IN8BIO, Inc. — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022. The company is a clinical-stage biopharmaceutical company developing gamma-delta T-cell therapies. Its lead candidates, INB-200 for newly diagnosed glioblastoma and INB-100 for leukemia patients undergoing stem-cell transplantation, were in Phase 1 trials. IN8BIO has no approved products and has generated no product revenue.
Financial results and liquidity
| Metric | Q1 2022 | Q1 2021 / comparison |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $2.381 million | $1.245 million; up $1.136 million |
| General and administrative expense | $3.764 million | $1.118 million; up $2.646 million |
| Total operating expenses / net loss | $6.145 million | $2.363 million; loss increased $3.782 million |
| Net loss per share, basic and diluted | $0.33 | $0.82 |
| Cash used in operating activities | $4.559 million | $2.507 million |
| Cash used in investing activities | $0.253 million | None reported |
| Cash used in financing activities | $0.102 million | $0.435 million |
Cash was $32.107 million at March 31, 2022, down from $37.021 million at December 31, 2021. Management stated that cash on hand was expected to fund operating expenses and capital requirements for at least 12 months from issuance of the financial statements. The company reported an accumulated deficit of $38.836 million and stockholders’ equity of $32.835 million.
Current assets were $33.274 million and current liabilities were $2.068 million. Total liabilities were $3.703 million, primarily lease liabilities; the company reported no long-term debt. Remaining fixed lease payment obligations were stated as $2.9 million, including $0.8 million due within 12 months. The 2020 PPP loan had been repaid in full in August 2021.
Changes versus prior year
- Operating expenses rose 160% year over year. R&D growth primarily reflected clinical-trial and contract-manufacturing activity for INB-200, plus higher personnel costs.
- G&A growth primarily reflected increased staffing and stock-based compensation, legal expenses following the IPO, insurance, and public-company costs.
- Operating cash use increased to $4.559 million from $2.507 million. Q1 2022 cash use included the larger net loss, partly offset by noncash stock compensation and working-capital movements.
Outlook, management commentary, and risks
- Management expected initial INB-200 Phase 1 results in the second half of 2022 and topline results for all cohorts in the first half of 2023. Initial INB-100 cohort results were expected in 2022, with topline results for all cohorts in 2023.
- The company planned to initiate an INB-400 Phase 1b/2 program and expected to file several INDs through 2023, with the first filing expected in the second half of 2022. These are forward-looking plans, not assurances.
- Management expects expenses and operating losses to increase as clinical and preclinical programs advance. Additional capital will be needed; future equity financing could dilute shareholders, while debt or partnerships could impose restrictions or require relinquishing rights.
- Reported early clinical observations were from very small patient groups: all three reported INB-200 cohort 1 patients had no dose-limiting toxicities, and all three INB-100 patients remained in morphologic complete response through March 2022. These preliminary observations do not establish efficacy and may change as data mature.
- Key risks include clinical and regulatory failure or delay, patient enrollment, complex cell-therapy manufacturing, reliance on third parties and single-source supplies, and intellectual-property license obligations. The filing disclosed a lentiviral-vector manufacturing backlog and current supply estimated to cover approximately 29 patients.
- COVID-19-related site, staffing, supply-chain, and capital-market disruption remained possible; management also cited inflation and geopolitical uncertainty. The company reported no material legal proceedings. Disclosure controls were assessed as effective at the reasonable-assurance level; internal-control effectiveness was not evaluated in this report under the applicable transition period.
Important facts for investors to verify
- Whether trial enrollment, safety follow-up, and the stated 2022–2023 data and IND timelines remain on track; assess the limited patient counts and preliminary nature of reported results.
- Whether cash burn, clinical spending, and lease/build-out costs are consistent with the stated minimum 12-month runway, and when additional financing may be required.
- Whether lentiviral-vector supply and manufacturing capacity can support planned trials, given the disclosed backlog and estimated supply for approximately 29 patients.
- Potential dilution from equity awards and future fundraising; 18,812,267 common shares were outstanding at quarter-end, and 3,013,205 stock options were outstanding.
- Milestone, royalty, patent-maintenance, and other obligations under the Emory and UABRF licenses, and any risks to maintaining those rights.