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]

Core Insights - SAB Biotherapeutics has appointed Lucy To as Chief Financial Officer, effective August 12, 2024, bringing over 18 years of investment banking and strategic operational expertise to the company [6] - The company is focused on developing SAB-142, a therapeutic aimed at delaying the onset and progression of type 1 diabetes (T1D), with top-line Phase 1 data expected by the end of 2024 [1][6] - SAB utilizes a novel immunotherapy platform that generates human immunoglobulins without the need for human donors, targeting serious unmet needs in immune and autoimmune disorders [2] Company Overview - SAB BIO is a clinical-stage biopharmaceutical company developing high-potency immunoglobulins (IgGs) to treat immune and autoimmune disorders [2] - The lead asset, SAB-142, employs a disease-modifying therapeutic approach to change the treatment paradigm for T1D [2] - The company’s DiversitAb™ drug development system leverages advanced genetic engineering to produce a diverse range of specifically targeted human IgGs [2] Leadership and Strategy - Lucy To's role will encompass corporate finance, corporate strategy, and broader strategic business relationships [6] - The company aims to deliver value to shareholders while transforming the landscape of T1D treatment [1]

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 ...

Core Viewpoint - SAB Biotherapeutics is advancing its clinical-stage biopharmaceutical product, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D) and will present findings at the ADA 84th Scientific Sessions in June 2024 [1][2] Company Overview - SAB Biotherapeutics focuses on developing human immunoglobulins (IgGs) for treating immune and autoimmune disorders without relying on human donors or convalescent plasma [12] - The company's lead asset, SAB-142, is designed to modify the disease progression of T1D, potentially changing the treatment paradigm [12] Product Details - SAB-142 is a fully human alternative to rabbit anti-thymocyte globulin (ATG), which has shown efficacy in slowing disease progression in clinical trials for T1D [3][10] - The mechanism of action for SAB-142 involves targeting immune cells that destroy pancreatic beta cells, aiming to preserve insulin production [4] - Unlike rabbit ATG, SAB-142 is expected to minimize adverse immune reactions, allowing for safer and more consistent re-dosing [4] Clinical Development - Following FDA IND clearance in May 2024, the company is expanding its clinical program for SAB-142 [11] - The ADA 84th Scientific Sessions will feature a poster presentation on the assessment of tolerance and safety for SAB-142, highlighting its potential in diabetes treatment [2][9]

Core Insights - SAB Biotherapeutics announced the departure of CFO Michael King, who will take on a CEO role at a privately-held oncology company, effective June 4, 2024, while remaining an advisor until the end of the year [1][3] - The Board of Directors has initiated a search for a permanent CFO, with Mark Conley serving as Interim CFO during this transition [2] - The company reaffirmed its fiscal year 2024 outlook and upcoming milestones, including a topline data readout from its Phase 1 study of lead candidate SAB-142 [4] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing human, multi-targeted, high-potency immunoglobulins (IgGs) for treating immune and autoimmune disorders, specifically targeting type 1 diabetes (T1D) with its lead asset SAB-142 [5] - The company utilizes advanced genetic engineering and antibody science to produce a diverse range of specifically targeted, high-potency human IgGs without the need for human donors or convalescent plasma [5]

Core Insights - The U.S. FDA has cleared SAB Biotherapeutics' IND application for SAB-142, a therapy aimed at treating type 1 diabetes (T1D) [1][3] - The ongoing HUMAN trial will generate data for a future Phase 2B trial, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142 [2][3] Company Overview - SAB Biotherapeutics is a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hIgG) to delay T1D onset or progression [1][7] - The company utilizes advanced genetic engineering to produce high-potency immunoglobulins without the need for human donors or convalescent plasma [7][8] Trial Design - Phase 1 of the SAB-142 trial is a randomized, double-blind, placebo-controlled study with a dose range from 0.03 mg/kg to 2.5 mg/kg [3] - The trial aims to validate the safety and immunogenicity profile of SAB-142, with no observed serum sickness in the third cohort [3][4] Mechanism of Action - SAB-142 is designed to target immune cells that destroy pancreatic beta cells, similar to rabbit anti-thymocyte globulin (ATG), but aims to avoid adverse immune reactions associated with animal-derived treatments [6][4] - Previous clinical trials have shown that rabbit ATG can slow beta cell destruction and preserve insulin production, which is critical for blood sugar regulation [5][6]

Core Insights - SAB Biotherapeutics, Inc. is focused on developing human anti-thymocyte immunoglobulin (hIgG) to delay the onset or progression of type 1 diabetes (T1D) [1][5] - The company reported financial results for Q1 2024, highlighting a net loss of $4.0 million and a cash position of $45.2 million as of March 31, 2024 [4][6] Company Updates - The company appointed Dr. Jay Skyler, a renowned T1D expert, to its Board of Directors, increasing the board size to 11 members, with 9 being independent [2] - SAB has transitioned its corporate headquarters to Miami, FL, while maintaining its Research and Development Campus in South Dakota [2] Pipeline and Milestones - SAB's partnership with INNODIA was showcased at an annual meeting in Belgium, where updates on SAB-142 were presented to global T1D partners [3] - The Phase 1 clinical development of SAB-142 is on track, with the third cohort fully enrolled and dosed without any observed serum sickness [3] Financial Performance - Cash, cash equivalents, and available-for-sale securities totaled $45.2 million as of March 31, 2024, down from $56.6 million as of December 31, 2023, primarily due to ongoing research expenses [6] - Research and Development expenses increased to $7.1 million in Q1 2024 from $4.5 million in Q1 2023, reflecting a focus on the autoimmunity space with SAB-142 [6] - General and Administrative expenses rose to $4.2 million in Q1 2024 from $3.4 million in Q1 2023, driven by increased headcount to support research activities [6] - Non-operating income surged to $6.4 million in Q1 2024 from $48,000 in Q1 2023, mainly due to changes in fair value of warrant liabilities and an Australian research and development tax credit [6] - The net loss for Q1 2024 was $4.0 million, translating to an earnings per share of $(0.43), compared to a net loss of $7.4 million and $(0.15) per share in Q1 2023 [6]