Cullinan Therapeutics reported third-quarter 2026 results alongside clinical and regulatory progress across its autoimmune and cancer programs. The company highlighted a planned December data update for its CD19-directed therapy CLN-978, new studies for two cancer programs, and a regulatory submission underway for zipalertinib in a lung cancer combination.
Cullinan had $313.8 million in cash and investments at September 30 and said its funding runway extends into 2029.
Key details
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CLN-978 in autoimmune diseases: Cullinan plans to present data in December from trials in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren’s disease. The update is expected to include multi-dose results from about 20 patients across the three conditions, with a focus on initial clinical activity, biomarkers and safety. It will also include longer follow-up for responding SLE and RA patients given a single target dose, plus initial single-dose data in Sjögren’s disease.
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Velinotamig advances in autoimmune conditions: In October, Cullinan began a global Phase 1/2 study in relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia, following U.S. and Australian clearances. Separately, partner Genrix Bio presented results from its study in China at ACR Convergence 2026. Among seven SLE patients with elevated proteinuria at baseline, five had rapid, marked reductions and four achieved a complete renal response. The company described the safety profile as favorable.
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CLN-049 moves into later-stage testing for AML: Cullinan started a potentially registrational Phase 2 study in relapsed or refractory acute myeloid leukemia (AML). The study will first optimize the dose, then move to an expansion cohort using the selected dose. The design followed discussions with the FDA after a positive end-of-Phase 1 meeting in July.
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A second CLN-049 study is underway: In November, Cullinan also began a Phase 1/2 study combining CLN-049 with venetoclax and azacitidine in newly diagnosed AML. Updated results from the program’s earlier dose-escalation study in relapsed or refractory AML and myelodysplastic syndrome are scheduled for presentation at the ASH Annual Meeting on December 13.
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Zipalertinib regulatory submission underway: Cullinan’s partner Taiho Oncology began submitting an application to the FDA for zipalertinib combined with chemotherapy as a first-line treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations. The application is being submitted through the FDA’s Real-Time Oncology Review program, is based on the Phase 3 REZILIENT3 trial, and was expected to be completed in November.
What changes for investors
The clearest near-term financial point is Cullinan’s stated cash runway into 2029. On the development side, CLN-049 has entered a Phase 2 study intended to support registration, while zipalertinib has moved into the U.S. application process for a first-line combination. The December presentations will add clinical data for CLN-978 and CLN-049; the release did not provide further third-quarter income-statement figures in the material supplied here.