Cullinan Therapeutics (CGEM) Morgan Stanley 23rd Annual Global Healthcare Conference summary

Key pipeline updates and catalysts

• Multiple near-term catalysts expected, including initial data from key clinical programs in the first half of 2026, with a focus on autoimmune diseases and oncology.

• CLN-978, a CD19 x CD3 T-cell engager, is prioritized for autoimmune diseases, with IND clearance and three ongoing studies in lupus, RA, and Sjogren's.

• Initial lupus data timing shifted to 1H 2026 due to enrollment challenges, with protocol amendments to broaden eligibility and accelerate recruitment.

• Oncology program zipolirenib is on track for NDA submission by year-end, with recent positive data in heavily pretreated lung cancer patients.

• CLN-049, a FLT3 x CD3 T-cell engager, will have initial clinical data presented in Q4.

Strategic partnerships and business development

• Recent licensing of belanotamab from China enables accelerated, cost-effective clinical development and expands the autoimmune pipeline.

• Collaboration with Taiho Oncology for zipolirenib includes $130M in regulatory milestones and a 50/50 U.S. profit share.

• Partnerships with academic groups and patient advocacy organizations are enhancing trial execution and enrollment.

Scientific rationale and differentiation

• T-cell engagers and CAR-T therapies offer deeper B-cell depletion and potential disease modification in autoimmune diseases compared to monoclonal antibodies.

• CLN-978 is designed for high potency, broad tissue penetration, and a favorable safety profile, aiming for community-based administration.

• Belanotamab complements CLN-978 by targeting plasma cells, broadening the range of treatable autoimmune diseases.