Immunome — Third Quarter 2026 Earnings Summary
Financial Performance:
- Reported a net loss of $85.8 million for the quarter ended September 30, 2026, compared to a net loss of $57.5 million in the same period in 2025.
- Research and development expenses were $69.5 million for the quarter, an increase from $49.2 million in the prior year period, including $6.6 million in stock-based compensation.
- General and administrative expenses were $20.9 million for the quarter, an increase from $10.9 million in the prior year period, including $6.2 million in stock-based compensation.
- Total operating expenses were $90.4 million for the quarter, up from $60.1 million in the prior year period.
- Cash, cash equivalents, and marketable securities totaled $461.6 million as of September 30, 2026.
- Interest income was $4.6 million for the quarter, compared to $2.7 million in the prior year period.
- Net loss per share (basic and diluted) was $0.76, compared to $0.65 in the prior year period.
- Weighted-average shares outstanding were 113.6 million, compared to 88.0 million in the prior year period.
- Accumulated deficit increased to $940.9 million as of September 30, 2026, from $728.2 million as of December 31, 2025.
Guidance and Future Outlook:
- The company expects its current cash position to fund operations into 2028.
- Varegacestat PDUFA target action date is set for April 28, 2027.
- The company expects to initiate a Phase 1 trial for IM-1340 by year-end 2026.
- 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.
Business Segments and Product Lines:
- Varegacestat: The U.S. FDA accepted the NDA in July 2026; the EMA validated the MAA in October 2026 for the treatment of adults with desmoid tumors. Additional Phase 3 RINGSIDE data, including patient-reported outcomes, were presented at the 2026 ESMO Congress.
- IM-1021: Phase 1 trial is ongoing with updated data expected at the ASH Annual Meeting on December 14, 2026. Among 19 response-evaluable B-cell non-Hodgkin lymphoma patients, the objective response rate was 53% (10/19), including five complete responses. Among 11 response-evaluable diffuse large B-cell lymphoma patients, the objective response rate was 64% (7/11), including three complete responses.
- IM-1617: First patient dosed in June 2026 in a Phase 1 first-in-human trial for advanced solid tumors; the study includes colorectal cancer, non-small cell lung cancer, and breast cancer.
- IM-1340: Received IND clearance in September 2026; it is a potential first-in-class ADC targeting an undisclosed solid tumor target with a Phase 1 trial initiation expected by year-end 2026.
- IM-3050: First patient dosed in July 2026 in a Phase 1 first-in-human trial for FAP-expressing advanced solid tumors.
- Preclinical ADC Pipeline: IM-1335 is directed at an undisclosed solid tumor target; additional undisclosed ADCs are in discovery.
Market and Competitive Landscape:
- Immunome is advancing a portfolio of first-in-class and best-in-class cancer therapies, including antibody-drug conjugates and a radioligand therapy.
- The company highlights the proprietary HC74 TOP1 inhibitor payload used in its ADC programs.
Risks and Challenges:
- Forward-looking statements involve risks including the potential for regulatory approvals to be delayed, denied, or subject to unanticipated conditions.
- Risks include the possibility that preclinical or early clinical data may not predict later clinical data, regulatory approval, or commercial viability.
- Risks include reliance on third-party vendors and the potential for product candidates to fail to achieve intended endpoints.
- Uncertainties exist regarding capital requirements and the expected cash runway.
Management Commentary and Tone:
- Clay B. Siegall, Ph.D., President and CEO, stated the company made "significant progress across our oncology pipeline in recent months."
- Management expressed confidence in advancing varegacestat toward approval and launch, noting the company now has three programs in the clinic with a fourth expected by year-end.
- Management indicated they look forward to presenting updated Phase 1 data for IM-1021 at ASH in December.
Other Key Points:
- The company has no collaboration revenue reported for the quarter ended September 30, 2026, or the same period in 2025.
- Unrealized loss on marketable securities was $134,000 for the quarter ended September 30, 2026, compared to an unrealized gain of $24,000 in the prior year period.
- Total assets decreased to $505.5 million as of September 30, 2026, from $683.2 million as of December 31, 2025, primarily due to a reduction in cash and cash equivalents.
- Total liabilities increased to $51.2 million as of September 30, 2026, from $48.8 million as of December 31, 2025.
- Company
- IMMUNOME INC
- Sector
- Healthcare
- Industry
- Biotechnology