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].

Core Insights - IN8bio, Inc. is advancing innovative gamma-delta T cell therapies for cancer patients, focusing on unmet medical needs and aiming for "Cancer Zero" [2] - The company reported significant clinical progress, particularly with its INB-100 and INB-600 platforms, showcasing promising data in treating various cancers [5][6] Financial Highlights - For Q1 2025, IN8bio reported a net loss of $5.6 million, or $0.07 per share, an improvement from a net loss of $8.6 million, or $0.20 per share, in Q1 2024 [17][21] - Research and Development (R&D) expenses decreased to $3.0 million from $4.9 million year-over-year, while General and Administrative (G&A) expenses fell to $2.7 million from $3.7 million [14][21] - As of March 31, 2025, the company had cash of $11.9 million, down from $13.0 million a year earlier [17] Clinical Developments - INB-100 demonstrated a 100% relapse-free rate in treated Acute Myeloid Leukemia (AML) patients with a median follow-up of 20.1 months [5][6] - The INB-600 platform showed strong preclinical data, indicating potential applications in both oncology and autoimmune diseases, with lead candidates targeting CD19 and CD33 [6][12] Upcoming Milestones - IN8bio plans to present updated clinical data for INB-200 at the ASCO 2025 Annual Meeting on May 30, 2025 [9] - The company will also present at the ISCT 2025 Annual Meeting and the ASGCT 2025 Annual Meeting, highlighting advancements in gamma-delta T cell therapies [10][12] Corporate Strategy - IN8bio is focused on expanding its pipeline with the INB-600 gamma-delta T cell engager platform, which aims to enhance immune surveillance and reduce safety risks associated with conventional therapies [2][3] - The company is committed to operational execution and achieving meaningful data milestones to support its clinical programs [5][6]

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]

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 ...