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[10-Q] BURZYNSKI RESEARCH INSTITUTE INC Quarterly Earnings Report

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
10-Q

Burzynski Research Institute (BZYR) filed its Q2 2025 10‑Q, showing continued operating losses and heavy reliance on related‑party funding. The company reported a net loss of $333,867 for the quarter and $665,318 for the six months ended August 31, 2025. R&D expense was $255,117 and G&A was $78,750 for the quarter.

Liquidity remains strained: cash was $931, current liabilities were $70,902, and stockholders’ equity (deficit) was $(69,571) as of August 31, 2025. Additional paid‑in capital rose to $129,940,711, reflecting contributions and clinical trial costs paid directly by Dr. S.R. Burzynski during the period. Shares outstanding were 131,448,444 as of October 14, 2025.

The company’s IND 43742 is under a full clinical hold, and management discloses substantial doubt about the ability to continue as a going concern within one year. Operations and clinical activities are funded under a Research Funding Agreement with Dr. Burzynski; the 10‑Q notes the company may need additional capital even with ongoing related‑party support.

Burzynski Research Institute (BZYR) ha depositato il suo 10‑Q del secondo trimestre 2025, mostrando continue perdite operative e una forte dipendenza dal finanziamento da parte di parti correlate. L'azienda ha riportato una perdita netta di $333,867 per il trimestre e $665,318 per i primi sei mesi chiusi al 31 agosto 2025. Le spese di R&D sono state $255,117 e G&A $78,750 per il trimestre.

La liquidità resta sotto pressione: la cassa era $931, le passività correnti ammontavano a $70,902, e l'equity dei soci (deficit) era $(69,571) al 31 agosto 2025. Il capitale versato aggiuntivo è salito a $129,940,711, riflettendo contributi e costi delle prove cliniche pagati direttamente dal Dr. S.R. Burzynski durante il periodo. Le azioni in circolazione erano 131,448,444 al 14 ottobre 2025.

L'IND 43742 della società è soggetto a un congelamento clinico completo, e la direzione dichiara un dubbio sostanziale sulla capacità di proseguire come going concern entro un anno. Le operazioni e le attività cliniche sono finanziate tramite un Accordo di Finanziamento della Ricerca con il Dott. Burzynski; il 10‑Q segnala che la società potrebbe aver bisogno di ulteriori capitali anche con il sostegno continuo da parte di parti correlate.

Burzynski Research Institute (BZYR) presentó su 10‑Q del segundo trimestre de 2025, mostrando pérdidas operativas continuas y una fuerte dependencia de financiamiento de partes relacionadas. La empresa reportó una pérdida neta de $333,867 para el trimestre y $665,318 para los seis meses terminado el 31 de agosto de 2025. El gasto en I+D fue $255,117 y G&A fue $78,750 para el trimestre.

La liquidez sigue siendo estresada: el efectivo era $931, los pasivos corrientes eran $70,902, y el patrimonio de los accionistas (déficit) era $(69,571) al 31 de agosto de 2025. El capital social adicionales se incrementó a $129,940,711, reflejando contribuciones y costos de ensayos clínicos pagados directamente por el Dr. S.R. Burzynski durante el período. Las acciones en circulación eran 131,448,444 al 14 de octubre de 2025.

La IND 43742 de la empresa está bajo un congelamiento clínico total, y la dirección divulga una fuerte duda sobre la capacidad de continuar como empresa en marcha dentro de un año. Las operaciones y las actividades clínicas se financian con un Acuerdo de Financiación de la Investigación con el Dr. Burzynski; el 10‑Q señala que la empresa podría necesitar capital adicional incluso con el apoyo continuo de partes relacionadas.

Burzynski Research Institute (BZYR) 은 2025년 2분기 10‑Q 를 제출했으며, 계속된 영업손실과 관련 당사자 자금에 대한 의존도가 여전히 높음을 보여주고 있습니다. 회사는 분기에 $333,867의 순손실과 2025년 8월 31일로 종료되는 6개월 동안 $665,318의 손실을 보고했습니다. R&D 지출은 $255,117이고 분기 G&A는 $78,750였습니다.

유동성은 여전히 악화되고 있습니다: 현금은 $931, 유동부채는 $70,902, 그리고 2025년 8월 31일 기준 주주지분(적자)은 $(69,571) 이었습니다. 추가 납입 자본은 $129,940,711 로 증가했으며, 이는 기간 동안 Dr. S.R. Burzynski 에 의해 직접 지출된 기여금과 임상 시험 비용을 반영합니다. 발행주식 수는 2025년 10월 14일 기준 131,448,444주였습니다.

회사의 IND 43742 는 전임상 보류 상태이며, 경영진은 1년 이내에 지속가능성에 대한 실질적 의문을 제기합니다. 운영 및 임상 활동은 Burzynski 박사와의 연구 자금 조달 계약에 따라 자금 조달되며, 10‑Q 는 관련 당사자 지원이 계속되더라도 추가 자본이 필요할 수 있음을 언급합니다.

Burzynski Research Institute (BZYR) a déposé son 10‑Q du deuxième trimestre 2025, montrant des pertes d'exploitation continues et une forte dépendance au financement provenant de parties liées. L'entreprise a enregistré une perte nette de $333,867 pour le trimestre et $665,318 pour les six mois terminé le 31 août 2025. Les dépenses R&D étaient de $255,117 et les frais G&A de $78,750 pour le trimestre.

La liquidité reste tendue : la trésorerie était de $931, les passifs courants de $70,902, et les capitaux propres des actionnaires (déficit) de $(69,571) au 31 août 2025. Le capital social supplémentaires a augmenté à $129,940,711, reflétant les contributions et les coûts d essais cliniques payés directement par le Dr. S.R. Burzynski pendant la période. Les actions en circulation étaient de 131,448,444 au 14 octobre 2025.

L'IND 43742 de la société est soumis à une mise en attente clinique complète, et la direction déclare un doute substantiel quant à la capacité de continuer en tant que going concern dans un délai d'un an. Les opérations et les activités cliniques sont financées dans le cadre d'un accord de financement de la recherche avec le Dr Burzynski ; le 10‑Q indique que la société pourrait avoir besoin de capital supplémentaire même avec le soutien continu des parties liées.

Burzynski Research Institute (BZYR) hat seinen Q2 2025 10‑Q eingereicht, was weiterhin Betriebsverluste und eine starke Abhängigkeit von Finanzierung durch verbundene Parteien zeigt. Das Unternehmen meldete einen Nettoverlust von $333,867 für das Quartal und $665,318 für das die sechs Monate bis zum 31. August 2025. Die F&E-Ausgaben betrugen $255,117 und G&A waren $78,750 für das Quartal.

Die Liquidität bleibt angespannt: Bargeld betrug $931, die kurzfristigen Verbindlichkeiten $70,902, und das Eigenkapital der Aktionäre (Defizit) $(69,571) zum 31. August 2025. Zusätzliches paid‑in Capital stieg auf $129,940,711, was Beiträge und Kosten klinischer Studien widerspiegelt, die während der Periode direkt von Dr. S.R. Burzynski bezahlt wurden. Die Anzahl der ausstehenden Aktien betrug zum 14. Oktober 2025 131,448,444.

Der IND 43742 des Unternehmens steht unter einem vollständigen klinischen Haltezustand, und das Management äußert erhebliche Zweifel an der Fortführung des Geschäftsbetriebs innerhalb eines Jahres. Betrieb und klinische Aktivitäten werden im Rahmen einer Research Funding Agreement mit Dr. Burzynski finanziert; der 10‑Q weist darauf hin, dass die Gesellschaft möglicherweise zusätzliches Kapital benötigen könnte, selbst bei fortgesetzter Unterstützung durch verbundene Parteien.

معهد بيرزينسكي للأبحاث (BZYR) قد قدّم نموذجه 10‑Q للربع الثاني من 2025، مما يُظهر استمرار الخسائر التشغيلية واعتمادًا ثقيلًا على التمويل من أطراف ذات صلة. الشركة أبلغت عن خسارة صافية قدرها $333,867 للربع و $665,318 للستة أشهر المنتهية في 31 أغسطس 2025. بلغت نفقات البحث والتطوير $255,117 والنفقات العامة والإدارية $78,750 للربع.

سيولة الشركة ما زالت ضاغطة: كان النقد $931، كانت الالتزامات الحالية $70,902، وحقوق المساهمين (عجز) $(69,571) حتى 31 أغسطس 2025. ارتفع رأس المال الإضافي المستثمر إلى $129,940,711، عاكسا المساهمات وتكاليف التجارب السريرية المدفوعة مباشرة من الدكتور سي ار بورزينسكي خلال الفترة. عدد الأسهم المصدرة كان 131,448,444 حتى 14 أكتوبر 2025.

IND 43742 للشركة تحت تعليق سريري كامل، وتذكر الإدارة شكوك كبيرة حول القدرة على الاستمرار ككيان قائم خلال سنة. العمليات والأنشطة الإكلينيكية مموّلة بموجب اتفاق تمويل بحث مع الدكتور Burzynski؛ يلاحظ الـ10‑Q أن الشركة قد تحتاج إلى رأس مال إضافي حتى مع استمرار الدعم من الأطراف المرتبطة.

Burzynski Research Institute (BZYR) 已提交其 2025 年第二季度的 10‑Q,显示持续的运营亏损以及对关联方资金的高度依赖。该公司本季度净亏损为 $333,867,截至 2025 年 8 月 31 日的六个月累计亏损为 $665,318。本季度的研发支出为 $255,117,管理与销售费用为 $78,750

流动性仍然紧张:现金为 $931,流动负债为 $70,902,股东权益(赤字)为 $(69,571),截至 2025 年 8 月 31 日。追加实缴资本增至 $129,940,711,反映在该期间由 Burzynski 博士直接支付的捐助与临床试验成本。已发行股票数量为 131,448,444 股,截止至 2025 年 10 月 14 日。

公司的 IND 43742 正处于 完全临床暂停,管理层披露在一年内存在 继续经营能力的重大不确定性。运营与临床活动由与 Burzynski 博士签署的研究资助协议提供资金;10‑Q 指出,即使在持续的关联方支持下,公司可能仍需要额外资本。

Positive
  • None.
Negative
  • Going concern warning: management states substantial doubt about continuing operations within one year.
  • Clinical hold: IND 43742 remains under a full clinical hold, preventing new patient enrollment.

Insights

Full clinical hold persists; commercialization remains contingent on FDA.

BZYR states IND 43742 is under full clinical hold, preventing enrollment into trials. Without lifting the hold, clinical progress and any regulatory submissions are constrained. The filing recounts historical FDA interactions and confirms the current status.

The New License Agreement grants exclusive rights in the U.S. and Canada, but the company notes exploitation depends on future FDA approval. Therefore, near‑term revenue from Antineoplastons is not available under the disclosed status.

The filing does not provide timing for resolution; activity depends on FDA actions and company responses. Subsequent company disclosures would be needed to track regulatory changes.

Going concern risk with minimal cash and related‑party funding reliance.

As of August 31, 2025, cash was $931 versus current liabilities of $70,902, and the equity deficit was $(69,571). The company recorded a six‑month net loss of $665,318, while operating cash outflow was $(144,050).

Management explicitly cites substantial doubt about continuing as a going concern within one year. Operations are funded under a Research Funding Agreement with Dr. Burzynski; the filing emphasizes dependence on this support and the possibility of needing additional capital.

Planned spend is approximately $600,000 for the remaining two quarters of the fiscal year ending February 28, 2026; adequacy hinges on ongoing contributions and any supplemental financing.

Burzynski Research Institute (BZYR) ha depositato il suo 10‑Q del secondo trimestre 2025, mostrando continue perdite operative e una forte dipendenza dal finanziamento da parte di parti correlate. L'azienda ha riportato una perdita netta di $333,867 per il trimestre e $665,318 per i primi sei mesi chiusi al 31 agosto 2025. Le spese di R&D sono state $255,117 e G&A $78,750 per il trimestre.

La liquidità resta sotto pressione: la cassa era $931, le passività correnti ammontavano a $70,902, e l'equity dei soci (deficit) era $(69,571) al 31 agosto 2025. Il capitale versato aggiuntivo è salito a $129,940,711, riflettendo contributi e costi delle prove cliniche pagati direttamente dal Dr. S.R. Burzynski durante il periodo. Le azioni in circolazione erano 131,448,444 al 14 ottobre 2025.

L'IND 43742 della società è soggetto a un congelamento clinico completo, e la direzione dichiara un dubbio sostanziale sulla capacità di proseguire come going concern entro un anno. Le operazioni e le attività cliniche sono finanziate tramite un Accordo di Finanziamento della Ricerca con il Dott. Burzynski; il 10‑Q segnala che la società potrebbe aver bisogno di ulteriori capitali anche con il sostegno continuo da parte di parti correlate.

Burzynski Research Institute (BZYR) presentó su 10‑Q del segundo trimestre de 2025, mostrando pérdidas operativas continuas y una fuerte dependencia de financiamiento de partes relacionadas. La empresa reportó una pérdida neta de $333,867 para el trimestre y $665,318 para los seis meses terminado el 31 de agosto de 2025. El gasto en I+D fue $255,117 y G&A fue $78,750 para el trimestre.

La liquidez sigue siendo estresada: el efectivo era $931, los pasivos corrientes eran $70,902, y el patrimonio de los accionistas (déficit) era $(69,571) al 31 de agosto de 2025. El capital social adicionales se incrementó a $129,940,711, reflejando contribuciones y costos de ensayos clínicos pagados directamente por el Dr. S.R. Burzynski durante el período. Las acciones en circulación eran 131,448,444 al 14 de octubre de 2025.

La IND 43742 de la empresa está bajo un congelamiento clínico total, y la dirección divulga una fuerte duda sobre la capacidad de continuar como empresa en marcha dentro de un año. Las operaciones y las actividades clínicas se financian con un Acuerdo de Financiación de la Investigación con el Dr. Burzynski; el 10‑Q señala que la empresa podría necesitar capital adicional incluso con el apoyo continuo de partes relacionadas.

Burzynski Research Institute (BZYR) 은 2025년 2분기 10‑Q 를 제출했으며, 계속된 영업손실과 관련 당사자 자금에 대한 의존도가 여전히 높음을 보여주고 있습니다. 회사는 분기에 $333,867의 순손실과 2025년 8월 31일로 종료되는 6개월 동안 $665,318의 손실을 보고했습니다. R&D 지출은 $255,117이고 분기 G&A는 $78,750였습니다.

유동성은 여전히 악화되고 있습니다: 현금은 $931, 유동부채는 $70,902, 그리고 2025년 8월 31일 기준 주주지분(적자)은 $(69,571) 이었습니다. 추가 납입 자본은 $129,940,711 로 증가했으며, 이는 기간 동안 Dr. S.R. Burzynski 에 의해 직접 지출된 기여금과 임상 시험 비용을 반영합니다. 발행주식 수는 2025년 10월 14일 기준 131,448,444주였습니다.

회사의 IND 43742 는 전임상 보류 상태이며, 경영진은 1년 이내에 지속가능성에 대한 실질적 의문을 제기합니다. 운영 및 임상 활동은 Burzynski 박사와의 연구 자금 조달 계약에 따라 자금 조달되며, 10‑Q 는 관련 당사자 지원이 계속되더라도 추가 자본이 필요할 수 있음을 언급합니다.

Burzynski Research Institute (BZYR) a déposé son 10‑Q du deuxième trimestre 2025, montrant des pertes d'exploitation continues et une forte dépendance au financement provenant de parties liées. L'entreprise a enregistré une perte nette de $333,867 pour le trimestre et $665,318 pour les six mois terminé le 31 août 2025. Les dépenses R&D étaient de $255,117 et les frais G&A de $78,750 pour le trimestre.

La liquidité reste tendue : la trésorerie était de $931, les passifs courants de $70,902, et les capitaux propres des actionnaires (déficit) de $(69,571) au 31 août 2025. Le capital social supplémentaires a augmenté à $129,940,711, reflétant les contributions et les coûts d essais cliniques payés directement par le Dr. S.R. Burzynski pendant la période. Les actions en circulation étaient de 131,448,444 au 14 octobre 2025.

L'IND 43742 de la société est soumis à une mise en attente clinique complète, et la direction déclare un doute substantiel quant à la capacité de continuer en tant que going concern dans un délai d'un an. Les opérations et les activités cliniques sont financées dans le cadre d'un accord de financement de la recherche avec le Dr Burzynski ; le 10‑Q indique que la société pourrait avoir besoin de capital supplémentaire même avec le soutien continu des parties liées.

Burzynski Research Institute (BZYR) hat seinen Q2 2025 10‑Q eingereicht, was weiterhin Betriebsverluste und eine starke Abhängigkeit von Finanzierung durch verbundene Parteien zeigt. Das Unternehmen meldete einen Nettoverlust von $333,867 für das Quartal und $665,318 für das die sechs Monate bis zum 31. August 2025. Die F&E-Ausgaben betrugen $255,117 und G&A waren $78,750 für das Quartal.

Die Liquidität bleibt angespannt: Bargeld betrug $931, die kurzfristigen Verbindlichkeiten $70,902, und das Eigenkapital der Aktionäre (Defizit) $(69,571) zum 31. August 2025. Zusätzliches paid‑in Capital stieg auf $129,940,711, was Beiträge und Kosten klinischer Studien widerspiegelt, die während der Periode direkt von Dr. S.R. Burzynski bezahlt wurden. Die Anzahl der ausstehenden Aktien betrug zum 14. Oktober 2025 131,448,444.

Der IND 43742 des Unternehmens steht unter einem vollständigen klinischen Haltezustand, und das Management äußert erhebliche Zweifel an der Fortführung des Geschäftsbetriebs innerhalb eines Jahres. Betrieb und klinische Aktivitäten werden im Rahmen einer Research Funding Agreement mit Dr. Burzynski finanziert; der 10‑Q weist darauf hin, dass die Gesellschaft möglicherweise zusätzliches Kapital benötigen könnte, selbst bei fortgesetzter Unterstützung durch verbundene Parteien.

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Table of Contents

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 August 31, 2025

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 October 14, 2025, 131,448,444 shares of the Registrant’s Common Stock were outstanding.

Table of Contents

BURZYNSKI RESEARCH INSTITUTE, INC.

Form 10-Q

Table of Contents

PART I — FINANCIAL INFORMATION

Item 1.

Financial Statements

3

Item 2.

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

15

Item 4.

Controls and Procedures

20

PART II — OTHER INFORMATION

20

Item 1.

Legal Proceedings

20

Item 5.

Other Information

20

Item 6.

Exhibits

21

2

Table of Contents

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.

STATEMENTS OF OPERATIONS

(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 income

Loss before provision for income tax

 

(665,318)

 

(741,170)

Provision for income tax

Net loss

$

(665,318)

$

(741,170)

Earnings per share information:

Basic and diluted loss per common share

$

(0.01)

$

(0.01)

Weighted average number of common shares outstanding

 

131,448,444

 

131,448,444

See accompanying notes to financial statements.

4

Table of Contents

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

For the Six Months Ended August 31, 2025

(UNAUDITED)

    

    

    

Additional

    

    

Total

Common Stock

Paid-in

Retained

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Equity (Deficit)

Balance at February 28, 2025

131,448,444

$

131,449

$

129,303,327

$

(129,476,413)

$

(41,637)

Cash contributed by S.R. Burzynski M.D., Ph.D.

 

 

49,117

 

 

49,117

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

 

 

254,255

 

 

254,255

Net loss

 

 

 

(331,451)

 

(331,451)

Balance at May 31, 2025

131,448,444

$

131,449

$

129,606,699

$

(129,807,864)

$

(69,716)

Cash contributed by S.R. Burzynski M.D., Ph.D.

 

 

95,017

 

 

95,017

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

 

 

238,995

 

 

238,995

Net loss

 

 

 

(333,867)

 

(333,867)

Balance at August 31, 2025

131,448,444

$

131,449

$

129,940,711

$

(130,141,731)

$

(69,571)

See accompanying notes to financial statements.

5

Table of Contents

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

For the Six Months Ended 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.

6

Table of Contents

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

For the Six Months Ended August 31, 2025 and 2024

    

2025

    

2024

CASH FLOWS FROM OPERATING ACTIVITIES

Net loss

$

(665,318)

$

(741,170)

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.

 

493,250

 

471,125

Changes in operating assets and liabilities

Prepaids

(400)

600

Accounts payable

 

6,926

 

68,293

Accrued liabilities

 

21,492

 

(6,476)

NET CASH USED BY OPERATING ACTIVITIES

 

(144,050)

 

(207,628)

CASH FLOWS FROM FINANCING ACTIVITIES

Contribution of capital

 

144,134

 

207,534

NET CASH PROVIDED BY FINANCING ACTIVITIES

 

144,134

 

207,534

NET INCREASE (DECREASE) IN CASH

 

84

 

(94)

CASH AT BEGINNING OF PERIOD

 

847

 

1,310

CASH AT END OF PERIOD

$

931

$

1,216

See accompanying notes to financial statements.

7

Table of Contents

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 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 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. 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 August 31, 2025 and February 28, 2025, results of operations for the three and six months ended August 31, 2025 and 2024, and cash flows for the six months ended August 31, 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.

8

Table of Contents

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.

9

Table of Contents

NOTE D.

ACCRUED LIABILITIES

The Company’s accrued liabilities consist of audit, accounting, and legal fees as follows:

    

August 31, 2025

    

February 28, 2025

Legal Fees

$

29,759

$

17,665

Accounting Fees

 

 

7,802

Audit Fees

 

17,200

 

Total

$

46,959

$

25,467

NOTE E.

STOCK OPTIONS AND WARRANTS

At August 31, 2025, 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 August 31, 2025.

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 200,000,000 shares of $.001 par value common stock, and 131,448,444 shares are issued and outstanding as of August 31, 2025 and February 28, 2025. Amounts funded by Dr. Burzynski as mentioned in Note A were $637,384 during the six months ended August 31, 2025, and $678,659 during the six months ended August 31, 2024.

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 six months ended August 31, 2025 and 2024, 600,000 stock options were excluded from the calculation of diluted loss per share because their effect would be anti-dilutive.

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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 thirty-four other countries have issued the patents. Various Patents for cancer treatment and diagnosis in the United States and Canada were licensed to the Company pursuant to the Original License Agreement.

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 eight (8) issued United States Patents, four (4) issued Canadian Patents and one (1) issued Mexican Patent. Pursuant to the terms of 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 such date. 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 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 “New US Patents”). The first of these New US Patents includes the patent which was originally issued to the Company on May 31, 2022 and re-assigned to Dr. Burzynski in early 2023, covering methods of treatment of leptomeningeal disease using Antineoplaston. This New US Patent is expected to expire on June 11, 2038. The second of these New US Patents includes the patent issued to Dr. Burzynski on March 21, 2023, also covering methods of treatment of leptomeningeal disease using Antineoplaston. This New US Patent is expected to expire on June 11, 2038. The third of these New US Patents includes the patent issued to Dr. Burzynski on April 21, 2020, covering methods for the treatment of recurrent glioblastoma (RGBM). This New US Patent is expected to expire on May 8, 2037. The fourth of these New US Patents includes the patent issued to Dr. Burzynski on February 1, 2022, covering methods for the treatment of glioblastoma multiforme. This New US Patent is expected to expire on May 8, 2037. The fifth of these New US Patents includes the patent issued to Dr. Burzynski on January 7, 2025, covering methods for the treatment of glioblastoma multiforme. This New US Patent is expected to expire on May 8, 2037. 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.

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 two parties agreed to the following:

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.

11

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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 $1,000,000 in a given Company fiscal year.

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 one-year term thereafter, unless one party notifies the other party at least thirty days prior to the expiration of the term of the agreement of its intention not to renew the agreement. In addition to the foregoing termination provisions, the 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.

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 10% of the Company’s gross income, which royalty interest shall include gross receipts from all future sales, distributions and manufacture of Antineoplastons. On May 22, 2023, the parties amended and restated the royalty agreement in connection with the execution of the New License Agreement and to limit the scope of such agreement to the United States and Canada. Under the royalty agreement, Dr. Burzynski will have the right to either produce Antineoplaston products for use in his medical practice to treat up to 1,000 patients without paying any fees to the Company, or purchase from the Company Antineoplaston products for use in his medical practice to treat up to 1,000 patients at a price of the Company’s cost to produce the Antineoplaston products plus 10%. Dr. Burzynski will also have the right to either lease or purchase all the manufacturing equipment located at 12707 Trinity Drive, Stafford, Texas at a fair market price. The Company will also have the right to lease from Dr. Burzynski the entire premise located at 12707 Trinity Drive, Stafford, Texas at arms-length terms at rates competitive with those available in the market at that time, provided that Dr. Burzynski does not need the facility for his use.

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 Note 4. 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 three years after they are filed.

Deferred tax assets consisted of the following at August 31, 2025, and February 28, 2025:

August 31, 2025

    

February2024

Net operating loss

$

130,962

$

125,096

Alternate Minimum Tax Credit Carryforward

 

42,603

 

42,603

 

173,565

 

167,699

Alternate Minimum Tax Credit Carryforward

 

(173,565)

 

(167,699)

$

$

The actual provision for income tax for the three and six months ended August 31, 2025 and 2024 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,

2025

    

2024

Expected expense (benefit)

$

(70,112)

$

(77,666)

Taxed directly to Dr. Burzynski

 

70,112

 

77,666

Nondeductible expenses and other adjustments

 

11,762

 

(8,449)

Change in valuation allowance

 

(11,762)

 

8,449

State taxes

Provision for income tax

$

$

    

Six Months Ended August 31,

2025

    

2024

Expected expense (benefit)

$

(139,717)

$

(155,646)

Taxed directly to Dr. Burzynski

 

139,717

 

155,646

Nondeductible expenses and other adjustments

5,866

 

13,127

Change in valuation allowance

(5,866)

 

(13,127)

State taxes

Provision for income tax

$

$

At August 31, 2025, the Company had a net deferred tax asset of $0, which includes a valuation allowance of $173,565. The Company’s ability to utilize net operating loss ("NOL") carryforwards and alternative minimum tax credit carryforwards will

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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 August 31, 2025, the Company has net operating loss carryforwards in the amount of $473,902 that will expire between 2026 and 2038, and $149,725 that will carryforward indefinitely.

NOTE J.

SUBSEQUENT EVENTS

In accordance with ASC Topic 855-10, the Company has analyzed its operations subsequent to August 31, 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 August 31, 2025, and the results of operations comparing the three and six months ended August 31, 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 August 31, 2025 Compared to Three Months Ended August 31, 2024

Research and development costs were approximately $255,000 and $277,000 for the three months ended August 31, 2025 and 2024, respectively. The decrease of $22,000 or 8% was due to an increase in personnel costs of $17,000 offset by a decrease in facility and equipment costs of $28,000 and consulting and quality control costs of $11,000, due to fewer regulatory requests during the quarter.

General and administrative expenses were approximately $79,000 and $93,000 for the three months ended August 31, 2025 and 2024, respectively. The decrease of $14,000 or 15% was due to an increase in professional fees of $33,000 offset by a decrease in other costs of $47,000, as a result of a lower volume of regulatory filings and reporting requirements during the quarter.

The Company had net losses of approximately $334,000 and $370,000 for the three months ended August 31, 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 and in general and administrative expenses of the Company as described above.

Six Months Ended August 31, 2025 Compared to Six Months Ended August 31, 2024

Research and development costs were approximately $525,000 and $503,000 for the six months ended August 31, 2025 and 2024, respectively. The increase of $22,000 or 4% was due to an increase in personnel costs of $42,000, offset by a decrease in facility and equipment costs of $8,000 and consulting and quality control costs of $12,000, due to additional regulatory requests during the first half of the year.

General and administrative expenses were approximately $140,000 and $238,000 for the six months ended August 31, 2025 and 2024, respectively. The decrease of $98,000 or 41% was due to a decrease in legal and other professional costs of $30,000 and other costs of $68,000, as a result of a lower volume of regulatory filings and reporting requirements during the first half of the year.

The Company had net losses of approximately $665,000 and $741,000 for the six months ended August 31, 2025 and 2024, respectively. The decrease in the net loss from 2024 to 2025 is primarily due to lower general and administrative expenses, partially offset by higher research and development costs 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 $600,000 during the remaining two quarters 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 August 31, 2025 and February 28, 2025.

    

August 31, 2025

    

February 28, 2025

Current Assets

$

1,331

847

Current Liabilities

$

70,902

$

42,484

Working Capital Deficit

 $

(69,571)

(41,637)

As of August 31, 2025, we had negative working capital of $69,571. 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 August 31, 2025, we had cash of $931, total liabilities of $70,902, and an accumulated deficit of $130,141,731. 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 Six Months Ended August 31, 2025 and the Six Months Ended August 31, 2024

 

The following table sets forth the primary sources and uses of cash for the periods presented below:

 

Six Months Ended August 31,

2025

    

2024

Net cash provided by operating activities

$

(144,050)

(207,628)

Net cash used in financing activities

144,134

$

207,534

Net change in cash

84

 

(94)

Net Cash Provided by (Used in) Operating Activities

Net cash used in operating activities was $(144,050) for the six months ended August 31, 2025, compared to $(207,628) for the same period in 2024, an increase of $63,578. The increase 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 $144,134 for the six months ended August 31, 2025, compared to $207,534 for the same period in 2024, a decrease of $63,400. 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 six-month period ended August 31, 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 August 31, 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

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: October 14, 2025

 

 

22

FAQ

What was BZYR’s net loss for the quarter and year-to-date?

Net loss was $333,867 for the quarter and $665,318 for the six months ended August 31, 2025.

How much cash did BZYR have as of August 31, 2025?

Cash and cash equivalents were $931 as of August 31, 2025.

What is BZYR’s current financial position and equity?

Current liabilities were $70,902 and total stockholders’ equity (deficit) was $(69,571) as of August 31, 2025.

Is there a going concern warning in BZYR’s filing?

Yes. The company discloses substantial doubt about its ability to continue as a going concern within one year.

What is the status of BZYR’s clinical program under IND 43742?

IND 43742 is under a full clinical hold, and the company cannot enroll new patients.

How is BZYR funding its operations?

Operations are funded via a Research Funding Agreement with Dr. S.R. Burzynski, including direct payment of trial expenses and capital contributions.

How many shares of BZYR were outstanding?

There were 131,448,444 common shares outstanding as of October 14, 2025.
Burzynski Resh Inst Inc

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