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Tenaya Therapeutics, Inc.
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Tenaya Therapeutics, Inc.
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2025-09-04
Tenaya Therapeutics, Inc.
References: August 26, 2025
Tenaya Therapeutics, Inc.
Response Received
1 company response(s)
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Tenaya Therapeutics, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2022-08-12
Tenaya Therapeutics, Inc.
Summary
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2022-08-15
Tenaya Therapeutics, Inc.
Summary
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Tenaya Therapeutics, Inc.
Response Received
3 company response(s)
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SEC wrote to company
2021-07-15
Tenaya Therapeutics, Inc.
Summary
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2021-07-26
Tenaya Therapeutics, Inc.
References: July 15, 2021
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Company responded
2021-07-27
Tenaya Therapeutics, Inc.
Summary
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2021-07-27
Tenaya Therapeutics, Inc.
Summary
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Tenaya Therapeutics, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2021-06-24
Tenaya Therapeutics, Inc.
Summary
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2021-07-09
Tenaya Therapeutics, Inc.
References: June 24, 2021
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Tenaya Therapeutics, Inc.
Awaiting Response
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SEC wrote to company
2021-06-03
Tenaya Therapeutics, Inc.
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 001-40656 | Read Filing View |
| 2025-09-04 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-08-26 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 001-40656 | Read Filing View |
| 2025-03-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 333-286005 | Read Filing View |
| 2022-08-15 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-12 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-26 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-15 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-24 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-10 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 001-40656 | Read Filing View |
| 2025-08-26 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 001-40656 | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | 333-286005 | Read Filing View |
| 2022-08-12 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-15 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-24 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-04 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-03-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-15 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-27 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-26 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | Company Response | Tenaya Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-09-10 - UPLOAD - Tenaya Therapeutics, Inc. File: 001-40656
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 10, 2025 Faraz Ali Chief Executive Officer Tenaya Therapeutics, Inc. 171 Oyster Point Boulevard, Suite 500 South San Francisco, CA 94080 Re: Tenaya Therapeutics, Inc. Form 10-K for the Year Ended December 31, 2024 File No. 001-40656 Dear Faraz Ali: 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 cc: Jennifer Drimmer, J.D. </TEXT> </DOCUMENT>
2025-09-04 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Wilson Sonsini Goodrich & Rosati Professional Corporation 650 Page Mill Road Palo Alto, California 94304-1050 o: 650.493.9300 f: 866.974.7329 September 4, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Gary Newberry Kevin Vaughn Daniel Crawford Laura Crotty Re: Tenaya Therapeutics, Inc. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 10, 2025 File No. 001-40656 Ladies and Gentlemen: On behalf of our client, Tenaya Therapeutics, Inc. (the “ Company ”), we submit this letter in response to comments from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) contained in its letter dated August 26, 2025, regarding the above-referenced Annual Report on Form 10-K (File No. 001-40656) of the Company, filed on March 10, 2025. In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business Our Gene Therapy Programs TN-201: Gene Therapy for MYBPC3-associated HCM, page 7 1. We note your disclosures describing TN-201 as “potential first-in class and best-in-class” and describing trial results as “encouraging” with respect to interim safety and biopsy data. Please note that safety and efficacy determinations are the exclusive authority of the FDA or equivalent foreign regulator. In future filings, please refrain from providing such conclusory statements regarding safety and efficacy and replace such statements with a discussion of the objective data based on your trial observations, such as indicating that the product candidate was well tolerated, providing a descriptions of any serious adverse events with the number of instances each type of event was observed, and indicating how many times U.S. Securities and Exchange Commission September 4, 2025 Page 2 the trial endpoints were met or were not met. Similarly, refrain from describing TN-401 as a “potential best-in-class AAV-based gene therapy.” The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company will revise its disclosure to remove any description of its trial results as “encouraging” with respect to interim safety and biopsy data and to remove any reference to TN-201 and TN-401 potentially being “first-in-class” or “best-in-class”. Intellectual Property , page 18 2. Please revise future filings to disclose the specific jurisdictions for your issued and pending foreign patents for each patent family The Company acknowledges the Staff’s comment and respectfully advises the Staff that in future filings the Company will revise its intellectual property disclosure to include the foreign jurisdictions of its material issued and pending foreign patents for each patent family, in a manner that is consistent with the following (subject to completing the bracketed language below). “ Intellectual Property Our success depends in part on our ability to obtain and maintain intellectual property protection for our product candidates, technology, manufacturing processes and know-how, to operate without infringing, misappropriating or otherwise violating the intellectual property or other proprietary rights of others and to prevent others from infringing, misappropriating or otherwise violating our intellectual property or other proprietary rights. To protect our intellectual property rights, we primarily rely on patent and trade secret laws, confidentiality procedures, and agreements, including employee disclosure and invention assignment agreements. Our policy is to seek to protect our proprietary position by, among other methods, pursuing patent applications in the U.S., European Union (EU) and other select jurisdictions related to our proprietary technology, inventions, improvements and product candidates that are important to our business. Our patent portfolio is intended to cover our product candidates and components thereof, their methods of use and processes for their manufacture, medical devices and systems for their administration, our proprietary reagents and assays and any other inventions that are commercially important to our business. Each of our lead product candidates is covered by at least one or more issued U.S. patents, which are described below. We also have numerous pending patent applications, and will continue to file new patent applications, in the U.S., the EU and other select countries covering our lead product candidates, as well as our early-stage programs in preclinical development. Beyond these issued patents and pending patent applications, our owned and exclusively licensed patent portfolio also covers various aspects of our core capabilities, including our gene delivery expression cassettes and vectors, recombinant capsid proteins, gene editing technology, manufacturing processes and medical devices. TN-201 : With regard to TN-201, we own [number] issued U.S. patents covering a recombinant adeno-associated virus (rAAV) virion whose vector genome encodes MYBPC3 and methods of using the same for treating cardiomyopathy, [number] pending non-provisional U.S. patent applications, and [number] pending foreign patent applications. The pending foreign patent applications are in a number of jurisdictions, including [include preponderance of jurisdictions across primary geographic regions]. Any U.S. Securities and Exchange Commission September 4, 2025 Page 3 U.S. or foreign patents issued from the pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. The issued U.S. patents and pending U.S. non-provisional patent applications are directed to various aspects of TN-201, including MYBPC3 gene expression cassettes, rAAV vectors, rAAV viral genomes and methods of using such compositions for therapeutic indications. TN-301: With regard to TN-301, we own [number] issued U.S. patents, [number] pending non-provisional U.S. patent application and [number] issued foreign patents in [include jurisdictions in which foreign applications have been issued] and [number] pending foreign patent applications covering TN-301 and various analogs. The pending applications are in a number of jurisdictions, including [include preponderance of jurisdictions across primary geographic regions]. Any U.S. or foreign patents issued from these pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. We also own three patent families that cover methods of treatment of various diseases and disorders with TN-301 and its analogs, with [number] issued U.S. patent, [number] pending non-provisional U.S. patent applications, [number] pending PCT application and [number] foreign patent applications in multiple jurisdictions including [include preponderance of jurisdictions across primary geographic regions]. Any U.S. or foreign patents issued from the pending applications are expected to expire between [year] and [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. We also own [number] patent family that covers additional HDAC6i compounds, with [number] pending non-provisional U.S. patent application and [number] pending foreign patent applications in multiple jurisdictions including [include preponderance of jurisdictions across primary geographic regions]. Any U.S. or foreign patents issued from these pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account.. TN-401: With regard to TN-401, we own [number] issued U.S. patent, [number] pending U.S. non-provisional patent applications, [number] issued foreign patent in [include jurisdictions in which foreign applications have been issued], and [number] foreign patent applications. The pending foreign patent applications are in a number of jurisdictions, including [include preponderance of jurisdictions across primary geographic regions]. Any U.S. or foreign patents issued from the pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees and without taking potential patent term extensions or adjustments into account. These patent applications are related to proprietary PKP2 gene expression vectors and methods of use. We own [number] pending U.S. non-provisional patent application and [number] foreign patent applications in multiple jurisdictions, including [include preponderance of jurisdictions across primary geographic regions], related to PKP2 therapeutic treatment methods. Any U.S. or foreign patents issued from the pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. We own [number] pending U.S. non-provisional patent application and [number] foreign patent applications in multiple jurisdictions, including [include preponderance of jurisdictions across primary geographic regions], related to capsids for PKP2 therapy and methods of use. Any U.S. or foreign patents issued from the pending patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other U.S. Securities and Exchange Commission September 4, 2025 Page 4 governmental fees, and without taking potential patent term extensions or adjustments into account. We own [number] pending PCT patent application related to methods for modulating gene expression. Any U.S. or foreign patents issued from national stage filings of this PCT patent application are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. We own [number] issued U.S. patent and [number] pending non-provisional U.S. patent application related to methods for treating arrhythmogenic right ventricular cardiomyopathy. Any U.S. patent issued from the pending patent application is expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account. We own [number] pending U.S. provisional patent applications related to methods for measuring a response to PKP2 gene therapy. Patents claiming priority to these U.S. provisional patent applications are expected to expire in [year], assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and without taking potential patent term extensions or adjustments into account.” U.S. Securities and Exchange Commission September 4, 2025 Page 5 * * * * Please direct any questions with respect to this letter to me at (650) 849-3041 or jknapp@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Jennifer Knapp Jennifer Knapp cc: Faraz Ali, M.B.A., Tenaya Therapeutics, Inc. Jennifer Drimmer Rokovich, J.D., Tenaya Therapeutics, Inc. Emily A. Coskey, J.D., Wilson Sonsini Goodrich & Rosati, P.C.
2025-08-26 - UPLOAD - Tenaya Therapeutics, Inc. File: 001-40656
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 26, 2025 Faraz Ali Chief Executive Officer Tenaya Therapeutics, Inc. 171 Oyster Point Boulevard, Suite 500 South San Francisco, CA 94080 Re: Tenaya Therapeutics, Inc. Form 10-K for the Year Ended December 31, 2024 File No. 001-40656 Dear Faraz Ali: We have reviewed your filing and have the following comments. 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 the Year Ended December 31, 2024 Part I Item 1. Business Our Gene Therapy Programs TN-201: Gene Therapy for MYBPC3-associated HCM, page 7 1. We note your disclosures describing TN-201 as "potential first-in class and best-in- class" and describing trial results as "encouraging" with respect to interim safety and biopsy data. Please note that safety and efficacy determinations are the exclusive authority of the FDA or equivalent foreign regulator. In future filings, please refrain from providing such conclusory statements regarding safety and efficacy and replace such statements with a discussion of the objective data based on your trial observations, such as indicating that the product candidate was well tolerated, providing a descriptions of any serious adverse events with the number of instances each type of event was observed, and indicating how many times the trial endpoints were met or were not met. Similarly, refrain from describing TN-401 as a "potential best-in-class AAV-based gene therapy." August 26, 2025 Page 2 Intellectual Property , page 18 2. Please revise future filings to disclose the specific jurisdictions for your issued and pending foreign patents for each patent family. 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 Gary Newberry at 202-551-3761 or Kevin Vaughn at 202-551-3494 if you have questions regarding comments on the financial statements and related matters. Please contact Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Drimmer, J.D. </TEXT> </DOCUMENT>
2025-03-27 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP March 27, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549-3720 Attention: Joshua Gorsky Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-3 Filed March 21, 2025 File No. 333-286005 Acceleration Request Requested Date: March 31, 2025 Requested Time: 4:00 P.M. Eastern Time, or as soon thereafter as practicable Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tenaya Therapeutics, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-286005) (the “ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Jennifer Knapp at (650) 849-3041. Please direct any questions or comments regarding this acceleration request to Jennifer Knapp at (650) 849-3041. [Signature page follows] Securities and Exchange Commission March 27, 2025 Page 2 Sincerely, TENAYA THERAPEUTICS, INC. /s/ Faraz Ali, M.B.A. Faraz Ali, M.B.A. Chief Executive Officer cc: Jennifer Drimmer Rokovich, J.D., Tenaya Therapeutics, Inc. Jennifer Knapp, Wilson Sonsini Goodrich & Rosati, P.C. Emily A. Coskey, Wilson Sonsini Goodrich & Rosati, P.C.
2025-03-26 - UPLOAD - Tenaya Therapeutics, Inc. File: 333-286005
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Faraz Ali Chief Executive Officer Tenaya Therapeutics, Inc. 171 Oyster Point Boulevard, Suite 500 South San Francisco, CA 94080 Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-3 Filed March 21, 2025 File No. 333-286005 Dear Faraz Ali: 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 Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Knapp </TEXT> </DOCUMENT>
2022-08-15 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP August 15, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549-3720 Attention: Joshua Gorsky Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-3 Filed August 10, 2022 File No. 333-266741 Acceleration Request Requested Date: August 17, 2022 Requested Time: 4:00 P.M. Eastern Time, or as soon thereafter as practicable Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tenaya Therapeutics, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-266741) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Jennifer Knapp at (650) 849-3041. Please direct any questions or comments regarding this acceleration request to Jennifer Knapp at (650) 849-3041. [Signature page follows] Securities and Exchange Commission August 15, 2022 Page 2 Sincerely, TENAYA THERAPEUTICS, INC. /s/ Leone D. Patterson, M.B.A. Leone D. Patterson, M.B.A. Chief Financial and Business Officer cc: Jennifer Drimmer Rokovich, J.D., Tenaya Therapeutics, Inc. Jennifer Knapp, Wilson Sonsini Goodrich & Rosati, P.C.
2022-08-12 - UPLOAD - Tenaya Therapeutics, Inc.
United States securities and exchange commission logo
August 12, 2022
Faraz Ali, M.B.A.
Chief Executive Officer
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, 5th Floor
South San Francisco, California 94080
Re:Tenaya Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 10, 2022
File No. 333-266741
Dear Mr. Ali:
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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Emily A. Coskey
2021-07-27 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Morgan Stanley & Co. LLC 1585 Broadway New York, New York 10036 Cowen and Company, LLC 599 Lexington Avenue New York, New York 10022 Piper Sandler & Co. 800 Nicollet Mall, Suite 800 Minneapolis, MN 55402 July 27, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Tracey Houser Brian Cascio Tom Kluck Suzanne Hayes Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-257820) 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 (the “Act”), we, the representatives of the several underwriters (the “Representatives”), hereby join in the request of Tenaya Therapeutics, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended, so that it will be declared effective at 4:00 PM, Eastern Daylight Time, on Thursday, July 29, 2021 or as soon thereafter as practicable, or at such later time as the Company’s outside counsel, Wilson Sonsini Goodrich & Rosati, P.C., may orally request via telephone call that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as the Representatives, wish to advise you that there have been, or there will be, distributed to each underwriter or dealer who is reasonably anticipated to participate in the distribution of the securities as many copies of the preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as the Representatives, each confirm on behalf of ourselves and the other participating underwriters that we have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issuance. [Signature page immediately follows] Very truly yours, MORGAN STANLEY & CO. LLC COWEN AND COMPANY, LLC PIPER SANDLER & CO. As Representatives of the several underwriters By: MORGAN STANLEY & CO. LLC. By: /s/ Chris Rigoli Name: Chris Rigoli Title: Vice President By: COWEN AND COMPANY, LLC By: /s/ Jason Fenton Name: Jason Fenton Title: Managing Director By: PIPER SANDLER & CO. By: /s/ Chad Huber Name: Chad Huber Title: Managing Director [Signature Page to Underwriters’ Acceleration Request]
2021-07-27 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP July 27, 2021 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tracey Houser Brian Cascio Tom Kluck Suzanne Hayes Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-257820) Acceleration Request Requested Date: Thursday, July 29, 2021 Requested Time: 4:00 P.M. Eastern Daylight Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tenaya Therapeutics, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-257820) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Jennifer Knapp at (650) 849-3041. The Company understands that the Staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate to the offering of the securities covered by the Registration Statement. [Signature page follows] * * * * Sincerely, TENAYA THERAPEUTICS, INC. /s/ Faraz Ali Faraz Ali, M.B.A. Chief Executive Officer cc: Faraz Ali, M.B.A., Tenaya Therapeutics, Inc. Leone D. Patterson, M.B.A., Tenaya Therapeutics, Inc. Kenneth A. Clark, Wilson Sonsini Goodrich & Rosati, P.C. Jennifer Knapp, Wilson Sonsini Goodrich & Rosati, P.C. Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C. Alan F. Denenberg, Davis Polk & Wardwell LLP Stephen Salmon, Davis Polk & Wardwell LLP
2021-07-26 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP 650 Page Mill Road Palo Alto, CA 94304-1050 650.493.9300 650.493.6811 www.wsgr.com July 26, 2021 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tracey Houser Brian Cascio Tom Kluck Suzanne Hayes Re: Tenaya Therapeutics, Inc. Registration Statement on Form S-1 Filed July 9, 2021 File No. 333-257820 Ladies and Gentlemen: On behalf of our client, Tenaya Therapeutics, Inc. (“Tenaya” or the “Company”), we submit this letter in response to the comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated July 15, 2021, relating to the above referenced Registration Statement on Form S-1, filed on July 9, 2021 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and an amendment to the Registration Statement (the “Amended Registration Statement”). In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page references appearing in the headings and Staff comments below (which are references to the original Registration Statement), all page references herein correspond to the Amended Registration Statement. Form S-1 Prospectus Summary Our Pipeline, page 4 U.S. Securities and Exchange Commission July 26, 2021 Page 2 1. We note your response to comment 2 and your revised disclosure in the pipeline table. We reissue in part our prior comment. The table continues to include separate line items for “Next Generation Capsids” and “New Generation Target Identification Methods” that are all in the early stages of discovery. We further note that these programs are vague and do not appear to be discussed in detail in the prospectus, including the summary, business, use of proceeds or MD&A sections. Please limit your table to product candidates that are sufficiently material to your business to warrant inclusion in your table. If these general programs are material, identify the indications and expand your disclosure elsewhere to identify more specifically these programs or candidates. In response to the Staff’s comment, the Company has revised the pipeline table on pages 4 and 126 of the Amended Registration Statement to remove the “Next Generation Capsids” and “New Generation Target Identification Methods” line items from the pipeline table. * * * * U.S. Securities and Exchange Commission July 26, 2021 Page 3 Please direct any questions regarding the Company’s responses or the Amended Registration Statement to me at (650) 849-3041 or jknapp@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Jennifer Knapp Jennifer Knapp cc: Faraz Ali, Tenaya Therapeutics, Inc. Kenneth A. Clark, Wilson Sonsini Goodrich & Rosati, P.C. Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C.
2021-07-15 - UPLOAD - Tenaya Therapeutics, Inc.
United States securities and exchange commission logo
July 15, 2021
Faraz Ali
Chief Executive Officer
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, 5th Floor
South San Francisco, CA 94080
Re:Tenaya Therapeutics, Inc.
Registration Statement on Form S-1
Filed July 9, 2021
333-257820
Dear Mr. Ali:
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.
Form S-1
Prospectus Summary
Our Pipeline, page 4
1.We note your response to comment 2 and your revised disclosure in the pipeline table. We
reissue in part our prior comment. The table continues to include separate line items
for “Next Generation Capsids" and "New Generation Target Identification Methods” that
are all in the early stages of discovery. We further note that these programs are vague and
do not appear to be discussed in detail in the prospectus, including the summary, business,
use of proceeds or MD&A sections. Please limit your table to product candidates that are
sufficiently material to your business to warrant inclusion in your table. If these general
programs are material, identify the indications and expand your disclosure elsewhere to
identify more specifically these programs or candidates.
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.
FirstName LastNameFaraz Ali
Comapany NameTenaya Therapeutics, Inc.
July 15, 2021 Page 2
FirstName LastName
Faraz Ali
Tenaya Therapeutics, Inc.
July 15, 2021
Page 2
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 Tracey Houser at 202-551-3736 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tom Kluck at 202-551-3233 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Knapp
2021-07-09 - CORRESP - Tenaya Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
650 Page Mill Road
Palo Alto, CA 94304-1050
650.493.9300
650.493.6811
www.wsgr.com
July 9, 2021
Via EDGAR
U.S. Securities and Exchange
Commission
Division of Corporation Finance
Office of Life
Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Brian Cascio
Tracey Houser
Tom Kluck
Suzanne Hayes
Re:
Tenaya Therapeutics, Inc.
Amended Draft Registration Statement on Form S-1
Submitted June 16, 2021
CIK No. 0001858848
Ladies and Gentlemen:
On behalf of our client,
Tenaya Therapeutics, Inc. (“Tenaya” or the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) contained in its letter dated June 24, 2021, relating to the above referenced Amended Draft Registration Statement on Form S-1, confidentially submitted on June 16,
2021 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and a revised draft of the Registration Statement (the “Revised Registration Statement”).
In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s
response. Except for page references appearing in the headings and Staff comments below (which are references to the original Registration Statement), all page references herein correspond to the Revised Registration Statement.
AUSTIN BEIJING BOSTON
BRUSSELS HONG KONG LONDON LOS
ANGELES NEW YORK
PALO ALTO SAN DIEGO
SAN FRANCISCO SEATTLE SHANGHAI WASHINGTON, DC
WILMINGTON, DE
U.S. Securities and Exchange Commission
July 9, 2021
Page
2
Draft Registration Statement on Form S-1 Amendment No. 1
Prospectus Summary
Our
Pipeline, page 4
1.
Please explain in the meaning of the information in the column titled “USA
Epl.”
In response to the Staff’s comment, the Company has revised the disclosure on pages 4
and 126 of the Revised Registration Statement to clarify that this column, now labelled “USA Prevalence”, refers to the number of patients in the United States with the indication based on publicly available data.
2.
The table includes three separate programs with the general description “New Targets”
that are all in the early stages of discovery. Please limit your table to product candidates that are sufficiently material to your business to warrant inclusion in your table. If these New Targets are material, identify the indications and expand
your disclosure elsewhere to identify more specifically these programs or candidates.
In response to the
Staff’s comment, the Company has revised the table on pages 4 and 126 of the Revised Registration Statement to remove New Targets.
Use of
Proceeds, page 95
3.
We note your revised disclosure and response to comment 4. For the product candidates TN-201 in your MYBPC3 program and TYA-11631 in your HDAC6i program, please disclose if the proceeds will be sufficient to fund all three phases of clinical development. If
not, disclose the phase of development you reasonable expect to complete with the proceeds from this offering.
In response to the Staff’s comment, the Company has revised the disclosure on page 98 of the Revised Registration Statement to include
disclosure regarding how far each of TN-201 and TYA-11631 is expected to advance in the development process with the proceeds from the offering.
Business
Our Management Team and Investors,
page 124
4.
Your response to comment 6 provides that the names of these investors are disclosed in the
prospectus because they are holders in the Company’s preferred stock and are named as investors in the Company’s press releases. As noted in your response, these investors are currently not required to be disclosed in the principal
stockholders section and you have not undertaken to provide updated information with respect to these investments. For these reasons, the identity of these parties does not provide meaningful information upon which to make an investment decision.
Please remove the disclosure from your prospectus as highlighting these investors without undertaking to provide updated information is not appropriate.
U.S. Securities and Exchange Commission
July 9, 2021
Page
3
In response to the Staff’s comment, the Company has revised the disclosure on
pages 9, 127, and 128 of the Revised Registration Statement to remove RA Capital Management, the funds and accounts managed by T. Rowe Price Associates, and GV.
8. Common Stock, page F-20
5.
We note your disclosure in response to comment 8. Please tell us how you determined that the
shares of common stock issued for the early exercise of options and restricted stock that are subject to repurchase are to be reflected as outstanding, since the transaction is not considered substantive for accounting purposes. Refer to ASC 718-10-55-31.a. for guidance.
The Company respectfully advises the Staff that, while the Company does consider the shares of common stock issued for the early exercise of
options and unvested restricted stock that are subject to repurchase non-substantive for accounting purposes and for earnings per share computations in accordance with ASC 718-10-55-31.a, the Company includes such shares in its number of shares of common stock outstanding as it considers such shares outstanding from a legal perspective.
In response to the Staff’s comment, the Company has revised the disclosure on pages F-20 and F-40 of the Revised Registration Statement to disclose the number of shares of common stock issued for the early exercise of options and unvested restricted stock that are subject to repurchase.
2. Summary of Significant Accounting Policies, page F-35
6.
Please disclose your consideration of ASU 2020-06,
including whether you adopted this accounting pronouncement on January 1, 2021 and the impact adoption has had or may have on your consolidated financial statements. In this regard, we note your
outstanding convertible preferred stock that could be subject to beneficial conversion feature accounting. Refer to SAB Topic 11:M for guidance.
The Company respectfully advises the Staff that it has not yet adopted accounting standard ASU 2020-06
and that the Company’s outstanding convertible preferred stock instruments did not include any cash conversion features or beneficial conversion features at issuance or subsequent to issuance as defined under current guidance. The Company
currently does not expect the adoption of ASU 2020-06 to have a material impact on its financial statements. In response to the Staff’s comment, the Company has revised the disclosure on page F-34 of the Revised Registration Statement.
* * * *
U.S. Securities and Exchange Commission
July 9, 2021
Page
4
Please direct any questions regarding the Company’s responses or the Revised
Registration Statement to me at (650) 849-3041 or jknapp@wsgr.com.
Sincerely,
WILSON SONSINI GOODRICH & ROSATI
Professional Corporation
/s/ Jennifer Knapp
Jennifer Knapp
cc:
Faraz Ali, Tenaya Therapeutics, Inc.
Kenneth A. Clark, Wilson Sonsini Goodrich & Rosati, P.C.
Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C.
2021-06-24 - UPLOAD - Tenaya Therapeutics, Inc.
United States securities and exchange commission logo
June 24, 2021
Faraz Ali
Chief Executive Officer
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, 5th Floor
South San Francisco, CA 94080
Re:Tenaya Therapeutics, Inc.
Amended Draft Registration Statement on Form S-1
Submitted June 16, 2021
CIK No. 0001858848
Dear Mr. Ali:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 Amendment No. 1
Prospectus Summary
Our Pipeline, page 4
1.Please explain in the meaning of the information in the column titled “USA Epl."
2.The table includes three separate programs with the general description “New Targets”
that are all in the early stages of discovery. Please limit your table to product candidates
that are sufficiently material to your business to warrant inclusion in your table. If these
New Targets are material, identify the indications and expand your disclosure elsewhere
to identify more specifically these programs or candidates.
Use of Proceeds, page 95
FirstName LastNameFaraz Ali
Comapany NameTenaya Therapeutics, Inc.
June 24, 2021 Page 2
FirstName LastNameFaraz Ali
Tenaya Therapeutics, Inc.
June 24, 2021
Page 2
3.We note your revised disclosure and response to comment 4. For the product candidates
TN-201 in your MYBPC3 program and TYA-11631 in your HDAC6i program, please
disclose if the proceeds will be sufficient to fund all three phases of clinical development.
If not, disclose the phase of development you reasonable expect to complete with the
proceeds from this offering.
Business
Our Management Team and Investors, page 124
4.Your response to comment 6 provides that the names of these investors are disclosed in
the prospectus because they are holders in the Company’s preferred stock and are named
as investors in the Company’s press releases. As noted in your response, these investors
are currently not required to be disclosed in the principal stockholders section and you
have not undertaken to provide updated information with respect to these investments. For
these reasons, the identity of these parties does not provide meaningful information upon
which to make an investment decision. Please remove the disclosure from your prospectus
as highlighting these investors without undertaking to provide updated information is not
appropriate.
8. Common Stock, page F-20
5.We note your disclosure in response to comment 8. Please tell us how you determined
that the shares of common stock issued for the early exercise of options and restricted
stock that are subject to repurchase are to be reflected as outstanding, since the transaction
is not considered substantive for accounting purposes. Refer to ASC 718-10-55-31.a. for
guidance.
2. Summary of Significant Accounting Policies, page F-35
6.Please disclose your consideration of ASU 2020-06, including whether you adopted this
accounting pronouncement on January 1, 2021 and the impact adoption has had or may
have on your consolidated financial statements. In this regard, we note your outstanding
convertible preferred stock that could be subject to beneficial conversion feature
accounting. Refer to SAB Topic 11:M for guidance.
You may contact Tracey Houser at 202-551-3736 or Brian Cascio at 202-5513676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tom Kluck at 202-551-3233 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
FirstName LastNameFaraz Ali
Comapany NameTenaya Therapeutics, Inc.
June 24, 2021 Page 3
FirstName LastName
Faraz Ali
Tenaya Therapeutics, Inc.
June 24, 2021
Page 3
Office of Life Sciences
cc: Jennifer Knapp
2021-06-03 - UPLOAD - Tenaya Therapeutics, Inc.
United States securities and exchange commission logo
June 3, 2021
Faraz Ali
Chief Executive Officer
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, 5th Floor
South San Francisco, CA 94080
Re:Tenaya Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted May 7, 2021
CIK No. 0001858848
Dear Mr. Ali:
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
Our Pipeline, page 4
1.Please revise your pipeline table to condense the preclinical phases to no more than two
columns and to separately depict clinical phases 1, 2 and 3.
Overview of heart disease, page 5
2.We note your statements that you have the opportunity to advance multiple product
candidates into the clinic by ____ and that TN-201 is a potentially curative therapy.
Given that you have not completed any IND enabling studies, these statement appears to
be an inappropriate predictions that the FDA will approve multiple INDs and that the
product will be effective. Please remove these statements. Additionally, in other
FirstName LastNameFaraz Ali
Comapany NameTenaya Therapeutics, Inc.
June 3, 2021 Page 2
FirstName LastNameFaraz Ali
Tenaya Therapeutics, Inc.
June 3, 2021
Page 2
instances where you reference advancing candidates to the clinic, please revise to more
specifically reference clinical trials, as opposed to the clinic.
"Our amended and restated bylaws ...", page 91
3.Please revise the narrative in the risk factor to disclose that there is also a risk that your
exclusive forum provisions may result in increased costs for investors to bring a claim.
Use of Proceeds, page 96
4.Please revise your disclosure to separately quantify the amount of proceeds you expect to
allocate to TN-201 and TYA-11631. Additionally, indicate how far in the development
process you expect to get for each of your product candidates with the proceeds from this
offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Estimates
Stock-Based Compensation, page 114
5.Please expand your disclosure to include the valuation methodologies used by the
independent third party valuation firm to estimate your total equity value along with the
nature of material assumptions used within those methodologies. If more than
one methodology is used, provide a discussion of the weighting of those methodologies.
Our Management Team and Investors, page 122
6.We note that you identify certain entities as investors in your company that do not appear
to be among your principal stockholders as disclosed on page 215. If material, please
expand your disclosure to describe the nature of each named entity's investment
and explain to us why including this information is appropriate. Please also explain in
your response letter your plans to update investors about any changes these entities make
with respect to their investments in the company.
Business
Third Party Agreements, page 170
7.Please indicate which product candidate(s) rely on intellectual property licensed from
UTSW.
9. Stock-Based Compensation
Restricted Stock, page F-22
8.We note that when you repurchase shares of common stock related to early exercise of
options, you reduce the number of shares of common stock outstanding. Please disclose
your accounting policy for the issuance of shares of common stock from the early exercise
of stock options prior to vesting. Refer to ASC 718-10-55-31.a. for guidance.
FirstName LastNameFaraz Ali
Comapany NameTenaya Therapeutics, Inc.
June 3, 2021 Page 3
FirstName LastName
Faraz Ali
Tenaya Therapeutics, Inc.
June 3, 2021
Page 3
13. Subsequent Events, page F-25
9.Please expand your disclosures for the stock options grants to include the total amount of
compensation expense to be recognized over the 4 year vesting period.
General
10.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 Brian Cascio at 202-551-3676 or Tracey Houser at 202-551-3736 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tom Kluck at 202-551-3233 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Knapp