Cullinan Therapeutics Holds $439M, Schedules Q2 CLN-978 Data and Zipalertinib NDA

CGEMCGEM

On December 31, 2025, Cullinan Therapeutics held $439.0 million in cash and investments, funding operations into 2029 under its current plan. It plans initial CLN-978 data in systemic lupus and rheumatoid arthritis in Q2 2026, repeat dosing data in Q3 2026, and has completed zipalertinib’s rolling NDA and REZILIENT3 enrollment.

1. Pipeline Milestones

Cullinan Therapeutics will present initial CLN-978 data for systemic lupus erythematosus and rheumatoid arthritis in Q2 2026, followed by repeat dosing results in Q3 and Sjögren’s disease data in Q4. The company also expects velinotamig Phase 1 autoimmune data in Q4 2026 and plans to advance CLN-049 AML dose expansion and registrational trial initiation in H2 2026.

2. Zipalertinib Collaboration

With partner Taiho Oncology, the company completed a rolling NDA submission for zipalertinib in EGFR exon 20 insertion NSCLC and fully enrolled the REZILIENT3 frontline study, expecting top-line results by end-2026. Cullinan is eligible for $30 million upon second-line approval, up to $100 million upon first-line approval, plus a 50/50 U.S. profit share.

3. Financial Performance

As of December 31, 2025, cash, cash equivalents, short- and long-term investments and interest receivable totaled $439.0 million, providing runway into 2029. Fourth-quarter R&D expenses rose to $42.9 million from $40.5 million, while G&A expenses declined to $12.3 million from $14.6 million year-over-year.

Sources

F