CLN-978 - (OUTRACE RA)

Aug. 06, 2026: Cullinan Therapeutics (NASDAQ: CGEM) outlined 2026-2027 catalysts across immunology and oncology. For CLN-978 (CD19xCD3), initial single-dose SLE data presented at EULAR 2026 showed improved disease-activity lab markers, deep dose-dependent peripheral B-cell depletion, dose-dependent recovery, and favorable safety; initial multi-dose SLE data are planned for Q4 2026, with Phase 2 expansion in SLE and lupus nephritis in early 2027. In RA, initial single-dose and multi-dose data showed disease activity improvement in most patients, including two DAS28-ESR remissions, reduced autoantibodies while preserving vaccine titers, and deep dose-dependent B-cell depletion; additional multi-dose RA data are due in Q3 2026, with Phase 2 expansion in early 2027. Initial Sjögren’s disease single-dose escalation data are planned for Q4 2026.

For velinotamig (BCMAxCD3), early data from a Genrix Bio Phase 1/2 China study showed two SLE nephritis patients achieved complete renal response with favorable safety; additional multi-dose data are expected in Q4 2026, and a global Phase 1/2 basket study in autoimmune cytopenias is planned for early 2027.

For CLN-049 (FLT3xCD3), after a positive FDA End-of-Phase 1 meeting in July, a potentially registrational Phase 2 study in relapsed/refractory AML will start in Q3 2026; a Phase 1 dose-escalation update is expected in Q4 2026, and a Phase 1/2 triplet study with venetoclax and azacitidine in newly diagnosed AML will start in Q4 2026.

Zipalertinib’s NDA in EGFR exon 20 insertion NSCLC was accepted by FDA, with a PDUFA date of Feb. 27, 2027; REZILIENT3 top-line results are expected by end of 2026. Cash and investments were $356.0 million as of June 30, 2026, with runway into 2029.