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 (SABS) has been added to the NASDAQ Biotechnology Index effective December 20, 2021. This index tracks biotech and pharmaceutical firms listed on Nasdaq that meet specific criteria, including market cap. SAB, a clinical-stage biopharmaceutical company, focuses on immunotherapy development using fully-human polyclonal antibodies without human donors. The inclusion in the index may enhance visibility and liquidity for shareholders, and reflects its compliance with industry standards.
SAB Biotherapeutics (Nasdaq: SABS) announced that its therapeutic candidate, SAB-185, effectively neutralizes the Omicron variant of SARS-CoV-2, according to FDA laboratory testing. This confirmation comes as SAB-185 progresses through a NIH-sponsored Phase 3 trial aimed at treating COVID-19. The results show that SAB-185 maintains potent neutralization against Omicron, although with a slight reduction in efficacy compared to the original strain. The ongoing trial includes around 1,200 participants to evaluate the safety and effectiveness of this fully-human polyclonal antibody.
SAB Biotherapeutics announced positive topline results from a Phase 2a challenge study of SAB-176, showing a statistically significant reduction in viral load (p = 0.026) and clinical symptoms for seasonal influenza. The treatment was safe and well-tolerated among participants. This achievement marks the second clinical proof of concept for the company's DiversitAb™ platform within two months, further emphasizing its ability to generate broadly neutralizing antibodies against rapidly mutating viruses. Plans are underway to progress SAB-176 into a Phase 2 trial starting in 2Q 2022.
SAB Biotherapeutics announced key advancements in its pipeline, including the progression of SAB-185 to Phase 3 in the NIH-sponsored ACTIV-2 Trial for COVID-19 after a positive recommendation from the Data Safety Monitoring Board. The company also secured an additional $60.5 million from the Department of Defense for the continued development of SAB-185, bringing total funding since March 2020 to over $203 million. Financial results reveal a cash position of $30 million post-business combination, but a net loss of $5.6 million for 2021, compared to a net income of $11.7 million in 2020.
SAB Biotherapeutics announced the completion of its business combination with Big Cypress Acquisition Corp., with shares commencing trading on Nasdaq under the ticker symbols SABS and SABSW on October 25, 2021. The transaction received approval from both companies' shareholders, resulting in gross proceeds of approximately $30 million. SAB aims to utilize these funds to advance its clinical programs, including those related to COVID-19 and influenza, and has secured an additional $60.5 million government award. SAB is focused on developing its unique DiversitAb™ immunotherapy platform.