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]

"Lucy's proven track record and experience will prove invaluable to SAB as we continue to deliver on our upcoming milestones for SAB-142," notes Samuel J. Reich, Chairman and CEO of SAB. "I'm thrilled to welcome her to our team and look forward to her impact on the organization as we deliver value to our shareholders and transform the landscape of T1D." "I am incredibly excited to join the SAB team during this transformational time for the company where we expect top-line Phase 1 data for our lead candidate ...

New name, logo and website updates, stock symbol will remain SABS MIAMI, June 20, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced its new name, SAB BIO, and visual identity to more closely align with its mission to treat and prevent immune and autoimmune disor ...

MIAMI, June 18, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced that it will present a poster at the ADA 84th Scientific Sessions on June 21-24, 2024 in Orlando, Florida. The poster will be presented by SAB's Senior Program Manager, Eric Sandhurst, Ph.D, and p ...

MIAMI, May 30, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of T1D, today announced that effective June 4, its Chief Financial Officer Michael King will be departing the company to accept a role as CEO at a privately-held oncology company. He will continue as an advisor to SAB through the end of th ...

MIAMI, May 21, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (NASDAQ:SABS) (the "Company" or "SAB"), today announced that the U.S. Food and Drug Administration (FDA) has provided clearance for the Company's investigational new drug (IND) application to proceed for its phase 1 clinical trial for type 1 diabetes (T1D) therapy SAB-142. SAB is a clinical-stage biopharmaceutical company with a novel immunotherapy platform developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progressio ...