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$20.1 million upfront with a milestone-driven additional $20.1 million to advance INB-619, IN8bio’s novel gamma-delta (“γδ”) T cell engager through an Investigational New Drug (“IND”) application Financing led by Coastlands Capital with participation from new and existing biotechnology investors Initial proceeds extend cash runway into the first half of 2027 NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (“IN8Bio” or the “Company”) (Nasdaq: INAB), a clinical-stage biopharmaceutical company develo ...

Clinical Trials and Product Development - The Phase 1 trial of INB-100 demonstrated 100% complete remission (CR) in acute myeloid leukemia (AML) patients, with a median follow-up of 20.1 months, and 100% progression-free survival (PFS) and overall survival (OS) rates at one year post-transplant[99] - INB-200 showed a median PFS of 16.1 months in patients receiving repeated doses, representing a 133% increase over the expected 6.9 months for standard-of-care, with preliminary data indicating improved outcomes compared to historical controls[101] - INB-619 effectively eliminated CD19+ B cells in patients with Systemic Lupus Erythematosus (SLE), demonstrating minimal release of inflammatory cytokines associated with cytokine release syndrome (CRS)[105] - INB-400's Phase 2 trial enrollment was suspended in September 2024 to conserve cash resources, while preliminary data from additional centers reported a median PFS of 10.8 months[102] - The company plans to complete enrollment of the INB-100 expansion cohort by year-end 2025 or early 2026, with long-term follow-up results anticipated in 2026[100] - INB-600, a proprietary T cell engager platform, aims to enhance immune responses against solid tumors and autoimmune diseases by selectively activating gamma-delta T cells[103] - The company introduced INB-300 and INB-500, targeting both solid and liquid tumors, with INB-500 focusing on producing gamma-delta T cells from induced pluripotent stem cells (iPSCs)[110] - The company received Orphan Drug Designation from the FDA for INB-400, covering a broad range of malignant glioma indications, including relapsed and newly diagnosed GBM[102] Financial Performance and Funding - The company has not generated any revenue since its inception in 2016 and has primarily funded operations through equity sales, including an initial public offering (IPO) and private placements[114] - As of September 30, 2025, the company has cash of $10.7 million, which is not anticipated to fund projected operating expenses for at least 12 months, raising substantial doubt about its ability to continue as a going concern[115] - The company expects to incur additional losses in the future as it advances product candidates through clinical trials and expands its portfolio[115] - The company has raised an aggregate of $143.0 million from the sale of equity and equity-linked securities through September 30, 2025[134] - Interest income for the three months ended September 30, 2025, was $0.1 million, compared to $0 million in the same period in 2024[129] - The company plans to raise additional capital through equity and/or debt offerings and strategic collaborations to support product development[116] - Cash used in operating activities was $10.6 million for the nine months ended September 30, 2025, primarily due to a net loss of $14.5 million[152] - Cash provided by financing activities was $10.1 million during the nine months ended September 30, 2025, mainly from $8.4 million in net proceeds from the ATM program[156] - The company has not generated any product revenue since inception and does not expect to do so in the foreseeable future[145] - The company anticipates substantial increases in expenses related to ongoing activities, particularly in clinical trials and product development[142] Expenses and Cost Management - Research and development expenses for the three months ended September 30, 2025, were $2.1 million, a decrease of $1.2 million from $3.3 million in the same period in 2024[126] - General and administrative expenses for the three months ended September 30, 2025, were $1.9 million, down from $2.7 million in the prior year, reflecting a decrease in personnel-related costs[128] - Total operating expenses for the nine months ended September 30, 2025, were $14.8 million, a decrease of $9.6 million from $24.4 million in the same period in 2024[130] - Research and development expenses for the nine months ended September 30, 2025, were $7.6 million, down from $13.4 million in the prior year, primarily due to a decrease in personnel-related costs[131] Stock and Warrants - The company may receive up to $12.1 million from the exercise of outstanding common stock warrants, although there is no assurance of receiving these proceeds[116] - As of September 30, 2025, the company had issued and outstanding 248,382 pre-funded warrants, 129,296 Series A warrants, 303,574 Series B warrants, and 997,638 Series C warrants[138] - The company expects to receive up to $8.1 million from the exercise of Series C warrants and pre-funded warrants, and up to $4.1 million from Series B warrants, contingent on full cash exercise[139] - The company sold 511,057 shares under the ATM program in the three months ended September 30, 2025, generating net proceeds of approximately $1.1 million, and 1,815,346 shares in the nine months ended September 30, 2025, generating net proceeds of approximately $8.5 million[140] Regulatory and Compliance - The company adopted ASU 2023-07 effective January 1, 2025, which requires public entities to disclose significant expenses and other segment items on an interim and annual basis[164] - The company is evaluating the impact of adopting ASU 2023-09, effective for fiscal years beginning after December 15, 2024, with early adoption permitted[165] - The company qualifies as an emerging growth company (EGC) and may take advantage of reduced disclosure requirements until December 31, 2026[166] - The company will cease to be an EGC if it exceeds $1.235 billion in annual revenue or $700 million in market value of stock held by non-affiliates[167] - The company has elected not to "opt out" of the extended transition period for complying with new accounting standards, delaying adoption until standards apply to private companies[168] - The company is classified as a smaller reporting company and may continue to be so until the market value of stock held by non-affiliates is less than $250 million[169] - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[172] - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[173]

Core Insights - IN8bio, Inc. has announced the addition of The Ohio State University as a new clinical site for its ongoing Phase 1 trial of INB-100, a gamma-delta T cell therapy for leukemia patients undergoing haploidentical stem cell transplantation [1][2] Company Overview - IN8bio is a clinical-stage biopharmaceutical company focused on developing gamma-delta T cell-based immunotherapies for cancer and autoimmune diseases [4] - The lead program, INB-100, targets acute myeloid leukemia and evaluates haplo-matched allogeneic gamma-delta T cells administered post-hematopoietic stem cell transplant [4] Clinical Trial Details - The Phase 1 trial aims to assess the safety, durability, and anti-leukemic activity of INB-100 in the post-transplant setting [3] - Principal Investigator Dr. Joseph P. McGuirk leads the trial, which has shown encouraging long-term survival outcomes compared to historical data [3] - The trial has reported immune reconstitution, including the expansion and persistence of INB-100 gamma-delta T cells up to one year post-treatment, and an absence of severe graft-versus-host disease [3] Strategic Partnerships - The collaboration with The Ohio State University reflects strong interest in INB-100 and aims to accelerate enrollment in the Phase 1 trial [2] - The trial is expected to provide follow-up data next year, with multiple patients showing long-term leukemic remissions beyond four to five years [3]

Core Insights - IN8bio, Inc. presented new preclinical data for its γδ T cell engager program, INB-619, at the 2025 ACR Convergence Meeting, highlighting its potential in treating cancer and autoimmune diseases [1][2] Preclinical Data - INB-619 demonstrated complete elimination of B cells in preclinical SLE donor models, showing efficacy comparable to FDA-approved CD19 and CD20 engagers like blinatumomab and mosunetuzumab [2][8] - The compound exhibited minimal secretion of adverse cytokines, such as IL-6, at significantly lower concentrations than currently marketed compounds [2][6] Mechanism and Safety Profile - INB-619's design allows for higher doses and deeper B cell depletion, potentially leading to an immune reset not observed with other protein engagers [3][4] - The therapy selectively expanded γδ T cells without activating CD4+ or CD8+ αβ T cells, indicating a potentially improved safety and tolerability profile [3][4] Unique Properties - INB-619 is a first-in-class, CD19-targeted, pan-γδ T cell engager that activates and expands both V-delta-1 and V-delta-2 T cell subsets, leading to effective B cell depletion [4][8] - Unlike conventional T cell engagers, INB-619 does not engage the CD3 receptor, significantly reducing the risk of toxicities such as cytokine release syndrome and neurotoxicity [5][6] Clinical Implications - The results suggest that INB-619 could transform the treatment landscape for autoimmune diseases by safely eliminating pathogenic B cells and driving immune reset [6][8] - The data indicated robust, dose-dependent B cell killing and γδ T cell expansion, maintaining a favorable cytokine profile consistent with γδ T cell biology [6][8] Company Overview - IN8bio is a clinical-stage biopharmaceutical company focused on developing γδ T cell therapies for unmet medical needs, with additional programs targeting acute myeloid leukemia and glioblastoma [7]

Clinical Trial Results - INB-100 demonstrated 100% complete remission (CR) in acute myeloid leukemia (AML) patients with a median follow-up of 20.1 months, surpassing real-world control groups with 67.8% progression-free survival (PFS) and 74.7% overall survival (OS) at one year [100]. - INB-200 achieved a median PFS of 16.1 months, a 133% increase over the expected 6.9 months for standard-of-care, with 40% of patients remaining progression-free for over 18 months [101][108]. - INB-619 showed complete targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, indicating a safer immunotherapy alternative [105][108]. - The company is currently enrolling an expansion cohort for INB-100, targeting up to 15 additional patients to confirm improvements in relapse-free and OS [100]. - INB-600, a proprietary T cell engager platform, aims to enhance anti-tumor responses while minimizing risks of cytokine release syndrome (CRS) [103]. - The company presented preclinical data for INB-300, demonstrating proof-of-concept against leukemia antigen targets CD33 and CD123, indicating potential for distinguishing tumor from healthy tissue [107]. - As of May 31, 2025, patients receiving repeated doses of INB-200 showed a median PFS of 10.8 months in a multi-center trial, with additional data expected later this year [102]. - The company expects to present further preclinical data for the INB-600 platform in the second half of 2025, indicating ongoing development and potential applications [106]. Financial Performance - As of June 30, 2025, the company has $13.2 million in cash, which is not anticipated to fund projected operating expenses for at least 12 months, raising substantial doubt about its ability to continue as a going concern [111]. - Total operating expenses for the three months ended June 30, 2025, were $5.2 million, a decrease of $3.5 million compared to $8.7 million for the same period in 2024 [123]. - Research and development expenses decreased to $2.5 million for the three months ended June 30, 2025, from $5.2 million in the prior year, primarily due to a $1.3 million decrease in personnel-related costs [124]. - General and administrative expenses were $2.7 million for the three months ended June 30, 2025, down from $3.5 million in the same period in 2024, reflecting cost savings in personnel and professional services [125]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future [116]. - The company expects to incur additional losses as it advances product candidates through clinical trials and expands its portfolio [111]. - Interest income for the three months ended June 30, 2025, was $0.1 million, an increase of $0.05 million compared to the same period in 2024 [126]. - For the six months ended June 30, 2025, total operating expenses were $10.9 million, a decrease of $6.5 million from $17.3 million in 2024 [127]. - Research and development expenses decreased to $5.5 million for the six months ended June 30, 2025, down from $10.1 million in the prior year, a reduction of $4.6 million [128]. - General and administrative expenses were $5.4 million for the six months ended June 30, 2025, compared to $7.3 million in the prior year, reflecting a decrease of $1.9 million [129]. - As of June 30, 2025, the company had cash of $13.2 million, which is expected to fund operations into June 2026 [132]. - The company raised an aggregate of $139.6 million from the sale of equity and equity-linked securities through June 30, 2025 [131]. - Net cash used in operating activities was $7.0 million for the six months ended June 30, 2025, primarily due to a net loss of $10.6 million [150]. - The company sold 1,304,289 shares under the ATM program during the six months ended June 30, 2025, resulting in net proceeds of approximately $7.4 million [139]. - The company expects substantial increases in expenses contingent on additional funding for ongoing activities, particularly for clinical trials [140]. - As of June 30, 2025, the company had fixed lease payment obligations of $3.8 million, with $1.4 million payable within 12 months [147]. - The company has not generated any product revenue and has incurred net losses and negative cash flows from operations since inception [143]. - The company may receive up to $9.8 million from the exercise of outstanding warrants, assuming full cash exercise [136]. - Cash used in operating activities was $14.0 million for the six months ended June 30, 2024, primarily due to a net loss of $17.2 million [151]. - Non-cash charges included $2.4 million in stock-based compensation, reflecting increased employee headcount [152]. - Cash used in investing activities was $0.2 million during the six months ended June 30, 2024, mainly for property and equipment purchases [153]. - Cash provided by financing activities was $3.1 million for the six months ended June 30, 2024, primarily from the issuance of common stock [155]. - Cash provided by financing activities was $9.2 million for the six months ended June 30, 2025, primarily from the ATM program [154]. Corporate Governance and Compliance - The company adopted ASU 2023-07 effective January 1, 2025, which requires enhanced disclosures about reportable segments [163]. - The company qualifies as an emerging growth company (EGC) and can take advantage of reduced disclosure requirements until December 31, 2026 [165]. - The company is also classified as a smaller reporting company, allowing it to present only the two most recent fiscal years of audited financial statements [170]. - Research and development expenses include salaries, stock-based compensation, and lab supplies, with all costs expensed as incurred [159]. - The company has not experienced material adjustments to prior estimates of accrued research and development expenses [161]. Operational Adjustments - The company plans to implement cash preservation measures, including workforce reduction and prioritization of its pipeline, to address liquidity needs [112]. - The company executed a one-for-thirty reverse stock split on June 5, 2025, adjusting the per share exercise price and number of shares issuable under outstanding options and warrants [114].

Core Insights - IN8bio, Inc. announced that a patient with grade 4, IDH-mutant glioma has been progression-free and alive for four years after receiving INB-200 gamma-delta T cell therapy, marking a significant clinical milestone [1][2] - The Phase 1 trial of INB-200 demonstrated an extended median progression-free survival (mPFS) of 16.1 months, which is more than double the 6.9 months typically observed with the standard Stupp protocol for newly diagnosed glioblastoma [2] - INB-200 is the first genetically modified gamma-delta T cell therapy evaluated in glioblastoma and has shown a favorable safety profile along with signals of long-term benefit [2][3] Company Overview - IN8bio is a clinical-stage biopharmaceutical company focused on developing gamma-delta T cell-based immunotherapies for cancer and autoimmune diseases [4] - The company's lead program, INB-100, targets acute myeloid leukemia, while INB-200 and INB-400 programs are focused on glioblastoma [4] - Gamma-delta T cells are a specialized population of T cells that can differentiate between healthy and diseased tissue, which is a key aspect of IN8bio's therapeutic approach [4]

Core Viewpoint - IN8bio, Inc. announced promising long-term clinical data from its Phase 1 trial of INB-200 for glioblastoma multiforme (GBM), showing significant improvements in median progression-free survival (mPFS) compared to standard-of-care treatments [1][2][5]. Clinical Data Summary - The Phase 1 trial results indicate that repeated doses of INB-200 led to an mPFS of 16.1 months, which is an increase of 9.2 months or 132.6% over the historical mPFS of 6.9 months associated with the standard-of-care Stupp protocol [2][5]. - Notably, four patients (40%) who received repeated doses of INB-200 remain alive and progression-free for a median of over two years, with three of them returning to work [6][5]. - No dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed among the 13 patients treated with INB-200, with most adverse events being Grade 1-2 and consistent with typical chemotherapy side effects [3][5]. Comparison with Historical Data - The mPFS of 16.1 months for patients receiving multiple doses of INB-200 exceeds the historical median overall survival (mOS) of 14.6 months associated with the standard-of-care Stupp protocol [5][6]. - The results demonstrate that 50% of patients receiving repeated doses remained progression-free for over 18 months, compared to 0% of patients who received a single dose [6]. Future Developments - IN8bio is also conducting a Phase 2 clinical trial of INB-400 for newly diagnosed GBM, which currently shows an mPFS of 10.8 months, with further updates expected in late 2025 [7]. - The company aims to leverage its gamma-delta T cell therapies to provide innovative treatment options for solid tumors like GBM, focusing on eliminating chemotherapy-resistant cancer cells [7].

Core Insights - IN8bio, Inc. announced promising preclinical data for its INB-619 program, a γδ T cell therapy targeting CD-19, which effectively eliminated disease-causing B cells in patients with Systemic Lupus Erythematosus [1][2][3] Group 1: Treatment Potential - INB-619 shows potential as a novel treatment for autoimmune diseases by selectively clearing harmful B cells while minimizing inflammatory responses, unlike traditional T cell engagers [2][7] - The therapy demonstrated complete depletion of pathogenic B cells, including harmful IgG1 and IgM antibodies, indicating its effectiveness in treating autoimmune conditions [7][8] Group 2: Mechanism and Advantages - INB-619 expands and activates both Vδ1+ and Vδ2+ subtypes of γδ T cells, addressing the challenge of low γδ T cell levels in chronic disease patients [3][7] - The therapy does not trigger significant release of inflammatory cytokines, such as IL-6, which are commonly associated with severe side effects like cytokine release syndrome [8] Group 3: Future Directions - IN8bio is exploring potential partnerships and additional indications for autoimmune diseases and cancer where γδ T cell biology can be leveraged [4] - The company is advancing its lead program, INB-100, focused on acute myeloid leukemia, and evaluating other γδ T cell therapies for various oncology and autoimmune indications [5]

Core Insights - IN8bio, Inc. announced new data on its proprietary γδ T cell manufacturing program, showcasing advancements in their technology at the ISCT 2025 Annual Meeting, which earned them the Host Region Abstract Award [1][7] - The DeltEx™ Allo manufacturing process effectively induces donor-derived T cells to express γδ T cell receptors associated with enhanced cancer cytotoxicity, confirmed by gene expression profiling across multiple batches [2][8] - The company maintains hands-on control over all manufacturing steps, which is crucial for the development of safe and effective cellular therapies, positioning IN8bio as a leader in γδ T cell manufacturing [3][7] Key Findings from INB-100 Study - The INB-100 clinical trial demonstrated durable long-term remissions in adult AML patients with complex disease characteristics, with γδ T cells showing long-term expansion and persistence for over one year [5][8] - The manufacturing program has been automated, allowing for rapid and reproducible production of cryopreserved cell therapy doses, with the trial continuing to enroll an expansion cohort at the recommended Phase 2 dose [5] - All analyzed clinical batches showed a consistent shift from αβ-TCR to γδ-TCR dominance, indicating that the manufacturing process drives the final TCR composition rather than the donor material [8] Company Overview - IN8bio is focused on developing γδ T cell-based immunotherapies for cancer and autoimmune diseases, with its lead program, INB-100, targeting acute myeloid leukemia using haplo-matched allogeneic γδ T cells [6] - The company is also exploring autologous DeltEx DRI γδ T cells for glioblastoma and advancing novel γδ T cell engagers for potential oncology and autoimmune indications [6]