EMERYVILLE, Calif., March 15, 2011 /PRNewswire/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced financial results for the year ended December 31, 2010.
"2010 was a year of important progress, especially on the regulatory front," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "Bionovo advanced the lead drug Menerba with both the FDA and EMA. Reaching agreement with the Agencies on the CMC and the overall clinical development plan to NDA clears the way forward and provides accurate development costs and timelines to potential partners. We expect to be able to initiate the Phase 3 clinical trials for Menerba early in the 3rd quarter of this year.
Key Events and Milestones
- In 2010, the Company announced the following regarding Menerba™, its lead drug candidate for the treatment of menopausal hot flashes:
- In December, the Company received minutes from its successful meeting with the FDA in November, confirming agreements reached on the clinical development plan for Menerba.
- In September, an "End of Phase 2" Type B meeting with the FDA resulted in a binding agreement on the Chemistry, Manufacturing and Control (CMC) plan for Menerba.
- In July, the Company received formal guidance from the European Medicines Agency (EMA), defining and approving a regulatory pathway to marketing approval for Menerba in Europe.
- The Company also had continued progress in terms of basic science and other pipeline candidates:
- Studies were published describing:
- how metabolic adaptability contributes to the metastasis of tumors. This work is integral to the Company's development of drugs that disrupt metabolic pathways as a mechanism.
- the cancer prevention mechanism of estrogen receptor beta. As a leading pharmaceutical company in the mediation of estrogen receptors, such studies are critical for potential new products for the Company.
- potential estrogen receptor modulating drugs for treating menopausal conditions. This is, essentially, a potential roadmap for further pipeline candidates in the Bionovo women's health platform.
- Menerba's effect on neural pathways related to temperature regulation, further strengthening the Company's understanding of the mechanism of action for Menerba.
- the discovery of distinct classes of genes regulated by estrogen receptor beta, adding even more to Bionovo's demonstrated understanding of the mechanisms of estrogen receptors.
- A proprietary, innovative method of high throughput LC-MS/MS tandem quantification of multiple bioactive compounds was described, which is essential to the development of Menerba.
- A fundamental patent was issued for Bezielle™ in the treatment of metastatic breast cancer.
- Studies were published describing:
- In 2010, the Company was active in accessing the capital markets and government grants for needed funding:
- In December, the Company filed its intent with the SEC to launch a fully committed underwritten public offering. This offering closed in February 2011 for a total of $27.4 million in net proceeds.
- In November, the Company announced that it had received a Qualifying Therapeutic Discovery Program (QTDP) grant of $489,000 from the federal government for the Menerba and Bezielle programs.
- In October, the Company announced the closing of a registered direct offering with select investors for net proceeds of $2.5 million. Although not noted at the time, these fundamental investors were integral to the later, larger, underwritten offering that closed in February of 2011.
- In September, the Company announced that it had received an NIH grant of $174,000 to develop drugs for the treatment of female-specific obesity and metabolic syndrome.
- In July, Bionovo entered into a $15 million, at-the-market firm commitment financing agreement with Aspire Capital. Although the Company has not yet accessed this facility, it is still available under the original conditions. Further, Aspire Capital participated in the underwritten offering that closed in February, 2011.
- The Company also announced additions to its network of advisors and consultants, including leading healthcare professionals with extensive experience in the development of therapeutic treatments:
- Dr. Richard Weiner, PhD, Emeritus Professor in the Department of Obstetrics, Gynecology and Reproductive Sciences, at the University of California, San Francisco.
- Dr. Paul Pui-Hay But, PhD, Chief Scientist for the Food and Drug Authentication Laboratory Ltd., Hong Kong, China.
Full Year Results
For the year ended December 31, 2010 total revenues were $0.6 million compared with $0.3 million for the same period in 2009. Revenues in 2010 consisted of a Qualifying Therapeutic Discovery Project Credit of $0.5 million and $0.1 million in a National Institute of Health (NIH) grant drawdown. Revenue in 2009 was comprised of approximately $55,000 in limited research services revenue combined with $0.2 million in NIH grant drawdown.
For the year ended December 31, 2010 total operating expenses were $18.2 million compared with $16.6 million for the same period in 2009. The increase in 2010 operating expenses were primarily due to additional expenses to support our Menerba manufacturing process development.
The net loss for the year ended December 31, 2010 was $17.7 million, or $0.80 per share, compared with a net loss of $16.4 million, or $0.98 per share, for the same period in 2009. The year-over-year increase in net loss was driven primarily by the expenses related to the Menerba manufacturing process development and 2010 director and employee performance bonuses.
As of December 31, 2010, cash, cash equivalents and short-term investments totaled approximately $2.6 million compared to $15.9 million at December 31, 2009. The decrease is due to the public offering completed in October of 2009 resulting in net proceeds of $17.4 million, whereas the public offering completed in October 2010 generated net proceeds of $2.5 million. The net cash used in operating activities for 2010 was $14.2 million, compared with $13.3 million in 2009.
On February 10th, the Company laid out key milestones for 2011, which are reiterated here:
Manufacture of drug material at higher potency for clinical and non-clinical testing.
Early first quarter. Completed.
Conduct a 40 patient, 28-day "tolerability" trial at higher doses planned for later studies.
Late first quarter, early second quarter.
Non-clinical study for toxicity in rodents.
Late first quarter, early second quarter.
Manufacture of clinical material for Phase 3 study, using FDA-approved commercial process.
Complete contracts, IRB approval and training at U.S. clinical sites for the Phase 3 study.
First and second quarter.
Initiate patient recruitment and screening in the Phase 3 study.
End of the second quarter.
Initiate dosing in the Phase 3 study.
Early in the third quarter.
Data Safety Monitoring Board interim reviews of Phase 3 data.
Five reviews are planned during the course of the Phase 3 study.
Completion of recruitment for the Phase 3 study.
Anticipated by the end of the second quarter, 2012.
Data available from the Phase 3 study.
Anticipated by the end of the fourth quarter, 2012.
Bionovo will conduct a conference call and webcast to review the Company's financial results and plans for 2011. Interested parties can access the call by dialing 1-888-428-7458, or can listen via a live audio only webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available by dialing 1-888-632-8973 or 1-585-295-6791 (replay code: 71929604#) through March 18, 2011 or via audio webcast at http://bionovo.com/investors/events beginning on March 16, 2011.
The Company also announced today that, on March 14, 2011, the company received a letter from Nasdaq stating that, for the last 30 consecutive business days, the bid price of its common stock has closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market. The letter further stated that the company has been provided a period of 180 calendar days, or until September 12, 2011, to regain compliance. If, at anytime before September 12, 2011, the bid price of the common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will provide written notification that compliance has been regained, and this matter will be closed.
In the event the Company does not regain compliance with the Rule within the 180 day period, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split if necessary. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days, or until March 14, 2012.
For further information on the relevant Nasdaq rules, please consult Nasdaq Listing Rules 5550(a)(2) – bid price, 5810(c)(3)(A) – compliance period, 5810(b) – public disclosure, and 5505 – Capital Market criteria.
The deficiency letter has no effect on the listing of the company's common stock at this time and its common stock will continue to trade on the Nasdaq Capital Market under the symbol "BNVI".
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Financial Tables on Following Pages
(A Development Stage Company)
Consolidated Statements of Operations
Three months ended December 31,
Twelve months ended December 31,
Accumulated from February 1, 2002 (Date of inception) to December 31,
(in thousands, except per share data)
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Change in fair value of warrant liability
Total other income (expense)
Loss before income tax
Income tax provision
Basic and diluted net loss per common share
Shares used in computing basic and diluted net loss per share
(A Development Stage Company)
Consolidated Balance Sheets
(in thousands, except share amounts)
Cash and cash equivalents
Other current assets
Total current assets
Property and equipment, net
Patents pending, net
LIABILITIES AND SHAREHOLDERS’ EQUITY
Accrued compensation and benefits
Current portion of capital lease obligations
Current portion of notes payable
Other current liabilities
Total current liabilities
Non-current portion of capital lease obligations
Non-current portion of notes payable
Commitments and contingencies
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding
Common stock $0.0001 par value, 340,000,000 shares authorized, 24,530,112 and 21,503,738 shares outstanding at December 31, 2010 and 2009, respectively
Additional paid-in capital
Accumulated other comprehensive (loss) income
Total shareholders’ equity
Total liabilities and shareholders’ equity
See accompanying notes to these consolidated financial statements
* The balance sheet at December 31, 2009 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
SOURCE Bionovo, Inc.