SAB Biotherapeutics Provides Company Update for Full Year 2022

SIOUX FALLS, S.D., March 31, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulin (hIgG) antibodies, also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the full year ended December 31, 2022, and provided a company update.

“I am pleased to share the meaningful progress SAB has made this past year advancing our groundbreaking, proprietary immunotherapy platform, a powerful approach and the only one in the world that generates targeted and fully-human immunoglobulin antibodies without the need for human donors. We continue to use this platform to create first-of-its-kind approaches and set new standards in developing differentiated treatments for a myriad of complex diseases. SAB’s clinically validated platform has the potential to deliver new treatments for patients with unmet medical needs, including potential for a highly desired disease-modifying approach in difficult-to-treat chronic autoimmune disorders, where we’ve made tremendous progress in our type 1 diabetes program. Our Clostridioides difficile Infection, or C. diff, investigational product is the first and only to deliver a multi-targeted approach to the entire complex lifecycle of the C. diff pathogen. C. diff is a devastating disease recognized by the CDC as an urgent antibiotic resistance threat,” said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “Our focus remains on enhancing patient outcomes while also generating long-term value for our shareholders.”

Pipeline Milestones and Updates

SAB continues to execute its strategy to build a proprietary immunology pipeline addressing complex immune disorders and respiratory and gastrointestinal diseases that disproportionately affect immunocompromised patients, including the elderly. Below are some key highlights and milestones from the year 2022:

• Advanced our SAB-142 type 1 diabetes program and completed numerous pre-clinical activities, including an IND-enabling GLP toxicology study, which was completed in early 2023. 
• Expanded our pipeline with SAB-195, a new, differentiated research program to treat C. diff, a potentially terminal gastrointestinal infectious disease with few effective treatments.
• Announced new clinical data for SAB’s Influenza Phase 2a challenge trial, validating SAB-176’s proof of concept in reducing viral load and improving symptoms of influenza, while also reinforcing the ability to generate broadly neutralizing antibodies to H1N1 pandemic strain as well as all tested viral variants of influenza A and B.
• Presented new pre-clinical data for SAB-185 demonstrating the therapeutic candidate to be effective against the majority of SARS-CoV-2 variants, including Omicron.
• Announced results from a project collaborating with global biotechnology leader CSL, confirming that SAB’s DiversitAb polyclonal platform can generate functional and fully-human anti-idiotype polyclonal antibodies to effectively target and neutralize autoantibodies associated with autoimmune diseases.
• Forged an exclusive manufacturing services agreement with Emergent BioSolutions Inc. to provide contract development and manufacturing services to produce SAB’s fully-human IgG antibody products. 
• Welcomed Alexandra Kropotova, M.D., to be the company’s new Chief Medical Officer. Dr. Kropotova brings to SAB more than 20 years of experience in all phases of global clinical development, translational medicine and medical affairs. Prior to joining SAB, Dr. Kropotova was the Therapeutic Area Head of Global Specialty R&D at Teva Pharmaceuticals, where she led innovative drug development focused on delivering on a broad portfolio of immunology, respiratory, and immuno-oncology assets spanning from pre-IND to BLA/NDA filing of biologics and complex drug-device combination products and was instrumental in clinical development of Dupixent at Sanofi.
• Announced the appointment of Rear Admiral (RADM), retired, Scott Giberson, a former Assistant U.S. Surgeon General and two-star admiral with the U.S. Public Health Service and current President of AMI Health to SAB’s Board of Directors
• Negotiated settlement with the US Government in October 2022 and received first payment of $8.6 million in November 2022, with a second and final payment of $8.2 million in January 2023, to close out work for manufacturing of SAB-185, the company’s clinical stage therapeutic candidate for COVID-19.
• Raised $7.9 million in a private placement of common stock to advance our pipeline of first-in-class therapeutic candidates and fund working capital.
• Presented an overview of the Company’s DiversitAb Platform and data showing benefits of fully-human IgG antibody products derived from cows vs. human-derived plasma and highlighted data on SAB-176 for seasonal and pandemic influenza and SAB-185 for COVID-19 at the 2022 Plasma Product Biotechnology Conference in Cyprus.
• Presented “Novel Biologic Therapeutics for Infectious Diseases,” focusing on SAB-176, a novel pan-influenza immunotherapeutic, SAB-195, an immunotherapeutic for Clostridioides difficile Infection, and SAB-185, a broadly neutralizing COVID-19 treatment, at the Pharma Partnering Conference in Boston.

Financial Guidance