IN8BIO, Inc. — Form 10-Q Summary
Reporting period: Three and nine months ended September 30, 2022. Financial amounts below are in millions of dollars unless otherwise noted. IN8BIO is a clinical-stage biopharmaceutical company developing gamma-delta T-cell therapies; it has no approved products and has generated no product revenue.
Financial results and position
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense | $4.3 | $1.4 | $10.1 | $4.7 |
| General and administrative expense | $3.1 | $2.0 | $10.6 | $4.1 |
| Total operating expenses / net loss | $7.4 | $3.4 | $20.7 | $8.8 |
| Basic and diluted loss per share | $(0.34) | $(0.25) | $(1.05) | $(1.26) |
| Net cash used in operating activities | Not presented by quarter | $16.2 | $11.3 |
Gross margin is not applicable because the company reported no revenue. Cash was $27.6 million at September 30, 2022, down from $37.0 million at December 31, 2021; cash and restricted cash totaled $27.9 million. Total assets were $38.4 million, total liabilities $8.8 million, and stockholders’ equity $29.6 million. Accumulated deficit was $53.4 million. The filing reports no long-term debt; lease liabilities totaled $4.8 million, with fixed lease payments of $6.4 million, including $1.4 million due within 12 months.
Investing activities used $2.4 million in the first nine months, primarily for Alabama laboratory build-out. Financing activities provided $9.2 million, principally from the August 2022 equity offering. The company reported $9.8 million net proceeds from that offering. Cash and restricted cash declined by $9.4 million during the period.
Changes versus comparable periods
- Q3 net loss increased to $7.4 million from $3.4 million; nine-month net loss increased to $20.7 million from $8.8 million.
- Q3 R&D expense rose $2.9 million, primarily from INB-400 clinical and manufacturing activity, higher personnel costs, and facility costs. Nine-month R&D rose $5.5 million.
- Q3 G&A expense rose $1.1 million, and nine-month G&A rose $6.5 million, mainly reflecting increased staffing, public-company costs, legal expenses, and insurance.
- Operating cash use increased to $16.2 million from $11.3 million for the nine-month comparison. Prior-year financing was higher, at $34.2 million, largely due to the IPO, versus $9.2 million in 2022.
- Common shares outstanding increased from 18.8 million at year-end 2021 to 24.5 million at September 30, 2022, including the August offering.
Outlook, developments, and risks
- Management expects expenses and operating losses to increase as clinical development and pipeline work continue. It expects to finance operations through additional equity or debt, collaborations, licensing, or other strategic arrangements; financing availability and terms are uncertain.
- The filing states that September 30 cash would not fund projected expenses and capital needs for at least 12 months from issuance of the statements, and management says cash is not expected to support the operating plan beyond 2023. It identifies substantial doubt about the company’s ability to continue as a going concern. Without additional capital, programs may be delayed, reduced, or discontinued.
- INB-200 and INB-100 were in Phase 1 trials. Management expected initial INB-200 topline results from the first repeated-dose cohort in early 2023, updated INB-100 results at the late-2022 ASH meeting, and initial results across INB-100 cohorts in 2023.
- Management reported that all three high-risk AML patients in the first INB-100 cohort remained alive and progression-free for more than one year, with two remaining in morphologic complete remission for more than two years; it described safety as manageable, with no dose-limiting toxicities. These are early, limited-patient clinical results and may change as data mature and are verified.
- INB-400’s IND was filed in November 2022, after quarter-end; the company said it was identifying potential sites for a planned Phase 1b/2 program, subject to FDA clearance. The company also announced a University of Louisville manufacturing partnership for INB-400 and reported expansion of its DeltEx platform to iPSC-derived gamma-delta T cells.
- Key risks include early-stage clinical and regulatory uncertainty, patient enrollment, complex cell-therapy manufacturing and reliance on third parties and single-source suppliers, supply-chain constraints, intellectual-property license obligations, and access to future capital. COVID-19 disruptions, inflation, market volatility, and geopolitical tensions may add pressure to operations and financing.
- No material legal proceedings were reported. Management concluded disclosure controls and procedures were effective at the reasonable-assurance level as of September 30, 2022; the company was not yet required to evaluate internal control over financial reporting in this 10-Q.
Investor verification points
- Confirm the timing and terms of additional financing, and monitor cash burn against management’s stated runway and going-concern warning.
- Review subsequent INB-100 and INB-200 clinical updates, including patient counts, follow-up, safety events, and whether preliminary findings are confirmed.
- Track FDA status and site activation for INB-400, and verify the timing and cost of planned clinical development.
- Assess manufacturing capacity, lentiviral-vector availability, supplier concentration, and progress on the laboratory build-out and lease commitments.
- Monitor dilution from future equity issuance and the company’s ability to meet license, clinical, and other operating obligations.