Immunome, Inc. — Q2 2022 Form 10-Q
Reporting period: Three and six months ended June 30, 2022. Unaudited results; filed August 5, 2022. Immunome is a clinical-stage biopharmaceutical company developing antibody therapeutics, with programs focused on oncology and infectious disease. It reported no product revenue and expects none for the foreseeable future.
Financial performance and liquidity
| Metric | Q2 2022 | Q2 2021 | Six months 2022 | Six months 2021 |
|---|---|---|---|---|
| Research and development expense | $5.7 million | $3.2 million | $13.8 million | $5.2 million |
| General and administrative expense | $3.2 million | $2.5 million | $6.8 million | $4.4 million |
| Total operating expenses | $8.9 million | $5.7 million | $20.6 million | $9.6 million |
| Net loss | $8.9 million | $5.2 million | $20.6 million | $9.1 million |
| Net loss per share, basic and diluted | $0.74 | $0.46 | $1.70 | $0.83 |
- Cash and liquidity: Cash and cash equivalents were $34.6 million at June 30, 2022, down from $49.2 million at December 31, 2021. Cash, including restricted cash, declined $14.6 million in the first half.
- Cash flow: Operating activities used $14.4 million in the first half, versus $7.3 million a year earlier; investing activities used $0.2 million. Financing provided $0.03 million, compared with $27.4 million in the prior-year period, which included a stock-and-warrant offering.
- Balance sheet: Total assets were $39.0 million and total liabilities $8.7 million. The filing reports no outstanding long-term debt; the PPP loan was forgiven in May 2021. Operating lease liabilities totaled $0.2 million.
- Margins: Not meaningful because the company had no product revenue. Accumulated deficit was $99.7 million.
Material changes and unusual items
- First-half R&D expense increased $8.6 million year over year, while G&A expense increased $2.4 million. Management attributed the R&D increase principally to lower DoD reimbursements as spending on the BCP-01 program and reimbursable costs declined; personnel costs also rose. G&A growth primarily reflected higher personnel costs and stock-based compensation.
- DoD reimbursements recorded as offsets to R&D expense were $0.6 million in the first half of 2022, versus $8.1 million in the first half of 2021. The company had received $17.4 million of the $17.6 million available under the agreement by June 30, 2022.
- The company recorded $0.8 million of CARES Act employee retention credit receivable in the first half of 2022. The 2021 comparative period included $0.5 million of other income from PPP loan forgiveness.
- Share-based compensation expense was $2.6 million for the first half, compared with $1.1 million a year earlier.
Outlook, risks, and contingencies
- Management expects cash at June 30, 2022 to fund planned operating expenses and capital expenditures for at least 12 months from the filing date, but says additional financing will be needed beyond that period. The estimate is based on assumptions that may prove imprecise.
- The Phase 1b study of IMM-BCP-01 in patients with SARS-CoV-2 infection was underway; topline data were expected in the second half of 2022. The company planned to submit an IND for oncology candidate IMM-ONC-01 in the second half of 2022. These are forward-looking plans, not assured outcomes.
- Management expects expenses and operating losses to increase as it advances discovery, preclinical and clinical programs. Funding may come from equity or debt offerings, collaborations, alliances, or licensing; none is a committed source. The $75 million ATM facility had not been used as of the filing.
- Key risks include clinical and regulatory uncertainty, ability to raise capital, reliance on third parties, competition, and uncertainty around COVID-19 and its variants. Failure to obtain funding could require delaying, reducing, or ending programs or pursuing strategic alternatives.
- 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. No material litigation was reported.
Important facts for investors to verify
- Whether cash burn and operating costs remain consistent with the stated minimum 12-month runway, and the timing and terms of any additional financing.
- Progress and results of the IMM-BCP-01 Phase 1b study, and whether IMM-ONC-01 reaches the planned IND submission stage.
- Remaining DoD agreement funding and the effect of reduced reimbursements on reported R&D costs.
- Potential dilution from the ATM facility, outstanding warrants, and stock options; 12,127,385 common shares were outstanding as of August 2, 2022.