Cullinan Therapeutics (CGEM) Stifel 2026 Virtual Immunology and Inflammation Forum summary

Portfolio and program updates

• Leading T cell engager portfolio spans immunology and oncology, with multiple clinical-stage assets advancing toward key milestones.

• CLN-978 (CD19 T cell engager) is being developed for lupus, RA, and Sjögren's disease, with a comprehensive multi-dose and single-dose data update planned for December.

• Velinotamig (BCMA T cell engager) is advancing in SLE, with proof-of-concept data to be presented at ACR in November and plans to initiate phase I in autoimmune cytopenias by early 2027.

• CLN-049 (FLT3 T cell engager) is progressing to a potentially registrational phase II study in relapsed/refractory AML, with updated phase I results expected in December.

• Zipalertinib (oral TKI) for EGFR exon 20 NSCLC showed practice-changing results in frontline patients, with a second-line NDA under review and a PDUFA date in February 2027.

Clinical data highlights and strategy

• Single-dose CLN-978 at 20 and 30 mcg achieved marked B-cell depletion and significant clinical responses in SLE and RA, with favorable safety and potential for repeat dosing.

• Biomarker studies confirmed deep B-cell depletion in tissue and lymph nodes, supporting the clinical impact of the 30 mcg dose.

• December update will provide the most comprehensive clinical data set for a CD19 T cell engager, enabling cross-indication validation and informing phase II dose selection.

• Multi-dose regimens are being evaluated for induction therapy followed by treatment-free response, with re-treatment possible for responders.

• Safety profile for CLN-978 at 20 and 30 mcg remains strong, with no Grade 3 CRS at these doses; higher dose cohorts discontinued due to safety.

Forward-looking plans and financials

• Phase II studies for CLN-978 in lupus, RA, and Sjögren's disease are set to begin in early 2027, focusing on dose confirmation and disease-specific subsets like lupus nephritis.

• Velinotamig will expand into autoimmune cytopenias and other plasma cell-driven diseases, leveraging established hematology networks for rapid proof-of-concept.

• CLN-049 phase II in AML will start imminently, with a combination study with venetoclax in frontline planned for Q4.

• Collaboration with Taiho provides significant non-dilutive capital and a 50/50 US profit share, supporting continued investment in the pipeline.

• Cash position exceeds $350 million as of June, providing runway into 2029 and covering all planned development activities.