Burzynski Research Institute BZYR

Burzynski Research Institute, Inc. is engaged in the research, production, marketing, promotion and sale of medical chemical compounds known as Antineoplastons, which are growth inhibiting peptides, amino acid derivatives and organic acids that occur naturally in human bodily fluids and certain foods. The company has developed six natural formulations and six synthetic formulations of Antineoplastons, with the synthetic versions A10 and AS2 1 being used in its current clinical programs. Burzynski Research Institute, Inc. believes these agents inhibit cancer cell growth while sparing normal tissues and is focused on advancing them through preclinical experiments and clinical studies. At present, the firm supplies Antineoplastons solely for use by Stanislaw R. Burzynski, M. D., Ph. D., in his clinical research at the Burzynski Clinic. The company has not recorded any significant operating revenue since its founding and remains a development stage entity awaiting possible regulatory clearance for its product.

Burzynski Research Institute, Inc. has not produced any meaningful operating revenue to date. The company’s sole source of funding consists of payments received from Stanislaw R. Burzynski, which are derived from his medical practice and governed by various agreements between the company and the doctor. These payments are recorded as additional paid in capital. The firm anticipates generating revenue only if Antineoplastons obtain approval for sale and use from the U. S. Food and Drug Administration or comparable health authorities. In the meantime, Burzynski Research Institute, Inc. may seek additional capital through the sale of its securities or other financing arrangements to sustain its research and development activities.

Burzynski Research Institute, Inc. operates within the highly competitive oncology therapeutic market, where numerous large pharmaceutical corporations, biotechnology enterprises, academic research centers and government sponsored programs pursue novel cancer treatments with considerably greater financial and research capabilities. The company’s niche centers on its proprietary Antineoplaston compounds, which have received orphan drug designation from the FDA for the treatment of brain stem glioma and glioma, a status that could confer seven years of marketing exclusivity upon eventual approval. Although the firm previously held a portfolio of patents covering Antineoplaston formulation and use, many of those rights have expired and it now relies on a newer license agreement with its founder for a limited set of patents in the United States and Canada. The absence of any commercial sales history and the reliance on a single individual for funding place Burzynski Research Institute, Inc. at an early stage relative to established rivals, but its unique chemical platform and regulatory recognitions provide potential differentiators should the product advance through the approval process.

Burzynski Research Institute, Inc. provides its Antineoplaston compounds exclusively to Stanislaw R. Burzynski, M. D., Ph. D., for use in his clinical research at the Burzynski Clinic. Patients who participate in the company’s phase II clinical trials at the clinic receive the investigational therapy as part of those studies. To date, more than two thousand two hundred patients have received at least one dose of Antineoplastons through these research programs, covering a variety of malignancies such as glioma, glioblastoma, astrocytoma and medulloblastoma. The firm does not sell its product to hospitals, pharmacies or any other third party distributors, and no additional commercial customers are identified in the filing.