MIAMI, March 19, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced the closing of an underwritten public offering of 19,324,677 shares of its common stock at a public offering price of $3.85 per share, and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 2,753,246 shares of common ...

Core Viewpoint - SAB Biotherapeutics, Inc. has announced a public offering of common stock and pre-funded warrants to raise approximately $85 million to fund the development of its clinical-stage product candidate, SAB-142, targeting type 1 diabetes and other autoimmune diseases [1][2]. Group 1: Offering Details - The company is offering 19,324,677 shares of common stock at a price of $3.85 per share and pre-funded warrants for 2,753,246 shares at $3.8499 each, with gross proceeds expected to be around $85 million before expenses [1]. - Underwriters have a 30-day option to purchase an additional 3,311,688 shares on the same terms [1]. - The offering is expected to close on or about March 19, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the continued development of SAB-142 through clinical trials, manufacturing, regulatory activities, and general corporate purposes [2]. Group 3: Company Overview - SAB Biotherapeutics is focused on developing human immunoglobulin G (hIgG) to treat autoimmune disorders, utilizing advanced genetic engineering and proprietary technology [6]. - The lead candidate, SAB-142, aims to modify the treatment paradigm for type 1 diabetes by delaying onset and potentially preventing disease progression in Stage 3 patients [6]. - SAB-142 is currently in a registrational Phase 2b clinical trial named SAFEGUARD [6].

Core Viewpoint - SAB Biotherapeutics, Inc. has announced a public offering of 19,324,677 shares at a price of $3.85 per share, aiming to raise approximately $85 million for the development of its clinical-stage product candidate, SAB-142, targeting type 1 diabetes and other autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes pre-funded warrants to purchase up to 2,753,246 shares at a price of $3.8499 per warrant, with gross proceeds expected to be around $85 million before expenses [1]. - The underwriters have a 30-day option to purchase an additional 3,311,688 shares under the same terms [1]. - The offering is expected to close on or about March 19, 2026, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the continued development of SAB-142 through clinical trials, as well as for manufacturing, regulatory, operational activities, and general corporate purposes [2]. Group 3: Management and Regulatory Information - Jefferies, UBS Investment Bank, Citigroup, and Barclays are acting as joint book-running managers for the offering, with Chardan as the lead manager [3]. - The offering is made under a shelf registration statement filed with the SEC, and a final prospectus supplement will be available on the SEC's website [4]. Group 4: Company Overview - SAB Biotherapeutics is focused on developing human immunoglobulin G (hIgG) to treat immune and autoimmune disorders, utilizing advanced genetic engineering and antibody science [6]. - The lead candidate, SAB-142, aims to modify the treatment paradigm for type 1 diabetes by delaying onset and potentially preventing disease progression in Stage 3 patients [6].

MIAMI, March 17, 2026 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced that it has commenced an underwritten public offering of shares of its common stock (and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of common stock). SAB BIO also intends to grant the underwriters a 30-day o ...

Core Insights - SAB Biotherapeutics, Inc. announced promising early data from the Phase 1 trial of SAB-142, indicating preservation of C-peptide levels in adult patients with type 1 diabetes (T1D) [2][4][9] Group 1: Clinical Trial Results - In the Phase 1 T1D cohort, four out of six adult participants treated with SAB-142 (2.5 mg/kg) showed no decrease in C-peptide levels at Day 120 compared to baseline, while the placebo group exhibited a decline [2][3] - The mean C-peptide levels in SAB-142 treated participants increased above baseline by Day 120, contrasting with the predicted decline in the placebo group [4][9] - The study included six adult participants aged 19 to 40, all with established T1D and residual beta cell function at baseline [3][4] Group 2: Mechanism of Action and Efficacy - The preservation of C-peptide is a positive clinical marker for endogenous insulin production, suggesting that SAB-142 may modify the disease course in T1D [3][4] - Biomarker evidence indicated T cell exhaustion, supporting the hypothesis that SAB-142 engages its intended biological mechanism [3][4] Group 3: Future Developments - The Phase 1 study met its primary objectives, allowing SAB Biotherapeutics to advance SAB-142 into the registrational Phase 2b SAFEGUARD trial, which aims to evaluate safety and efficacy in new-onset T1D patients [9][14] - Topline data from the SAFEGUARD trial is expected in the second half of 2027, with the trial currently enrolling participants globally [9][14] Group 4: Company Overview - SAB Biotherapeutics is focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies for autoimmune disorders, with SAB-142 as a lead candidate targeting T1D [16] - The company utilizes advanced genetic engineering to produce hIgG without the need for human donors, aiming to address serious unmet medical needs [16]

Core Insights - SAB Biotherapeutics, Inc. has advanced its lead candidate SAB-142 into the registrational Phase 2b SAFEGUARD study, with multiple patients already dosed and enrollment expected to complete by the end of 2026, with topline data anticipated in the second half of 2027 [1][3][7] - The company raised $175 million in an oversubscribed private placement to fully fund the SAFEGUARD study, indicating strong investor confidence [1][11] - SAB-142 has shown a favorable safety profile in Phase 1 clinical data, with no serum sickness and low immunogenicity observed across all cohorts [1][7][11] Financial Highlights - For the fiscal year 2025, SAB reported a net income of $13.3 million, a significant improvement from a net loss of $34.1 million in 2024 [13] - The company had cash, cash equivalents, and available-for-sale securities totaling $143.5 million as of December 31, 2025, providing operational runway through 2028 [13] - Research and development expenses for 2025 were $34.4 million, compared to $30.3 million in 2024, reflecting ongoing investment in clinical development [13] Clinical Development - SAB-142 is being developed as a disease-modifying immunotherapy for type 1 diabetes (T1D), with the potential to delay disease progression [1][11][14] - The Phase 1 study results confirmed that SAB-142 does not cause serum sickness and has low/no immunogenicity, supporting its chronic dosing in outpatient settings [7][11] - The company has activated multiple clinical trial sites in the U.S., Australia, and New Zealand for the SAFEGUARD study [7] Leadership and Governance - David Zaccardelli, Pharm.D., was appointed as Chair of the Board of Directors in January 2026, bringing over 20 years of biopharmaceutical experience [6] - Rita Jain, M.D., was also appointed as an Independent Director in January 2026, adding expertise in biopharmaceutical development and regulatory affairs [11]

Product Development and Clinical Trials - The company is focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) to treat autoimmune disorders, with a lead candidate, SAB-142, targeting type 1 diabetes (T1D) to potentially change the treatment paradigm [21]. - SAB-142 has shown clinical validation in approximately 800 human subjects, with no incidence of serum sickness or neutralizing anti-drug antibodies reported in the Phase 1 study [29]. - The company received Investigational New Drug (IND) clearance from the FDA in May 2024 and initiated the registrational Phase 2b clinical trial, called the SAFEGUARD study, in Q3 2025 [31]. - The company aims to address the significant unmet medical needs in new onset Stage 3 T1D patients, as there are currently no approved therapies for delaying disease progression in this group [40]. - The Phase 2 clinical trial results for low-dose rATG demonstrated statistically significant preservation of C-peptide levels and reduction of HbA1C compared to placebo [42][47]. - The MELD-ATG trial showed that both 2.5 mg/kg and 0.5 mg/kg doses of rATG preserved C-peptide levels significantly compared to placebo, indicating potential for effective treatment [46][47]. - The company plans to initiate a global Phase 2b study called SAFEGUARD to assess the safety, efficacy, and tolerability of SAB-142 in patients with Stage 3 new onset T1D [84]. - The SAFEGAURD study will enroll 159 participants aged 5–40 years with new onset Stage 3 T1D, with a primary efficacy endpoint of stimulated C-peptide showing at least a 40% difference with 80% power [85]. - Part B of the study includes a randomized cohort of 147 patients evaluating two active dose levels of SAB-142 (1.5 mg/kg and 2.5 mg/kg) versus placebo, administered intravenously [85]. - Part C of the study is a 12-month long-term extension designed to evaluate the safety and efficacy of SAB-142 over a 24-month treatment period, allowing for robust safety data collection [91]. - The Phase 1 trial confirmed that SAB-142 does not cause sustained lymphodepletion, with lymphocyte counts returning to baseline within 1 to 3 days post-dosing [82]. - The Phase 1 trial included a cohort of redosed healthy volunteers, demonstrating the potential for safe and reliable redosing without major immune reactions [58]. - The Phase 1 trial showed that SAB-142 preserved regulatory T cells (Tregs) while inducing markers consistent with Treg activation, supporting its disease-modifying potential [78]. - SAB-142 treatment resulted in sustained elevation of PD-1+ Tconv cells over a 120-day period, indicating a controlled immune response [72]. - The first patient in the Phase 2b study was dosed in December 2025, with topline data expected in the second half of 2027 [93]. Market and Competitive Landscape - The prevalence of T1D is increasing, with an estimated 9.5 million people living with T1D worldwide in 2024, projected to rise to 14.7 million by 2040 [35]. - Current therapies for T1D, primarily insulin injections, have significant limitations, including a reduced life expectancy of 10-15 years and high rates of acute complications [34]. - The company is facing competition from major pharmaceutical and biotechnology companies, which may have greater financial resources and established market presence [104]. - The company aims to identify, acquire, and develop additional product candidates through business development efforts [168]. Regulatory Environment - The regulatory pathway for T1D indications using SAB-142 has been established with the FDA and other regulatory agencies, with over 30 immunoglobulin products previously approved by CBER [30]. - The FDA targets a 180-day review period for original NADAs and a 10-month review period for standard BLAs, with expedited review options available [128][131][136]. - The company is developing hIgG product candidates regulated as biological products by the FDA, which requires a New Animal Drug Application (NADA) for marketing in the U.S. [115][117]. - The FDA's review process for biologic products includes evaluating safety, purity, and potency, and may involve advisory committee recommendations [132]. - The company is subject to rigorous FDA regulations post-approval, including inspections and reporting of GMP deviations [134]. - Significant regulatory obligations will arise if any product candidates receive marketing approval, including compliance with Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs) [170]. - The approval process for product candidates can be lengthy and unpredictable, with potential delays due to additional data requests from regulatory authorities [182]. - The company has not submitted any New Animal Drug Applications (NADA) or Biologics License Applications (BLA) to the FDA [195]. Financial and Operational Considerations - The company may incur losses for the foreseeable future and has a limited operating history, making future forecasting difficult [156]. - The company is a clinical-stage biopharmaceutical entity and has incurred significant losses since inception, expecting to continue this trend for the foreseeable future [160]. - The company anticipates significant operating losses due to ongoing research and development, preclinical testing, and clinical trials, alongside general administrative costs [160]. - The company has received over $200 million in funding from U.S. Government programs for emerging disease and medical countermeasures [149]. - The company has not completed the development of any product candidates and does not expect to generate revenue from them for several years, if ever [190]. - The company may not have the financial resources to continue development if regulatory approval is delayed or prevented [193]. - The company’s financial results may fluctuate significantly, impacting stock price and investor confidence [161]. - The company must attract and retain skilled personnel to manage growth effectively, which may be challenging given limited resources [158]. Intellectual Property - The company actively seeks to protect its intellectual property, including patents related to its production platform and hIgG technology, to maintain competitive advantages [106]. - The company has over 50 issued patents or pending applications as of March 2026, with global patent protection expected to extend to 2041 and beyond [110]. - The company has pending patent applications for ungulate-derived hIgG that specifically bind influenza antigens, with potential expiration in 2042 and 2044 [113]. - The company has pending patent applications related to anti-thymocyte globulin (ATG) products, with potential expiration in 2041 and 2045 [113]. - The company has granted patents in major markets for a HAC vector related to human antibody heavy and light chains, with expiration dates ranging from 2030 to 2041 [113][114]. Manufacturing and Production - The company is expanding its manufacturing capabilities with two cGMP facilities in Sioux Falls, South Dakota, including a 200L scale suite for larger Phase 2 studies [98]. - The proprietary production platform allows for the generation of targeted, high-potency human immunoglobulin (hIgG) without human donors, enhancing scalability and market supply [96]. - The company expects to rely on third parties for the production of clinical and commercial quantities of its products, which must comply with GMP regulations [133]. - The company has not entered into long-term manufacturing agreements, which could affect the production and supply of its product candidates [159]. Risks and Challenges - The company faces risks related to potential product liability lawsuits that could divert resources and limit commercialization efforts [158]. - The company may face challenges in enrolling patients for clinical trials, which could delay or terminate trials and increase development costs [184]. - There is a high failure rate for drugs in clinical trials, and positive results from early studies may not predict later success [201]. - Delays in obtaining approvals could significantly harm the commercial prospects of product candidates and impair revenue generation [209]. - Undesirable side effects from product candidates could interrupt or halt clinical trials, potentially leading to more restrictive regulatory approvals [214]. - Regulatory authorities may require additional clinical trials or impose stricter designs if the risk-benefit profile of product candidates is viewed negatively [218]. - Any negative occurrences could limit the commercial success of product candidates and adversely affect the company's financial condition [220].

Summary of SAB Biotherapeutics FY Conference Call Company Overview - **Company**: SAB Biotherapeutics (Ticker: SABS) - **Industry**: Biotechnology, specifically focusing on therapies for type 1 diabetes - **Lead Asset**: SAB-142, a human anti-thymocyte globulin aimed at treating type 1 diabetes by preserving beta cells [4][5] Core Points and Arguments Mission and Product Development - SAB Biotherapeutics aims to transform type 1 diabetes treatment by developing therapies that change disease progression rather than just managing symptoms [4] - SAB-142 is currently in a Phase IIb trial, targeting a multi-billion dollar market with significant unmet medical needs [4][5] Mechanism of Action - SAB-142 works by inducing T-cell exhaustion while preserving regulatory T cells (Tregs), which is crucial for preserving beta cells and improving glycemic function [12][14] - The drug is designed to avoid the safety issues associated with rabbit-derived anti-thymocyte globulin, such as serum sickness and immunogenicity [16][18] Clinical Trials and Study Design - The SAFEGUARD study is a global Phase IIb trial enrolling newly diagnosed Stage 3 type 1 diabetes patients within 100 days of diagnosis [22] - The primary endpoint is C-peptide preservation, with a clinically meaningful target of 40% preservation compared to placebo [23] - Secondary endpoints include HbA1c reduction and insulin use frequency, which are important for demonstrating overall treatment efficacy [24] Market Opportunity - There are approximately 64,000 new type 1 diabetes patients diagnosed annually in the U.S., representing a significant addressable market [39] - SAB Biotherapeutics plans to expand its market by targeting earlier-stage patients (Stage 2) in future studies [40] Competitive Landscape - Tzield, a competing product, has shown preservation of C-peptide but not reduction in HbA1c, while SAB-142 aims to achieve both [46] - The dosing regimen for SAB-142 is significantly shorter (2 days) compared to Tzield (12 days), which may enhance patient compliance and market competitiveness [46][48] Regulatory Strategy - The company has received agreement from the FDA that the SAFEGUARD study is a pivotal study, potentially sufficient for regulatory approval [33] - The precedent set by Tzield's approval may lower the bar for SAB-142's approval, as it has shown that C-peptide preservation can be a sufficient endpoint [44] Financial Position - As of the end of 2025, SAB Biotherapeutics had $140 million in cash, providing a runway to fund the SAFEGUARD trial through to top-line data and beyond into 2028 [50] Additional Important Information - The company is preparing for commercial launch, exploring patient-provider journeys, and assessing market dynamics [41] - Future updates will include enrollment progress and data from completed Phase I studies, which will be shared at scientific venues [37] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the biotechnology sector focused on type 1 diabetes treatment.

Summary of SAB Biotherapeutics Conference Call Company Overview - **Company**: SAB Biotherapeutics (NasdaqCM:SABS) - **Focus**: Development of new medicines for type 1 diabetes, aiming to change the course of the disease rather than just treat symptoms [2][3] Industry Context - **Market Opportunity**: Type 1 diabetes represents a major unmet medical need with no approved drugs currently available, creating a multi-billion dollar market opportunity [3][6] - **Patient Demographics**: Approximately 64,000 new patients are diagnosed with type 1 diabetes each year [6] Key Product Information - **Lead Asset**: SAB-142, an anti-thymocyte immunoglobulin that is fully human [2][15] - **Mechanism of Action**: SAB-142 induces T cell exhaustion while preserving regulatory T cells (Tregs), which is critical for self-tolerance [11][15] - **Clinical Trials**: Currently in a pivotal phase 2b trial named SAFEGUARD, targeting newly diagnosed patients within 100 days of diagnosis [28][43] Clinical Trial Details - **Phase 1 Study**: Completed in 2024, demonstrated safety and absence of serum sickness or anti-drug antibodies [17][22] - **Dosing for SAFEGUARD**: Two doses being tested: 2.5 mg/kg and 1.5 mg/kg [19][20] - **Primary Endpoint**: C-peptide preservation at one year, with a target of 40% preservation considered clinically meaningful [44][47] - **Enrollment Timeline**: Expected to complete enrollment by the end of 2026, with data anticipated in the second half of 2027 [43] Competitive Landscape - **Competitors**: Tzield, which is under review for approval in stage 3 type 1 diabetes, has shown regulatory clarity and a potential path for approval based on C-peptide preservation [53] Commercial Strategy - **Market Preparation**: Early commercial activities are underway, including the hiring of David Zaccardelli as chairman, who has experience in successful drug launches [49] - **Addressable Market**: Focus on newly diagnosed patients and potential expansion to stage 2 patients, which could significantly increase the market size [50][51] Financial Health - **Cash Position**: SAB Biotherapeutics had approximately $140 million in cash at the end of 2025, sufficient to fund operations through 2028 [54] Additional Insights - **Regulatory Strategy**: Engaging with regulatory agencies to ensure a clear path for approval and to establish a favorable safety profile before moving to younger patient populations [29][30] - **Long-term Vision**: The company aims to develop therapies that can preserve beta cell function in earlier stages of type 1 diabetes, potentially leading to a functional cure [50][51]

Company Overview - Acumen Pharmaceuticals is a micro-cap biotech company focused on developing treatments for Alzheimer's disease, aiming to help patients "hold on to their moments" [1] - The company is addressing a significant market opportunity, with over 7 million people in the U.S. currently living with Alzheimer's, projected to rise to nearly 13 million by 2050 [1] Product Development - Acumen's lead drug candidate, sabirnetug, is a humanized monoclonal antibody targeting toxic amyloid-beta oligomers (AβOs), which are believed to contribute to synaptic dysfunction and neurodegeneration in Alzheimer's [7][8] - In its Phase 1 clinical trial (INTERCEPT-AD), sabirnetug demonstrated a favorable safety profile and positive biomarker effects, including reductions in amyloid plaque measures [9] - The FDA granted Fast Track designation for sabirnetug, facilitating its development for early Alzheimer's treatment [9] Clinical Trials and Future Plans - Acumen has initiated the Phase 2 ALTITUDE-AD trial to evaluate sabirnetug's ability to slow cognitive decline in early Alzheimer's patients, with topline results expected in late 2026 [10] - The company is also developing a next-generation strategy to enhance antibody delivery to the brain through a collaboration with JCR Pharmaceuticals, aiming for non-clinical data in early 2026 [12] Market Sentiment and Analyst Ratings - Analysts express optimism about Acumen's prospects, with Stifel's analyst Paul Matteis rating ABOS a Buy and setting a price target of $10, indicating a potential upside of 405% [15] - The stock has a Strong Buy consensus rating from Wall Street, with an average target price suggesting a 223% gain over the next year [15] Industry Context - The biotech sector is recovering from a cyclical trough, with improving macro conditions, increased FDA approvals, and rising investor confidence expected to drive strong performance in 2026 [3][4] - Biotech stocks are often influenced by catalysts such as clinical trial data and regulatory decisions, making careful stock selection crucial [5]