Immunome (IMNM) investor relations material

Lead program and commercialization plans

• Lead asset Varegacestat, a gamma secretase inhibitor, completed a phase III trial with a hazard ratio of 0.16 and strong top-line data; full results to be presented at a mid-year oncology conference.

• NDA submission to the FDA is targeted for the second quarter, with commercialization possible by year-end or early next year, pending regulatory review.

• Commercialization strategy includes direct sales in the US, Europe, and Canada, with distributors in Latin America, MENA, and a partnership in Asia.

• Varegacestat offers once-daily dosing, improved pharmacokinetics, and higher response rates compared to existing therapies, addressing pain and tumor reduction in desmoid cancer.

• Market opportunity could reach $1 billion annually if priced similarly to competitors and treating 3,000 patients.

Product differentiation and patient impact

• Varegacestat’s superior pharmacokinetics allow for lower dosing and once-daily administration, improving adherence and patient experience.

• Clinical data indicate a high response rate and significant tumor volume reduction, with median reduction in the upper 80% range.

• Pain relief is a key benefit, with data on pain reduction to be released in the full dataset.

• Flexible dosing options and planned blister packs will support long-term use and dose adjustments.

• Real-world usage is expected to see patients on therapy for an average of 20 months, with strong potential for long-term adherence.

Pipeline and R&D strategy

• The pipeline includes a next-generation ADC program, with the ROR1 ADC in clinical trials and data expected later this year.

• Five additional ADCs are in manufacturing or IND planning, targeting solid tumors such as colon and lung cancer.

• ROR1 ADC is focused on B-cell lymphomas and select solid tumors, with a diagnostic tool in development to optimize patient selection.

• Dose and schedule optimization is a priority, with expansion of clinical sites and a focus on differentiated efficacy in heavily pretreated patients.

• Approval strategy for ROR1 ADC targets patients with multiple prior therapies, aiming for a high response rate and clear differentiation from competitors.