Immunome (IMNM) investor relations material

Varegacestat regulatory and launch priorities

• FDA PDUFA action date is at the end of April 2027; commercial and manufacturing preparations are underway.

• EMA application was submitted and validated; regulatory work is ongoing in the U.S. and Europe, with Japan clinical and regulatory activities and distributor discussions in other territories.

• Additional varegacestat trials are intended to support potential label expansion; it is planned as the first commercial product.

• Launch positioning emphasizes higher response rate, once-daily dosing and pain relief versus nirogacestat; the stated aim is first-choice use in incident patients and treatment consideration across prevalent patients.

• U.S. desmoid market estimates cited: ~1,600 incident patients annually, >30,000 prevalent patients and 10,000–11,000 seeking therapy each year; pricing is undecided, with a premium price anticipated.

Commercial strategy

• Launch readiness draws on experienced medical affairs, commercial and manufacturing leaders, including leaders from Seagen; management said preparations are in place to move quickly after approval.

• No peak-sales guidance has been given; management described a potential large global market and cited nirogacestat at ~$390,000 per year of therapy and an average 20 months on treatment in varegacestat’s trial.

• Default strategy is to retain varegacestat and ADC assets; ex-U.S. partnerships remain an option if terms are productive, with interest in varegacestat reported.

ADC platform and pipeline

• ADC design uses a payload described as permeable and outside tested resistance mechanisms, aiming for resistance avoidance and bystander activity.

• Antibody selection targets high tumor expression, limited normal-tissue expression and rapid internalization; thousands of antibodies are screened for suitable epitopes.

• Pipeline strategy favors novel targets over crowded targets such as HER2, TROP2 and Nectin-4; five ADCs are in clinical development, with additional INDs planned.

• Further ADC clinical data are expected over the next 12 months, beginning with ASH in the coming weeks, to assess the technology and programs.