Business context and reporting period
Immunome, Inc. is a clinical-stage biopharmaceutical company developing antibody therapeutics using a human memory B-cell platform, with programs in oncology and infectious disease. This unaudited Form 10-Q covers the quarter and nine months ended September 30, 2022. The company had not generated product revenue and expected none for the foreseeable future.
As of September 30, 2022, its lead programs were IMM-BCP-01, a SARS-CoV-2 antibody cocktail in a Phase 1b study initiated in June 2022, and IMM-ONC-01, an oncology program targeting IL-38. The company reported preclinical neutralization activity for IMM-BCP-01 against Omicron and dominant sub-lineages, including BA.4/5.
Financial results and liquidity
Amounts below are in millions of dollars, except per-share data. Operating margins are not meaningful because the company reported no product revenue.
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Research and development expense | 5.2 | 4.5 | 19.0 | 9.7 |
| General and administrative expense | 3.3 | 3.2 | 10.1 | 7.6 |
| Total operating expenses | 8.5 | 7.7 | 29.1 | 17.4 |
| Net loss | 8.5 | 7.7 | 29.1 | 16.9 |
| Net loss per share | $0.75 | $0.65 | $2.45 | $1.49 |
At September 30, cash and cash equivalents were $27.1 million, versus $49.2 million at December 31, 2021; restricted cash was an additional $0.1 million. Current assets were $29.2 million and current liabilities $7.4 million. Total liabilities were $7.5 million, with no outstanding borrowing reported; the prior $0.5 million PPP loan had been forgiven in 2021. Stockholders’ equity was $23.1 million and accumulated deficit was $108.2 million.
For the first nine months, operating cash use was $22.0 million, investing cash use was $0.2 million, and financing provided $0.03 million, principally from stock-option exercises. Cash and restricted cash decreased by $22.2 million. Management expected available cash to fund planned operating expenses and capital expenditures for at least 12 months from the November 14, 2022 filing date, but stated that additional financing would be needed beyond that period.
Material changes versus the prior comparable period
- Nine-month operating expenses rose $11.8 million year over year, and net loss increased $12.3 million. R&D expense increased $9.3 million and G&A increased $2.5 million.
- Management attributed much of the nine-month R&D increase to a $12.7 million reduction in DoD reimbursement-related contra-expense as BCP-01 spending and reimbursable costs declined. Higher personnel and share-based compensation costs also contributed; lower outsourced research and materials costs partly offset the increase.
- Nine-month operating cash use increased from $11.4 million to $22.0 million. The prior-year period included $28.0 million of net financing cash proceeds, while 2022 financing activity was minimal.
- Q3 R&D expense increased $0.7 million year over year, despite lower outsourced research and materials costs, primarily reflecting reduced DoD reimbursement offsets.
Outlook, risks, contingencies, and unusual items
- Management expected R&D and G&A costs and operating losses to increase as the company advances current and future research, preclinical work, and clinical trials. It anticipated IMM-BCP-01 topline safety and pharmacokinetic data by year-end 2022, with results to be announced in early 2023, and planned to submit an IND for IMM-ONC-01 by mid-2023.
- The company had not used its ATM agreement, which permits up to $75 million of common-stock sales, or its shelf registration statement, which permits up to $200 million of securities. Neither represents committed financing. Management warned that capital may not be available on acceptable terms or at all; insufficient funding could force delays, reductions, or termination of programs, or strategic alternatives including collaborations, a merger, or sale.
- In September 2022, Immunome reduced the exercise price of its Series B warrants from $45 to $10 per share and removed its call right. The modification generated a $0.6 million deemed dividend, increasing net loss attributable to common stockholders for EPS purposes; it did not change total stockholders’ equity. No warrants were exercised during the first nine months of 2022.
- License agreements could require up to approximately $2.6 million in development and regulatory milestone payments and up to approximately $1.5 million in commercial milestone payments, in addition to royalties or other payments if applicable. The filing reported no material litigation.
- Key risks include clinical and regulatory uncertainty, competition, reliance on vendors, ability to raise capital, and uncertainty about future COVID-19 variants and their impact on the company and its programs. The company reported no significant COVID-19 impact on operations or financial statements to date.
Important facts for investors to verify
- Whether IMM-BCP-01’s Phase 1b safety and pharmacokinetic results were delivered on the stated timeline and support further development.
- Whether IMM-ONC-01’s IND submission occurred as planned and what subsequent regulatory and development milestones were reported.
- Cash burn, remaining cash runway, and any financing or collaboration activity after September 30, 2022; management’s runway estimate relies on assumptions and was not a guarantee.
- The terms and potential dilution from any future use of the $75 million ATM facility, shelf registration, or warrant exercises; 1.3 million common-stock warrants were outstanding at September 30, 2022.
- The extent to which DoD reimbursements, employee retention credits, and changes in program spending affected reported R&D costs and cash flows.