Immunome, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. The unaudited filing reports Immunome as a targeted-oncology biopharmaceutical company with one clinical-stage asset, AL102, and three preclinical programs. It has not generated product-sales revenue.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 |
|---|---|---|
| Collaboration revenue | $1.0 million | $2.4 million |
| Research and development expense | $15.4 million | $3.9 million |
| In-process research and development (IPR&D) expense | $112.0 million | — |
| General and administrative expense | $6.0 million | $2.9 million |
| Operating loss | $132.3 million | $4.5 million |
| Interest income | $2.8 million | $0.2 million |
| Net loss | $129.5 million | $4.3 million |
| Basic and diluted loss per share | $2.51 | $0.35 |
| Net cash from (used in) operating activities | $(11.2) million | $24.2 million |
| Net cash used in investing activities | $(37.2) million | $(0.1) million |
| Net cash provided by financing activities | $219.4 million | $0.03 million |
At March 31, 2024, cash and cash equivalents were $269.7 million and marketable securities were $40.0 million, or $309.7 million combined. Current assets were $313.3 million and current liabilities $30.8 million. Total liabilities were $34.2 million; the filing reports no borrowings. Liabilities include deferred revenue, payables, accrued expenses and operating leases. Accumulated deficit was $352.3 million. Gross margin is not meaningful because revenue is collaboration revenue, not product sales.
Material changes versus the prior-year quarter
- Net loss increased by $125.2 million, principally because the quarter included $112.0 million of IPR&D expense: $73.4 million associated with the Ayala asset acquisition and $38.6 million with the Zentalis license. These acquired assets had no alternative future use and were expensed.
- R&D expense rose $11.5 million, reflecting increased preclinical program and discovery activity, personnel costs and AL102-related trial activity. G&A expense increased $3.1 million, including higher personnel, share-based compensation and professional fees.
- Collaboration revenue declined $1.3 million as fewer R&D activities were allocated to AbbVie.
- Operating cash flow moved from $24.2 million provided to $11.2 million used. The prior-year quarter benefited from a $27.6 million increase in deferred revenue; Q1 2024 cash use reflects operating needs and working-capital changes. The $112.0 million IPR&D charge was noncash.
- Cash and cash equivalents increased substantially, primarily following the February public offering. The offering issued 11.5 million shares at $20 per share and generated $215.4 million net proceeds. The company also issued shares as consideration for the Ayala and Zentalis transactions, increasing dilution.
Business developments, outlook and risks
- AL102: Acquired from Ayala on March 25, 2024, with approximately $20.0 million cash and 2.18 million Immunome shares as upfront consideration. RINGSIDE Part B, a Phase 3 placebo-controlled trial in desmoid tumors, completed enrollment of 156 patients in February 2024. Immunome expects topline results in the second half of 2025 and is undertaking additional manufacturing and pharmacology work to support a potential NDA. AL102 has FDA Fast Track and orphan-drug designations. Ayala milestone payments could total up to $37.5 million; BMS milestones and royalties also apply under the assumed license.
- Other programs: IM-1021 (ROR1 ADC) and IM-3050 (FAP radioligand therapy) are preclinical, with IND submissions anticipated in Q1 2025. IM-4320 is an anti-IL-38 immunotherapy program, with an IND submission planned later. These are company plans, not assured outcomes.
- Funding outlook: Management expects March 31 cash, cash equivalents and marketable securities to fund current and planned operating expenses and capital expenditures for at least 12 months from the May 14, 2024 filing date. It expects expenses to increase as it advances AL102 and preclinical programs and states that additional financing will be needed for longer-term objectives. A May 2024 ATM agreement permits up to $200 million in share sales; no shares had been sold under it as of the filing.
- Key risks: The company has a history of losses and no approved products; clinical, regulatory, manufacturing, enrollment and commercialization outcomes are uncertain. AL102’s prior development was conducted by Ayala, and the company warns that prior results may not predict future outcomes. Competition includes an FDA-approved treatment for progressing desmoid tumors. Further equity financing could dilute shareholders, and acquisitions and licenses bring contingent milestones, royalties and integration and execution risks.
- Other items: The Atreca asset purchase had not closed at March 31, 2024 and remained subject to conditions, including Atreca stockholder approval. The company reported no material legal proceedings. Management said disclosure controls and procedures were effective as of March 31, 2024, with no material quarter-period change in internal control over financial reporting. Max Rosett was appointed CFO on May 9, 2024.
Important facts for investors to verify
- RINGSIDE Part B trial progress, data quality and the expected timing and results of the planned second-half 2025 topline readout.
- Actual cash runway as development spending rises, and any ATM issuance, other financing or resulting dilution after the filing date.
- Progress toward the planned Q1 2025 IND submissions for IM-1021 and IM-3050, and subsequent development plans for IM-4320.
- Potential milestone and royalty obligations under the Ayala, BMS, Zentalis and other license arrangements, which may become payable as development or commercial milestones are achieved.
- Whether the Atreca transaction closes and the operational and financial effects of integrating acquired assets and advancing multiple programs.