Cullinan Therapeutics (CGEM) investor relations material

Pipeline and Strategic Overview

• Four clinical programs are advancing, focusing on high-impact, validated targets with demonstrated monotherapy efficacy and large market potential.

• T-cell engagers are a core focus, with CLN-049 (FLT3 x CD3) for AML and CLN-978 (CD19 x CD3) for autoimmune diseases as high-priority assets.

• CLN-978 is progressing in global studies for RA, lupus, and Sjögren's, with initial data expected in 2026.

• CLN-049 has received FDA Fast Track designation for relapsed/refractory AML and is supported by robust cash reserves extending runway into 2029.

Clinical Efficacy and Response Durability

• CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrated a 31% CR+CRh rate at 12 µg/kg in relapsed/refractory AML, including 50% CR/CRh in TP53-mutated patients at this dose.

• Responses were durable, with most lasting beyond 16 weeks, and some patients achieving MRD-negative status, including one maintaining response for over 36 weeks.

• Efficacy was observed regardless of baseline FLT3 expression or genetic risk, supporting broad applicability.

• The patient population was heavily pretreated and included high-risk genetic subtypes.

Safety and Tolerability

• CLN-049 showed a favorable safety profile, with most CRS events being Grade 1/2, no Grade 3 CRS at two step-up doses, and no dose-limiting toxicities at the highest dose.

• Other adverse events were manageable and consistent with expectations for this patient population, with Grade ≥3 events in >10% including febrile neutropenia and decreased white blood cell count.

• Tolerability is favorable, with low neurotoxicity and manageable CRS, making outpatient administration feasible even in frail patients.