UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO (State or other jurisdiction of incorporation or organization) 350 5th Avenue, Suite 5330 New York, New York 10118 (Address of principal executive offices) (Zip ...

Financial Performance - IN8bio reported a net loss of $30.0 million, or $1.00 per basic and diluted common share, for the year ended December 31, 2023, compared to a net loss of $28.5 million, or $1.36 per basic and diluted common share, for the prior year[14]. - The total operating expenses for the year ended December 31, 2023, were $30.3 million, compared to $28.5 million in the prior year[14]. - As of December 31, 2023, IN8bio had cash of $21.3 million, an increase from $18.2 million as of December 31, 2022[6]. Research and Development - Research and Development (R&D) expenses increased to $16.8 million for the year ended December 31, 2023, from $14.1 million in the prior year, primarily due to increased personnel-related costs and clinical trial activities[6]. - IN8bio plans to submit an investigational new drug (IND) application for a Phase 3 randomized control trial in 2024 for INB-100[5]. - INB-200 demonstrated that all patients treated exceeded a median progression-free survival (PFS) of seven months, surpassing the standard-of-care median PFS of four to seven months[5]. - The company achieved 100% remission in evaluable patients (n=10) treated with INB-100 in leukemia, with all patients remaining alive and progression-free past 12 months[3]. Administrative Expenses - General and Administrative (G&A) expenses decreased to $13.5 million for the year ended December 31, 2023, from $14.5 million in the prior year, attributed to cost savings in D&O insurance premiums and professional services[6]. Capital and Funding - IN8bio secured initial gross proceeds of $14.4 million from a private placement in December 2023, extending its cash runway into Q1 2025, with potential for up to $32.5 million in additional capital[3]. Leadership Changes - The company appointed Dr. Corinne Epperly to the Board of Directors, enhancing its leadership in immuno-oncology and cell therapy[3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 82-5462585 | | --- | --- | | (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and ...

PART I FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents the unaudited condensed financial statements for IN8bio, Inc., including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's organization, accounting policies, and specific financial line items for the period ended March 31, 2023 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheets (in thousands) | Metric | March 31, 2023 (unaudited) (in thousands) | December 31, 2022 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Cash | $10,860 | $18,182 | | Total Current Assets | $14,402 | $22,234 | | Total Assets | $24,678 | $33,039 | | Total Current Liabilities | $3,748 | $5,822 | | Total Liabilities | $7,890 | $10,307 | | Total Stockholders' Equity | $16,788 | $22,732 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Condensed Statements of Operations | Operating Expense | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Research and development | $4,385 | $2,381 | | General and administrative | $3,470 | $3,764 | | Total operating expenses | $7,855 | $6,145 | | Other income | $330 | $— | | Net loss | $(7,525) | $(6,145) | | Net loss per share – basic and diluted | $(0.30) | $(0.33) | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%20Equity) Condensed Statements of Stockholders' Equity | Metric | Balance at December 31, 2022 (in thousands) | Balance at March 31, 2023 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------ | | Common Stock (Shares) | 24,545,157 | 24,960,869 | | Additional Paid-In Capital (in thousands) | $83,941 | $85,522 | | Accumulated Deficit (in thousands) | $(61,212) | $(68,737) | | Total Stockholders' Equity (in thousands) | $22,732 | $16,788 | | Net loss (3 months ended March 31, 2023) (in thousands) | N/A | $(7,525) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(7,439) | $(4,559) | | Net cash used in investing activities | $(429) | $(253) | | Net cash provided by (used in) financing activities | $547 | $(102) | | Net decrease in cash and restricted cash | $(7,321) | $(4,914) | | Cash and restricted cash at end of period | $11,113 | $32,358 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) [1. Organization and Nature of Operations](index=7&type=section&id=1.%20ORGANIZATION%20AND%20NATURE%20OF%20OPERATIONS) - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on gamma-delta T cell product candidates for solid and liquid tumors, with lead candidates INB-200 (glioblastoma), INB-100 (hematologic malignancies), and INB-400 (glioblastoma) in clinical trials[20](index=20&type=chunk) - The Company has incurred recurring losses and negative operating cash flows since inception, with net losses of **$7.5 million** and **$6.1 million** for the three months ended March 31, 2023 and 2022, respectively, and an accumulated deficit of **$68.7 million** as of March 31, 2023[22](index=22&type=chunk) - Existing cash of **$10.9 million** as of March 31, 2023, plus **$9.9 million** net proceeds from ATM sales post-quarter, are not sufficient to fund operations beyond February 2024, raising substantial doubt about the Company's ability to continue as a going concern[25](index=25&type=chunk)[26](index=26&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The condensed financial statements are prepared in conformity with U.S. GAAP, with no material changes to significant accounting policies since the December 31, 2022 Annual Report[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - Estimates and assumptions are used for accruals of R&D expenses, deferred tax assets/liabilities, stock-based compensation, and useful lives of property and equipment[30](index=30&type=chunk) [3. Prepaid Expenses and Other Current Assets](index=9&type=section&id=3.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) Prepaid Expenses and Other Current Assets (in thousands) | Prepaid Expense | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :------------------------ | :------------------------------ | :------------------------------- | | Prepaid research and development | $2,225 | $2,562 | | Prepaid insurance | $716 | $1,258 | | Other | $601 | $232 | | Total prepaid expenses and other current assets | $3,542 | $4,052 | [4. Property and Equipment, Net](index=9&type=section&id=4.%20PROPERTY%20AND%20EQUIPMENT,%20NET) Property and Equipment, Net (in thousands) | Asset Category | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :----------------------- | :------------------------------ | :------------------------------- | | Machinery and equipment | $364 | $358 | | Furniture and fixtures | $370 | $335 | | Software | $126 | $126 | | Leasehold improvements | $3,902 | $3,899 | | Less accumulated depreciation and amortization | $(564) | $(321) | | Property and equipment, net | $4,198 | $4,397 | | Depreciation and amortization expense (3 months) | $243 | $16 | [5. Construction in Progress](index=9&type=section&id=5.%20CONSTRUCTION%20IN%20PROGRESS) Construction in Progress (in thousands) | Category | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :------------------------------ | :------------------------------- | | Furniture | $— | $29 | | Internal use software not yet in service | $45 | $— | | Total construction in progress | $45 | $29 | [6. Accrued Expenses and Other Current Liabilities](index=10&type=section&id=6.%20ACCURRED%20EXPENSES%20AND%20OTHER%20CURRENT%20LIABILITIES) Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expense | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :------------------------------ | :------------------------------- | | Accrued clinical trials | $559 | $253 | | Accrued compensation | $422 | $1,460 | | Accrued legal | $104 | $211 | | Accrued other | $407 | $418 | | Total accrued expenses and other current liabilities | $1,492 | $2,342 | [7. Stockholders' Equity](index=10&type=section&id=7.%20STOCKHOLDERS%20EQUITY) - The Company's authorized capital stock consists of **500 million** shares ($0.0001 par value), with **490 million** designated as common stock and **10 million** as preferred stock. No preferred stock was outstanding as of March 31, 2023, and December 31, 2022[39](index=39&type=chunk) [8. Stock-Based Compensation](index=10&type=section&id=8.%20STOCK-BASED%20COMPENSATION) - The 2020 Equity Incentive Plan, effective July 29, 2021, initially reserved **4.2 million** shares, with an automatic annual increase. As of March 31, 2023, **2.355 million** shares were available for grant[41](index=41&type=chunk) Stock Option Activity | Stock Option Activity | Outstanding at Dec 31, 2022 | Granted | Forfeited | Outstanding at Mar 31, 2023 | | :-------------------------------- | :-------------------------- | :-------- | :-------- | :-------------------------- | | Number of Stock Options | 4,003,294 | 20,750 | (169,040) | 3,855,004 | | Weighted Average Exercise Price | $4.90 | $2.00 | $2.27 | $5.00 | | Weighted Average Remaining Contractual Term (years) | 8.28 | N/A | N/A | 8.39 | | Aggregate Intrinsic Value (in thousands) | $860 | N/A | N/A | $51 | Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :---------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Research and development | $389 | $294 | | General and administrative | $470 | $470 | | Total stock-based compensation expense | $859 | $764 | [9. License Agreements](index=12&type=section&id=9.%20LICENSE%20AGREEMENTS) - The Company holds an exclusive worldwide license from Emory University, Children's Healthcare of Atlanta, Inc., and UAB Research Foundation (Emory License Agreement) for immunotherapy-related patents and know-how for gamma-delta T cells, requiring development milestones, tiered running royalties, and annual maintenance fees[47](index=47&type=chunk)[48](index=48&type=chunk) - An exclusive worldwide license from UABRF (UABRF License Agreement) covers immunotherapy-related patents for gamma-delta T cells, CAR-T cells, and combination treatments, with consideration including an upfront payment, common stock issuance, development milestones, and various royalties[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) [10. Net Loss Per Share](index=13&type=section&id=10.%20NET%20LOSS%20PER%20SHARE) Net Loss Per Share | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :---------------------------------------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss (in thousands) | $(7,525) | $(6,145) | | Net loss per share—basic and diluted | $(0.30) | $(0.33) | | Weighted-average number of shares used in computing net loss per share—basic and diluted | 24,732,580 | 18,800,546 | - Potentially dilutive securities (stock options) were excluded from diluted net loss per share calculation as their effect was antidilutive due to the Company's net loss[55](index=55&type=chunk)[56](index=56&type=chunk) [11. Commitments and Contingencies](index=13&type=section&id=11.%20COMMITMENTS%20AND%20CONTINGENCIES) - The Company has commitments to intellectual property licensors based on clinical, regulatory, financial, and sales milestones, including single-digit royalties on commercial sales under the Emory and UABRF License Agreements[57](index=57&type=chunk) - The Company is not currently party to any material legal proceedings[58](index=58&type=chunk) [12. Facility Leases](index=13&type=section&id=12.%20FACILITY%20LEASES) Lease Cost (in thousands) | Lease Cost | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :---------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Amortization of finance right-of-use assets | $188 | $149 | | Interest on finance lease liabilities | $33 | $14 | | Operating lease cost | $288 | $112 | | Short-term lease cost | $116 | $105 | | Total lease cost | $625 | $380 | Undiscounted Cash Flows (in thousands) | Undiscounted Cash Flows | Finance Leases (in thousands) | Operating Leases (in thousands) | | :------------------------------------- | :---------------------------- | :------------------------------ | | Remainder of 2023 | $581 | $891 | | 2024 | $566 | $1,212 | | 2025 | $302 | $1,224 | | 2026 | $— | $1,013 | | 2027 | $— | $767 | | Thereafter | $— | $422 | | Total lease payment | $1,449 | $5,529 | | Total lease liabilities | $1,318 | $4,210 | [13. Subsequent Events](index=15&type=section&id=13.%20SUBSEQUENT%20EVENTS) - Subsequent to March 31, 2023, the Company sold **4,789,479** shares of common stock under its ATM program, generating approximately **$9.9 million** in net proceeds[69](index=69&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results for the three months ended March 31, 2023, highlighting its clinical-stage biopharmaceutical focus, financial performance, liquidity challenges, and critical accounting estimates [Overview](index=16&type=section&id=Overview) - IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell product candidates for solid and liquid tumors, utilizing its DeltEx platform for allogeneic, autologous, iPSC, and genetically modified cell therapy approaches[73](index=73&type=chunk) - The company plans to initiate a Phase 2 clinical trial for INB-400 (newly diagnosed GBM) in H2 2023, continue Phase 1 trials for INB-200 (GBM) and INB-100 (hematologic malignancies), and submit an IND for INB-410 (allogeneic GBM) in late 2023 with additional funding[74](index=74&type=chunk) - Due to recurring operating losses and no product sales, the company's existing cash and recent ATM proceeds are insufficient to fund operations beyond February 2024, indicating substantial doubt about its ability to continue as a going concern[77](index=77&type=chunk)[78](index=78&type=chunk) [Other First Quarter Business and Clinical Highlights](index=17&type=section&id=Other%20First%20Quarter%20Business%20and%20Clinical%20Highlights) - New preclinical data in ovarian cancer from the INB-400 program will be presented at the ASGCT 26th Annual Meeting, demonstrating gamma-delta T cells' potential to target solid tumor cells outside the brain[82](index=82&type=chunk) - INB-400 (autologous) and INB-410 (allogeneic) received FDA Orphan Drug Designation for malignant gliomas, including newly diagnosed GBM, granting potential seven-year market exclusivity[82](index=82&type=chunk) - Positive INB-100 Phase 1 data showed durable complete responses (CRs) in **100%** of evaluable patients with high-risk leukemias, including those who failed prior therapies, with all patients remaining alive at last assessment[83](index=83&type=chunk) [Components of Our Results of Operations](index=18&type=section&id=Components%20of%20Our%20Results%20of%20Operations) - The Company has not generated any revenue from product sales since inception and does not expect to in the foreseeable future, relying on equity sales and potential collaboration/license agreements for future revenue[85](index=85&type=chunk)[77](index=77&type=chunk) - Research and development expenses, expensed as incurred, primarily cover employee-related costs, consultant fees, preclinical studies, CRO/CMO expenses, intellectual property, and regulatory compliance, and are expected to increase with clinical development[86](index=86&type=chunk)[88](index=88&type=chunk) - General and administrative expenses, including salaries, professional fees, and public company costs, are expected to increase with organizational growth and continued R&D activities[89](index=89&type=chunk)[90](index=90&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating Expenses and Net Loss (in thousands) | Operating Expense | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Change (in thousands) | | :------------------------ | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | | Research and development | $4,385 | $2,381 | $2,004 | | General and administrative | $3,470 | $3,764 | $(294) | | Total operating expenses | $7,855 | $6,145 | $1,710 | | Other income | $330 | $— | $330 | | Loss from operations | $(7,525) | $(6,145) | $(1,380) | | Net loss | $(7,525) | $(6,145) | $(1,380) | Research and Development Expenses by Category (in thousands) | R&D Expense Category | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Change (in thousands) | | :------------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | | INB-100 | $86 | $34 | $52 | | INB-200 | $60 | $364 | $(304) | | INB-400 | $1,135 | $144 | $991 | | Personnel expenses (incl. stock-based comp) | $2,026 | $1,152 | $874 | | Facility-related and other | $1,044 | $675 | $369 | | Total research and development expenses | $4,385 | $2,381 | $2,004 | - General and administrative expenses decreased by **$0.3 million** to **$3.5 million** for Q1 2023, primarily due to lower insurance, accounting, and recruiting costs[96](index=96&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2023, the Company had **$10.9 million** in cash. Subsequent to this date, an additional **$9.9 million** in net proceeds was raised through the ATM program[99](index=99&type=chunk) - The Company's current cash and subsequent ATM proceeds are projected to fund operations only until **February 2024**, leading to substantial doubt about its ability to continue as a going concern[99](index=99&type=chunk)[101](index=101&type=chunk) - Future funding requirements are substantial and depend on factors like clinical trial progress, regulatory approvals, manufacturing costs, intellectual property maintenance, and commercialization efforts[104](index=104&type=chunk)[105](index=105&type=chunk) [Cash Flows](index=23&type=section&id=Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(7,439) | $(4,559) | | Net cash used in investing activities | $(429) | $(253) | | Net cash provided by (used in) financing activities | $547 | $(102) | | Net decrease in cash | $(7,321) | $(4,914) | - Net cash used in operating activities increased to **$7.4 million** in Q1 2023 (from **$4.6 million** in Q1 2022), primarily due to a higher net loss and changes in operating assets and liabilities, partially offset by non-cash charges[114](index=114&type=chunk)[115](index=115&type=chunk) - Net cash used in investing activities increased to **$0.4 million** in Q1 2023 (from **$0.3 million** in Q1 2022), mainly due to increased construction-in-progress for leasehold improvements[116](index=116&type=chunk)[117](index=117&type=chunk) - Net cash provided by financing activities was **$0.5 million** in Q1 2023, driven by **$0.7 million** from common stock issuance via ATM, offset by **$0.2 million** in finance lease principal payments[118](index=118&type=chunk) [Critical Accounting Estimates](index=23&type=section&id=Critical%20Accounting%20Estimates) - Critical accounting estimates include the accrual of research and development expenses, which are estimated based on task completion and vendor information, and stock-based compensation, valued using the Black-Scholes option-pricing model with subjective assumptions[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) [Recent Accounting Pronouncements](index=24&type=section&id=Recent%20Accounting%20Pronouncements) - No new accounting guidance adopted during Q1 2023 or pending guidance is expected to have a material impact on the financial statements or disclosures[124](index=124&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=24&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) - The Company qualifies as an Emerging Growth Company (EGC) under the JOBS Act, allowing reduced disclosure requirements and an extended transition period for new accounting standards until **December 31, 2026**, or earlier if certain revenue/market value thresholds are met[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - The Company is also a 'smaller reporting company,' which provides additional exemptions, such as presenting only two fiscal years of audited financial statements and reduced executive compensation disclosures[128](index=128&type=chunk)[129](index=129&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, IN8bio, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2023, concluding they were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - As of **March 31, 2023**, the Company's disclosure controls and procedures were evaluated by management, including the CEO and CFO, and concluded to be effective at the reasonable assurance level[133](index=133&type=chunk) - There were no changes in internal control over financial reporting during the three months ended **March 31, 2023**, that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[134](index=134&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently involved in any material legal proceedings that are expected to have a significant adverse effect on its business, operating results, or financial condition - The Company is not currently a party to any material legal proceedings that are believed to have a material adverse effect on its business, operating results, or financial condition[137](index=137&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks associated with investing in IN8bio's common stock, covering financial viability, product development, manufacturing, intellectual property, business operations, commercialization, regulatory compliance, and stock ownership [Summary of Selected Risk Factors Associated with Our Business](index=27&type=section&id=Summary%20of%20Selected%20Risk%20Factors%20Associated%20with%20Our%20Business) - There is substantial doubt about the Company's ability to continue as a going concern, requiring significant additional funding, which if not secured, could lead to delays, reductions, or termination of development programs[139](index=139&type=chunk) - The Company faces significant competition from companies with greater resources and experience, and its novel cell therapy approaches present substantial development, manufacturing, and commercialization challenges[139](index=139&type=chunk) - Dependence on successful clinical development, regulatory approval, and commercialization of gamma-delta T cell product candidates is critical, with risks including uncertain clinical utility, complex manufacturing, and reliance on third parties[139](index=139&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=28&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) - The Company's existing cash and recent ATM proceeds are insufficient to fund operations beyond **February 2024**, creating substantial doubt about its going concern ability and necessitating further capital raises[141](index=141&type=chunk) - Raising additional capital through equity or convertible debt may dilute existing stockholders and impose restrictive covenants, while collaborations might require relinquishing valuable intellectual property rights[144](index=144&type=chunk)[145](index=145&type=chunk) - The Company has incurred significant operating losses since inception (**$68.7 million** accumulated deficit as of **March 31, 2023**) and expects continued losses, with no guarantee of achieving or maintaining profitability[149](index=149&type=chunk) [Risks Related to the Development of Our Product Candidates](index=31&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) - The business is highly dependent on the successful clinical development, regulatory approval, and commercialization of its gamma-delta T cell product candidates (INB-200, INB-100, INB-400), which are in early stages and may never receive approval[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - Success in preclinical studies or early-stage clinical trials does not guarantee similar results in later, larger trials, and product candidates may fail to demonstrate desired safety and efficacy, leading to delays or abandonment[165](index=165&type=chunk)[166](index=166&type=chunk) - Difficulties in patient enrollment for clinical trials, especially for rare disorders or elderly populations, could delay or adversely affect clinical development activities[191](index=191&type=chunk)[192](index=192&type=chunk) - Serious adverse events or unexpected side effects identified during development or post-approval could lead to discontinuation of programs, denial of regulatory approval, or market withdrawal, limiting commercial potential[194](index=194&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk) [Risks Related to Manufacturing and Our Dependence on Third Parties](index=41&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Our%20Dependence%20on%20Third%20Parties) - The manufacturing process for genetically engineered human cells (INB-200, INB-300, INB-400) is complex, highly regulated, and susceptible to product loss, failure, or variation due to logistical issues, manufacturing errors, contamination, or inherent differences in donor materials[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) - The Company relies on third-party contractors and CMOs for manufacturing, which entails risks such as inability to meet specifications, procure capacity, comply with cGMP, or maintain quality control, potentially delaying regulatory approval or commercialization[220](index=220&type=chunk)[225](index=225&type=chunk) - Dependence on a single third-party supplier for automated manufacturing devices and lentiviral vectors poses a critical risk; any disruption could delay manufacturing and clinical trials[230](index=230&type=chunk) [Risks Related to Our Intellectual Property](index=45&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The Company's product candidates are critically dependent on exclusive license agreements with UABRF, CHOA, and Emory University; breaches could lead to termination of licenses and cessation of product development[248](index=248&type=chunk)[250](index=250&type=chunk) - Inability to obtain and maintain broad and robust patent protection for product candidates and technology could allow competitors to commercialize similar products, adversely affecting the Company's market position[254](index=254&type=chunk)[255](index=255&type=chunk)[259](index=259&type=chunk) - The Company faces risks of third parties alleging infringement, misappropriation, or violation of their intellectual property rights, which could lead to expensive litigation, licensing requirements, or forced cessation of development/commercialization[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk) - Reliance on third parties requires sharing trade secrets, increasing the risk of misappropriation or unauthorized disclosure, which could harm the Company's business and competitive position[283](index=283&type=chunk)[285](index=285&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=54&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) - The Company is highly dependent on its co-founders, President and CEO William Ho, and Chief Scientific Officer Dr. Lawrence Lamb; their loss or inability to attract and retain other qualified personnel could impede development and business strategy[291](index=291&type=chunk)[292](index=292&type=chunk) - Planned organizational expansion in R&D, manufacturing, and commercialization may be difficult to manage due to limited financial resources and management experience, potentially disrupting operations[294](index=294&type=chunk) - Compromises to information technology systems or sensitive data, whether internal or via third parties, could lead to significant disruptions, regulatory investigations, litigation, and reputational harm[297](index=297&type=chunk)[298](index=298&type=chunk)[301](index=301&type=chunk) [Risks Related to Commercialization and Regulatory Compliance](index=57&type=section&id=Risks%20Related%20to%20Commercialization%20and%20Regulatory%20Compliance) - Even with regulatory approvals, product candidates will face ongoing oversight, including manufacturing, labeling, and post-market requirements, and may be subject to restrictions or withdrawal if compliance failures or new problems arise[313](index=313&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and third-party payors, which is uncertain and may require significant resources to educate the medical community on the benefits of novel product candidates[320](index=320&type=chunk)[321](index=321&type=chunk) - Relationships with healthcare providers and payors are subject to federal and state healthcare fraud and abuse laws; non-compliance could result in substantial penalties, fines, and exclusion from government programs[329](index=329&type=chunk) - Coverage and adequate reimbursement for product candidates are uncertain, and healthcare legislative reforms (e.g., ACA, IRA) could negatively impact pricing, demand, and profitability[331](index=331&type=chunk)[333](index=333&type=chunk)[335](index=335&type=chunk) [Risks Related to the Ownership of Our Common Stock](index=64&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Our%20Common%20Stock) - The market price of the Company's common stock is volatile and can fluctuate substantially due to various factors, including clinical trial results, competitor actions, regulatory developments, and general economic conditions, potentially leading to investor losses[350](index=350&type=chunk)[351](index=351&type=chunk) - Concentrated ownership by executive officers, directors, and principal stockholders (**64%** of outstanding common stock as of **March 31, 2023**) may limit new investors' influence on significant corporate decisions and could delay or prevent acquisitions[353](index=353&type=chunk) - Provisions in corporate charter documents and Delaware law (Section 203 DGCL) could make an acquisition more difficult and may prevent stockholders from replacing current management, potentially depressing the stock price[354](index=354&type=chunk)[355](index=355&type=chunk) [General Risk Factors](index=67&type=section&id=General%20Risk%20Factors) - Unstable market and economic conditions, including recent bank closures, public health crises, and geopolitical tensions (e.g., Russia-Ukraine war), may have serious adverse consequences on the Company's business, financial condition, and share price[361](index=361&type=chunk) - The Company maintains cash deposits exceeding federally insured limits; adverse developments in the financial services industry could threaten liquidity and result in loss of uninsured deposits[362](index=362&type=chunk) - Operating as a public company incurs increased costs and requires substantial management time for compliance, and failure to maintain effective internal control over financial reporting could harm the business and stock price[364](index=364&type=chunk)[365](index=365&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered sales of equity securities and details the use of proceeds from the Company's initial public offering (IPO), with **$31.8 million** of the **$32.3 million** net proceeds utilized as of the report date - No unregistered sales of equity securities occurred during the period[369](index=369&type=chunk) - The Company completed its IPO on **August 3, 2021**, issuing **4 million** shares at **$10.00** per share, yielding **$32.3 million** in net proceeds. As of the report date, **$31.8 million** of these proceeds have been used, with no material change in the planned use[370](index=370&type=chunk)[372](index=372&type=chunk) [Item 3. Defaults Upon Senior Securities](index=69&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the Company for the reporting period - This item is not applicable[374](index=374&type=chunk) [Item 4. Mine Safety Disclosures](index=69&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company for the reporting period - This item is not applicable[375](index=375&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the Company for the reporting period - This item is not applicable[376](index=376&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=69&type=section&id=Item%206.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Form 10-Q, including corporate governance documents, certifications from executive officers, and XBRL interactive data files - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Rules 13a-14(a) and 18 U.S.C. Section 1350), and Inline XBRL Instance Document and Taxonomy Extension Documents[377](index=377&type=chunk)[378](index=378&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organizati ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-5462585 (State or other jurisdiction of in ...

PART I—FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for IN8bio, Inc., including the balance sheets, statements of operations, statements of stockholders' equity, and cash flows, along with accompanying notes for the period ended March 31, 2022 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) | Metric | March 31, 2022 (unaudited) (in thousands) | December 31, 2021 (Note 2) (in thousands) | | :-------------------------------- | :--------------------------------------- | :-------------------------------------- | | Cash | $32,107 | $37,021 | | Total Current Assets | $33,274 | $38,980 | | Total Assets | $36,538 | $42,223 | | Total Current Liabilities | $2,068 | $2,256 | | Total Liabilities | $3,703 | $4,040 | | Total Stockholders' Equity | $32,835 | $38,183 | - The company's cash decreased from **$37.021 million** at December 31, 2021, to **$32.107 million** at March 31, 2022. Total assets also decreased from **$42.223 million** to **$36.538 million** over the same period[10](index=10&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) | Operating Expenses (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $2,381 | $1,245 | | General and administrative | $3,764 | $1,118 | | Total operating expenses | $6,145 | $2,363 | | Loss from operations | $(6,145) | $(2,363) | | Net loss | $(6,145) | $(2,363) | | Net loss attributable to common stockholders | $(6,145) | $(3,069) | | Net loss per share – basic and diluted | $(0.33) | $(0.82) | | Weighted-average shares outstanding | 18,800,546 | 3,764,488 | - The net loss for the three months ended March 31, 2022, significantly increased to **$6.145 million** from **$2.363 million** in the prior year period. This was driven by substantial increases in both research and development expenses (from **$1.245 million** to **$2.381 million**) and general and administrative expenses (from **$1.118 million** to **$3.764 million**)[13](index=13&type=chunk) [Condensed Statements of Convertible Preferred Stock, Common Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock,%20Common%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) | Equity Component (in thousands) | Balance at Dec 31, 2021 | Stock Option Exercises | Stock-Based Compensation Expense | Net Loss | Balance at Mar 31, 2022 | | :------------------------------ | :---------------------- | :--------------------- | :------------------------------- | :------- | :---------------------- | | Common Stock (Shares) | 18,781,242 | 31,025 | — | — | 18,812,267 | | Common Stock (Amount) | $2 | $0 | $0 | $0 | $2 | | Additional Paid-In Capital | $70,872 | $33 | $764 | $0 | $71,669 | | Accumulated Deficit | $(32,691) | $0 | $0 | $(6,145) | $(38,836) | | Total Stockholders' Equity | $38,183 | $33 | $764 | $(6,145) | $32,835 | - Total stockholders' equity decreased from **$38.183 million** at December 31, 2021, to **$32.835 million** at March 31, 2022, primarily due to a net loss of **$6.145 million**, partially offset by stock-based compensation expense and stock option exercises[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,559) | $(2,507) | | Net cash used in investing activities | $(253) | $0 | | Net cash used in financing activities | $(102) | $(435) | | Net decrease in cash and restricted cash | $(4,914) | $(2,942) | | Cash and restricted cash at end of period | $32,358 | $15,052 | - Net cash used in operating activities increased to **$4.559 million** for the three months ended March 31, 2022, from **$2.507 million** in the prior year, primarily driven by the increased net loss. Investing activities used **$0.253 million** in 2022, compared to none in 2021, mainly for construction in progress[18](index=18&type=chunk)[102](index=102&type=chunk)[104](index=104&type=chunk) [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on gamma-delta T cell therapies for cancer, with lead candidates INB-200 (glioblastoma) and INB-100 (leukemia) in Phase 1 clinical trials. The company completed its IPO in August 2021, raising **$32.3 million** net proceeds[21](index=21&type=chunk)[24](index=24&type=chunk) - The company has incurred recurring losses and negative operating cash flows since inception, with an accumulated deficit of **$38.8 million** as of March 31, 2022. Management believes existing cash of **$32.1 million** is sufficient for at least 12 months[25](index=25&type=chunk)[26](index=26&type=chunk) - Stock-based compensation expense was **$764,000** for the three months ended March 31, 2022, up from **$361,000** in the prior year, allocated to research and development (**$294,000**) and general and administrative (**$470,000**)[45](index=45&type=chunk) - The company holds exclusive worldwide licenses under agreements with Emory University, Children's Healthcare of Atlanta, Inc., and UAB Research Foundation for immunotherapy-related patents and know-how concerning gamma-delta T cells[46](index=46&type=chunk)[50](index=50&type=chunk) Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2022 | December 31, 2021 | | :-------------------------------- | :------------- | :---------------- | | Accrued clinical trials | $206 | $196 | | Accrued compensation | $318 | $926 | | Accrued other | $360 | $113 | | Total | $884 | $1,235 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2022, highlighting business overview, recent developments, financial performance, liquidity, and critical accounting estimates [Overview](index=15&type=section&id=Overview) - IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell therapies for cancer, utilizing its DeltEx platform. Lead candidates INB-200 (glioblastoma) and INB-100 (leukemia) are in Phase 1 clinical trials[71](index=71&type=chunk)[72](index=72&type=chunk) - The company completed its IPO on August 3, 2021, raising **$32.3 million** in net proceeds. Since inception, it has funded operations primarily through equity sales, totaling **$75.6 million** gross proceeds through March 31, 2022[73](index=73&type=chunk)[74](index=74&type=chunk) - IN8bio has incurred significant operating losses, with net losses of **$6.1 million** and **$2.4 million** for the three months ended March 31, 2022 and 2021, respectively, and an accumulated deficit of **$38.8 million** as of March 31, 2022[75](index=75&type=chunk) [Other First Quarter Business Highlights](index=16&type=section&id=Other%20First%20Quarter%20Business%20Highlights) - INB-200 Phase 1 clinical trial for newly diagnosed GBM showed no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), or neurotoxicity in cohort 1 (n=3). Patients exceeded expected progression-free survival (PFS) based on age and MGMT status[77](index=77&type=chunk) - INB-100 Phase 1 clinical trial for leukemia patients undergoing HSCT showed all three treated patients remain in morphologic complete response (CR) with durable remissions (9-23 months). The safety profile was manageable with no DLTs, Grade 3+ GvHD, CRS, or neurotoxicity[77](index=77&type=chunk) - The company expanded its clinical and regulatory teams with the appointments of Urvashi Patel, Ph.D., as Vice President, Regulatory Affairs, and Stacey Bilinski as Vice President, Clinical Operations, bringing over 45 years of combined experience[77](index=77&type=chunk) [Impact of COVID-19](index=17&type=section&id=Impact%20of%20COVID-19) - The COVID-19 pandemic continues to impact clinical sites, startup activities for Phase 1/2 trials, third-party manufacturing, and logistics, potentially disrupting supply chains and material availability/cost[79](index=79&type=chunk) - The pandemic may affect the timing of regulatory approvals, clinical trial enrollment, availability of materials, and the company's ability to access capital, negatively impacting short-term and long-term liquidity[79](index=79&type=chunk) [Components of Our Results of Operations](index=17&type=section&id=Components%20of%20Our%20Results%20of%20Operations) - The company has not generated any revenue since inception and does not expect to in the foreseeable future. Future revenue depends on successful product development, regulatory approval, or collaboration/license agreements[80](index=80&type=chunk) - Research and development expenses include employee-related costs, consultant fees, preclinical study expenses, CRO/CMO fees, intellectual property costs, and regulatory compliance. These costs are expensed as incurred and are expected to increase as product candidates advance[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - General and administrative expenses cover salaries, stock-based compensation, professional fees (legal, accounting), travel, and facility costs. These are expected to increase with organizational growth and public company operating costs[84](index=84&type=chunk)[85](index=85&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) | Operating Expenses (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $2,381 | $1,245 | $1,136 | | General and administrative | $3,764 | $1,118 | $2,646 | | Total operating expenses | $6,145 | $2,363 | $3,782 | | Net loss | $(6,145) | $(2,363) | $(3,782) | - Research and development expenses increased by **$1.136 million**, primarily due to increased third-party clinical trial activities and contract manufacturing for INB-200, and higher personnel costs from increased headcount[89](index=89&type=chunk) - General and administrative expenses increased by **$2.646 million**, mainly due to higher personnel costs (salaries, benefits, stock-based compensation) from increased headcount, and increased legal and insurance expenses associated with operating as a public company[90](index=90&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2022, the company had **$32.1 million** in cash and believes this is sufficient to fund operating expenses and capital expenditure requirements for at least the next 12 months[91](index=91&type=chunk) - Future capital requirements are substantial and depend on factors like the scope and timing of preclinical and clinical trials, regulatory review, manufacturing costs, commercialization activities, intellectual property maintenance, and strategic collaborations[94](index=94&type=chunk)[97](index=97&type=chunk) Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,559) | $(2,507) | | Net cash used in investing activities | $(253) | $0 | | Net cash used in financing activities | $(102) | $(435) | | Net decrease in cash | $(4,914) | $(2,942) | - Cash used in operating activities increased to **$4.6 million** in Q1 2022 (from **$2.5 million** in Q1 2021) due to higher net loss and decreases in accrued expenses. Cash used in investing activities was **$0.3 million** in Q1 2022 for construction in progress[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) [Critical Accounting Estimates](index=21&type=section&id=Critical%20Accounting%20Estimates) - The company's critical accounting estimates include research and development costs and stock-based compensation. R&D costs are expensed as incurred, with estimates made for accrued expenses based on vendor progress[109](index=109&type=chunk)[110](index=110&type=chunk) - Stock-based compensation is expensed based on grant date fair values, estimated using the Black-Scholes option-pricing model. Key assumptions include expected volatility (based on comparable public companies), expected life (simplified method), risk-free interest rate, and zero dividend rate[111](index=111&type=chunk) [Recent Accounting Pronouncements](index=23&type=section&id=Recent%20Accounting%20Pronouncements) - The company evaluated ASU 2019-12, Income Taxes (Topic 740), effective for fiscal years beginning after December 15, 2021, and determined it does not have a material impact on its condensed financial statements[32](index=32&type=chunk)[113](index=113&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=23&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) - IN8bio qualifies as an Emerging Growth Company (EGC) and a Smaller Reporting Company, allowing it to take advantage of reduced disclosure and other requirements, including an extended transition period for complying with new accounting standards[114](index=114&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, IN8bio, Inc. is exempt from providing quantitative and qualitative disclosures about market risk as per Item 10 of Regulation S-K - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2022, concluding they were effective at a reasonable assurance level - As of March 31, 2022, the company's disclosure controls and procedures were evaluated by management, including the CEO and CFO, and concluded to be effective at the reasonable assurance level[122](index=122&type=chunk) - Due to a transition period for newly public companies, management is not required to evaluate the effectiveness of internal control over financial reporting until after the filing of the Annual Report on Form 10-K for the year ending December 31, 2022[123](index=123&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) IN8bio, Inc. is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition - The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could have a material adverse effect on its business[126](index=126&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) This section outlines the significant risks associated with investing in IN8bio's common stock, covering financial position, product development, manufacturing, intellectual property, business operations, commercialization, regulatory compliance, and stock ownership [Summary of Selected Risk Factors Associated with Our Business](index=25&type=section&id=Summary%20of%20Selected%20Risk%20Factors%20Associated%20with%20Our%20Business) - The company requires substantial additional funding and may face delays or termination of development programs if capital is unavailable[128](index=128&type=chunk) - Significant operating losses have been incurred since inception, with expectations of continued losses and uncertainty in achieving profitability[128](index=128&type=chunk) - The business is dependent on the successful clinical development, regulatory approval, and commercialization of its gamma-delta T cell product candidates, which utilize novel and complex approaches[128](index=128&type=chunk) - The ongoing COVID-19 pandemic and geopolitical tensions could adversely impact clinical trials, supply chains, and business development activities[128](index=128&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=26&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) - Developing pharmaceutical products is expensive and time-consuming; the company will need substantial additional funding for ongoing operations and planned research and clinical development activities[129](index=129&type=chunk) - The company has incurred significant operating losses (**$6.1 million** in Q1 2022) and an accumulated deficit of **$38.8 million**, expecting increased expenses as product candidates advance through clinical trials and commercialization[133](index=133&type=chunk)[75](index=75&type=chunk) - As an early clinical-stage biotechnology company with a limited operating history and no approved products, evaluating future success and viability is difficult, and unforeseen expenses or delays may occur[139](index=139&type=chunk) [Risks Related to the Development of Our Product Candidates](index=28&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) - The business relies on successful clinical development, regulatory approval, and commercialization of gamma-delta T cell product candidates (INB-200, INB-100), which are in early stages and may never be commercialized[141](index=141&type=chunk) - Success in preclinical studies or early-stage clinical trials does not guarantee success in later trials, and product candidates may fail to demonstrate desired safety and efficacy[149](index=149&type=chunk) - Interim or preliminary clinical trial data may change as more patient data become available and are subject to audit, potentially leading to material differences in final data[153](index=153&type=chunk) - Novel approaches to cell therapies, including genetic modification and allogeneic gamma-delta T cells, present significant development, manufacturing, and commercialization challenges, such as variability in donor cells and immune reactions[155](index=155&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - The ongoing COVID-19 pandemic has impacted and may continue to impact clinical trials through delays in enrollment, supply chain disruptions, and diversion of healthcare resources, potentially affecting business operations and financial condition[184](index=184&type=chunk)[185](index=185&type=chunk) [Risks Related to Manufacturing and Our Dependence on Third Parties](index=38&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Our%20Dependence%20on%20Third%20Parties) - The manufacturing process for genetically engineered human cells (e.g., INB-200) is complex, highly regulated, and susceptible to product loss or failure due to logistical issues, manufacturing errors, contamination, or variability in starting materials[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) - The company relies on third-party contractors for manufacturing product candidates and lentiviral vectors, posing risks related to compliance with cGMP, quality control, and potential supply disruptions if contractors fail to perform adequately[213](index=213&type=chunk)[214](index=214&type=chunk)[223](index=223&type=chunk) - Damage or loss to storage freezers for biologic specimens and clinical lentivectors at research facilities could cause significant delays and expenses[222](index=222&type=chunk) - Reliance on third-party healthcare professionals to administer gamma-delta T cells introduces risks of incorrect administration, diminished therapeutic effect, or patient injury, potentially harming the company's reputation and business[224](index=224&type=chunk)[225](index=225&type=chunk) [Risks Related to Our Intellectual Property](index=45&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's business is critically dependent on exclusive license agreements with UABRF, CHOA, and Emory University for immunotherapy-related patents and know-how. Breach of these agreements could lead to loss of intellectual property rights and termination of product development[240](index=240&type=chunk)[241](index=241&type=chunk)[244](index=244&type=chunk) - Obtaining and maintaining patent protection for product candidates and technology is uncertain, expensive, and complex. Issued patents may not provide meaningful protection, and competitors could circumvent them[247](index=247&type=chunk)[248](index=248&type=chunk)[252](index=252&type=chunk) - Third parties may allege infringement of their intellectual property rights, leading to costly litigation, potential licensing fees, or forced cessation of development/commercialization. Such claims could negatively impact business success[259](index=259&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) - Reliance on third parties requires sharing trade secrets, increasing the risk of misappropriation or unauthorized disclosure, which could harm the company's competitive position[277](index=277&type=chunk)[280](index=280&type=chunk) [Risks Related to Our Business Operations, Employee Matters and Managing Growth](index=53&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations,%20Employee%20Matters%20and%20Managing%20Growth) - The company is highly dependent on its co-founders, William Ho (CEO) and Dr. Lawrence Lamb (CSO), and the loss of their services or inability to recruit and retain other key personnel could harm the business[286](index=286&type=chunk)[287](index=287&type=chunk) - Planned organizational expansion may lead to difficulties in managing growth, including implementing systems, expanding facilities, and recruiting personnel, potentially disrupting operations[289](index=289&type=chunk) - Strategic collaborations may not materialize or could require relinquishing important rights, and the company's information technology systems are vulnerable to cyberattacks and security incidents, risking disruption, data loss, and regulatory penalties[290](index=290&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk) - The ability to use net operating losses (NOLs) to offset future taxable income may be limited due to ownership changes or changes in tax law, potentially accelerating or increasing future tax liabilities[300](index=300&type=chunk)[301](index=301&type=chunk) - The business is exposed to product liability risks inherent in testing, manufacturing, and selling biopharmaceutical products, which could lead to expensive litigation, substantial damages, and harm to reputation[303](index=303&type=chunk)[306](index=306&type=chunk) [Risks Related to Commercialization and Regulatory Compliance](index=57&type=section&id=Risks%20Related%20to%20Commercialization%20and%20Regulatory%20Compliance) - Even if regulatory approvals are obtained, product candidates will be subject to ongoing regulatory oversight for manufacturing, labeling, promotion, and safety. Non-compliance could lead to severe penalties, including withdrawal of approval[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk) - Market acceptance by physicians, patients, and third-party payors is crucial for commercial success. Failure to achieve adequate acceptance due to cost, efficacy, safety, or other factors could prevent profitability[314](index=314&type=chunk)[315](index=315&type=chunk) - Establishing sales and marketing capabilities or securing agreements with third parties is essential for commercialization. Failure to do so could limit revenue generation[317](index=317&type=chunk) - Obtaining regulatory approval outside the United States is complex and time-consuming, and failure to do so would limit market opportunities and expose the company to international operational risks[318](index=318&type=chunk)[319](index=319&type=chunk) - Relationships with healthcare stakeholders are subject to federal and state healthcare fraud and abuse laws. Non-compliance could result in substantial penalties and reputational harm[321](index=321&type=chunk) - Coverage and adequate reimbursement for product candidates may not be available from third-party payors, which could hinder profitable sales and market demand[323](index=323&type=chunk)[325](index=325&type=chunk) - Healthcare legislative reforms, such as the ACA and drug pricing initiatives, could negatively impact business by limiting reimbursement amounts and increasing pricing pressures[326](index=326&type=chunk)[331](index=331&type=chunk) - Actual or perceived failures to comply with evolving data privacy and security obligations (e.g., HIPAA, GDPR, CCPA) could lead to regulatory investigations, litigation, fines, and business disruptions[333](index=333&type=chunk)[341](index=341&type=chunk) [Risks Related to the Ownership of Our Common Stock](index=63&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Our%20Common%20Stock) - The public market for common stock may not be liquid enough for quick sales at market price, and market volatility (due to inflation, geopolitical tensions) could adversely affect the share price[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) - Concentration of common stock ownership among executive officers, directors, and principal stockholders (**71%** as of April 11, 2022) may prevent new investors from influencing significant corporate decisions[348](index=348&type=chunk) - Raising additional capital through equity or convertible debt could dilute existing stockholders' ownership and impose restrictive covenants. Relinquishing rights to product candidates may be necessary for collaborations[349](index=349&type=chunk)[350](index=350&type=chunk) - Provisions in corporate charter documents and Delaware law (Section 203 DGCL) could make an acquisition more difficult and prevent attempts to replace current management, potentially depressing the stock price[353](index=353&type=chunk)[354](index=354&type=chunk) [General Risk Factors](index=66&type=section&id=General%20Risk%20Factors) - Lack of research coverage by industry or financial analysts, or unfavorable reports, could lead to a decline in stock price and trading volume[360](index=360&type=chunk) - Operating as a public company incurs increased legal, accounting, and compliance costs, requiring substantial management time for new initiatives like Sarbanes-Oxley Act Section 404 compliance[361](index=361&type=chunk)[362](index=362&type=chunk) - Failure to maintain an effective system of internal control over financial reporting could lead to inaccurate financial reports, fraud, loss of investor confidence, and negative impact on stock price[363](index=363&type=chunk)[364](index=364&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered sales of equity securities occurred and details the use of net proceeds from the company's Initial Public Offering (IPO) - No unregistered sales of equity securities occurred during the period[366](index=366&type=chunk) - The company completed its IPO on August 3, 2021, issuing **4,000,000 shares** at **$10.00 per share**, receiving net proceeds of **$32.3 million** after deducting underwriters' discounts, commissions, and offering costs[367](index=367&type=chunk) - As of March 31, 2022, **$0.2 million** of the IPO proceeds have been used, with no material change in the planned use of proceeds from what was disclosed in the Registration Statement[369](index=369&type=chunk) [Item 3. Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to IN8bio, Inc. for the reporting period - This item is not applicable[371](index=371&type=chunk) [Item 4. Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to IN8bio, Inc. for the reporting period - This item is not applicable[372](index=372&type=chunk) [Item 5. Other Information](index=68&type=section&id=Item%205.%20Other%20Information) This item is not applicable to IN8bio, Inc. for the reporting period - This item is not applicable[373](index=373&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=68&type=section&id=Item%206.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Form 10-Q, including corporate governance documents and certifications Selected Exhibits Filed | Exhibit Number | Description | | :------------- | :---------- | | 3.1 | Amended and Restated Certificate of Incorporation | | 3.2 | Amended and Restated Bylaws | | 31.1 | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) | | 31.2 | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) | | 32.1* | Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 | | 101.INS | Inline XBRL Instance Document | | 104 | Cover Page Interactive Data File | [SIGNATURES](index=69&type=section&id=Signatures) - The report is signed by William Ho, Chief Executive Officer (Principal Executive Officer), and Patrick McCall, Chief Financial Officer and Secretary (Principal Financial and Accounting Officer), on May 12, 2022[379](index=379&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Delaware 82-5462585 (I.R.S. Employer Registrant's telephone number, including area code: (646) 600-6438 Securities registered pursuant to Section 12(b) of the A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39692 IN8BIO, INC. (Exact name of Registrant as specified in its Charter) Delaware 82-5462585 (State or other jurisdiction ...