UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~May~~August 31, 2024


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number 000-23425

Burzynski Research Institute, Inc.

(Exact name of Registrant as specified in its charter)


Delaware		76-0136810
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

9432 Katy Freeway, Suite 200, Houston, Texas 77055

(Address of principal executive offices)

(713) 335-5697

(Registrant’s telephone number)

(Former name, former address, and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Trading Name of each exchange on which registered
None	BZYR	None

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. Yes ⌧ No ◻

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ◻

Accelerated filer ◻

Non-accelerated filer ⌧

Smaller reporting company ☒

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ⌧

APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: As of ~~July~~October 3, 2024, 131,448,444 shares of the Registrant’s Common Stock were outstanding.

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BURZYNSKI RESEARCH INSTITUTE, INC.

Form 10-Q

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PART I — FINANCIAL INFORMATION

Item 1.	Financial Statements	3

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11

Item 4.	Controls and Procedures	15

PART II — OTHER INFORMATION		15

Item 1.	Legal Proceedings	15

Item 5.	Other Information	15

Item 6.	Exhibits	16

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Item 1.Financial Statements

BURZYNSKI RESEARCH INSTITUTE, INC.

BALANCE SHEETS

(UNAUDITED)


	~~May~~August 31,		February 29,
	2024		2024
ASSETS

Current assets
Cash and cash equivalents	$	~~297~~1,216	$	1,310
Prepaids		~~700~~400		1,000

Total current assets		~~997~~1,616		2,310

Total assets	$	~~997~~1,616	$	2,310

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

Current liabilities
Accounts payable	$	7077,~~605~~303	$	9,010
Accrued liabilities		5811,~~260~~947		18,423

CURRENT AND TOTAL LIABILITIES		~~128~~89,~~865~~250		27,433

Commitments and contingencies

Stockholders’ equity (deficit)
Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 shares issued and outstanding as of May 31, 2024 and February 29, 2024		131,449		131,449
Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 shares issued and outstanding as of August 31, 2024 and February 29, 2024		131,449		131,449
Additional paid-in capital		128,~~202~~612,~~221~~293		127,933,634
Retained deficit		(128,~~461~~831,~~538~~376)		(128,090,206)

Total stockholders’ equity (deficit)		(~~127~~87,~~868~~634)		(25,123)

Total liabilities and stockholders’ equity (deficit)	$	~~997~~1,616	$	2,310

See accompanying notes to financial statements.

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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)


	Three Months Ended ~~May~~August 31,
	2024		2023
Operating expenses
Research and development	$	~~226~~277,~~088~~176	$	~~182~~214,~~114~~057
General and administrative		~~145~~92,~~244~~622		~~105~~38,~~291~~047

Total operating expenses		~~371~~369,~~332~~838		~~287~~252,~~405~~104

Operating loss		(~~371~~369,~~332~~838)		(~~287~~252,~~405~~104)

Other income		—		—
Loss before provision for income tax		(369,838)		(252,104)

Loss before provision for income tax		(371,332)		(287,405)
Provision for income tax		—		—
Net loss	$	(~~371~~369,~~332~~838)	$	(~~287~~252,~~405~~104)

Earnings per share information:

Basic and diluted loss per common share	$	(0.00)	$	(0.00)

Weighted average number of common shares outstanding		131,448,444		131,448,444


	Six Months Ended August 31,
	2024		2023
Operating expenses
Research and development	$	503,264	$	396,171
General and administrative		237,906		143,338

Total operating expenses		741,170		539,509

Operating loss		(741,170)		(539,509)

Other income		—		—

Loss before provision for income tax		(741,170)		(539,509)

Net loss	$	(741,170)	$	(539,509)

Earnings per share information:

Basic and diluted loss per common share	$	(0.01)	$	(0.00)

Weighted average number of common shares outstanding		131,448,444		131,448,444

See accompanying notes to financial statements.

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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

For the ~~Three~~Six Months Ended ~~May~~August 31, 2024

(UNAUDITED)


				Additional				Total
	Common Stock			Paid-in		Retained		Stockholders’
	Shares	Amount		Capital		Deficit		Equity (Deficit)
Balance at February 29, 2024	131,448,444	$	131,449	$	127,933,634	$	(128,090,206)	$	(25,123)

Cash contributed by S.R. Burzynski M.D., Ph.D.	—		—		58,517		—		58,517

FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D.	—		—		210,070		—		210,070

Net loss	—		—		—		(371,332)		(371,332)

Balance at May 31, 2024	131,448,444	$	131,449	$	128,202,221	$	(128,461,538)	$	(127,868)

Cash contributed by S.R. Burzynski M.D., Ph.D.	—		—		149,017		—		149,017

FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D.	—		—		261,055		—		261,055

Net loss	—		—		—		(369,838)		(369,838)

Balance at August 31, 2024	131,448,444	$	131,449	$	128,612,293	$	(128,831,376)	$	(87,634)

See accompanying notes to financial statements.

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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

For the ~~Three~~Six Months Ended ~~May~~August 31, 2023

(UNAUDITED)


				Additional				Total
	Common Stock			Paid-in		Retained		Stockholders’
	Shares	Amount		Capital		Deficit		Equity (Deficit)
Balance at February 28, 2023	131,448,444	$	131,449	$	126,609,599	$	(126,754,775)	$	(13,727)

Cash contributed by S.R. Burzynski M.D., Ph.D.	—		—		64,517		—		64,517

FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D.	—		—		166,097		—		166,097

Net loss	—		—		—		(287,405)		(287,405)

Balance at May 31, 2023	131,448,444	$	131,449	$	126,840,213	$	(127,042,180)	$	(70,518)

Cash contributed by S.R. Burzynski M.D., Ph.D.	—		—		121,017		—		121,017

FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D.	—		—		197,129		—		197,129

Net loss	—		—		—		(252,104)		(252,104)

Balance at August 31, 2023	131,448,444	$	131,449	$	127,158,359	$	(127,294,284)	$	(4,476)

See accompanying notes to financial statements.

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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

For the ~~Three~~Six Months Ended ~~May~~August 31, 2024 and 2023


	2024		2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(~~371~~741,~~332~~170)	$	(~~287~~539,~~405~~509)
Adjustments to reconcile net loss to net cash used by operating activities:
FDA clinical trial expenses paid directly by S.R. Burzynski M.D., Ph.D.		~~210~~471,~~070~~125		~~166~~363,~~097~~226

Changes in operating assets and liabilities
Prepaids		~~300~~600		~~300~~600
Accounts payable		6168,~~595~~293		10(12,~~187~~570)
Accrued liabilities		39(6,~~837~~476)		453,~~518~~182

NET CASH USED BY OPERATING ACTIVITIES		(59207,~~530~~628)		(65185,~~303~~071)

CASH FLOWS FROM FINANCING ACTIVITIES
Contribution of capital		58207,~~517~~534		64185,~~517~~534

NET CASH PROVIDED BY FINANCING ACTIVITIES		58207,~~517~~534		64185,~~517~~534

NET DECREASE IN CASH		(1,013)		(786)
NET INCREASE (DECREASE) IN CASH		(94)		463

CASH AT BEGINNING OF PERIOD		1,310		934

CASH AT END OF PERIOD	$	~~297~~1,216	$	~~148~~1,397

See accompanying notes to financial statements.

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BURZYNSKI RESEARCH INSTITUTE, INC.

NOTES TO FINANCIAL STATEMENTS

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 81.0% of the outstanding common stock of the Company, and also is the inventor and original patent holder of certain drug products known as “Antineoplastons.”

The Company and Dr. Burzynski have entered into various agreements, as further described in Note B. 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, none of the Antineoplaston drugs have received FDA approval; further, there can be no assurance that FDA approval will be granted.

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. 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 ~~May~~August 31, 2024 and February 29, 2024, results of operations for the three and six months ended ~~May~~August 31, 2024 and 2023, and cash flows for the ~~three~~six months ended ~~May~~August 31, 2024 and 2023. 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 29, 2024.

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

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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.

STOCK OPTIONS AND WARRANTS

At ~~May~~August 31, 2024, the Company had one stock-based employee compensation plan, which is described below.

On September 14, 1996, the Company granted 600,000 stock options, with an exercise price of $0.35 per share, to an officer who is no longer with the Company. The options vested as follows:


		Vesting Date
400,000	options	September 14, 1996
100,000	options	June 1, 1997
100,000	options	June 1, 1998

The options are valid in perpetuity. None of the options have been exercised as of ~~May~~August 31, 2024.

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 D.

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 ~~three~~six months ended ~~May~~August 31, 2024 and 2023, 600,000 stock options were excluded from the calculation of diluted loss per share because their effect would be anti-dilutive.

NOTE E.

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.

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The Company recognizes interest and penalties as interest expense when they are accrued or assessed.

The federal income tax returns of the Company for 2023, 2022, and 2021 are subject to examination by the IRS, generally for three years after they are filed.

The actual provision for income tax for the three and six months ended August 31, 2024 and 2023 differ from the amounts computed by applying the U.S. federal income tax rate of 21% to the pretax loss as a result of the following:

The actual provision for income tax for the three months ended May 31, 2024 and 2023 differ from the amounts computed by applying the U.S. federal income tax rate of 21% to the pretax loss as a result of the following:


	Three Months Ended August 31,
	2024		2023
Expected expense (benefit)	$	(77,666)	$	(52,942)
Taxed directly to Dr. Burzynski		77,666		52,942
Nondeductible expenses and other adjustments		(8,449)		(13,869)
Change in valuation allowance		8,449		13,869
State taxes		—		—
Provision for income tax	$	—	$	—


	Six Months Ended August 31,
	2024		2023
Expected expense (benefit)	$	(77155,~~980~~646)	$	(60113,~~355~~297)
Taxed directly to Dr. Burzynski		77155,~~980~~646		60113,~~355~~297
Nondeductible expenses and other adjustments		~~(21~~13,~~576)~~127		11(1,~~926~~943)
Change in valuation allowance		21(13,~~576~~127)		~~(11~~1,~~926)~~943
State taxes		—		—
Provision for income tax	$	—	$	—

At ~~May~~August 31, 2024, the Company had a net deferred tax asset of $0, which includes a valuation allowance of $~~185~~177,~~807~~358. The Company’s ability to utilize net operating loss ("NOL") carryforwards and alternative minimum tax credit carryforwards will depend on its ability to generate adequate future taxable income. The Company has no historical earnings on which to base an expectation of future taxable income. Accordingly, a full valuation allowance for deferred tax assets has been provided.

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 80% of future taxable income. Under the Act, carrybacks of NOLs were disallowed. In March 2020, the Coronavirus Aid, Relief, and Economic Security ("CARES") Act was enacted providing a five-year carryback for losses incurred in 2018, 2019, or 2020, which allows companies to modify tax returns up to five years prior to offset taxable income from those tax years. The CARES Act also temporarily suspended the NOL limit of 80% of taxable income.

As of ~~May~~August 31, 2024, the Company has net operating loss carryforwards in the amount of $473,902 that will expire between 2026 and 2038, and $~~208~~167,~~022~~788 that will carryforward indefinitely.

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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 ~~May~~August 31, 2024, and the results of operations comparing the three and six months ended ~~May~~August 31, 2024 and 2023. 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 29, 2024.

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 patients 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.

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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 four 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 ~~May~~August 31, 2024 Compared to Three Months Ended ~~May~~August 31, 2023

Research and development costs were approximately $~~226~~277,000 and $~~182~~214,000 for the three months ended ~~May~~August 31, 2024 and 2023, respectively. The increase of $4463,000 or 2429% was due to an increase in ~~facility~~personnel ~~and equipment~~ costs of $2242,000, ~~consulting~~ and ~~other~~facility ~~research~~ and ~~development~~equipment costs of $122,000, ~~and~~offset ~~personnel~~by ~~costs~~a decrease of $211,000 of other research and development costs, as a result of additional requests imposed by the Food and Drug Administration.

General and administrative expenses were approximately $~~145~~93,000 and $~~105~~38,000 for the three months ended ~~May~~August 31, 2024 and 2023, respectively. The increase of $4055,000 or 38144% was due to an increase in ~~legal and~~ other ~~professional~~ costs of $1758,000, ~~primarily~~pertaining ~~relating~~ to ~~various~~patents, ~~discussions~~offset ~~with~~by ~~our~~a ~~outside~~decrease ~~law~~in ~~firm~~legal and ~~consultants regarding the Company’s current clinical hold on IND 43742 and~~ other ~~future~~professional ~~developments relating to Antineoplaston patents, and other~~ costs of $233,000, as a result of increased reporting requirements from regulatory agencies.

The Company had net losses of approximately $~~371~~370,000 and $~~287~~252,000 for the three months ended ~~May~~August 31, 2024 and 2023, respectively. The increase in the net loss from 2024 to 2023 is primarily due to an overall increase in research and development costs and in general and administrative expenses of the Company as described above.

~~Liquidity~~Six ~~and~~Months ~~Capital~~Ended ~~Resources~~August 31, 2024 Compared to Six Months Ended August 31, 2023

~~The~~Research ~~Company’s~~and ~~operations~~development ~~have~~costs ~~been~~were ~~funded~~approximately ~~entirely~~$503,000 ~~by contributions from Dr. Burzynski~~ and ~~from funds generated from Dr. Burzynski’s medical practice. Effective March 1~~$396,000 ~~1997,~~for the ~~Company~~six ~~entered~~months ~~into~~ended aAugust ~~Research~~31, ~~Funding~~2024 ~~Agreement~~and ~~with~~2023, Drrespectively. ~~Burzynski~~ ~~(the~~The ~~“Research~~increase ~~Funding~~of ~~Agreement”)~~$107,000 ~~pursuant~~or to27% ~~which~~was ~~the~~due ~~Company agreed~~ to ~~undertake~~an ~~all~~increase ~~scientific research~~ in ~~connection~~facility ~~with~~and ~~the~~equipment ~~development~~costs of ~~new~~$44,000 ~~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 ascosts isof ~~required to conduct Antineoplaston research~~$63, ~~and Dr. Burzynski funds the Company’s research expenses~~000, ~~including expenses to conduct the clinical trials. Dr. Burzynski also provides the Company laboratory and research space~~ as ~~needed~~a toresult ~~conduct~~of ~~the~~additional ~~Company’s~~requests ~~research~~imposed ~~activities. The Research Funding Agreement also provides that Dr. Burzynski may fulfill his funding obligations in part~~ by ~~providing~~ the ~~Company~~Food ~~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~~Drug ~~budget of expenses for the operation of the Company, together with other unanticipated but necessary expenses which the Company incurs~~Administration.

~~The~~General ~~amounts~~and ~~which~~administrative ~~Dr. Burzynski~~expenses iswere ~~obligated~~approximately to$238,000 ~~pay~~and ~~under~~$143,000 for the ~~agreement~~six ~~shall~~months beended ~~reduced~~August ~~dollar~~31, ~~for~~2024 ~~dollar~~and by2023, ~~the~~respectively. The ~~following:~~increase ~~(1) any~~of ~~income~~$95,000 ~~which~~or ~~the~~66% ~~Company~~was ~~receives~~due ~~for~~to ~~services~~an ~~provided~~increase toin legal and other ~~companies~~professional ~~for~~costs ~~research~~of $14,000, primarily relating to various discussions with our outside law firm and~~/or~~ ~~development~~consultants ofregarding ~~other~~the ~~products,~~Company’s ~~less~~current ~~such~~clinical ~~identifiable~~hold ~~marginal~~on orIND ~~additional~~43742 ~~expenses~~and ~~necessary~~other tofuture ~~produce~~developments ~~such~~relating ~~income~~to Antineoplaston patents, orand ~~(2) the~~other ~~net~~costs ~~proceeds~~of $81,000 as a result of ~~any~~reduced ~~stock~~reporting requirements from regulatory agencies.

The Company had net losses of approximately $741,000 and $540,000 for the six months ended August 31, 2024 and 2023, respectively. The increase in the net loss from 2023 to 2024 is primarily due to an overall increase in research and development costs and an increase in general and administrative expenses of the Company as described above.

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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.

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, 2025. 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 $~~900~~600,000 during the remaining ~~three~~two quarters of the fiscal year ending February 28, 2025. 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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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 ~~May~~August 31, 2024 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

None.

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Item 6. Exhibits


3.1		Certificate of Incorporation of the Company, as amended (incorporated by reference from Exhibits 3(i)— (iii) to Form 10-SB filed with the Securities and Exchange Commission on November 25, 1997 (File No.000-23425)).

3.2		Amended Bylaws of the Company (incorporated by reference from Exhibit 3 (iv) to Form 10-SB filed with the Securities and Exchange Commission on November 25, 1997 (File No.000-23425)).

31.1*		Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as amended.

31.2*		Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as amended.

32.1*		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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.

101.SCH*		Inline XBRL Taxonomy Extension Schema Document.

101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document.

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.
	By:	/s/ Stanislaw R. Burzynski
		Stanislaw R. Burzynski,
		President and Chairman of the Board of Directors
		(Principal Executive Officer)
Date: July 15, 2024
Date: October 10, 2024

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