8-K: IN8bio Reports Promising First Quarter 2025 Results: Gamma-Delta T Cell Therapies Show Durable Remissions

IN8bio announces positive Q1 2025 financial results and highlights, including durable remissions in AML patients treated with INB-100 and advancements in their INB-600 T cell engager platform.

Summary

• IN8bio reported its financial results and business highlights for the first quarter ended March 31, 2025.
• The company's INB-100 Phase 1 clinical data continues to show long-term durable remissions, with 100% of treated Acute Myeloid Leukemia (AML) patients remaining relapse-free with a median follow-up of 20.1 months as of January 17, 2025.
• IN8bio celebrated the 5th anniversary of the first patient treated with their gamma-delta T cell therapy, INB-100, who remains alive and in remission.
• New data on INB-600, a next-generation gamma-delta T cell engager (TCE) platform, was presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting.
• The company raised approximately $4.1 million from the sale of common stock under the ATM and exercise of warrants in 1Q25.
• Research and Development (R&D) expenses were $3.0 million for the three months ended March 31, 2025, compared with $4.9 million in the prior year.
• General and administrative (G&A) expenses were $2.7 million for the three months ended March 31, 2025, compared with $3.7 million for the comparable prior year period.
• The company reported a net loss of $5.6 million, or $0.07 per basic and diluted common share, for the three months ended March 31, 2025, compared with a net loss of $8.6 million, or $0.20 per basic and diluted common share, for the comparable prior year period.
• As of March 31, 2025, the Company had cash of $11.9 million, compared with $13.0 million for the comparable prior year.
• In April 2025, the Company received aggregate gross proceeds of $1.9 million from the exercise of its Series A and Series B common stock warrants.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with promising clinical data, reduced expenses, and upcoming presentations. However, the company is still operating at a loss and has a limited cash position, which tempers the overall sentiment.

Positives

• INB-100 shows durable remissions in AML patients, with 100% relapse-free survival at a median follow-up of 20.1 months.
• The first patient treated with INB-100 five years ago remains alive and in remission.
• INB-600 platform shows promise as a next-generation gamma-delta T cell engager.
• The 1-year progression-free survival (PFS) rate across all leukemia patients is 90.9% and 1-year overall survival (OS) is 100%, outperforming comparative real-world historical control data.
• R&D and G&A expenses have decreased compared to the prior year.
• Net loss has decreased compared to the prior year.
• The company presented positive Phase 1 data for INB-100 at the 2025 Transplantation & Cellular Therapy (TCT) Annual Meeting showing durable remissions.

Negatives

• The company reported a net loss of $5.6 million for the quarter.
• Cash position decreased from $13.0 million to $11.9 million compared to the prior year.

Risks

• The company's ability to achieve anticipated milestones, including expected presentations and data readouts from its trials and advancement of clinical development plans, is subject to uncertainty.
• The company may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations.
• The company's reliance on third parties, including licensors and clinical research organizations, poses a risk.

Future Outlook

IN8bio anticipates upcoming oral presentations at ASCO, ISCT, and ASGCT annual meetings, showcasing data from their INB-200 and gamma-delta T cell manufacturing platform, as well as preclinical data on INB-600.

Management Comments

• William Ho, CEO & co-founder, stated that IN8bio is redefining the landscape with their innovative INB-600 TCE platform.
• He also mentioned that the preclinical data unveiled at AACR represents a leap forward, achieving picomolar potency, enhancing immune surveillance, and potentially mitigating some of the safety risks associated with conventional CD3-targeted TCEs.

Industry Context

IN8bio's focus on gamma-delta T cell therapies and T cell engagers aligns with the growing interest in novel T cell-based immunotherapies for cancer and autoimmune diseases. The company's INB-600 platform aims to address limitations of conventional CD3-targeted TCEs, potentially offering a safer and more effective approach.

Comparison to Industry Standards

• The 1-year progression-free survival (PFS) rate across all leukemia patients is 90.9% and 1-year overall survival (OS) is 100%, outperforming comparative real-world historical control data obtained from both the Center for International Blood & Marrow Transplant Research (CIBMTR) and from the University of Kansas Cancer Center.
• This suggests that IN8bio's INB-100 therapy is showing promising results compared to standard treatments for high-risk AML and leukemias.

Stakeholder Impact

• Shareholders: Positive clinical data and reduced expenses could lead to increased investor confidence.
• Patients: Promising clinical data suggests potential for improved treatment options for cancer patients.
• Employees: Continued progress and pipeline expansion could lead to job security and growth opportunities.

Next Steps

• Oral presentation of INB-200 data at the ASCO 2025 Annual Meeting.
• Oral presentation at the ISCT 2025 Annual Meeting.
• Oral presentation at the ASGCT 2025 Annual Meeting.
• Advancement of the INB-600 platform into oncology and autoimmune indications.

Key Dates

Keywords

IN8bio, Gamma-delta T cell therapy, INB-100, INB-600, AML, Leukemia, T cell engager, Immunotherapy, Clinical trial, Financial results