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BIONOVO, INC.

$N/A (N/A)

BNVI.PK

Press Release

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Bionovo Announces First Quarter 2010 Highlights and Financial Results

EMERYVILLE, Calif., May 11, 2010 /PRNewswire via COMTEX/ --Bionovo, Inc. (Nasdaq: BNVI) today announced first quarter highlights and financial results for the three months ended March 31, 2010.

"The first four months of 2010 were characterized by intense activity within the company, as we prepared data for the regulatory agencies. We, along with our regulatory, scientific and medical advisors, have compiled a body of information on Menerba that should help it move forward in 2010," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "The rest of 2010 is poised to be even more intense for Bionovo, as we expect to be able to initiate the next stage of clinical trials for Menerba, with positive feedback from the regulatory agencies."

"While the company has been strongly focused on progressing Menerba, we have been making good progress in the scientific and clinical community in developing our cancer program. For example, Bezielle, our promising, novel, oral drug for metastatic breast cancer, was selected as one of the 'top 100 investigational drugs' by the prestigious publication R&D Directions," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "Furthermore, the U.S. Patent and Trademark Office has now issued a key patent for Bezielle, as described in our previous press release."

Key Events To Date

    --The Company announced that the US Patent and Trademark Office (USPTO)

     has issued a patent covering a method of using Bionovo's proprietary

     drug candidate Bezielle(R) (BZL101) for the treatment of metastatic

     breast cancer. Bionovo's US Patent covers a method of treating breast

     cancer using Bezielle. This patent also covers the use of Bionovo's

     proprietary Bezielle formulation as a monotherapy for the treatment of

     breast cancer. The patent is expected to provide coverage through at

     least November 13, 2026.

      "Following two positive Phase 1 trials of Bezielle, this is another

       critical milestone in Bionovo's efforts to develop Bezielle into a

       valuable treatment option for an indication that needs new, safe

       treatment options. Furthermore, intellectual property protection is

       essential for successfully partnering our drug candidates, and further

       assuring shareholder value creation," said Dr. Cohen.



    --The Company held its Annual Meeting of Stockholders on Monday, May 3,

     2010. In this meeting, all nominated directors were elected and all

     proposals were approved by the stockholders.

      On behalf of the Board of Directors, Dr. Cohen continued, "We are

       gratified by the support offered by our stockholders in these

       challenging times. We are focused on creating long term shareholder

       value."



    -- The Company announced the appointment of quality control and

     botanical authentication expert, Paul Pui-Hay But, Ph.D., to the

     company's Scientific Advisory Board. Dr. But is the Chief Scientist for

     the Food and Drug Authentication Laboratory Ltd., Hong Kong, China, and

     a leading investigator and consultant on botanical authentication and

     Chinese medicine quality control.

      "We are honored to have Dr. Paul But join our Scientific Advisory Board,

       given his well established expertise in the field of botanical

       authentication and Chinese medicine quality control. This expertise has

       proven invaluable to the development of our manufacturing process for

       our botanical drug candidates," said Dr. Cohen.



First Quarter Results

Total operating expenses for the three months ending March 31, 2010 were $4.7 million compared to $4.6 million for the same period in 2009. Total operating expenses for the first quarter included the purchase of manufacturing supplies and raw materials and testing for the Menerba manufacturing process development. The Company expects operating expenses to decrease in the second quarter.

The Company reported a net loss for the three months ended March 31, 2010 of $4.7 million, or $0.04 per share, compared with a net loss of $4.7 million, or $0.06 per share, for the same period in 2009.

The Company ended the quarter with $11.8 million in cash, cash equivalents and short term investments, and began the quarter with $15.9 million, a difference of $4.1 million. The cash balance at the end of the quarter reflects the cash expenses mentioned above as well as capital expenditures to support the Menerba manufacturing process development.

Conference Call

The Company will conduct a conference call and webcast to review the financial results and the Company's plans for 2010 later today, Tuesday, May 11, 2010 at 5:00 p.m. (Eastern).

Interested parties can access the call by dialing (877) 317-6789 or (412) 317-6789, or can listen via a live internet webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via webcast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 440464, through May 14, 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





                                         Bionovo, Inc.

                                 (A Development Stage Company)

                        Condensed Consolidated Statements of Operations

                      (Unaudited, in thousands, except per share amounts)



                                   Three months ended        Accumulated

                                                            from February

                                        March 31,                         1,

                                        ---------           2002 (Date of

                                                           inception) to

                                                              March 31,

                                                              ---------

                                    2010             2009          2010

                                    ----                           ----



    Revenues                          $-               $-        $1,180



    Operating expenses:

      Research and development     3,806            3,601        43,512

      General and administrative     852            1,009        18,454

      Merger cost                                       -         1,964

    Total operating expenses       4,658            4,610        63,930

                                   -----            -----        ------



    Loss from operations          (4,658)          (4,610)      (62,750)



      Change in fair value of

       warrant liability               -                -           831

      Interest income                  8               54         2,082

      Interest expense               (14)             (33)         (474)

      Other income (expense),

       net                             3              (79)         (164)

                                     ---              ---          ----

    Net loss                     $(4,661)         $(4,668)     $(60,475)

                                 =======          =======      ========

      Basic and diluted net loss

       per common share           $(0.04)          $(0.06)       $(1.23)

                                  ======           ======        ======



      Shares used in computing

       basic and diluted net

       loss per share            107,541           76,363        49,163

                                 =======           ======        ======







                                 Bionovo, Inc.

                         (A Development Stage Company)

                          Consolidated Balance Sheets

                      (in thousands, except share amounts)





                                                                   December

                                                      March 31,       31,

                                                             2010       2009

                                                             ----       ----

                                                      (unaudited)

                                        ASSETS

    Current assets:

        Cash and cash equivalents                          $3,366     $2,799

        Short-term investments                              8,393     13,135

        Receivables                                           114        251

        Prepaid expenses                                      191        214

        Other current assets                                  126        161

                                                              ---        ---

              Total current assets                         12,190     16,560

    Property and equipment, net                             6,599      6,197

    Patent pending, net                                       978        822

    Other assets                                              531        570

              Total assets                                $20,298    $24,149

                                                          =======    =======



                        LIABILITIES AND SHAREHOLDERS' EQUITY



    Current liabilities:

        Accounts payable                                     $724       $311

        Accrued compensation and benefits                     340        367

        Current portion of lease

         obligations                                          403        476

        Current portion of notes payable                       60         59

        Other current liabilities                           1,046        823

                                                            -----        ---

              Total current liabilities                     2,573      2,036

        Non-current portion of lease

         obligations                                           15         96

        Non-current portion of notes

         payable                                              106        121

              Total liabilities                             2,694      2,253

                                                            -----      -----



    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,

         107,618,690 and 107,518,690

         shares outstanding at March 31,

         2010 and December 31, 2009,

         respectively                                          11      11

        Additional paid-in capital                         78,069     77,704

        Accumulated other comprehensive

         loss                                                  (1)        (5)

        Accumulated deficit                               (60,475)   (55,814)

                                                          -------    -------

              Total shareholders' equity                   17,604     21,896

                                                           ------     ------

                   Total liabilities and

                    shareholders' equity                  $20,298    $24,149

                                                          =======    =======


* 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.