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BIONOVO, INC.

$N/A (N/A)

BNVI.PK

Press Release

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Bionovo Announces 2008 Highlights and Year-End Financial Results

EMERYVILLE, Calif., March 12, 2009 /PRNewswire-FirstCall via COMTEX/ -- Bionovo, Inc. (Nasdaq: BNVI) today announced financial results for the year ended December 31, 2008.

"Scientific development, regulatory progress and growth accurately characterize Bionovo in 2008," said Isaac Cohen, O.M.D., Bionovo's chairman and chief executive officer. "We successfully laid the scientific groundwork and regulatory filings which ultimately is essential for the successful approval and marketing of several safe and efficacious drug candidates, which address significant areas of currently unmet medical need. We look forward to 2009 as a year for clinical progress and commercial partnering. This progress is reflected by the increased interest by the scientific community and is evidenced by the number of key opinion leaders, with three National Academy of Science members, who are now actively involved with the progress and development of Bionovo's drugs."

Corporate Issues


    --  Bionovo made several notable additions to its Board of Directors;

        leading healthcare professionals with extensive experience in the

        development of life science companies, including:

        --  George Butler, formerly of Astra Zeneca and Novartis,

        --  Louis Drapeau, CEO of Insite Vision and formerly in leadership roles

            at Nektar Therapeutics and BioMarin, and

        --  John D. Baxter. M.D., member of the National Academy of Sciences,

            and a founder and director of Scios/Nova, Karo-Bio A.B. (Stockholm),

            Calhoun Vision, and SciClone Pharmaceuticals (SCLN).




    --  During 2008, Bionovo significantly strengthened its Scientific Advisory

        Board (SAB) with the addition of several world-renowned scientists and

        clinicians:

        --  Ethan Weiss, M.D., University of California at San Francisco,

        --  Willa A Hsueh, M.D., The Methodist Hospital, Houston,

        --  Jan Ake Gustafsson, M.D., Ph.D., member, National Academy of

            Sciences and formerly of the Karolinska Institute, and

        --  Bert W. O'Malley, M.D., Recipient of the 2008 National Medal

            for Science, member, the National Academy of Sciences, and currently

            at the Baylor College of Medicine.



MF101


    --  An independent physician survey shows strong evidence that, if approved,

        Menerba(TM) (MF101) could become first-line treatment for menopausal

        symptoms. This suggests that Menerba could take a leading position in a

        multi-billion dollar market.

    --  Bionovo announced that it has developed a novel analytical 2-dimensional

        liquid chromatography mass spectrometry-based (LC/LC-MS/MS) multiplexing

        platform that allows for the rapid, specific, sensitive automated

        quantification of the active pharmaceutical compounds of Menerba. If

        applied to botanical drug product production, this technique should

        facilitate exquisite batch-to-batch consistency and control of the final

        drug product.

    --  Multiple papers were presented to the Endocrine Society indicating that

        estrogen receptor beta may have a role in cancer prevention - suggesting

        that Menerba may have an ultimate role in cancer treatment beyond its

        current proposed indication for menopausal hot flashes.

    --  Also presented at the Endocrine Society was a study describing the

        development of a neural model for thermoregulation in the brain,

        providing more specific scientific support for Menerba's mechanism

        of action and efficacy potential.

    --  Bionovo announced that further analysis of the data from its

        successfully completed phase 2 study of Menerba showed that Menerba was

        able to reduce "night awakenings" from menopausal hot flashes

        at a statistically significant level. This sign of efficacy in the most

        debilitating aspect of hot flashes is further evidence that Menerba may

        provide an unmatched combination of safety and efficacy in comparison to

        other treatments being developed or currently on the market.



BZL101 and other Cancer Drug Candidates


    --  A peer-reviewed study published in the journal Cancer Biology and

        Treatment, described the powerful and selective mechanism of action for

        BZL101 in cancer tumors.

    --  Another study was presented at American Association for Cancer Research

        (AACR) that detailed the unique mechanisms of action for two other

        Bionovo drug candidates for the treatment of cancer, BN107 and BN108.

    --  Results from a second clinical study of BZL101 in advanced breast cancer

        was presented at ASCO, indicating BZL101's favorable tolerability

        and safety profile, and exhibiting encouraging signs of positive

        efficacy.

        --  Further results from this study were presented to the Society of

            Integrative Oncology (SIO), where the abstract was the highest

            scoring abstract.

    --  Additional studies of BN107 and BN108 were presented at the San Antonio

        Breast Cancer Symposium, indicating promising signs of potential

        efficacy for both cancer drug candidates.



VG101


    --  Laboratory studies were presented at the 7th Annual Oxford International

        Conference on the Science of Botanicals & American Society of

        Pharmacognosy 4th Interim Meeting, describing the structural elucidation

        of active estrogen receptor beta selective compounds from VG101,

        Bionovo's drug candidate for vaginal atrophy. This structural

        elucidation is key to the development of the drug candidate's

        mechanism of action and intellectual property protection.

    --  In vivo safety and efficacy data were presented to the Endocrine

        Society, indicating VG101 may have superior clinical activity to

        existing drug products for the treatment of menopausal vaginal dryness.

    --  This data was further detailed to the North American Menopause Society

        (NAMS), indicating that VG101 may well provide superior efficacy and

        safety versus estrogen therapy.



Full Year Result

For the year ended December 31, 2008 total revenues were $0.2 million compared with $0.6 million for the same period in 2007. Revenues in 2008 consisted of a National Institute of Health (NIH) grant drawdown, whereas revenues in 2007 included the recognition of licensing revenues from a licensing and technology agreement with a Taiwanese company that has been terminated.

For the year ended December 31, 2008 total operating expenses were $17.5 million compared with $14.2 million for the same period in 2007. The increase in 2008 operating expenses include the impact of research and development expenses for the development of our lead drug candidates, clinical trial expenses and a related increase in operational support.

The net loss for the year ended December 31, 2008 was $16.7 million, or $0.22 per share, compared with a net loss of $12.9 million, or $0.20 per share, for the same period in 2007. The year-over-year increase in net loss was driven primarily by the increased activity related to our clinical trials and a related increase in operational support.

As of December 31, 2008, cash, cash equivalents and short-term investments totaled approximately $13.6 million compared to $33.3 million at December 31, 2007. The decrease in cash, cash equivalents and short-term investments included $3.2 million in capital expenditures for a facility expansion which is now complete. The net cash used in operating activities for 2008 was $15.2 million, compared with $10.3 million in 2007.

2009 Expense and Cash Guidance

Revenues for 2009 will include a further drawdown on an NIH grant. The company has submitted and will submit further applications for grants throughout the year.

Operating expenses in 2009 are expected follow a run-rate slightly under $1.0 million per month - which is the current run rate -- due to decreased clinical activities in the first half of the year and operational efficiencies implemented in the first quarter of 2009. Operating expenses will increase as and when clinical trial activities increase.

The Company currently has enough funds to continue operating through 2009 into the first quarter of 2010. 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 2009 later today, Thursday, March 12, 2009 at 4:30 p.m. ET.

Interested parties can access the call by dialing (877) 356-5706 or (706) 643-0580, 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 (800) 642-1687 or (706) 645-9291, access code 88102099, through March 15, 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.




    Company Contacts:             Investor Contacts:



    Claire Fong                   Joe Diaz, Robert Blum

    Tom Chesterman                Joe Dorame

    Tel: 510.601.2000             Lytham Partners, LLC

    investor@bionovo.com          Tel: 602.889.9700

                                  bnvi@lythampartners.com







                        Financial Tables on Following Pages








                                      Bionovo, Inc.

                              (A Development Stage Company)

                          Consolidated Statements of Operations

                                       (Unaudited)



                          Three months ended        Twelve months ended

                             December 31,               December 31,

                           2008        2007           2008        2007



    Revenues             $232,676     $330,875      $232,676     $581,750

    Operating

     expenses:

      Research

       and

       development      2,534,329    2,725,299    11,415,669    9,937,743

      General

       and

       administrative   1,244,777    1,594,320     6,097,426    4,283,567

      Merger cost               -            -             -            -

    Total

     operating

     expenses           3,779,106    4,319,619    17,513,095   14,221,310

    Loss from

     operations        (3,546,430)  (3,988,744)  (17,280,419) (13,639,560)

      Change

       in fair

       value of

       warrant

       liability                -            -             -            -

      Interest

       income              91,507      331,987       730,069      849,944

      Interest

       expense            (30,514)     (17,685)     (128,712)     (86,582)

      Other

       expense                (35)     (16,158)      (16,971)     (21,398)

    Loss before

     income tax        (3,485,472)  (3,690,600)  (16,696,033) (12,897,596)

      Income tax

       provision             (484)      (1,002)       (3,740)      (3,402)

    Net loss          $(3,485,956) $(3,691,602) $(16,699,773)$(12,900,998)

    Basic and

     diluted

     net loss

     per

     common

     share                 $(0.05)      $(0.05)       $(0.22)      $(0.20)



    Shares

     used in

     computing

     basic

     and

     diluted

     net loss

     per common

     share             76,363,101   72,867,303    76,353,428   65,762,764







                                        Accumulated

                                           from

                                        February 1,

                                           2002

                                         (Date of

                                         Inception)

                                            to

                                           2008



    Revenues                              $892,166

    Operating expenses:

      Research and development          27,207,874

      General and administrative        13,549,193

      Merger cost                        1,964,065

    Total operating expenses            42,721,132

    Loss from operations               (41,828,966)

      Change in fair value of

       warrant liability                   831,288

      Interest income                    1,990,486

      Interest expense                    (365,730)

      Other expense                        (64,074)

    Loss before income tax             (39,436,996)

      Income tax provision                 (12,742)

    Net loss                          $(39,449,738)

    Basic and diluted net loss

     per common share                       $(0.94)

    Shares used in computing

     basic and diluted net loss

     per common share                   42,100,877






                                 Bionovo, Inc.

                         (A Development Stage Company)

                          Consolidated Balance Sheets



                                                 December 31,  December 31,

                                                     2008         2007

                                                 (Unaudited)     (Note *)

                      ASSETS

    Current assets:

      Cash and cash equivalents                    $3,270,180  $28,472,485

      Short-term investments                       10,292,495    4,823,938

      Receivables                                     126,038      285,899

      Prepaid expenses and other current assets       804,646      405,381

    Total current assets                           14,493,359   33,987,703

    Property and equipment, net                     6,937,610    3,900,248

    Other assets and patent pending, net            1,073,478      277,220

    Total assets                                  $22,504,447  $38,165,171



        LIABILITIES AND SHAREHOLDERS' EQUITY

    Current liabilities:

      Accounts payable                               $520,560     $299,677

      Accrued clinical and costs of other studies      72,882      298,559

      Accrued compensation and benefits               456,214      462,485

      Current portion of lease obligation             682,087      706,710

      Other current liabilities                       596,453      949,200

    Total current liabilities                       2,328,196    2,716,631

    Non-current portion of lease obligation           544,603      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; 76,363,101 and

     76,343,101 shares issued and outstanding as

     of June 30, 2008 and December 31, 2007,

     respectively                                       7,636        7,634

    Additional paid-in capital                     59,049,514   57,660,045

    Accumulated other comprehensive income             24,236        4,480

    Accumulated deficit                           (39,449,738) (22,749,965)

    Total shareholders' equity                     19,631,648   34,922,194

    Total liabilities and shareholders' equity    $22,504,447  $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.



SOURCE Bionovo, Inc.

http://www.bionovo.com