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United States securities and exchange commission logo
December 16, 2022
Geoffrey S. Dow, Ph.D.
President and Chief Executive Officer
60 Degrees Pharmaceuticals, Inc.
1025 Connecticut Avenue NW Suite 1000
Washington, D.C. 20036
Re: 60 Degrees
Pharmaceuticals, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted December
5, 2022
CIK No. 0001946563
Dear Geoffrey S. Dow:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1, submitted
December 5, 2022
Prospectus Summary, page 4
1. We note your response
to prior comment 2 and your inclusion of the pipeline table on
pages 5 and 65. Please
revise your pipeline table to remove the "Earliest Possible
Marketing Date in USA"
column. Given that FDA approval of your products for the
treatment of your
stated indications is not within your control, it is inappropriate to predict
the earliest date that
such approval may be obtained for all of your products aside from
Arakoda, which has been
approved by the FDA only for the prevention of malaria. As
requested by our prior
comment, please also depict the phase or status of development for
each product candidate
including separate columns for preclinical development, Phase 1,
Phase 2 and Phase 3
trials with arrows showing where each program has progressed.
Geoffrey S. Dow, Ph.D.
60 Degrees Pharmaceuticals, Inc.
December 16, 2022
Page 2
Strategy, page 8
2. We note your disclosure that in 2023, you plan to execute a
randomized, placebo-
controlled double blind clinical study to prove that Arakoda
accelerates time to sustained
clinical recovery in patients with mild-moderate disease with no risk
factors. Since your
previous Phase II trial was terminated early, please clarify whether
the new trial will be
Phase II or Phase III.
Key Relationships & Licenses, page 10
3. Please disclose the maximum amount in milestone payments that could be
due under the
Exclusive License Agreement with the U.S. Army Medical Materiel
Development
Activity.
Common stock to be outstanding after the offering, page 15
4. We note your response to prior comment 11. Please expand footnote 3 to
address the
common stock that could be issuable upon conversion of the preferred
stock that will be
issued for accrued interest on the Knight Loan. Please also revise
this section to indicate
what disclosure this footnote is intended to modify.
Business, page 64
5. We note your response to prior comment 18 and your inclusion of the
section entitled
"Key Relationships & Licenses." We reissue our prior comment in part.
In an appropriate
location, disclose how your licensing arrangement with the United
States Army, which
you disclose excludes P. vivax malaria, would impact any targeted
marketing efforts of
Arakoda for its currently approved use.
Arakoda, page 66
6. We note your response to prior comment 19 and your revised disclosure on
page 66. We
reissue our comment in part. If any of the p-values from Phase II of the
clinical
investigation were not statistically significant, please clarify that
here and include
balancing disclosure in your prospectus summary. Please also clarify
here and in your
prospectus summary whether the trial was designed to show if the
observed results could
be due to the administration of Arakoda on a standalone basis, or prior
COVID infection,
FirstName LastNameGeoffrey S. Dow, Ph.D.
prior vaccination, or both, or whether the results could be due to
chance. We also note the
Comapany Name60
p-value Degrees
in Figure B onPharmaceuticals,
page 8 is 0.1209.Inc.
If the results shown could
be due to chance,
please revise to
December 16, 2022 Page 2make that clear.
FirstName LastName
Geoffrey S. Dow, Ph.D.
FirstName
60 DegreesLastNameGeoffrey S. Dow, Ph.D.
Pharmaceuticals, Inc.
Comapany16,
December Name60
2022 Degrees Pharmaceuticals, Inc.
December
Page 3 16, 2022 Page 3
FirstName LastName
You may contact Franklin Wyman at 202-551-3660 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related
matters. Please contact Joshua Gorsky at 202-551-7836 or Tim Buchmiller at
202-551-
3635 with any other questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Ross D. Carmel, Esq.