TPST

Announced positive interim data from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma (rrMM) Announced Cincinnati Children’s Applied Gene and Cell Therapy Center (“AGCTC”) as Lead Manufacturing Partner Appointed Andrew Fang, Ph.D., as Head of Business Development BRISBANE, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. “We made strong progress in the first quarter as we continued to execute across our lead program TPST-2003,” said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. “We advanced key activities supporting the planned initiation of our U.S. registrational study of TPST-2003 in patients with rrMM, including announcing our lead manufacturing partner AGCTC and taking delivery of the TPST-2003 lentiviral vector, a critical component in the manufacturing of TPST-2003. At the same time, we strengthened our ability to unlock value across our remaining portfolio with the appointment of Andrew Fang, Ph.D., as our Head of Business Development, whose focus on strategic partnerships, licensing and corporate transactions will help position us for long-term growth. We believe these milestones further reinforce our momentum and our path toward delivering meaningful impact for patients and shareholders alike.” Recent Highlights TPST-2003 Positive interim results across two ongoing clinical trials (REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, and POEMS-1 Phase 1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome), both of which are being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics: 100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across REDEEM-1 and POEMS-1 trials. Favorable safety profile with no Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in REDEEM-1 trial appears to be emerging as a potentially differentiating attribute in its class. Prior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 mont...

Completed strategic acquisition of dual-targeting CAR-T assets from Factor Bioscience Inc. Named Matt Angel, Ph.D., Chief Executive Officer & President Announced positive interim data from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma (rrMM) BRISBANE, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, today reported financial results for the year ended December 31, 2025, and provided a corporate update. “2025 was a transformative year for Tempest as we strengthened our pipeline with the strategic acquisition of a portfolio of next-generation CAR-T assets,” said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. “The portfolio is already proving potentially fruitful as we reported encouraging early clinical data from our lead CAR-T program, TPST-2003, which is being tested in a Phase 1/2a trial in patients with relapsed or refractory multiple myeloma. The data, which suggests a favorable safety and efficacy profile for TPST-2003, reinforced our belief that this therapy has the potential to differentiate itself from currently approved CAR-T treatments and provide a meaningful option for patients who continue to face limited durable treatment options. We look forward to the potential initiation of a U.S. registrational study of TPST-2003 in patients with rrMM later this year, while we continue our strategy of leveraging partner-funded and externally supported development where possible to advance our pipeline.” 2025 & Recent Accomplishments TPST-2003 Announced positive interim results from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, which is being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics: 100% complete response (CR) rate among all six efficacy evaluable patients as of the January 31, 2026 data cutoff Favorable safety profile with no Grade >3 cytokine release syndrome (“CRS”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”) appears to be emerging as a potentially differentiating attribute in its class Prior investigator-initiated trial (“IIT”) reached median progression free survival (PFS) of 23.1 months, including in patients with ex...

100% complete response (CR) rate among all six efficacy evaluable patients Favorable safety profile with no Grade >3 CRS or ICANS Prior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease 36 patients with relapsed/refractory multiple myeloma treated to date across two studies Tempest plans to submit a U.S. IND and, subject to clearance, initiate a U.S. registrational study in 2026 BRISBANE, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced cell therapy and small molecule product candidates to treat cancer, today announced clinical data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, a CD19/BCMA dual-targeting CAR-T therapy. TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma (“rrMM”) through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics (“Novatim”). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia. As of the January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 IIT and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, patients enrolled in the REDEEM-1 trial have received a median of four prior lines of therapy. All six patients currently evaluable for efficacy in the REDEEM-1 trial – three treated at dose level 1 (1 x 106 cells/kg) and three at dose level 2 (2 x 106 cells/kg) – achieved a CR according to the International Myeloma Working Group (IMWG) uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate (“ORR”) was 100% (25/25). Clinical responses were observed consistently across dose levels and study settings, which Tempest believes supports the reproducibility of TPST-2003’s parallel dual-targeting CAR architec...

BRISBANE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended September 30, 2025 and provided a corporate update. “We are continuing our strategic alternatives process with the goal of maximizing value for stockholders,” said Stephen Brady, president and chief executive officer of Tempest. “In addition, we look forward to the start of the TPST-1495 Phase 2 in collaboration with the NCI and the Cancer Prevention Clinical Trials Network and remain confident in the potential of amezalpat to transform the treatment of first-line HCC and bring meaningful benefit to patients and their families.” —————— 1 If approved by the U.S. Food and Drug Administration (FDA). Financial Results Third Quarter 2025 Tempest ended the quarter with $7.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company’s at-the-market offering program. Net loss and net loss per share for the quarter were $3.5 million and $0.79, respectively, compared to $10.6 million and $5.32, respectively, for the same period in 2024. Research and development expenses for the quarter were $0.6 million, compared to $7.6 million for the same period in 2024. The $7.0 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives. General and administrative expenses for the quarter were $3.0 million, compared to $3.0 million for the same period in 2024, and were primarily related to consulting and professional services. Year-to-Date Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million. Net loss and net loss per share for the nine months ended September 30, 2025 were $22.2 million and $5.71, respectively, compared to $28.0 million and $15.48, respectively, for the same period in 2024. Research and development expenses for the nine months ended September 30, 2025 were $12.1 million, compared to $17.7 million for the same period in 202...

Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China Granted orphan drug designation from the European Medicines Agency (EMA) for amezalpat for the treatment of patients with HCC Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual Meeting Granted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP) BRISBANE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended June 30, 2025 and provided a corporate update. “We are pleased to see the continued progress of our clinical oncology portfolio, including the recent clearance in China to initiate a pivotal trial of amezalpat combination therapy in first-line HCC, expanding on similar clearances we received in the U.S. and Europe from the FDA and EMA,” said Stephen Brady, president and chief executive officer of Tempest. “We believe these milestones reflect both the promise of our therapies and the dedication of the team who brought the programs to this point. We remain actively engaged in our strategic alternatives process with the goal of maximizing value for stockholders and patients.” ____________________ 1 If approved by the U.S. Food and Drug Administration (FDA). Recent Highlights Amezalpat (TPST-1120) (clinical PPARα antagonist): Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line HCC in China. Granted orphan drug designation from the EMA for amezalpat for the treatment of patients with HCC. Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting, supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment. Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC. TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): Granted Orphan Drug designation by the FDA to treat patients with FAP. Corporate: Announced cost-cutting measures and...

Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual Meeting Granted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP) Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAP Granted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC) BRISBANE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2025 and provided a corporate update. “The amezalpat program continues to produce data that reinforce its potential as a cancer therapy, most recently in a presentation at AACR showing that amezalpat reduced immunosuppression and activated the immune system to attack tumors. We were pleased to present these data that elucidate one part of the amezalpat mechanism of action and support the positive randomized Phase 2 data, including the benefit seen in patients with markers of immune resistance,” said Stephen Brady, president and chief executive officer of Tempest. “We are actively engaged in exploring strategic alternatives to advance our promising clinical-stage programs and maximize stockholder value and, given the data, continue to have strong conviction in the potential of our oncology portfolio to drive meaningful impact for patients facing cancer.” ________________ 1 If approved by the U.S. Food and Drug Administration (FDA). Recent Highlights Amezalpat (TPST-1120) (clinical PPARα antagonist): Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment. Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC. TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): Granted Orphan Drug designation by the FDA to treat patients with FAP. Received a “Study May Proceed” letter from the FDA for the Phase 2 trial for the treatment of...

• Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma (HCC) • Announced Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into First-Line HCC Pivotal Trial • Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of Familial Adenomatous Polyposis (FAP) BRISBANE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the year ended 2024 and provided a corporate update. “2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future,” said Stephen Brady, president and chief executive officer of Tempest. “Despite challenging capital markets, our lean team excelled, reporting key OS data from the ongoing randomized Phase 2 trial of amezalpat in first-line hepatocellular carcinoma. As previously announced, we have secured broad regulatory agreement with both the FDA and EMA on the Phase 3 plan and received both Orphan Drug and Fast Track designations from the FDA. We also advanced our second clinical program, TPST-1495, with a Phase 2 clinical trial for the treatment of patients with FAP, with data expected in 2026. Our focus remains on execution with excellence while securing the resources necessary to drive these promising drug candidates forward.” 2024 & Recent Accomplishments Amezalpat (TPST-1120) (clinical PPARα antagonist): Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC. Received a “Study May Proceed” letter from the FDA to evaluate amezalpat in combination with atezolizumab (TECENTRIQ®) and bevacizumab (Avastin®), the current standard of care for unresectable or metastatic HCC, in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC. Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC. Announced positive feedback from the end-of-Phase 2...