8-K: Tempest posts 2025 loss; CAR-T shows 100% CR

Tempest Therapeutics reported a narrower 2025 loss with $7.7M cash, unveiled 100% CR in early rrMM CAR-T data, closed CAR-T asset acquisition, and outlined 2026 registrational study plans.

Summary

• Reported 2025 net loss of $26.3M ($6.33/share) versus $41.8M ($19.50/share) in 2024; year-end cash and equivalents were $7.7M (down from $30.3M at 2024 year-end).
• R&D expense decreased to $12.6M (from $28.5M in 2024) as efforts were reprioritized; G&A was $14.0M (vs. $13.6M in 2024), reflecting one-time separation costs.
• TPST-2003 dual-targeting CD19/BCMA CAR-T in rrMM showed 100% complete response among 6 efficacy-evaluable patients as of the January 31, 2026 cutoff, with no Grade >3 CRS or ICANS; 36 rrMM patients have been treated across two studies; prior IIT reached median PFS of 23.1 months.
• Completed an all-stock acquisition of next-generation CAR-T assets from Factor Bioscience, including TPST-2003; partner Novatim Immune Therapeutics is sponsoring REDEEM-1 and targets a partner-funded China BLA filing in 2027.
• Financed operations with equity: June 2025 RDO netted $4.1M, November 2025 offering up to $8.35M generated $3.8M net proceeds in 2025, and $2.8M from an ATM program; in March 2026, announced a private placement of up to $6M ($2M upfront, up to $4M via warrants).
• Amezalpat (TPST-1120) for HCC received FDA Orphan Drug and Fast Track designations, EMA Orphan Drug designation, China pivotal trial clearance, and supportive AACR 2025 data.
• TPST-1495 received FDA Orphan Drug designation for FAP and a Study May Proceed letter; a Phase 2 FAP study is planned for 2026 and is expected to be NCI-funded via the Cancer Prevention Clinical Trials Network.
• Matt Angel, Ph.D., was named Chief Executive Officer & President.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this as moderately positive: compelling early CAR-T signals and regulatory momentum are offset by a very limited cash runway, continued losses, small clinical sample size, and ongoing financing needs.

Positives

• TPST-2003 early efficacy: 100% CR among 6 efficacy-evaluable rrMM patients with no Grade >3 CRS/ICANS, suggesting a potentially favorable safety/efficacy profile.
• Durability signal: prior IIT reported median PFS of 23.1 months, including patients with extramedullary disease.
• Partner-supported development reduces cash needs (partner-sponsored REDEEM-1 and planned, partner-funded China BLA in 2027).
• Multiple regulatory tailwinds: FDA Orphan and Fast Track (amezalpat/HCC), EMA Orphan (HCC), China pivotal clearance (amezalpat).
• Operating profile improved: net loss narrowed to $26.3M from $41.8M; R&D down by $15.9M year over year.
• TPST-1495 Phase 2 in FAP expected to be NCI-funded in 2026, enabling progress without internal capital outlay.
• Strategic CAR-T asset acquisition broadens pipeline and provides a clinical-stage lead (TPST-2003).

Negatives

• Cash and equivalents dropped to $7.7M at 12/31/2025 from $30.3M a year earlier, indicating a limited runway.
• Continuing operating losses ($26.6M operating loss in 2025) and negative cash burn necessitate additional financing.
• G&A rose to $14.0M (from $13.6M) due to separation costs, reflecting restructuring-related expenses.
• Key TPST-2003 dataset remains small (n=6 efficacy-evaluable), with U.S. IND submission still pending.
• Shareholder dilution risk elevated due to 2025–2026 equity financings, outstanding warrants, and a 1-for-13 reverse stock split in April 2025.

Risks

• Need for additional capital to fund planned programs and continue as a going concern.
• Unexpected safety or efficacy data could arise in ongoing or planned trials.
• Prior preclinical/clinical results may not predict future outcomes; past results may not be indicative of future results.
• Clinical trial site activation or patient enrollment may be slower than expected.
• Loss of key personnel could impair execution.
• Competitive dynamics and regulatory changes may adversely affect development.
• Volatility and uncertainty in biotech capital markets may restrict financing access.
• Potential for unexpected litigation or disputes.

Future Outlook

Plans in 2026 include presenting additional REDEEM-1 results, submitting a U.S. IND, and, subject to clearance, initiating a Phase 2b U.S. registrational study for TPST-2003 in rrMM; initiating an NCI-funded Phase 2 study of TPST-1495 in FAP with first patient expected in 2026; and supporting partner-led efforts toward a planned, partner-funded China BLA filing for TPST-2003 in 2027, while continuing to leverage partner-funded and externally supported development.

Management Comments

• 2025 was described as transformative, highlighted by the strategic acquisition of next-generation CAR-T assets.
• Early TPST-2003 clinical data suggest a favorable safety and efficacy profile with potential differentiation from currently approved CAR-Ts.
• The team aims to initiate a U.S. registrational study of TPST-2003 in rrMM later in 2026, while leveraging partner-funded and externally supported development to advance the pipeline.

Industry Context

StockSavvy.ai notes that dual-targeting CAR-T approaches in multiple myeloma aim to address antigen escape and durability limitations seen with BCMA-only therapies like Carvykti (J&J/Legend) and Abecma (BMS/2seventy). A 100% CR rate in six evaluable patients with no Grade >3 CRS/ICANS is encouraging for an early dataset and aligns with industry interest in multi-target CAR-Ts (e.g., academic and China-based programs such as Gracell’s dual-targeting efforts). However, the very small sample size and the company’s limited cash balance reflect typical early-stage biotech risk factors amid a challenging capital-raising environment.

Comparison to Industry Standards

• Multiple myeloma CAR-T benchmarks: Approved BCMA-directed CAR-Ts (Carvykti, Abecma) demonstrate high response rates but carry notable CRS/ICANS management requirements; Tempest’s early TPST-2003 readout (100% CR in 6 evaluable, no Grade >3 CRS/ICANS) is directionally favorable but remains too small to compare definitively.
• Durability context: Prior IIT median PFS of 23.1 months compares favorably with durability goals in rrMM; however, cross-trial comparisons are inherently limited and require larger, controlled datasets.
• Pipeline breadth vs. peers: The addition of dual-targeting CAR-T assets and externally funded development resembles strategies by smaller cell therapy players seeking capital-efficient advancement, contrasting with larger incumbents (J&J/Legend, BMS/2seventy) who fund extensive global programs internally.
• Regulatory momentum: Orphan and Fast Track designations for amezalpat mirror standard de-risking pathways for oncology assets and can expedite review timelines, consistent with industry practices.
• Funding model: NCI-funded Phase 2 (TPST-1495) aligns with industry norms for leveraging non-dilutive support in early-phase studies, aiding capital conservation compared with fully internally funded peers.

Management Changes

Stakeholder Impact

• Shareholders: dilution risk from recent and potential future equity financings and warrants; prior 1-for-13 reverse split in April 2025.
• Patients: early TPST-2003 results in rrMM and multiple regulatory designations (HCC, FAP) suggest potential access to new therapies pending successful trials.
• Employees: one-time separation costs indicate restructuring activity during 2025.
• Partners and collaborators: reliance on partner-sponsored and externally funded programs may accelerate development while conserving cash.
• Creditors: current liabilities reduced to $3.3M at year-end 2025 from $14.2M in 2024, improving near-term leverage.

Next Steps

• Present additional REDEEM-1 Phase 1/2a TPST-2003 results and updated IIT data in 2026.
• Submit a U.S. IND and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in rrMM in 2026.
• Initiate an NCI-funded Phase 2 study of TPST-1495 in FAP with first patient enrollment expected in 2026.
• Support partner-led efforts toward a planned, partner-funded China BLA filing for TPST-2003 in 2027.

Key Dates

Recommendation

Promising early TPST-2003 efficacy and safety signals, plus regulatory wins for other assets, are encouraging; however, the dataset is very small, cash is only $7.7M with ongoing losses and continued financing needs, and dilution risk is elevated. A hold stance is warranted pending larger clinical datasets and clearer balance sheet visibility around the 2026 registrational plans.

Keywords

Tempest Therapeutics, TPST, TPST-2003, CAR-T, multiple myeloma, BCMA, CD19, REDEEM-1, Amezalpat, TPST-1120, hepatocellular carcinoma, TPST-1495, Familial Adenomatous Polyposis, orphan drug, Fast Track, registered direct offering, private placement, reverse stock split, Novatim Immune Therapeutics, Factor Bioscience