Correspondence 0001193125-25-330311 from Tempest Therapeutics, Inc. (TPST)
Tempest Therapeutics, Inc.
Date: Dec. 23, 2025 · CIK: 0001544227 · Accession: 0001193125-25-330311
AI Filing Summary & Sentiment
File numbers found in text: 333-292026
Referenced dates: December 12, 2025
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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