Cullinan Reports Narrower Third-Quarter 2026 Net Loss of $49.4 Million

The Tip Desk · November 12, 2026 · 3 min read

Third-quarter 2026 net loss narrowed to $49.4 million from $50.6 million a year earlier. Cash, cash equivalents, investments and interest receivable were $313.8 million as of September 30, 2026, with runway still stated as into 2029.

Cullinan Therapeutics, Inc. (CGEM), a clinical-stage biopharmaceutical company developing T cell engagers for autoimmune diseases and cancer, reported a net loss of $49.4 million for the third quarter of 2026, compared with $50.6 million a year earlier.

The company said partner Taiho Oncology initiated an NDA submission in October for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC under the U.S. FDA Real-Time Oncology Review program, with completion expected in November. The submission is based on the Phase 3 REZILIENT3 trial, which the company said met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy versus chemotherapy alone. An NDA for zipalertinib monotherapy in relapsed EGFR ex20ins NSCLC remains under review with a PDUFA target action date of February 27, 2027. Cullinan said it is eligible to receive $30 million and $100 million upon U.S. approvals for second-line and first-line EGFR ex20ins NSCLC, respectively, and a 50/50 U.S. profit share.

On the oncology T cell engager, the company initiated in October a potentially registrational Phase 2 study of CLN-049 (FLT3xCD3) in relapsed/refractory AML, later than the third-quarter start it had outlined after a July End-of-Phase 1 meeting with the FDA. The study incorporates a dose-optimization phase before a single-arm expansion at the RP2D. In November it also initiated a Phase 1/2 study of CLN-049 with venetoclax and azacitidine in newly diagnosed AML. Updated Phase 1 dose-escalation data in relapsed/refractory AML or MDS will be presented at the 2026 ASH Annual Meeting on December 13.

Velinotamig (BCMAxCD3) moved from a planned early-2027 global basket study to initiation in October after U.S. FDA IND clearance and HREC clearance in Australia, in relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia. At ACR Convergence 2026 the company shared Genrix Bio Phase 1/2 data in China: in 5 of 7 patients with SLE and elevated baseline proteinuria, rapid and marked reductions were observed, with 4 achieving a complete renal response and a favorable safety profile.

CLN-978 (CD19xCD3) multi-dose regimen data in SLE, RA and Sjögren’s disease will be shared in a December webcast covering about 20 patients, consolidating the separate third-quarter RA and fourth-quarter SLE/Sjögren’s plans given in the second-quarter update. Phase 2 expansion in SLE, lupus nephritis and RA remains planned for early 2027.

Research and development expenses were $40.2 million in the third quarter of 2026, compared with $42.0 million in the same period of 2025. General and administrative expenses were $12.4 million, versus $13.6 million a year earlier. Total operating expenses were $52.6 million. Interest income was $3.3 million, down from $5.1 million. Basic and diluted net loss was $0.74 a share, versus $0.77 a year earlier.

Cash, cash equivalents, short- and long-term investments, and interest receivable were $313.8 million as of September 30, 2026. Cullinan said it expects those cash resources to provide runway into 2029 under its current operating plan. President and CEO Nadim Ahmed said the company remains focused on strengthening its position in T cell engagers, with December CLN-978 data and ASH CLN-049 updates among the next catalysts.