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Biomea Fusion, Inc.
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SEC wrote to company
2024-07-18
Biomea Fusion, Inc.
Summary
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Biomea Fusion, Inc.
Response Received
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SEC wrote to company
2024-06-12
Biomea Fusion, Inc.
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2024-06-21
Biomea Fusion, Inc.
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Biomea Fusion, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2022-10-19
Biomea Fusion, Inc.
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2022-10-20
Biomea Fusion, Inc.
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Biomea Fusion, Inc.
Response Received
4 company response(s)
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SEC wrote to company
2021-04-02
Biomea Fusion, Inc.
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2021-04-12
Biomea Fusion, Inc.
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2021-04-13
Biomea Fusion, Inc.
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2021-04-13
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2021-04-15
Biomea Fusion, Inc.
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2021-04-15
Biomea Fusion, Inc.
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Biomea Fusion, Inc.
Response Received
1 company response(s)
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2021-03-12
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2021-03-26
Biomea Fusion, Inc.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2025-08-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 333-289262 | Read Filing View |
| 2024-07-18 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 001-40335 | Read Filing View |
| 2024-06-21 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2024-06-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 001-40335 | Read Filing View |
| 2022-10-20 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2022-10-19 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-15 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-15 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-12 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-02 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-03-26 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-03-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 333-289262 | Read Filing View |
| 2024-07-18 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 001-40335 | Read Filing View |
| 2024-06-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | 001-40335 | Read Filing View |
| 2022-10-19 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-15 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-02 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-03-12 | SEC Comment Letter | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2022-10-20 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-15 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-13 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-04-12 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
| 2021-03-26 | Company Response | Biomea Fusion, Inc. | DE | N/A | Read Filing View |
2025-08-13 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP Biomea Fusion, Inc. 1599 Industrial Road San Carlos, CA 94070 August 13, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance – Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 File No. 333-289262 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Biomea Fusion, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-289262) (the “Registration Statement”), so that it may become effective at 4:01 pm Eastern time on August 15, 2025, or as soon thereafter as practicable. Very truly yours, BIOMEA FUSION, INC. By: /s/ Michael J.M. Hitchcock, Ph.D. Name: Michael J.M. Hitchcock, Ph.D. Title: Interim Chief Executive Officer and Director Cc: Maggie Wong, Goodwin Procter LLP Alicia Tschirhart, Goodwin Procter LLP
2025-08-12 - UPLOAD - Biomea Fusion, Inc. File: 333-289262
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 12, 2025 Dr. Michael J.M. Hitchcock Interim Chief Executive Officer and Director Biomea Fusion, Inc. 1599 Industrial Road San Carlos, CA 94070 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 Filed August 5, 2025 File No. 333-289262 Dear Dr. Michael J.M. Hitchcock: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Alicia M. Tschirhart, Esq. </TEXT> </DOCUMENT>
2024-07-18 - UPLOAD - Biomea Fusion, Inc. File: 001-40335
July 18, 2024
Franco Valle
Principal Financial and Accounting Officer
Biomea Fusion, Inc.
900 Middlefield Road, 4th Floor
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Filed March 28, 2024
File No. 001-40335
Dear Franco Valle:
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
2024-06-21 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP June 21, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Vanessa Robertson Tracie Mariner RE: Biomea Fusion, Inc. Form 10-K for Fiscal Year Ended December 31, 2023 Filed March 28, 2024 File No. 001-40335 To the addressees set forth above: On behalf of Biomea Fusion, Inc. (the “Company”), this letter responds to the comments set forth in the letter to the Company dated June 12, 2024 from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”), relating to the financial statements and related disclosures in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed on March 28, 2024. For your convenience, we have repeated the comment from the June 12, 2024 letter in italicized print, and the Company’s response is provided below the comment. Form 10-K for Fiscal Year Ended December 31, 2023 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and Development Expenses, page 103 1. You disclose, on page 101, that you track direct costs by stage of program, clinical or preclinical. Please address the following: • Revise your disclosure in future filings to break out clinical costs by program or by indication separately for each period presented. • If you do not track clinical costs on a more granular level, revise your disclosure to explain the reason. • For preclinical costs, revise your disclosure to break out the total amount spent for each period presented. • Provide us with your proposed disclosure. Company Response to Comment 1: The Company respectfully acknowledges the Staff’s comment and undertakes to provide the requested detail for external research and development expenses by stage of program or type of research and development activity as shown below, to the extent such spend is attributable to a specific stage of program. Many of these expenses are shared among various programs and product candidates and, as such, the Company does not track expenses by program or indication. In addition, the Company will provide a breakdown of research and development expenses consistent with the following tabular and narrative disclosure in its future periodic reports filed with the SEC, where applicable, beginning with the Company’s upcoming Form 10-Q for the three months and six months ending June 30, 2024. Research and Development Expenses We track research and development expenses to the extent such spend is attributable to a specific stage of program or type of research and development activity. Many of these expenses are shared among various programs and product candidates and, as such, we do not track expenses by program or indication. The following table summarizes our research and development expenses by stage of program and type of research and development activity incurred during the periods indicated (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 $ Change 2024 2023 $ Change External costs Clinical activities related expenses $ [ ] $ [ ] $ [ ] $ [ ] $ [ ] $ [ ] Pre-clinical activities related expenses [ ] [ ] [ ] [ ] [ ] [ ] Expenses related to manufacturing of clinical and research material [ ] [ ] [ ] [ ] [ ] [ ] Other external costs [ ] [ ] [ ] [ ] [ ] [ ] Internal costs: [ ] [ ] [ ] [ ] [ ] [ ] Personnel-related expenses (including stock-based compensation) [ ] [ ] [ ] [ ] [ ] [ ] Facilities and other allocated expenses [ ] [ ] [ ] [ ] [ ] [ ] Total research and development expenses $ [ ] $ [ ] $ [ ] $ [ ] $ [ ] $ [ ] Biomea Fusion, Inc. is committed to fully complying with the SEC disclosure requirements. Please do not hesitate to contact me by telephone at (650) 460-7636 with any questions or comments regarding this correspondence. Very truly yours, /s/ Franco Valle Chief Financial Officer cc: Thomas Butler, Biomea Fusion, Inc. Rainer (Ramses) Erdtmann, Biomea Fusion, Inc.
2024-06-12 - UPLOAD - Biomea Fusion, Inc. File: 001-40335
United States securities and exchange commission logo
June 12, 2024
Franco Valle
Principal Financial and Accounting Officer
Biomea Fusion, Inc.
900 Middlefield Road, 4th Floor
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Filed March 28, 2024
File No. 001-40335
Dear Franco Valle:
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, 2023
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Research and Development Expenses, page 103
1.You disclose, on page 101, that you track direct costs by stage of program, clinical or
preclinical. Please address the following:
•Revise your disclosure in future filings to break out clinical costs by program or by
indication separately for each period presented.
•If you do not track clinical costs on a more granular level, revise your disclosure to
explain the reason.
•For preclinical costs, revise your disclosure to break out the total amount spent for
each period presented.
•Provide us with your proposed disclosure.
In closing, we remind you that the company and its management are responsible for the
FirstName LastNameFranco Valle
Comapany NameBiomea Fusion, Inc.
June 12, 2024 Page 2
FirstName LastName
Franco Valle
Biomea Fusion, Inc.
June 12, 2024
Page 2
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
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
2022-10-20 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP Biomea Fusion, Inc. 900 Middlefield Road, 4th Floor Redwood City, CA 94063 October 20, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance – Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Biomea Fusion, Inc. Registration Statement on Form S-3 File No. 333-267884 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Biomea Fusion, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-267884) (the “Registration Statement”), so that it may become effective at 4:01 pm Eastern time on October 24, 2022, or as soon thereafter as practicable. Very truly yours, BIOMEA FUSION, INC. By: /s/ Thomas Butler Name: Thomas Butler Title: Principal Executive Officer Cc: Maggie Wong, Goodwin Procter LLP
2022-10-19 - UPLOAD - Biomea Fusion, Inc.
United States securities and exchange commission logo
October 19, 2022
Mr. Franco Valle
Chief Financial Officer
Biomea Fusion, Inc.
900 Middlefield Road, 4th Floor
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Registration Statement on Form S-3
Filed on October 14, 2022
File No. 333-267884
Dear Mr. Franco Valle:
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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Alicia Tschirhart
2021-04-15 - UPLOAD - Biomea Fusion, Inc.
United States securities and exchange commission logo
April 15, 2021
Thomas Butler
Chief Executive Officer
Biomea Fusion, Inc.
726 Main Street
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed April 12, 2021
File No. 333-254793
Dear Mr. Butler:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our April 2, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note that you have revised this section to include an additional table depicting your
active discovery programs in response to prior comment 1. Please remove this
additional table from the Prospectus Summary. We will not object to a narrative
description in the Prospectus Summary that summarizes this table.
FirstName LastNameThomas Butler
Comapany NameBiomea Fusion, Inc.
April 15, 2021 Page 2
FirstName LastName
Thomas Butler
Biomea Fusion, Inc.
April 15, 2021
Page 2
You may contact Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7967 or Ada D. Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Miles P. Jennings, Esq.
2021-04-15 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP 140 Scott Drive Menlo Park, California 94025 Tel: +1.650.328.4600 Fax: +1.650.463.2600 www.lw.com FIRM / AFFILIATE OFFICES April 15, 2021 Beijing Boston Brussels Century City Chicago Dubai Düsseldorf Frankfurt Hamburg Hong Kong Houston London Los Angeles Madrid Milan Moscow Munich New York Orange County Paris Riyadh San Diego San Francisco Seoul Shanghai Silicon Valley Singapore Tokyo Washington, D.C. VIA EDGAR AND HAND DELIVERY United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Dillon Hagius and Ada D. Sarmento Re: Biomea Fusion, Inc. Registration Statement on Form S-1 Publicly filed on March 26, 2021 File No. 333-254793 Ladies and Gentlemen: On behalf of Biomea Fusion, Inc. (the “Company” or “Biomea”), we are hereby filing Amendment No. 2 (“Amendment No. 2”) to the Registration Statement on Form S-1 (“Registration Statement”). The Company previously filed a Registration Statement on Form S-1 on March 26, 2021 and Amendment No. 1 to the Registration Statement on April 12, 2021, in each case, with the U.S. Securities and Exchange Commission (the “Commission”). Amendment No. 2 has been revised to reflect the Company’s responses to the comment letter received on April 15, 2021 from the staff of the Commission (the “Staff”). For ease of review, we have set forth below each of the numbered comments of your letter in bold type followed by the Company’s responses thereto. April 15, 2021 Page 2 Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. We note that you have revised this section to include an additional table depicting your active discovery programs in response to prior comment 1. Please remove this additional table from the Prospectus Summary. We will not object to a narrative description in the Prospectus Summary that summarizes this table. Response: The Company acknowledges the Staff’s comment and advises the SEC that it has revised pages 2, 109 and 115 of Amendment No. 2 accordingly. * * * April 15, 2021 Page 3 We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (415) 395-8198 or by fax at (650) 463-2600 with any questions or comments regarding this correspondence. Very truly yours, /s/ Miles P. Jennings Miles P. Jennings of LATHAM & WATKINS LLP cc: Thomas Butler, Biomea Fusion, Inc. Rainer (Ramses) Erdtmann, Biomea Fusion, Inc. Brian Cuneo, Latham & Watkins LLP Charles Kim, Cooley LLP Jonie Kondracki, Cooley LLP
2021-04-13 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP Biomea Fusion, Inc. 726 Main Street Redwood City, California 94063 April 13, 2021 VIA EDGAR AND E-MAIL United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Ada D. Sarmento and Dillon Hagius Re: Biomea Fusion, Inc. Registration Statement on Form S-1 (Registration No. 333-254793) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (File No. 333-254793) (the “Registration Statement”) of Biomea Fusion, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on April 15, 2021, or as soon as practicable thereafter, or at such other time thereafter as our counsel, Latham & Watkins LLP may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Miles Jennings at (415) 395-8198. Thank you for your assistance in this matter. Very truly yours, BIOMEA FUSION, INC. By: /s/ Thomas Butler Thomas Butler Chief Executive Officer CC: Rainer (Ramses) Erdtmann, Biomea Fusion, Inc. Brian Cuneo, Latham & Watkins LLP Charles Kim, Cooley LLP Jonie Kondracki, Cooley LLP
2021-04-13 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP April 13, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Dillon Hagius Ada D. Sarmento Eric Atallah Daniel Gordon Re: Biomea Fusion, Inc. Registration Statement on Form S-1 (File No. 333-254793) 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 April 12, 2021 and the date hereof, approximately 290 copies of the Preliminary Prospectus dated April 12, 2021 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. 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 Thursday, April 15, 2021 or as soon thereafter as practicable. [Signature page follows] Very truly yours, J.P. MORGAN SECURITIES LLC JEFFERIES LLC PIPER SANDLER & CO. As representatives of the Underwriters By: J.P. Morgan Securities LLC By: /s/ Benjamin Burdett Name: Benjamin Burdett Title: Managing Director By: Jefferies LLC By: /s/ Matt Kim Name: Matt Kim Title: Managing Director By: Piper Sandler & Co. By: /s/ Chad E. Huber Name: Chad E. Huber Title: Managing Director
2021-04-12 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP 140 Scott Drive Menlo Park, California 94025 Tel: +1.650.328.4600 Fax: +1.650.463.2600 www.lw.com FIRM / AFFILIATE OFFICES April 12, 2021 Beijing Boston Brussels Century City Chicago Dubai Düsseldorf Frankfurt Hamburg Hong Kong Houston London Los Angeles Madrid Milan Moscow Munich New York Orange County Paris Riyadh San Diego San Francisco Seoul Shanghai Silicon Valley Singapore Tokyo Washington, D.C. VIA EDGAR AND HAND DELIVERY File No. 377-04224 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Dillon Hagius and Ada D. Sarmento Re: Biomea Fusion, Inc. Registration Statement on Form S-1 Publicly filed on March 26, 2021 File No. 333-254793 Ladies and Gentlemen: On behalf of Biomea Fusion, Inc. (the “Company” or “Biomea”), we are hereby filing Amendment No. 1 (“Amendment No. 1”) to the Registration Statement on Form S-1 (“Registration Statement”). The Company previously filed a Registration Statement on Form S-1 on March 26, 2021 to the U.S. Securities and Exchange Commission (the “Commission”). Amendment No. 1 has been revised to reflect the Company’s responses to the comment letter received on April 2, 2021 from the staff of the Commission (the “Staff”). For ease of review, we have set forth below each of the numbered comments of your letter in bold type followed by the Company’s responses thereto. April 12, 2021 Page 2 Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. We note your response to prior comment 2 regarding the two programs in your pipeline table on page 2 with undisclosed targets which appear to be in the discovery phase. Since your filing contains minimal discussion of these two programs, it appears that these programs are not sufficiently material to your operations to warrant inclusion in the pipeline table. Please remove these two programs. We also believe that Optimization should be depicted under the Discovery column. A textual discussion of the program is a more appropriate place to make distinctions regarding different segments within a particular phase. Please revise accordingly. Response: The Company acknowledges the Staff’s comment and advises the SEC that it has revised pages 2, 107 and 114 of Amendment No. 1 accordingly. * * * April 12, 2021 Page 3 We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (415) 395-8198 or by fax at (650) 463-2600 with any questions or comments regarding this correspondence. Very truly yours, /s/ Miles P. Jennings Miles P. Jennings of LATHAM & WATKINS LLP cc: Thomas Butler, Biomea Fusion, Inc. Rainer (Ramses) Erdtmann, Biomea Fusion, Inc. Brian Cuneo, Latham & Watkins LLP Charles Kim, Cooley LLP Jonie Kondracki, Cooley LLP
2021-04-02 - UPLOAD - Biomea Fusion, Inc.
United States securities and exchange commission logo
April 2, 2021
Thomas Butler
Chief Executive Officer
Biomea Fusion, Inc.
726 Main Street
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Registration Statement on Form S-1
Filed March 26, 2021
File No. 333-254793
Dear Mr. Butler:
We have reviewed your registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your response to prior comment 2 regarding the two programs in your pipeline
table on page 2 with undisclosed targets which appear to be in the discovery phase.
Since your filing contains minimal discussion of these two programs, it appears that these
programs are not sufficiently material to your operations to warrant inclusion in the
pipeline table. Please remove these two programs. We also believe that Optimization
should be depicted under the Discovery column. A textual discussion of the program is a
more appropriate place to make distinctions regarding different segments within a
particular phase. Please revise accordingly.
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
FirstName LastNameThomas Butler
Comapany NameBiomea Fusion, Inc.
April 2, 2021 Page 2
FirstName LastName
Thomas Butler
Biomea Fusion, Inc.
April 2, 2021
Page 2
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7967 or Ada D. Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Miles P. Jennings, Esq.
2021-03-26 - CORRESP - Biomea Fusion, Inc.
CORRESP 1 filename1.htm CORRESP 140 Scott Drive Menlo Park, California 94025 Tel: +1.650.328.4600 Fax: +1.650.463.2600 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris Dubai Riyadh March 26, 2021 Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. Milan VIA EDGAR File No. 377-04224 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Ada D. Sarmento and Dillon Hagius Re: Biomea Fusion, Inc. Draft Registration Statement on Form S-1 Confidentially submitted on February 12, 2021 CIK No. 0001840439 Ladies and Gentlemen: On behalf of Biomea Fusion, Inc. (the “Company” or “Biomea”), we are hereby submitting a Draft Registration Statement on Form S-1 (“Registration Statement”). The Company previously submitted a Draft Registration Statement on Form S-1 on February 12, 2021 (the “Draft Submission”) to the U.S. Securities and Exchange Commission (the “Commission”) on a confidential basis pursuant to Title I, Section 106 under the Jumpstart Our Business Startups Act. The Registration Statement has been revised to reflect the Company’s responses to the comment letter to the Draft Submission received on March 12, 2021 from the staff of the Commission (the “Staff”). For ease of review, we have set forth below each of the numbered comments of your letter in bold type followed by the Company’s responses thereto. March 26, 2021 Page 2 Draft Registration Statement on Form S-1 submitted February 12, 2021 Prospectus Summary Overview, page 1 1. Please remove your statement that you believe that your capabilities and platform uniquely position you to be a leader in developing irreversible small molecules. Given the number of product candidates that never receive FDA approval, the time required to obtain approval and your current stage of development, this statement is not appropriate. Please remove any similar statements throughout the prospectus. Response: The Company acknowledges the Staff’s comment and advises the SEC that it has revised pages 1, 93 and 108 of the Registration Statement accordingly. 2. We note that you have included in your pipeline table two programs with undisclosed targets which appear to be in the discovery phase. Given the early-stage development of these programs, please explain why each program is sufficiently material to your business to warrant inclusion in your pipeline table. Please also explain what is involved in “Optimization” and why you believe this is a separate and distinct development phase, as opposed to part of IND-Enabling. Response: The Company respectfully advises the Staff that the Company believes the inclusion of the two programs with undisclosed targets to be appropriate given the early stage of the Company’s entire pipeline, with a lead development candidate for the first undisclosed program to be declared in 2022, shortly after the filing of an IND for the BMF-219 program in the second half of 2021. In addition, the Company anticipates using a material portion of the proceeds of the offering on the two programs with undisclosed candidates, and therefore believes their prominence to be appropriate and helpful for investors evaluating an investment decision. The Company further respectfully advises the Staff that it has distinguished between the “optimization” and “IND-enabling” stages of development because it expects to undertake efforts to improve the chemistry of its potential lead development candidates during the “optimization stage” and prior to selecting a lead candidate from each program for IND-enabling studies. The Company views this step as being particularly important for its programs given the complex scaffold creation process required to promote irreversible binding. Upon commencement of such IND-enabling studies such underlying chemistry would not be subject to further change. March 26, 2021 Page 3 Our FUSION System discovery platform, page 2 3. Please remove the reference to the transaction value for Pharmacyclics from this section. This is not appropriate disclosure for the Prospectus Summary where full and proper context is not provided. We note several references to the management team’s experience developing ibrutinib. Please balance this disclosure throughout the prospectus by noting that past experiences are no guarantee of future success. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has removed the references to the transaction value for Pharmacyclics from and has added balancing disclosure to pages 3 and 106 of the Registration Statement. Our Product Candidates, page 4 4. We note your statements throughout your filing that you believe BMF-219 is a potentially “first-in-class” irreversible menin inhibitor. These statements imply an expectation of regulatory approval and are inappropriate given the length of time and uncertainty with respect to securing marketing approval. Please remove the phrase “first-in-class” throughout your filing, including, but not limited to, on pages 107 and 108 in your Business section. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised pages 4, 107 and 108 of the Registration Statement to remove the phrase “first-in-class”. Our Strategy, page 4 5. We note your disclosure here and in the Business section that your strategy is to “rapidly advance” BMF-219 into and through clinical development and to evaluate opportunities to “accelerate” development timelines. Please revise this disclosure to remove any implication that you will be successful in commercializing your product candidates in a rapid or accelerated manner as such statements are speculative. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised pages 4 and 108 of the Registration Statement so as not to suggest that the Company will be successful in commercializing its product candidates in a rapid or accelerated manner. Risk Factors If we are unable to obtain, maintain, enforce and adequately protect our patents and other intellectual property rights, page 55 6. You state here that you rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to your technology and product candidates, but you later disclose on page 125 that you currently do not own or in-license any issued patents with respect to any of your product candidates, including BMF-219. Please revise this risk factor accordingly. March 26, 2021 Page 4 Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised page 55 of the Registration Statement to properly reflect that the Company relies on patent applications rather than issued patents. Our amended and restated certificate of incorporation and amended and restated bylaws will provide for an exclusive forum, page 73 7. Please revise this risk factor to disclose that there is also a risk that your exclusive forum provision may result in increased costs for investors to bring a claim. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised page 73 of the Registration Statement accordingly. Competition, page 123 8. Please disclose the basis for your belief that you are the only company with the ability to discover and develop irreversible binders specifically against menin. Please also revise your disclosure regarding the encouraging clinical benefit and strong pharmacologic validation of menin from preliminary Phase 1 results of other product candidates to avoid any suggestion that such product candidates have demonstrated safety or efficacy. Findings of safety and efficacy are solely within the authority of the FDA and are assessed throughout all clinical trial phases. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised page 123 of the Registration Statement to clarify the Company’s belief that it is the only Company currently developing irreversible binders specifically against menin rather than the only company with the ability to do so. Additionally, the Company respectfully acknowledges the Staff’s comment regarding the suggestion of encouraging clinical benefit and pharmacological validation of menin from other product candidates and advises the Staff that it has revised page 123 of the Registration Statement to remove any suggestion that such product candidates have demonstrated safety or efficacy. Intellectual Property, page 124 9. Please revise to disclose the specific product candidates or technologies to which the patent applications relate and the type of patent protection you are trying to obtain (composition of matter, use or process). Please also briefly explain what an ex-U.S. patent application is. If that is meant to refer to a foreign patent application, please identify the jurisdiction. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised page 125 of the Registration Statement accordingly. March 26, 2021 Page 5 Principal Stockholders, page 157 10. Please revise to disclose how the entities listed in footnote 4 are affiliated with the Tavistock Group. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised page 157 of the Registration Statement accordingly. General 11. Please supplementally 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. Response: The Company acknowledges the SEC’s comment and advises the SEC that it will supplementally provide the SEC with copies of all written communications, as defined in Rule 405 under the Securities Act, that the Company, or anyone authorized to do so on the Company’s behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. * * * March 26, 2021 Page 6 We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (415) 395-8198 or by fax at (650) 463-2600 with any questions or comments regarding this correspondence. Very truly yours, /s/ Miles P. Jennings Miles P. Jennings of LATHAM & WATKINS LLP cc: Thomas Butler, Biomea Fusion, Inc. Rainer (Ramses) Erdtmann, Biomea Fusion, Inc. Brian Cuneo, Latham & Watkins LLP Charles Kim, Cooley LLP Jonie Kondracki, Cooley LLP
2021-03-12 - UPLOAD - Biomea Fusion, Inc.
United States securities and exchange commission logo
March 12, 2021
Thomas Butler
Chief Executive Officer
Biomea Fusion, Inc.
726 Main Street
Redwood City, CA 94063
Re:Biomea Fusion, Inc.
Draft Registration Statement on Form S-1
Submitted February 12, 2021
CIK No. 0001840439
Dear Mr. Butler:
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
Prospectus Summary
Overview, page 1
1.Please remove your statement that you believe that your capabilities and platform
uniquely position you to be a leader in developing irreversible small molecules. Given the
number of product candidates that never receive FDA approval, the time required to
obtain approval and your current stage of development, this statement is not appropriate.
Please remove any similar statements throughout the prospectus.
2.We note that you have included in your pipeline table two programs with undisclosed
targets which appear to be in the discovery phase. Given the early-stage development of
FirstName LastNameThomas Butler
Comapany NameBiomea Fusion, Inc.
March 12, 2021 Page 2
FirstName LastNameThomas Butler
Biomea Fusion, Inc.
March 12, 2021
Page 2
these programs, please explain why each program is sufficiently material to your business
to warrant inclusion in your pipeline table. Please also explain what is involved in
"Optimization" and why you believe this is a separate and distinct development phase, as
opposed to part of IND-Enabling.
Our FUSION System discovery platform, page 2
3.Please remove the reference to the transaction value for Pharmacyclics from this section.
This is not appropriate disclosure for the Prospectus Summary where full and proper
context is not provided. We note several references to the management team's experience
developing ibrutinib. Please balance this disclosure throughout the prospectus by noting
that past experiences are no guarantee of future success.
Our Product Candidates, page 4
4.We note your statements throughout your filing that you believe BMF-219 is a potentially
"first-in-class" irreversible menin inhibitor. These statements imply an expectation of
regulatory approval and are inappropriate given the length of time and uncertainty with
respect to securing marketing approval. Please remove the phrase "first-in-
class" throughout your filing, including, but not limited to, on pages 107 and 108 in your
Business section.
Our Strategy, page 4
5.We note your disclosure here and in the Business section that your strategy is to "rapidly
advance" BMF-219 into and through clinical development and to evaluate opportunities to
"accelerate" development timelines. Please revise this disclosure to remove any
implication that you will be successful in commercializing your product candidates in a
rapid or accelerated manner as such statements are speculative.
Risk Factors
If we are unable to obtain, maintain, enforce and adequately protect our patents and other
intellectual property rights, page 55
6.You state here that you rely upon a combination of patents, trade secret protection and
confidentiality agreements to protect the intellectual property related to your technology
and product candidates, but you later disclose on page 125 that you currently do not own
or in-license any issued patents with respect to any of your product candidates, including
BMF-219. Please revise this risk factor accordingly.
Our amended and restated certificate of incorporation and amended and restated bylaws will
provide for an exclusive forum, page 73
7.Please revise this risk factor to disclose that there is also a risk that your exclusive forum
provision may result in increased costs for investors to bring a claim.
FirstName LastNameThomas Butler
Comapany NameBiomea Fusion, Inc.
March 12, 2021 Page 3
FirstName LastName
Thomas Butler
Biomea Fusion, Inc.
March 12, 2021
Page 3
Competition, page 123
8.Please disclose the basis for your belief that you are the only company with the ability to
discover and develop irreversible binders specifically against menin. Please also revise
your disclosure regarding the encouraging clinical benefit and strong pharmacologic
validation of menin from preliminary Phase 1 results of other product candidates to avoid
any suggestion that such product candidates have demonstrated safety or efficacy.
Findings of safety and efficacy are solely within the authority of the FDA and are assessed
throughout all clinical trial phases.
Intellectual Property, page 124
9.Please revise to disclose the specific product candidates or technologies to which the
patent applications relate and the type of patent protection you are trying to obtain
(composition of matter, use or process). Please also briefly explain what an ex-U.S. patent
application is. If that is meant to refer to a foreign patent application, please identify the
jurisdiction.
Principal Stockholders, page 157
10.Please revise to disclose how the entities listed in footnote 4 are affiliated with the
Tavistock Group.
General
11.Please supplementally 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 Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7976 or Ada D. Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Miles P. Jennings, Esq.