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].

Corporate Highlights and Recent Developments Expanded Pipeline with INB-600 Gamma-Delta T Cell Engager Platform Demonstrated Additional Clinical Progress Across Gamma-Delta T Cell Therapy Pipeline 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 ...

NEW YORK, April 29, 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 announced that it will present new clinical and preclinical data from its pipeline of gamma-delta T cell therapies at several upcoming scientific conferences. "The breadth of data we're presenting at upcoming medical conferences reflects the scientific rigor and clinical potential of IN8bio's gamma-de ...

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