Burzynski Research Institute Narrows Loss Amid FDA Hold, Funding Reliance

TL;DR

**BZYR is a speculative bet on a single individual's funding and an unapproved drug, with an FDA clinical hold making it a high-risk, low-probability play.**

AI Summary

Burzynski Research Institute, Inc. (BZYR) reported a net loss of $333,867 for the three months ended August 31, 2025, a 9.7% improvement from the $369,838 net loss in the same period of 2024. For the six months ended August 31, 2025, the net loss was $665,318, an 11.4% improvement from the $741,170 loss in the prior year. Research and development expenses decreased by 7.9% to $255,117 for the three months, but increased by 4.4% to $525,389 for the six months. General and administrative expenses decreased significantly by 15.1% to $78,750 for the three months and by 41.2% to $139,929 for the six months. The company remains entirely dependent on funding from S.R. Burzynski M.D., Ph.D., who contributed $637,384 in capital during the six months ended August 31, 2025. BZYR's IND 43742 is under a full clinical hold by the FDA, preventing new patient enrollment, and the company has not generated significant revenue since its inception, raising substantial doubt about its ability to continue as a going concern.

Why It Matters

For investors, BZYR's continued reliance on Dr. Burzynski for all funding, coupled with the FDA's full clinical hold on IND 43742, presents an extremely high-risk profile. The lack of independent revenue generation and the 'going concern' warning indicate severe financial instability. Employees face job insecurity given the company's precarious financial state and dependence on a single individual's continued willingness and ability to fund operations. Customers (potential patients) are directly impacted by the FDA clinical hold, which prevents new enrollments in trials for Antineoplaston drugs, limiting access to this experimental treatment. The broader market for cancer therapeutics sees BZYR as a cautionary tale of prolonged R&D without market approval, highlighting the immense challenges and regulatory hurdles in drug development, especially for unproven therapies.

Risk Assessment

Risk Level: high — The company has not generated significant revenue since its inception, incurred recurring operating losses of $665,318 for the six months ended August 31, 2025, and has an accumulated deficit of $130,141,731. Furthermore, BZYR is entirely dependent on S.R. Burzynski M.D., Ph.D. for all capital and operational funding, and its investigational new drug application (IND 43742) is currently under a full clinical hold by the FDA, preventing new patient enrollment.

Analyst Insight

Investors should avoid BZYR due to its extreme economic dependency on a single individual, lack of revenue, recurring losses, and the critical FDA clinical hold. The 'going concern' warning and the speculative nature of its Antineoplaston drugs, which lack FDA approval, make it an unsuitable investment for all but the most risk-tolerant speculators.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

$1,331

total Debt

$0

net Income

$ (333,867)

eps

$ (0.00)

gross Margin

N/A

cash Position

$931

revenue Growth

N/A

Key Numbers

• $665,318 — Net Loss (Six Months) (Improved by 11.4% from $741,170 in prior year, but still significant.)
• $130,141,731 — Accumulated Deficit (Indicates substantial historical losses and financial instability.)
• $637,384 — Capital Contribution by Dr. Burzynski (Represents 100% of funding for the six months ended August 31, 2025, highlighting economic dependency.)
• $931 — Cash and Cash Equivalents (Extremely low cash balance as of August 31, 2025, indicating liquidity issues.)
• 131,448,444 — Common Shares Outstanding (Consistent share count, but no market value due to lack of exchange listing.)
• 0% — Revenue from External Sources (Company has no significant revenue, relying solely on related-party funding.)
• 81.0% — Ownership by Dr. Burzynski (Highlights concentrated control and related-party risk.)
• $46,959 — Accrued Liabilities (Increased from $25,467, primarily due to legal and audit fees.)

Key Players & Entities

• BURZYNSKI RESEARCH INSTITUTE INC (company) — Registrant in 10-Q filing
• S.R. Burzynski M.D., Ph.D. (person) — President, Chairman of the Board, majority owner (81.0%), inventor, and primary funder
• FDA (regulator) — U.S. Food and Drug Administration, placed IND 43742 on full clinical hold
• $333,867 (dollar_amount) — Net loss for the three months ended August 31, 2025
• $665,318 (dollar_amount) — Net loss for the six months ended August 31, 2025
• $130,141,731 (dollar_amount) — Retained deficit as of August 31, 2025
• $637,384 (dollar_amount) — Capital contributed by S.R. Burzynski M.D., Ph.D. during the six months ended August 31, 2025
• Antineoplastons (other) — Investigational drugs for cancer treatment
• IND 43742 (other) — Investigational New Drug application under full clinical hold
• Delaware (other) — State of incorporation for Burzynski Research Institute, Inc.

FAQ

Risk Factors

• FDA Clinical Hold [high — regulatory]: The company's IND 43742 is under a full clinical hold by the FDA, preventing new patient enrollment. This significantly hinders research and development progress and the potential for future drug approval.
• Dependence on Related-Party Funding [high — financial]: The company is entirely dependent on capital contributions from S.R. Burzynski M.D., Ph.D., who provided $637,384 in the six months ended August 31, 2025. This creates significant concentration risk and raises questions about long-term financial sustainability.
• Going Concern Uncertainty [high — financial]: With substantial accumulated deficits of $130,141,731 and no significant revenue generation, coupled with the FDA clinical hold, there is substantial doubt about the company's ability to continue as a going concern.
• Extremely Low Cash Position [high — financial]: As of August 31, 2025, cash and cash equivalents stood at a mere $931. This critically low liquidity poses immediate operational challenges and highlights the reliance on external funding.
• Lack of Revenue Generation [high — financial]: The company has generated 0% revenue from external sources since its inception. This complete absence of commercial success underscores the speculative nature of its business model.
• No FDA Drug Approval [high — regulatory]: None of the Antineoplaston drugs have received FDA approval. Without approval, the company cannot generate revenue from its core research and development activities.
• Increasing Accrued Liabilities [medium — financial]: Accrued liabilities increased to $46,959 from $25,467, primarily due to legal and audit fees. This increase, while not substantial in absolute terms, points to ongoing operational costs and potential future obligations.
• Limited Operational Scale [medium — operational]: The company's total assets are only $1,331 as of August 31, 2025, reflecting a very small operational footprint and limited capacity for large-scale research or commercialization.

Industry Context

The pharmaceutical industry, particularly in oncology, is highly competitive and capital-intensive, with long development cycles and significant regulatory hurdles. Companies like Burzynski Research Institute operate in a space where groundbreaking therapies are sought, but success is contingent on rigorous clinical trials and FDA approval. The industry trend is towards targeted therapies and personalized medicine, requiring substantial investment in research and development.

Regulatory Implications

The FDA's full clinical hold on IND 43742 is the most significant regulatory implication, completely halting new patient enrollment and any progress towards drug approval. Without the removal of this hold, the company's core business operations are effectively frozen, posing an existential threat.

What Investors Should Do

1. Monitor FDA communications regarding IND 43742.
2. Assess the sustainability of Dr. Burzynski's funding.
3. Evaluate the company's ability to secure alternative funding or generate revenue.
4. Consider the implications of the 'going concern' warning.

Key Dates

• 2025-08-31: End of Q2 2025 reporting period — Reflects continued net losses and dependence on Dr. Burzynski's funding, with a critical cash position.
• 2025-02-28: End of Q1 2025 reporting period — Shows a similar financial state prior to the current reporting period, with a slightly lower cash balance.
• 2023-05-22: New License Agreement with Dr. Burzynski — Established new licensing terms for Antineoplastons, crucial for the company's ongoing research and potential future commercialization.
• 2019-07-02: Termination of Original License Agreement — Marked the expiration of the previous licensing agreement, necessitating a new arrangement for the company to continue its work with Antineoplastons.
• 1993: FDA Sanctioned Clinical Trials for Antineoplastons — The initiation of FDA-sanctioned trials laid the groundwork for the company's existence and its focus on cancer drug development.

Glossary

IND

Investigational New Drug application, a submission to the FDA to seek approval to start clinical trials in humans. (BZYR's IND 43742 is under a full clinical hold, preventing new patient enrollment and halting progress.)

Clinical Hold

A status imposed by the FDA on an IND, halting all clinical trials for a drug. This can be due to safety concerns, insufficient data, or other regulatory issues. (The company's IND is under a full clinical hold, directly impacting its ability to conduct research and develop its drugs.)

Antineoplastons

A class of drugs developed by Dr. S.R. Burzynski, primarily investigated for cancer treatment. (These are the core focus of BZYR's research and development efforts, but they have not yet received FDA approval.)

Additional Paid-in Capital

An equity account that represents the amount investors have paid for stock above its par value. In BZYR's case, it includes funds contributed by Dr. Burzynski. (This account shows significant contributions from Dr. Burzynski, highlighting the company's reliance on his funding.)

Retained Deficit

The cumulative net losses of a company that have not been offset by net income. It is the opposite of retained earnings. (BZYR has a substantial retained deficit of $130,141,731, indicating a long history of unprofitability.)

Going Concern

A business's ability to continue operating for the foreseeable future, typically considered to be at least one year. Auditors assess this, and substantial doubt can be raised. (The company's financial condition raises substantial doubt about its ability to continue as a going concern.)

Operating Expenses

Costs incurred by a company in its normal course of business, excluding cost of goods sold. For BZYR, this includes R&D and G&A. (Total operating expenses decreased by 9.7% for the three months ended August 31, 2025, contributing to a smaller net loss.)

Weighted Average Number of Common Shares Outstanding

The average number of shares of common stock outstanding during a period, used for calculating earnings per share. (This number has remained constant at 131,448,444, indicating no new share issuances or buybacks.)

Year-Over-Year Comparison

Compared to the prior year's six-month period, Burzynski Research Institute has reduced its net loss by 11.4% to $665,318, primarily driven by a significant 41.2% decrease in general and administrative expenses. However, research and development expenses saw a slight increase of 4.4%. The company's cash position has improved slightly from $847 to $931, but remains critically low. The accumulated deficit has widened, and the company continues to face substantial doubt about its ability to continue as a going concern due to its complete reliance on related-party funding and the ongoing FDA clinical hold.

Filing Documents

• bzyr-20250831x10q.htm (10-Q) — 717KB
• bzyr-20250831xex31d1.htm (EX-31.1) — 11KB
• bzyr-20250831xex31d2.htm (EX-31.2) — 12KB
• bzyr-20250831xex32d1.htm (EX-32.1) — 6KB
• bzyr-20250831xex32d2.htm (EX-32.2) — 7KB
• 0001104659-25-099284.txt ( ) — 2853KB
• bzyr-20250831.xsd (EX-101.SCH) — 26KB
• bzyr-20250831_cal.xml (EX-101.CAL) — 22KB
• bzyr-20250831_def.xml (EX-101.DEF) — 58KB
• bzyr-20250831_lab.xml (EX-101.LAB) — 191KB
• bzyr-20250831_pre.xml (EX-101.PRE) — 124KB
• bzyr-20250831x10q_htm.xml (XML) — 309KB

— FINANCIAL INFORMATION

PART I — FINANCIAL INFORMATION Item 1.

Financial Statements

Financial Statements 3 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 15 Item 4.

Controls and Procedures

Controls and Procedures 20

— OTHER INFORMATION

PART II — OTHER INFORMATION 20 Item 1.

Legal Proceedings

Legal Proceedings 20 Item 5. Other Information 20 Item 6. Exhibits 21 2 Table of Contents

Financial Statements

Item 1. Financial Statements BURZYNSKI RESEARCH INSTITUTE, INC. BALANCE SHEETS (UNAUDITED) August 31, February 28, 2025 2025 ASSETS Current assets Cash and cash equivalents $ 931 $ 847 Prepaids 400 — Total current assets 1,331 847 Total assets $ 1,331 $ 847 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities Accounts payable $ 23,943 $ 17,017 Accrued liabilities 46,959 25,467 Current and total liabilities 70,902 42,484 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 August 31, 2025 and February 28, 2025 131,449 131,449 Additional paid-in capital 129,940,711 129,303,327 Retained deficit ( 130,141,731 ) ( 129,476,413 ) Total stockholders' equity (deficit) ( 69,571 ) ( 41,637 ) Total liabilities and stockholders' equity (deficit) $ 1,331 $ 847 See accompanying notes to financial statements. 3 Table of Contents BURZYNSKI RESEARCH INSTITUTE, INC. (UNAUDITED) Three Months Ended August 31, 2025 2024 Operating expenses Research and development $ 255,117 $ 277,176 General and administrative 78,750 92,662 Total operating expenses 333,867 369,838 Operating loss ( 333,867 ) ( 369,838 ) Other income — — Loss before provision for income tax ( 333,867 ) ( 369,838 ) Provision for income tax — — Net loss $ ( 333,867 ) $ ( 369,838 ) 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, 2025 2024 Operating expenses Research and development $ 525,389 $ 503,264 General and administrative 139,929 237,906 Total operating expenses 665,318 741,170 Operating loss ( 665,318 ) ( 741,170 ) Other

NOTES TO FINANCIAL STATEMENTS (UNAUDITED)

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 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 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 distribu

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View this 10-Q filing on SEC EDGAR