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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, 2012

 

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, 2012, 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

11

 

 

 

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 29,

 

 

 

2012

 

2012

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

2,636

 

$

17,297

 

TOTAL CURRENT ASSETS

 

2,636

 

17,297

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation of $19,509 and $18,996 at November 30, 2012 and February 29, 2012, respectively

 

2,906

 

3,419

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

5,542

 

$

20,716

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

52,977

 

$

12,265

 

Accrued liabilities

 

37,449

 

49,699

 

CURRENT AND TOTAL LIABILITIES

 

90,426

 

61,964

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ deficit

 

 

 

 

 

Common stock, $.001 par value; 200,000,000 shares authorized; 131,448,444 issued and outstanding at November 30, 2012 and February 29, 2012, respectively

 

131,449

 

131,449

 

Additional paid-in capital

 

106,388,682

 

101,428,376

 

Retained deficit

 

(106,605,015

)

(101,601,073

)

 

 

 

 

 

 

TOTAL STOCKHOLDERS’ DEFICIT

 

(84,884

)

(41,248

)

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

$

5,542

 

$

20,716

 

 

See accompanying notes to financial statements.

 

3



Table of Contents

 

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 

 

Three Months Ended

 

 

 

November 30,

 

 

 

2012

 

2011

 

Operating expenses

 

 

 

 

 

Research and development

 

$

1,430,406

 

$

1,764,352

 

General and administrative

 

99,164

 

75,451

 

Depreciation

 

171

 

177

 

Total operating expenses

 

1,529,741

 

1,839,980

 

 

 

 

 

 

 

Net loss before provision for income tax

 

(1,529,741

)

(1,839,980

)

 

 

 

 

 

 

Provision for income tax

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(1,529,741

)

$

(1,839,980

)

 

 

 

 

 

 

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,

 

 

 

2012

 

2011

 

Operating expenses

 

 

 

 

 

Research and development

 

$

4,465,736

 

$

4,939,748

 

General and administrative

 

537,793

 

185,623

 

Depreciation

 

513

 

531

 

Total operating expenses

 

5,004,042

 

5,125,902

 

 

 

 

 

 

 

Other income

 

100

 

 

 

 

 

 

 

 

Net loss before provision for income tax

 

(5,003,942

)

(5,125,902

)

 

 

 

 

 

 

Provision for income tax

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(5,003,942

)

$

(5,125,902

)

 

 

 

 

 

 

Loss per share information:

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$

(0.04

)

$

(0.04

)

 

 

 

 

 

 

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’ DEFICIT

For the Nine Months Ended November 30, 2012

(UNAUDITED)

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

Additional

 

 

 

Stockholders’

 

 

 

Shares

 

Amount

 

Paid-in Capital

 

Retained Deficit

 

Deficit

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance February 29, 2012

 

131,448,444

 

$

131,449

 

$

101,428,376

 

$

(101,601,073

)

$

(41,248

)

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

523,682

 

 

523,682

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

4,276,728

 

 

4,276,728

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrants issued for services

 

 

 

159,896

 

 

159,896

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

(5,003,942

)

(5,003,942

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance November 30, 2012

 

131,448,444

 

$

131,449

 

$

106,388,682

 

$

(106,605,015

)

$

(84,884

)

 

See accompanying notes to financial statements.

 

5



Table of Contents

 

BURZYNSKI RESEARCH INSTITUTE, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 

 

Nine Months Ended November 30,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

Net loss

 

$

(5,003,942

)

$

(5,125,902

)

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

 

 

 

 

 

Depreciation

 

513

 

531

 

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

 

4,276,728

 

4,762,103

 

Warrants issued for services

 

159,896

 

 

Changes in operating assets and liabilities

 

 

 

 

 

Accounts payable

 

40,712

 

(35,638

)

Accrued liabilities

 

(12,250

)

10,365

 

 

 

 

 

 

 

NET CASH USED BY OPERATING ACTIVITIES

 

(538,343

)

(388,541

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

Contribution of capital

 

523,682

 

387,199

 

 

 

 

 

 

 

NET CASH PROVIDED BY FINANCING ACTIVITIES

 

523,682

 

387,199

 

 

 

 

 

 

 

NET DECREASE IN CASH

 

(14,661

)

(1,342

)

 

 

 

 

 

 

CASH AT BEGINNING OF PERIOD

 

17,297

 

17,476

 

 

 

 

 

 

 

CASH AT END OF PERIOD

 

$

2,636

 

$

16,134

 

 

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., a Delaware corporation (the “Company”), include expenses incurred directly by S.R. Burzynski, M.D., Ph.D. (“Dr. Burzynski”) within his medical practice, related to the conduct of U.S. Food and Drug Administration (“FDA”) approved clinical trials for Antineoplaston drugs used in the treatment of cancer.  These expenses have been reported as research and development costs and as additional paid-in capital.  Cash contributions received from Dr. Burzynski, which are used to fund general operating expenses, 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 80.9% of the outstanding stock of the Company, and also is the inventor and original patent holder of certain drug products known 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 an Antineoplaston 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, 2012 and February 29, 2012, results of operations for the three and nine months ended November 30, 2012 and 2011 and cash flows for the nine months ended November 30, 2012 and 2011.  All adjustments are of a normal recurring nature.  The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year.  These statements should be read in conjunction with the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended February 29, 2012.

 

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

 

At November 30, 2012, 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:

 

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, 2012.

 

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 and loss per share regarding the provisions of FASB ASC 718 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, 2012, none of the aforementioned warrants have been exercised and none of the remaining 1,000,000 shares have vested as a result of a closing of a transaction by SRB.

 

NOTE D.                      LOSS PER 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, 2012 and 2011, respectively, 1,600,000 and 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.

 

8



Table of Contents

 

The federal income tax returns of the Company for 2011, 2010, and 2009 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, 2012 and 2011, 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,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(520,112

)

$

(625,594

)

Effect of expenses deducted directly by Dr. Burzynski

 

520,112

 

625,594

 

Nondeductible expenses and other adjustments

 

19,231

 

6,018

 

Change in valuation allowance

 

(19,231

)

(6,018

)

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

 

 

Nine Months Ended November 30,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Expected income tax benefit

 

$

(1,701,340

)

$

(1,742,807

)

Effect of expenses deducted directly by Dr. Burzynski

 

1,701,340

 

1,742,807

 

Nondeductible expenses and other adjustments

 

69,202

 

(7,955

)

Change in valuation allowance

 

(69,202

)

7,955

 

State tax

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

 

$

 

 

At November 30, 2012, the Company had a net deferred tax asset of $0, which includes a valuation allowance of $277,812.  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 valuation allowance for deferred tax assets has been provided.  At November 30, 2012, the Company had net operating loss carryforwards available to offset future taxable income in the amount of $672,332, which may be carried forward and will expire if not used between 2013 and 2033 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, 2012, and the results of operations comparing the three and nine months ended November 30, 2012 and 2011.  It should be read in conjunction with the financial statements and the notes thereto included elsewhere in this report and in conjunction with the Annual Report on Form 10-K for the year ended February 29, 2012.

 

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 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.

 

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

 

9



Table of Contents

 

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 is currently conducting a feasibility assessment.  ResearchPoint has secured interest and commitments from a number of sites selected.  Upon completion of this assessment, a randomized, international phase III study will commence.  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.

 

Results of Operations

 

Three Months Ended November 30, 2012 Compared to Three Months Ended November 30, 2011

 

Research and development costs were approximately $1,430,000 and $1,764,000 for the three months ended November 30, 2012 and 2011, respectively.  The decrease of $334,000 or 19% was due to decreases in material costs of $433,000, facility and equipment costs of $20,000, and other research and development costs of $3,000, offset by an increase in personnel costs of $79,000 and consulting and quality control costs of $43,000.

 

General and administrative expenses were approximately $99,000 and $75,000 for the three months ended November 30, 2012 and 2011, respectively.  The increase of $24,000 or 32% was due to an increase in legal and professional fees.

 

The Company had net losses of approximately $1,530,000 and $1,840,000 for the three months ended November 30, 2012 and 2011, respectively.  The decrease in the net loss from 2011 to 2012 is primarily due to the overall decrease in research and development expenses, offset by an increase in general and administrative expenses of the Company described above.

 

Nine Months Ended November 30, 2012 Compared to Nine Months Ended November 30, 2011

 

Research and development costs were approximately $4,466,000 and $4,940,000 for the nine months ended November 30, 2012 and 2011, respectively.  The decrease of $474,000 or 10% was due to decreases in material costs of $906,000 and facility and equipment costs of $59,000, offset by an increase in personnel costs of $383,000 and consulting and quality control costs of $108,000.

 

General and administrative expenses were approximately $538,000 and $186,000 for the nine months ended November 30, 2012 and 2011, respectively.  The increase of $352,000 or 189% was due to an increase in legal and professional fees.

 

The Company had net losses of approximately $5,004,000 and $5,126,000 for the nine months ended November 30, 2012 and 2011, respectively.  The decrease in the net loss from 2011 to 2012 is primarily due to the overall decrease research and development expenses, offset by an increase in general and administrative expenses of the Company 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

 

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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 29, 2013.  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 $1,500,000 during the remaining quarter of the fiscal year ending February 28, 2013.  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 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, 2012 that have materially affected or are reasonably likely to materially affect our internal controls subsequent to that date.

 

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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 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

 

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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

 

 

(Chief Executive Officer)

 

 

Date: January 14, 2013

 

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