Welcome to our dedicated page for SAB BIOTHERAPEUTICS news (Ticker: SABS), a resource for investors and traders seeking the latest updates and insights on SAB BIOTHERAPEUTICS stock.
SAB Biotherapeutics, Inc. (Nasdaq: SABS), or SAB BIO, generates frequent news as a clinical-stage biopharmaceutical company advancing fully human immunoglobulin G (hIgG) and human anti-thymocyte immunoglobulin (hATG) therapies for immune and autoimmune disorders. Most recent headlines focus on SAB-142, the company’s multi-specific, fully human anti-thymocyte globulin in development as a potentially disease-modifying, redosable immunotherapy for autoimmune type 1 diabetes (T1D) in new-onset, Stage 3 patients.
News updates commonly cover clinical milestones for SAB-142, including Phase 1 trial results and the launch and progress of the Phase 2b registrational SAFEGUARD study. Releases describe safety, pharmacodynamic, and immunogenicity findings, such as the absence of serum sickness and anti-drug antibodies in the Phase 1 trial, as well as the design and enrollment status of the SAFEGUARD trial at multiple centers around the world.
SABS news also highlights SAB BIO’s scientific presence at major medical meetings. The company regularly announces oral and poster presentations at conferences such as the European Association for the Study of Diabetes (EASD), the International Society for Pediatric and Adolescent Diabetes (ISPAD), and the Asian Conference on Innovative Therapies for Diabetes Management. These items detail new data on SAB-142’s mechanism of action, immunomodulatory effects without sustained lymphodepletion, and pharmacokinetic profiling.
Investors and observers will also find corporate and investor-relations updates, including participation in healthcare investor conferences and changes to the Board of Directors, as well as summaries of quarterly financial results and business highlights. For anyone tracking SABS, this news feed provides an ongoing view into SAB BIO’s clinical development progress, scientific communications, governance developments, and key events related to its lead program SAB-142 and its broader human IgG platform.
SAB Biotherapeutics announced that its investigational therapeutic, SAB-176, has received both Breakthrough Therapy and Fast Track designations from the FDA for treating high-risk patients and post-exposure prophylaxis of Type A and B influenza. This dual designation could significantly expedite its development and regulatory process. SAB-176, a fully-human multi-epitope binding antibody, shows promise against antiviral-resistant strains of influenza. The company is poised to initiate a Phase 2b trial after receiving FDA guidance, highlighting its clear regulatory pathway for further development. The therapy aims to offer broad protection against evolving influenza strains, potentially addressing significant health concerns globally.
SAB Biotherapeutics has announced the FDA granting Fast Track designation for SAB-176, an investigational immunotherapy for treating Type A and Type B influenza in high-risk patients. This therapeutic approach is significant as it produces fully-human antibodies without needing human donors, utilizing the proprietary DiversitAb™ platform. The FDA's approval facilitates the advancement into a Phase 2b trial to evaluate the safety and efficacy of SAB-176, particularly among patients with antiviral-resistant influenza strains. This innovative therapy aims to provide broad protection against rapidly mutating influenza viruses, responding to the global health challenges posed by seasonal and pandemic influenza.
SAB Biotherapeutics announced the appointment of Erick Lucera, CFA, to its Board of Directors, effective April 4, 2023. Lucera, with over 30 years of experience in the biotechnology and medical device sectors, previously served as CFO for AVEO Oncology. His extensive background includes leadership roles at various biotech firms where he oversaw financial strategies and helped raise significant capital. The Executive Chairman, Samuel J. Reich, expressed confidence in Lucera's abilities to guide SAB through significant milestones in its immunotherapy development programs targeting critical health issues like C. difficile and type 1 diabetes.
SAB Biotherapeutics reported its financial results for the year ended December 31, 2022, highlighting progress in its immunotherapy platform, which creates fully-human polyclonal antibodies without human donors. The company advanced its type 1 diabetes program and introduced SAB-195 for C. diff, while achieving positive results in its Influenza and SARS-CoV-2 therapeutic candidates. SAB's cash reserves declined to $15 million from $33.2 million in 2021, with reduced annual net cash consumption from $60 million to $18 million. The company will restate its 2021 financials due to an accounting error. Despite these challenges, SAB maintains its guidance to fund operations through December 2023.
SAB Biotherapeutics (NASDAQ: SABS) recently featured CEO Eddie Sullivan on Episode 67 of ICR's podcast, "Welcome to the Arena." The discussion highlighted SAB's innovative immunotherapy platform, which produces fully-human polyclonal antibodies without relying on human donors. Sullivan shared insights on their polyclonal antibody research, the application of cows in their processes, and the challenges facing the biotech industry. ICR's podcast, aimed at enhancing corporate communication, has been running since August 2021.
SAB Biotherapeutics (Nasdaq: SABS, SABSW) announced that its co-founder and CEO, Dr. Eddie Sullivan, will present at the 2023 BIO CEO & Investor Conference in New York City from February 6-9. The presentation will feature SAB's proprietary DiversitAb™ platform, which uniquely produces fully-human polyclonal antibodies without human donors. Dr. Sullivan emphasized the importance of developing therapies for viral infections like COVID-19 and influenza and highlighted progress in treating autoimmune disorders. Interested parties can schedule meetings through the BIO One-on-One Partnering system.
SAB Biotherapeutics (SABS) has received an additional $8.2 million from the U.S. Department of Defense, raising the total amount to $16.8 million since November 2022, related to the closeout of a discontinued COVID-19 contract. The contract was originally awarded in 2019 but was terminated in August 2022 due to misalignment with government requirements. CEO Eddie Sullivan noted that this funding validates SAB's antibody platform, which is moving to Phase 3 development for various medical programs, including Influenza and Type 1 Diabetes. The company expects sufficient cash flow to fund operations through 2023.
SAB Biotherapeutics (SABS) announced the successful completion of a GLP-tox study for SAB-142, its fully-human polyclonal therapeutic aimed at delaying type 1 diabetes onset. The study demonstrated SAB-142's well-tolerated profile at various doses and its pharmacodynamic effects compared to FDA-approved treatments. The company plans to file an IND within 12 months. SAB-142's development marks a significant milestone, potentially offering a safer treatment option for patients by reducing immune-related adverse reactions commonly seen with animal-derived therapies.
SAB Biotherapeutics (Nasdaq: SABS) announced that Dr. Alexandra Kropotova will present at the Biotech Showcase in San Francisco on Jan. 10, 2023. Her presentation will focus on SAB's innovative DiversitAb™ platform, which develops fully-human polyclonal antibodies using transchromosomic cows, offering potential treatments for complex diseases like influenza and type 1 diabetes. The company emphasizes its commitment to addressing multiple disease targets simultaneously, showcasing promising data from clinical trials that indicate long-lasting efficacy against various pathogens.
SAB Biotherapeutics (SABS) announced promising results from a collaboration with CSL, confirming that its DiversitAb™ platform can produce fully-human anti-idiotype polyclonal antibodies. These findings demonstrated the potential to target and neutralize autoantibodies linked to autoimmune diseases, such as neuromyelitis optica. The platform effectively developed treatments that bind to harmful autoantibodies without broad immunosuppression, indicating significant therapeutic implications for various autoimmune disorders. SAB aims to provide effective treatment options for patients affected by these diseases.