Summary of IN8bio Conference Call - February 05, 2026 Company Overview - **Company**: IN8bio (NasdaqGM:INAB) - **Focus**: Development of cellular therapies using gamma delta T cells - **Key Personnel**: William Ho (CEO), Dr. Larry Lamb (Chief Scientific Officer) [1][2] Core Programs and Pipeline - **Ongoing Programs**: - **INB-100**: Allogeneic cell therapy for leukemia patients undergoing transplantation, currently enrolling an expansion cohort with updated phase one data expected by year-end [3] - **INB-619**: T cell engager platform targeting CD19 for both oncology and autoimmune diseases [3] - **INB-200 and INB-400**: Genetically modified gamma-delta T cell programs targeting solid tumors, particularly glioblastoma [3][4] Glioblastoma Treatment Insights - **Mechanism of Action**: Targets the DNA damage response (DDR) pathway, which is fundamental to all cells, making it potentially applicable to various solid tumors [33] - **Clinical Trial Results**: - Patients treated with INB-200 and INB-400 showed a median progression-free survival (PFS) of 13 months, compared to 6.6 months in the control group [14] - Overall survival (OS) for treated patients reached 17.2 months, with some patients remaining progression-free for over 4 years [15][47] - No major toxicity signals or adverse events reported [11] T Cell Engager Platform - **INB-619**: A unique CD19 targeting T cell engager designed to minimize cytokine release syndrome (CRS) while effectively depleting B cells [22][27] - **Comparative Efficacy**: INB-619 demonstrated comparable or superior potency to existing B-cell depleters like Amgen's blinatumomab and Roche's mosunitumab, with a significantly wider therapeutic window [26][27] Financial and Operational Updates - **Recent Financing**: Raised $20.1 million led by Coastlands Capital, with participation from Franklin Templeton and other investors, providing runway through 2027 [28][50] - **Upcoming Milestones**: - Public peer-reviewed publication of glioblastoma data - FDA guidance on regulatory path for glioblastoma program - Mouse data for INB-619 expected by late summer [53] Additional Insights - **Market Positioning**: IN8bio has chosen not to pursue autoimmune diseases with cell therapies, focusing instead on oncology due to concerns about the safety and efficacy of existing treatments in that area [20] - **Histopathology Findings**: Analysis of treated patients showed significant infiltration of gamma-delta T cells, indicating effective targeting of tumors [19] Conclusion - IN8bio is making significant strides in the development of innovative therapies for glioblastoma and leukemia, with promising clinical results and a solid financial foundation to support ongoing research and development efforts [29]

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ ) T cell therapies for cancer and autoimmune diseases, today announced that William Ho, CEO and co-founder, will be presenting the following investor and scientific conferences in February. Conference participation details are as follows: Noble Emerging Growth Virtual Equity ConferenceDate: Thursday, February 5, 2026Time: 3:00 p.m. ETLocation: Virtual Inve ...

Repeat-doses of DeltEx™ Drug-Resistant Immunotherapy gamma-delta (γδ) T cells (DRI) nearly doubled median progression-free survival (mPFS) to 13.0 months compared to only 6.6 months (+97%) in a control cohort treated with the standard-of-care (SOC) Stupp protocolMedian overall survival (mOS) continues to climb, currently at 17.2+ months as of December 31, 2025, with several patients who remain progression-free for multiple years (1.4 – 4.6 years) compared to only 13.2 months for SOC (+30.3%)Treatment remain ...

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Core Viewpoint - IN8bio has secured a private placement financing of approximately $40.2 million to advance its γδ T cell therapies, particularly focusing on the INB-619 product candidate for cancer and autoimmune diseases [2][4]. Financing Details - The financing includes an initial closing of about $20.1 million, with the potential for an additional $20.1 million based on milestone achievements [1][4]. - The initial tranche involves the sale of 5,127,029 shares of common stock at $1.38 per share and pre-funded warrants for up to 9,452,677 shares at a price of $1.3799 [4]. - The financing is led by Coastlands Capital, with participation from other investors such as Stonepine Capital Management and 683 Capital Partners [3][4]. Use of Proceeds - The net proceeds will fund IND enabling studies for INB-619, with early animal model data expected for discussions with the FDA in 2026 and potential IND submission in 2027 [5]. - A portion of the funds will also support the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs for glioblastoma to the FDA [5]. Company Overview - IN8bio is a clinical-stage biopharmaceutical company focused on developing γδ T cell therapies for unmet medical needs, particularly in oncology and autoimmune diseases [9][10]. - The lead program, INB-100, targets acute myeloid leukemia, while INB-200 and INB-400 focus on glioblastoma [10].

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]