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].

Revenue Performance - Total revenue for the three months ended March 31, 2025, was $0, a decrease of $0.9 million or 100% compared to $944,575 for the same period in 2024 due to the termination of the JPEO Rapid Response Contract[160]. - Total revenue for the three months ended March 31, 2025, was 100% derived from government grants, with no receivables written off[197]. Expenses - Research and development expenses for the three months ended March 31, 2025, were $7,657,321, a decrease of $488,749 or 6.0% from $8,146,070 in 2024[162]. - Salaries and benefits within research and development increased by $951,996 or 41.5% year-over-year, totaling $3,245,785 for the three months ended March 31, 2025[153]. - Clinical trial expenses rose significantly by $1,121,148 or 139.1% year-over-year, amounting to $1,927,208 for the three months ended March 31, 2025[153]. - Outside laboratory services decreased by $944,883 or 56.8% year-over-year, totaling $718,272 for the three months ended March 31, 2025[153]. - General and administrative expenses for the three months ended March 31, 2025, were $3,114,781, a decrease of $1,074,340 or 25.7% from $4,189,121 in 2024[159]. - General and administrative expenses decreased by $1.1 million, or 25.6%, to $3.1 million for the three months ended March 31, 2025, compared to $4.2 million in the same period of 2024[164]. Financial Position - The net loss for the three months ended March 31, 2025, was $5,196,773 compared to a net loss of $5,025,745 for the same period in 2024[159]. - Cash, cash equivalents, and investments totaled $12.9 million as of March 31, 2025, down from $20.8 million as of December 31, 2024[171]. - Net cash used in operating activities was $7.8 million for the three months ended March 31, 2025, a decrease of $3.0 million compared to $10.8 million in the same period of 2024[180]. - Net cash provided by investing activities was $4.7 million for the three months ended March 31, 2025, compared to a net cash outflow of $31.4 million in the same period of 2024[180]. - The accumulated deficit reached $129.4 million as of March 31, 2025, with expectations of continued losses as product candidates are developed and commercialized[186]. - The company anticipates needing additional capital to fund operations and support long-term plans, with potential financing through equity or debt[187]. Non-Operating Income - Total non-operating income decreased by $0.4 million, or 6.07%, to $5.6 million for the three months ended March 31, 2025, primarily due to a decrease in the fair value of warrant liabilities[166]. - Interest income decreased by $0.4 million, or 87.45%, to $62,498 for the three months ended March 31, 2025, compared to $497,893 in the same period of 2024[169]. Regulatory and Development Plans - The company plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate its therapeutic candidate for new-onset Type 1 diabetes[145]. - The proprietary platform is expected to generate additional novel therapeutic candidates, enhancing the company's pipeline[143]. - The company has a demonstrated regulatory pathway through multiple agencies, streamlining the development of new drug products[148]. Tax and Currency Exposure - The valuation allowance on net deferred tax assets increased by approximately $2.5 million during the three months ended March 31, 2025[185]. - The company does not hedge foreign currency exchange rate risk, with liabilities in foreign currencies deemed not material as of March 31, 2025[199]. - A 10% change in market interest rates is not expected to materially affect the company's financial condition or results of operations[198]. - The company conducts nearly all business in U.S. dollars, minimizing exposure to foreign currency fluctuations[199]. Operating Losses - The company has incurred operating losses for several years and expects to continue generating losses for the foreseeable future[173].

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)

Summary of SAB Biotherapeutics (SABS) Conference Call Company Overview - **Company**: SAB Biotherapeutics (SABS) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company specializing in human IgG products for autoimmunity, particularly type one diabetes (T1D) [4][5] Key Milestones and Developments - **Clinical Trials**: Recently completed Phase 1 trial for an anti-thymocyte globulin asset, focusing on T1D [4][12] - **Mechanism of Action**: The product aims to replicate the efficacy of rabbit antithymocyte globulin (thymoglobin) without the associated immunogenicity and serum sickness [12][15] - **Phase 2 SAFE Guard Study**: Planned to start in mid-2025, targeting newly diagnosed T1D patients within 100 days of diagnosis [42][56] Proprietary Technology - **Transchromosomic Cow Platform**: Unique in the world, allowing for the production of human IgG from genetically engineered cows [6][7] - **Advantages**: Higher plasma yield (60 times more than humans), robust immune response, and established infrastructure for animal care [9][10] Clinical Data Insights - **Phase 1 Trial Results**: - Doses ranged from 0.003 mg/kg to 2.5 mg/kg, with a focus on serum sickness and T cell markers [13][14] - Demonstrated activation of T cells leading to exhaustion signals without long-term lymphodepletion [14][18] - **Safety Profile**: No significant lymphodepletion observed; transient lymphopenia was expected and not clinically significant [22][24] Future Plans and Expectations - **Next Steps**: - Continue with Phase 2 study focusing on preservation of C peptide at one year [42] - Potential for redosing based on favorable safety and immunogenicity data [49][50] - **Expected Data Timeline**: Interim analysis expected within a year of trial start, with top-line data anticipated in mid-2027 [56][57] Market and Competitive Landscape - **Unique Positioning**: SAB Biotherapeutics is positioned as a leader in the development of human IgG therapies for autoimmune diseases, with a focus on unmet medical needs where existing rabbit products are not suitable [39][54] - **Physician Feedback**: Positive feedback from key opinion leaders (KOLs) regarding the preservation of Tregs and the dual exhaustion of CD4 and CD8 T cells [53][54] Additional Considerations - **Regulatory Path**: The product's safety profile and lack of immunogenicity are expected to facilitate regulatory approval [49][50] - **Broader Applications**: Potential future indications include scleroderma, lupus nephritis, and celiac disease, expanding the therapeutic scope beyond T1D [39][40]

Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders [2] - The company's lead asset, SAB-142, targets type 1 diabetes (T1D) with a disease-modifying therapeutic approach aimed at delaying onset and potentially preventing disease progression [2] - SAB BIO utilizes advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, enabling the generation of a diverse repertoire of specifically targeted, high-potency human IgGs [2] Upcoming Events - SAB BIO management will participate in the Guggenheim SMID Cap Biotech Conference on February 6, 2025, with a fireside chat scheduled from 2:00 to 2:25 PM ET [1] - The company will also present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, from 10:00 to 10:30 AM ET [1] - Live webcasts and archived recordings of these events will be available on the SAB BIO investor relations website [1]

Core Insights - SAB BIO announced positive topline data from a Phase 1 trial of SAB-142, which met its primary objectives related to safety and pharmacodynamic activity, allowing it to advance to Phase 2b clinical development [1][2][3] Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders, specifically targeting type 1 diabetes (T1D) with its lead asset, SAB-142 [9] Phase 1 Trial Summary - The Phase 1 trial was a randomized, double-blind, placebo-controlled study among healthy volunteers and participants with T1D, aimed at establishing safety, tolerability, pharmacokinetic, immunogenicity, and pharmacodynamic profiles for SAB-142 [3][4] - The trial demonstrated that SAB-142 was generally well-tolerated, with no reported serum sickness or anti-drug antibodies at the target dose [6][7] Safety and Efficacy - SAB-142 exhibited a favorable safety profile, supporting chronic dosing in an outpatient setting, with a dose range from 0.03 mg/kg to 2.5 mg/kg [7] - The mechanism of action (MoA) of SAB-142 was shown to be analogous to rabbit ATG, with sustained immunomodulation and clinically validated multi-target mechanisms [7] Future Development Plans - Based on the positive data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate its therapeutic potential in adult and pediatric patients with new-onset T1D [4][6]

Core Viewpoint - SAB BIO is hosting a Research and Development webinar on January 28, 2025, to discuss topline data from the Phase 1 clinical trial of its lead candidate, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D) [1][4]. Company Overview - SAB BIO is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) to treat and prevent immune and autoimmune disorders without the need for human donors or convalescent plasma [5]. - The lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression [5]. Webinar Details - The webinar is scheduled for January 28, 2025, at 8:00 AM ET, featuring presentations from SAB BIO's management and Dr. Michael Haller, a key opinion leader in diabetes research [2][4]. - A live question and answer session will follow the presentations, and a replay will be available on the SAB BIO website [2]. Phase 1 Trial Information - The Phase 1 trial for SAB-142 is a randomized, double-blind, placebo-controlled study designed to establish the safety, tolerability, pharmacokinetic, immunogenicity, and pharmacodynamic profile of the drug in healthy volunteers and participants with T1D [3].

Core Viewpoint - SAB Biotherapeutics, Inc. has established a clinical advisory board to guide the development of its leading therapeutic candidate, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D) [1][2][3] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human immunoglobulins to treat immune and autoimmune disorders, with a particular emphasis on T1D [8][9] - The company's lead asset, SAB-142, is designed to modify the disease course of T1D by delaying its onset and potentially preventing progression [8] Clinical Advisory Board - The newly formed clinical advisory board consists of leading experts in T1D therapy development, expected to provide strategic direction and insights on clinical protocols [2][4] - Founding members include prominent figures from various prestigious institutions, enhancing the company's research and development capabilities [4] SAB-142 Overview - SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG), with a mechanism of action similar to rabbit ATG, which has shown efficacy in slowing disease progression in clinical trials [5][6] - Unlike rabbit ATG, SAB-142 is a human antibody, allowing for safe and consistent re-dosing without the adverse immune reactions associated with animal-derived treatments [7] Mechanism of Action - SAB-142 targets multiple immune cells that destroy pancreatic beta cells, aiming to preserve insulin-producing cells and regulate blood sugar levels [6][7]