10-K: Tempest pivots to dual CAR‑T; cash runway tight

Tempest Therapeutics closed a share-funded CAR‑T asset deal, reported striking early multiple myeloma data, and outlined 2026 milestones, but flagged a going‑concern risk with just $7.7M in cash and reliance on an uncertain funding commitment.

Summary

• Closed the acquisition of dual‑targeting CAR‑T programs from Erigen/Factor on Feb 3, 2026, issuing 8,268,495 shares of common stock.
• Lead program TPST‑2003 (autologous CD19/BCMA CAR‑T for rrMM) showed 100% CR in 6/6 evaluable patients in the REDEEM‑1 Phase 1/2a trial and 100% ORR (25/25) across early studies; safety showed no Grade ≥3 CRS and no Grade ≥3 ICANS.
• Plans in 2026: submit an IND and potentially initiate a U.S. registrational study for TPST‑2003; China partner (Novatim) expects Phase 2b initiation by end‑2026 with interim data in 2027.
• Pipeline includes: TPST‑3003 (allogeneic CD19/BCMA; partner‑sponsored IIT potentially starting Q3 2026), TPST‑4003 (in vivo CD19/BCMA for lupus; partner‑sponsored IIT potentially starting Q2 2026), TPST‑2206 (autologous CD70/CD70; China Phase 1 planned Q2 2026), and TPST‑3206 (allogeneic CD70/CD70).
• Amezalpat (PPARα antagonist) is Phase 3‑ready in 1L HCC with positive randomized Phase 1b/2 data: median OS 21 months vs 15 months control (HR 0.65); FDA End‑of‑Phase 2 alignment (Aug 2024), Study May Proceed (Nov 2024), U.S. ODD (Jan 2025), FTD (Feb 2025), EMA ODD (Jun 2025); pursuing business development for pivotal trial.
• TPST‑1495 (dual EP2/EP4) to enter NCI‑funded Phase 2 in FAP in 2026 (Study May Proceed received Mar 2025).
• Cash and cash equivalents were $7.7M at Dec 31, 2025 (vs. $30.3M in 2024); net loss of $26.3M in 2025 (vs. $41.8M in 2024); R&D $12.6M and G&A $14.0M.
• Going‑concern substantial doubt: expects cash to fund operations for less than 12 months; has a funding commitment from Factor up to $20.0M (inclusive of amounts raised post‑APA), with $13.75M available as of filing, but timing and ability to satisfy conditions are uncertain.
• Capital actions: reverse stock split (1‑for‑13) on Apr 8, 2025; Warrant Dividend issued Feb 3, 2026 (6,784,989 warrants at $18.48, expiring Feb 3, 2031); RDOs in Jun 2025 (~$4.1M) and Nov 2025 (~$3.8M); ATM sales (~$2.8M) in 2025; Private Placement Mar 20, 2026 (~$2.0M gross) with pre‑funded and common warrants.
• Rights Plan (stockholder rights plan) approved Jan 27, 2026; rights now expire Oct 10, 2026, designed to deter accumulations >10% (15% for passive institutions).

Sentiment

Score: 4

Explanation: StockSavvy.ai views this as strategically positive on clinical potential but financially constrained: early CAR‑T data are strong, yet the going‑concern warning, small cash balance, uncertain funding commitment, and dilution overhang weigh heavily on risk.

Positives

• Compelling early efficacy for TPST‑2003 in rrMM: 100% CR (6/6) in REDEEM‑1 evaluable patients; 100% ORR (25/25) across early studies; favorable safety (no Grade ≥3 CRS or ICANS reported).
• Clear 2026 development path: planned U.S. IND and potential registrational study for TPST‑2003; China partner funding Phase 2b by end‑2026 with interim data in 2027.
• Amezalpat shows clinically meaningful survival signal in 1L HCC (median OS 21 vs 15 months; HR 0.65) with FDA End‑of‑Phase 2 alignment, Study May Proceed, ODD (US & EU), and FTD—Phase 3‑ready pending BD.
• TPST‑1495 Phase 2 in FAP is NCI‑funded via CP‑CTNet, reducing internal capital needs.
• Debt de‑risked: repaid Oxford loan in April 2025; no long‑term debt outstanding at year‑end.
• Strategic collaborations/licensing: Novatim and Factor deals broaden CAR‑T modalities (autologous, allogeneic, in vivo) with large commercial milestone potential and modest running royalties.

Negatives

• Going‑concern substantial doubt: $7.7M year‑end cash funds operations for less than 12 months; reliance on an uncertain funding commitment (up to $20.0M with $13.75M remaining) creates execution risk.
• Material near‑ and long‑term capital needs across CAR‑T and small molecule programs; recent raises were small (ATM ~$2.8M; RDOs ~$7.9M; Private Placement ~$2.0M).
• Significant future milestone and royalty obligations: up to $80M dev and $1.24B commercial to Novatim; up to $40M dev and $620M commercial to Factor; running royalties mid‑single to high‑teens.
• Potential dilution overhang from issued shares (8,268,495 to Erigen) and large warrant overhang (6,784,989 dividend warrants at $18.48; additional Series A/B warrants).
• Clinical datasets for TPST‑2003 are early, small, and China‑generated; U.S. and EU regulators may limit reliance on ex‑U.S. data.
• Operating scale is minimal (four employees as of Mar 1, 2026), increasing reliance on partners and CDMOs.

Risks

• Ability to continue as a going concern; failure to secure additional capital could force delay, reduction, or wind‑down of operations.
• Uncertainty of access to the Factor funding commitment (up to $20.0M), including meeting conditions and timing of any funding.
• Regulatory acceptance of China‑generated data from Novatim‑led studies may be limited by FDA or other agencies.
• Dependence on third parties for clinical development, manufacturing (CDMOs), and supply may lead to delays, quality issues, or higher costs.
• Competition in CAR‑T (BCMA and dual‑targeting) and HCC is intense; competitors may advance faster or show superior efficacy/safety.
• Stock price volatility, thin trading, and Nasdaq listing risk; anti‑takeover provisions (Rights Plan, staggered board) may impact corporate actions.
• Potential need for significant additional dilutive equity financings or costly partnerships to fund pivotal studies.
• Milestone/royalty obligations to licensors reduce future economics and may constrain strategic options.

Future Outlook

Focus in 2026 is on TPST‑2003: submit an IND and, subject to FDA clearance, potentially initiate a U.S. registrational study; China partner expects to start a registrational Phase 2b by end‑2026 with interim data in 2027. Amezalpat remains Phase 3‑ready in 1L HCC with plans to secure a partner to fund pivotal development. TPST‑1495 Phase 2 in FAP is planned to start in 2026 with NCI funding. The company aims to progress allogeneic and in vivo CAR‑T programs via partner‑sponsored investigator‑initiated trials while maintaining a capital‑efficient posture.

Management Comments

• Prioritizing a capital‑efficient development strategy across the portfolio, seeking partner support, external funding, and staged investments based on data and regulatory feedback.
• The safety and depth of response observed with TPST‑2003 support accelerating interactions with FDA and planning for a potential U.S. registrational study in 2026.
• Amezalpat is Phase 3‑ready in first‑line HCC following positive randomized Phase 1b/2 data and FDA alignment; the path forward is via business development.
• The NCI‑funded TPST‑1495 FAP study enables advancement with limited internal capital deployment.

Industry Context

StockSavvy.ai notes that dual‑targeting CAR‑T approaches (e.g., CD19/BCMA) are a key competitive frontier in refractory multiple myeloma, with large incumbents (Johnson & Johnson/Legend, BMS, AstraZeneca) advancing BCMA‑based and dual constructs; demonstrating durable responses with manageable CRS/ICANS is critical. In first‑line HCC, the bar is high given prior IO/TKI combinations (e.g., atezolizumab+bevacizumab), making Tempest’s reported six‑month OS improvement noteworthy but requiring confirmation in a pivotal trial. Regulatory acceptance of China‑generated datasets will be closely scrutinized in the U.S. and EU.

Comparison to Industry Standards

• Multiple Myeloma CAR‑T: Tempest reports 100% CR in 6/6 evaluable REDEEM‑1 patients and 100% ORR (25/25) across early studies, with median PFS 23.1 months in an IIT. By comparison, approved BCMA CAR‑Ts such as cilta‑cel (J&J/Legend) and ide‑cel (BMS) have shown high ORR (~73–97%) and deep responses in larger studies; however, Tempest’s sample size is small and from China‑led studies, and longer follow‑up in broader populations is needed to benchmark durability and safety (CRS/ICANS) rigorously.
• HCC first‑line: Amezalpat + atezolizumab/bevacizumab achieved median OS 21 months vs 15 months (HR 0.65) in randomized Phase 1b/2. In IMbrave150, atezolizumab+bevacizumab reported median OS around 19 months in updated analyses, suggesting Tempest’s exploratory data are competitive; definitive assessment awaits a pivotal trial with OS as primary endpoint.
• Safety: Reported absence of Grade ≥3 CRS and ICANS with TPST‑2003 at early stages compares favorably to the known risk profiles of current CAR‑Ts; confirmation in larger, global studies will be key.
• Regulatory momentum: End‑of‑Phase 2 FDA alignment and FTD for amezalpat are consistent with pathways leveraged by peers for expedited development in high‑need indications.

Management Changes

Corporate Governance

Legal Proceedings

• No material legal proceedings disclosed.

Related Party Transactions

• Acquired CAR‑T assets from Erigen LLC and Factor Bioscience Inc.; issued 8,268,495 shares at closing on Feb 3, 2026.
• Entered into a funding commitment letter with Factor to provide up to $20.0M in financial support (inclusive of other financings) for at least 18 months post‑closing, subject to conditions; $13.75M available as of filing.
• Amended and Restated License and Collaboration Agreement with Factor Bioscience Limited for TPST‑3003 and TPST‑3206 (milestones up to $660M and royalties mid‑single to high‑teens).
• Amended and Restated Master Services Agreement with Factor Bioscience Inc. to provide services on a fee‑for‑service basis.
• March 20, 2026 Private Placement included Factor as an investor (231,482 shares and accompanying warrants).

Stakeholder Impact

• Shareholders: Significant dilution from the CAR‑T asset share issuance and warrant overhang; potential further dilution from future capital raises.
• Employees: 2025 reduction‑in‑force and shift to capital‑efficient strategy; equity plan amendment increases potential employee equity grants.
• Partners: Increased reliance on Novatim (China trials/funding) and Factor (services/licensing); execution risk distributed across partners.
• Customers/Patients: Potential for impactful therapies in rrMM and HCC if pivotal programs are funded and successful.
• Creditors: Oxford loan repaid; reduced creditor risk.

Next Steps

• Submit IND for TPST‑2003 in 2026 and, subject to FDA clearance, potentially initiate a U.S. registrational study in 2026.
• China partner (Novatim) to initiate a registrational Phase 2b study for TPST‑2003 by end‑2026; interim data expected in 2027.
• Present additional REDEEM‑1 and updated IIT results at a scientific meeting in 2026.
• Initiate NCI‑funded Phase 2 TPST‑1495 study in FAP in 2026.
• Advance TPST‑3003 and TPST‑4003 via partner‑sponsored IITs (planned Q3 2026 and Q2 2026 starts, respectively).
• TPST‑2206 China Phase 1 in RCC planned to begin Q2 2026; assess ex‑China development based on data.
• Pursue business development to fund amezalpat Phase 3 in first‑line HCC.
• File registration statement to register Warrant Dividend shares for exercise; pursue stockholder approval for March 2026 Private Placement warrant share issuance within 90 days.

Key Dates

Recommendation

Strong early CAR‑T efficacy signals and Phase 3‑ready HCC asset are offset by acute financing risk, heavy future obligations, and data generalizability questions. A hold stance is warranted pending clarity on funding, U.S. IND progress for TPST‑2003, and BD for amezalpat.

Keywords

CAR-T, dual-targeting, BCMA, CD19, HCC, PPAR alpha, amezalpat, Fast Track, Orphan Drug, FAP, EP2/EP4, Novatim, Factor Bioscience, Rights Plan, Warrant Dividend, Going Concern, Private Placement, Registered Direct Offering, Multiple Myeloma, Lupus