UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
(Mark
One)
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x
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QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For the quarterly period ended
May 31, 2008
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o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934
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For the transition period from
to
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Commission file
number 000-23425
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Burzynski Research Institute, Inc.
(Exact name of small business issuer as specified in its charter)
Delaware
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76-0136810
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(State or other jurisdiction of incorporation or
organization)
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(IRS Employer Identification No.)
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9432 Old Katy Road, Suite 200,
Houston, Texas 77055
(Address of principal executive offices)
(713) 335-5697
(Issuers telephone number)
(Former name, former address, and former fiscal year, if changed since
last report)
Check whether the
issuer (1) filed all reports required to be filed by Section 13 or 15(d) of
the Exchange Act during the past 12 months (or 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 is a shell company (as defined in Rule 12b-2
of the Exchange Act). Yes
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No
x
APPLICABLE ONLY TO CORPORATE ISSUERS
State the number of shares outstanding of each of the issuers classes
of common equity, as of the latest practicable date: As of January 10,
2008, 131,388,444 shares of the Registrants Common Stock were outstanding.
Transitional Small
Business Disclosure Format (Check one): Yes
o
No
x
BURZYNSKI RESEARCH INSTITUTE, INC.
Form 10-QSB
Table of Contents
PART I FINANCIAL INFORMATION
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Item 1.
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Financial Statements
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Item 2.
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Managements Discussion and Analysis or Plan of Operation
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Item 3.
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Controls and Procedures
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PART II OTHER INFORMATION
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Item 1.
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Legal Proceedings
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Item 5.
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Other
Information
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Item 6.
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Exhibits
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BURZYNSKI RESEARCH INSTITUTE, INC.
CONDENSED BALANCE SHEETS
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May, 31
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February 28,
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2008
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2008
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(Unaudited)
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ASSETS
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Current assets
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Cash and cash equivalents
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$
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4,454
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$
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3,161
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TOTAL CURRENT ASSETS
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4,454
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3,161
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Property and equipment, net of accumulated depreciation
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6,676
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7,150
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TOTAL ASSETS
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$
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11,130
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$
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10,311
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LIABILITIES AND
STOCKHOLDERS DEFICIT
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Current liabilities
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Accounts payable
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$
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53,296
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$
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33,430
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Accrued liabilities
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27,916
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35,127
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CURRENT AND TOTAL LIABILITIES
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81,212
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68,557
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Commitments and contingencies
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Stockholders deficit
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Common stock, $.001 par value; 200,000,000 shares authorized,
131,388,444 issued
and outstanding
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131,389
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131,389
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Additional paid-in capital
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80,534,592
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79,264,295
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Discount on common stock
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(100
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(100
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Retained deficit
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(80,735,963
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(79,453,830
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)
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TOTAL STOCKHOLDERS (DEFICIT)
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(70,082
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(58,246
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)
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TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT)
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$
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11,130
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$
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10,311
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See
accompanying notes to financial statements.
F-1
CONDENSED STATEMENTS OF OPERATION
BURZYNSKI RESEARCH INSTITUTE, INC.
(UNAUDITED)
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Three Months Ended
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May 31
2008
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May 31
2007
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Operating expenses
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Research and development
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$
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1,212,810
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$
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1,017,452
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General and administrative
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66,038
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43,119
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Depreciation
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474
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498
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Total operating expenses
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1,279,322
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1,061,069
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Net (loss) before income tax
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(1,279,322
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Provision for income tax
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State tax
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2,811
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NET (LOSS)
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$
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(1,282,133
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$
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(1,061,069
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Earnings per share information:
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Basic and diluted (loss) per common share
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$
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(0.01
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$
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(0.01
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Weighted average number of common shares outstanding
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131,388,444
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131,388,444
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See
accompanying notes to financial statements.
F-2
STATEMENTS OF STOCKHOLDERS DEFICIT
BURZYNSKI RESEARCH INSTITUTE, INC.
(UNAUDITED)
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Additional
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Discount on
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Common
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Paid-in
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Common
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Retained
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Stock
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Capital
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Stock
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Deficit
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Balance February 28, 2008
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$
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131,389
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$
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79,264,295
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$
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(100
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$
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(79,453,830
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Cash contributed by S.R. Burzynski, M.D., Ph.D.
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110,000
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FDA clinical trial expenses paid directly by S.R. Burzynski, M.D.,
Ph.D.
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1,160,297
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Net (loss)
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(1,282,133
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Balance May 31, 2008
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$
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131,389
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$
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80,534,592
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$
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(100
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$
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(80,735,963
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See
accompanying notes to financial statements.
F-3
STATEMENTS OF CASH FLOWS
BURZYNSKI RESEARCH INSTITUTE, INC.
(UNAUDITED)
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Three Months Ended
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May 31,
2008
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May 31,
2007
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CASH FLOWS FROM OPERATING ACTIVITIES
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Net (loss)
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$
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(1,282,133
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$
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(1,061,069
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Adjustments to reconcile net (loss) to net cash used by operating
activities:
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Depreciation
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474
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498
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FDA clinical trial expenses paid directly by S.R. Burzynski, M.D.,
Ph.D.
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1,160,297
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964,090
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Increase (decrease)
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Accounts payable
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19,866
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3,820
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Accrued liabilities
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(7,211
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26,195
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NET CASH (USED IN) OPERATING ACTIVITIES
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(108,707
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(66,466
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CASH FLOWS FROM INVESTING ACTIVITIES
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Purchase of property and equipment
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(6,838
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NET CASH (USED) BY INVESTING ACTIVITES
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(6,838
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CASH FLOWS FROM FINANCING ACTIVITIES
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Additional paid-in capital
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110,000
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85,000
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NET CASH PROVIDED BY FINANCING ACTIVTIES
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110,000
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85,000
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NET INCREASE IN CASH
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1,293
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11,696
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CASH AT BEGINNING OF PERIOD
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3,161
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10,650
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CASH AT END OF PERIOD
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$
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4,454
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$
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22,346
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Supplemental Disclosures
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Cash paid during the period for state taxes
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$
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2,211
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$
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See accompanying
notes to financial statements
F-4
NOTES TO CONDENSED FINANCIAL STATEMENTS
BURZYNSKI RESEARCH INSTITUTE, INC.
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. Other funds received from Dr. Burzynski
have also been reported as additional paid-in capital. Expenses related to Dr. Burzynskis
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 over 80% 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 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. In September 2004, the
Company announced that the FDA awarded orphan drug status to Antineoplastons
A10 and AS2-1 for the treatment of brain stem glioma.
The accompanying unaudited
condensed financial statements have been prepared in accordance with accounting
principles generally accepted in the United States of America for interim
financial information. Certain disclosures and information normally included in
financial statements have been condensed or omitted. In the opinion of
management of the Company, these financial statements contain all adjustments
necessary for a fair presentation of financial position as of May 31, 2008
and February 29, 2008, and results of operations for the three months
ended May 31, 2008 and 2007, and cash flows for the three months ended May 31,
2008 and 2007. All such 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 Companys Annual Report on Form 10-KSB
for the year ended February 29, 2008.
F-5
NOTES TO CONDENSED FINANCIAL STATEMENTS -
continued
BURZYNSKI RESEARCH INSTITUTE, INC.
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. Burzynskis medical practice. A portion of Dr. Burzynskis 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 managements 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. Burzynskis 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 Companys 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.
NOTE C.
STOCK OPTIONS
At May 31, 2008, 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 $.35 per share,
to an officer who is no longer with the Company. The options vested as follows:
400,000 options
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September 14,
1996
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100,000 options
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June 1,
1997
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100,000 optons
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June 1,
1998
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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 additional shares have been issued since September 14,
1996. None of the options have been
exercised as of May 31, 2008.
F-6
NOTES TO CONDENSED FINANCIAL STATEMENTS -
continued
BURZYNSKI RESEARCH INSTITUTE, INC.
NOTE C.
STOCK OPTIONS - continued
Effective March 1, 2006,
the company adopted the fair value recognition provisions of FASB Statement No. 123(R),
Share-Based Payment
, using the
modified-prospective-transition method.
Under that transition method, compensation cost recognized after March 1,
2006 includes: (a) compensation cost for all share-based payments granted
prior to , but not yet vested as of March 1, 2006, based on the grant date
fair value estimated in accordance with the original provisions of Statement
123, and (b) compensation cost for all share-based payments granted
subsequent to March 1, 2006, based on the grant-date fair value estimated
in accordance with the provisions of Statement 123(R).
The company did not grant any
options and no options previously granted vested in any of the periods
presented in these financial statements.
Due to this fact there was no effect on net income and earnings per
share if the company had applied the fair value recognition provisions of
Statement 123 to options granted under the companys stock option plan in all
periods presented.
NOTE D.
INCOME TAXES
The Company adopted the
provisions of FASB Interpretation No. 48,
Accounting
for Uncertainty in Income Taxes
, on March 1, 2007. As of March 1, 2007 the total amount of
unrecognized tax benefits was $-0-. As a
result of the implementation of Interpretation 48, the Company had no material
change in the amounts of unrecognized tax benefits as a result of tax positions
taken during a prior period or the current period.
The federal income tax returns
of the Company for 2007, 2006, and 2005 are subject to examination by the IRS,
generally for three years after they are filed.
The Company recognizes interest
accrued related to unrecognized tax benefits in interest expense and penalties
in operating expenses.
F-7
NOTES TO CONDENSED FINANCIAL STATEMENTS -
continued
BURZYNSKI RESEARCH INSTITUTE, INC.
NOTE D.
INCOME TAXES - continued
The actual provision for income
tax for the three and nine months ended differ from the amounts computed by
applying the U.S. federal income tax rate of 34% to the pretax income as a
result of the following:
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Three Months
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May 31,
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May 31,
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2008
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2007
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Expected (benefit)
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$
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(434,969
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$
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(360,763
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Taxed directly to Dr. Burzynski
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435,925
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360,763
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Nondeductible expenses and other
adjustments
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3,068
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4,074
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Change in valuation allowance
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(4,024
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(4,074
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)
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State taxes
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2,811
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Provision for income tax
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$
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2,811
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$
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F-8
Item 2.
Managements Discussion and Analysis or Plan of
Operation
The following is a discussion of the
financial condition of the Company as of May 31, 2008, and the results of
operations comparing the three months ended May 31, 2008 and May 31,
2007. It should be read in conjunction with the financial statements and the notes
thereto included elsewhere in this report.
Introduction
The Company was incorporated under the laws
of the State of Delaware in 1984 in order to engage in the research,
production, marketing, promotion and sale of certain medical chemical compounds
composed of growth-inhibiting peptides, amino acid derivatives and organic
acids which are known under the trade name Antineoplastons. The Company
believes Antineoplastons are useful in the treatment of human cancer and is
currently conducting Phase II clinical trials of Antineoplastons relating to
the treatment of cancer. The Company has generated no significant revenue since
its inception, and does not expect to generate any operating revenues until
such time, if any, as Antineoplastons are approved for use and sale by the FDA.
The Companys sole source of funding is S.R. Burzynski, M.D., Ph.D. (Dr. Burzynski),
the Companys President and Chief Executive Officer. Dr. Burzynski funds
the Companys operations from his medical practice pursuant to certain
agreements between Dr. Burzynski and the Company
.
Funds received by the Company from Dr. Burzynski are
reported as additional paid-in capital to the Company.
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
currently has 19 open FDA-approved clinical trials. 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
.
In September 2004, the Company announced
that the FDA awarded orphan drug status to Antineoplastons A10 and AS2-1 for
treating patients with brain stem gliomas.
Results of Operations
Three Months
Ended May 31, 2008 Compared to Three Months Ended May 31, 2007
Research and development costs were approximately $1,213,000 and
$1,017,000 for the three months ended May 31, 2008 and 2007,
respectively. The increase of $196,000
or 19% was due to increases in material costs of $209,000 and facility and
equipment costs of $42,000 offset by decreases in personnel cost of $49,000,
consulting and quality control costs of $4,000 and other research and
development costs of $2,000.
General and administrative expenses were approximately $66,000 and
$43,000 for the three months ended May 31, 2008 and 2007, respectively. The increase of $23,000 or 53% was due to
increases in legal and professional fees of $20,000, and in other general and
administrative expenses of $3,000.
The Company had net losses of approximately $1,282,000 and $1,061,000
for the three months ended May 31, 2008 and 2007, respectively. The increase in the net loss from 2007 to
2008 is primarily due to the increases in research and development costs due to
increases in material costs and facility and equipment costs offset by
decreases in research and development costs
due to decreases in personnel cost, consulting and quality control costs
and other research and development costs; and increases in general and
administrative expenses due to increases in legal and professional fees and
other general and administrative cost.
Liquidity
and Capital Resources
The Companys operations have been funded
entirely by Dr. Burzynski with funds generated from Dr. Burzynskis
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
F-9
treatment of cancer and Dr. Burzynski
agreed to fund the Companys 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
Companys research expenses, including expenses to conduct the clinical trials.
Dr. Burzynski also provides the Company laboratory and research space as
needed to conduct the Companys 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 Companys 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.
Dr. Burzynski has unlimited and free
access to all equipment which the Company owns, so long as such use does not
conflict with the Companys use of such equipment, including without
limitation, all equipment used in the manufacturing of Antineoplastons used in
the clinical trials. 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 Company entered into a third amendment to
the Research Funding Agreement, effective March 1, 2007, whereby the
Company and Dr. Burzynski extended the term thereof until February 29,
2008, with an automatic renewal for additional one-year terms, 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.
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 $3,800,000 during the remaining three quarters of the fiscal year
ending February 28, 2009. 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 Companys research and FDA-related
costs, there is no assurance that Dr. Burzynski will be able to continue
to fund the Companys operations pursuant to the Research Funding Agreement or
otherwise. The Company believes Dr. Burzynski will be financially able to
fund the Companys operations at least through the fiscal year ending February 28,
2009. In addition, Dr. Burzynskis medical practice has successfully
funded the Companys research activities over the last 22 years and, in 1997,
his medical practice was expanded to include traditional cancer treatment
options such as chemotherapy, 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 Companys Antineoplaston
clinical trials. As a result of the expansion of Dr. Burzynskis medical
practice, the financial condition of the medical practice has improved Dr. Burzynskis
ability to fund the Companys operations.
The Company may be required to seek
additional capital through equity or debt financing or the sale of assets until
the Companys 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
F-10
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.
Managements 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 3.
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 Companys management, including the Companys
principal executive officer (who is also the Companys principal financial
officer), of the effectiveness of the Companys disclosure controls and procedures
pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as
amended. Based on that evaluation, the Companys principal executive officer
(who is also the Companys principal financial officer) concluded that the
Companys disclosure controls and procedures are effective in timely alerting
him 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 Companys internal controls
or in other factors that could significantly affect internal controls
subsequent to the date of evaluation above.
PART II
OTHER INFORMATION
Item 1.
Legal Proceedings
The Companys activities are subject to
regulation by various governmental agencies, including the FDA, which regularly
monitor the Companys operations and often impose requirements on the conduct
of its clinical trials and other aspects of the Companys business operations.
The Companys 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
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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)).
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3.2
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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)).
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31.1
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Certification of Chief Executive Officer and Principal Financial
Officer pursuant to Rules 13a-14 and 15d-14 of the Securities Exchange
Act of 1934, as amended, filed herewith.
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32.1
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Certification of Chief Executive Officer and 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.
|
F-11
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.
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By:
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/s/ Stanislaw R. Burzynski
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Stanislaw R. Burzynski,
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President, Secretary, Treasurer and
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Chairman of the Board of Directors
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(Chief Executive Officer and
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Principal Financial Officer)
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Date: July 15
,
2008
F-12
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