Cullinan reports Q3 2026 results, flags December CLN-978 data and zipalertinib NDA progress

Cullinan Therapeutics reported third quarter 2026 results on November 10, 2026, alongside a corporate update covering its T cell engager pipeline in autoimmune disease and cancer.

For CLN-978, a CD19xCD3 T cell engager, the company said that in a December webcast it will share data in systemic lupus erythematosus, rheumatoid arthritis, and Sjögren's disease, including multi-dose regimen data from about 20 patients focused on initial clinical activity, biomarker data and safety.¹ The update will also include updated single target dose data with longer follow-up for responding SLE and RA patients, and initial single target dose data for Sjögren's disease patients.¹

For velinotamig, a BCMAxCD3 T cell engager, Cullinan is evaluating it in relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia, while Genrix Bio is evaluating it in treatment-refractory moderate to severe SLE in China.¹ At ACR Convergence 2026, new data from the Genrix Bio study showed rapid and marked reductions in proteinuria in 5 of 7 SLE patients with elevated baseline proteinuria, with 4 achieving a complete renal response and a favorable safety profile observed.¹

In oncology, Cullinan initiated a potentially registrational Phase 2 study of CLN-049 in relapsed/refractory AML in October, incorporating a dose-optimization phase before a single-arm expansion cohort at the recommended Phase 2 dose, as aligned with the FDA following a positive End-of-Phase 1 meeting in July.¹ In November, the company also initiated a Phase 1/2 study combining CLN-049 with venetoclax and azacitidine in newly diagnosed AML patients.¹ Updated dose escalation results will be detailed at the 2026 ASH Annual Meeting on December 13, 2026.¹

For zipalertinib, partnered with Taiho Oncology, Taiho initiated an NDA submission in October for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC under the FDA's Real-Time Oncology Review program,¹ with completion of the submission expected in November.¹ Separately, an NDA for zipalertinib monotherapy in relapsed EGFR ex20ins NSCLC remains under review, with a PDUFA target action date of February 27, 2027.¹

On finances, cash, cash equivalents, short- and long-term investments, and interest receivable totaled $313.8 million as of September 30, 2026, which the company said provides runway into 2029 under its current operating plan.¹