EMERYVILLE, Calif., March 15 /PRNewswire-FirstCall/ -- Bionovo, Inc. today announced financial results for the year ended December 31, 2009.
“2009 was a year of continued regulatory progress and scientific discovery,” said Isaac Cohen, O.M.D., Bionovo’s Chairman and Chief Executive Officer. “We have primarily focused on accomplishing the many tasks necessary for the progression of our menopausal hot flash drug candidate, Menerba, to the next level of clinical development. Specifically, we believe we have all the necessary manufacturing process controls and analytical methods in place for consistent production of the drug. 2010 is poised to be an eventful year for Bionovo as we expect to be able to initiate the next stage of clinical trials for Menerba by mid-year.”
Dr. Cohen continued, “In addition to our efforts to move Menerba through the approval process we completed many important scientific and clinical tasks supporting our cancer drug candidate portfolio. We can now confidently assert that we have a robust drug pipeline with multiple, validated drug candidates in both cancer treatment and women’s health. Since Bionovo is engaged in its own discovery and development process, it should be noted that we own 100% of the rights on all of our drug candidates.”
Mary Tagliaferri, M.D., Bionovo’s President and Chief Medical Officer, added, “The accomplishments of the Bionovo team have clearly been recognized by the scientific and clinical community, as more and more key opinion leaders become educated and involved in our exciting future. We look forward to 2010 as a year for pivotal clinical progress and commercial partnering development.”
Key Events and Milestones
Full Year Results
For the year ended December 31, 2009 total revenues were $0.3 million compared with $0.2 million for the same period in 2008. Revenues in 2009 consisted of a National Institute of Health (NIH) grant drawdown combined with approximately $55,000 in limited research services revenue, whereas revenues in 2008 included only the NIH grant.
For the year ended December 31, 2009 total operating expenses were $16.6 million compared with $17.5 million for the same period in 2008. The decrease in 2009 operating expenses are primarily due to decreases in clinical trial expenses partially offset by increases in expenses to support our Menerba manufacturing process development.
The net loss for the year ended December 31, 2009 was $16.4 million, or $0.20 per share, compared with a net loss of $16.7 million, or $0.22 per share, for the same period in 2008. The year-over-year decrease in net loss was driven primarily by the decreased activity related to our clinical trials.
As of December 31, 2009, cash, cash equivalents and short-term investments totaled approximately $15.9 million compared to $13.6 million at December 31, 2008. The increase is due to the public offering completed in October of 2009 resulting in net proceeds of $17.4 million, partially offset by cash used in operating activities. The net cash used in operating activities for 2009 was $13.3 million, compared with $15.3 million in 2008.
2010 Expense and Cash Guidance
Operating expenses in 2010 are expected to follow a run-rate of $1.0-1.5 million per month. Operating expenses will increase from the current run rate of $1.0 million per month when clinical trial activities increase.
The Company currently has enough funds to continue operating through 2010 into the first quarter of 2011. The Company will need to seek additional funding prior to that time, in order to continue operations and/or to increase the clinical testing program and other research.
Conference Call
The Company will conduct a conference call and web cast to review the financial results and the Company’s plans for 2010 later today, Monday, March 15, 2010 at 5:00 p.m. ET.
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via web cast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 438591, through March 18, 2010.
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
CONTACT: Tom Chesterman of Bionovo, Inc., +1-510-601-2000,
investor@bionovo.com; or Investors, Joe Diaz, Robert Blum, or Joe Dorame,
all of Lytham Partners, LLC, +1-602-889-9700, bnvi@lythampartners.com, for
Bionovo, Inc.
Web site: http://www.bionovo.com/
