SAB Biotherapeutics, Inc. develops fully human anti-thymocyte immunoglobulin and multi-specific human immunoglobulin G therapies for type 1 diabetes and other autoimmune diseases. Its lead program, SAB-142, is a disease-focused immunotherapy candidate for autoimmune type 1 diabetes, supported by the company’s transchromosomic cattle, or Tc-Bovine, production system for generating targeted hIgG antibodies.
Recurring news themes include SAB-142 clinical and mechanistic data, scientific conference presentations, financial results and business updates, and capital actions such as common stock and pre-funded warrant offerings that fund clinical development, manufacturing, regulatory activity and general corporate purposes.
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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