Cullinan Therapeutics (CGEM) Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary

Pipeline strategy and portfolio updates

• Focus on first-in-class or best-in-class molecules for cancer and autoimmune diseases, with a de-risked pipeline targeting clinically validated indications.

• Three of four pipeline molecules are T-cell engagers, now a core capability, with recent discontinuation of two programs to prioritize resources.

• CLN-978, a CD19 x CD3 T-cell engager, is prioritized for autoimmune diseases, with a dedicated immunology team and global development across three indications.

• Initial data for lupus expected in H1 2026, RA in H2 2026, and a Sjögren's study recently opened for recruitment.

• External validation from recent scientific meetings and pharma interest in CD19 T-cell engagers supports the strategy.

Key clinical programs and data highlights

• CLN-049, a FLT3 x CD3 T-cell engager for AML, showed a 30% composite complete response rate in dose escalation, with broad applicability across AML subtypes.

• Oral presentation at ASH provides external validation; development and regulatory path for AML is clear and capital-efficient.

• Zipalertinib, an EGFR inhibitor for NSCLC, is on track for NDA submission by year-end, with potential for non-dilutive capital and significant milestone payments.

• Cash position of $475 million and recent program discontinuations extend runway into 2029, supporting continued advancement without near-term capital needs.

CLN-049: Patient population, efficacy, and safety

• CLN-049 targets FLT3, expressed in over 80% of AML patients, enabling broad treatment potential beyond mutation-specific therapies.

• 30% complete response rate observed in a heavily pretreated, high-risk AML population, with responses seen regardless of genetic mutations.

• Durability data is still maturing, with some responses out to six months; further updates expected at ASH.

• Safety profile benefits from restricted FLT3 expression, with mild CRS and ICANS, and manageable myelosuppression.

• All-comer enrollment strategy aims for broad applicability across fragmented AML subtypes.