On August 6, 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 quarter ended June 30, 2025 and provided a business update (Press release, Immunome, AUG 6, 2025, View Source [SID1234654866]).
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"Immunome made substantial progress in the second quarter of 2025, underscored by the continued advancement of our clinical programs towards key milestones," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We look forward to sharing topline data for the RINGSIDE trial of varegacestat before the end of this year, and we are well-positioned to support a new drug application submission for that program as appropriate."
"We recently dosed the third cohort of patients in the dose escalation study of IM-1021, our ROR1 ADC. We are excited by the profile of HC74, the proprietary TOP1 inhibitor payload contained in IM-1021, and are making progress towards IND submission for three additional ADCs utilizing that technology."
Pipeline Highlights
Varegacestat:
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Immunome expects to report topline data for the Phase 3 RINGSIDE Part B study before the end of 2025.
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Two additional analyses of the Phase 2 RINGSIDE Part A study were presented at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025, both of which can be found in the Investors portion of Immunome’s website:
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Subgroup Analysis of the Phase 2 Part of the RINGSIDE Phase 2/3 Trial of Varegacestat for Treatment of Desmoid Tumors
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Change in T2-Weighted Signal Intensity, Change in Tumor Volume, and Exposure-Response Analysis in the RINGSIDE Phase 2 Study of Varegacestat in Patients with Desmoid Tumors
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The European Medicines Agency granted Orphan Drug Designation to varegacestat in July 2025. Varegacestat previously received Orphan Drug Designation from the U.S. Food and Drug Administration in November 2023.
IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with patients recently dosed at the third dose level. The 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 received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial before the end of 2025.
Preclinical Pipeline: Immunome’s three preclinical ADCs against solid tumor targets, IM-1617, IM-1340 and IM-1335, each of which incorporates HC74, are currently undergoing IND-enabling work. Additional undisclosed ADCs are in discovery and lead optimization.
Second Quarter 2025 Financial Results
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As of June 30, 2025, cash, cash equivalents and marketable securities totaled $268.0 million. Immunome expects its current cash position to fund operations into 2027.
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Research and development expenses for the quarter ended June 30, 2025 were $40.5 million, including stock-based compensation costs of $2.2 million.
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General and administrative expenses for the quarter ended June 30, 2025 were $10.0 million, including stock-based compensation expense of $3.1 million.
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Immunome reported a net loss of $43.4 million for the quarter ended June 30, 2025.