Emeryville, CA, May 9, 2008 -- Bionovo, Inc. (NASDAQ: BNVI) today announced results for the first quarter of 2008.
Quarter Results
The company did not report any revenue for the three months ended March 31, 2008. Revenues for the three months ended March 31, 2007 were $3,750, received from our licensing and technology transfer agreement with United Biotechnology Corporation of Taiwan. In October of 2007, we terminated the agreement following notice of material breach of the Agreement by UBC and we recognized the remaining deferred revenue of $91,250 in December 2007.
Total operating expenses for the three months ending March 31, 2008 were $4.2 million compared to $3.5 million for the same period in 2007.
The company reported a net loss for the three months ended March 31, 2008 of $3.9 million, or $0.05 per share, compared with a net loss of $3.3 million, or $0.05 per share, for the same period in 2007.
The Company ended the quarter with $29.4 million in cash, cash equivalents and short term investments, and began the quarter with $33.3 million, a difference of $3.9 million.
Company Highlights
| · | Patient enrollment and dosing continues in the Phase 1 portion of the BZL101 Phase 1/2 clinical trial for advanced metastatic breast cancer. Presentations, papers and scientific discussions have expounded the mechanisms of action and described the positive progress to date. |
| · | Bionovo presented data on two additional preclinical anti-cancer drug candidates -- BN107 and BN108 -- at the American Association of Cancer Research (AACR) conference in April. BN107 induces apoptosis through the mitochondrial pathway, and induces cell death only in estrogen receptor negative breast cancer cells. BN108 induces cancer cell death by rapid inactivation of both AKT and mTOR pathways in breast cancer cells, but not in normal cells. |
| · | The Company commissioned and reported results from two independent physician surveys which showed the Company’s drug candidate MF101 could become first-line treatment for menopausal vasomotor symptoms (hot flashes). In both qualitative and quantitative studies, 124 board certified physicians in internal medicine or obstetrics and gynecology specializing in the treatment of menopause reported that MF101, if approved, would be their drug of choice for the treatment of hot flashes. In addition, 92% of physicians reported they would prescribe MF101 before prescribing an antidepressant agent for hot flashes. |
| · | Three additional members were appointed to the Board of Directors: George Butler, Louis Drapeau, and John Baxter. |
“The first quarter of the year was a very productive quarter for Bionovo, with tremendous scientific and operational progress,” said Dr. Isaac Cohen, O.M.D., Bionovo’s Chairman and Chief Executive Officer. “We are positioned quite well for 2008, a year in which we will have additional new drug candidates in clinical trials, each addressing a significant unmet medical need with great commercial opportunity.”
“We believe that our scientific and operational success is not yet reflected in our stock price,” Dr. Cohen continued. “However, our value has been re-affirmed throughout the scientific community, as reflected by the industry reception of our scientific papers and quality of our new board members.”
A full financial report on Form 10-Q is expected to be filed on Friday, May 9, 2008.Bionovo, Inc.
Bionovo 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.
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.
Source: Bionovo, Inc.
Bionovo, Inc.
(A Development Stage Company)
Condensed Statements of Operations
(Unaudited)
| | | | | | | | | | | | | |
| | | | | | | | | | | | Accumulated from | |
| | | | | | | | | | | | February 1, 2002 | |
| | | | Three months | | | | Three months | | | | (Date of inception) To | |
| | | | ended March 31, | | | | ended March 31, | | | | March 31, | |
| | | | 2008 | | | | 2007 | | | | 2008 | |
| Revenues | | $ | | | | $ | 3,750 | | | $ | 659,490 | |
| Operating expenses: | | | | | | | | | | | | |
| Research and development | | | 2,387,393 | | | | 2,788,668 | | | | 18,179,598 | |
| General and administrative | | | 1,822,027 | | | | 694,921 | | | | 9,273,794 | |
| Merger cost | | | — | | | | — | | | | 1,964,065 | |
| Total operating expenses | | | 4,209,420 | | | | 3,483,589 | | | | 29,417,457 | |
| Loss from operations | | | (4,209,420 | ) | | | (3,479,839 | ) | | | (28,757,967 | ) |
| Change in fair value of warrant liability | | | — | | | | — | | | | 831,288 | |
| Interest income | | | 306,192 | | | | 149,712 | | | | 1,374,609 | |
| Interest expense | | | (26,537 | ) | | | (14,081 | ) | | | (263,554 | ) |
| Other income (expense) | | | (15,575 | ) | | | | | | | 129,321 | |
| Income (loss) before income tax | | | (3,945,340 | ) | | | (3,344,208 | ) | | | (26,686,303 | ) |
| Income tax provision | | | (3,256 | ) | | | (800 | ) | | | (12,258 | ) |
| Net loss | | $ | (3,948,596 | ) | | $ | (3,345,008 | ) | | $ | (26,698,561 | |
| Basic and diluted net loss per common share | | $ | (0.05 | ) | | $ | (0.05 | ) | | $ | (0.70 | ) |
| Shares used in computing basic and diluted net loss per common share | | | 76,343,101 | | | | 61,525,518 | | | | 37,914,036 | |
Bionovo, Inc.(A Development Stage Company)
Consolidated Balance Sheet
| | | | | | | | | |
| | | | March 31, | | | | December 31, | |
| | | | 2008 | | | | 2007 | |
| | | | (Unaudited) | | | | (Note 1*) | |
ASSETS | | | | | | | | |
| Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 19,187,934 | | | $ | 28,472,485 | |
Short-term investments | | | 10,198,744 | | | | 4,823,938 | |
Receivables | | | 19,942 | | | | 285,899 | |
Prepaid expenses and other current assets | | | 530,709 | | | | 405,381 | |
| Total current assets | | | 29,937,329 | | | | 33,987,703 | |
| Property and equipment, net | | | 4,040,105 | | | | 3,900,248 | |
| Other assets and patent pending, net | | | 733,445 | | | | 277,220 | |
| Total assets | | $ | 34,710,879 | | | $ | 38,165,171 | |
| | | | | | | | | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
| Current liabilities: | | | | | | | | |
| Accounts payable | | $ | 206,799 | | | $ | 299,677 | |
| Accrued clinical costs | | | 152,444 | | | | 298,559 | |
| Accrued compensation and benefits | | | 553,242 | | | | 462,485 | |
| Current portion of lease obligation | | | 928,252 | | | | 706,710 | |
| Other current liabilities | | | 540,922 | | | | 949,200 | |
| Total current liabilities | | | 2,381,659 | | | | 2,716,631 | |
| Non-current portion of lease obligation | | | 1,018,976 | | | | 526,346 | |
| Commitments and contingencies | | | | | | | | |
| Shareholders’ equity: | | | | | | | | |
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding | | | | | | | | |
| Common stock, $0.0001 par value, 190,000,000 shares authorized; 76,343,101 shares issued and outstanding as of March 31, 2008 and December 31, 2007, respectively. | | | 8,166 | | | | 8,166 | |
| Additional paid-in capital | | | 57,980,224 | | | | 57,659,513 | |
| Accumulated other comprehensive income | | | 20,415 | | | | 4,480 | |
| Accumulated deficit | | | (26,698,561) | | | | (22,749,965) | |
| Total shareholders’ equity | | | 31,310,244 | | | | 34,922,194 | |
| Total liabilities and shareholders’ equity | | $ | 34,710,879 | | | $ | 38,165,171 | |
* The balance sheet at December 31, 2007 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.
