MIAMI, Nov. 04, 2025 (GLOBE NEWSWIRE) -- SAb Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced that four oral presentations and two poster presentations have been accepted for presentation at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes (ISPAD) being held November 5-8, 2025 in Montréal, Canada. Data high ...

Core Viewpoint - SAB Biotherapeutics, Inc. is advancing its clinical-stage biopharmaceutical product, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D), as highlighted by multiple presentations at the EASD Annual Meeting [1][5]. Company Developments - The company presented four oral presentations and one invited presentation at the EASD, showcasing preclinical and Phase 1 data for SAB-142, which is currently being evaluated in a Phase 2b SAFEGUARD clinical study for new-onset Stage 3 autoimmune T1D patients [2][3]. - SAB-142 demonstrated a clinically validated, multi-specific mechanism of action with sustained immunomodulation in a Phase 1 clinical study, distinguishing itself from rabbit ATG by not causing sustained lymphodepletion [4][5]. - The Phase 1 study involved 68 healthy volunteers and T1D patients, indicating the potential of SAB-142 to be a best-in-class T1D immunotherapy [4]. Clinical Study Insights - A novel pharmacokinetic assay for SAB-142 showed a dose-proportional and reproducible pharmacokinetic profile, with optimal short PK profile and sustained immunomodulatory effect observed up to Day 120 [4]. - The INNODIA-sponsored MELD-ATG study confirmed the disease-modifying potential of rabbit ATG in new-onset Stage 3 autoimmune T1D patients, achieving primary endpoint of C-peptide preservation at 12 months with a 2.5 mg/kg dose [6][7]. Collaborations and Partnerships - SAB is collaborating with INNODIA, which is leading the charge to bring revolutionary disease-modifying therapies to T1D patients, leveraging their clinical trial network in Australia and New Zealand [4][6]. - The partnership with INNODIA and leading European T1D centers aims to advance SAB-142 into the Phase 2b clinical study [6][8].

Core Insights - SAB Biotherapeutics, Inc. is set to present at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) from September 15 to 19, 2025, showcasing its innovative immunotherapy platform targeting autoimmune type 1 diabetes (T1D) [1][4] Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-specific, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders, specifically targeting autoimmune T1D with its lead asset, SAB-142 [8] - The company utilizes advanced genetic engineering and antibody science to create Transchromosomic (Tc) Bovine™, which allows for the production of a diverse range of specifically targeted, high-potency human IgGs without the need for human donors or convalescent plasma [8] EASD Presentations - The company will have four oral presentations at EASD, including a symposium hosted by INNODIA focused on life-changing therapies for T1D [2][3] - Key presentations include: - "Immunomodulation Without Sustained Lymphodepletion: SAB-142, a Fully Human Anti-Thymocyte Globulin" by Alexandra Kropotova on September 16, 2025 [2] - "Mechanism of Action of a Fully Human Anti-Thymocyte Globulin, SAB-142, for the Treatment of Type 1 Diabetes" by Christoph Bausch on September 18, 2025 [3] - "Novel Pharmacokinetic Assay for Measuring SAB-142" and "Specimen Quality for Multicenter Clinical Trials" by Eric Sandhurst on September 18, 2025 [3][4] INNODIA Overview - INNODIA is an international non-profit organization dedicated to preventing and curing type 1 diabetes, stemming from a European public-private partnership [6][7] - It represents a collaboration between those developing new therapies and those with the necessary tools and experience [7]

PART I [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, changes in stockholders' equity, and cash flows, along with detailed notes on business and accounting policies [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a significant decrease in total assets and stockholders' equity from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash, cash equivalents, and short-term investments, alongside an increased accumulated deficit | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------------------- | :------------ | :---------------- | :------- | :------- | | Cash and cash equivalents | $3,692,217 | $8,897,966 | $(5,205,749) | -58.50% | | Short-term investments | $2,021,335 | $11,862,746 | $(9,841,411) | -82.96% | | Total current assets | $9,308,121 | $23,792,229 | $(14,484,108) | -60.88% | | Total assets | $30,129,488 | $44,195,469 | $(14,065,981) | -31.83% | | Total current liabilities | $10,677,337 | $7,979,600 | $2,697,737 | 33.81% | | Warrant liabilities | $1,980,512 | $6,389,226 | $(4,408,714) | -68.99% | | Total liabilities | $18,113,273 | $18,225,893 | $(112,620) | -0.62% | | Total stockholders' equity | $12,016,215 | $25,969,576 | $(13,953,361) | -53.73% | | Accumulated deficit | $(139,479,893)| $(124,168,850) | $(15,311,043) | 12.33% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased net losses for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to the absence of grant revenue and a negative change in the fair value of warrant liabilities in the three-month period. Operating expenses saw a slight increase in R&D for the three months but a slight decrease for the six months, while G&A expenses decreased for both periods | Metric (3 Months Ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :------------ | :------------ | :------------ | :------- | | Grant revenue | $0 | $263,137 | $(263,137) | -100.00% | | Research and development | $6,996,660 | $6,822,198 | $174,462 | 2.56% | | General and administrative | $2,735,401 | $3,642,637 | $(907,236) | -24.90% | | Total operating expenses | $9,732,061 | $10,464,835 | $(732,774) | -7.00% | | Loss from operations | $(9,732,061) | $(10,201,698) | $469,637 | -4.60% | | Changes in fair value of warrant liabilities | $(627,056) | $2,216,973 | $(2,844,029) | -128.28% | | Net loss | $(10,114,270) | $(7,335,455) | $(2,778,815) | 37.88% | | Basic and diluted loss per share| $(1.09) | $(0.79) | $(0.30) | 37.97% | | Metric (6 Months Ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :------------ | :------------ | :------------ | :------- | | Grant revenue | $0 | $1,207,712 | $(1,207,712) | -100.00% | | Research and development | $14,653,981 | $14,769,253 | $(115,272) | -0.78% | | General and administrative | $5,850,182 | $8,030,773 | $(2,180,591) | -27.15% | | Total operating expenses | $20,504,163 | $22,800,026 | $(2,295,863) | -10.07% | | Loss from operations | $(20,504,163) | $(21,592,314) | $1,088,151 | -5.04% | | Changes in fair value of warrant liabilities | $4,408,713 | $7,685,192 | $(3,276,479) | -42.63% | | Net loss | $(15,311,043) | $(12,361,200) | $(2,949,843) | 23.86% | | Basic and diluted loss per share| $(1.65) | $(1.34) | $(0.31) | 23.13% | [Condensed Consolidated Statements of Changes In Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20In%20Stockholders%27%20Equity) The statements of changes in stockholders' equity reflect a decrease in total equity from $25.97 million at December 31, 2024, to $12.02 million at June 30, 2025, primarily due to the net loss incurred during the period and an increase in accumulated deficit. Stock-based compensation added to additional paid-in capital | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Common stock | $935 | $936 | | Additional paid-in capital | $155,794,142 | $157,032,218 | | Accumulated other comprehensive loss | $(135,410) | $(15,805) | | Accumulated deficit | $(124,168,850) | $(139,479,893)| | Total stockholders' equity | $25,969,576 | $12,016,215 | - Stock-based compensation for the six months ended June 30, 2025, was **$1,240,149**, contributing to additional paid-in capital[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities decreased compared to 2024, while investing activities shifted from a net cash outflow to a net cash inflow, primarily due to decreased purchases and increased sales/maturities of investments. Financing activities continued to use cash, but at a lower rate | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | Change | % Change | | :-------------------------------------------- | :-------------- | :-------------- | :-------------- | :------- | | Net cash used in operating activities | $(14,948,761) | $(18,467,790) | $3,519,029 | -19.05% | | Net cash provided by (used in) investing activities | $9,868,940 | $(20,140,390) | $30,009,330 | -149.00% | | Net cash used in financing activities | $(347,829) | $(715,457) | $367,628 | -51.38% | | Net decrease in cash and cash equivalents | $(5,205,749) | $(39,323,624) | $34,117,875 | -86.76% | | Cash and cash equivalents, End of period | $3,692,217 | $17,242,442 | $(13,550,225) | -78.59% | [Notes to Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and disclosures for the financial statements, covering the company's business, accounting policies, financial instruments, equity, and subsequent events. Key highlights include the company's focus on immunotherapeutic antibodies, its liquidity challenges, and a significant Series B private placement completed post-period end to fund clinical trials [(1) Nature of Business](index=7&type=section&id=%281%29%20Nature%20of%20Business) SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human polyclonal immunotherapeutic antibodies for immune system disorders and infectious diseases. Its lead candidate, SAB-142, targets Type 1 Diabetes. The company faces liquidity challenges due to ongoing net losses and negative cash flows, but a recent $175 million Series B offering is expected to fund operations for the next twelve months and advance the SAB-142 Phase 2b SAFEGUARD study - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human polyclonal immunotherapeutic antibodies (hIgG) for immune system disorders and infectious diseases. Its lead candidate, SAB-142, is a human anti-thymocyte globulin (ATG) aimed at preventing or delaying Type 1 Diabetes (T1D)[13](index=13&type=chunk) - The company has experienced net losses and negative cash flows from operations, with an accumulated deficit of **$139.5 million** as of June 30, 2025, and anticipates continued losses[15](index=15&type=chunk) - On July 21, 2025, the company secured approximately **$175 million** in gross proceeds from a Series B private placement offering, intended to fund the Phase 2b SAFEGUARD study of SAB-142 and for general corporate purposes. This funding is expected to cover operating cash needs for the next twelve months[16](index=16&type=chunk)[17](index=17&type=chunk) Australian R&D Tax Credit Income | Period | 2025 (million) | 2024 (million) | | :----- | :------------- | :------------- | | 3 months | $0.3 | $0.3 | | 6 months | $0.8 | $0.6 | [(2) Summary of Significant Accounting Policies](index=7&type=section&id=%282%29%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements, including adherence to GAAP for interim reporting, the company's status as an emerging growth company, consolidation principles, use of estimates, fair value measurements, and policies for revenue recognition, R&D expenses, and stock-based compensation - The financial statements are prepared in accordance with U.S. GAAP for interim financial statements and SEC rules, with certain information condensed or omitted[19](index=19&type=chunk) - The company is an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised financial accounting standards, which may affect comparability with other public companies[20](index=20&type=chunk)[21](index=21&type=chunk) - Revenue is primarily generated from government grants, recognized as research and development services occur or conditions are met. No revenue was recognized for the three and six months ended June 30, 2025, due to grant terminations[51](index=51&type=chunk)[52](index=52&type=chunk)[63](index=63&type=chunk) - Research and development expenses are expensed as incurred, including licensing fees, consultant fees, animal care, equipment depreciation, salaries, and stock-based compensation[43](index=43&type=chunk) [(3) New accounting standards](index=14&type=section&id=%283%29%20New%20accounting%20standards) The company is currently evaluating the impact of ASU 2024-03, 'Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Topic 220)', which requires additional disclosures for certain expenses and is effective for annual periods beginning after December 15, 2026 - ASU 2024-03 requires additional disclosure in the notes to financial statements of specified information about certain expenses such as purchases of inventory, employee compensation, depreciation, intangible asset amortization, and depreciation and other expenses[61](index=61&type=chunk) - This ASU is effective for annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact[62](index=62&type=chunk) [(4) Revenue](index=16&type=section&id=%284%29%20Revenue) The company recognized no grant revenue for the three and six months ended June 30, 2025, a significant decrease from the prior year due to the termination of US Department of Defense grants in 2022 and the satisfaction of all related obligations by December 31, 2024 Grant Revenue | Period | 2025 | 2024 | | :----- | :--- | :--- | | 3 months ended June 30 | $0 | $0.3 million | | 6 months ended June 30 | $0 | $1.2 million | - The decrease in revenue is due to the termination of various US Department of Defense grants in 2022, with all obligations satisfied by December 31, 2024[63](index=63&type=chunk) [(5) Earnings per share](index=16&type=section&id=%285%29%20Earnings%20per%20share) Due to net losses in both periods, basic and diluted loss per common share were identical, as all potentially dilutive securities were anti-dilutive. The loss per share increased for both the three and six months ended June 30, 2025, compared to 2024 Basic and Diluted Loss Per Share | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss attributable to shareholders | $(10,114,270) | $(7,335,455) | $(15,311,043) | $(12,361,200) | | Weighted-average common shares outstanding | 9,294,469 | 9,255,025 | 9,293,018 | 9,248,503 | | Net loss per share, basic and diluted | $(1.09) | $(0.79) | $(1.65) | $(1.34) | - Potentially dilutive securities (stock options, restricted stock awards, warrants, earnout shares, Series A Preferred Stock) were excluded from diluted EPS calculation as their effect would be anti-dilutive[64](index=64&type=chunk)[65](index=65&type=chunk) [(6) Property, plant and equipment](index=17&type=section&id=%286%29%20Property%2C%20plant%20and%20equipment) Net property, plant, and equipment decreased from $15.37 million at December 31, 2024, to $13.86 million at June 30, 2025, primarily due to accumulated depreciation and amortization. Depreciation and amortization expense also decreased for both the three and six months ended June 30, 2025, compared to 2024 Property, Plant and Equipment, Net | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total Property, plant and equipment, gross | $29,935,070 | $29,941,933 | | Less: accumulated depreciation and amortization | $(16,076,966) | $(14,573,924) | | Property, plant and equipment, net | $13,858,104 | $15,368,009 | Depreciation and Amortization Expense | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Expense | $0.8 million | $1.0 million | $1.5 million | $3.0 million | [(7) Leases](index=17&type=section&id=%287%29%20Leases) The company holds various operating and finance leases for lab space, office, and an animal facility. Operating lease liabilities increased significantly, while finance lease liabilities slightly decreased. The weighted-average remaining lease term for operating leases increased, reflecting new lease agreements, while the finance lease term slightly decreased - The company renewed an operating lease for lab space through December 31, 2029, with monthly costs of approximately **$50 thousand** through 2025 and annual **2% increases**. It also entered a new office lease in Miami Beach in April 2024 for **62 months**[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) - A finance lease for an animal facility, entered in December 2018, has a **20-year term** at an **8% interest rate**, with monthly payments of **$34 thousand**. The company has an option to purchase the asset[72](index=72&type=chunk) Lease Liabilities and Terms | Metric | June 30, 2025 (Operating) | June 30, 2025 (Finance) | December 31, 2024 (Operating) | December 31, 2024 (Finance) | | :-------------------------------- | :------------------------ | :---------------------- | :---------------------------- | :-------------------------- | | Operating lease right-of-use assets | $3,006,354 | N/A | $970,294 | N/A | | Finance lease right-of-use assets | N/A | $3,539,423 | N/A | $3,582,835 | | Operating lease liabilities, current portion | $815,064 | N/A | $393,430 | N/A | | Finance lease liabilities, current portion | N/A | $148,156 | N/A | $142,563 | | Operating lease liabilities, noncurrent | $2,255,008 | N/A | $581,148 | N/A | | Finance lease liabilities, noncurrent | N/A | $3,200,416 | N/A | $3,275,919 | | Weighted-average remaining lease term (years) | 3.99 | 13.42 | 2.85 | 13.92 | | Weighted-average discount rate (percentage) | 9.39% | 7.72% | 7.76% | 7.72% | [(8) Accrued Expenses and Other Current Liabilities](index=19&type=section&id=%288%29%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Total accrued expenses and other current liabilities increased by $1.62 million, or 29.6%, from December 31, 2024, to June 30, 2025, primarily driven by increases in payroll and employee-related costs and accrued research and development expenses Accrued Expenses and Other Current Liabilities | Category | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------------------- | :------------ | :---------------- | :------- | :------- | | Payroll and employee-related costs | $5,085,498 | $4,170,381 | $915,117 | 21.94% | | Accrued research and development expenses | $808,363 | $237,164 | $571,199 | 240.85% | | Accrued legal fees | $264,224 | $42,159 | $222,065 | 526.77% | | Accrued financing fees payable | $213,000 | $479,250 | $(266,250)| -55.56% | | Other accrued expenses | $699,133 | $521,639 | $177,494 | 34.03% | | Total | $7,091,760 | $5,473,036 | $1,619,764 | 29.60% | [(9) Notes Payable](index=19&type=section&id=%289%29%20Notes%20Payable) The company fully repaid its insurance financing note by June 22, 2025, resulting in no outstanding notes payable as of June 30, 2025. Interest expense related to these notes decreased for both the three and six months ended June 30, 2025, compared to the prior year - The company had no insurance financing note payable at June 30, 2025, as the current agreement was fully repaid through installment payments, with the final payment on June 22, 2025[81](index=81&type=chunk) Insurance Financing Note Payable and Interest Expense | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Insurance financing note payable | $0 | $275,849 | | Interest Expense (Insurance Financing Note) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :---------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Expense | $1 thousand | $4 thousand | $6 thousand | $12 thousand | [(10) Stockholders' Equity](index=19&type=section&id=%2810%29%20Stockholders%27%20Equity) The company's authorized capital stock includes 800 million common shares and 10 million preferred shares. Key activities include the issuance and conversion of Series A Preferred Stock, the contingent nature of Earnout Shares from a prior business combination, and the establishment of a sales agreement for up to $20 million in common stock, under which no shares have been sold as of June 30, 2025 - The company's authorized capital stock consists of **800,000,000** shares of common stock and **10,000,000** shares of preferred stock[83](index=83&type=chunk) - In connection with the September 2023 Offering, **67,154** shares of Series A-1 Preferred Stock were issued. Following stockholder approval, **24,918** shares converted into **3,954,674** common shares, and the remaining **42,236** shares converted to Series A-2 Preferred Stock, convertible into common stock at **$6.30 per share**[86](index=86&type=chunk)[87](index=87&type=chunk) - The Business Combination Agreement includes an earnout provision for **1,200,000** Earnout Shares, contingent on the company meeting specific VWAP thresholds within five years. **150,806** shares are contingently issuable, while **1,049,194** are legally issued but returnable if thresholds are not met[90](index=90&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) - As of June 30, 2025, the company had not sold any shares under its **$20 million** Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., entered into on January 26, 2024[96](index=96&type=chunk) [(11) Stock Option Plans](index=23&type=section&id=%2811%29%20Stock%20Option%20Plans) The company operates the 2014 and 2021 Equity Incentive Plans, with a significant increase in shares available for grant under the 2021 plan following a 2024 amendment. Stock option activity for the six months ended June 30, 2025, showed new grants, forfeitures, and expirations, resulting in a decrease in outstanding options. Unrecognized compensation cost for non-vested options is approximately $5.2 million. Restricted stock units also vested, with a portion withheld for taxes - As of June 30, 2025, **728,650** shares were reserved under the 2014 Equity Incentive Plan, and **7,712,758** shares were reserved under the 2021 Equity Incentive Plan, with **5,006,023** shares available for grant under the latter after an amendment increased the pool by **3,900,000** shares[98](index=98&type=chunk)[99](index=99&type=chunk) Stock Option Activity (Six Months Ended June 30, 2025) | Metric | Options | Weighted Average Exercise Price | | :-------------------------- | :------ | :------------------------------ | | Outstanding, Dec 31, 2024 | 2,967,950 | $7.05 | | Granted | 25,000 | $1.67 | | Forfeited | (2,800) | $2.90 | | Expired | (55,122)| $21.68 | | Outstanding, June 30, 2025 | 2,935,028 | $6.73 | | Vested and exercisable, June 30, 2025 | 960,276 | $12.69 | - Total unrecognized compensation cost for non-vested stock options was approximately **$5.2 million** as of June 30, 2025, to be recognized over a weighted-average period of **2.58 years**[102](index=102&type=chunk) Stock-based Compensation Expense | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $347,467 | $274,317 | $679,756 | $490,668 | | General and administrative | $279,731 | $327,116 | $560,393 | $728,210 | | Total | $627,198 | $601,433 | $1,240,149 | $1,218,878 | [(12) Warrants](index=26&type=section&id=%2812%29%20Warrants) The company has various outstanding warrants, including Public, Private Placement, PIPE, Ladenburg, and Preferred Warrants. Most warrants expire on October 22, 2026. Preferred Tranche B Warrants expired unexercised on January 1, 2025. Public and Private Placement Warrants are liability-classified, with their fair value changes impacting the statements of operations. Preferred Warrants are also derivative liabilities due to cash redemption clauses - All outstanding Public and Private Placement Warrants expire on **October 22, 2026**, unless earlier exercised or redeemed[109](index=109&type=chunk)[111](index=111&type=chunk) - On January 1, 2025, **42,846** Preferred Tranche B Warrants expired unexercised, resulting in a **$3 thousand** gain recognized in other income[119](index=119&type=chunk)[120](index=120&type=chunk) - Public Warrants and Private Placement Warrants are accounted for as liabilities, with changes in fair value recognized in the condensed consolidated statements of operations. Preferred Warrants are also classified as derivative liabilities due to cash redemption upon a fundamental transaction[122](index=122&type=chunk)[125](index=125&type=chunk) Warrant Liabilities and Valuation Inputs (June 30, 2025 vs. Dec 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Public Warrant liability | $191,475 | $432,975 | | Private Placement Warrant liability | $6,946 | $15,708 | | Preferred Warrants | $1,782,091 | $5,940,543 | | Valuation Input (Public/Private Placement Warrants) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------------- | :------------ | :---------------- | | Risk-free interest rate | 3.86% | 4.19% | | Expected term remaining (periods) | 1.31 | 1.81 | | Implied volatility | 208.9% | 160.9% | | Closing common stock price | $1.76 | $3.79 | | Valuation Input (Preferred Tranche C Warrants) | June 30, 2025 | December 31, 2024 | | :--------------------------------------------- | :------------ | :---------------- | | Risk-free interest rate | 3.70% | 4.32% | | Expected term remaining (periods) | 3.41 | 3.91 | | Implied volatility | 100.0% | 95.0% | | Underlying Stock Price (Preferred Series A) | $143.10 | $309.37 | [(13) Fair Value Measurements](index=32&type=section&id=%2813%29%20Fair%20Value%20Measurements) The company measures certain assets and liabilities at fair value on a recurring basis, classifying them into a three-level hierarchy. Cash equivalents and mutual funds are Level 1, while Private Placement Warrants and Preferred Warrants are Level 3 due to the use of unobservable inputs. The fair value of Level 3 liabilities decreased significantly from December 31, 2024, to June 30, 2025 - Fair value measurements are categorized into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than quoted prices), and Level 3 (unobservable inputs)[128](index=128&type=chunk)[129](index=129&type=chunk) Assets and Liabilities Measured at Fair Value (June 30, 2025) | Category | Total | Level 1 | Level 2 | Level 3 | | :-------------------------- | :------------ | :------------ | :------ | :------ | | Cash equivalents (Money market funds) | $2,946,517 | $2,946,517 | $0 | $0 | | Short-term investments (Mutual funds) | $2,021,335 | $2,021,335 | $0 | $0 | | Public Warrant liability | $191,475 | $191,475 | $0 | $0 | | Private Placement Warrant liability | $6,946 | $0 | $0 | $6,946 | | Preferred Warrants | $1,782,091 | $0 | $0 | $1,782,091| Changes in Level 3 Fair Value Measurements (Dec 31, 2024 to June 30, 2025) | Liability | Balance, Dec 31, 2024 | Change in fair value | Balance, June 30, 2025 | | :-------------------------------- | :-------------------- | :------------------- | :--------------------- | | Private Placement Warrant liability | $15,708 | $(8,762) | $6,946 | | Preferred Warrant liabilities | $5,940,543 | $(4,158,452) | $1,782,091 | [(14) Investments](index=33&type=section&id=%2814%29%20Investments) The company held no available-for-sale debt securities as of June 30, 2025, a change from December 31, 2024, when it held U.S. treasury securities. Net gains on equity securities recognized during the period decreased for the three months but increased for the six months ended June 30, 2025, compared to 2024 - The company held no available-for-sale debt securities as of June 30, 2025. At December 31, 2024, it held **$6.22 million** in U.S. treasury securities[133](index=133&type=chunk) Net Gains (Losses) on Equity Securities | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net gains (losses) recognized | $(3,730) | $7,645 | $1,209 | $15,169 | | Realized net gains (losses) | $13,460 | $0 | $25,333 | $0 | | Unrealized net gains (losses) | $(17,190) | $7,645 | $(24,124) | $15,169 | [(15) Income Taxes](index=34&type=section&id=%2815%29%20Income%20Taxes) Due to current and prior year losses, the company does not expect to have an income tax provision and continues to record a valuation allowance on its net deferred tax assets, which increased by approximately $4.5 million during the six months ended June 30, 2025 - The company does not expect to have an Income Tax Provision due to current and prior year losses[138](index=138&type=chunk) - A valuation allowance on net deferred tax assets increased by approximately **$4.5 million** during the six months ended June 30, 2025[138](index=138&type=chunk) [(16) Related Party Transactions](index=34&type=section&id=%2816%29%20Related%20Party%20Transactions) There were no related party transactions for the three and six months ended June 30, 2025, and 2024 - No related party transactions occurred for the three and six months ended June 30, 2025, and 2024[139](index=139&type=chunk) [(17) Employee Benefit Plan](index=34&type=section&id=%2817%29%20Employee%20Benefit%20Plan) The company sponsors a 401(k) retirement plan with matching contributions. Contributions decreased slightly for the six months ended June 30, 2025, compared to the prior year - The company sponsors a 401(k) retirement plan with matching contributions of **100%** on **3%** of employee contributions and an additional **50%** match on the next **2%**[140](index=140&type=chunk) Company 401(k) Contributions | Period | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Contributions | $85 thousand | $72 thousand | $220 thousand | $229 thousand | [(18) Commitments and Contingencies](index=34&type=section&id=%2818%29%20Commitments%20and%20Contingencies) The company is not currently involved in any material litigation or threatened legal actions that are expected to have a material adverse effect on its financial condition, results of operations, or liquidity - The company is not a party to any material litigation, nor is it aware of any pending or threatened litigation expected to materially affect its financial condition, results of operations, or liquidity[141](index=141&type=chunk) [(19) Segment Reporting](index=35&type=section&id=%2819%29%20Segment%20Reporting) The company operates as a single reportable segment, with its chief executive officer reviewing overall operating results and significant expenses to allocate resources and assess performance. The primary focus is on the development of human anti-thymocyte globulin for T1D - The company's business activities are organized into one reportable segment, with the chief operating decision maker (CODM) reviewing operating results in their entirety[142](index=142&type=chunk) - The CODM assesses performance by reviewing GAAP operating expenses and significant expenses by function, along with the annual budget, on a quarterly basis[143](index=143&type=chunk) Operating Expense Categories | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total research and development expense | $6,996,660 | $6,822,198 | $14,653,981 | $14,769,253 | | Total general and administrative expenses | $2,735,401 | $3,642,637 | $5,850,182 | $8,030,773 | | Total operating expense | $9,732,061 | $10,464,835 | $20,504,163 | $22,800,026 | [(20) Subsequent Events](index=35&type=section&id=%2820%29%20Subsequent%20Events) On July 21, 2025, the company completed a Series B private placement, issuing 1,000,000 Series B Convertible Preferred Stock shares and warrants, generating approximately $175 million in gross proceeds. The Series B Preferred Stock is convertible into 100,000,000 common shares, subject to stockholder approval and certain beneficial ownership limitations. The company also agreed to nominate up to two individuals designated by RA Capital Healthcare Fund, L.P. to its Board of Directors - On July 21, 2025, the company entered into a securities purchase agreement for a Series B private placement, issuing **1,000,000** Series B Convertible Preferred Stock shares and warrants to purchase up to **1,500,000** additional Series B Preferred Stock shares[146](index=146&type=chunk) - The Series B Offering generated approximately **$175 million** in gross proceeds, before fees and expenses[16](index=16&type=chunk) - Each Series B Preferred Stock share is convertible into **100** common shares at a conversion price of **$1.75 per share**, subject to stockholder approval and a conversion cap limiting beneficial ownership to **4.99%** (or up to **19.99%** by election)[148](index=148&type=chunk)[149](index=149&type=chunk) - The company agreed to nominate up to two individuals designated by RA Capital Healthcare Fund, L.P. to its Board of Directors, reducing the board size to **nine persons**[151](index=151&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&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, highlighting its clinical-stage biopharmaceutical focus, lead product candidate SAB-142 for T1D, and the financial performance for the three and six months ended June 30, 2025, compared to 2024. It details revenue decline, changes in operating expenses, non-operating income, and liquidity, emphasizing the recent Series B offering to fund future operations and clinical trials [Company Overview](index=38&type=section&id=Company%20Overview) SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human, multi-specific, high-potency immunoglobulins (IgGs) for autoimmune disorders, leveraging its proprietary Tc Bovine platform. Its lead candidate, SAB-142, is a human anti-thymocyte globulin (ATG) for Type 1 Diabetes (T1D), which has received FDA IND clearance and positive Phase 1 data. The company plans to advance SAB-142 into a Phase 2b SAFEGUARD study - SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human, multi-specific, high-potency immunoglobulins (IgGs) to treat and prevent autoimmune disorders, utilizing its proprietary Tc Bovine platform[155](index=155&type=chunk)[156](index=156&type=chunk) - The lead product candidate, SAB-142, is a human anti-thymocyte globulin (ATG) focused on preventing or delaying the progression of Type 1 Diabetes (T1D)[157](index=157&type=chunk) - SAB-142 received FDA IND clearance in May 2024, announced positive topline Phase 1 clinical trial data in January 2025, and plans to advance into a Phase 2b SAFEGUARD study, with FDA alignment on the trial design[159](index=159&type=chunk) [Components of Results of Operations](index=40&type=section&id=Components%20of%20Results%20of%20Operations) This section details the primary components of the company's financial results: revenue, operating expenses (research and development, general and administrative), and nonoperating income/expense (warrant liabilities, other income, interest income, interest expense). Grant revenue has ceased, and R&D expenses are expected to increase with clinical trial advancements, while G&A expenses are also anticipated to rise with workforce expansion and commercialization efforts - Revenue is primarily from government grants, but no revenue was recognized for the three and six months ended June 30, 2025, due to the termination of US Department of Defense grants[162](index=162&type=chunk) - Research and development expenses, expensed as incurred, include salaries, benefits, lab supplies, animal care, and clinical trial costs. These are expected to increase as SAB-142 advances through Phase 2 clinical trials[163](index=163&type=chunk)[165](index=165&type=chunk) - General and administrative expenses, including payroll, professional fees, and corporate costs, are anticipated to rise with workforce expansion and preparations for potential commercialization[168](index=168&type=chunk) - Nonoperating income (expense) includes changes in the fair value of warrant liabilities, Australian R&D tax credits, dividend income, and interest income/expense[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) The company experienced a 100% decrease in revenue for both the three and six months ended June 30, 2025, due to grant terminations. Research and development expenses slightly increased for the three-month period but slightly decreased for the six-month period, while general and administrative expenses decreased for both periods. Non-operating income saw a significant decrease due to changes in warrant liabilities, and interest income declined substantially due to lower cash and investment balances Revenue Comparison (YoY) | Period | 2025 | 2024 | Change | % Change | | :----- | :--- | :--- | :----- | :------- | | 3 Months Ended June 30 | $0 | $263,137 | $(263,137) | -100.0% | | 6 Months Ended June 30 | $0 | $1,207,712 | $(1,207,712) | -100.0% | Research and Development Expenses Comparison (YoY) | Period | 2025 | 2024 | Change | % Change | | :----- | :--- | :--- | :----- | :------- | | 3 Months Ended June 30 | $6,996,660 | $6,822,198 | $174,462 | 2.6% | | 6 Months Ended June 30 | $14,653,981 | $14,769,253 | $(115,272) | -0.8% | General and Administrative Expenses Comparison (YoY) | Period | 2025 | 2024 | Change | % Change | | :----- | :--- | :--- | :----- | :------- | | 3 Months Ended June 30 | $2,735,401 | $3,642,637 | $(907,236) | -24.9% | | 6 Months Ended June 30 | $5,850,182 | $8,030,773 | $(2,180,591) | -27.2% | Non-operating Income Comparison (YoY) | Metric (3 Months Ended June 30) | 2025 | 2024 | Change | % Change | | :-------------------------------- | :--- | :--- | :----- | :------- | | Changes in fair value of warrant liabilities | $(627,056) | $2,216,973 | $(2,844,029) | -128.3% | | Total non-operating income | $(331,426) | $2,584,805 | $(2,916,231) | -112.8% | | Metric (6 Months Ended June 30) | 2025 | 2024 | Change | % Change | | :-------------------------------- | :--- | :--- | :----- | :------- | | Changes in fair value of warrant liabilities | $4,408,713 | $7,685,192 | $(3,276,479) | -42.63% | | Total non-operating income (expense) | $5,250,970 | $8,528,154 | $(3,277,184) | -38.43% | Interest Income Comparison (YoY) | Period | 2025 | 2024 | Change | % Change | | :----- | :--- | :--- | :----- | :------- | | 3 Months Ended June 30 | $13,562 | $374,557 | $(360,995) | -96.38% | | 6 Months Ended June 30 | $76,060 | $872,450 | $(796,390) | -91.28% | [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) The company continues to experience net losses and negative operating cash flows, with an accumulated deficit of $139.5 million as of June 30, 2025. However, a significant $175 million gross proceeds from a Series B offering in July 2025 is expected to fund operations for the next twelve months and the Phase 2b SAFEGUARD study. The company also has a shelf registration statement for up to $50 million in securities, with $20 million available under a sales agreement - As of June 30, 2025, the company had an accumulated deficit of **$139.5 million** and anticipates continued losses, requiring additional capital[189](index=189&type=chunk) - A Series B Offering on July 21, 2025, generated approximately **$175 million** in gross proceeds, intended to fund the Phase 2b SAFEGUARD study of SAB-142 and general corporate purposes, providing sufficient operating cash for the next twelve months[190](index=190&type=chunk)[192](index=192&type=chunk) - The company has a Shelf Registration Statement allowing it to offer and sell up to **$50.0 million** in securities, with **$20.0 million** available under a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co[199](index=199&type=chunk) Cash Flows Summary (Six Months Ended June 30) | Cash Flow Activity | 2025 | 2024 | Change | % Change | | :-------------------------------- | :-------------- | :-------------- | :-------------- | :------- | | Net cash used in operating activities | $(14,948,761) | $(18,467,790) | $3,519,029 | -19.05% | | Net cash provided by (used in) investing activities | $9,868,940 | $(20,140,390) | $30,009,330 | -149.00% | | Net cash used in financing activities | $(347,829) | $(715,457) | $367,628 | -51.38% | [Contractual Obligations and Commitments](index=50&type=section&id=Contractual%20Obligations%20and%20Commitments) As of June 30, 2025, there were no material changes to the company's contractual obligations and commitments outside the ordinary course of business - No material changes to contractual obligations and commitments outside the ordinary course of business as of June 30, 2025[205](index=205&type=chunk) [Income Taxes](index=50&type=section&id=Income%20Taxes) Due to ongoing losses, the company does not anticipate an income tax provision and continues to maintain a valuation allowance on its net deferred tax assets, which increased by approximately $4.5 million during the first half of 2025 - The company does not expect to have an Income Tax Provision due to current and prior year losses[206](index=206&type=chunk) - A valuation allowance on net deferred tax assets increased by approximately **$4.5 million** during the six months ended June 30, 2025[206](index=206&type=chunk) [Off-Balance Sheet Arrangements](index=50&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet financing arrangements or relationships with unconsolidated entities for the periods presented - The company did not have any off-balance sheet financing arrangements or relationships with unconsolidated entities for the periods presented[207](index=207&type=chunk) [Critical Accounting Policies and Estimates](index=50&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting estimates and assumptions, which require significant management judgment, remain consistent with those disclosed in its Annual Report on Form 10-K for 2024, with no significant changes during the three months ended June 30, 2025 - The company's critical accounting estimates and assumptions are consistent with those in its Annual Report on Form 10-K for the year ended December 31, 2024, with no significant changes during the three months ended June 30, 2025[209](index=209&type=chunk) [JOBS Act Accounting Election](index=50&type=section&id=JOBS%20Act%20Accounting%20Election) As an 'emerging growth company' under the JOBS Act, the company has elected to take advantage of the extended transition period for complying with new or revised accounting standards, which may result in financial statements not being comparable to other public companies - The company is an 'emerging growth company' and has elected to take advantage of the extended transition period for complying with new or revised accounting standards under the JOBS Act[210](index=210&type=chunk)[213](index=213&type=chunk) - This election means the company will adopt new or revised standards at the time private companies adopt them, potentially making its financial statements not comparable to other public companies[211](index=211&type=chunk)[213](index=213&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk disclosures indicate no revenue for the current period, with prior revenue entirely from government grants. Its primary exposure to market risk is interest income volatility, but a 10% change in interest rates is not expected to have a material effect. Foreign currency risk is also deemed immaterial, as most business is conducted in U.S. dollars and foreign currency liabilities are not significant - The company recognized no revenue for the three and six months ended June 30, 2025; **100%** of prior year revenue was from government grants[215](index=215&type=chunk) - Primary market risk exposure is to interest income volatility, but a **10%** change in market interest rates is not expected to materially affect the business[216](index=216&type=chunk) - Foreign currency risk is not material, as most business is in U.S. dollars, and foreign currency liabilities are insignificant[217](index=217&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. There were no material changes in internal control over financial reporting during the six months ended June 30, 2025 - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[219](index=219&type=chunk) - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[220](index=220&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation, nor is it aware of any pending or threatened litigation that would materially affect its business, operating results, financial condition, or cash flows - The company is not currently a party to any material litigation, nor is it aware of any pending or threatened litigation that would materially affect its business, operating results, financial condition, or cash flows[223](index=223&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors described in the 2024 Annual Report, except for a new risk related to the obligation to file a registration statement for shares issuable upon conversion of Series B Preferred Stock and warrants. The potential sale of these shares could significantly dilute existing shareholders and cause a decline in the market price of the company's securities - No material changes from the risk factors described in the 2024 Annual Report, except for a new risk related to the Series B Offering[224](index=224&type=chunk) - The company is obligated to file a registration statement for the resale of shares of common stock issuable upon conversion of Series B Preferred Stock and warrants, which could represent **2,690%** of total common stock outstanding as of June 30, 2025[225](index=225&type=chunk)[226](index=226&type=chunk) - The registration and potential sale of these securities, or the perception of such sales, could cause the market price of the company's common stock and public warrants to decline significantly[225](index=225&type=chunk)[226](index=226&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - None[227](index=227&type=chunk) [Item 3. Defaults Upon Senior Securities](index=53&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None[228](index=228&type=chunk) [Item 4. Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[229](index=229&type=chunk) [Item 5. Other Information](index=53&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025 - None of the company's directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the six months ended June 30, 2025[230](index=230&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including certificates of designations, forms of warrants, securities purchase agreements, registration rights agreements, support agreements, and certifications from executive officers - Exhibits include Certificate of Designations of Series B Convertible Non-Voting Preferred Stock, Forms of Preferred Warrants, Securities Purchase Agreement, Registration Rights Agreement, Support Agreement, Letter Agreement with RA Capital Healthcare Fund, L.P., and certifications of principal executive and financial officers[231](index=231&type=chunk) [Signatures](index=57&type=section&id=Signatures) The report is duly signed on August 7, 2025, by Samuel J. Reich, Chair and Chief Executive Officer, and Lucy To, Chief Financial Officer - The report was signed on August 7, 2025, by Samuel J. Reich (Chair and CEO) and Lucy To (CFO)[238](index=238&type=chunk)

Core Insights - SAB BIO recently raised $175 million in an oversubscribed private placement, which included participation from strategic investor Sanofi and top-tier biotech investors [1][4][7] - The financing extends the company's operational runway until mid-2028, allowing for the completion of the pivotal Phase 2b SAFEGUARD study for SAB-142, aimed at delaying the progression of type 1 diabetes [1][4][7] - The SAFEGUARD study is expected to initiate in Q3 2025 following alignment with the FDA on the study's design [2][6][7] Recent Corporate Highlights - The private placement closed on July 22, 2025, and involved the issuance of up to 1,000,000 shares of Series B nonvoting convertible preferred stock, convertible into up to 100,000,000 shares of common stock at a price of $1.75 per share [7] - The company also issued warrants for up to 1,500,000 shares of Series B preferred stock, potentially raising an additional $284 million if fully exercised [7] - SAB BIO's lead candidate, SAB-142, targets autoimmune type 1 diabetes with a disease-modifying approach [9] Recent Clinical and Regulatory Updates - The company completed full randomization of its Phase 1 study in healthy volunteers and successfully enrolled participants with type 1 diabetes to assess the safety, tolerability, pharmacokinetics, and immunogenicity of SAB-142, with final data expected in Q4 2025 [7] - A Type B meeting with the FDA in May 2025 provided feedback that aligned the company on the progression and design of the SAFEGUARD study, which will serve as supportive evidence for future regulatory approvals [7] Q2 2025 Financial Results - As of June 30, 2025, SAB BIO held cash and equivalents of $5.7 million, down from $20.8 million as of December 31, 2024 [12] - Research and development expenses were $7.0 million for Q2 2025, compared to $6.8 million in Q2 2024, reflecting a slight increase due to fluctuating spending priorities [12] - The company reported a net loss of $10.1 million for Q2 2025, compared to a net loss of $7.3 million for the same period in 2024 [12]

Core Viewpoint - SAB BIO has successfully raised $175 million in an oversubscribed private placement financing to fund its pivotal Phase 2b SAFEGUARD study for SAB-142, aimed at delaying the progression of autoimmune type 1 diabetes (T1D) in newly diagnosed patients [2][5]. Group 1: Financing Details - The private placement includes participation from strategic investor Sanofi and several new investors such as RA Capital Management, Commodore Capital, and Blackstone Multi-Asset Investing, among others [1][3]. - The financing agreement allows for the issuance of up to 1,000,000 shares of Series B nonvoting convertible preferred stock, convertible into up to 100,000,000 shares of common stock at a price of $1.75 per share [4]. - There is potential for an additional $284 million in gross proceeds if milestone-based warrants are fully exercised [2][4]. Group 2: Use of Proceeds - The net proceeds from the private placement will be used to fully fund the Phase 2b SAFEGUARD study of SAB-142 and for working capital and general corporate purposes [5]. - The combined proceeds from the private placement and the company's current cash are expected to extend the cash runway into the middle of 2028 [5]. Group 3: Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human anti-thymocyte immunoglobulin (hIgG) to treat autoimmune T1D [2][9]. - The company's lead asset, SAB-142, aims to change the treatment paradigm for T1D by delaying onset and potentially preventing disease progression [9][10].

Core Viewpoint - SAB BIO is making significant progress in developing its immunotherapy platform aimed at delaying the onset or progression of type 1 diabetes (T1D), with recent positive Phase 1 topline data for its lead asset, SAB-142 [2][5]. Recent Pipeline Developments - In April 2025, SAB BIO completed patient dosing in the last cohort of the Phase 1 clinical study of SAB-142, indicating advancement in its clinical trials [2]. Corporate Updates from Q1 2025 - The company has implemented budget initiatives that are contributing to cost savings, particularly in manufacturing processes, which are expected to enhance financial performance in 2025 [7]. - SAB BIO has achieved a Qualified Person (QP) declaration for its in-house CMC manufacturing process for SAB-142, meeting European manufacturing standards for investigational medical drug products [7]. Q1 2025 Financial Results - As of March 31, 2025, SAB BIO held cash and equivalents of $12.9 million, down from $20.8 million as of December 31, 2024 [7]. - Research and development (R&D) expenses were $7.7 million for Q1 2025, a slight decrease from $8.1 million in Q1 2024, attributed to fluctuations in spending priorities for the SAB-142 program [7]. - General and administrative expenses decreased to $3.1 million in Q1 2025 from $4.2 million in Q1 2024, driven by reduced payroll and professional fees [7]. - Other income for Q1 2025 was $5.6 million, down from $6.4 million in Q1 2024, primarily due to changes in fair value of warrant liabilities and reduced net interest income [7]. - The company reported a net loss of $5.2 million for Q1 2025, compared to a net loss of $5.0 million for Q1 2024 [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ 777 W 41 St, Suite 401 st Miami Beach, Florida 33140 (Address of principal executive offices) (Zip Code) (I.R.S. Empl ...

Core Insights - SAB BIO announced positive topline data for SAB-142, indicating its potential as a best-in-class disease-modifying therapy for Type 1 Diabetes (T1D) [2][6] - The company is set to advance its development program and begin enrolling patients in a Phase 2b trial for SAB-142 in mid-2025 [2][6] Recent Pipeline Developments - The Phase 1 clinical trial of SAB-142 met its primary objectives related to safety and pharmacodynamic activity, allowing progression to Phase 2b [6] - The U.S. FDA granted clearance for the investigational new drug (IND) application for SAB-142 on May 21, 2024 [6] - A clinical advisory board was established to provide expert guidance for the development of SAB-142 [6] Corporate Updates from Fiscal Year 2024 - Lucy To was appointed as Chief Financial Officer on July 31, 2024 [6] - Jay Skyler, MD, MACP, FRCP, joined SAB BIO's Board of Directors on May 6, 2024 [6] - Samuel J. Reich expanded his role as Chief Executive Officer on February 2, 2024 [6] Fiscal Year 2024 Financial Results - SAB BIO reported cash and equivalents of $20.8 million as of December 31, 2024, down from $56.6 million a year earlier [6] - Research and development expenses increased to $30.3 million in 2024 from $16.5 million in 2023 [6] - General and administrative expenses decreased to $14.0 million in 2024 from $23.8 million in 2023 [6] - The company reported a net loss of $34.1 million for the year ended December 31, 2024, compared to a net loss of $42.2 million in 2023 [6]

PART I [Business Overview](index=5&type=section&id=Item%201.%20Business) 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](index=21&type=chunk) - 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](index=22&type=chunk) - **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](index=26&type=chunk)[29](index=29&type=chunk) - 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](index=58&type=chunk)[61](index=61&type=chunk)[68](index=68&type=chunk) - SAB Biotherapeutics faces intense competition from major pharmaceutical and biotechnology companies with greater resources and experience in R&D, manufacturing, and commercialization[65](index=65&type=chunk)[66](index=66&type=chunk) - 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](index=69&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) - 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](index=77&type=chunk)[79](index=79&type=chunk)[83](index=83&type=chunk) - 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](index=114&type=chunk)[116](index=116&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) 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](index=122&type=chunk)[123](index=123&type=chunk) - 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](index=130&type=chunk)[131](index=131&type=chunk) - 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](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Difficulties in patient enrollment for clinical trials, unexpected costs, or delays in development and commercialization could materially harm the business[147](index=147&type=chunk)[150](index=150&type=chunk)[167](index=167&type=chunk) - 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](index=65&type=chunk)[267](index=267&type=chunk)[269](index=269&type=chunk) - 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](index=278&type=chunk)[279](index=279&type=chunk)[284](index=284&type=chunk) - 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](index=292&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) [Item 1B. Unresolved Staff Comments](index=72&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - No unresolved staff comments were reported[337](index=337&type=chunk) [Item 1C. Cybersecurity](index=72&type=section&id=Item%201C.%20Cybersecurity) 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](index=339&type=chunk) - External cybersecurity assessment firms are engaged for regular system audits, threat assessments, 24-hour monitoring, and security enhancements[341](index=341&type=chunk) - 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](index=345&type=chunk)[346](index=346&type=chunk) - The company has not experienced any cybersecurity threats or incidents that have materially affected its business strategy, results of operations, or financial condition[343](index=343&type=chunk) [Item 2. Properties](index=75&type=section&id=Item%202.%20Properties) 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](index=350&type=chunk)[351](index=351&type=chunk) - 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](index=352&type=chunk)[353](index=353&type=chunk) - 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](index=354&type=chunk)[355](index=355&type=chunk) - 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](index=356&type=chunk) [Item 3. Legal Proceedings](index=76&type=section&id=Item%203.%20Legal%20Proceedings) 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](index=357&type=chunk) [Item 4. Mine Safety Disclosures](index=76&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine Safety Disclosures are not applicable to SAB Biotherapeutics - Mine Safety Disclosures are not applicable[358](index=358&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=77&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=360&type=chunk) 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](index=361&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future, retaining funds for business growth[362](index=362&type=chunk)[363](index=363&type=chunk) - No recent sales of unregistered securities or issuer purchases of equity were reported for the year ended **December 31, 2024**[365](index=365&type=chunk)[366](index=366&type=chunk) [Item 6. [Reserved]](index=77&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=78&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=369&type=chunk)[370](index=370&type=chunk) - 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](index=371&type=chunk)[372](index=372&type=chunk) - 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](index=373&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk) 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](index=393&type=chunk) 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](index=394&type=chunk)[395](index=395&type=chunk) 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](index=396&type=chunk)[397](index=397&type=chunk) 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](index=398&type=chunk) 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](index=402&type=chunk)[405](index=405&type=chunk) - 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](index=405&type=chunk)[406](index=406&type=chunk) 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](index=414&type=chunk)[415](index=415&type=chunk) - 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](index=416&type=chunk) - 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](index=417&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures about Market Risk](index=90&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable to SAB Biotherapeutics - Quantitative and Qualitative Disclosures about Market Risk are not applicable[439](index=439&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=90&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) 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](index=440&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=90&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) 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](index=441&type=chunk) [Item 9A. Controls and Procedures](index=90&type=section&id=Item%209A.%20Controls%20and%20Procedures) 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](index=444&type=chunk) - Internal control over financial reporting was evaluated based on the COSO framework and determined to be effective as of **December 31, 2024**[447](index=447&type=chunk) - 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](index=448&type=chunk)[449](index=449&type=chunk) [Item 9B. Other Information](index=92&type=section&id=Item%209B.%20Other%20Information) 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](index=450&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=93&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to SAB Biotherapeutics - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[451](index=451&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=93&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) 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](index=475&type=chunk)[476](index=476&type=chunk)[479](index=479&type=chunk) - Key executive officers include **Samuel J. Reich** (CEO & Chairman), **Eddie J. Sullivan** (President), **Lucy To** (CFO), **Christoph Bausch** (COO), and **Alexandra Kropotova** (CMO)[453](index=453&type=chunk)[455](index=455&type=chunk)[456](index=456&type=chunk)[458](index=458&type=chunk)[459](index=459&type=chunk)[460](index=460&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, all comprised solely of independent directors[484](index=484&type=chunk) - **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](index=485&type=chunk)[488](index=488&type=chunk)[495](index=495&type=chunk) - The Board oversees risk, receiving reports from executive management on operational, financial, legal, regulatory, strategic, transactional, and reputational risks[505](index=505&type=chunk) - 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](index=506&type=chunk)[507](index=507&type=chunk) [Item 11. Executive Compensation](index=104&type=section&id=Item%2011.%20Executive%20Compensation) 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 ($) | | :-------------------------- | :--- | :--------- | :---------------- | :---------------- | :---------------------------- | :------------------------- | :---------- | | Samuel J. Reich | 2024 | 518,300 | 1,800,690 | — | 250,000 | 13,800 | 2,582,790 | | | 2023 | 350,000 | 202,598 | — | — | 13,200 | 565,798 | | Eddie J. Sullivan, PhD. | 2024 | 480,900 | 852,773 | — | 250,000 | 13,482 | 1,597,155 | | | 2023 | 377,200 | 202,598 | — | — | 25,359 | 605,157 | | Alexandra Kropotova, MD | 2024 | 540,100 | 554,050 | — | 236,250 | 13,800 | 1,344,200 | | | 2023 | 525,000 | — | 147,125 | 236,250 | 13,200 | 921,575 | | Lucy To | 2024 | 164,400 | 239,300 | — | — | 731 | 404,431 | | | 2023 | — | — | — | — | — | — | | Christoph Bausch, PhD | 2024 | 412,200 | 622,162 | — | 150,000 | 12,385 | 1,196,747 | | | 2023 | 325,000 | 106,123 | — | 105,000 | 13,200 | 549,323 | - Executive employment agreements include annual base salaries, eligibility for bonus plans, participation in benefit plans, and severance packages upon termination without cause or non-renewal, which include a year's base salary, accrued bonus, full vesting of unvested equity, and COBRA premium reimbursement[516](index=516&type=chunk)[518](index=518&type=chunk)[519](index=519&type=chunk)[520](index=520&type=chunk)[521](index=521&type=chunk)[522](index=522&type=chunk) Summary Director Compensation Table (2024) | Name | Fees Earned or Paid in Cash ($) | 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: **$8,000**)[527](index=527&type=chunk) - Non-employee directors receive an initial equity award of options to purchase **35,000 common shares** (vesting over **three years**) and annual equity awards of options to purchase **20,000 common shares** (vesting over **two years**)[528](index=528&type=chunk)[529](index=529&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=113&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section outlines beneficial ownership of common stock for executives, directors, and major stockholders, alongside equity compensation plan details Shares Beneficially Owned as of March 21, 2025 | Beneficial Owner | Common Stock | Percent | Series A-2 Preferred Stock | Percent | Total Voting Power | | :--------------------------------- | :----------- | :------ | :------------------------- | :------ | :----------------- | | Christine Hamilton | 883,568 | 9.44 % | — | * % | 5.51 % | | Eddie J. Sullivan, PhD | 660,391 | 7.01 % | — | * % | 4.1 % | | Samuel J. Reich | 303,385 | 3.19 % | — | * % | 1.87 % | | Andrew Moin | 458,457 | 4.94 % | 28,380 | 67.54 % | 31.1 % | | All directors and executive officers as a group (14 persons) | 2,578,764 | 25.97 % | 28,380 | 67.54 % | 42.67 % | | Entities affiliated with BVF Partners | 917,826 | 9.88 % | 12,217 | 29.07 % | 17.9 % | | Entities Managed by RTW Investments, LP | 1,024,335 | 9.99 % | — | * % | 6.03 % | - The percentage of beneficial ownership is calculated based on **9,288,868 shares of common stock** outstanding as of **March 21, 2025**, including shares exercisable within **60 days**[538](index=538&type=chunk) Equity Compensation Plan Information as of December 31, 2024 | Plan Type | Number of Securities to be Issued Upon Exercise of Outstanding Options and Awards | Weighted-average Exercise Price of Outstanding Securities ($) | 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](index=545&type=chunk)[692](index=692&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=118&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) 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](index=546&type=chunk) - Indemnification agreements are in place with each director and executive officer, providing for indemnification and expense advancements for claims arising from their service[547](index=547&type=chunk) - A written Related Party Transaction Policy requires the Audit Committee to review and approve transactions involving related persons exceeding **$120,000**, ensuring they are consistent with the company's best interests[549](index=549&type=chunk)[550](index=550&type=chunk) [Item 14. Principal Accounting Fees and Services](index=120&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section details aggregate audit fees billed by EisnerAmper LLP for 2024 and 2023, noting the Audit Committee's pre-approval policy Aggregate Fees Billed by EisnerAmper LLP (2024 vs. 2023) | (US Dollars) | 2024 ($) | 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](index=552&type=chunk) - 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](index=553&type=chunk)[555](index=555&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=123&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) 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](index=558&type=chunk)[560](index=560&type=chunk)[561](index=561&type=chunk) - 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](index=559&type=chunk) - 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](index=562&type=chunk)[563](index=563&type=chunk) [Item 16. Form 10-K Summary](index=126&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item indicates that no Form 10-K Summary is provided - No Form 10-K Summary is provided[564](index=564&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=129&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) 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](index=575&type=chunk) - 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](index=576&type=chunk) [Consolidated Balance Sheets](index=130&type=section&id=Consolidated%20Balance%20Sheets) 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](index=581&type=chunk) - Warrant liabilities decreased from **$11.8 million** in 2023 to **$6.4 million** in 2024[581](index=581&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=131&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=584&type=chunk) - Total revenue decreased by **40.9%** year-over-year, while total operating expenses increased by **9.7%**[584](index=584&type=chunk) - Loss from operations increased from **$38.1 million** in 2023 to **$42.9 million** in 2024[584](index=584&type=chunk) - 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](index=584&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity](index=132&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) 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](index=587&type=chunk) - 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](index=587&type=chunk) [Consolidated Statements of Cash Flows](index=133&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) 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](index=414&type=chunk)[415](index=415&type=chunk) - Net cash used in investing activities increased by **$11.8 million** in 2024, mainly due to increased purchases of short-term investments[416](index=416&type=chunk) - 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](index=417&type=chunk) [Notes to Consolidated Financial Statements](index=135&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) 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](index=591&type=chunk) - 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](index=593&type=chunk)[595](index=595&type=chunk) - 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](index=629&type=chunk)[630](index=630&type=chunk) - Research and development expenses are expensed as incurred, including licensing fees, consultant fees, animal care, equipment depreciation, and employee compensation[621](index=621&type=chunk) - Stock-based compensation is recognized using a fair-value measurement method, utilizing the Black-Scholes option-pricing model for valuation[625](index=625&type=chunk)[626](index=626&type=chunk) - 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](index=608&type=chunk)[712](index=712&type=chunk)[715](index=715&type=chunk)[719](index=719&type=chunk) - 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](index=734&type=chunk) - 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](index=746&type=chunk)