STIFEL 2026 HEALTHCARE CONFERENCE - CULLINAN THERAPEUTICS INC

Financial Performance:

• Reported over $300 million in cash as of end-September, with a runway extending into 2029.
• Non-dilutive capital pipeline includes $130 million in regulatory milestones and a 50-50 U.S. profit share from the Taiho collaboration.
• Near-term profitability expected from the Zipalertnib partnership with Taiho, given their lean commercial organization and existing product portfolio.
• Capital efficiency highlighted through the strategic use of Zipalertnib proceeds to fund the T-cell engager programs.

Guidance and Future Outlook:

• Planning to present multi-dose data for CLN978 in December, including Sjogren's disease insights.
• Expect PDUFA date for Zipalertnib second-line indication in February 2027; frontline indication submission anticipated for early 2027 acceptance and subsequent PDUFA.
• CLN049 pivotal study in relapsed/refractory AML is actively recruiting; aiming for Phase 2 success metrics based on 12 mcg/kg dosing.
• CLN978 aims to move into Phase 2 studies in 2025, targeting consistent deep B-cell depletion across indications.

Business Segments and Product Lines:

• CLN978 (CD19 T-cell engager): Focused on autoimmune rheumatic diseases (SLE, RA, Sjogren's); initial data showed clinical remissions and biomarker impact; IND cleared in US/Australia.
• CLN979/Velagotamab (BCMA T-cell engager): Partnership with Generics Bio; China proof-of-concept data in SLE presented at ACR; global Phase 1/2 in autoimmune cytopenias cleared IND; targeting plasma-cell driven diseases.
• CLN049 (FLT3 T-cell engager): Pivotal Phase 2 study initiated for FLT3-mutated AML; end-of-Phase 1 meeting completed; focuses on limiting prior lines to two.
• Zipalertnib (Tyrosine Kinase Inhibitor): Partnered with Taiho for Exon 20 NSCLC; presented best-in-class PFS in frontline setting; submitted under Real-Time Oncology Review (RTOR); second-line PDUFA set for Feb 2027.

Market and Competitive Landscape:

• Positioned as a first-mover in CD19 T-cell engagers for autoimmunity, surpassing competitors like Roche who have pivoted to new molecules.
• Closing the gap on BCMA competitors (e.g., Caribou, Omeros) by clearing INDs and initiating Phase 1/2 studies, leveraging execution speed.
• Competitive advantage cited in the ability to address both broad B-cell depletion (CD19) and long-lived plasma cell depletion (BCMA).
• Zipalertnib data demonstrates best-in-class PFS in frontline Exon 20 NSCLC setting.

Risks and Challenges:

• Safety: Cytokine Release Syndrome (CRS) risk managed via multi-step-up dosing regimens; observed mostly Grade 1-2, with mitigation strategies for higher doses.
• Clinical Trial Complexity: Enrolling heavily pretreated patients (4-6 prior therapies) which may impact generalizability, though reflects unmet need; RA Phase 2 may require broader populations per investor expectations.
• Regulatory Pathways: Dependence on single-arm registration pathways for lupus nephritis and navigating FDA review timelines for multiple concurrent submissions.
• Execution: Critical need to maintain speed in moving from Phase 1 to Phase 2 across multiple programs to stay ahead of competition.

Management Commentary and Tone:

• Management expressed high confidence and excitement, describing the pipeline as a "leading portfolio" with "breakthrough treatment" potential.
• Tone is execution-focused, emphasizing speed, differentiation, and the strategic fit of the Taiho partnership for capital generation.
• Nadeem Ahmed (CEO) and Jeff Jones (CMO) provided detailed, data-driven answers, highlighting specific dosing strategies and biomarker correlations.

Analyst Questions and Answers:

• CLN978 Data Specifics: December update will cover ~20 patients across SLE, RA, and Sjogren's; includes tissue biopsy data for Sjogren's to demonstrate B-cell depletion in glands.
• Durability Expectations: Management targets durable responses (e.g., 30% DORIS in SLE for 6 months; DAS28 response in RA for 4-5 months) to establish commercial viability.
• Velagotamab Strategy: CD19 and BCMA targets selected to cover the full B-cell lineage; partnership with Generics Bio allowed rapid patient accrual in China for early proof-of-concept.
• Cash Runway & Profitability: Confirmed ability to fund operations through 2029 with current cash and Zipalertnib milestones; profitability expected quickly due to Taiho's commercialization.

Other Key Points:

• CLN978 is the first company-sponsored CD19 data presented and the first to clear an IND in the US for this indication.
• Velagotamab acquired from Generics Bio for $20M upfront cash, a fraction of recent BCMA deal values, representing significant strategic value.
• Zipalertnib data stopped early due to strong efficacy signals; final Overall Survival analysis expected by end of year.
• Strategic pivot to focus on "treatment-free" durable remission as the ultimate product profile goal for autoimmune indications.