8-K: IN8bio Reports Promising Clinical Data and Financial Results for 2024

IN8bio highlights durable remissions in cancer trials and strategic pipeline optimization in its fourth quarter and full-year 2024 report.

Summary

• IN8bio reported its financial results for the fourth quarter and full year ended December 31, 2024.
• The company's clinical programs continue to show long-term durable remissions in hard-to-treat cancers, including glioblastoma (GBM) and acute myeloid leukemia (AML).
• Notably, 100% of treated AML patients remained relapse-free.
• IN8bio expanded its pipeline with the INB-600 platform, featuring a novel gamma-delta T Cell engager (TCE) targeting CD19.
• The company is focusing on aligning resources to drive high-impact programs forward.
• IN8bio believes it has sufficient cash to support operations and achieve anticipated development milestones throughout 2025 and into 2026.
• The company raised approximately $16.6 million in gross proceeds through equity offerings during 2024 through February 2025.
• R&D expenses were $3.6 million for the three months ended December 31, 2024, compared to $4.5 million for the same period in the prior year.
• For the year ended December 31, 2024, R&D expenses were $17.0 million, compared to $16.8 million in the prior year.
• The net loss for the three months ended December 31, 2024, was $6.2 million, or $0.08 per share, compared to a net loss of $7.6 million, or $0.22 per share, for the comparable prior year period.
• The net loss for the year ended December 31, 2024, was $30.4 million, or $0.57 per share, compared to a net loss of $30.0 million, or $1.00 per share, for the prior year.
• As of December 31, 2024, IN8bio had cash of $11.1 million, compared to $21.3 million as of December 31, 2023.

Sentiment

Score: 7

Explanation: The document presents a generally positive outlook due to promising clinical data and strategic pipeline optimization. However, concerns about cash runway and the need for additional funding temper the overall sentiment.

Positives

• The INB-100 program continues to demonstrate 100% long term durable response rates as of January 17, 2025, reinforcing its potential to help treat and maintain remissions in high-risk AML patients.
• The INB-600 platform has the potential to reshape the T cell engager landscape by potentially improving both the durability of response and safety compared to existing CD3 targeting TCE therapies.
• INB-619 demonstrated potent B-cell depletion and sustained gamma-delta T cell expansion in preclinical studies.
• INB-100 showed durable remissions with a favorable safety profile, with no cytokine release syndrome (CRS) or neurotoxicity (ICANs) reported to date.
• Updated data from the INB-200 trial showed the majority of patients exceeded their expected progression-free survival.
• The company raised approximately $16.6 million in gross proceeds through equity offerings, extending the company's cash runway into March 2026.
• Guidance from the U.S. Food and Drug Administration (FDA) confirmed relapse-free survival (RFS) in AML patients as an acceptable primary endpoint for a potential pivotal randomized control trial.

Negatives

• The company paused enrollment in the Phase 2 INB-400 glioblastoma program to focus resources and explore partnership opportunities.
• Cash decreased from $21.3 million as of December 31, 2023, to $11.1 million as of December 31, 2024.
• The company is seeking additional funding sources to advance allogeneic product for glioblastoma and other solid tumors.

Risks

• The company's ability to raise additional capital is uncertain, which could force them to delay or reduce development programs.
• Clinical trials may be delayed and may not have satisfactory outcomes.
• Regulatory approvals to conduct trials or to market products are uncertain.
• The company relies on third parties, including licensors and clinical research organizations.

Future Outlook

IN8bio anticipates achieving development milestones throughout 2025 and into 2026, driven by advancing clinical programs and delivering value to patients and stakeholders. The company aims to complete enrollment into the expansion cohort of the INB-100 Phase 1 clinical trial in 2025 and is advancing preparations for a potential registrational Phase 2 trial with possible IND submission anticipated in 2026 based on receipt of additional funding.

Management Comments

• William Ho, Chief Executive Officer and co-founder of IN8bio, commented, 'In 2024, IN8bio made significant progress advancing its pipeline of gamma-delta T cell therapies and positioning the Company for long-term success.'
• Mr. Ho continued, 'We have also disclosed our novel INB-600 platform, which we believe has the potential to reshape the T cell engager landscape by potentially improving both the durability of response and safety compared to existing CD3 targeting TCE therapies.'

Industry Context

IN8bio's focus on gamma-delta T cell therapies places it within the competitive landscape of companies developing novel immunotherapies for cancer. The INB-600 platform, targeting CD19, positions the company in the growing field of T cell engagers, aiming to improve upon existing CD3-targeting therapies.

Comparison to Industry Standards

• The 100% relapse-free survival rate in AML patients treated with INB-100 is a highly competitive result when compared to standard treatments and other experimental therapies.
• Companies like Kite Pharma (Gilead) and Novartis are leaders in CAR-T cell therapies, which also target hematological malignancies, but IN8bio's gamma-delta T cell approach offers a potentially different mechanism of action and safety profile.
• The development of INB-600, a gamma-delta T cell engager, puts IN8bio in competition with companies developing bispecific antibodies and other T cell redirection strategies, such as Amgen and Roche.
• The reported R&D expenses of $17.0 million for the year ended December 31, 2024, is relatively low compared to larger pharmaceutical companies, reflecting IN8bio's stage as a clinical-stage biopharmaceutical company.

Stakeholder Impact

• Shareholders: The durable remissions in cancer trials and strategic pipeline optimization could positively impact shareholder value.
• Employees: The company's focus on high-impact programs and operational efficiency initiatives may affect employee roles and responsibilities.
• Patients: The development of innovative gamma-delta T cell therapies could provide new treatment options for cancer patients.
• Suppliers: The company's R&D activities and clinical trials may impact relationships with suppliers of research materials and clinical trial services.
• Creditors: The company's cash position and ability to raise additional capital may affect its creditworthiness.

Next Steps

• Accelerating patient enrollment in expansion cohort of ongoing Phase 1 clinical trial including the inclusion of an additional investigational center.
• Aim to complete enrollment into the expansion cohort in 2025.
• Expect to present updated clinical data in the second half of 2025.
• Advancing preparations for potential registrational Phase 2 trial with possible IND submission anticipated in 2026 based on receipt of additional funding.
• Continue to evaluate early clinical data for signs of efficacy and durability.
• Report additional findings at upcoming medical meetings in 2025.
• Seek additional funding sources to advance allogeneic product for glioblastoma and other solid tumors.
• Present preclinical data evaluating potency, expansion potential, and safety profile at medical meetings in the second quarter of 2025.
• Plan to advance towards IND-enabling studies with additional funding to support future clinical development.
• Exploring partnership and collaboration options to accelerate development of the platform.

Key Dates