On May 12, 2026 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 March 31, 2026, and provided a business update.

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"This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "The NDA submission for varegacestat is an important milestone that reflects our commitment to improving the lives of patients with desmoid tumors, for whom new treatment options are still needed. We are also pleased that detailed Phase 3 RINGSIDE data were selected for oral presentation at ASCO (Free ASCO Whitepaper). In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance."

Pipeline Highlights

Varegacestat:

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In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.
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Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.
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Data from RINGSIDE, the global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, have been selected for presentation in an oral abstract session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
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In December 2025, Immunome announced positive topline results from RINGSIDE:
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The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001).
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The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review.
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In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review.
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Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in participants with B-cell lymphoma at multiple dose levels. Immunome expects to present initial lymphoma data for IM-1021 in 2026.

IM-3050: In March 2026, Immunome initiated the first clinical trial site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.

IM-1617: In April 2026, Immunome received IND clearance for IM-1617 and plans to initiate a Phase 1 trial in the second quarter of 2026. IM-1617 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload.

Preclinical ADC Pipeline: Immunome expects to submit INDs for IM-1340 and IM-1335 in mid- and late 2026, respectively. The programs are each directed at undisclosed solid tumor targets and incorporate HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

First Quarter 2026 Financial Results

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As of March 31, 2026, cash and cash equivalents totaled $582.7 million. Immunome expects its current cash position to fund operations into 2028.
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Research and development expenses for the quarter ended March 31, 2026, were $46.4 million, including stock-based compensation costs of $3.7 million.
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General and administrative expenses for the quarter ended March 31, 2026, were $13.0 million, including stock-based compensation expense of $4.2 million.
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Immunome reported a net loss of $53.8 million for the quarter ended March 31, 2026.

(Press release, Immunome, MAY 12, 2026, View Source [SID1234665539])