Immunome, Inc. — Q3 2021 Form 10-Q
Reporting period: Three and nine months ended September 30, 2021. Unaudited financial statements. Immunome is a clinical-stage-development biopharmaceutical company focused on oncology and infectious disease; its programs were in preclinical development, and it had no product revenue.
Financial performance and position
| Metric | Q3 2021 | Q3 2020 | Nine months 2021 | Nine months 2020 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense, net of DoD reimbursements | $4.5 million | $1.6 million | $9.7 million | $5.7 million |
| General and administrative expense | $3.2 million | $1.2 million | $7.6 million | $2.5 million |
| Total operating expenses | $7.7 million | $2.8 million | $17.4 million | $8.2 million |
| Net loss | $7.7 million | $8.4 million | $16.9 million | $13.8 million |
| Net loss per share, basic and diluted | $0.65 | $7.52 | $1.49 | $12.44 |
- At September 30, 2021, cash was $56.2 million, current assets were $61.2 million, and total assets were $62.6 million. Current liabilities were $7.8 million; total liabilities were also $7.8 million. The balance sheet reported no long-term debt and $16,000 of equipment-loan payable.
- For the first nine months, operating cash use was $11.4 million, investing cash use was $65,000, and financing provided $28.0 million. Cash and restricted cash increased $16.5 million to $56.3 million.
- Gross margin is not applicable because the company reported no product sales. The filing does not provide a clear cash runway estimate beyond management’s statement below.
Changes versus comparable periods
- Net R&D expense rose $2.9 million in Q3 and $4.1 million year to date; net G&A expense rose $2.0 million and $5.1 million, respectively. The filing attributes higher costs principally to supplies and outsourced research, increased headcount and share-based compensation, and public-company professional, legal, consulting and insurance costs.
- Q3 net loss was lower than the prior-year period despite higher operating expenses, primarily because Q3 2020 included a $5.5 million non-cash warrant-liability fair-value charge. Year-to-date net loss increased, reflecting higher operating expenses; the 2020 period also included that warrant charge.
- The DoD award for the COVID-19 antibody program was increased from $13.3 million to $17.6 million in May 2021. DoD reimbursements recorded as contra-R&D expense were $5.3 million for Q3 2021 and $13.4 million for the first nine months of 2021.
- In April 2021, Immunome raised $27.0 million gross in a private placement of common stock and warrants, or $26.4 million net. In August, it sold 14,115 shares to an individual investor for $225,000.
Outlook, risks and unusual items
- Management expected September 30 cash to fund operating expenses and capital expenditures for at least 12 months from the filing date, including planned Phase 1b studies for IMM-BCP-01 and IMM-ONC-01. It expects losses and negative operating cash flows to continue and says additional financing will be needed beyond that period.
- Management planned to submit an IND for the IMM-BCP-01 COVID-19 antibody cocktail in Q4 2021 and for the lead anti-IL-38 oncology program IMM-ONC-01 in Q1 2022. These were plans, not reported achievements.
- A shelf registration statement effective October 14, 2021 permits issuance of up to $200 million of securities. An October ATM agreement permits sales of up to $75 million of common stock; no shares had been sold under it as of the filing. Further equity issuance could dilute shareholders, and management cautioned that financing may not be available on acceptable terms.
- The $0.5 million PPP loan was forgiven in May 2021 and recognized as other income. License agreements may require up to approximately $2.6 million in development and regulatory milestones, plus potential commercial milestones and royalties.
- The filing identifies risks including uncertain preclinical and clinical outcomes, regulatory approval, competition, dependence on financing and third parties, and uncertainty around COVID-19’s effect on operations and development timelines. Management reported no material legal proceedings.
- Management concluded disclosure controls and procedures were ineffective due to material weaknesses involving journal-entry review, timely and effective account-balance review, and insufficient accounting personnel. Remediation efforts were underway but were not yet considered complete.
Important facts for investors to verify
- Whether planned IND submissions and clinical-development timelines were achieved, and how program data support progression.
- Actual cash burn and remaining runway relative to management’s estimate, including any use of the shelf registration or ATM.
- DoD reimbursement collections and remaining award funding, including the reported $2.4 million receivable and $1.8 million unbilled receivable at quarter-end.
- Progress and effectiveness of remediation of the disclosed material weaknesses.
- Potential dilution from outstanding warrants, stock options, and any future securities sales; 12,100,387 common shares were outstanding as of November 12, 2021.