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4D Molecular Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
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4D Molecular Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-08-11
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2023-08-11
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4D Molecular Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-30
4D Molecular Therapeutics, Inc.
Filing - SEC Comment Letter to 4D Molecular Therapeutics, Inc.
UPLOAD · 2022-08-30
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Company responded
2022-09-01
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2022-09-01
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4D Molecular Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-04
4D Molecular Therapeutics, Inc.
Filing - SEC Comment Letter to 4D Molecular Therapeutics, Inc.
UPLOAD · 2022-04-04
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Company responded
2022-04-13
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2022-04-13
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4D Molecular Therapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2021-10-13
4D Molecular Therapeutics, Inc.
Filing - SEC Comment Letter to 4D Molecular Therapeutics, Inc.
UPLOAD · 2021-10-13
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Company responded
2021-10-26
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2021-10-26
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Company responded
2021-10-26
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2021-10-26
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4D Molecular Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-12-11
4D Molecular Therapeutics, Inc.
Filing - SEC Comment Letter to 4D Molecular Therapeutics, Inc.
UPLOAD · 2020-12-11
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4D Molecular Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2020-12-04
4D Molecular Therapeutics, Inc.
Filing - SEC Comment Letter to 4D Molecular Therapeutics, Inc.
UPLOAD · 2020-12-04
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Company responded
2020-12-07
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2020-12-07
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Company responded
2020-12-08
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2020-12-08
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Company responded
2020-12-08
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2020-12-08
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4D Molecular Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2020-11-17
4D Molecular Therapeutics, Inc.
Filing - Correspondence from 4D Molecular Therapeutics, Inc.
CORRESP · 2020-11-17
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-11 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-05-08 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | 333-295650 | Read Filing View |
| 2023-08-11 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-08-11 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-09-01 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-13 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-04 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-26 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-26 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-11 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-07 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-04 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-17 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-08 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | 333-295650 | Read Filing View |
| 2023-08-11 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-04 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-13 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-11 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-04 | SEC Comment Letter | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-11 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-08-11 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-09-01 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-13 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-26 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-10-26 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-08 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-07 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-17 | Company Response | 4D Molecular Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-05-11 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 4D Molecular Therapeutics, Inc. 5858 Horton Street, #455 Emeryville, California 94608 May 11, 2026 VIA EDGAR 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: Lauren Hamill Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-3 (Registration No. 333-295650) To the addressee set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-295650) (the “ Registration Statement ”) of 4D Molecular Therapeutics, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on May 13, 2026, 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 Mark Roeder at (650) 463-3043 or John Williams at (415) 395-8223. Thank you for your assistance in this matter. Very truly yours, 4D M OLECULAR T HERAPEUTICS , I NC . By: /s/ Kristian Humer Kristian Humer Chief Financial Officer cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. Scott Bizily, J.D., Ph.D., 4D Molecular Therapeutics, Inc. Mark V. Roeder, Latham & Watkins LLP John C. Williams, Latham & Watkins LLP
2026-05-08 - UPLOAD - 4D Molecular Therapeutics, Inc. File: 333-295650
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 8, 2026 David Kirn Chief Executive Officer 4D Molecular Therapeutics, Inc. 5858 Horton Street #455 Emeryville, CA 94608 Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-3 Filed May 7, 2026 File No. 333-295650 Dear David Kirn: 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: John Williams </TEXT> </DOCUMENT>
2023-08-11 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
August 11, 2023
David Kirn, M.D.
Chief Executive Officer
4D Molecular Therapeutics, Inc.
5858 Horton Street #455
Emeryville, CA 94608
Re:4D Molecular Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 9, 2023
File No. 333-273845
Dear David Kirn:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip S. Stoup
2023-08-11 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 4D Molecular Therapeutics, Inc. 5858 Horton Street, #455 Emeryville, California 94608 August 11, 2023 VIA EDGAR 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: Jason Drory Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-3 (Registration No. 333-273845) To the addressee set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-273845) (the “Registration Statement”) of 4D Molecular Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on August 15, 2023, 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 Mark Roeder at (650) 463-3043 or Phillip Stoup at (415) 395-8216. Thank you for your assistance in this matter. Very truly yours, 4D MOLECULAR THERAPEUTICS, INC. By: /s/ August Moretti August Moretti Chief Financial Officer cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. Scott Bizily, J.D., Ph.D., 4D Molecular Therapeutics, Inc. Mark V. Roeder, Latham & Watkins LLP Phillip S. Stoup, Latham & Watkins LLP
2022-09-01 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
4D Molecular Therapeutics, Inc.
5858 Horton Street, #455
Emeryville, California 94608
September 1,
2022
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:
Dillon Hagius
Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-3 (Registration No. 333-267013)
To the addressee set forth above:
In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the
Registration Statement on Form S-3 (Registration No. 333-267013) (the “Registration Statement”) of 4D Molecular Therapeutics, Inc. (the
“Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on September 6, 2022, 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 Mark Roeder at (650) 463-3043 or Phillip Stoup at (415) 395-8216.
Thank you for your
assistance in this matter.
Very truly yours,
4D MOLECULAR THERAPEUTICS, INC.
By:
/s/ August Moretti
August Moretti
Chief Financial Officer
cc:
David Kirn, M.D., 4D Molecular Therapeutics, Inc.
Scott Bizily, J.D., Ph.D., 4D Molecular Therapeutics, Inc.
Mark V. Roeder, Latham & Watkins LLP
Phillip S. Stoup, Latham & Watkins LLP
2022-08-30 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
August 30, 2022
David Kirn, M.D.
Chief Executive Officer
4D Molecular Therapeutics, Inc.
5858 Horton Street #455
Emeryville, California 94608
Re:4D Molecular Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 23, 2022
File No. 333-267013
Dear Dr. Kirn:
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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Mark V. Roeder
2022-04-13 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 4D Molecular Therapeutics, Inc. 5858 Horton Street, #455 Emeryville, California 94608 April 13, 2022 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: Alan Campbell Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-3 (Registration No. 333-263925) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-263925) (the “Registration Statement”) of 4D Molecular Therapeutics, 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, 2022, 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 Mark Roeder at (650) 463-3043 or Phillip Stoup at (415) 395-8216. Thank you for your assistance in this matter. Very truly yours, 4D MOLECULAR THERAPEUTICS, INC. By: /s/ August Moretti August Moretti Chief Financial Officer cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. Scott Bizily, J.D., Ph.D., 4D Molecular Therapeutics, Inc. Mark V. Roeder, Latham & Watkins LLP Phillip S. Stoup, Latham & Watkins LLP
2022-04-04 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
April 4, 2022
David Kirn, M.D.
Chief Executive Officer
4D Molecular Therapeutics, Inc.
5858 Horton Street #455
Emeryville, California 94608
Re:4D Molecular Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 29, 2022
File No. 333-263925
Dear Dr. Kirn:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Mark V. Roeder, Esq.
2021-10-26 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP October 26, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Michael Davis Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-260508) 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 as of the time of this filing, the underwriters have not yet made any distribution of the Preliminary Prospectus of 4D Molecular Therapeutics, Inc. (the “Registrant”) dated October 26, 2021. 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 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 of 1933, 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 Thursday, October 28, 2021 or as soon thereafter as practicable. [signature page follows] Very truly yours, GOLDMAN SACHS & CO. LLC SVB LEERINK LLC EVERCORE GROUP L.L.C. As representatives of the Underwriters GOLDMAN SACHS & CO. LLC By: /s/ Elizabeth Wood Name: Elizabeth Wood Title: Managing Director SVB LEERINK LLC By: /s/ Anurag Jindal, M.D. Name: Anurag Jindal, M.D. Title: Senior Managing Director EVERCORE GROUP L.L.C. By: /s/ Maren Winnick Name: Maren Winnick Title: Senior Managing Director [Signature Page to Acceleration Request Letter]
2021-10-26 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 4D Molecular Therapeutics, Inc. 5858 Horton Street, #455 Emeryville, California 94608 October 26, 2021 VIA EDGAR 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: Michael Davis Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-1 (Registration No. 333-260508) 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 (Registration No. 333-260508) (the “Registration Statement”) of 4D Molecular Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on October 28, 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 Mark Roeder at (650) 463-3043 or Phillip Stoup at (415) 395-8216. Thank you for your assistance in this matter. Very truly yours, 4D MOLECULAR THERAPEUTICS, INC. By: /s/ August Moretti August Moretti Chief Financial Officer cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. Mark Roeder, Latham & Watkins LLP Phillip Stoup, Latham & Watkins LLP David Peinsipp, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP
2021-10-13 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
October 13, 2021
David Kirn, M.D.
Chief Executive Officer
4D Molecular Therapeutics, Inc.
5858 Horton Street #455
Emeryville, California 94608
Re:4D Molecular Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted October 8, 2021
CIK No. 0001650648
Dear Dr. Kirn:
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 Michael Davis at 202-551-4385 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Mark V. Roeder, Esq.
2020-12-11 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
November 10, 2020
David Kirn
Chief Executive Officer
4D Molecular Therapeutics Inc.
5858 Horton Street #455
Emeryville, CA 94608
Re:4D Molecular Therapeutics Inc.
Draft Registration Statement on Form S-1
Submitted October 14, 2020
CIK No. 0001650648
Dear Dr. Kirn:
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 balance the disclosure in the summary with disclosure that your product candidates
are based on a novel AAV gene therapy technology with which there is limited regulatory
and clinical experience and that few gene therapy products have been approved by the
FDA or comparable foreign regulatory agencies Therefore, it is difficult to predict how
long it will take to development your product candidates and obtaining regulatory
approval. Also disclose in the summary that the regulatory approval process for novel
product candidatescan be more expensive and take longer than for other, better known or
extensively studied therapeutic modalities. Finally, revise your disclosure on page 5 and
FirstName LastNameDavid Kirn
Comapany Name4D Molecular Therapeutics Inc.
November 10, 2020 Page 2
FirstName LastNameDavid Kirn
4D Molecular Therapeutics Inc.
November 10, 2020
Page 2
page 117 that you will "apply [y]our modular product design and engineering approach to
accelerate the pace of product development" to remove any implication that you will be
able to accelerate the development of your product candidates as such statements are
speculative.
2.Please delete the statements that an evolved vector increases the likelihood of success and
could accelerate the pace of product development and that your competitive advantages
and experience uniquely position you to successfully create, develop and manufacture
targeted gene therapies. Given the number of product candidates that never receive FDA
approval, the time required to obtain approval and the number of companies currently
developing product candidates, your statements that you are in a unique position, have an
increased likelihood of success and can develop products more quickly is not appropriate.
Our Therapeutic Vector Evolution Platform, page 2
3.Please substantiate your statement that you have developed an "industry-leading"
collection of synthetic capsid sequences.
4.Please revise your disclosure here and in the Business section to provide appropriate
context for various conclusions and predictions as to the performance of your product
candidates and revise and/or remove any statements that imply safety or efficacy as safety
and efficacy are determinations that are solely within the authority of the FDA or similar
foreign regulators. For example, we note statements that your vectors "achieved enhanced
delivery, increased transgene expression, reduced immunogenicity and/or improved
antibody resistance when compared to conventional AAV vectors," that you expect to
demonstrate improved safety and efficacy of your product candidates versus conventional
AAV vectors and various other claims regarding the superiority of your product
candidates to those using conventional AAV vectors, including certain statements in the
sections regarding competition and differentiation of your various product
candidates. Please revise your disclosure to remove any suggestion that there is an
expectation that your product candidates will be safe and effective or will have improved
safety and efficacy over conventional AAV vectors and instead refer to the relevant
objective data from your preclinical trials or studies that relate to your product candidate's
performance.
5.We note your disclosure here and in the Business section regarding preclinical head-to-
head comparisons between your targeted and evolved vectors with relevant conventional
AAV vectors. If you have not conducted actual head-to-head trials, please revise your
disclosure to clearly state this fact and disclose why you believe these comparisons
are appropriate. If you provide disclosure regarding results from other trials, expand your
disclosure to provide the other information regarding these trials that would help an
investor make a meaningful comparison (e.g, number of subjects, dosage, how the
baseline was measured in each study, etc.).
Our Product Candidate Pipeline, page 3
FirstName LastNameDavid Kirn
Comapany Name4D Molecular Therapeutics Inc.
November 10, 2020 Page 3
FirstName LastNameDavid Kirn
4D Molecular Therapeutics Inc.
November 10, 2020
Page 3
6.We note your disclosure on page 166 that planning is underway for an IND-enabling GLP
toxicology and biodistribution study of 4D-710 in NHP. Please revise the pipeline table to
shorten the line for 4D-710 and revise the anticipated milestone accordingly. We also note
that you have included in your pipeline table 4D-710, 4D-135, 4D-3XX and 4D-7XX, all
of 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.
7.Please explain what is involved in "lead-optimization" and why you believe this is a
separate and distinct development phase, as opposed to part of vector discovery and/or
IND-Enabling studies.
Implications of Being an Emerging Growth Company, page 7
8.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.
Risk Factors
Our success depends on our ability to protect our intellectual property and our proprietary
technologies, page 51
9.Please revise this risk factor to disclose the patent rights or technologies subject to march-
in rights.
Use of Proceeds, page 86
10.Please revise to clarify whether you expect that you will able to complete the IND-
enabling studies for 4D-150 and 4D-710 and the Phase 1/2 clinical trial for 4D-125 using
the proceeds from this offering.
Business
Our Proprietary Therapeutic Vector Evolution Platform, page 140
11.Please substantiate your statement that you have the "largest and most diverse portfolio of
targeted and evolved vectors in the field of gene therapy."
Competition and Differentiation: AAV Gene Therapy for wet AMD and Diabetic Retinopathy,
page 150
12.We note your disclosure that, to your knowledge, 4D-150 would be the only AAV gene
therapy asset in wet AMD and DR that has shown superior transduction on human retinal
cells ex vivo versus conventional AAV vectors such as AAV2 and is the first gene therapy
product candidate for the eye to directly inhibit three different angiogenic growth factor
targets, including VEGF and PlGF. Please revise these statements to eliminate any
FirstName LastNameDavid Kirn
Comapany Name4D Molecular Therapeutics Inc.
November 10, 2020 Page 4
FirstName LastName
David Kirn
4D Molecular Therapeutics Inc.
November 10, 2020
Page 4
implication that 4D-150 is effective and to provide the data that support these claims.
Strategic Collaborations, page 172
13.Please provide the current expiration date for the last-to-expire licensed patent right under
the Roche Agreement, the uniQure agreements and the UC Agreements.
You may contact Jenn Do at 202-551-3743 or Jeanne Baker at 202-551-3691 if you have
questions regarding comments on the financial statements and related matters. Please contact
Ada Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-12-08 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP December 8, 2020 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Ada Sarmento Suzanne Hayes Jenn Do Jeanne Baker Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-250150) 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 December 7, 2020 and the date hereof, approximately 2,457 copies of the Preliminary Prospectus, dated December 7, 2020, 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, December 10, 2020 or as soon thereafter as practicable. [signature page follows] Very truly yours, GOLDMAN SACHS & CO. LLC BOFA SECURITIES, INC. EVERCORE GROUP L.L.C. As representatives of the Underwriters GOLDMAN SACHS & CO. LLC By: /s/ Elizabeth Wood Name: Elizabeth Wood Title: Managing Director BOFA SECURITIES, INC. By: /s/ Michele A.H. Allong Name: Michele A.H. Allong Title: Authorized Signatory EVERCORE GROUP L.L.C. By: /s/ Maren Winnick Name: Maren Winnick Title: Senior Managing Director [Signature Page to Acceleration Request Letter]
2020-12-08 - CORRESP - 4D Molecular Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 4D Molecular Therapeutics, Inc. 5858 Horton Street, #455 Emeryville, California 94608 December 8, 2020 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 Sarmento Suzanne Hayes Jenn Do Jeanne Baker Re: 4D Molecular Therapeutics, Inc. Registration Statement on Form S-1 (Registration No. 333-250150) 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 (Registration No. 333-250150) (the “Registration Statement”) of 4D Molecular Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on December 10, 2020, 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 Benjamin Potter at (650) 470-4809 or Phillip Stoup at (415) 391-0600. Thank you for your assistance in this matter. Very truly yours, 4D MOLECULAR THERAPEUTICS, INC. By: /s/ August Moretti August Moretti Chief Financial Officer cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. Alan C. Mendelson, Latham & Watkins LLP Benjamin A. Potter, Latham & Watkins LLP Phillip Stoup, Latham & Watkins LLP David Peinsipp, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP
2020-12-07 - CORRESP - 4D Molecular Therapeutics, 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
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December 7, 2020
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VIA EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention: Ada Sarmento
Suzanne Hayes
Jenn Do
Jeanne Baker
Re:
4D Molecular Therapeutics, Inc.
Registration Statement on Form
S-1
Filed November 17, 2020
File No. 333-250150
Ladies and Gentlemen:
4D Molecular
Therapeutics, Inc. (the “Company”) has submitted to the U.S. Securities and Exchange Commission (the “Commission”) on the date hereof Amendment No. 1 to its Registration Statement on Form S-1 (the “Registration Statement”). The Company previously submitted to the Commission a Registration Statement on Form S-1 (File No. 333-250150) on November 17, 2020 (the “Prior Filing”). The Registration Statement has been revised to reflect the Company’s responses to the comment letter to the Prior
Filing received on December 3, 2020 from the staff of the Commission (the “Staff”), and we are hereby providing the Company’s responses to the Staff’s letter.
For ease of review, we have set forth below each of the numbered comments of the Staff’s letter in bold type followed by the
Company’s responses thereto.
December 7, 2020
Page
2
Prospectus Summary
Our Therapeutic Vector Evolution Platform, page 2
1.
We note your revisions in response to prior comment 4. Please revise your disclosure on pages 2 and 118
where you discuss your head-to-head comparisons with conventional AAV vectors to state, if true, that you have not conducted any clinical studies in patients comparing
your targeted and evolved vectors to conventional AAV vectors. Please also revise your disclosure on pages 2 and 118 that you “expect” to demonstrate the superior capabilities of your targeted and evolved vectors and product
candidates as you advance through clinical trials to remove the expectation regarding how your vectors and product candidates will perform in clinical trials as such statements are speculative.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages
2 and 118 of the Registration Statement and throughout the Registration Statement where applicable.
Our Product Candidate Pipeline, page 3
2.
We note the added table depicting your most advanced discovery and research programs. Additionally, we note
that your filing does not include a discussion of 4D-3XX or 4D-7XX, which implies that these programs are not sufficiently material to your operations to warrant
discussion. Please delete the references to these programs from your summary.
Response: The Company respectfully acknowledges the Staff’s comment and has removed the references to these
programs on page 3 of the Registration Statement and throughout the Registration Statement where applicable.
3.
We note your response to comment 7 and believe TVP and Lead Optimization should be depicted together under a
column heading such as discovery or research and development. A textual discussion of the program is a more appropriate place to make the distinctions regarding different tasks within a particular phase.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages
3, 119, and 147 of the Registration Statement and throughout the Registration Statement where applicable.
Business
Competition and Differentiation: AAV Gene Therapy for wet AMD and Diabetic Retinopathy, page 155
4.
We note your response to prior comment 12. Please revise your statement that
4D-150 would be the only AAV gene therapy asset in wet AMD and DR that has shown
December 7, 2020
Page
3
superior transduction on human retinal cells ex vivo versus conventional AAV vectors such as AAV2 to clarify, if true, that your statement is based solely on in vitro studies you conducted
comparing R100 to AAV2 discussed on page 138.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 153 and 154 of the Registration Statement and throughout the Registration Statement where applicable.
Principal Stockholders, page 222
5.
Please revise your disclosure to identify the natural person or persons who have voting and investment
control of the shares held by the entities affiliated with BVF.
Response: The Company
respectfully acknowledges the Staff’s comment and has revised the disclosure on page 223 of the Registration Statement and throughout the Registration Statement where applicable.
10. Redeemable Convertible Preferred Stock
Funding Agreement with CFF (unaudited) page F-39
6.
We note the $10.0 million received from CFF is to “be used to advance the development program for 4D-710, the Company’s lead product in cystic fibrosis, or any other therapeutic approved by the Program Advisory Group (“PAG”) to alleviate pulmonary complications of cystic fibrosis”. With
reference to the specific terms of the Funding Agreement, please address the need to separately classify the $10.0 million as restricted cash. Refer to Rule 5-02.1 of Regulation S-X.
Response: The Company acknowledges the
Staff’s comment and respectfully notes that Rule 5-02.1 of Regulation S-X requires separate disclosure of cash or cash items “which are restricted as to
withdrawal or usage.” In response to the Staff’s comments, the Company notes that $10.0 million received from the Cystic Fibrosis Foundation (“CFF”) does not include any cash that is restricted as to withdrawal
or usage.
The terms of the Company’s funding agreement with CFF (the “CFF Agreement”) do not require the
Company to place the proceeds into a restricted bank account and do not impose any restrictions on the use of any bank account balances in order to comply with the use of proceeds provision of the CFF Agreement. Consequently, the funds the Company
received from CFF are not segregated and are not deposited in separate accounts. CFF is not a signatory to any of the Company’s accounts.
The Company further advises the Staff that it can, without any contractual limitations, withdraw and use such funds in any way as it deems
appropriate to satisfy any and all obligations of the Company. The CFF funds are comingled with all other funds of the Company and are completely fungible with the Company’s other funds. All funds from CFF are deposited in the Company’s
general bank accounts and are available to support its operations. There are no Company imposed limitations with respect to these funds.
December 7, 2020
Page
4
Rule 5-02 (1) of Regulation S-X requires that the provisions of any restrictions be described in a note to the financial statements, which the Company has included in Note 10 to the financial statements on page
F-40 of the Registration Statement. In addition, in response to the Staff’s comment, the Company has clarified that the funds are not restricted as to withdrawal or usage on pages 106, 178, and F-40 of the Registration Statement.
* * *
December 7, 2020
Page
5
We hope the foregoing answers are responsive to your comments. Please do not hesitate to
contact me by telephone at (415) 391-0600 or by fax at (650) 463-2600 with any questions or comments regarding this correspondence.
Very truly yours,
/s/ Phillip S. Stoup
Phillip S. Stoup, Esq.
of LATHAM & WATKINS LLP
cc:
David Kirn, M.D., 4D Molecular Therapeutics, Inc.
August J. Moretti, 4D Molecular Therapeutics, Inc.
Benjamin A. Potter, Esq., Latham & Watkins LLP
David Peinsipp, Esq., Cooley LLP
Charles S. Kim, Esq., Cooley LLP
Kristin VanderPas, Esq., Cooley LLP
2020-12-04 - UPLOAD - 4D Molecular Therapeutics, Inc.
United States securities and exchange commission logo
December 3, 2020
David Kirn
Chief Executive Officer
4D Molecular Therapeutics Inc.
5858 Horton Street #455
Emeryville, CA 94608
Re:4D Molecular Therapeutics Inc.
Registration Statement on Form S-1
Filed November 17, 2020
File No. 333-250150
Dear Dr. Kirn:
We have reviewed your 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.
Registration Statement on Form S-1
Prospectus Summary
Our Therapeutic Vector Evolution Platform, page 2
1.We note your revisions in response to prior comment 4. Please revise your disclosure on
pages 2 and 118 where you discuss your head-to-head comparisons with conventional
AAV vectors to state, if true, that you have not conducted any clinical studies in patients
comparing your targeted and evolved vectors to conventional AAV vectors. Please also
revise your disclosure on pages 2 and 118 that you "expect" to demonstrate the superior
capabilities of your targeted and evolved vectors and product candidates as you advance
through clinical trials to remove the expectation regarding how your vectors and product
candidates will perform in clinical trials as such statements are speculative.
FirstName LastNameDavid Kirn
Comapany Name4D Molecular Therapeutics Inc.
December 3, 2020 Page 2
FirstName LastNameDavid Kirn
4D Molecular Therapeutics Inc.
December 3, 2020
Page 2
Our Product Candidate Pipeline, page 3
2.We note the added table depicting your most advanced discovery and research programs.
Additionally, we note that your filing does not include a discussion of 4D-3XX or 4D-
7XX, which implies that these programs are not sufficiently material to your operations to
warrant discussion. Please delete the references to these programs from your summary.
3.We note your response to comment 7 and believe TVP and Lead Optimization should be
depicted together under a column heading such as discovery or research and
development. A textual discussion of the program is a more appropriate place to make the
distinctions regarding different tasks within a particular phase.
Business
Competition and Differentiation: AAV Gene Therapy for wet AMD and Diabetic Retinopathy,
page 155
4.We note your response to prior comment 12. Please revise your statement that 4D-150
would be the only AAV gene therapy asset in wet AMD and DR that has shown superior
transduction on human retinal cells ex vivo versus conventional AAV vectors such as
AAV2 to clarify, if true, that your statement is based solely on in vitro studies you
conducted comparing R100 to AAV2 discussed on page 138.
Principal Stockholders, page 222
5.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by the entities affiliated with BVF.
10. Redeemable Convertible Preferred Stock
Funding Agreement with CFF (unaudited), page F-39
6.We note the $10.0 million received from CFF is to "be used to advance the development
program for 4D-710, the Company’s lead product in cystic fibrosis, or any other
therapeutic approved by the Program Advisory Group (“PAG”) to alleviate pulmonary
complications of cystic fibrosis". With reference to the specific terms of the Funding
Agreement, please address the need to separately classify the $10.0 million as restricted
cash. Refer to Rule 5-02.1 of Regulation S-X.
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.
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 Jenn Do at 202-551-3743 or Jeanne Baker at 202-551-3691 if you have
FirstName LastNameDavid Kirn
Comapany Name4D Molecular Therapeutics Inc.
December 3, 2020 Page 3
FirstName LastName
David Kirn
4D Molecular Therapeutics Inc.
December 3, 2020
Page 3
questions regarding comments on the financial statements and related matters. Please contact
Ada Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-11-17 - CORRESP - 4D Molecular Therapeutics, 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 November 17, 2020 Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris Dubai Riyadh 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 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Ada Sarmento Suzanne Hayes Jenn Do Jeanne Baker Re: 4D Molecular Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted October 14, 2020 CIK No. 0001650648 Ladies and Gentlemen: 4D Molecular Therapeutics, Inc. (the “Company”) has submitted to the U.S. Securities and Exchange Commission (the “Commission”) on the date hereof a revised Registration Statement on Form S-1 (the “Registration Statement”). The Company previously submitted to the Commission on October 14, 2020 a draft Registration Statement on Form S-1 (the “Draft Submission”) 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 November 10, 2020 from the staff of the Commission (the “Staff”), and we are hereby providing the Company’s responses to the Staff’s letter. For ease of review, we have set forth below each of the numbered comments of the Staff’s letter in bold type followed by the Company’s responses thereto. November 17, 2020 Page 2 Prospectus Summary Overview, page 1 1. Please balance the disclosure in the summary with disclosure that your product candidates are based on a novel AAV gene therapy technology with which there is limited regulatory and clinical experience and that few gene therapy products have been approved by the FDA or comparable foreign regulatory agencies. Therefore, it is difficult to predict how long it will take to development your product candidates and obtaining regulatory approval. Also disclose in the summary that the regulatory approval process for novel product candidates can be more expensive and take longer than for other, better known or extensively studied therapeutic modalities. Finally, revise your disclosure on page 5 and page 117 that you will “apply [y]our modular product design and engineering approach to accelerate the pace of product development” to remove any implication that you will be able to accelerate the development of your product candidates as such statements are speculative. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 1, 2 and 6 of the Registration Statement and throughout the Registration Statement where applicable. 2. Please delete the statements that an evolved vector increases the likelihood of success and could accelerate the pace of product development and that your competitive advantages and experience uniquely position you to successfully create, develop and manufacture targeted gene therapies. Given the number of product candidates that never receive FDA approval, the time required to obtain approval and the number of companies currently developing product candidates, your statements that you are in a unique position, have an increased likelihood of success and can develop products more quickly is not appropriate. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 1, 6, 149, 158 and 166 of the Registration Statement and throughout the Registration Statement where applicable. Our Therapeutic Vector Evolution Platform, page 2 3. Please substantiate your statement that you have developed an “industry-leading” collection of synthetic capsid sequences. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 2 and 117 of the Registration Statement to remove this disclosure. 4. Please revise your disclosure here and in the Business section to provide appropriate context for various conclusions and predictions as to the performance of your product candidates and revise and/or remove any statements that imply safety or efficacy as November 17, 2020 Page 3 safety and efficacy are determinations that are solely within the authority of the FDA or similar foreign regulators. For example, we note statements that your vectors “achieved enhanced delivery, increased transgene expression, reduced immunogenicity and/or improved antibody resistance when compared to conventional AAV vectors,” that you expect to demonstrate improved safety and efficacy of your product candidates versus conventional AAV vectors and various other claims regarding the superiority of your product candidates to those using conventional AAV vectors, including certain statements in the sections regarding competition and differentiation of your various product candidates. Please revise your disclosure to remove any suggestion that there is an expectation that your product candidates will be safe and effective or will have improved safety and efficacy over conventional AAV vectors and instead refer to the relevant objective data from your preclinical trials or studies that relate to your product candidate’s performance. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 1, 2, 124, 126, 127, 138, 140 and 146 of the Registration Statement and throughout the Registration Statement where applicable. 5. We note your disclosure here and in the Business section regarding preclinical head-to- head comparisons between your targeted and evolved vectors with relevant conventional AAV vectors. If you have not conducted actual head-to-head trials, please revise your disclosure to clearly state this fact and disclose why you believe these comparisons are appropriate. If you provide disclosure regarding results from other trials, expand your disclosure to provide the other information regarding these trials that would help an investor make a meaningful comparison (e.g, number of subjects, dosage, how the baseline was measured in each study, etc.). Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 138, 139, 140 and 143 of the Registration Statement and throughout the Registration Statement where applicable. Our Product Candidate Pipeline, page 3 6. We note your disclosure on page 166 that planning is underway for an IND-enabling GLP toxicology and biodistribution study of 4D-710 in NHP. Please revise the pipeline table to shorten the line for 4D-710 and revise the anticipated milestone accordingly. We also note that you have included in your pipeline table 4D-710, 4D-135, 4D-3XX and 4D-7XX, all of 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. Response: The Company respectfully advises the Staff that it has updated the disclosure on pages 166 and 171 of the Registration Statement to reflect that 4D-710’s IND-enabling GLP toxicology and biodistribution studies are currently underway. November 17, 2020 Page 4 Accordingly, the Company respectfully informs the Staff that it does not believe the presentation of 4D-710 in its pipeline table (the “Pipeline Table”) needs to be modified. In response to the Staff’s comment regarding the inclusion of 4D-710 in the Pipeline Table, the Company believes that the inclusion of this product candidate is appropriate as the Company has engaged IND-enabling studies for it and anticipates initiating a Phase 1/2 clinical trial within the second half of 2021. Further, the Company believes it is material disclosure for an investor as part of the use of proceeds, as set forth on page 87 of the Registration Statement, is designated to be used to fund 4D-710’s ongoing IND-enabling study activities. In response to the Staff’s comment regarding the inclusion of 4D-135, 4D-3XX and 4D-7XX in the Pipeline Table, the Company respectfully informs the Staff that it has revised its disclosure on page 3 of the Registration Statement and throughout the Registration Statement where applicable to remove these programs (the “Discovery Programs”) from the Pipeline Table and, similar to several other recently public clinical-stage biopharmaceutical companies, has included in the Registration Statement a separate table summarizing the Company’s most advanced research and discovery programs (the “Discovery Program Table”). The Company believes that it is appropriate to include the Discovery Program Table separate from the Pipeline Table as part of the use of proceeds, as set forth on page 87 of the Registration Statement, is designated to be used to fund other research and development activities which includes the Discovery Programs, and the Discovery Programs are relevant to an investor’s understanding of the Company’s longer term strategy and approach, including the potential for, and types of, additional development programs that may result from the Company’s discovery efforts utilizing its Therapeutic Vector Evolution platform. Further, the inclusion of these Discovery Programs further illustrates for an investor how the Company intends to utilize the Therapeutic Vector Evolution platform’s modularity to develop other product candidates utilizing its current vectors. 7. Please explain what is involved in “lead-optimization” and why you believe this is a separate and distinct development phase, as opposed to part of vector discovery and/or IND-Enabling studies. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 3 of the Registration Statement and throughout the Registration Statement where applicable. Further, the Company respectfully informs the Staff that it views lead optimization as a distinct development phase, as compared to the Target Vector Profile (“TVP”) selection process and IND-enabling studies, because different research and development tasks are conducted during this phase. For example, as compared to TVP selection, where the Company utilizes its Therapeutic Vector Evolution platform to initially identify vectors from its libraries with the strongest match to the TVP that it will then advance through preclinical studies, in the lead optimization phase of clinical development the Company is engaging in in vivo and ex vivo studies to determine which of the identified vectors to advance through November 17, 2020 Page 5 the more extensive studies needed for a potential IND submission. Similarly, the IND-enabling studies phase of clinical development is different as the Company generally conducts studies in addition to the in vivo and in vitro studies done in the lead optimization phase, such as GLP toxicology studies, to prepare for a potential IND submission. Implications of Being an Emerging Growth Company, page 7 8. 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 respectfully acknowledges the Staff’s comment and undertakes that it will provide the Staff with any written materials that it or anyone authorized to do so on its behalf presents to potential investors in reliance on Section 5(d) of the Securities Act. Risk Factors Our success depends on our ability to protect our intellectual property and our proprietary technologies, page 51 9. Please revise this risk factor to disclose the patent rights or technologies subject to march-in rights. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 52 of the Registration Statement accordingly. Use of Proceeds, page 86 10. Please revise to clarify whether you expect that you will able to complete the IND- enabling studies for 4D-150 and 4D-710 and the Phase 1/2 clinical trial for 4D-125 using the proceeds from this offering. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 87 of the Registration Statement accordingly. Business Our Proprietary Therapeutic Vector Evolution Platform, page 140 11. Please substantiate your statement that you have the “largest and most diverse portfolio of targeted and evolved vectors in the field of gene therapy.” Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 145 of the Registration Statement to remove this disclosure. November 17, 2020 Page 6 Competition and Differentiation: AAV Gene Therapy for wet AMD and Diabetic Retinopathy, page 150 12. We note your disclosure that, to your knowledge, 4D-150 would be the only AAV gene therapy asset in wet AMD and DR that has shown superior transduction on human retinal cells ex vivo versus conventional AAV vectors such as AAV2 and is the first gene therapy product candidate for the eye to directly inhibit three different angiogenic growth factor targets, including VEGF and PlGF. Please revise these statements to eliminate any implication that 4D-150 is effective and to provide the data that support these claims. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 138 and 155 of the Registration Statement accordingly. Strategic Collaborations, page 172 13. Please provide the current expiration date for the last-to-expire licensed patent right under the Roche Agreement, the uniQure agreements and the UC Agreements. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 176, 177 and 179 of the Registration Statement accordingly. * * * November 17, 2020 Page 7 We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (650) 463- 4693 or by fax at (650) 463-2600 with any questions or comments regarding this correspondence. Very truly yours, /s/ Phillip S. Stoup Phillip S. Stoup, Esq. of LATHAM & WATKINS LLP cc: David Kirn, M.D., 4D Molecular Therapeutics, Inc. August J. Moretti, 4D Molecular Therapeutics, Inc. Benjamin A. Potter, Esq., Latham & Watkins LLP David Peinsipp, Esq., Cooley LLP Charles S. Kim, Esq., Cooley LLP Kristin VanderPas, Esq., Cooley LLP
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