Immunome, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended December 31, 2022. This is an annual filing, not a standalone fourth-quarter report. Immunome is a clinical-stage biopharmaceutical company developing antibody therapeutics using its human memory B-cell discovery platform; it had no product sales or approved products.
Financial performance and position
| Metric | FY2022 / Dec. 31, 2022 | FY2021 / Dec. 31, 2021 |
|---|---|---|
| Revenue from product sales | None | None |
| Research and development expense | $23.3 million | $14.1 million |
| General and administrative expense | $13.6 million | $11.1 million |
| Total operating expenses / operating loss | $36.9 million | $25.2 million |
| Net loss | $36.9 million | $24.7 million |
| Net loss per share, basic and diluted | $3.09 | $2.14 |
| Cash and cash equivalents | $20.3 million | $49.2 million |
| Net cash used in operating activities | $28.7 million | $18.2 million |
| Total assets / total liabilities | $24.0 million / $7.4 million | $57.9 million / $9.7 million |
- Research and development expense rose $9.2 million, reflecting increased IMM-BCP-01 spending after DoD reimbursements reached their $17.6 million cap, and increased IMM-ONC-01 development costs.
- Operating cash use increased year over year. Investing activities used $0.2 million; financing activities provided $0.03 million in 2022. The company reported no material outstanding debt at year-end; its equipment loan had been repaid in 2021.
- There was no operating margin to assess given the absence of product revenue. DoD reimbursements and employee-retention credits reduced expenses rather than being reported as revenue.
- Year-end working capital was approximately $15.3 million. The company also had a $0.8 million employee-retention-credit receivable and $0.1 million of restricted cash.
Material changes and notable items
- Net loss widened by $12.2 million, while operating expenses increased $11.7 million. The prior-year result included $0.5 million of other income from forgiveness of the PPP loan.
- In September 2022, Immunome reduced the Series B warrant exercise price from $45 to $10 per share and removed its call right. The modification produced a $0.6 million deemed dividend, increasing loss attributable to common stockholders for per-share reporting; it did not change total stockholders’ equity.
- After year-end, Immunome received a $30 million upfront payment under a January 2023 AbbVie collaboration. The payment was not included in December 31, 2022 cash. The agreement offers potential additional platform payments, option fees, milestones and royalties; the stated potential total of up to $2.8 billion is contingent, not assured revenue.
- Cash and cash equivalents declined by $28.9 million during 2022, from $49.2 million to $20.3 million.
Outlook, management commentary and risks
- Management said year-end cash plus the $30 million AbbVie upfront payment was expected to fund operations for at least 12 months from the March 16, 2023 filing date. The company expects continued losses and says additional financing will be needed to support its longer-term research and development plans.
- IMM-ONC-01, an anti-IL-38 antibody for solid tumors, remained preclinical. Immunome planned to submit an IND by mid-2023; this was a goal, not a guarantee.
- IMM-BCP-01, a COVID-19 antibody cocktail, entered a Phase 1b study in June 2022. The first cohort was dosed with no significant treatment-related adverse events reported in January 2023. Immunome decided to seek a partner to continue the trial and further development. The filing also describes the study as suspended, so its operating status should be confirmed.
- The AbbVie collaboration covers discovery work in three tumor types for at least 66 months and grants AbbVie options on up to 10 validated target-antibody pairs. It restricts Immunome from pursuing certain work and products in the covered areas while the agreement is in effect. Future payments depend on research, option exercises and product development and sales.
- Key risks include recurring losses and financing needs; uncertain preclinical and clinical outcomes; the ability to find a partner for IMM-BCP-01; dependence on third-party manufacturers and vendors; regulatory, intellectual-property and commercialization risks; and potential dilution from future equity issuance.
- On March 10, 2023, Silicon Valley Bank was closed. The filing says Immunome incurred no loss on deposits held there and subsequently transferred its deposits to another institution.
- Ernst & Young audited the 2022 financial statements and issued an unqualified opinion. Deloitte was replaced in September 2022; the company reported no disagreements or reportable events. Management concluded internal control over financial reporting was effective, but the company was not required to obtain an auditor attestation.
Important facts for investors to verify
- Confirm the current cash balance, cash runway and financing needs, including whether AbbVie has made any payments beyond the $30 million upfront amount.
- Check progress and timing of the IMM-ONC-01 IND and any subsequent clinical plans.
- Confirm whether a partner was secured for IMM-BCP-01 and whether its Phase 1b study resumed or was discontinued.
- Review the AbbVie agreement’s research restrictions, termination provisions, option exercises and conditions for potential milestone or royalty payments.
- Assess potential dilution from outstanding warrants, options and available equity-issuance programs; the filing reports 12,128,843 common shares outstanding at year-end 2022.