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You should not rely upon forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
This Annual Report on Form 10-K includes references and citations to third-party publications.
Such publications and related materials are provided for informational purposes only.
All other trademarks, service marks, and trade names in this Annual Report are the property of their respective owners.
Business Overview We are a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders.
The Company s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to potentially change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients.
Using advanced genetic engineering and antibody science, we developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma.
We have optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine , to produce hIgG.
Our drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders and address a wide range of serious unmet needs in human diseases.
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All other trademarks, service marks and trade names in this Annual Report on Form 10-K are the property of their respective owners.
Business Overview We are a clinical-stage biopharmaceutical company focused on the development of human polyclonal immunotherapeutic antibodies, or human immunoglobulin G (hIgG), to address immunology disorders.
Our internally discovered antibodies are both target-specific and polyclonal, meaning they are comprised of multiple hIgG and can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders.
We have optimized genetic engineering in the development of transchromosomic cattle, or Tc Bovine, which produce hIgG.
Our Development Pipeline The following table highlights our current development pipeline: SAB-142: Our Lead Product Candidate Our wholly owned lead product candidate, SAB-142 is a human anti-thymocyte globulin (ATG) focused on preventing or delaying the progression of T1D.
SAB-142 is a first-in-class, human, multi-target ATG treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D.
SAB-142 is expected to reduce autoimmune -cell destruction and delay progression or onset of T1D in patients with Stage 3 or Stage 2 T1D, respectively.
In 3 addition, data from more than 700 human subjects treated with antibodies produced by our platform support expectation of a zero-serum sickness rate and zero incidence of neutralizing anti-drug antibodies (ADA) within the upcoming SAB-142 clinical trials.
Our regulatory pathway has also been established with the United States Food and Drug Administration (FDA) as well as United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and Therapeutic Good Administration (TGA) in Australia.
CBER has approved over 36 immunoglobulin products from both human- and animal-derived plasma.