Tempest Therapeutics (TPST) investor relations material

Pipeline overview and development strategy

• Diversified pipeline includes cell therapies (CAR-T) and small molecules, with several programs in clinical and preclinical stages.

• Key CAR-T assets target CD19/BCMA and CD70, with both autologous and allogeneic approaches for multiple myeloma, POEMS syndrome, SLE, and renal cell carcinoma.

• Strategic partnerships fund and de-risk clinical development, especially in China and with the NCI for certain programs.

• Multiple value-inflecting milestones are projected through Q4 2027, including IND filings, interim data, and registrational trial starts.

TPST-2003 dual CAR-T clinical results

• TPST-2003 is the first parallel-structure dual-target CAR-T for rrMM with EMD and POEMS syndrome, showing 100% CR in CAR-T naïve patients.

• Phase 1/2 trials report 100% ORR among patients with measurable disease, 89.5% CR rate, and median PFS of 23.1 months.

• EMD subgroup had a PET ORR of 85.7% and median PFS of 23.1 months, outperforming approved BCMA CAR-T therapies in this population.

• All evaluable patients at 12 months were MRD-negative, indicating deep and durable responses.

Safety and pharmacokinetics

• No grade ≥3 CRS or ICANS observed in REDEEM-1; all CRS/ICANS events were manageable and resolved with standard care.

• Safety profile is favorable and comparable to approved BCMA CAR-T therapies, with lower rates of severe CRS and ICANS.

• CAR-T cell persistence observed in 66.7% of patients at 6 months and 50% at 12 months post-infusion.