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]

Clinical Trials and Product Development - The company has conducted two Phase 1 clinical trials for gamma-delta T cell technologies, demonstrating long-term durable remissions with patients remaining alive and in remission for over three years[95]. - INB-100 showed a 100% complete remission rate in acute myeloid leukemia patients with a median follow-up of 20.1 months, exceeding real-world control groups[96]. - INB-200 demonstrated a 79% increase in median progression-free survival (12.4 months) compared to the standard-of-care regimen (6.9 months)[98]. - INB-600, a new T cell engager platform, has shown potential for sustained anti-tumor responses and minimal risk of cytokine release syndrome[100]. - The company has a portfolio of preclinical programs, including INB-300 and INB-500, aimed at advancing cellular manufacturing for allogeneic therapies[103]. - The company is actively seeking collaborative partners for its product candidates, including INB-400[125]. Financial Position and Funding - The company has $11.9 million in cash as of March 31, 2025, which is not anticipated to fund operations for the next 12 months, raising concerns about its ability to continue as a going concern[107]. - The company expects to incur additional losses as it advances product candidates through clinical trials and seeks to expand its portfolio[107]. - In April 2025, the company raised $1.9 million through the exercise of Series A and Series B warrants, resulting in the issuance of 9,321,081 shares of common stock[110]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future[112]. - The company is seeking alternative funding sources and strategic partnerships to support the development of its product candidates[99]. - The company plans to seek additional capital through equity and/or debt offerings to support ongoing operations and product development[125]. - The company raised an aggregate of $135.9 million from the sale of securities through March 31, 2025[124]. - The company sold 7,362,852 shares under the ATM program during the three months ended March 31, 2025, resulting in net proceeds of approximately $3.7 million[132]. - Cash used in operating activities was $3.1 million for the three months ended March 31, 2025, primarily due to a net loss of $5.6 million[143]. - Cash provided by financing activities was $3.9 million during the three months ended March 31, 2025, mainly from $3.7 million in net proceeds from the ATM program[147]. - The company expects to continue financing operations through additional equity or debt financings, which may result in dilution to existing stockholders[138]. - The company had no long-term debt and no material non-cancelable purchase commitments as of the reporting date[141]. - The company may face challenges in raising additional funds due to potential worsening global economic conditions and geopolitical tensions[139]. Operating Expenses and Losses - Research and development expenses decreased to $2.972 million for the three months ended March 31, 2025, from $4.903 million in the same period of 2024, a reduction of $1.931 million[120]. - General and administrative expenses were $2.688 million for the three months ended March 31, 2025, down from $3.742 million in the prior year, reflecting a decrease of $1.054 million[120]. - The total operating expenses for the three months ended March 31, 2025, were $5.660 million, compared to $8.645 million for the same period in 2024, a decrease of $2.985 million[120]. - The net loss for the three months ended March 31, 2025, was $5.550 million, an improvement of $3.012 million compared to a net loss of $8.562 million in the prior year[120]. - As of March 31, 2025, the company had cash of $11.9 million, which is expected to fund operations into March 2026[125]. - The company reported a net increase in cash and restricted cash of $771,000 for the three months ended March 31, 2025[142]. Regulatory and Reporting Status - The company adopted ASU 2023-07 effective January 1, 2025, which requires enhanced disclosures about reportable segments[155]. - The company is classified as a "smaller reporting company" with a market value threshold of $250.0 million for non-affiliates[160]. - Annual revenue must be less than $100.0 million to maintain smaller reporting company status, alongside a market value of less than $700.0 million[160]. - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report[161]. - Reduced disclosure obligations regarding executive compensation apply to the company as a smaller reporting company[161]. - The company is not required to provide certain market risk disclosures due to its classification as a smaller reporting company[162].

Financial Performance - IN8bio reported a net loss of $5.6 million, or $0.07 per share, for Q1 2025, compared to a net loss of $8.6 million, or $0.20 per share, in the same period last year[18]. - Net loss for Q1 2025 was $5,550 million, compared to a net loss of $8,562 million in Q1 2024, indicating an improvement of 35.9%[23]. - Net loss per share improved from $(0.20) in Q1 2024 to $(0.07) in Q1 2025[23]. - Total operating expenses for Q1 2025 were $5,660 million, down 34.4% from $8,645 million in Q1 2024[23]. - Interest income increased from $83 million in Q1 2024 to $110 million in Q1 2025, a growth of 32.5%[23]. Research and Development - Research and Development (R&D) expenses decreased to $3.0 million in Q1 2025 from $4.9 million in the prior year, primarily due to reduced clinical trial activities[14]. - Research and development expenses decreased from $4,903 million in Q1 2024 to $2,972 million in Q1 2025, a reduction of 39.4%[23]. - The INB-600 TCE platform was presented at the AACR 2025 Annual Meeting, showcasing its potential applications in oncology and autoimmune diseases[4]. - The company is advancing its differentiated pipeline, including INB-600, which targets both Vδ1+ and Vδ2+ T cell subsets to enhance therapeutic efficacy[8]. Clinical Outcomes - INB-100 demonstrated a 100% relapse-free rate in treated Acute Myeloid Leukemia (AML) patients with a median follow-up of 20.1 months as of January 17, 2025[4]. - The 1-year progression-free survival (PFS) rate for all leukemia patients treated with INB-100 was reported at 90.9%, with a 1-year overall survival (OS) rate of 100%[8]. - Upcoming milestones include an oral presentation of INB-200 at the ASCO 2025 Annual Meeting on May 30, 2025[8]. Financial Position - The company had cash of $11.9 million as of March 31, 2025, compared to $13.0 million in the same period last year[18]. - Total assets decreased from $20,944 million as of December 31, 2024, to $19,869 million as of March 31, 2025, representing a decline of approximately 5.1%[21]. - Total liabilities decreased from $6,466 million to $5,992 million, a reduction of about 7.3%[21]. - Total stockholders' equity decreased from $14,478 million to $13,877 million, reflecting a decline of approximately 4.2%[21]. - The company reported a total current asset increase from $12,578 million to $12,725 million, a rise of approximately 1.2%[21]. Capital Raising - IN8bio raised approximately $4.1 million from the sale of common stock and the exercise of warrants in Q1 2025[4]. - Weighted-average number of shares used in computing net loss per share increased from 43,287,325 in Q1 2024 to 83,482,125 in Q1 2025[23]. Cost Management - General and Administrative (G&A) expenses were $2.7 million for Q1 2025, down from $3.7 million in the comparable prior year period, reflecting cost savings in personnel and professional services[15].

Core Insights - IN8bio, Inc. is advancing innovative gamma-delta T cell therapies for cancer patients, focusing on unmet medical needs and aiming for "Cancer Zero" [2] - The company reported significant clinical progress, particularly with its INB-100 and INB-600 platforms, showcasing promising data in treating various cancers [5][6] Financial Highlights - For Q1 2025, IN8bio reported a net loss of $5.6 million, or $0.07 per share, an improvement from a net loss of $8.6 million, or $0.20 per share, in Q1 2024 [17][21] - Research and Development (R&D) expenses decreased to $3.0 million from $4.9 million year-over-year, while General and Administrative (G&A) expenses fell to $2.7 million from $3.7 million [14][21] - As of March 31, 2025, the company had cash of $11.9 million, down from $13.0 million a year earlier [17] Clinical Developments - INB-100 demonstrated a 100% relapse-free rate in treated Acute Myeloid Leukemia (AML) patients with a median follow-up of 20.1 months [5][6] - The INB-600 platform showed strong preclinical data, indicating potential applications in both oncology and autoimmune diseases, with lead candidates targeting CD19 and CD33 [6][12] Upcoming Milestones - IN8bio plans to present updated clinical data for INB-200 at the ASCO 2025 Annual Meeting on May 30, 2025 [9] - The company will also present at the ISCT 2025 Annual Meeting and the ASGCT 2025 Annual Meeting, highlighting advancements in gamma-delta T cell therapies [10][12] Corporate Strategy - IN8bio is focused on expanding its pipeline with the INB-600 gamma-delta T cell engager platform, which aims to enhance immune surveillance and reduce safety risks associated with conventional therapies [2][3] - The company is committed to operational execution and achieving meaningful data milestones to support its clinical programs [5][6]

Core Insights - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on developing gamma-delta T cell therapies for cancer and autoimmune diseases, and it will present new clinical and preclinical data at several upcoming scientific conferences [1][2] Upcoming Presentations - At the American Association for Cancer Research (AACR) 2025, IN8bio will present a poster on a novel gamma-delta T cell engager platform for cancer immunotherapy on April 30, 2025 [3] - At the International Society for Cell & Gene Therapy (ISCT) 2025, IN8bio will deliver an oral presentation on the manufacturing process of donor-derived allogeneic ex vivo expanded and activated gamma-delta T cell products on May 9, 2025, and a poster on the implementation of an electronic quality management system on May 8, 2025 [4] - At the American Society of Gene & Cell Therapy (ASGCT) 2025 Conference, IN8bio will present a poster on the INB-600 T cell engager platform on May 15, 2025, and an oral presentation on the molecular signature of expanded gamma-delta T cell products on May 17, 2025 [5] - At the American Society of Clinical Oncology (ASCO) 2025, IN8bio will present an oral presentation on the Phase 1 study of gene-modified autologous gamma-delta T cells in newly diagnosed glioblastoma multiforme patients on May 30, 2025 [6][7] Company Overview - IN8bio is developing gamma-delta T cell-based immunotherapies targeting cancer and autoimmune diseases, with its lead program, INB-100, focused on acute myeloid leukemia using haplo-matched allogeneic gamma-delta T cells post-hematopoietic stem cell transplant [7]

Core Insights - IN8bio, Inc. announced new preclinical data from its γδ T cell engager (γδ-TCE) platform, demonstrating effective cancer-killing activity in leukemia models while minimizing cytokine release [1][2] Group 1: Technology and Innovation - IN8bio's γδ-TCE platform specifically activates γδ T cells, avoiding the excessive inflammatory responses associated with traditional CD3-based T cell engagers [2] - The lead molecules, INB-619 and INB-633, showed potent anti-cancer activity with minimal inflammatory cytokine release in preclinical studies [2][9] - The platform allows for γδ T cell expansion without genetic engineering, offering a scalable approach to immunotherapy [4] Group 2: Clinical Applications and Future Potential - The early results in leukemia models suggest potential applications for the technology in other hard-to-treat cancers and autoimmune diseases [3][5] - IN8bio is expanding its therapeutic pipeline beyond genetically engineered therapies, exploring various disease indications and partnership opportunities [5] Group 3: Key Findings from Preclinical Studies - INB-619 and INB-633 demonstrated strong, dose-related killing of leukemia cells at low concentrations, activating key γδ T cell subsets [9] - Both molecules promoted activation and degranulation of γδ T cells with minimal changes in dangerous cytokines, reducing the risk of cytokine release syndrome [9]

Core Insights - IN8bio, Inc. is presenting a novel gamma-delta T cell engager platform at the AACR Annual Meeting 2025, highlighting its potential in cancer immunotherapy [1][2] - The company focuses on developing innovative therapies for cancer and autoimmune diseases using gamma-delta T cells, which have unique properties that may overcome limitations of current therapies [2][4] Company Overview - IN8bio is a clinical-stage biopharmaceutical company specializing in gamma-delta T cell-based immunotherapies for cancer and autoimmune diseases [4] - The lead program, INB-100, targets acute myeloid leukemia by evaluating haplo-matched allogeneic gamma-delta T cells post-hematopoietic stem cell transplant [4] - The company is also exploring autologous DeltEx DRI gamma-delta T cells for glioblastoma and advancing novel gamma-delta T cell engagers for various oncology and autoimmune indications [4] Presentation Details - The poster presentation titled "A novel gamma-delta T cell engager platform for cancer immunotherapy" will take place on April 30, 2025, during the Immunology/T Cell Engagers and Novel Antibody-Based Therapies session [3] - The presentation will showcase early findings in acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (B-ALL), supporting the broader strategy of utilizing gamma-delta T cells across multiple cancers [2][3]