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SAB Biotherapeutics, Inc. (NASDAQ: SABS) is a clinical-stage biopharmaceutical company pioneering in the development and commercialization of fully human polyclonal antibodies using its proprietary DiversitAb™ platform. Unlike traditional methods involving human plasma or serum, SAB leverages genetically engineered transchromosomic cattle (Tc Bovine™) to produce large volumes of human antibodies (immunoglobulin G) in response to specific antigens.
The company's core technologies aim to provide novel therapies for a wide range of immune and autoimmune disorders, including its lead asset SAB-142, which targets type 1 diabetes (T1D). SAB-142 is a human anti-thymocyte immunoglobulin designed to modulate the body's immune response, potentially delaying the onset and progression of T1D. This innovative approach has shown promise in early clinical trials, with Phase 1 studies demonstrating safety and biological activity without the adverse reactions commonly associated with animal-derived therapies.
Recent achievements include the FDA granting Breakthrough Therapy and Fast Track Designations to SAB-176, a fully human polyclonal antibody targeting multiple strains of Influenza A and B. This reflects the potential of SAB's platform to address unmet medical needs swiftly and effectively.
SAB is actively pursuing multiple projects and partnerships to expand its clinical pipeline. Notable collaborations include a pharmacokinetic and safety study for SAB-176, conducted in partnership with the Henry Jackson Foundation and the NMRC Clinical Trials Center. Additionally, SAB’s ongoing Phase 1 clinical trial for SAB-142 has successfully completed dosing the third cohort with no observed serum sickness.
Financially, SAB reported positive results for Q1 2024, with sufficient cash reserves expected to fund operations into 2026, assuming the exercise of outstanding Tranche B warrants. The company's strategic relocation of its headquarters to Miami, FL, and the recent appointment of Dr. Jay Skyler to its Board of Directors underscore its commitment to T1D research and treatment.
SAB Biotherapeutics continues to engage with the scientific and investment communities, providing regular updates on its progress and maintaining transparency in its forward-looking statements. As a pioneer in biopharmaceutical innovation, SAB is poised to make significant contributions to the treatment of immune and autoimmune disorders.
SAB Biotherapeutics (Nasdaq: SABS) announced the departure of its Chief Financial Officer, Michael King, effective June 4, 2024. King is leaving to become CEO at a privately-held oncology company but will continue as an advisor to SAB until the end of the year. The company has initiated a search for his permanent replacement. In the interim, Mark Conley, Vice President of Finance, will serve as Interim CFO. SAB remains optimistic about its future, focusing on expanding its clinical programs, including the delay or progression of type 1 diabetes with its hIgG therapy. The company confirmed its 2024 financial outlook and upcoming milestones, including a Phase 1 data readout for SAB-142.
SAB Biotherapeutics (Nasdaq: SABS) announced that the FDA has cleared its IND application for SAB-142, a type 1 diabetes therapy, to proceed to a Phase 1 clinical trial in the US.
SAB-142, a human anti-thymocyte immunoglobulin (hIgG), aims to delay the onset or progression of type 1 diabetes. The ongoing HUMAN trial will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SAB-142 in both healthy volunteers and participants with type 1 diabetes.
The HUMAN trial is a randomized, double-blind, placebo-controlled, single-ascending dose study, with doses ranging from 0.03mg/kg to 2.5mg/kg. The trial design mimics the MELD-ATG study, whose topline results are expected in 2025.
The third cohort has been fully enrolled and dosed without observed serum sickness. This clearance marks a significant advancement in SAB's mission to slow disease progression in type 1 diabetes patients.
SAB Biotherapeutics (Nasdaq: SABS) announced its Q1 2024 financial results and company updates. The company highlighted its focus on T1D immunotherapy, with significant progress in its SAB-142 program. Key pipeline milestones include the complete enrollment of the third cohort in its Phase 1 trial with no serum sickness observed and an impactful partnership with INNODIA. Financially, SAB reported a net loss of $4.0 million, a marked improvement from the $7.4 million loss in the previous year. Operating expenses increased, driven by higher R&D and G&A costs, reflecting intensified efforts in T1D research. Cash reserves stand at $45.2 million, anticipated to fund operations into 2026, assuming full exercise of outstanding warrants.
SAB Biotherapeutics announced the appointment of Dr. Jay Skyler to its Board of Directors. Dr. Skyler's expertise in type 1 diabetes research will benefit the company's SAB-142 program, focusing on delaying the onset of type 1 diabetes. With over five decades of experience in diabetes research, Dr. Skyler's contributions are expected to advance SAB's disease-modifying therapy.
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