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Sagimet Biosciences Inc.
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Sagimet Biosciences Inc.
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SEC wrote to company
2024-08-19
Sagimet Biosciences Inc.
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2024-08-22
Sagimet Biosciences Inc.
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Sagimet Biosciences Inc.
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2024-01-16
Sagimet Biosciences Inc.
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2024-01-23
Sagimet Biosciences Inc.
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2024-01-23
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SEC wrote to company
2023-07-06
Sagimet Biosciences Inc.
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2023-07-10
Sagimet Biosciences Inc.
References: July 6,
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2023-07-11
Sagimet Biosciences Inc.
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2023-07-11
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Sagimet Biosciences Inc.
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2023-04-20
Sagimet Biosciences Inc.
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-07 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 001-41742 | Read Filing View |
| 2025-05-05 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 001-41742 | Read Filing View |
| 2024-08-22 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-08-19 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 333-281582 | Read Filing View |
| 2024-01-23 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-01-23 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-01-16 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 377-07049 | Read Filing View |
| 2023-07-11 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-10 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-06 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-04-20 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-07 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 001-41742 | Read Filing View |
| 2025-04-22 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 001-41742 | Read Filing View |
| 2024-08-19 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 333-281582 | Read Filing View |
| 2024-01-16 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | 377-07049 | Read Filing View |
| 2023-07-06 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-04-20 | SEC Comment Letter | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-05 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-08-22 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-01-23 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2024-01-23 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
| 2023-07-10 | Company Response | Sagimet Biosciences Inc. | DE | N/A | Read Filing View |
2025-05-07 - UPLOAD - Sagimet Biosciences Inc. File: 001-41742
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Thierry Chauche Principal Financial and Accounting Officer Sagimet Biosciences Inc. 155 Bovet Road, Suite 303 San Mateo, California 94402 Re: Sagimet Biosciences Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-41742 Dear Thierry Chauche: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-05-05 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
May 5, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street NE
Washington, DC 20549
Attention: Vanessa Robertson
Tracie Mariner
Re: Sagimet Biosciences Inc.
Form 10-K for Fiscal Year Ended December 31,
2024
File No. 001-41742
To the addressees above:
This letter is submitted on behalf of Sagimet Biosciences
Inc. (the "Company"), a Delaware corporation, in response to the comment letter (the "Comment Letter") from the
Staff of the Division of Corporation Finance (the "Staff") of the Securities and Exchange Commission (the "Commission"),
dated April 22, 2025, relating to the Company's Form 10-K for the fiscal year ended December 31, 2024 (the "Form 10-K"), filed
on March 12, 2025.
For your convenience, the response below is prefaced
by the text of the Staff's comment.
Item 7. Management's Discussion and Analysis of Financial Condition
and Results of Operations
Results of operations
Research and development, page 117
1. Please provide quantitative disclosures, to be included in future filings, for the type of research
and development expenses incurred (i.e. by nature or type of expense) for each period presented, which should reconcile to total research
and development expense. In addition, revise to disclose the extent to which you track certain of your research and development costs
on a project basis and, if applicable, disclose the amounts tracked for each project, where material.
Company's Response
The Company acknowledges the
Staff's comment requesting additional quantitative disclosures in future filings made with the SEC. Beginning with its Form 10-Q
for the quarter ended March 31, 2025, the Company will revise its disclosure to provide new quantitative disclosures that set forth with
respect to research and development ("R&D") expenses incurred by ‘nature' or ‘type' of expense.
This information will be provided in summary tabular format and the table will reconcile to total R&D expenses shown on the Condensed
Statements of Operations and Comprehensive Loss, as shown in Exhibit A .
The Company respectfully further
advises the Staff that it tracks R&D expenses as either ‘external' R&D expenses or ‘internal' R&D
expenses. The Company's external R&D expenses primarily consist of expenses for clinical development and research, including
expenses related to agreements with contract research organizations; expenses for manufacturing and non-clinical studies incurred through
contract manufacturing organizations; and external consulting and others. The Company tracks the majority of its external R&D expense
by product candidate, which consists of expenses for denifanstat and TVB-3567. External R&D expenses incurred for denifanstat are
substantially all of the Company's external R&D expenses, and as such the Company believes disclosing external R&D expenses
for the Company's other product candidate would not materially enhance an investor's understanding of the Company's
total external R&D expenses currently. The Company will include in its narrative disclosures that external R&D expenses for denifanstat
are substantially all of the costs, as shown in Exhibit A below. The Company will continue to monitor and to the extent external
R&D expenses for TVB-3567 become meaningful to investors in the future, the Company will disclose external R&D expenses by product
candidate.
The Company's internal
R&D expenses primarily consist of personnel-related costs, including salaries, bonuses, benefits, payroll taxes and stock-based compensation
for employees engaged in R&D functions. The Company does not track internal R&D expenses on a project-by-project, product candidate
or development phase basis because those costs are generally deployed across multiple development projects and allocation of these costs
to individual projects is impractical.
The Company intends to include
a similar table to that set forth on Exhibit A in each Quarterly Report on Form 10-Q and Annual Report on Form 10-K on a prospective
basis, beginning with its Form 10-Q for the quarter ended March 31, 2025. Such a table will be included in the section titled Management's
Discussion and Analysis of Financial Condition and Results of Operations . Because the Company's Form 10-Q for the quarter ended
March 31, 2025 has not yet been finalized, the amounts accompanying the table are not included in Exhibit A . The Company believes
that this additional disclosure will sufficiently address the Staff's comment.
***
As always, we appreciate the Staff's review and
comments. Please contact the undersigned at the contact information you have on file if you have any questions or comments.
Sincerely,
/s/ David Happel
cc:
Thierry Chauche, Sagimet Biosciences Inc.
Elizabeth Rozek, Esq., Sagimet Biosciences Inc.
Rachael Bushey, Esq., Goodwin Procter LLP
Jennifer Porter, Esq., Goodwin Procter LLP
Goodwin Procter LLP
Three Embarcadero Center, 28 th Floor
San Francisco, CA 94111
goodwinlaw.com
+1 (415) 733-6000
Exhibit A
Research and development
– Research and development expenses for the three months ended March 31, 2025 and 2024 were comprised of the following (in thousands):
Three Months Ended March 31,
2025
2024
$ Change
% Change
External expenses
Clinical development and research
$ -
$ 1,844
$ -
- %
Manufacturing and non-clinical
-
2,001
-
- %
External consulting and other
-
346
-
- %
Subtotal - external expenses
$ -
$ 4,191
$ -
- %
Internal expenses
Personnel costs
$ -
$ 582
$ -
- %
Stock-based compensation
-
246
-
- %
Other internal operating expenses
-
243
-
- %
Subtotal - internal expenses
$ -
$ 1,071
$ -
- %
Total R&D expenses
$ -
$ 5,262
$ -
- %
External research and development
expenses for denifanstat represent substantially all of the external expenses for the three months ended March 31, 2025 and 2024.
2025-04-22 - UPLOAD - Sagimet Biosciences Inc. File: 001-41742
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 22, 2025 Thierry Chauche Principal Financial and Accounting Officer Sagimet Biosciences Inc. 155 Bovet Road, Suite 303 San Mateo, California 94402 Re: Sagimet Biosciences Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-41742 Dear Thierry Chauche: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for Fiscal Year Ended December 31, 2024 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of operations Research and development, page 117 1. Please provide quantitative disclosures, to be included in future filings, for the type of research and development expenses incurred (i.e. by nature or type of expense) for each period presented, which should reconcile to total research and development expense. In addition, revise to disclose the extent to which you track certain of your research and development costs on a project basis and, if applicable, disclose the amounts tracked for each project, where material. In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. April 22, 2025 Page 2 Please contact Vanessa Robertson at 202-551-3649 or Tracie Mariner at 202-551- 3744 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2024-08-22 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
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Sagimet Biosciences Inc.
155 Bovet Road, Suite 303
San Mateo, California 94402
August 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-7553
Re: Sagimet Biosciences Inc.
Registration Statement on Form S-3
Filed August 15, 2024 (File No. 333-281582)
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, Sagimet Biosciences Inc. (the “Company”) hereby requests
that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-281582) (the “Registration
Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:01 P.M., Eastern
Time, on August 26, 2024, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration
Statement be declared effective at some other time.
Please contact Jennifer L.
Porter, Esq. of Goodwin Procter LLP, at (445) 207-7806 to provide notice of effectiveness, or if you have
any questions or comments concerning this request.
[Remainder of the page intentionally left
blank]
Very truly yours,
SAGIMET BIOSCIENCES INC.
By:
/s/ David Happel
Name:
David Happel
Title:
President and Chief Executive Officer
2024-08-19 - UPLOAD - Sagimet Biosciences Inc. File: 333-281582
August 19, 2024
Dave Happel
Chief Executive Officer
Sagimet Biosciences Inc.
155 Bovet Road, Suite 303
San Mateo, CA 94402
Re:Sagimet Biosciences Inc.
Registration Statement on Form S-3
Filed August 15, 2024
File No. 333-281582
Dear Dave Happel:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jennifer Porter
2024-01-23 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
January 23, 2024
United States
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549
Attention: Tyler Howes
Re: Sagimet
Biosciences Inc.
Registration Statement on Form S-1
File No. 333-276664
Ladies and
Gentlemen:
Pursuant to
Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities Act”),
we wish to advise that as of the time of this filing, the underwriters have not yet made any distribution of the Preliminary Prospectus
of Sagimet Biosciences Inc. (the “Registrant”) dated January 23, 2024. However, the underwriters are taking steps
to see that all underwriters, brokers or dealers participating in the public offering of shares of the Registrant’s common stock
pursuant to the above-captioned Registration Statement, as amended (the “Registration Statement”), are promptly furnished
with sufficient copies of the preliminary and final prospectus to enable them to comply with the prospectus delivery requirements of
Sections 5(b)(1) and (2) of the Securities Act.
We wish to
advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the
Securities Exchange Act of 1934, as amended.
We hereby join
in the request of the Registrant that the effectiveness of the above-captioned Registration Statement be accelerated to 4:00 p.m. Eastern
Time, on January 25, 2024 or as soon thereafter as practicable.
[signature
page follows]
Very truly yours,
GOLDMAN SACHS & CO. LLC
COWEN AND COMPANY, LLC
LEERINK PARTNERS LLC
As
representatives of the Underwriters
By:
Goldman
Sachs & Co. LLC
By:
/s/ Lyla Bibi
Name: Lyla Bibi
Title: Managing Director
By:
Cowen
and Company, LLC
By:
/s/ Bill Follis
Name: Bill Follis
Title: Managing Director
By:
Leerink
Partners LLC
By:
/s/ Jon Civitarese
Name: Jon Civitarese
Title: Senior Managing Director
2024-01-23 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
VIA EDGAR
January 23, 2024
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tyler Howes
Re: Sagimet Biosciences Inc.
Acceleration Request for Registration Statement on Form S-1
File No. 333-276664
Ladies and Gentlemen,
Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the “Act”), Sagimet Biosciences Inc. (the “Company”) hereby
requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated
to January 25, 2024 at 4:00 p.m. Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter
LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request,
the Company acknowledges that it is aware of its responsibilities under the Act.
Once the Registration
Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Jennifer Porter at (415) 207-7806.
If you have any questions
regarding this request, please contact Jennifer Porter of Goodwin Procter LLP at (445) 207-7806.
Sincerely,
SAGIMET BIOSCIENCES INC.
/s/ David Happel
David Happel
President and Chief Executive Officer
cc: Elizabeth Rozek, Esq., Sagimet Biosciences Inc.
Rachael Bushey, Goodwin Procter LLP
Jennifer Porter, Goodwin Procter LLP
2024-01-16 - UPLOAD - Sagimet Biosciences Inc. File: 377-07049
United States securities and exchange commission logo
January 16, 2024
David Happel
Chief Executive Officer
Sagimet Biosciences Inc.
155 Bovet Road, Suite 303
San Mateo, CA 94402
Re:Sagimet Biosciences Inc.
Draft Registration Statement on Form S-1
Submitted January 10, 2024
CIK No. 0001400118
Dear David Happel:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Porter, Esq.
2023-07-11 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
VIA EDGAR
July 11, 2023
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Cindy Polynice
Alan Campbell
Angela Connell
Gary Newberry
Re: Sagimet
Biosciences Inc. (the “Registrant”)
Registration Statement on Form S-1 (File No. 333-272901)
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 460 of the General Rules and
Regulations under the Securities Act of 1933, as amended, we wish to advise that between July 10, 2023 and the date hereof, approximately
1,821 copies of the Preliminary Prospectus, dated July 10, 2023, were distributed to prospective underwriters, institutional
investors and prospective dealers in connection with the above-captioned Registration Statement, as amended.
We wish to advise you that the participating underwriters
have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
We hereby join in the request of the Registrant
that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time on July 13,
2023, or as soon thereafter as practicable.
[signature page follows]
Very truly yours,
GOLDMAN SACHS & CO.
LLC
COWEN AND COMPANY, LLC
PIPER SANDLER & CO.
As representatives of the Underwriters
GOLDMAN SACHS & CO.
LLC
By:
/s/ Lyla Bibi
Name: Lyla Bibi
Title: Managing Director
COWEN AND COMPANY, LLC
By:
/s/ Tanya Joseph
Name: Tanya Joseph
Title: Managing Director
PIPER SANDLER & CO.
By:
/s/ Chad Huber
Name: Chad Huber
Title: Managing Director
[Signature
Page to Acceleration Request Letter]
2023-07-11 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
VIA EDGAR
July 11, 2023
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Cindy Polynice
Alan Campbell
Angela Connell
Gary Newberry
Re: Sagimet Biosciences Inc.
Acceleration Request for Registration Statement on Form S-1
File No. 333-272901
Ladies and Gentlemen,
Pursuant to
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Sagimet Biosciences Inc. (the
“Company”) hereby requests that the effective date of the above-referenced registration statement (the
“Registration Statement”) be accelerated to July 13, 2023 at 4:00 p.m. Eastern Time, or as soon thereafter
as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be
declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its
responsibilities under the Act.
Once the Registration
Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Rachael Bushey at (445) 207-7805
or Alicia Tschirhart at (415) 733-6156.
If you have any questions
regarding this request, please contact Rachael Bushey of Goodwin Procter LLP at (445) 207-7805.
Sincerely,
SAGIMET BIOSCIENCES INC.
/s/ David Happel
David Happel
President and Chief Executive Officer
cc: Dennis Hom, Sagimet Biosciences Inc.
Rachael Bushey, Goodwin Procter LLP
Marianne Sarrazin, Goodwin Procter LLP
Alicia Tschirhart, Goodwin Procter LLP
2023-07-10 - CORRESP - Sagimet Biosciences Inc.
CORRESP
1
filename1.htm
Goodwin Procter LLP
Three Embarcadero Center, 28th Floor
San Francisco, CA 94111
goodwinlaw.com
+1 (415) 733-6000
July 10, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street NE
Washington, DC 20549
Attention:
Cindy Polynice
Alan Campbell
Angela Connell
Gary Newberry
Re:
Sagimet Biosciences Inc.
Amendment No. 1 to Registration Statement
on Form S-1
Filed July 3, 2023
Registration Statement on Form S-1 Filed
June 23, 2023
File No. 333-272901
Ladies and Gentlemen:
This letter is submitted on behalf of Sagimet
Biosciences Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the
“Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s
Registration Statement on Form S-1 filed on June 23, 2023, as amended by Amendment No. 1 to Registration Statement on Form S-1,
filed on July 3, 2023 (the “Registration Statement”), as set forth in the Staff’s letter dated July 6,
2023 (the “Comment Letter”). The Company is concurrently filing Amendment No. 2 to the Registration Statement
(“Amendment No. 2”), which includes changes to reflect responses to the Staff’s comments and other updates.
For reference purposes, the text of the
Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the
reproduced the Staff’s comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions
of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment
No. 2. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment
No. 2.
The responses provided herein are based upon information
provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via email a copy of each
of this letter and Amendment No. 2 (marked to show changes from the Registration Statement).
Amendment No. 1 to Registration Statement on Form S-1
Business
Data for selected competitor product candidates, page 120
1. We note your revised disclosure on pages 120-121 which presents data from multiple other clinical drug candidates for the
treatment of NASH. Given that you do not appear to have conducted head-to-head trials of your product candidate against any of the product
candidates included in this disclosure, the inclusion of this information does not appear to be appropriate. Please remove this disclosure
from the prospectus. You may cite competitor product candidates without presenting data from competitor clinical trials.
RESPONSE: The Company acknowledges
the Staff’s comment and has revised its disclosure on pages 120-121 of Amendment No. 2 to remove the disclosure from
the prospectus in response to the Staff’s comment.
License agreement with Ascletis, page 121
2. We note your disclosure indicating that in July 2023 you assigned additional patents and patent applications to Gannex. Please
revise your disclosure to disclose the subject matter of the additional patents and patent applications assigned to Gannex.
RESPONSE: The Company acknowledges
the Staff’s comment and has revised its disclosure on pages 121-122 of Amendment No. 2 to disclose the subject matter of
the additional patents and patent applications assigned to Gannex in response to the Staff’s comment.
Exhibits
3. We note that Exhibit 10.24 appears to contain redactions. Please revise your exhibit index to disclose that this exhibit contains
redactions. Please also file the July 2023 Assignment and Assumption Agreement referenced on page 122 as an exhibit to your
registration statement. Alternatively, please tell us why this agreement is not required to be filed.
RESPONSE: The Company acknowledges
the Staff’s comment and has revised the exhibit index in Amendment No. 2 to indicate that Exhibit 10.24 contains redactions.
The Company further advises the Staff that it has filed the July 2023 Assignment and Assumption Agreement as Exhibit 10.29 to
Amendment No. 2 in response to the Staff’s comment.
***
If you should have any questions regarding the
enclosed matters, please contact me at (445) 207-7805.
Sincerely,
/s/ Rachael M. Bushey, Esq.
Rachael M. Bushey, Esq.
Enclosures
cc:
David Happel, Sagimet Biosciences Inc.
Dennis Hom, Sagimet Biosciences Inc.
Elizabeth Rozek, Sagimet Biosciences Inc.
Marianne Sarrazin, Goodwin Procter LLP
Alicia Tschirhart, Goodwin Procter LLP
John T. McKenna, Cooley LLP
Natalie Y. Karam, Cooley LLP
Denny Won, Cooley LLP
2023-07-06 - UPLOAD - Sagimet Biosciences Inc.
United States securities and exchange commission logo
July 6, 2023
David Happel
President and Chief Executive Officer
Sagimet Biosciences Inc.
155 Bovet Road, Suite 303
San Mateo, California 94402
Re:Sagimet Biosciences Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed July 3, 2023
Registration Statement on Form S-1
Filed June 23, 2023
File No. 333-272901
Dear David Happel:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
Business
Data for selected competitor product candidates, page 120
1.We note your revised disclosure on pages 120-121 which presents data from multiple
other clinical drug candidates for the treatment of NASH. Given that you do not appear to
have conducted head-to-head trials of your product candidate against any of the product
candidates included in this disclosure, the inclusion of this information does not appear to
be appropriate. Please remove this disclosure from the prospectus. You may cite
competitor product candidates without presenting data from competitor clinical trials.
FirstName LastNameDavid Happel
Comapany NameSagimet Biosciences Inc.
July 6, 2023 Page 2
FirstName LastName
David Happel
Sagimet Biosciences Inc.
July 6, 2023
Page 2
License agreement with Ascletis, page 121
2.We note your disclosure indicating that in July 2023 you assigned additional patents and
patent applications to Gannex. Please revise your disclosure to disclose the subject matter
of the additional patents and patent applications assigned to Gannex.
Exhibits
3.We note that Exhibit 10.24 appears to contain redactions. Please revise your exhibit index
to disclose that this exhibit contains redactions. Please also file the July 2023 Assignment
and Assumption Agreement referenced on page 122 as an exhibit to your registration
statement. Alternatively, please tell us why this agreement is not required to be filed.
You may contact Gary Newberry at 202-551-3761 or Angela Connell at 202-551-3426 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
2023-04-20 - UPLOAD - Sagimet Biosciences Inc.
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.
FirstName LastNameDavid Happel
Comapany NameSagimet Biosciences Inc.
April 20, 2023 Page 2
FirstName LastNameDavid Happel
Sagimet Biosciences Inc.
April 20, 2023
Page 2
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
FirstName LastNameDavid Happel
Comapany NameSagimet Biosciences Inc.
April 20, 2023 Page 3
FirstName LastName
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 trial results, page 99
15.Please revise this section to clearly disclose the primary and secondary endpoints of the
clinical trial and whether they were achieved.
FirstName LastNameDavid Happel
Comapany NameSagimet Biosciences Inc.
April 20, 2023 Page 4
FirstName LastName
David Happel
Sagimet Biosciences Inc.
April 20, 2023
Page 4
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