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

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

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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-5462585 (State or other jurisdiction of in ...

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

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

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

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

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

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