Immunome's EMA Validates Varegacestat MAA

The Tip Desk · November 12, 2026 · 3 min read

Cash, cash equivalents and marketable securities stood at $461.6 million as of September 30, 2026, and the company said it expects that position to fund operations into 2028.

Immunome, Inc. (IMNM), a clinical-stage targeted oncology company, reported a net loss of $85.8 million for the quarter ended September 30, 2026, as it advanced varegacestat toward a U.S. PDUFA date and added antibody-drug conjugates to the clinic.

The company said the European Medicines Agency validated its Marketing Authorization Application for varegacestat in adults with desmoid tumors in October 2026. The U.S. Food and Drug Administration had accepted the New Drug Application in July 2026 and assigned a PDUFA target action date of April 28, 2027. President and Chief Executive Officer Clay B. Siegall said the company continues to advance varegacestat toward approval and launch.

Additional Phase 3 RINGSIDE data, including patient-reported outcomes, were presented across three posters and a rapid oral session at the 2026 European Society for Medical Oncology Congress.

Beyond varegacestat, Immunome said it now has three programs in the clinic, with IM-1340 expected to become the fourth by year-end 2026. The company received IND clearance for IM-1340, a potential first-in-class solid tumor antibody-drug conjugate incorporating its proprietary HC74 TOP1 inhibitor payload, in September 2026 and plans to initiate a Phase 1 trial by year-end. The trial is expected to include patients with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, small cell lung cancer and neuroendocrine neoplasms.

The Phase 1 trial of IM-1021, an ROR1-targeted ADC, is ongoing. Immunome expects to present an updated dataset at the 2026 American Society of Hematology Annual Meeting on December 14, 2026. Previously reported results as of the June 26, 2026 abstract data cutoff showed an objective response rate of 64% (7 of 11) among response-evaluable patients with diffuse large B-cell lymphoma, including three complete responses. Across 19 response-evaluable patients with B-cell non-Hodgkin lymphoma, the objective response rate was 53% (10 of 19), including five complete responses. Among 25 treated B-NHL patients, treatment-emergent adverse events were reported in 92%; grade 3 or higher events occurred in 52%, most commonly neutropenia at 44%.

The first patient was dosed in June 2026 in the Phase 1, first-in-human trial of IM-1617, a solid tumor ADC also incorporating HC74, and in July 2026 in the Phase 1 trial of IM-3050, an investigational FAP-targeted radioligand therapy. Immunome expects to submit an IND for IM-1335 in late 2026. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

Research and development expenses were $69.5 million for the quarter ended September 30, 2026, including $6.6 million of stock-based compensation. General and administrative expenses were $20.9 million, including $6.2 million of stock-based compensation. Total operating expenses were $90.4 million, producing a loss from operations of $90.4 million. Collaboration revenue was zero. Interest income was $4.6 million. Net loss per share was $0.76 on 113.6 million weighted-average shares.

Cash and cash equivalents were $212.8 million and marketable securities were $248.7 million as of September 30, 2026. Accumulated deficit was $940.9 million. Immunome said it expects its current cash position to fund operations into 2028.