This Prospectus Supplement No. 3 supplements our Prospectus dated December 15, 2006 as supplemented by Prospectus Supplement No. 1 dated January 24, 2007 and Prospectus Supplement No. 2 dated February 27, 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 March 19, 2007, the closing price of our common stock on the OTC Bulletin Board was $4.83.
This Prospectus Supplement includes the attached Annual Report for the fiscal year ended December 31, 2006 on Form 10-KSB of Bionovo, Inc., as filed by us with the U.S. Securities and Exchange Commission on March 14, 2007.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-KSB
| x | ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2006
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 000-50073
BIONOVO, INC.
(Name of Small Business Issuer in Its Charter)
Delaware | | 20-5526892 |
(State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification No.) |
| 5858 Horton Street Suite 375, Emeryville, California 94086 (510) 601-2000 | |
| (Address of Principal Executive Offices, Including Zip Code and Telephone Number, Including Area Code) | |
| | |
| Securities registered under Section 12(b) of the Exchange Act: None | |
| | |
| | |
| Common stock, par value $.0001 per share | |
| (Title of Class) | |
Check whether the issuer is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. o
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the past 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. Yes x No o
Check if there is no disclosure of delinquent filers in response to Item 405 of Regulation S-B contained in this form, and no disclosure will be contained, to the best of the issuer's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. x
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
State issuer's revenues for its most recent fiscal year: $15,000.
As of February 28, 2007, the Issuer had 63,720,224 shares of common stock outstanding. The aggregate market value of the shares of common stock held by non-affiliates of the Issuer (43,826,369 shares), based on the average of the closing price on February 28, 2007 of $5.75 per share of common stock, was approximately $252,001,622.
Note: For purposes of this Report, shares held by non-affiliates were determined by aggregating the number of shares held by officers and directors of the Issuer, and by others who, to Issuer's knowledge, own 5% or more of Issuer's common stock, including shares of preferred stock convertible into common stock, and subtracting those shares from the total number of shares outstanding. The price quotations supplied by the OTC Bulletin Board represent prices between dealers and do not include retail mark-up, markdown or commission and do not represent actual transactions.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Issuer’s definitive Proxy Statement for the 2007 Annual Meeting of Stockholders, to be filed within 120 days after the end of the fiscal year covered by this Form 10-KSB, are incorporated by reference into Part III of this Form 10-KSB.
Transitional Small Business Disclosure Format (check one): Yes o No x
TABLE OF CONTENTS
PART 1 | | | | |
Item 1. | | DESCRIPTION OF BUSINESS | | 1 |
Item 2. | | DESCRIPTION OF PROPERTY | | 13 |
Item 3. | | LEGAL PROCEEDINGS | | 13 |
Item 4. | | SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. | | 13 |
PART II | | | | |
Item 5. | | MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND SMALL BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES. | | 13 |
Item 6. | | MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION | | 15 |
Item 7. | | FINANCIAL STATEMENTS. | | 35 |
Item 8. | | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. | | 35 |
Item 8A. | | CONTROLS AND PROCEDURES. | | 35 |
Item 8B. | | OTHER INFORMATION. | | 36 |
PART III | | | | |
Item 9. | | DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT. | | 36 |
Item 10. | | EXECUTIVE COMPENSATION | | 36 |
Item 11. | | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | | 36 |
Item 12. | | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | | 36 |
Item 13. | | EXHIBITS | | 36 |
Item 14. | | PRINCIPAL ACCOUNTANT FEES AND SERVICES | | 38 |
CAUTIONARY NOTES REGARDING FORWARD-LOOKING STATEMENTS
This report on Form 10-KSB contains forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to:
· | our plans to develop, conduct clinical trials of and market new drug products and the timing of these development programs; |
· | our estimates regarding our capital requirements and our needs for additional financing; |
· | our estimates of expenses and future revenues and profitability; |
· | our estimates of the size of the markets for our drug products; |
· | the rate and degree of market acceptance of our drug products; and |
· | the success of other competing drug products and therapies that may become available. |
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail under the heading “Risk Factors” in Item 6. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. Except as required by law, we assume no obligation to update any forward-looking statements after the date of this report.
This report also contains estimates made by independent parties and by us relating to market size and growth and other industry data. These estimates involve a number of assumptions and limitations and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the industries in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
Item 1. DESCRIPTION OF BUSINESS
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.
Many of the top 35 worldwide selling prescription drugs are derived from natural products (SOURCE: (i) Butler MS. Natural products to drugs: natural product derived compounds in clinical trials. Nat Prod Rep. 2005 Apr;22(2): 162-95. E pub 2005 Mar 8. Review; and (ii) Butler MS. The role of natural product chemistry in drug discovery. J Nat Prod. 2004 Dec;67(12): 2141-53. Review.). Moreover, approximately 62% of all chemotherapeutic agents are derived from natural or botanical products (SOURCE: (i) Newman DJ, Cragg GM, Snader KM. Natural products as sources of new drugs over the period 1981-2002. J Nat Prod. 2003 Jul;66(7): 1022-37. Review; and (ii) Cragg GM, Newman DJ. Plants as a source of anti-cancer agents. J. Ethnopharmacol. 2005 Aug 22;100(1-2). 72-9.). There were 15 new natural product-derived drugs launched from 2000 to 2003, as well as 15 natural product-derived compounds in Phase III clinical trials or registration at the end of 2003 (SOURCE: Butler MS. The role of natural product chemistry in drug discovery. J Nat Prod. 2004 Dec;67(12): 2141-53. Review.). Some of the new drugs were new drug types such as the antimalarial arteether, echinocandin- derived antifungal caspofungin and the anti-Alzheimer’s drug galantamine.
Although as many as 120 of the drugs used by physicians today are still produced from botanical fractions and are not synthesized, like atropine, codeine, quinine, morphine, steroids, taxanes and vinca derivatives (SOURCE: Kinghorn AD. The role of pharmacognosy in modern medicine. Expert Opin Pharmacother. 2002 Feb;3(2):77-9. Review.), we are aware of only a handful of companies attempting to create new drugs from botanical sources. We believe opportunities to discover and develop important new drugs from botanical extracts remain largely untapped.
We have one drug, MF101, designed to alleviate the symptoms of menopause, currently undergoing Phase II clinical trials, and an anti-cancer agent for breast, pancreatic an ovarian cancer, BZL101, for which we have received approval from the FDA to conduct a Phase II clinical trial. We are in the process of preparing IND submissions to the U.S. Food and Drug Administration (or FDA) for Phase I trials of a second anti-cancer agent, AA102, and another drug, VG101, for the treatment of post-menopausal vaginal dryness.
We select plant extracts to screen against well-understood therapeutic targets. Biological assays developed by us or others are used to screen and validate a substantial pipeline of botanical extracts we believe have therapeutic applications.
With MF101 currently undergoing a Phase II human trials and the recent submission to the FDA of our Phase I trial results, we are a leader in seeking FDA approval for novel formulations derived from natural substances.
Corporate History
On April 6, 2005, Bionovo Biopharmaceuticals, Inc., or Bionovo Biopharmaceuticals, completed a reverse merger transaction with Lighten Up Enterprises International, Inc., a Nevada corporation formed on January 29, 1998. Until the merger, Lighten Up Enterprises International, Inc., or Lighten Up, engaged in the development, publishing, marketing and sale of a cook book of recipes. Lighten Up discontinued these activities following the merger. Upon the closing of the merger, the directors and management of Bionovo Biopharmaceuticals became the directors and management of Lighten Up.
On June 29, 2005, we changed our name from Lighten Up Enterprises International, Inc. to Bionovo, Inc. and changed our state of incorporation to Delaware. Bionovo Biopharmaceuticals continues as our wholly-owned, operating subsidiary.
Bionovo Biopharmaceuticals was formed and began operation in the state of California in February 2002 and subsequently reincorporated into the state of Delaware in March 2004. Until June 29, 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.
Market Overview
Menopause. Menopause refers to the period after a woman ceases menstruating. It is estimated that approximately 75% of the 36 million menopausal women in the U.S. experience unpleasant, menopause-related side effects including hot flashes, depression and vaginal dryness (SOURCE:Kronenberg F., Hot flashes: epidemiology and physiology. Ann N Y Acad Sci 1990; 592:52-86; discussion 123-33). Moreover, menopause is associated with difficulties concentrating, mood swings, vaginal dryness, frequent urination, weight gain, vaginal and urethral infections, depression and migraine headaches, as well as life-threatening conditions such as heart disease, osteoporosis, cognitive decline and breast cancer.
For decades, administration of estrogen and progesterone through hormone replacement therapy (or HRT) has been the primary treatment for the symptoms of menopause such as hot flashes. Recent studies, however, have found the risks associated with long-term use of HRT outweigh the benefits (SOURCE:(i) Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. Jama 2002; 288:321-33;(ii) Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. Jama 2003; 289:2651-62; (iii)Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004; 291:1701-12; and (iv) Hays J, Ockene JK, Brunner RL, et al. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003; 348:1839-54.). MF101 is intended to be used in lieu of HRT and to control climacteric symptoms in patients.
Breast and Ovarian Cancer. According to the American Cancer Society (ACS) 2005 Cancer Facts And Figures, breast cancer is the second leading cause of cancer death in women, with more than 200,000 newly diagnosed cases each year and over 2 million survivors in the U.S. Cancer is characterized by uncontrolled cell division resulting in the growth of a mass of cells commonly known as a tumor. Breast cancer, like other forms of cancer, if not eradicated, can spread or metastasize throughout the body. To date, there is no cure for women with advanced metastatic breast cancer. Ovarian cancer is a silent disease that has no specific symptoms until late in its course. According to the American Cancer Society (Estimated New Cancer Cases and Deaths by Sex for All Sites, US, 2005), it is the leading cause of death among gynecological malignancies, and claims more women's lives each year than all other gynecological tumors combined. Also, according to Current Medical Diagnosis and Treatment (Tierney et al., 2002), greater than 75% of cases are diagnosed in the advanced stages of the disease (Stages III and IV). Among patients with disease in Stages III and IV, the five-year overall survival rate is 17% with distinct metastasis and 36% with local spread (SOURCE: Current Medical Diagnosis and Treatment (Tierney et al., 2002)).
Breast cancer patients are treated with chemotherapy, hormonal therapy or monoclonal antibody drugs. BZL101 is a capase independent apoptotic inducer designed to kill cancer cells and increase survival rates.
The standard treatment for Stage III ovarian cancer includes surgery followed by chemotherapy. The majority of patients diagnosed with Stage III disease receive chemotherapy (SOURCE: (i) Berkenblit A, Cannistra SA. Advances in the management of epithelial ovarian cancer. J Reprod Med. 2005 Jun;50(6):426-38; (ii) Cannistra SA. Medical Progree: Cancer of the Ovary. M Engl J Med 2004; 351:2519-2529, Dec 9, 2004.). Women diagnosed with Stage IV ovarian cancer are treated in the same manner as Stage III, but the estimated percentage of those treated with chemotherapy drops to 90% because chemotherapy is no longer considered effective for some patients. We believe BZL101 can potentially be used to lower tumor burden and improve survival.
Business Strategy
Our goal is to achieve a position of sustainable leadership in the biopharmaceutical industry. Our strategy consists of the following key elements:
Integrate Scientific Discoveries with Natural Substances Used in Traditional Chinese Medicine
For more than 4,000 years, Chinese people have used Traditional Chinese Medicine (or TCM), for the prevention and treatment of disease. Advances in science and technology and analytical methodology for natural products, can be harnessed for the discovery and development of new drugs from the botanicals used in TCM. We intend to continue to integrate cutting edge scientific discoveries and modern medicine with our expertise in natural substances used in TCM to discover and screen novel formulations derived from botanicals.
Focus on Cancer and Women’s Health
We have intentionally directed our focus on initial medical applications with urgent needs and very large potential markets. With this strategy, even a small market penetration should result in relatively substantial revenue streams. Under this strategy, we have initially directed our attention to the design of drugs to target cancer and women’s health.
According to the American Cancer Society (ACS) 2005 Cancer Facts and Figures, cancer is the leading cause of death in the U.S., yet there remain unmet needs, and current treatments remain ineffective and inadequate for some populations. In the current propitious health care regulatory environment, the FDA regulatory requirements for approval of cancer drugs has been modified because of the immediacy for treatment of this disease. There are approximately 27 million women suffering menopausal symptoms such as hot flashes and vaginal dryness (SOURCE: Kronenberg F., Hot flashes: epidemiology and physiology. Ann N Y Acad Sci 1990; 592:52-86; discussion 123-33). To date, pharmaceutical interventions offered for women suffering menopausal symptoms are either partially unsatisfactory, or they have significant undesirable side-effects. Relying in part on what we believe to be our novel system for the assessment of selective estrogen receptors ((α) and (β)) modulators, or SERMs, their downstream co-regulatory proteins and their transcriptional outcome as well as pro-apoptotic agents, we intend to continue to target this significant market opportunity for drugs targeting cancer and women’s health.
Develop Our Existing Product Portfolio
We have one drug, MF101, designed to alleviate the symptoms of menopause, currently in Phase II clinical trials that commenced in January 2006. We completed a Phase I clinical trial of a second drug, BZL101, an anti-cancer agent for breast, pancreatic, and ovarian cancer in 2004 and have recently received approval from the U.S. Food and Drug Administration (or FDA) of an investigational new drug (or IND) application to conduct a Phase II clinical trial for breast cancer. We also are in the process of preparing an IND application for a Phase I/II clinical trial of BZL101 with respect to pancreatic cancer, and are planning to submit IND applications for a Phase I/II trial of a second anti-cancer agent, AA102, and a Phase I trial for another drug, VG101, an intra-vaginal suppository (VG101) for the treatment of postmenopausal vulvar and vaginal atrophy (vaginal dryness). We intend to further develop these drugs both by expanding our internal resources and by collaborating with leading governmental and educational institutions as well as other companies.
Foster Academic and Industry Collaborations
We have developed research and development relationships with faculty members at the University of California at San Francisco (UCSF), the University of California at Berkeley (UCB), the University of California at Davis (UCD), University of Texas, Southwestern (UTS) and the University of Colorado Health Sciences College (UCHSC). These collaborations provide access to leading intellectual and physical resources, and we believe should augment funding for academic development and accelerate technology transfer of promising innovations. We intend to continue our collaboration with UCSF, UCB, UCD, UTS and UCHSC. We also intend to leverage the intellectual resources of other major research centers by seeking additional academic collaborations.
We will also seek strategic scientific collaborations with other biotechnology and pharmaceutical companies in order to expand and accelerate the process to product development. We believe this will augment our research and development capabilities as well as provide potential sales channels for our products. We plan to target specific biotech and pharmaceutical companies in need of Bionovo’s proprietary technology or potential products in the endeavor to reach licensing and development agreements.
Diversify Application of Drug Candidates for Extended Indications
Many of our initial products under development are not specific for women’s health, although the initial clinical trials will focus on this application. Anticancer therapeutics, for example, will apply to a wide range of oncological applications. Similarly, hormonally-active drugs could potentially be used to treat prostate cancer or osteoporosis. Accordingly, we intend to pursue alternative applications for our drug candidates when deemed appropriate, to increase our chances of commercial success.
Product and Drug Pipeline
We currently focus on developing drug products designed to treat cancer and women’s health through multiple targets via well-defined physiological regulatory mechanisms. Over forty promising substances have already been identified and are ready to be taken through the FDA approval process.
We currently have the following drug candidates in human trials in the U.S.:
| · | MF101, a selective estrogen receptor beta (ER(β)) agonist, is designed to alleviate the symptoms of menopause, including hot flashes, night sweats, and bone mineral loss. In our Phase I clinical trial of MF101 during 2004, 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 or hormonal status. The most common adverse events observed in the trial were anticipated gastrointestinal disturbances. We also observed that MF101 did not adversely alter serum reproductive hormones. A multicenter, Phase II double-blind, placebo-controlled, randomized clinical trial under the directorship of Dr. Deborah Grady at the University of California, San Francisco commenced in January 2006. |
| · | BZL101, an apoptosis inducing factor (AIF) translocator/activator, is an anticancer agent for breast, pancreatic and ovarian cancers that also may be effective in the treatment of other solid tumors. 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, we plan to enroll the first patient to the dose escalation portion of the Phase I/II study in April 2007. |
Our drug pipeline also includes the following drugs that have not yet entered human clinical trials, but for which IND applications are being prepared:
| · | AA102, an apoptosis inducer, is an anticancer agent that attenuates mitochodrial membrane potential to cause a cytochrome c release and caspase activation to induce apoptosis. An IND application currently is being prepared. Assuming approval of the IND, a Phase I clinical trial is expected to commence in February 2008. |
| · | VG101, a combination of selective ER(β)agonist, vasodilator and an antimicrobial agent, is an intra-vaginal gel for the treatment of postmenopausal vaginal dryness. An IND application is being prepared for submission to the FDA. Assuming approval of the IND, a Phase I clinical trial is expected to commence in January 2008. |
Scientific Discovery Platforms
Screening Philosophy
A useful strategy for the discovery of biologically active compounds from plants utilizes information about the traditional medicinal use of these botanical agents. An advantage to this strategy over random screening is that the extensive clinical tradition and literature may allow for some rationalization with respect to the biological potential for their reputed use. Since most organisms living today evolved under similar adaptation pressures, it is plausible that plants can interact with mammalian organic processes, along similar lines as nutrition from food, and therefore, can be utilized to regulate pathological conditions as they do normal physiological functioning.
As an example, experimental antineoplastic (inhibiting or preventing the growth or development of malignant cells) agents derived from botanicals have been under study in China since the mid-fifties. Agents discovered through this effort include: campothecin (CPT) and hydroxycampothecin (OPT) from CAMPOTHECA ACUMINATA Decne, Harringtonine and homoheringtonine from several species of CEPHALOTAXUS, Indirubin from BAPHICACANTHES CUSIA Bremek and INDIGOFERA TINCTORIA L. and Kanglaite from COIX LACHRYMA- JOBI L.
Our strategic advantage for drug development is our extensive clinical knowledge and experience with natural compounds coupled with definitive knowledge of the proper scientific tools for screening. Instead of creating massive screens, we select the most likely candidate compounds and test them for efficacy and toxicity with state of the art screening models such as estrogen receptor regulation or induction of apoptosis. To date, our positive hit rate has varied between 25% to 40%.
Our clinical knowledge also accelerates the preclinical testing due to the longstanding anecdotal knowledge regarding the toxicities of these agents. The shorter time to clinic provides an opportunity to exercise major savings and prolong the exploitation of the patent.
Scientific Discovery Platform I: Anticancer Drugs
A substantial number of Chinese medicinal herbs have traditionally been used to prevent and treat cancer. These herbal preparations are purported to have many biological effects including direct anti-proliferative effects on cancer cells, anti-mutagenic activity, and stimulatory or suppressive effects on immune responses.
Aqueous and ethanol extracts from seventy-one Chinese medicinal herbs historically used for cancer treatment were evaluated for antiproliferative activity on five breast cancer cell lines. Twenty-six percent (19/71) of the extracts demonstrated greater than 50% growth inhibition on 80% of the cancer cell lines tested while five more herbs showed the same activity on fewer cell lines. These results, as well as our data from dose-response curves, DNA fragmentation and flow cytometric analyses, indicate that many of the herbs have significant growth inhibitory effects on breast cancer cells in vitro. Furthermore, in vivo tests of some of the extracts in a mouse xenograph model show a significant inhibition of tumor formation with oral administration, with no toxicity or compromise to the mice activity including fluid and food intake.
Scientific Discovery Platform II: Hormone Replacement Therapy and Selective Estrogen Receptor Modulators
Over 300 plants synthesize compounds that interact with estrogen receptors (ER), known as phytoestrogens. Elucidating how phytoestrogens regulate ER transcriptional and cell proliferation pathways could have a profound impact on women. For example, phytoestrogens may prevent some cancers that are common in postmenopausal women. In fact, the lowest rates of breast, endometrial and colon cancers are observed in countries that have a high consumption of phytoestrogens in their diet.
Our goal is to identify herbs that may be effective at preventing or treating breast cancer as well as potential compounds for hormone replacement therapy (HRT). We have tested 71 herbs that are used in Traditional Chinese Medicine (TCM) for their ability to regulate transcriptional activity in the presence of ER(α) or ER(β). Over forty five percent (46.4%) of the herbs show selective activity on the two ERs. In these studies, we identified the herbs that selectively regulate ER(α) or ER(β) and recruit coregulatory proteins to ER(β).
These studies have the potential to identify natural selective estrogen receptor modifiers (SERMs), such as the drug tamoxifen, that may be used, with FDA approval, to prevent and treat breast cancer. In addition, we anticipate these studies will provide leads for HRT that do not increase the risk of breast cancer. Other indications for estrogenic compounds or SERMs are osteoporosis, cardiovascular disease prevention, arthritis and menopausal symptomatic management (such as hot flashes, insomnia, vaginal dryness and decreased libido).
Pharmacology
After assessing the functional activity of whole herb extracts in our established assay systems, we aim to isolate anticancer and estrogenic compounds from herbal extracts to identify their structure and to evaluate their pharmacodynamic and pharmacokinetic properties. The following studies will be conducted for all extracts in order to comply with FDA regulatory demands:
| · | Fractionation of Whole Herb Extracts. These studies will be done in order to discover the active components as well as for production markers. |
| | |
| · | Evaluation of the Pharmacokinetic and Metabolism of Isolated Compounds. Since the drugs are designed to have greater selectivity and less toxicity, these studies will allow us to further determine the potential effects. |
| · | Botanical Drug Consistency Measures. Bionovo has developed methods for simultaneous intra batch and inter batch consistency measures using state of the art technology. |
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| · | Biological Measures. Specific biochemical assays will be employed to measure biological specificity and effect. |
We will also repeat all quantifiable biological measures, pertaining to the drug, available through our proposed drug platforms. This will ensure qualitative efficacy control of proposed drugs. By identifying compounds both biologically, as well as pharmacologically, we believe we will be able to overcome any FDA hurdles regarding drug consistency.
Clinical Trials Design
Many companies with good science suffer from a lack of sufficient clinical knowledge, poor clinical trials design expertise or limited access to reputable clinical facilities to conduct their early trials. Since our approach to drug design relies heavily on clinical experience and expertise, in our respective fields, we emphasize sound clinical trial design as one of our strengths.
All of our drug trials follow traditional methods for assessment as well as auxiliary clinical and objective measures in order to strengthen our primary and secondary claims.
Scientific Consultants
We use consultants to provide us with expert advice and consultation on our scientific programs and strategies. They also serve as contacts for us throughout the broader scientific community. We have consulting agreements with a number of academic scientists and clinicians, who collectively serve as our Scientific Advisory Board. These individuals serve as key consultants with respect to our product development programs and strategies. They possess expertise in numerous scientific fields, including pharmacology, cancer, estrogen receptor biology and clinical drug testing.
We retain each consultant according to the terms of a consulting agreement. Under such agreements, we pay them a consulting fee. In addition, some consultants hold options to purchase our common stock, subject to the vesting requirements contained in the consulting agreements. Our consultants are employed by institutions other than ours, and therefore may have commitments to, or consulting or advisory agreements with, other entities or academic institutions that may limit their availability to us.
Research and Development
Our pre-clinical research is conducted at UCSF, UCB and UCHSC. We employ seven full-time individuals and one part-time individual who are active in our research and development activities. We collaborate through academic grants with four separate laboratories in our drug development.
These research and development activities accounted for 90% to 95% of the total staff time during each of those periods. 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.
Intellectual Property and Patent Protection
Patent protection is important to our business. The patent position of companies in the pharmaceutical field generally is highly uncertain, involves complex legal and factual questions, and has recently been the subject of much litigation. Therefore, we cannot assure you that any patent applications relating to our products or processes will result in patents being issued, or that the resulting patents, if any, will provide protection against competitors who successfully challenge our patents, obtain patents that may have an adverse effect on our ability to conduct business, or are able to circumvent our patent position. It is possible that other parties have conducted or are conducting research and could make discoveries of compounds or processes that would precede any of our discoveries. Finally, there can be no assurance that others will not independently develop similar pharmaceutical products which will compete against ours, or cause our drug product candidates and compounds to become obsolete. We have filed four patent applications with the United State Patent & Trademark Office and one patent application with the Taiwan Intellectual Property Office related to our drug candidates, but we cannot be certain that they will issue as patents.
Our competitive position is also dependent upon unpatented trade secrets. We intend to implement a policy of requiring our employees, consultants and advisors to execute proprietary information and invention assignment agreements upon commencement of employment or consulting relationships with us. These agreements will provide that all confidential information developed or made known to the individual during the course of their relationship with us must be kept confidential, except in specified circumstances. However, we cannot assure you that these agreements will provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure of confidential information. Further, invention assignment agreements executed by consultants and advisors may conflict with, or be subject to, the rights of third parties with whom such individuals have employment or consulting relationships. In addition, we cannot assure you that others will not independently develop equivalent proprietary information and techniques or otherwise gain access to our trade secrets, that such trade secrets will not be disclosed, or that we can effectively protect our rights to unpatented trade secrets.
We may be required to obtain licenses to patents or proprietary rights of others. We cannot assure you that any licenses required under any such patents or proprietary rights would be made available on terms acceptable to us or at all. If we do not obtain such licenses, we could encounter delays in product market introductions while we attempt to design around such patents, or could find that the development, manufacture, or sale of products requiring such licenses could be foreclosed. Litigation may be necessary to defend against or assert claims of infringement to enforce patents issued to us or exclusively licensed to us, to protect trade secrets or know-how owned by us, or to determine the scope and validity of the proprietary rights of others. In addition, we may become involved in oppositions in foreign jurisdictions or interference proceedings declared by the United States Patent and Trademark Office to determine the priority of inventions with respect to our patent applications or those of our licensors. Litigation, opposition, or interference proceedings could result in substantial costs to and diversion of effort by, and may have a material adverse impact on, us. In addition, we cannot assure you that our efforts will be successful. See “Risk Factors” in Item 6.
Collaborations
United Biotech Corporation
In November 2003, we granted an exclusive license of our product candidates MF101 and BZL101 to United Biotech Corporation (or UBC), an affiliate of Maywufa Enterprise Group, for Taiwan. The intellectual property in MF101 and BZL101 licensed to UBC was developed by us. The license is non-transferable except to a member of Maywufa Enterprise Group. Under this collaboration, UBC will seek approval from the Taiwan DOH for clinical trials of the product candidates and following approval will conduct such trials, all at UBC’s expense. We will supply MF101 and BZL101 to UBC for the trials at cost, and, generally at our expense, we will also conduct independent quality assurance studies of the product candidates to ensure compliance with U.S. and Taiwan good manufacturing practices and complete Chemistry, Manufacturing and Control (CMC) and absorption, distribution, metabolism, elimination and toxicology (ADMET) studies to satisfy Taiwan DOH guidelines.
UBC paid us a licensing fee of $150,000 upon the execution of the licensing agreement and, following approval to commercially market the product candidates, will pay us royalty fees for its sales of MF101 and BZL101 in Taiwan. The royalty fee rate, however, will be reduced after five years from the time a product candidate was launched in the event no patent is granted in Taiwan for the product. UBC is prohibited from competing with itself in Taiwan with respect to MF101 and BZL101 directly or through a related party. We will remain the owner of all patents, continuations, improvements and all other intellectual property relating to the product candidates.
The licensing agreement with UBC has an initial term of 10 years and will automatically renew for successive 3 year periods unless either party gives 12 months notice of its intention not to renew. The agreement may also be terminated if the applications for necessary approval by Taiwan governmental authorities for the sale of either product candidate are rejected, and upon breach by or winding up of a party.
Other collaborations
We have entered into a number of collaborative relationships with various universities and scientists and clinicians primarily serving on our Scientific Advisory Board. These collaborations do not provide us any revenue but assist us in the pre-clinical and clinical development of our product candidates, by allowing us to investigate certain of their mechanisms, processes and implications.
Government Regulation and Environmental Issues
Regulation by governmental authorities in the United States and foreign countries is a significant factor in the development, manufacture, and expected marketing of our drug product candidates and in our ongoing research and development activities. The nature and extent to which such regulation will apply to us will vary depending on the nature of any products developed. We anticipate that all of our drug product candidates will require regulatory approval by governmental agencies prior to commercialization. In particular, human therapeutic products are subject to rigorous preclinical and clinical testing and other approval procedures of the FDA and similar regulatory authorities in foreign countries. Various federal statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage, and record-keeping related to such products and their marketing. The process of obtaining these approvals and the subsequent compliance with the appropriate federal statutes and regulations requires substantial time and financial resources. Any failure by us or our collaborators to obtain, or any delay in obtaining, regulatory approval could adversely affect the marketing of any products developed by us, our ability to receive product revenues, and our liquidity and capital resources.
The development, manufacture, marketing, and distribution of drug products are extensively regulated by the FDA in the U.S. and similar regulatory agencies in other countries. The steps ordinarily required before a new drug may be marketed in the U.S., which are similar to steps required in most other countries, include:
| · | preclinical laboratory tests, preclinical studies in animals, formulation studies and the submission to the FDA of an investigational new drug application; |
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| · | adequate and well-controlled clinical trials to establish the safety and efficacy of the drug; |
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| · | the submission of a new drug application to the FDA; and |
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| · | FDA review and approval of the new drug application (NDA) or biologics license application (BLA). |
Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal studies. The results of preclinical testing are submitted to the FDA as part of an investigational new drug (IND) application. A 30-day waiting period after the filing of each IND application is required prior to commencement of clinical testing in humans. At any time during the 30-day period or at any time thereafter, the FDA may halt proposed or ongoing clinical trials until the FDA authorizes trials under specified terms. The IND application process may be extremely costly and substantially delay development of our drug product candidates. Moreover, positive results of preclinical tests will not necessarily indicate positive results in subsequent clinical trials. The FDA may require additional animal testing after an initial IND is approved and prior to Phase III trials. These additional studies are customary for drugs intended for use by healthy populations. Our menopausal drug, MF101, may be subjected to such studies, which may delay or damage our ability to complete trials and obtain a marketing license.
Clinical trials to support new drug applications are typically conducted in three sequential phases, although the phases may overlap. During Phase I, clinical trials are conducted with a small number of subjects to assess metabolism, pharmacokinetics, and pharmacological actions and safety, including side effects associated with increasing doses. Phase II usually involves studies in a limited patient population to:
| · | assess the efficacy of the drug in specific, targeted indications; |
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| · | assess dosage tolerance and optimal dosage; and |
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| · | identify possible adverse effects and safety risks. |
If a compound is found to be potentially effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to further demonstrate clinical efficacy and to further test for safety within an expanded patient population at geographically dispersed clinical trial sites.
After successful completion of the required clinical trials, a new drug application (NDA) is generally submitted. The FDA may request additional information before accepting the NDA for filing, in which case the NDA must be resubmitted with the additional information. Once the submission has been accepted for filing, the FDA reviews the NDA and responds to the applicant. FDA requests for additional information or clarification often significantly extend the review process. The FDA may refer the NDA to an appropriate advisory committee for review, evaluation and recommendation as to whether the NDA should be approved, although the FDA is not bound by the recommendation of an advisory committee.
If the FDA evaluations of the application and the manufacturing facilities are favorable, the FDA may issue an approval letter or an “approvable” letter. An approvable letter will usually contain a number of conditions that must be met in order to secure final approval of the NDA and authorization of commercial marketing of the drug for certain indications. The FDA may also refuse to approve the NDA or issue a “not approvable” letter outlining the deficiencies in the submission and often requiring additional testing or information.
The Food and Drug Administration’s Modernization Act codified the FDA’s policy of granting “fast track” approval of cancer therapies and other therapies intended to treat severe or life threatening diseases and having potential to address unmet medical needs. Previously, the FDA approved cancer therapies primarily based on patient survival rates or data on improved quality of life. The FDA considered evidence of partial tumor shrinkage, while often part of the data relied on for approval, insufficient by itself to warrant approval of a cancer therapy, except in limited situations. Under the FDA’s revised policy, which became effective in 1998, the FDA has broadened authority to consider evidence of partial tumor shrinkage or other clinical outcomes for approval. This revised policy is intended to facilitate the study of cancer therapies and shorten the total time for marketing approvals. We intend to take advantage of this policy; however, it is too early to tell what effect, if any, these provisions may have on the approval of our drug product candidates.
Sales outside the United States of products we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources. In most cases, if the FDA has not approved a product for sale in the United States, the product may be exported for sale outside of the United States, only if it has been approved in any one of the following: the European Union, Canada, Australia, New Zealand, Japan, Israel, Switzerland and South Africa. There are specific FDA regulations that govern this process.
We are also subject to various federal, state and local laws, regulations and recommendations relating to safe working conditions, laboratory and manufacturing practices, and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work. We cannot accurately predict the extent of government regulation that might result from future legislation or administrative action.
Manufacturing
We currently have no manufacturing capabilities. To date, we have engaged an overseas manufacturer experienced in FDA Good Manufacturing Practices (or GMP) for drug production, for the supply of our product candidates and other compounds solely for our pre-clinical research and development activities. We have not entered into a formal written agreement with this manufacturer, and submit purchase orders on an as needed basis. We believe that numerous alternative manufacturers exist that would be capable of fulfilling our current product supply needs in the event we were unable to obtain product from our current manufacturer.
In order to successfully commercialize our drug product candidates, we, or third parties with whom we contract, must be able to manufacture products in commercial quantities in compliance with the FDA’s current GMP (or cGMP) at acceptable costs and in a timely manner. As we do not own a cGMP manufacturing facility, we expect to contract with third parties to provide us with cGMP production capacity when appropriate.
Marketing and Sales
We currently have no sales activities, and no employee is engaged in selling any of our products, as we have not received FDA approval to do so. Marketing activities are related to web-site design, and attendance at industry tradeshows and conferences, where we promote the results of our research activities.
Competition
Competition in the pharmaceutical and biotechnology industries is intense. Our competitors include pharmaceuticals companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies that are active in different but related fields represent substantial competition for us. Many of our competitors have significantly greater capital resources, larger research and development staffs and facilities and greater experience in drug development, regulation, manufacturing and marketing than we do. These organizations also compete with us to recruit qualified personnel, attract partners for joint ventures or other collaborations, and license technologies that are competitive with ours. To compete successfully in this industry we must identify novel and unique drugs or methods of treatment and then complete the development of those drugs as treatments in advance of our competitors.
The drugs that we are attempting to develop will have to compete with existing therapies. In addition, a large number of companies are pursuing the development of pharmaceuticals that target the same diseases and conditions that we are targeting. Other companies have products or drug candidates in various stages of pre-clinical or clinical development to treat diseases for which we are also seeking to discover and develop drug candidates. Some of these potential competing drugs are further advanced in development than our drug candidates and may be commercialized earlier.
In particular, there are numerous companies attempting to discover and develop drugs to treat cancer. Many of them are targeting pathways similar to those targeted by us. However, we believe few of the companies are attempting to develop drugs derived from natural products and fewer companies are trying to discover drugs from botanical extracts. Moreover, we are not aware of many companies attempting to discover and develop more selective estrogen receptor modulators.
Our lead product candidate for metastatic breast cancer, BZL101, may be used for patients with either hormone receptor positive of negative tumors, and is designed for use in both premenopausal and postmenopausal patients and patients who are both HER2 positive and 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 MF101. These advantages include: lower pricing, greater efficacy and reduced toxicity.
We believe we posses the competitive advantage of using unique techniques with extracts that are considered to be safe and tolerable in humans. We also believe that finding lead drugs that are orally tolerable and potentially safe from the start of the discovery process provides an advantage in the pharmaceutical industry.
Employees
As of December 31, 2006, we had 19 full time employees and one part time employee, none of whom are represented by a collective bargaining agreement, and we have never experienced a work stoppage. We believe we have good relations with our employees.
Our principal office housing our research and development and administrative functions is located in Emeryville, California. This estimated 9,360 square feet facility is under a long-term lease to us through October 2010. The property is in satisfactory condition for the purpose for which it is used. We also lease 2,767 square feet of laboratory space in Aurora, Colorado, which lease terminates November 2009.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
Market Information
Our shares of common stock are quoted and listed for trading on the OTC Bulletin Board under the symbol “BNVI.OB.”
On February 28, 2007, the closing bid quotation for our common stock was $5.75. The following table sets forth the high and low closing prices for our common stock for the quarterly periods indicated as reported by the OTC Bulletin Board:
| | Years ended December 31, | |
| | 2006 | | 2005 | |
| | High | | Low | | High | | Low | |
First | | $ | 1.15 | | $ | 0.73 | | $ | 1.10 | | $ | 0.11 | |
Second | | | 1.61 | | | 1.00 | | | | | | | |
Second (April 1 to 5, 2005) | | | | | | | | | 1.00 | | | 1.00 | |
Second (April 6 to June 30, 2005) | | | | | | | | | 2.25 | | | 0.75 | |
Third | | | 1.60 | | | 1.18 | | | 2.20 | | | 1.15 | |
Fourth | | | 1.49 | | | 1.08 | | | 1.25 | | | 0.80 | |
The market information for the quarter ending June 30, 2005 is divided at April 6, 2005, the closing date of our reverse merger transaction.
These bid prices represent prices quoted by broker-dealers on the OTC Bulletin Board. The quotations reflect inter-dealer prices, without retail mark-up, mark-down or commissions, and may not represent actual transactions.
As of February 28, 2007, there were approximately 350 holders of record of our common stock.
Dividend Policy
We do not expect to pay a dividend on our common stock in the foreseeable future. The payment of dividends on our common stock is within the discretion of our board of directors, subject to our certificate of incorporation. We intend to retain any earnings for use in our operations and the expansion of our business. Payment of dividends in the future will depend on our future earnings, future capital needs and our operating and financial condition, among other factors.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table sets forth additional information as of December 31, 2006, concerning shares of our common stock that may be issued upon the exercise of options and other rights under our existing equity compensation plans and arrangements, divided between plans approved by our shareholders and plans or arrangements not submitted to the shareholders for approval. The information includes the number of shares covered by, and the weighted average exercise price of, outstanding options and other rights and the number of shares remaining available for future grants excluding the shares to be issued upon exercise of outstanding options, warrants, and other rights.
Plan category | | Shares of common stock issued and shares of common stock to be issued upon exercise of outstanding options | | Weighted-average exercise price of outstanding options | | Number of securities remaining available for future issuance under equity compensation plan (excluding securities reflected in the previous columns) | |
Equity compensation plans approved by stockholders (1) | | | 2,952,254 | | $ | 0.7443 | | | 3,544,534 | |
Equity compensation plans not approved by stockholders | | | 103,212 | | $ | 0.0083 | | | 0 | |
Total | | | 3,055,466 | | $ | 0.7194 | | | 3,544,534 | |
(1) Equity compensation plans approved by shareholders include our 2006 Stock Option Plan.
Recent Sales of Unregistered Securities
On January 19, 2007, we completed a private placement to accredited investors of 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 our 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 us 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.
Item 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes that appear elsewhere in this report. In addition to historical consolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this report, particularly in the section entitled “Risk Factors” set forth later in this Item 6.
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 in order to facilitate our corporate name change from Lighten Up Enterprises International, Inc. to Bionovo, Inc.
Since our future business will be that of Bionovo Biopharmaceuticals only, the information in this annual report is that of Bionovo Biopharmaceuticals as if Bionovo Biopharmaceuticals had been the registrant for all the periods presented in this annual report. Management’s Discussion and Analysis or Plan of Operation and the audited consolidated financial statements presented in this annual 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.
Plan of Operation
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 approximately $10 million from private placements of common stock and warrants in April and May 2005, $864,484 from warrants exercised in the first quarter of 2006, $1,258,024 from warrants exercised in the second quarter of 2006, $87,500 from warrants exercised in the third quarter of 2006, and $43,750 from warrants exercised in the fourth quarter of 2006. In January 2007, we concluded a private placement offering of approximately 10.5 million shares and warrants convertible into approximately 3.68 million shares at an execise price of $2.25 per shares. We received aggregate proceeds of approximately $15 million as result of this financing.
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 December 31, 2006 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 prospectus 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 prospectus do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Research and Development Activities and Cost Allocations
Included in research and development expenses are the following activities and related expenses: basic research and preclinical expense, clinical trials and drug development expense. 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 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.
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.
Prior to December 31, 2006, 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.
Clinical Development Strategy and Ongoing Clinical Programs
Our research and development costs from 2002 to September 30, 2006 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, we plan to enroll the first patient to the dose escalation portion of the Phase I/II study in April 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 cream 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 | | $3.5M | | 180 | | Q1 2006 to | | $40M | | 1,000 | | Q2 2008 to |
| | | | | | | | | | | | Q2 2007 | | | | | | Q4 2009 |
| | | | | | | | | | | | | | | | | | |
BZL101-Metastatic Breast Cancer | | 0 | | 0 | | Completed | | $5.5M | | 100 | | | | $25M | | 480 | | |
| | | | | | | | | | | | | | | | | | |
BZL101-Pancreatic cancer | | $2.0M | | 25 | | | | 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 | | | | 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 | | | | Advancing VG101 to Phase II trials will be based on the results of the Phase I trial and receipt of necessary funding. |
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
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 intellectual property has been completed or services have been rendered; (iii) the fee is fixed or determinable, and (iv) collectibility is reasonably assured.
Drug 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 101 and 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 accordance with SFAS 123(R) and EITF 98-16, and these costs are a component of general and administrative expense. Prior to the adoption of Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment,” (“SFAS 123(R)”), We 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 our statement of operations as the exercise price of our 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, we 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 our 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). We have applied the provisions of SAB 107 in its adoption of SFAS 123(R). We adopted SFAS 123(R) using the modified prospective transition method, which requires the application of the accounting standard as of the beginning of our current year. Our financial statements as of and for the year ended December 31, 2006 reflect the impact of SFAS 123(R). In accordance with the modified prospective transition method, Our 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 period is based on the value of share-based awards that are expected to vest during the period. Stock compensation expense recognized in our statement of operations for 2006 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 SFAS 123(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 (which are currently estimated to be minimal). 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 our 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.
Our determination of estimated fair value of share-based awards utilizes the Black-Scholes option-pricing model. The Black-Scholes model is affected by our stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to, our expected stock price volatility over the term of the awards, and actual and projected employee stock option exercise behaviors.
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 SFAS No. 5.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements to report for the fiscal year ended December 31, 2006 or December 31, 2005. 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 Operation for the fiscal year ended December 31, 2006 compared to the fiscal year ended December 31, 2005.
Revenue, Costs of Revenue and Gross Margins.
A comparison of revenue, costs of revenue, and gross margins for the years ended December 31, 2006 and 2005 are as follows:
| | Fiscal Year Ended December 31, | | | | | |
| | 2006 | | 2005 | | Change | | % Change | |
Revenue | | | | | | | | | |
License | | | 15,000 | | | 15,000 | | | 0 | | | 0 | % |
Total Revenue | | | 15,000 | | | 15,000 | | | 0 | | | 0 | % |
| | | | | | | | | | | | | |
Costs of Revenue | | | | | | | | | | | | | |
License | | | 0 | | | 0 | | | 0 | | | 0 | % |
Total Costs of Revenue | | | 0 | | | 0 | | | 0 | | | 0 | % |
| | | | | | | | | | | | | |
Gross Margin | | | | | | | | | | | | | |
License | | | 15,000 | | | 15,000 | | | 0 | | | 0 | % |
| | | 100.00 | % | | 100.00 | % | | | | | | |
Total Gross Margin | | | 15,000 | | | 15,000 | | | 0 | | | 0 | % |
| | | 100.00 | % | | 100.00 | % | | | | | | |
Revenue was $15,000 for the twelve months ended December 31, 2006, which was the same as the revenue of $15,000 for the twelve months ended December 31, 2005. Revenue for both periods is the result of the licensing agreement with a Taiwan biotech corporation. We do not expect our revenues to have a material impact on our financial results during the remainder of 2007.
Pursuant to our development stage, none of our products have received FDA approval. We will have limited revenue for at least the next 36 months, except for the current licensing arrangement with a Taiwan 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.
Operating Expenses. A comparison of operating expenses for the years ended December 31, 2006 and 2005 are as follows:
| | Fiscal years ended | | | | | |
| | December 31, | | | | | |
| | 2006 | | 2005 | | Change | | % Change | |
Research and development | | | 4,021,149 | | | 1,535,534 | | | 2,485,615 | | | 162 | % |
General and administrative | | | 1,488,225 | | | 982,162 | | | 506,063 | | | 52 | % |
Merger costs | | | - | | | 1,964,065 | | | (1,964,065 | ) | | -100 | % |
Sales and marketing | | | 310,941 | | | 73,736 | | | 237,205 | | | 322 | % |
Total Operating Expenses | | | 5,820,315 | | | 4,555,497 | | | 1,264,818 | | | 28 | % |
Research and development expenses increased $2,485,615 to $4,021,149 for the year ended December 31, 2006, as compared to expenses of $1,535,534 for the same period in 2005. The increase is directly related to advancing the development of our drug candidates. All costs currently incurred in 2006 and 2005, in the research and development of drugs for cancer and women’s health were expensed as incurred.
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, increased by $506,063 to $1,488,225, for the year ended December 31, 2006, as compared to $982,162 for the same period in 2005. The increase for the current year was primarily due to the increase in business activities related to supporting the development of our company.
Merger cost is directly related to the most recent reverse merger and warrants issued to an advisor for services rendered in connection with the reverse merger. Payment was made via a grant of warrants. The cost associated is related to warrants issued for services performed by the advisor relating to the merger that took place in April 2005. We didn’t incur and type of merger cost in 2006. In 2005, we incurred an aggregate of $1,964,065 in merger related expenses. The primary expense being the fair value of warrants granted to consultants and advisors. There were no such merger related costs in 2006.
Sales and marketing expenses include salaries, commissions and expenses of sales and marketing personnel, travel and entertainment, and other selling and marketing costs. Sales and marketing expenses increased by $237,205 to $310,941 for the year ended December 31, 2006, as compared to $73,736 for the same period in 2005. The increase relates to improving the Company's website and attendance at a variety of industry tradeshows and conventions. 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 increased by $94,461, to $242,923 for the year ended December 31, 2006, as compared to $148,462 for the same period in 2005. The increase relates to an increase in the average balance of invested cash and short-term investments. Interest expense in 2006 is derived from leases on laboratory equipment. Interest expense in 2005 was primarily derived from convertible notes issued in 2004, which were converted to equity in April 2005. Interest expense decreased by $26,377 to $47,354 for the year ended December 31, 2006, as compared to $73,731 for the same period in 2005. The decrease relates to not having any convertible note interest expense in 2006. The majority of the convertible notes were converted to equity in April 2005.
Pursuant to registration rights granted to the investors in the Company's April 6, 2005 and May 5, 2005 private placements, we were obligated to file a registration statement with the Securities and Exchange Commission to register the resale of the shares of common stock (including shares of common stock that may be acquired upon exercise of warrants) issued in the private placements within 90 days of April 6, 2005. In addition, we were obligated to have such "resale" registration rights agreement declared effective by the SEC as soon as possible and, in any event, within 180 days (or 210 days if the registration statement is reviewed by the SEC) after April 6, 2005. If the registration statement was not filed or is, for any reason, not declared effective within the foregoing time periods, we were required to pay liquidated damages to such investors. Liquidated damages, if any, were to be paid in cash in an amount equal to 1% of the investor's paid investment for the first 30 days (or part thereof) after the relevant date (i.e., filing date or effective date), and for any subsequent 30-day period (or part thereof) thereafter. On November 2, 2005, the registration statement was declared effective.
Effective December 31, 2005, we and all of the shareholders who received warrants pursuant to the April and May 2005 private placements, agreed to an amendment of the registration rights related to warrants they received. The amended registration rights changed the registration rights from demand with liquidated damages, to piggy-back registration rights, and no liquidated damages. The result of the change is that we are no longer required to record and measure the fair value of the warrants as a derivative liability. The change in fair value of warrant liability of $831,288 for the December 31, 2005 period, is the aggregate change in fair value from the date of issuance through the effective date of the amendment to the registration rights agreement. In addition, we agreed to use our commercially reasonable best efforts to maintain the "resale" registration statement for the period of time originally required by both registration rights agreements.
Pursuant to our development stage, none of our products have received FDA approval. We will have limited revenue for at least the next 36 months, except for the current licensing arrangement with a Taiwan 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
At December 31, 2006 and December 31, 2005, our cash, cash equivalents and short-term investments were equal to $3,055,456 and $6,448,054, 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 fiscal 2006 was from the capital received pursuant to warrants (issued in the April/May 2005 private placement) being exercised. Our primary source of cash during fiscal 2005 was from the capital received pursuant to private placements of common stock, as described below.
In 2006, our cash flow from operating activities was primarily the result of cost incurred in operating our business, our cash flow from investing activities was primarily the result of fixed asset purchases, and our cash flow from financing activities were from warrants exercised.
In 2005, our cash flow from operating activities was primarily the result of cost incurred in operating our business, our cash flow from investing activities was primarily the result of fixed asset purchases, and our cash flow from financing activities were from the private placements that occurred in April/May 2005.
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 $0.54 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 80.96 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.
On January 19, 2007, we 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 our 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 us 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.
At December 31, 2006, we had obligations for leased equipment from various sources as shown below. Interest rates on such debt range from 9% to 10%. We also lease office space and equipment under non-cancelable operating and capital leases with various expiration dates through 2010.
As of December 31, 2006, future minimum lease payments that come due in the current and following fiscal years ending December 30:
Period Ended December 31, 2006 | | Capital Leases | | Operating Leases | |
2007 | | $ | 336,539 | | $ | 516,658 | |
2008 | | | 315,728 | | | 527,393 | |
2009 | | | 0 | | | 533,741 | |
2010 | | | 0 | | | 407,366 | |
2011 and thereafter | | | 0 | | | 0 | |
Total minimum lease payments | | | 652,267 | | $ | 1,985,157 | |
Less: Amount representing interest | | | (59,193 | ) | | | |
Present value of minimum lease payments | | | 593,074 | | | | |
Less: Current portion | | | (292,333 | ) | | | |
Obligations under capital lease, net of current portion | | $ | 300,741 | | | | |
Deferred Revenue Items
We have $102,500 of deferred revenue as of December 31, 2006, compared to $117,500 as of December 31, 2005.
Risk Factors
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 $9.8 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 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; |
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| · | the products, if approved, may not be produced in commercial quantities or at reasonable costs; |
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| · | the potential products, once approved, may not achieve commercial acceptance; |
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| · | regulatory or governmental authorities may apply restrictions to our potential products, which could adversely affect their commercial success; or |
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| · | 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 |
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| · | 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; |
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| · | the scope and results of preclinical testing and human studies; |
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| · | the time and costs involved in obtaining regulatory approvals; |
| · | the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
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| · | competing technological and market developments; |
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| · | our ability to establish additional collaborations; |
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| · | changes in our existing collaborations; |
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| · | the cost of manufacturing scale-up; and |
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| · | 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; |
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| · | withdrawal of the products from the market; |
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| · | voluntary or mandatory recalls; |
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| · | fines; |
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| · | suspension of regulatory approvals; |
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| · | product seizures; or |
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| · | 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; |
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| · | the timing and scope of regulatory approvals for these products; |
| · | the availability and cost of manufacturing, marketing and sales capabilities; |
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| · | the effectiveness of our marketing and sales capabilities; |
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| · | the price of our products; |
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| · | the availability and amount of third-party reimbursement; and |
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| · | 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 three 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; |
| | |
| · | litigation costs; and |
| | |
| · | 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, 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 31% 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 |
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| · | 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 51,660,722 shares (of these shares, 4,875,998 are issuable upon the exercise of outstanding warrants), which is directly related to our reverse merger and April/May 2005 private placement. In February 2007, pursuant to a private placement completed in January 2007, we filed a registration statement covering 14,939,820 additional shares. The current and proposed registration statement represent 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.
Item 7. FINANCIAL STATEMENTS.
The financial statements listed on the index to financial statements on page F-1 are filed as part of this Annual Report on Form 10-KSB.
Not applicable.
(a) Evaluation of Disclosure Controls and Procedures.
As of the end of the period covered by this Annual Report on Form 10-KSB, 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 Annual Report on Form 10-KSB, 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.
None.
PART III
Item 10. EXECUTIVE COMPENSATION.
The information required by this item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2007 Annual Meeting of Stockholders.
The information required by this item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2007 Annual Meeting of Stockholders.
Item 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
The information required by this item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2007 Annual Meeting of Stockholders.
| | Description of Exhibit |
| | |
2.1(1) | | Agreement of Merger and Plan of Reorganization, dated as of April 6, 2005, among Lighten Up Enterprises International, Inc., LTUP Acquisition Corp. and Bionovo, Inc. |
2.2(2) | | Agreement and Plan of Merger, dated as of June 28, 2005, between Lighten Up Enterprises International, Inc. and Bionovo, Inc. |
3.1(3) | | Certificate of Incorporation of Bionovo, Inc. |
3.2(2) | | By-laws of Bionovo, Inc. |
4.1(4) | | Form of Private Placement Warrant |
4.2(9) | | Form of Common Stock Certificate |
| | Description of Exhibit |
4.3(3) | | Form of Bridge Warrant |
4.4(5) | | Form of Private Placement Warrant |
10.1(4) | | Form of Private Placement Subscription Agreement |
10.2(4) | | Form of Private Placement Investor Questionnaire |
10.3(4) | | Form of Private Placement Registration Rights Agreement |
10.4(4) | | Form of Private Placement Acknowledgement and Amendment |
10.5(2) | | Registration Rights Agreement, dated September 30, 2004 |
10.6(10) | | Stock Incentive Plan, as amended |
10.7(11) | | Employment Agreement, dated July 1, 2004, between Bionovo, Inc. and Isaac Cohen |
10.8(11) | | Assignment and Assumption Agreement, dated April 6, 2005, among Registrant, Bionovo, Inc. and Isaac Cohen regarding Employment Agreement |
10.9(11) | | Employment Agreement, dated July 1, 2004, between Bionovo, Inc. and Mary Tagliaferri |
10.10(11) | | Assignment and Assumption Agreement, dated April 6, 2005, among the Registrant, Bionovo, Inc. and Mary Tagliaferri regarding Employment Agreement |
10.11(6) | | Licensing & Technology Transfer Agreement, dated as of November 6, 2003, with United Biotech Corporation (certain terms of this agreement have been omitted and are subject to confidential treatment granted by the SEC) |
10.12(3) | | Sublease, dated as of December 17, 2003, with Extensity |
10.13(3) | | Landlord Consent to Sublease, dated as of December 30, 2003, with Extensity, Inc. and CA-Emeryville Properties Limited Partnership |
10.14(3) | | Addendum to Sublease, dated as of April 20, 2004, with Geac Enterprise Solutions, Inc. |
10.15(3) | | Landlord Consent to Addendum to Sublease, dated July 16, 2004, with CA-Emeryville Properties Limited Partnership and Geac Enterprise Solutions, Inc. |
10.16(3) | | Exchange Agreement, dated as of April 4, 2005, with Mary E. Ross and Gary C. Lewis |
10.17(3) | | Declaration dated as of April 6, 2005 by Mary E. Ross |
10.18(3) | | Declaration dated as of April 6, 2005 by Gary C. Lewis |
10.19(3) | | Office Lease, dated as of July 6, 2005, with Emery Station Joint Venture, LLC |
| | Description of Exhibit |
10.20(3) | | Sublease Agreement, dated as of August 1, 2005, with MycoLogics |
10.21(3) | | Merrill Lynch Bank USA Irrevocable Letter of Credit |
10.22(7) | | First Amendment to Registration Rights Agreement |
10.23(7) | | Amendment to Registration Rights Agreement |
21.1(8) | | Subsidiary of Registrant |
23.1* | | Consent of PMB Helin Donovan, LLP |
31.1* | | Certification of Principal Executive Officer. |
31.2* | | Certification of Principal Executive Officer. |
32.1* | | Section 1350 Certification of Principal Executive Officer. |
32.2* | | Section 1350 Certification of Principal Executive Officer. |
* | Filed herewith. |
| |
(1) | Incorporated by reference from Bionovo, Inc.’s Current Report on Form 8-K filed with the SEC on April 8, 2005. |
| |
(2) | Incorporated by reference from Bionovo, Inc.’s Definitive Proxy Statement on Schedule 14C filed with the SEC on June 3, 2005. |
| |
(3) | Incorporated by reference from Bionovo, Inc.’s Registration Statement on Form SB-2, as amended, initially filed with the SEC on July 5, 2005. |
| |
(4) | Incorporated by reference from Bionovo, Inc.’s Current Report on Form 8-K filed with the SEC on May 11, 2005. |
| |
(5) | Incorporated by reference from Bionovo, Inc.’s Current Report on Form 8-K filed with the SEC on January 22, 2007. |
| |
(6) | Incorporated by reference from Bionovo, Inc.’s Current Report on Form 8-K, as amended and filed with the SEC on October 19, 2005. |
| |
(7) | Incorporated by reference from Bionovo, Inc.’s Current Report on Form 8-K filed with the SEC on March 10, 2006. |
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(8) | Incorporated by reference from Bionovo, Inc.’s Annual Report on Form 10-KSB For the fiscal year ended December 31, 2005 filed with the SEC on March 31, 2006. |
| |
(9) | Incorporated by reference from Exhibit 4 to the Registrant’s Form 10SB 12G filed with the SEC on November 7, 2002. |
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(10) | Incorporated by reference from the Registrant’s Schedule 14A filed with the SEC on April 17, 2006 |
| |
(11) | Incorporated by reference from the Registrant’s Form 8-K/A, Amendment No. 1, filed with the SEC on June 3, 2005) |
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
SIGNATURES
In accordance with Section 13 or 15 (d) of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 14th day of March, 2007.
| | |
| BIONOVO, INC. |
| | |
| By: | /s/ Isaac Cohen |
|
Isaac Cohen |
| President and Chief Executive Officer |
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature | | Title | | Date |
| | | | |
/s/Isaac Cohen | | | | |
Isaac Cohen | | Chairman, President, Chief Executive Officer, | | March 14, 2007 |
| | and Chief Scientific Officer (Principal | | |
| | Executive Officer) | | |
/s/James P. Stapleton | | | | |
James P. Stapleton | | Chief Financial Officer (Principal Financial | | March 14, 2007 |
| | and Accounting Officer) | | |
| | | | |
/s/David Naveh | | | | |
David Naveh | | Director | | March 14, 2007 |
| | | | |
| | | | |
/s/Mary Tagliaferri | | | | |
Mary Tagliaferri | | Director, Vice President, Chief Regulatory | | March 14, 2007 |
| | Officer, Secretary and Treasurer | | |
| | | | |
/s/Michael Vanderhoof | | | | |
Michael Vanderhoof | | Director | | March 14, 2007 |
| | | | |
| | | | |
/s/Frances W. Preston | | | | |
Frances W. Preston | | Director | | March 14, 2007 |
| | | | |
| | | | |
/s/Brooks Corbin | | | | |
Brooks Corbin | | Director | | March 14, 2007 |
Bionovo, Inc. Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm for the Years Ended December 31, 2006 and December 31, 2005 | | F-2 |
Consolidated Balance Sheet as of December 31, 2006 | | F-3 |
Consolidated Statements of Operations for the Years Ended December 31, 2006 and December 31, 2005 and for the period February 1, 2002 (date of inception) to December 31, 2006 | | F-4 |
Consolidated Statement of Stockholder's Deficit for the Years Ended December 31, 2006 and December 31, 2005 and for the period February 1, 2002 (date of inception) to December 31, 2006 | | F-5 |
Consolidated Statements of Cash Flows for the Years Ended December 31, 2006 and December 31, 2005 and for the period February 1, 2002 (date of inception) to December 31, 2006 | | F-6 |
Notes to Consolidated Financial Statements | | F-7 |
Report of Independent Registered Public Accounting Firm
To the Stockholders’
Bionovo, Inc.
Emeryville, California
We have audited the accompanying consolidated balance sheets of Bionovo, Inc. (“BIONOVO”) as of December 31, 2006 and 2005, and the related consolidated statements of operations, stockholders’ equity and cash flows for the years ended December 31, 2006 and 2005. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We did not audit the consolidated financial statements of Bionovo (f/k/a Lighten Up Enterprises International, Inc.) from inception on February 1, 2002 through December 31, 2004. The consolidated financial statements as of December 31, 2004 and for the period from inception on February 1, 2002 through December 31, 2004, were audited by other auditors whose reports reflected a net loss of $593,630 of the total net loss from inception. Those statements were audited by other auditors whose report has been furnished to us, and our opinion, insofar as it relates to the amounts included for such prior periods, is based solely on the report of the other auditors.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statement is free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit includes consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statement. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Bionovo, Inc. as of December 31, 2006 and 2005 and the consolidated results of their operations and their consolidated cash flows for the years ended December 31, 2006 and 2005, in conformity with accounting principles generally accepted in the United States of America.
As discussed in Note 1 to the consolidated financials statements, the Company changed its method of accounting for stock-based compensation upon adoption of Financial Accounting Standards No. 123(R), “Share-Based Payment.”
| | | |
/s/ PMB Helin Donovan, LLP | | | |
PMB Helin Donovan, LLP San Francisco, California March 1, 2007 | | | |
|
(A Development Stage Company) |
Consolidated Balance Sheets |
| | December 31 | | December 31 | |
| | 2006 | | 2005 | |
Assets | | | | | | | |
| | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 2,571,439 | | $ | 4,588,400 | |
Short-term securities | | | 484,017 | | | 1,859,654 | |
Due from officers | | | 1,796 | | | 1,796 | |
Prepaid expenses and other current assets | | | 183,528 | | | 54,926 | |
| | | | | | | |
Total current assets | | | 3,240,780 | | | 6,504,776 | |
| | | | | | | |
Property and equipment, | | | | | | | |
net of accumulated depreciation | | | 1,672,904 | | | 561,578 | |
| | | | | | | |
Other assets: | | | | | | | |
Intangible assets - patent pending, net of amortization | | | 58,613 | | | 27,675 | |
| | | | | | | |
| | $ | 4,972,297 | | $ | 7,094,029 | |
| | | | | | | |
Liabilities and Stockholders' Deficit | | | | | | | |
| | | | | | | |
Current liabilities: | | | | | | | |
Accounts payable and accrued expenses | | $ | 780,393 | | $ | 427,004 | |
Current portion leases | | | 292,333 | | | 108,523 | |
Deferred revenue - current portion | | | 15,000 | | | 15,000 | |
| | | | | | | |
Total current liabilities | | | 1,087,726 | | | 550,527 | |
| | | | | | | |
Long term portion leases | | | 300,741 | | | 239,695 | |
Deferred revenue | | | 87,500 | | | 102,500 | |
| | | | | | | |
Total Liabilities | | | 1,475,967 | | | 892,722 | |
| | | | | | | |
Stockholders' Deficit: | | | | | | | |
Common stock, $0.0001 par value | | | | | | | |
Authorized shares - 100,000,000, issued and outstanding 51,337,224 and, | | | | | | | |
46,112,448 in 2006 and 2005, respectively | | | 5,134 | | | 4,611 | |
Additional paid-in capital | | | 13,340,163 | | | 10,436,099 | |
Deferred Compensation | | | - | | | (8,236 | ) |
Deficit accumulated during development stage | | | (9,848,967 | ) | | (4,231,167 | ) |
| | | | | | | |
Total stockholders' equity (deficit) | | | 3,496,330 | | | 6,201,307 | |
| | | | | | | |
| | $ | 4,972,297 | | $ | 7,094,029 | |
The accompanying notes form an integral part of these consolidated financial statements.
|
(A Development Stage Company) |
Consolidated Statements of Operations |
| | | | | | Accumulated from | |
| | | | | | | |
| | Year ended | | Year ended | | (Date of Inception) | |
| | December 31, | | December 31, | | to | |
| | 2006 | | 2005 | | December 31, 2006 | |
| | | | | | | | | | |
Revenue | | $ | 15,000 | | $ | 15,000 | | $ | 77,740 | |
| | | | | | | | | | |
Cost of sales | | | - | | | - | | | - | |
| | | | | | | | | | |
Gross Profit | | | 15,000 | | | 15,000 | | | 77,740 | |
| | | | | | | | | | |
Operating expenses: | | | | | | | | | | |
Research and development | | | 4,021,149 | | | 1,535,534 | | | 5,854,462 | |
General and administrative | | | 1,488,225 | | | 982,162 | | | 2,783,023 | |
Merger cost | | | - | | | 1,964,065 | | | 1,964,065 | |
Sales and marketing | | | 310,941 | | | 73,736 | | | 385,177 | |
| | | | | | | | | | |
Total operating expenses | | | 5,820,315 | | | 4,555,497 | | | 10,986,727 | |
| | | | | | | | | | |
Loss from operations | | | (5,805,315 | ) | | (4,540,497 | ) | | (10,908,987 | ) |
| | | | | | | | | | |
Other income (expense): | | | | | | | | | | |
Change in fair value of warrant liability | | | - | | | 831,288 | | | 831,288 | |
Unrealized loss on short term securities | | | (18,592 | ) | | (2,259 | ) | | (20,851 | ) |
Loss on sale of assets | | | (4,854 | ) | | | | | (4,854 | ) |
Interest expense | | | (47,354 | ) | | (73,731 | ) | | (150,435 | ) |
Interest income | | | 261,515 | | | 148,462 | | | 410,472 | |
| | | | | | | | | | |
Total other income (expense) | | | 190,715 | | | 903,760 | | | 1,065,620 | |
| | | | | | | | | | |
| | | (5,614,600 | ) | | (3,636,737 | ) | | (9,843,367 | ) |
| | | | | | | | | | |
Provision for income taxes | | | (3,200 | ) | | (800 | ) | | (5,600 | ) |
| | | | | | | | | | |
Net loss | | $ | (5,617,800 | ) | $ | (3,637,537 | ) | $ | (9,848,967 | ) |
| | | | | | | | | | |
Net loss per share basic and diluted | | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.33 | ) |
| | | | | | | | | | |
Weighted average shares outstanding basic and diluted | | | 49,923,115 | | | 40,062,516 | | | 30,193,063 | |
The accompanying notes form an integral part of these consolidated financial statements.
|
(A Development Stage Company) |
Statements of Stockholders' Equity (Deficit) |
Inception through December 31, 2006 |
| | Common | | | | | | Accumulated | | | |
| | Stock | | Additional | | Deferred | | Deficit During | | | |
| | Number of | | Paid-In | | Stock | | Development | | | |
| | Shares | | 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 | ) | $ | - | | $ | - | | $ | - | |
| | | | | | | | | | | | | | | | |
Balance, December 31, 2002 | | | 20,400,000 | | | (2,040 | ) | | - | | | - | | | - | |
| | | | | | | | | | | | | | | | |
Net loss | | | - | | | - | | | - | | | (55,682 | ) | | (55,682 | ) |
| | | | | | | | | | | | | | | | |
Balance, December 31, 2003 | | | 20,400,000 | | | (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 | | | 27,960 | | | | | | (593,630 | ) | | (563,630 | ) |
| | | | | | | | | | | | | | | | |
Issuance of shares for reverse merger | | | 4,000,000 | | | (400 | ) | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Issuance of common stock for funds received by private placement net of financing cost | | | 20,461,000 | | | 9,930,370 | | | - | | | - | | | 9,932,416 | |
| | | | | | | | | | | | | | | | |
Issuance of common stock for conversion on notes payable | | | 1,251,448 | | | 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 | | $ | 10,436,099 | | $ | (8,236 | ) | $ | (4,231,167 | ) | $ | 6,201,307 | |
| | | | | | | | | | | | | | | | |
Issuance of common stock for exercise of warrants | | | 5,024,776 | | | 2,304,555 | | | - | | | - | | | 2,305,058 | |
| | | | | | | | | | | | | | | | |
Issuance of common stock for services | | | 200,000 | | | 164,980 | | | - | | | - | | | 165,000 | |
| | | | | | | | | | | | | | | | |
Amortization of deferred stock compensation | | | - | | | - | | | 8,236 | | | - | | | 8,236 | |
| | | | | | | | | | | | | | | | |
Stock based compensation | | | - | | | 434,529 | | | - | | | - | | | 434,529 | |
| | | | | | | | | | | | | | | | |
Net loss | | | - | | | - | | | - | | | (5,617,800 | ) | | (5,617,800 | ) |
| | | | | | | | | | | | | | | | |
Balance, December 31, 2006 | | | 51,337,224 | | $ | 13,340,163 | | $ | - | | $ | (9,848,967 | ) | $ | 3,496,330 | |
The accompanying notes form an integral part of these consolidated financial statements.
Bionovo, Inc. |
(A Development Stage Company) |
Consolidated Statements of Cash Flows |
| | | | Accumulated from February 1, 2002 | |
| | Years ended | | (Date of | |
| | December 31 | | Inception) to | |
| | 2006 | | 2005 | | December 31, 2006 | |
| | | | | | | | | | |
Cash flows provided by (used for) operating activities: | | | | | | | | | | |
Net loss | | $ | (5,617,800 | ) | $ | (3,637,537 | ) | $ | (9,948,967 | ) |
| | | | | | | | | | |
Adjustments to reconcile net loss to net cash provided by (used for) operating activities: | | | | | | | | | | |
Noncash compensation expense for warrants issued | | | - | | | 1,964,065 | | | 1,964,065 | |
Noncash compensation expense for options issued | | | 434,529 | | | - | | | 464,529 | |
Amortization of note discount | | | - | | | 117,235 | | | 139,084 | |
Amortization of deferred stock compensation | | | 8,236 | | | 8,236 | | | 16,472 | |
Issuance of common stock for services | | | 165,000 | | | - | | | 165,000 | |
Change in fair value of warrant liability | | | - | | | (831,288 | ) | | (831,288 | ) |
Amortization of intangible assets | | | 4,031 | | | 1,042 | | | 5,073 | |
Depreciation | | | 258,571 | | | 23,188 | | | 286,670 | |
Unrealized loss on short term securities | | | 18,592 | | | 2,259 | | | 20,851 | |
Purchases of trading securities - inflows | | | (3,358,955 | ) | | (3,389,654 | ) | | (6,748,609 | ) |
Proceeds of securities of - outflows | | | 4,716,000 | | | 1,530,000 | | | 6,246,000 | |
| | | | | | | | | | |
Changes in assets and liabilities: | | | | | | | | | | |
(Increase) decrease in assets: | | | | | | | | | | |
Prepaid expenses | | | (128,602 | ) | | (54,926 | ) | | (183,796 | ) |
| | | | | | | | | | |
Increase (decrease) in liabilities: | | | | | | | | | | |
Accounts payable and accrued expenses | | | 437,390 | | | 179,389 | | | 763,226 | |
Deferred revenue | | | (15,000 | ) | | (15,000 | ) | | 102,500 | |
Accrued pension payable | | | (84,000 | ) | | 32,000 | | | - | |
| | | | | | | | | | |
Total adjustments | | | 2,455,792 | | | (433,454 | ) | | 2,410,045 | |
| | | | | | | | | | |
Net cash provided by (used for) operating activities | | | (3,162,008 | ) | | (4,070,991 | ) | | (7,439,190 | ) |
| | | | | | | | | | |
Cash flows used for investing activities: | | | | | | | | | | |
Acquisition of intangible assets | | | (34,969 | ) | | (17,435 | ) | | (46,233 | ) |
Acquisition of fixed assets | | | (776,882 | ) | | (218,309 | ) | | (1,009,961 | ) |
Advance to officers | | | - | | | - | | | (1,796 | ) |
| | | | | | | | | | |
Net cash used for investing activities | | | (811,851 | ) | | (235,744 | ) | | (1,057,990 | ) |
| | | | | | | | | | |
Cash flows provided by financing activities: | | | | | | | | | | |
Payments under capital lease obligations | | | (348,160 | ) | | - | | | (348,160 | ) |
Proceeds from issuance of common stock and warrants net of financing cost | | | 2,305,058 | | | 8,749,122 | | | 11,054,180 | |
Proceeds from issuance of common stock | | | - | | | - | | | 500,000 | |
Payments on convertible notes payable | | | - | | | (50,000 | ) | | (50,000 | ) |
Payments for financing costs for convertible notes | | | - | | | - | | | (87,401 | ) |
| | | | | | | | | | |
Net cash provided by financing activities | | | 1,956,898 | | | 8,699,122 | | | 11,068,619 | |
| | | | | | | | | | |
Net increase (decrease) in cash | | | (2,016,961 | ) | | 4,392,387 | | | 2,571,439 | |
| | | | | | | | | | |
Cash, beginning of year | | | 4,588,400 | | | 196,013 | | | - | |
| | | | | | | | | | |
Cash, end of period | | $ | 2,571,439 | | $ | 4,588,400 | | $ | 2,571,439 | |
| | | | | | | | | | |
Supplemental disclosure of cash flow information: | | | | | | | | | | |
Interest paid | | $ | 31,420 | | $ | - | | $ | 134,507 | |
| | | | | | | | | | |
Income taxes paid | | $ | 800 | | $ | 800 | | $ | 4,800 | |
| | | | | | | | | | |
Supplemental disclosure of noncash investing and financing activities- | | | | | | | | | | |
Noncash warrant expense for warrants issued | | $ | - | | $ | 1,964,065 | | $ | 1,964,065 | |
| | | | | | | | | | |
Adjustment in warrant liability | | $ | - | | $ | 7,030,026 | | $ | 7,030,026 | |
| | | | | | | | | | |
Converstion of notes payable to common stock | | $ | - | | $ | 450,000 | | $ | 450,000 | |
| | | | | | | | | | |
Assets acquried under capital lease | | $ | 593,015 | | $ | 356,599 | | $ | 949,614 | |
| | | | | | | | | | |
Stock based compensation | | $ | 434,529 | | $ | - | | $ | 464,529 | |
| | | | | | | | | | |
Conversion of accrued interest payable | | $ | - | | $ | 11,697 | | $ | 11,697 | |
| | | | | | | | | | |
Issuance of common stock with reverse merger | | $ | - | | $ | 400 | | $ | 400 | |
| | | | | | | | | | |
Issuance of common stock for services | | $ | 165,000 | | $ | - | | $ | 165,000 | |
The accompanying notes form an integral part of these consolidated financial statements.
Bionovo, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Formation and Business of the Company:
Bionovo, Inc. (“Bionovo”) was incorporated in Nevada on January 29, 1998 under the name Lighten Up Enterprises International, Inc. On April 6, 2005, Bionovo, Inc.,(formerly known as "Lighten Up Enterprises International, Inc.) acquired all the outstanding shares of Bionovo Biopharmaceuticals, Inc. ("BIOPHARMA"), in exchange for 42,112,448 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 statements 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 Bionovo, Inc., (the legal acquirer, formerly known as “Lighten Up Enterprises International, Inc.) 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 business combination are those of the accounting acquirer.
For purposes of these financial statements, references to the "Company" shall mean Bionovo Inc., (formerly Lighten Up Enterprises, Inc.) and its wholly owned legal subsidiary BIOPHARMA.
Bionovo Biopharmaceuticals, Inc., 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 and tradition substances used in traditional Chinese medicine. The Company is developing drugs to treat breast and ovarian cancers, and for menopause.
History:
Lighten Up Enterprises International, Inc. was formed to engage in the development, publishing, marketing and sale of a cook book of recipes. Lighten Up Enterprises International, Inc., failed to generate adequate revenue from the cook book recipes, and in April 2005, it formally abandoned its efforts related to the development, publishing, marketing and sale of a cook book of recipes. On April 6, 2005, it completed a merger with Bionovo Biopharmaceuticals, Inc., a drug discovery and development company focusing on cancer and women’s health, pursuant to which Bionovo Biopharmaceuticals, Inc.'s business became its sole business.
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, Inc. was Bionovo, Inc. It changed its name to Bionovo Biopharmaceuticals, Inc. in order to facilitate the Company's corporate name change from Lighten Up Enterprises International, Inc. to Bionovo, Inc. The business of Bionovo Biopharmaceuticals, Inc, is now the sole business of the Company.
Merger of Bionovo, Inc. and Bionovo Biopharmaceuticals, Inc.:
BioPharma completed a reverse merger transaction on April 6, 2005 with Lighten Up Enterprises International, Inc., a Nevada corporation formed on January 29, 1998. Until the merger, Lighten Up Enterprises International, Inc., or Lighten Up, had nominal amount of assets and liabilities, Effective with the merger dated, 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. 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, the Company changed its corporate name from Lighten Up Enterprises International, Inc. to Bionovo, Inc. and changed its state of incorporation from Nevada to Delaware. Bionovo Biopharmaceuticals currently remains a wholly-owned subsidiary of Bionovo, Inc.
Basis of Consolidation:
The consolidated financial statements include the accounts of Bionovo, Inc. and its wholly owned subsidiaries Bionovo Biopharmaceuticals Inc. All significant intercompany balances and transactions have been eliminated.
Development Stage Company:
The Company has not generated any significant revenue since inception. The accompanying financial statement has, 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 Chinese 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 and ovarian cancers and to alleviate the symptoms of menopause. The production and marketing of the Company’s products and its ongoing research and development activities will 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.
For the year ended December 31, 2006 and 2005, revenues of $15,000 and $15,000, respectively, were from a license agreement. The Company has no significant operating history and, from February 1, 2002, (inception) to December 31, 2006, has generated a net loss of $9,848,967. The accompanying financial statements for the year ended December 31, 2006, have been prepared assuming the Company will continue as a going concern. During the year 2007, management intends to raise 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.
Liquidity:
The Company has sustained recurring losses and negative cash flows from operations. Over the past year, the Company’s growth has been funded through a combination of private equity, debt, and lease financing. As of December 31, 2006, the Company had $2,571,439 of unrestricted cash and $484,017 in short-term securities. During 2006, the Company obtained financing through exercise of warrants related to private placements from 2005. Additionally, in January 2007, the Company obtained additional financing of approximately $15 million through the sale of its common stock and 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. The Company expects that it will need to raise substantial additional capital to accomplish its business plan over the next several years. In future years, the Company expects to seek to obtain additional funding through private equity. There can be no assurance as to the availability or terms upon which such financing and capital might be available.
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.
Cash and 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 December 31, 2006, 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.
Short-Term Investments:
As part of its cash management program, the Company maintains a portfolio of marketable investment securities. The securities are investment grade and a term to earliest maturity generally of less than one year and may include tax exempt securities, certificates of deposit, and common stock. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. The fair value of substantially all securities is determined by quoted market prices. The estimated fair value of securities for which there are no quoted market prices is based on similar types of securities that are traded in the market.
Property and Equipment:
Property and equipment are recorded at cost. Expenditures for major additions and improvements are capitalized, and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method for financial statement purposes. The Company uses other depreciation methods (generally accelerated) for tax purposes where appropriate. The estimated useful lives for significant property and equipment categories are as follows:
Office and Laboratory equipment | | 3 to 5 years |
Computer equipment and software | | 3 years |
Lease-hold improvements | | term of lease agreement |
As of December 31, 2006, net of accumulated depreciation of $286,670, the Company had $1,674,397 in lab equipment (of which $949,015 is leased), $52,411 of computer equipment, $48,227 in office furniture/equipment, and $184,538 in leasehold improvements. The Company had $258,571 and $23,188 in depreciation and amortization expense in 2006 and 2005, respectively.
Assets Held under Capital Leases:
Assets held under capital leases are recorded at the lower of the net present value of the minimum lease payments or the fair value of the leased asset at the inception of the lease. Amortization expense is computed using the straight-line method over the shorter of the estimated useful lives of the assets or the period of the related lease.
Impairment of Long-Lived Assets:
The Company assesses the impairment of its long-lived assets periodically in accordance with the provisions of Statement of Financial Accounting Standards ("SFAS") 144, "Accounting for the Impairment and Disposal of Long-Lived Assets". Whenever events or changes in circumstances indicate that the carrying amounts of long-lived assets may not be recoverable, the Company will compare undiscounted net cash flows estimated to be generated by those assets to the carrying amount of those assets. When these undiscounted cash flows are less than the carrying amounts of the assets, the Company will record impairment losses to write the asset down to fair value, measured by the discounted estimated net future cash flows expected to be generated from the assets. To date there has been no impairment.
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 capitalized $63,686 in patent licensing costs as of December 31, 2006. Amortization expense charged to operations was $4,031 for 2006 and $1,042 for 2005.
Income Taxes:
The Company accounts for its income taxes using the Financial Accounting Standards Board Statements of Financial Accounting Standards No. 109, “Accounting for Income Taxes,” which requires the establishment of a deferred tax asset or liability for the recognition of future deductible or taxable amounts and operating loss and tax credit carryforwards. Deferred tax expense or benefit is recognized as a result of timing differences between the recognition of assets and liabilities for book and tax purposes during the year.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred tax assets are recognized for deductible temporary differences and operating loss, and tax credit carryforwards. A valuation allowance is established, when necessary, to reduce that deferred tax asset if it is “more likely than not” that the related tax benefits will not be realized.
Deferred Revenue:
Deferred revenue consists of upfront fees received for technology licensing that have not yet been recognized or earned. The Company recognized revenue derived from its licensing in accordance with SAB No. 104. These deferred revenues are recognized on a straight-line basis over the period of the arrangement.
Convertible Notes Payable:
During 2004, the Company had issued convertible debt securities with non-detachable conversion features. The values assigned to the warrants and embedded conversion feature of the Debentures followed the guidance of the EITF Issue No. 98-5, “Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios”, EITF 00-19: “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock”, FAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity” and EITF Issue No. 00-27, “Application of Issue No. 98-5 to Certain Convertible Instruments” of the FASB’s Emerging Issues Task Force. The debt discount associated with the Warrants and embedded conversion feature is amortized to interest expense over the life of the Debenture or upon earlier conversion of the Debenture using the effective yield method. All convertible debentures were either converted or repaid during April 2005.
Stock and Warrants Issued to Third Parties
The Company accounts for stock and stock warrants issued to third parties, including customers, in accordance with the provisions of the Emerging Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services , and EITF 01-9, Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products) . Under the provisions of EITF 96-18, if none of the Company’s agreements have a disincentive for nonperformance, the Company records a charge for the fair value of the stock and the portion of the warrants earned from the point in time when vesting of the stock or warrants becomes probable. EITF 01-9 requires that the fair value of certain types of warrants issued to customers be recorded as a reduction of revenue to the extent of cumulative revenue recorded from that customer. The Company has not given any stock based consideration to a customer.
Stock-Based Compensation:
On January 1, 2006, the Company adopted SFAS 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 shares issued through its employee stock purchase plan, based on estimated fair values. In March 2005, the Securities and Exchange Commission issued Staff Accounting Bulletin 107 (“SAB 107”) relating to SFAS 123(R). The Company has applied the provisions of SAB 107 in its adoption of SFAS 123(R). The Company adopted SFAS 123(R) using the modified prospective transition method, which requires the application of the accounting standard as of the beginning in 2006. The Company’ financial statements as of and for the year ended December 31, 2006 reflect the impact of SFAS 123(R). In accordance with the modified prospective transition method, The Company’ financial statements for prior periods do not include the impact of SFAS 123(R).
Stock compensation expense recognized during the period is based on the value of share-based awards that are expected to vest during the period. Stock compensation expense recognized in The Company’ statement of operations for 2006 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 in 2006 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 SFAS 123(R). As stock compensation expense recognized in the statement of operations is based on awards ultimately expected to vest, it has not been reduced for estimated forfeitures because they are estimated to be neglible. 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.
The Company’ determination of estimated fair value of share-based awards utilizes the Black-Scholes option-pricing model. The Black-Scholes model is affected by The Company’ stock price as well as assumptions regarding certain highly complex and subjective variables. These variables include, but are not limited to, The Company’ expected stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors.
SFAS 123(R) requires the calculation of the beginning balance of the pool of excess tax benefits (additional paid-in capital pool or “APIC pool”) available to absorb tax deficiencies recognized subsequent to its adoption. SFAS 123(R) states that this beginning APIC pool shall include the net excess tax benefits that would have arisen had the company adopted the original Statement 123. FASB Staff Position (“FSP”) 123(R)-3 provides a simplified method for determining this APIC pool, which The Company may elect to adopt up to one year from its initial adoption of SFAS 123(R). The Company has made the decision to elect the simplified method for determining its APIC pool as provided in FSP 123(R)-3. The Company will recognize tax attributes associated with changes in the APIC pool based on provisions in the tax law that identify the sequence in which those amounts are utilized for tax purposes.
Prior to the adoption of SFAS 123(R), The Company accounted for stock-based awards to employees and directors using the intrinsic value method in accordance with Accounting Principles Board Opinion 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 SFAS 123, compensation expense is recorded on the date of grant if the current market price of the underlying stock exceeded the exercise price. Any compensation expense is recorded on a straight-line basis over the vesting period of the grant.
Stock-Based Compensation (Continued):
For grants in 2006, the following assumptions were used: (i) no expected dividends; (ii) a risk-free interest rate of 6.0% (iii) expected volatility 65.0%, and (iv) an expected life of the stated life of the option for options granted in 2006. The fair value was determined using the Black-Scholes option-pricing model.
The estimated fair value of grants of stock options and warrants to nonemployees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under each of the option plans as described above.
Fair Value of Financial Instruments:
The carrying amount of cash equivalents, short-term investments, accounts payable, accrued expenses, warrant liability, and notes payable approximates their fair value either due to the short duration to maturity or a comparison to market interest rates for similar instruments.
Revenue Recognition:
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 (intellectual property) has been completed or services have been rendered; (iii) the fee is fixed or determinable, and (iv) collectibility is reasonably assured.
Technology (Drug) 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 101 and 104, nonrefundable upfront license fees are recognized over the ten year 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 the Company's continuing research and development efforts.
Research and Development:
Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses and allocated facility costs. External expenses consist of costs associated with outsourced clinical research organization activities, sponsored research studies, product registration, and investigator sponsored trials. In accordance with SFAS No. 2, "Accounting for Research Development Costs", all such costs are charged to expense as incurred.
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 years ended December 31, 2006 and 2005, comprehensive loss is equivalent to the Company’s reported net loss. Accordingly, a separate statement of comprehensive loss is not presented.
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.
Basic and Diluted Loss Per Share:
In accordance with SFAS No. 128, "Earnings Per Share," the basic loss per share is computed by dividing the loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Basic net loss per share excludes the dilutive effect of stock options or warrants and convertible notes Diluted net earnings (loss) per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents, consisting of shares that might be issued upon exercise of common stock options and warrants. In periods where losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.
| | Year Ended December 31, | |
| | 2006 | | 2005 | |
Numerator | | | | | | | |
Net Loss | | $ | (5,617,800 | ) | $ | (3,637,537 | ) |
| | | | | | | |
Denominator | | | | | | | |
Weighted average common shares outstanding | | | 49,923,115 | | | 40,062,516 | |
| | | | | | | |
Total shares, basic | | | 51,337,224 | | | 46,112,448 | |
| | | | | | | |
Net loss per common share: | | | | | | | |
Basic and diluted | | $ | (0.11 | ) | $ | (0.09 | ) |
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:
| | Year ended | | Year ended | |
| | December 31, | | December 31, | |
| | 2006 | | 2005 | |
Options to purchase common stock | | | 2,952,254 | | | 2,772,254 | |
Options to purchase common stock - Outside plan | | | 103,212 | | | 103,212 | |
Warrants to purchase common stock | | | 4,832,248 | | | 9,919,524 | |
| | | | | | | |
Potential equivalent shares excluded | | | 7,887,714 | | | 12,794,990 | |
The Company operates in a single business segment that includes the research and development of pharmaceutical drugs.
Reclassifications:
Certain amounts in the prior periods presented have been reclassified to conform to the current period financial statement presentation. These reclassifications have no effect on previously reported net loss.
Recent Accounting Pronouncements:
In February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial Instruments--an amendment of FASB Statements No. 133 and 140. Companies are required to apply Statement 155 as of the first annual reporting period that begins after September 15, 2006. The Company does not believe adoption of SFAS No. 155 will have a material effect on its unaudited condensed consolidated financial position, results of operations or cash flows.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets--an amendment of FASB Statement No. 140. Companies are required to apply Statement 156 as of the first annual reporting period that begins after September 15, 2006. The Company does not believe adoption of SFAS No. 156 will have a material effect on its unaudited condensed consolidated financial position, results of operations or cash flows.
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 will adopt FIN 48 as of January 1, 2007, as required. The Company has determined that there is no impact in adopting FIN 48.
In September 2006, the SEC staff issued Staff Accounting Bulletin No. 108 (SAB 108), “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” which addresses how uncorrected errors in previous years should be considered when quantifying errors in current-year financial statements. SAB 108 requires companies to consider the effect of all carry over and reversing effects of prior-year misstatements when quantifying errors in current-year financial statements and the related financial statement disclosures. SAB 108 must be applied to annual financial statements for the first fiscal year ending after November 15, 2006. We are currently assessing the impact of adopting SAB 108 but do not expect that it will have a material impact on our financial condition or results of operations.
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.
On September 29, 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 No. 158 requires an entity to recognize in its statement of financial position the overfunded or underfunded status of a defined benefit postretirement plan measured as the difference between the fair value of plan assets and the benefit obligation. An entity will be required to recognize as a component of other comprehensive income, net of tax, the actuarial gains and losses and the prior service costs and credits that arise pursuant to FASB Statements No. 87, “Employers’ Accounting for Pensions” and No. 106, “Employers’ Accounting for Postretirement Benefits Other Than Pensions.” Furthermore, SFAS No. 158 requires that an entity use a plan measurement date that is the same as its fiscal year-end. An entity will be required to disclose additional information in the notes to financial statements about certain effects on net periodic benefit cost in the upcoming fiscal year that arise from delayed recognition of the actuarial gains and losses and the prior service costs and credits. The requirement to recognize the funded status of a defined benefit postretirement plan and the related disclosure requirements is effective for fiscal years ending after December 15, 2006. The requirement to change the measurement date to the year-end reporting date is for fiscal years ending after December 15, 2008. We do not anticipate this statement will have any impact on our results of operations or financial condition.
NOTE 2 TRADING SECURITIES:
The Company’s short-term investments comprise equity and debt securities, all of which are classified as trading securities and are carried at their fair value based on the quoted market prices of the securities at December 31, 2006. Net realized and unrealized gains and losses on trading securities are included in net earnings. For purpose of determining realized gains and losses, the cost of securities sold is based on specific identification.
The composition of trading securities, classified as current assets, were all corporate bonds at December 31, 2006, and 2005.
| | Year ended | | Year ended | |
| | December 31, 2006 | | December 31, 2005 | |
| | | Cost | | | Fair Value | | | Cost | | | Fair Value | |
Bonds | | $ | 485,000 | | $ | 484,017 | | $ | 1,861,925 | | $ | 1,859,654 | |
Total trading securities | | $ | 485,000 | | $ | 484,017 | | $ | 1,861,925 | | $ | 1,859,654 | |
Investment income for the years ended December 31, 2006, and 2005 consists of the following:
| | Year ended | | Year ended | |
| | December 31, 2006 | | December 31, 2005 | |
| | | | | |
Dividend and interest income | | $ | 261,515 | | $ | 148,462 | |
Net unrealized holding losses | | | (18,592 | ) | | (2,259 | ) |
Net investment income | | $ | 242,943 | | $ | 146,203 | |
NOTE 3 LICENSE AGREEMENT:
In 2003, the Company entered into a licensing and technology transfer agreement with a Taiwan biotech corporation wherein the rights to certain technology restricted to a certain geographic region were transferred to the Taiwan 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 10% of future sales. The amount received for the license agreement is being recognized on a straight-line basis over the 10 year term. Additional fees may be earned by the Company in the future for additional clinical work.
NOTE 4 BALANCE SHEET COMPONENT:
Accounts Payable and Accrued Liabilities:
A summary is as follows:
| | December 31, | | December 31, | |
| | 2006 | | 2005 | |
Accounts Payable and Accrued liabilities: | | | | | |
| | | | | |
Accounts payable | | $ | 546,909 | | $ | 223,880 | |
Accrued salaries and wages | | | 114,356 | | | 48,913 | |
Accrued pension payable | | | 0 | | | 84,000 | |
Other accrued liabilities | | | 119,128 | | | 70,211 | |
| | | | | | | |
| | $ | 780,393 | | $ | 427,004 | |
NOTE 5 SIMPLIFIED EMPLOYEE PENSION PLAN:
The Company had 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. Effective January 1, 2006, the Company no longer contributes to the Plan. Defined contribution pension expense for the Company was $0 for 2006 and $84,000 for 2005.
NOTE 6 CONVERTIBLE NOTES PAYABLE:
The Company had issued $500,000 of convertible notes payable on September 30, 2004. The notes are secured and bear interest at 6% per annum. Principal and interest was due on September 30, 2005. The notes are convertible into common stock at a conversion price equal to $0.3596 per share of stock at the option of the holder prior to the due date. It had been determined that there was no beneficial element of the conversion feature after the allocation of the warrants, discussed below, as set forth in EITF 00-27, as the conversion feature approximates the fair value of the shares on the date they were issued.
Additionally, the note holders received 556,123 warrants to purchase common stock in connection with the issuance of convertible notes. The warrants are exercisable at $0.5394 per share of stock and are for a term of five years. The fair value attributable to these warrants was $0 as of September 30, 2004. The fair value was determined using Black-Scholes option-pricing method, a 3.50% risk-free interest rate, and 0.0% expected volatility for a nonpublic company.
On April 6, 2005, the holders of convertible promissory notes elected to convert $450,000 of the then outstanding $500,000 convertible promissory notes to common stock pursuant to the terms of the notes. The remaining $50,000 and applicable interest was repaid.
NOTE 7 RECLASSIFICATION OF WARRANT LIABILITY:
Pursuant to registration rights granted to the investors in the Company's April 6, 2005 and May 5, 2005 private placements, the Company was obligated to file a registration statement with the Securities and Exchange Commission to register the resale of the shares of common stock (including shares of common stock that may be acquired upon exercise of warrants) issued in the private placements within 90 days of April 6, 2005. In addition, the Company was obligated to have such "resale" registration rights agreement declared effective by the SEC as soon as possible and, in any event, within 180 days (or 210 days if the registration statement is reviewed by the SEC) after April 6, 2005. If the registration statement was not filed or is, for any reason, not declared effective within the foregoing time periods, the Company was required to pay liquidated damages to such investors. Liquidated damages, if any, were to be paid in cash in an amount equal to 1% of the investor's paid investment for the first 30 days (or part thereof) after the relevant date (i.e., filing date or effective date), and for any subsequent 30-day period (or part thereof) thereafter. On November 2, 2005, the registration statement was declared effective,
Effective December 31, 2005, the Company and all of the shareholders whom received warrants pursuant to the April and May 2005 private placements, agreed to an amendment of registration rights related to warrants they received. The amended registration rights changed the registration rights from demand with liquidated damages, to piggy-back registration rights, and no liquidated damages. The result of the change is that the Company is no longer required to record and measure the fair value of the warrants as a derivative liability. The change in fair value of warrant liability of $831,288 for the December 31, 2005 period, is the change aggregate change in fair value from the date of issuance till the effective date of the amendment to the registration rights agreement.
Accounting guidance requires that warrants with certain types of registration rights must be classified as liabilities. In accordance with Emerging Issues Task Force (EITF) Issue No. 00-19, "Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In a Company's Own Stock," the Company previously reported the fair value of its common stock warrants as a Liability. When the warrant holders approved the amendment to the registration rights agreement and waived the liquidated damage provision, the warrant liability of $7,030,026 was reclassified to equity as additional paid-in capital also pursuant to EITF 00-19.
NOTE 8 EQUITY - COMMON STOCK:
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 we 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.
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. Pursuant to the call notice, warrant holders purchased 2,671,062 shares, warrants exercisable at $0.75 per share represented 2,495,125 shares, while warrants exercisable at $1.00 per share represented 175,937 shares. Warrants representing 62,500 shares exercisable at $0.75 per share, were cancelled, as the warrant holders failed to exercise pursuant to the call notice.
Unrelated to the call notice, during the year ending December 31, 2006, certain warrant holder's exercised common stock purchase warrants representing 2,353,714 shares, for which the Company received $257,776.
Conversion of convertible notes into 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 paid. 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 was repaid from the proceeds of the private placements.
Shares Reserved for Future Issuance:
The Company has reserved shares of common stock for future issuance as follows:
| | December 31 | | December 31 | |
| | 2006 | | 2005 | |
| | | | | |
Stock Option Plan | | | 3,544,534 | | | 3,496,788 | |
Stock Option - outside of plan | | | 103,212 | | | 103,212 | |
Common stock warrants | | | 4,832,248 | | | 9,919,524 | |
| | | | | | | |
| | | 8,479,994 | | | 13,519,524 | |
NOTE 9 COMMITMENTS:
Letter of Credit
Merrill Lynch Bank USA has issued a Letter of Credit to the Company, 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.
Leases
The Company leases certain office and laboratory equipment under agreements that are classified as capital leases. The cost of equipment under capital leases is included in the Balance Sheets as property and equipment and was $949,015 and $356,000 at December 31, 2006 and December 31, 2005, respectively. Accumulated amortization of leased equipment at December 31, 2005 and December 31, 2004, was approximately $130,501 and $4,106, respectively. Amortization of assets under capital leases is included in depreciation expense.
The Company leases its laboratory and office facilities for various terms under long-term, non-cancelable operating lease agreements. The leases expire at various dates through 2010. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties. The leases provide for increases in future minimum annual rental payments. Also, the agreements generally require the Company to pay executory costs (real estate taxes, insurance, and repairs), which are approximately $13,388 per month. Lease expense totaled $228,966 and $51,745 during 2006 and 2005, respectively.
The Company has signed a new premise lease effective October 2006 for 4 years for office and lab space in Emeryville, California. Monthly rents start at $27,161 per month and increase to $33,947 per month in the final year. The Company has signed a new premise lease effective November, 2006 for 3 years for lab space in Aurora, Colorado. Monthly rent is $2,767.
Future minimum lease payments under non-cancelable capital and operating leases are as follows:
Period Ended December 31, 2006 | | Capital Leases | | Operating Leases | |
2007 | | $ | 336,539 | | $ | 516,658 | |
2008 | | | 315,728 | | | 527,393 | |
2009 | | | 0 | | | 533,741 | |
2010 | | | 0 | | | 407,366 | |
2011 and thereafter | | | 0 | | | 0 | |
Total minimum lease payments | | | 652,267 | | $ | 1,985,157 | |
Less: Amount representing interest | | | (59,193 | ) | | | |
Present value of minimum lease payments | | | 593,074 | | | | |
Less: Current portion | | | (292,333 | ) | | | |
Obligations under capital lease, net of current portion | | $ | 300,741 | | | | |
NOTE 10 STOCK OPTIONS:
On April 6, 2005, in connection with the completion of the reverse merger, the board of directors of our company assumed and adopted the Stock Incentive Plan, as amended, of Bionovo Biopharmaceuticals which we refer to as the Plan, and 3,496,788 shares of common stock for issuance under the Plan. In May 2006, shareholders approved an increase of 3,000,000 additional shares for the option plan.
Under the Plan, incentive options to purchase the Company's common stock may be granted to employees at prices not lower than fair market value at the date of grant as determined by the Board of Directors. Non-statutory options (options that do not qualify as incentive options) may be granted to employees and consultants at prices no lower than 85% of fair market value at the date of grant as determined by the Board of Directors. In addition, incentive or non-statutory options may be granted to persons owning more than 10% of the voting power of all classes of stock at prices no lower than 110% of the fair market value at the date of grant as determined by options (no longer than ten years from the date of grant, five years in certain instances). Options granted generally vest at a rate of 50% per year.
Activity under the Plan is as follows:
| | | | | | Weighted | | | |
| | Shares | | Number of | | Average | | | |
| | Available | | Shares | | Exercise | | Aggregate | |
| | For Grant | | Granted | | Price | | Price | |
Balance at December 31, 2004 | | | 1,434,746 | | | 1,565,254 | | $ | 0.54 | | $ | 843,358 | |
| | | | | | | | | | | | | |
Increase in plan | | | 496,788 | | | - | | $ | - | | | - | |
Options granted | | | (1,207,000 | ) | | 1,207,000 | | $ | 0.90 | | $ | 1,086,300 | |
Options exercised | | | - | | | - | | $ | - | | | - | |
Options cancelled | | | - | | | - | | $ | - | | | - | |
Options expired | | | - | | | - | | $ | - | | | - | |
| | | | | | | | | | | | | |
Balance at December 31, 2005 | | | 724,534 | | | 2,772,254 | | $ | 0.68 | | $ | 1,895,374 | |
| | | | | | | | | | | | | |
Increase in plan | | | 3,000,000 | | | - | | $ | - | | | - | |
Options granted | | | (200,000 | ) | | 200,000 | | $ | 1.60 | | $ | 320,000 | |
Options exercised | | | - | | | - | | $ | - | | | - | |
Options cancelled | | | 20,000 | | | (20,000 | ) | $ | 0.90 | | | (18,000 | ) |
Options expired | | | - | | | - | | $ | - | | | - | |
| | | | | | | | | | | | | |
Balance at December 31, 2006 | | | 3,544,534 | | | 2,952,254 | | $ | 0.74 | | $ | 2,197,374 | |
During the year ended December 31, 2006 and 2005, the Company issued options to purchase 200,000 and 1,207,000 shares of common stock, respectively, to its employees and directors. The fair value of each option grant is computed on the date of grant using the Black-Scholes option pricing model.
The following is a summary of changes to outstanding stock options during the fiscal year ended December 31, 2006:
| | | | Weighted | | Weighted Average | | | |
| | Number of | | Average | | Remaining | | Aggregate | |
| | Share | | Exercise | | Contractual | | Intrinsic | |
| | Options | | Price | | Term | | Value | |
Outstanding at December 31, 2005 | | | 2,772,254 | | $ | 0.68 | | | 8.69 | | $ | 4,130,658 | |
Granted | | | 200,000 | | | 1.60 | | | 9.50 | | | 298,000 | |
Exercised | | | - | | | - | | | - | | | - | |
Forfeited or expired | | | 20,000 | | $ | 0.90 | | | 9.50 | | | 29,800 | |
| | | | | | | | | | | | | |
Outstanding at December 31, 2006 | | | 2,952,254 | | $ | 0.74 | | | 8.33 | | $ | 4,398,858 | |
| | | | | | | | | | | | | |
Vested and expected to vest | | | | | | | | | | | | | |
at December 31, 2006 | | | 2,952,254 | | $ | 0.74 | | | 8.33 | | $ | 4,398,858 | |
| | | | | | | | | | | | | |
Options exercisable at December 31, 2006 | | | 2,246,966 | | $ | 0.68 | | | 7.60 | | $ | 3,347,979 | |
At December 31, 2006, there were 3,544,534 shares available for grant under the employee stock option plan.
The table below presents information related to stock option activity for the fiscal ended December 31, 2006 and 2005 (in thousands):
| | Fiscal year ended December 31 | |
| | 2006 | | 2005 | |
| | | | | |
Total intrinsic value of stock options exercised | | $ | — | | $ | — | |
Cash received from stock option exercises | | $ | — | | $ | — | |
Gross income tax benefit from the exercise of stock options | | $ | — | | $ | — | |
The aggregate intrinsic value of $4,398,858 as of December 31, 2006 is based on Bionovo's closing stock price of $1.49 on that date 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 twelve months ended December 31, 2006 was nil as no options were exercised. The total number of in-the-money options exercisable as of December 31, 2006 was $3,347,979.
As of December 31, 2006, the total remaining unrecognized compensation cost related to non-vested stock options and restricted stock awards, net of forfeitures, was approximately $410,534. That cost is expected to be recognized over a weighted-average period of one year.
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 year ended December 31, 2006 which was incurred as follows:
| | Fiscal year ended 31-Dec | |
Research and development | | $ | 213,969 | |
General and administrative | | | 220,561 | |
Stock compensation expense | | | 434,530 | |
The fair values of all stock options granted during the fiscal year ended December 31, 2006 and 2005 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 | | | 65 | % | | 66 - 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 for 2006 was determined using the volatility of the Company's own stock for 2006. Expected volatility for 2005 was determined using an average volatility of a peer group and the volatility of the Company's own stock. In 2005, 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 fiscal year ended December 31, 2006 and 2005 was $0.83 and $0.50 per share, respectively, using the Black-Scholes option pricing model. For the twelve months ended December 31, 2006 the Company granted stock options to employees and directors totaling 200,000 shares.
Prior to January 1, 2006, the Company accounted for its stock options, restricted stock and employee stock purchase plan in accordance with the intrinsic value provisions of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25"). Under APB 25, the difference between the quoted market price as of the date of grant and the contractual purchase price of shares was recognized as compensation expense over the vesting period on a straight-line basis. The Company did not recognize compensation expense in its consolidated financial statements for stock options as the exercise price was not less than 100% of the fair value of the underlying common stock on the date of grant. The following table illustrates the effect on net income and net income per share had the Company recognized compensation expense consistent with the fair value provisions of SFAS No. 123 "Accounting for Stock-Based Compensation" prior to the adoption of SFAS 123R:
| | 2005 | |
| | | |
Net income (loss) as reported | | $ | (3,637,537 | ) |
Compensation recognized under APB 25 | | | — | |
Compensation recognized under SFAS 123 | | | (6,472 | ) |
| | | | |
Pro-forma net loss | | $ | (3,644,009 | ) |
| | | | |
Net loss per share: | | | | |
Basic and diluted — as reported | | $ | (0.09 | ) |
Basic and diluted — pro-forma | | $ | (0.09 | ) |
For grants in 2005, the following assumptions were used: (i) no expected dividends; (ii) a risk-free interest rate of 5.0%; (iii) expected volatility 66% to 90.0%; and (iv) an expected life of the stated life of the option for options granted in 2005. The fair value was determined using the Black-Scholes option-pricing model.
The estimated fair value of grants of stock options and warrants to nonemployees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under each of the option plans as described above.
Total options under the Plan at December 31, 2005, comprised the following:
| | Number | | Weighted | | Number | |
| | Outstanding | | Average | | Exercisable | |
Option | | as of | | Remaining | | as of | |
Exercise | | December 31 | | Contractual life | | December 31 | |
Price | | 2005 | | (Years) | | 2005 | |
| | | | | | | |
$ 0.292 | | | 905,254 | | | 8.50 | | | 599,254 | |
$ 0.833 | | | 732,000 | | | 8.33 | | | 531,000 | |
$ 0.900 | | | 1,135,000 | | | 10.00 | | | - | |
| | | | | | | | | | |
Total | | | 2,772,254 | | | 8.94 | | | 1,130,254 | |
| | | | | | | | | | |
Total options under the Plan at December 31, 2006, comprised the following:
| | Number | | Weighted | | Number | |
| | Outstanding | | Average | | Exercisable | |
Option | | as of | | Remaining | | as of | |
Exercise | | December 31 | | Contractual life | | December 31 | |
Price | | 2006 | | (Years) | | 2006 | |
| | | | | | | |
$ 0.292 | | | 905,254 | | | 7.50 | | | 854,254 | |
$ 0.833 | | | 732,000 | | | 7.33 | | | 732,000 | |
$ 0.900 | | | 1,115,000 | | | 9.00 | | | 557,500 | |
$ 1.600 | | | 200,000 | | | 9.50 | | | - | |
| | | | | | | | | | |
Total | | | 2,952,254 | | | 8.33 | | | 2,143,754 | |
The following warrants are each exercisable into one share of common stock:
| | | | Weighted | | | |
| | | | Average | | | |
| | Number of | | Exercise | | Aggregate | |
| | Shares | | Price | | Price | |
| | | | | | | |
Balance at December 31, 2004 | | | 556,123 | | $ | 0.53952 | | $ | 300,039 | |
- | | | | | | - | | | - | |
Warrants granted | | | 9,363,401 | | $ | 0.5993 | | $ | 5,611,306 | |
Warrants exercised | | | - | | | - | | | - | |
Warrants cancelled | | | - | | | - | | | - | |
Warrants expired | | | - | | | - | | | - | |
| | | | | | | | | | |
Balance at December 31, 2005 | | | 9,919,524 | | $ | 0.5959 | | $ | 5,911,345 | |
| | | | | | | | | | |
Warrants granted | | | - | | $ | - | | $ | - | |
Warrants exercised | | | 5,024,776 | | | 0.67 | | | 2,305,244 | |
Warrants cancelled | | | 62,500 | | | 0.75 | | | - | |
Warrants expired | | | | | | - | | | - | |
| | | | | | | | | | |
Balance at December 31, 2006 | | | 4,832,248 | | $ | 0.74 | | $ | 3,559,357 | |
The common stock warrants are comprised of the following:
| | Number | | Weighted | |
| | Outstanding | | Average | |
| | as of | | Remaining | |
| | December 31 | | Contractual life | |
| | 2005 | | (Years) | |
| | | | | |
$ 0.010 | | | 1,979,630 | | | 3.75 | |
$ 0.360 | | | 132,421 | | | 4.25 | |
$ 0.500 | | | 2,136,100 | | | 4.25 | |
$ 0.539 | | | 556,123 | | | 4.25 | |
$ 0.750 | | | 2,557,625 | | | 4.25 | |
$ 1.000 | | | 2,557,625 | | | 4.25 | |
| | | | | | | |
Total | | | 9,919,524 | | | | |
| | Number | | Weighted | |
| | | | Average | |
| | | | Remaining | |
Exercise | | December 31 | | Contractual life | |
Price | | 2006 | | (Years) | |
| | | | | |
$ 0.010 | | | - | | | - | |
$ 0.360 | | | - | | | - | |
$ 0.500 | | | 2,033,500 | | | 3.25 | |
$ 0.539 | | | 556,123 | | | 3.25 | |
$ 0.750 | | | - | | | - | |
$ 1.000 | | | 2,242,625 | | | 3.25 | |
| | | | | | | |
Total | | | 4,832,248 | | | | |
During the following fiscal years, the numbers of warrants to purchase common stock which will expire in the next five years if unexercised are:
Fiscal Year | | | |
Ending December 31, | | Number | |
| | | |
2007 | | | - | |
2008 | | | - | |
2009 | | | 556,123 | |
2010 | | | 4,276,125 | |
2011 | | | - | |
| | | | |
| | | 4,832,248 | |
The estimated fair value of the warrants was calculated using the Black-Scholes valuation model. For grants in 2005 the following assumptions were used: (i) no expected dividends, (ii) risk free interest rate of 4.0%, (iii) expected volatility of 90%, and (iv) expected life in the stated life of the warrant. The fair value of the warrants ranged from $0.62 to $0.89. No warrants were granted in 2006.
In September 2004, In connection with Bionovo Biopharmaceuticals’ $500,000 principal amount of 6% convertible secured notes bridge financing completed on September 30, 2004, Bionovo Biopharmaceuticals issued to investors in the bridge financing warrants, or bridge warrants, exercisable for 556,123 shares of Bionovo Biopharmaceuticals common stock at an exercise price of $0.53 per share. The bridge warrants were exercisable until the earlier of September 30, 2011 and the fifth anniversary of Bionovo Biopharmaceuticals’ merger with a company required to file reports pursuant to Section 13(a) or 15(d) of the Exchange Act. Upon the closing of our reverse merger transaction, the bridge warrants were amended to become bridge warrants to purchase shares of our common stock upon the same terms and conditions as the bridge warrants issued by Bionovo Biopharmaceuticals. The bridge warrants expire on April 6, 2010.
In connection with the closing of the bridge financing, Bionovo Biopharmaceuticals issued five-year warrants to Duncan Capital, LLC as partial compensation for acting as placement agent in the transaction. Upon the closing of our reverse merger transaction, these placement agent warrants were amended to become warrants to purchase shares of our common stock upon the same terms and conditions as the placement agent warrants issued in the bridge financing by Bionovo Biopharmaceuticals. The bridge placement agent warrants are exercisable in whole or in part, at an exercise price of $0.35 per share, before September 30, 2009 for up to 132,421 shares of common stock. These warrants contain provisions that protect the holders thereof against dilution by adjustment of the purchase price in certain events, such as stock splits or reverse stock splits, stock dividends, recapitalizations or similar events. The holders of these warrants will not possess any rights as stockholders unless and until they exercise their warrants. The bridge placement agent warrants do not confer upon holders any voting or any other rights as stockholders.
In April 2005, as part of the closing of Bionovo Biopharmaceuticals’ April 6, 2005 private placement, Bionovo Biopharmaceuticals issued five-year warrants to purchase a total of 2,023,875 shares of Bionovo Biopharmaceuticals common stock at an exercise price of $0.75 per share and 2,023,875 shares of Bionovo Biopharmaceuticals common stock at an exercise price of $1.00 per share. The warrants were exercisable in whole or in part until April 6, 2010. Upon the closing of our reverse merger transaction, the April 2005 private placement warrants were amended to become warrants to purchase shares of our common stock upon the same terms and conditions as the April 2005 private placement warrants issued by Bionovo Biopharmaceuticals.
In connection with the closing of the April 2005 private placement, Bionovo Biopharmaceuticals issued five-year warrants to Duncan Capital, LLC as partial compensation for acting as placement agent in the transaction. Upon the closing of our reverse merger transaction, these placement agent warrants were amended to become warrants to purchase shares of our common stock upon the same terms and conditions as the placement agent warrants issued in the April 2005 private placement by Bionovo Biopharmaceuticals. The April 2005 placement agent warrants are exercisable in whole or in part, at an exercise price of $0.50 per share, before April 6, 2010 for up to 1,709,100 shares of common stock. These warrants contain provisions that protect the holders thereof against dilution by adjustment of the purchase price in certain events, such as stock splits or reverse stock splits, stock dividends, recapitalizations or similar events. The holders of these warrants will not possess any rights as stockholders unless and until they exercise their warrants. The April 2005 placement agent warrants do not confer upon holders any voting or any other rights as stockholders.
In connection with the closing of our reverse merger transaction on April 6, 2005, we 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. These warrants contain provisions that protect the holders thereof against dilution by adjustment of the purchase price in certain events, such as stock splits or reverse stock splits, stock dividends, recapitalizations or similar events. The holders of these warrants will not possess any rights as stockholders unless and until they exercise their warrants. The reverse merger warrants do not confer upon holders any voting or any other rights as stockholders.
In May 2005, as part of the closing of our May 5, 2005 private placement, we issued five-year warrants to purchase a total of 533,750 shares of common stock at an exercise price of $0.75 per share and 533,750 shares of common stock at an exercise price of $1.00 per share. The warrants are exercisable in whole or in part until May 5, 2010.
In connection with the closing of our May 2005 private placement, we issued five-year warrants to Duncan Capital, LLC as partial compensation for acting as placement agent in the transaction. These May 2005 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 427,000 shares of common stock. These warrants contain provisions that protect the holders thereof against dilution by adjustment of the purchase price in certain events, such as stock splits or reverse stock splits, stock dividends, recapitalizations or similar events. The holders of these warrants will not possess any rights as stockholders unless and until they exercise their warrants. The May 2005 placement agent warrants do not confer upon holders any voting or any other rights as stockholders.
The provision for income taxes on the statements of operations consists of $3,200 and $800 for the years ended December 31, 2006 and 2005, respectively.
Deferred tax assets (liabilities) are comprised of the following at December 31:
| | 2006 | | 2005 | |
Net operating loss carryforward | | $ | 3,225,000 | | $ | 458,000 | |
Depreciation and amortization | | | (50,000 | ) | | - | |
Deferred revenue | | | - | | | 40,000 | |
| | | 3,175,000 | | | 498,000 | |
Less valuation allowance | | | (3,175,000 | ) | | (498,000 | ) |
| | $ | - | | $ | - | |
Deferred taxes arise from temporary differences in the recognition of certain expenses for tax and financial reporting purposes. At December 31, 2006 and 2005, management determined that realization of these benefits is not assured and has provided a valuation allowance for the entire amount of such benefits. At December 31, 2006, net operating loss carryforwards were approximately $8,111,000 for federal tax purposes that expire at various dates from 2023 through 2026 and $8,050,000 for state tax purposes that expire in 2014 through 2016 .
Utilization of net operating loss carryforwards may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986, as amended, and similar state regulations. The annual limitation may result in the expiration of substantial net operating loss carryforwards before utilization.
The provision for income taxes differs from the amount computed by applying the U.S. federal statutory tax rate (34% in 2006 and 2005) to income taxes as follows:
| | December 31, 2006 | | December 31, 2005 | |
Tax benefit computed at 34% | | $ | (1,909,000 | ) | $ | (1,236,000 | ) |
Change in valuation allowance | | | 2,677,000 | | | 305,000 | |
Change in carryovers and tax attributes | | | (764,800 | ) | | 931,800 | |
| | $ | 3,200 | | $ | 800 | |
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 closing date (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.
The following Proforma Balance sheet is presented to reflect solely the January 2007 private placement:
Bionovo, Inc. |
(A Development Stage Company) |
Consolidated Balance Sheets - Proforma |
| | | | Private Placement | |
| | December 31 | | January 19 | | | |
| | 2006 | | 2007 | | | |
Assets | | | | | | | |
| | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 2,571,439 | | | 14,505,891 | | | 17,077,330 | |
Short-term securities | | | 484,017 | | | | | | 484,017 | |
Due from officers | | | 1,796 | | | | | | 1,796 | |
Prepaid expenses and other current assets | | | 183,528 | | | | | | 183,528 | |
| | | | | | | | | | |
Total current assets | | | 3,240,780 | | | | | | 17,746,671 | |
| | | | | | | | | | |
Property and equipment, | | | | | | | | | | |
net of accumulated depreciation | | | 1,672,904 | | | | | | 1,672,904 | |
| | | | | | | | | | |
Other assets: | | | | | | | | | | |
Intangible assets - patent pending, net of amortization | | | 58,613 | | | | | | 58,613 | |
| | | | | | | | | | |
| | $ | 4,972,297 | | | | | $ | 19,478,188 | |
| | | | | | | | | | |
Liabilities and Stockholders' Deficit | | | | | | | | | | |
| | | | | | | | | | |
Current liabilities: | | | | | | | | | | |
Accounts payable and accrued expenses | | | 780,393 | | | | | | 780,393 | |
Current portion leases | | | 292,333 | | | | | | 292,333 | |
Deferred revenue | | | 15,000 | | | | | | 15,000 | |
| | | | | | | | | | |
Total current liabilities | | | 1,087,726 | | | | | | 1,087,726 | |
| | | | | | | | | | |
Long term portion leases | | | 300,741 | | | | | | 300,741 | |
Deferred revenue | | | 87,500 | | | | | | 87,500 | |
| | | | | | | | | | |
Total Liabilities | | | 1,475,967 | | | | | | 1,475,967 | |
| | | | | | | | | | |
Stockholders' Deficit: | | | | | | | | | | |
Common stock, $0.0001 par value | | | | | | | | | | |
Authorized shares - 100,000,000, issued and outstanding 51,337,224, and | | | | | | | | | | |
61,858,224 in 2006 and 2006 proforma, respectively | | | 5,134 | | | 1,052 | | | 6,186 | |
Additional paid-in capital | | | 13,340,163 | | | 14,504,839 | | | 27,845,002 | |
Deferred Compensation | | | - | | | | | | | |
Deficit accumulated during development stage | | | (9,848,967 | ) | | | | | (9,848,967 | ) |
| | | | | | | | | | |
Total stockholders' equity | | | 3,496,330 | | | | | | 18,002,221 | |
| | | | | | | | | | |
| | $ | 4,972,297 | | | | | $ | 19,478,188 | |
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT
In connection with the Annual Report on Form 10-KSB of Bionovo, Inc. (the “Company”) for the fiscal year ended December 31, 2006, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies, pursuant to 18 U.S.C. Section 1350:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and