Core Insights - Tempest Therapeutics announced promising clinical data from the ongoing REDEEM-1 Phase 1/2a trial for TPST-2003, a dual-targeting CAR-T therapy for relapsed/refractory multiple myeloma [1][6] Clinical Data Summary - TPST-2003 is designed to enhance response depth and durability in patients with relapsed/refractory multiple myeloma through a dual-targeting CAR structure [2] - As of January 31, 2026, 36 patients with relapsed/refractory multiple myeloma have received TPST-2003, with a median of four prior lines of therapy [3] - All six evaluable patients in the REDEEM-1 trial achieved a complete response (CR), resulting in an overall response rate (ORR) of 100% among 25 evaluable patients [4][8] Safety Profile - TPST-2003 demonstrated a favorable safety profile across all dose levels, with no Grade >3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [7][9] - The prior investigator-initiated trial (IIT) showed a median progression-free survival (PFS) of 23.1 months, including patients with extramedullary disease [8][10] Future Development Plans - Tempest plans to accelerate the development of TPST-2003 and intends to submit a U.S. IND application, aiming to initiate a U.S. registrational study in 2026 [6][15] - The company is also exploring the potential of TPST-2003 for treating large B-cell lymphoma and other related indications [6][12] Treatment Landscape - Approved CAR-T therapies have shown clinical benefits in relapsed/refractory multiple myeloma, but challenges such as relapse and toxicity management remain prevalent [13] - TPST-2003's dual-targeting CAR structure aims to address tumor heterogeneity and antigen escape, which are significant factors in disease progression [14]

Core Insights - Tempest Therapeutics, Inc. is advancing its CAR-T assets post-transaction while maintaining a capital-efficient operational model [1][6] Strategic Priorities - The company will prioritize the development of its dual-targeting CD19/BCMA CAR-T program, TPST-2003, with clinical data expected from an ongoing Phase 1 trial in China and a registrational Phase 2b trial anticipated to start by the end of 2026 [2][3] - TPST-4003, an in vivo CAR-T program, aims to deliver the same dual-targeting construct without ex vivo cell manufacturing, with plans for preclinical development and potential clinical entry through a partner-funded trial [4][6] - Amezalpat is positioned for pivotal development in first-line hepatocellular carcinoma (HCC), with plans for business development discussions to advance this program [4] - The company plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis (FAP), with first patient enrollment expected in Q1 2026, funded by the National Cancer Institute [5][6] Pipeline Expansion - Tempest is expanding its next-generation CAR-T pipeline, which includes additional dual-targeting CAR-T programs such as TPST-3003, TPST-2206, and TPST-3206 [6][7]

Core Insights - Tempest Therapeutics, Inc. has successfully closed an all-stock transaction to acquire dual-targeting CAR-T programs and secured financing support from Factor Bioscience Inc., enhancing its portfolio and operational runway [1][4] Group 1: Transaction Details - The transaction includes a diverse portfolio of clinical-stage product candidates and extends the operational runway to mid-2027, supporting multiple potential value-generating milestones [1][4] - The acquisition brings next-generation CAR-T assets, including TPST-2003, a dual-targeting CD-19/BCMA CAR-T, with a biologics license application (BLA) filing in China planned for 2027 [4][5] - The transaction was finalized following stockholder approval of share issuance at the 2025 Annual Meeting on January 27, 2026 [4] Group 2: Leadership Changes - Dr. Matt Angel has joined Tempest as President and CEO, expressing excitement about developing the innovative pipeline for treating solid tumors and hematologic malignancies [2][4] - Stephen Brady, Chair of the Board, acknowledged the contributions of outgoing board members and emphasized the importance of the transaction for the company's financial stability and future milestones [2][3] Group 3: Pipeline Developments - Amezalpat (TPST-1120) is ready for Phase 3 trials in first-line liver cancer, supported by global regulatory agreement and positive Phase 2 data [5] - TPST-2003 has completed Phase 1 trials in patients with relapsed/refractory multiple myeloma, with data expected in 2026 and a BLA in China planned for 2027 [5] - Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis (FAP) in Q1 2026, funded by the National Cancer Institute [5][11]

BRISBANE, Calif., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company with a pipeline of targeted and immune-mediated therapeutics to fight cancer, today announced the record date of January 30, 2026 (the “Record Date”) for the distribution of warrants to purchase Tempest common stock (“Warrants”) as a dividend (the “Warrant Dividends”), as contemplated by Tempest’s previously announced Asset Purchase Agreement (the “Asset Purchase ...

Table of Contents FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TEMPEST THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 45-1472564 (Primary Standard Industrial Code Number) As filed with the Securities and Exchange Commission on December 9, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (I.R.S. Employer Identification Number) 2000 Sierr ...

Core Viewpoint - Tempest Therapeutics, Inc. has successfully closed a registered direct offering, raising approximately $4.25 million, with potential additional proceeds of up to $4.1 million from short-term unregistered warrants [1][3]. Group 1: Offering Details - The company sold 1,172,414 shares of common stock at an offering price of $3.625 per share [1]. - Concurrently, short-term unregistered warrants were issued to purchase an additional 1,172,414 shares at an exercise price of $3.50 per share, which are immediately exercisable and will expire in eighteen months [1][3]. - The total gross proceeds from the offering are approximately $4.25 million before deducting fees and expenses [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for working capital and general corporate purposes [3]. Group 3: Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [7].

Core Viewpoint - Tempest Therapeutics, Inc. has entered into a definitive agreement for a registered direct offering of common stock, aiming to raise approximately $4.25 million, with potential additional proceeds of up to $4.1 million from short-term unregistered warrants [1][3]. Group 1: Offering Details - The company will sell 1,172,414 shares of common stock at an offering price of $3.625 per share [1]. - Concurrently, short-term unregistered warrants will be issued to purchase an additional 1,172,414 shares at an exercise price of $3.50 per share, which will be immediately exercisable and expire in eighteen months [1][3]. - The closing of the offering is expected to occur on or about November 25, 2025, subject to customary closing conditions [1]. Group 2: Financial Implications - The aggregate gross proceeds from the offering are expected to be approximately $4.25 million before deducting fees and expenses [3]. - If the short-term unregistered warrants are fully exercised, the potential additional gross proceeds could reach approximately $4.1 million [3]. - The net proceeds from this offering are intended primarily for working capital and general corporate purposes [3]. Group 3: Regulatory and Compliance Information - The shares are being offered under a "shelf" registration statement filed with the SEC, which was declared effective on January 27, 2025 [4]. - The short-term unregistered warrants are offered in a private placement and have not been registered under the Securities Act [5].

Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Core Viewpoint - Tempest Therapeutics, Inc. has announced an all-stock acquisition of dual-targeting CAR-T programs from Factor Bioscience, aimed at expanding its clinical pipeline and extending its operational runway to mid-2027 [1][2][4] Group 1: Acquisition Details - The acquisition includes the first clinical-stage CD19/BCMA dual-CAR T program, TPST-2003, designed for patients with extramedullary disease [2][3] - Tempest will issue 8,268,495 shares of common stock to Factor, representing 65% of the outstanding shares post-transaction [9] - The transaction is expected to close in early 2026, pending stockholder approval and other customary conditions [12] Group 2: Pipeline Expansion - The acquisition will diversify Tempest's pipeline, which includes amezalpat (Phase 3-ready) and TPST-1495 (Phase 2 expected to start soon) [3][4] - TPST-2003 has completed Phase 1 trials in patients with relapsed multiple myeloma, with data expected in 2026 and a biologics license application planned for 2027 in China [4] - Tempest plans to continue developing additional preclinical and research-stage programs, including TPST-2206 and TPST-3003 [4] Group 3: Financial and Operational Outlook - Existing cash and an investment commitment from Factor are expected to support operations through mid-2027, including key development milestones [2][9] - The company plans to pursue business development discussions or additional financing to advance the pivotal development of amezalpat in first-line liver cancer [4] - The anticipated preclosing equity financing is expected to extend Tempest's runway and support significant milestones [3][4] Group 4: Leadership Changes - Upon closing, Matt Angel, Ph.D., will become the President and CEO, while Stephen Brady will transition to Chairman of the board [3][9] - Dr. Angel has extensive experience in biotechnology and cell therapy, having previously led Factor Bioscience and other cell therapy companies [8][10]

Financial Position - As of September 30, 2025, the company had cash and cash equivalents totaling $7.5 million, down from $30.3 million as of December 31, 2024[96]. - The accumulated deficit as of September 30, 2025, is $229.3 million, indicating ongoing financial challenges[96]. - As of September 30, 2025, the company had $3.5 million in material cash requirements payable within 12 months, including $1.1 million related to the Brisbane Lease[136]. - The primary use of cash is to fund operating expenses, primarily research and development expenditures, headcount costs, and lease expenses[135]. - The company has no long-term debt and no material non-cancelable purchase commitments with service providers[137]. - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates less than $700 million[140]. Research and Development - Research and development expenses for Q3 2025 were $570,000, a decrease of 92% compared to $7.6 million in Q3 2024[108]. - Total research and development expenses for the nine months ended September 30, 2025, were $12.1 million, a decrease of $5.6 million (32%) from $17.7 million in the same period in 2024[114]. - Amezalpat research costs for the nine months ended September 30, 2025, were $5.3 million, down 24% from $7.0 million in 2024[116]. - Research and development expenses decreased by $7.0 million to $0.6 million for the three months ended September 30, 2025, compared to $7.6 million for the same period in 2024, primarily due to re-prioritizing efforts towards exploring strategic alternatives[110]. Clinical Trials and Designations - Amezalpat is set to begin a pivotal Phase 3 study in first-line hepatocellular carcinoma (HCC), with positive feedback received from the FDA on the trial design[90]. - The FDA granted Orphan Drug Designation for amezalpat in January 2025, and Fast Track Designation in February 2025, which may provide regulatory advantages[91][92]. - TPST-1495 is expected to enter a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in late 2025, pending potential delays due to the U.S. government shutdown[94]. Expenses and Losses - General and administrative expenses for Q3 2025 were $3.0 million, a slight increase of 1% from $2.99 million in Q3 2024[108]. - The net loss for Q3 2025 was $3.5 million, a reduction of 67% compared to a net loss of $10.6 million in Q3 2024[108]. - General and administrative expenses remained stable at $3.0 million for the three months ended September 30, 2025, compared to the same period in 2024[112]. - Interest expense related to the Oxford Loan was eliminated in the three months ended September 30, 2025, compared to $329 thousand in the same period in 2024[113]. - Cash used in operating activities for the nine months ended September 30, 2025, was $23.2 million, compared to $22.9 million in 2024[128]. - Cash used in operating activities for the nine months ended September 30, 2024, was $22.9 million, with a net loss of $28.0 million[130]. Financing Activities - The company repaid the Oxford Loan in full in April 2025, which had a total outstanding amount of $3.5 million[123]. - The company sold 312,830 shares of common stock for proceeds of $2.8 million under the ATM Program as of September 30, 2025[125]. - The net proceeds from a registered direct offering on June 11, 2025, were approximately $4.1 million after deducting fees and expenses[127]. - Cash provided by financing activities for the nine months ended September 30, 2025, included net proceeds from a registered direct offering of $4.1 million[133]. - Cash provided by financing activities for the nine months ended September 30, 2024, included proceeds from the issuance of common stock totaling $8.8 million[134]. Stock and Corporate Actions - A one-for-thirteen reverse stock split was executed on April 8, 2025, adjusting the number of shares and options accordingly[101]. - There have been no significant changes to critical accounting policies since December 31, 2024[138].