Immunome Inc. quarterly report, Q1 FY2022

Business context and reporting period

Immunome, Inc. is a clinical-stage biopharmaceutical company using a human memory B-cell platform to discover antibody therapeutics, primarily in oncology and infectious disease. This unaudited Form 10-Q covers the quarter ended March 31, 2022; comparative results are for the quarter ended March 31, 2021. The company had no product-sales revenue.

Financial performance and liquidity

Gross profit and operating margins are not meaningful because the company reported no product revenue. Cash, cash equivalents and restricted cash totaled $43.0 million at quarter-end. Total liabilities were $9.9 million, including $0.2 million of operating lease liabilities; the filing reports no material funded debt balance. Current assets were $46.3 million and current liabilities $9.7 million. Accumulated deficit was $90.8 million.

Material changes versus the prior comparable period

• Net loss increased $7.8 million year over year, while operating expenses rose $7.8 million.
• R&D expense increased $6.1 million, including higher oncology outsourced research and raw-material costs and increased personnel costs. Lower DoD reimbursements also reduced the offset to R&D expense by $3.4 million.
• G&A expense increased $1.7 million, primarily due to personnel, share-based compensation, professional fees and insurance.
• Operating cash use increased $2.8 million. Cash and cash equivalents declined $6.4 million from year-end 2021 during the quarter.
• The company adopted ASC 842 lease accounting on January 1, 2022, recognizing an initial right-of-use asset and lease liability of approximately $0.2 million; management said adoption did not materially affect operations or cash flows.

Outlook, risks and unusual items

• Management expects cash at March 31, 2022 to fund planned operating expenses and capital expenditures for at least 12 months from the May 12, 2022 filing date, including planned IMM-BCP-01 studies and IMM-ONC-01 development. This estimate depends on assumptions and cash could be exhausted sooner; additional financing will be needed beyond that period.
• IMM-BCP-01 received clearance to proceed with a Phase 1b trial after a clinical hold was resolved in Q1 2022; recruitment was underway. The DoD agreement had approximately $0.2 million of potential reimbursement remaining at quarter-end.
• Management planned to submit an IND for the oncology candidate IMM-ONC-01 in the second half of 2022. These are forward-looking plans, not assured outcomes.
• The company may seek financing through equity, debt, collaborations or licensing. Its $75 million ATM facility had not been used as of the filing; equity issuance could dilute shareholders, while collaborations could require surrendering rights or future economics.
• Management expects continued losses and rising R&D costs. Key risks include clinical and regulatory uncertainty, development and manufacturing challenges, competition, reliance on vendors, capital availability, and the uncertain effects of COVID-19 and variants. The company reported no material litigation and no significant COVID-19 impact to date.
• Potential license obligations include up to approximately $2.6 million in development and regulatory milestones and up to approximately $1.5 million in commercial milestones, plus royalties, if applicable milestones are achieved and products are sold.

Important facts for investors to verify

• Whether cash burn and development spending remain consistent with management’s stated runway and trial plans.
• Progress, recruitment, safety and results for IMM-BCP-01, and the timing and regulatory status of the planned IMM-ONC-01 IND.
• Remaining DoD reimbursement availability and any changes to the contract or program funding.
• Any future ATM usage, other financing, resulting dilution, or changes in access to capital.
• Clinical, regulatory, vendor, intellectual-property and other risks disclosed in the company’s filings; management reported disclosure controls were effective as of March 31, 2022.