Cullinan Therapeutics (CGEM) Citi’s 2026 Virtual Oncology Leadership Summit summary

Pipeline strategy and priorities

• 2026 expected to be a pivotal year with multiple catalysts across the pipeline, focusing on T-cell engagers CLN-978 and CLN-049.

• CLN-978 targets autoimmune diseases with high binding affinity, small size, and subcutaneous administration, aiming to move up in treatment sequence and displace monoclonal antibodies.

• Three high-value autoimmune indications (lupus, RA, Sjögren's) with first company-sponsored CD19 T-cell engager data expected in 2026.

• Oncology pipeline includes CLN-049 (FLT3 x CD3 T-cell engager for AML) and zipalertinib (EGFR exon 20 TKI for NSCLC), both addressing large, unmet needs.

• Pipeline focuses on first-in-class or best-in-class molecules with transformative potential and a de-risked profile.

CLN-049 (FLT3 x CD3 T-cell engager for AML)

• Dose escalation data showed compelling monotherapy efficacy, with a composite complete response rate of about 30% and durable responses, including in TP53-mutated patients.

• Safety profile is favorable, with a low rate of high-grade cytokine release syndrome (CRS) managed by step-up dosing.

• Expansion cohorts to begin in Q2 2026, with a registration-enabling study in relapsed/refractory AML planned by end of 2027.

• Addressable market for relapsed/refractory AML is estimated at $1 billion, with potential for multi-billion opportunity in the frontline setting.

• Regulatory pathway includes a single-arm phase II study for accelerated approval and a phase III study for frontline expansion.

Zipalertinib (EGFR exon 20 TKI for NSCLC)

• Rolling NDA submission for relapsed EGFR exon 20 NSCLC to be completed this quarter; frontline study enrollment to finish in first half of 2026.

• U.S. market opportunity estimated at 3,000–5,000+ patients annually; 50/50 profit share with Taiho and $130 million in regulatory milestones expected.

• Favorable safety and efficacy data in relapsed/refractory patients support confidence in frontline success.

• Frontline phase III study compares platinum-based standard of care with and without zipalertinib, leveraging a proven regulatory strategy.