Tempest Reports Third Quarter 2026 Financial Results and Provides Business Update

(NASDAQ:TPST) Tempest Therapeutics, Inc. reported financial results for the quarter ended September 30, 2026, and provided a business update. The company exercised its option under an agreement with Hebei Senlang Biotechnology Co., Ltd. to obtain an exclusive license to develop and commercialize Senlang’s CD7-targeted lentiviral vector platform and associated in vivo CAR-T candidates worldwide, excluding China. The lead program, TPST-4903, is a BCMA/GPRC5D dual-targeting in vivo CAR-T candidate currently being evaluated in a Phase 1 dose-escalation study in patients with relapsed or refractory multiple myeloma (rrMM), with initial data expected to be presented at an upcoming scientific conference. Tempest unveiled its next-generation in vivo CAR-T pipeline, including lead product candidate TPST-4003, a dual-targeting CD19/BCMA in vivo CAR-T candidate. In July 2026, Tempest executed a strategic partnership with Hebei Senlang Biotechnology to collaborate on the development of proprietary in vivo CAR-T product candidates, including TPST-4003. An investigator-initiated trial in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis or multiple sclerosis is expected to begin in the fourth quarter of 2026. In September 2026, Tempest completed a private placement of pre-funded warrants and Series C and D warrants for gross proceeds of approximately $2.5 million (approximately $1.8 million net of placement agent fees and offering expenses), excluding up to approximately $5.0 million of gross proceeds that may be received upon the cash exercise of the Series C and D warrants. On August 13, 2026, Tempest entered into a purchase agreement with Lincoln Park Capital Fund, LLC, giving the company the right to sell up to $25.0 million of its common stock, increasing to $50.0 million if the initial amount is sold, over a 24-month period beginning September 1, 2026. Through September 30, 2026, Tempest sold 350,000 shares to Lincoln Park for gross proceeds of approximately $0.3 million. The Board of Directors was strengthened with the appointments of independent directors Nancy Freda-Smith and John W. Frederick. Tempest ended the quarter with $0.9 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. Net loss and net loss per share for the quarter were $3.6 million and $0.21, respectively, compared to $3.5 million and $0.79 for the same period in 2025. Research and development expenses for the quarter were $0.2 million, compared to $0.6 million for the same period in 2025. General and administrative expenses for the quarter were $2.6 million, compared to $3.0 million for the same period in 2025. Financing costs related to the Lincoln Park equity line of credit for the quarter were $0.8 million, consisting of $0.66 million for the fair value of commitment shares issued to Lincoln Park and $0.15 million of issuance costs. For the nine months ended September 30, 2026, cash used in operating activities was $12.4 million. Net loss and net loss per share for the nine months ended September 30, 2026 were $36.6 million and $2.54, respectively, compared to $22.2 million and $5.71 for the same period in 2025. Research and development expenses for the nine months ended September 30, 2026 were $2.1 million, compared to $12.1 million for the same period in 2025. General and administrative expenses for the nine months ended September 30, 2026 were $11.5 million, compared to $10.4 million for the same period in 2025. Acquired in-process research and development expenses for the nine months ended September 30, 2026 were $22.2 million, compared to nil for the same period in 2025. As of September 30, 2026, total assets were $8.76 million and total liabilities were $10.59 million. There is substantial doubt about the company’s ability to continue as a going concern, as existing cash and cash equivalents are expected to fund projected operating expense requirements for less than 12 months from the date the financial statements were available to be issued.

Tempest Announces Development Collaboration with Senlang Biotechnology for TPST-4003, a CD7-Targeted Next-Generation In Vivo CAR-T

(NASDAQ:TPST) Tempest Therapeutics, Inc. announced a strategic partnership with Hebei Senlang Biotechnology Co., Ltd. to develop Tempest’s proprietary TPST-4003 product candidate, beginning with an investigator-initiated trial in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis or multiple sclerosis. The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026. The initial study is designed to generate clinical evidence of safety, pharmacodynamic activity, and therapeutic potential of TPST-4003, building on promising findings from related pipeline preclinical and clinical research. Senlang will coordinate and support trial execution in China and has been granted an exclusive option to negotiate and enter into a definitive license agreement for TPST-4003 in China. Key assessments in the trial are expected to include treatment-emergent adverse events, generation and expansion of peripheral blood CD4+ and CD8+ CAR-T cells and CD56+ CAR-NK cells, CAR transgene copy number, and the depth and kinetics of CD19+ B-cell depletion and B-cell subset reconstitution. The company expects initial safety and pharmacodynamic data from the first patients as early as the first half of 2027. The initial trial is expected to assess the safety, cellular kinetics and pharmacodynamic activity of TPST-4003 in patients with MG or MS.

Tempest Unveils Next-Generation In Vivo CAR-T Pipeline, with First Clinical Study Planned for the Fourth Quarter of 2026

(NASDAQ: TPST) Tempest Therapeutics, Inc. announced details of its next-generation in vivo CAR-T platform and plans to advance TPST-4003, its lead in vivo CAR-T product candidate, into a first investigator-initiated clinical trial in patients with nervous system autoimmune diseases. The trial is expected to enroll approximately 10 patients, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first half of 2027. TPST-4003 combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-targeting CD19/BCMA CAR construct. Interim Phase 1/2a clinical data generated with TPST-2003 demonstrated a 100% complete response rate and successful U.S. manufacturing. Initial study planning has involved discussions with six prospective clinical centers and principal investigators experienced in neurological autoimmune diseases. The company projects that initial safety and pharmacodynamic data from the first patients are expected in the first half of 2027, followed by an interim clinical update including preliminary safety, pharmacodynamic and efficacy data in the second half of 2027.

Tempest Therapeutics Announces Warrant Exercise for Approximately $2 Million in Gross Proceeds

Tempest Therapeutics, Inc. announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase an aggregate of 1,172,414 shares of the Company's common stock at a reduced exercise price of $1.73 per share. The original exercise price of these warrants was $3.50 per share, and they were originally issued on November 26, 2025. The closing of the warrant exercise transaction is expected to occur on or about May 29, 2025, subject to satisfaction of customary closing conditions. As consideration for the exercise of such existing warrants for cash, the Company will issue new unregistered short-term warrants to purchase up to an aggregate of 2,344,828 shares of common stock at an exercise price of $1.73 per share. The aggregate gross proceeds from the exercise of the existing warrants are expected to be approximately $2 million, before deducting placement agent fees and other offering expenses payable by the Company. The additional potential gross proceeds from the new short-term warrants, if fully exercised on a cash basis, will be approximately $4 million. The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes. H.C. Wainwright is acting as the exclusive placement agent for the transaction.

Tempest Presents Clinical Update at ISCT 2026 Annual Meeting

Tempest Therapeutics, Inc. (NASDAQ:TPST) presented new clinical data for its lead dual-targeting CAR-T therapy, TPST-2003, at the ISCT Annual Meeting in Dublin, Ireland. The company reported a 100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across two ongoing Phase 1 trials (REDEEM-1 and POEMS-1). In the POEMS-1 trial, all five evaluable patients achieved a 100% CR VEGF rate within two months. To date, 44 patients have been treated with TPST-2003 across three studies, and the therapy demonstrated a favorable safety profile with no Grade > 3 CRS or ICANS. These results support the clinical benefit of TPST-2003 and its potential as a class-leading therapy for relapsed/refractory multiple myeloma (rrMM) if replicated in registrational trials.

Tempest to Advance Dual-Targeting CAR-T Platform with Clinical Update at ISCT 2026 Annual Meeting

Tempest Therapeutics, Inc. (NASDAQ:TPST) announced it will present recent clinical data for its dual-targeting CAR-T therapy candidate TPST-2003 at the ISCT Annual Meeting in Dublin, May 6-9, 2026. Interim data from the ongoing REDEEM-1 Phase 1/2a trial showed a 100% complete response rate among all six efficacy then-evaluable patients, with a favorable safety profile. The REDEEM-1 trial targets full enrollment of 29 patients and is being conducted at eight clinical sites in China by Novatim Immune Therapeutics. Additional trials are underway for TPST-2003 in multiple myeloma and POEMS syndrome. The company highlights the potential of TPST-2003 to improve outcomes for patients with relapsed/refractory multiple myeloma, including those with extramedullary disease.