SAB BIO Reports Full Year 2024 Operating and Financial Results

Rhea-AI Summary

SAB BIO (SABS) announced its Q4 and full-year 2024 financial results, highlighting positive topline data from Phase 1 trials of SAB-142, their human anti-thymocyte immunoglobulin therapy for Type 1 Diabetes. The study met primary objectives for safety and pharmacodynamic activity, paving the way for Phase 2b trials expected mid-2025.

Financial highlights for FY2024 include:

• Cash position of $20.8M (down from $56.6M in 2023)
• R&D expenses increased to $30.3M (from $16.5M in 2023)
• G&A expenses decreased to $14.0M (from $23.8M in 2023)
• Net loss improved to $34.1M (from $42.2M in 2023)
• Other net income of $8.8M (compared to $4.1M expense in 2023)

Positive

• Phase 1 trial of SAB-142 met primary objectives for safety and efficacy
• FDA clearance received for IND application
• G&A expenses reduced by 41% year-over-year
• Net loss improved by 19% compared to previous year
• Other net income improved by $12.9M year-over-year

Negative

• Cash position decreased by 63% to $20.8M
• R&D expenses increased by 84% year-over-year
• Continued significant net loss of $34.1M

Insights

Biotechnology Analyst

SAB BIO's positive Phase 1 data for SAB-142 represents a significant clinical milestone for this $15.1M market cap company. The trial met primary objectives for safety and pharmacodynamic activity in healthy volunteers, enabling advancement to Phase 2b development expected mid-2025. SAB-142 targets type 1 diabetes (T1D) through a novel fully human anti-thymocyte immunoglobulin approach that could potentially modify disease progression - a substantial unmet need in T1D management.

The FDA's IND clearance and establishment of a clinical advisory board further validate their development approach. However, investors should carefully consider the company's financial position. Cash reserves decreased dramatically from $56.6M to $20.8M during 2024, while R&D expenses increased by 83.6% to $30.3M. Though the net loss improved to $34.1M from $42.2M, the current burn rate suggests a runway without additional financing.

The positive clinical data provides potential partnering opportunities, which management explicitly mentioned as a strategic focus. Securing development partnerships will be crucial for advancing their autoimmune pipeline while preserving capital. The company's ability to translate this positive Phase 1 data into a successful Phase 2b program will determine whether SAB-142 can become the "best-in-class" T1D therapy management suggests it could be.

Financial Analyst

SAB BIO's financial position reveals significant concerns despite clinical progress. The cash burn rate is alarming - reserves decreased 63% year-over-year to $20.8M, while annual losses stand at $34.1M. This indicates a runway of less than one year without additional financing, creating substantial pressure to secure partnerships or raise capital in 2025.

The 83.6% increase in R&D expenses to $30.3M reflects investment in clinical development but exacerbates cash concerns. While G&A expenses decreased to $14.0M from $23.8M, and net losses improved to $34.1M from $42.2M, these improvements are insufficient to offset the rapid cash depletion.

Management's emphasis on building development partnerships indicates awareness of the financing challenge. The tiny $15.1M market cap compared to $34.1M annual losses shows investors remain skeptical despite positive Phase 1 results. This creates a challenging dynamic: SAB must demonstrate sufficient clinical progress to attract partners without exhausting resources. The gap between the company's current valuation and development costs suggests the market has priced in significant financing risk. The advancement to Phase 2b will likely necessitate either a substantial partnership deal or dilutive financing in the near term - making 2025 a pivotal year for determining whether their promising T1D therapy can overcome these financial hurdles.

SAB-142 Phase 1 trial positive topline data announced at KOL event

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
khollon@sab.bio

Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

FAQ

What were the key findings from SAB-142's Phase 1 trial for Type 1 Diabetes?

The Phase 1 trial met primary objectives for safety and pharmacodynamic activity in healthy volunteers, enabling advancement to Phase 2b development.

How much cash does SABS have as of December 2024?

SAB BIO reported $20.8 million in cash and equivalents as of December 31, 2024, down from $56.6 million in 2023.

When will SABS begin Phase 2b trials for SAB-142?

SAB BIO anticipates initiating Phase 2b clinical trials for SAB-142 in mid-year 2025.

What was SABS's net loss for fiscal year 2024?

SAB BIO reported a net loss of $34.1 million for FY2024, improved from $42.2 million in 2023.

How much did SABS spend on R&D in 2024?

R&D expenses were $30.3 million in 2024, an increase from $16.5 million in 2023.