Business Description

4 ​ ​ ​ ITEM 1A. RISK FACTORS 19 ​ ​ ​ ITEM 1B. UNRESOLVED STAFF COMMENTS 29 ​ ​ ​ ITEM 1C. CYBERSECURITY 30 ​ ​ ​ ITEM 2. PROPERTIES 30 ​ ​ ​ ITEM 3. LEGAL PROCEEDINGS 30 ​ ​ ​ ITEM 4. MINE SAFETY DISCLOSURES 30 ​ ​ ​ PART II ​ 31 ​ ​ ​ ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY; RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 31 ​ ​ ​ ITEM 6. [RESERVED] 31 ​ ​ ​ ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 31 ​ ​ ​ ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 34 ​ ​ ​ ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 34 ​ ​ ​ ITEM 9A. CONTROLS AND PROCEDURES 34 ​ ​ ​ ITEM 9B. OTHER INFORMATION 35 ​ ​ ​ ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 35 ​ ​ ​ PART III ​ 35 ​ ​ ​ ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 35 ​ ​ ​ ITEM 11. EXECUTIVE COMPENSATION 37 ​ ​ ​ ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 38 ​ ​ ​ ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 38 ​ ​ ​ ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 40 ​ ​ ​ PART IV ​ 41 ​ ​ ​ ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 41 ​ ​ ​ ITEM 16. FORM 10-K SUMMARY 41 ​ ​ 3 Table of Contents PART I ​ ITEM 1. BUSINESS ​ General ​ Burzynski Research Institute, Inc. (the “Company”) was incorporated under the laws of the State of Delaware in 1984 in order to engage in the research, production, marketing, promotion and sale of certain medical chemical compounds composed of growth-inhibiting peptides, amino acid derivatives and organic acids which are known under the trade name “Antineoplastons.” The Company believes Antineoplastons are useful in the treatment of human cancer and is currently reviewing data of its Phase II clinical trials of Antineoplastons relating to the treatment of various cancers. Antineoplastons have not been approved for sale or use by the Food and Drug Administration of the United States Department of Health and Human Services (“FDA”) or anywhere in the world. In the event Antineoplastons receive such approval and are registered in the United States or Canada, of which there can be no assurance, the Company will commence commercial operations, which shall include the production, marketing, promotion and sale of Antineoplastons in the United States or Canada. In 2004, the FDA approved the designation of Antineoplastons as an “orphan drug” under the Orphan Drug Act of 1983. See “ Orphan Drug Designation ” below for a detailed description of this designation and its meaning. The Company currently provides Antineoplastons solely for use by Stanislaw R. Burzynski, M.D., Ph.D. (“Dr. Burzynski”) in clinical research. ​ The Company has not generated any significant operating revenue since its inception. The Company’s sole source of funding for its operations has been and continues to be payments made by Dr. Burzynski from funds generated from Dr. Burzynski’s medical practice pursuant to various arrangements between the Company and Dr. Burzynski. See “ Certain Relationships and Related Transactions, and Director Independence .” The Company reports funds pursuant to such arrangements as additional paid-in capital. See “ Management’s Discussion and Analysis of Financial Condition and Results of Operations .” The Company does not expect to generate significant operating revenue until such time, if any, as Antineoplastons are approved for use and sale by the FDA. However, the Company may seek additional funding for operations through the sale of its securities. ​ Antineoplastons ​ Dr. Burzynski commenced his cancer research in 1967 focusing on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer. In the course of his research, Dr. Burzynski identified certain peptides, amino acid derivatives and organic acids in these biochemicals which appear to inhibit the growth of cancer cells. These derivatives were given the name “Antineoplastons” by Dr. Burzynski. ​ Antineoplastons are found in the bodily fluids of humans and food and were initially isolated by Dr. Burzynski from normal human blood and urine. Dr. Burzynski believes these substances counteract the development of cancerous growth through a biochemical process which does not inhibit the growth of normal tissues. To date, Dr.…