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IN8bioC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-06
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Earnings documents stored for INAB.

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Investor releaseQuarter not tagged2026-08-06

IN8bio Reports Second Quarter 2026 Financial Results and Recent Business Highlights

GlobeNewswire
Advanced next-generation gamma delta (γδ) T cell engager (TCE) platform demonstrating a novel mechanism for γδ T cell expansion, deep target cell depletion, and favorable cytokine profile; Initial in vivo data expected in the second half of 2026 Presented updated data at ASCO 2026 demonstrating median overall survival (mOS) exceeding 19.5 months and still climbing, across all patients with newly diagnosed glioblastoma (GBM) treated with repeat-dosing of DeltEx™ Drug Resistant Immunotherapy (DRI) Published peer-reviewed clinical data from Phase 1 INB-200 trial in The Journal of Clinical Oncology (JCO) demonstrating DeltEx™ DRI more than doubled expected median progression-free survival (mPFS) in newly diagnosed GBM Reported new translational AI proteomic and immunogenomic analyses demonstrating DeltEx DRI preserves immune function and positively remodels the GBM tumor microenvironment, providing additional evidence supporting its therapeutic efficacy potential NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, today reported financial results and business highlights for the second quarter ended June 30, 2026. “The second quarter marked an important period of scientific and clinical validation for γδ T cell therapeutics and IN8bio. Our γδ TCE platform is progressing, with INB-619 advancing into initial animal models. We are pleased to remain on track for reporting initial in vivo data this year,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “In addition, peer-reviewed and updated clinical data from our glioblastoma program continue to demonstrate a favorable safety profile and provide strong evidence that γδ T cells are clinically active and can be delivered safely to potentially improve patient outcomes. We remain focused on disciplined execution, as we continue to seek a regulatory pathway for our glioblastoma program, with the ultimate goal of bringing much needed treatment to patients.” Advancing Next-Generation γδ TCE Platform (INB-619) Continued advancement of proprietary INB-600 platform of novel γδ T cell engagers, designed to selectively eliminate targets such as CD19, potentially reducing toxicities including cytokine release syndrome (CRS) and…Read full document

Advanced next-generation gamma delta (γδ) T cell engager (TCE) platform demonstrating a novel mechanism for γδ T cell expansion, deep target cell depletion, and favorable cytokine profile; Initial in vivo data expected in the second half of 2026 Presented updated data at ASCO 2026 demonstrating median overall survival (mOS) exceeding 19.5 months and still climbing, across all patients with newly diagnosed glioblastoma (GBM) treated with repeat-dosing of DeltEx™ Drug Resistant Immunotherapy (DRI) Published peer-reviewed clinical data from Phase 1 INB-200 trial in The Journal of Clinical Oncology (JCO) demonstrating DeltEx™ DRI more than doubled expected median progression-free survival (mPFS) in newly diagnosed GBM Reported new translational AI proteomic and immunogenomic analyses demonstrating DeltEx DRI preserves immune function and positively remodels the GBM tumor microenvironment, providing additional evidence supporting its therapeutic efficacy potential NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, today reported financial results and business highlights for the second quarter ended June 30, 2026. “The second quarter marked an important period of scientific and clinical validation for γδ T cell therapeutics and IN8bio. Our γδ TCE platform is progressing, with INB-619 advancing into initial animal models. We are pleased to remain on track for reporting initial in vivo data this year,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “In addition, peer-reviewed and updated clinical data from our glioblastoma program continue to demonstrate a favorable safety profile and provide strong evidence that γδ T cells are clinically active and can be delivered safely to potentially improve patient outcomes. We remain focused on disciplined execution, as we continue to seek a regulatory pathway for our glioblastoma program, with the ultimate goal of bringing much needed treatment to patients.” Advancing Next-Generation γδ TCE Platform (INB-619) Continued advancement of proprietary INB-600 platform of novel γδ T cell engagers, designed to selectively eliminate targets such as CD19, potentially reducing toxicities including cytokine release syndrome (CRS) and infections, while expanding the therapeutic window compared with conventional CD3-targeting T cell engagers. Advancing INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases, into IND-enabling studies following encouraging early preclinical data demonstrating complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release, including IL-6 and TNF-α. Remain on track to report initial in vivo preclinical data in the second half of 2026. Reported Clinical and Translational Advances for DeltEx™ DRI in Newly Diagnosed Glioblastoma During the second quarter, IN8bio reported multiple clinical and scientific milestones supporting the clinical activity of γδ T cells and IN8bio’s DeltEx™ DRI platform: Published the first peer-reviewed clinical results of DeltEx DRI in newly diagnosed GBM in The Journal of Clinical Oncology. Among all patients treated, no dose-limiting toxicities (DLTs), CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. Presented updated clinical data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating encouraging survival benefit in repeat-dose treated patients, with mPFS of 13.0 months versus 6.6 months for contemporaneously enrolled patients receiving only standard-of-care (SOC) and mOS exceeding 19.5+ months versus 13.2 months for SOC. Presented new translational data at the International Society for Cell & Gene Therapy (ISCT) and International Society for Cell & Gene Therapy (ISCT) and American Society of Gene & Cell Therapy (ASGCT) Annual Meetings integrating artificial intelligence (AI), immunogenomics, histopathology, transcriptomics and spatial proteomics. Repeated DeltEx™ DRI dosing demonstrated preserved immune function during chemotherapy and positively remodeled the glioblastoma tumor microenvironment. IN8bio Chief Scientific Officer Lawrence Lamb co-authored a review in Nature Communications highlighting advances in γδ T cell engineering, γδ T cell engagers, CAR γδ T cells and combination immunotherapy strategies, reinforcing IN8bio's scientific leadership in the rapidly expanding γδ T cell field. Upcoming Anticipated Milestones Report initial preclinical animal data for INB-619 in the second half of 2026. Report on FDA discussions regarding the potential regulatory pathways for the DeltEx™ DRI GBM program. INB-100 program clinical update at a scientific meeting in late 2026. Provide additional clinical and translational updates from the DeltEx™ DRI GBM program. Second Quarter 2026 Financial Highlights Cash position: As of June 30, 2026, the Company had cash of $18.0 million, compared with $13.2 million, for the comparable prior year period. Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2026, compared with $2.5 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended June 30, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation. Net loss: The Company reported a net loss of $4.8 million, or $0.25 per basic and diluted common share, for the three months ended June 30, 2026, compared with a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the comparable prior year period. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell and γδ T cell engager (TCE) product candidates to address unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s pipeline is anchored by INB-600, a novel γδ T cell engager platform with potential applications across oncology and autoimmune indications. IN8bio is also advancing INB-100, an allogeneic γδ T cell candidate for adult patients with high-risk leukemias undergoing haploidentical stem cell transplantation, and INB-200/400, an autologous genetically modified γδ T cell candidate for newly diagnosed glioblastoma (GBM). For more information about IN8bio, visit www.IN8bio.com. Forward Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential of IN8bio’s product candidates; the potential of IN8bio’s INB-600 platform to improve durability and safety compared with traditional CD3-targeting engagers; IN8bio’s ability to achieve anticipated milestones, including receipt of guidance from the FDA on regulatory pathways for the DeltEx™ DRI GBM program, expected presentations and data readouts from its preclinical studies and clinical trials including preclinical in vivo data for INB-619, patient dosing timelines and advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform and TCE program; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause IN8bio’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section entitled “Risk Factors” in IN8bio’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2026, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Investors and Corporate Contact: IN8bio, Inc.Patrick [email protected] Media ContactKimberly HaKKH [email protected]

Investor releaseQuarter not tagged2026-05-08

IN8bio Reports First Quarter 2026 Financial Results and Recent Business Highlights

GlobeNewswire
Advancing next-generation γδ T cell engager platform with initial animal data expected in 2026 Reported glioblastoma (GBM) data showing ~97% improvement in progression-free survival vs. standard-of-care; updated median overall survival (mOS) data to be presented at ASCO 2026 Hosting R&D Day on May 21, 2026 in New York City NEW YORK, May 07, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, today reported financial results and business highlights for the first quarter ended March 31, 2026. “In the first quarter of 2026, we continued to advance our next-generation TCE platform and clinical programs,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “Our encouraging GBM data positions us to engage the FDA on potential regulatory pathways forward, and we expect to deliver meaningful preclinical, regulatory and clinical milestones across our pipeline this year. As industry interest in novel TCEs accelerates, our next-generation platform is designed to address the key challenges in TCE development. We believe IN8bio is well positioned to create meaningful value for patients and shareholders in 2026 and beyond. We look forward to sharing further updates across our programs at our upcoming R&D Day in New York City on May 21, 2026.” Key Highlights Advancing Next-Generation Gamma-Delta T Cell Engager Platform (INB-619) Continued to advance our internally developed INB-600 platform of novel γδ T cell engagers, designed to potently eliminate targets such as CD19, potentially reduce toxicities such as cytokine release syndrome (CRS) and widen the therapeutic window over traditional CD3-targeting engagers. Presented encouraging preclinical data for INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases. The data showed complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release (IL-6, TNF-α), reinforcing the platform’s differentiation and therapeutic potential. Progressing INB-619 into IND-enabling studies, with initial animal data expected in 2026. Presented Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma In January 2026, IN8bio reported updated data as of December 31, 2025, from it…Read full document

Advancing next-generation γδ T cell engager platform with initial animal data expected in 2026 Reported glioblastoma (GBM) data showing ~97% improvement in progression-free survival vs. standard-of-care; updated median overall survival (mOS) data to be presented at ASCO 2026 Hosting R&D Day on May 21, 2026 in New York City NEW YORK, May 07, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, today reported financial results and business highlights for the first quarter ended March 31, 2026. “In the first quarter of 2026, we continued to advance our next-generation TCE platform and clinical programs,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “Our encouraging GBM data positions us to engage the FDA on potential regulatory pathways forward, and we expect to deliver meaningful preclinical, regulatory and clinical milestones across our pipeline this year. As industry interest in novel TCEs accelerates, our next-generation platform is designed to address the key challenges in TCE development. We believe IN8bio is well positioned to create meaningful value for patients and shareholders in 2026 and beyond. We look forward to sharing further updates across our programs at our upcoming R&D Day in New York City on May 21, 2026.” Key Highlights Advancing Next-Generation Gamma-Delta T Cell Engager Platform (INB-619) Continued to advance our internally developed INB-600 platform of novel γδ T cell engagers, designed to potently eliminate targets such as CD19, potentially reduce toxicities such as cytokine release syndrome (CRS) and widen the therapeutic window over traditional CD3-targeting engagers. Presented encouraging preclinical data for INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases. The data showed complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release (IL-6, TNF-α), reinforcing the platform’s differentiation and therapeutic potential. Progressing INB-619 into IND-enabling studies, with initial animal data expected in 2026. Presented Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma In January 2026, IN8bio reported updated data as of December 31, 2025, from its Phase 1 (INB-200) and Phase 2 (INB-400) clinical trials evaluating DeltEx drug resistant immunotherapy (DRI) γδ T cells in patients with newly diagnosed GBM. The data included a concurrent standard-of-care (SOC) control group enrolled at the same time and clinical sites as treated patients. Median progression-free survival (mPFS) for repeat dose patients was 13.0 months versus 6.6 months for SOC patients (+97% improvement). Median overall survival (mOS) in repeat dose patients is still climbing, currently at 17.2+ months as of December 31, 2025, surpassing the 13.2-months for the SOC control arm. Several patients remained progression-free beyond two years, including one grade 4, IDH-mutant glioma patient who remains progression-free with no additional therapy for more than 4.5 years. No dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), neurotoxicity (ICANS), tumor inflammation-associated neurotoxicity (TIAN) or other unexpected severe adverse events were reported. Updated mOS results to be presented at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting (Abstract 2077, Poster 442) on June 1, from 1:30 - 4:30 p.m. CDT. IN8bio Research & Development Day 2026 IN8bio will host its R&D Day on May 21, 2026 (9:00 - 11:30 a.m. EDT), in New York City. The event will feature presentations on the Company’s γδ TCE platform targeting oncology and autoimmune diseases. The Company will also provide updates on its clinical program in GBM, including a clinical perspective from renowned neuro-oncologist Dr. David Reardon, Director, Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Register Online: https://investors.in8bio.com/news-events/events-presentations. Upcoming Conferences & Anticipated Milestones International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting (Dublin, Ireland) Title: Unraveling Complexity: The Impact, Interactions and Outcomes of a γδ T Cell Therapy in Glioblastoma Poster Details: 1253 Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 - 2:30 p.m. EDT) Title: Lean Infrastructure for CGT Early-Stage Companies: Leveraging Integrated Digital Platforms to Achieve Sustainable Operation Efficiency and Scalable Compliance Poster Details: 801 Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 - 2:30 p.m. EDT) American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting (Boston, MA) Title: Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance? Abstract: 328 Date and Time: May 14, 2026, 11:00 - 11:15 a.m. EDT Anticipated Milestones Guidance from the FDA on potential accelerated regulatory pathways for GBM program in 2H26. Publication of Phase 1 INB-200 clinical data in newly diagnosed GBM patients in a peer-reviewed journal. Additional GBM clinical updates, including updated mOS data at ASCO 2026. Initial TCE preclinical animal data and additional IND-enabling data for INB-619 in 2H26. Completion of INB-100 patient dosing and presentation of long-term follow-up results at a medical meeting in late 2026. First Quarter 2026 Financial Highlights Cash position: As of March 31, 2026, the Company had cash of $21.9 million, compared with $11.9 million, for the comparable prior year period. Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended March 31, 2026, compared with $3.0 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. The decrease primarily reflects lower clinical trial activity in the INB-400 program. General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended March 31, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. Net loss: The Company reported a net loss of $5.1 million, or $0.26 per basic and diluted common share, for the three months ended March 31, 2026, compared with a net loss of $5.6 million, or $2.16 per basic and diluted common share, for the comparable prior year period. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell and γδ T cell engager (TCE) product candidates to address unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s pipeline is anchored by INB-600, a novel γδ T cell engager platform with potential applications across oncology and autoimmune indications. IN8bio is also advancing INB-100, an allogeneic γδ T cell candidate for adult patients with high-risk leukemias undergoing haploidentical stem cell transplantation, and INB-200/400, an autologous genetically modified γδ T cell candidate for newly diagnosed glioblastoma (GBM). For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential of IN8bio’s product candidates; the potential of repeat-dose γδ T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma; the potential of IN8bio’s INB-600 platform to improve durability and safety compared with traditional CD3-targeting engagers; IN8bio’s ability to achieve anticipated milestones, including receipt of guidance from the FDA on regulatory pathways, expected presentations and data readouts from its preclinical studies and clinical trials, patient dosing timelines and advancement of clinical development plans; the milestone-driven closing of the private placement and the use of proceeds from the private placement; IN8bio’s cash runway; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform and TCE program; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause IN8bio’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section entitled “Risk Factors” in IN8bio’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 12, 2026, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Investors & Company Contacts: IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact Kimberly Ha KKH Advisors 917.291.5744 [email protected]

Investor releaseQuarter not tagged2026-03-13

IN8bio Reports Fourth Quarter and Full-Year 2025 Financial Results - Highlights Durable Survival Improvements in Glioblastoma, Advancing Pipeline and Strengthened Financial Position for 2026

GlobeNewswire
Presented updated glioblastoma (“GBM”) data demonstrating durable survival and a favorable safety profile across Phase 1 and Phase 2 programs, with repeat dosing of DeltEx™ Drug-Resistant Immunotherapy γδ T cells (“DRI”) nearly doubling median progression-free survival (“mPFS”) to 13.0 months versus 6.6 months in a contemporaneous standard-of-care control cohort (+97%) Closed initial $20.1 million tranche of a private placement of up to $40.2 million in gross proceeds; net proceeds extend cash runway into the first half of 2027 and support advancement of the gamma-delta T cell engager (“TCE”) platform Continued advancement of gamma-delta T cell therapies and TCE pipeline across oncology and autoimmune diseases with multiple milestones expected in 2026 NEW YORK, March 12, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (“γδ”) T cell therapies and γδ T cell engagers for cancer and autoimmune diseases, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2025. “In 2025, we delivered meaningful progress financially and across our clinical γδ T cell therapy programs and our next-generation T cell engager platform,” said William Ho, co-founder and Chief Executive Officer of IN8bio. “Our deep knowledge of γδ T cell biology and their powerful immune properties enables us to create potential first-in-class or best-in-class programs to address significant unmet medical needs. Last year, we reported updated survival data from our INB-200 and 400 Phase 1 and 2 programs in GBM, along with data from a contemporaneously enrolled standard-of-care (“SOC”) control group. Patients treated with our DeltEx DRI γδ T cells nearly doubled the mPFS, compared to the SOC group, despite a higher number of patients receiving only partial resections. These findings underscore the aggressive nature of GBM, even with SOC treatment, and highlight the significant need for new treatment options. Importantly, our recent financing strengthens our balance sheet and is expected to extend our cash runway to allow us to advance multiple high-value programs. With differentiated science, advancing clinical programs, and a novel TCE platform, we believe IN8bio is well positioned to achieve key milestones and deliver value to shareholders and patients in 2026.”…Read full document

Presented updated glioblastoma (“GBM”) data demonstrating durable survival and a favorable safety profile across Phase 1 and Phase 2 programs, with repeat dosing of DeltEx™ Drug-Resistant Immunotherapy γδ T cells (“DRI”) nearly doubling median progression-free survival (“mPFS”) to 13.0 months versus 6.6 months in a contemporaneous standard-of-care control cohort (+97%) Closed initial $20.1 million tranche of a private placement of up to $40.2 million in gross proceeds; net proceeds extend cash runway into the first half of 2027 and support advancement of the gamma-delta T cell engager (“TCE”) platform Continued advancement of gamma-delta T cell therapies and TCE pipeline across oncology and autoimmune diseases with multiple milestones expected in 2026 NEW YORK, March 12, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (“γδ”) T cell therapies and γδ T cell engagers for cancer and autoimmune diseases, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2025. “In 2025, we delivered meaningful progress financially and across our clinical γδ T cell therapy programs and our next-generation T cell engager platform,” said William Ho, co-founder and Chief Executive Officer of IN8bio. “Our deep knowledge of γδ T cell biology and their powerful immune properties enables us to create potential first-in-class or best-in-class programs to address significant unmet medical needs. Last year, we reported updated survival data from our INB-200 and 400 Phase 1 and 2 programs in GBM, along with data from a contemporaneously enrolled standard-of-care (“SOC”) control group. Patients treated with our DeltEx DRI γδ T cells nearly doubled the mPFS, compared to the SOC group, despite a higher number of patients receiving only partial resections. These findings underscore the aggressive nature of GBM, even with SOC treatment, and highlight the significant need for new treatment options. Importantly, our recent financing strengthens our balance sheet and is expected to extend our cash runway to allow us to advance multiple high-value programs. With differentiated science, advancing clinical programs, and a novel TCE platform, we believe IN8bio is well positioned to achieve key milestones and deliver value to shareholders and patients in 2026.” Key Highlights Strengthened Balance Sheet with up to $40.2 Million Private Placement In December 2025, IN8bio announced a private placement of up to $40.2 million in gross proceeds, including $20.1 million in an initial closing and the potential for an additional milestone-based $20.1 million. Financing led by Coastlands Capital, with participation from new and existing investors. Net proceeds of $18.5 million expected to extend the Company’s cash runway into the first half of 2027. Proceeds intended to support IND-enabling studies for INB-619 γδ TCE, further discussions with the FDA on potential clinical pathways for the GBM program, continued advancement of the Company’s γδ T cell therapy programs, and general corporate purposes. Presented Updated Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma In January 2026, IN8bio reported updated data from its INB-200 Phase 1 and INB-400 Phase 2 trials evaluating DeltEx DRI γδ T cells in newly diagnosed GBM. The data included a contemporaneous SOC control group from multiple clinical sites. mPFS for repeat dose DeltEx DRI patients was 13.0 months vs. 6.6 months for SOC control cohort (+97% improvement). Median overall survival (“mOS”) in repeat dose patients had not yet been reached at 17.2+ months, surpassing the 13.2-month final mOS for SOC control arm. Several patients remained progression-free beyond two years, and one grade 4 glioma patient remains progression-free for greater than 4.5 years, highlighting the long-term benefit of INB-200. No dose-limiting toxicities (“DLTs”), cytokine release syndrome (“CRS”), neurotoxicity (“ICANS”), tumor inflammation-associated neurotoxicity (“TIAN”) or other unexpected severe adverse events were observed. Results reinforce the potential of repeat-dose γδ T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma and support continued regulatory engagement regarding potential clinical pathways. Continued Advancing Next-Generation Gamma-Delta T Cell Engager Platform Continued advancing INB-600 platform, featuring novel γδ T cell engagers designed to potentially improve durability and safety compared with traditional CD3-targeting engagers. Progressing INB-619, a CD19-targeting γδ T cell engager for potential use in oncology and autoimmune diseases into IND-enabling studies with initial animal data expected in 2026. Presented encouraging preclinical data including complete B-cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release at The American College of Rheumatology (“ACR”) Convergence 2025 meeting, supporting differentiation of the platform. Leadership Update In February 2026, IN8bio announced the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer. Dr. Rochlin has played a central role in advancing the Company’s clinical and preclinical programs, manufacturing capabilities, and strategic execution, and will continue overseeing company operations as IN8bio advances its pipeline and prepares for its next phase of growth. Anticipated Milestones Guidance from the FDA on potential regulatory pathway by the second half of 2026 Additional clinical updates on our GBM programs, including final mOS data from the total data set, at medical meetings in mid- and late-2026 Initial preclinical animal data and additional IND-enabling data for INB-619 expected in the second half of 2026 Completion of patient dosing in INB-100 in early 2026 and report long-term follow-up results at a medical meeting in late 2026 Fourth Quarter and Full Year 2025 Financial Highlights IN8bio significantly improved its financial profile in 2025, reducing its full-year net loss by 36% year-over-year and ending the year with more than double the cash on hand compared to the prior year. Cash position: As of December 31, 2025, the Company had cash of $27.1 million, compared with $11.1 million as of December 31, 2024. Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended December 31, 2025, compared with $3.6 million for the comparable prior year period. R&D expenses were $10.2 million for the year ended December 31, 2025, compared with $17.0 million in the prior year. Non-cash stock-based compensation expense included in R&D expense was $1.2 million for the full year 2025 and $0.3 million for the fourth quarter of 2025. General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended December 31, 2025, compared with $2.6 million for the comparable prior year period. G&A expenses were $9.7 million for the year ended December 31, 2025, compared with $12.6 million in the prior year. Non-cash stock-based compensation expense included in G&A expense was $2.0 million for the full year 2025 and $0.4 million for the fourth quarter of 2025. Severance and related charges: Severance and related charges were nil for the year ended December 31, 2025, compared with $1.1 million in the prior year. Net loss: The Company reported a net loss of $4.9 million, or $0.45 per basic and diluted common share, for the three months ended December 31, 2025, compared with a net loss of $6.2 million, or $2.38 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2025, net loss was $19.4 million, or $4.44 per basic and diluted common share, compared with a net loss of $30.4 million, or $17.05 per basic and diluted common share, for the prior year. IN8bio enters 2026 with a strengthened balance sheet, advancing clinical programs, and multiple regulatory milestones ahead. The Company remains focused on generating meaningful clinical data, advancing its γδ T cell platforms toward key inflection points, and deploying capital efficiently across its highest-priority programs across oncology and autoimmune diseases. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell and γδ T cell engager (TCE) product candidates to address unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s lead programs consist of INB-100, an allogeneic γδ T cell candidate for adult patients with high-risk leukemias undergoing haploidentical stem cell transplantation, and INB-200/400, an autologous genetically modified γδ T cell candidate for newly diagnosed Glioblastoma (GBM). The Company is also developing a novel γδ T cell engager platform, INB-600, for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential of IN8bio’s product candidates; the potential of repeat-dose γδ T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma; the potential of IN8bio’s INB-600 platform to improve durability and safety compared with traditional CD3-targeting engagers; IN8bio’s ability to achieve anticipated milestones, including receipt of guidance from the FDA on regulatory pathways, expected presentations and data readouts from its preclinical studies and clinical trials, patient dosing timelines and advancement of clinical development plans; the milestone-driven closing of the private placement and the use of proceeds from the private placement; IN8bio’s cash runway; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform and TCE program; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause IN8bio’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section entitled “Risk Factors” in IN8bio’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2025, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Investors & Company Contacts: IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact Kimberly Ha KKH Advisors 917.291.5744 [email protected]

Investor releaseQuarter not tagged2025-11-07

IN8bio Reports Third Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
Presented new preclinical data on INB-619, a novel gamma-delta (γδ) T cell engager (TCE), demonstrating equivalent potency comparable to FDA-approved commercial products with minimal adverse cytokine release, highlighting its potential to achieve deep B cell depletion with an improved safety profile Expanded Phase 1 INB-100 trial to The James Comprehensive Cancer Center at The Ohio State University, supporting faster enrollment to complete the Phase 1 expansion cohort Continued to advance IN8bio’s proprietary γδ T cell platform with ongoing pipeline progression and updated INB-200/400 clinical data in newly diagnosed glioblastoma (GBM) to be presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today reported financial results and business highlights for the third quarter ended September 30, 2025. Key Highlights: Presented New Preclinical Data on INB-619 at ACR Convergence 2025 IN8bio presented compelling new preclinical data on INB-619, its CD19 targeting γδ TCE, at the 2025 American College of Rheumatology (ACR) Convergence Meeting. In preclinical systemic lupus erythematosus (SLE) donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to commercial CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab. The data showed that INB-619’s selective γδ T cell activation drives deep B cell depletion with minimal cytokine release, confirming the potential for improved safety over conventional CD3-directed engagers in development. INB-619’s targeted immune activation and cytokine-sparing design could allow for higher doses, deeper B cell depletion and immune reset that has not been observed with other protein engagers to date. Expanded INB-100 Clinical Trial to Multiple Sites IN8bio expanded the Phase 1 trial of INB-100 to include The Ohio State University (OSU), diversifying centers and accelerating patient enrollment. The addition of Sarah A. Wall, M.D., the Director of Clinical Operations for the Transplant and Cell Therapy Program and an expert in elderly patients with leukemias from this leading academic institution, underscores the strong clinical interest in advancing INB-1…Read full document

Presented new preclinical data on INB-619, a novel gamma-delta (γδ) T cell engager (TCE), demonstrating equivalent potency comparable to FDA-approved commercial products with minimal adverse cytokine release, highlighting its potential to achieve deep B cell depletion with an improved safety profile Expanded Phase 1 INB-100 trial to The James Comprehensive Cancer Center at The Ohio State University, supporting faster enrollment to complete the Phase 1 expansion cohort Continued to advance IN8bio’s proprietary γδ T cell platform with ongoing pipeline progression and updated INB-200/400 clinical data in newly diagnosed glioblastoma (GBM) to be presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today reported financial results and business highlights for the third quarter ended September 30, 2025. Key Highlights: Presented New Preclinical Data on INB-619 at ACR Convergence 2025 IN8bio presented compelling new preclinical data on INB-619, its CD19 targeting γδ TCE, at the 2025 American College of Rheumatology (ACR) Convergence Meeting. In preclinical systemic lupus erythematosus (SLE) donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to commercial CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab. The data showed that INB-619’s selective γδ T cell activation drives deep B cell depletion with minimal cytokine release, confirming the potential for improved safety over conventional CD3-directed engagers in development. INB-619’s targeted immune activation and cytokine-sparing design could allow for higher doses, deeper B cell depletion and immune reset that has not been observed with other protein engagers to date. Expanded INB-100 Clinical Trial to Multiple Sites IN8bio expanded the Phase 1 trial of INB-100 to include The Ohio State University (OSU), diversifying centers and accelerating patient enrollment. The addition of Sarah A. Wall, M.D., the Director of Clinical Operations for the Transplant and Cell Therapy Program and an expert in elderly patients with leukemias from this leading academic institution, underscores the strong clinical interest in advancing INB-100, a donor-derived, allogeneic γδ T cell therapy in patients with leukemias undergoing haploidentical stem cell transplantation. William Ho, CEO and co-founder of IN8bio, commented, “During the quarter, we continued to execute on our goal of developing next-generation γδ T cell therapies. Our focus on the novel biology of γδ T cells underscores our advancements along with the strength and versatility of our DeltEx™ platform. This quarter, we expanded our INB-100 clinical operations to additional sites to accelerate enrollment, and we reported compelling preclinical data at the 2025 ACR Convergence Meeting. Our INB-619 program is a novel and differentiated program in a sea of CD3-based TCE’s that have yet to achieve immune reset in the autoimmune disease setting. We remain focused on delivering the next generation of γδ T cell therapies designed to redefine immune modulation and improve patient outcomes.” Upcoming Anticipated Pipeline Milestones and Events Updated Phase 1 and 2 data from the INB-200/400 program in newly diagnosed GBM to be presented at the SNO Annual Meeting, November 19-23, 2025 Additional preclinical data from INB-619 γδ T cell engager program in oncology will be presented at the American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 Third Quarter 2025 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $2.1 million for the three months ended September 30, 2025, compared with $3.3 million for the comparable prior year period. This amount includes non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million for the three months ended September 30, 2025. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program last year and personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024. The Company continues to prioritize programs demonstrating the strongest clinical signal and commercial opportunity. General and administrative (G&A) expenses: G&A expenses were $1.9 million for the three months ended September 30, 2025, compared with $2.7 million for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $0.4 million for the three months ended September 30, 2025. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services. Net loss: The Company reported a net loss of $3.9 million, or $0.85 per basic and diluted common share, for the three months ended September 30, 2025, compared with a net loss of $7.1 million, or $4.49 per basic and diluted common share, for the comparable prior year period. Cash position: As of September 30, 2025, the Company had cash of $10.7 million, compared with $4.0 million as of September 30, 2024. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell product candidates for unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company's lead program, INB-100, is focused on acute myeloid leukemia, evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The Company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential to accelerate enrollment of the Phase 1 trial of INB-100; the potential of INB-619 to achieve deep B cell depletion and immune reset with an improved safety profile over conventional CD3-directed engagers in development, including the potential for higher dose levels; IN8bio’s ability to develop gamma-delta T cell therapies that redefine immune modulation and improve patient outcomes; IN8bio’s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials and advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 7, 2025, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. (1) All share amounts and per share amounts disclosed above have been restated to reflect a one-for-thirty reverse stock split effected in June 2025. Refer to the Quarterly Report on Form 10-Q, for details. (1) All share amounts and per share amounts disclosed above have been restated to reflect a one-for-thirty reverse stock split effected in June 2025. Refer to the Quarterly Report on Form 10-Q, for details. Investors & Company Contacts: IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact Kimberly Ha KKH Advisors 917.291.5744 [email protected]

Investor releaseQuarter not tagged2025-08-08

IN8bio Reports Second Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
Delivered an oral presentation at ASCO 2025 Annual Meeting, demonstrating extended median progression-free survival (mPFS) in patients receiving multiple doses of INB-200, including a patient remaining progression-free for over four years. Received the Host Region USA East Abstract Award at ISCT 2025 for IN8bio’s DeltEx™ manufacturing platform. Presented preclinical data at ASGCT 2025 on INB-619, a novel gamma-delta T cell engager, and its ability to induce pan-gamma-delta T cell expansion and target CD19+ B cells in lupus patient samples. NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today reported financial results and business highlights for the second quarter ended June 30, 2025. Key Highlights: Durable Four-Year PFS Milestone in Glioblastoma: A patient in IN8bio's INB-200 clinical trial has now surpassed four years without progression, a significant clinical milestone in front-line, grade IV glioblastoma (GBM), demonstrating the potential for extended overall survival and the durability of IN8bio’s therapy. Positive Clinical Data Presented at ASCO 2025: IN8bio presented positive new data showing that GBM patients receiving multiple doses of INB-200 achieved mPFS of 16.1 months as of May 31, 2025, more than double the 6.9 months typically observed with the standard-of-care Stupp protocol. 40% of patients receiving multiple doses remain progression-free for over 18 months with no significant toxicities observed as of May 31, 2025. Award for Innovative Cell Therapy Manufacturing: The Company was recognized with the Host Region USA East Abstract Award at the ISCT 2025 Annual Meeting for its DeltEx™ platform. IN8bio showcased its robust manufacturing processes and scalable technology platform, essential for advancing cell therapy treatments with consistency and operational efficiency. New Preclinical Data in Autoimmune Diseases: IN8bio presented exciting new preclinical results at ASGCT 2025 for its innovative gamma-delta T cell engager (INB-619). INB-619 demonstrated complete, targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, representing a potentially safer immunotherapy alternative with the ability to drive deeper B cell depletion. William Ho, CEO and c…Read full document

Delivered an oral presentation at ASCO 2025 Annual Meeting, demonstrating extended median progression-free survival (mPFS) in patients receiving multiple doses of INB-200, including a patient remaining progression-free for over four years. Received the Host Region USA East Abstract Award at ISCT 2025 for IN8bio’s DeltEx™ manufacturing platform. Presented preclinical data at ASGCT 2025 on INB-619, a novel gamma-delta T cell engager, and its ability to induce pan-gamma-delta T cell expansion and target CD19+ B cells in lupus patient samples. NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today reported financial results and business highlights for the second quarter ended June 30, 2025. Key Highlights: Durable Four-Year PFS Milestone in Glioblastoma: A patient in IN8bio's INB-200 clinical trial has now surpassed four years without progression, a significant clinical milestone in front-line, grade IV glioblastoma (GBM), demonstrating the potential for extended overall survival and the durability of IN8bio’s therapy. Positive Clinical Data Presented at ASCO 2025: IN8bio presented positive new data showing that GBM patients receiving multiple doses of INB-200 achieved mPFS of 16.1 months as of May 31, 2025, more than double the 6.9 months typically observed with the standard-of-care Stupp protocol. 40% of patients receiving multiple doses remain progression-free for over 18 months with no significant toxicities observed as of May 31, 2025. Award for Innovative Cell Therapy Manufacturing: The Company was recognized with the Host Region USA East Abstract Award at the ISCT 2025 Annual Meeting for its DeltEx™ platform. IN8bio showcased its robust manufacturing processes and scalable technology platform, essential for advancing cell therapy treatments with consistency and operational efficiency. New Preclinical Data in Autoimmune Diseases: IN8bio presented exciting new preclinical results at ASGCT 2025 for its innovative gamma-delta T cell engager (INB-619). INB-619 demonstrated complete, targeted depletion of harmful B cells in lupus samples without significant inflammatory cytokines, representing a potentially safer immunotherapy alternative with the ability to drive deeper B cell depletion. William Ho, CEO and co-founder, IN8bio, commented, “We believe this quarter clearly demonstrates our ability to deliver transformative outcomes in cancer and autoimmune disease. We had an oral presentation at ASCO, reached a remarkable four-year PFS milestone in a grade IV glioblastoma patient, demonstrated the potential of our T cell engager platform to treat autoimmune diseases, and highlighted our robust cell therapy manufacturing capabilities. We’re proud of these continued accomplishments, which demonstrate our ability to be a leader in gamma-delta T cell therapies and highlight our potential to help transform the treatment of cancer and autoimmune disease. We’ve also extended our runway into June 2026.” Upcoming Anticipated Pipeline Milestones and Events Update on enrollment in INB-100 expansion cohort in leukemia patients Glioblastoma clinical update from INB-200 and INB-400 clinical trials Additional preclinical data from INB-619 T cell engager program for cancer and autoimmune diseases in 4Q25 Second Quarter 2025 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2025, compared with $5.2 million in the prior year. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program and reduced personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024. General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended June 30, 2025, compared with $3.5 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation of $0.7 million. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services. Net loss: The company reported a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the three months ended June 30, 2025, compared with a net loss of $8.6 million, or $5.51 per basic and diluted common share, for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $1.2 million, along with one-time charges related to the Company’s pipeline prioritization announcement in September 2024. Cash position: As of June 30, 2025, the Company had cash of $13.2 million, compared with $10.2 million for the comparable prior year. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell product candidates for unmet medical needs. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: INB-200’s (i) treatment potential for patients with GBM, (ii) extended survival potential and durability compared to outcomes observed in other clinical trials of IDH-mutant glioma patients; INB-619’s ability to (i) efficiently target CD19+ B cells in lupus patient samples and induce pan-γδ T cell expansion without significant inflammatory cytokines and (ii) provide a safer immunotherapy alternative with the ability to drive deeper B cell depletion; IN8bio’s DeltEx platform’s ability to help advance cell therapy treatments with consistency and operational efficiency; IN8bio’s ability to (i) deliver transformative outcomes in cancer and autoimmune diseases and (ii) be a leader in gamma-delta T cell therapies; IN8bio’s ability to achieve other anticipated milestones, including expected presentations and data readouts from its trials and advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2025, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact: KKH Advisors Kimberly Ha 917.291.5744 [email protected]

Investor releaseQuarter not tagged2025-05-08

IN8bio Reports First Quarter 2025 Financial Results and Recent Business Highlights

GlobeNewswire
Phase 1 clinical data of INB-100 continues to demonstrate long-term durable remissions, with 100% of treated Acute Myeloid Leukemia (AML) patients remaining relapse-free with median follow-up of 20.1 months as of January 17, 2025, as presented at the 2025 Transplantation & Cellular Therapy (TCT) Meetings On May 1st, 2025, we celebrated the 5th anniversary of the first patient ever treated with a gamma-delta T cell therapy being developed by IN8bio. This older patient with complex AML and multiple genetic abnormalities was treated with INB-100 and remains alive and in remission today Presented new data on INB-600, a next-generation gamma-delta T cell engager (TCE) platform at the American Association for Cancer Research (AACR) 2025 Annual Meeting with potential applications across both oncology and autoimmune diseases Continued operational execution with strategic focus on meaningful data milestones including an upcoming oral presentation of INB-200 at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting Raised aggregate net proceeds of approximately $4.1 million from the sale of common stock under the ATM and exercise of warrants in 1Q25 NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the first quarter ended March 31, 2025 and recent corporate highlights. “IN8bio stands at the forefront of gamma-delta T cell innovation, pioneering transformative therapies for cancer patients with urgent unmet needs. Driven by our commitment to scientific excellence, we are advancing our mission of Cancer ZeroTM with elegant, cutting-edge approaches. Our clinical data showcases robust activity, delivering extended progression-free survival and a unique safety profile across challenging cancers to date. As the biopharmaceutical industry excitedly embraces novel T cell engagers, IN8bio is once again redefining the landscape with our innovative INB-600 TCE platform. The preclinical data unveiled at AACR represents a leap forward,” said William Ho, CEO & co-founder, IN8bio. “Harnessing our deep expertise, we’ve engineered a breakthrough technology that achieves picomolar potency, enhances immune surveillance, and potentially mitigates some of the safety risks associated with conventional…Read full document

Phase 1 clinical data of INB-100 continues to demonstrate long-term durable remissions, with 100% of treated Acute Myeloid Leukemia (AML) patients remaining relapse-free with median follow-up of 20.1 months as of January 17, 2025, as presented at the 2025 Transplantation & Cellular Therapy (TCT) Meetings On May 1st, 2025, we celebrated the 5th anniversary of the first patient ever treated with a gamma-delta T cell therapy being developed by IN8bio. This older patient with complex AML and multiple genetic abnormalities was treated with INB-100 and remains alive and in remission today Presented new data on INB-600, a next-generation gamma-delta T cell engager (TCE) platform at the American Association for Cancer Research (AACR) 2025 Annual Meeting with potential applications across both oncology and autoimmune diseases Continued operational execution with strategic focus on meaningful data milestones including an upcoming oral presentation of INB-200 at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting Raised aggregate net proceeds of approximately $4.1 million from the sale of common stock under the ATM and exercise of warrants in 1Q25 NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the first quarter ended March 31, 2025 and recent corporate highlights. “IN8bio stands at the forefront of gamma-delta T cell innovation, pioneering transformative therapies for cancer patients with urgent unmet needs. Driven by our commitment to scientific excellence, we are advancing our mission of Cancer ZeroTM with elegant, cutting-edge approaches. Our clinical data showcases robust activity, delivering extended progression-free survival and a unique safety profile across challenging cancers to date. As the biopharmaceutical industry excitedly embraces novel T cell engagers, IN8bio is once again redefining the landscape with our innovative INB-600 TCE platform. The preclinical data unveiled at AACR represents a leap forward,” said William Ho, CEO & co-founder, IN8bio. “Harnessing our deep expertise, we’ve engineered a breakthrough technology that achieves picomolar potency, enhances immune surveillance, and potentially mitigates some of the safety risks associated with conventional CD3-targeted TCEs. We’re excited to advance this platform into both oncology and autoimmune indications and continue building a differentiated pipeline that promises to reshape the future of medicine.” Corporate Highlights and Recent Developments Expanded Pipeline with INB-600 Gamma-Delta T Cell Engager Platform Presented new preclinical data at the 2025 American Association for Cancer Research (AACR) Annual Meeting highlighting the INB-600 platform, including lead candidates INB-619 (targeting CD19) and INB-633 (targeting CD33). Preclinical studies demonstrated strong, antigen-specific cytotoxicity against leukemia cells and primary B cells with minimal inflammatory cytokine release, potentially addressing key limitations of conventional CD3-based TCEs. INB-600 TCE platform significantly expands both Vδ1+ and Vδ2+ subsets to address the reduced cell counts that have limited earlier γδ TCE therapies in cancer patients. Targeted B cell elimination (INB-619) highlights potential applications in B cell–driven autoimmune diseases as well as oncology indications. Demonstrated Additional Clinical Progress Across Gamma-Delta T Cell Therapy Pipeline Presented Positive Phase 1 data (February 2025) for INB-100 (Allogeneic Gamma-Delta T Cell Therapy for High-Risk AML and Leukemias) at the 2025 Transplantation & Cellular Therapy (TCT) Annual Meeting showing durable remissions, with 100% of treated AML patients remaining relapse-free with 20.1 month median follow-up as of January 17, 2025. Observed a favorable safety profile, with no cases of cytokine release syndrome (CRS) or neurotoxicity (ICANs) reported to date. 1-Year Survival Rates Exceeded Real-World Control Groups: The 1-year progression-free survival (PFS) rate across all leukemia patients is 90.9% and 1-year overall survival (OS) is 100%, outperforming comparative real-world historical control data obtained from both the Center for International Blood & Marrow Transplant Research (CIBMTR) and from the University of Kansas Cancer Center. Participation at Immuno-Oncology 360° (IO360°) Conference William Ho, Chief Executive Officer and co-founder of IN8bio, Co-Chaired Day 2 of the Immuno-Oncology 360° (IO360°) Conference on March 25, 2025, delivering opening remarks, leading the “State of the IO Market, Investments and Deals Plenary” session, and presenting on the promise of gamma-delta T cell engagers for oncology and autoimmune diseases, including INB-619. Upcoming Anticipated Pipeline Milestones and Events American Society of Clinical Oncology (ASCO) 2025 Annual Meeting (May 30, 2025): Upcoming oral presentation: "INB-200: Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)" will present updated clinical data from IN8bio’s Phase 1 trial of INB-200. The data will be featured in the Central Nervous System Tumors Oral Abstract Session. International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting (May 9, 2025): Upcoming oral presentation: "From Donor to Therapy: How Robust Manufacturing Shapes the TCR Repertoire and Cytotoxic Power of Donor-Derived Allogeneic ex vivo Expanded and Activated γδ T Cell Products" will highlight the power of the company’s gamma-delta T cell manufacturing platform. The data will demonstrate the TCR diversity, genomic profiling and cytotoxic function of donor-derived clinical gamma-delta T cell therapies. Mariska ter Haak, Senior Director, Analytical Development at IN8bio, will present during the Oral Abstract Session – Immunotherapy. Poster Presentation: “Selection and Implementation of the Electronic Quality Management System for High Complexity Clinical Stage Cellular Therapy Company.” This will be presented by Guoling Chen, Senior Director, Quality Operations. American Society of Gene & Cell Therapy (ASGCT) 2025 Annual Meeting (May 17, 2025): Upcoming oral presentation: "Decoding the Molecular Signature of Expanded Gamma Delta T Cell Products; TCR and Immune Gene Expression from Allogeneic Derived Products" will present new data characterizing the TCR repertoire and immune gene expression profiles of IN8bio’s clinical expanded gamma-delta T cell products. This data will show the robustness and reproducibility of the in-house developed manufacturing platform at IN8bio. Mariska ter Haak, Senior Director, Analytical Development, will deliver the presentation at the New Orleans Ernest N. Morial Convention Center. Poster Presentation: “INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells” will demonstrate the use of the novel CD19 γδ TCE for driving deep B cell depletion and potential application in autoimmune disease including Lupus. This will be presented by Lawrence Lamb, Ph.D., Co-Founder and Chief Scientific Officer. First Quarter 2025 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $3.0 million for the three months ended March 31, 2025, compared with $4.9 million in the prior year. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation. The change was primarily due to decreased but some remaining clinical trial-related activities for the INB-400 program and a decrease in personnel-related costs, in each case as a result of the Company’s pipeline prioritization announced in September 2024. General and administrative (G&A) expenses: G&A expenses were $2.7 million for the three months ended March 31, 2025, compared with $3.7 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services. Net loss: The company reported a net loss of $5.6 million, or $0.07 per basic and diluted common share, for the three months ended March 31, 2025, compared with a net loss of $8.6 million, or $0.20 per basic and diluted common share, for the comparable prior year period. Cash position: As of March 31, 2025, the Company had cash of $11.9 million, compared with $13.0 million for the comparable prior year. Subsequently, in April 2025, the Company received aggregate gross proceeds of $1.9 million from the exercise of its Series A and Series B common stock warrants. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program, INB-100, is focused on AML evaluating haplo-matched allogeneic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma, and advancing novel gamma-delta TCEs for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the ability of IN8bio’s INB-600 TCE platform to (i) be applicable across both oncology and autoimmune indications, (ii) demonstrate consistent results in future clinical trials, (iii) offer a more precise and powerful method of mobilizing the immune system against cancer cells; IN8bio’s ability to advance its INB-600 platform; INB-100’s continued ability to (a) demonstrate long-term durable remissions, (b) avoid cases of CRS and/or ICANs and (c) outperform real-world historical controls; the strength of IN8bio’s manufacturing platform; IN8bio’s ability to achieve other anticipated milestones, including expected presentations and data readouts from its trials and advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 13, 2025, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Investors & Company Contacts: IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact Kimberly Ha KKH Advisors 917.291.5744 [email protected]

Investor releaseQuarter not tagged2025-03-14

IN8bio Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Highlights

GlobeNewswire
Ongoing Phase 1 and Phase 2 clinical programs continue to exhibit long-term durable remissions in hard-to-treat cancers, including glioblastoma (GBM) and 100% of treated Acute Myeloid Leukemia (AML) patients remaining relapse-free Expanded pipeline with INB-600 platform, featuring novel gamma-delta T Cell engager (TCE) targeting CD19 for potential use in oncology and autoimmune diseases Continued operational execution with strengthened strategic focus on aligning resources in an effort to drive high-impact programs forward Maintaining cash position to support operations and achievement of anticipated development milestones throughout 2025 and into 2026 NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2024. William Ho, Chief Executive Officer and co-founder of IN8bio, commented, “In 2024, IN8bio made significant progress advancing its pipeline of gamma-delta T cell therapies and positioning the Company for long-term success. The INB-100 program continues to demonstrate 100% long term durable response rates as of January 17, 2025, reinforcing its potential to help treat and maintain remissions in high-risk AML patients.” Mr. Ho continued, “We have also disclosed our novel INB-600 platform, which we believe has the potential to reshape the T cell engager landscape by potentially improving both the durability of response and safety compared to existing CD3 targeting TCE therapies. Throughout 2025, we remain focused on driving innovation, advancing our clinical programs and delivering value to patients and our stakeholders.” Key Highlights Announced INB-600 Platform & INB-619, a Novel Preclinical Gamma-Delta TCE Introduced INB-619, a proprietary next generation gamma-delta TCE targeting CD19 for potential use in oncology and autoimmune diseases (March 2025) Demonstrated potent B-cell depletion and sustained gamma-delta T cell expansion in preclinical studies, offering commercial and scientific advantages by potentially improving durability and safety over existing CD3 targeting TCE therapies Demonstrated Additional Clinical Progress with INB-100 (Allogeneic Gamma-Delta T Cell Therapy for AML & Leukemias) for High-Risk AML Presented ne…Read full document

Ongoing Phase 1 and Phase 2 clinical programs continue to exhibit long-term durable remissions in hard-to-treat cancers, including glioblastoma (GBM) and 100% of treated Acute Myeloid Leukemia (AML) patients remaining relapse-free Expanded pipeline with INB-600 platform, featuring novel gamma-delta T Cell engager (TCE) targeting CD19 for potential use in oncology and autoimmune diseases Continued operational execution with strengthened strategic focus on aligning resources in an effort to drive high-impact programs forward Maintaining cash position to support operations and achievement of anticipated development milestones throughout 2025 and into 2026 NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2024. William Ho, Chief Executive Officer and co-founder of IN8bio, commented, “In 2024, IN8bio made significant progress advancing its pipeline of gamma-delta T cell therapies and positioning the Company for long-term success. The INB-100 program continues to demonstrate 100% long term durable response rates as of January 17, 2025, reinforcing its potential to help treat and maintain remissions in high-risk AML patients.” Mr. Ho continued, “We have also disclosed our novel INB-600 platform, which we believe has the potential to reshape the T cell engager landscape by potentially improving both the durability of response and safety compared to existing CD3 targeting TCE therapies. Throughout 2025, we remain focused on driving innovation, advancing our clinical programs and delivering value to patients and our stakeholders.” Key Highlights Announced INB-600 Platform & INB-619, a Novel Preclinical Gamma-Delta TCE Introduced INB-619, a proprietary next generation gamma-delta TCE targeting CD19 for potential use in oncology and autoimmune diseases (March 2025) Demonstrated potent B-cell depletion and sustained gamma-delta T cell expansion in preclinical studies, offering commercial and scientific advantages by potentially improving durability and safety over existing CD3 targeting TCE therapies Demonstrated Additional Clinical Progress with INB-100 (Allogeneic Gamma-Delta T Cell Therapy for AML & Leukemias) for High-Risk AML Presented new Phase 1 data showing durable remissions with 100% of treated AML patients remaining relapse-free (February 2025) Observed favorable safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANs) reported to date Presented expanded clinical data at 2025 Tandem Meetings reinforcing potential of INB-100 to significantly reduce post-transplant relapse in high-risk AML patients relative to historical real-world data Presented Continued Durable Remissions in Phase 1 Trial of INB-200 (Autologous, Drug-Resistant Gamma-Delta T Cell Therapy for Glioblastoma) Presented updated data in a plenary oral presentation at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, showing the majority of patients exceeded their expected progression free survival based on age and tumor status Highlighted potential long-term benefits of INB-200. As of October 18, 2024, five patients remained alive, three patients had returned to work, and one IDH-mutant, grade 4 glioma patient remained progression free for an impressive 40.5 months post treatment Strategically Optimized Pipeline and Launched Operational Efficiency Initiatives Paused enrollment in the Phase 2 INB-400 glioblastoma program – despite compelling data – to focus resources while exploring partnership and alternative funding opportunities Implemented cost-saving measures to extend cash runway and prioritize pipeline development Raised approximately $16.6 million in gross proceeds through various equity offerings, including through our at-the-market (“ATM”) offering program and private placements, during 2024 through February 2025, extending the Company’s cash runway into March 2026 Upcoming Anticipated Pipeline Milestones and Important Events INB-100: For the potential treatment of high-risk leukemias including AML Accelerating patient enrollment in expansion cohort of ongoing Phase 1 clinical trial including the inclusion of an additional investigational center Aim to complete enrollment into the expansion cohort in 2025. Guidance from the U.S. Food and Drug Administration (FDA) confirmed relapse-free survival (RFS) in AML patients as an acceptable primary endpoint for a potential pivotal randomized control trial Expect to present updated clinical data in the second half of 2025 Advancing preparations for potential registrational Phase 2 trial with possible IND submission anticipated in 2026 based on receipt of additional funding INB-200 and INB-400 (Autologous Gamma-Delta T Cell Therapy for Glioblastoma & Solid Tumors): Continue to evaluate early clinical data for signs of efficacy and durability Report additional findings at upcoming medical meetings in 2025 Seek additional funding sources to advance allogeneic product for glioblastoma and other solid tumors INB-600 and INB-619 (Gamma-Delta T Cell Engager Targeting CD19 – Oncology & Autoimmune Diseases): Present preclinical data evaluating potency, expansion potential, and safety profile at medical meetings in the second quarter of 2025 Plan to advance towards IND-enabling studies with additional funding to support future clinical development Exploring partnership and collaboration options to accelerate development of the platform Fourth Quarter and Full Year 2024 Financial Highlights Research and Development (R&D) expenses: R&D expenses were $3.8 million for the three months ended December 31, 2024, compared with $4.5 million for the comparable prior year period. R&D expenses were $17.2 million for the year ended December 31, 2024, compared with $16.8 million in the prior year. The change was primarily due to increased clinical trial-related activities for the INB-100 and INB-400 programs and was partially offset by a decrease in personnel-related costs and facility-related and other expenses, in each case as a result of the Company’s pipeline prioritization announced in September 2024. General and administrative (G&A) expenses: G&A expenses were $2.6 million for the three months ended December 31, 2024, compared with $3.1 million for the comparable prior year period. G&A expenses were $12.6 million for the year ended December 31, 2024, compared with $13.5 million in the prior year. The change was primarily due to cost savings related to director and officer insurance premiums, professional services, and personnel-related costs, partially offset by an increase in legal and consulting expenses. Severance and related charges: Severance and related charges were $1.1 million for the year ended December 31, 2024, compared with zero in the prior year. These were one-time costs related to the September 2024 workforce reduction, including non-cash stock-based compensation expense and severance payments. Net loss: The company reported a net loss of $6.4 million, or $0.08 per basic and diluted common share, for the three months ended December 31, 2024, compared with a net loss of $7.6 million, or $0.22 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2024, net loss was $30.7 million, or $0.57 per basic and diluted common share, compared with a net loss of $30.0 million, or $1.00 per basic and diluted common share, for the prior year. Cash position: As of December 31, 2024, the Company had cash of $11.1 million as of December 31, 2024, compared with $21.3 million as of December 31, 2023. Subsequently, in February 2025, the Company sold common stock under its ATM offering program and had Series C warrants exercised for aggregate net proceeds of $4.1 million. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program, INB-100, is focused on AML evaluating haplo-matched allogeneic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma, and advancing novel gamma-delta TCEs for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the ability of gamma-delta T cell therapies to continue to exhibit long-term durable remissions in hard-to-treat cancers; IN8bio’s ability to expand pipeline and potential partnership opportunities, including those related to INB-200, INB-400 and INB-600; IN8bio’s ability to drive high-impact programs forward and position for long-term success; the ability of INB-600 to reshape the TCE landscape and to improve durability and safety over existing CD3-targeting TCE therapies; the evaluation of INB-619 in preclinical studies and its applicability for oncology and autoimmune indications; INB-100’s ability to continue to achieve durable remissions in AML patients; IN8bio’s anticipated cash runway; the potential long-term benefits of INB-200; plans to accelerate patient enrollment for INB-100, to complete the expansion cohort in 2025 and to advance preparations for a potential registrational Phase 2 trial; IN8bio’s ability to achieve other anticipated milestones, including expected presentations and data readouts from its trials, enrollment of additional patients in its clinical trials, IND submissions and advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Investors & Company Contacts: Glenn Schulman, PharmD, MPH 203.494.7411 [email protected] IN8bio, Inc. Patrick McCall 646.933.5603 [email protected] Media Contact: Kimberly Ha KKH Advisors 917.291.5744 [email protected]

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook