IN8bio(INAB)
Search documents
IN8bio(INAB) - 2025 Q4 - Annual Report
2026-03-12 20:15
Financial Position - As of December 31, 2025, the company has $27.1 million in cash, which is insufficient to cover projected operating expenses and capital expenditures after April 2027, raising substantial doubt about its ability to continue as a going concern [34]. Clinical Trials and Development - The company plans to report initial long-term follow-up data from the Phase 1 clinical trial of INB-100 at a medical meeting in late 2026, with patient treatment already completed in the INB-200 and INB-400 programs [38]. - Enrollment in the Phase 2 clinical trial of INB-400 was suspended in September 2024, with further clinical updates expected in mid- and late-2026, including additional median overall survival (mOS) data [38]. - The company aims to advance INB-619 into clinical development, with preliminary animal model data expected in 2026 and an IND submission targeted for 2027 [39]. - The Phase 1 clinical trial of INB-100 aims to treat at least 25 patients with hematologic malignancies undergoing haploidentical HSCT, with a focus on safety and tolerability [79]. - The company has completed enrollment in the Phase 1 INB-200 trial, with further updates expected in 2026 [125]. Intellectual Property and Licensing - The intellectual property portfolio consists of 11 patent families as of December 31, 2025, protecting the DeltEx platform and product candidates across multiple cancer and autoimmune indications [41]. - The company actively seeks to protect its intellectual property, owning or exclusively licensing five issued U.S. patents and 21 other issued foreign patents as of December 31, 2025 [171]. - The company has licensed multiple patents related to its product candidates, with expected expiration dates ranging from 2030 to 2044 [176][175]. - An exclusive license agreement with Emory University and other institutions allows the company to develop and commercialize products related to gamma-delta T cells [152]. - The Emory license agreement requires the company to pay development milestones totaling up to $1.4 million and annual minimum royalties starting at $0.5 million, increasing to $1.5 million by the fifth year [153]. Manufacturing and Production - The company has established an automated, scalable manufacturing platform and plans to expand its internal manufacturing capabilities and collaborate with contract development and manufacturing organizations (CDMOs) [41]. - The company has automated its manufacturing processes to enhance quality and scalability, allowing for rapid development of product candidates [72]. - The company currently relies on third-party contract manufacturers for all required raw materials and finished products for clinical trials [163]. - Gamma-delta T cells account for less than 10% of all lymphocytes, presenting challenges in manufacturing sufficient quantities for effective therapies [69]. Clinical Efficacy and Safety - The company has observed durable, long-term progression-free remissions in patients with high-risk leukemia and glioblastoma, with some patients exceeding four years of remission [44]. - INB-100 demonstrated a disease-free survival rate of over 70% at seven years for patients with high levels of gamma-delta T cells, compared to less than 20% for those with low levels [78]. - As of January 17, 2025, 100% of AML patients treated with INB-100 remained relapse-free after a median follow-up of 20.1 months [84]. - The trial reported a median morphologic complete response duration of 18.8 months across all patients and 23.3 months for AML patients [84]. - INB-100 showed a 90.9% progression-free survival rate and 100% overall survival rate at one year for treated patients [88]. - The one-year relapse rate for AML patients in the INB-100 trial was significantly lower than the 32.2% rate reported in the CIBMTR national database [87]. - INB-100 has a manageable safety profile with no dose-limiting toxicities or treatment-related Grade 3 or greater adverse events reported [92]. - No dose-limiting toxicities were observed in the INB-200 and INB-400 trials, with only one treatment-related serious adverse event reported [114]. Market Opportunity and Competition - The incidence of GBM in the U.S. is approximately 3.5 per 100,000 individuals, with an estimated 14,500 new cases in 2023, highlighting a significant unmet medical need [99]. - The global market opportunity for GBM treatments is estimated to exceed $4 billion, driven by the high recurrence rate and limited effectiveness of current therapies [99]. - The biotechnology industry is characterized by intense competition, with potential competitors including larger pharmaceutical companies and academic institutions [164]. - The company faces competition from various sources, including those with greater financial resources and experience in clinical trials and regulatory approvals [166]. - The company anticipates facing increasing competition as new therapies enter the market, which may affect its commercial opportunities [168]. Regulatory Environment - The FDA's review process for biologic product candidates typically involves a 10-month review for standard applications and 6 months for priority reviews [198]. - The company must submit a Biologics License Application (BLA) after completing clinical trials, which includes all relevant data from studies [197]. - The FDA may require post-marketing studies to monitor the safety and effectiveness of approved products [202]. - The company must navigate various regulatory requirements for clinical trials, including approvals from Institutional Review Boards (IRBs) [191]. - The company is eligible for expedited development programs like Fast Track designation for products addressing serious conditions [204]. - The FDA may condition approval on Risk Evaluation and Mitigation Strategies (REMS) to manage known risks associated with products [202]. Compliance and Legal Considerations - Compliance with HIPAA and HITECH regulations is essential for covered entities and business associates, with potential civil monetary penalties for violations [227]. - Pharmaceutical manufacturers must report price metrics like average sales price and best price, which may be affected by mandatory discounts and future import regulations [228]. - The Physician Payments Sunshine Act requires manufacturers to report payments to healthcare professionals, complicating compliance due to varying state laws [229]. - Many states have enacted stricter fraud and abuse statutes that apply to Medicaid and other state programs, complicating compliance efforts for pharmaceutical companies [230]. - Non-compliance with healthcare laws can lead to significant penalties, including exclusion from government programs and reputational harm [232].
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· 2026-03-12 20:01
Core Insights - IN8bio, Inc. reported significant financial progress and advancements in its clinical γδ T cell therapy programs and T cell engager platform in 2025, with a focus on addressing unmet medical needs in cancer and autoimmune diseases [2] Financial Highlights - The company reduced its full-year net loss by 36% year-over-year, reporting a net loss of $19.4 million for 2025 compared to $30.4 million in 2024 [11][18] - Cash position improved significantly, with $27.1 million as of December 31, 2025, compared to $11.1 million at the end of 2024 [11][20] - Research and Development (R&D) expenses decreased to $10.2 million in 2025 from $17.0 million in 2024, while General and Administrative (G&A) expenses also saw a reduction to $9.7 million from $12.6 million [11][22] Clinical Developments - Updated clinical data from the INB-200 and INB-400 trials showed that patients treated with DeltEx DRI γδ T cells nearly doubled the median progression-free survival (mPFS) to 13.0 months compared to 6.6 months in the standard-of-care control group, representing a 97% improvement [5][7] - The median overall survival (mOS) for repeat dose patients had not yet been reached at 17.2+ months, surpassing the 13.2-month final mOS for the standard-of-care control arm [7] - No dose-limiting toxicities or severe adverse events were reported, reinforcing the potential of repeat-dose γδ T cell therapy to improve outcomes in newly diagnosed glioblastoma [12] Financing and Strategic Initiatives - IN8bio announced a private placement of up to $40.2 million, with an initial closing of $20.1 million, expected to extend the cash runway into the first half of 2027 [3][6] - Proceeds from the financing will support IND-enabling studies for the INB-619 γδ T cell engager and further discussions with the FDA regarding clinical pathways for the GBM program [6] Leadership Update - Kate Rochlin, Ph.D., was promoted to President and Chief Operating Officer, continuing to oversee the company's operations and strategic execution as it advances its clinical pipeline [9] Anticipated Milestones - Guidance from the FDA on potential regulatory pathways is expected in the second half of 2026, along with additional clinical updates on GBM programs and preclinical data for INB-619 [13]
IN8bio (NasdaqGM:INAB) FY Conference Transcript
2026-03-02 15:52
Summary of IN8bio FY Conference Call (March 02, 2026) Company Overview - **Company**: IN8bio (NasdaqGM:INAB) - **Focus**: Development of gamma delta T cells as therapeutics for oncology and autoimmune diseases - **Expertise**: The company claims to be among the world's best in gamma delta T cell therapeutics, with a scientific co-founder having over 30 years of experience in the field [1][2] Clinical Programs - **Current Programs**: - INB-100: Focused on leukemia, specifically acute myeloid leukemia (AML) - INB-200 and INB-400: Genetically modified gamma delta T cell programs targeting solid tumors, with INB-200 focusing on glioblastoma - **Clinical Results**: - Patients in remission for over 4 years, particularly in severe cases of AML and glioblastoma [2][3] - **Pipeline Status**: - INB-300 and INB-500 programs are currently on hold due to capital constraints [4] Financials - **Recent Financing**: - Raised $40.2 million in December, with $20.1 million in the first tranche expected to last until the first half of 2027 [3] - **Future Funding**: A second tranche is contingent on achieving specific milestones later in the year [3][33] Treatment Approach - **Unique Strategy**: - Focus on reducing tumor mass to minimal residual disease before attacking remaining cells with gamma delta T cells, which are engineered to survive conventional chemotherapy [8][9] - **Dosing Strategy**: - Patients receive doses every 28 days, aiming to keep tumor cells static or reduce them over time [10][11] Clinical Data - **Patient Outcomes**: - Median progression-free survival for control patients was 6.6 months, while those receiving multiple doses had a median progression-free survival of 13 months and overall survival of 17.2 months [16][17] - **Statistical Significance**: - Data shows a direct correlation between the number of doses and survival rates, with a P value of less than 0.05 indicating statistical significance [20] T-Cell Engager Platform - **New Platform**: - INB-619 T cell engager platform aims to widen the therapeutic window and improve tolerability in autoimmune diseases [4][21] - **Challenges in Autoimmune Treatment**: - Current therapies often lead to lymphodepletion and associated risks, particularly for women of childbearing age [21][22] - **Innovative Design**: - The new T-cell engager targets both CD19 and gamma delta T cells, aiming to avoid common issues like cytokine release syndrome (CRS) [24][25] Competitive Landscape - **Market Position**: - IN8bio believes it is undervalued compared to competitors, citing its unique approach and promising clinical results [32] - **Head-to-Head Comparisons**: - Conducted experiments against FDA-approved drugs, demonstrating equivalent or superior B-cell depletion with a wider therapeutic window [27][28] Future Outlook - **Regulatory Path**: - Plans to seek FDA guidance based on current data, with potential for accelerated approval pathways [34] - **Upcoming Milestones**: - Anticipated updates on clinical data and animal model results later in the year [32][33] Conclusion - IN8bio is positioned as a leader in gamma delta T cell therapeutics, with promising clinical data and a unique approach to treating difficult cancers and autoimmune diseases. The company is actively seeking to advance its pipeline and regulatory strategy while addressing capital constraints.
IN8bio (NasdaqGM:INAB) FY Earnings Call Presentation
2026-03-02 14:50
Harnessing the Power of Gamma -Delta T Cells March 2, 2026 IN8bio, Inc. | IN8bio, Inc. | +1 646.600.6GDT (6438) +1 646.600.6GDT (6438) | | infinf o@IN8bio.com o@IN8bio.com | | www.IN8bio.com www.IN8bio.com Disclaimer The material in this presentation regarding IN8bio, Inc . ("we," "us" or the "Company") is for informational purposes only . This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , that involve substantial risks and unc ...
IN8bio to Present at TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-24 13:00
Company Overview - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases [3] - The company's lead programs include 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) [3] - IN8bio is also developing a preclinical pipeline that includes a novel γδ T cell engager platform, INB-600, aimed at oncology and autoimmune indications [3] Upcoming Events - William Ho, CEO and co-founder of IN8bio, will present at the TD Cowen 46 Annual Health Care Conference on March 2, 2026, at 9:50 am ET [1] - The conference will take place from March 2-4, 2026, in Boston, and will feature one-on-one investor meetings hosted by management [2] - A live webcast and replay link for the conference will be available on the IN8bio website under the "Events and Presentations" section [2]
IN8bio Promotes Kate Rochlin, Ph.D., to President and Chief Operating Officer
Globenewswire· 2026-02-09 13:00
Core Insights - IN8bio has promoted Kate Rochlin, Ph.D., to President and Chief Operating Officer, effective immediately, to enhance leadership during a critical growth phase [1][2] Company Overview - IN8bio is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta (γδ) T cell therapies and T cell engagers for cancer and autoimmune diseases [1][6] - The company's lead program, INB-100, targets acute myeloid leukemia, while other programs include INB-200 and INB-400 for glioblastoma, and INB-600 for oncology and autoimmune indications [6] Leadership and Experience - Dr. Rochlin has over 17 years of experience in biotechnology, including roles in scientific research, intellectual property, business development, and clinical manufacturing [3] - Prior to her role at IN8bio, she served as Chief Business Officer at Curadigm, contributing to the company's spin-out from Nanobiotix [3] Clinical Advancements - Under Dr. Rochlin's leadership, IN8bio has advanced its clinical programs, including the development of INB-619, which has shown promising preclinical results in achieving complete B cell depletion with minimal adverse effects [4] - The company has made significant progress in its clinical manufacturing program, supporting multiple Phase 1 and 2 clinical trials in glioblastoma and hematological cancers [4] Future Outlook - Dr. Rochlin expressed confidence in the company's position to build on momentum from encouraging clinical data and aims to execute corporate priorities for long-term success [5]
IN8bio (NasdaqGM:INAB) Conference Transcript
2026-02-05 21:02
Summary of IN8bio Conference Call - February 05, 2026 Company Overview - **Company**: IN8bio (NasdaqGM:INAB) - **Focus**: Development of cellular therapies using gamma delta T cells - **Key Personnel**: William Ho (CEO), Dr. Larry Lamb (Chief Scientific Officer) [1][2] Core Programs and Pipeline - **Ongoing Programs**: - **INB-100**: Allogeneic cell therapy for leukemia patients undergoing transplantation, currently enrolling an expansion cohort with updated phase one data expected by year-end [3] - **INB-619**: T cell engager platform targeting CD19 for both oncology and autoimmune diseases [3] - **INB-200 and INB-400**: Genetically modified gamma-delta T cell programs targeting solid tumors, particularly glioblastoma [3][4] Glioblastoma Treatment Insights - **Mechanism of Action**: Targets the DNA damage response (DDR) pathway, which is fundamental to all cells, making it potentially applicable to various solid tumors [33] - **Clinical Trial Results**: - Patients treated with INB-200 and INB-400 showed a median progression-free survival (PFS) of 13 months, compared to 6.6 months in the control group [14] - Overall survival (OS) for treated patients reached 17.2 months, with some patients remaining progression-free for over 4 years [15][47] - No major toxicity signals or adverse events reported [11] T Cell Engager Platform - **INB-619**: A unique CD19 targeting T cell engager designed to minimize cytokine release syndrome (CRS) while effectively depleting B cells [22][27] - **Comparative Efficacy**: INB-619 demonstrated comparable or superior potency to existing B-cell depleters like Amgen's blinatumomab and Roche's mosunitumab, with a significantly wider therapeutic window [26][27] Financial and Operational Updates - **Recent Financing**: Raised $20.1 million led by Coastlands Capital, with participation from Franklin Templeton and other investors, providing runway through 2027 [28][50] - **Upcoming Milestones**: - Public peer-reviewed publication of glioblastoma data - FDA guidance on regulatory path for glioblastoma program - Mouse data for INB-619 expected by late summer [53] Additional Insights - **Market Positioning**: IN8bio has chosen not to pursue autoimmune diseases with cell therapies, focusing instead on oncology due to concerns about the safety and efficacy of existing treatments in that area [20] - **Histopathology Findings**: Analysis of treated patients showed significant infiltration of gamma-delta T cells, indicating effective targeting of tumors [19] Conclusion - IN8bio is making significant strides in the development of innovative therapies for glioblastoma and leukemia, with promising clinical results and a solid financial foundation to support ongoing research and development efforts [29]
IN8bio to Present at Upcoming Investor and Scientific Conferences in February
Globenewswire· 2026-02-03 13:00
Company Overview - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases [3] - The company's lead program, INB-100, targets acute myeloid leukemia using haplo-matched allogeneic γδ T cells post-hematopoietic stem cell transplant [3] - IN8bio is also advancing autologous DeltEx DRI γδ T cells for glioblastoma in its INB-200 and INB-400 programs, along with INB-600, which focuses on novel γδ T cell engagers for oncology and autoimmune indications [3] Conference Participation - William Ho, CEO and co-founder of IN8bio, will present at the Noble Emerging Growth Virtual Equity Conference on February 5, 2026, at 3:00 p.m. ET [1] - The company will also participate in the IO360° Conference on February 12, 2026, where it will present on its DeltEx Drug Resistant Immunotherapy (DRI) approach to solid tumors and share results from a Phase 1/2 study in newly diagnosed glioblastoma [2]
IN8bio Presents Updated Phase I/II Data Demonstrating Meaningful and Durable Survival Improvements in Newly Diagnosed Glioblastoma
Globenewswire· 2026-01-12 13:00
Core Insights - IN8bio, Inc. reported updated clinical data from its INB-200 Phase 1 and INB-400 Phase 2 trials for newly diagnosed glioblastoma (GBM), showing significant improvements in progression-free survival compared to historical standard-of-care data [1][4] Clinical Trial Results - Patients receiving DeltEx™ Drug-Resistant Immunotherapy γδ T cells (DeltEx DRI) demonstrated a median progression-free survival (mPFS) of 13.0 months, nearly double the 6.6 months observed in the standard-of-care (SOC) control cohort, representing a 97% improvement [4][5] - The median overall survival (mOS) for DeltEx DRI patients is currently at 17.2+ months, compared to 13.2 months for SOC, indicating a 30.3% increase [4][5] - Eight out of fourteen DeltEx DRI patients (57%) remained progression-free longer than their expected overall survival based on age and MGMT status, while only one patient (10%) in the control group achieved this [5] Safety Profile - The DeltEx DRI treatment exhibited a well-tolerated safety profile, with no severe adverse events (SAEs) or dose-limiting toxicities (DLTs) reported [4][6] - No cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity (ICANS) was observed, further supporting the safety of the treatment [6][9] Immune Response Insights - Elevated levels of γδ T cells were observed in treated patients, along with immune cell infiltration within tumors and broader systemic immune activation, suggesting a significant immune impact [7] - The localized intracranial delivery of DeltEx DRI may drive systemic immune responses, which is crucial for combating GBM, a disease characterized by rapid progression and poor outcomes [7] Company Background - IN8bio is a clinical-stage biopharmaceutical company focused on developing γδ T cell therapies for unmet medical needs, including programs targeting acute myeloid leukemia and glioblastoma [8]
IN8bio announces up to $40.2M at-the-market private placement (NASDAQ:INAB)
Seeking Alpha· 2025-12-19 14:01
Group 1 - The article does not provide any relevant content regarding company or industry insights [1]