Filed Pursuant to Rule 424(b)(3)
File Number 333-126399
PROSPECTUS SUPPLEMENT NO. 6
Prospectus Supplement No. 6
to Prospectus dated December 15, 2006
as supplemented by
Prospectus Supplement No. 1 dated January 24, 2007
Prospectus Supplement No. 2 dated February 27, 2007
Prospectus Supplement No. 3 dated March 20, 2007
Prospectus Supplement No. 4 dated April 19, 2007 and
Prospectus Supplement No. 5 dated May 2, 2007
BIONOVO, INC.
This Prospectus Supplement No. 6 supplements our Prospectus dated December 15, 2006 as supplemented by Prospectus Supplement No. 1 dated January 24, 2007, Prospectus Supplement No. 2 dated February 27, 2007, Prospectus Supplement No. 3 dated March 20, 2007, Prospectus Supplement No. 4 dated April 19, 2007 and Prospectus Supplement No. 5 dated May 2, 2007. The shares that are the subject of the Prospectus have been registered to permit their resale to the public by the selling stockholders named in the Prospectus. We are not selling any shares of common stock in this offering and therefore will not receive any proceeds from this offering, except upon the exercise of warrants.
Our common stock is quoted on the Over-the-Counter Bulletin Board under the symbol BNVI.OB. On May 10, 2007, the closing price of our common stock on the OTC Bulletin Board was $5.05.
This Prospectus Supplement includes the attached Current Report dated May 9, 2007 on Form 8-K of Bionovo, Inc., as filed by us with the U.S. Securities and Exchange Commission on May 10, 2007 and the attached Quarterly Report for the three months ended March 31, 2007 on Form 10-QSB of Bionovo, Inc., as filed by us with the U.S. Securities and Exchange Commission on May 8, 2007.
YOU SHOULD READ THE PROSPECTUS, PROSPECTUS SUPPLEMENT NO. 1, PROSPECTUS SUPPLEMENT NO. 2, PROSPECTUS SUPPLEMENT NO. 3, PROSPECTUS SUPPLEMENT NO. 4, PROSPECTUS SUPPLEMENT NO. 5 AND THIS PROSPECTUS SUPPLEMENT NO. 6, CAREFULLY BEFORE YOU INVEST, INCLUDING THE RISK FACTORS WHICH BEGIN ON PAGE 4 OF THE PROSPECTUS.
NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS SUPPLEMENT IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this Prospectus Supplement is May 11, 2007.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
_______________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 9, 2007
BIONOVO, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
000-50073 | 87-0576481 |
(Commission File Number) | (IRS Employer Identification Number) |
5858 Horton Street, Suite 375
Emeryville, California 94608
(Address of principal executive offices)
Registrant’s telephone number, including area code: (510) 601-2000
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
Effective May 9, 2007, Bionovo, Inc. (the “Company”) amended paragraph one of Article IV of its Certificate of Incorporation to increase the total authorized shares of Common Stock of the Company from 90,000,000 to 190,000,000, as approved by the Company's stockholders at the Company’s Annual Meeting of Stockholders held on May 1, 2007. The Certificate of Amendment to the Certificate of Incorporation is attached hereto as Exhibit 3.1 to this Current Report on Form 8-K.
Item 9.01 Financial Reports and Exhibits.
Exhibit No. Description
3.1 | Certificate of Amendment to Certificate of Incorporation. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | |
| BIONOVO, INC. |
| | |
Date: May 10, 2007 | By: | /s/ James P. Stapleton |
| Name: James P. Stapleton |
| Title: Chief Financial Officer |
CERTIFICATE OF AMENDMENT
OF THE
CERTIFICATE OF INCORPORATION
OF
BIONOVO, INC.
(a Delaware corporation)
The undersigned, Isaac Cohen, hereby certifies that:
1. He is the Chairman of the Board, President, Chief Executive Officer and Chief Scientific Officer of Bionovo, Inc. (the “Corporation”), a Delaware corporation, and is duly authorized by the unanimous written consent of the Board of Directors of the Corporation to execute this instrument.
2. The present name of the Corporation is “Bionovo, Inc.” The Corporation filed its Certificate of Incorporation under the name “Bionovo, Inc.” with the Secretary of State of the State of Delaware on June 28, 2005, and filed a Certificate of Merger with the Secretary of State of the State of Delaware on June 29, 2005.
3. This Certificate of Amendment of the Certificate of Incorporation was duly approved by the Corporation’s Board of Directors and duly adopted by written consent of the stockholders of the Corporation in accordance with the applicable provisions of Sections 228 and 242 of the General Corporation Law of the State of Delaware.
4. The first paragraph of Section 1 of Article IV of the Certificate of Incorporation of the Corporation is hereby amended to read in its entirety as follows:
“ARTICLE IV
Capitalization, Preemptive Rights and Voting
Section 1. Authorized Shares. The Corporation shall have the authority to issue two classes of shares to be designated, respectively, “Common Stock” and “Preferred Stock." The total number of shares of capital stock which the Corporation shall have the authority to issue is TWO HUNDRED MILLION (200,000,000) shares, of which ONE HUNDRED NINETY MILLION (190,000,000) shall be Common Stock, and TEN MILLION (10,000,000) shares shall be Preferred Stock. Each share of Common stock shall have a par value of $0.0001, and each share of Preferred Stock shall have a par value of $0.0001.”
IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment of the Certificate of Incorporation to be executed this 9th day of May 2007.
By: /s/ Isaac Cohen
Isaac Cohen
Chairman of the Board,
President, Chief Executive Officer and Chief Scientific Officer
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
x Quarterly Report under Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the quarterly period ended March 31, 2007
o Transition Report under Section 13 or 15(d) of the Exchange Act
For the transition period ____________ to ____________
Commission File Number 000-50073
BIONOVO, INC.
(Exact name of Small Business Issuer as Specified in Its Charter)
DELAWARE (State or Other Jurisdiction of Incorporation or Organization) | 20-5526892 (I.R.S. Employer Identification No.) |
5858 Horton Street
Suite 375
Emeryville, California 94608
(Address of Principal Executive Offices)
510-601-2000
(Issuer's Telephone Number, Including Area Code)
Check whether the issuer (1) 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 issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days x Yes o No
Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). o Yes x No
State the number of shares outstanding of each of the issuer's classes of common stock: 65,174,983 shares of $0.0001 par value Common Stock outstanding as of the date of this filing.
Transitional Small Business Disclosure Format (check one): Yes o No x
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION | Page |
| |
Item 1. Financial Statements (Unaudited) | |
Condensed Consolidated Financial Statements: | |
Condensed Consolidated Balance Sheet (Unaudited) | F-1 |
Condensed Consolidated Statements of Operations (Unaudited). | F-2 |
Condensed Consolidated Statement of Stockholders’ Equity (Deficit) (Unaudited) | F-3 |
Condensed Consolidated Statements of Cash Flows (Unaudited) | F-4 |
Notes to Condensed Consolidated Financial Statements (Unaudited). | F-5 |
Item 2. Management’s Discussion and Analysis or Plan of Operations. | 1 |
Item 3. Controls and Procedures. | 18 |
| |
PART II OTHER INFORMATION | |
Item 1. Legal Proceedings | 19 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 19 |
Item 3. Defaults Upon Senior Securities. | 19 |
Item 4. Submission of Matters to a Vote of Securities Holders | 19 |
Item 5. Other Information | 19 |
Item 6. Exhibits | 19 |
| |
Bionovo, Inc. (formerly Lighten Up Enterprises International, Inc.)
(A Development Stage Company)
Consolidated Balance Sheet (Unaudited)
| | March 31 | |
| | 2007 | |
Assets | | | |
| | | |
Current assets: | | | |
Cash and cash equivalents | | $ | 16,914,374 | |
Short-term securities | | | 386,617 | |
Due from officers | | | 1,796 | |
Prepaid expenses and other current assets | | | 202,695 | |
| | | | |
Total current assets | | | 17,505,482 | |
| | | | |
Property and equipment, | | | | |
net of accumulated depreciation | | | 1,940,746 | |
| | | | |
Other assets: | | | | |
Intangible assets - patent pending, net of amortization | | | 59,687 | |
| | | | |
| | $ | 19,505,915 | |
| | | | |
Liabilities and Stockholders' Equity | | | | |
| | | | |
Current liabilities: | | | | |
Accounts payable and accrued expenses | | | 1,422,151 | |
Current portion leases | | | 299,831 | |
Deferred revenue | | | 15,000 | |
| | | | |
Total current liabilities | | | 1,736,982 | |
| | | | |
| | | | |
Long term portion leases | | | 223,189 | |
Deferred revenue | | | 83,750 | |
| | | | |
Total Liabilities | | | 2,043,921 | |
| | | | |
Stockholders' Equity: | | | | |
| | | | |
Common stock, $0.0001 par value | | | | |
Authorized shares - 100,000,000, issued and outstanding of 64,944,983 | | | 6,493 | |
Additional paid-in capital | | | 30,649,476 | |
Deferred Compensation | | | - | |
Deficit accumulated during development stage | | | (13,193,975 | ) |
| | | | |
Total stockholders' equity | | | 17,461,994 | |
| | | | |
| | $ | 19,505,915 | |
See the accompanying notes to these condensed consolidated financial statements.
Bionovo, Inc. (formerly Lighten Up Enterprises International, Inc.)
(A Development Stage Company)
Consolidated Statements of Operations (Unaudited)
| | | | | | Accumulated from | |
| | Three months ended | | Three months ended | | February 1, 2002 | |
| | March 31, | | March 31, | | (Date of Inception) to | |
| | 2007 | | 2006 | | March 31, 2007 | |
| | | | | | | |
Revenue | | $ | 3,750 | | $ | 3,750 | | $ | 81,490 | |
| | | | | | | | | | |
Cost of sales | | | - | | | - | | | - | |
| | | | | | | | | | |
Gross Profit | | | 3,750 | | | 3,750 | | | 81,490 | |
| | | | | | | | | | |
Operating expenses: | | | | | | | | | | |
Research and development | | | 2,788,668 | | | 745,288 | | | 8,643,130 | |
General and administrative | | | 602,775 | | | 340,456 | | | 3,385,798 | |
Merger cost | | | - | | | - | | | 1,964,065 | |
Sales and marketing | | | 92,146 | | | 92,562 | | | 477,323 | |
| | | | | | | | | | |
Total operating expenses | | | 3,483,589 | | | 1,178,306 | | | 14,470,316 | |
| | | | | | | | | | |
Loss from operations | | | (3,479,839 | ) | | (1,174,556 | ) | | (14,388,826 | ) |
| | | | | | | | | | |
Change in fair value of warrant liability | | | - | | | - | | | 831,288 | |
Unrealized loss on short term securities | | | - | | | - | | | (20,851 | ) |
Loss on sale of assets | | | - | | | | | | (4,854 | ) |
Interest expense | | | (14,081 | ) | | (5,287 | ) | | (164,516 | ) |
Interest income | | | 149,712 | | | 60,370 | | | 560,184 | |
| | | | | | | | | | |
Total other income (expense) | | | 135,631 | | | 55,083 | | | 1,201,251 | |
| | | | | | | | | | |
Loss before income | | | | | | | | | | |
taxes | | | (3,344,208 | ) | | (1,119,473 | ) | | (13,187,575 | ) |
| | | | | | | | | | |
Provision for income taxes | | | (800 | ) | | (1,600 | ) | | (6,400 | ) |
| | | | | | | | | | |
Net income (loss) | | $ | (3,345,008 | ) | $ | (1,121,073 | ) | $ | (13,193,975 | ) |
| | | | | | | | | | |
Net income (loss) per share basic and diluted | | $ | (0.05 | ) | $ | (0.02 | ) | $ | (0.42 | ) |
| | | | | | | | | | |
Weighted average shares outstanding basic and diluted | | | 61,525,518 | | | 46,602,160 | | | 31,684,429 | |
See the accompanying notes to these condensed consolidated financial statements.
Bionovo, Inc. (formerly Lighten Up Enterprises International, Inc.)
(A Development Stage Company)
Statements of Stockholders' Equity (Deficit) (Unaudited)
| | | | | | | | | | Accumulated | | | |
| | Common Stock | | Additional | | Deferred | | Deficit During | | | |
| | Number of | | | | Paid-In | | Stock | | Development | | | |
| | Shares | | Amount | | Capital | | Compensation | | Stage | | Total | |
| | | | | | | | | | | | | |
Balance at inception (February 1, 2002) - Adjusted | | | | | | | | | | | | | |
to reflect effect of stock split on June 17, 2004, and | | | | | | | | | | | | | |
March 4, 2004, and reverse merger on April 6, 2005 | | | 20,400,000 | | $ | 2,040 | | $ | (2,040 | ) | $ | - | | $ | - | | $ | - | |
| | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2002 | | | 20,400,000 | | | 2,040 | | | (2,040 | ) | | - | | | - | | | - | |
| | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | - | | | - | | | - | | | (55,682 | ) | | (55,682 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2003 | | | 20,400,000 | | | 2,040 | | | (2,040 | ) | | - | | | (55,682 | ) | | (55,682 | ) |
| | | | | | | | | | | | | | | | | | | |
Noncash compensation | | | | | | | | | | | | | | | | | | | |
expense for options issued | | | - | | | - | | | 30,000 | | | - | | | - | | | 30,000 | |
Net loss | | | - | | | - | | | - | | | - | | | (537,948 | ) | | (537,948 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2004 | | | 20,400,000 | | | 2,040 | | | 27,960 | | | | | | (593,630 | ) | | (563,630 | ) |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
Issuance of shares for reverse merger | | | 4,000,000 | | | 400 | | | (400 | ) | | | | | | | | | |
Issuance of common stock for funds received by private placement | | | | | | | | | | | | | | | | | | | |
net of financing cost | | | 20,461,000 | | | 2,046 | | | 9,930,370 | | | - | | | - | | | 9,932,416 | |
Issuance of common stock for conversion on notes payable | | | 1,251,448 | | | 125 | | | 461,697 | | | - | | | - | | | 461,822 | |
Amortization of deferred stock compensation | | | - | | | - | | | 16,472 | | | (8,236 | ) | | - | | | 8,236 | |
| | | | | | | | | | | | | | | | | | | |
Net loss | | | - | | | - | | | - | | | - | | | (3,637,537 | ) | | (3,637,537 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2005 | | | 46,112,448 | | $ | 4,611 | | $ | 10,436,099 | | $ | (8,236 | ) | $ | (4,231,167 | ) | $ | 6,201,307 | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
Issuance of common stock for exercise of warrants | | | 5,024,776 | | | 503 | | | 2,304,555 | | | - | | | - | | | 2,305,058 | |
Issuance of common stock for services | | | 200,000 | | | 20 | | | 164,980 | | | - | | | - | | | 165,000 | |
Amortization of deferred stock compensation | | | - | | | - | | | - | | | 8,236 | | | - | | | 8,236 | |
Stock option expense related to 123R | | | - | | | - | | | 434,529 | | | - | | | - | | | 434,529 | |
Net loss | | | - | | | - | | | - | | | - | | | (5,617,800 | ) | | (5,617,800 | ) |
| | | | | | | | | | | | | | | | | | | |
Balance, December 31, 2006 | | | 51,337,224 | | $ | 5,134 | | $ | 13,340,163 | | $ | - | | $ | (9,848,967 | ) | $ | 3,496,330 | |
| | | | | | | | | | | | | | | | | | | |
Issuance of common stock from private placement (unaudited) | | | | | | | | | | | | | | | | | | | |
net of financing cost | | | 10,521,000 | | | 1,053 | | | 14,503,477 | | | - | | | | | | 14,504,530 | |
Issuance of common stock for exercise of warrants (unaudited) | | | 3,056,759 | | | 303 | | | 2,663,775 | | | - | | | | | | 2,664,078 | |
Issuance of common stock for exercise of options (unaudited) | | | 30,000 | | | 3 | | | 8,748 | | | | | | | | | 8,751 | |
Stock option expense related to 123R (unaudited) | | | - | | | - | | | 133,313 | | | - | | | | | | 133,313 | |
Net loss (unaudited) | | | - | | | - | | | - | | | - | | | | | | | |
| | | | | | | | | | | | | | | (3,345,008 | ) | | (3,345,008 | ) |
Balance, March 31, 2007 (unaudited) | | | 64,944,983 | | $ | 6,493 | | $ | 30,649,476 | | $ | - | | $ | (13,193,975 | ) | $ | 17,461,994 | |
See the accompanying notes to these condensed consolidated financial statements.
Bionovo, Inc. (formerly Lighten Up Enterprises International, Inc.)
(A Development Stage Company)
Consolidated Statements of Cash Flows (Unaudited)
| | Three months ended | | February 1, 2002 | |
| | March 31 | | (Date of Inception) to | |
| | 2007 | | 2006 | | March 31, 2007 | |
Cash flows provided by (used for) operating | | | | | | | |
activities: | | | | | | | |
Net loss | | $ | (3,345,008 | ) | $ | (1,121,073 | ) | $ | (13,193,974 | ) |
| | | | | | | | | | |
Adjustments to reconcile net loss | | | | | | | | | | |
to net cash provided by (used for) | | | | | | | | | | |
operating activities: | | | | | | | | | | |
Noncash compensation expense for warrants issued | | | - | | | - | | | 1,964,065 | |
Noncash compensation expense for options issued | | | 133,313 | | | 233,019 | | | 597,842 | |
Amortization of note discount | | | - | | | - | | | 138,815 | |
Amortization of deferred stock compensation | | | - | | | 2,059 | | | 16,472 | |
Issuance of common stock for services | | | - | | | - | | | 165,000 | |
Change in fair value of warrant liability | | | - | | | - | | | (831,288 | ) |
Amortization of intangible assets | | | 1,097 | | | 853 | | | 6,170 | |
Depreciation | | | 116,308 | | | 35,706 | | | 402,978 | |
Unrealized loss on short term securities | | | - | | | 6,129 | | | 20,851 | |
Purchases of trading securities | | | (387,600 | ) | | (2,191,612 | ) | | (7,136,209 | ) |
Proceeds from sales of trading securities | | | 485,000 | | | 1,403,893 | | | 6,731,000 | |
| | | | | | | | | | |
Changes in assets and liabilities: | | | | | | | | | | |
(Increase) decrease in assets: | | | | | | | | | | |
Prepaid expenses | | | (19,167 | ) | | 28,337 | | | (202,695 | ) |
| | | | | | | | | | |
Increase (decrease) in liabilities: | | | | | | | | | | |
Accounts payable and accrued expenses | | | 641,759 | | | (64,087 | ) | | 1,404,985 | |
Deferred revenue | | | (3,750 | ) | | (3,750 | ) | | 98,750 | |
| | | | | | | | | | |
Total adjustments | | | 966,960 | | | (549,453 | ) | | 3,376,736 | |
| | | | | | | | | | |
Net cash used for operating activities | | | (2,378,048 | ) | | (1,670,526 | ) | | (9,817,238 | ) |
| | | | | | | | | | |
Cash flows used for investing activities: | | | | | | | | | | |
Acquisition of intangible assets | | | (2,172 | ) | | (20,069 | ) | | (48,405 | ) |
Acquisition of fixed assets | | | (384,150 | ) | | (135,501 | ) | | (1,394,111 | ) |
Advance to officers | | | - | | | - | | | (1,796 | ) |
| | | | | | | | | | |
Net cash used for investing activities | | | (386,322 | ) | | (155,570 | ) | | (1,444,312 | ) |
| | | | | | | | | | |
Cash flows provided by financing activities: | | | | | | | | | | |
Payments under capital lease obligations | | | (70,054 | ) | | - | | | (418,214 | ) |
Proceeds from issuance of common stock and warrants | | | | | | | | | | |
net of financing cost | | | 17,177,359 | | | 864,484 | | | 28,231,539 | |
Proceeds from issuance of common stock | | | - | | | - | | | 500,000 | |
Payments on convertible notes payable | | | - | | | - | | | (50,000 | ) |
Payments for financing costs for convertible notes | | | - | | | - | | | (87,401 | ) |
| | | | | | | | | | |
Net cash provided by financing activities | | | 17,107,305 | | | 864,484 | | | 28,175,924 | |
| | | | | | | | | | |
Net increase (decrease) in cash | | | 14,342,935 | | | (961,612 | ) | | 16,914,374 | |
| | | | | | | | | | |
Cash, beginning of year | | | 2,571,439 | | | 4,588,400 | | | - | |
| | | | | | | | | | |
Cash, end of period | | $ | 16,914,374 | | $ | 3,626,788 | | $ | 16,914,374 | |
| | | | | | | | | | |
Supplemental disclosure of cash flow | | | | | | | | | | |
information: | | | | | | | | | | |
Interest paid | | $ | 26,597 | | $ | - | | $ | 161,104 | |
| | | | | | | | | | |
Income taxes paid | | $ | 800 | | $ | - | | $ | 5,600 | |
| | | | | | | | | | |
Supplemental disclosure of noncash investing | | | | | | | | | | |
and financing activities- | | | | | | | | | | |
| | | | | | | | | | |
Noncash warrant expense for warrants issued | | $ | - | | $ | - | | $ | 1,964,065 | |
| | | | | | | | | | |
Adjustment in warrant liability | | $ | - | | $ | - | | $ | 7,030,026 | |
| | | | | | | | | | |
Converstion of notes payable to common stock | | $ | - | | $ | - | | $ | 450,000 | |
| | | | | | | | | | |
Assets acquried under capital lease | | $ | - | | $ | - | | $ | 949,614 | |
| | | | | | | | | | |
Stock based compensation | | $ | 133,313 | | $ | 233,019 | | $ | 597,842 | |
| | | | | | | | | | |
Conversion of accrued interest payable | | $ | - | | $ | - | | $ | 11,697 | |
| | | | | | | | | | |
Issuance of common stock with reverse merger | | $ | - | | $ | - | | $ | 400 | |
| | | | | | | | | | |
Issuance of common stock for services | | $ | - | | $ | - | | $ | 165,000 | |
See the accompanying notes to these condensed consolidated financial statements.
NOTE 1. BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
BUSINESS AND BASIS OF PRESENTATION
Bionovo, Inc. ("Bionovo" or the "Company") is a drug discovery and development company focusing on cancer and women's health. Currently, the Company is conducting research and development activity which integrates scientific discoveries with natural substances used in traditional East Asian medicine. The Company is developing drugs to treat breast, ovarian and pancreatic cancers, and for menopause.
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-QSB and do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete consolidated financial statements. These condensed consolidated financial statements and related notes should be read in conjunction with the audited consolidated financial statements of Bionovo, Inc. (unless the context indicates otherwise, together with its wholly-owned subsidiary Bionovo Biopharmaceuticals, Inc., the "Company" or “Bionovo”) for the fiscal years ended December 31, 2006 and 2005 included in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments which are of a normal recurring nature and which are necessary to present fairly the consolidated financial position of the Company as of March 31, 2007, and the results of operations for the three months ended March 31, 2007 and 2006 and cash flows for the three months ended March 31, 2007 and 2006. The results for the three months ended March 31, 2007 are not necessarily indicative of the results that may be expected for the entire fiscal year.
Basis of Consolidation:
The consolidated financial statements include the accounts of Bionovo, Inc. and its wholly owned subsidiary Bionovo Biopharmaceuticals Inc. All significant intercompany balances and transactions have been eliminated.
Formation of the Company:
Bionovo, Inc. (formerly Lighten Up Enterprises International, Inc.) was incorporated in Nevada on January 29, 1998, and subsequently reincorporated in the State of Delaware on June 29, 2005. On April 6, 2005, Bionovo, Inc. (then known as Lighten Up Enterprises International, Inc.) acquired all the outstanding shares of Bionovo Biopharmaceuticals, Inc. (then known as Bionovo, Inc.) ("BIOPHARMA"), in exchange for 37,842,448 restricted shares of its common stock in a reverse triangular merger (the "Merger"). The acquisition has been accounted for as a reverse merger (recapitalization) with BIOPHARMA deemed to be the accounting acquirer. Accordingly, the historical financial information presented herein are those of BIOPHARMA, as adjusted to give effect to any difference in the par value of the issuer's and the accounting acquirer's stock with an offset to capital in excess of par value, and those of BIOPHARMA (the legal acquirer) since the Merger. The retained earnings of the accounting acquirer have been carried forward after the acquisition and BIOPHARMA's basis of its assets and liabilities were carried over in the recapitalization. Operations prior to the Merger are those of the accounting acquirer.
Development Stage Company:
The Company has not generated any significant revenue since inception. The accompanying financial statements have, therefore, been prepared using the accounting formats prescribed by SFAS No. 7 for a development stage enterprise (DSE). Although the Company has recognized some nominal amount of revenue, the Company still believes it is devoting substantial efforts on developing the business and, therefore, still qualifies as a DSE.
The Company is a development stage entity and is primarily engaged in the development of pharmaceuticals (integration of scientific discoveries with natural substances used in traditional East Asian medicine) to treat cancer and women's health. The initial focus of the Company's research and development efforts will be the generation of products for the treatment of breast, ovarian and pancreatic cancers and to alleviate the symptoms of menopause. The production and marketing of the Company's products and its ongoing research and development activities are and will continue to be subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any drug developed by the Company must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process implemented by the Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act. The Company has limited experience in conducting and managing the preclinical and clinical testing necessary to obtain regulatory approval. There can be no assurance that the Company will not encounter problems in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.
The Company's success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company.
SIGNIFICANT ACCOUNTING POLICIES
There have been no significant changes in Bionovo's significant accounting policies during the three months ended March 31, 2007 as compared to what was previously disclosed in Bionovo's Annual Report on 10-KSB for the year ended December 31, 2006.
Use of Estimates:
The preparation of consolidated financial statements, in conformity with accounting principles generally accepted in the United States of America, requires management to make estimates and assumptions that affect the amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.
Management makes estimates that affect, deferred income tax assets, estimated useful lives of property and equipment, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the year in which such adjustments are determined.
CONCENTRATION OF CREDIT RISK
Financial instruments potentially subjecting Bionovo to concentrations of credit risk consist primarily of cash, cash equivalents and marketable debt securities. Bionovo generally invests excess cash in low risk, liquid instruments.
Cash Equivalents:
The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents. As of March 31, 2007, the Company maintains its cash and cash equivalents with a major investment firm and a major bank.
Cash Concentration:
The Company maintains its cash in bank accounts, which at times may exceed federally insured limits. The Company has not experienced any losses on such accounts.
INCOME TAXES
Bionovo records a tax provision for the anticipated tax consequences of the reported results of operations. In accordance with Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes", the provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for the operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax assets are expected to be realized or settled. Bionovo records a valuation allowance to reduce deferred tax assets to the amount that is believed more likely than not to be realized. Management believes that sufficient uncertainty exists regarding the future realization of deferred tax assets and, accordingly, a full valuation allowance has been provided against net deferred tax assets. Tax expense has taken into account any change in the valuation allowance for deferred tax assets where the realization of various deferred tax assets is subject to uncertainty.
STOCK-BASED COMPENSATION
Prior to the adoption of Statement of Financial Accounting Standards No. 123 (revised 2004), "Share-Based Payment," ("SFAS 123(R)"), Bionovo accounted for stock-based awards to employees and directors using the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25"). Under the intrinsic value method that was used to account for stock-based awards prior to January 1, 2006, which had been allowed under the original provisions of Statement 123, no stock compensation expense had been recognized in Bionovo statement of operations as the exercise price of Bionovo stock options granted to employees and directors equaled the fair market value of the underlying stock at the date of grant. On January 1, 2006, Bionovo adopted SFAS 123(R) which requires the measurement and recognition of compensation expense for all share-based awards made to employees and directors, including employee stock options and employee stock purchases, based on estimated fair values. SFAS 123(R) supersedes Bionovo's previous accounting for share-based awards under APB 25 for periods beginning in 2006. In March 2005, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 107 ("SAB 107") relating to SFAS 123(R). Bionovo has applied the provisions of SAB 107 in its adoption of SFAS 123(R). Bionovo adopted SFAS 123(R) using the modified prospective transition method, which requires the application of the accounting standard as of the beginning of Bionovo's current year. Bionovo's financial statements as of and for the three months ended March 31, 2007 reflect the impact of SFAS 123(R). In accordance with the modified prospective transition method, Bionovo's financial statements for prior periods have not been restated to reflect, and do not include, the impact of SFAS 123(R).
Stock compensation expense recognized during the periods are based on the value of share-based awards that are expected to vest during the period. Stock compensation expense recognized in Bionovo's statement of operations for 2007 includes compensation expense related to share-based awards granted prior to January 1, 2006 that vested during the current period based on the grant date fair value estimated in accordance with the pro forma provisions of SFAS 123. Stock compensation expense during the current period also includes compensation expense for the share-based awards granted subsequent to January 1, 2006 based on the grant date fair value estimated in accordance with the provisions of SFAS123(R). As stock compensation expense recognized in the statement of operations is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS 123(R) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. In the Bionovo's pro forma information required under SFAS 123 for the periods prior to 2006, forfeitures were estimated and factored into the expected term of the options.
Bionovo's determination of estimated fair value of share-based awards utilizes the Black-Scholes option-pricing model. The Black-Scholes model is affected by Bionovo's stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to, Bionovo's expected stock price volatility over the term of the awards, and actual and projected employee stock option exercise behaviors.
NET LOSS PER SHARE
Basic net income (loss) per share is computed using the weighted average number of outstanding shares of common stock and diluted net income (loss) per share is computed using the weighted average number of outstanding shares of common stock and dilutive potential common shares during the period. Potential common shares that are anti-dilutive are excluded from the computation of diluted net income (loss) per share.
Statement of Financial Accounting Standards No. 128, "Earnings per Share," requires that employee equity share options, nonvested shares and similar equity instruments granted by Bionovo be treated as potential common shares outstanding in computing diluted earnings per share. Diluted shares outstanding include the dilutive effect of in-the-money options which is calculated based on the average share price for each fiscal period using the treasury stock method. Under the treasury stock method, the amount the employee must pay for exercising stock options, the amount of compensation cost for future service that Bionovo has not yet recognized, and the amount of benefits that would be recorded in additional paid-in capital when the award becomes deductible are assumed to be used to repurchase shares.
The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, are as follows:
| | Period ended March 31 | |
| | 2007 | | 2006 | |
Options to purchase common stock | | | 3,395,254 | | | 2,700,254 | |
Options to purchase common stock - Outside plan | | | 103,212 | | | 103,212 | |
Warrants to purchase common stock | | | 6,194,309 | | | 9,919,416 | |
| | | | | | | |
Potential equivalent shares excluded | | | 9,692,775 | | | 12,722,882 | |
Intangible assets - Patent Costs:
Intangible assets consist of patent licensing costs incurred to date. The Company is amortizing the patent cost incurred to date, over a 15 year period. If the patents are not awarded, the costs related to those patents will be expensed in the period that determination is made. The Company has net carrying amount of $59,687 in patent licensing costs as of March 31, 2007. Amortization expense charged to operations for the three months ended March 31, 2007 and 2006 was $1,097 and $853, respectively.
Comprehensive Loss:
Comprehensive loss consists of net loss and other gains and losses affecting shareholders' equity that, under generally accepted accounting principles, are excluded from net loss in accordance with Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income." The Company, however, does not have any components of other comprehensive loss as defined by SFAS No. 130 and therefore, for the three months ended March 31, 2007 and 2006, comprehensive loss is equivalent to the Company's reported net loss. Accordingly, a separate statement of comprehensive loss is not presented.
RECENT ACCOUNTING PRONOUNCEMENTS:
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, “Fair Value Measurement”, (FAS 157). This Standard defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair value measurements. FAS 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years. We have not determined the effect that the adoption of FAS 157 will have on our consolidated results of operations, financial condition or cash flows.
In September 2006, the FASB issued SFAS No. 158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans, an amendment of FASB Statements No. 87, 88, 106, and 132(R) (SFAS 158). Under SFAS 158, companies must: a) recognize a net liability or asset to report the funded status of their plans on their statement of financial position, b) measure a plan’s assets and its obligations that determine its funded status as of the end of the employer’s fiscal year, and c) recognize changes in the funded status of a defined benefit postretirement plan in the year in which the changes occur in comprehensive income. The Company adopted the measurement date provisions of SFAS 158 effective October 1, 2006. The Company will adopt the recognition provisions of SFAS 158 as of the end of fiscal year 2007 as required by SFAS 158. See Note 11 for further information regarding the Company’s adoption of SFAS 158.
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 159, The Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159 permits entities to choose to measure many financial instruments and certain other items at fair value that are not currently required to be measured at fair value. SFAS 159 also establishes presentation and disclosure requirements designed to facilitate comparisons between entities that choose different measurement attributes for similar types of assets and liabilities. SFAS 159 is effective for the Company’s year ending September 30, 2009. The Company is currently evaluating the impact of SFAS 159 on the Company’s financial statements.
In June 2006, the FASB issued Interpretation No.48, “Accounting for Uncertainty in Income Taxes — An Interpretation of FASB Statement No. 109”, (FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes”. FIN 48 also prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return that results in a tax benefit. Additionally, FIN 48 provides guidance on de-recognition, statement of operations classification of interest and penalties, accounting in interim periods, disclosure, and transition. This interpretation is effective for fiscal years beginning after December 15, 2006. The Company has adopted FIN 48 as of January 1, 2007, as required. The Company has determined that there is no impact in adopting FIN 48.
In December 2006, the FASB issued FASB Staff Position EITF 00-19-2, Accounting for Registration Payment Arrangements (“FSP EITF 00-19-2”), which provides guidance on the accounting for registration payment arrangements. FSP EITF 00-19-2 specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with FASB Statement No. 5, Accounting for Contingencies. A registration payment arrangement is defined in FSP EITF 00-19-2 as an arrangement with both of the following characteristics: (1) the arrangement specifies that the issuer will endeavor (a) to file a registration statement for the resale of specified financial instruments and/or for the resale of equity shares that are issuable upon exercise or conversion of specified financial instruments and for that registration statement to be declared effective by the Securities and Exchange Commission within a specified grace period, and/or (b) to maintain the effectiveness of the registration statement for a specified period of time (or in perpetuity); and (2) the arrangement requires the issuer to transfer consideration to the counterparty if the registration statement for the resale of the financial instrument or instruments subject to the arrangement is not declared effective or if effectiveness of the registration statement is not maintained. FSP EITF 00-19-2 is effective for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified subsequent to December 21, 2006. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP EITF 00-19-2, this guidance is effective for financial statements issued for fiscal years beginning after December 15, 2006, and interim periods within those fiscal years. The adoption of FSP EITF 00-19-2 on January 1, 2007 did not have a material impact on the Company’s financial position or results of operations.
.
NOTE 2. LIQUIDITY:
The Company has sustained recurring losses and negative cash flows from operations. Historically, the Company's growth has been funded through a combination of private equity, debt, and lease financing. As of March 31, 2007, the Company had approximately $16,915,000 of unrestricted cash and $386,617 in short-term securities. During the three months ended March 31, 2007, the Company obtained additional financing through a private placement of common shares and the exercise of warrants. The Company believes that, as a result of this, it currently has sufficient cash and financing commitments to meet its funding requirements over the next year. However, the Company has experienced and continues to experience negative operating margins and negative cash flows from operations, as well as an ongoing requirement for substantial additional capital investment.
For the three month period ended March 31, 2007, revenues of $3,750 were from a license agreement. The Company has no significant operating history and, from February 1, 2002, (inception) to March 31, 2007, has generated a net loss of $13,193,975. The accompanying financial statements for the three month period ended March 31, 2007, have been prepared assuming the Company will continue as a going concern. During 2007, management intends to seek additional debt and/or equity financing to fund future operations and to provide additional working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet the Company's needs.
The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.
NOTE 3. SHARE-BASED COMPENSATION
The Company adopted SFAS 123R on January 1, 2006 under the modified prospective method; as such, prior periods do not include share-based compensation expense related to SFAS 123R. The modified prospective method requires the application of SFAS 123R to new awards and to awards modified, repurchased, or cancelled after the effective date. Additionally, compensation cost for the portion of outstanding awards for which service has not been rendered (such as unvested options) that are outstanding as of the date of adoption are recognized as the remaining services are rendered. The Company recognizes the fair value of stock-based compensation awards in cost of processing and services expense and selling, general and administrative expense in the condensed consolidated statement of income on a straight line basis over the vesting period.
The Company's stock-based compensation primarily consists of the following:
Stock Options: The Company generally grants stock options to employees and directors at exercise prices equal to the fair market value of the Company's stock at the dates of grant. Stock options are typically granted throughout the year, generally vest three years thereafter and expire 10 years from the date of the award. The Company recognizes compensation expense for the fair value of the stock options over the requisite service period for each separate vesting portion of the stock option award.
Restricted Stock: The Company awards shares of stock to employees and directors and consultants that are restricted. During the period of restriction, the holder of restricted stock has voting rights and is entitled to receive all distributions including dividends paid with respect to the stock. The Company recognizes stock compensation expense relating to the issuance of restricted stock based on the market price on the date of award over the period during which the restrictions expire, which is generally one year from the date of grant, on a straight-line basis. All restricted stock are approved by the Company's Board of Directors.
NOTE 3. SHARE-BASED COMPENSATION (CONTINUED):
General Option Information
The following is a summary of changes to outstanding stock options during the three months ended March 31, 2007:
| | | | Weighted | | Weighted Average | | | |
| | Number of | | Average | | Remaining | | Aggregate | |
| | Share | | Exercise | | Contractual | | Intrinsic | |
| | Options | | Price | | Term | | Value | |
| | | | | | | | | |
Outstanding at December 31, 2006 | | | 2,952,254 | | $ | 0.74 | | | 8.08 | | $ | 4,398,858 | |
Granted | | | 473,000 | | $ | 1.65 | | | 9.75 | | | 704,770 | |
Exercised | | | 30,000 | | $ | 0.29 | | | - | | | - | |
Forfeited or expired | | | - | | | - | | | | | $ | - | |
| | | | | | | | | | | | | |
Outstanding at March 31, 2007 | | | 3,395,254 | | $ | 0.87 | | | 8.18 | | $ | 19,590,616 | |
| | | | | | | | | | | | | |
Vested and expected to vest | | | | | | | | | | | | | |
at March 31, 2007 | | | 3,395,254 | | $ | 0.87 | | | 8.18 | | $ | 19,590,616 | |
| | | | | | | | | | | | | |
Options exercisable at March 31, 2007 | | | 2,091,441 | | $ | 0.61 | | | 6.15 | | $ | 12,067,612 | |
At March 31, 2007, there were 3,101,534 shares available for grant under the employee stock option plan.
The table below presents information related to stock option activity for the three month period ended March 31, 2007 and 2006 (in thousands):
| | Three months ended March 31 | |
| | 2007 | | 2006 | |
| | | | | |
Total intrinsic value of stock options exercised | | $ | 173,100 | | $ | — | |
Cash received from stock option exercises | | $ | 8,751 | | $ | — | |
Gross income tax benefit from the exercise of stock options | | $ | 0 | | $ | — | |
The aggregate intrinsic value of $19,590,616 as of March 31, 2007 is based on Bionovo's closing stock price of $5.77 on March 30, 2007, and represents the total pretax intrinsic value, which would have been received by the option holders had all option holders exercised their options as of that date. The total intrinsic value of options exercised during the three months ended March 31, 2007 was $173,100, as 30,000 options were exercised. The total number of in-the-money options exercisable as of March 31, 2007 was $12,067,612.
As of March 31, 2007, the total remaining unrecognized compensation cost related to non-vested stock options and restricted stock awards, net of forfeitures, was approximately $876,316. That cost is expected to be recognized over a weighted-average period of one year.
NOTE 3. SHARE-BASED COMPENSATION (CONTINUED):
Valuation and Expense Information under SFAS 123(R)
The following table summarizes stock compensation expense related to employee stock options and employee stock based compensation under SFAS 123(R) for the three months ended March 31, 2007 and 206 which was incurred as follows:
| | Three months ended | | Three months ended | |
| | March 31 | | March 31 | |
| | 2007 | | 2006 | |
Research and development | | $ | 96,888 | | | 92,909 | |
General and administrative | | | 36,425 | | | 55,110 | |
Stock compensation expense | | | 133,313 | | | 148,019 | |
The weighted-average estimated fair value of employee stock options granted during the three months ended March 31, 2007 and 2006 was $1.65 and $0 per share, respectively, using the Black-Scholes option pricing model, with the following weighted-average assumptions for grants:
The fair values of all stock options granted during the three months ended March 31, 2007 and 2006 were estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:
| | 2006 | | 2005 | |
Expected life (in years) | | | 5 | | | 5 | |
Average risk-free interest rate | | | 6.0 | % | | 4.0 | % |
Expected volatility | | | 81 | % | | 90 | % |
Expected dividend yield | | | 0 | % | | 0 | % |
The expected term of employee stock options represents the period the stock options are expected to remain outstanding from date of grant and is based on the guidance of SAB No. 107, accordingly the period is the average of the vesting period and the term of the option. The risk-free interest rate is based on the U.S. treasury yield curve in effect as of the grant date. Expected volatility was determined using an average volatility of a peer group and the volatility of the Company's own stock. Management determined that utilizing only the volatility measured by the Company was not meaningful pursuant to limited stock trading activity and history.
The weighted-average estimated fair value of stock options granted (based on grant date) during the three months ended March 31, 2007 and 2006 was $1.65 and $0 per share, respectively. For the three months ended March 31, 2007 the Company granted stock options to employees and consultants totaling 473,000 shares.
A summary of warrants for the three months ended March 31, 2007 is as follows:
| | | | Weighted | | | |
| | | | Average | | | |
| | Number of | | Exercise | | Aggregate | |
| | Shares | | Price | | Price | |
Balance at December 31, 2005 | | | 9,919,524 | | $ | 0.5959 | | $ | 5,911,345 | |
| | | | | | | | | | |
Warrants granted | | | - | | $ | - | | $ | - | |
Warrants exercised | | | 5,024,776 | | $ | 0.66 | | $ | 2,305,058 | |
Warrants cancelled | | | 62,500 | | $ | 0.75 | | | - | |
Warrants expired | | | - | | $ | - | | | - | |
| | | | | | | | | | |
Balance at December 31, 2006 | | | 4,832,248 | | $ | 0.74 | | $ | 3,559,357 | |
| | | | | | | | | | |
Warrants granted | | | 4,418,820 | | $ | 2.13 | | $ | 9,389,993 | |
Warrants exercised | | | 3,056,759 | | $ | 0.87 | | $ | 2,662,717 | |
Warrants cancelled | | | - | | | - | | | - | |
Warrants expired | | | - | | | - | | | - | |
| | | | | | | | | | |
Balance at March 31, 2007 | | | 6,194,309 | | $ | 1.66 | | $ | 10,286,632 | |
During the three months ended March 31, 2007, no restricted stock awards were granted.
NOTE 4. LICENSE AGREEMENT:
In 2003, the Company entered into a licensing and technology transfer agreement with a Taiwanese biotech corporation wherein the rights to certain technology restricted to a certain geographic region were transferred to the Taiwanese corporation for a period of 10 years, which will automatically renew for periods of 3 years, unless a 12-month written notice is given by either party to the agreement. The license agreement was for a one-time fee of $150,000 and future royalties based on a percentage of future sales. Additional fees may be earned by the Company in the future for additional clinical work.
NOTE 5. SIMPLIFIED EMPLOYEE PENSION PLAN:
The Company has a Simplified Employee Pension Plan (the "Plan"), which covers two officers of the Company. The Plan was established in 2004 and is administered by an outside administrator. In 2006, the Company created a 401(k) Plan ("Plan") to provide retirement and incidental benefits for its employees. Employees may contribute from 1% to 15% of their annual compensation to the Plan, limited to a maximum annual amount as set periodically by the Internal Revenue Service. Effective January 1, 2006, the Company will no longer contribute to the Simplified Employee Pension Plan.
NOTE 6. EQUITY:
In April and May 2005 the Company completed private placements selling 20,461,000 shares of common stock to accredited investors at a price of $0.50 per share. The Company received gross proceeds of $10,230,500. As part of the closing of the private placements the Company issued five-year warrants to purchase a total of 2,557,625 shares of common stock at an exercise price of $0.75 per share and 2,557,625 shares of common stock at an exercise price of $1.00 per share. The warrants are exercisable in whole or part until May 5, 2010.
In connection with the closing of the private placements, the Company issued five-year warrants placement agent warrants to Duncan Capital, LLC as partial compensation for acting as placement agent in the transaction. These placement agent warrants are exercisable in whole or in part, at an exercise price of $0.50 per share, before May 5, 2010 for up to 2,136,100 shares of common stock.
In connection with the closing of the private placements, on April 6, 2005, the convertible notes resulting from the September 30, 2004 bridge financing of $500,000 were converted into common stock at $0.36 per share or repaid. The aggregate principal amount of the convertible secured notes of $450,000 was converted into a total of 1,251,448 shares of common stock. The remaining $50,000 principal and applicable interest was repaid from the proceeds of the private placements described above.
In connection with the closing of the Merger on April 6, 2005, the Company issued five-year warrants to Duncan Capital, LLC as partial compensation for its advisory services relating to the merger. These reverse merger warrants are exercisable in whole or in part, at an exercise price of $0.01 per share, before April 6, 2010 for up to 1,979,630 shares of common stock. On March 15, 2006, Duncan Capital, LLC exercised the warrant for an aggregate amount of $19,796.30.
On March 17, 2006, the Company issued a call notice to all holders of the common stock purchase warrants ($0.75 exercise price) issued in the April 6, 2005 and May 5, 2005 private placements. Section 3(c) of the warrants permit the Company to call for cancellation all or a part of the unexercised portion of the warrants upon the occurrence of certain events. The events required are (i) an effective registration statement registering the resale of the shares of common stock underlying the warrants, (ii) the closing bid price of the common stock for each of the ten (10) consecutive trading days equals or exceeds $0.9375 and (iii) the average daily trading volume of the common stock for such ten (10) days period equals or exceeds 100,000 shares. As of March 16, 2006, each of the foregoing events had occurred. The holders of these warrants had until April 10, 2006 to exercise all or a portion of the unexercised portion of such warrants, and any such warrants not so exercised will automatically be canceled on that date. As of March 31, 2006, warrant holders exercised warrants representing 1,085,625 shares, for which the Company received $844,687.50. As of April 10, 2006, warrant holders exercised warrants to purchase an additional 1,585,437 shares at exercise prices of $0.75 and $1.00, for which the Company received $1,202,594. Pursuant to warrants not being exercised by April 10, 2006, warrants representing 62,500 shares exercisable at $0.75 per share, were cancelled. Of the 2,671,062 exercised, warrants exercisable at $0.75 per share represented 2,495,125 shares, while warrants exercisable at $1.00 per share represented 175,937 shares. In June 2006, certain warrant holders exercised common stock purchase warrants representing 140,234 shares, for which the Company received $55,429. In July 2006, certain warrant holder's exercised common stock purchase warrants representing 87,500 shares, for which the Company received $87,500.
On January 19, 2007, the Company completed a private placement to accredited investors of approximately 10,521,000 shares of our common stock, at a purchase price of $1.50 per share, which is equal to a 4.5% discount from the average closing market price of its common stock over the twenty day period ending on the pricing date of January 12, 2007, for gross proceeds of $15,781,500. As part of the private placement, the investors were issued five-year warrants to purchase up to an aggregate of 3,682,350 shares of our common stock, at an initial exercise price of $2.25. The warrants are callable by the Company when the trailing 10-day average of the closing market share price of our common stock equals or exceeds $2.75. Holders of called warrants will have 60 days to exercise their warrants after the call notice.
The net proceeds from the private placement, following the payment of offering-related expenses, will be used by us largely to fund the Phase I and II clinical trials for our products and for working capital and other general corporate purposes. At the closing of the private placement, we paid Cambria Capital, LLC and Blaylock Capital, LLC, the placement agents for the private placement, cash compensation of an aggregate of $1,262,520 and five-year warrants to purchase up to an aggregate of 736,470 shares of our common stock, at an exercise price of $1.50.
The Company has agreed, pursuant to the terms of the registration rights agreements with the investors, to (i) use our best efforts to file a shelf registration statement with respect to the resale of the shares of our common stock sold to the investors and shares of our common stock issuable upon exercise of the warrants with the SEC within 45 days after the closing date; (ii) use our best efforts to have the shelf registration statement declared effective by the SEC within 90 days after the filing deadline (or 120 days in the event of a full review of the shelf registration statement by the SEC), (iii) use our commercially reasonable efforts to keep the shelf registration statement effective until all registrable securities (a) have been sold pursuant to the registration statement or an exemption from the registration requirements of the Securities Act of 1933 or (b) may be sold under Rule 144(k) under the Securities Act. The Company filed a registration statement with the SEC on Form SB-2 on February 12, 2007.
The private placement was made solely to “accredited investors,” as that term is defined in Regulation D under the Securities Act of 1933. Each investor in the private placement submitted a subscription agreement and investor questionnaire in which the investor made certain representations and warranties as to their status as an “accredited investor.” The shares of common stock and warrants to purchase common stock were not registered under the Securities Act of 1933, or the securities laws of any state, and were offered and sold in reliance on the exemption from registration afforded by Section 4(2) and Regulation D (Rule 506) under the Securities Act of 1933 and corresponding provisions of state securities laws, which exempts transactions by an issuer not involving any public offering. No form of general solicitation or general advertising was used to offer or sell the above securities, and each certificate representing shares of common stock and each warrant sold in the private placement contains a legend to the effect that the securities represented by such instruments are restricted and may not be resold without registration under the Securities Act of 1933 or an exemption from that Act.
On March 9, 2007, the Company issued a call notice to all holders of the common stock purchase warrants ($1.00 exercise price) issued in the April 6, 2005 and May 5, 2005 private placements. Section 3(c) of the warrants permit the Company to call for cancellation all or a part of the unexercised portion of the warrants upon the occurrence of certain events. The events required are (i) an effective registration statement registering the resale of the shares of common stock underlying the warrants, (ii) the closing bid price of the common stock for each of the ten (10) consecutive trading days equals or exceeds $1.25 and (iii) the average daily trading volume of the common stock for such ten (10) days period equals or exceeds 100,000 shares. As of March 8, 2007, each of the foregoing events had occurred. The holders of these warrants had until March 31, 2007 to exercise all or a portion of the unexercised portion of such warrants, and any such warrants not so exercised will automatically be canceled on that date. As of March 31, 2007, warrant holders exercised warrants representing 2,242,625, shares, for which the Company received $2,242,625. As of March 31, 2007, all of the $1.00 warrants from the April 6, 2005 and May 5, 2005 private placements have been exercised pursuant to this call notice, or exercised prior to the call notice.
During the first quarter ended March 31, 2007, certain warrant holder's exercised common stock purchase warrants representing 814,134 shares, for which the Company received $420,092.
Option Grants:
On January 3, 2007, the Board of Directors issued options for 473,000 shares of common stock to employees and directors with an exercise price of $1.65 (fair market value on January 3, 2007). This grant was approved by the Board of Directors on November 2, 2006.
On April 2, 2007, the Board of Directors issued options for 229,500 shares of common stock to employees and directors with an exercise price of $5.75 (fair market value on April 2, 2007) of which four directors received option grants for 67,500 shares of common stock each. This grant was approved by the Board of Directors on March 8, 2007.
NOTE 7. COMMITMENTS AND CONTINGENCIES:
Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company's management and its legal counsel assess such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company's legal counsel evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought therein.
If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company's financial statements. If the assessment indicates that a potentially material loss contingency is not probable, but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material, would be disclosed.
Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the nature of the guarantee would be disclosed.
Merrill Lynch Bank USA has issued a Letter of Credit to the Company, in the approximate aggregate amount of $381,000, to secure the Company's lease of laboratory equipment. The Company collateralized the Letter of Credit with a cash deposit in the approximate amount of $381,000.
The Company has received a loan commitment from General Electric which allowed the Company to purchase $1,002,000 of laboratory equipment from Agilent Technologies, Inc. (“Agilent”). The loan is for three years, with a 25% down payment. Once the Company has received all of the Agilent equipment, and the equipment is installed an operating as designed, the Company will execute the loan documents.
NOTE 8. SUBSEQUENT EVENTS:
None
This Discussion and Analysis should be read in conjunction with our audited financial statements and accompanying footnotes included in our Annual Report on Form 10-KSB for the year ended December 31, 2006.
This section contains forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, including those identified in our most recently filed Annual Report Form 10-KSB and our registration statement on Form SB-2 and those described elsewhere is this Report under the heading "Risk Factors" that may cause actual results to differ materially from those discussed in, or implied by, such forward-looking statements.
Forward-looking statements within this Form 10-QSB are identified by words such as "believes," "anticipates," "expects," "intends," "may," and other similar expressions. However, these words are not the only means of identifying such statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Actual results could differ materially from those anticipated in, or implied by, forward-looking statements as a result of various factors, including the risks outlined elsewhere in this Report.
We completed a reverse merger transaction on April 6, 2005 with Lighten Up Enterprises International, Inc., or Lighten Up, a Nevada corporation initially formed on January 29, 1998. Until the merger, Lighten Up engaged in the development, publishing, marketing and sale of a cook book of recipes, which we discontinued following the merger and succeeded to the business of Bionovo Biopharmaceuticals, Inc. The directors and management of Bionovo Biopharmaceuticals thereupon became the directors and management of Lighten Up. Bionovo Biopharmaceuticals has been considered the acquirer in this transaction, frequently referred to as a "reverse merger" of a shell company, and accounted for as a recapitalization. Bionovo Biopharmaceuticals' financial statements are the historical financial statements of the post-merger entity, Bionovo, Inc. Accordingly, no goodwill or other adjustment in basis of assets is recorded, the shares of the shell, the legal surviving entity, are treated as issued as of the date of the transaction, and the shares held by the controlling shareholders after the transaction, are treated as outstanding for the entirety of the reporting periods. On June 29, 2005, we changed our corporate name from Lighten Up Enterprises International, Inc. to Bionovo, Inc. and changed our state of incorporation from Nevada to Delaware. Bionovo Biopharmaceuticals currently remains a wholly-owned subsidiary of Bionovo, Inc.
Bionovo Biopharmaceuticals, Inc. was incorporated and began operations in the State of California in February 2002 and subsequently reincorporated into the State of Delaware in March 2004. Until June 28, 2005, the name of Bionovo Biopharmaceuticals was Bionovo, Inc. It changed its name to Bionovo Biopharmaceuticals, Inc. in order to facilitate our corporate name change from Lighten Up Enterprises International, Inc. to Bionovo, Inc.
Since our current and future business will be that of Bionovo Biopharmaceuticals only, the historical information in this quarterly report is that of Bionovo Biopharmaceuticals as if Bionovo Biopharmaceuticals had been the registrant for all the periods presented in this quarterly report. The historical information in the Management's Discussion and Analysis or Plan of Operation and the audited consolidated financial statements presented in this quarterly report include those of Bionovo Biopharmaceuticals prior to the reverse merger, as these provide the most relevant information for us on a continuing basis.
Overview
We are a drug discovery and development company focusing on cancer and women's health. Our focus is on new drugs from botanical sources, as well as new chemical entity (or NCE) drug development. Our goal is to achieve a position of sustainable leadership in the biopharmaceutical industry.
The first steps in attaining this goal are to receive FDA approval for our menopausal drug (MF101) which is intended to alleviate the symptoms of menopause, including hot flashes and night sweats, and our anti-cancer drug (BZL101) intended to treat breast, ovarian, and pancreatic cancers as well as other solid tumors. Both of these product candidates have advanced to clinical trials and are under current development. Our current drug pipeline also includes two drugs that have not yet entered human clinical trials, but for which IND applications are being prepared.
The biopharmaceutical industry is attempting to develop more specific and targeted therapies in the attempt to treat conditions and diseases. This effort has led to various trends in the industry that received large infrastructure as well as research and development capital investments in the past 15 years. These trends include rational drug design, combinatorial chemistry, structural drug design, antisense drugs, protein drugs, monoclonal antibodies among others. Although some successes can be named, most trends failed to produce significant numbers of drugs and more so, drugs that are very safe and very effective.
In recent years, many pharmaceutical companies returned to search for small molecule drugs, that to date, account for the largest number of ethical drugs in human use. This trend resulted in renewed interest by some companies and many universities in natural products, and the discovery of new compounds and new drug classes from natural products.
Another trend that has surfaced in the practice of medicine, rather than in the pharmaceutical industry itself, is the use of polytherapy in the treatment of diseases and disorders. Rarely are chronic medical conditions treated with a single drug. The attempt to develop drugs with multiple targets is not as common.
Since our inception, we have funded our operations primarily through proceeds of $500,000 from the private placement of convertible debt in September 2004, aggregate proceeds of $10.2 million from private placements of common stock and warrants in April and May 2005, and aggregate proceeds of $15.7 million from a private placement of common stock and warrants in January 2007.
Most of our efforts to date have been to discover and develop our pipeline of product candidates, to develop our product platform and to seek or obtain patents for our intellectual property. Research and development expenditures through March 31, 2007 were related primarily to the development of our lead product candidates MF101 and BZL101, and to filing patent applications on our inventions.
We have generated insignificant revenues to date, and therefore can draw no conclusions regarding the seasonality of our business.
Our financial statements included elsewhere in this quarterly report have been prepared assuming that we will continue as a going concern. We are currently a development-stage enterprise and, as such, our continued existence is dependent upon debt and equity financing from outside investors. We have yet to generate a positive internal cash flow and until meaningful sales of our products begin, we are totally dependent upon debt and equity funding. So far we have been able to raise the capital necessary to reach this stage of product development and have been able to obtain funding for operating requirements, but there can be no assurance that we will be able to continue to do so. Moreover, there is no assurance that if and when FDA premarket approval is obtained for one or more of our drug candidates, that the drugs will achieve market acceptance or that we will achieve a profitable level of operations. Our financial statements included elsewhere in this quarterly report do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Research and Development Activities
Included in research and development expenses are the following activities and related expenses: basic research and preclinical expenses, clinical trials and drug development expenses. During the three months ended March 31, 2007, we incurred research and development expenses of $2,788,668. During the fiscal years ended December 31, 2006 and December 31, 2005, we incurred research and development expenses of $4,021,149 and $1,535,534, respectively. We further expect that research and development expenses will increase over the coming months as we continue development of our drugs.
Basic research and preclinical expense includes discovery research, chemical development, pharmacology, product development, regulatory expenses relating to all applications for FDA Investigational New Drug licenses, and patent related legal costs related to our internal research programs.
Clinical trials and drug development expense includes external costs of manufacturing study medications and of conducting clinical trials, as well as internal costs for clinical development, regulatory compliance, and pharmaceutical development.
Most of our product development programs are at an early stage. Accordingly, the successful development of our product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. Product candidates that may appear promising at early stages of development may not reach the market for a number of reasons. Product candidates may be found ineffective or cause harmful side effects during clinical trials, may take longer to progress through clinical trials than anticipated, may fail to receive necessary regulatory approvals and may prove impracticable to manufacture in commercial quantities at a reasonable cost and with acceptable quality. The lengthy process of seeking FDA approvals requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining regulatory approvals could materially adversely affect our product development efforts. Because of these risks and uncertainties, we cannot predict when or whether we will successfully complete the development of our product candidates or the ultimate product development cost or whether we will obtain any approval required by the FDA on a timely basis, if at all.
Clinical Development Strategy and Ongoing Clinical Programs
Our research and development costs from 2002 to March 31, 2007 have principally related to our pre-clinical and clinical development of MF101, BZL101, and to a lesser degree AA102, and VG101.
During 2004, we completed a Phase I trial of MF101. In the trial, we observed no grade III or IV adverse events (as categorized by the National Institutes of Health, National Cancer Institute, Common Toxicity Criteria). Further, we observed that short term use of MF101 showed no adverse effect on hematology, liver and renal function or hormonal status. The most common adverse events observed in the trial were anticipated minor gastrointestinal disturbances. We entered into commitments with six clinical sites for a Phase II clinical trial evaluating MF101 for the treatment of vasomotor symptoms under the directorship of Dr. Deborah Grady at the University of California, San Francisco. The Phase II trial commenced in January of 2006 and recruitment for enrollment to the clinical trial closed on October 31, 2006.
During 2004, we also completed a Phase I clinical trial of BZL101 for metastatic breast cancer. We submitted our Phase I report to the FDA summarizing the results of the trial. The FDA has accepted our Phase I/II trial of BZL101 for metastatic breast cancer and. The first patient was enrolled to the BZL101 trial on April 18, 2007.
Based on preclinical testing, Bionovo is seeking FDA approval for a Phase I/II clinical trial of BZL101 for the treatment of pancreatic cancer. Subject to FDA approval, Bionovo expects to commence the Phase I/II trial of BZL101 for pancreatic cancer in the next 12 months.
AA102, is an anticancer agent and VG101, is an intra-vaginal suppository for the treatment of postmenopausal vulvar and vaginal atrophy (vaginal dryness). Assuming approval of the IND submissions for these drugs, the Phase I/II clinical trial of AA102 is expected to commence in January 2008, and the Phase I trial of VG101 is expected to commence in January 2008.
The decision to advance each of our four lead product candidates through clinical testing will be based on the results of completed preclinical and clinical studies. A summary of the anticipated dates and estimated expenses associated with the development of these product candidates is shown below. We do not anticipate any revenue from any of our lead product candidates until 2010 at the earliest.
| | Phase I | | Phase II | | Phase III |
Drug | | Cost | | # of Patients | | Timing | | Cost | | # of Patients | | Timing | | Cost | | # of Patients | | Timing |
MF101 | | 0 | | 0 | | Completed | | $5.5M | | 180 | | Q1 2006 to | | $40M | | 1,000 | | Q2 2008 to |
| | | | | | | | | | | | Q2 2007 | | | | | | Q4 2009 |
| | | | | | | | | | | | | | | | | | |
BZL101-Metastatic Breast Cancer | | 0 | | 0 | | Completed | | $5.5M | | 100 | | Q2 2007 to Q2 2009 | | $25M | | 480 | | Q4 2009 to Q3 2011 |
| | | | | | | | | | | | | | | | | | |
BZL101-Pancreatic cancer | | $2.0M | | 25 | | Q4 2007 to Q1 2009 | | Advancing BZL101 to Phase III trials for pancreatic cancer will be based on the results of the Phase I/II trial and receipt of necessary funding. |
| | | | | | | | | | | | | | | | | | |
AA102 | | $3.5M | | 60 | | Q1 2008 to Q1 2009 | | Advancing AA102 to Phase III trials will be based on the results of the Phase I/II trial and receipt of necessary funding. |
| | | | | | | | | | | | | | | | | | |
VG101 | | $1.5M | | 25 | | Q1 2008 to Q1 2009 | | Advancing VG101 to Phase II trials will be based on the results of the Phase I trial and receipt of necessary funding. |
Research and Development Cost Allocations
We have many research projects ongoing at any one time. We have the ability to utilize our financial and human resources across several research projects. Our internal resources, employees and infrastructure, are not directly tied to any individual research project and are typically deployed across multiple projects. Our clinical development programs are developing each of our product candidates in parallel for multiple disease indications, while our basic research activities are seeking to discover potential drug candidates for multiple new disease indications. We do not record or maintain information regarding the costs incurred for our research and development programs on a program specific basis. In addition, we believe that allocating costs on the basis of time incurred by our employees does not accurately reflect the actual costs of a project.
Prior to March 31, 2007, we did not specifically identify all external clinical trial and drug development expenses by program. By December 2007, we plan to report external clinical trial and drug development expenses by program.
Critical Accounting Policies and Estimates
An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact the financial statements. Management believes the following critical accounting policies reflect its more significant estimates and assumptions used in the preparation of the financial statements. We review the accounting policies used in our financial statements on a regular basis. In addition, management has reviewed these critical accounting policies and related disclosures with our audit committee.
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. On an ongoing basis, we evaluate these estimates, including those related to clinical trial accruals, income taxes (including the valuation allowance for deferred tax assets), restructuring costs and stock-based compensation. Estimates are based on historical experience, information received from third parties and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions.
Changes in 2006
On January 1, 2006, Bionovo adopted Statement of Financial Accounting Standards No. 123 (revised 2004), "Share-Based Payment," ("SFAS 123(R)") which requires the measurement and recognition of compensation expense for all share-based awards made to employees and directors, including employee stock options and employee stock purchases, based on estimated fair values. Prior to the adoption of SFAS 123(R), Bionovo accounted for stock-based awards to employees and directors using the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees." Under the intrinsic value method, which had been allowed under the original provisions of Statement 123, no stock compensation expense had been recognized in Bionovo's statement of operations as the exercise price of Bionovo's stock options granted to employees and directors equaled the fair market value of the underlying stock at the date of grant.
Revenue .
Revenue is generated from collaborative research and development arrangements, technology licenses, and government grants. To date, only revenue from technology licenses has been received.
Revenue is recognized when the four basic criteria of revenue recognition are met: (i) a contractual agreement exists; (ii) transfer of technology has been completed or services have been rendered; (iii) the fee is fixed or determinable, and (iv) collectibility is reasonably assured.
Technology license agreements are for a term of ten years and consist of nonrefundable upfront license fees and royalty payments. In accordance with Staff Accounting Bulletin 104, nonrefundable upfront license fees are recognized over the license term using the straight-line method of accounting when the technology is transferred or accessed, provided that the technology transferred or accessed is not dependent on the outcome of our continuing research and development efforts.
Stock-Based Compensation .
Stock-based compensation to outside consultants is recorded at fair market value in general and administrative expense. We do not record expense relating to stock options granted to employees with an exercise price greater than or equal to market price at the time of grant. Pro-forma net loss and loss per share is reported in accordance with the requirements of SFAS 123 and 148. This disclosure shows net loss and loss per share as if we had accounted for our employee stock options under the fair value method of those statements. Pro-forma information is calculated using the Black-Scholes pricing method on the date of grant. This option valuation model requires input of highly subjective assumptions. Because employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in our management's opinion, the existing model does not necessarily provide a reliable single measure of fair value of our employee stock options.
In order to determine the fair value of our stock for periods prior to the date of our reverse merger transaction, we estimated the fair value per share by reviewing values of other development stage biopharmaceutical organizations, comparing products in development, status of clinical trails, and capital received from government and private organizations. Once a total value was determined, we then factored the number of shares outstanding, or possibly outstanding, resulting in an estimated value per share. Once we completed our reverse merger transaction on April 6, 2005, the trading price of our common stock was used.
For periods prior to our reverse merger transaction, we chose not to obtain contemporaneous valuations of our stock by any unrelated valuation specialist after realizing the cost of services would be substantial and that the benefit derived would not be substantially different from our estimate as we had used a multi-tiered approach to estimate the value of our stock.
Commitments and Contingencies .
Commitments and Contingencies are disclosed in the footnotes of the financial statements according to generally accepted accounting principles. If a contingency becomes probable, and is estimatable by management, a liability is recorded per FAS 5.
We had no off-balance sheet arrangements to report for the three months ended March 31, 2007. We have not entered into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support.
Results of Operations
Comparison of Three Months Ended March 31, 2007 and March 31, 2006
Revenues .
Revenue of $3,750 for the three months ended March 31, 2007, was the same as compared to revenue of $3,750 for the three months ended March 31, 2006. Revenue for both periods is the result of the licensing and technology transfer agreement with a Taiwanese biotech corporation. We do not expect our revenues to have a material impact on our financial results during the remainder of 2007.
Research and Development.
Research and development expenses were $2,788,668 and $745,288 for the three months ended March 31, 2007 and 2006, respectively, an increase of $2,043,380 or 274%. The increase is directly related to advancing the development of our drug candidates. All costs currently incurred in the research and development of drugs for cancer and women's health were expensed as incurred.
Effective January 1, 2006, we adopted SFAS No. 123(R), which is discussed further below. SFAS No. 123(R) required that we recognize the fair value of equity awards granted to our employees as compensation expense in the income statement over the requisite service period. For the three months ended March 31, 2007, we recognized $96,888 in stock-based compensation expense as a result of the adoption of SFAS No. 123(R), which is included in research and development expenses.
General and Administrative.
General and administrative expenses, which include personnel costs for finance, administration, information systems, and general management, as well as facilities expenses, professional fees, legal expenses, and other administrative costs, were $602,775 and $340,456 for the three months ended March 31, 2007 and 2006, respectively, a increase of $262,319 or 77%. The increase for the current year was primarily due to an increase in facility rental and legal expenses, in addition to an increase in business activities related to supporting the development of our Company.
Effective January 1, 2006, we adopted SFAS No. 123(R), which is discussed further below. SFAS No. 123(R) required that we recognize the fair value of equity awards granted to our employees as compensation expense in the income statement over the requisite service period. For the three months ended March 31, 2007, we recognized $36,425 in stock-based compensation expense as a result of the adoption of SFAS No. 123(R), which is included in general and administrative expenses.
Sales and Marketing.
Sales and marketing expenses include public relations related to our drug development and clinical trials, participation in conventions and tradeshows, and website related expenses. Sales and marketing expenses were $92,146 and $92,562 for the three months ended March 31, 2007 and 2006, respectively, a decrease of $416 or 0%. The decrease relates to fewer industry tradeshows and conventions attended. We expect to have limited sales and marketing expenses for the foreseeable future.
Other Income (Expense).
Other income and expense includes interest income and interest expense. Interest income is primarily derived from short-term interest-bearing securities and money market accounts. Net interest income was $149,712 and $60,370 for the three months ended March 31, 2007 and 2006, respectively, an increase of $89,342 or 148%. The increase relates to an increase in the average balance of invested cash and short-term investments. Interest expense was $14,081 and $5,287 for the three months ended March 31, 2007 and 2006, respectively, an increase of $8,794 or 166%. For the three months ended March 31, 2007, interest expense is directly related to equipment lease agreements.
Stock compensation expense.
On January 1, 2006, we adopted Statement of Financial Accounting Standards No.123 (revised 2004), "Share-Based Payment," (SFAS 123(R)) which requires the measurement and recognition of compensation expense for all share-based awards made to our employees and directors including employee stock options and employee stock purchases based on estimated fair values.
Our computation of expected volatility is based on a combination of historical and estimated stock price volatility consistent with SFAS 123(R) and SAB 107. Prior to the first quarter of fiscal 2006, we had determined our expected stock price volatility in accordance with SFAS 123 for purposes of our pro forma information. The selection of our volatility approach was based upon our assessment that a mix of historical and expected volatility is more representative of future stock price trends than historical volatility.
The risk-free interest rate assumption is based upon U.S. Treasury bond rates appropriate for the term of our employee stock options. The dividend yield assumption is based on management's expectation of no dividend payouts in the near future.
The expected term of employee stock options represents the weighted-average period the stock options are expected to remain outstanding and is based on the average of the vesting term and the full term of the options.
If factors change and we employ different assumptions in the application of SFAS 123(R) in future periods, the compensation expense that we record under SFAS 123(R) may differ significantly from what we have recorded in the current period.
We are a development stage enterprise and none of our products have received FDA approval. Accordingly, we will have limited revenue for at least the next 18 months, except for the current licensing arrangement with a Taiwanese biotech company, and any others that we enter into. We expect to increase research and development expenses as we conduct FDA type clinical trials for our drug product candidates. Associated with these clinical trials, general and administrative support expenses will increase. Sales and marketing expenses will be minimal until our drug products clinical trials are completed, and approval from the FDA has been received.
Liquidity and Capital Resources
When evaluating our overall cash position for the purpose of assessing our liquidity, we consider our cash and cash equivalents, short-term and long-term investments in marketable debt securities and restricted cash.
At March 31, 2007 our cash and cash equivalents and short-term securities were equal to $16,914,374 and $386,617, respectively. Our principal cash requirements are for research and development, operating expenses, including equipment, supplies, employee costs, capital expenditures and funding of operations. Our primary source of cash during the three month period ended March 31, 2007 was from the capital received pursuant to the January 2007 private placement of our common stock, as described below.
Since inception, we have financed our operations principally through the sale of equity and debt securities, described chronologically below.
On September 30, 2004, Bionovo Biopharmaceuticals completed a bridge financing to accredited investors of $500,000 principal amount 6% convertible secured notes, and warrants to purchase 556,123 shares of Bionovo Biopharmaceuticals common stock at $0.539 per share. On April 6, 2005, immediately prior to the closing of our reverse merger transaction, $450,000 aggregate principal amount of the convertible secured notes was converted into a total of 1,251,448 shares of Bionovo Biopharmaceuticals common stock. The remaining $50,000 principal amount of the notes were repaid from the proceeds of the April 6, 2005 private placement described below. Upon the closing of our reverse merger transaction, the warrants issued in the bridge financing and the common stock issued upon conversion of the notes, were amended to become warrants to purchase common stock of our company and were exchanged for shares of our common stock, respectively.
On April 6, 2005, immediately prior to the closing of our reverse merger transaction, Bionovo Biopharmaceuticals completed a private placement of 80.955 Units to accredited investors at a price of $100,000 per Unit. Each Unit was comprised of 200,000 shares of Bionovo Biopharmaceuticals common stock and warrants to purchase 25,000 shares of Bionovo Biopharmaceuticals common stock for $0.75 per share and 25,000 shares of Bionovo Biopharmaceuticals common stock for $1.00 per share exercisable for a period of five years. Bionovo Biopharmaceuticals received gross proceeds of $8,095,500 at the closing of the private placement. Upon the closing of the reverse merger, the common stock and warrants issued in the private placement were exchanged for shares of our common stock and amended to become warrants to purchase common stock of our company, respectively.
On May 5, 2005, we completed a private placement of 21.35 Units to accredited investors at a price of $100,000 per Unit. Each Unit was comprised of 200,000 shares of common stock and warrants to purchase 25,000 shares of common stock for $0.75 per share and 25,000 shares of common stock for $1.00 per share exercisable for a period of five years. We received gross proceeds of $2,135,000 at the closing of the private placement.
Merrill Lynch Bank USA has issued a Letter of Credit for our account, in the approximate aggregate amount of $381,000, to secure our lease of laboratory equipment. We have collateralized the Letter of Credit with a cash deposit in the approximate amount of $381,000. No amounts have been advanced under the Letter of Credit.
On March 17, 2006, the Company issued a call notice to all holders of the common stock purchase warrants ($0.75 exercise price) issued in the April 6, 2005 and May 5, 2005 private placements. Section 3(c) of the warrants permit the Company to call for cancellation all or a part of the unexercised portion of the warrants upon the occurrence of certain events. The events required are (i) an effective registration statement registering the resale of the shares of common stock underlying the warrants, (ii) the closing bid price of the common stock for each of the ten (10) consecutive trading days equals or exceeds $0.9375 and (iii) the average daily trading volume of the common stock for such ten (10) days period equals or exceeds 100,000 shares. As of March 16, 2006, each of the foregoing events had occurred. The holders of these warrants had until April 10, 2006 to exercise all or a portion of the unexercised portion of such warrants, and any such warrants not so exercised will automatically be canceled on that date. As of March 31, 2006, warrant holders exercised warrants representing 1,085,625 shares, for which the Company received $844,687.50. As of April 10, 2006, warrant holders exercised warrants to purchase an additional 1,585,437 shares at exercise prices of $0.75 and $1.00, for which the Company received $1,202,594. Pursuant to warrants not being exercised by April 10, 2006, warrants representing 62,500 shares exercisable at $0.75 per share, were cancelled. Of the 2,671,062 exercised, warrants exercisable at $0.75 per share represented 2,495,125 shares, while warrants exercisable at $1.00 per share represented 175,937 shares. In June 2006, certain warrant holder's exercised common stock purchase warrants representing 140,234 shares, for which the Company received $55,429. In July 2006, certain warrant holder's exercised common stock purchase warrants representing 87,500 shares, for which the Company received $87,500.
On January 19, 2007, the Company completed a private placement to accredited investors of approximately 10,521,000 shares of our common stock, at a purchase price of $1.50 per share, which is equal to a 4.5% discount from the average closing market price of its common stock over the twenty day period ending on the pricing date of January 12, 2007, for gross proceeds of $15,781,500. As part of the private placement, the investors were issued five-year warrants to purchase up to an aggregate of 3,682,350 shares of our common stock, at an initial exercise price of $2.25. The warrants are callable by the Company when the trailing 10-day average of the closing market share price of our common stock equals or exceeds $2.75. Holders of called warrants will have 60 days to exercise their warrants after the call notice.
The net proceeds from the private placement, following the payment of offering-related expenses, will be used by us largely to fund the Phase I and II clinical trials for our products and for working capital and other general corporate purposes. At the closing of the private placement, we paid Cambria Capital, LLC and Blaylock Capital, LLC, the placement agents for the private placement, cash compensation of an aggregate of $1,262,520 and five-year warrants to purchase up to an aggregate of 736,470 shares of our common stock, at an exercise price of $1.50.
The Company has agreed, pursuant to the terms of the registration rights agreements with the investors, to (i) use our best efforts to file a shelf registration statement with respect to the resale of the shares of our common stock sold to the investors and shares of our common stock issuable upon exercise of the warrants with the SEC within 45 days after the closing date; (ii) use our best efforts to have the shelf registration statement declared effective by the SEC within 90 days after the filing deadline (or 120 days in the event of a full review of the shelf registration statement by the SEC), (iii) use our commercially reasonable efforts to keep the shelf registration statement effective until all registrable securities (a) have been sold pursuant to the registration statement or an exemption from the registration requirements of the Securities Act of 1933 or (b) may be sold under Rule 144(k) under the Securities Act. The Company filed a registration statement with the SEC on Form SB-2 on February 12, 2007.
The private placement was made solely to “accredited investors,” as that term is defined in Regulation D under the Securities Act of 1933. Each investor in the private placement submitted a subscription agreement and investor questionnaire in which the investor made certain representations and warranties as to their status as an “accredited investor.” The shares of common stock and warrants to purchase common stock were not registered under the Securities Act of 1933, or the securities laws of any state, and were offered and sold in reliance on the exemption from registration afforded by Section 4(2) and Regulation D (Rule 506) under the Securities Act of 1933 and corresponding provisions of state securities laws, which exempts transactions by an issuer not involving any public offering. No form of general solicitation or general advertising was used to offer or sell the above securities, and each certificate representing shares of common stock and each warrant sold in the private placement contains a legend to the effect that the securities represented by such instruments are restricted and may not be resold without registration under the Securities Act of 1933 or an exemption from that Act.
On March 9, 2007, the Company issued a call notice to all holders of the common stock purchase warrants ($1.00 exercise price) issued in the April 6, 2005 and May 5, 2005 private placements. Section 3(c) of the warrants permit the Company to call for cancellation all or a part of the unexercised portion of the warrants upon the occurrence of certain events. The events required are (i) an effective registration statement registering the resale of the shares of common stock underlying the warrants, (ii) the closing bid price of the common stock for each of the ten (10) consecutive trading days equals or exceeds $1.25 and (iii) the average daily trading volume of the common stock for such ten (10) days period equals or exceeds 100,000 shares. As of March 8, 2007, each of the foregoing events had occurred. The holders of these warrants had until March 31, 2007 to exercise all or a portion of the unexercised portion of such warrants, and any such warrants not so exercised will automatically be canceled on that date. As of March 31, 2007, warrant holders exercised warrants representing 2,242,625, shares, for which the Company received $2,242,625. As of March 31, 2007, all of the $1.00 warrants from the April 6, 2005 and May 5, 2005 private placements have been exercised pursuant to this call notice, or exercised prior to the call notice.
During the first quarter ended March 31, 2007, certain warrant holders exercised common stock purchase warrants representing 814,134 shares, for which the Company received $420,092.
RISK FACTORS
Stockholders should carefully consider the following risk factors, together with the other information included and incorporated by reference in this Form 10-QSB.
We operate in a rapidly changing environment that involves a number of risks, some of which are beyond our control. This discussion highlights some of the risks which may affect future operating results. These are the risks and uncertainties we believe are most important for you to consider. Additional risks and uncertainties not presently known to us, which we currently deem immaterial or which are similar to those faced by other companies in our industry or business in general, may also impair our business operations. If any of the following risks or uncertainties actually occurs, our business, financial condition and operating results would likely suffer.
Risks Relating to Our Business and Industry
We have a history of net losses, which we expect to continue for at least several years and, as a result, we are unable to predict the extent of any future losses or when, if ever, we will become profitable or if we will be able to continue as a going concern.
We have incurred $13.2 million in cumulative net losses from our inception in 2002, and we expect losses to continue for the next several years. Our net loss for the three month period ended March 30, 2007 was $3,345,008. Our net loss for the fiscal year ended December 31, 2006 was $5.6 million, and for the fiscal year ended December 31, 2005 was $3.6 million. To date, we have only recognized revenues from a technology license and we do not anticipate generating significant revenues from sales of our products, if approved, for at least several years, if at all. All of our product candidates are in development and none has been approved for commercial sale. We expect to increase our operating expenses over the next several years as we expand clinical trials for our product candidates currently in clinical development, including MF101 and BZL101, advance our other anti-cancer and women's health product candidates into clinical trials, expand our research and development activities, and seek regulatory approvals and eventually engage in commercialization activities in anticipation of potential FDA approval of our product candidates. Because of the numerous risks and uncertainties associated with developing our product candidates and their potential for commercialization, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we are unable to achieve and sustain profitability, the market value of our common stock will likely decline and we may not be able to continue as a going concern.
We have a limited operating history and are considered a development stage company.
We are considered a development stage company for accounting purposes because we have not generated any material revenues to date. Accordingly, we have limited relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of market acceptance, failure to establish business relationships and competitive disadvantages as against larger and more established companies.
Our product development and commercialization involves a number of uncertainties, and we may never generate sufficient revenues from the sale of potential products to become profitable.
We have generated no significant revenues to date. To generate revenue and to achieve profitability, we must successfully develop, clinically test, market and sell our potential products. Even if we generate revenue and successfully achieve profitability, we cannot predict the level of that profitability or whether it will be sustainable. We expect that our operating results will fluctuate from period to period as a result of differences in when we incur expenses and receive revenues from sales of our potential products, collaborative arrangements and other sources. Some of these fluctuations may be significant.
All of our products in development will require extensive additional development, including preclinical testing and human studies, as well as regulatory approvals, before we can market them. We cannot predict if or when any of the products we are developing or those being co-developed with us will be approved for marketing. There are many reasons that we or our collaborative partners may fail in our efforts to develop our potential products, including the possibility that:
· | preclinical testing or human studies may show that our potential products are ineffective or cause harmful side effects; |
· | the products may fail to receive necessary regulatory approvals from the FDA or foreign authorities in a timely manner, or at all; |
· | the products, if approved, may not be produced in commercial quantities or at reasonable costs; |
· | the potential products, once approved, may not achieve commercial acceptance; |
· | regulatory or governmental authorities may apply restrictions to our potential products, which could adversely affect their commercial success; or |
· | the proprietary rights of other parties may prevent us or our partners from marketing our potential products. |
We intend to build marketing and sales capabilities in the United States and eventually internationally which is an expensive and time-consuming process and may increase our losses.
Developing the sales force to market and sell our potential products is a difficult, expensive and time-consuming process. In addition to developing a sales force within our company, we will likely rely on third-party distributors to distribute our potential products. The distributors would be responsible for providing many marketing support services, including customer service, order entry, shipping and billing and customer reimbursement assistance. Our anticipated reliance on these third parties means our results may suffer if any of them are unsuccessful or fail to perform as expected. We may not be able to build sales and marketing capabilities sufficient to successfully commercialize our potential products in the territories where they receive marketing approval.
Our drug development programs will require substantial additional future funding which could hurt our operational and financial condition.
Our drug development programs require substantial additional capital to successfully complete them, arising from costs to:
· | conduct research, preclinical testing and human studies; |
· | establish pilot scale and commercial scale manufacturing processes and facilities; and |
· | establish and develop quality control, regulatory, marketing, sales and administrative capabilities to support these programs. |
Our future operating and capital needs will depend on many factors, including:
· | the pace of scientific progress in our research and development programs and the magnitude of these programs; |
· | the scope and results of preclinical testing and human studies; |
· | the time and costs involved in obtaining regulatory approvals; |
· | the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
· | competing technological and market developments; |
· | our ability to establish additional collaborations; |
· | changes in our existing collaborations; |
· | the cost of manufacturing scale-up; and |
· | the effectiveness of our commercialization activities. |
We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include regulatory approvals, the timing of events outside our direct control such as negotiations with potential strategic partners and other factors. Any of these uncertain events can significantly change our cash requirements as they determine such one-time events as the receipt of major milestones and other payments.
If additional funds are required to support our operations and we are unable to obtain them on favorable terms, we may be required to cease or reduce further development or commercialization of our potential products, to sell some or all of our technology or assets or to merge with another entity.
Our potential products face significant regulatory hurdles prior to marketing which could delay or prevent sales.
Before we obtain the approvals necessary to sell any of our potential products, we must show through preclinical studies and human testing that each potential product is safe and effective. We have a number of products moving toward or currently in clinical trials. Failure to show any potential product's safety and effectiveness would delay or prevent regulatory approval of the product and could adversely affect our business. The clinical trials process is complex and uncertain. The results of preclinical studies and initial clinical trials may not necessarily predict the results from later large-scale clinical trials. In addition, clinical trials may not demonstrate a potential product's safety and effectiveness to the satisfaction of the regulatory authorities. A number of companies have suffered significant setbacks in advanced clinical trials or in seeking regulatory approvals, despite promising results in earlier trials.
The rate at which we complete our clinical trials depends on many factors, including our ability to obtain adequate supplies of the potential products to be tested and patient enrollment. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites and the eligibility criteria for the trial. Delays in patient enrollment may result in increased costs and longer development times. In addition, our collaborative partners may have rights to control product development and clinical programs for products developed under the collaborations. As a result, these collaborators may conduct these programs more slowly or in a different manner than we had expected. Even if clinical trials are completed, we or our collaborative partners still may not apply for FDA approval in a timely manner or the FDA still may not grant approval.
In addition, the manufacturing and marketing of approved potential products is subject to extensive government regulation, including by the FDA, DEA and state and other territorial authorities. The FDA administers processes to assure that marketed products are safe, effective, consistently uniform, of high quality and marketed only for approved indications. Failure to comply with applicable regulatory requirements can result in sanctions up to the suspension of regulatory approval as well as civil and criminal sanctions.
Failure to obtain regulatory approvals in foreign jurisdictions would prevent us from marketing our products internationally.
We intend to have our product candidates marketed outside the United States. In order to market products in the European Union, Asia and many other non-U.S. jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. We may be unable to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market. The approval procedure varies among countries and can involve additional and costly clinical testing and data review. The time required to obtain approval may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval, including approval of delivery devices for our product candidates. We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory agencies in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory agencies in other foreign countries or by the FDA. The failure to obtain these approvals could harm our business and result in decreased revenues.
Our products, if and when any of them are approved, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements, or if such products exhibit unacceptable problems.
Any product for which we obtain marketing approval, together with the manufacturing processes, and advertising and promotional activities for such product, will be subject to continued regulation by the FDA and other regulatory agencies. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Any adverse effects observed after the approval and marketing of a product candidate could result in the withdrawal of any approved products from the marketplace. Absence of long-term safety data may also limit the approved uses of our products, if any, to short-term use. Later discovery of previously unknown problems with our products or their manufacture, or failure to comply with regulatory requirements, may result in:
· | restrictions on such products or manufacturing processes; |
· | withdrawal of the products from the market; |
· | voluntary or mandatory recalls; |
· | suspension of regulatory approvals; |
· | injunctions or the imposition of civil or criminal penalties. |
If we are slow to adapt, or unable to adapt, to changes in existing regulatory requirements or adoption of new regulatory requirements or policies, we may lose marketing approval for them when and if any of them are approved, resulting in decreased revenue from milestones, product sales or royalties.
If our competitors develop and market products that are more effective than our existing product candidates or any products that we may develop, or if they obtain marketing approval for their products before we do, our commercial opportunity will be reduced or eliminated.
The pharmaceutical and biotechnology industry is highly competitive. Pharmaceutical and biotechnology companies are under increasing pressure to develop new products, particularly in view of lengthy product development and regulatory timelines, expiration of patent protection and recent setbacks experienced by several products previously approved for marketing. We compete with many companies that are developing therapies for the treatment of cancer and the symptoms of menopause. Several companies are developing products with technologies that are similar to ours. We also face competition in the field of cancer treatment and therapies for the symptoms of menopause from academic institutions and governmental agencies. Many of our competitors may have greater financial and human resources or more experience in research and development than we have, or both, and they may have established sales, marketing and distribution capabilities. If we or our collaborators receive regulatory approvals for our product candidates, some of our products will compete with well-established, FDA-approved therapies that have generated substantial sales over a number of years. In addition, we will face competition based on many different factors, including:
· | the safety and effectiveness of our products; |
· | the timing and scope of regulatory approvals for these products; |
· | the availability and cost of manufacturing, marketing and sales capabilities; |
· | the effectiveness of our marketing and sales capabilities; |
· | the price of our products; |
· | the availability and amount of third-party reimbursement; and |
· | the strength of our patent position. |
We also anticipate that we will face increased competition in the future as new companies enter our target markets and scientific developments surrounding cancer therapies and drugs for menopause continue to accelerate. Competitors may develop more effective or more affordable products, or may achieve patent protection or commercialize products before us or our collaborators. In addition, the health care industry is characterized by rapid technological change. New product introductions, technological advancements, or changes in the standard of care for our target diseases could make some or all of our products obsolete.
Our lead product candidate for metastatic breast cancer, BZL101, may be used for patients with either hormone receptor positive or negative tumors, and is designed for use in both premenopausal and postmenopausal patients and patients who are both HER2 positive and negative. "HER2" is a gene that codes for an epidermal growth factor receptor that is over expressed in a significant portion of women diagnosed with breast cancer and the over expression of this gene is associated with a poorer medical prognosis, such as lower survival rates and increased recurrence of breast cancer. Those patients where the HER2 gene is over expressed are HER2 positive and those where the gene is not over expressed are HER2 negative. Accordingly, it can be expected to compete with most forms of current therapies for metastatic breast cancer, including hormonal therapy, chemotherapy or biologic therapy. Below is a summary of commonly used drug therapies for the treatment of metastatic breast cancer and the pharmaceutical companies that distribute them. Each of these companies would compete directly with us relative to BZL101.
Therapy | | Drug | | Pharmaceutical Company |
| | | | |
Hormonal Therapy | | Nolvadex | | AstraZeneca |
| | Faslodex | | AstraZeneca |
| | Arimidex | | AstraZeneca |
| | Femara | | Novartis |
| | Aromasin | | Pfizer |
| | | | |
Chemotherapy | | Abraxane | | Abraxis |
| | Adriamycin | | Pharmacia |
| | Adrucil | | SP Pharmaceuticals |
| | Cytoxan | | Baxter |
| | Ellence | | Pfizer |
| | Gemzar | | Eli Lilly |
| | Maxtrex | | Pharmacia |
| | Mutamycin | | Faulding DBL |
| | Navelbine | | Pierre Fabre |
| | Taxol | | Bristol-Myers Squibb |
| | Taxotere | | Aventis |
| | Velban | | Eli Lilly |
| | | | |
Biologic Agent Therapy | | Herceptin | | Genentech |
While we are developing BZL101 to minimize many of the adverse side effects associated with the above breast cancer treatments and further clinical testing has yet to be completed, certain of the above drug therapies may have advantages relative to BZL101. These advantages include: lower pricing, greater efficacy and reduced toxicity.
Our lead product candidate for the treatment of menopausal symptoms, MF101, would be expected to compete with postmenopausal hormone replacement therapy which has been the primary treatment of menopausal symptoms such as hot flashes. Leading hormonal agents include Premarin and Prempro by Wyeth Pharmaceuticals, Cenestin, Estradiol (generic) and Medroxy-Progesterone Acetate by Barr Pharmaceuticals, and Ogen, Provera and Estring by Pfizer. In addition, MF101 may be expected to compete with newer generation anti-depressants used to treat hot flash frequency, such as venlafaxine by Wyeth, fluoxetine by Eli Lilly and paroxetine by Glaxo Smith Kline. The makers of these hormonal agents would compete directly with us relative to MF101.
While we are developing MF101 to minimize many of the risks associated with long-term use of HRT indicated in recent studies and further clinical testing has yet to be completed, certain hormone replacement therapies may have advantages relative to MF 101. These advantages include: lower pricing, greater efficacy and reduced toxicity.
We will face uncertainty in any commercialization of our product candidates relating to coverage, pricing and reimbursement due to health care reform and heightened scrutiny from third-party payers, which may make it difficult or impossible to sell our product candidates on commercially reasonable terms.
Sales of prescription drugs depend significantly on access to the formularies, or lists of approved prescription drugs, of third-party payers such as government and private insurance plans, as well as the availability of reimbursement to the consumer from these third party payers. These third party payers frequently require drug companies to provide predetermined discounts from list prices, and they are increasingly challenging the prices charged for medical products and services. Our potential products may not be considered cost-effective, may not be added to formularies and reimbursement to the consumer may not be available or sufficient to allow us to sell our potential products on a competitive basis.
In addition, the efforts of governments and third-party payers to contain or reduce the cost of health care will continue to affect the business and financial condition of drug companies such as us. A number of legislative and regulatory proposals to change the health care system have been discussed in recent years, including price caps and controls for pharmaceuticals. These proposals could reduce and/or cap the prices for our potential products or reduce government reimbursement rates for such products. In addition, an increasing emphasis on managed care in the United States has and will continue to increase pressure on drug pricing. We cannot predict whether legislative or regulatory proposals will be adopted or what effect those proposals or managed care efforts may have on our business. The announcement and/or adoption of such proposals or efforts could adversely affect our business.
We expect to rely heavily on collaborative relationships and termination of any of these programs could reduce the financial resources available to us, including research funding and milestone payments.
Our strategy for developing and commercializing many of our potential products, including products aimed at larger markets, includes entering into collaborations with corporate partners, licensors, licensees and others. These collaborations will provide us with funding and research and development resources for potential products. These agreements also will give our collaborative partners significant discretion when deciding whether or not to pursue any development program. Our collaborations may not be successful.
In addition, our collaborators may develop drugs, either alone or with others, that compete with the types of drugs they currently are developing with us. This would result in less support and increased competition for our programs. If any of our collaborative partners breach or terminate their agreements with us or otherwise fail to conduct their collaborative activities successfully, our product development under these agreements will be delayed or terminated.
We may have disputes in the future with our collaborators, including disputes concerning who owns the rights to any technology developed. These and other possible disagreements between us and our collaborators could delay our ability and the ability of our collaborators to achieve milestones or our receipt of other payments. In addition, any disagreements could delay, interrupt or terminate the collaborative research, development and commercialization of certain potential products, or could result in litigation or arbitration. The occurrence of any of these problems could be time-consuming and expensive and could adversely affect our business.
Currently, we have a collaborative relationship with United Biotech Corporation (or UBC), an affiliate company of Maywufa Enterprise Group, under a Licensing & Technology Transfer Agreement. We have licensed to UBC the right to seek investigational new drug licenses and conduct clinical trials of MF101 and BZL101, and to market either such product in Taiwan if approved by the Taiwan Department of Health (or DOH). The licensing agreement may be terminated if the Taiwan DOH or other applicable Taiwan governmental authority rejects the application to sell either product candidate, and for breach by or winding up of a party. Because UBC bears the material expenses to develop these product candidates in Taiwan, termination of the licensing agreement would require us to either fund development activities in Taiwan directly and thus incur significant expense, or seek another collaborative relationship where development expenses of MF101 and BZL101 in Taiwan would be borne by a third party in exchange for marketing rights in that territory. There is no assurance that a suitable alternative third party would be identified, and even if identified, there is no assurance that the terms of any new relationship would be commercially acceptable to us.
Failure to secure patents and other proprietary rights or challenges to those patents and rights may significantly hurt our business.
Our success will depend on our ability to obtain and maintain patents and proprietary rights for our potential products and to avoid infringing the proprietary rights of others, both in the United States and in foreign countries. Patents may not be issued from any of these applications currently on file, or, if issued, may not provide sufficient protection.
To date, we have filed five patent applications with the United States Patent and Trademark Office and one patent applications with the Taiwan Intellectual Property Office. Our patent position, like that of many pharmaceutical companies, is uncertain and involves complex legal and technical questions for which important legal principles are unresolved. We may not develop or obtain rights to products or processes that are patentable. Even if we do obtain patents, they may not adequately protect the technology we own or have licensed. In addition, others may challenge, seek to invalidate, infringe or circumvent any patents we own or license, and rights we receive under those patents may not provide competitive advantages to us.
Several drug companies and research and academic institutions have developed technologies, filed patent applications or received patents for technologies that may be related to our business. In addition, we may not be aware of all patents or patent applications that may impact our ability to make, use or sell any of our potential products. For example, US patent applications may be kept confidential while pending in the Patent and Trademark Office and patent applications filed in foreign countries are often first published six months or more after filing. Any conflicts resulting from the patent rights of others could limit our ability to obtain meaningful patent protection. If other companies obtain patents with conflicting claims, we may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization of our potential products.
We may also need to initiate litigation, which could be time-consuming and expensive, to enforce our proprietary rights or to determine the scope and validity of others' rights. If any of our competitors have filed patent applications in the United States which claim technology we also have invented, the Patent and Trademark Office may require us to participate in expensive interference proceedings to determine who has the right to a patent for the technology.
If third parties successfully assert that we have infringed their patents and proprietary rights or challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and delay or prevent the development of our product candidates.
The manufacture, use or sale of our potential products may infringe the patent rights of others. Any litigation to determine the scope and validity of such third party patent rights would be time consuming and expensive. If we are found to infringe on the patent or intellectual property rights of others, we may be required to pay damages, stop the infringing activity or obtain licenses covering the patents or other intellectual property in order to use, manufacture or sell our products. Any required license may not be available to us on acceptable terms or at all. If we succeed in obtaining these licenses, payments under these licenses would reduce any earnings from our products. In addition, some licenses may be non-exclusive and, accordingly, our competitors may have access to the same technology as that which is licensed to us. If we fail to obtain a required license or are unable to alter the design of our product candidates to make the licenses unnecessary, we may be unable to commercialize one or more of them, which could significantly affect our ability to achieve, sustain or grow our commercial business.
If we are unable to protect our trade secrets, we may be unable to protect our interests in proprietary know-how that is not patentable or for which we have elected not to seek patent protection.
In an effort to protect our unpatented proprietary technology, processes and know-how, we require our employees, consultants, collaborators and advisors to execute confidentiality agreements. These agreements, however, may not provide us with adequate protection against improper use or disclosure of confidential information. These agreements may be breached, and we may not become aware of, or have adequate remedies in the event of, any such breach. In addition, in some situations, these agreements may conflict with, or be subject to, the rights of third parties with whom our employees, consultants, collaborators or advisors have previous employment or consulting relationships. Also, others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets.
There is a substantial risk of product liability claims in our business. If we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face even greater risks upon any commercialization by us of our product candidates. We have product liability insurance covering our clinical trials in the amount of $5 million, which we currently believe is adequate to cover any product liability exposure we may have. Clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance or increase our existing coverage at a reasonable cost to protect us against losses that could have a material adverse effect on our business. An individual may bring a product liability claim against us if one of our products or product candidates causes, or is claimed to have caused, an injury or is found to be unsuitable for consumer use. Any product liability claim brought against us, with or without merit, could result in:
· | liabilities that substantially exceed our product liability insurance, which we would then be required to pay from other sources, if available; |
· | an increase of our product liability insurance rates or the inability to maintain insurance coverage in the future on acceptable terms, or at all; |
· | withdrawal of clinical trial volunteers or patients; |
�� | damage to our reputation and the reputation of our products, resulting in lower sales; |
· | regulatory investigations that could require costly recalls or product modifications; |
· | the diversion of management's attention from managing our business. |
Our product candidates may have difficulties with market acceptance even after FDA approval.
To date, there are no botanical drugs that have received FDA approval and therefore it is difficult to speculate how drugs derived from botanical extracts will be accepted by physicians, patients, third party payers and members of formulary committees who compile the list of medications included in health plans and hospital formularies. Moreover, physicians rely on peer reviewed medical journals as a primary source of information for evidence based medicine. If results of our clinical trials are not published in widely distributed, peer reviewed medical journals, our products may not be widely accepted by the medical community.
Even if we receive regulatory approvals for the commercial sale of our product candidates, the commercial success of these products will depend on, among other things, their acceptance by physicians, patients, third-party payers and other members of the medical community as a therapeutic and cost-effective alternative to competing products and treatments. If our product candidates fail to gain market acceptance, we may be unable to earn sufficient revenue to continue our business. Market acceptance of, and demand for, any product candidate that we may develop and commercialize will depend on many factors, including:
· | our ability to provide acceptable evidence of safety and efficacy; |
· | the prevalence and severity of side effects or other reactions; |
· | the convenience and ease of use; |
· | availability, relative cost and relative efficacy of alternative and competing products and treatments; |
· | the effectiveness of our marketing and distribution strategy; |
· | the publicity concerning our products or competing products and treatments; and |
· | our ability to obtain third-party insurance coverage and adequate payment levels. |
If our product candidates do not become widely accepted by physicians, patients, third-party payers and other members of the medical community, it is unlikely that we will ever become profitable.
Claims relating to any improper handling, storage or disposal of biological and hazardous materials by us could be time-consuming and costly.
Our research and development activities in our Denver, Colorado and Emeryville, California facilities involve the controlled storage, use and disposal of hazardous materials. We are subject to government regulations relating to the use, manufacture, storage, handling and disposal of hazardous materials and waste products. Although we believe that our safety procedures for handling and disposing of these hazardous materials comply with the standards prescribed by applicable laws and regulations, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident, we could be held liable for any damages that result or we could be penalized with fines, and any liability could exceed the limits of or fall outside our insurance coverage. We may not be able to maintain insurance on acceptable terms, or at all. Further, we could be required to incur significant costs to comply with current or future environmental laws and regulations.
Because we have limited manufacturing experience, we depend on third-party manufacturers to manufacture product candidates for us. If we cannot rely on third-party manufacturers, we will be required to incur significant costs and devote significant efforts to establish our own manufacturing facilities and capabilities.
We do not have any manufacturing experience, nor do we have any manufacturing facilities. We currently rely upon third-party manufacturers to manufacture all clinical quantities of our product candidates. We depend on these third-party manufacturers to perform their obligations in a timely manner and in accordance with applicable governmental regulations. Our third-party manufacturers may encounter difficulties with meeting our requirements, including problems involving:
· | inconsistent production yields; |
· | poor quality control and assurance or inadequate process controls; and |
· | lack of compliance with regulations set forth by the FDA or other foreign regulatory agencies. |
These contract manufacturers may not be able to manufacture our product candidates at a cost or in quantities necessary to make them commercially viable. We also have no control over whether third-party manufacturers breach their agreements with us or whether they may terminate or decline to renew agreements with us. To date, our third party manufacturers have met our manufacturing requirements, but we cannot assure you that they will continue to do so. Furthermore, changes in the manufacturing process or procedure, including a change in the location where the drug is manufactured or a change of a third-party manufacturer, may require prior FDA review and approval in accordance with the FDA's current Good Manufacturing Practices, or cGMPs. There are comparable foreign requirements. This review may be costly and time-consuming and could delay or prevent the launch of a product. The FDA or similar foreign regulatory agencies at any time may also implement new standards, or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of products. If we or our contract manufacturers are unable to comply, we or they may be subject to regulatory action, civil actions or penalties.
If we are unable to enter into agreements with additional manufacturers on commercially reasonable terms, or if there is poor manufacturing performance on the part of our third party manufacturers, we may not be able to complete development of, or market, our product candidates.
If we lose the services of our co-founders who serve as directors and officers of our company, our operations could be disrupted and our business could be harmed.
Our business plan relies significantly on the continued services of our co-founders, Isaac Cohen and Mary Tagliaferri. If we were to lose the services of one or both of them, our ability to continue to execute our business plan could be materially impaired. In addition, while we have employment agreements with Mr. Cohen and Dr. Tagliaferri, the agreements would not prevent either of them from terminating their employment with us. Neither Mr. Cohen nor Dr. Tagliaferri have indicated they intend to leave our company, and we are not aware of any facts or circumstances that suggest either of them might leave us.
Risks Related to Our Common Stock
Volatility of our stock price could adversely affect stockholders.
The market price of our common stock may fluctuate significantly in response to factors, some of which are beyond our control, including the following:
· | the results of research or development testing of our or our competitors' products; |
· | technological innovations related to diseases we are studying; |
· | new commercial products introduced by our competitors; |
· | government regulation of our industry; |
· | receipt of regulatory approvals by our competitors; |
· | our failure to receive regulatory approvals for products under development; |
· | developments concerning proprietary rights; or |
· | litigation or public concern about the safety of our products. |
The stock market in general has recently experienced extreme price and volume fluctuations. In particular, market prices of securities of drug development companies have experienced fluctuations that often have been unrelated or disproportionate to the operating results of these companies. Continued market fluctuations could result in extreme volatility in the price of our common stock, which could cause a decline in the value of our common stock. Price volatility might be worse if the trading volume of our common stock is low.
Our common stock is considered "a penny stock" and may be difficult to sell.
The SEC has adopted regulations which generally define "penny stock" to be an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to specific exemptions. As the market price of our common stock has been less than $5.00 per share during this quarter, our common stock is considered a "penny stock" according to SEC rules. This designation requires any broker or dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules may restrict the ability of brokers or dealers to sell our common stock and may affect the ability of investors to sell their shares. In addition, since our common stock is currently traded on the NASDAQ's OTC Bulletin Board, investors may find it difficult to obtain accurate quotations for our common stock and may experience a lack of buyers to purchase such stock or a lack of market makers to support the stock price.
Our principal stockholders have significant voting power and may take actions that may not be in the best interest of other stockholders.
Our officers, directors and principal stockholders control approximately 33% of our currently outstanding common stock. If these stockholders act together, they may be able to exert significant control over our management and affairs requiring stockholder approval, including approval of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interests of all our stockholders.
Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.
Provisions of our certificate of incorporation, bylaws and provisions of applicable Delaware law may discourage, delay or prevent a merger or other change in control that a stockholder may consider favorable. Pursuant to our certificate of incorporation, our board of directors may issue additional shares of common or preferred stock. Any additional issuance of common stock could have the effect of impeding or discouraging the acquisition of control of us by means of a merger, tender offer, proxy contest or otherwise, including a transaction in which our stockholders would receive a premium over the market price for their shares, and thereby protects the continuity of our management. Specifically, if in the due exercise of his/her or its fiduciary obligations, the board of directors were to determine that a takeover proposal was not in our best interest, shares could be issued by our board of directors without stockholder approval in one or more transactions that might prevent or render more difficult or costly the completion of the takeover by:
· | diluting the voting or other rights of the proposed acquirer or insurgent stockholder group, |
· | putting a substantial voting block in institutional or other hands that might undertake to support the incumbent board of directors, or |
| effecting an acquisition that might complicate or preclude the takeover. |
Our certificate of incorporation also allows our board of directors to fix the number of directors in the by-laws. Cumulative voting in the election of directors is specifically denied in our certificate of incorporation. The effect of these provisions may be to delay or prevent a tender offer or takeover attempt that a stockholder may determine to be in his, her or its best interest, including attempts that might result in a premium over the market price for the shares held by the stockholders.
We also are subject to Section 203 of the Delaware General Corporation Law. In general, these provisions prohibit a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder, unless the transaction in which the person became an interested stockholder is approved in a manner presented in Section 203 of the Delaware General Corporation Law. Generally, a "business combination" is defined to include mergers, asset sales and other transactions resulting in financial benefit to a stockholder. In general, an "interested stockholder" is a person who, together with affiliates and associates, owns, or within three years, did own, 15% or more of a corporation's voting stock. This statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire us.
We do not anticipate paying cash dividends for the foreseeable future, and therefore investors should not buy our stock if they wish to receive cash dividends.
We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
A significant number of our shares will be eligible for sale and their sale or potential sale may depress the market price of our common stock.
Sales of a significant number of shares of our common stock in the public market could harm the market price of our common stock. We have an effective registration statement registering the resale of up to 42,112,448 shares of our common stock, which represents a super majority of our currently outstanding shares of common stock. As additional shares of our common stock become available for resale in the public market pursuant to that registration statement, and otherwise, the supply of our common stock will increase, which could decrease its price. Some or all of such shares of common stock may be offered from time to time in the open market pursuant to Rule 144, and these sales may have a depressive effect on the market for our shares of common stock. In general, a person who has held restricted shares for a period of one year may, upon filing with the SEC a notification on Form 144, sell into the market common stock in an amount equal to the greater of 1% of the outstanding shares or the average weekly number of shares sold in the last four weeks prior to such sale. Such sales may be repeated once each three months, and any of the restricted shares may be sold by a non-affiliate after they have been held two years.
We are exposed to the impact of interest rate changes and changes in the market values of our investments.
Our exposure to market rate risk for changes in interest rates relates primarily to our investment portfolio. We have not used derivative financial instruments in our investment portfolio. We invest our excess cash in debt instruments of the United States Government and its agencies, and in high-quality corporate issuers that, by policy, limit the amount of credit exposure to any one issuer. We protect and preserve our invested funds by limiting default, market and reinvestment risk. Investments in both fixed rate and floating rate interest earning instruments carry a degree of interest rate risk. Fixed rate securities may have their fair market value adversely impacted due to a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if forced to sell securities that have declined in market value due to changes in interest rates.
Item 3. Controls And Procedures.
(a) Evaluation of Disclosure Controls and Procedures.
As of the end of the period covered by this Quarterly Report on Form 10-QSB, we evaluated under the supervision of our Chief Executive Officer and our Chief Financial Officer, the effectiveness of our disclosure controls and procedures, as defined in Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e) . Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.
(b) Changes in Internal Control over Financial Reporting.
During the period covered by this Quarterly Report on Form 10-QSB, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Given the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, will have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Further, the design of a control system must reflect the fact that there are resource constraints, and that benefits of controls must be considered relative to their costs. The design of any system of controls is also based in part on certain assumptions regarding the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
None
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults upon Senior Securities
None
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Exhibit Number | | Description |
10.1 | | Fitzsimons Redevelopment Authority |
| | |
31.1 | | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
31.2 | | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
32.1 | | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* |
| | |
32.2 | | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* |
* The certifications attached as Exhibits 32.1 and 32.2 accompany this Quarterly Report on Form 10-QSB pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed "filed" by Bionovo, Inc. for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
SIGNATURES
In accordance with the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: May 8, 2007
| | |
| BIONOVO, INC. |
| | |
| By: | /s/ Isaac Cohen |
|
Isaac Cohen, Chief Executive |
| Officer and President |
| (Principal Executive Officer) |
| | |
| | |
| By: | /s/ James P. Stapleton |
| James P. Stapleton, Chief Financial Officer |
| (Principal Financial Officer and Principal |
| Accounting Officer) |
FITZSIMONS REDEVELOPMENT AUTHORITY
AMENDMENT TWO TO SPACE LEASE
THIS AMENDMENT TWO TO SPACE LEASE (this “Amendment”) is entered into as of the _____________ day of ________________, 2007, by and between Fitzsimons Redevelopment Authority (“Landlord”) a governmental entity created by the City of Aurora, Colorado and the Regents of the University of Colorado, whose address or principal place of business is 12635 East Montview Blvd., Suite 100, Aurora, Colorado, 80045, and BioNovo, Inc. (“Tenant”).
RECITALS:
A. On or about November 16, 2006, Landlord and Tenant entered into a Space Lease (the “Lease”) pertaining to Premises located at 12635 E. Montview Blvd., Suite 155, Aurora, CO 80045.
B. The Lease has heretofore been amended by Amendment One dated January 25, 2007.
C. Landlord and Tenant now desire to revise the Lease in the manner and form hereinafter set forth.
NOW, THEREFORE, for good and valuable consideration, Landlord and Tenant hereby agree as follows:
| 1. | Premises will be revised to add Suite 137 located in the Bioscience Park Center, 12635 E. Montview Blvd., Aurora, CO 80045 (“Office Space”). |
| 2. | Basic Rent. Exhibit E of the Lease is hereby revised to increase Basic Rent to include an additional $473 per month; which amount will escalate at a rate of three percent per year on December 1 of each year (e.g. rent for Office Space will increase to $487 per month December 1, 2007 and $502 per month December 1, 2008). This is a flat rate and includes janitorial services, Operating Expenses, and utilities (excluding phone and data). |
| 3. | Commencement Date for Office Space shall be May 1, 2007. |
| 4. | Stated Expiration Date shall be November 30, 2009. |
| 5. | Security Deposit shall increase by $473 for a total of security deposit of $6,507. |
| 6. | Ratification of Lease. This Amendment modifies only the terms and conditions of the Lease as provided herein and no others. This Amendment will prevail over any other provisions of the Lease, which are inconsistent with this Amendment or the state of facts contemplated by this Amendment. |
Executed as a sealed instrument as of the date first above written.
FITZSIMONS REDEVELOPMENT AUTHORITY BIONOVO, INC.
| | | |
By: __________________________________ | | | By: ___________________________________ |
Edward J. Tauer, | | | |
Title: Chairman of the Board Title: | | | Title:__________________________________ |
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14 OR 15d-14 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Isaac Cohen, Chief Executive Officer of Bionovo, Inc. (the "Company"), certify that:
1. I have reviewed this quarterly report on Form 10-QSB of the Company;
2. Based on my knowledge, this 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 report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and we 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 the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(c) disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors:
(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 the registrant'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 the registrant's internal control over financial reporting.
| | |
| | /s/ Isaac Cohen | |
| | Isaac Cohen, Chief Executive Officer and President (Principal Executive Officer) Date: May 8, 2007 |
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14 OR 15d-14 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, James P. Stapleton, Chief Financial Officer of Bionovo, Inc. (the "Company"), certify that:
1. I have reviewed this quarterly report on Form 10-QSB of the Company;
2. Based on my knowledge, this 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 report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and we 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 the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(c) disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors:
(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 the registrant'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 the registrant's internal control over financial reporting.
| | |
| | /s/ James P. Stapleton | |
| | James P. Stapleton, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) Date: May 8, 2007 |
Exhibit 32.1
BIONOVO, INC.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Bionovo, Inc. (the "Company") on Form 10-QSB for the period ending March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Isaac Cohen, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 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.
| | |
| | /s/ Isaac Cohen | |
| | Isaac Cohen, Chief Executive Officer and President (Principal Executive Officer) Date: May 8, 2007 |
A signed original of this written statement required by Section 906 has been provided to Bionovo, Inc. and will be retained by Bionovo, Inc., and furnished to the Securities and Exchange Commission or its staff upon request.