- Trial Phase
- Preclinical (first-in-human investigator-initiated trial planned; first dosing expected Q4 2026)
- Time to Market
- Years away at best — approval of a first-in-human in vivo CAR-T for autoimmune disease would need multiple larger trials after the planned ~10-patient IIT; realistically 5+ years or never. Nearest data milestone: H1 2027.
- Why 6/10
- No regulatory/pivotal binary is scheduled; the nearest hard, company-stated catalysts are first patient dosing of the ~10-patient MG/MS investigator-initiated trial (expected Q4 2026) and initial clinical data (expected H1 2027) on Tempest's lead asset at a ~$19M market cap — early-stage milestones that should dominate the stock but are a tiny first-in-human readout, not a PDUFA/pivotal decision.
Watch for (1) first dosing of TPST-4003 in Q4 2026 and any initial clinical data in H1 2027 — positive data in a single-asset micro-cap could move the stock dramatically; (2) financing events, since cash was only ~$0.8M at Q2 2026 and the company faces a Nasdaq equity-deficiency delisting notice — dilution/survival risk likely precedes any data catalyst. Do not size a position on the $11 single-analyst target without acknowledging the delisting and cash-runway overhang.
Price Chart
Executive Summary
TPST-4003 is Tempest Therapeutics' (Nasdaq: TPST) lead in vivo CAR-T candidate — a CD7-targeted mRNA/lipid-nanoparticle therapy for autoimmune diseases, initially myasthenia gravis and multiple sclerosis. It is the centerpiece of a company that pivoted from small molecules to CAR-T via a February 2026 all-stock acquisition of Factor Bioscience assets, and it has a July 2026 development collaboration with China's Senlang Biotechnology. The drug has no human data yet: a ~10-patient investigator-initiated trial is expected to begin dosing in Q4 2026 with initial data in H1 2027. The setup is a high-risk binary: the stock (~$1.13, ~$19M market cap) is entirely driven by this early-stage program, but the company had only ~$0.8M of cash at Q2 2026, faces a Nasdaq delisting deficiency notice, and carries significant dilution overhang — so financing risk likely precedes any data catalyst.
How It Works
CAR-T therapy reprograms a patient's own immune cells (T cells) to attack a chosen target. "In vivo" CAR-T skips the expensive lab step used in traditional CAR-T: instead of removing a patient's cells, modifying them in a factory, and infusing them back, the drug is injected as messenger RNA (mRNA) wrapped in tiny fat particles (lipid nanoparticles) that convert the patient's own T cells into CAR-T cells inside the body. TPST-4003 targets CD7, a protein on T cells, to delete the self-attacking T cells that drive autoimmune disease — initially myasthenia gravis (immune attack on nerve-muscle junctions causing weakness) and multiple sclerosis (immune attack on the brain and spinal cord).
Trial Status
No human data yet. Tempest unveiled its in vivo CAR-T platform July 15, 2026 with TPST-4003 as lead candidate, then on July 21, 2026 signed a collaboration with China's Hebei Senlang Biotechnology to run an investigator-initiated trial (IIT) in ~10 patients with myasthenia gravis (MG) or multiple sclerosis (MS). First enrollment/dosing is expected in Q4 2026, with initial clinical data expected in H1 2027 per the Q2 2026 business update.
The Two-Sided Case
Upcoming Catalysts
- First patient enrollment/dosing of TPST-4003 IIT in China (expected Q4 2026)
- Initial clinical data from the ~10-patient MG/MS IIT (expected H1 2027)
- Likely capital raise / financing given ~$0.8M cash at Q2 2026
- Nasdaq compliance-plan outcome (deficiency letter May 2026; possible 180-day cure period)
- Stockholder meeting/charter-amendment vote (adjourned July 27, 2026; reconvened Aug 17, 2026)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Tempest Therapeutics PRESS-RELEASE TPST ·Originating report