IN8BIO, Inc. — Q1 2024 Form 10-Q
Business context and reporting period
For the three months ended March 31, 2024. IN8BIO is a clinical-stage biopharmaceutical company developing gamma-delta T-cell therapies; it has no approved products and has generated no product revenue. Its lead programs include INB-400 (Phase 2 in newly diagnosed glioblastoma), INB-200 (Phase 1 in newly diagnosed glioblastoma) and INB-100 (Phase 1 in hematologic malignancies following stem-cell transplant).
Financial performance and position
| Metric | Q1 2024 | Q1 2023 / comparison |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $4.903 million | $4.385 million |
| General and administrative expense | $3.742 million | $3.470 million |
| Total operating expenses | $8.645 million | $7.855 million |
| Net loss | $8.562 million | $7.525 million |
| Net loss per share, basic and diluted | $0.20 | $0.30 |
| Cash used in operating activities | $7.919 million | $7.439 million |
| Cash and restricted cash at quarter-end | $13.271 million | $11.113 million at March 31, 2023 |
Cash alone was $13.015 million at March 31, down from $21.282 million at December 31, 2023. Current assets were $15.755 million and current liabilities $3.844 million. Total liabilities were $8.023 million, primarily lease liabilities; the company reported no long-term debt. Fixed lease payment obligations were $7.2 million, including $2.1 million due within 12 months.
Material changes versus the prior period
- Net loss increased $1.037 million year over year, as operating expenses rose $0.790 million and the prior-year period’s $0.330 million of one-time other income did not recur. Q1 2024 included $0.083 million of interest income.
- R&D expense increased $0.518 million, mainly due to higher personnel costs, including stock-based compensation. G&A expense increased $0.272 million, largely due to personnel and rent costs.
- Operating cash use increased $0.480 million. Cash and restricted cash declined $8.267 million during the quarter.
- The Birmingham operating lease was modified and expanded in March, increasing right-of-use assets and lease liabilities.
Outlook, risks and unusual items
- Going concern: Management says available cash is expected to fund projected operating expenses and capital expenditures only into January 2025; the filing states substantial doubt about the company’s ability to continue as a going concern for 12 months from issuance. The company is pursuing financing and collaboration options and has implemented near-term cash-preservation measures.
- Financing and dilution: Through May 2, 2024, the company sold 856,624 shares through its ATM program for approximately $1.0 million net. Potential warrant proceeds are not assured: up to approximately $14.8 million from Series A warrants may depend on INB-100 data and market-price and trading-volume conditions; Series B warrants could provide up to approximately $17.7 million if exercised and not redeemed. Additional equity financing could dilute shareholders; the company’s public float also limits shelf offerings under the baby-shelf rules.
- Clinical and business outlook: Management reported dosing the first patient in the INB-400 Phase 2 trial, completing INB-200 Cohort 3 enrollment, and continuing INB-100 expansion enrollment at its recommended Phase 2 dose. It anticipated clinical updates in 2024. A planned 2025 IND submission for an allogeneic INB-400 study is contingent on additional funding. These are plans, not assured outcomes; no financial guidance was provided.
- Key risks: Clinical efficacy and safety remain unproven; development, enrollment, manufacturing and regulatory timelines are uncertain. The filing notes grade 1/2 graft-versus-host disease in approximately 60% of INB-100 patients treated to date. It also identifies reliance on third-party manufacturing and suppliers, possible stock dilution, and cash deposits above FDIC insurance limits.
- The company reported no material legal proceedings and stated that disclosure controls and procedures were effective at the reasonable-assurance level as of March 31, 2024.
Important facts for investors to verify
- Whether financing, ATM sales, warrant exercises or collaborations provide sufficient cash to extend runway beyond January 2025, and the resulting dilution or terms.
- INB-100 follow-up data and whether the Series A warrant exercise conditions are met; also the Series B redemption and exercise terms.
- Clinical updates, enrollment, safety and efficacy evidence for INB-400, INB-200 and INB-100, including whether anticipated milestones remain on schedule.
- Quarterly cash burn, lease obligations and any further cost-preservation actions or changes to development plans.