Immunome, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a standalone fourth-quarter report. Immunome is a preclinical biopharmaceutical company developing antibody therapeutics using a human memory B-cell discovery platform, focused primarily on oncology and infectious disease.
Financial performance and position
| Metric | FY2021 | FY2020 |
|---|---|---|
| Product revenue | None | None |
| Research and development expense, net of DoD reimbursements | $14.1 million | $7.5 million |
| General and administrative expense | $11.1 million | $4.8 million |
| Total operating expenses | $25.2 million | $12.3 million |
| Net loss | $24.7 million | $17.8 million |
| Net loss per share, basic and diluted | $2.14 | $5.26 |
| Cash used in operating activities | $18.2 million | $12.1 million |
| Cash and cash equivalents at year-end | $49.2 million | $39.8 million |
As a pre-revenue development-stage company, Immunome reported operating losses rather than operating profit; profit margins are not meaningful. Operating expenses increased by $12.9 million year over year. R&D expense rose $6.6 million, reflecting higher supplies, outsourced services and personnel costs, partly offset by increased DoD reimbursements. G&A rose $6.3 million, including higher personnel costs and public-company professional, insurance and legal expenses.
Net cash provided by financing activities was $27.8 million in 2021, primarily from the April private placement. Cash and cash equivalents plus restricted cash totaled $49.3 million at year-end. Total liabilities were $9.7 million; the balance sheet reported no long-term debt or equipment loan payable at December 31, 2021. The $0.5 million PPP loan was forgiven in May 2021 and recognized as other income. The company reported no income tax expense and maintained a full valuation allowance against deferred tax assets.
Business developments and comparison
- IMM-BCP-01: A three-antibody cocktail targeting SARS-CoV-2, developed with DoD support. Immunome submitted an IND in November 2021. The filing reports that in March 2022, after a brief clinical hold, the FDA communicated that the study could be initiated; this is a post-year-end update, not a FY2021 clinical result. The DoD award was increased to $17.6 million in May 2021. At year-end, approximately $0.2 million of reimbursement remained available, and the company stated the award would not cover all planned Phase 1b costs.
- IMM-ONC-01: A preclinical anti-IL-38 antibody program for solid tumors. The company planned to submit an IND in the second half of 2022. Reported supporting evidence was preclinical, including activity in animal models; no product candidate had been tested in humans at the time described.
- The company reported more than 70 identified cancer targets and anticipated its discovery platform could advance one to two programs into IND-enabling studies annually. These are management expectations, not established outcomes.
Liquidity, outlook and risks
Management said year-end cash was expected to fund operations for at least 12 months from the March 28, 2022 filing date, including planned studies, but emphasized that estimates could prove imprecise and additional financing would be needed. The company had an effective shelf registration statement for up to $200 million and an ATM agreement allowing sales of up to $75 million; no ATM shares had been sold by year-end. Equity issuance, warrants and stock-based compensation create potential dilution. Management also stated that inadequate financing could require delaying, reducing or terminating programs, pursuing strategic alternatives, or ceasing operations.
- The company has a history of losses, no product sales, and expects significant future operating losses; successful development, regulatory approval and commercialization are uncertain.
- Key execution risks include clinical and regulatory delays or failure, changing SARS-CoV-2 variants and competition, patient enrollment, reliance on third-party manufacturers and vendors, and dependence on DoD reimbursement for the COVID-19 program.
- Patent protection, licensing obligations, reimbursement and pricing, data privacy, and the ability to obtain additional capital are material risks. No material legal proceedings were reported.
- Management reported that material weaknesses in internal control identified for 2020 were remediated and that internal control over financial reporting was effective at December 31, 2021. The independent auditor did not attest to internal-control effectiveness.
Investor facts to verify
- Subsequent FDA and clinical-trial progress for IMM-BCP-01, including the trial’s actual start, enrollment, safety and results.
- Progress toward the planned IMM-ONC-01 IND submission and the strength and reproducibility of its preclinical evidence.
- Cash burn, cash runway, DoD reimbursement collections and remaining award availability, as well as the timing and terms of any future financing.
- Potential dilution from the shelf and ATM programs, outstanding warrants and equity awards.
- Whether platform output, third-party manufacturing capacity and intellectual-property rights support the company’s stated development plans.