On March 19, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the full year ended December 31, 2024 and provided a business update (Press release, Immunome, MAR 19, 2025, View Source [SID1234651258]).
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"Immunome’s efficient execution in 2024 laid the foundation for a productive 2025," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We are pleased with the progress of our pipeline and, with multiple programs now in clinical development, we expect that our recent financing will support multiple clinical milestones. We particularly look forward to topline data in the second half of 2025 for the RINGSIDE trial of varegacestat, which we believe will demonstrate significant benefits for patients with desmoid tumors."
"Our highly capable team is achieving our vision of a broad, differentiated portfolio of ADCs. We recently dosed the first patient in the Phase 1 clinical trial of IM-1021, our ROR1-targeted ADC. Three additional novel ADCs, IM-1617, IM-1335 and IM-1340, are in IND-enabling manufacturing, with additional discovery-stage programs under evaluation. We recently submitted the IND for IM-3050, our FAP radiotherapy, and anticipate initiating a Phase 1 clinical trial for that program later this year."
Pipeline Highlights
Varegacestat: Full enrollment for the Phase 3 RINGSIDE Part B study of varegacestat for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing the manufacturing and pharmacology work required to support a new drug application filing for varegacestat.
IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with the first patient dosed in February 2025. The Phase 1 trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.
IM-3050: Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025.
Preclinical Pipeline – Immunome’s preclinical pipeline also includes three novel ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, which are currently undergoing IND-enabling work, and additional, undisclosed ADCs in discovery and lead optimization.
Fourth Quarter and Recent Corporate Highlights
· Successfully completed an upsized underwritten public offering for gross proceeds of $172.5 million in January 2025, providing capital that is expected to support achievement of clinical milestones for varegacestat, IM-1021 and IM-3050 and the advancement Immunome’s preclinical pipeline.
· Nominated IM-1617, IM-1340 and IM-1335 as novel ADC candidates, with IND-enabling work initiated in late 2024.
· Presented data highlighting preclinical efficacy for IM-1021 and a differentiated profile for HC74, Immunome’s proprietary TOP1 ADC payload, at the 36th ORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in October 2024.
Full-year 2024 Financial Results
· As of December 31, 2024, cash, cash equivalents and marketable securities totaled $217.3 million, which does not include gross proceeds of $172.5 million from the January 2025 financing. Immunome’s current cash runway is expected to extend into 2027.
· Research and development expenses for the year ended December 31, 2024 were $129.5 million, including stock-based compensation costs of $5.1 million.
· In-process research and development expenses for the year ended December 31, 2024 were $152.3 million. These expenses were related to Immunome’s business development activity.
· General and administrative expenses for the year ended December 31, 2024 were $33.0 million, including stock-based compensation expense of $10.6 million.
· Immunome reported a net loss of $293.0 million for the year ended December 31, 2024.