0001104659-14-002333.txt : 20140114 0001104659-14-002333.hdr.sgml : 20140114 20140114160710 ACCESSION NUMBER: 0001104659-14-002333 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20131130 FILED AS OF DATE: 20140114 DATE AS OF CHANGE: 20140114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BURZYNSKI RESEARCH INSTITUTE INC CENTRAL INDEX KEY: 0000724445 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 760136810 STATE OF INCORPORATION: DE FISCAL YEAR END: 0228 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-23425 FILM NUMBER: 14527481 BUSINESS ADDRESS: STREET 1: 12000 RICHMOND AVE CITY: HOUSTON STATE: TX ZIP: 77082 10-Q 1 a13-26588_110q.htm QUARTERLY REPORT PURSUANT TO SECTIONS 13 OR 15(D)

Table of Contents

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

x

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended November 30, 2013

 

o

TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE 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)

 

(IRS 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)

 

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 x  No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).  Yes x  No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See definition of “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer o

(Do not check if a smaller reporting company)

 

Smaller reporting company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).  Yes o  No x

 

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 November 30, 2013, 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

9

 

 

 

Item 4.

Controls and Procedures

12

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

12

 

 

 

Item 6.

Exhibits

12

 

2



Table of Contents

 

Item 1.   Financial Statements

 

BURZYNSKI RESEARCH INSTITUTE, INC.

BALANCE SHEETS

 

 

 

November 30,

 

February 28,

 

 

 

2013

 

2013

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

84

 

$

1,192

 

TOTAL CURRENT ASSETS

 

84

 

1,192

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation of $20,192 and $19,679 at November 30, 2013 and February 28, 2013, respectively

 

2,223

 

2,736

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

2,307

 

$

3,928

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

163,068

 

$

47,501

 

Accrued liabilities

 

31,760

 

41,089

 

CURRENT AND TOTAL LIABILITIES

 

194,828

 

88,590

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ deficit

 

 

 

 

 

Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 issued and outstanding at November 30, 2013 and February 28, 2013, respectively

 

131,449

 

131,449

 

Additional paid-in capital

 

111,222,333

 

107,883,768

 

Retained deficit

 

(111,546,303

)

(108,099,879

)

 

 

 

 

 

 

TOTAL STOCKHOLDERS’ DEFICIT

 

(192,521

)

(84,662

)

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

$

2,307

 

$

3,928

 

 

See accompanying notes to financial statements.

 

3



Table of Contents

 

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 

 

Three Months Ended

 

 

 

November 30,

 

 

 

2013

 

2012

 

Operating expenses

 

 

 

 

 

Research and development

 

$

937,471

 

$

1,430,406

 

General and administrative

 

45,226

 

99,164

 

Depreciation

 

171

 

171

 

TOTAL OPERATING EXPENSES

 

982,868

 

1,529,741

 

 

 

 

 

 

 

Net loss before provision for income tax

 

(982,868

)

(1,529,741

)

 

 

 

 

 

 

Provision for income tax

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(982,868

)

$

(1,529,741

)

 

 

 

 

 

 

Loss 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

 

 

 

 

Nine Months Ended

 

 

 

November 30,

 

 

 

2013

 

2012

 

Operating expenses

 

 

 

 

 

Research and development

 

$

3,171,220

 

$

4,465,736

 

General and administrative

 

274,691

 

537,793

 

Depreciation

 

513

 

513

 

TOTAL OPERATING EXPENSES

 

3,446,424

 

5,004,042

 

 

 

 

 

 

 

Other income

 

 

100

 

 

 

 

 

 

 

Net loss before provision for income tax

 

(3,446,424

)

(5,003,942

)

 

 

 

 

 

 

Provision for income tax

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(3,446,424

)

$

(5,003,942

)

 

 

 

 

 

 

Loss per share information:

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$

(0.03

)

$

(0.04

)

 

 

 

 

 

 

Weighted average number of common shares outstanding

 

131,448,444

 

131,448,444

 

 

See accompanying notes to financial statements.

 

4



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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENT OF STOCKHOLDERS’ DEFICIT

For the Nine Months Ended November 30, 2013

(UNAUDITED)

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

Additional

 

 

 

Stockholders’

 

 

 

Shares

 

Amount

 

Paid-in Capital

 

Retained Deficit

 

Deficit

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance February 28, 2013

 

131,448,444

 

$

131,449

 

$

107,883,768

 

$

(108,099,879

)

$

(84,662

)

 

 

 

 

 

 

 

 

 

 

 

 

Cash contributed by S.R. Burzynski, M.D., Ph.D. and related parties

 

 

 

339,100

 

 

339,100

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

2,999,465

 

 

2,999,465

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

(3,446,424

)

(3,446,424

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance November 30, 2013

 

131,448,444

 

$

131,449

 

$

111,222,333

 

$

(111,546,303

)

$

(192,521

)

 

See accompanying notes to financial statements.

 

5



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BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 

 

Nine Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net loss

 

$

(3,446,424

)

$

(5,003,942

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation

 

513

 

513

 

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

 

2,999,465

 

4,276,728

 

Warrants issued for services

 

 

159,896

 

Changes in operating assets and liabilities

 

 

 

 

 

Accounts payable

 

115,567

 

40,712

 

Accrued liabilities

 

(9,329

)

(12,250

)

 

 

 

 

 

 

NET CASH USED IN OPERATING ACTIVITIES

 

(340,208

)

(538,343

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

Contribution of capital

 

339,100

 

523,682

 

 

 

 

 

 

 

NET CASH PROVIDED BY FINANCING ACTIVITIES

 

339,100

 

523,682

 

 

 

 

 

 

 

NET DECREASE IN CASH

 

(1,108

)

(14,661

)

 

 

 

 

 

 

CASH AT BEGINNING OF PERIOD

 

1,192

 

17,297

 

 

 

 

 

 

 

CASH AT END OF PERIOD

 

$

84

 

$

2,636

 

 

See accompanying notes to financial statements

 

6



Table of Contents

 

BURZYNSKI RESEARCH INSTITUTE, INC.

NOTES TO FINANCIAL STATEMENTS

 

NOTE A.BASIS OF PRESENTATION

 

The financial statements of Burzynski Research Institute, Inc. (the Company), a Delaware corporation, include expenses incurred related to clinical trials, which were sanctioned by the U.S. Food and Drug Administration (FDA) in 1993, for Antineoplaston drugs used in the treatment of cancer.  These expenses are incurred directly by S.R. Burzynski, M.D., Ph.D. (Dr. Burzynski or “SRB”) on behalf of the Company and have been reported as research and development costs and as additional paid-in capital.  Other funds received from Dr. Burzynski have also been reported as additional paid-in capital.  Expenses related to Dr. Burzynski’s medical practice (unrelated to the clinical trials) have not been included in these financial statements.  Dr. Burzynski is the President, Chairman of the Board and owner of approximately 81% of the outstanding common stock of the Company, and also is the inventor and original patent holder of certain drug products knows as “Antineoplastons,” which he has licensed to the Company.

 

The Company and Dr. Burzynski have entered into various agreements, which provide 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.

 

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 is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations. 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 accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Certain disclosures and information normally included in financial statements have been condensed or omitted. In the opinion of management of the Company, these financial statements contain all adjustments necessary for a fair presentation of financial position as of November 30, 2013 and February 28, 2013, results of operations for the three and nine months ended November 30, 2013 and 2012, and cash flows for the nine months ended November 30, 2013 and 2012.  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, 2013.

 

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.

 

The Company is economically dependent on its funding through Dr. Burzynski’s medical practice.  A portion of Dr. Burzynski’s patients are admitted and treated as part of the clinical trial programs, which are regulated 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.

 

It is also the intention of the directors and management to seek additional capital through the sale of securities.  The proceeds from such sales will be used to fund the Company’s operating deficit until it achieves positive operating cash flow.  There can be no assurance that the Company will be able to raise such additional capital.

 

7



Table of Contents

 

NOTE C.STOCK OPTIONS AND WARRANTS

 

At November 30, 2013, 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.  In addition, for a period of 10 years from the grant date, they increase in the same percentage of any new shares of stock issued; however, no shares were issued during such 10-year periods from the grant dates.  None of the options have been exercised as of November 30, 2013.

 

The Company accounts for stock-based compensation under the provisions of Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 718, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employee officers based on estimated fair values as of the date of grant. Compensation expense is recognized on a straight-line basis over the requisite service period.

 

The Company accounts for share-based payments to non-employees, with guidance provided by FASB ASC 505-50, Equity-Based Payments to Non-Employees.

 

The Company did not grant any options and no options previously granted vested in any of the periods presented in these financial statements. Thus, there was no effect on net loss or loss per share regarding the provisions of FASB ASC 718 or FASB ASC 505-50 in any of the periods presented.

 

Effective July 5, 2012, the Company entered into a Marketing and Consulting Agreement (the “Marketing Agreement”) with Worldwide Medical Consultants, Inc. (“WMC”) and CARIGEN, LTD (“SRB”), an entity wholly-owned and controlled by Dr. Burzynski, pursuant to which WMC will (i) provide SRB with various marketing and consulting services to assist SRB in locating and developing cancer or health related centers in certain foreign markets and (ii) make payments to the Company equal to 10% of each consulting fee received by WMC for the aforementioned services provided to SRB, net of certain expenses incurred by WMC (“WMC Payment”). In consideration of the WMC Payment, the Company agreed to grant to WMC warrants to acquire an aggregate of 2,000,000 shares of the Company’s Common Stock, exercisable at $0.10 per share with a ten year exercise period, with 1,000,000 shares vesting upon execution of the agreement and the remaining 1,000,000 shares to vest upon the first closing of a transaction by SRB as a result of the services provided by WMC under the Marketing Agreement. The fair market value of the vested warrants as of the date of grant was measured using the Black-Scholes option pricing model and totaled approximately $160,000 or $0.16 per warrant. As of November 30, 2013, none of the aforementioned warrants have been exercised.

 

NOTE D.LOSS PER COMMON SHARE

 

The Company accounts for loss per share in accordance with FASB ASC 260, Earnings per Share. Basic loss per share amounts are calculated by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding for the periods, including the dilutive effect of all common stock equivalents. Dilutive options and warrants that are issued during a period or that expire or are canceled during a period are reflected in the computations for the time they were outstanding during the periods being reported. During the three and nine month periods ended November 30, 2013 and 2012, 1,600,000 warrants and stock options were excluded from the calculation of diluted loss per share because their effect would be anti-dilutive.

 

NOTE E.INCOME TAXES

 

The Company follows the provisions of FASB ASC 740-10, Accounting for Uncertainty in Income Taxes.  The Company is not aware of any material unrecognized tax uncertainties as a result of tax positions previously taken.

 

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

 

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Table of Contents

 

The federal income tax returns of the Company for 2012, 2011, and 2010 are subject to examination by the IRS, generally for three years after they are filed.

 

The actual provision for income tax for the three and nine month periods ended November 30, 2013 and 2012, respectively, differ from the amounts computed by applying the U.S. federal income tax rate of 34% to the pretax loss as a result of the following:

 

 

 

Three Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(334,175

)

$

(520,112

)

Effect of expenses deducted directly by Dr. Burzynski

 

334,175

 

520,112

 

Nondeductible expenses and other adjustments

 

5,655

 

19,231

 

Change in valuation allowance

 

(5,655

)

(19,231

)

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

 

 

Nine Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(1,171,784

)

$

(1,701,340

)

Effect of expenses deducted directly by Dr. Burzynski

 

1,171,784

 

1,701,340

 

Nondeductible expenses and other adjustments

 

36,672

 

(69,202

)

Change in valuation allowance

 

(36,672

)

69,202

 

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

At November 30, 2013, the Company had a net deferred tax asset of $0, which includes a valuation allowance of $296,442. The Company’s ability to utilize net operating loss carryforwards and alternative minimum tax credit carryforwards will depend on its ability to generate adequate future taxable income.  The Company has no historical earnings on which to base an expectation of future taxable income.  Accordingly, a full valuation allowance for deferred tax assets has been provided.  At November 30, 2013, the Company had net operating loss carryforwards available to offset future taxable income in the amount of $730,916, which may be carried forward and will expire if not used between 2020 and 2034 in varying amounts.

 

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

 

The following is a discussion of the financial condition of the Company as of November 30, 2013, and the results of operations comparing the three and nine months ended November 30, 2013 and 2012.  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, 2013.

 

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 that is closed for enrollment.  All clinical trials were closed for enrollment by the Company as of September 24, 2012.  The Company is currently conducting one FDA-approved clinical trial.  The Company holds 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 and diagnosis of cancer, once an Antineoplaston drug is approved for sale by the FDA.

 

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.

 

9



Table of Contents

 

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 is acceptable to support a regulatory submission seeking new drug approval.  On February 23, 2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint (“ResearchPoint”) to initiate and manage a pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma.  ResearchPoint has secured interest and commitments from a number of sites selected.  A randomized, international phase III study will commence upon availability of funds.  The study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone.

 

Partial 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 which may have been related to the administration of Antineoplastons.  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 investigational new drug application (“IND”) 43,742.  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 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 43,742) for enrollment effective September 25, 2012, and that it would also terminate the protocol once all active patients had completed the study.

 

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 43,742 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 protocols B-52 and B-54 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 FDA’s satisfaction, the Company could not legally conduct the identified clinical studies under such IND.

 

In a letter dated April 9, 2013, the Company responded to the issues raised by the FDA in its January 9, 2013 letter to the Company.  In a letter dated May 9, 2013 from the FDA, the FDA advised the Company that the Company’s April 9, 2013 letter was not a complete response to all the issues listed in the FDA’s letter dated January 9, 2013, and the FDA also identified the issues that were not fully addressed by the Company’s response.  The FDA further advised the Company that until it satisfactorily addressed all the issues in the FDA’s letter dated January 9, 2013, that the FDA could not complete its review, and the clinical hold could not be removed.

 

The amendment submitted to the IND by the Company dated August 29, 2013 was reviewed by the FDA and was determined to be a complete response to the issues raised but still needed further clarification.  Further analysis of all serious somnolence and overdose events in patients receiving Antineoplastons was requested by the FDA.

 

A revised investigator’s brochure was submitted to the FDA on November 25, 2013.  Currently the FDA is reviewing the revised Investigator’s brochure and whether the data provided is satisfactory for the continuation of the clinical program.  The clinical hold is still in place at this time.

 

Results of Operations

 

Three Months Ended November 30, 2013 Compared to Three Months Ended November 30, 2012

 

Research and development costs were approximately $937,000 and $1,430,000 for the three months ended November 30, 2013 and 2012, respectively.  The decrease of $493,000 or 35% was due to decreases in personnel costs of $277,000, material costs of $150,000, facility and equipment costs of $44,000, consulting and quality control costs of $19,000, and other research and developments costs of $3,000, as a result of cost cuts made due to a decrease in production related to Clinical Trial holds.

 

10



Table of Contents

 

General and administrative expenses were approximately $45,000 and $99,000 for the three months ended November 30, 2013 and 2012, respectively.  The decrease of $54,000 or 55% was due to a decrease in legal and professional fees of $54,000 as a result of cost cuts made due to a decrease in production related to Clinical Trial holds.

 

The Company had net losses of approximately $983,000 and $1,530,000 for the three months ended November 30, 2013 and 2012, respectively.  The decrease in the net loss from 2012 to 2013 is primarily due to an overall decrease in research and development costs and a decrease in general and administrative expenses of the Company as described above.

 

Nine Months Ended November 30, 2013 Compared to Nine Months Ended November 30, 2012

 

Research and development costs were approximately $3,171,000 and $4,466,000 for the nine months ended November 30, 2013 and 2012, respectively.  The decrease of $1,295,000 or 29% was due to decreases in personnel costs of $592,000, material costs of $518,000, facility and equipment costs of $116,000, consulting and quality control costs of $48,000, and other research and development costs of $21,000, as a result of cost cuts made due to a decrease in production related to Clinical Trial holds.

 

General and administrative expenses were approximately $275,000 and $538,000 for the nine months ended November 30, 2013 and 2012, respectively.  The decrease of $263,000 or 49% was due to decreases in legal and professional fees of $262,000 and other general and administrative costs of $1,000, as a result of cost cuts made due to a decrease in production related to Clinical Trial holds.

 

The Company had net losses of approximately $3,446,000 and $5,004,000 for the nine months ended November 30, 2013 and 2012, respectively.  The decrease in the net loss from 2012 to 2013 is primarily due to the overall decrease in research and development costs and general and administrative expenses of the Company as described above.

 

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.  In the event the research results in the approval of any additional patents for the treatment of cancer, Dr. Burzynski shall own all such patents, but shall license to the Company the patents based on the same terms, conditions and limitations as are in the current license between Dr. Burzynski and the Company.

 

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, 2014.  It is expected that the Research Funding Agreement will continue to renew each year prospectively unless terminated under the provisions of the agreement.

 

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 $1,100,000 during the remaining quarter of the fiscal year ending February 28, 2014.  The Company estimates that ninety-five percent (95%) of this amount will be spent on research and development and the continuance of FDA-approved clinical trials.  While the Company anticipates that Dr. Burzynski will continue to fund the

 

11



Table of Contents

 

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.  The Company believes Dr. Burzynski will be financially able to fund the Company’s operations for at least the next year.  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 in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials.  As a result of the expansion of Dr. Burzynski’s medical practice, the financial condition of the medical practice has improved Dr. Burzynski’s ability to fund the Company’s operations.

 

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.

 

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.

 

Item 4.   Controls and Procedures

 

Within the 90 days prior to the date of this report, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s principal executive and financial officers, of the effectiveness of the Company’s disclosure controls and procedures pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as amended.  Based on that evaluation, the Company’s principal executive and financial officers concluded that the Company’s disclosure controls and procedures are effective in timely alerting them to material information required to be included in periodic filings with the Securities and Exchange Commission.  A controls system cannot provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.  There were no significant changes in the Company’s internal controls or in other factors that could significantly affect internal controls over financial reporting that occurred during the fiscal quarter ended November 30, 2013 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 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

 

12



Table of Contents

 

 

 

 

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, filed herewith.

 

 

 

 

 

31.2

 

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

 

 

 

 

 

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, filed herewith.

 

 

 

 

 

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, filed herewith.

 

 

 

 

 

101.INS

 

XBRL Instance Document

 

 

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

13



Table of Contents

 

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

 

 

(Chief Executive Officer)

 

 

 

 

 

 

Date: January 14, 2014

 

 

 

14


EX-31.1 2 a13-26588_1ex31d1.htm EX-31.1

EXHIBIT 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO RULES 13a-14 AND 15d-14
OF THE SECURITIES EXCHANGE ACT OF 1934
(Section 302 of the Sarbanes-Oxley Act of 2002)

 

I, Stanislaw R. Burzynski, certify that:

 

1.                                      I have reviewed this quarterly report on Form 10-Q of Burzynski Research Institute, Inc. (“BRI”);

 

2.                                      Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.                                      Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of BRI as of, and for, the periods presented in this quarterly report;

 

4.                                      I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for BRI and have:

 

(a)                                 Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to BRI is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)                                 Designated such internal control over financial reporting, or caused such internal control over financial reporting to be designated under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)                                  Evaluated the effectiveness of BRI’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

 

(d)                                 Disclosed in this quarterly report any change in BRI’s internal control over financial reporting that occurred during BRI’s most recent fiscal quarter (BRI’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, BRI’s internal control over financial reporting; and

 

5.                                      I have disclosed, based on our most recent evaluation of internal control over financial reporting, to BRI’s auditors and the audit committee of BRI’s board of directors (or persons performing the equivalent functions of an audit committee):

 

(a)                                 All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect BRI’s ability to record, process, summarize and report financial information; and

 

(b)                                 Any fraud, whether or not material, that involves management or other employees who have a significant role in BRI’s internal control over financial reporting.

 

 

Date: January 14, 2014

/s/ Stanislaw R. Burzynski

 

Stanislaw R. Burzynski,

 

President and Chairman of the Board of Directors

 

(Chief Executive Officer)

 


EX-31.2 3 a13-26588_1ex31d2.htm EX-31.2

EXHIBIT 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULES 13a-14 AND 15d-14
OF THE SECURITIES EXCHANGE ACT OF 1934
(Section 302 of the Sarbanes-Oxley Act of 2002)

 

I, Patryk P. Goscianski, certify that:

 

1.                                      I have reviewed this quarterly report on Form 10-Q of Burzynski Research Institute, Inc. (“BRI”);

 

2.                                      Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.                                      Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of BRI as of, and for, the periods presented in this quarterly report;

 

4.                                      I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for BRI and have:

 

(a)                                 Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to BRI is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)                                 Designated such internal control over financial reporting, or caused such internal control over financial reporting to be designated under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)                                  Evaluated the effectiveness of BRI’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

 

(d)                                 Disclosed in this quarterly report any change in BRI’s internal control over financial reporting that occurred during BRI’s most recent fiscal quarter (BRI’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, BRI’s internal control over financial reporting; and

 

5.                                      I have disclosed, based on our most recent evaluation of internal control over financial reporting, to BRI’s auditors and the audit committee of BRI’s board of directors (or persons performing the equivalent functions of an audit committee):

 

(a)                                 All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect BRI’s ability to record, process, summarize and report financial information; and

 

(b)                                 Any fraud, whether or not material, that involves management or other employees who have a significant role in BRI’s internal control over financial reporting.

 

 

Date: January 14, 2014

/s/ Patryk P. Goscianski

 

Patryk P. Goscianski,

 

Secretary and Treasurer

 

(Principal Financial Officer)

 


EX-32.1 4 a13-26588_1ex32d1.htm EX-32.1

EXHIBIT 32.1

 

Certification of Chief Executive Officer Pursuant to 18 U.S.C. § 1350
(Section 906 of the Sarbanes-Oxley Act of 2002)

 

In connection with the Quarterly Report of Burzynski Research Institute, Inc. (the “Company”) on Form 10-Q for the period ended November 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)                                 The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)                                 The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

A signed original of this written statement required by Section 906 has been provided to Burzynski Research Institute, Inc. and will be retained by Burzynski Research Institute, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

Date: January 14, 2014

 

 

 

 

/s/ Stanislaw R. Burzynski

 

Stanislaw R. Burzynski

 

President and Chairman of the Board of Directors

 

(Chief Executive Officer)

 


EX-32.2 5 a13-26588_1ex32d2.htm EX-32.2

EXHIBIT 32.2

 

Certification of Principal Financial Officer Pursuant to 18 U.S.C. § 1350
(Section 906 of the Sarbanes-Oxley Act of 2002)

 

In connection with the Quarterly Report of Burzynski Research Institute, Inc. (the “Company”) on Form 10-Q for the period ended November 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)                                 The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)                                 The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

A signed original of this written statement required by Section 906 has been provided to Burzynski Research Institute, Inc. and will be retained by Burzynski Research Institute, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

Date: January 14, 2014

 

 

 

 

/s/ Patryk P. Goscianski

 

Patryk P. Goscianski

 

Secretary and Treasurer

 

(Principal Financial Officer)

 


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STOCK OPTIONS AND WARRANTS
9 Months Ended
Nov. 30, 2013
STOCK OPTIONS AND WARRANTS  
STOCK OPTIONS AND WARRANTS

NOTE C.STOCK OPTIONS AND WARRANTS

 

At November 30, 2013, 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.  In addition, for a period of 10 years from the grant date, they increase in the same percentage of any new shares of stock issued; however, no shares were issued during such 10-year periods from the grant dates.  None of the options have been exercised as of November 30, 2013.

 

The Company accounts for stock-based compensation under the provisions of Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 718, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employee officers based on estimated fair values as of the date of grant. Compensation expense is recognized on a straight-line basis over the requisite service period.

 

The Company accounts for share-based payments to non-employees, with guidance provided by FASB ASC 505-50, Equity-Based Payments to Non-Employees.

 

The Company did not grant any options and no options previously granted vested in any of the periods presented in these financial statements. Thus, there was no effect on net loss or loss per share regarding the provisions of FASB ASC 718 or FASB ASC 505-50 in any of the periods presented.

 

Effective July 5, 2012, the Company entered into a Marketing and Consulting Agreement (the “Marketing Agreement”) with Worldwide Medical Consultants, Inc. (“WMC”) and CARIGEN, LTD (“SRB”), an entity wholly-owned and controlled by Dr. Burzynski, pursuant to which WMC will (i) provide SRB with various marketing and consulting services to assist SRB in locating and developing cancer or health related centers in certain foreign markets and (ii) make payments to the Company equal to 10% of each consulting fee received by WMC for the aforementioned services provided to SRB, net of certain expenses incurred by WMC (“WMC Payment”). In consideration of the WMC Payment, the Company agreed to grant to WMC warrants to acquire an aggregate of 2,000,000 shares of the Company’s Common Stock, exercisable at $0.10 per share with a ten year exercise period, with 1,000,000 shares vesting upon execution of the agreement and the remaining 1,000,000 shares to vest upon the first closing of a transaction by SRB as a result of the services provided by WMC under the Marketing Agreement. The fair market value of the vested warrants as of the date of grant was measured using the Black-Scholes option pricing model and totaled approximately $160,000 or $0.16 per warrant. As of November 30, 2013, none of the aforementioned warrants have been exercised.

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ECONOMIC DEPENDENCY
9 Months Ended
Nov. 30, 2013
ECONOMIC DEPENDENCY  
ECONOMIC DEPENDENCY

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.

 

The Company is economically dependent on its funding through Dr. Burzynski’s medical practice.  A portion of Dr. Burzynski’s patients are admitted and treated as part of the clinical trial programs, which are regulated 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.

 

It is also the intention of the directors and management to seek additional capital through the sale of securities.  The proceeds from such sales will be used to fund the Company’s operating deficit until it achieves positive operating cash flow.  There can be no assurance that the Company will be able to raise such additional capital.

XML 17 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
BALANCE SHEETS (USD $)
Nov. 30, 2013
Feb. 28, 2013
Current assets    
Cash and cash equivalents $ 84 $ 1,192
TOTAL CURRENT ASSETS 84 1,192
Property and equipment, net of accumulated depreciation of $20,192 and $19,679 at November 30, 2013 and February 28, 2013, respectively 2,223 2,736
TOTAL ASSETS 2,307 3,928
Current liabilities    
Accounts payable 163,068 47,501
Accrued liabilities 31,760 41,089
CURRENT AND TOTAL LIABILITIES 194,828 88,590
Commitments and contingencies      
Stockholders' deficit    
Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 issued and outstanding at November 30, 2013 and February 28, 2013, respectively 131,449 131,449
Additional paid-in capital 111,222,333 107,883,768
Retained deficit (111,546,303) (108,099,879)
TOTAL STOCKHOLDERS' DEFICIT (192,521) (84,662)
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT $ 2,307 $ 3,928
XML 18 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
STATEMENTS OF CASH FLOWS (USD $)
9 Months Ended
Nov. 30, 2013
Nov. 30, 2012
CASH FLOWS FROM OPERATING ACTIVITIES    
Net loss $ (3,446,424) $ (5,003,942)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation 513 513
FDA clinical trial expenses paid directly by S.R. Burzynski, M.D., Ph.D. 2,999,465 4,276,728
Warrants issued for services   159,896
Changes in operating assets and liabilities    
Accounts payable 115,567 40,712
Accrued liabilities (9,329) (12,250)
NET CASH USED IN OPERATING ACTIVITIES (340,208) (538,343)
CASH FLOWS FROM FINANCING ACTIVITIES    
Contribution of capital 339,100 523,682
NET CASH PROVIDED BY FINANCING ACTIVITIES 339,100 523,682
NET DECREASE IN CASH (1,108) (14,661)
CASH AT BEGINNING OF PERIOD 1,192 17,297
CASH AT END OF PERIOD $ 84 $ 2,636
XML 19 Show.js IDEA: XBRL DOCUMENT /** * Rivet Software Inc. * * @copyright Copyright (c) 2006-2011 Rivet Software, Inc. All rights reserved. * Version 2.4.0.3 * */ var Show = {}; Show.LastAR = null, Show.hideAR = function(){ Show.LastAR.style.display = 'none'; }; Show.showAR = function ( link, id, win ){ if( Show.LastAR ){ Show.hideAR(); } var ref = link; do { ref = ref.nextSibling; } while (ref && ref.nodeName != 'TABLE'); if (!ref || ref.nodeName != 'TABLE') { var tmp = win ? win.document.getElementById(id) : document.getElementById(id); if( tmp ){ ref = tmp.cloneNode(true); ref.id = ''; link.parentNode.appendChild(ref); } } if( ref ){ ref.style.display = 'block'; Show.LastAR = ref; } }; Show.toggleNext = function( link ){ var ref = link; do{ ref = ref.nextSibling; }while( ref.nodeName != 'DIV' ); if( ref.style && ref.style.display && ref.style.display == 'none' ){ ref.style.display = 'block'; if( link.textContent ){ link.textContent = link.textContent.replace( '+', '-' ); }else{ link.innerText = link.innerText.replace( '+', '-' ); } }else{ ref.style.display = 'none'; if( link.textContent ){ link.textContent = link.textContent.replace( '-', '+' ); }else{ link.innerText = link.innerText.replace( '-', '+' ); } } }; XML 20 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
BASIS OF PRESENTATION
9 Months Ended
Nov. 30, 2013
BASIS OF PRESENTATION  
BASIS OF PRESENTATION

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% of the outstanding common stock of the Company, and also is the inventor and original patent holder of certain drug products knows as “Antineoplastons,” which he has licensed to the Company.

 

The Company and Dr. Burzynski have entered into various agreements, which provide 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.

 

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 is currently conducting clinical trials on various Antineoplastons in accordance with FDA regulations. 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 accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Certain disclosures and information normally included in financial statements have been condensed or omitted. In the opinion of management of the Company, these financial statements contain all adjustments necessary for a fair presentation of financial position as of November 30, 2013 and February 28, 2013, results of operations for the three and nine months ended November 30, 2013 and 2012, and cash flows for the nine months ended November 30, 2013 and 2012.  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, 2013.

XML 21 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
BALANCE SHEETS (Parenthetical) (USD $)
Nov. 30, 2013
Feb. 28, 2013
BALANCE SHEETS    
Property and equipment, accumulated depreciation (in dollars) $ 20,192 $ 19,679
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized 200,000,000 200,000,000
Common stock, shares issued 131,448,444 131,448,444
Common stock, shares outstanding 131,448,444 131,448,444
XML 22 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
INCOME TAXES (Details) (USD $)
3 Months Ended 9 Months Ended
Nov. 30, 2013
Nov. 30, 2012
Nov. 30, 2013
Nov. 30, 2012
Income Taxes        
U.S. federal income tax rate (as a percent)     34.00%  
Actual income tax benefit        
Expected income tax benefit $ (334,175) $ (520,112) $ (1,171,784) $ (1,701,340)
Effect of expenses deducted directly by Dr. Burzynski 334,175 520,112 1,171,784 1,701,340
Nondeductible expenses and other adjustments 5,655 19,231 36,672 (69,202)
Change in valuation allowance (5,655) (19,231) (36,672) 69,202
Deferred tax assets:        
Net deferred tax asset 0   0  
Valuation allowance 296,442   296,442  
Net operating loss carry forwards available to offset future income $ 730,916   $ 730,916  
IRS
       
Income Taxes        
Period after filing income tax returns subject to examination     3 years  
XML 23 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
9 Months Ended
Nov. 30, 2013
Document and Entity Information  
Entity Registrant Name BURZYNSKI RESEARCH INSTITUTE INC
Entity Central Index Key 0000724445
Document Type 10-Q
Document Period End Date Nov. 30, 2013
Amendment Flag false
Current Fiscal Year End Date --02-28
Entity Current Reporting Status Yes
Entity Filer Category Smaller Reporting Company
Entity Common Stock, Shares Outstanding 131,448,444
Document Fiscal Year Focus 2014
Document Fiscal Period Focus Q3
XML 24 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
STATEMENTS OF OPERATIONS (USD $)
3 Months Ended 9 Months Ended
Nov. 30, 2013
Nov. 30, 2012
Nov. 30, 2013
Nov. 30, 2012
Operating expenses        
Research and development $ 937,471 $ 1,430,406 $ 3,171,220 $ 4,465,736
General and administrative 45,226 99,164 274,691 537,793
Depreciation 171 171 513 513
TOTAL OPERATING EXPENSES 982,868 1,529,741 3,446,424 5,004,042
Other income       100
Net loss before provision for income tax (982,868) (1,529,741) (3,446,424) (5,003,942)
NET LOSS $ (982,868) $ (1,529,741) $ (3,446,424) $ (5,003,942)
Loss per share information:        
Basic and diluted loss per common share (in dollars per share) $ (0.01) $ (0.01) $ (0.03) $ (0.04)
Weighted average number of common shares outstanding (in shares) 131,448,444 131,448,444 131,448,444 131,448,444
XML 25 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK OPTIONS AND WARRANTS (Tables)
9 Months Ended
Nov. 30, 2013
STOCK OPTIONS AND WARRANTS  
Schedule of vesting of options

 

 

Vesting Date

 

400,000 options

 

September 14, 1996

 

100,000 options

 

June 1, 1997

 

100,000 options

 

June 1, 1998

 

XML 26 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
INCOME TAXES
9 Months Ended
Nov. 30, 2013
INCOME TAXES  
INCOME TAXES

NOTE E.INCOME TAXES

 

The Company follows the provisions of FASB ASC 740-10, Accounting for Uncertainty in 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 2012, 2011, and 2010 are subject to examination by the IRS, generally for three years after they are filed.

 

The actual provision for income tax for the three and nine month periods ended November 30, 2013 and 2012, respectively, differ from the amounts computed by applying the U.S. federal income tax rate of 34% to the pretax loss as a result of the following:

 

 

 

Three Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(334,175

)

$

(520,112

)

Effect of expenses deducted directly by Dr. Burzynski

 

334,175

 

520,112

 

Nondeductible expenses and other adjustments

 

5,655

 

19,231

 

Change in valuation allowance

 

(5,655

)

(19,231

)

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

 

 

Nine Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(1,171,784

)

$

(1,701,340

)

Effect of expenses deducted directly by Dr. Burzynski

 

1,171,784

 

1,701,340

 

Nondeductible expenses and other adjustments

 

36,672

 

(69,202

)

Change in valuation allowance

 

(36,672

)

69,202

 

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

At November 30, 2013, the Company had a net deferred tax asset of $0, which includes a valuation allowance of $296,442. The Company’s ability to utilize net operating loss carryforwards and alternative minimum tax credit carryforwards will depend on its ability to generate adequate future taxable income.  The Company has no historical earnings on which to base an expectation of future taxable income.  Accordingly, a full valuation allowance for deferred tax assets has been provided.  At November 30, 2013, the Company had net operating loss carryforwards available to offset future taxable income in the amount of $730,916, which may be carried forward and will expire if not used between 2020 and 2034 in varying amounts.

XML 27 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
STOCK OPTIONS AND WARRANTS (Details) (USD $)
9 Months Ended 0 Months Ended 0 Months Ended 9 Months Ended
Nov. 30, 2013
item
Jul. 05, 2012
Worldwide Medical Consultants, Inc. ("WMC")
CARIGEN, LTD ("SRB")
Nov. 30, 2013
Worldwide Medical Consultants, Inc. ("WMC")
CARIGEN, LTD ("SRB")
Jun. 01, 1998
Stock options
Jun. 01, 1997
Stock options
Sep. 14, 1996
Stock options
Nov. 30, 2013
Stock options
Nov. 30, 2012
Stock options
STOCK OPTIONS AND WARRANTS                
Number of share-based compensation plans 1              
STOCK OPTIONS AND WARRANTS                
Granted (in shares)           600,000    
Exercise price (in dollars per share)           $ 0.35    
Vested (in shares)       100,000 100,000 400,000 0 0
Number of Shares Issued             0  
Period from the grant dates for which the awards increase in the same percentage of any new shares of stock issued             10 years  
Exercised (in shares)             0  
Marketing Agreement                
Consulting fee (as a percent)   10.00%            
Warrants to be granted to acquire shares of common stock (in shares)   2,000,000            
Exercisable price (in dollars per share)   $ 0.10            
Warrants exercise period   10 years            
Shares vesting upon execution of the agreement   1,000,000            
Remaining shares to vest upon the first closing of a transaction by SRB under the marketing agreement   1,000,000            
Fair value of vested warrants at date of grant   $ 160,000            
Fair value of vested warrants at date of grant (in dollars per share)   $ 0.16            
Warrants exercised (in shares)     0          
XML 28 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
INCOME TAXES (Tables)
9 Months Ended
Nov. 30, 2013
INCOME TAXES  
Schedule of actual provision for income tax that differs from the amounts computed by applying the U.S. federal income tax rate to the pretax loss

 

Three Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(334,175

)

$

(520,112

)

Effect of expenses deducted directly by Dr. Burzynski

 

334,175

 

520,112

 

Nondeductible expenses and other adjustments

 

5,655

 

19,231

 

Change in valuation allowance

 

(5,655

)

(19,231

)

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

 

 

Nine Months Ended November 30,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(1,171,784

)

$

(1,701,340

)

Effect of expenses deducted directly by Dr. Burzynski

 

1,171,784

 

1,701,340

 

Nondeductible expenses and other adjustments

 

36,672

 

(69,202

)

Change in valuation allowance

 

(36,672

)

69,202

 

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

XML 29 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
BASIS OF PRESENTATION (Details)
Nov. 30, 2013
BASIS OF PRESENTATION  
Percentage of outstanding stock owned by the President and Chairman of the Board 81.00%
XML 30 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
LOSS PER COMMON SHARE (Details)
3 Months Ended 9 Months Ended
Nov. 30, 2013
Nov. 30, 2012
Nov. 30, 2013
Nov. 30, 2012
LOSS PER COMMON SHARE        
Warrants and stock options excluded from calculation of diluted loss per share 1,600,000 1,600,000 1,600,000 1,600,000
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STATEMENT OF STOCKHOLDERS' DEFICIT (USD $)
Total
Common Stock
Additional Paid-in Capital
Retained Deficit
Balance at Feb. 28, 2013 $ (84,662) $ 131,449 $ 107,883,768 $ (108,099,879)
Balance (in shares) at Feb. 28, 2013   131,448,444    
Increase (Decrease) in Stockholders' Equity        
Cash contributed by S.R. Burzynski, M.D., Ph.D. and related parties 339,100   339,100  
FDA clinical trial expenses paid directly by S.R. Burzynski, M.D., Ph.D. 2,999,465   2,999,465  
Net loss (3,446,424)     (3,446,424)
Balance at Nov. 30, 2013 $ (192,521) $ 131,449 $ 111,222,333 $ (111,546,303)
Balance (in shares) at Nov. 30, 2013   131,448,444    
XML 33 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
LOSS PER COMMON SHARE
9 Months Ended
Nov. 30, 2013
LOSS PER COMMON SHARE  
LOSS PER COMMON SHARE

NOTE D.LOSS PER COMMON SHARE

 

The Company accounts for loss per share in accordance with FASB ASC 260, Earnings per Share. Basic loss per share amounts are calculated by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding for the periods, including the dilutive effect of all common stock equivalents. Dilutive options and warrants that are issued during a period or that expire or are canceled during a period are reflected in the computations for the time they were outstanding during the periods being reported. During the three and nine month periods ended November 30, 2013 and 2012, 1,600,000 warrants and stock options were excluded from the calculation of diluted loss per share because their effect would be anti-dilutive.

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