BZYR 10-Q
Burzynski Research Institute Inc (BZYR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Title of each class | Trading | Trading Name of each exchange on which registered | ||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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BURZYNSKI RESEARCH INSTITUTE, INC.
Form 10-Q
Table of Contents
PART I — FINANCIAL INFORMATION | ||
3 | ||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 15 | |
20 | ||
20 | ||
20 | ||
20 | ||
21 | ||
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Item 1.Financial Statements
BURZYNSKI RESEARCH INSTITUTE, INC.
BALANCE SHEETS
(UNAUDITED)
November 30, | February 28, | ||||||
| 2025 | | 2025 | | |||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | | $ | | |||
Prepaids | | — | |||||
Total current assets |
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Total assets | $ | | $ | | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities | |||||||
Accounts payable | $ | | $ | | |||
Accrued liabilities |
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Current and total liabilities |
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Commitments and contingencies |
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Stockholders’ equity (deficit) | |||||||
Common stock, $ |
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Additional paid-in capital |
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Retained deficit |
| ( |
| ( | |||
Total stockholders’ equity (deficit) |
| ( |
| ( | |||
Total liabilities and stockholders’ equity (deficit) | $ | | $ | | |||
See accompanying notes to financial statements.
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BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended November 30, | ||||||
2025 | | 2024 | ||||
Operating expenses | ||||||
Research and development | $ | | $ | | ||
General and administrative |
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Total operating expenses |
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Operating loss |
| ( |
| ( | ||
Other income |
| — |
| — | ||
Loss before provision for income tax |
| ( |
| ( | ||
Provision for income tax | — | — | ||||
Net loss | $ | ( | $ | ( | ||
Earnings per share information: | ||||||
Basic and diluted loss per common share | $ | ( | $ | ( | ||
Weighted average number of common shares outstanding |
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Nine Months Ended November 30, | ||||||
2025 | | 2024 | ||||
Operating expenses | ||||||
Research and development | $ | | $ | | ||
General and administrative |
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Total operating expenses |
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Operating loss |
| ( |
| ( | ||
Other income | — | — | ||||
Loss before provision for income tax |
| ( |
| ( | ||
Provision for income tax | — | — | ||||
Net loss | $ | ( | $ | ( | ||
Earnings per share information: | ||||||
Basic and diluted loss per common share | $ | ( | $ | ( | ||
Weighted average number of common shares outstanding |
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See accompanying notes to financial statements.
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BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the Nine Months Ended November 30, 2025
(UNAUDITED)
| | | Additional | | | Total | ||||||||
Common Stock | Paid-in | Retained | Stockholders’ | |||||||||||
| Shares | | Amount | | Capital | | Deficit | | Equity (Deficit) | |||||
Balance at February 28, 2025 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
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FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
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Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at May 31, 2025 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
| | |||||
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
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Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at August 31, 2025 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
| |
| — |
| | |||||
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
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Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at November 30, 2025 | | $ | | $ | | $ | ( | $ | ( | |||||
See accompanying notes to financial statements.
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BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the Nine Months Ended November 30, 2024
(UNAUDITED)
| | | Additional | | | Total | ||||||||
Common Stock | Paid-in | Retained | Stockholders’ | |||||||||||
| Shares | | Amount | | Capital | | Deficit | | Equity (Deficit) | |||||
Balance at February 29, 2024 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
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FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
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| — |
| | |||||
Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at May 31, 2024 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
| |
| — |
| | |||||
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
| |
| — |
| | |||||
Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at August 31, 2024 | | $ | | $ | | $ | ( | $ | ( | |||||
Cash contributed by S.R. Burzynski M.D., Ph.D. | — |
| — |
| |
| — |
| | |||||
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | — |
| — |
| |
| — |
| | |||||
Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at November 30, 2024 | | $ | | $ | | $ | ( | $ | ( | |||||
See accompanying notes to financial statements.
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BURZYNSKI RESEARCH INSTITUTE, INC.
STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Nine Months Ended November 30, 2025 and 2024
| 2025 | | 2024 | |||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
Net loss | $ | ( | $ | ( | ||
Changes in operating assets and liabilities | ||||||
Prepaids | ( | | ||||
Accounts payable |
| |
| | ||
Accrued liabilities |
| ( |
| ( | ||
NET CASH USED BY OPERATING ACTIVITIES |
| ( |
| ( | ||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
Contribution of capital | | | ||||
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D. | | | ||||
NET CASH PROVIDED BY FINANCING ACTIVITIES |
| |
| | ||
NET INCREASE (DECREASE) IN CASH |
| |
| ( | ||
CASH AT BEGINNING OF PERIOD |
| |
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CASH AT END OF PERIOD | $ | | $ | | ||
See accompanying notes to financial statements.
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BURZYNSKI RESEARCH INSTITUTE, INC.
NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
NOTE A. | BASIS OF PRESENTATION |
The financial statements of Burzynski Research Institute, Inc. (the “Company”), a Delaware corporation, include expenses incurred related to clinical trials, which were sanctioned by the U.S. Food and Drug Administration (FDA) in 1993, for Antineoplaston drugs used in the treatment of cancer. These expenses are incurred directly by S.R. Burzynski, M.D., Ph.D. (Dr. Burzynski or “SRB”) on behalf of the Company and have been reported as research and development costs and as additional paid-in capital. Other funds received from Dr. Burzynski have also been reported as additional paid-in capital. Expenses related to Dr. Burzynski’s medical practice (unrelated to the clinical trials) have not been included in these financial statements. Dr. Burzynski is the President, Chairman of the Board and owner of approximately
The Company and Dr. Burzynski have entered into various agreements, as further described in Note H. The Original License Agreement between the Company and Dr. Burzynski provided the Company the exclusive right in the United States, Canada, and Mexico to use, manufacture, develop, sell, distribute, sublicense and otherwise exploit all the rights, titles and interest in Antineoplaston drugs used in the treatment of cancer, once the drug is approved for sale by the FDA. On July 2, 2019, the Original License Agreement between the Company and Dr. Burzynski terminated upon the expiration of the last patent licensed to the Company under such agreement. On May 22, 2023, the Company entered into the New License Agreement with Dr. Burzynski, pursuant to which Dr. Burzynski licensed to the Company the exclusive rights in the territory (composed of the United States and Canada) to make, have made, use, sell, offer for sale, and distribute or otherwise exploit the licensed products and services relating to Antineoplastons, including but not limited to any patent rights which may be granted in these countries.
The Company is primarily engaged as a research and development facility for Antineoplaston drugs being tested for the use in the treatment of cancer. The Company’s investigational new drug application (“IND”) 43742 is currently under full clinical hold and the Company cannot enroll new patients into any clinical trials until the full clinical hold is removed by the FDA. At this time, however,
The Company’s administrative offices are located in Houston, Texas; its research and production facilities are in Stafford, Texas. The Company operates primarily as a research and development facility of Antineoplaston drugs. Segment information is not presented since all of the Company’s operations are attributed to a single reportable segment. This single operating segment has been identified based on internal management structure and reporting to the Company’s Chief Operating Decision Maker (“CODM”), the Company’s President. The Company’s CODM evaluates segment performance based on the operating loss of the segment and uses internal financial statements to make decisions regarding resource allocation. Operating loss used by the CODM are presented on the accompanying statements of operations. The Company has had no significant revenue from external sources.
The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Certain disclosures and information normally included in financial statements have been condensed or omitted. In the opinion of management of the Company, these financial statements contain all adjustments necessary for a fair presentation of financial position as of November 30, 2025 and February 28, 2025, results of operations for the three and nine months ended November 30, 2025 and 2024, and cash flows for the nine months ended November 30, 2025 and 2024. All adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year. These statements should be read in conjunction with the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended February 28, 2025.
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NOTE B. | ECONOMIC DEPENDENCY |
The Company has not generated significant revenues since its inception and has suffered losses from operations, has a working capital deficit and has an accumulated deficit. Dr. Burzynski has funded the capital and operational needs of the Company through his medical practice since inception, and has entered into various agreements to continue such funding. Because the Company is entirely dependent upon the contributions for research provided by Dr. Burzynski under a 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 a 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.
The Company is economically dependent on its funding through Dr. Burzynski’s medical practice. In the past, a portion of Dr. Burzynski’s patients have been admitted and treated as part of the clinical trial programs. The Company’s IND 43742 is currently under full clinical hold and the Company cannot enroll new patients into any clinical trials until the full clinical hold is removed by the FDA. The FDA imposes numerous regulations and requirements regarding these patients, and the Company is subject to inspection at any time by the FDA. These regulations are complex and subject to interpretation and though it is management’s intention to comply fully with all such regulations, there is the risk that the Company is not in compliance and is thus subject to sanctions imposed by the FDA. In addition, as with any medical practice, Dr. Burzynski is subject to potential claims by patients and other potential claimants commonly arising out of the operation of a medical practice. The risks associated with Dr. Burzynski’s medical practice directly affect his ability to fund the operations of the Company.
NOTE C. | GOING CONCERN |
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has not generated significant revenue since its inception, has incurred recurring operating losses, has a working capital deficit and an accumulated deficit, and has experienced negative operating cash flows. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
The Company’s ability to continue as a going concern is dependent upon the continued financial support of Dr. Burzynski through his medical practice, as provided under a research funding agreement. The Company is economically dependent on this arrangement. In the event that Dr. Burzynski is unable or unwilling to continue providing such funding, the Company would be required to obtain alternative financing. There can be no assurance that such financing will be available on acceptable terms, or at all. If the Company is unable to obtain such funding, it would likely be required to cease operations.
Management is evaluating strategic options to secure additional sources of capital through equity or debt financing, or other arrangements. However, there can be no assurance that these efforts will be successful. Even with Dr. Burzynski’s continued contributions, additional funding may be required until the Company achieves positive cash flows from operations, which may never occur.
Accordingly, the financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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NOTE D. | ACCRUED LIABILITIES |
The Company’s accrued liabilities consist of audit, accounting, and legal fees as follows:
| November 30, 2025 | | February 28, 2025 | |||
Legal Fees | $ | $ | | |||
Accounting Fees |
| — |
| | ||
Audit Fees |
| — |
| — | ||
Total | $ | | $ | | ||
NOTE E. | STOCK OPTIONS AND WARRANTS |
At November 30, 2025, the Company had
On September 14, 1996, the Company granted
Vesting Date | |||
options | | September 14, 1996 | |
options |
| June 1, 1997 | |
options |
| June 1, 1998 |
The options are valid in perpetuity.
The Company accounts for share-based payments to non-employees in accordance with the guidance provided by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation to include share-based payments granted to non-employees in exchange for goods or services used or consumed in an entity’s own operations.
NOTE F. | STOCKHOLDERS’ EQUITY |
The Company has authorized
NOTE G. | LOSS PER COMMON SHARE |
The Company accounts for loss per share in accordance with FASB ASC 260, Earnings per Share. Basic loss per share amounts are calculated by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding for the periods, including the dilutive effect of all common stock equivalents. Dilutive options and warrants that are issued during a period or that expire or are canceled during a period are reflected in the computations for the time they were outstanding during the periods being reported. During the nine months ended November 30, 2025 and 2024,
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NOTE H. | AGREEMENTS WITH, AND OTHER RELATED PARTY TRANSACTIONS: |
The Company has agreements with its majority shareholder and President Dr. Burzynski as further described below:
Original License Agreement
Dr. Burzynski owned patents involving the formulation, preparation, manufacture, production, use, dosage and treatment with Antineoplastons. The United States Patent Office and Patent Offices of
The Original License Agreement granted to the Company the exclusive right, in the United States, Canada, and Mexico, to use, manufacture, develop, sell, distribute, sub-license and otherwise exploit all of Dr. Burzynski’s rights, title, and interests, including patent rights, in Antineoplaston drugs in the treatment and diagnosis of cancer. Under the Original License Agreement, the Company owned exclusive rights to
New License Agreement
On May 22, 2023, the Company entered into the New License Agreement with Dr. Burzynski, pursuant to which Dr. Burzynski licensed to the Company the exclusive rights in the Territory (composed of the United States and Canada) to make, have made, use, sell, offer for sale, and distribute or otherwise exploit the licensed products and services relating to Antineoplastons, including but not limited to any patent rights which may be granted in these countries. The New License Agreement currently covers
Research Funding Agreement
Effective March 1, 1997, Dr. Burzynski restructured his funding arrangement with the Company and entered into a Research Funding Agreement. On May 22, 2023, the parties amended and restated the Research Funding Agreement in connection with the execution of the New License Agreement and to limit the scope of the Research Funding Agreement to the United States and Canada. Under this agreement, the
| 1. | The Company agrees to undertake all scientific research (including clinical trials) in connection with the development of new or improved Antineoplastons for the treatment of cancer in the United States and Canada. The Company will hire such personnel as is required to fulfill its obligations under the agreement. |
| 2. | Dr. Burzynski agrees to fund in its entirety all basic research, which the Company undertakes in connection with the development of other Antineoplastons or refinements to existing Antineoplastons for the treatment of cancer. |
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| 3. | As FDA approval of Antineoplastons will benefit both parties, Dr. Burzynski agrees to pay the expenses to conduct the clinical trials for the Company. |
| 4. | Dr. Burzynski agrees to provide the Company such laboratory and research space as the Company needs at the Trinity Drive facility in Stafford, Texas, and such office space as is necessary at Trinity Drive and at his medical facility. |
| 5. | In the event the research described in the agreement results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions and limitations as in the New License Agreement. |
| 6. | Dr. Burzynski shall have unlimited and free access to all equipment which the Company owns and controls, so long as such use is not in conflict with the Company’s use of such equipment, including without limitation to all equipment used in manufacturing of Antineoplastons used in the clinical trials. |
| 7. | The amounts, which Dr. Burzynski is obligated to pay under the agreement, shall be reduced dollar for dollar by the following: |
a. 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 (such as the purchase of chemicals, products or equipment) solely necessary to engage in such other research and development activity, and
b. The net proceeds of any stock offering or private placement, which the Company receives during the term of the engagement up to a maximum of $
| 8. | Effective March 1, 2024, the term of the Research Funding Agreement was extended to February 28, 2025, and is automatically renewable for an additional |
Royalty Agreement
Effective March 1, 1997, the Company entered into a royalty agreement with Dr. Burzynski whereby upon receiving FDA approval for interstate marketing and distribution, the Company agrees to pay Dr. Burzynski a royalty interest equivalent to
The term of this agreement is indefinite and will continue until such time as the parties agree that it is in their mutual interest to terminate such agreement.
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Other Related Party Transactions
Dr. Burzynski owns the production facility located at Trinity Drive. There is no formal lease agreement between Dr. Burzynski and the Company; however, the Research Funding Agreement described above provides that Dr. Burzynski will allow the Company the use of the building. In addition, the Royalty Agreement states that after FDA approval is granted (though approval is not assured) the Company may rent the facility at competitive rates if Dr. Burzynski does not need the facility for his use. The actual facility costs are included in the financial statements as set forth in clause 4 above. In addition, Dr. Burzynski’s medical clinic performs certain administrative functions such as accounting, and allows the Company the use of some office space. Since May of 2000, Dr. Burzynski’s and the chief financial officer’s entire salaries are paid through his medical practice and he is not compensated directly by the Company for his services.
NOTE I. | INCOME TAXES |
The Company follows the provisions of FASB ASC 740, Income Taxes. The Company is not aware of any material unrecognized tax uncertainties as a result of tax positions previously taken.
The Company recognizes interest and penalties as interest expense when they are accrued or assessed.
The federal income tax returns of the Company for 2024, 2023, and 2022 are subject to examination by the IRS, generally for
Deferred tax assets consisted of the following at November 30, 2025, and February 28, 2025:
November 30, 2025 | | February 28, 2025 | ||||
Net operating loss | $ | | $ | | ||
Alternate Minimum Tax Credit Carryforward |
|
| | |||
|
| | ||||
Alternate Minimum Tax Credit Carryforward |
| ( |
| ( | ||
$ | — | $ | — | |||
The actual provision for income tax for the three and nine months ended November 30, 2025 and 2024 differ from the amounts computed by applying the U.S. federal income tax rate of
| Three Months Ended November 30, | |||||
2025 | | 2024 | ||||
Expected expense (benefit) | $ | ( | $ | ( | ||
Taxed directly to Dr. Burzynski |
| |
| | ||
Nondeductible expenses and other adjustments |
| ( |
| ( | ||
Change in valuation allowance |
| |
| | ||
State taxes | — | — | ||||
Provision for income tax | $ | | $ | | ||
| Nine Months Ended November 30, | |||||
2025 | | 2024 | ||||
Expected expense (benefit) | $ | ( | $ | ( | ||
Taxed directly to Dr. Burzynski |
| |
| | ||
Nondeductible expenses and other adjustments | |
| ( | |||
Change in valuation allowance | ( |
| | |||
State taxes | — | — | ||||
Provision for income tax | $ | | $ | | ||
At November 30, 2025, the Company had a net deferred tax asset of $
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will depend on its ability to generate adequate future taxable income. The Company has
As a result of the Tax Cuts and Jobs Act of 2017 (the "Act"), NOL carryforwards generated in years beginning after December 31, 2017, would carryforward indefinitely, and would apply to
As of November 30, 2025, the Company has net operating loss carryforwards in the amount of $
NOTE J. | SUBSEQUENT EVENTS |
In accordance with ASC Topic 855-10, the Company has analyzed its operations subsequent to November 30, 2025 to the date these financial statements were issued and has determined that it does not have any additional material subsequent events to disclose in these financial statements.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following is a discussion of the financial condition of the Company as of November 30, 2025, and the results of operations comparing the three and nine months ended November 30, 2025 and 2024. It should be read in conjunction with the financial statements and the notes thereto included elsewhere in this report and in conjunction with the Annual Report on Form 10-K for the year ended February 28, 2025.
Forward-Looking Statements
Certain matters discussed in this quarterly report, except for historical information contained herein, may constitute “forward-looking statements” that are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking statements provide current expectations of future events based on certain assumptions. These statements encompass information that does not directly relate to any historical or current fact and often may be identified with words such as “anticipates,” “believes,” “expects,” “estimates,” “intends,” “plans,” “projects” and other similar expressions. Management’s expectations and assumptions regarding Company operations and other future results are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the anticipated results or other expectations expressed in the forward-looking statements.
Introduction
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. The Company’s clinical trial initiated in April 2016 for children and adults with Diffuse Intrinsic Pontine Glioma (DIPG) (protocol “BT-55”) is currently under full clinical hold.
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 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 procedure, meaning that the design and planned analysis of the Phase III study of combination Antineoplastons A10 and AS2-1 plus radiation therapy (“RT”) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma (protocol “BT-52”), are acceptable to support a regulatory submission seeking new drug approval. However, the FDA placed a full clinical hold on IND 43742 regarding such Phase III clinical trial. Please see the section below entitled “Clinical Hold on Phase II and Phase III Clinical Trials.”
Clinical Hold on Phase II and Phase III Clinical Trials
In a letter dated June 25, 2012, the Company informed the FDA of a serious adverse event in which a patient who was receiving Antineoplastons developed grade 4 hypernatremia and subsequently died. The Antineoplaston-related hypernatremia was categorized by the investigator as possibly related to the study drug. Of the 2,297 patients who have received at least one dose of Antineoplastons, the serious adverse events (SAEs) which have been experienced are as follows: hemoglobin (grade 3: 0.13%; grade 4: 0.04%), extravasation (grade 3: 0.04%), pain (grade 3: 0.04%), fatigue (grade 3: 0.09%; grade 4: 0.04%), fever (grade 3: 0.09%), injection site reaction (grade 3: 0.04%), vomiting (grade 3: 0.09%), hypernatremia (grade 3: 0.09%; grade 4: 1.12%; grade 5: 0.26%), confusion (grade 3: 0.04%), seizure (grade 3: 0.04%), somnolence (grade 3: 0.35%; grade 4: 0.04%), pain: head/headache (grade 3: 0.09%) and pain: joint (grade 3: 0.04%).
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On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43742. The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated. The FDA cited 21 C.F.R. § 312.42(b)(2)(i), 21 C.F.R. § 312.42(b)(1)(iv), and 21 C.F.R. § 312.42(b)(3)(i), as grounds for imposition of a clinical hold; and 21 C.F.R. § 312.305(a)(2), a criteria for expanded access use. The FDA advised the Company that until it resolved the matter to the FDA’s satisfaction, the Company could not enroll new pediatric patients in any protocol under such IND. The Company later notified the FDA in a September 24, 2012 letter that it was closing pediatric protocol BT-10 (under IND 43742) for enrollment effective September 25, 2012, and that it would also terminate the protocol once all active patients had completed the study. As of February 17, 2015, all patients discontinued treatment under protocol BT-10 and such protocol was closed as of March 10, 2015.
In a teleconference on January 9, 2013 between the FDA and the Company, followed by a letter of the same date, the FDA notified the Company that the agency was placing IND 43742 on partial clinical hold, due to a lack of a complete response to the issues raised by the FDA and what the FDA deemed a misleading, erroneous, and incomplete investigator brochure. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R. § 312.42(b)(1)(iii), as grounds for imposition of a clinical hold. The FDA further advised the Company that until it resolved the matter to the FDA’s satisfaction, that the Company could not enroll new adult or pediatric patients in any protocol under such IND. The FDA also placed protocol BT-52 on clinical hold due to what the FDA deemed to be an unreasonable and significant risk of illness or injury to human subjects. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R.§ 312.42(B)(1)(i), as grounds for imposition of a clinical hold. The FDA advised the Company that until it resolved the matter to the FDA’s satisfaction, the Company could not legally conduct the identified clinical study under such IND. In a teleconference with the FDA on September 16, 2013 and pursuant to the Company’s notification letter dated September 17, 2013, the Company notified the FDA that the proposed Phase III protocol BT-54 had been withdrawn from further consideration.
After several amendments to the IND which were reviewed by the FDA, the FDA concluded that BT-52 can be initiated and the partial clinical hold was removed by the FDA on June 20, 2014.
Additionally, the Company received IRB approval on February 4, 2015 for FDA reviewed protocol BT-55 open label, Phase II study of Antineoplaston A10 and AS2-1 in patients with a Diffuse Intrinsic Brainstem Glioma (DIPG) in five treatment groups based on patient’s age and prior treatment.
On April 20, 2016, the Company received a full clinical hold letter from the FDA based on FDA’s inspection of S.R. Burzynski’s manufacturing facility in March 2015. On April 27, 2016, the Company requested to change the full clinical hold to partial clinical hold to allow patient #1 to continue the Antineoplaston treatment according to protocol BT-55, since the patient was enrolled before the full clinical hold was imposed. Based on the FDA’s position regarding the Company’s request on April 27, 2016 and the Company’s teleconference with the FDA on May 3, 2016, the Company removed patient #1 from the study.
A temporary restraining order from the US District Court of Rhode Island allowed the resumption of patient #1’s Antineoplaston therapy on May 17, 2016. As a result of such temporary restraining order, a subsequent letter from the FDA dated May 26, 2016 informed the Company that the full clinical hold was replaced and a partial clinical hold was imposed. As a result, patient #1 restarted treatment under IND 43742.
On June 14, 2016, the FDA issued a letter to the Company in connection with the FDA’s inspection of S.R. Burzynski’s manufacturing facility (the “SRB Manufacturing”) in March 2015. The SRB Manufacturing addressed the issues raised in the letter in a response letter submitted to the FDA on July 5, 2016 and in subsequent letters.
On February 20, 2017, BRI informed the FDA of the death of patient #1 on February 19, 2017. No new patients can be enrolled to protocol BT-55 or BT-52 until the partial hold on IND 43742 is lifted. On August 24, 2017, the FDA imposed a full clinical hold on IND 43742 until deficiencies regarding the SRB Manufacturing are resolved.
On December 1, 2021, the FDA issued a letter to the Company informing the Company that IND 43742 may be placed on inactive status.
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Termination of the Original License Agreement
Pursuant to the terms of the License Agreement dated June 29, 1983, as superseded by an Amended License Agreement dated April 24, 1989 and a Second Amended License Agreement dated March 1, 1990 between the Company and Dr. Burzynski (collectively, the “Original License Agreement”), the Original License Agreement terminated on July 2, 2019 upon the expiration of the last patent licensed to the Company from Dr. Burzynski. As of July 2, 2019, all patents previously licensed by the Company under the Original License Agreement have expired.
New License Agreement
On May 22, 2023, the Company entered into a new License Agreement (the “New License Agreement”) with Dr. Burzynski, pursuant to which Dr. Burzynski licensed to the Company the exclusive rights in the Territory (composed of the United States and Canada) to make, have made, use, sell, offer for sale, and distribute or otherwise exploit the licensed products and services relating to Antineoplastons, including but not limited to any patent rights which may be granted in these countries. The New License Agreement currently covers five United States patents owned by Dr. Burzynski. The Company will not be able to exploit such rights under the New License Agreement until such time as Antineoplastons are approved, of which there can be no assurance, by the FDA for sale in the United States.
Results of Operations
Three Months Ended November 30, 2025 Compared to Three Months Ended November 30, 2024
Research and development costs were approximately $261,000 and $301,000 for the three months ended November 30, 2025 and 2024, respectively. The decrease of $40,000 or 13% was due to an increase in personnel costs of $8,000 offset by a decrease in facility and equipment costs of $47,000 and consulting and quality control costs of $2,000, due to fewer regulatory requests during the quarter.
General and administrative expenses were approximately $68,000 and $51,000 for the three months ended November 30, 2025 and 2024, respectively. The increase of $17,000 or 33% was due to an increase in professional fees of $7,000 and other costs of $10,000, as a result of more regulatory filings and reporting requirements during the quarter.
The Company had net losses of approximately $329,000 and $352,000 for the three months ended November 30, 2025 and 2024, respectively. The decrease in the net loss from 2025 to 2024 is primarily due to an overall decrease in research and development costs offset by an increase in general and administrative expenses of the Company as described above.
Nine Months Ended November 30, 2025 Compared to Nine Months Ended November 30, 2024
Research and development costs were approximately $786,000 and $804,000 for the nine months ended November 30, 2025 and 2024, respectively. The decrease of $18,000 or 2% was due to an increase in personnel costs of $50,000, offset by a decrease in facility and equipment costs of $55,000 and consulting and quality control costs of $13,000, due to fewer regulatory requests during the period.
General and administrative expenses were approximately $208,000 and $289,000 for the nine months ended November 30, 2025 and 2024, respectively. The decrease of $81,000 or 28% was due to a decrease in legal and other professional costs of $23,000 and other costs of $58,000, as a result of a lower volume of regulatory filings and reporting requirements during the period.
The Company had net losses of approximately $994,000 and $1,093,000 for the nine months ended November 30, 2025 and 2024, respectively. The decrease in the net loss from 2024 to 2025 is primarily due to lower research and development costs and general and administrative expenses of the Company as described above.
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Liquidity and Capital Resources
The Company’s operations have been funded entirely by contributions from Dr. Burzynski and from 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.
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 Research Funding Agreement, as amended, contains an annual automatic renewal provision providing for an additional one-year term, unless one party notifies the other party at least thirty days prior to the expiration of the then current 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, 2026. It is expected that the Research Funding Agreement will continue to renew each year prospectively unless terminated under the provisions of the agreement.
On May 22, 2023, the parties amended and restated the Research Funding Agreement in connection with the execution of the New License Agreement and to limit the scope of the Research Funding Agreement to the United States and Canada.
The Research Funding Agreement automatically terminates in the event that Dr. Burzynski owns less than fifty percent 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 $300,000 during the remaining quarter of the fiscal year ending February 28, 2026. 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, gene-targeted therapy, immunotherapy and hormonal therapy.
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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The following table summarized our total current assets, liabilities and working capital as of November 30, 2025 and February 28, 2025.
| November 30, 2025 | | February 28, 2025 | |||
Current Assets | $ | 2,265 | $ | 847 | ||
Current Liabilities | $ | 69,608 | $ | 42,484 | ||
Working Capital Deficit | $ | (67,343) | $ | (41,637) | ||
As of November 30, 2025, we had negative working capital of $67,343. We have incurred net losses since our inception and we anticipate net losses and negative operating cash flows for the near future, and we may not be profitable or realize growth in the value of our assets. To date, our primary sources of capital have been cash generated from funds generated from Dr. Burzynski’s medical practice. As of November 30, 2025, we had cash of $2,165, total liabilities of $69,608, and an accumulated deficit of $130,470,593. As of February 28, 2025, we had cash of $847, total liabilities of $42,484, and an accumulated deficit of $129,476,413.
Cash Flow
Comparison of the Nine Months Ended November 30, 2025 and the Nine Months Ended November 30, 2024
The following table sets forth the primary sources and uses of cash for the periods presented below:
Nine Months Ended November 30, | ||||||
2025 | | 2024 | ||||
Net cash used in operating activities | $ | (967,156) | (1,097,903) | |||
Net cash provided by financing activities | 968,474 | $ | 1,097,206 | |||
Net change in cash | $ | 1,318 |
| (697) | ||
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities was $(967,156) for the nine months ended November 30, 2025, compared to $(1,097,903) for the same period in 2024, a decrease of $130,747. The decrease was primarily due to fewer expenses in the current period.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities was $968,474 for the nine months ended November 30, 2025, compared to $1,097,206 for the same period in 2024, a decrease of $128,732. The decrease was primarily due to fewer proceeds from financing activities.
Critical Accounting Policies and Estimates
Our financial results are affected by the selection and application of accounting policies and methods. In the nine-month period ended November 30, 2025 there were no changes to the application of critical accounting policies disclosed in our Annual Report on Form 10-K for the year ended February 28, 2025.
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Item 4. Controls and Procedures
Within the 90 days prior to the date of this report, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s principal executive and financial officers, of the effectiveness of the Company’s disclosure controls and procedures pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as amended. Based on that evaluation, the Company’s principal executive and financial officers concluded that the Company’s disclosure controls and procedures are effective in timely alerting them to material information required to be included in periodic filings with the Securities and Exchange Commission. A controls system cannot provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. There were no significant changes in the Company’s internal controls or in other factors that could significantly affect internal controls over financial reporting that occurred during the fiscal quarter ended November 30, 2025 that have materially affected or are reasonably likely to materially affect our internal controls subsequent to that date.
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
The Company’s activities are subject to regulation by various governmental agencies, including the FDA, which regularly monitor the Company’s operations and often impose requirements on the conduct of its clinical trials and other aspects of the Company’s business operations. The Company’s policy is to comply with all such regulatory requirements. From time to time, the Company is also subject to potential claims by patients and other potential claimants commonly arising out of the operation of a medical practice. The Company seeks to minimize its exposure to claims of this type wherever possible.
Currently, the Company is not a party to any material pending legal proceedings. Moreover, the Company is not aware of any such legal proceedings that are contemplated by governmental authorities with respect to the Company or any of its properties.
Item 5. Other Information
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Item 6. Exhibits
3.1 | ||
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31.1* |
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31.2* |
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32.1* |
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32.2* |
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101.INS* |
| Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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101.SCH* |
| Inline XBRL Taxonomy Extension Schema Document. |
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101.CAL* |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF* |
| Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB* |
| Inline XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE* |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
104* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |
_____________________________________________________________ * Filed herewith. |
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SIGNATURES
In accordance with the requirements of the Exchange Act, the Company caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BURZYNSKI RESEARCH INSTITUTE, INC. | |
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| By: | /s/ Stanislaw R. Burzynski |
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| Stanislaw R. Burzynski, |
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| President and Chairman of the Board of Directors |
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| (Principal Executive Officer) |
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Date: January 13, 2026 |
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| By: | /s/ Patryk P. Goscianski |
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| Patryk P. Goscianski, |
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| Treasurer |
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| (Principal Financial Officer and Principal Accounting Officer) |
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Date: January 13, 2026 |
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