IN8BIO, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended December 31, 2022. This is an annual filing; the supplied text does not provide separate fourth-quarter financial results. IN8BIO is a clinical-stage biopharmaceutical company developing gamma-delta T-cell therapies. It had no approved products and generated no revenue.
Financial performance and liquidity
| Metric | FY2022 / Dec. 31, 2022 | FY2021 / Dec. 31, 2021 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $14.1 million | $7.3 million |
| General and administrative expense | $14.5 million | $7.3 million |
| Total operating expenses and net loss | $28.5 million | $14.7 million |
| Basic and diluted loss per share | $1.36 | $1.47 |
| Cash | $18.2 million | $37.0 million |
| Net cash used in operating activities | $24.1 million | $13.5 million |
| Net cash used in investing activities | $3.7 million | $0.3 million |
| Net cash provided by financing activities | $9.0 million | $33.0 million |
Gross margins are not applicable because the company had no product revenue. At year-end, current assets were $22.2 million and current liabilities were $5.8 million. Total liabilities were $10.3 million; the company reported no long-term debt, but had $7.5 million of fixed lease payment obligations, including $2.0 million due within 12 months. Accumulated deficit was $61.2 million.
Changes versus FY2021
- Net loss widened by $13.9 million as total operating expenses nearly doubled. R&D spending rose $6.7 million, largely due to INB-400 clinical-trial and manufacturing costs, higher personnel costs, and facility expenses.
- G&A spending increased $7.2 million, driven by professional services, public-company insurance and other costs, and personnel.
- Operating cash use increased by $10.6 million. Cash declined $18.8 million during 2022, despite $9.4 million of net proceeds from the August follow-on offering.
- Common shares outstanding increased from 18.8 million to 24.5 million during 2022. As of March 29, 2023, 24.94 million shares were outstanding.
Business, outlook, and material risks
- Going concern: The auditor’s report includes an explanatory paragraph stating that recurring losses raise substantial doubt about the company’s ability to continue as a going concern. Management said $18.2 million of year-end cash would fund operations only through mid-July 2023, including reserves for necessary winddown expenses. The company was pursuing equity or debt financing, ATM sales, collaborations, licensing, or other arrangements; none was assured. Cost reductions could delay or limit development plans.
- Financing: The company completed a $9.4 million net follow-on offering in August 2022 and had an ATM program under a shelf registration. Because its public float was below $75 million, use of the shelf for primary offerings was subject to the SEC’s baby-shelf limit. Through March 29, 2023, ATM sales totaled 435,901 shares and approximately $0.8 million net proceeds.
- Pipeline plans, conditional on funding: INB-200 was in a Phase 1 trial for newly diagnosed glioblastoma (GBM); management expected to complete Cohort 3 enrollment in 2023. INB-400’s FDA-cleared IND supported a planned Phase 2 GBM trial, with enrollment expected in the second half of 2023 and initial data in 2025. INB-100 was in Phase 1 for high-risk hematologic malignancies in patients undergoing stem-cell transplantation; management expected to complete enrollment and determine the recommended Phase 2 dose in 2023, with topline results in 2024. An INB-410 IND submission was planned for the second half of 2023. These are management estimates, not assurances.
- Early clinical observations: As of year-end, eight patients had received INB-200. The company reported no dose-limiting toxicities in the first two cohorts, but the trial was small and ongoing; reported survival observations are preliminary and not evidence of established efficacy. Six patients had received INB-100 by the disclosed update; low-grade skin GvHD was reported in treated patients, while no grade 3-or-higher GvHD, CRS, or ICANS had been observed. The filing cautions that interim clinical data can change as follow-up and verification continue.
- Key risks: The company is pre-revenue and dependent on additional capital, clinical and regulatory success, and third-party manufacturing. Risks include dilution or unfavorable financing terms, trial delays or failure, adverse events, manufacturing and supplier constraints, competition, and uncertainty over reimbursement. Management reported effective disclosure controls and internal control over financial reporting as of December 31, 2022; the auditor did not attest to internal controls.
Important facts for investors to verify
- Current cash, actual operating runway, and whether financing or strategic arrangements have been secured since the filing.
- ATM usage, remaining financing capacity under applicable shelf limits, and resulting share dilution.
- Updated enrollment, safety, and follow-up data for INB-200 and INB-100, including whether early observations persist in larger or longer-followed cohorts.
- Whether the planned INB-400 Phase 2 and INB-410 development milestones occurred on schedule and remain funded.
- Manufacturing capacity, third-party supply availability, lease commitments, and any changes to the going-concern assessment.