SABSW - SAB Biotherapeutics Announces Q3 2023 Financial Results and Provides Company Updates | Benzinga
Raises combined $67.1M in private placement plus Tranche warrant exercise with syndicate of leading investors
Received approval by the Human Research Ethics Committee (HREC) to commence a First-in-Human Phase 1 clinical trial investigating SAB-142 in Australia
Appoints Michael G. King Jr. as new Chief Financial Officer
SIOUX FALLS, S.D., Nov. 14, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (NASDAQ:SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today reported financial results for the third quarter ended October 31, 2023, and provided a company update.
"The third quarter of 2023 was a pivotal growth point for SAB as we advance SAB-142, our T1D immunotherapy. The recently-announced private placement offering has paved the way for advancement of SAB-142 in clinical trials, sustaining our operations through 2026 and topline Phase 2 results," said Eddie J. Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. "We continue to add senior expertise to our team, including the hiring of Mike King as our Chief Financial Officer and the election of Andrew Moin of Sessa Capital to our Board of Directors. Given this growth and our recent clinical milestones, I am confident in our mission to provide critical immunotherapeutic options to T1D patients."
Pipeline Updates and Anticipated Milestones
SAB continues to execute on its strategy for the development of proprietary immunotherapeutic fully-human antibodies, or fully-human immunoglobulins (hIgGs), to treat and prevent immune and autoimmune disorders with a strategic focus on T1D disease modification.
Clinical/Regulatory Update:
- Received approval by the Human Research Ethics Committee (HREC) to commence a First-in-Human Phase 1 clinical trial investigating SAB-142 in Australia. The Phase 1 trial will evaluate the company's lead therapeutic candidate, SAB-142, a first in-class hIgG being developed as a disease-modifying treatment to delay the onset and progression of T1D. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAB-142. Approval by the HREC is confirmation that SAB has successfully completed all pre-clinical safety and efficacy testing required to commence a Phase 1 clinical trial.
- Received Acknowledgement of a Clinical Trial Notification (CTN) from the Australian Government Department of Health Therapeutic Goods Administration (TGA) submitted for the Phase 1 study.
- Successfully registered the Phase 1 trial with the Australian New Zealand Clinical Trials Registry (ANZCTR). More information about the Phase 1 clinical trial with SAB-142 (ACTRN:12623001089628) can be found here.
- Phase 1 First-in-Human trial expected to commence Q42023 in Australia.
- US IND filing anticipated in 2024.
Strategy Update:
- Announced the Company has entered into a private placement offering that will provide up to $110 million in gross proceeds to SAB, which will used to clinically advance SAB-142, and is expected to advance to clinical trials in Q4 2023. SAB-142 is a fully-human alternative to rabbit anti-thymocyte globulin (rATG). SAB-142's mechanism of action is similar to that of rATG, which has been clinically validated in multiple clinical trials for T1D, demonstrating the ability to slow down disease progression in patients with new or recent onset of ...