Executive Summary / Key Takeaways

• Differentiated Technology with Promising Clinical Data: IN8bio is at the forefront of gamma-delta T cell therapy, with its DeltEx platform showing compelling early clinical results in INB-100 for AML (100% CR, PFS, OS at one year) and INB-200 for GBM (mPFS of 16.1 months vs. SOC 6.9 months). The novel INB-600 T cell engager platform also demonstrates significant preclinical advantages, including minimal cytokine release syndrome risk.
• Strategic Pipeline Prioritization: The company has strategically focused resources, suspending enrollment in the INB-400 Phase 2 GBM trial and implementing a 49% workforce reduction to extend its cash runway and prioritize high-impact programs.
• Acute Liquidity Challenges: Despite recent financing efforts, IN8bio faces substantial doubt about its ability to continue as a going concern, with existing cash of $13.20 million as of June 30, 2025, projected to fund operations only into June 2026.
• Heavy Reliance on Future Funding: The company's ability to advance its promising pipeline hinges on securing significant additional capital through equity/debt offerings or strategic collaborations, with potential proceeds from outstanding warrants offering some, but not assured, relief.
• Competitive Niche in a Crowded Field: IN8bio's specialized gamma-delta T cell approach offers potential advantages in specificity and safety over broader CAR-T and checkpoint inhibitor therapies from larger competitors, but it lags significantly in financial scale, profitability, and commercialization infrastructure.

A New Frontier in Immunotherapy: IN8bio's DeltEx Platform

IN8bio, Inc. ($INAB) stands as a clinical-stage biopharmaceutical company dedicated to the ambitious mission of "Cancer Zero," aiming for the safe elimination of all cancer cells in every patient. Its core strategy revolves around the discovery, development, and commercialization of innovative gamma-delta T cell product candidates and T cell engagers (TCEs) for both cancer and autoimmune diseases. This journey began with the formation of Incysus, Inc. in 2015, evolving through reincorporations and mergers to establish IN8bio in August 2020, headquartered in New York. The company swiftly built its intellectual property foundation through exclusive license agreements with the UAB Research Foundation and Emory University, securing critical immunotherapy-related patents and know-how for its gamma-delta T cell programs.

The immuno-oncology landscape is intensely competitive, dominated by large pharmaceutical and biotechnology companies with vast resources. IN8bio carves out a niche with its proprietary DeltEx platform, which employs allogeneic, autologous, induced pluripotent stem cell (iPSC), and genetically modified cell therapy approaches. This platform is designed to effectively identify and eradicate tumor and targeted cells, offering a differentiated approach compared to traditional T cell therapies. For instance, the newly introduced INB-600 T cell engager platform represents a potentially revolutionary advancement, harnessing gamma-delta T cells through a distinctive mechanism that optimizes effector function and targeted cytotoxicity.

Unlike traditional T cell engagers that can trigger severe side effects like cytokine release syndrome (CRS) and T cell exhaustion by broadly activating all T cells, INB-600 selectively activates both Vd1 and Vd2 gamma-delta T cell subsets. This selective activation leverages their innate tumor-recognition capabilities with minimal risk of CRS, offering potentially greater safety and tolerability than current CAR-T and CD3-based TCE approaches. The pan-activation and expansion of both Vd1 and Vd2 compartments broaden therapeutic potential, combining the rapid antigen presentation and immune activation of Vd2 cells with the persistent durability and tissue residence properties of Vd1 cells. This technological edge positions IN8bio to potentially achieve deeper responses and eliminate cancers or pathogenic B cells associated with autoimmune diseases, providing a distinct competitive advantage over the broader, less targeted portfolios of industry giants like Bristol-Myers Squibb (BMY) and Merck (MRK).

Clinical Momentum and Strategic Prioritization

IN8bio's pipeline showcases promising early clinical data, particularly with its lead candidates. INB-100, an allogeneic gamma-delta T cell product candidate, is in a Phase 1 clinical trial for acute myeloid leukemia (AML) in patients undergoing haploidentical stem cell transplantation (HSCT). As of January 17, 2025, 100% of AML patients across both original and expansion cohorts remain in complete remission (CR), with a median follow-up of 20.1 months. These results significantly exceed real-world matched control groups from the CIBMTR national database (67.8% PFS, 74.7% OS at one-year) and the Kansas University Cancer Center (57.4% PFS, 66.7% OS at one-year). The observed peripheral gamma-delta T cell expansion and persistence for one year is a first for an allogeneic cellular therapy, indicating durable remissions. The company received FDA regulatory guidance for a Phase 2 randomized controlled trial for AML, with progression-free survival (PFS) as the primary endpoint, and an expansion cohort targeting up to 15 additional patients is currently enrolling, with long-term follow-up results anticipated in 2026. While Grade 1 and/or 2 GvHD was observed in approximately 60% of INB-100 patients, it was responsive to steroid treatment, and management believes high HLA matching will not be required for clinical activity.

The DeltEx drug-resistant immunotherapy (DRI) technology is another key differentiator, genetically engineering gamma-delta T cells to synergize with conventional chemotherapies. INB-200, an autologous DRI candidate, has completed patient enrollment and dosing in its Phase 1 trial for newly diagnosed glioblastoma (GBM). As of June 9, 2025, one patient has surpassed four years without progression, a significant milestone in frontline GBM. Patients receiving repeated doses of INB-200 (cohorts 2 and 3 combined) demonstrated a median PFS (mPFS) of 16.1 months as of May 31, 2025, more than double the expected 6.9 months for the standard-of-care (SOC) Stupp protocol. Notably, these mPFS results have already surpassed the historical median overall survival (mOS) of 14.6 months associated with the SOC Stupp protocol alone, with no serious toxicities, CRS, or ICANS observed. Additional updates on median OS are expected later this year.

In a strategic move to conserve cash, IN8bio suspended patient enrollment in the Phase 2 clinical trial for INB-400, its corporate-sponsored DRI program for newly diagnosed GBM, in September 2024. This pipeline prioritization reflects a focus on optimizing resource allocation, with the company actively seeking additional funding or strategic partnerships for this program. Despite the suspension, preliminary data from three additional centers for INB-400 reported an mPFS of 10.8 months as of May 31, 2025. The company also received the Host Region USA East Abstract Award at ISCT 2025 for its DeltEx manufacturing platform, underscoring its robust and scalable processes, a critical operational advantage in cell therapy.

Preclinical programs further underscore IN8bio's innovative breadth. INB-600, the gamma-delta T cell engager platform, showed in vitro studies (INB-619 targeting CD19, INB-633 targeting CD33) demonstrating strong, antigen-specific cytotoxicity against ALL and AML cell lines, promoting robust gamma-delta T cell expansion and activation with minimal inflammatory cytokine release. Furthermore, INB-619 successfully eliminated disease-causing B cells in lupus patient samples, highlighting its potential in autoimmune diseases. Additional preclinical data for INB-600 are expected in the second half of 2025. Other preclinical programs include INB-300, a non-signaling CAR construct for solid and liquid tumors, and INB-500, focusing on iPSC-derived gamma-delta T cells for off-the-shelf innate cell therapies.

Financial Health and the Path Forward

Despite the promising clinical and preclinical advancements, IN8bio faces significant financial headwinds. The company has incurred recurring losses and negative operating cash flows since its inception, reporting net losses of $10.60 million for the six months ended June 30, 2025, compared to $17.20 million for the same period in 2024. This has resulted in an accumulated deficit of $132.30 million as of June 30, 2025.

In response, IN8bio has implemented aggressive cash preservation measures. Research and development expenses decreased by $4.60 million for the six months ended June 30, 2025, compared to the prior year, primarily due to a $2.60 million reduction in personnel-related costs (including stock-based compensation) following a 49% workforce reduction in September 2024, and a $2.00 million decrease in direct clinical costs for INB-200 and INB-400.

General and administrative expenses also saw a $1.90 million decrease for the six months ended June 30, 2025, driven by lower personnel costs, reduced directors and officers insurance premiums, and a cut in professional services.

As of June 30, 2025, IN8bio held $13.20 million in cash. However, based on its revised business strategy, this existing cash is not anticipated to fund projected operating expenses and capital expenditure requirements for a period of at least 12 months from the August 7, 2025, filing date of the condensed financial statements. This raises substantial doubt about the company's ability to continue as a going concern.

Historically, IN8bio has funded its operations through various public and private equity offerings, raising an aggregate of $139.60 million in gross proceeds through June 30, 2025. Recent financing activities in the first half of 2025 included approximately $7.40 million in net proceeds from its at-the-market (ATM) program and $2.30 million from warrant exercises. Potential additional proceeds from outstanding Series A, B, and C warrants could amount to $1.70 million, $4.10 million, and $8.10 million, respectively, though the realization of these proceeds is not assured.

The company's future hinges on its ability to raise additional capital through equity/debt offerings or strategic collaborations. The biotechnology market environment, characterized by volatility, inflation, and geopolitical tensions, presents challenges for securing such funding. A one-for-thirty reverse stock split was effected in June 2025, aimed at improving stock price and market liquidity, but its long-term impact on capital raising remains to be seen.

Compared to its larger, more established competitors like Gilead Sciences (GILD) and Novartis (NVS), IN8bio's financial metrics, such as its negative gross, operating, and net profit margins, starkly contrast with the robust positive margins of its rivals. This highlights IN8bio's early-stage, R&D-intensive profile and its acute need for external capital to bridge the gap to potential commercialization.

Conclusion

IN8bio stands at a pivotal juncture, balancing the immense potential of its innovative gamma-delta T cell therapies with the pressing reality of its financial constraints. The clinical data from INB-100 and INB-200 are highly encouraging, demonstrating durable remissions and significant improvements in progression-free survival in challenging cancers. The INB-600 T cell engager platform also presents a compelling technological advantage with its selective activation and reduced risk of severe side effects, positioning IN8bio as a leader in a specialized, high-growth segment of immunotherapy.

However, the company's ability to fully capitalize on these scientific breakthroughs is critically dependent on its success in securing additional funding. The explicit "going concern" warning underscores the urgency of this challenge. While IN8bio's technological differentiation offers a strong competitive moat against larger, more diversified pharmaceutical companies, its limited financial resources and commercialization experience remain significant vulnerabilities. For investors, IN8bio represents a high-risk, high-reward proposition, where the long-term value creation hinges on the successful execution of its clinical development roadmap and the timely acquisition of substantial capital to translate its scientific promise into approved, revenue-generating products. The coming quarters, with anticipated long-term follow-up results for INB-100 and INB-200, and additional preclinical data for INB-600, will be crucial indicators of the company's trajectory.