The following is a discussion of the financial condition of the Company as of February 28, 2021 and February 29, 2020 and the results of operations for the fiscal years ended February 28, 2021 and February 29, 2020. It should be read in conjunction with the financial statements and the notes thereto included elsewhere in this report. The following discussion contains forward-looking statements.





Introduction

The Company has generated no significant revenue since its inception, and does not expect to generate any operating revenues until such time, if any, as Antineoplastons are approved for use and sale by the FDA. The Company's sole source of funding is Dr. Burzynski, who funds the Company's operations from his medical practice pursuant to certain agreements between Dr. Burzynski and the Company. See "Certain Relationships and Related Transactions, and Director Independence." Funds received by the Company from Dr. Burzynski are reported as additional paid-in capital to the Company.





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The Company is primarily engaged as a research and development facility of drugs currently being tested for the use in the treatment of cancer, and provides consulting services. All clinical trials were closed for enrollment by the Company as of September 24, 2012. The Company is currently conducting one FDA approved clinical trial.

On September 3, 2004, the FDA granted the Company's request for "orphan drug designation" ("ODD") for the Company's Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma and, on October 30, 2008, the FDA granted the Company's request for ODD for Antineoplastons (A10 and AS2-1 Antineoplaston) for the treatment of all gliomas.

On January 13, 2009, the Company announced that the Company had reached an agreement with the FDA for the Company to move forward with a pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed diffuse, intrinsic brainstem gliomas ("DBSG"). The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure, meaning that the design and planned analysis of the Phase III study of combination Antineoplastons A10 and AS2-1 ("ANP therapy") plus radiation therapy ("RT") in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma (protocol "BT-52"), is acceptable to support a regulatory submission seeking new drug approval. Protocol BT-52, at the FDA's request, was revised in 2014 to study only patients with diffuse, intrinsic pontine gliomas (DIPG), which accounts for ~80% of brainstem gliomas. The study is a randomized, international phase III study of combination ANP therapy + RT vs. RT alone in patients with newly diagnosed DIPG in order to assess overall survival and tolerability. The study's objective is to evaluate overall survival of patients with newly-diagnosed DIPG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone. Safety is also being assessed. The study of BT-52 will commence upon availability of funds.

On September 16, 2013, the Company notified the FDA that it had withdrawn protocol BT-54 from further consideration. This was to be a randomized phase III study of combination Antineoplaston therapy vs. Temozolomide in children ages > 6 months to < 18 years with recurrent and/or progressive optic pathway glioma, after Carboplatin or Cisplatin Therapy, in order to assess progression free survival and tolerability. However, after SPA, the FDA advised the Company that it would not receive approval for the proposed BT-54 Phase III clinical trial.





Results of Operations

Fiscal Year Ended February 28, 2021 Compared to Fiscal Year Ended February 29, 2020

Research and development costs were approximately $1,023,000 and $1,203,000 for the fiscal years ended February 28, 2021 and February 29, 2020, respectively. The decrease of $180,000 or 15% was due to a decrease in personnel costs of $34,000, consulting and quality control costs of $65,000, other research and development costs of $20,000, material costs of $27,000, and facility and equipment costs of $34,000, as a result of reduction of requirements imposed by the Food and Drug Administration.

General and administrative expenses were approximately $278,000 and $432,000 for the fiscal years ended February 28, 2021 and February 29, 2020, respectively. The decrease of $154,000 or 36% was due to a decrease in legal and professional fees of $77,000 and other general and administrative expenses of $76,000, as a result of a reduction in requests from regulatory agencies.

The Company had net losses of approximately $1,204,000 and $1,634,000 for the years ended February 28, 2021 and February 29, 2020, respectively. The decrease in net loss from 2020 to 2021 was primarily static due to an overall decrease in research and development costs and a decrease in general and administrative expenses of the Company as described above. As of February 28, 2021, the Company had a total stockholders' deficit of approximately $(46,000).





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Liquidity and Capital Resources

The Company's operations have been funded entirely by Dr. Burzynski with funds generated from Dr. Burzynski's medical practice. Effective March 1, 1997, the Company entered into a Research Funding Agreement with Dr. Burzynski (the "Research Funding Agreement"), pursuant to which the Company agreed to undertake all scientific research in connection with the development of new or improved Antineoplastons for the treatment of cancer and Dr. Burzynski agreed to fund the Company's Antineoplaston research for that purpose. Under the Research Funding Agreement, the Company hires such personnel as is required to conduct Antineoplaston research, and Dr. Burzynski funds the Company's research expenses, including expenses to conduct the clinical trials. Dr. Burzynski also provides the Company laboratory and research space as needed to conduct the Company's research activities. The Research Funding Agreement also provides that Dr. Burzynski may fulfill his funding obligations in part by providing the Company such administrative support as is necessary for the Company to manage its business. Dr. Burzynski pays the full amount of the Company's monthly and annual budget of expenses for the operation of the Company, together with other unanticipated but necessary expenses which the Company incurs. In the event the research results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents. Dr. Burzynski has unlimited and free access to all equipment which the Company owns, so long as such use does not conflict with the Company's use of such equipment, including without limitation, all equipment used in the manufacturing of Antineoplastons used in the clinical trials. The amounts which Dr. Burzynski is obligated to pay under the agreement shall be reduced dollar for dollar by the following: (1) any income which the Company receives for services provided to other companies for research and/or development of other products, less such identifiable marginal or additional expenses necessary to produce such income, or (2) the net proceeds of any stock offering or private placement which the Company receives during the term of the agreement up to a maximum of $1,000,000 in a given Company fiscal year.

The Company entered into a third amendment to the Research Funding Agreement, effective March 1, 2007, whereby the Company and Dr. Burzynski extended the term thereof until February 28, 2008, with an automatic renewal for an additional one year term, unless one party notifies the other party at least thirty days prior to the expiration of the term of the agreement of its intention not to renew the agreement. Subject to the foregoing, the term of the Research Funding Agreement was renewed and extended until February 28, 2022, which is also automatically renewable for an additional one year term unless one party notifies the other party at least thirty days prior to the expiration of the term of the agreement of its intention not to renew the agreement.

The Research Funding Agreement automatically terminates in the event that Dr. Burzynski owns less than fifty percent (50%) of the outstanding shares of the Company, or is removed as President and/or Chairman of the Board of the Company, unless Dr. Burzynski notifies the Company in writing of his intention to continue the agreement notwithstanding this automatic termination provision.

The Company estimates that it will spend approximately $1,200,000 in the fiscal year ending February 28, 2022. The Company estimates that ninety-five percent (95%) of this amount will be spent on research and development and the continuance of FDA approved clinical trials. While the Company anticipates that Dr. Burzynski will continue to fund the Company's research and FDA related costs, there is no assurance that Dr. Burzynski will be able to continue to fund the Company's operations pursuant to the Research Funding Agreement or otherwise. In addition, Dr. Burzynski's medical practice has successfully funded the Company's research activities over the last 25 years and, in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, immunotherapy, hormonal therapy and gene targeted therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company's Antineoplaston clinical trials.

Because the Company currently is entirely dependent upon the contributions for research provided by Dr. Burzynski under the Research Funding Agreement, the Company would not be able to continue conducting its clinical trials if Dr. Burzynski ceased funding the Company's research. In such event, the Company would be required to find immediate funding which may not be available on acceptable terms or at all. If this were to occur and the Company were not able to find adequate sources of funding, the Company would be required to cease operations. Even with Dr. Burzynski's continued contributions under the Research Funding Agreement, the Company may be required to seek additional capital through equity or debt financing or the sale of assets until the Company's operating revenues are sufficient to cover operating costs and provide positive cash flow; however, there can be no assurance that the Company will be able to raise such additional capital on acceptable terms to the Company. In addition, there can be no assurance that the Company will ever achieve positive operating cash flow.





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