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Bionovo Announces Second Quarter 2009 Highlights and Financial Results

EMERYVILLE, Calif., Aug. 10 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced second quarter highlights and financial results for the three months ended June 30, 2009.

Company Highlights

    -- Further results from the phase 1B clinical trial of Bezielle (BZL101)
       in 27 patients with metastatic breast cancer showed Bezielle to be
       safe and well-tolerated with encouraging evidence of clinical activity
       in a heavily pretreated patient population - most importantly

       -- 31% had stable disease for more than 90 days;
       -- 13% had stable disease for more than 180 days;
       -- three patients had objective tumor regression;
       -- one patient had objective tumor regression while on Bezielle
          therapy for 449 days and continues to be stable off of study
          medication for over 600 days;
       -- a second patient continues to be stable for 832 days and has not
          started any new anticancer treatment;
       -- a third patient was stable without any new anticancer therapy for
          591 days;
       -- there were no deaths or serious adverse events that were attributed
          to Bezielle (BZL101); and
       -- the most common side effects associated with Bezielle (BZL101) were
          minor and gastrointestinal in nature.

       These results provide further evidence that Bezielle (BZL101) may
       provide an important option for women suffering from advanced breast
       cancer, an extremely difficult to treat subset of the breast cancer

    -- On the SERM platform, a peer-reviewed study published in the journal
       "Public Library of Science One" found that when comparing the gene
       expression induced by ERb compounds to that induced by estradiol, some
       differences existed in both the classes of genes regulated and the
       magnitude of regulation.  These results demonstrate that ERb-selective
       agonists do not entirely mimic the actions of estradiol after binding
       to ERb, suggesting that the two classes of drugs will have different
       biological effects and different side effect profiles.  Additionally,
       this study found that different types of ERb-selective drugs regulated
       different genes to varying extents and that therefore different
       ERb-selective drugs should exert distinct clinical effects. Of the
       different compounds investigated, Menerba (MF101) was one of the most
       ERb-selective, and patterns of gene expression were most disparate
       between Menerba and estradiol.  Menerba also demonstrated unique cell
       type-specific gene regulation.

    -- The Company continues to work towards satisfying the FDA's requests
       for clarification of the manufacturing and analytical strategy to be
       used in ensuring the consistency of its drug products.

    -- The Company is aggressively pursuing a variety of funding options
       which include government grants, partnering, and debt and equity

    -- The Company has selected two more potential contract manufacturing
       organizations (CMO) to handle clinical, and possibly, commercial
       needs, and expects to qualify the primary CMO for clinical production
       by the end of September.

Second Quarter Results

Total operating expenses for the three months ending June 30, 2009 were $4.1 million compared to $4.4 million for the same period in 2008 and $4.6 million for the first quarter of 2009. Total operating expenses for the second quarter included purchases of lab supplies and raw materials to support the manufacturing process development efforts of its lead drug candidate, Menerba. Company management expects operating expenses to decrease further in the third quarter.

The Company reported a net loss for the three months ended June 30, 2009 of $4.1 million, or $0.05 per share, compared with a net loss of $4.2 million, or $0.06 per share, for the same period in 2008.

The Company ended the quarter with $5.4 million in cash, cash equivalents and short term investments, and began the quarter with $9.1 million, a difference of $3.7 million. The cash balance at the end of the quarter reflects the expenses mentioned above. The Company received $116,000 in a government grant payment following the quarter close, and is aggressively pursuing further grants and other forms of financing.

The Company has secured additional long-term debt funding from its landlord, totaling $204,000 year-to-date, and is continuing to explore alternative financing from a variety of sources.

"We are encouraged by the progress we have been making over the last quarter and are confident we can address the FDA's requests in a timely fashion and resume clinical testing of Menerba in the near future," stated Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. He added, "We are heartened by the increasing support we are gaining in the scientific and medical communities, and the continuing discoveries we are making in the lab in support of our drug candidates. We look forward to submitting the CMC package to the FDA and believe that a bright future lies ahead for Bionovo and our drug candidates."

Conference Call

The Company will conduct a conference call and webcast to review the financial results for the second quarter of fiscal year 2009 and the Company's plans for the remainder of the year at 5:00 p.m. ET on Monday, August 10, 2009.

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 A replay of the call is available via web cast at for 30 days or by playback at (877) 344-7549 or (412) 317-0088, conference code 432836, through August 13, 2009.

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:

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 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)
                        Consolidated Statements of Operations
                 (Unaudited, in thousands, except per share amounts)

                                                              from February 1,
                                                               2002 (Date of
                         Three months ended    Six months ended  inception) to
                                June 30,             June 30,      June 30,
                         ------------------     ---------------- ------------
                             2009      2008      2009      2008      2009
                             ----      ----      ----      ----      ----

    Revenues                   $7        $-        $7        $-      $899

    Operating expenses:
      Research and
       development          2,954     2,553     6,555     4,940    33,763
      General and
       administrative       1,175     1,808     2,184     3,630    15,733
      Merger cost               -         -         -         -     1,964
                              ---       ---       ---       ---     -----
    Total operating
     expenses               4,129     4,361     8,739     8,570    51,460
                            -----     -----     -----     -----    ------

    Loss from operations   (4,122)   (4,361)   (8,732)   (8,570)  (50,561)

      Change in fair
       value of warrant
       liability                -         -         -         -       831
      Interest income          16       190        70       496     2,061
      Interest expense        (22)      (36)      (55)      (62)     (421)
      Other expense            (6)        -       (85)      (19)     (162)
                              ---       ---       ---       ---      ----
    Net loss              $(4,134)  $(4,207)  $(8,802)  $(8,155) $(48,252)
                           ======     =====     =====     =====     =====
      Basic and diluted
       net loss per
       common share        $(0.05)   $(0.06)   $(0.12)   $(0.11)   $(1.09)
                            =====     =====     =====     =====     =====

      Shares used in
       computing basic
       and diluted
       net loss per share   76,363    76,344    76,363    76,344    44,393
                            ======    ======    ======    ======    ======

                                  Bionovo, Inc.
                          (A Development Stage Company)
                            Consolidated Balance Sheets
                         (in thousands, except share amounts)

                                                  June 30,     December 31,
                                                    2009           2008
                                                    ----           ----
    Current assets:
      Cash and cash equivalents                     $4,397        $3,270
      Short-term investments                         1,006        10,292
      Receivables                                       44           126
      Prepaid expenses and other current
       assets                                          472           805
                                                       ---           ---
        Total current assets                         5,919        14,493
    Property and equipment, net                      6,601         6,938
    Other assets and patent pending, net             1,334         1,073
                                                     -----         -----
        Total assets                               $13,854       $22,504
                                                   =======       =======


    Current liabilities:
      Accounts payable                                $408          $521
      Accrued clinical and costs of other
       studies                                          60            73
      Accrued compensation and benefits                443           456
      Current portion of lease obligations             638           682
      Current portion of notes payable                   7             -
      Other current liabilities                        717           595
                                                       ---           ---
        Total current liabilities                    2,273         2,327
      Non-current portion of lease obligation          260           545
      Non-current portion of notes payable              92             -
                                                       ---           ---
        Total liabilities                            2,625         2,872
                                                     -----         -----

    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,
       76,363,101 and 76,363,101 shares
       outstanding at June 30, 2009 and
       December 31, 2008, respectively                   8             8
      Additional paid-in capital                    59,471        59,050
      Accumulated other comprehensive gain               2            24
      Accumulated deficit                          (48,252)      (39,450)
                                                   -------       -------
        Total shareholders' equity                  11,229        19,632
                                                    ------        ------
          Total liabilities and shareholders'
           equity                                  $13,854       $22,504
                                                   =======       =======

    * The balance sheet at December 31, 2008 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.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Bionovo Announces Positive Developments in On-going Phase 1/2 Cancer Drug Trial
2. Bionovo Announces Publication of the Paper Detailing the Mechanism of Action of Its Cancer Drug BZL101
3. Bionovo Discovers New Estrogen Regulatory Elements for Breast Cancer and Osteoporosis Drugs
4. Bionovos Drug Candidate for Menopausal Symptoms Shows Effect on Neural Pathways Related to Temperature Regulation
5. Bionovo Elucidates Mechanism of Breast Cancer Control by Estrogen Receptor Beta
6. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
7. Bionovos MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes
8. Bionovos VG101 Shows Greater Efficacy Than Estrogen in the Treatment of Vaginal Dryness
9. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
10. Bionovo Presents Positive Results from Phase 1B Trial of BZL101 for Metastatic Breast Cancer at the Society for Integrative Oncology
11. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
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