this will be feasible in the future if one or more of the conditions/events described in this paragraph occur. First, the position of Arakoda in the DoD formulary (Tricare, deployed personnel) needs to be improved from second/third tier to at least equivalency with competing products (as is the case for civilian use as recommended by the CDC). Second, the shelf-life of the existing product requires extension, which is known to be technically possible as the shelf-life of Kodatef in Australia is 48 months, but appropriate data must be generated to meet FDA requirements. Finally, a change in the operational footprint of DoD deployments to areas with higher malaria attack rates (e.g., the Liberia deployment to manage the Ebola outbreak in 2014) may lead to a rapid reassessment by DoD of the position of Arakoda in the formulary (advancement of the last approved prophylactic antimalarial to co-equal standard of care took thirteen years).

 

Arakoda entered the U.S. civilian supply chain in the third quarter of 2019. For the three months ended March 31, 2022, 91 boxes were sold to pharmacies and dispensaries. Sales increased by 101% to 183 boxes to patients for the three months ended March 31, 2023. The increase in commercial sales volume reflects the response to the reduction of our wholesale acquisition cost effective January 2023.

 

Kodatef sales to our distributor Biocelect in Australia for the three months ended March 31, 2023 were $36,438 ($0 for the three months ended March 31, 2022). Sales to Biocelect are currently subject to a profit share distribution once the original transfer price has been recouped. As of March 31, 2023, no profit share has been due to us and also ($0 for the three months ended March 31, 2022).

 

During the first three months of 2023, we recorded our first sale of Arakoda/Kodatef to our European distributor Scandinavian Biopharma Distribution AB. Product will be distributed there on a named patient basis. As in Australia a profit distribution share is possible depending on the retail price established.

 

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Cost of Revenues, Gross (Loss) Profit, and Gross Margin

 

The cost of goods sold was $73,120 for the three months ended March 31, 2023, as compared to $90,134 for the three months ended March 31, 2022. The decrease in cost of goods sold is primarily due to lower commercial sales. The Gross Margin % fell to (325.81)% for the three months ended March 31, 2023 from (91.68)% for the three months ended March 31, 2022. This is due to the current low sales volume and the fixed part of cost of goods. As the sales volume continues to grow the gross margin will improve as the variable cost of goods of each Unit sold is substantially less than the sales price.

 

Other Operating Revenues

 

    Three Months Ended March 31,              
    2023     2022     $ Change     % Change  
Research revenues   $ 4,292     $ 117,147     $ (112,855 )     (96.34 )%

 

The research revenues earned by us were $4,292 for the three months ended March 31, 2023, as compared to $117,147 for the three months ended March 31, 2022. Our research revenues have historically been derived mostly from a single, awarded research grant in the amount of $4,999,814 at the beginning of December 2020 (with an additional $720,000 awarded February 26, 2021) from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (which may be referred to as “JPEO”) to study Arakoda in mild-to-moderate COVID-19 patients. A majority of the study was completed in 2021 with the planned lab data analysis and the submission of the final study report completed during the first nine months of 2022. During the three months ended March 31, 2022, we recognized $94,908 in revenue from the JPEO, compared to $0 during the three months ended March 31, 2023. We also earn research revenues from the Australian Tax Authority for research activities conducted in Australia. The revenue was $4,292 at the end of three months ended March 31, 2023 compared to $22,239 during the three months ended March 31, 2022.

 

Operating Expenses

 

    Three Months Ended March 31,              
    2023     2022     $ Change     % Change  
Research and development   $ 123,994     $ 63,057     $ 60,937       96.64 %
General and administrative     775,014       174,692      

600,322

      343.65  
Total operating expenses   $

899,008

    $ 237,749     $

661,259

      278.13 %

  

Research and Development Expenses

 

Research and development costs increased during the three months ended March 31, 2023 when compared to the three months ended March 31, 2022 as we incurred initiation costs related to our Phase IIB COVID-19 clinical trial, which is expected to commence in the second half of 2023. Direct COVID-19-related trial costs are 85% of the costs through the three months ended March 31, 2023 at $105,257 and 29% of the costs for the three months ended March 31, 2022 at $18,514.

 

General and Administrative Expenses

 

For the three months ended March 31, 2023, our general and administrative expenses increased by 344% or $600,322. During the three months ended March 31, 2023 we spent substantially more for accounting and auditing at $370,605 (up from $8,634 for the three months ended March 31, 2022). Additionally, during the three months ended March 31, 2023, we incurred $164,539 of investor outreach expenses, $29,333 of advertising and promotion expenses, and $90,000 of pharmacovigilance monitoring costs (up from $0, $0, and $12,000 for the three months ended March 31, 2022, respectively).

 

Interest and Other Income (Expense), Net

 

   Three Months Ended
March 31,
         
   2023   2022   $ Change   % Change 
Interest expense  $(1,141,429)  $(762,217)  $(379,212)   49.75%
Change in fair value of derivative liabilities   (5,134)   -    (5,134)   NA 
Loss on debt extinguishment   (839,887)   -    (839,887)   NA 
Change in fair value of promissory note   339,052    -    339,052    NA 
Other income   591    18,732    (18,141)   (96.84)
Total Interest and Other Income (Expense), Net  $

(1,646,807

)  $(743,485)  $(903,322)   121.50%

 

Interest Expense

 

For the three months ended March 31, 2023, we recognized $1,141,429 of interest expense ($762,217 for the three months ended March 31, 2022). The increase is primarily related to growing principal and interest balances with the primary lender Knight. Cash paid for interest expense was $2,193 and none for the three months ended March 31, 2023 and March 31, 2022, respectively.

  

Change in Fair Value of Derivative Liabilities

 

For the twelve months ended March 31, 2023, we recognized a change in fair value of derivative liabilities of ($5,134) (none for the three months ended March 31, 2022). The increase is related to derivatives generated from the bridge funding raise in May 2022.

 

Loss on debt extinguishment

 

For the three months ended March 31, 2023, we recognized a ($839,887) loss on debt extinguishment (none for the three months ended March 31, 2022). The increase is related to the conversion of the cumulative outstanding debt pursuant to the Knight Debt Conversion Agreement in January 2023.

 

Change in Fair Value of Promissory Note

 

For the three months ended March 31, 2023, we recognized a $339,052 gain on the fair value of the promissory note with Knight (none for the three months ended March 31, 2022). Our cumulative debt outstanding with Knight was not measured at fair value on a recurring basis prior to the Knight Debt Conversion Agreement executed in January 2023, hence we recorded a $0 change in fair value for the three months ended March 31, 2022.

 

Other Income (Expense), Net

 

For the three months ended March 31, 2023, we recognized $591 in other income compared to $18,732 for the three months ended March 31, 2022.

 

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Twelve Months Ended December 31, 2022, and 2021

 

The following table sets forth our results of operations for the periods presented:

 

    Twelve Months Ended
December 31,
 
Consolidated Statements of Operations Data:   2022     2021  
Product revenues – net of discounts and rebates   $ 192,913     $ 1,078,440  
Service revenues     30,295       81,900  
Product and service revenues     223,208       1,160,340  
Cost of revenues     432,370       850,742  
Gross (loss) profit     (209,162 )     309,598  
Research revenues     288,002       5,192,516  
Net revenue     78,840       5,502,114  
Operating expenses:                
Research and development     525,563       5,510,866  
General and administrative expenses     1,303,722       1,115,350  
Total operating expenses     1,829,285       6,626,216  
Loss from operations     (1,750,445 )     (1,124,102 )
Interest and other income (expense), net:                
Interest expense     (3,989,359 )     (3,172,712 )
Derivative expense     (504,613 )     -  
Change in fair value of derivative liabilities     (10,312 )     -  

Gain on debt extinguishment

    120,683       -  

Other income (expense)

    (43,238 )     37,515  
Total interest and other income (expense), net     (4,426,839 )     (3,135,197 )
Loss from operations before provision for income taxes     (6,177,284 )     (4,259,299 )
Provision for income taxes     500       1,000  
Net loss including noncontrolling interest     (6,177,784 )     (4,260,299 )
Net gain (loss) noncontrolling interest     3,936       (8,554 )
Net loss - attributed to 60 Degrees Pharmaceuticals Inc     (6,181,720 )     (4,251,745 )
                 
Comprehensive loss:                
Net loss     (6,177,784 )     (4,260,299 )
Unrealized foreign currency translation loss     (2,127     (3,031 )
Total comprehensive loss     (6,179,911 )     (4,263,330 )
                 
Net gain (loss) – noncontrolling interest     3,936       (8,554 )
Unrealized foreign currency translation gain from noncontrolling interest     -       1,588  
Comprehensive loss - attributed to 60 Degrees Pharmaceuticals, Inc.   $ (6,183,847 )   $ (4,256,364 )

  

The following table sets forth our results of operations as a percentage of revenue:

 

   Twelve Months Ended
December 31,
 
Consolidated Statements of Operations Data:  2022   2021 
Product revenues – net of discounts and rebates   86.43%   92.94%
Service revenues   13.57    7.06 
Product and service revenues   100.00    100.00 
Cost of revenues   193.71    73.32 
Gross (loss) profit   (93.71)   26.68 
Research revenues   129.03    447.50 
Net revenue   35.32    474.18 
Operating expenses:          
Research and development   235.46    474.94 
General and administrative expenses   584.08    96.12 
Total operating expenses   819.54    571.06 
Loss from operations   (784.22)   (96.88)
Interest and other income (expense), net:          
Interest expense   (1,787.28)   (273.43)
Derivative expense   (226.07)   - 
Change in fair value of derivative liabilities   (4.62)   - 
Gain on debt extinguishment   54.07    - 

Other income (expense)

   (19.37)   3.23 
Total interest and other income (expense), net   (1,983.27)   (270.20)
Loss from operations before provision for income taxes   (2,767.49)   (367.08)
Provision for income taxes   0.22    0.09 
Net loss including noncontrolling interest   (2,767.71)   (367.17)
Net gain (loss) - noncontrolling interest   1.76    (0.74)
Net loss – attributable to 60 Degrees Pharmaceuticals, Inc.   (2,769.47)   (366.43)
           
Comprehensive loss:          
Net loss including noncontrolling interest   (2,767.71)   (367.17)
Unrealized foreign currency translation loss   (0.95)   (0.26)
Total comprehensive loss   (2,768.66)   (367.43)
           
Net gain (loss) – noncontrolling interest   1.76    (0.74)
Unrealized foreign currency translation gain from noncontrolling interest   -    0.14 
Comprehensive loss - attributed to 60 Degrees Pharmaceuticals, Inc.   (2,770.42)%   (366.83)%

 

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Comparison of the Twelve Months Ended December 31, 2022, and 2021

 

Product and Service Revenue, Discounts and Rebates, Net Sales Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin

 

    Twelve Months Ended December 31,              
    2022     2021     $ Change     % Change  
Product revenues – net of discounts and rebates   $ 192,913     $ 1,078,440     $ (885,527 )     (82.11 )%
Service revenues     30,295       81,900       (51,605 )     (63.01 )
Net product and service revenues     223,208       1,160,340       (937,132 )     (80.76 )
Cost of revenues     432,370       850,742       (418,372 )     (49.18 )
Gross (loss) profit   $ (209,162 )   $ 309,598     $ (518,760 )     (167.56 )%
Gross margin     (93.71 )%     26.68 %                

 

Product Revenues – Net of Discounts and Rebates, Service Revenue and Net Product and Service Revenues

 

Our product revenues were $192,913 for the twelve months ended December 31, 2022, as compared to $1,078,440 for the twelve months ended December 31, 2021. As of December 31, 2022, one government customer accounted for 14% (and 95% as of December 31, 2021) of our total sales. The decrease in sales was mainly due to a 3-year Arakoda acquisition contract that involved purchasing a full lot (7,500 boxes) in 2020 and a half lot (3,750 boxes) in 2021, which was fulfilled by August 31, 2021. This contract was executed by the United States Army Medical and Materiel Development Activity (USAMMDA) to support commercialization efforts.

 

We offer discounts and rebates to the civilian U.S. supply chain distribution channel. We record sales when our third-party logistics (“3PL”) partner transfers boxes into their title model. Discounts and rebates are offered to our 3PL partner amounting to 2%. Then product is transferred normally to one of the three large U.S. pharmaceutical distributors where rebates range form 10-15%. Lastly, we have relationships with several large pharmacy benefit managers (“PBMs”) that allows patients to purchase Arakoda at a discount. The rebate associated with PBMs ranges from 15% to 39.75% depending on the amount of coverage provided. For the twelve months ending December 31, 2022, discounts and rebates were $59,552 compared to none for the twelve months ending December 31, 2021. There were neither discounts nor rebates on direct sales to USAMMDA.

 

Although, as of the date of this prospectus, we were not in discussions with the DoD about additional/future procurement, we anticipate that this will be feasible in the future if one or more of the conditions/events described in this paragraph occur. First, the position of Arakoda in the DoD formulary (Tricare, deployed personnel) needs to be improved from second/third tier to at least equivalency with competing products (as is the case for civilian use as recommended by the CDC). Second, the shelf-life of the existing product requires extension, which is known to be technically possible as the shelf-life of Kodatef in Australia is 48 months, but appropriate data must be generated to meet FDA requirements. Finally, a change in the operational footprint of DoD deployments to areas with higher malaria attack rates (e.g., the Liberia deployment to manage the Ebola outbreak in 2014) may lead to a rapid reassessment by DoD of the position of Arakoda in the formulary (advancement of the last approved prophylactic antimalarial to co-equal standard of care took thirteen years).

 

Arakoda entered the U.S. civilian supply chain in the third quarter of 2019. For the twelve months ended December 31, 2021, 389 boxes were sold to pharmacies and dispensaries. Sales increased by 47% to 570 boxes to patients for the twelve months ended December 31, 2022. Increasing commercial sales reflect organic growth, since no active marketing efforts were made during the pandemic and the wholesale acquisition cost has not changed from launch in 2019 through December 31, 2022.

 

Kodatef sales to our distributor Biocelect in Australia for the twelve months ended December 31, 2022 were $86,763 ($37,046 for the twelve months ended December 31, 2021). Sales to Biocelect are currently subject to a profit share distribution once the original transfer price has been recouped. As of December 31, 2022, no profit share has been due to us, though we did settle the historical profit share through September 30, 2022 for $24,381 (AUD$35,000) on January 16, 2023.

 

During 2022, we recorded our first sale of Arakoda/Kodatef to our European distributor Scandinavian Biopharma Distribution AB. Product will be distributed there on a named patient basis. As in Australia a profit distribution share is possible depending on the retail price established.

 

We also earned $30,295 from storing the Army’s Arakoda purchases through August 31, 2022 (when the contract ended) compared to $81,900 earned through the twelve months ended December 31, 2021 of which $57,000 of revenue was related to shipping stored Arakoda.

  

Cost of Revenues, Gross (Loss) Profit, and Gross Margin

 

The cost of goods sold was $432,370 for the twelve months ended December 31, 2022, as compared to $850,742 for the twelve months ended December 31, 2021. The decrease in cost of goods sold was primarily due to sale of a half lot to the government in 2021. The Gross Margin % fell to (94)% for the twelve months ended December 31, 2022 from 27% for the twelve months ended December 31, 2021. This is due to the current low sales volume and the fixed part of cost of goods. As the sales volume continues to grow the gross margin will improve as the variable cost of goods of each Unit sold is substantially less than the sales price.

 

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Other Operating Revenues

 

    Twelve Months Ended December 31,              
    2022     2021     $ Change     % Change  
Research revenues   $ 288,002     $ 5,192,516     $ (4,904,514 )     (94.45 )%

 

The research revenues earned by us were $288,002 for the twelve months ended December 31, 2022, as compared to $5,192,516 for the twelve months ended December 31, 2021. Our research revenues are derived mostly from a single, awarded research grant in the amount of $4,999,814 (with an additional $720,000 awarded February 26, 2021) from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (which may be referred to as “JPEO”) at the beginning of December 2020 to study Arakoda in mild-to-moderate COVID-19 patients. The trial was actively recruiting patients from February to September of 2021; hence the majority of the grant revenue was earned in the first nine months of 2021 ending on September 30 ($4,935,335). At the end of 2021, $245,552 remained on the grant. The study was largely completed with the planned lab data analysis and the submission of the final study report completed during the first nine months of 2022 ending on September 30. We also earn research revenues from the Australian Tax Authority for research expenses conducted in Australia. The revenue was $42,250 at the end of twelve months ended December 31, 2022 compared to $19,511 at the twelve months ended December 31, 2021.

 

Operating Expenses

 

    Twelve Months Ended December 31,              
    2022     2021     $ Change     % Change  
Research and development   $ 525,563     $ 5,510,866     $ (4,985,303 )     (90.46 )%
General and administrative     1,303,722       1,115,350       188,372       16.89  
Total operating expenses   $ 1,829,285     $ 6,626,216     $ (4,796,931 )     (72.39 )%

  

Research and Development Expenses

 

We considerably reduced research and development costs as we completed our Phase II COVID-19 trial in 2022. Direct COVID-19 related trial costs are 49% of the costs through the twelve months ended December 31, 2022 at $256,581 and 86% of the costs for the twelve months ended December 31, 2021 at $4,721,635. Research and development costs are expected to increase substantially in 2023, as the second COVID-19 clinical trial and supporting activities are initiated in the second half of the year.

 

General and Administrative Expenses

 

For the twelve months ended December 31, 2022, our general and administrative expenses increased by 17% or $188,372. While the net amounts did not change substantially for the twelve months ended December 31, in 2022 we spent substantially more for accounting and auditing at $173,975 (up from $15,071 for the twelve months ended December 31, 2021) and recorded $415,257 in professional services to be paid in stock (none for the 12 months ended December 31, 2021). Whereas, we spent substantially less for legal, regulatory advice and insurance, $202,974 at twelve months ended December 31, 2022 ($446,884 at twelve months ended December 31, 2021).

 

Interest and Other Income (Expense), Net

 

    Twelve Months Ended December 31,              
    2022     2021     $ Change     %  Change  
Interest expense     (3,989,359 )     (3,172,712 )     (816,647 )     25.74 %
Derivative expense     (504,613 )     -       (504,613 )     NA  
Change in fair value of derivative liabilities     (10,312 )     -       (10,312 )     NA  
Gain on debt extinguishment     120,683       -       120,683       NA  
Other (expense) income     (43,238 )     37,515       (80,753 )     215.26  
Total Interest and Other Income (Expense), Net   $ (4,426,839 )   $ (3,135,197 )   $ (1,291,642 )     41.20 %

 

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Interest Expense

 

For the twelve months ended December 31, 2022, we recognized $3,989,359 of interest expense ($3,172,712 for the twelve months ended December 31, 2021). The increase is primarily related to growing principal and interest balances with the primary lender Knight. Cash paid for interest expense was $2,193 and none for the twelve months ended December 31, 2022 and December 31, 2021, respectively.

 

Derivative Expense

 

For the twelve months ended December 31, 2022, we recognized $504,613 of derivative expense (none for the twelve months ended December 31, 2021). The increase is related to the raising of $1,105,000 of bridge funding.

 

Change in Fair Value of Derivative Liabilities

 

For the twelve months ended December 31, 2022, we recognized a change in fair value of derivative liabilities of $10,312 (none for the twelve months ended December 31, 2021). The increase is related to derivatives generated from the bridge funding raise.

 

Gain on debt extinguishment

 

For the twelve months ended December 31, 2022, we recognized a $120,683 gain on debt extinguishment (none for the twelve months ended December 31, 2021). The increase is related to the renegotiation of the Xu Yu promissory note.

 

Other Income (Expense), Net

 

For the twelve months ended December 31, 2022, we recognized ($43,238) in other income (expense) compared to $37,515 for the twelve months ended December 31, 2021. In 2022, it was uncovered that federal tax form 8992 may have not been properly filed. We have elected to record a $30,000 tax liability for the audit of the twelve months ended December 31, 2022, $10,000 each for the years ended December 31, 2019, 2020 and 2021 (none for the twelve months ended December 31, 2021). For the twelve months ended December 31, 2021 we recorded $38,500 of PPA loan forgiveness income (none for the twelve months ended December 31, 2022).

 

Liquidity and Capital Resources

 

We had net cash used in operating activities of $1,009,980 for the twelve months ended December 31, 2022, and the cash balance was $29,993 as of March 31, 2023 ($264,865 as of December 31, 2022). Based on current internal projections, should the full amount of the proceeds from this offering be realized, and if our planned COVID-19 clinical study is eligible to receive Australian government research and development tax rebates and it is possible to borrow and receive funds from a lender ahead of issuance of those tax rebates, we estimate that we will have sufficient funds to remain viable through March 31, 2024 (sufficient to complete an optional futility analysis at 33% enrolment in the clinical study if desired). However, we may not remain viable until March 31, 2024, if we end up being ineligible for research tax credits or cannot borrow against their future issuance. We cannot give assurance that we can increase our cash balances or limit our cash consumption and thus maintain sufficient cash balances for our planned operations or future acquisitions. Future business demands may lead to cash utilization at levels greater than recently experienced. We may need to raise additional capital in the future. However, we cannot assure you that we will be able to raise additional capital on acceptable terms, or at all.

 

To date, we have funded our operations through debt and equity financings.

 

Going Concern

 

As of March 31, 2023, we had an accumulated deficit of $31,415,209. In their audit report for the fiscal year ended December 31, 2022 included in this report, our auditors have expressed their concern as to our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate cashflows from operations and obtain financing.

 

The accompanying consolidated financial statements for the twelve months ended December 31, 2022, and December 31, 2021, respectively, included an explanatory note referring to our recurring operating losses and expressing substantial doubt in our ability to continue as a going concern. Our consolidated financial statements have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business. To date, we have not yet established an ongoing source of revenues and cash flows sufficient to cover our operating costs and allow us to continue as a going concern. These factors among others raise substantial doubt about our ability to continue as a going concern for at least one year from the date of issuance of the accompanying consolidated financial statements.

 

Our ability to continue as a going concern is dependent upon our ability to generate profitable operations in the future and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they become due. The outcome of these matters cannot be predicted with any certainty at this time and raise substantial doubt that we will be able to continue as a going concern. Our consolidated financial statements do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.

 

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Borrowings

 

On December 10, 2015, we entered into the Loan Agreement and Engagement with Knight, as amended eight times, pursuant to which, we originally borrowed $500,000 at a per annum interest rate of 15% (the “Knight Loan”) and a debenture agreement of face value $3 million on April 24, 2018 (the “Knight Debenture”). As of March 31, 2023, the current outstanding balance of the Knight Loan and Knight Debenture, following the Knight Debt Conversion Agreement (described below) is $21,815,841.

 

Pursuant to the Knight Debt Conversion Agreement, executed January 9, 2023 and modified on January 13, 2023, and again on January 27, 2023, Knight and us agreed, to formalize a previously negotiated term sheet that, in the event of a successful initial public offering, we will fix Knight’s cumulative debt to the value as it stood on March 31, 2022, which consisted of $10,770,037 in principal and $8,096,486 in accumulated interest, and to convert the aforementioned amounts, should we consummate an initial public offering that results in gross proceeds of at least $7,000,000 prior to December 31, 2023 as follows:

 

 We agreed to convert the principal amount into (i) that number of shares of common stock equal to dividing the principal amount by an amount equal to the offering price of the common stock in the initial public offering discounted by 15% (the “Conversion Common Shares”), rounding up for fractional shares, in a number of Conversion Shares up to 19.9% of our outstanding common stock after giving effect of the initial public offering; (ii) we will make a milestone payment of $10 million to Knight if, after the date of a qualifying initial public offering, we sell Arakoda or if a Change of Control (as per the definition included in the original loan agreement dated on December 10, 2015) occurs, provided that the purchaser of Arakoda or individual or entity gaining control of us is not Knight or an affiliate of Knight; (iii) following the License and Supply agreement dated on December 10, 2015 and subsequently amended on January 21, 2019, an expansion of existing distribution rights to Tafenoquine/Arakoda to include COVID-19 indications as well as malaria prevention across the Territory as defined in said documents, subject to U.S. Army approval; and (iv) we will retain Knight or an affiliate of Knight to provide financial consulting services, management, strategic and/or regulatory advice of value $30,000 per month for five years (the parties will negotiate the terms of that consulting agreement separately in good faith).

 

  The parties agreed to convert the accrued interest into that number of shares (the “Conversion Preferred Shares” and, together with the Conversion Common Shares, the “Conversion Shares”) of a new class of preferred stock (the “Preferred Stock”) by dividing the Accrued Interest by $100.00, then rounding up. The Preferred Stock shall have the following rights, preferences, and designations: (i) have a 6% cumulative dividend accumulated annually on March 31; (ii) shall be non-voting stock; (iii) are not redeemable, (iv) be convertible to shares of common stock at a price equal to the lower of (1) the price paid for the shares of common stock in the initial public offering and (2) the 10 day volume weighted average share price immediately prior to conversion; and (v) conversion of the preferred stock to common shares will be at our sole discretion. Notwithstanding the foregoing, we shall not convert the Preferred Stock into shares of common stock if as a result of such conversion Knight will own 19.9% or more of our outstanding common stock.

 

  In addition to the conversion of the debt, for a period commencing on January 1, 2022 and ending upon the earlier of 10 years after the closing of the initial public offering or the conversion or redemption in full of the Conversion Preferred Shares, we shall pay Knight a royalty equal to 3.5% of our net sales (the “Royalty”), where “Net Sales” has the same meaning as in our license agreement with the U.S. Army for Tafenoquine. Upon the qualified initial public offering, we shall calculate the royalty payable to Knight at the end of each calendar quarter. We shall pay to Knight the royalty amounts due with respect to a given calendar quarter within fifteen (15) business days after the end of such calendar quarter. Each payment of royalties due to Knight shall be accompanied by a statement specifying the total gross sales, the net sales and the deductions taken to arrive to net sales. For clarification purposes, the first royalty payment will be performed following the above instructions, on the first calendar quarter in which the qualified initial public offering takes place and will cover the sales of the period from January 1, 2022, until the end of said calendar quarter.

 

Should an initial public offering not occur by January 1, 2024, then all terms of the original Knight Loan and Knight Debenture would resume including any interest earned after March 31, 2022.

 

On October 11, 2017, we issued a $750,000 promissory note, as amended (the “Avante Note”), to Avante International Limited (“Avante”) with accrued interest at an annual rate of 5.0% for the first six months, and 10% thereafter. On December 23, 2017, Avante transferred the Avante Note to Xu Yu Equity Conversion Note. 

 

On December 11, 2022, Avante and us amended the Avante Note (the “Amendment”). The Amendment added a provision to automatically convert the outstanding principal and accumulated interest through March 31, 2022 to shares of common stock in the event we consummate an initial public offering. The Amendment also provides Avante the option to convert the outstanding principal and accumulated interest through March 31, 2022 to equity in the Company at the maturity date and will have 30 days from maturity to exercise this option. Cumulative interest after March 31, 2022 will be forfeited should the lender elect to convert the Note into equity. We evaluated the Amendment and determined that it constitutes an extinguishment as the option to convert interest through March 31, 2022 and is considered the addition of a substantive conversion option. Accordingly, the Amendment resulted in extinguishment accounting and a corresponding extinguishment gain of $120,683, which represents the difference between the carrying value of the Avante Note just prior to the Amendment and the fair value of the Avante Note just after the Amendment.

 

The extinguishment accounting resulted in a fair value of the Avante Note, including the Amendment of $1,099,578. The discount of $120,683 and costs incurred with third parties directly related to the Amendment of $1,767 will be amortized over the remaining life of the debt using the effective interest method. Amortization of the discount on the Avante Note, including the Amendment for the year ended December 31, 2022 was $4,955 ($0 in 2021). Interest expense related to the Note, including the Amendment, for the year ended December 31, 2022 was $115,546 ($104,558 in 2021). Interest expense related to the Note, for the three months ended March 31, 2023 and March 31, 2022 was $30,262 and $27,413, respectively.

 

On May 14, 2020, we issued the note to the U.S. Small Business Administration with a principal amount of $150,000 and a per annum interest rate of 3.75%. The current outstanding balance of the COVID-19 Loan is $161,552 as of March 31, 2023.

 

On May 19, 2022, we issued a Convertible Promissory Note to Geoffrey Dow, as assigned to the Geoffrey S. Dow Revocable Trust dated August 27, 2018 on May 19, 2022 (the “Geoffrey Dow Trust Note”), in the amount of $44,444.44 and a per annum interest rate of 6%. Upon the occurrence of our initial public offering, the balance of such note will convert immediately prior to the initial public offering at a price equal to 80% of the price per share of the common stock sold in the initial public offering.

 

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On May 19, 2022, we issued a Convertible Promissory Note to Mountjoy Trust in the amount of $294,444.42 and a per annum interest rate of 6%. Upon the occurrence of our initial public offering, the balance of such note will convert immediately prior to the initial public offering at a price equal to 80% of the price per share of the common stock sold in the initial public offering.

 

On May 24, 2022, we issued a note in the amount of $333,333.30 to Bigger Capital Fund, LP. On the date of the pricing of our initial public offering, we will deliver to Bigger Capital Fund, LP shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to July 24, 2023, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on July 24, 2023.

 

On May 24, 2022, we issued a note in the amount of $277,777.78 to Cavalry Investment Fund, LP. On the date of the pricing of our initial public offering, we will deliver to Cavalry Investment Fund, LP shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to July 24, 2023, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on July 24, 2023.

 

On May 24, 2022, we issued a note in the amount of $277,777.78 to Walleye Opportunities Master Fund Ltd. On the date of the pricing of our initial public offering, we will deliver to Walleye Opportunities Master Fund Ltd shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to July 24, 2023, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on July 24, 2023. 

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Cyberbahn Federal Solutions, LLC with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Cyberbahn Federal Solutions, LLC shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Ariana Bakery Inc with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Ariana Bakery Inc shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $333,333.30 to Sabby Volatility Warrant Master Fund, Ltd. with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Sabby Volatility Warrant Master Fund, Ltd. shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $55,555.55 to Steel Anderson with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Steel Anderson shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

On May 8, 2023, we issued a note in the amount of $111,111.10 to Bixi Gao & Ling Ling Wang with a 10% original issue discount. On the date of the pricing of our initial public offering, we will deliver to Bixi Gao & Ling Ling Wang shares of our common stock equal to (i) 100% of the face value of the note divided by the initial public offering price per share or (ii) if we fail to complete the initial public offering prior to May 4, 2024, the number of shares of our common stock calculated using a $27 million pre-money valuation and the number of our outstanding shares of common stock on May 4, 2024.

 

Contractual Obligations

 

The following table summarizes our contractual obligations as of December 31, 2022:

 

    Payments Due By
Period
                   
          Less than                 More than  
    Total     1 year     1-3 years     4-5 years     5 years  
Principal obligations on the debt arrangements   $ 8,997,383     $ 8,847,383     $ -     $ 1,574     $ 148,426  
Interest obligations on the debt arrangements     15,097,215       15,097,215       -       -       -  
Operating leases     13,000       13,000       -       -       -  
Purchase obligations     1,338,668       1,338,668