Home Alternative guide SAB Biotherapeutics Provides Company Update for Q1 2022

SAB Biotherapeutics Provides Company Update for Q1 2022

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Full data from Phase 2a trial that evaluated SAB-176 for the treatment of seasonal influenza expected in Q3 2022 – first set of clinical data from new platform

Phase 2 data for SAB-185 should be available later this year

Sufficient cash flow planned to operate until 2023

SIOUX FALLS, SD, May 12, 2022 (GLOBE NEWSWIRE) — SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted and potent fully human polyclonal antibodies without the need for human donors, today announced financial results for the first quarter ended March 31, 2022, and provided a company update.

“Over the past 24 months, we have seen remarkable progress in our platform and the validation of our technology in a real environment. We’ve also built tremendous capabilities and infrastructure by rapidly advancing our proof of concept. We seek to advance our discovery and early-stage programs in oncology, type 1 diabetes and organ transplantation (induction/rejection), while the publication of our full readouts of data from our phase 2 trials of SAB 185 and SAB 176 is expected in the second half of 2022,” said Eddie J. Sullivan, Ph.D., co-founder, president and CEO of SAB Biotherapeutics.

Pipeline updates and planned milestones

SAB continues to implement its strategy to build a proprietary portfolio of immune and autoimmune diseases, including respiratory diseases that disproportionately affect immunocompromised patients.

  • Full readout of data for Phase 2a challenge study for SAB-176 scheduled for Q3.
  • Phase 2 data for SAB-185 is expected to be available from NIH NIAID for the ACTIV-2 trial later this year.
  • Initial human polyclonal proof-of-principle data in immuno-oncology expected in Q3 2022.
  • Forecast of advanced IND-enabling studies for SAB-142, a fully human antithymocyte globulin therapeutic candidate for type 1 diabetes and organ transplantation (induction/rejection) to initiate the fourth trimester.

The Company is evaluating clinical plans to further develop its polyclonal antibody therapeutic candidates, SAB-185 for COVID-19 and SAB-176 for seasonal influenza, in immunocompromised patients and other high-risk populations, including including the potential for post-exposure prophylactic use, as well as the potential development of alternative routes of administration, in advancing the platform.

Additionally, SAB continues to run its rapid-response antibody program under contract with the US Department of Defense (DOD). The program involves multiple targets and other strategic activities to support the warfighter, in addition to facilitating preparation for future emerging threats.

Financial results for the 1st quarter of 2022

  • Cash position. Cash and cash equivalents were $22.4 million as of March 31, 2022, compared to $33.2 million as of December 31, 2021, primarily due to $1.3 million of additional capital expansion , an increase in non-cash working capital of $5.1 million and SAB’s year-to-date operating loss. SAB government contract work is expected to provide additional funding not reflected in the balance sheet.
  • Research and development (R&D) expenditure. R&D expenses were $13.3 million for the three months ended March 31, 2022, compared to $12.7 million for the three months ended March 31, 2021. The increase is primarily due to higher workforce in the research and development function, contract manufacturing, increased clinical work, and increases in the Company’s production capacity and associated expenses for materials and supplies supporting research and development.
  • General and administrative expenses (G&A). General and administrative expenses were $5.2 million for the three months ended March 31, 2022, compared to $3.3 million for the three months ended March 31, 2021. The increase is primarily due to business consulting, regulatory and compliance. Additionally, SAB recognized increased compliance costs due to its going public at the end of 2021.
  • Net revenue. Net earnings were $1.0 million for the three months ended March 31, 2022, for basic and diluted earnings per share of $0.02, compared to net earnings of $1.4 million for the three months ended March 31, 2021, for basic and diluted earnings per share of $0.05.

Financial orientation: Based on its current operating plans, SAB expects that its existing cash and cash equivalents, as well as its U.S. government funding as of March 31, 2022, will be sufficient to fund its operating expenses and capital expenditure needs up to 2023.

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company developing a novel class of immunotherapies using fully human polyclonal antibodies with a focus on creating a leading pipeline for immune and autonomic diseases. -immune. SAB has applied advanced genetic engineering and antibody science to develop Bovine™ transchromosomal (Tc) cells that produce fully human antibodies targeting specific diseases, including infectious diseases such as COVID-19 and influenza, immune disorders and autoimmune diseases, including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human disease. It produces natural, specifically targeted and high potency human polyclonal immunotherapies. SAB currently has several ongoing drug development programs and collaborations with the US government and global pharmaceutical companies. For more information about SAB, visit: https://www.sabbiotherapeutics.com/ and follow @SABBantibody on Twitter.

CONTACTS

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Media Relations:
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Forward-looking statements

Certain statements made herein 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 are generally accompanied by words such as “believe”, ” may”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “should”, “would”, “plan”, “predict”, “potential”, “seems”, “seeks”, “future”, “prospects” and similar expressions which predict or indicate future events or trends or which are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of SAB-185, our influenza program and other discovery programs, our rush to 2023 and potential future collaborations between the government and third parties. or funded programs.

These statements are based on SAB’s current expectations and are not predictions of actual performance. These forward-looking statements are provided for informational purposes only and are not intended to serve and should not be relied upon by any investor as a guarantee, assurance, prediction or definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict, will differ from assumptions and are beyond SAB’s control. A more detailed description of the risks and uncertainties can be found in the sections titled “Risk Factors” on Forms 10-K and 10-Q, all of which will be filed with the United States Securities and Exchange Commission and available at https://www.sec.gov/