Cullinan Therapeutics (CGEM) investor relations material

Portfolio and program updates

• Focused on developing first-in-class and best-in-class molecules for oncology and autoimmune diseases, with rapid early-phase development to identify transformative therapies.

• Lead autoimmune program CLN-978, a CD19 x CD3 bispecific, is in phase 1 trials for SLE, RA, and Sjogren’s disease, all actively enrolling globally.

• Initial clinical data for SLE and RA expected in the first half of 2026, with a slight delay for SLE data disclosure.

• Added a BCMA-targeting bispecific (belantamab) to the portfolio, with development in partnership with Genrix Bio in China.

• Oncology program zipalertinib TKI for EGFR exon 20 NSCLC is preparing for a regulatory filing by year-end, pending feedback.

Clinical development strategy and study design

• T cell engagers in autoimmune disease show potential for durable responses without ongoing immune suppression, differentiating them from traditional therapies.

• CLN-978 designed for high affinity to CD19 and optimized CD3 binding, aiming for deep B cell depletion with a favorable cytokine window.

• SLE proof-of-concept study uses a modified single ascending dose (part A) to identify optimal dosing, followed by repeat dosing (part B) for deeper, durable responses.

• Recent protocol updates broadened eligibility by relaxing prior therapy requirements and lowering SLEDAI score cutoff, expected to increase enrollment.

• Patients have been dosed in SLE and RA studies; Sjogren’s study is ramping up screening.

Scientific rationale and competitive landscape

• Deep B cell depletion in SLE can induce immune reset and durable, treatment-free remission, as shown in CAR-T studies.

• RA has strong evidence for T cell engagers, with clinical benefit demonstrated in prior studies; deeper B cell depletion may yield greater efficacy.

• Sjogren’s is a B cell-centric disease; T cell engagers are expected to be effective, building on monoclonal antibody experience.

• BCMA-targeting therapies may carry higher infection risk than CD19, but risk is considered manageable with established mitigation strategies.