IN8bio, Inc. (NASDAQ:INAB) has announced a strategic restructuring to concentrate its resources on the INB-100 program for acute myeloid leukemia (AML), driven by encouraging clinical outcomes and a difficult financial landscape. The company is implementing significant cost-saving measures, including a workforce reduction of approximately 49% and the suspension of its glioblastoma multiforme (GBM) program.
Strategic Shift to AML Program
The decision to narrow the focus to INB-100 comes after the GBM program, featuring INB-400, struggled to attract investor interest and faced high development costs. IN8bio believes that the capital required to generate pivotal data for INB-400 was not feasible in the current market. Despite pausing the GBM program, the company remains optimistic about potential partnerships or renewed investor interest in the future.
Financial Restructuring and Private Placement
To support the INB-100 program, IN8bio has successfully completed a $12.4 million private placement. The funding round included participation from existing healthcare-focused institutional investors, a large mutual fund, and new institutional investors. The net proceeds are expected to sustain company operations into 2026.
Under the terms of the agreement, IN8bio will sell shares of common stock and pre-funded warrants, combined with warrants, at a purchase price of $0.395 per unit. The capital will be used to further the clinical development of INB-100 and continue patient enrollment in the expansion cohort.
Clinical Trial Expansion and Design
IN8bio is expanding its ongoing Phase I trial (NCT03533816) to enroll an additional 25 patients at the recommended Phase II dose of 3 x 106 γδ T cells/kg. A control cohort of ten patients receiving standard haplotransplantation will be monitored in parallel to provide a comparative analysis. Enrollment in the expansion population is expected to be completed in the first half of 2025, with further updates anticipated in 2025 and 2026.
Promising Early Clinical Data
As of August 30, all AML patients treated with INB-100 in the Phase I trial remained relapse-free after a median follow-up of 18.7 months. Notably, some patients have remained alive and relapse-free for over three years following treatment with INB-100. These encouraging results have solidified the company's decision to prioritize the AML program.
Cost Reduction Measures
In addition to the workforce reduction, IN8bio's executive management team and board will reduce their cash compensation by 11%. The restructuring is expected to incur cash expenses of $0.3 million in the third quarter of 2024, primarily related to severance payments.
Future Milestones
IN8bio anticipates several key milestones in the coming years, including the submission of an IND for a Phase II trial in AML in the first half of 2025 and topline data from the INB-100 expansion cohort in 2025. The company aims to submit a Biologic License Application (BLA) in 2029, with potential first sales of INB-100 in the United States in 2030.
