Executive Summary / Key Takeaways

• IN8bio is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta T cell therapies and T cell engagers for cancer and autoimmune diseases, leveraging its proprietary DeltEx platform.
• Positive clinical data from lead programs, particularly INB-100 in high-risk AML showing 100% complete remission and durable responses, and INB-200 in newly diagnosed GBM demonstrating a 79% increase in median progression-free survival compared to standard of care, highlight the potential of the platform.
• The company faces significant financial headwinds, with recurring losses, negative operating cash flows, and existing cash of $11.9 million as of March 31, 2025, expected to fund operations only into March 2026, raising substantial doubt about its ability to continue as a going concern.
• A strategic pipeline prioritization and workforce reduction in September 2024 aimed to conserve capital and focus on key programs, but the need for substantial additional funding through equity, debt, or partnerships remains critical for advancing the pipeline and achieving milestones.
• While IN8bio's novel gamma-delta T cell technology offers potential advantages in efficacy and safety compared to conventional T cell therapies, it faces intense competition from larger, better-funded companies with established infrastructure and approved products, requiring successful execution and significant capital to carve out market share.

Unveiling the Gamma-Delta Frontier

IN8bio, Inc. is charting a course in the complex landscape of cellular immunotherapy, specifically focusing on the unique capabilities of gamma-delta T cells. Since its foundational steps beginning in 2015 and culminating in its current identity in 2020, the company has been built upon exclusive licenses to immunotherapy-related patents from key academic institutions like UAB Research Foundation, Emory University, and Children's Healthcare of Atlanta. This intellectual property forms the bedrock of its proprietary DeltEx platform, designed to discover, develop, and commercialize gamma-delta T cell product candidates for challenging solid and liquid tumors, and more recently, autoimmune diseases.

The core of IN8bio's technological differentiation lies in its approach to harnessing gamma-delta T cells. Unlike the more common alpha-beta T cells, gamma-delta T cells possess innate tumor-recognition capabilities and can be activated and expanded ex vivo. The DeltEx platform employs various strategies, including allogeneic (donor-derived), autologous (patient-derived), and genetically modified approaches. A key innovation is the DeltEx Drug Resistant Immunotherapy (DRI) technology, which genetically engineers gamma-delta T cells to resist chemotherapy, enabling synergistic combination therapies. More recently, the company introduced its INB-600 T cell engager (TCE) platform, designed to selectively activate Vd1 and Vd2 gamma-delta T cell subsets, potentially offering a more targeted and safer approach compared to traditional TCEs that broadly activate all T cells and can lead to significant cytokine release syndrome (CRS). Preclinical data for INB-600 candidates (INB-619 targeting CD19 and INB-633 targeting CD33) presented in April 2025 demonstrated strong, antigen-specific cytotoxicity, robust gamma-delta T cell activation, and importantly, minimal release of inflammatory cytokines like IL-6, IL-10, and IL-17a, which are typically associated with severe CRS. The ability of INB-619 to deplete B cells also suggests potential applications in B cell-driven autoimmune diseases.

This technological foundation positions IN8bio in a highly competitive field. Established players like Gilead Sciences (GILD) and Novartis (NVS), through their CAR-T therapies, command significant market share in blood cancers and possess vast commercial infrastructure and R&D resources. More direct competitors like Adaptimmune Therapeutics (ADAP) and Precision BioSciences (DTIL) are also developing engineered T-cell and gene-edited cell therapies, often with broader pipelines and deeper financial pockets. While these larger and more established companies benefit from scale, existing partnerships, and faster regulatory processes for certain therapy types, IN8bio's focus on gamma-delta T cells offers a potential competitive edge. The clinical data emerging from its early trials suggest potential for durable responses and favorable safety profiles compared to some conventional approaches. For instance, recent competitor data presented at ASCO 2024 highlighted the correlation between donor cell persistence and HLA matching, a challenge IN8bio is addressing in its haploidentical INB-100 program. However, IN8bio's current financial state and limited infrastructure represent significant disadvantages compared to these well-capitalized rivals.

Clinical Progress and Operational Realities

IN8bio's strategic focus is currently centered on advancing its lead clinical programs, INB-100 and INB-200, a prioritization solidified by the September 2024 restructuring. The INB-100 program, an allogeneic gamma-delta T cell therapy for high-risk leukemias undergoing haploidentical stem cell transplantation, has yielded particularly encouraging Phase 1 data. As of the February 2025 update, 100% of acute myeloid leukemia (AML) patients across both original and expansion cohorts remained in complete remission (CR) with a median follow-up of 20.1 months. These patients demonstrated one-year progression-free survival (PFS) and overall survival (OS) rates exceeding real-world control groups, supported by gamma-delta T cell persistence beyond one year. The company has received FDA guidance on a Phase 2 trial for INB-100 in AML, with relapse-free survival as the primary endpoint in a randomized controlled trial, and is enrolling an expansion cohort (target up to 25 patients) to confirm these promising results, with long-term follow-up anticipated in late 2025 and 2026.

The INB-200 program, an autologous DeltEx DRI therapy for newly diagnosed glioblastoma (GBM), has completed patient dosing in its Phase 1 trial. Longer-term follow-up data presented in November 2024 showed that patients receiving repeated doses of INB-200 demonstrated a 79% increase in median PFS (12.4 months) compared to the standard-of-care Stupp regimen (6.9 months). While the corporate-sponsored INB-400 Phase 2 trial for GBM (also using DeltEx DRI) had enrollment suspended in September 2024 as the company seeks partnership opportunities, preliminary data from treated patients are still expected in 2025. The company had previously received Orphan Drug Designation for INB-400 in malignant gliomas in April 2023.

Financially, IN8bio's operational activities reflect its stage of development and recent strategic adjustments. For the three months ended March 31, 2025, the company reported a net loss of $5.55 million, an improvement from the $8.562 million net loss in the same period of 2024. Total operating expenses decreased to $5.66 million in Q1 2025 from $8.645 million in Q1 2024. This reduction was primarily driven by a $1.931 million decrease in research and development expenses ($2.972 million in Q1 2025 vs. $4.903 million in Q1 2024) and a $1.054 million decrease in general and administrative expenses ($2.688 million in Q1 2025 vs. $3.742 million in Q1 2024). The decrease in R&D was largely attributable to a $1.261 million reduction in personnel-related costs following the September 2024 workforce reduction, as well as decreased direct clinical costs for the suspended INB-400 program and INB-200, partially offset by increased costs for the prioritized INB-100 program. G&A expenses also saw reductions in personnel costs, insurance premiums, and professional services.

Despite these cost-saving measures, the company's liquidity remains a critical challenge. As of March 31, 2025, IN8bio had cash of $11.9 million. Based on its current operating plan, this cash is anticipated to fund projected operating expenses and capital expenditure requirements only into March 2026. This limited cash runway, coupled with recurring losses and negative operating cash flows (cash used in operating activities was $3.122 million in Q1 2025), leads to substantial doubt about the company's ability to continue as a going concern. The company's accumulated deficit stood at $127.2 million as of March 31, 2025.

To address this, management's plans primarily involve raising additional capital through equity and/or debt offerings, including utilizing its at-the-market (ATM) program (which generated $3.7 million in net proceeds in Q1 2025) and private placements. The company also has outstanding warrants that could potentially provide additional proceeds upon exercise (up to $1.9 million from Series A, up to $8.1 million from Series C, and up to $4.1 million from Series B, if not redeemed). Subsequent to Q1 2025, the company received approximately $1.9 million in net proceeds from warrant exercises and exchanges in April 2025. Identifying strategic collaborations, licensing, or other arrangements for its product candidates, particularly for INB-400 and earlier-stage assets, is also a key part of the strategy to secure funding and support development. However, there is no guarantee that these efforts will be successful or sufficient to fund operations beyond the current runway. Failure to secure additional capital would necessitate significant delays, scaling back, or discontinuation of research and development programs.

Operational risks extend beyond funding. The complex manufacturing process for cell therapies, reliance on third-party manufacturers and single suppliers for critical components (like the automated manufacturing device and lentiviral vectors), and dependence on third-party healthcare professionals for cell administration all pose potential challenges that could delay trials or hinder commercialization. The September 2024 workforce reduction, while intended to optimize resources, also carries risks of losing institutional knowledge and impacting employee morale, potentially affecting operational execution.

Outlook and Critical Considerations

The outlook for IN8bio is heavily dependent on its ability to secure additional funding and continue demonstrating compelling clinical data. Management anticipates completing enrollment for the INB-100 expansion cohort in 2025, with long-term follow-up results expected in late 2025 and 2026. Preliminary data from the suspended INB-400 trial are also slated for 2025, and additional preclinical data for the promising INB-600 platform are expected in the spring of 2025. These data readouts represent crucial catalysts that could potentially attract investors or strategic partners.

The strategic decision to focus resources on INB-100 appears validated by the strong, durable remission data observed to date. However, translating this early success into a registrational trial and eventual commercial product requires substantial capital and successful navigation of regulatory pathways. The pursuit of partnerships for INB-400 and earlier assets acknowledges the financial constraints and seeks to leverage external resources, but securing such deals on favorable terms is uncertain in the competitive biotech market.

The company's technological edge in gamma-delta T cells, particularly the potential for enhanced efficacy, persistence, and safety profiles demonstrated in early data and preclinical studies, forms the core of its investment thesis. The INB-600 TCE platform, with its ability to selectively activate gamma-delta subsets and minimize inflammatory cytokine release, represents a potentially significant advancement if preclinical promise translates to the clinic. However, the novelty of these approaches also means they are less proven than established CAR-T therapies, potentially facing greater regulatory scrutiny and slower market adoption even if approved.

Conclusion

IN8bio stands at a critical juncture. Its innovative DeltEx platform and emerging clinical data, particularly the durable remissions seen with INB-100 in high-risk AML and the encouraging PFS data from INB-200 in GBM, offer a compelling scientific narrative and suggest the potential of gamma-delta T cell therapies to address significant unmet medical needs. The introduction of the INB-600 TCE platform further expands the potential applications of its technology.

However, the company's financial position presents a stark reality. With a limited cash runway extending only into March 2026 and substantial doubt about its ability to continue as a going concern, securing significant additional funding is paramount. The success of planned data readouts, efforts to attract strategic partners, and the ability to raise capital through equity or warrant exercises will dictate the company's path forward. While the technological promise and early clinical wins provide a foundation for optimism, investors must weigh this potential against the significant financial and execution risks inherent in early-stage biotechnology development and the intense competitive pressures from larger, more established players in the cell therapy space. The story of IN8bio is one of scientific innovation meeting financial exigency, where the realization of its therapeutic potential hinges on overcoming immediate capital challenges.