0001554855-25-002032 | 10-Q | XBRL Viewer | 60 Degrees Pharmaceuticals INC

INCOME TAXES (Details) - USD ($)	3 Months Ended		9 Months Ended
INCOME TAXES (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
INCOME TAXES
Provision for income taxes	$ 250	$ 250	$ 1,813	$ 751

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-4

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-21

Reference 3: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (ee)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 8: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.7)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-10

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(9))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477250/944-220-S99-1

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Subparagraph (a)
-SubTopic 20
-Topic 740
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482659/740-20-45-2

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h))
-SubTopic 10
-Topic 235
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

+ Details

SHARE-BASED COMPENSATION

9 Months Ended

Sep. 30, 2025

SHARE-BASED COMPENSATION

SHARE-BASED COMPENSATION

10. SHARE-BASED COMPENSATION

The following is a summary of share-based compensation expenses reported in the consolidated condensed statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
Research and Development	$	-	$	600,000	$	-	$	3,227,300
General and Administrative Expenses		79,000		68,974		344,383		319,709
Total Share-Based Compensation Expense Included in Operating Expenses	$	79,000	$	668,974	$	344,383	$	3,547,009

Share-Based Compensation under 2022 Equity Incentive Plan

On November 22, 2022, the Company adopted the 2022 Equity Incentive Plan (the “2022 Plan”), which provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units and performance awards to eligible employees, directors and consultants, to be granted from time to time by the Board of Directors of the Company. To date, the Company has granted shares of common stock, restricted stock units, stock options to employees, non-employees, and directors under the 2022 Plan. As of September 30, 2025, the number of remaining shares available for issuance under the 2022 Plan is equal to 57,068.

Stock Options

The Company grants stock options to employees, non-employees, and directors with exercise prices equal to the closing price of the underlying shares of the Company’s common stock on the Nasdaq Capital Market on the date that the options are granted. Options granted generally have a term of five to ten years from the grant date and are subject to vesting as determined in the individual award agreement. The Company estimates the fair value of stock options on the grant date by applying the Black-Scholes option pricing valuation model.

There were no stock options granted during the three months ended September 30, 2025. During the nine months ended September 30, 2025, the Company granted a total of 120,000 stock options to two executives at a per share exercise price of $6.55. These options are subject to vesting annually in five equal tranches, with the first 20% tranche fully vested on the date of grant and thereafter, vest on the last date of each fiscal year beginning December 31, 2025. The weighted average grant date fair value of options granted during the nine months ended September 30, 2025 was $4.55.

During the three and nine months ended September 30, 2024, Company granted a total of 17,005 stock options at a weighted average per share exercise price of $54.62. The weighted average grant date fair value of options granted during the three and nine months ended September 30, 2024 was $8.78.

The following table summarizes the significant assumptions used in determining the fair value of options granted during the three and nine months ended September 30, 2025 and 2024:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
Weighted-average grant date fair value	$	N/A	$	8.78	$	4.55	$	8.78
Risk-free interest rate		N/A		3.62% - 4.17%		4.36%		3.62% - 4.17%
Expected volatility		N/A		86.00% - 87.00%		90.00%		86.00% - 87.00%
Expected term (years)		N/A		6.41 - 10.00		4.50		6.41 - 10.00
Expected dividend yield		N/A		0.00%		0.00%		0.00%

For the three months ended September 30, 2025 and 2024, the Company recognized $34,882 and $15,246 of compensation expense related to stock option awards, respectively ($212,030 and $15,246 for the nine months ended September 30, 2025 and 2024, respectively).

Restricted Stock Units

Compensation cost for service-based RSUs is based on the grant date fair value of the award, which is the closing market price of the Company’s common stock on the grant date multiplied by the number of shares awarded.

During the three and nine months ended September 30, 2025 and 2024, 0 shares of common stock underlying RSUs vested and no RSUs were granted. The Company recognized $0 of compensation expense related to vested RSUs for the three and nine months ended September 30, 2025 and 2024.

Annual Performance Bonus

In December 2024, the Board approved the payment of 2024 performance bonuses to executives of the Company. Each executive was provided the option of receiving up to $20,000 in cash, with the remainder paid in shares of common stock determined based on the closing market price on January 2, 2025. On January 20, 2025, the Company issued a total of 15,809 shares of common stock to the executives in settlement of the share-based portion of the 2024 performance bonuses. Approximately 2,748 shares were withheld to cover payroll tax withholdings.

Share-Based Payments to Vendors for Services

In 2023, the Company issued shares of common stock as share-based payments to certain vendors in exchange for services to be rendered to the Company in the future. For fully vested, nonforfeitable equity instruments that are granted at the date the Company and a nonemployee enter into an agreement for goods or services, the Company recognizes the fair value of the equity instruments as a prepaid asset on the grant date, as defined in ASC 718. The corresponding cost is expensed over the service period depending on the specific facts and circumstances of the agreement with the nonemployee. As of September 30, 2025, the remaining unamortized balance of prepaid assets related to these share-based payments for which the grant date criteria has been met and the services are expected to be rendered within one year is $240,004 ($306,181 at December 31, 2024), which is presented as a component of prepaid and other assets on the accompanying consolidated condensed balance sheets. The unamortized balance of noncurrent prepaid assets related to these share-based payments for which the services are expected to be rendered beyond one year is $0 ($66,176 at December 31, 2024), reported in long-term prepaid expense on the accompanying consolidated condensed balance sheets.

The agreements with the nonemployees do not include any provisions to claw back the share-based payments in the event of nonperformance by the nonemployees. Subject to applicable federal and state securities laws, the nonemployees can sell the received equity instruments.

Consolidated Condensed Balance Sheets - USD ($)

Sep. 30, 2025

Dec. 31, 2024

Current Assets:

Cash and Cash Equivalents

$ 4,115,779

$ 1,659,353

Accounts Receivable

674,036

486,748

Prepaid and Other Assets

992,390

1,068,940

Short-Term Investments

1,728,472

Inventory (Note 3)

527,004

442,764

Total Current Assets

6,309,209

5,386,277

Property and Equipment, net (Note 4)

227,752

149,808

Other Assets:

Long-Term Prepaid Expense

66,176

Intangible Assets, net (Note 5)

152,383

157,084

Total Other Assets

152,383

223,260

Total Assets

6,689,344

5,759,345

Current Liabilities:

Accounts Payable and Accrued Expenses

1,391,347

1,007,618

SBA EIDL (including accrued interest) (Note 7)

8,772

Derivative Liabilities (Note 8)

797,275

640,830

Total Current Liabilities

2,197,394

1,657,220

Long-Term Liabilities:

SBA EIDL (including accrued interest) (Note 7)

144,992

147,119

Total Long-Term Liabilities

144,992

147,119

Total Liabilities

2,342,386

1,804,339

SHAREHOLDERS' EQUITY:

Series A Preferred Stock, $0.0001 par value, 1,000,000 shares authorized; 76,480 and 76,480 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively (Note 6)

9,567,439

Common Stock, $0.0001 par value, 150,000,000 shares authorized; 4,104,469 and 566,908 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively (Note 6)

^[1]

410

Additional Paid-in Capital(1)

^[1]

41,172,888

34,860,590

Accumulated Other Comprehensive Income

144,039

135,471

Accumulated Deficit

(46,454,556)

(40,527,957)

60P Shareholders’ Equity:

4,430,220

4,035,600

Noncontrolling Interest

(83,262)

(80,594)

Total Shareholders' Equity

4,346,958

3,955,006

Total Liabilities and Shareholders' Equity

$ 6,689,344

$ 5,759,345

[1]	Prior periods presented have been adjusted to reflect the 1:5 reverse stock split on February 24, 2025.

SUBSEQUENT EVENTS (Details)								1 Months Ended		3 Months Ended		9 Months Ended
SUBSEQUENT EVENTS (Details)	Oct. 21, 2025 Number $ / shares shares	Oct. 08, 2025 Number shares	Sep. 30, 2025 Director shares	Feb. 24, 2025	Feb. 18, 2025	Feb. 10, 2025	Nov. 06, 2024	Nov. 13, 2025 USD ($) $ / shares shares	Jul. 31, 2024	Sep. 30, 2025 Director shares	Sep. 30, 2024 $ / shares shares	Sep. 30, 2025 Director $ / shares shares	Sep. 30, 2024 $ / shares shares
Subsequent Event [Line Items]
Reverse stock split				1:5	1:5	On February 10, 2025, the Board of Directors approved a 1:5 reverse split ratio. On February 24, 2025, the Company effected the 1:5 reverse stock split (the “1:5 Reverse Stock Split”, and together with the 1:12 Reverse Stock Split, the “Reverse Stock Splits”).	On November 6, 2024, a majority of the Company’s stockholders approved an additional reverse stock split at a split ratio ranging between 1:3 and 1:5, as determined by the Board of Directors in its sole discretion.		Following stockholder approval in July 2024, the Company effected a reverse stock split at a ratio of 1:12, which was effective as of August 12, 2024 (the “1:12 Reverse Stock Split”).			1:5
Stock option granted										0	17,005	120,000	17,005
Per share exercise price (in dollars per share) \| $ / shares											$ 54.62	$ 6.55	$ 54.62
Director [Member]
Subsequent Event [Line Items]
Number of directors \| Director			4							4		4
H.C. Wainwright & Co., LLC [Member] \| 2025 ATM Agreement [Member]
Subsequent Event [Line Items]
ATM Offering			0
Subsequent Event [Member]
Subsequent Event [Line Items]
Number of directors \| Number		5
Number of shares available for issuance (in shares)		250,000
Reverse stock split		1:3 to 1:10
Subsequent Event [Member] \| Stock Options [Member] \| Director [Member]
Subsequent Event [Line Items]
Number of directors \| Number	4
Stock option granted	32,000
Per share exercise price (in dollars per share) \| $ / shares	$ 1.46
Stock option term	7 years
Subsequent Event [Member] \| Stock Options [Member] \| Director One [Member]
Subsequent Event [Line Items]
Stock option granted	8,000
Subsequent Event [Member] \| H.C. Wainwright & Co., LLC [Member] \| 2025 ATM Agreement [Member]
Subsequent Event [Line Items]
ATM Offering								125,979
Common stock sales agreement weighted average price per share \| $ / shares								$ 1.62
Proceeds from common stock sales agreement net \| $								$ 196,356

Consolidated Condensed Balance Sheets (Parentheticals) - $ / shares

Sep. 30, 2025

Dec. 31, 2024

Common stock, par value (in dollars per share)

^[1]

$ 0.0001

Common stock, shares authorized

^[1]

150,000,000

Common stock, shares issued

^[1]

4,104,469

566,908

Common stock, shares outstanding

^[1]

4,104,469

566,908

Series A Preferred Stock

Preferred stock, par value (in dollars per share)

$ 0.0001

Preferred stock, shares authorized

1,000,000

Preferred stock, shares issued

76,480

Preferred stock, shares outstanding

76,480

[1]	Prior periods presented have been adjusted to reflect the 1:5 reverse stock split on February 24, 2025.

SHARE-BASED COMPENSATION (Tables)

9 Months Ended

Sep. 30, 2025

SHARE-BASED COMPENSATION

Schedule of Share-Based Compensation Expenses

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
Research and Development	$	-	$	600,000	$	-	$	3,227,300
General and Administrative Expenses		79,000		68,974		344,383		319,709
Total Share-Based Compensation Expense Included in Operating Expenses	$	79,000	$	668,974	$	344,383	$	3,547,009

Schedule of Fair Value of Options Granted

The following table summarizes the significant assumptions used in determining the fair value of options granted during the three and nine months ended September 30, 2025 and 2024:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
Weighted-average grant date fair value	$	N/A	$	8.78	$	4.55	$	8.78
Risk-free interest rate		N/A		3.62% - 4.17%		4.36%		3.62% - 4.17%
Expected volatility		N/A		86.00% - 87.00%		90.00%		86.00% - 87.00%
Expected term (years)		N/A		6.41 - 10.00		4.50		6.41 - 10.00
Expected dividend yield		N/A		0.00%		0.00%		0.00%

PROPERTY AND EQUIPMENT - Schedule of Property and Equipment (Details) - USD ($)	Sep. 30, 2025	Dec. 31, 2024
Schedule of Property and Equipment [Line Items]
Property and Equipment, at cost	$ 403,437	$ 299,241
Accumulated Depreciation	(175,685)	(149,433)
Property and Equipment, net	227,752	149,808
Lab Equipment [Member]
Schedule of Property and Equipment [Line Items]
Property and Equipment, at cost	333,010	233,411
Machinery [Member]
Schedule of Property and Equipment [Line Items]
Property and Equipment, at cost	55,800	55,800
Computer Equipment [Member]
Schedule of Property and Equipment [Line Items]
Property and Equipment, at cost	11,597	7,000
Furniture [Member]
Schedule of Property and Equipment [Line Items]
Property and Equipment, at cost	$ 3,030	$ 3,030

DEBT - Schedule of the Current Future Payment Obligations (Details)	Sep. 30, 2025 USD ($)
Schedule of the Current Future Payment Obligations [Abstract]
2025 (remaining three months)
2026	465
2027	3,220
2028	3,333
2029	3,470
Thereafter	139,512
Total	$ 150,000

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(22))
-SubTopic 10
-Topic 210
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 235
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477314/942-235-S99-2

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-4

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-3

Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 55
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482949/835-30-55-8

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(16))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 7: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 69B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481568/470-20-55-69B

Reference 8: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 69C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481568/470-20-55-69C

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1D
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1D

Reference 10: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 944
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-03(a)(16)(a)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478777/944-210-S99-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (b)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-4

+ Details

PROPERTY AND EQUIPMENT

9 Months Ended

Sep. 30, 2025

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

4. PROPERTY AND EQUIPMENT

Property and Equipment, net consists of:

	September 30, 2025		December 31, 2024
Lab Equipment	$	333,010	$	233,411
Machinery		55,800		55,800
Computer Equipment		11,597		7,000
Furniture		3,030		3,030
Property and Equipment, at cost		403,437		299,241
Accumulated Depreciation		(175,685)		(149,433)
Property and Equipment, net	$	227,752	$	149,808

Depreciation expense for the three months ended September 30, 2025 and 2024 was in the amount of $12,225 and $4,334, respectively ($28,155 and $6,277 for the nine months ended September 30, 2025 and 2024, respectively).

INVENTORY - Schedule of Inventory (Details) - USD ($)	Sep. 30, 2025	Dec. 31, 2024
Schedule of Inventory [Abstract]
Raw Material (API)	$ 345,195
Work in Process		284,883
Finished Goods	426,491	157,881
Total Inventory	771,686	442,764
Reserve for Expiring Inventory	(244,682)
Inventory	$ 527,004	$ 442,764

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2025
Insider Trading Arrangements [Line Items]
Rule 10b5-1 Arrangement Adopted [Flag]	false
Non-Rule 10b5-1 Arrangement Adopted [Flag]	false
Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Terminated [Flag]	false

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2025

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

11. COMMITMENTS AND CONTINGENCIES

Leases

The Company is a party to a single lease for its office space located in Washington, DC, which was most recently renewed for an additional one-year term that expires March 31, 2026. As the term of the office lease is 12 months, the lease is not recorded on the balance sheet. The Company recognizes lease expense on this lease as short-term lease costs. Operating lease costs, including short-term leases, were in the amount of $5,573 and $4,938 for the three months ended September 30, 2025 and 2024, respectively ($15,340 and $24,067 for the nine months ended September 30, 2025 and 2024, respectively).

Board of Directors

In November and December 2022, the Company signed agreements with four director nominees (Cheryl Xu, Paul Field, Charles Allen, and Stephen Toovey) which came into effect on July 11, 2023, the date the Company’s Registration Statement was declared effective. Each director is entitled to receive cash compensation of $11,250 quarterly. In addition, the two non-audit committee chairs (Toovey, Field) will receive $1,250 per quarter and the audit committee chair (Allen) will receive an additional $2,000 per quarter. In addition, each director is entitled to receive annual equity-based compensation awards, with the amounts and terms to be determined by the Compensation Committee.

Contingencies

The Company’s operations are subject to a variety of local and state regulations. Failure to comply with one or more of those regulations could result in fines, restrictions on its operations, or losses of permits that could result in the Company ceasing operations.

Contingent Compensation

Following the Company’s IPO and the conversion of the outstanding debt pursuant to the Knight Debt Conversion Agreement as discussed in Note 8, the Company is obligated to pay Knight a contingent milestone payment of $10 million if the Company sells Arakoda or if a Change of Control occurs. The Company accounts for the contingent milestone payment as a derivative liability (See Note 8).

On July 15, 2015, the Company 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 the Company 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. 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. The Company must make a minimum annual royalty payment of 3% of Net Sales (as defined in the U.S. Army Agreement) for Net Sales less than $35 million, and 5% of Net Sales greater than $35 million, with US government sales excluded from the definition of Net Sales. In addition, the Company must pay fees upon the achievement of certain milestones. The Company accrues the minimum annual royalty when the related sales occur. The achievement of the remaining milestones under the U.S. Army Agreement are not considered probable and thus no accruals for the related milestone payments have been made.

On December 20, 2024, the Company entered into a Patent License Agreement with Tufts Medical Center (“Tufts MC”), in which the Company obtained a license to research and commercialize the licensed technology with respect to the use of tafenoquine for treatment and/or prevention of babesiosis (the “Tufts MC Agreement”). The term of the Tufts MC Agreement will continue until the expiration or final abandonment of the last patent application or issued patent for the use of tafenoquine for treatment and/or prevention of babesiosis, unless terminated earlier by the parties. On the earlier of (x) the date of patent issuance or (y) the date of regulatory approval for the use of tafenoquine product in treatment of babesiosis, the Company must make royalty payments equal to 4% of Net Sales (as defined in the Tufts MC Agreement) for tafenoquine sold in a format labeled for use in the treatment of babesiosis or 2% of Net Sales for 60P products that are not sold in a format labeled for use in the treatment of babesiosis. In addition, for all sublicense revenue received by 60P from sales of sublicensed products, the Company must make royalty payments equal to 20% of the revenue received by the Company for sales of tafenoquine sold in a format labeled for use in the treatment of babesiosis or 10% for sales of tafenoquine that are not sold in a format labeled for use in the treatment of babesiosis. As of September 30, 2025, the royalty period has not commenced, thus no accruals have been made.

Litigation, Claims and Assessments

From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of September 30, 2025, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the results of the Company’s operations.

COMMITMENTS AND CONTINGENCIES (Details)			3 Months Ended		9 Months Ended
COMMITMENTS AND CONTINGENCIES (Details)	Dec. 20, 2024	Jul. 15, 2015 USD ($)	Sep. 30, 2025 USD ($) Director	Sep. 30, 2024 USD ($)	Sep. 30, 2025 USD ($) Director	Sep. 30, 2024 USD ($)
Commitments and Contingencies [Line Items]
Number of pending or threatened lawsuits			0		0
Office space lease renewed term			1 year		1 year
Operating lease costs			$ 5,573	$ 4,938	$ 15,340	$ 24,067
Number of non audit committee chairs			2		2
Licensed technology term.		20 years
Annual royalty payment		5.00%
Percentage of royalty payments of net sales	4.00%
Percentage of revenue	20.00%
Charles Allen [Member]
Commitments and Contingencies [Line Items]
Cash compensation			$ 2,000		$ 2,000
Paul Field [Member]
Commitments and Contingencies [Line Items]
Cash compensation			1,250		1,250
US Government Sales [Member]
Commitments and Contingencies [Line Items]
Royalty expense		$ 35,000,000
U.S. Army Agreement [Member]
Commitments and Contingencies [Line Items]
Royalty expense		$ 35,000,000
Tufts MC Agreement [Member]
Commitments and Contingencies [Line Items]
Royalty expense					0
Board of Directors Chairman [Member]
Commitments and Contingencies [Line Items]
Annual royalty payment		3.00%
Board of Directors Chairman [Member] \| Stephen Toovey [Member]
Commitments and Contingencies [Line Items]
Cash compensation			$ 11,250		$ 11,250
Director [Member]
Commitments and Contingencies [Line Items]
Number of director nominees \| Director			4		4
Equity-based compensation awards term					annual
Minimum [Member]
Commitments and Contingencies [Line Items]
Percentage of treatment of babesiosis	2.00%
Maximum [Member]
Commitments and Contingencies [Line Items]
Percentage of treatment of babesiosis	10.00%
IPO [Member]
Commitments and Contingencies [Line Items]
Payment			$ 10,000,000		$ 10,000,000

INTANGIBLE ASSETS - Schedule of Intangible Assets (Details) - USD ($)	Sep. 30, 2025	Dec. 31, 2024
Schedule of Intangible Assets [Abstract]
Patents	$ 152,267	$ 127,603
Website Development Costs	106,407	104,622
Intangible Assets, at cost	258,674	232,225
Accumulated Amortization	(106,291)	(75,141)
Intangible Assets, net	$ 152,383	$ 157,084

DERIVATIVE LIABILITIES (Details) - USD ($)		9 Months Ended
DERIVATIVE LIABILITIES (Details) - USD ($)	Mar. 31, 2022	Sep. 30, 2025	Sep. 30, 2024
Derivative Liabilities [Line Items]
Conversion of Stock, Shares Converted (in Shares)	18,473
Sale of stock, percentage of ownership	19.90%
Milestone Payment		$ 10,000,000
Redemption term.		For the period ending upon the earlier of (i) 10 years after the closing of the IPO, or (ii) the conversion or redemption in full of the Series A Preferred Stock, the Company will pay to Knight a royalty equal to 3.5% of the Company’s net sales (the “Royalty”) on a quarterly basis, where “Net Sales” has the same meaning as in the Company’s license agreement with the U.S. Army for tafenoquine.
Royalty percentage		3.50%
(Gain) loss on change in fair value of derivative liabilities		$ (156,445)	$ 1,683,034
Series A Non-Voting Convertible Preferred Stock [Member]
Derivative Liabilities [Line Items]
Designated shares (in Shares)	80,965	80,965

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

INTANGIBLE ASSETS (Details) - USD ($)	3 Months Ended		9 Months Ended
INTANGIBLE ASSETS (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
INTANGIBLE ASSETS
Capitalized website development-related costs	$ 1,785	$ 3,299	$ 1,785	$ 25,374
Amortization expense	10,605	10,325	31,150	28,004
Write-downs	$ 0	$ 2,922	0	$ 11,300
Capitalized patent expenses			$ 60,209

- Definition

The aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Section 45
-Paragraph 28
-Subparagraph (b)
-SubTopic 10
-Topic 230
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482740/230-10-45-28

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 18
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-18

Reference 3: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 11
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-11

Reference 4: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 55
-Paragraph 24
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476153/220-40-55-24

Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476148/220-40-50-12

Reference 6: http://www.xbrl.org/2003/role/exampleRef
-Name Accounting Standards Codification
-Section 55
-Paragraph 40
-SubTopic 30
-Topic 350
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482640/350-30-55-40

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 350
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482665/350-30-50-2

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 350
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482686/350-30-45-2

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476148/220-40-50-6

+ Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Liabilities Measured at Fair Value (Details) - USD ($)	Sep. 30, 2025	Dec. 31, 2024
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities	$ 797,275	$ 640,830
Level 1 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities
Level 2 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities
Level 3 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities	797,275	640,830
Derivative Liabilities [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities	797,275	640,830
Derivative Liabilities [Member] \| Level 1 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities
Derivative Liabilities [Member] \| Level 2 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities
Derivative Liabilities [Member] \| Level 3 [Member]
Schedule of Liabilities Measured at Fair Value [Line Items]
Total derivative liabilities	$ 797,275	$ 640,830

Consolidated Condensed Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss	$ (5,929,267)	$ (5,906,739)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation	28,155	6,277
Amortization	31,150	28,004
Amortization of ROU Asset		13,517
Amortization of Capitalized Share-Based Payments	132,353	3,531,763
Share-Based Compensation under Equity Incentive Plan	212,030	15,246
Change in Fair Value of Derivative Liabilities	156,445	(1,683,034)
Write-offs of Capitalized Patents		11,300
Change in Inventory Reserve	244,682
Changes in Operating Assets and Liabilities:
Accounts Receivable	(187,288)	(92,490)
Prepaid and Other Assets	10,373	(99,756)
Inventory	(328,922)	14,133
Accounts Payable and Accrued Liabilities	455,378	171,411
Accrued Interest, net	18,345	(5,853)
Reduction of Lease Liability		(13,650)
Net Cash Used in Operating Activities	(5,156,566)	(4,009,871)
CASH FLOWS FROM INVESTING ACTIVITIES
Capitalization of Patents	(20,868)	(49,869)
Purchases of Fixed Assets	(60,000)	(103,773)
Acquisition of Intangibles	(1,785)	(25,374)
Purchase of Short-Term Investments		(1,708,000)
Maturities of Short-Term Investments	1,708,000
Net Cash Provided by (Used in) Investing Activities	1,625,347	(1,887,016)
CASH FLOWS FROM FINANCING ACTIVITIES
Net Proceeds from January 2024 Offering		1,898,296
Net Proceeds from January 2025 Offering	804,346
Net Proceeds from February 2025 Offering	908,627
Net Proceeds from July 2025 Offering	4,281,300
Shares Withheld for Net Share Settlement of Performance Bonuses	(18,000)
Net proceeds from ATM Offering		1,729,810
Net proceeds from Private Placement		3,414,502
Proceeds from Exercise of Pre-Funded Warrants	2,804	9,990
Net Cash Provided by Financing Activities	5,979,077	7,052,598
Effect of Exchange Rate Changes on Cash	8,568	2,492
Change in Cash and Cash Equivalents	2,456,426	1,158,203
Cash and Cash Equivalents—Beginning of Period	1,659,353	2,142,485
Cash and Cash Equivalents—End of Period	4,115,779	3,300,688
NONCASH INVESTING/FINANCING ACTIVITIES
Fair Value of Warrants Issued to Underwriters		71,364
Purchases of Fixed Assets included in Accounts Payable	46,099
Conversion Of Series A Preferred Stock Into Common Stock		290,601
Capitalized Patent Costs included in Accounts Payable	3,796
Gross Shares Issued for Annual Performance Bonuses	$ 121,544

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2025

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The financial statements of 60P are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company has prepared the accompanying consolidated condensed financial statements pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”). These financial statements are unaudited and, in the opinion of management, all adjustments considered necessary for a fair presentation of the Company’s financial position, results of operations, and cash flows have been included and are of a normal and recurring nature. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 due to various factors. These consolidated condensed financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto as of and for the years ended December 31, 2024 and 2023, included in the Company’s annual report on Form 10-K, as filed with the SEC on March 27, 2025 (the “Annual Report”). Certain information, footnote disclosures, and significant accounting policies that would substantially duplicate the disclosures contained in the Annual Report have been omitted.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates, and those estimates may be material. Significant estimates include the reserve for inventory, the fair value of derivative liabilities, and stock-based compensation.

Reverse Stock Splits

Following stockholder approval in July 2024, the Company effected a reverse stock split at a ratio of 1:12, which was effective as of August 12, 2024 (the “1:12 Reverse Stock Split”). On November 6, 2024, a majority of the Company’s stockholders approved an additional reverse stock split at a split ratio ranging between 1:3 and 1:5, as determined by the Board of Directors in its sole discretion. On February 10, 2025, the Board of Directors approved a 1:5 reverse split ratio. On February 24, 2025, the Company effected the 1:5 reverse stock split (the “1:5 Reverse Stock Split”, and together with the 1:12 Reverse Stock Split, the “Reverse Stock Splits”). Beginning February 24, 2025, the common stock traded on The Nasdaq Capital Market on a split adjusted basis.

Proportional adjustments were made to the number of shares of common stock issuable upon exercise or conversion of the Company’s equity awards, warrants, and other equity instruments convertible into common stock, as well as the respective exercise prices, if applicable, in accordance with the terms of the instruments. Unless otherwise noted, all references to numbers of shares of the Company’s common stock and per share information presented in these consolidated condensed financial statements have been retroactively adjusted, as appropriate, to reflect the Reverse Stock Splits, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital.

Concentrations

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments, accounts receivable, inventory purchases, and borrowings.

Significant customers represent any customer whose business makes up 10% of receivables or revenues. At September 30, 2025, significant customers represented 89% of receivables (consisting of six total customers and two significant customers at 75% and 13%, respectively), and 95% of receivables at December 31, 2024 (consisting of three total customers and one significant customer). For the three months ended September 30, 2025, significant customers comprised 80% of total net product revenues (consisting of four total customers and one significant customer at 80%). For the three months ended September 30, 2024, 92% of total net product revenues (consisting of two total customers and one significant customer) were generated from significant customers. For the nine months ended September 30, 2025, 91% of total net product revenues (consisting of four total customers and two significant customers at 73% and 18%, respectively) were generated from significant customers. For the nine months ended September 30, 2024, 94% of total net product revenues (consisting of three total customers and one significant customer) were generated from significant customers.

Currently, the Company has exclusive relationships with distributors in Australia and Europe. A failure to perform by any of our current distributors would create disruption for patients in those markets.

Since the Company first started working on tafenoquine, all inventory has been acquired in a collaborative relationship from a sole vendor. Should the vendor cease to supply tafenoquine, it would take significant costs and efforts to rebuild the supply chain with a new sole vendor sourcing the active pharmaceutical ingredient (“API”).

Segment Information

Since its inception, the Company operates and manages its business as a single identifiable segment, focused on the development and marketing of new medicines for the treatment and prevention of infectious diseases. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”).

The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income or loss for purposes of evaluating performance, making operating decisions, allocating resources, and planning and forecasting for future periods. The significant components of consolidated net income or loss regularly provided to the CODM include net product revenues and the significant expense categories presented in the accompanying consolidated condensed statements of operations and comprehensive loss (cost of revenues, research and development, and general and administrative expenses). These are presented at the consolidated level and used by the CODM to monitor budgeted versus actual results to make key operating decisions. The information and operating expense categories presented in the accompanying consolidated condensed statements of operations and comprehensive loss are fully reflective of the significant expense categories and amounts that are regularly provided to the CODM.

The measure of segment assets that is regularly reported to the CODM includes cash and cash equivalents and short-term investments, each as reported on the consolidated condensed balance sheets. Total consolidated cash and cash equivalents and short-term investments were $4,115,779 and $3,387,825 as of September 30, 2025 and December 31, 2024, respectively.

Derivative Liabilities

The Company analyzes all financial instruments with features of both liabilities and equity under FASB ASC Topic No. 480, Distinguishing Liabilities from Equity (“ASC 480”), and FASB ASC Topic No. 815, Derivatives and Hedging (“ASC 815”). The classification of derivative financial instruments is reassessed each reporting period. Derivative liabilities are adjusted to reflect fair value at each reporting period, with any increase or decrease in the fair value recorded in the results of operations, as a component of other income or expense as change in fair value of derivative liabilities. As of September 30, 2025, derivative liabilities consist of contingent payment arrangements. The Company uses a probability-weighted expected return method to determine the fair value of these instruments.

Upon conversion or repayment of a debt or equity instrument in exchange for equity shares, where the embedded conversion option has been bifurcated and accounted for as a derivative liability (generally convertible debt and warrants), the Company records the equity shares at fair value on the date of conversion, relieves all related debt, derivative liabilities, and unamortized debt discounts, and recognizes a net gain or loss on debt extinguishment, if any.

Equity or liability instruments that become subject to reclassification under ASC Topic 815 are reclassified at the fair value of the instrument on the reclassification date.

Equity-Classified Warrants

As of September 30, 2025, the Company accounts for all outstanding warrants to purchase common stock as equity-classified instruments based on an assessment of the warrants’ specific terms and applicable authoritative guidance in ASC 480 and ASC 815. This assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the respective issuance dates and as of each subsequent reporting period while the warrants are outstanding.

Revenue Recognition

The Company recognizes revenue in accordance with FASB ASC Topic No. 606, Revenue from Contracts with Customers (“ASC 606”). Revenues are recognized when control is transferred to customers in amounts that reflect the consideration the Company expects to be entitled to receive in exchange for those goods. Revenue recognition is evaluated through the following five steps: (i) identification of the contract, or contracts, with a customer; (ii) identification of the performance obligations in the contract; (iii) determination of the transaction price; (iv) allocation of the transaction price to the performance obligations in the contract; and (v) recognition of revenue when or as a performance obligation is satisfied. As part of the accounting for these arrangements, the Company may be required to make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation.

Revenues from product sales are recorded at the net sales price, or “transaction price,” which may include estimates of variable consideration that result from product returns. The Company determines the amount of variable consideration by using either the expected value method or the most-likely-amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price, which reflects the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. Reserves are established for the estimates of variable consideration based on the amounts the Company expects to be earned or to be claimed on the related sales.

The Company receives the majority of its revenues from sales of its Arakoda product to resellers in the US and abroad. The Company records US commercial revenues as a receivable when our American distributor transfers shipped product to their title model for 60P. Foreign sales to both Australia and Europe are recognized as a receivable at the point product is shipped to distributor. The shipments to Australia and Europe are further subject to profit sharing agreements for boxes sold to customers.

Research and Development Costs

The Company accounts for research and development costs in accordance with FASB ASC Subtopic No. 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, research and development costs are expensed as incurred. Accordingly, internal research and development costs are expensed as incurred. Prepayments for research and development services are deferred and amortized over the service period as the services are provided. Advance payments for specific materials, equipment, or facilities determined to have no alternative future use are initially deferred and recognized as research and development expense when the related goods are delivered.

The Company recorded $809,777 and $940,063 in research and development expense during the three months ended September 30, 2025 and 2024, respectively, ($1,467,283 and $4,372,571 for the nine months ended September 30, 2025 and 2024, respectively). The Company has also issued shares of common stock to nonemployees in exchange for research and development services. The Company recognizes prepaid research and development costs on the grant date, as defined in FASB ASC Subtopic No. 718, Compensation - Stock Compensation. See Note 10 for further details.

Fair Value of Financial Instruments

The carrying value of the Company’s financial instruments included in current assets and current liabilities (such as cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses) approximate their fair value due to the short-term nature of such instruments.

The inputs used to measure fair value are based on a hierarchy that prioritizes observable and unobservable inputs used in valuation techniques. These levels, in order of highest to lowest priority, are described below:

Level 1	-	Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities.

Level 2	-	Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

Level 3	-	Unobservable inputs reflecting the Company’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

The Company’s financial instruments recorded at fair value on a recurring basis at September 30, 2025, and December 31, 2024 include the derivative liability associated with the contingent milestone payment due to Knight upon a future sale of Arakoda or a Change of Control, which is carried at fair value based on Level 3 inputs. The Company uses a probability-weighted expected return method to determine the fair value of the contingent milestone payment using significant inputs such as the timing and probability of discrete potential exit scenarios, forward interest rate curves, and discount rates based on implied and market yields. See Note 8 for more information on Derivative Liabilities.

Liabilities measured at fair value at September 30, 2025 and December 31, 2024 are as follows:

	September 30, 2025
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	797,275	$	797,275
Total	$	-	$	-	$	797,275	$	797,275

	December 31, 2024
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	640,830	$	640,830
Total	$	-	$	-	$	640,830	$	640,830

There were no transfers of financial instruments between Level 1, Level 2, and Level 3 during the periods presented.

A rollforward of liabilities measured at fair value using Level 3 inputs for the three and nine months ended September 30, 2025 and 2024 is presented in Note 8 – Derivative Liabilities.

Assets and Liabilities Not Measured at Fair Value on a Recurring Basis

In addition to assets and liabilities that are measured at fair value on a recurring basis, the Company also measures certain assets and liabilities at fair value on a nonrecurring basis. The Company’s non-financial assets, including Intangible Assets and Property and Equipment, are measured at fair value when there is an indication of impairment and the carrying amount exceeds the asset’s projected undiscounted cash flows. These assets are recorded at fair value only when an impairment charge is recognized.

Certificates of deposit, classified as cash equivalents or short-term investments depending on the instrument’s original time to maturity, are measured at amortized cost, which approximates fair value as of September 30, 2025 and December 31, 2024.

Foreign Currency Transactions and Translation

The individual financial statements of each group entity are measured and presented in the currency of the primary economic environment in which the entity operates (its functional currency). The consolidated condensed financial statements of the Company are presented in United States dollars, which is the functional currency of the Company and the presentation currency for the consolidated condensed financial statements.

For the purpose of presenting consolidated condensed financial statements, the assets and liabilities of the Company’s foreign operations are mostly translated at exchange rates prevailing on the reporting date. Income and expense items are translated at the average exchange rates for the period, unless exchange rates fluctuate significantly during that period, in which case the exchange rates at the dates of the transactions are used. Exchange differences arising, if any, are recognized as a component of other comprehensive income (loss) as unrealized foreign currency translation gain (loss).

Exchange rates along with historical rates used in these financial statements are as follows:

	Average Exchange Rate
	Three Months Ended September 30,				Nine Months Ended September 30,				As of
Currency	2025		2024		2025		2024		September 30, 2025		December 31, 2024
1 AUD =	0.65	USD	0.67	USD	0.64	USD	0.66	USD	0.66	USD	0.62	USD

Reclassifications

Certain prior period interim amounts have been reclassified for consistency with the current period presentation. These reclassifications had no material effect on the consolidated condensed results of operations and comprehensive loss, shareholders’ equity, or cash flows.

Share-Based Payments

On November 22, 2022, the Company adopted the 2022 Equity Incentive Plan also referred to as (“2022 Plan”). The 2022 Plan and related share-based awards are discussed more fully in Note 10.

The Company accounts for share-based payments in accordance with ASC Subtopic 718, Compensation - Stock Compensation (“ASC 718”). The Company measures compensation for all share-based payment awards granted to employees, directors, and nonemployees, based on the estimated fair value of the awards on the date of grant. For awards that vest based on continued service, the service-based compensation cost is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the awards. For service vesting awards with compensation expense recognized on a straight-line basis, at no point in time does the cumulative grant date value of vested awards exceed the cumulative amount of compensation expense recognized. The grant date is determined based on the date when a mutual understanding of the key terms of the share-based awards is established. The Company accounts for forfeitures as they occur.

The Company estimates the fair value of all stock option awards as of the grant date by applying the Black-Scholes option pricing model. The application of this valuation model involves assumptions, including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends and the expected term of the option. Due to the lack of a public market for the Company’s common stock prior to the IPO and lack of company-specific historical implied volatility data, the Company has based its computations of expected volatility on the historical volatility of a representative group of public companies with similar characteristics of the Company, including stage of development and industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company generally uses the simplified method as prescribed by the SEC Staff Accounting Bulletin Topic 14, Share-Based Payment, to estimate the expected term for stock options, whereby, the expected term equals the midpoint of the weighted average remaining time to vest, vesting period and the contractual term of the options due to its lack of historical exercise data. For certain options granted out-of-the-money, the Company’s best estimate of the expected term is the contractual term of the award. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The assumptions used in calculating the fair value of share-based awards represent management’s best estimates and involve inherent uncertainties and the application of significant judgment.

Compensation expense for restricted stock units (“RSUs”) with only service-based vesting conditions is recognized on a straight-line basis over the vesting period. Compensation cost for service-based RSUs is based on the grant date fair value of the award, which is the closing market price of the Company’s common stock on the grant date multiplied by the number of shares awarded.

For awards that vest upon a liquidity event or a change in control, the performance condition is not probable of being achieved until the event occurs. As a result, no compensation expense is recognized until the performance-based vesting condition is achieved, at which time the cumulative compensation expense is recognized. Compensation cost related to any remaining time-based service for share-based awards after the liquidity-based event is recognized on a straight-line basis over the remaining service period.

For fully vested, nonforfeitable equity instruments that are granted at the date the Company and a nonemployee enter into an agreement for goods or services, the Company recognizes the fair value of the equity instruments on the grant date. The corresponding cost is recognized as an immediate expense or a prepaid asset and expensed over the service period depending on the specific facts and circumstances of the agreement with the nonemployee. See Note 10 for further details.

Net Loss per Common Share

Net Loss per Common Share is computed by dividing net loss attributable to common shareholders by the weighted average number of common shares outstanding during each period. The Company includes pre-funded warrants, which carry a nominal exercise price per share, in its computation of basic and diluted net loss per share beginning on the date of issuance. The cumulative dividends accrued on the Series A Preferred Stock during the period are reflected as an increase to net loss or a reduction of net income in determining basic and diluted net loss attributable to common stockholders.

As the Company reported a net loss for all periods presented, the calculation of diluted net loss per common share is the same as basic net loss per common share.

As a result of the 1:5 Reverse Stock Split, which was effective as of February 24, 2025, all shares of outstanding common stock and net loss per common share calculations have been retroactively adjusted for all periods presented.

Related Parties

Parties are considered to be related to the Company if the parties, directly or indirectly, through one or more intermediaries, control, are controlled by, or are under common control with the Company. Related parties also include principal owners of the Company, its management, members of the immediate families of principal owners of the Company and its management and other parties with which the Company may deal with if one party controls or can significantly influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests.

Subsequent Events

The Company considers events or transactions that occur after the balance sheet date, but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through November 13, 2025, which is the date the financial statements were issued. See Note 12.

Recently Adopted and Issued Accounting Pronouncements

From time to time, the FASB issues Accounting Standards Updates (“ASU”) to amend the authoritative literature in the ASC. The Company regularly evaluates new ASUs to determine the impact that these pronouncements may have on the consolidated condensed financial statements. Other than the pronouncements listed below, the Company believes that those issued to date either (i) provide supplemental guidance, (ii) are technical corrections, or (iii) are not applicable to the Company’s consolidated condensed financial statements or related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses and segment profit or loss. ASU 2023-07 also requires entities with a single reportable segment to provide all segment disclosures under ASC 280, including the new required disclosures under the ASU. The Company adopted ASU 2023-07 on a retrospective basis for the 2024 annual period, and for interim periods beginning in 2025. The impact is limited to the Company’s financial statement disclosures, which are presented in the Segment Information section above.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. The Company will adopt this standard for the annual period ending December 31, 2025. The impact of ASU 2023-09 will be limited to the Company’s financial statement disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which applies to all public business entities that file financial statements with the SEC. The amendments in this ASU require public business entities to disclose on an annual and interim basis, disaggregated information about certain income statement expense line items. The new standard is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. The Company is currently evaluating the impact that ASU 2024-03 will have on its financial statement disclosures.

NATURE OF OPERATIONS (Details) - USD ($)	9 Months Ended
NATURE OF OPERATIONS (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Dec. 31, 2024
Nature of Operations [Line Items]
Cash and cash equivalents	$ 4,115,779		$ 1,659,353
Net cash used in operating activities	(5,156,566)	$ (4,009,871)
Company’s debt	8,772		8,772
Accounts payable and accrued expenses	$ 1,391,347		$ 1,007,618

INVENTORY (Details) - USD ($)	3 Months Ended		9 Months Ended
INVENTORY (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
INVENTORY
Inventory Write-down	$ 436,561	$ 1,165	$ 436,596	$ 18,490

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2025

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of Liabilities Measured at Fair Value

Liabilities measured at fair value at September 30, 2025 and December 31, 2024 are as follows:

	September 30, 2025
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	797,275	$	797,275
Total	$	-	$	-	$	797,275	$	797,275

	December 31, 2024
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	640,830	$	640,830
Total	$	-	$	-	$	640,830	$	640,830

Schedule of Exchange Rates along with Historical Rates

Exchange rates along with historical rates used in these financial statements are as follows:

	Average Exchange Rate
	Three Months Ended September 30,				Nine Months Ended September 30,				As of
Currency	2025		2024		2025		2024		September 30, 2025		December 31, 2024
1 AUD =	0.65	USD	0.67	USD	0.64	USD	0.66	USD	0.66	USD	0.62	USD

INCOME TAXES

9 Months Ended

Sep. 30, 2025

INCOME TAXES

INCOME TAXES

9. INCOME TAXES

The Company did not record a federal income tax provision or benefit for the three and nine months ended September 30, 2025 and 2024 due to taxable losses. The Company recorded a provision for income taxes for the District of Columbia of $250 and $250 for the three months ended September 30, 2025 and 2024, respectively, thereby reflecting the minimum statutory tax due ($1,813 and $751 for the nine months ended September 30, 2025 and 2024, respectively).

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 740
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477617/942-740-50-1

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 740
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478822/944-740-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 5: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480990/946-20-50-13

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/740/tableOfContent

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-14

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-21

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-17

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-2

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

STOCKHOLDERS' EQUITY (Tables)

9 Months Ended

Sep. 30, 2025

STOCKHOLDERS’ EQUITY

Schedule of Equity-Classified Warrants

The following table presents a summary of the activity for the Company’s equity-classified warrants during the three and nine months ended September 30, 2025:

	Number of Warrants	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)
Total outstanding, December 31, 2024(1)	1,765,070	$	17.59	3.26
Granted	747,200		3.56	2.00
Exercised	(385,200)		0.01	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, March 31, 2025	2,127,070	$	15.85	2.60
Granted	-		-	-
Exercised	-		-	-
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, June 30, 2025	2,127,070	$	15.85	2.10
Granted(2)	6,338,788		1.65	3.31
Exercised	(878,264)		0.001	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, September 30, 2025	7,587,594	$	5.82	2.82
Total exercisable, September 30, 2025	7,587,594	$	5.82	2.82

(1)	Weighted average remaining contractual life at December 31, 2024 excludes 385,200 Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at March 31, 2025, June 30, 2025 and September 30, 2025.

(2)	Weighted average remaining contractual life excludes 878,264 Pre-Funded Warrants issued July 2025 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at September 30, 2025.

The following table presents a summary of the activity for the Company’s equity-classified warrants during the three and nine months ended September 30, 2024:

	Number of Warrants	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)
Total outstanding, December 31, 2023	52,737	$	369.98	4.47
Granted	140,884		22.48	5.00
Exercised	(8,326)		0.60	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, March 31, 2024	185,295	$	122.36	4.67
Granted	-		-	-
Exercised	(8,326)		0.60	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, June 30, 2024	176,969	$	128.09	4.41
Granted(1)	1,782,612		4.70	-
Exercised	-		-	-
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, September 30, 2024(1)	1,959,581	$	15.84	4.16
Total exercisable, September 30, 2024(2)	756,680	$	29.96	4.16

(1)

Weighted average remaining contractual life calculations exclude (i) 579,711 Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date, (ii) 43,479 September 2024 Agent Warrants and 579,711 Series A Warrants issued September 2024 that expire five years from the Stockholder Approval Date, defined above, and (iii) 579,711 Series B Warrants issued September 2024 that expire eighteen months from the Stockholder Approval Date, which had not yet occurred as of September 30, 2024.

(2)

Weighted average remaining contractual life calculation excludes 579,711 exercisable Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date.

DEBT (Details) - USD ($)		9 Months Ended	12 Months Ended
DEBT (Details) - USD ($)	May 14, 2020	Sep. 30, 2025	Dec. 31, 2024
Debt [Line Items]
Amortization discount		$ 153,764	$ 155,891
Current maturity		8,772	8,772
Long-Term Liabilities		$ 144,992	$ 147,119
Small Business Administration [Member]
Debt [Line Items]
Principal amount	$ 150,000
Annual interest rate	3.75%
Balloon Payment [Member]
Debt [Line Items]
Balloon payment	$ 731
SBA [Member]
Debt [Line Items]
Maturity date	Oct. 12, 2050

DEBT (Tables)

9 Months Ended

Sep. 30, 2025

DEBT

Schedule of the Current Future Payment Obligations

The current future payment obligations of the principal are as follows:

Period	Principal Payments
2025 (remaining three months)	$	-
2026		465
2027		3,220
2028		3,333
2029		3,470
Thereafter		139,512
Total	$	150,000

SHARE-BASED COMPENSATION (Details)		3 Months Ended				9 Months Ended		12 Months Ended
SHARE-BASED COMPENSATION (Details)	Jan. 20, 2025 shares	Sep. 30, 2025 USD ($) Number shares	Jun. 30, 2025 USD ($)	Mar. 31, 2025 USD ($) shares	Sep. 30, 2024 USD ($) $ / shares shares	Sep. 30, 2025 USD ($) Number $ / shares shares	Sep. 30, 2024 USD ($) $ / shares shares	Dec. 31, 2024 USD ($)
Share-Based Compensation [Line Items]
Per share exercise price (in dollars per share) \| $ / shares					$ 54.62	$ 6.55	$ 54.62
Weighted average grant date fair value of options granted (in Dollars per share) \| $ / shares					$ 8.78	$ 4.55	$ 8.78
Stock option award \| $		$ 34,882	$ 34,503	$ 142,645	$ 15,246	$ 212,030	$ 15,246
Compensation expense \| $		79,000			$ 668,974	344,383	$ 3,547,009
Cash \| $								$ 20,000
Shares payroll tax withholdings (in Shares)	2,748
Unamortized balance \| $						240,004		306,181
Long-term prepaid expense \| $		$ 0				$ 0		$ 66,176
Stock option granted to number of executives \| Number		2				2
Stock option granted		0			17,005	120,000	17,005
Stock Options [Member]
Share-Based Compensation [Line Items]
Stock option granted term						term of five to ten years
Restricted Stock Units (RSUs) [Member]
Share-Based Compensation [Line Items]
Compensation expense \| $		$ 0			$ 0	$ 0	$ 0
First Tranche [Member]
Share-Based Compensation [Line Items]
Options Vesting percentage						20.00%
Common Stock, par value $0.0001 per share
Share-Based Compensation [Line Items]
Shares of common stock to the executives in settlement	15,809
Common Stock, par value $0.0001 per share \| Restricted Stock Units (RSUs) [Member]
Share-Based Compensation [Line Items]
Vested shares (in Shares)		0			0	0	0
Common Stock, par value $0.0001 per share
Share-Based Compensation [Line Items]
Shares of common stock to the executives in settlement				15,809
Common Stock, par value $0.0001 per share \| Restricted Stock Units (RSUs) [Member]
Share-Based Compensation [Line Items]
Stock option granted		0			0	0	0
Two Thousand Twenty Two Equity Incentive Plan [Member]
Share-Based Compensation [Line Items]
Number of shares available for grant (in shares)		57,068				57,068

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)							1 Months Ended	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Feb. 24, 2025	Feb. 18, 2025	Feb. 10, 2025	Dec. 31, 2024	Nov. 06, 2024	Jul. 31, 2024	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Summary of Significant Accounting Policies [Line Items]
Reverse stock split		1:5	1:5	On February 10, 2025, the Board of Directors approved a 1:5 reverse split ratio. On February 24, 2025, the Company effected the 1:5 reverse stock split (the “1:5 Reverse Stock Split”, and together with the 1:12 Reverse Stock Split, the “Reverse Stock Splits”).		On November 6, 2024, a majority of the Company’s stockholders approved an additional reverse stock split at a split ratio ranging between 1:3 and 1:5, as determined by the Board of Directors in its sole discretion.	Following stockholder approval in July 2024, the Company effected a reverse stock split at a ratio of 1:12, which was effective as of August 12, 2024 (the “1:12 Reverse Stock Split”).			1:5
Cash equivalents and short-term (in Dollars)	$ 4,115,779				$ 3,387,825			$ 4,115,779		$ 4,115,779
Research and development (in Dollars)								$ 809,777	$ 940,063	$ 1,467,283	$ 4,372,571
Customer Concentration Risk [Member] \| Significant Customers [Member] \| Accounts Receivable [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage	89.00%				95.00%
Customer Concentration Risk [Member] \| Significant Customers [Member] \| Revenue Benchmark [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage								80.00%	92.00%	91.00%	94.00%
Customer Concentration Risk [Member] \| Significant Customers [Member] \| Accounts Receivable Or Revenue Benchmark [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage										10.00%
Customer Concentration Risk [Member] \| Significant Customer One [Member] \| Accounts Receivable [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage	75.00%
Customer Concentration Risk [Member] \| Significant Customer One [Member] \| Revenue Benchmark [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage								80.00%		73.00%
Customer Concentration Risk [Member] \| Significant Customer Two [Member] \| Accounts Receivable [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage	13.00%
Customer Concentration Risk [Member] \| Significant Customer Two [Member] \| Revenue Benchmark [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration percentage										18.00%

INVENTORY (Tables)

9 Months Ended

Sep. 30, 2025

INVENTORY

Schedule of Inventory

Inventory consists of the following major classes:

	September 30, 2025		December 31, 2024
Raw Material (API)	$	345,195	$	-
Work in Process		-		284,883
Finished Goods		426,491		157,881
Total Inventory		771,686		442,764
Reserve for Expiring Inventory		(244,682)		-
Inventory	$	527,004	$	442,764

INTANGIBLE ASSETS

9 Months Ended

Sep. 30, 2025

INTANGIBLE ASSETS

INTANGIBLE ASSETS

5. INTANGIBLE ASSETS

Intangible Assets, net consists of:

	September 30, 2025		December 31, 2024
Patents	$	152,267	$	127,603
Website Development Costs		106,407		104,622
Intangible Assets, at cost		258,674		232,225
Accumulated Amortization		(106,291)		(75,141)
Intangible Assets, net	$	152,383	$	157,084

During the three months ended September 30, 2025 and 2024, the Company capitalized website development related costs of $1,785 and $3,299, respectively, in connection with the upgrade and enhancement of functionality of the corporate website at www.60degreespharma.com ($1,785 and $25,374 for the nine months ended September 30, 2025 and 2024, respectively). Amortization expense for the three months ended September 30, 2025 and 2024, was in the amount of $10,605 and $10,325, respectively ($31,150 and $28,004 for the nine months ended September 30, 2025 and 2024, respectively). During the three months ended September 30, 2025 and 2024 write-downs for expired or obsolete patents totaled $0 and $2,922, respectively ($0 and $11,300 for the nine months ended September 30, 2025 and 2024, respectively).

The following table summarizes the estimated future amortization expense for our patents and website development costs as of September 30, 2025:

Period	Patents		Website Development Costs
2025 (remaining three months)	$	1,816	$	5,754
2026		7,264		13,027
2027		7,264		3,689
2028		7,264		397
2029		7,264		-
Thereafter		38,435		-
Total	$	69,307	$	22,867

The Company has recorded $60,209 in capitalized patent expenses that will become amortizable as the patents they are associated with are awarded.

INTANGIBLE ASSETS (Tables)

9 Months Ended

Sep. 30, 2025

INTANGIBLE ASSETS

Schedule of Intangible Assets

Intangible Assets, net consists of:

	September 30, 2025		December 31, 2024
Patents	$	152,267	$	127,603
Website Development Costs		106,407		104,622
Intangible Assets, at cost		258,674		232,225
Accumulated Amortization		(106,291)		(75,141)
Intangible Assets, net	$	152,383	$	157,084

Schedule of Estimated Future Amortization Expense for Our Patents and Website Development Costs

The following table summarizes the estimated future amortization expense for our patents and website development costs as of September 30, 2025:

Period	Patents		Website Development Costs
2025 (remaining three months)	$	1,816	$	5,754
2026		7,264		13,027
2027		7,264		3,689
2028		7,264		397
2029		7,264		-
Thereafter		38,435		-
Total	$	69,307	$	22,867

STOCKHOLDERS' EQUITY - Schedule of Equity-Classified Warrants (Details) - $ / shares

3 Months Ended

9 Months Ended

12 Months Ended

Sep. 30, 2025

Jun. 30, 2025

Mar. 31, 2025

Sep. 30, 2024

Jun. 30, 2024

Mar. 31, 2024

Sep. 30, 2025

Sep. 30, 2024

Dec. 31, 2024

Dec. 31, 2023

Schedule of Equity-Classified Warrants [Line Items]

Weighted Average Remaining Contractual Life (Years), Expired

Warrants [Member]

Schedule of Equity-Classified Warrants [Line Items]

Number of Warrants, Total outstanding, Beginning

2,127,070

1,765,070

^[1]

176,969

185,295

52,737

1,765,070

^[1]

52,737

Weighted Average Exercise Price, Total outstanding, Beginning

$ 15.85

$ 17.59

^[1]

$ 128.09

$ 122.36

$ 369.98

$ 17.59

^[1]

$ 369.98

Weighted Average Remaining Contractual Life (Years), Total outstanding, Beginning

3 years 3 months 3 days

^[1]

4 years 5 months 19 days

Number of Warrants, Granted

6,338,788

^[2]

747,200

1,782,612

140,884

Weighted Average Exercise Price, Granted

$ 1.65

^[2]

$ 3.56

$ 4.7

$ 22.48

Weighted Average Remaining Contractual Life (Years), Granted

3 years 3 months 21 days

^[2]

2 years

5 years

Number of Warrants, Exercised

878,264

(385,200)

(8,326)

Weighted Average Exercise Price, Exercised

$ 0.001

$ 0.01

$ 0.6

Weighted Average Remaining Contractual Life (Years), Exercised

Indefinite

Number of Warrants, Forfeited

Weighted Average Exercise Price, Forfeited

Weighted Average Remaining Contractual Life (Years), Forfeited

Number of Warrants, Expired

Weighted Average Exercise Price, Expired

Weighted Average Remaining Contractual Life (Years), Expired

Number of Warrants, Total outstanding, Ending

7,587,594

2,127,070

1,959,581

^[3]

176,969

185,295

7,587,594

1,959,581

^[3]

1,765,070

^[1]

52,737

Weighted Average Exercise Price, Total outstanding, Ending

$ 5.82

$ 15.85

$ 15.84

^[3]

$ 128.09

$ 122.36

$ 5.82

$ 15.84

^[3]

$ 17.59

^[1]

$ 369.98

Weighted Average Remaining Contractual Life (Years), Total outstanding, Ending

2 years 9 months 25 days

2 years 1 month 6 days

2 years 7 months 6 days

4 years 1 month 28 days

^[3]

4 years 4 months 28 days

4 years 8 months 1 day

Number of Warrants, Total exercisable

7,587,594

756,680

^[4]

7,587,594

756,680

^[4]

Weighted Average Exercise Price,Total exercisable

$ 5.82

$ 29.96

^[4]

$ 5.82

$ 29.96

^[4]

Weighted Average Remaining Contractual Life (Years),Total exercisable

2 years 9 months 25 days

4 years 1 month 28 days

^[4]

[1]	Weighted average remaining contractual life at December 31, 2024 excludes 385,200 Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at March 31, 2025, June 30, 2025 and September 30, 2025.
[2]	Weighted average remaining contractual life excludes 878,264 Pre-Funded Warrants issued July 2025 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at September 30, 2025.
[3]	Weighted average remaining contractual life calculations exclude (i) 579,711 Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date, (ii) 43,479 September 2024 Agent Warrants and 579,711 Series A Warrants issued September 2024 that expire five years from the Stockholder Approval Date, defined above, and (iii) 579,711 Series B Warrants issued September 2024 that expire eighteen months from the Stockholder Approval Date, which had not yet occurred as of September 30, 2024.
[4]	Weighted average remaining contractual life calculation excludes 579,711 exercisable Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date.

DEBT

9 Months Ended

Sep. 30, 2025

DEBT

DEBT

7. DEBT

On May 14, 2020, the Company received COVID-19 EIDL lending from the U.S. Small Business Administration (SBA) in the amount of $150,000. The loan bears interest at an annual rate of 3.75% calculated on a monthly basis. Monthly payments of $731 were required beginning in November 2022, with a final balloon payment equal to the remaining principal due at the maturity date of October 12, 2050. The balance as of September 30, 2025 and December 31, 2024 was $153,764 and $155,891, respectively. The current maturity at September 30, 2025 is $8,772 and the long-term liability is $144,992 ($8,772 and $147,119 at December 31, 2024, respectively). The loan is collateralized by all tangible and intangible personal property of the Company. The Company is prohibited from accepting future advances under any superior liens on the collateral without the prior consent of SBA.

The current future payment obligations of the principal are as follows:

Period	Principal Payments
2025 (remaining three months)	$	-
2026		465
2027		3,220
2028		3,333
2029		3,470
Thereafter		139,512
Total	$	150,000

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8A
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-8A

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/470/tableOfContent

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482925/835-30-45-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1E

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

+ Details

STOCKHOLDERS' EQUITY (Details) - USD ($)

1 Months Ended

3 Months Ended

9 Months Ended

12 Months Ended

Sep. 30, 2025

Sep. 03, 2025

Jul. 16, 2025

Jul. 15, 2025

Feb. 24, 2025

Feb. 18, 2025

Feb. 10, 2025

Feb. 06, 2025

Feb. 05, 2025

Jan. 30, 2025

Jan. 28, 2025

Nov. 06, 2024

Aug. 01, 2024

Jul. 26, 2024

Jul. 22, 2024

Jul. 12, 2024

Mar. 31, 2022

Jul. 31, 2025

Sep. 30, 2024

Jul. 31, 2024

Sep. 30, 2025

Jun. 30, 2025

Mar. 31, 2025

Sep. 30, 2024

Jun. 30, 2024

Mar. 31, 2024

Sep. 30, 2025

Sep. 30, 2024

Dec. 31, 2024

Jan. 31, 2025

Stockholders’ Equity [Line Items]

Common stock shares authorized

^[1]

150,000,000

Common stock par value (in dollars per share)

^[1]

$ 0.0001

Common stock, shares issued

^[1]

4,104,469

566,908

Common stock outstanding

^[1]

4,104,469

566,908

Reverse stock split

1:5

On February 10, 2025, the Board of Directors approved a 1:5 reverse split ratio. On February 24, 2025, the Company effected the 1:5 reverse stock split (the “1:5 Reverse Stock Split”, and together with the 1:12 Reverse Stock Split, the “Reverse Stock Splits”).

On November 6, 2024, a majority of the Company’s stockholders approved an additional reverse stock split at a split ratio ranging between 1:3 and 1:5, as determined by the Board of Directors in its sole discretion.

Following stockholder approval in July 2024, the Company effected a reverse stock split at a ratio of 1:12, which was effective as of August 12, 2024 (the “1:12 Reverse Stock Split”).

1:5

Additional common share

204,312

Sale of stock price per share (in dollars per share)

$ 3.575

$ 5.105

Exercise of warrants

408,621

Exercise price of warrants (in dollars per share)

$ 3.855

Net proceeds from Private Placement

$ 908,627

$ 804,346

$ 3,414,502

Aggregate shares of common stock

300,700

Dividends percentage

6.00%

Dividends preferred stock

1,076,975

Shares converted

18,473

Proceeds from Exercise of Pre-Funded Warrants

$ 2,804

$ 9,990

Placement Agent Warrants [Member]

Stockholders’ Equity [Line Items]

Exercise of warrants

22,554

15,325

Exercise price of warrants (in dollars per share)

$ 4.469

$ 6.382

Warrants, each warrant to purchase one share of Common Stock

Stockholders’ Equity [Line Items]

Exercise price of warrants (in dollars per share)

$ 2.95

Number of Warrants, Exercised

878,264

(385,200)

(8,326)

Number of warrants granted

6,338,788

^[2]

747,200

1,782,612

140,884

Number of warrants exercisable

7,587,594

756,680

^[3]

7,587,594

756,680

^[3]

7,587,594

756,680

^[3]

Weighted average exercise price (in dollars per share)

$ 0.001

$ 0.01

$ 0.6

Pre-Funded Warrant [Member]

Stockholders’ Equity [Line Items]

Sale of stock price per share (in dollars per share)

$ 1.899

Units issued

878,264

Warrant shares

Number of Warrants, Exercised

878,264

1,263,464

16,652

Proceeds from Exercise of Pre-Funded Warrants

$ 878

$ 0

$ 2,804

$ 9,990

Number of warrants granted

878,264

579,711

Number of warrants exercisable

385,200

Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)

878,264

1,263,464

16,652

Class of Warrant or Right, Outstanding

Series A Warrants [Member]

Stockholders’ Equity [Line Items]

Number of warrants granted

579,711

Series B Warrants [Member]

Stockholders’ Equity [Line Items]

Warrants exercisable expiry term

18 months

Number of warrants granted

579,711

September 2024 Agent Warrants [Member]

Stockholders’ Equity [Line Items]

Number of warrants granted

43,479

July 2025 Pre-Funded Warrants [Member]

Stockholders’ Equity [Line Items]

Exercise price of warrants (in dollars per share)

$ 0.001

Date from which warrants exercisable

Jul. 16, 2025

July 2025 A-1 Warrants [Member]

Stockholders’ Equity [Line Items]

Exercise price of warrants (in dollars per share)

$ 1.9

Date from which warrants exercisable

Jul. 16, 2025

Date of warrants exercisable expiry

Jul. 15, 2030

July Two Thousand Twenty Five A Two Warrants [Member]

Stockholders’ Equity [Line Items]

Exercise price of warrants (in dollars per share)

$ 1.9

Date from which warrants exercisable

Jul. 16, 2025

Date of warrants exercisable expiry

Jan. 15, 2027

July 2025 Placement Agent Warrants [Member]

Stockholders’ Equity [Line Items]

Warrants exercisable expiry term

5 years

Exercise price of warrants (in dollars per share)

$ 2.375

Date from which warrants exercisable

Jul. 16, 2025

Date of warrants exercisable expiry

Jul. 15, 2030

July 2025 Placement Agent Warrants [Member] | Maximum [Member]

Stockholders’ Equity [Line Items]

Aggregate shares of common stock

197,368

July 2025 Offering [Member]

Stockholders’ Equity [Line Items]

Sale of stock price per share (in dollars per share)

$ 1.9

Net proceeds from Private Placement

$ 4,281,300

Units issued

1,753,314

Common Stock, par value $0.0001 per share

Stockholders’ Equity [Line Items]

Purchase of common stock

14,667

Shares converted

6,667

8,000

Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)

878,264

385,200

8,326

WallachBeth Capital LLC [Member]

Stockholders’ Equity [Line Items]

Common stock aggregate offering price

$ 1,253,603

ATM Offering

135,568

Gross proceeds

$ 1,994,583

Sales agreement termination date

Sep. 03, 2025

H C Wainwright And Co LLC [Member]

Stockholders’ Equity [Line Items]

Exercise of warrants

43,479

Exercise price of warrants (in dollars per share)

$ 8.63

H C Wainwright And Co LLC [Member] | 2025 ATM Agreement [Member]

Stockholders’ Equity [Line Items]

ATM Offering

Common stock aggregate gross sales proceeds authorized

$ 1,397,532

Sales agent commission percentage

3.00%

Series A Preferred Stock [Member]

Stockholders’ Equity [Line Items]

Preferred stock shares authorized

1,000,000

Preferred stock shares, par value (in dollars per share)

$ 0.0001

Preferred stock shares issued

76,480

Preferred stock shares outstanding

76,480

Reverse stock split

as adjusted for the 1:12 Reverse Stock Split after August 12, 2024 and the 1:5 Reverse Stock Split after February 24, 2025

Warrants exercisable expiry term

5 years

Dividends percentage

19.90%

Dividends preferred stock

$ 128,097

$ 116,571

$ 372,960

$ 352,333

Common stock conversion price per share (in dollars per share)

$ 100

Convertible Preferred Stock, Shares Issued upon Conversion

1,032

1,291

Preferred stock, convertible, shares issuable

2,323

Series A Non-Voting Convertible Preferred Stock [Member]

Stockholders’ Equity [Line Items]

Designated shares

80,965

Common Stock, par value $0.0001 per share | Warrants, each warrant to purchase one share of Common Stock

Stockholders’ Equity [Line Items]

Aggregate shares of common stock

300,700

Convertible Common Stock [Member]

Stockholders’ Equity [Line Items]

Common stock, shares issued

14,667

IPO [Member]

Stockholders’ Equity [Line Items]

Sale of stock price per share (in dollars per share)

$ 300

[1]	Prior periods presented have been adjusted to reflect the 1:5 reverse stock split on February 24, 2025.
[2]	Weighted average remaining contractual life excludes 878,264 Pre-Funded Warrants issued July 2025 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at September 30, 2025.
[3]	Weighted average remaining contractual life calculation excludes 579,711 exercisable Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date.

SHARE-BASED COMPENSATION - Schedule of Fair Value of Options Granted (Details) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Fair Value Measurement Inputs and Valuation Techniques [Abstract]
Weighted-average grant date fair value (in Dollars per share)		$ 8.78	$ 4.55	$ 8.78
Risk-free interest rate			4.36%
Risk-free interest rate, minimum		3.62%		3.62%
Risk-free interest rate, maximum		4.17%		4.17%
Expected volatility			90.00%
Expected volatility, minimum		86.00%		86.00%
Expected volatility, maximum		87.00%		87.00%
Expected term (years)			4 years 6 months
Expected term, minimum (years)		6 years 4 months 28 days		6 years 4 months 28 days
Expected term, maximum (years)		10 years		10 years
Expected dividend yield		0.00%	0.00%	0.00%

INTANGIBLE ASSETS - Schedule of Estimated Future Amortization Expense for Our Patents and Website Development Costs (Details)	Sep. 30, 2025 USD ($)
Patents [Member]
Schedule of Estimated Future Amortization Expense for Our Patents and Website Development Costs [Line Items]
2025 (remaining nine months)	$ 1,816
2026	7,264
2027	7,264
2028	7,264
2029	7,264
Thereafter	38,435
Total	69,307
Website Development Costs [Member]
Schedule of Estimated Future Amortization Expense for Our Patents and Website Development Costs [Line Items]
2025 (remaining nine months)	5,754
2026	13,027
2027	3,689
2028	397
2029
Thereafter
Total	$ 22,867

DERIVATIVE LIABILITIES - Schedule of Derivative Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($)	3 Months Ended
	Sep. 30, 2025	Jun. 30, 2025	Mar. 31, 2025	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024
Schedule of Derivative Liabilities Measured at Fair Value on a Recurring Basis [Line Items]
Beginning balance			$ 640,830
Ending balance	$ 797,275
Fair Value, Inputs, Level 3 [Member]
Schedule of Derivative Liabilities Measured at Fair Value on a Recurring Basis [Line Items]
Beginning balance			640,830
Ending balance	797,275
Fair Value, Recurring [Member] \| Contingent Milestone Payment [Member] \| Fair Value, Inputs, Level 3 [Member]
Schedule of Derivative Liabilities Measured at Fair Value on a Recurring Basis [Line Items]
Beginning balance	776,172	$ 635,725	640,830	$ 567,050	$ 565,949	$ 2,306,796
Change in fair value	21,103	140,447	(5,105)	56,712	1,101	(1,740,847)
Ending balance	$ 797,275	$ 776,172	$ 635,725	$ 623,762	$ 567,050	$ 565,949

SHARE-BASED COMPENSATION - Schedule of Share-Based Compensation Expenses (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Schedule of Share-Based Compensation Expenses [Line Items]
Total Share-Based Compensation Expense Included in Operating Expenses	$ 79,000	$ 668,974	$ 344,383	$ 3,547,009
Research and Development Expense [Member]
Schedule of Share-Based Compensation Expenses [Line Items]
Total Share-Based Compensation Expense Included in Operating Expenses		600,000		3,227,300
General and Administrative Expenses [Member]
Schedule of Share-Based Compensation Expenses [Line Items]
Total Share-Based Compensation Expense Included in Operating Expenses	$ 79,000	$ 68,974	$ 344,383	$ 319,709

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2025

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

Derivative Liabilities

Equity or liability instruments that become subject to reclassification under ASC Topic 815 are reclassified at the fair value of the instrument on the reclassification date.

Equity-Classified Warrants

Revenue Recognition

Research and Development Costs

Fair Value of Financial Instruments

Level 1	-	Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities.

Level 2	-	Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

Level 3	-	Unobservable inputs reflecting the Company’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

Liabilities measured at fair value at September 30, 2025 and December 31, 2024 are as follows:

	September 30, 2025
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	797,275	$	797,275
Total	$	-	$	-	$	797,275	$	797,275

	December 31, 2024
	Level 1		Level 2		Level 3		Total
Liabilities:
Derivative Liabilities	$	-	$	-	$	640,830	$	640,830
Total	$	-	$	-	$	640,830	$	640,830

There were no transfers of financial instruments between Level 1, Level 2, and Level 3 during the periods presented.

A rollforward of liabilities measured at fair value using Level 3 inputs for the three and nine months ended September 30, 2025 and 2024 is presented in Note 8 – Derivative Liabilities.

Assets and Liabilities Not Measured at Fair Value on a Recurring Basis

Foreign Currency Transactions and Translation

Exchange rates along with historical rates used in these financial statements are as follows:

	Average Exchange Rate
	Three Months Ended September 30,				Nine Months Ended September 30,				As of
Currency	2025		2024		2025		2024		September 30, 2025		December 31, 2024
1 AUD =	0.65	USD	0.67	USD	0.64	USD	0.66	USD	0.66	USD	0.62	USD

Reclassifications

Share-Based Payments

On November 22, 2022, the Company adopted the 2022 Equity Incentive Plan also referred to as (“2022 Plan”). The 2022 Plan and related share-based awards are discussed more fully in Note 10.

Net Loss per Common Share

As the Company reported a net loss for all periods presented, the calculation of diluted net loss per common share is the same as basic net loss per common share.

Related Parties

Subsequent Events

Recently Adopted and Issued Accounting Pronouncements

Consolidated Condensed Statements of Shareholders' Equity (Unaudited) - USD ($)	Total	Preferred Stock Series A	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)	Total Shareholders’ Equity (Deficit) Attributable to 60P	Noncontrolling Interest on Shareholders
Balance at Dec. 31, 2023	$ 4,798,096	$ 9,858,040	$ 10	$ 27,457,373	$ (32,580,850)	$ 135,561	$ 4,870,134	$ (72,038)
Balance (in Shares) at Dec. 31, 2023		78,803	96,847
Issuance of common stock and warrants, net of underwriting discounts and offering costs paid at closing and deferred offering costs (Note 6)	1,898,296		$ 9	1,898,287			1,898,296
Issuance of common stock and warrants, net of underwriting discounts and offering costs paid at closing and deferred offering costs (Note 6) (in Shares)			87,683
Issuance of common stock upon exercise of Pre-Funded Warrants	4,995		$ 1	4,994			4,995
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)			8,326
Issuance of shares for RSUs (in Shares)			3,201
Net foreign translation gain (loss)	(3,894)					(3,894)	(3,894)
Net income (loss)	427,985				430,470		430,470	(2,485)
Balance at Mar. 31, 2024	7,125,478	$ 9,858,040	$ 20	29,360,654	(32,150,380)	131,667	7,200,001	(74,523)
Balance (in Shares) at Mar. 31, 2024		78,803	196,057
Balance at Dec. 31, 2023	4,798,096	$ 9,858,040	$ 10	27,457,373	(32,580,850)	135,561	4,870,134	(72,038)
Balance (in Shares) at Dec. 31, 2023		78,803	96,847
Share-based compensation expense	15,246
Net income (loss)	(5,906,739)
Balance at Sep. 30, 2024	5,962,847	$ 9,567,439	$ 38	34,815,790	(38,482,920)	139,207	6,039,554	(76,707)
Balance (in Shares) at Sep. 30, 2024		76,480	372,397
Balance at Mar. 31, 2024	7,125,478	$ 9,858,040	$ 20	29,360,654	(32,150,380)	131,667	7,200,001	(74,523)
Balance (in Shares) at Mar. 31, 2024		78,803	196,057
Issuance of common stock upon exercise of Pre-Funded Warrants	4,995		$ 1	4,994			4,995
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)			8,326
Issuance of shares for RSUs (in Shares)			1,069
Voluntary return of shares issued to vendor for services (in shares)			(2,000)
Net foreign translation gain (loss)	3,137					3,137	3,137
Net income (loss)	(4,174,226)				(4,172,755)		(4,172,755)	(1,471)
Balance at Jun. 30, 2024	2,959,384	$ 9,858,040	$ 21	29,365,648	(36,323,135)	134,804	3,035,378	(75,994)
Balance (in Shares) at Jun. 30, 2024		78,803	203,452
Voluntary conversion of Series A Preferred Stock into common stock		$ (290,601)	$ 1	290,600
Voluntary conversion of Series A Preferred Stock into common stock (in Shares)		(2,323)	14,667
Issuance of common stock pursuant to ATM Offering, net of offering costs paid at closing and deferred offering costs (Note 6)	1,729,810		$ 14	1,729,796			1,729,810
Issuance of common stock pursuant to ATM Offering, net of offering costs paid at closing and deferred offering costs (Note 6) (in Shares)			135,568
Issuance of warrants in Private Placement, net of offering costs paid at closing and deferred offering costs	3,414,502			3,414,502			3,414,502
Share-based compensation expense	15,246			15,246			15,246
Net foreign translation gain (loss)	4,403					4,403	4,403
Net income (loss)	(2,160,498)				(2,159,785)		(2,159,785)	(713)
Issuance of common stock for fractional shares pursuant to Reverse Stock Split rounding adjustment			$ 2	(2)
Issuance of common stock for fractional shares pursuant to Reverse Stock Split rounding adjustment (in shares)			18,710
Balance at Sep. 30, 2024	5,962,847	$ 9,567,439	$ 38	34,815,790	(38,482,920)	139,207	6,039,554	(76,707)
Balance (in Shares) at Sep. 30, 2024		76,480	372,397
Balance at Dec. 31, 2024	3,955,006	$ 9,567,439	$ 57	34,860,590	(40,527,957)	135,471	4,035,600	(80,594)
Balance (in Shares) at Dec. 31, 2024		76,480	566,908
Issuance of common stock and warrants pursuant to January 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6)	804,346		$ 20	804,326			804,346
Issuance of common stock and warrants pursuant to January 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6) (in Shares)			204,312
Issuance of common stock and warrants pursuant to February 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6)	908,627		$ 30	908,597			908,627
Issuance of common stock and warrants pursuant to February 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6) (in Shares)			300,700
Issuance of common stock upon exercise of Pre-Funded Warrants	1,926		$ 38	1,888			1,926
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)			385,200
Issuance of shares for annual performance bonuses, net of shares withheld for taxes	103,544		$ 2	103,542			103,544
Issuance of shares for annual performance bonuses, net of shares withheld for taxes (in Shares)			15,809
Share-based compensation expense	142,645			142,645			142,645
Net foreign translation gain (loss)	(9,904)					(9,904)	(9,904)
Net income (loss)	(1,877,301)				(1,876,549)		(1,876,549)	(752)
Issuance of common stock for fractional shares pursuant to Reverse Stock Split rounding adjustment (in shares)			38
Balance at Mar. 31, 2025	4,028,889	$ 9,567,439	$ 147	36,821,588	(42,404,506)	125,567	4,110,235	(81,346)
Balance (in Shares) at Mar. 31, 2025		76,480	1,472,891
Balance at Dec. 31, 2024	3,955,006	$ 9,567,439	$ 57	34,860,590	(40,527,957)	135,471	4,035,600	(80,594)
Balance (in Shares) at Dec. 31, 2024		76,480	566,908
Share-based compensation expense	212,030
Net income (loss)	(5,929,267)
Balance at Sep. 30, 2025	4,346,958	$ 9,567,439	$ 410	41,172,888	(46,454,556)	144,039	4,430,220	(83,262)
Balance (in Shares) at Sep. 30, 2025		76,480	4,104,469
Balance at Mar. 31, 2025	4,028,889	$ 9,567,439	$ 147	36,821,588	(42,404,506)	125,567	4,110,235	(81,346)
Balance (in Shares) at Mar. 31, 2025		76,480	1,472,891
Share-based compensation expense	34,503			34,503			34,503
Net foreign translation gain (loss)	17,242					17,242	17,242
Net income (loss)	(1,734,930)				(1,733,726)		(1,733,726)	(1,204)
Balance at Jun. 30, 2025	2,345,704	$ 9,567,439	$ 147	36,856,091	(44,138,232)	142,809	2,428,254	(82,550)
Balance (in Shares) at Jun. 30, 2025		76,480	1,472,891
Issuance of common stock and warrants pursuant to July 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6)	4,281,300		$ 175	4,281,125			4,281,300
Issuance of common stock and warrants pursuant to July 2025 Offering, net of offering costs paid at closing and deferred offering costs (Note 6) (in Shares)			1,753,314
Issuance of common stock upon exercise of Pre-Funded Warrants	878		$ 88	790			878
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares)			878,264
Share-based compensation expense	34,882			34,882			34,882
Net foreign translation gain (loss)	1,230					1,230	1,230
Net income (loss)	(2,317,036)				(2,316,324)		(2,316,324)	(712)
Balance at Sep. 30, 2025	$ 4,346,958	$ 9,567,439	$ 410	$ 41,172,888	$ (46,454,556)	$ 144,039	$ 4,430,220	$ (83,262)
Balance (in Shares) at Sep. 30, 2025		76,480	4,104,469

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Exchange Rates along with Historical Rates (Details) - United States of America, Dollars	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024	Dec. 31, 2024
Schedule of Exchange Rates along with Historical Rates [Line Items]
Average Exchange Rate	0.65	0.67	0.64	0.66
Exchange Rate	0.66		0.66		0.62

NATURE OF OPERATIONS

9 Months Ended

Sep. 30, 2025

NATURE OF OPERATIONS

NATURE OF OPERATIONS

1. NATURE OF OPERATIONS

60 Degrees Pharmaceuticals, Inc. was incorporated in Delaware on June 1, 2022 and merged on the same day with 60 Degrees Pharmaceuticals, LLC, a District of Columbia limited liability company organized on September 9, 2010 (“60P LLC”). 60 Degrees Pharmaceuticals, Inc. and its subsidiary (referred to collectively as the “Company”, “60P”, or “60 Degrees Pharmaceuticals”) is a specialty pharmaceutical company that specializes in the development and marketing of new medicines for the treatment and prevention of infectious diseases. 60P achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. Currently, 60P’s pipeline under development covers development programs for tick-borne fungal 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 and/or botanical extracts from Australian Chestnut Trees. The Company’s headquarters are located in Washington, D.C., with a majority-owned subsidiary in Australia.

Risks and Uncertainties

The Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the risks associated with developing product candidates and successfully launching and commercializing its drug/device combination products, the Company’s ability to obtain regulatory approval of such products in the United States and other geography markets, the uncertainty of the broad adoption of its approved products by physicians and consumers, and significant competition.

In addition, higher rates of inflation have resulted in the U.S. Federal Reserve raising interest rates. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. Furthermore, if additional banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, the Company or its partners’ ability to access existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on the Company’s business and financial condition, including the Company’s ability to access additional capital on favorable terms, or at all, which could in the future negatively affect the Company’s ability to pursue its business strategy.

Going Concern

The Company’s future results are subject to substantial risks and uncertainties. Since its inception, the Company has not demonstrated the ability to generate enough revenues to date to cover operating expenses and has accumulated losses to date. At September 30, 2025, the Company had cash and cash equivalents totaling $4,115,779, as compared to cash and cash equivalents totaling $1,659,353 at December 31, 2024. During the nine months ended September 30, 2025 the Company used cash of $5,156,566 in its operating activities. The Company’s capital commitments over the next twelve months include interest payments on the Company’s debt arrangement of $8,772 and $1,391,347 to satisfy accounts payable and accrued expenses.

To date, the Company has funded its operations primarily with proceeds from sales of common stock and warrants for the purchase of common stock, sales of preferred stock, proceeds from the issuance of convertible debt and borrowings under loan and security agreements.

Continuation as a going concern is dependent upon the Company’s ability to meet its financial requirements, raise additional capital, and achieve gross profitability from the Company’s single marketed product. To achieve profitability, the Company expects it will need to raise additional capital to fund its activities relating to commercial support for its existing product and any future clinical research trials and operating activities. However, there can be no assurance that it will ever achieve or maintain profitability. These conditions, among others, raise substantial doubt about the ability of the Company to continue as a going concern for one year from the date these consolidated condensed financial statements are issued.

Management plans to fund operations of the Company through third party and related party debt/advances, private placement of restricted securities and the issuance of stock in a subsequent offering until such a time as the business achieves profitability or a business combination may be achieved. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are favorable to the Company. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If the Company raises funds through collaborations, or other similar arrangements with third parties, it may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company and/or may reduce the value of its common stock. If the Company is unable to raise additional funds through equity or debt financings when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market its product candidates even if the Company would otherwise prefer to develop and market such product candidates itself.

As such, management concluded that such plans do not alleviate the substantial doubt about the ability of the Company to continue as a going concern for one year from the date these consolidated condensed financial statements are issued.

The consolidated condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of obligations in the normal course of business, and do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern.

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2025

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

12. SUBSEQUENT EVENTS

The Company has evaluated subsequent events through November 13, 2025, which is the date the financial statements were issued.

2025 Annual Meeting of Stockholders

On October 8, 2025, the Company conducted its virtual 2025 Annual Meeting of Stockholders (the “2025 Annual Meeting”). The Company’s stockholders of record at the close of business on August 29, 2025, the record date for the determination of stockholders entitled to vote at the 2025 Annual Meeting, approved the proposals to (1) elect five directors to serve until the 2026 Annual Meeting of Stockholders and until their respective successors are duly elected and qualified; (2) approve an amendment to the 2022 Plan to increase the number of shares of common stock available for issuance by 250,000 shares; (3) approve an amendment to the Company’s Certificate of Incorporation, to effect a reverse stock split of the common stock at a reverse stock split ratio ranging from 1:3 to 1:10 inclusive, as may be determined at the appropriate time by the Board of Directors, in its sole discretion; and (4) ratify the selection of RBSM LLP by the Board of Directors as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2025.

Option Grant

On October 21, 2025, the Company’s Board of Directors approved the grant of 32,000 stock options to each of the four directors (8,000 per director) at a per share exercise price of $1.46. These stock options were fully vested on the date of grant and have a term of seven years.

2025 ATM Agreement

Pursuant to the 2025 ATM Agreement described in Note 6, between October 16, 2025 and November 13, 2025, the Company sold an aggregate of 125,979 shares at a weighted average price per share of $1.62, generating net proceeds to the Company of $196,356, after deducting commissions and certain other offering expenses.

There have been no other events or transactions during this time which would have a material effect on these consolidated condensed financial statements.

INVENTORY

9 Months Ended

Sep. 30, 2025

INVENTORY

INVENTORY

3. INVENTORY

Inventory consists of the following major classes:

	September 30, 2025		December 31, 2024
Raw Material (API)	$	345,195	$	-
Work in Process		-		284,883
Finished Goods		426,491		157,881
Total Inventory		771,686		442,764
Reserve for Expiring Inventory		(244,682)		-
Inventory	$	527,004	$	442,764

The Company regularly monitors its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated net realizable value, and records write-downs for inventory that has expired, inventory that has a cost basis in excess of its expected net realizable value, and inventory in excess of expected sales requirements. Any write-downs of inventories are charged to cost of revenues in the consolidated condensed statements of operations and comprehensive loss. During the three months ended September 30, 2025 and 2024, write downs for expired inventory were $436,561 and $1,165, respectively ($436,596 and $18,490 for the nine months ended September 30, 2025 and 2024, respectively).

PROPERTY AND EQUIPMENT (Details) - USD ($)	3 Months Ended		9 Months Ended
PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
PROPERTY AND EQUIPMENT
Depreciation	$ 12,225	$ 4,334	$ 28,155	$ 6,277

- Definition

The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets.

+ References + Details

Consolidated Condensed Statements of Operations and Comprehensive (Loss) Income (Unaudited) - USD ($)

3 Months Ended

9 Months Ended

Sep. 30, 2025

Sep. 30, 2024

Sep. 30, 2025

Sep. 30, 2024

Income Statement [Abstract]

Product Revenues – net of Discounts and Rebates

$ 437,602

$ 135,293

$ 702,086

$ 365,939

Cost of Revenues

537,690

111,687

661,013

266,688

Gross (Loss) Profit

(100,088)

23,606

41,073

99,251

Research Revenues

90,960

12,818

390,630

43,177

Net (Loss) Revenue

(9,128)

36,424

431,703

142,428

Operating Expenses:

Research and Development

809,777

940,063

1,467,283

4,372,571

General and Administrative Expenses

1,506,620

1,215,053

4,805,648

3,419,747

Total Operating Expenses

2,316,397

2,155,116

6,272,931

7,792,318

Loss from Operations

(2,325,525)

(2,118,692)

(5,841,228)

(7,649,890)

Interest Expense

(1,708)

(1,467)

(4,719)

(6,490)

Change in Fair Value of Derivative Liabilities

(21,103)

(56,712)

(156,445)

1,683,034

Other Income, net

31,550

16,623

74,938

67,358

Total Interest and Other Income (Expense), net

8,739

(41,556)

(86,226)

1,743,902

Loss from Operations before Provision for Income Taxes

(2,316,786)

(2,160,248)

(5,927,454)

(5,905,988)

Provision for Income Taxes (Note 9)

250

1,813

751

Net Loss including Noncontrolling Interest

(2,317,036)

(2,160,498)

(5,929,267)

(5,906,739)

Net Loss – Noncontrolling Interest

(712)

(713)

(2,668)

(4,669)

Net Loss – attributed to 60 Degrees Pharmaceuticals, Inc.

(2,316,324)

(2,159,785)

(5,926,599)

(5,902,070)

Comprehensive Loss:

Net Loss

(2,317,036)

(2,160,498)

(5,929,267)

(5,906,739)

Unrealized Foreign Currency Translation Gain

1,230

4,403

8,568

3,646

Total Comprehensive Loss

(2,315,806)

(2,156,095)

(5,920,699)

(5,903,093)

Net Loss – Noncontrolling Interest

(712)

(713)

(2,668)

(4,669)

Comprehensive Loss – attributed to 60 Degrees Pharmaceuticals, Inc.

(2,315,094)

(2,155,382)

(5,918,031)

(5,898,424)

Cumulative Dividends on Series A Preferred Stock

(128,097)

(116,571)

(372,960)

(352,333)

Net Loss - attributed to common stockholders

$ (2,443,191)

$ (2,271,953)

$ (6,290,991)

$ (6,250,757)

Net Loss per Common Share:

Basic (in Dollars per share)

$ (0.66)

$ (4.65)

$ (2.92)

$ (21.74)

Diluted (in Dollars per share)

$ (0.66)

$ (2.92)

$ (4.65)

$ (21.74)

Weighted Average Number of Common Shares Outstanding(1)

Basic (in Shares)

^[1]

3,675,407

488,654

2,152,682

287,529

Diluted (in Shares)

^[1]

3,675,407

2,152,682

488,654

287,529

[1]	Prior periods presented have been adjusted to reflect the 1:5 reverse stock split on February 24, 2025.

PROPERTY AND EQUIPMENT (Tables)

9 Months Ended

Sep. 30, 2025

PROPERTY AND EQUIPMENT

Schedule of Property and Equipment

Property and Equipment, net consists of:

	September 30, 2025		December 31, 2024
Lab Equipment	$	333,010	$	233,411
Machinery		55,800		55,800
Computer Equipment		11,597		7,000
Furniture		3,030		3,030
Property and Equipment, at cost		403,437		299,241
Accumulated Depreciation		(175,685)		(149,433)
Property and Equipment, net	$	227,752	$	149,808

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2025	Nov. 13, 2025
Document Information [Line Items]
Entity Registrant Name	60 DEGREES PHARMACEUTICALS, INC.
Document Type	10-Q
Amendment Flag	false
Entity Central Index Key	0001946563
Document Period End Date	Sep. 30, 2025
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q3
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-41719
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-2406880
Entity Address, Address Line One	1025 Connecticut Avenue
Entity Address, Address Line Two	NW Suite 1000
Entity Address, City or Town	Washington
Entity Address, State or Province	DC
Entity Address, Postal Zip Code	20036
City Area Code	202
Local Phone Number	327-5422
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		4,230,448
Common Stock, par value $0.0001 per share
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	SXTP
Security Exchange Name	NASDAQ
Warrants, each warrant to purchase one share of Common Stock
Document Information [Line Items]
Title of 12(b) Security	Warrants, each warrant to purchase one share of Common Stock
Trading Symbol	SXTPW
Security Exchange Name	NASDAQ

STOCKHOLDERS' EQUITY

9 Months Ended

Sep. 30, 2025

STOCKHOLDERS’ EQUITY

STOCKHOLDERS’ EQUITY

6. STOCKHOLDERS’ EQUITY

Pursuant to the Certificate of Incorporation of 60 Degrees Pharmaceuticals, Inc., the Company’s authorized shares consist of (a) 150,000,000 shares of common stock, par value $0.0001 per share and (b) 1,000,000 shares of preferred stock, par value $0.0001 per share, of which 80,965 have been designated as Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”). As of September 30, 2025, 4,104,469 shares of Common Stock and 76,480 shares of Series A Preferred Stock are issued and outstanding.

Following stockholder approval in November 2024, on February 18, 2025, the Company filed an additional Amendment to the Certificate of Incorporation with the Secretary of State of Delaware to effect the 1:5 Reverse Stock Split of the issued and outstanding shares of the Company’s common stock, which was effective as of February 24, 2025. As of the effective time of the 1:5 Reverse Stock Split, every five (5) issued and outstanding shares of the Company’s common stock were automatically combined and converted into one (1) issued and outstanding share of the Company’s common stock.

No fractional shares of common stock were issued in connection with the Reverse Stock Splits. All fractional shares were rounded up to the nearest whole share with respect to outstanding shares of common stock. The Reverse Stock Splits did not change the authorized number of shares of common stock or preferred stock, the par value of the common stock, or the number of issued and outstanding shares of Series A Preferred Stock. All references to numbers of shares of the Company’s common stock and per share information in these consolidated condensed financial statements have been retroactively adjusted, as appropriate, to reflect the Reverse Stock Splits, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital.

Common Stock

January 2025 Offering

On January 28, 2025, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company sold, in a registered direct offering priced at-the-market under the rules of Nasdaq, an aggregate of 204,312 shares of common stock at a purchase price of $5.105 per share. The shares were offered pursuant to a “shelf” registration statement on Form S-3 (Registration No. 333-280796). In a concurrent private placement, the Company also issued to the investors unregistered warrants (the “January 2025 Warrants”) to purchase up to an aggregate of 408,621 shares of common stock at an exercise price of $3.855 per share. The January 2025 Warrants are exercisable upon issuance, or January 30, 2025, and expire twenty-four months from the date of issuance, or January 30, 2027. The registered direct offering and concurrent private placement (together, the “January 2025 Offering”) closed on January 30, 2025, resulting in net proceeds to the Company of approximately $804,346, after deducting the placement agent fees and other offering expenses paid by the Company.

As compensation for acting as the placement agent for the January 2025 Offering, in addition to certain cash fees, the Company issued H.C. Wainwright & Co., LLC (the “Placement Agent”) warrants to purchase up to 15,325 shares of common stock at an exercise price of $6.382 (the “January 2025 Agent Warrants”). The January 2025 Agent Warrants were exercisable upon issuance and expire twenty-four months from the date of issuance.

February 2025 Offering

On February 5, 2025, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company sold, in a registered direct offering priced at-the-market under the rules of Nasdaq, an aggregate of 300,700 shares of the Company’s common stock at a purchase price of $3.575 per share. In a concurrent private placement, the Company separately issued to the investors unregistered warrants to purchase up to an aggregate of 300,700 shares of common stock at an exercise price of $2.95 per share (the “February 2025 Warrants”). The February 2025 Warrants were immediately exercisable upon issuance and expire twenty-four months from the date of issuance. The registered direct offering and concurrent private placement (together, the “February 2025 Offering”) closed on February 6, 2025, resulting in net proceeds to the Company of approximately $908,627, after deducting the placement agent fees and other offering expenses paid by the Company.

As compensation for acting as the placement agent for the February 2025 Offering, in addition to certain cash fees, the Company issued the Placement Agent warrants to purchase up to 22,554 shares of common stock at an exercise price of $4.469 (the “February 2025 Agent Warrants”). The February 2025 Agent Warrants were exercisable upon issuance and expire twenty-four months from the date of issuance.

July 2025 Offering

On July 15, 2025, the Company entered into a securities purchase agreement with certain institutional investors pursuant to which the Company sold, in a registered direct offering (the “July 2025 Offering”), 1,753,314 units at an offering price of $1.90 per unit and 878,264 pre-funded units at an offering price of $1.899 per pre-funded unit. Each unit consisted of (i) one share of common stock, (ii) one series A-1 warrant exercisable for one share of common stock (the “July 2025 A-1 Warrants”), and (iii) one series A-2 warrant exercisable for one share of common stock (the “July 2025 A-2 Warrants” and together with the July 2025 A-1 Warrants, the “July 2025 Warrants”). Each pre-funded unit consists of one pre-funded warrant exercisable for one share of common stock (the “July 2025 Pre-Funded Warrants”) and warrants identical to the July 2025 Warrants included in the units. The July 2025 Pre-Funded Warrants have an exercise price of $0.001 per share, and were immediately exercisable beginning on July 16, 2025 until exercised in full. The July 2025 A-1 Warrants have an exercise price of $1.90 per share and are exercisable beginning on July 16, 2025 until July 15, 2030. The July 2025 A-2 Warrants have an exercise price of $1.90 per share and are exercisable beginning on July 16, 2025 until January 15, 2027.

As compensation for acting as the placement agent for the July 2025 Offering, the Company also issued to H.C. Wainwright & Co., LLC warrants (the “July 2025 Placement Agent Warrants”) to purchase up to 197,368 shares of common stock. The July 2025 Placement Agent Warrants have an exercise price equal to $2.375 per share and are exercisable upon issuance, or July 16, 2025, and expire five years from the date of issuance, or July 15, 2030.

The July 2025 Offering was made pursuant to the Company’s registration statement on Form S-1 (File No. 333-288550), which was declared effective by the Securities and Exchange Commission (the “SEC”) on July 15, 2025, and the final prospectus, which was filed with the SEC on July 16, 2025. The Offering closed on July 16, 2025, resulting in net proceeds to the Company of approximately $4,281,300, after deducting placement agent fees and other offering expenses paid by the Company.

2025 ATM Agreement

On September 5, 2025, the Company entered into an At-The-Market Sales Agreement (the “2025 ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) pursuant to which the Company may, from time to time, offer and sell shares of its common stock, having aggregate gross sales proceeds of up to $1,397,532 (the “2025 ATM Offering”). As compensation for acting as the sales agent for the 2025 ATM Offering, Wainwright will be entitled to a commission of 3.0% of the gross proceeds from sales of shares in the 2025 ATM Offering.

The common stock to be sold under the 2025 ATM Agreement, if any, will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 and accompanying base prospectus (Registration Statement No. 333-280796), which was declared effective by the SEC on July 18, 2024, and a prospectus supplement dated September 5, 2025 relating to the offer and sale of the shares pursuant to the 2025 ATM Agreement. As of September 30, 2025, no shares had been sold pursuant to the 2025 ATM Agreement. See Note 12 – Subsequent Events.

2024 ATM Offering

On July 12, 2024, the Company entered into an At-the-Market Issuance Sales Agreement (the “2024 ATM Agreement”) with WallachBeth Capital LLC as sales agent, to sell shares of common stock having an aggregate offering price of up to $1,253,603 from time to time, through an “at the market offering” program (the “2024 ATM Offering”). The offer and sale of shares of common stock from the ATM Offering were made pursuant to the Company’s shelf registration statement on Form S-3 and accompanying base prospectus (Registration Statement No. 333-280796) contained therein which became effective on July 18, 2024. The prospectus supplement was subsequently amended four times to increase the maximum aggregate offering price under the ATM Agreement. From July 19, 2024 to August 1, 2024, the Company sold a total of 135,568 shares in the ATM Offering for gross proceeds of $1,994,583.

On September 3, 2025, the Company and Wallachbeth Capital LLC entered into a Waiver and Termination Agreement, agreeing to terminate the 2024 ATM Agreement effective as of September 3, 2025.

Preferred Stock Conversions

On July 22, 2024 and July 26, 2024, the Company converted 1,291 and 1,032 shares of Series A Preferred Stock, respectively, held by Knight Therapeutics Inc. into 8,000 shares and 6,667 shares of common stock, respectively.

Warrant Exercises

During the three months ended September 30, 2025 and 2024 the Company issued 878,264 and 0 shares of common stock upon the exercise of 878,264 and 0 pre-funded warrants, respectively, resulting in proceeds to the Company of $878 and $0, respectively. During the nine months ended September 30, 2025 and 2024 the Company issued 1,263,464 and 16,652 shares of common stock upon the exercise of 1,263,464 and 16,652 pre-funded warrants, respectively, resulting in proceeds to the Company of $2,804 and $9,990, respectively.

Common Stock Warrants

As of September 30, 2025, the Company accounts for all issued and outstanding warrants to purchase common stock as equity-classified instruments based on the guidance in ASC 480 and ASC 815.

As compensation for acting as the placement agent for the Private Placement, the Company issued to H.C. Wainwright & Co., LLC warrants to purchase up to 43,479 shares of stock (the “September 2024 Agent Warrants”). The September 2024 Agent Warrants have substantially the same terms as the Series A Warrants, except that the September 2024 Agent Warrants have an exercise price equal to $8.63 per share.

The following table presents a summary of the activity for the Company’s equity-classified warrants during the three and nine months ended September 30, 2025:

	Number of Warrants	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)
Total outstanding, December 31, 2024(1)	1,765,070	$	17.59	3.26
Granted	747,200		3.56	2.00
Exercised	(385,200)		0.01	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, March 31, 2025	2,127,070	$	15.85	2.60
Granted	-		-	-
Exercised	-		-	-
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, June 30, 2025	2,127,070	$	15.85	2.10
Granted(2)	6,338,788		1.65	3.31
Exercised	(878,264)		0.001	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, September 30, 2025	7,587,594	$	5.82	2.82
Total exercisable, September 30, 2025	7,587,594	$	5.82	2.82

(1)	Weighted average remaining contractual life at December 31, 2024 excludes 385,200 Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at March 31, 2025, June 30, 2025 and September 30, 2025.

(2)	Weighted average remaining contractual life excludes 878,264 Pre-Funded Warrants issued July 2025 that do not have a contractual expiration date, for which 0 warrants remain outstanding and exercisable at September 30, 2025.

The following table presents a summary of the activity for the Company’s equity-classified warrants during the three and nine months ended September 30, 2024:

	Number of Warrants	Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)
Total outstanding, December 31, 2023	52,737	$	369.98	4.47
Granted	140,884		22.48	5.00
Exercised	(8,326)		0.60	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, March 31, 2024	185,295	$	122.36	4.67
Granted	-		-	-
Exercised	(8,326)		0.60	Indefinite
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, June 30, 2024	176,969	$	128.09	4.41
Granted(1)	1,782,612		4.70	-
Exercised	-		-	-
Forfeited	-		-	-
Expired	-		-	-
Total outstanding, September 30, 2024(1)	1,959,581	$	15.84	4.16
Total exercisable, September 30, 2024(2)	756,680	$	29.96	4.16

(1)

(2)

Weighted average remaining contractual life calculation excludes 579,711 exercisable Pre-Funded Warrants issued September 2024 that do not have a contractual expiration date.

Series A Preferred Stock

During the three and nine months ended September 30, 2025 and 2024, the Company converted 0 and 2,323 shares of Series A Preferred Stock, respectively, held by Knight Therapeutics Inc. into 0 shares and 14,667 shares of common stock, respectively.

The holders of shares of Series A Preferred Stock have the rights, preferences, powers, restrictions, and limitations as set forth below.

Voting Rights - The holders of shares of Series A Preferred Stock are not entitled to any voting rights.

Dividends - From and after the date of issuance of any share of Series A Preferred Stock, cumulative dividends shall accrue, whether or not declared by the Board and whether or not there are funds legally available for the payment of dividends, on a daily basis in arrears at the rate of 6.0% per annum on the sum of the Liquidation Value (as defined below). Accrued dividends shall be paid in cash only when, as and if declared by the Board out of funds legally available therefor or upon a liquidation or redemption of the Series A Preferred Stock. On March 31 of each calendar year, any accrued and unpaid dividends shall accumulate and compound on such date, and are cumulative until paid or converted. Holders of shares of Series A Preferred Stock are entitled to receive accrued and accumulated dividends prior to and in preference to any dividend, distribution, or redemption on shares of Common Stock or any other class of securities that is designated as junior to the Series A Preferred Stock. During the three and nine months ended September 30, 2025, dividends in the amount of $128,097 and $372,960 accrued on outstanding shares of Series A Preferred Stock ($116,571 and $352,333 during the three and nine months ended September 30, 2024). As of September 30, 2025, cumulative dividends on outstanding shares of Series A Preferred Stock amount to $1,076,975. To date, the Company has not declared or paid any dividends.

Liquidation Rights - In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series A Preferred Stock then outstanding will share ratably in any distribution of the remaining assets and funds of the Company with all other stockholders as if each share of Series A Preferred Stock had been converted by the Company to Common Stock as described below.

Conversion Rights - The Company has the right, in its sole discretion, to convert all or any portion of the outstanding shares of Series A Preferred Stock (including any fraction of a share), plus the aggregate accrued or accumulated and unpaid dividends thereon into a number of shares of Common Stock determined by (i) multiplying the number of shares to be converted by $100 per share, as adjusted for any stock splits, stock dividends, recapitalizations or similar transactions with respect to the Series A Preferred Stock (but unchanged as a result of the Reverse Stock Splits impacting the common stock on August 12, 2024 and February 24, 2025) (the “Liquidation Value”), (ii) plus all accrued and accumulated and unpaid dividends on such shares to be converted, and then (ii) dividing the result by the then-effective Conversion Price in effect, provided that such conversion would not result in the holders of shares of Series A Preferred Stock owning more than 19.9% of the outstanding shares of common stock on an as-converted basis. The “Conversion Price” is equal to the lesser of (a) the Liquidation Value, (b) the offering price per share of Common Stock in the Company’s IPO, as adjusted for the 1:12 Reverse Stock Split after August 12, 2024 and the 1:5 Reverse Stock Split after February 24, 2025, or $300 per share, or (c) the 10-day volume weighted average price per share of Common Stock, as reasonably determined by the Company.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8A
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-8A

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478448/946-505-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480237/815-40-50-6

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

DERIVATIVE LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2025

DERIVATIVE LIABILITIES

Schedule of Derivative Liabilities Measured at Fair Value on a Recurring Basis

A reconciliation of the beginning and ending balances for the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows for the three and nine months ended September 30, 2025:

	Contingent Milestone Payment
Derivative liabilities - December 31, 2024	$	640,830
Change in fair value		(5,105)
Derivative liabilities - March 31, 2025		635,725
Change in fair value		140,447
Derivative liabilities - June 30, 2025		776,172
Change in fair value		21,103
Derivative liabilities - September 30, 2025	$	797,275

	Contingent Milestone Payment
Derivative liabilities - December 31, 2023	$	2,306,796
Change in fair value		(1,740,847)
Derivative liabilities - March 31, 2024		565,949
Change in fair value		1,101
Derivative liabilities - June 30, 2024		567,050
Change in fair value		56,712
Derivative liabilities - September 30, 2024	$	623,762

DERIVATIVE LIABILITIES

9 Months Ended

Sep. 30, 2025

DERIVATIVE LIABILITIES

DERIVATIVE LIABILITIES

8. DERIVATIVE LIABILITIES

In accordance with the provisions of ASC 815, derivative liabilities are initially measured at fair value at the commitment date and subsequently remeasured at each reporting period, with any increase or decrease in the fair value recorded in the results of operations within other income/expense as the change in fair value of derivative liabilities.

As of September 30, 2025 and December 31, 2024, derivative liabilities consist of the contingent milestone payment due to Knight Therapeutics, Inc. (“Knight”), a former lender of the Company, as required by the Debt Conversion Agreement executed between the Company and Knight on January 9, 2023, as subsequently amended (the “Knight Debt Conversion Agreement”). Key points of this agreement were as follows:

●

The Parties agreed to fix Knight’s cumulative debt to the value as it stood on March 31, 2022, which consisted of principal and accumulated interest. As a result of the completion of the IPO, the cumulative outstanding principal as of March 31, 2022 converted to 18,473 shares of common stock (representing 19.9% ownership of the Company’s common stock after giving effect to the IPO), and the entirety of the accumulated interest as of March 31, 2022 converted into 80,965 shares of Series A Preferred Stock, in full satisfaction of the Company’s obligations with respect to the outstanding principal and accumulated interest.

●

The Parties agreed that the Company will make a milestone payment of $10 million to Knight if, after the IPO, the Company sells 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 the Borrower is not the Lender or an affiliate of the Lender.

●

For the period ending upon the earlier of (i) 10 years after the closing of the IPO, or (ii) the conversion or redemption in full of the Series A Preferred Stock, the Company will pay to Knight a royalty equal to 3.5% of the Company’s net sales (the “Royalty”) on a quarterly basis, where “Net Sales” has the same meaning as in the Company’s license agreement with the U.S. Army for tafenoquine.

Upon consummation of the IPO, the Company concluded that the contingent milestone payment is a freestanding financial instrument that meets the definition of a derivative under ASC 815, and accordingly, the fair value of the derivative liability is marked to market each reporting period until settled. The Royalty due to Knight was determined to be an embedded component of the Series A Preferred Stock, however, is exempt from derivative accounting under the ASC 815 scope exception for specified volumes of sales or service revenues. Therefore, the Company accrues a royalty expense as sales are made.

The valuation of the contingent milestone payment includes significant unobservable inputs such as the timing and probability of discrete potential exit scenarios, forward interest rate curves, and discount rates based on implied and market yields.

	Contingent Milestone Payment
Derivative liabilities - December 31, 2024	$	640,830
Change in fair value		(5,105)
Derivative liabilities - March 31, 2025		635,725
Change in fair value		140,447
Derivative liabilities - June 30, 2025		776,172
Change in fair value		21,103
Derivative liabilities - September 30, 2025	$	797,275

	Contingent Milestone Payment
Derivative liabilities - December 31, 2023	$	2,306,796
Change in fair value		(1,740,847)
Derivative liabilities - March 31, 2024		565,949
Change in fair value		1,101
Derivative liabilities - June 30, 2024		567,050
Change in fair value		56,712
Derivative liabilities - September 30, 2024	$	623,762

Changes in the fair value of derivative liabilities are included in other income (expense) in the accompanying consolidated condensed statements of operations and comprehensive loss. During the nine months ended September 30, 2025 and 2024, the Company recorded a net (loss) gain on the change in the fair value of derivative liabilities of ($156,445) and $1,683,034, respectively.

- Definition

The entire disclosure for derivative instruments and hedging activities including, but not limited to, risk management strategies, non-hedging derivative instruments, assets, liabilities, revenue and expenses, and methodologies and assumptions used in determining the amounts.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 182
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480401/815-10-55-182

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 185
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480401/815-10-55-185

Reference 3: http://www.xbrl.org/2003/role/exampleRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 184
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480401/815-10-55-184

Reference 4: http://www.xbrl.org/2003/role/exampleRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 181
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480401/815-10-55-181

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (a)(5)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4H
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4H

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4H
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4H

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 15
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480960/815-15-50-3

Reference 13: http://www.xbrl.org/2003/role/exampleRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 183
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480401/815-10-55-183

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (a)(4)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4K
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4K

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4I
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4I

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4F
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-4F

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-2

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-2

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(1)(iii)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-2

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(1)(ii)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-2

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)(1)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-2

Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-1B

Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1A
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-1A

Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1A
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-1A

Reference 27: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1A
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-1A

Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-1A

Reference 29: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/815/tableOfContent

Reference 30: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480237/815-40-50-5

Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-5C

+ Details