SAB BIO Reports Full Year 2024 Operating and Financial Results

MIAMI, March 31, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), ("SAB BIO" or the "Company"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced financial results for the fourth quarter of 2024 in addition to its full year financial results for the fiscal year ended December 31, 2024, and reported on recent accomplishments and anticipated milestones.

Samuel J. Reich, Chairman and CEO of SAB BIO stated, "Our recent announcement of positive topline data for SAB-142, further strengthens our belief that SAB-142 has the potential to be the best in-class disease-modifying therapy for T1D.  We are well-positioned to continue our positive momentum in 2025 as we advance our development program and begin enrolling patients into a Phase 2b trial for SAB-142. Moving forward, we will be focused on building strong development partnerships that help advance our autoimmune pipeline as we look to announce further data readouts in 2025."

Recent Pipeline Developments

• On January 28, 2025, SAB BIO announced positive topline data from Phase 1 clinical trials of SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of Type 1 Diabetes. The study met its primary objectives in healthy volunteers related to safety and pharmacodynamic activity. The trial enables SAB-142 to advance to Phase 2b clinical development which is anticipated to initiate mid-year 2025. SAB BIO hosted a virtual R&D event also on January 28, 2025, to discuss the topline results and featured presentations from SAB BIO's management team and T1D Key Opinion Leader (KOL) Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology. A replay of the event can be accessed at this link or through the Events section of the SAB BIO company website.
  
  
• On May 21, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) provided clearance for the Company's investigational new drug (IND) application to proceed with a Phase 1 clinical trial (the HUMAN trial – fully HUman anti-thymocyte biologic in first-in-MAN clinical study) evaluating SAB-142 in type 1 diabetes.
  
  

Corporate Updates from Fiscal Year 2024

• On August 5, 2024, the Company announced the founding of a clinical advisory board to provide expert insight and guidance to the Company in the clinical development of SAB-142.
• On July 31, 2024, the Company announced the appointment of Lucy To as Chief Financial Officer.
• On May 6, 2024, the Company announced Jay Skyler, MD, MACP, FRCP was appointed to SAB BIO's Board of Directors.
• On February 2, 2024, Samuel J. Reich expanded his role as Chief Executive Officer.

Fiscal Year 2024 Financial Results

• SAB Biotherapeutics held cash and equivalents of $20.8 million at December 31, 2024, compared to $56.6 million at December 31, 2023.
• R&D expenses of $30.3 million and $16.5 million for the years ended December 31, 2024 and December 31, 2023 respectively.
• General and administrative expenses of $14.0 million and $23.8 million for the years ended December 31, 2024 and December 31, 2023 respectively.

• Other net income of $8.8 million for the year ended December 31, 2024, and net other expense of $4.1 million for the year ended December 31, 2023.
• SAB reported a net loss of $34.1 million and $42.2 million for the years ended December 31, 2024 and December 31, 2023 respectively.
  
  

About SAB BIO

SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company's lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB BIO's drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB BIO, visit: https://www.SAB.bio/ and follow SAB BIO on Twitter/X and LinkedIn.

Forward-Looking Statements

Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "to be," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the data, development, clinical results, and efficacy of our T1D program and other discovery programs, the Company's ability to raise additional funds on favorable terms, financial projections and future financial and operating results (including estimated cost savings and cash runway), and the outcome of current or potential future government and other third-party collaborations or funded programs.

These statements are based on the current expectations of SAB BIO and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry's results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned "Risk Factors" in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB BIO disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

CONTACTS

Media Relations:

Kaelan Hollon,

Vice President of Communications

[email protected]

Investor Relations:

Kevin Gardner

LifeSci Advisors

[email protected]

Chris Calabrese

LifeSci Advisors

[email protected]