8-K: IN8bio Reports Positive Clinical Trial Results and Secures Funding, Extending Cash Runway into 2025

IN8bio announced positive clinical trial results for its cancer therapies and secured funding to extend its cash runway into the first quarter of 2025.

Summary

• IN8bio reported its financial results for the fourth quarter and full year of 2023, highlighting progress in its clinical programs and financial position.
• The company's INB-100 study in leukemia showed 100% of evaluable patients (n=10) remained in remission, with six patients progression-free past 12 months, demonstrating the first-ever durable persistence of an allogeneic cellular therapy.
• The INB-200 study in glioblastoma (GBM) showed all patients exceeded a progression-free survival (PFS) of seven months, surpassing the standard-of-care median PFS of four to seven months.
• A private placement in December 2023 raised $14.4 million, extending the company's cash runway into the first quarter of 2025, with potential for an additional $32.5 million.
• Research and development expenses increased to $16.8 million for the year ended December 31, 2023, compared to $14.1 million in the prior year, primarily due to increased personnel and clinical trial costs.
• The company reported a net loss of $30.0 million for the year ended December 31, 2023, compared to a net loss of $28.5 million in the prior year.
• As of December 31, 2023, IN8bio had $21.3 million in cash, compared to $18.2 million at the end of 2022.

Sentiment

Score: 8

Explanation: The document presents very positive clinical trial results and secures funding, indicating a strong outlook for the company. The positive data from both the INB-100 and INB-200 trials are particularly encouraging, and the extended cash runway provides financial stability. However, the company is still in the clinical stage and faces risks associated with drug development.

Positives

• The INB-100 study demonstrated the first-ever durable persistence of an allogeneic cellular therapy, with 100% of evaluable patients remaining in remission.
• The INB-200 study showed all patients exceeded the standard-of-care median PFS for GBM.
• The company successfully secured funding to extend its cash runway into 1Q 2025.
• IN8bio is advancing multiple clinical programs across different cancer types.
• The company has a strong cash position of $21.3 million as of December 31, 2023.

Negatives

• The company reported a net loss of $30.0 million for the year ended December 31, 2023.
• Research and development expenses increased to $16.8 million for the year ended December 31, 2023.

Risks

• The company's future success depends on the successful completion of clinical trials and regulatory approvals.
• There are risks associated with clinical trial commencement, patient enrollment, and follow-up.
• The company relies on third parties for clinical research and manufacturing.
• There are risks associated with public health crises, rising inflation, and regulatory developments.
• The company may not realize the intended benefits of its DeltEx platform.

Future Outlook

IN8bio anticipates several milestones in 2024, including enrolling additional patients in the INB-100 study, reporting long-term follow-up results for INB-100 and INB-200, presenting preclinical data for INB-300, and dosing the first patient in the Phase 2 trial of INB-400. The company also plans to potentially submit an IND application for a Phase 3 trial for INB-100 and a Phase 1b trial for INB-400.

Management Comments

• William Ho, CEO of IN8bio, stated that the company entered 2024 with significant momentum.
• He also noted that the team executed operationally and successfully advanced their programs despite a difficult environment in 2023.
• Management believes that IN8bio is well-positioned for significant nearand long-term catalysts as they advance their pipeline.

Industry Context

This announcement is significant in the context of the broader immuno-oncology field, particularly in the development of cell-based therapies. The reported durable persistence of allogeneic gamma-delta T cells in the INB-100 study is a notable achievement, as is the positive PFS data for INB-200 in GBM, a difficult-to-treat cancer. The successful private placement also positions IN8bio to continue its clinical development efforts.

Comparison to Industry Standards

• The reported 100% remission rate and durable persistence in the INB-100 study is a very positive result compared to other allogeneic cell therapies, where long-term efficacy and persistence have been a challenge.
• The INB-200 study's median PFS exceeding seven months is also a positive result, as the standard of care for GBM typically results in a median PFS of four to seven months. Companies such as Novocure with their Optune device and various pharmaceutical companies developing new chemotherapies are the current standard of care.
• The company's cash runway into 1Q 2025 is a positive sign, as many biotech companies struggle with funding. This is a key metric for investors to compare against other similar stage biotech companies.

Management Changes

Stakeholder Impact

• Shareholders will likely view the positive clinical trial results and extended cash runway favorably.
• Employees may be encouraged by the company's progress and financial stability.
• Patients with leukemia and GBM may benefit from the company's therapies.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• Enroll an additional 10 patients in the INB-100 expansion cohort.
• Report Phase 1 long-term follow-up results for INB-100 and INB-200 at multiple medical meetings throughout 2024.
• Potentially submit an IND application for a Phase 3 randomized control trial for INB-100 in 2024.
• Present additional preclinical data for INB-300 at the AACR Annual Meeting in April 2024.
• Dose the first patient and treat up to 15 patients in the Phase 2 trial of INB-400.
• Potentially submit an IND for a Phase 1b allogeneic gamma-delta T cell study in relapsed GBM in 2024.

Key Dates

Keywords

IN8bio, Gamma-delta T cells, Immunotherapy, Leukemia, Glioblastoma, INB-100, INB-200, INB-400, Clinical Trials, Cancer Therapy, Private Placement, Biopharmaceutical