SAB BIOTHERAPEUTICS INC Stock Price, News & Analysis

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.

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.