SAB BIO Announces Second Quarter 2024 Financial Results and Provides Company Updates

Rhea-AI Summary

SAB BIO (Nasdaq: SABS) reported its Q2 2024 financial results and provided company updates. Key highlights include:

1. FDA clearance for SAB-142 IND application
2. Appointment of Lucy To as CFO
3. Founding of a new Clinical Advisory Board
4. Cash position of $37.3 million as of June 30, 2024
5. R&D expenses increased to $6.8 million in Q2 2024
6. Net loss of $7.3 million for Q2 2024

The company reaffirmed its cash runway into 2026 and remains focused on developing SAB-142 for delaying or stopping the progression of type 1 diabetes. SAB-142 is on track for a topline Phase 1 data readout by year-end.

Positive

• FDA clearance for SAB-142 IND application, enabling clinical development in the U.S.
• Appointment of Lucy To as CFO, bringing healthcare investment expertise
• Founding of a new Clinical Advisory Board with T1D experts
• Reaffirmed cash runway into 2026
• SAB-142 on track for topline Phase 1 data readout by year-end

Negative

• Net loss increased to $7.3 million in Q2 2024 from $6.9 million in Q2 2023
• Cash position decreased to $37.3 million from $56.6 million at the end of 2023
• R&D expenses increased to $6.8 million in Q2 2024 from $3.7 million in Q2 2023
• G&A expenses increased to $3.6 million in Q2 2024 from $2.9 million in Q2 2023

Insights

Financial Analyst

SAB BIO's Q2 2024 results reveal a mixed financial picture. While R&D expenses increased significantly to $6.8 million (up 83.8% YoY), reflecting investment in their T1D program, the company's cash position decreased to $37.3 million from $56.6 million at year-end 2023. This burn rate is concerning, but management's assertion of cash runway into 2026 provides some reassurance. The narrowing net loss ($7.3 million vs $6.9 million YoY) and improved EPS ($(0.79) vs $(1.36)) are positive signs, largely due to non-operating income from warrant liabilities. However, investors should monitor the increasing G&A expenses, which could pressure margins as the company scales.

Medical Research Analyst

The FDA's clearance of SAB's IND for SAB-142 is a significant milestone, enabling clinical development for T1D patients in the U.S. This progress, coupled with the formation of a Clinical Advisory Board comprising T1D experts, demonstrates SAB's commitment to advancing its novel immunotherapy platform. The anticipated Phase 1 topline data readout by year-end could be a important catalyst for the stock. However, investors should note that early-stage clinical trials in T1D are notoriously challenging, with many promising therapies failing in later stages. The company's focus on delaying or stopping T1D progression addresses a critical unmet need, but success is far from guaranteed in this complex autoimmune disease.

Market Research Analyst

SAB BIO's rebranding and strategic focus on T1D position it in a niche but potentially lucrative market. The global T1D market is projected to reach $9.6 billion by 2025, driven by increasing prevalence and demand for innovative therapies. SAB's approach of using human anti-thymocyte immunoglobulin (hIgG) is unique, potentially offering a competitive edge if successful. The appointment of Lucy To as CFO, with her background in healthcare investments, could enhance SAB's financial strategy and investor relations. However, the company faces stiff competition from established pharma giants and well-funded biotechs in the T1D space. Investors should weigh the potential upside against the high risks inherent in early-stage biotech companies targeting complex diseases.

FDA provided clearance to SAB’s IND

Appointed Lucy To as Chief Financial Officer

Announced founding of a new Clinical Advisory Board

MIAMI, Aug. 08, 2024 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), (“SAB” 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 reported financial results for the second quarter ended June 30, 2024, and provided a company update.

“We’ve had a strong quarter as we drive closer to our upcoming SAB-142 milestones. We continue to see an urgent need for transformative therapies in this space, and specifically for innovative approaches like SAB-142 which could delay or stop the progression of type 1 diabetes,” notes SAB chairman and CEO Samuel J. Reich, “We continue to build partnerships with clinical and strategic advisors with deep expertise in T1D research and clinical development. I am very pleased with the continued development progress of SAB-142 which remains on track for a topline Phase 1 data readout by the end of the year. "

Pipeline and Corporate Updates

On May 21, 2024, SAB announced that the FDA provided clearance for SAB’s IND application for SAB-142, which enables clinical development of SAB-142 for patients with T1D in the U.S.

As part of its continuing strategic evolution, SAB rebranded on June 20, 2024 as SAB BIO, maintaining its corporate headquarters in Miami. The Company continues to execute its corporate strategy through building partnerships and expertise that advance its program focus on T1D, including a recent poster presentation at the American Diabetes Association 84^th Scientific Session on June 23.

On July 31, 2024, SAB announced the appointment of Lucy To as Chief Financial Officer of SAB BIO, effective August 12, 2024. Ms. To joins SAB from Wells Fargo Securities, where she led healthcare investments as Managing Director.

On August 5, 2024, the Company announced the founding of a new Clinical Advisory Board, comprised of world-renowned experts in T1D and disease modifying therapeutic development. The Clinical Advisory Board will work closely with SAB leadership to advance and inform its clinical development program for SAB-142.

Q2 2024 Financial Results

Financial Guidance: Based on its current operating plans and assuming the receipt of funds upon the exercise of all outstanding Tranche B warrants, SAB reaffirms it has sufficient cash sufficient to fund its operations into 2026.

• Cash Position: Cash, cash equivalents, and available for sale securities totaled $37.3 million as of June 30, 2024 compared to $56.6 million as of December 31, 2023, driven primarily by continued research and related expenses as the Company advances its lead therapeutic candidates.
• Research and Development (R&D) Expenses: R&D expenses were $6.8 million for three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023. R&D expenses were $14.8 million for six months ended June 30, 2024, compared to $8.2 million for the six months ended June 30, 2023. The increase was primarily due to prioritizing focus in the autoimmunity space with SAB-142, a disease-modifying fully human hIgG aimed at preventing onset or disease progression of T1D.
• General and Administrative Expense: G&A expenses were $3.6 million for the three months ended June 30, 2024, compared to $2.9 million for the three months ended June 30, 2023. G&A expenses were $8.0 million for the six months ended June 30, 2024, compared to $6.3 million for the six months ended June 30, 2023. G&A expenses grew primarily due to increased headcount to support the Company’s continued research activities and development of its product candidates.
• Non-operating Income: Non-operating income was $2.9 million for the three months ended June 30, 2024, compared to $0.4 million of expense for the three months ended June 30, 2023. Non-operating income was $9.2 million for the six months ended June 30, 2024, compared to $0.4 million of expense for the six months ended June 30, 2023. This increase was primarily due to the change in fair value of warrant liabilities and an Australian research and development tax credit.
• Net Loss: Net loss was $7.3 million for the three months ended June 30, 2024, for an earnings per basic and diluted share of $(0.79), as compared to a net loss of $6.9 million for the three months ended June 30, 2023 for an earnings per basic and diluted share of $(1.36). Net loss was $12.4 million for the six months ended June 30, 2024, for an earnings per basic and diluted share of $(1.34), as compared to a net loss of $14.2 million for the six months ended June 30, 2023 for an earnings per basic and diluted share of $(2.82).
  

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’s DiversitAb™ 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, visit: https://www.SAB.bio/ and follow SAB on Twitter 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 impact members of SAB’s leadership team will have on the Company’s business and results of operations, our expected cash runway and the development and efficacy of our T1D program and other discovery programs.

These statements are based on the current expectations of SAB 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 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 SAB BIO's (SABS) key financial results for Q2 2024?

SAB BIO reported a net loss of $7.3 million, cash position of $37.3 million, R&D expenses of $6.8 million, and G&A expenses of $3.6 million for Q2 2024.

What major regulatory milestone did SAB BIO (SABS) achieve for SAB-142 in Q2 2024?

SAB BIO received FDA clearance for its IND application for SAB-142, allowing clinical development for type 1 diabetes patients in the U.S.

When is SAB BIO (SABS) expecting topline Phase 1 data for SAB-142?

SAB BIO expects to release topline Phase 1 data for SAB-142 by the end of 2024.

Who did SAB BIO (SABS) appoint as its new CFO in Q2 2024?

SAB BIO appointed Lucy To as Chief Financial Officer, effective August 12, 2024. She previously led healthcare investments as Managing Director at Wells Fargo Securities.