Immutep (IMM) Jefferies Global Healthcare Conference 2025 summary

Strategic focus and pipeline highlights

• Focus on immuno-oncology and autoimmune diseases, leveraging pioneering work in the LAG-3 space with unique assets and partnerships, notably with Merck for phase III trials in non-small cell lung cancer.

• Five programs in total, with eftilagimod (FD) as a unique MHC class II agonist, not an anti-LAG-3, showing strong safety and efficacy across multiple cancer indications.

• Robust clinical data from phase II trials in non-small cell lung cancer, demonstrating efficacy across all TPS levels and a favorable safety profile, supporting advancement to phase III.

• Head and neck cancer program targets CPS below 1, an area of high unmet need, with promising survival data and upcoming FDA discussions.

• IMP761, the first LAG-3 agonist for autoimmune diseases, is in phase I trials, aiming for a curative approach by targeting rogue T-cells without broadly suppressing the immune system.

Clinical development and commercial outlook

• Phase III trial in non-small cell lung cancer is a global, 750-patient study with Merck, designed to set a new standard of care and potentially extend KEYTRUDA exclusivity.

• First patient dosed in March; futility analysis expected late 2025/early 2026, with last patient in by Q3 2026 and interim analysis possible late 2026 to mid-2027.

• Commercial potential is significant, with easy subcutaneous administration and alignment with existing standards of care, leveraging KEYTRUDA’s market dominance.

• Additional programs in soft tissue sarcoma, urothelial carcinoma, and metastatic breast cancer, with soft tissue sarcoma phase II meeting its primary endpoint and detailed data expected later this year.

• Financially strong position with over AUD 146 million (~$95 million) in cash, supporting operations through 2026 and ongoing business development discussions.

Industry trends and competitive positioning

• Bispecifics and ADCs are seen as industry trends, but clinical reality and safety profiles will determine long-term success; FD’s unique mode of action and efficacy in cold cancers (low TPS/CPS) set it apart.

• FD offers a straightforward, safe, and cost-effective option, with no need for co-medications, making it attractive for future pharmacoeconomic considerations.

• Regulatory and reimbursement environments favor therapies with broad efficacy and manageable safety, supporting FD’s positioning.

• Ongoing engagement with FDA and other regulators for both oncology and autoimmune programs, with fast track designation in head and neck cancer.

• Dual listing in Australia and the U.S. provides access to diverse capital markets and investor support.