SAB Biotherapeutics Reports Third Quarter 2021 Financial Results

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SAB-185 advanced to phase 3 of NIH-sponsored ACTIV-2 trial for treatment of COVID-19 following positive DSMB recommendation in interim analysis

Allocation of an additional $ 60.5 million from DoD as part of expanding the scope of advancement of the SAB-185

Strengthening of the management team with the appointment of Russell Beyer as CFO

SIOUX FALLS, SD, November 22, 2021 (GLOBE NEWSWIRE) – SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a new immunotherapy platform that produces human polyclonal antibodies without having need for human donors, today released its financial results for the third quarter ended September 30, 2021 and provided a company update.

“We have entered the next stage of our growth with our recent debut as a public company, evidenced by the finalization of our business combination with Big Cypress Acquisition Corp. in October, ”said Eddie J. Sullivan, PhD, Co-Founder, President, and CEO of SAB Biotherapeutics. “Our pipeline of potent and scalable human polyclonal antibodies based on our new DiversitAb ™ platform continues to advance, and our clinical programs for SAB-185 and SAB-176 show strong therapeutic potential as they advance in trials. clinics. We have built a strong team with exceptional experience and knowledge, enabling us to advance the development of highly effective human polyclonal therapies with the potential to address the emergence, mutation and diversity of modern health challenges. “

Recent developments and next steps

Pipeline Updates:

  • Infectious diseases pipeline:
    • SAB-185, a polyclonal antibody-based therapeutic candidate for the treatment of COVID-19 is currently being evaluated in the ongoing phase 3 ACTIV-2 trial in collaboration with the National Institutes of Health (NIH) of United States for the treatment of outpatients with mild to moderate COVID-19
      • In September, announced that an Independent Data Safety Oversight Board (DSMB) recommended moving to Phase 3 following a pre-defined interim data review for safety and efficacy SAB-185 in the Phase 2 portion of the ACTIV-2 trial
      • Additional $ 60.5 Million Allocated In September For Expanded U.S. Department Of Defense Reach (DoD) for advanced clinical development through licensure and commercial manufacture; SAB has announced four awards currently totaling over $ 203 million since March 2020
      • Dosed the first patient in the phase 3 trial in October 2021
    • SAB-176, a quadrivalent polyclonal antibody therapeutic candidate currently being evaluated in an ongoing Phase 2a challenge study for the treatment of seasonal influenza
      • The first phase 2a data is expected in the fourth quarter of this year
  • Autoimmune disease pipeline:
    • SAB-142, a human polyclonal antibody therapeutic candidate for type 1 diabetes and organ transplantation (induction / rejection) currently in preclinical development
      • Studies enabling IND should begin in the first quarter of 2022

Company highlights

  • Successful Completion of Business Combination with Big Cypress Acquisition Corp. The business combination, which closed in October 2021, generated gross proceeds for SAB of approximately $ 30 million. SAB now trades on the Nasdaq under the symbol “SABS”.
  • In September 2021, appointed Russell Beyer to the Company’s management team as Chief Financial Officer. Russell brings over 30 years of experience overseeing finance functions at pharmaceutical and other Fortune 100 companies.

Nine-month 2021 financial results

  • Treasury – Following the closing of the business combination with Big Cypress on October 22, 2021, cash and cash equivalents, on a pro forma basis, were $ 30 million. Cash and cash equivalents as at September 30, 2021 were $ 10.8 million, compared to $ 13.5 million as at September 30, 2020.
  • Research and development (R&D) expenditure – R&D expenses amounted to $ 46.5 million for the nine months to date to September 30, 2021, compared to $ 12.6 million for the same period in 2020. The increase is mainly due to advancement of SAB-185 for COVID-19.
  • General and administrative expenses (G&A) – General and administrative expenses were $ 9.3 million for the nine months ended September 30, 2021, compared to $ 4.9 million for the same period in 2020. The increase is mainly due to services to the support for business growth.
  • Net loss – Net loss was $ 5.6 million for the nine-month period ended September 30, 2021, compared to net income of $ 11.7 million for the same period in 2020.

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

Contacts:
Melissa Ullerich
+1 605-679-4609
[email protected]

Courtney turiano
Stern IR
212-698-8687
[email protected]

Forward-looking statements
Certain statements made here that are not historical facts are forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually accompanied by words such as “believe”, ” may “,” will “,” estimate “,” continue “,” anticipate “,” intend “,” expect “,” should “,” “) to at in”, “future”, ” perspective ”and similar phrases which predict or indicate future events or trends or which are not statements of historical matters. These forward-looking statements include, without limitation, statements regarding future events. These statements are based on SAB’s current expectations and are not actual performance predictions. These forward-looking statements are provided for informational purposes only and are not intended to be used as, and should not be construed by, an 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. Forward-looking statements are subject to various risks and uncertainties, including, but not limited to, those relating to the COVID-19 pandemic; SAB’s ability to achieve positive results for its product candidates, the availability of financing and trends affecting SAB’s financial condition or results of operations. These factors should not be construed as exhaustive and should be read in conjunction with the other caveats described in the sections entitled “Risk Factors” in the Company’s Proxy Circular / Prospectus filed with the Securities and Exchange Commission (the “SEC”). on September 24, 2021. These factors may be updated from time to time in SAB’s periodic documents with the SEC, which are available on the SEC’s website at www.sec.gov. Therefore, there are or will be significant factors that could cause actual results to differ materially from those shown in such statements. Forward-looking statements speak only as of the date of this press release, and SAB expressly disclaims any obligation or commitment to publicly update or revise any forward-looking statement..


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