On November 9, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class cancer therapies, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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"We made significant progress across our oncology pipeline in recent months," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We continue to advance varegacestat toward approval and launch, with an FDA PDUFA date of April 28, 2027, and recent EMA validation of our MAA. Beyond varegacestat, we now have three programs in the clinic, with IM-1340 expected to become the fourth by year-end. We are progressing the Phase 1 study of IM-1021, our ROR1-targeted ADC, and look forward to presenting updated Phase 1 data at ASH (Free ASH Whitepaper) in December."

Pipeline Highlights

Varegacestat:

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The U.S. FDA accepted the varegacestat NDA in July 2026 and assigned a PDUFA target action date of April 28, 2027.
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In October 2026, the EMA validated Immunome’s MAA for varegacestat for the treatment of adults with desmoid tumors.
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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 (ESMO) (Free ESMO Whitepaper) Congress.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, and Immunome expects to present an updated dataset at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 14, 2026. Previously reported results as of the June 26, 2026 abstract data cutoff included:

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Among 11 response-evaluable patients with diffuse large B-cell lymphoma (DLBCL), the objective response rate was 64% (7/11), including three complete responses. Across all 19 response-evaluable patients with B-cell non-Hodgkin lymphoma (B-NHL), the objective response rate was 53% (10/19), including five complete responses.
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Among 25 treated B-NHL patients, treatment-emergent adverse events (TEAEs) were reported in 92%. Grade 3 or higher TEAEs occurred in 52% of B-NHL patients, of which the most common was neutropenia (44%).

IM-1617: In June 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-1617 in patients with advanced solid tumors. IM-1617 is an ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer and breast cancer.

IM-1340: Immunome received IND clearance for IM-1340 in September 2026. The company plans to initiate a Phase 1 trial by year-end. IM-1340 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload. 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.

IM-3050: In July 2026, the first patient was dosed in the Phase 1, first-in-human trial evaluating IM-3050 in patients with FAP-expressing advanced solid tumors. The trial is designed to evaluate safety, tolerability, dosimetry, pharmacokinetics and preliminary anti-tumor activity of the investigational FAP-targeted radioligand therapy.

Preclinical ADC Pipeline: Immunome expects to submit an IND for IM-1335 in late 2026. The program is directed at an undisclosed solid tumor target and incorporates HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

Third Quarter 2026 Financial Results

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As of September 30, 2026, cash, cash equivalents and marketable securities totaled $461.6 million. Immunome expects its current cash position to fund operations into 2028.
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Research and development expenses for the quarter ended September 30, 2026, were $69.5 million, including stock-based compensation expense of $6.6 million.
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General and administrative expenses for the quarter ended September 30, 2026, were $20.9 million, including stock-based compensation expense of $6.2 million.
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Immunome reported a net loss of $85.8 million for the quarter ended September 30, 2026.

(Press release, Immunome, NOV 9, 2026, View Source [SID1234674496])