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SAB-185 is a human polyclonal antibody therapeutic that potently neutralizes live SARS-CoV-2 at titers 4X higher than convalescent plasma

Data suggests that SAB-185 may be an effective therapeutic against current and mutating strains of the virus

On-track to initiate clinical trials for potential COVID-19 therapeutic in early summer 2020

Sioux Falls, S.D., May 28, 2020 – SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human plasma donors, today announced in vitro data demonstrating that SAB-185, its COVID-19 therapeutic candidate, has highly-potent neutralizing antibodies to SARS-CoV-2 that are four times higher than the most potent human convalescent plasma serum sample evaluated. The company also announced that they initiated manufacturing of SAB-185 on May 25 to support the next phase of clinical development for its potential COVID-19 therapeutic, still on track to begin human trials in early summer.

“These data indicate this human polyclonal antibody therapeutic has potent neutralizing activity against live SARS-CoV-2. The neutralizing titers of SAB-185 are significantly higher than those of the most potent plasma of recovered COVID-19 patients we’ve been able to source,” said William B. Klimstra, PhD Associate Professor of Microbiology and Molecular Genetics, Associate Professor of Immunology and Member of the Center for Vaccine Research at The University of Pittsburgh. “We are still in the early stages of evaluating SAB-185, but the preliminary results are promising. My laboratory is conducting a series of studies to bring SAB-185 into clinical trials as soon as possible.”

“In just seven weeks, we’ve accelerated development of a specifically targeted natural human polyclonal therapeutic, without the need for human serum, and generated large volumes of highly-potent neutralizing antibodies to SARS-CoV-2, to produce clinical lots of our COVID-19 therapeutic candidate, SAB-185,” said Eddie J. Sullivan, PhD, President, CEO and Co-founder of SAB Biotherapeutics. “Consistent with data across SAB’s platform in other indications, these data suggest that our potential COVID-19 therapeutic may remain effective even as SARS-CoV-2 continues to evolve. SAB-185, which was developed from the original Wuhan strain sequences, demonstrated highly-potent neutralizing titers to the mutated Munich strain of the virus, believed to be most prevalent strain in the U.S.,” added Sullivan. “These data give us great confidence as we begin manufacturing clinical product and prepare to move forward in the regulatory pathway to provide a potential solution to combat COVID-19.”

SAB’s novel approach, leveraging genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible. As a fully human polyclonal antibody, SAB’s novel therapeutic candidate for COVID-19 deploys the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.

Data from SAB’s clinical trials in MERS coronavirus and other infectious disease targets have demonstrated the inherent optimal therapeutic properties of human polyclonal antibodies, including reduced immunogenicity and extended half-life, which point to the potential of this therapeutic approach for both treatment and prophylaxis.

“SAB Biotherapeutics has a successful preclinical track having developed more than a dozen effective antibodies from our DiversitAb™ platform in response to emerging infectious diseases during outbreaks of Ebola, Zika, Dengue, Hantavirus, and others,” said Sullivan. “A highly-potent, polyclonal antibody therapy for COVID-19, could prove critical in combatting this pandemic as it could potentially treat severely ill patients and provide protective antibodies for front-line responders, mission-critical staff, and high-risk populations, such as the elderly and immune compromised.”

About SAB Biotherapeutics, Inc.:
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB-185, a fully-human polyclonal antibody therapeutic candidate for COVID-19, is being developed in collaboration with CSL Behring and initial funding up to $9.4 million supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services through an existing Rapid Response contract with the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB).The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology. For more information visit: www.sabbiotherapeutics.com or follow @SABBantibody on Twitter.

Contact: Melissa Ullerich Tel: 605-679-4609
mullerich@sabbiotherapeutics.com

COVID-19 treatment candidate, a high-potency immunotherapy delivering human polyclonal antibodies targeted to SARS-CoV-2, generated from SAB’s novel platform technology, on-track for clinical evaluation as early as summer

King of Prussia, Pa. and Sioux Falls, S.D., April 8, 2020 – Global biotherapeutics leader, CSL Behring and innovative human antibody development company SAB Biotherapeutics (SAB) announced today their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate on track for clinical evaluation by early summer. The partnership joins the forces of CSL Behring’s leading protein science capabilities with SAB’s novel immunotherapy platform capable of rapidly developing and producing natural, highly-targeted, high-potency, fully human polyclonal antibodies without the need for blood plasma donations from recovered patients.

The therapeutic candidate, SAB-185, is generated from SAB’s proprietary DiversitAb™ platform producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2, the virus that causes COVID-19. Driven by advanced genetic engineering and antibody science, SAB’s novel approach, leveraging genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible. SAB’s approach has expedited the rapid development of a novel immunotherapy for COVID-19 deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.

“COVID-19 is a nearly unprecedented public health crisis,” said CSL Behring’s Executive Vice President and Head of R&D Bill Mezzanotte, M.D. “That’s why we’re combining our leading capabilities in plasma product development and immunology with external collaborators to help find multiple, rapid solutions. In the near-term, SAB Biotherapeutics’ novel immunotherapy platform provides a new and innovative solution to rapidly respond without the need for human plasma adding a different dimension to the industry-wide plasma-derived hyperimmune alliance effort we recently launched for the COVID-19 crisis. For future pandemics, SAB’s platform may allow us to even more rapidly respond to patients’ needs.”

“Our targeted high-potency immunotherapies leverage the native immune response thereby providing a highly-specific match against the complexity, diversity and mutation of a disease,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president, CEO and co-founder. “Our partnership with CSL Behring shifts our development trajectory to more rapidly scale-up and delivery of our highly targeted and potent COVID-19 therapeutic candidate, and deploy our unique capabilities to help combat this crisis. We have a successful preclinical track record for addressing infectious disease targets including Ebola, MERS, and SARS with our proprietary platform and appreciate that this collaboration with a global biopharmaceutical powerhouse will magnify the potential impact of a COVID-19 immunotherapy and provide an important framework for establishing sustainable solutions for the future.”

CSL Behring has provided seed funding to offset some initial development costs that were funded by SAB in good faith, responding to the global pandemic as quickly as possible. SAB has already secured approximately $7.2 million in funding through an interagency agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) and Biomedical Advanced Research and Development Authority (BARDA) to support SAB to complete manufacturing and preclinical studies. CSL Behring will then commit its clinical, regulatory, manufacturing and supply chain expertise and resources to deliver the therapeutic to the market as soon as possible, on terms to be agreed with SAB.

Earlier this year, the companies announced a collaboration to investigate SAB’s platform technology as a new source for human immunoglobulin G (IgG) and the potential for new therapies to treat challenging autoimmune, infectious and idiopathic diseases by leveraging SAB’s DiversitAb™ platform.

About CSL Behring CSL

Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For more information, visit www.cslbehring.com and for inspiring stories about the promise of biotechnology, visit Vita www.cslbehring.com/Vita

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical-stage, biopharmaceutical development company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly targeted, high-potency, immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and exploratory oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, a fully human polyclonal antibodies targeted to SARS-CoV-2 without using human donors. SAB185 is expected to be ready for evaluation as early as summer 2020. The company was also recently awarded a $27 million contract from the U.S. Department of Defense (DoD) to leverage its unique capabilities as part of a Rapid Response Antibody Program, valued at up to $27 million. For more information visit: www.sabbiotherapeutics.com.

Media contacts: SAB Biotherapeutics Melissa Ullerich mullerich@sabbiotherapeutics.com +1 605.679.4609

CSL Behring Greg Healy greg.healy@cslbehring.com +1 610-906-4564

Sioux Falls, S.D., March 31, 2020 – SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company, advancing a new class of immunotherapies leveraging the native human immune response, announced today it has been awarded a contract from the U.S. Department of Defense (DoD) to develop and test a Rapid Response Antibody Program, valued at up to $27 million.

This progressive and competitive, three-stage, multi-year contract calls for the development of a state-of-the-art, pharmaceutical platform technology capable of rapidly and reliably producing antibody-based Medical Countermeasures (MCM) for biological threats. The goal of the program, awarded through DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEOCBRND) Joint Project Lead CBRND Enabling Biotechnologies (JPL-CBRND-EB), is to accelerate the delivery of potent, human, polyclonal antibody therapeutics to address known and novel emerging biodefense (viral, bacterial or toxin) threats.

Driven by advanced genetic engineering and antibody science, SAB has developed the DiversitAb™ platform to naturally and rapidly produce large amounts of targeted human antibodies, without human donors.

Stage 1 of the contract, totaling $3.4 million, began in September of 2019 and continues through May 2020; demonstrating the platform’s potential to meet the DoD’s requirements for producing safe and efficacious cGMP material in less than six months at current scale. Stage 2 increases the scale of production to meet the DoD’s target number of doses of prototype drug product and fully-implemented demonstration of readiness. Stage 3 calls for production of an antibody product to an unknown threat, selected by the DoD in a “live fire” exercise as well as clinical activity through a Phase 1 trial.

“We have an obligation to apply our proprietary capabilities to produce high-potency immunotherapies to virtually any target on a large scale, to a rapid response capacity,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president, CEO and co-founder. “Our therapies leverage the native immune response thereby providing a highly-specific match against the complexity, diversity and mutation of disease.”

The company has developed more than a dozen effective antibodies from its DiversitAb platform in response to infectious disease targets during outbreaks of Ebola, Zika, Dengue and others.

“For a new disease target, we’re able to move quickly to a proof-of-concept in about 90 days,” added Sullivan.

“Infectious disease has been a strategic proving ground for our platform,” added Sullivan. “If we can perform under the most demanding of scenarios to challenging targets, it builds confidence that translates to a broader array of therapeutic programs,” Sullivan said.

SAB is also advancing a therapeutic pipeline including potential treatments for autoimmune diseases, inflammation, infectious diseases and cancers. The company recently entered a research collaboration with CSL Behring to explore new innovative immunotherapies, including human immunoglobulins.

“This initiative is solidifying a place for targeted human polyclonal antibodies in the immunotherapy space, showcasing the power of the native human biological immune response,” added Sullivan. “More importantly, we’re providing an innovative new tool in the medical countermeasures toolbox.”

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions.

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology.

Media contacts: Melissa Ullerich mullerich@sabbiotherapeutics.com +1 605-679-4609