IN8bio(US:INAB)2025-03-13 20:10Part I Business 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 platform1718 - 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 trials19 - 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 program2378 - 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 date2627 Our Pipeline and Strategy 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 202529 - Explore partnership opportunities for other candidates, including INB-400 for newly diagnosed GBM, for which Phase 2 enrollment was paused in September 202429 - Advance preclinical programs INB-300 (nsCAR), INB-500 (iPSC), and INB-600 (TCE) into clinical development, subject to additional funding or partnerships2930 - Continue to scale manufacturing capabilities, leveraging an automated, closed-system platform and collaborations with institutions like UAB and the University of Louisville32 Our Product Candidates 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 vitro115122 - 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 diseases24125 Intellectual Property 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 worldwide32147 - Patents and applications for INB-100 cover methods of HSCT and are expected to expire in 2036 and 2044150151 - 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)152153154 - 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 agreements164 Government Regulation 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 trials167168172 - The FDA offers expedited development programs such as Fast Track, Breakthrough Therapy, Accelerated Approval, and RMAT designation for qualifying product candidates intended for serious conditions177178182 - 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 penalties197198204 - 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 profitability213215 Risk Factors 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 programs229231 - 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 uncertain229267273 - The manufacturing process for cell therapies is complex and susceptible to product loss, contamination, and failure, which could delay clinical trials and commercialization230312 - 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 objectives230394 Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None486 Cybersecurity 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 processes492 - 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 functions488494 - The company employs various measures to manage cybersecurity risks, including risk assessments, encryption, network security controls, employee training, and penetration testing489 Properties 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, 2027499 - Leases approximately 18,000 sq. ft. of lab and office space in Birmingham, AL, expiring October 31, 2029, with a five-year extension option499 Legal Proceedings 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 proceedings500 Mine Safety Disclosures This item is not applicable to the company - Not applicable501 Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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, 2021504 - As of March 10, 2025, there were approximately 41 stockholders of record505 - The company has never paid cash dividends and does not plan to in the foreseeable future506 Management's Discussion and Analysis of Financial Condition and Results of Operations 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 concern521 - 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 million519537 - 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, 2024515544562 Quantitative and Qualitative Disclosures About Market Risk 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 information578 Financial Statements and Supplementary Data 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 operations586 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None697 Controls and Procedures 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, 2024698 - Management concluded that internal control over financial reporting was effective as of December 31, 2024700 - The report does not include an auditor's attestation on internal control over financial reporting, as permitted for emerging growth companies under the JOBS Act700 Other Information The company reports no other information for this item - None704 Part III Directors, Executive Officers and Corporate Governance 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 Statement708 Executive Compensation 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 Statement710 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 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 Statement711 Certain Relationships and Related Transactions, and Director Independence 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 Statement712 Principal Accountant Fees and Services 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 Statement713 Part IV Exhibits and Financial Statement Schedules 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-K716718 Form 10-K Summary The company reports no Form 10-K summary - None727