IN8BIO, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021; filed March 17, 2022. The company is a clinical-stage biopharmaceutical developer of gamma-delta T-cell cancer therapies. It reported no product revenue and had no approved products.
Financial results and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $7.347 million | $5.378 million |
| General and administrative expense | $7.306 million | $3.179 million |
| Total operating expenses / net loss | $14.653 million | $8.557 million |
| Net loss per common share, basic and diluted | $1.47 | $3.02 |
| Net cash used in operating activities | $13.509 million | $7.133 million |
- Expenses rose by $6.096 million year over year. R&D growth reflected clinical-trial, manufacturing and personnel costs; G&A growth reflected headcount, IPO-related legal costs, insurance and public-company expenses.
- At December 31, 2021, cash was $37.021 million, current assets were $38.980 million, current liabilities were $2.256 million, total liabilities were $4.040 million and stockholders’ equity was $38.183 million. The company reported no cash-flow or operating margin because it had no revenue.
- Net cash used in investing activities was $0.309 million; financing activities provided $32.955 million. The company reported $37.272 million of cash and restricted cash at year-end, including $0.251 million of restricted cash.
- The company said year-end cash would fund projected operating expenses and capital needs for at least 12 months from issuance of the financial statements. It expects to need substantial additional financing; no committed external funding source was disclosed.
- The August 2021 IPO raised $32.3 million net. The company said it had not used IPO proceeds as of the filing. The $0.2 million PPP loan was repaid in August 2021. No other long-term debt was reported.
- Contractual lease payments totaled $2.948 million at year-end. Separately, a lab build-out agreement had expected costs of up to $4.0 million, of which $0.2 million had been incurred.
Business, progress and changes
- INB-200: Autologous, genetically modified gamma-delta T cells for newly diagnosed glioblastoma (GBM), in a Phase 1 dose-escalation trial. The company planned to report initial topline results in the second half of 2022.
- INB-100: Donor-derived, allogeneic gamma-delta T cells for high-risk leukemia patients undergoing hematopoietic stem cell transplantation, in a Phase 1 trial. Initial first-cohort results were expected in 2022 and topline results across cohorts in 2023.
- Pipeline: INB-400 was planned as a Phase 1b/2 GBM program, with an initial autologous IND targeted for the second half of 2022 and a supplemental allogeneic IND thereafter. INB-300, a CAR-enabled program, remained preclinical. The company expected to file several pipeline INDs through 2023.
- Preliminary INB-200 disclosures reported no treatment-related dose-limiting toxicities in the described treated patients. One participant died after a second dose following an acute cardiopulmonary event; the company, investigator, safety board and FDA considered the death unlikely to be related to INB-200. The protocol was modified to mitigate similar cardiovascular risks, and the trial continued.
- For INB-100, the company reported three treated patients in morphologic complete remission, with no dose-limiting toxicities or treatment-related grade 3-or-higher adverse events reported to date. Grade 1–2 graft-versus-host disease occurred in some patients and was responsive to steroids or resolved.
- The filing contains inconsistent INB-200 enrollment descriptions: it reports 12 patients enrolled and six treated as of year-end, and elsewhere says six patients were enrolled in cohort 2 with two dosed. These figures should be reconciled against trial records and subsequent disclosures.
Outlook, risks and unusual items
- Management expects expenses and operating losses to increase as clinical development, manufacturing capacity, staffing and public-company costs expand. Profitability depends on successful development, regulatory approval and commercialization, none of which is assured.
- Key risks include clinical failure or safety findings, small early-stage trial populations, patient enrollment and retention, manufacturing variability or failure, dependence on third-party manufacturers and a single supplier for certain critical equipment and lentiviral vectors, regulatory uncertainty, intellectual-property and licensing risks, competition, and the need for additional capital.
- COVID-19 had affected or could affect trial enrollment, clinical-site capacity, supply chains, costs and access to capital. Management also cited inflation, market volatility and geopolitical tensions, including Russia’s invasion of Ukraine.
- The company relied on third parties for manufacturing and had no commercial-scale manufacturing capability or commercial supply agreements. It reported a lentiviral-vector supply sufficient for approximately 29 patients and noted industry manufacturing backlogs.
- No material legal proceedings were reported. The independent auditor issued an unqualified opinion on the financial statements. Management said disclosure controls were effective at a reasonable-assurance level; the filing included no auditor attestation on internal control over financial reporting under the newly public company transition provisions.
Investor verification priorities
- Reconcile INB-200 patient enrollment, cohort and dosing counts, and review updated safety and efficacy data, including follow-up on the reported death and protocol changes.
- Confirm current cash, cash burn, financing runway and subsequent financing or spending plans; the runway statement is based on year-end cash and management projections.
- Track whether planned IND submissions and trial timelines were achieved, and whether later data support the company’s preliminary claims.
- Assess manufacturing success rates, vector availability, third-party capacity, and the cost and timing of the Birmingham lab build-out.
- Review dilution exposure, including equity compensation and potential future capital raises, as well as license milestones, royalties and maintenance obligations.