By John Vandermosten, CFA

NASDAQ:INAB

READ THE FULL INAB RESEARCH REPORT

Following the announcement of its new γδ T cell engager platform INB-600, IN8bio, Inc. (NASDAQ:INAB) reported 2024 financial and operational results on March 14^th, 2025. Other corporate achievements since the third quarter report in mid-November include a stakeholder update on glioblastoma multiforme (GBM) and acute myeloid leukemia (AML) efforts and presentations at multiple investor and scientific conferences.

The most important information shared related to the INB-100 patients. Trial data was updated by about four months from early August 2024 to January 17^th, 2025 and were presented at the Transplantation & Cellular Therapy (TCT) Meetings in February. All of the acute myeloid leukemia (AML) patients across both original and expansion cohorts remain in complete remission (CR), with a median follow-up of 20.1 months. All of the AML patients achieved one year of both progression free survival (PFS) and overall survival (OS).

2024 Financial and Operational Results

IN8bio reported 2024 earnings along with the filing of its Form 10-K on March 13^th. IN8bio generated no revenues in 2024 and over the course of the year incurred operating expense of $30.7 million, producing a net loss of ($30.4) million or ($0.57) per share.

For the year ending December 31^st, 2024 and versus the same comparable prior year period:

• Research & development expenses totaled $17.0 million, rising slightly from $16.8 million due to a rise in direct costs related to the INB-100 and INB-400 programs. Declines in expenditures for the INB-200 program, lower preclinical spend and falling personnel expenses related to bonuses were a partial offset. In 3Q:24, IN8bio announced that the INB-400 program would be suspended;
• General & administrative expenses were $12.6 million, falling 6.5% from $13.5 million. The decrease was primarily due to lower salaries and bonus as a result of the workforce reduction and cost savings related to directors' and officers' insurance premiums, partially offset by an increase in legal and consulting expense;
• $1.1 million of severance and related charges was recognized compared to $0 in the prior year related to the restructuring announced in September 2024;
• Interest income was $230,000 versus $330,000 with the contribution related to interest paid on cash balances;
• Net loss was ($30.4) million, or ($0.57) per share, compared to ($30.0) million, or ($1.00) per share.

At the end of 2024, cash and marketable securities totaled $11.1 million, compared to year end 2023 cash balance of $21.3 million. Cash burn for 2024 was ($24.3) million versus ($23.9) million in the comparable prior year period. In the fourth quarter, the company conducted a private placement that raised a net $11.6 million. Following the end of the year, IN8bio sold 7.4 million shares under the at-the-market (ATM) facility generating $3.7 million. 1.4 million series C warrants were exercised for an additional $0.4 million. Management anticipates that the cash balance is sufficient to support company operations until March 2026.

INB-600 γδ T Cell Engager (TCE) Platform

On March 3^rd, IN8bio issued a press release introducing its γδ T cell engager (TCE) platform, INB-600. It features the CD19 targeting candidate INB-619. TCEs are attractive because they can be used to recruit, activate and expand γδ T cells in vivo at the site of the target cells. The approach can be used in oncology and in autoimmune disease. It is a technology that allows for targeted eradication of diseased cells using precision recruitment by the engager. CEO William Ho provided additional detail about the platform and candidate in a webcast recorded at the TD Cowen Health Care Conference also held on March 3^rd. Additional detail regarding the program will be presented at the IO360° Summit being held the week of March 24^th.

INB-619 is considered a next-generation γδ TCE targeting CD19 which eradicates B cells in preclinical models and maintains B cell depletion over time as γδ T cells expand in response to TCE stimulation. It targets and expands both Vδ1+ and Vδ2+ T cells, potentially leading to longer lasting immune responses and deeper B cell depletion. The candidate may be appropriate in cancer, immunology and inflammation indications. In contrast to established TCEs and related therapies, γδ T cells naturally secrete lower levels of IL-6, potentially reducing the risk of cytokine release syndrome (CRS) and neurotoxicity (ICANs), which is a hallmark of IN8bio’s approach.

What Are T Cell Engagers (TCEs)?

TCEs are a class of bispecific antibodies designed to recruit and activate T cells to kill target cells, usually cancer cells but they can also have autoimmune applications. TCEs work by simultaneously binding to a tumor-associated antigen (TAA) on cancer cells and the CD3 receptor on T cells. This dual binding brings T cells into close proximity to the cancer cells, leading to T cell activation, immune synapse formation, and subsequent cancer cell killing through cytotoxic mechanisms such as perforin and granzyme release.

TCEs are bispecific antibodies that present two distinct binding domains—one for the T cell (CD3) and one for the target cancer antigen. The TCEs activate T cells in an antigen-dependent manner, bypassing the need for costimulatory signals. Once activated, T cells induce apoptosis in target cells. Unlike traditional T cell responses, TCEs do not require major histocompatibility complex (MHC) presentation, making them effective even in tumors with MHC downregulation. Examples of approved TCEs include blinatumomab (Blincyto) which targets CD19 on B-cell malignancies, teclistamab (Tecvayli) which targets B-cell maturation antigen (BCMA) for multiple myeloma and talquet-amab (Talvey) which was approved in 2023 for relapsed or refractory multiple myeloma and targets GPRC5D and CD3. Many of the TCE are associated with concerning side effects such as cytokine release syndrome and on-target, off-tumor toxicity where healthy cells expressing the targeted antigen may also be affected. Another weakness is the molecule’s short half-life which requires that the drug be continuously infused due to rapid clearance.

IN8bio’s goal is to create a TCE that is less expensive, able to be used off the shelf, sidesteps T cell exhaustion and avoids cytokine release syndrome. Some of the indications that may be pursued include non-Hodgkin lymphoma (NHL), follicular lymphoma, diffuse large B-cell lymphoma (DLBCL) in oncology. In autoimmune disease, rheumatoid arthritis, systemic lupus, lupus erythematosus, Sjögren's syndrome, multiple sclerosis and myasthenia gravis. Management feels that this would be a compelling offering in the space and would address many of the existing shortcomings of approved and in-development assets in the space.

In a recent presentation, CEO William Ho summarized the advantages of the INB-619 asset:

• It is a pan γδ TCE which demonstrates ability to eliminate specific target cells in a dose-dependent manner;
• Significantly expands both Vδ1+ and Vδ2+ T cells;
• Expresses CD19 which broadly targets the B cell compartment;
• Its Vδ1+ cells resist exhaustion and can target tissue resident B cells for deeper B cell depletion;
• γδ T cells secrete less IL-6 and may reduce CRS & ICANs in contrast to CAR-T and CD3 TCEs;
• TCEs allow simpler manufacturing, lower costs, repeat dosing and avoid lymphodepletion.

IN8bio plans to provide additional data on the INB-619 program at other medical meetings this Spring.

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