SAB Biotherapeutics(SABS) - 2024 Q4 - Annual Report

PART I Business Overview SAB Biotherapeutics develops human polyclonal immunotherapeutic antibodies for immunology disorders, with lead candidate SAB-142 for Type 1 Diabetes, advancing to Phase 2b - SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human polyclonal immunotherapeutic antibodies (hIgG) for immunology disorders, including Type 1 Diabetes (T1D)[21] - The company's proprietary platform generates disease-targeted, polyclonal hIgG in large quantities without human plasma donors, offering a differentiated approach with no biosimilar pathway[22] - SAB-142, the lead product candidate for T1D, is a first-in-class human anti-thymocyte globulin (ATG) designed to delay T1D progression, with positive Phase 1 clinical trial results announced in January 2025 and a Phase 2b trial anticipated to initiate mid-2025[26][29] - The company's production platform involves genetically engineered transchromosomic cattle (Tc Bovine) to produce hIgG, which are hyperimmunized with desired immunogens, and plasma is collected and purified through a GMP process[58][61][68] - SAB Biotherapeutics faces intense competition from major pharmaceutical and biotechnology companies with greater resources and experience in R&D, manufacturing, and commercialization[65][66] - The company actively protects its intellectual property through patents covering its technology platform and products, with global patent protection expected to extend to 2041 and beyond for commercial-scale hIgG production[69][72][73] - Product candidates are regulated by the FDA as biological products, and the genetic modification of animals requires New Animal Drug Application (NADA) approval, involving a complex and lengthy review process by both CVM and CBER[77][79][83] - As of December 31, 2024, the company had 63 full-time employees, with 37 in R&D, 9 in clinical activities, and 17 in general and administrative roles, emphasizing employee safety, talent retention, development, diversity, and competitive compensation[114][116] Risk Factors Investing in SAB Biotherapeutics involves high risk due to its clinical-stage nature, significant losses, and uncertain path to profitability - The company is a clinical-stage biopharmaceutical company with a history of significant losses and expects to incur further losses, making future profitability uncertain and investment highly speculative[122][123] - Successful development of pharmaceutical products is highly uncertain, with potential failures at any stage due to lack of efficacy, unacceptable side effects, or inability to obtain regulatory approvals[130][131] - Regulatory approval for genetically modified animals (Tc Bovine) and therapeutic biological products (hIgG) is a lengthy, expensive, and unpredictable process, requiring both NADA and BLA approvals[140][141][142] - Difficulties in patient enrollment for clinical trials, unexpected costs, or delays in development and commercialization could materially harm the business[147][150][167] - The biopharmaceutical industry is highly competitive, with many competitors possessing greater financial, scientific, and marketing resources, potentially leading to faster product development or rendering SAB's technology obsolete[65][267][269] - The company's success depends on maintaining the proprietary nature of its technology through patents and trade secrets, but faces risks of infringement claims, litigation, and changes in patent laws[278][279][284] - As a public company, SAB incurs increased costs and demands on management for compliance with laws and regulations, and its stock price may be volatile due to market conditions and operational fluctuations[292][317][318] Item 1B. Unresolved Staff Comments The company reported no unresolved staff comments from the SEC - No unresolved staff comments were reported[337] Item 1C. Cybersecurity SAB Biotherapeutics implements a comprehensive cybersecurity risk management strategy, overseen by the Audit Committee, with no material incidents - The company has implemented tools, processes, and strategies to integrate cybersecurity risk management into decision-making[339] - External cybersecurity assessment firms are engaged for regular system audits, threat assessments, 24-hour monitoring, and security enhancements[341] - The Audit Committee, composed of members with diverse expertise, is central to the Board's oversight of cybersecurity risks, receiving regular briefings from the Senior Director of IT[345][346] - The company has not experienced any cybersecurity threats or incidents that have materially affected its business strategy, results of operations, or financial condition[343] Item 2. Properties SAB Biotherapeutics operates cGMP manufacturing, R&D, and biosecure animal facilities in South Dakota, plus corporate headquarters in Florida - The company operates a 17,300 square foot cGMP clinical manufacturing facility within the 60,000 square foot laboratory bay at the Sanford Research Center in Sioux Falls, South Dakota, with its lease expiring in December 2029[350][351] - A Research and Development Campus in Sioux Falls, SD, comprising 49,600 square feet of office and lab space (18,400 sq ft for R&D), has a lease expiring in October 2026, with an option to extend to October 2029[352][353] - The biosecure TC Cattle Facility (Pharm) in Canton, South Dakota, houses genetically engineered bovines for hyperimmunization and plasma collection, with its real property lease expiring in November 2038[354][355] - The corporate headquarters in Miami Beach, Florida, leases approximately 1,272 square feet of office space, with the lease set to expire in September 2029[356] Item 3. Legal Proceedings SAB Biotherapeutics is not currently involved in any material litigation, nor is it aware of any pending or threatened litigation - The company is not currently a party to any material litigation and is unaware of any pending or threatened litigation that would materially affect its business, operating results, financial condition, or cash flows[357] Item 4. Mine Safety Disclosures Mine Safety Disclosures are not applicable to SAB Biotherapeutics - Mine Safety Disclosures are not applicable[358] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities SAB Biotherapeutics' common stock and public warrants are listed on Nasdaq, with 254 holders, and the company has never paid cash dividends - Common stock and public warrants are listed on Nasdaq under symbols "SABS" and "SABSW"[360] Market Prices as of March 21, 2025 | Security | Closing Price | | :--------------------------------- | :------------ | | Common stock | $1.72 per share | | Public warrants | $0.025 per warrant | - As of March 21, 2025, there were 254 holders of record for common stock[361] - The company has never declared or paid cash dividends and does not intend to in the foreseeable future, retaining funds for business growth[362][363] - No recent sales of unregistered securities or issuer purchases of equity were reported for the year ended December 31, 2024[365][366] Item 6. [Reserved] This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section reviews SAB Biotherapeutics' financial condition, highlighting decreased grant revenue, increased R&D expenses, and substantial doubt about its going concern - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human polyclonal immunotherapeutic antibodies for immunology disorders, including T1D, utilizing a proprietary platform[369][370] - Positive topline Phase 1 clinical results for SAB-142 in T1D were announced in January 2025, with plans to advance to a Phase 2b trial in mid-2025[371][372] - The company's corporate strategy focuses on SAB-142 as a first-in-class, multi-target antibody treatment for T1D, leveraging its platform to develop hIgG-based therapies for immune system disorders and infectious diseases[373][374][375] Revenue Comparison (2024 vs. 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | % Change | | :---------------- | :--------- | :--------- | :----------- | :------- | | Grant revenue | 1,322,410 | 2,238,991 | (916,581) | (40.9)% | | Total revenue | 1,322,410 | 2,238,991 | (916,581) | (40.9)% | - Revenue decreased by $0.9 million (40.9%) in 2024, primarily due to the termination of the JPEO Rapid Response Contract, with no further revenue anticipated from this contract[393] Research and Development Expenses (2024 vs. 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | % Change | | :----------------------------- | :--------- | :--------- | :----------- | :------- | | Research and development | 30,251,667 | 16,515,005 | 13,736,662 | 83.2% | | Total R&D expenses | 30,251,667 | 16,515,005 | 13,736,662 | 83.2% | - R&D expenses increased by $13.7 million (83.2%) in 2024, driven by increases in outside lab services, laboratory supplies, salaries and benefits, project consulting, and clinical trial costs, as the company advances SAB-142 through Phase 2[394][395] General and Administrative Expenses (2024 vs. 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | % Change | | :----------------------------- | :--------- | :--------- | :----------- | :------- | | General and administrative | 13,981,263 | 23,799,306 | (9,818,043) | (41.3)% | | Total G&A expenses | 13,981,263 | 23,799,306 | (9,818,043) | (41.3)% | - General and administrative expenses decreased by $9.8 million (41.3%) in 2024, mainly due to reduced administrative support fees and non-capitalized financing costs, though future increases are anticipated with workforce expansion and commercialization efforts[396][397] Non-operating Income (Expense) (2024 vs. 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | % Change | | :------------------------------------ | :--------- | :--------- | :----------- | :------- | | Changes in fair value of warrant liabilities | 5,385,009 | (4,823,237) | 10,208,246 | (211.65)% | | Other income | 2,452,605 | 435,089 | 2,017,516 | 463.70% | | Total non-operating income (expense) | 7,837,614 | (4,388,148) | 12,225,762 | (278.61)% | - Total non-operating income increased by $12.2 million in 2024, primarily driven by a $10.2 million increase in the fair value of warrant liabilities, a $1.6 million increase in Australian R&D tax credit, and a $0.4 million increase in investment income[398] Cash, Cash Equivalents, and Investments (2024 vs. 2023) | Metric | December 31, 2024 (USD) | December 31, 2023 (USD) | | :------------------------------------ | :---------------------- | :---------------------- | | Cash, cash equivalents and investments | 20,760,712 | 56,566,066 | - The company's cash, cash equivalents, and investments decreased from $56.6 million in 2023 to $20.8 million in 2024, and existing resources are not sufficient to fund operating expenses for more than 12 months, raising substantial doubt about its ability to continue as a going concern[402][405] - The company relies on government grants and equity financings for liquidity and plans to seek additional capital through equity/debt financings or collaborative arrangements[405][406] Cash Flows Summary (2024 vs. 2023) | Cash Flow Activity | 2024 (USD) | 2023 (USD) | | :------------------------------------ | :----------- | :----------- | | Net cash used in operating activities | (34,292,009) | (25,119,405) | | Net cash used in investing activities | (11,962,267) | (152,704) | | Net cash provided by (used in) financing activities | (1,172,626) | 66,773,137 | | Net increase (decrease) in cash and cash equivalents | (47,668,100) | 41,519,172 | - Net cash used in operating activities increased by $9.2 million in 2024, primarily due to an increase in net loss adjusted for non-cash items and increased working capital needs for the Phase 1 trial[414][415] - Net cash used in investing activities increased by $11.8 million in 2024, mainly due to increased purchases of short-term investments following the 2023 PIPE, with minimal capital expenditures[416] - Net cash provided by (used in) financing activities decreased by $67.9 million in 2024 due to the absence of material equity financing activities compared to 2023[417] Item 7A. Quantitative and Qualitative Disclosures about Market Risk This item is not applicable to SAB Biotherapeutics - Quantitative and Qualitative Disclosures about Market Risk are not applicable[439] Item 8. Financial Statements and Supplementary Data The consolidated financial statements and supplementary data are included in Part IV, Item 15 of this Annual Report - The consolidated financial statements and supplementary data are included in Part IV, Item 15, starting on page F-1[440] Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure There were no changes in or disagreements with accountants on accounting and financial disclosure reported - No changes in or disagreements with accountants on accounting and financial disclosure were reported[441] Item 9A. Controls and Procedures Management concluded SAB Biotherapeutics' disclosure controls and internal control over financial reporting were effective, remediating a prior material weakness - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[444] - Internal control over financial reporting was evaluated based on the COSO framework and determined to be effective as of December 31, 2024[447] - A previously identified material weakness in internal control over financial reporting, concerning insufficient documentation of formalized processes, was fully remediated during the year ended December 31, 2024[448][449] Item 9B. Other Information No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or officers - None of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the year and quarter ended December 31, 2024[450] Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to SAB Biotherapeutics - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[451] PART III Item 10. Directors, Executive Officers and Corporate Governance This section details SAB Biotherapeutics' Board of Directors, executive officers, and corporate governance, including committees and risk oversight - The Board of Directors consists of 11 members, with 9 (Christine Hamilton, Jeffrey Spragens, William Polvino, David Link, Scott Giberson, Erick Lucera, Katie Ellias, Andrew Moin, and Jay Skyler) determined to be independent[475][476][479] - Key executive officers include Samuel J. Reich (CEO & Chairman), Eddie J. Sullivan (President), Lucy To (CFO), Christoph Bausch (COO), and Alexandra Kropotova (CMO)[453][455][456][458][459][460] - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, all comprised solely of independent directors[484] - Erick Lucera serves as Chairman of the Audit Committee, Christine Hamilton as Chairwoman of the Compensation Committee, and David Link as Chairman of the Nominating Committee[485][488][495] - The Board oversees risk, receiving reports from executive management on operational, financial, legal, regulatory, strategic, transactional, and reputational risks[505] - Compensation policies are designed to guard against excessive risk-taking through a balanced mix of short-term and long-term incentives, capped cash awards tied to performance, equity vesting periods, and a clawback policy[506][507] Item 11. Executive Compensation This section details compensation for SAB Biotherapeutics' executive officers and non-employee directors, including salaries, option awards, and benefits Summary Executive Compensation Table (2024 vs. 2023) | Name | Year | Salary ($) | Option Awards ($) | Stock Awards ($) | Non-Equity Incentive Plan ($) | All Other Compensation ($) | Total ($) | | :-------------------------- | :--- | :--------- | :---------------- | :---------------- | :---------------------------- | :------------------------- | :---------- | | Samuel J. Reich | 2024 | 518,300 | 1,800,690 | — | 250,000 | 13,800 | 2,582,790 | | | 2023 | 350,000 | 202,598 | — | — | 13,200 | 565,798 | | Eddie J. Sullivan, PhD. | 2024 | 480,900 | 852,773 | — | 250,000 | 13,482 | 1,597,155 | | | 2023 | 377,200 | 202,598 | — | — | 25,359 | 605,157 | | Alexandra Kropotova, MD | 2024 | 540,100 | 554,050 | — | 236,250 | 13,800 | 1,344,200 | | | 2023 | 525,000 | — | 147,125 | 236,250 | 13,200 | 921,575 | | Lucy To | 2024 | 164,400 | 239,300 | — | — | 731 | 404,431 | | | 2023 | — | — | — | — | — | — | | Christoph Bausch, PhD | 2024 | 412,200 | 622,162 | — | 150,000 | 12,385 | 1,196,747 | | | 2023 | 325,000 | 106,123 | — | 105,000 | 13,200 | 549,323 | - Executive employment agreements include annual base salaries, eligibility for bonus plans, participation in benefit plans, and severance packages upon termination without cause or non-renewal, which include a year's base salary, accrued bonus, full vesting of unvested equity, and COBRA premium reimbursement[516][518][519][520][521][522] Summary Director Compensation Table (2024) | Name | Fees Earned or Paid in Cash ($) | Option Awards ($) | Stock Awards ($) | Total ($) | | :------------------------ | :------------------------------ | :---------------- | :---------------- | :---------- | | Christine Hamilton, MBA | 32,000 | 78,450 | — | 110,450 | | Jeffrey G. Spragens | 31,417 | 45,822 | — | 77,239 | | David Link, MBA | 31,417 | 67,141 | — | 98,558 | | Katie Ellias | 5,833 | 174,619 | — | 180,452 | | William Polvino, MD | 31,417 | 77,801 | — | 109,218 | | Scott Giberson | 30,250 | 45,822 | — | 76,072 | | Erick Lucera | 35,500 | 45,822 | — | 81,322 | | Andrew Moin | — | — | — | — | | Jay Skyler, MD | 17,000 | 127,012 | — | 144,012 | - Non-employee directors receive annual cash retainers for Board service ($30,000) and additional retainers for committee roles (e.g., Audit Committee Chairperson: $8,000)[527] - Non-employee directors receive an initial equity award of options to purchase 35,000 common shares (vesting over three years) and annual equity awards of options to purchase 20,000 common shares (vesting over two years)[528][529] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters This section outlines beneficial ownership of common stock for executives, directors, and major stockholders, alongside equity compensation plan details Shares Beneficially Owned as of March 21, 2025 | Beneficial Owner | Common Stock | Percent | Series A-2 Preferred Stock | Percent | Total Voting Power | | :--------------------------------- | :----------- | :------ | :------------------------- | :------ | :----------------- | | Christine Hamilton | 883,568 | 9.44 % | — | * % | 5.51 % | | Eddie J. Sullivan, PhD | 660,391 | 7.01 % | — | * % | 4.1 % | | Samuel J. Reich | 303,385 | 3.19 % | — | * % | 1.87 % | | Andrew Moin | 458,457 | 4.94 % | 28,380 | 67.54 % | 31.1 % | | All directors and executive officers as a group (14 persons) | 2,578,764 | 25.97 % | 28,380 | 67.54 % | 42.67 % | | Entities affiliated with BVF Partners | 917,826 | 9.88 % | 12,217 | 29.07 % | 17.9 % | | Entities Managed by RTW Investments, LP | 1,024,335 | 9.99 % | — | * % | 6.03 % | - The percentage of beneficial ownership is calculated based on 9,288,868 shares of common stock outstanding as of March 21, 2025, including shares exercisable within 60 days[538] Equity Compensation Plan Information as of December 31, 2024 | Plan Type | Number of Securities to be Issued Upon Exercise of Outstanding Options and Awards | Weighted-average Exercise Price of Outstanding Securities ($) | Number of Securities Remaining Available for Future Issuance | | :------------------------------------------------ | :---------------------------------------------------------------- | :---------------------------------------------------------- | :----------------------------------------------------------- | | Equity compensation plans approved by security holders | 2,697,452 | 5.85 | 2,867,023 | | Equity compensation plans not approved by security holders | 301,860 | 17.05 | 426,790 | | Total | 2,999,312 | 14.08 | 3,193,813 | - The 2021 Omnibus Equity Incentive Plan allows for an annual increase in shares available for issuance by up to 5% of outstanding common stock, with a total aggregate limit of 500,000 shares for the annual increase[545][692] Item 13. Certain Relationships and Related Transactions, and Director Independence This section confirms no material related party transactions, details indemnification agreements, and outlines the Related Party Transaction Policy - No material related party transactions (exceeding $120,000 or 1% of average total assets) were reported from January 1, 2024, other than executive and director compensation[546] - Indemnification agreements are in place with each director and executive officer, providing for indemnification and expense advancements for claims arising from their service[547] - A written Related Party Transaction Policy requires the Audit Committee to review and approve transactions involving related persons exceeding $120,000, ensuring they are consistent with the company's best interests[549][550] Item 14. Principal Accounting Fees and Services This section details aggregate audit fees billed by EisnerAmper LLP for 2024 and 2023, noting the Audit Committee's pre-approval policy Aggregate Fees Billed by EisnerAmper LLP (2024 vs. 2023) | (US Dollars) | 2024 ($) | 2023 ($) | | :---------------- | :------- | :------- | | Audit fees | 316,650 | 299,687 | | Audit-related fees | — | — | | Tax fees | — | — | | All other fees | — | — | | Total | 316,650 | 299,687 | - Audit fees for 2024 and 2023 relate to professional services for financial statement audits, quarterly reviews, consents, and SEC filings[552] - The Audit Committee has a pre-approval policy for all audit and permissible non-audit services to be performed by the independent auditor, ensuring consistency with SEC rules on auditor independence[553][555] PART IV Item 15. Exhibits, Financial Statement Schedules This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K - The section provides a comprehensive list of exhibits, including agreements (e.g., Merger, Manufacturing Option, Securities Purchase), corporate governance documents (e.g., Certificate of Incorporation, Bylaws), equity plans, and certifications[558][560][561] - Financial statement schedules are omitted as they are either not required, not applicable, or the information is included in the consolidated financial statements or their notes[559] - Certain exhibits have been granted or requested confidential treatment, and specific certifications (Exhibits 32.1 and 32.2) are not deemed filed with the SEC[562][563] Item 16. Form 10-K Summary This item indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[564] Financial Statements Report of Independent Registered Public Accounting Firm EisnerAmper LLP issued an unqualified opinion on SAB Biotherapeutics' financial statements but noted substantial doubt about its going concern ability - EisnerAmper LLP issued an unqualified opinion on the consolidated financial statements for December 31, 2024 and 2023, affirming fair presentation in conformity with U.S. GAAP[575] - An explanatory paragraph was included, indicating substantial doubt about the company's ability to continue as a going concern due to net losses and negative cash flows from operations[576] Consolidated Balance Sheets Consolidated balance sheets show a significant decrease in total assets and stockholders' equity from 2023 to 2024, driven by reduced cash Consolidated Balance Sheet Summary (December 31, 2024 vs. 2023) | Metric | December 31, 2024 (USD) | December 31, 2023 (USD) | | :------------------------------------ | :---------------------- | :---------------------- | | Assets: | | | | Cash and cash equivalents | 8,897,966 | 56,566,066 | | Short-term investments | 11,862,746 | — | | Total current assets | 23,792,229 | 58,906,863 | | Property, plant and equipment, net | 15,368,009 | 19,736,519 | | Total assets | 44,195,469 | 83,941,253 | | Liabilities: | | | | Total current liabilities | 7,979,600 | 10,813,317 | | Warrant liabilities | 6,389,226 | 11,774,235 | | Total liabilities | 18,225,893 | 26,641,812 | | Stockholders' Equity: | | | | Total stockholders' equity | 25,969,576 | 57,299,441 | - Cash and cash equivalents decreased significantly from $56.6 million in 2023 to $8.9 million in 2024, while short-term investments increased from $0 to $11.9 million[581] - Warrant liabilities decreased from $11.8 million in 2023 to $6.4 million in 2024[581] Consolidated Statements of Operations and Comprehensive Loss SAB Biotherapeutics reported a net loss of $34.1 million in 2024, an improvement from $42.2 million in 2023, driven by decreased revenue and increased R&D Consolidated Statements of Operations and Comprehensive Loss (2024 vs. 2023) | Metric | 2024 (USD) | 2023 (USD) | | :------------------------------------ | :--------- | :--------- | | Grant revenue | 1,322,410 | 2,238,991 | | Total revenue | 1,322,410 | 2,238,991 | | Research and development expenses | 30,251,667 | 16,515,005 | | General and administrative expenses | 13,981,263 | 23,799,306 | | Total operating expenses | 44,232,930 | 40,314,311 | | Loss from operations | (42,910,520) | (38,075,320) | | Changes in fair value of warrant liabilities | 5,385,009 | (4,823,237) | | Interest expense | (318,401) | (315,284) | | Interest income | 1,285,998 | 584,966 | | Other income | 2,452,605 | 435,089 | | Total other income (expense) | 8,805,211 | (4,118,466) | | Net loss | (34,105,309) | (42,193,786) | | Basic and diluted loss per common share | (3.68) | (7.64) | - Net loss decreased from $42.2 million in 2023 to $34.1 million in 2024[584] - Total revenue decreased by 40.9% year-over-year, while total operating expenses increased by 9.7%[584] - Loss from operations increased from $38.1 million in 2023 to $42.9 million in 2024[584] - Changes in fair value of warrant liabilities shifted from a $4.8 million loss in 2023 to a $5.4 million gain in 2024[584] Consolidated Statements of Changes in Stockholders' Equity Total stockholders' equity decreased from $57.3 million in 2023 to $26.0 million in 2024, primarily due to net loss and foreign currency translation Consolidated Statements of Changes in Stockholders' Equity Summary (2024 vs. 2023) | Metric | December 31, 2024 (USD) | December 31, 2023 (USD) | | :------------------------------------ | :---------------------- | :---------------------- | | Total Stockholders' Equity | 25,969,576 | 57,299,441 | | Net loss | (34,105,309) | (42,193,786) | | Stock-based compensation | 2,941,796 | 2,423,720 | | Foreign currency translation | (162,477) | 26,420 | | Unrealized gain, change in fair value of available-for-sale securities | 647 | — | - Total stockholders' equity decreased by $31.3 million from $57.3 million in 2023 to $26.0 million in 2024[587] - The decrease was primarily due to a net loss of $34.1 million and a foreign currency translation loss of $162,477, partially offset by $2.9 million in stock-based compensation[587] Consolidated Statements of Cash Flows SAB Biotherapeutics experienced a net decrease in cash and cash equivalents of $47.7 million in 2024, driven by increased operating and investing cash usage Consolidated Statements of Cash Flows Summary (2024 vs. 2023) | Cash Flow Activity | 2024 (USD) | 2023 (USD) | | :------------------------------------ | :----------- | :----------- | | Net cash used in operating activities | (34,292,009) | (25,119,405) | | Net cash used in investing activities | (11,962,267) | (152,704) | | Net cash provided by (used in) financing activities | (1,172,626) | 66,773,137 | | Effect of exchange rate changes on cash and cash equivalents | (241,198) | 18,144 | | Net increase (decrease) in cash and cash equivalents | (47,668,100) | 41,519,172 | | Cash and cash equivalents, End of period | 8,897,966 | 56,566,066 | - Net cash used in operating activities increased by $9.2 million in 2024, primarily due to a higher net loss adjusted for non-cash items and increased working capital needs[414][415] - Net cash used in investing activities increased by $11.8 million in 2024, mainly due to increased purchases of short-term investments[416] - Net cash provided by financing activities decreased by $67.9 million in 2024, primarily due to the absence of material equity financing activities compared to 2023[417] Notes to Consolidated Financial Statements The notes detail SAB Biotherapeutics' business, accounting policies, and financial performance, highlighting its clinical-stage nature and going concern doubt - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human polyclonal immunotherapeutic antibodies (hIgG) for immune system disorders and infectious diseases, with SAB-142 as its lead candidate for T1D[591] - The company has experienced net losses and negative cash flows from operations, with an accumulated deficit of $124.2 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[593][595] - Revenue is primarily generated from government grants, recognized as qualifying R&D expenses are incurred or conditions are met, and is not within the scope of ASC 606[629][630] - Research and development expenses are expensed as incurred, including licensing fees, consultant fees, animal care, equipment depreciation, and employee compensation[621] - Stock-based compensation is recognized using a fair-value measurement method, utilizing the Black-Scholes option-pricing model for valuation[625][626] - Warrants are classified as either derivative liabilities (Public, Private Placement, and Preferred Warrants) or equity (Ladenburg, PIPE, and Preferred PIPE Placement Agent Warrants) based on ASC 815-40 and ASC 480, with liabilities remeasured at fair value each period[608][712][715][719] - The company has federal net operating loss carryforwards of approximately $59.9 million as of December 31, 2024, subject to an 80% limitation on future taxable income and a full valuation allowance[734] - A new lease agreement for the Sanford Health facility was entered into on January 30, 2025, effective January 1, 2025, with an initial five-year term[746]