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BIONOVO, INC.

$N/A (N/A)

BNVI.PK

Press Release

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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

       including:



       -- 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

       population.



    -- 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

       offerings.



    -- 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 http://bionovo.com/investors/events. A replay of the call is available via web cast at http://bionovo.com/investors/events 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: 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)

                        Consolidated Statements of Operations

                 (Unaudited, in thousands, except per share amounts)



                                                                 Accumulated

                                                              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

                                                    ----           ----

                                                 (unaudited)

                                    ASSETS

    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

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



                     LIABILITIES AND SHAREHOLDERS' EQUITY



    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.



    -0-                           08/10/2009

    /CONTACT:  Claire Fong or Tom Chesterman, both 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 /

    (BNVI)



CO:  Bionovo, Inc.



ST:  California

IN:  HEA MTC PHA IDC

SU:  ERN CCA TRI



PR

-- SF59358 --

0958 08/10/2009 15:00 EDT http://www.prnewswire.com