Immunome (IMNM) H.C. Wainwright 28th Annual Global Investment Conference summary

Portfolio and varegacestat

• Portfolio includes at least 10 ADCs against novel targets and one radioligand program; development is focused mainly on ADCs.

• Varegacestat was developed through Phase III after investment in CMC; its application has been filed and has a PDUFA date, with plans for a global launch.

• Desmoid tumors affect ~1,650 new U.S. patients annually, with ~11,000 prevalent cases; Phase III average treatment duration was 20 months, while the CEO estimated ~16 months in practice.

• A retreatment study is underway to assess restarting varegacestat after a treatment break and potentially support an FDA label.

• Some patients reported pain relief within 2–3 weeks; the CEO cited dramatic anti-tumor activity in ~95% of patients and a single-pill, once-daily formulation expected shortly after approval.

Varegacestat launch preparation

• Medical affairs is being built ahead of sales hiring, with teams engaging physicians and learning their needs before launch.

• The stated goal is to reach a meaningful share of patients with an easy-to-use therapy that reduces pain and tumor volume.

ROR1 ADC program

• ROR1 is expressed across liquid and solid tumors; development currently focuses on liquid tumors, where expression is described as widespread.

• A validated diagnostic tool for solid-tumor screening is nearly complete, addressing variable ROR1 expression and challenges with tissue staining.

• IM-1021 uses a rapidly internalizing antibody and ADC technology designed for bystander activity in heterogeneous tumors and to avoid resistance mechanisms.

• Development is focused on finding the right dose, schedule and heavily pretreated patient population; the goal is differentiated efficacy, durability and safety.

• The company intends to present data at ASH, subject to acceptance; a potential path discussed was breakthrough designation and a single-arm 3L+ study, followed by confirmatory earlier-line combination testing.