Business Context and Reporting Period
Immunome, Inc. (IMNM) is a biotechnology company developing targeted oncology therapies, primarily antibody-drug conjugates (ADCs). This Form 10-Q covers the quarterly period ended June 30, 2026. The company operates as a single segment focused on the discovery, design, and development of oncology therapeutics. As of the reporting date, Immunome has not generated any product revenue and remains in a pre-commercial stage, relying on equity financing and collaboration agreements to fund operations.
Key Financial Metrics
| Metric | Three Months Ended June 30, 2026 | Six Months Ended June 30, 2026 | Balance Sheet (June 30, 2026) |
|---|---|---|---|
| Revenue | $0 | $0 | N/A |
| Net Loss | $(73.1) million | $(127.0) million | N/A |
| Net Loss Per Share | $(0.65) | $(1.12) | N/A |
| Operating Expenses | $78.1 million | $137.5 million | N/A |
| Cash and Cash Equivalents | N/A | N/A | $217.7 million |
| Marketable Securities | N/A | N/A | $302.3 million |
| Total Liquidity | N/A | N/A | $520.0 million |
| Accumulated Deficit | N/A | N/A | $(855.1) million |
| Debt | N/A | N/A | $0 |
Material Changes vs. Prior Period
- Revenue Cessation: Collaboration revenue dropped to $0 for the three and six months ended June 30, 2026, compared to $4.0 million and $6.9 million in the same periods of 2025. This is due to the termination of the AbbVie Collaboration Agreement in July 2025, under which all revenue had been recognized by June 2025.
- Increased Operating Expenses: Total operating expenses increased by 55% year-over-year for the six-month period (from $98.1 million to $137.5 million).
- R&D Expenses: Rose from $77.3 million to $106.3 million, driven by increased clinical trial activities for IM-1021 and IM-3050, and IND-enabling activities for other assets. Varegacestat expenses decreased due to the completion of NDA filing activities.
- G&A Expenses: Rose from $20.7 million to $31.2 million, attributed to commercialization readiness costs and increased headcount.
- Net Loss Expansion: Net loss for the six months ended June 30, 2026, increased to $127.0 million from $85.0 million in the prior year period, primarily due to higher operating expenses and the absence of collaboration revenue.
- Liquidity Position: Cash and cash equivalents decreased from $653.5 million at December 31, 2025, to $217.7 million at June 30, 2026. This reduction was driven by net cash used in operating activities ($120.3 million) and significant investing activities ($316.4 million), primarily for the purchase of marketable securities ($302.2 million).
Guidance, Outlook, and Risks
- Regulatory Milestones: Immunome submitted a New Drug Application (NDA) for its lead candidate, varegacestat, in April 2026. The FDA accepted the NDA and assigned a PDUFA target action date of April 28, 2027. The company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by the end of 2026.
- Pipeline Progress:
- IM-1021: Phase 1 trial ongoing; initial lymphoma data expected in 2026.
- IM-1617: First participant dosed in Phase 1 trial in June 2026.
- IM-3050: First participant dosed in Phase 1 trial in July 2026.
- Preclinical: IND submissions for IM-1340 and IM-1335 are anticipated in mid-to-late 2026.
- Liquidity Outlook: Management expects existing cash, cash equivalents, and marketable securities ($520.0 million total) to fund operations for at least 12 months from the filing date. Additional capital will be required for future development and potential commercialization.
- Risk Factors:
- Regulatory Approval: No guarantee that varegacestat or other candidates will receive FDA or EMA approval.
- Capital Needs: Significant additional funding is required; failure to raise capital could force delays or termination of programs.
- Manufacturing & Supply Chain: Reliance on third-party manufacturers, including potential supply disruptions for radioligand therapies (IM-3050) and geopolitical risks affecting Chinese vendors (BIOSECURE Act).
- Competition: Intense competition in oncology, particularly for desmoid tumors (varegacestat) and ROR1-targeted therapies.
Investor Verification Checklist
- Verify the status of the varegacestat NDA review process and any potential FDA requests for additional data prior to the April 2027 PDUFA date.
- Monitor cash burn rates and the timeline for potential future equity offerings, given the $134.1 million remaining under the 2024 ATM Agreement.
- Review upcoming clinical data releases for IM-1021 (lymphoma) and the safety/efficacy data from the initial dosing of IM-1617 and IM-3050.
- Assess the impact of the BIOSECURE Act on the company's supply chain, particularly regarding any reliance on Chinese biotechnology vendors.
- Confirm the timeline and regulatory strategy for the European MAA submission for varegacestat.