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Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2026-07-02
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2026-07-02
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2026-04-07
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2026-04-08
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2026-04-01
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2026-04-01
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2025-12-12
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2025-12-23
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
References: December 12, 2025
↓
Company responded
2025-12-30
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-23
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2025-01-24
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-05-18
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2022-05-24
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-07-21
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2021-07-22
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-04-16
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2021-05-07
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-12
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2019-04-16
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-11-15
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2018-11-16
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
References: November 15, 2018
↓
Company responded
2018-12-03
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-11-20
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-11-01
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-03-08
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
↓
Company responded
2016-05-04
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2012-07-17
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-09
Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-02 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2026-07-02 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-297061 | Read Filing View |
| 2026-04-08 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2026-04-07 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-294843 | Read Filing View |
| 2026-04-01 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-294740 | Read Filing View |
| 2026-04-01 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-12-30 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-12-23 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-12-12 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-292026 | Read Filing View |
| 2025-01-24 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2024-07-23 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-280918 | Read Filing View |
| 2022-05-24 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2022-05-18 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-07-22 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-07-21 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-05-07 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-04-16 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2019-04-16 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2019-04-12 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-12-03 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-20 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-16 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-15 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-01 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2016-03-08 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2012-07-17 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2012-05-09 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-02 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-297061 | Read Filing View |
| 2026-04-07 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-294843 | Read Filing View |
| 2026-04-01 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-294740 | Read Filing View |
| 2025-12-12 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-292026 | Read Filing View |
| 2024-07-23 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | 333-280918 | Read Filing View |
| 2022-05-18 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-07-21 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-04-16 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2019-04-12 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-20 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-15 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2016-03-08 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2012-07-17 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2012-05-09 | SEC Comment Letter | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-07-02 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2026-04-08 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2026-04-01 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-12-30 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-12-23 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2025-01-24 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | Brisbane, CA | N/A | Read Filing View |
| 2022-05-24 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-07-22 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2021-05-07 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2019-04-16 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-12-03 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-16 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2018-11-01 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) | DE | N/A | Read Filing View |
2026-07-02 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP Tempest Therapeutics, Inc. 2000 Sierra Point Parkway, Suite 400 Brisbane, California, 94005 July 2, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Attention: Daniel Crawford RE: Tempest Therapeutics, Inc. (the “Company”) Registration Statement on Form S-3 (the “Registration Statement”) Filed June 26, 2026 File No. 333-297061 Dear Mr. Crawford: The Company hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration Statement will become effective as of 4:00 p.m. on July 7, 2026, or as soon thereafter as practicable. [Signature page follows] Very truly yours, Tempest Therapeutics, Inc. By: /s/ Matthew Angel Name: Matthew Angel Title: President and Chief Executive Officer
2026-07-02 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) File: 333-297061
July 2, 2026 Matthew Angel Chief Executive Officer Tempest Therapeutics, Inc. 2000 Sierra Point Parkway, Suite 400 Brisbane, CA 94005 Re: Tempest Therapeutics, Inc. Registration Statement on Form S-3 Filed June 26, 2026 File No. 333-297061 Dear Matthew Angel: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael J. Minahan, Esq.
2026-04-08 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP TEMPEST THERAPEUTICS, INC. 2000 Sierra Point Parkway, Suite 400 Brisbane, California April 8, 2026 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Alan Campbell Re: Tempest Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-294843) Request for Acceleration of Effective Date Mr. Campbell: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-294843) (the “Registration Statement”) to become effective on April 9, 2026 at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such other time as the Registrant or its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. Once the Registration Statement has been declared effective, please confirm that event with Jaime L. Chase of Cooley LLP at (202) 728-7096 or Asa M. Henin of Cooley LLP at (858) 550-6104. Very truly yours, Tempest Therapeutics, Inc. By: /s/ Nicholas Maestas Nicholas Maestas Chief Financial Officer cc: Matthew Angel, Tempest Therapeutics, Inc. Jaime L. Chase, Cooley LLP Asa M. Henin, Cooley LLP
2026-04-07 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) File: 333-294843
April 7, 2026
Matthew Angel
Chief Executive Officer
Tempest Therapeutics, Inc.
2000 Sierra Point Parkway, Suite 400
Brisbane, CA 94005
Re:Tempest Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 2, 2026
File No. 333-294843
Dear Matthew Angel:
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:Asa M. Henin
2026-04-01 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) File: 333-294740
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
April 1, 2026
Matthew Angel
Chief Executive Officer
Tempest Therapeutics, Inc.
200 Sierra Point Parkway, Suite 400
Brisbane, CA 94005
Re: Tempest Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 30, 2026
File No. 333-294740
Dear Matthew Angel:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Asa M. Henin
</TEXT>
</DOCUMENT>
2026-04-01 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP TEMPEST THERAPEUTICS, INC. 2000 Sierra Point Parkway, Suite 400 Brisbane, California April 1, 2026 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Chris Edwards Re: Tempest Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-294740) Request for Acceleration of Effective Date Mr. Edwards: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-294740) (the “Registration Statement”) to become effective on April 3, 2026 at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such other time as the Registrant or its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. Once the Registration Statement has been declared effective, please confirm that event with Jaime L. Chase of Cooley LLP at (202) 728-7096 or Asa M. Henin of Cooley LLP at (858) 550-6104. Very truly yours, Tempest Therapeutics, Inc. By: /s/ Nicholas Maestas Nicholas Maestas Chief Financial Officer cc: Matthew Angel, Tempest Therapeutics, Inc. Jaime L. Chase, Cooley LLP Asa M. Henin, Cooley LLP
2025-12-30 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP T EMPEST T HERAPEUTICS , I NC . 2000 Sierra Point Parkway, Suite 400 Brisbane, California December 30, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Daniel Crawford Ms. Laura Crotty Re: Tempest Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-292026) Request for Acceleration of Effective Date Mr. Crawford and Ms. Crotty: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-1 (File No. 333-292026) (the “ Registration Statement ”) to become effective on December 31, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such other time as the Registrant or its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. The Registrant hereby authorizes each of Asa Henin and Jaime Chase of Cooley LLP to make such a request on its behalf. Once the Registration Statement has been declared effective, please confirm that event with Asa Henin of Cooley LLP, counsel to the Registrant, at (858) 550-6104 or ahenin@cooley.com, or in his absence, Jaime Chase, at (202) 728-7096 or jchase@cooley.com. [Signature page follows] Very truly yours, Tempest Therapeutics, Inc. By: /s/ Stephen Brady Stephen Brady Chief Executive Officer cc: Nicholas Maestas, Tempest Therapeutics, Inc. Asa Henin, Cooley LLP Jaime Chase, Cooley LLP Signature Page to Company Acceleration Request – S-1
2025-12-23 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP Jaime L. Chase T: (202) 728-7096 jchase@cooley.com Via EDGAR December 23, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Daniel Crawford Laura Crotty Re: Tempest Therapeutics, Inc. Registration Statement on Form S-1 Filed December 9, 2025 File No. 333-292026 Ladies and Gentlemen: On behalf of Tempest Therapeutics, Inc. (the “ Company ”), the following information is submitted in response to the comments received from the staff (the “ Staff ”) of the U.S. Securities and Exchange Commission (the “ Commission ”) by letter dated December 12, 2025 (the “ Comment Letter ”) regarding the above-referenced Registration Statement on Form S-1 filed with the Commission on December 9, 2025 (the “ Form S-1 ”). For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the respective comment in the Comment Letter, the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s response. Registration Statement on Form S-1 General 1. We note your disclosure in the Form 8-K filed November 19, 2025, incorporated by reference into the registration statement, that as a result of an Asset Purchase Agreement with Erigen LLC and Factor Bioscience Inc., the company will acquire all rights, title and interest to four therapeutic assets. We further note that Erigen is expected to own 65% of the company on a fully-diluted basis; and the Co-Founder, Chairman and Chief Executive Officer of Factor will become the company’s Chief Executive Officer and President. We also note the Asset Purchase Agreement states you will receive funding from Factor of up to $20 million over 18-months pursuant to a commitment letter. Please revise to provide carveout financial statements for Erigen and/or Factor, including pro forma financial statements. Alternatively, please tell us why these financial statements are not required. Refer to Rule 11-01(d) of Regulation S-X. Cooley LLP 1299 Pennsylvania Avenue NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com December 23, 2025 Page Two Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company has determined that Erigen does not met the definition of a “business” under Rule 11-01(d) of Regulation S-X (“ Rule 11-01(d) ”) because: (i) Erigen has never had operations and only held the Assets (as defined below) for purposes of the Contemplated Transactions; (ii) Erigen has never generated revenue and has never engaged in revenue-producing operations; and (iii) other facts and circumstances, as more fully described below, demonstrate an insufficient continuity of operations before and after the Contemplated Transactions (as defined below) to provide an understanding of future operations with respect to the historical development activities of the Assets. Specifically, the pipeline of product candidates subject to licensing arrangements are in very early stages of development for which the historical development completed in China of the sole clinical asset may be supportive, but the development activities by the Company will be separate from the development activities in China and will include separate clinical studies and the establishment of manufacturing processes, and ultimately separate regulatory filings with data generated by the Company. Consequently, any such carve-out financial information would not provide meaningful information and is not readily available. To provide further context with respect to the Company’s analysis of Rule 11-01(d), the following summarizes the Contemplated Transactions, the nature and terms of the licensing parties, the relevant parties involved, the historical development of the Assets, and the preliminary accounting conclusion, which is informative in understanding the reasons why the Company has determined there is not sufficient continuity with respect to the activities of the Assets for which financial information would be meaningful. The Contemplated Transactions On November 19, 2025, the Company entered into an asset purchase agreement (the “ Asset Purchase Agreement ”) with Erigen LLC (“ Erigen ”) and Factor Bioscience Inc. (“ Factor ” and, together with Erigen, the “ Sellers ”), pursuant to which, among other things and subject to the terms and conditions contained therein, the Sellers will sell and transfer to the Company all rights, title and interest in all of the therapeutic assets primarily related to (a) the autologous BCMA/CD19 dual targeting CAR T-cell therapy known as ERI-2003, (b) the autologous CD70/CD70 dual-targeting CAR T cell therapy known as ERI-2206, (c) the allogeneic BCMA/CD19 dual-targeting CAR T-cell therapy with a gene edit in the TRAC locus that inactivates the T cell receptor known as ERI-3003, and (d) the allogeneic CD70/CD70 dual-targeting CAR T-cell therapy with a gene edit in the TRAC locus that inactivates the T cell receptor known as ERI-3206 (collectively, the “ Assets ”), solely in exchange for a fixed number of shares of the Company’s common stock issued to Erigen. Individual Assets to be referred to hereinafter will use their Erigen program names, ERI-2003, ERI-2206, ERI-3003 and ERI-3206. In connection with the new development programs, the Company plans to rename each to TPST-2003, TPST-2206, TPST-3003 and TPST-3206, respectively. The transactions contemplated by the Asset Purchase Agreement are referred to herein as the “ Contemplated Transactions. ” Erigen acquired the Assets pursuant to license and collaboration agreements with Novatim Immune Therapeutics, Inc., a China corporation focused on tumor immunotherapy (“ Novatim ”), and Factor. Consideration paid by Erigen to Novatim and Factor for the Assets was solely in the form of future development, regulatory and commercial milestones and future royalties associated with commercial product sales. No upfront consideration was given for these assets given the stage of development and the inherent uncertainty in the results associated with preclinical activities. Following the issuance of the Company’s common stock to Erigen and the concurrent distribution of the common stock to Matt Angel, Ph.D. and Lotus Capital (BVI) Limited (“ Lotus ”), Erigen’s sole members and pre-closing equityholders, Dr. Angel and Lotus are expected to own between (i) 23.7% and 36.7% and (ii) 16.8% and 26.0% of the Company’s common stock, respectively, dependent on the exercise of outstanding options and warrants and the issuance and exercise of the warrants expected to be issued as a special dividend in the Contemplated Transactions. No stockholder of the Company holds or will hold more than 50% ownership immediately before or after the Contemplated Transactions. In addition, Matt Angel and Lotus are not related parties nor have any arrangements to vote in concert. See “ Dilution ” below. Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com December 23, 2025 Page Three Following the acquisition, Dr. Angel, Co-Founder, Chairman and Chief Executive Officer of Factor, will be named as the Company’s Chief Executive Officer and President. Dr. Angel’s scientific background and knowledge of the Assets was instrumental in the decision to appoint him as the Company’s Chief Executive Officer following the Contemplated Transactions. Stephen Brady, the Company’s current Chief Executive Officer and President of the Company, is expected to assume the role of Chairman of the Company’s Board of Directors (the “ Board ”). Nicholas Maestas, the Company’s current Chief Financial Officer, Justin Trojanowski, the Company’s current Corporate Controller and Treasurer, and Robbie Starbody, the Company’s current Associate Director, Accounting & Finance, are expected to continue in such capacities after the closing of the Contemplated Transactions as full-time employees. Samuel Whiting, the Company’s current Executive Vice President and Chief Medical Officer, will continue to support the Company as a consultant. There are no other current or planned changes to the principal executive, financial or accounting officers of the Company. The Board is currently composed of five members. Upon closing of the Contemplated Transactions, it is anticipated that the Board will consist of four incumbent directors from the current Board, including Mr. Brady, and one new member, Dr. Angel, as the newly appointed Chief Executive Officer. Geoff Nichol, a current member of the Board, is expected to tender his resignation from the Board, effective upon the Closing. Parties to the Contemplated Transactions The Company The Company is a biotechnology company with two clinical-stage programs, TPST-1495 and amezalpat (previously known as TPST-1120), each with the potential to be first-in-class to treat a wide range of cancers. The Company expects TPST-1495 will soon start enrolling a Phase 2 in Familial Adenomatous Polyposis, a pre-colon cancer indication, whereas amezalpat is later stage and has received broad global regulatory approval from U.S. Food and Drug Administration (“ FDA ”), European Medicines Agency (“ EMA ”), and the National Medicinal Products Administration of China (“ NMPA ”) to proceed with a Phase 3 study in patients with first-line liver cancer (“ HCC ”). The FDA has also granted Orphan Drug Designation (“ ODD ”) and Fast Track Designation for amezalpat underscoring the agency’s recognition of the urgent need for new treatment options for HCC. These designations provide potential regulatory benefits, including increased engagement with the FDA, eligibility for accelerated approval and priority review, and, for ODD, potential market exclusivity upon approval. The Company assembled a global network of clinical investigators who specialize in HCC to help conduct the Phase 3 trial, and although the Company reduced research and development spend in recent months to ensure it had sufficient cash runway to enable a strategic or funding transaction, the Company expects that upon receipt of additional capital resulting from the anticipated milestones for both the existing programs as well as those related to the Contemplated Transactions, the Company will initiate the amezalpat Phase 3 trial, either alone or with a partner. The amezalpat Phase 3 trial and TPST-1495 Phase 2 trial would run concurrently for a time, with TPST-1495 Phase 2 data expected in 12-18 months and the amezalpat Phase 3 data expected in approximately three years, or earlier via preliminary assessment of efficacy if agreed upon with the FDA, EMA and NMPA. Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com December 23, 2025 Page Four Accordingly, the Company is currently an operating business that is and will continue to develop its product candidates following the Contemplated Transactions. The nature of the Company’s operations will continue to be significant and the historical development activities of its products are at much later stages than those of the Assets to be acquired from Erigen. Further, most of the executive officers and board members of the Company will continue to hold roles in the combined business. Factor Factor is advancing a pipeline of allogeneic cell therapies designed to treat devastating diseases with high unmet medical need. Factor is a wholly owned subsidiary of Factor Bioscience LLC. Factor also has two wholly owned subsidiaries, Factor Bioscience Limited and Factor Bioscience Pty Ltd. Factor is owned by two individuals, Dr. Angel and Christopher Rohde, who own 64% and 36% of the fully diluted units outstanding, respectively. Lotus and Erigen Dr. Angel and Andrew Yang have been pursuing biotechnology business ventures and corporate partnerships to identify and develop certain Factor assets as well as identify other assets outside of Factor. Mr. Yang has no affiliation with Factor. Mr. Yang formed Lotus for purposes of these pursuits and is the sole owner and managing member of Lotus. Similar to Mr. Yang, Dr. Angel formed Erigen for the purposes of these pursuits. Erigen was formed several years ago but was a dormant entity without any operating activity. Dr. Angel is the sole managing member of Erigen and holds 58.5% of the common units (consisting of 100% of the voting common units) and Lotus holds the remaining 41.5% of the common units (consisting of non-voting common units). Erigen has never had operations, has never generated any revenue and has never engaged in revenue-producing operations, and had no reported value of assets as of December 31, 2024 and had no net loss or net income for the year ended December 31, 2024. Erigen has no full-time employees. Pursuant to the license agreements described below, Erigen owns the rights to each of the Assets. To date, all development of ERI-2003 and ERI-2206 has been undertaken by Novatim. ERI-3003 and ERI-3206 are early, discovery-stage assets. Erigen has undertaken no efforts to advance any of the Assets. Novatim Novatim is a company organized under the laws of the People’s Republic of China focused on utilizing tumor immunotherapy to address unmet clinical needs. As discussed below, Erigen entered into an exclusive license and collaboration agreement with Novatim (the “ Novatim License Agreement ”) in July 2025 to develop and commercialize ERI-2003 and ERI-2206. Prior to the entering of the Novatim License Agreement, there were no agreements or shared ownership between Novatim and any of Erigen, Factor or the Company. License and Collaboration Agreements Between Factor, Erigen and Novatim Novatim License and Collaboration Agreement Pursuant to the Novatim License Agreement, Erigen obtained an exclusive license to specified patents and know-how in all fields worldwide (excluding Greater China, India, Turkey, and Russia) to exploit the ERI-2003 and ERI-2206 programs and allogeneic CAR-T therapies based on the ERI-2003 and ERI-2206 Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com December 23, 2025 Page Five programs. Erigen also received a right of first negotiation to negotiate a license to exploit allogeneic CAR-T therapies and in vivo CAR-T therapies in Greater China. Erigen is obligated to meet certain diligence milestones by specified dates and to use commercially reasonable efforts to develop and make commercially available at least one licensed product in the licensed territory. No upfront payment was paid pursuant to the Novatim License Agreement. Erigen is obligated to pay Novatim up to $80 million in total upon achievement of certain development milestones for the programs and up to $1.24 billion in total upon achievement of certain commercial milestones for the programs. In addition, Erigen is required to pay Novatim mid-to-high single-digit royalties on net sales of licensed products, subject to certain customary reductions, up to a lifetime maximum of $800 million, following which Erigen’s license shall become fully paid and royalty-free. Factor Amended and Restated License and Collaboration Agreement In November 2025, Erigen entered into an amended and restated license and collaboration agreement (the “ Restated Factor License Agreement ”) with Factor Bioscience Limited. Pursuant to the Restated Factor License Agreement, Erigen obtained an exclusive license to specified patents in all fields worldwide (excluding Greater China, India, Turkey, and Russia) to exploit the ERI-3003 and ERI-3206 programs. The Restated Factor License Agreement also establishes a Joint Steering Committee for the purposes of discussing and coordinating collaborat
2025-12-12 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) File: 333-292026
December 12, 2025
Stephen Brady
Chief Executive Officer
Tempest Therapeutics, Inc.
2000 Sierra Point Parkway, Suite 400
Brisbane, CA 94005
Re:Tempest Therapeutics, Inc.
Registration Statement on Form S-1
Filed December 9, 2025
File No. 333-292026
Dear Stephen Brady:
We have conducted a limited review of 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 a 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 letter, we may have additional comments.
Registration Statement on Form S-1
General
We note your disclosure in the Form 8-K filed November 19, 2025, incorporated by
reference into the registration statement, that as a result of an Asset Purchase
Agreement with Erigen LLC and Factor Bioscience Inc., the company will acquire all
rights, title and interest to four therapeutic assets. We further note that
Erigen is expected to own 65% of the company on a fully-diluted basis; and the Co-
Founder, Chairman and Chief Executive Officer of Factor will become the company’s
Chief Executive Officer and President. We also note the Asset Purchase Agreement
states you will receive funding from Factor of up to $20 million over 18-months
pursuant to a commitment letter. Please revise to provide carveout financial
statements for Erigen and/or Factor, including pro forma financial statements.
1.
December 12, 2025
Page 2
Alternatively, please tell us why these financial statements are not required. Refer to
Rule 11-01(d) 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.
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:Jaime Chase, Esq.
2025-01-24 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP TEMPEST THERAPEUTICS, INC. 2000 Sierra Point Parkway, Suite 400 Brisbane, California, 94005 (415) 798-8589 January 24, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Gary Guttenberg RE: Tempest Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-280918 Acceleration Request Requested Date: January 27, 2025 Requested Time: 4:00 p.m., Eastern time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-280918), as amended by the Pre-Effective Amendment No. 1 to Form S-3 (together, the “Registration Statement”) to become effective at 4:00 p.m. Eastern time on January 27, 2025, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Jaime Chase of Cooley LLP, counsel to the registrant, at (202) 728 7096. [Signature page follows] Sincerely, TEMPEST THERAPEUTICS, INC. By: /s/ Stephen Brady Stephen Brady Chief Executive Officer cc: Laura Berezin, Cooley LLP Jaime Chase, Cooley LLP
2024-07-23 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227) File: 333-280918
July 23, 2024
Stephen Brady
Chief Executive Officer
Tempest Therapeutics, Inc.
2000 Sierra Point Parkway, Suite 400
Brisbane, California, 94005
Re:Tempest Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 19, 2024
File No. 333-280918
Dear Stephen Brady:
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:Jaime Chase
2022-05-24 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP
1
filename1.htm
CORRESP
TEMPEST THERAPEUTICS, INC.
7000 Shoreline Court, Suite 275
South San Francisco, CA 94080
May 24, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of
Corporation Finance
100 F Street, N.E.
Washington, D.C.
20549
Attn: Gary Guttenberg
RE: Tempest Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-264989
Acceleration Request
Requested Date: Friday, May 27, 2022
Requested Time: 9:00 a.m. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Exchange Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3
(File No. 333-264989) (the “Registration Statement”) to become effective at 9:00 a.m. Eastern Time on Friday, May 27, 2022, or as soon thereafter as is practicable.
Once the Registration Statement has been declared effective, please orally confirm that event with Laura Berezin of Cooley LLP, counsel to the registrant, at
(650) 843-5128.
[Signature page follows]
Sincerely,
TEMPEST THERAPEUTICS, INC.
By:
/s/ Stephen Brady
Stephen Brady
Chief Executive Officer
cc:
Laura Berezin, Cooley LLP
Michael Mencher, Cooley LLP
2022-05-18 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
United States securities and exchange commission logo
May 18, 2022
Stephen Brady
Chief Executive Officer
Tempest Therapeutics, Inc.
7000 Shoreline Court; Suite 275
South San Francisco, CA 94080
Re:Tempest Therapeutics, Inc.
Registration Statement on Form S-3
Filed May 16, 2022
File No. 333-264989
Dear Mr. Brady:
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 Gary Guttenberg at (202) 551-6477 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Mencher
2021-07-22 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm Acceleration Request July 22, 2021 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Jessica Ansart Re: Acceleration Request for Tempest Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-257990) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tempest Therapeutics, Inc. (the “Company”), hereby requests that the effective date of the Company’s Registration Statement on Form S-3, Registration Number 333-257990 (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 P.M., Eastern Time or as soon thereafter as practicable, on July 23, 2021, 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 U.S. Securities and Exchange Commission. We would appreciate it if, as soon as the Registration Statement is declared effective, you would so inform Asher Rubin of Sidley Austin LLP at (410) 559-2881. Very truly yours, /s/ Stephen Brady Stephen Brady Chief Executive Officer CC: Frank Rahmani, Sidley Austin LLP Istvan A. Hajdu, Sidley Austin LLP
2021-07-21 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
United States securities and exchange commission logo
July 21, 2021
Stephen Brady
Chief Executive Officer
Tempest Therapeutics, Inc.
7000 Shoreline Court, Suite 275
South San Francisco, California, 94080
Re:Tempest Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 16, 2021
File No. 333-257990
Dear Mr. Brady:
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 Jessica Ansart at (202) 551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Asher Rubin
2021-05-07 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm CORRESP Millendo Therapeutics, Inc. 110 Miller Avenue, Suite 100 Ann Arbor, Michigan 48104 May 7, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: Millendo Therapeutics, Inc. Registration Statement on Form S-4 File No. 333-255198 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Millendo Therapeutics, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-4 (File No. 333-255198), as amended (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on May 11, 2021, or as soon thereafter as practicable. [Remainder of Page Intentionally Left Blank] Very truly yours, MILLENDO THERAPEUTICS, INC. By: /s/ Louis J. Arcudi III Name: Louis J. Arcudi III Title: President and Chief Executive Officer Signature Page to Acceleration Request
2021-04-16 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
United States securities and exchange commission logo
April 16, 2021
Louis J. Arcudi, III
President and Chief Executive Officer
Millendo Therapeutics, Inc.
110 Miller Avenue, Suite 100
Ann Arbor, MI 48104
Re:Millendo Therapeutics, Inc.
Registration Statement on Form S-4
Filed April 13, 2021
File No. 333-255198
Dear Mr. Arcudi:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stuart M. Falber, Esq.
2019-04-16 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm April 16, 2019 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 3030 Washington, D.C. 20549 Attn: Sonia Bednarowski Re: Millendo Therapeutics, Inc. Registration Statement on Form S-3 Filed April 5, 2019 File No. 333-230749 Acceleration Request Requested Date: April 18, 2019 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-230749), as amended (the “Registration Statement”), to become effective on April 18, 2019, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the staff (the “Staff”). The Registrant hereby authorizes each of Nicole Brookshire, Miguel J. Vega and Daniel Goldberg of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Nicole Brookshire of Cooley LLP at (617) 937-2357. [Signature page follows] Very truly yours, Millendo Therapeutics, Inc. By: /s/ Louis J. Arcudi, III Louis J. Arcudi, III Chief Financial Officer cc: Nicole Brookshire, Cooley LLP Miguel J. Vega, Cooley LLP Daniel Goldberg, Cooley LLP Darah Protas, Cooley LLP
2019-04-12 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
April 12, 2019
Julia Owens
Chief Executive Officer
Millendo Therapeutics, Inc.
301 North Main Street, Suite 100
Ann Arbor, MI 48104
Re:Millendo Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 5, 2019
File No. 333-230749
Dear Dr. Owens:
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 Sonia Bednarowski at 202-551-3666 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-12-03 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm OvaScience, Inc. 9 Fourth Avenue Waltham, Massachusetts 02451 December 3, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor RE: OvaScience, Inc. Registration Statement on Form S-3 File No. 333-228209 Request for Acceleration of Effectiveness Ladies and Gentlemen: In accordance with Rule 461 promulgated under the Securities Act of 1933, as amended, OvaScience, Inc. (the “Company”) hereby requests acceleration of the effective date of the Registration Statement on Form S-3 (File No. 333-228209), as amended (the “Registration Statement”), so that it may become effective at 9:00 a.m., Washington, D.C. time on December 6, 2018, or as soon as possible thereafter. The Company hereby authorizes Megan N. Gates, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. to orally modify or withdraw this request for acceleration. The Company respectfully requests that it be notified of such effectiveness by a telephone call to Ms. Gates at (617) 348-4443 and that such effectiveness also be confirmed in writing. Any questions regarding this request may be addressed to Ms. Gates. Very truly yours, OVASCIENCE, INC. /s/ Jonathan Gillis Jonathan Gillis Senior Vice President, Finance cc: OvaScience, Inc. Christopher A. Kroeger., M.D., M.B.A., President and Chief Executive Officer Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William C. Hicks, Esq. Megan N. Gates, Esq. Daniel A. Bagliebter, Esq. Cooley, LLP Miguel J. Vega, Esq. Nicole Brookshire, Esq.
2018-11-20 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
November 20, 2018
Christopher A. Kroeger, M.D., M.B.A.
President and Chief Executive Officer
OvaScience, Inc.
9 Fourth Avenue
Waltham, MA 02451
Re:OvaScience, Inc.
Registration Statement on Form S-3
Response dated November 16, 2018
File No. 333-228209
Dear Dr. Kroeger:
We have reviewed your November 16, 2018 response to our comment letter and have the
following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our November 15, 2018 letter.
Form S-3/A
General
1.We note your response to comment 1. However, the result of the purchasers' ability to
waive unsatisfied conditions is that the purchasers have control over closing conditions.
Therefore, our comment is reissued. You may withdraw the registration statement and
refile it after the shares have been issued or you may renegotiate the purchase agreement
to remove the purchasers' right to waive unsatisfied conditions.
FirstName LastNameChristopher A. Kroeger, M.D., M.B.A.
Comapany NameOvaScience, Inc.
November 20, 2018 Page 2
FirstName LastName
Christopher A. Kroeger, M.D., M.B.A.
OvaScience, Inc.
November 20, 2018
Page 2
You may contact Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Megan Gates, Esq.
2018-11-16 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm One Financial Center Boston, MA 02111 617 542 6000 mintz.com November 16, 2018 VIA EDGAR & OVERNIGHT MAIL Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Office of Healthcare and Insurance Re: OvaScience, Inc. Registration Statement on Form S-3 Filed November 6, 2018 File No. 333-228209 (the “Registration Statement”) Ladies and Gentlemen: We are submitting this letter on behalf of OvaScience, Inc. (the “Company”) and Millendo Therapeutics, Inc. (“Millendo”) in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated November 15, 2018 (the “Comment Letter”) from the Division of Corporation Finance, Office of Healthcare and Insurance, to Christopher A. Kroeger, M.D., M.B.A., President and Chief Executive Officer of the Company, relating to the above-referenced Registration Statement. For reference, we have set forth below in italics the Staff’s comment set forth in the Comment Letter. The response below is based on information provided to Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. by representatives of the Company and Millendo. Comment 1: It appears that Section 5 of the Stock Purchase Agreement provides that the purchaser has the option to waive Millendo’s and OvaScience’s obligations. Additionally, the Explanatory Note in the registration statement indicating that you expect this registration statement to become effective promptly after the closing of the post-closing financing appears to imply a waiver of the Section 5.5 condition that the resale registration statement shall have been declared effective by the SEC. Therefore, it does not appear that you have a valid exemption under Section 4(2) of the Securities Act of 1933. You may withdraw the registration statement and refile it once the shares are outstanding or amend the investment agreement to remove the investors’ ability to waive any of the closing conditions and refile your registration statement. For guidance, refer to Securities Act Sections Compliance & Disclosure Interpretation 139.11. Response 1: The Company respectfully acknowledges the Staff’s comments. As to the language in the Explanatory Note, the Company notes that the first sentence of the third paragraph was included in error and proposes to delete such sentence and replace it with the following: “OvaScience expects this registration statement to become effective prior to the Effective Time of the Merger.” As to the Staff’s comment regarding the purchaser’s control over the closing conditions in the Stock Purchase Agreement, we respectfully disagree with the Staff’s assessment. Section 5 of the Purchase Agreement contains customary closing conditions relating to the “bringdown” of BOSTON LONDON LOS ANGELES NEW YORK SAN DIEGO SAN FRANCISCO WASHINGTON MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. MINTZ November 16, 2018 Page 2 OvaScience’s and Millendo’s representations and warranties and covenants, satisfaction of consents and filings, the consummation of the Merger between the parties and the effectiveness of the registration statement on Form S-3. The Securities Act Compliance and Disclosure Interpretation 139.11 to which you have referred us provides (in pertinent part): “…a company will be permitted to register the resale of securities prior to their issuance if the company has completed a Section 4(2)-exempt sale of the securities… to the investor, and the investor is at market risk at the time of filing of the resale registration statement. The investor must be irrevocably bound to purchase a set number of securities for a set purchase price that is not based on market price or a fluctuating ratio.... There can be no conditions to closing that are within an investor’s control or that an investor can cause not to be satisfied. For example, closing conditions in capital formation transactions relating to the market price of the company’s securities or the investor’s satisfactory completion of its due diligence on the company are unacceptable conditions. The closing of the private placement of the unissued securities must occur within a short time after the effectiveness of the resale registration statement.” The Company believes that it has satisfied these criteria. The guidance requires that the purchaser be “at market risk” and “irrevocably bound” to consummate the investment transaction. The closing conditions must not be “within an investor’s control” and there can be no closing conditions “that an investor can cause not to be satisfied.” The closing conditions contained within the Stock Purchase Agreement comply with these requirements. The Company and Millendo have to satisfy certain conditions as a condition to the obligation of the purchaser to make its investment in OvaScience and these conditions are fully outside of the purchaser’s control. If the conditions are satisfied, the purchaser is irrevocably bound to make the investment at the price they committed to in the Stock Purchase Agreement. If for any reason, the Company is unable to satisfy the closing conditions, only then does the purchaser’s option to waive a condition come into play. At that point, the purchaser may decide not to proceed with its investment, or waive the relevant condition. That formulation makes logical sense. As long as the issuer complies with its side of the bargain, the investor is irrevocably bound. Only once the issuer fails to comply with the closing conditions (and therefore its side of the bargain), does the investor have the right to abandon the transaction or waive the non-compliance. The right to waive standard closing conditions does not mean that the investor is not irrevocably bound if the closing conditions are met. Put differently, the fact that the investor may decide to close even if the conditions (that the investor has no control over) are not met does not undermine the fact that the investor must close if the conditions are met. The SEC’s guidance provides examples that explain the type of impermissible “control” about which the SEC is concerned — such as a condition that requires a particular market price to be met or maintained, or that gives the investor a “walk-away” right if it is not satisfied with due diligence results. Those are only two examples, but they indicate that the impermissible level and kind of investor control from which the SEC’s concern is derived relate to the satisfaction of the condition itself (i.e., that the purchaser cannot cause a condition not to be met, such that purchaser would not actually be “irrevocably bound” to make the investment), not a potential waiver of a standard condition outside of the investor’s control if the issuer was unable to satisfy the condition. The purchaser’s right to waive standard closing conditions and proceed with a closing notwithstanding the failure to satisfy a condition is a common market feature in PIPE agreements and fundraising transactions of all types. There is a fundamental, qualitative difference between a MINTZ November 16, 2018 Page 3 closing condition that is within an investor’s discretion to control (such as satisfaction with results of due diligence) and a right to waive a closing condition that is not within an investor’s discretion to control (such as the closing of a merger). We believe that a waiver right over a closing condition does not constitute a bar to the ability of the Company to have its registration statement declared effective prior to the issuance of these shares. * * * * * MINTZ November 16, 2018 Page 4 We hope that the above response will be acceptable to the Staff. Please do not hesitate to call me or William C. Hicks of this firm at (617) 542-6000 with any comments or questions regarding this letter. We thank you for your time and attention. Sincerely, /s/ Megan N. Gates Megan N. Gates cc: Securities and Exchange Commission Jeffrey Gabor Suzanne Hayes OvaScience, Inc. Christopher A. Kroeger, M.D., M.B.A. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William C. Hicks Daniel Bagliebter Cooley LLP Miguel Vega Harley Brown
2018-11-15 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
November 15, 2018
Christopher A. Kroeger, M.D., M.B.A.
President and Chief Executive Officer
OvaScience, Inc.
9 Fourth Avenue
Waltham, MA 02451
Re:OvaScience, Inc.
Registration Statement on Form S-3
Filed November 6, 2018
File No. 333-228209
Dear Dr. Kroeger:
We have limited our review of your registration statement to those issues we have
addressed in our 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-3 Filed November 6, 2018
General
1.It appears that Section 5 of the Stock Purchase Agreement provides that the purchaser has
the option to waive Millendo's and OvaScience's obligations. Additionally, the
Explanatory Note in the registration statement indicating that you expect this registration
statement to become effective promptly after the closing of the post-closing financing
appears to imply a waiver of the Section 5.5 condition that the resale registration
statement shall have been declared effective by the SEC. Therefore, it does not appear
that you have a valid exemption under Section 4(2) of the Securities Act of 1933. You
may withdraw the registration statement and refile it once the shares are outstanding or
amend the investment agreement to remove the investors’ ability to waive any of the
FirstName LastNameChristopher A. Kroeger, M.D., M.B.A.
Comapany NameOvaScience, Inc.
November 15, 2018 Page 2
FirstName LastName
Christopher A. Kroeger, M.D., M.B.A.
OvaScience, Inc.
November 15, 2018
Page 2
closing conditions and refile your registration statement. For guidance, refer to Securities
Act Sections Compliance & Disclosure Interpretation 139.11.
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 Jeffrey Gabor at 202-551-2544 or Suzanne Hayes at 202-551-3675 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Megan Gates, Esq.
2018-11-01 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm OvaScience, Inc. 9 Fourth Avenue Waltham, Massachusetts 02451 November 1, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: OvaScience, Inc. Registration Statement on Form S-4 File No. 333-227547 Request for Acceleration of Effectiveness Ladies and Gentlemen: In accordance with Rule 461 promulgated under the Securities Act of 1933, as amended, OvaScience, Inc. (the “Company”) hereby requests acceleration of the effective date of the Registration Statement on Form S-4 (File No. 333-227547), as amended (the “Registration Statement”), so that it may become effective at 10:00 a.m. Washington, D.C. time on November 5, 2018, or as soon as possible thereafter. The Company hereby authorizes Megan N. Gates, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. to orally modify or withdraw this request for acceleration. The Company respectfully requests that it be notified of such effectiveness by a telephone call to Attorney Gates at (617) 348-4443 and that such effectiveness also be confirmed in writing. Any questions regarding this request may be addressed to Attorney Gates. Very truly yours, OVASCIENCE, INC. /s/ Jonathan Gillis Jonathan Gillis Senior Vice President, Finance cc: OvaScience, Inc. Christopher A. Kroeger., M.D., M.B.A., President and Chief Executive Officer Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William C. Hicks, Esq. Megan N. Gates, Esq. Daniel A. Bagliebter, Esq. Cooley, LLP Miguel J. Vega, Esq. Nicole Brookshire, Esq.
2016-05-04 - CORRESP - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
CORRESP 1 filename1.htm May 4, 2016 VIA EDGAR Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes, Assistant Director Re: OvaScience, Inc. Registration Statement on Form S-3 File No. 333-209778 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, OvaScience, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-209778) (the “Registration Statement”), so that it may become effective at 5:00 p.m. (Washington, D.C. time) on Thursday, May 5, 2016, or as soon thereafter as practicable. The Registrant hereby acknowledges that: (i) should the U.S. Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; (ii) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and (iii) the Registrant may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. [remainder of page intentionally left blank] Please call William C. Hicks (617-542-6000) of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, with any comments or questions regarding this matter. Very truly yours, OvaScience, Inc. By: /s/ Jeffrey Young Jeffrey Young Chief Financial Officer cc: Securities and Exchange Commission Dorman Yale Joseph McCann
2016-03-08 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
Mail Stop 4720
March 8, 2016
Michelle Dipp , M.D., PH.D.
Chief Executive Officer and Executive Chairman
OvaScience, Inc.
9 Fourth Avenue
Waltham, M A 02451
Re: OvaScience, Inc.
Registration Statement on Form S-3
Filed February 26, 2016
File No. 333-209778
Dear Dr. Dipp :
We have limited our review of your registration statement to those issues w e have
addressed in our comment . 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 com ment appl ies 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 the comment , we may have additional comments.
General
1. We note that you incorporate by reference your Annual Report on Form 10 -K for the year
ended December 31, 2015. However, the Form 10 -K incorporates by reference
information from your definitive proxy statement that has not been filed yet. Please note
that we will not be in a position to take your filing effective until you have amended the
Form 10 -K to include Part III information or filed the definitive proxy statement. Please
refer to Compliance and Disclosu re Interpretations, Securities Act Forms, Question
123.01 and Regulation S -K, Question 117.05 for guidance.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities Act rules require. Since the company and its management are in
Dr. Michelle Dipp
OvaScience, Inc.
March 8, 2016
Page 2
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclos ures they have made.
Notwithstanding our comment , in the event you request acceleration of the effective date
of the pending registration statement , please provide a written statement from the company
acknowledging that:
should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;
the action of the Commission or the staff, acting pursuant t o delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and
the company may not assert staff comments and the declaration of effect iveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceler ation of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
Please contact Dorrie Yal e at 202-551-8776 or Joseph McCann at 202 -551-6262 with any
questions.
Sincerely,
/s/ Joseph McCann for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: William C. Hicks , Esq.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2012-07-17 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
July 17 , 2012 Via E -mail Christopher Bleck Chief Operating Officer OvaScience, Inc. 800 Boylston Street, Suite 1555 Boston, Massachusetts 02199 Re: OvaScience, Inc. Registration Statement on Form 10-12G Filed April 11, 2012 File No. 000 -54647 Dear Mr. Bleck : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We u rge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Jeffrey Riedler Jeffrey Riedler Assistant Director cc: Lia Der Marderosian, Esq. WilmerHale 60 State Street Boston , MA 02109
2012-05-09 - UPLOAD - Tempest Therapeutics, Inc. (TPST) (CIK 0001544227)
May 8, 2012
Via E-mail
Christopher Bleck Chief Operating Officer OvaScience, Inc. 800 Boylston Street, Suite 1555 Boston, Massachusetts 02199
Re: OvaScience, Inc.
Registration Statement on Form 10-12G
Filed April 11, 2012 File No. 000-54647
Dear Mr. Bleck:
We have reviewed your filing 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 within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response. If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
General
1. Your registration statement will automatica lly become effective and you will become a
reporting company by operation of law on J une 11, 2012. Please be advised that if you
have not resolved all material comments by that time you should c onsider withdrawing
the registration statement prior to June 11, 2012. You can re-file the registration
statement when you are in a position to res pond to and resolve any material remaining
comments.
2. We note that you have submitted an applicati on for confidential treatment relating to
certain of your exhibits. Please be advised th at we will be performing a separate review
of this application and that th e review of your registration st atement will not be complete
until all comments concerning your confidentia l treatment request, if any, have been
cleared.
Christopher Bleck OvaScience, Inc. May 8, 2012 Page 2
3. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please disclose prominently in the beginning of
your registration statement that you are an emerging growth company, and revise your
registration statement to:
Describe how and when a company may lose emerging growth company status;
Briefly describe the various exemptions that are available to you, such as exemptions
from Section 404(b) of the Sarbanes-Oxl ey Act of 2002 and Section 14A(a) and (b)
of the Securities Exchange Act of 1934; and
State your election under Sec tion 107(b) of the JOBS Act:
o If you have elected to opt out
of the extended transition period for complying with
new or revised accounting standards pur suant to Section 107(b), include a
statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with new
or revised accounting standards under Sect ion 102(b)(1), provide a risk factor
explaining that this election allows you to delay the adoption of new or revised
accounting standards that have different effective dates for public and private
companies until those standards apply to pr ivate companies. Please state in your
risk factor that, as a resu lt of this election, your financial statements may not be
comparable to companies that comply with public company effective dates.
Include a similar statement in your critical accounting policy disclosures.
4. Please state expressly whether the research pe rformed at Massachusetts General Hospital
provides conclusive evidence that egg-produc ing cells exist in adult ovaries, that
precursor cells contribute to egg production in adults, and that egg- producing cells can be
grown and matured in an environment resemb ling an ovary. If controversy remains in
the scientific community as to these hypot heses, you should amend your disclosure to
note this and to discuss any potential ramifi cations, particularly how these uncertainties
cast doubt upon the possibility of developing AUGMENT and OvaTure. If appropriate,
you should amend your disclosure on the first pa ge of your registration statement, in the
risk factor beginning at the bottom of pa ge 32, and wherever else you discuss this
research and its implications.
Item 1. Business
Overview, page 1
5. Please provide additional information about the discovery pro cess relating to egg
precursor cells in adult mice, including the name of the laboratory as well as the type of
testing and research that was utilized.
Christopher Bleck OvaScience, Inc. May 8, 2012 Page 3
6. Please describe the “subsequent research” performed by your founder and others that
confirmed the existence of egg precursor cells in human ovaries , identify the other
individuals who performed this research and state the approximate dates that this research
was initiated and concluded.
AUGMENT, page 7
7. Please identify the independent institutional re view board that approved the protocol for
your AUGMENT study in December 2011, and the two IVF clinics where you plan to conduct the first phase of this study.
8. Please identify the database that will incl ude the results of the AUGMENT study and that
can be used to compare its results to those of other IVF clinical studies.
Government Regulation, page 16
9. In your analysis of whether AUGMENT will qualify as a 361 HCT/P on page 21 please
state, if true, either that it has a systemic ef fect or that it is dependent upon the metabolic
activity of living cells fo r its primary function.
Item 1A. Risk Factors
We will need substantial additional funding. If we are unable to raise capital when needed, we
would be forced to delay, reduce or el iminate our product development program or
commercialization efforts, page 31
10. Please include in this risk factor an estimate of the expenses you will incur in completing
your AUGMENT study and in launching comm ercial activities of this product.
Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are
the subject of standards and recommendations nu national non-governmental bodies . . .,” page
40
11. Please describe in this risk factor the voluntary guidelin es that you believe you should
either comply with or else potential ly harm your commercial prospects.
“If we are not able to obtain, or if there are de lays in obtaining, require d regulatory approvals, we
will not be able to commercialize OvaTure or other product candidates, and our ability to
generate revenue will be materially impaired,” page 42
12. This risk factor is substantially similar to the one on pages 34- 35. Please condense these
risk factors so as to avoid a ny repetition in your disclosure.
Christopher Bleck OvaScience, Inc. May 8, 2012 Page 4
Item 2. Financial Information
Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations
Stock-Based Compensation, page 70
13. Please expand your disclosure to in clude the following information:
For the contemporaneous and retrospectives va luations used to determine fair value,
please state, if true, that the valuatio ns were prepared by a related party;
Please describe the reverse backsolve a pproach to applying the option pricing
method, why it was the appropria te method at this stage of your development, and
disclose why you believe the most recent preferred stock financing is the best
indication of value;
Regarding your disclosure that a liquidity event was possible in three years, please
discuss why you believe that a sale was more likely to occur than an IPO or public
trading at December 7, 2011 considering your disclosure that in mid-to-late December your financial advisors introduced the possibility of undertaking the filing
of a Form 10 registration statemen t to become a public company; and
Continue to update your disclosure for al l equity related tran sactions through the
effectiveness date of th e registration statement.
Item 4. Security Ownership of Certain Be neficial Owners and Management, page 80
14. Please identify the individual(s) with voting an d/or dispositive power over the shares of
your common stock held by en tities affiliated with BBT Capital Management Advisors
LLC.
Item 15. Financial Statements
9. License Agreements, page F-18
15. Please revise your disclosure to explain why you classified the reimbursement of patent
and related costs incurred by MGH of $336,000 for licensed patents as a general and
administrative expense and not research and development.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
Christopher Bleck OvaScience, Inc. May 8, 2012 Page 5
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of the United States.
You may contact Keira Ino at (202) 551-3659 or Donald Abbott at (202) 551-3608 if you
have questions regarding comments on the financ ial statements and related matters. Please
contact Scot Foley at (202) 551-3383 or me at (202) 551-3715 with any other questions.
Sincerely,
/s/ Jeffrey Riedler
Jeffrey Riedler Assistant Director
cc: Lia Der Marderosian, Esq.
WilmerHale
60 State Street Boston, MA 02109
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