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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) reported its Q1 2022 financial results and company updates, emphasizing significant advancements in its immunotherapy platform.
Key highlights include:
- Cash and cash equivalents of $22.4 million as of March 31, 2022.
- R&D expenses increased to $13.3 million, attributed to expanded capabilities.
- Net income was $1 million, equating to $0.02 per share.
Full data from the Phase 2a trial for SAB-176 is expected in Q3 2022, with additional updates on SAB-185 and other pipeline candidates anticipated later this year.
SAB Biotherapeutics (NASDAQ: SABS) will participate in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The company's management team is scheduled for a live Fireside Chat on May 25, 2022, at 9:00 am EDT. An on-demand webcast will be available on their website, allowing investors to access the presentation for 90 days post-event. SAB Biotherapeutics focuses on developing immunotherapies using fully human polyclonal antibodies for various diseases, including COVID-19 and type 1 diabetes.
SAB Biotherapeutics has appointed Dr. Mark J. Ratain to its Board of Scientific Advisors to enhance its oncology platform. Dr. Ratain, a prominent expert in cancer treatment and clinical pharmacology, has published over 500 academic works and will contribute his extensive knowledge to advance SAB's fully-human polyclonal antibody therapies.
CEO Eddie J. Sullivan expressed enthusiasm about Dr. Ratain's addition, emphasizing the potential benefits for the company’s targeted multivalent immunotherapies aimed at treating cancer.
SAB Biotherapeutics reported significant progress in 2021, highlighted by the closing of its business combination and listing on NASDAQ. The company is advancing its pipeline of polyclonal antibodies, including SAB-185 for COVID-19 and SAB-176 for influenza, with initial data expected mid-2022. SAB's Rapid Response Antibody Program, in collaboration with the US Department of Defense, is also ongoing. With cash reserves of $33.2 million and additional government funding expected, SAB anticipates sufficient resources to support operations through Q3 2023.
SAB Biotherapeutics announced the discontinuation of patient enrollment in the NIH’s ACTIV-2 Phase 3 COVID-19 trial due to low hospitalization and death rates, which rendered the study statistically unworkable. Despite SAB-185 achieving pre-specified efficacy and safety criteria, the Data and Safety Monitoring Board deemed it operationally futile to continue the study. SAB Biotherapeutics is now exploring future clinical plans for SAB-185, targeting high-risk populations for prophylactic and therapeutic applications.
SAB Biotherapeutics announced significant findings regarding SAB-185, a fully-human polyclonal antibody candidate targeting SARS-CoV-2. The nonclinical data, part of a study conducted with the FDA, reveals that SAB-185 exhibits strong neutralizing capabilities against several COVID-19 variants, including Delta, and outperforms convalescent plasma. These results, published in The Journal of Infectious Diseases, suggest SAB-185's potential as an effective therapy for high-risk COVID-19 patients. The antibody is currently being tested in the NIH's Phase 3 ACTIV-2 trial.
SAB Biotherapeutics updates its Phase 3 ACTIV-2 trial for SAB-185, now pivoting to a placebo-controlled design to evaluate its efficacy against the Omicron variant of COVID-19. The trial, sponsored by the NIAID, will include an additional 800 participants, bringing the total to approximately 1,200. SAB-185 demonstrates neutralizing activity against COVID variants, including Omicron. The trial's design change reflects the need for effective treatments as Omicron now comprises about 95% of new cases in the US, aiming to restart data collection with minimal disruption.
SAB Biotherapeutics reported positive advancements for SAB-185, a fully-human polyclonal antibody for treating high-risk non-hospitalized COVID-19 patients, now in Phase 3 of the NIH-sponsored ACTIV-2 trial. Following a favorable DSMB review of Phase 2 data, over 700 patients have been enrolled, exceeding half of the 1,200 target. SAB-185 demonstrated significant viral load reductions in a small subset of high-risk patients, indicating potential efficacy. However, statistical significance was limited due to the protocol shift towards lower-risk participants in earlier phases.
SAB Biotherapeutics (Nasdaq: SABS) announced that co-founder and CEO Eddie J. Sullivan, PhD, will present at the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. The presentation will be available for on-demand viewing starting January 10 at 7:00 a.m. ET. SAB focuses on developing novel immunotherapies using fully-human polyclonal antibodies, targeting various diseases, including infectious diseases and cancer. Their DiversitAb™ platform aims to meet serious unmet medical needs.
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.
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