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

NEW YORK, March 18, 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 the Company will participate in multiple sessions at the Immuno-Oncology 360° (IO360°) Conference 2025, held March 24-26, 2025, in Boston, MA. William Ho, Chief Executive Officer and co-founder of IN8bio, will be Co-Chairing Day 2 of the conference starting at 8:15 AM EDT on March 25, 2 ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell therapies for cancer, with lead programs showing durable remissions but facing going concern doubts - **IN8bio is a clinical-stage biopharmaceutical company** focused on developing gamma-delta T cell product candidates and T cell engagers (TCEs) for cancer and autoimmune diseases using its DeltEx platform[17](index=17&type=chunk)[18](index=18&type=chunk) - The company's lead clinical programs, INB-100 for high-risk leukemias and INB-200 for newly diagnosed glioblastoma (GBM), have both demonstrated **long-term durable remissions** in Phase 1 trials[19](index=19&type=chunk) - A pipeline prioritization in September 2024 led to the **suspension of enrollment** in the Phase 2 trial of INB-400 for GBM to conserve capital, with the company now seeking strategic partnerships for the program[23](index=23&type=chunk)[78](index=78&type=chunk) - The company's financial statements raise **substantial doubt about its ability to continue as a going concern**, as existing cash is not expected to fund operations for at least 12 months from the financial statement issuance date[26](index=26&type=chunk)[27](index=27&type=chunk) [Our Pipeline and Strategy](index=9&type=section&id=Our%20Pipeline%20and%20Strategy) The company's strategy involves advancing lead clinical candidate INB-100, seeking partnerships for INB-400, and developing preclinical programs, all contingent on additional capital - Advance clinical candidate INB-100 for hematologic malignancies, with plans to complete the Phase 1 expansion cohort enrollment in **2025**[29](index=29&type=chunk) - Explore partnership opportunities for other candidates, including INB-400 for newly diagnosed GBM, for which Phase 2 enrollment was paused in **September 2024**[29](index=29&type=chunk) - Advance preclinical programs INB-300 (nsCAR), INB-500 (iPSC), and INB-600 (TCE) into clinical development, subject to additional funding or partnerships[29](index=29&type=chunk)[30](index=30&type=chunk) - Continue to scale manufacturing capabilities, leveraging an automated, closed-system platform and collaborations with institutions like UAB and the University of Louisville[32](index=32&type=chunk) [Our Product Candidates](index=21&type=section&id=Our%20Product%20Candidates) IN8bio's pipeline features lead candidates INB-100 for leukemia and INB-200/400 for GBM, both showing promising Phase 1 results, alongside preclinical programs INB-100 Phase 1 Trial Update (AML Patients) | Metric | Result | | :--- | :--- | | Complete Remission (CR) | 100% of AML patients remain in CR | | Median Follow-up | 20.1 months | | 1-Year Progression-Free Survival (PFS) | 100% | | 1-Year Overall Survival (OS) | 100% | INB-200 Phase 1 Trial Update (GBM Patients) | Metric | Result | | :--- | :--- | | Median PFS (Repeated Doses) | 12.4 months | | Increase vs. Standard of Care (6.9 mos) | 79% | | Patients Alive & in Remission (Repeated Doses) | 50% beyond expected median OS | - Preclinical program INB-300 uses a non-signaling CAR (nsCAR) to target tumor cells while preserving healthy tissue, showing a **6.7x difference in killing** between AML cells and healthy progenitor cells in vitro[115](index=115&type=chunk)[122](index=122&type=chunk) - INB-600 is a proprietary T cell engager (TCE) platform designed to activate and expand both Vd1+ and Vd2+ gamma-delta T cell subsets for applications in oncology and autoimmune diseases[24](index=24&type=chunk)[125](index=125&type=chunk) [Intellectual Property](index=49&type=section&id=Intellectual%20Property) As of December 31, 2024, IN8bio's IP portfolio includes 11 patent families with 4 issued U.S. and 23 issued foreign patents covering key product candidates, expiring from 2030 to 2044 - As of December 31, 2024, the company's IP portfolio included **11 patent families**, with **4 issued U.S. patents**, **23 issued foreign patents**, and over **40 pending applications** worldwide[32](index=32&type=chunk)[147](index=147&type=chunk) - Patents and applications for INB-100 cover methods of HSCT and are expected to expire in **2036 and 2044**[150](index=150&type=chunk)[151](index=151&type=chunk) - The IP for INB-200 and INB-400 covers composition of matter and methods of use, with patents expected to expire in **2030**; additional patents cover combination therapies with checkpoint inhibitors (expiring **2037**) and PARP inhibitors (expiring **2039**)[152](index=152&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) - The company also relies on trade secrets and know-how, particularly for its proprietary processes for expanding and activating gamma-delta T cells, protected by confidentiality and invention assignment agreements[164](index=164&type=chunk) [Government Regulation](index=54&type=section&id=Government%20Regulation) The company's operations are heavily regulated by the FDA, requiring IND and BLA submissions, and are subject to various healthcare laws and recent reforms like the Inflation Reduction Act - The company must follow a rigorous FDA approval process, including submitting an IND before clinical trials and a BLA for marketing, which requires demonstrating safety, purity, and potency through adequate and well-controlled trials[167](index=167&type=chunk)[168](index=168&type=chunk)[172](index=172&type=chunk) - The FDA offers expedited development programs such as Fast Track, Breakthrough Therapy, Accelerated Approval, and RMAT designation for qualifying product candidates intended for serious conditions[177](index=177&type=chunk)[178](index=178&type=chunk)[182](index=182&type=chunk) - The company is subject to numerous other healthcare laws, including the federal Anti-Kickback Statute, False Claims Act (FCA), and data privacy laws like HIPAA and the CCPA, violations of which can lead to substantial penalties[197](index=197&type=chunk)[198](index=198&type=chunk)[204](index=204&type=chunk) - Recent healthcare reforms, such as the Inflation Reduction Act (IRA), introduce measures like Medicare drug price negotiation and inflation rebates, which could impact future product pricing and profitability[213](index=213&type=chunk)[215](index=215&type=chunk) [Risk Factors](index=72&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including going concern doubts, early-stage product development uncertainties, manufacturing complexities, reliance on third parties, and intense competition - There is **substantial doubt regarding the company's ability to continue as a going concern**, as it will require significant additional funding to finance operations; failure to raise capital could force delays, reductions, or termination of development programs[229](index=229&type=chunk)[231](index=231&type=chunk) - The company's product candidates are based on novel gamma-delta T cell approaches, which present significant challenges in development, manufacturing, and commercialization, and their clinical utility is uncertain[229](index=229&type=chunk)[267](index=267&type=chunk)[273](index=273&type=chunk) - The manufacturing process for cell therapies is complex and susceptible to product loss, contamination, and failure, which could delay clinical trials and commercialization[230](index=230&type=chunk)[312](index=312&type=chunk) - The company is highly dependent on its co-founders, CEO William Ho and CSO Dr. Lawrence Lamb, and the loss of their services could impede the achievement of research and development objectives[230](index=230&type=chunk)[394](index=394&type=chunk) [Unresolved Staff Comments](index=91&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[486](index=486&type=chunk) [Cybersecurity](index=91&type=section&id=Item%201C.%20Cybersecurity) The audit committee oversees cybersecurity risk management, led by a third-party IT consultant, CFO, and COO, employing various measures to identify, assess, and mitigate threats - The board of directors' audit committee is responsible for overseeing the company's cybersecurity risk management processes[492](index=492&type=chunk) - The information security function is led by a third-party IT consultant in collaboration with the CFO and COO, who have over **10 years of experience** overseeing IT and security functions[488](index=488&type=chunk)[494](index=494&type=chunk) - The company employs various measures to manage cybersecurity risks, including risk assessments, encryption, network security controls, employee training, and penetration testing[489](index=489&type=chunk) [Properties](index=93&type=section&id=Item%202.%20Properties) The company leases executive offices in New York and laboratory/office space in Birmingham, with leases expiring in 2027 and 2029 respectively - Leases approximately **3,900 sq. ft.** of office space in New York, NY, expiring **February 28, 2027**[499](index=499&type=chunk) - Leases approximately **18,000 sq. ft.** of lab and office space in Birmingham, AL, expiring **October 31, 2029**, with a five-year extension option[499](index=499&type=chunk) [Legal Proceedings](index=93&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would be expected to have a material adverse effect on its business or financial condition - The company is not currently a party to any material legal proceedings[500](index=500&type=chunk) [Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[501](index=501&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=94&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "INAB" since July 2021, with approximately 41 stockholders, and no cash dividends have been paid or are anticipated - Common stock trades on Nasdaq under the symbol "**INAB**" since **July 30, 2021**[504](index=504&type=chunk) - As of **March 10, 2025**, there were approximately **41 stockholders of record**[505](index=505&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[506](index=506&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=95&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) IN8bio reported a net loss of **$30.4 million** in 2024, facing going concern doubts with **$11.1 million** cash, leading to trial suspension and workforce reduction to conserve capital Results of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $16,962 | $16,827 | | General and administrative | $12,637 | $13,510 | | Severance and related charges | $1,068 | $0 | | **Total operating expenses** | **$30,667** | **$30,337** | | **Net loss** | **$(30,437)** | **$(30,007)** | - The company's cash position was **$11.1 million** as of December 31, 2024; this amount, along with subsequent proceeds, is not anticipated to fund operations for at least twelve months, raising **substantial doubt about its ability to continue as a going concern**[521](index=521&type=chunk) - In September 2024, the company implemented a pipeline prioritization, suspending the INB-400 trial and reducing its workforce by approximately **49%**, resulting in a one-time severance charge of **$1.1 million**[519](index=519&type=chunk)[537](index=537&type=chunk) - The company raised net proceeds of **$11.2 million** from a private placement in October 2024 and **$3.8 million** from its ATM program during the year ended December 31, 2024[515](index=515&type=chunk)[544](index=544&type=chunk)[562](index=562&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=105&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, IN8bio is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide this information[578](index=578&type=chunk) [Financial Statements and Supplementary Data](index=105&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements show a **$30.4 million** net loss in 2024 and **$20.9 million** in total assets, with the auditor expressing substantial doubt about the company's going concern ability Key Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash | $11,120 | $21,282 | | Total Assets | $20,944 | $33,709 | | Total Liabilities | $6,466 | $8,772 | | Total Stockholders' Equity | $14,478 | $24,937 | Key Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Total operating expenses | $30,667 | $30,337 | | Net loss | $(30,437) | $(30,007) | | Net loss per share | $(0.57) | $(1.00) | - The independent auditor's report highlights **substantial doubt about the Company's ability to continue as a going concern** due to recurring losses from operations[586](index=586&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=128&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[697](index=697&type=chunk) [Controls and Procedures](index=128&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that both disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no auditor attestation provided as an emerging growth company - Management concluded that disclosure controls and procedures were **effective** as of December 31, 2024[698](index=698&type=chunk) - Management concluded that internal control over financial reporting was **effective** as of December 31, 2024[700](index=700&type=chunk) - The report does not include an auditor's attestation on internal control over financial reporting, as permitted for emerging growth companies under the JOBS Act[700](index=700&type=chunk) [Other Information](index=129&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[704](index=704&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=130&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The information required for this item, including details on directors, executive officers, and corporate governance practices, is incorporated by reference from the company's definitive proxy statement for its 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the 2025 Proxy Statement[708](index=708&type=chunk) [Executive Compensation](index=130&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item regarding executive compensation is incorporated by reference from the company's definitive proxy statement for its 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the 2025 Proxy Statement[710](index=710&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=130&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item, concerning security ownership and equity compensation plans, is incorporated by reference from the company's definitive proxy statement for its 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the 2025 Proxy Statement[711](index=711&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=130&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item, covering related party transactions and director independence, is incorporated by reference from the company's definitive proxy statement for its 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the 2025 Proxy Statement[712](index=712&type=chunk) [Principal Accountant Fees and Services](index=130&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The information required for this item regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for its 2025 Annual Meeting of Stockholders - Information is incorporated by reference from the 2025 Proxy Statement[713](index=713&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=131&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits filed with the Form 10-K, with financial statements included in Item 8 and a detailed exhibit index provided - This item provides a list of all financial statements, schedules, and exhibits filed with the Form 10-K[716](index=716&type=chunk)[718](index=718&type=chunk) [Form 10-K Summary](index=134&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no Form 10-K summary - None[727](index=727&type=chunk)

Financial Performance - IN8bio reported a net loss of $6.2 million, or $0.08 per share, for Q4 2024, compared to a net loss of $7.6 million, or $0.22 per share, in Q4 2023[18]. - Net loss for the year ended December 31, 2024, was $30,437 million, compared to a net loss of $30,007 million in 2023, reflecting a 1.4% increase in losses[24]. - Net loss per share improved to $(0.57) in 2024 from $(1.00) in 2023, showing a significant reduction in loss per share[24]. Cash Position and Funding - The company maintained a cash position of $11.1 million as of December 31, 2024, down from $21.3 million as of December 31, 2023[18]. - The company raised approximately $16.6 million in gross proceeds through equity offerings from 2024 to February 2025, extending its cash runway into March 2026[11]. - The total assets of IN8bio decreased to $20.9 million as of December 31, 2024, from $33.7 million as of December 31, 2023[22]. - The company reported a significant increase in additional paid-in capital to $136.1 million as of December 31, 2024, compared to $116.2 million in the prior year[22]. Research and Development - R&D expenses for Q4 2024 were $3.6 million, a decrease from $4.5 million in Q4 2023, while total R&D expenses for the year were $17.0 million, slightly up from $16.8 million in the prior year[14]. - Research and development expenses were $16,962 million in 2024, slightly up from $16,827 million in 2023, indicating a focus on innovation[24]. - IN8bio's INB-100 program demonstrated a 100% long-term durable response rate in treated Acute Myeloid Leukemia (AML) patients as of January 17, 2025[3]. - IN8bio introduced the INB-600 platform and INB-619, a novel preclinical gamma-delta T cell engager targeting CD19 for oncology and autoimmune diseases[4]. - The company paused enrollment in the Phase 2 INB-400 glioblastoma program to focus resources on other high-impact programs[11]. - IN8bio plans to present updated clinical data in the second half of 2025 and anticipates a potential IND submission for a registrational Phase 2 trial in 2026[14]. Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $30,667 million, an increase from $30,337 million in 2023, representing a 1.1% increase[24]. - The weighted-average number of shares used in computing net loss per share increased to 53,547,030 in 2024 from 29,864,932 in 2023, indicating potential dilution[24].

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-freeExpanded pipeline with INB-600 platform, featuring novel gamma-delta T Cell engager (TCE) targeting CD19 for potential use in oncology and autoimmune diseasesContinued operational execution with strengthened strategic focus on aligning resources in an effort to drive high-impact p ...

Proprietary platform represents the first known approach capable of sustained γδ T cell expansion, eliminating target cells with robust potencyINB-619, a next generation γδ TCE targeting CD19, eradicates B cells in preclinical models, maintaining depletion over time as γδ T cells expand in response to TCE stimulation γδ TCE targets and expands both Vδ1+ and Vδ2+ T cells, potentially leading to longer lasting immune responses and deeper B cell depletionUnlike traditional TCEs and CAR-T therapies, γδ T cells ...

NEW YORK, Feb. 26, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today announced that William Ho, CEO and co-founder, will be presenting at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 10:30 a.m. ET. A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at https://investors.in8bio.com. A ...

NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today announced that William Ho, CEO and co-founder, will be presenting at the: H.C. Wainwright 3rd Annual Cell Therapy Virtual ConferenceDate/Time Tuesday, February 25, 2025, at 11:00 a.m. ET. Webcast Link https://journey.ct.events/view/acb6057e-9d9b-427e-b490-eaf85a5c2910 A live webcast and replay will be available under "Events and ...

NEW YORK, Feb. 14, 2025 (GLOBE NEWSWIRE) -- February 14, 2025 – IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, yesterday presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii. The data, previously announced, reinforce INB-100’s potential to significantly reduce post-transplant relapse in high-risk acute myeloid leukemia (AML) patients, p ...

IN8bio (INAB) Update / Briefing February 11, 2025 04:08 PM ET Company Participants Glenn Schulman - Vice President, Head of Investor Relations & Corporate CommunicationsWilliam Ho - Director, President, CEO, and Co-FounderLou Vaickus - Interim CMOMichael R. Bishop - Director of the David and Etta Jonas Center for Cellular Therapy Conference Call Participants None - AnalystRamakanth Swayampakula - Managing Director & Senior Research AnalystSoumit Roy - Biotech Research Analyst Operator Good day, ladies and g ...