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United States securities and exchange commission logo
April 20, 2023
David Happel
President and Chief Executive Officer
Sagimet Biosciences Inc.
155 Bovet Road, Suite 303
San Mateo, California 94402
Re: Sagimet Biosciences
Inc.
Draft Registration
Statement on Form S-1
Submitted March 24,
2023
CIK No. 0001400118
Dear David Happel:
We have reviewed your 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.
Draft Registration Statement on Form S-1
Cover Page
1. Please disclose on your
prospectus cover page whether your offering is contingent upon
the final approval of
your NASDAQ listing. Please ensure the disclosure is consistent with
your underwriting
agreement.
Prospectus Summary
Overview, page 1
2. Please revise your
registration statement here and throughout to remove statements that
you are developing a
"first-in-class" therapeutic as such statements are speculative given
your current stage of
development.
David Happel
FirstName LastNameDavid
Sagimet Biosciences Inc. Happel
Comapany
April NameSagimet Biosciences Inc.
20, 2023
April 220, 2023 Page 2
Page
FirstName LastName
3. We note your discussion of the interim results of your FASCINATE-2
Phase 2b trial in
NASH and your statement that you expect that the topline liver biopsy
results will directly
show improvement in disease. Please revise this section and elsewhere
in your registration
statement, where appropriate, to discuss the limitations of reliance
on interim results. In
your revisions, please clarify that interim clinical trial results may
not be indicative of
future results.
4. Please revise your disclosure to clearly state whether the primary and
secondary endpoints
of the FASCINATE-1 clinical trial were achieved. Please also disclose
whether observed
results in this clinical trial were statistically significant in the
25mg and 75mg cohorts. To
the extent that this clinical trial did not achieve its primary and/or
secondary endpoints,
please revise the bullet titled "Comprehensive improvements across
biomarkers" to reflect
this fact.
5. We note your references here and on page 110 to a "de-risked"
development
strategy. Please remove these statements and any other statements that
imply that you will
be successful in mitigating or eliminating risk associated with drug
development.
6. We note your statement that denifanstat has been generally
well-tolerated to date. Please
revise this statement to reflect your disclosure (i) on page 99
indicating that TEAEs have
led to treatment discontinuation of 20 subjects in the ongoing
FASCINATE-2 trial and
(ii) on page 104 indicating that in Cohort 3 of your FASCINATE-1 Phase
2 trial, you
determined that the adverse effects were not balanced by the clinical
activity observed.
Our FASN inhibitor pipeline, page 3
7. Please revise your pipeline table here and on page 88 to reflect your
disclosure on page 76
indicating that that denifanstat is licensed to Ascletis in Greater
China, the clinical trials
for acne and recurrent GBM are being conducted in China and that
Ascletis has
commercialization rights to denifanstat in Greater China.
Our team, page 4
8. We note that you identify certain entities as investors in your
company here and on page
89. However, certain of these entities do not appear to be among your
principal
stockholders as disclosed on page 167. If material, please expand your
disclosure to
describe the nature of each such entity's investment in your company
and explain to us
why including this information is appropriate. Please also explain in
the response your
plans to update investors about any changes these entities make with
respect to their
investments in your company.
Risk Factors
Even if this offering is successful..., page 13
9. We note your statements here and on page 79 that you have relied on
private equity and
debt financings to fund your operations. To the extent that the
agreements governing these
David Happel
Sagimet Biosciences Inc.
April 20, 2023
Page 3
arrangements are still in place, please revise the prospectus, where
appropriate, to describe
the material terms of these agreements, as well as any debt associated
with them.
Our amended and restated certificate of incorporation..., page 61
10. Please revise this risk factor and your disclosure on page 173 to
disclose that Section 22 of
the Securities Act creates concurrent jurisdiction for state and
federal courts over all
actions brought to enforce any duty or liability created by the
Securities Act or the rules
and regulations thereunder.
Adverse developments affecting the financial services industry..., page 62
11. We note your disclose here that you had $9.5 million in cash and cash
equivalents at SVB
at the time of SVB's closure as well as your statement on page F-8
that as of December
31, 2022, your short-term marketable securities were invested with
SVB. Please revise
this risk factor to disclose whether SVB's closure has decreased the
value of your SVB-
held assets or inhibited your ability to access those assets.
Market, Industry and Other Data, page 66
12. We note your statement that you have not independently verified any
third-party
information in the prospectus. This statement may imply an
inappropriate disclaimer of
responsibility with respect to such information. Please either delete
this statement or
specifically state that you are liable for such information.
Use of Proceeds, page 67
13. Please revise to disclose how far the offering proceeds will allow you
to proceed in the
development of denifanstat. If any material amounts of other funds
will be necessary for
the development of denifanstat, state the amounts and sources of other
funds needed for
this purpose. For guidance, please refer to Item 504 of Regulation
S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
License agreement with Ascletis, page 76
14. Please revise your disclosure to explain why the $2.0 million
milestone payment under the
license agreement was "potentially triggered." To the extent the
milestone payment
obligation has been triggered and the milestone payment has not been
made, please
explain why.
Business
FASCINATE-1 Phase 2 clinical
FirstName LastNameDavid trial results, page 99
Happel
Comapany
15. NameSagimet
Please Biosciences
revise this section Inc.disclose the primary and
secondary endpoints of the
to clearly
clinical
April 20, 2023 trial
Pageand
3 whether they were achieved.
FirstName LastName
David Happel
FirstName LastNameDavid
Sagimet Biosciences Inc. Happel
Comapany
April NameSagimet Biosciences Inc.
20, 2023
April 420, 2023 Page 4
Page
FirstName LastName
Acne, page 110
16. We note your statement that you have shown in two separate Phase 1
clinical trials that
denifanstat can reduce the amount of sebum on patients' skin. Please
revise to briefly
describe these trials. In your revisions, please disclose whether the
trials were powered for
statistical significance.
General
17. Please provide us with copies of all written communications, as
defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your
behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they
retain copies of the communications.
You may contact Angela Connell at 202-551-3426 or Gary Newberry at
202-551-3761 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Cindy Polynice at 202-551-8707 or Alan Campbell at 202-551-4224 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Alicia Tschirhart