Navigation Links
YM BIOSCIENCES REPORTS THIRD QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS
Date:5/14/2009

MISSISSAUGA, ON, May 14 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Amex: YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for the third quarter of fiscal 2009, ended March 31, 2009.

"Just a few days ago we reported critically important data at the 100th AACR conference in Denver highlighting the mechanistic differences between nimotuzumab and the EGFR targeting antibody, Erbitux(R)," said David Allan, Chairman and CEO of YM BioSciences. "These data demonstrate that nimotuzumab is predisposed to bind to cancerous cells with high levels of EGFR on their surface while ignoring normal cells with low EGFR levels. For the competing drugs, binding is indiscriminate since they bind to low levels of EGFR and, as a result, these products cause severe toxicities as they interact with healthy tissues. With Erbitux(R) as the leading EGFR-targeting drug on the market and generating more than $1.5 billion in annual sales, these findings are profound and further define the significant opportunity for our lead product."

Nimotuzumab is being advanced globally on multiple fronts supported by a network of cooperative relationships. In total, more than 15 Phase II and Phase III trials are currently ongoing, ten of which are being conducted by YM or its licensees. During the third quarter of fiscal 2009:

    -   The National Cancer Centre of Singapore (NCCS) selected nimotuzumab
        for evaluation in the adjuvant setting in a multinational Phase III
        trial of more than 700 patients with cancers of the head and neck,
        citing the drug's benign safety profile. The trial is being supported
        by YM licensee, Innogene Kalbiotech Ltd., a subsidiary of the public
        company, Kalbe Farma.
    -   Two of YM's licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in
        Japan and Kuhnil Pharmaceutical Co. in Korea, are conducting a Phase
        II randomized, open-label trial evaluating nimotuzumab in patients
        with advanced or recurrent gastric cancer.
    -   YM's licensee in Europe, Oncoscience AG, reported that it continues
        to enroll patients into a randomized Phase III study evaluating
        nimotuzumab in adult glioma patients and into a randomized Phase
        IIb/IIIa trial in patients with advanced pancreatic cancer.
    -   YM and YM USA continued to enroll children with progressive, diffuse,
        intrinsic pontine glioma (DIPG) into a Phase II trial at multiple
        sites in the US, Canada and Israel and recruitment could be completed
        in late calendar 2009 or early 2010.

YM continues to prepare its second late-stage product, AeroLEF(R), for further development internationally. After consulting with regulatory bodies in Europe and Canada, the Company is now determining the optimal clinical path forward and conducting discussions with potential partners.

Financial Results (CDN dollars)

Total revenue (out-licensing revenue and interest income) for the third quarter of fiscal 2009, ended March 31, 2009 was $1.0 million compared with $1.8 million for the third quarter of fiscal 2008. Total revenue for the first nine months of fiscal 2009 was $4.8 million compared with $5.5 million for the first nine months of fiscal 2008. The majority of YM's out-licensing revenue comes from five out-licensing agreements with third party licensees for nimotuzumab. The decrease in revenue for the third quarter of fiscal 2009 compared to the same period in the prior year is mainly attributable to a 12 month extension of the revenue recognition period for the initial payment from one of YM's licensees. The decrease in revenue for the nine months ended March 31, 2009 compared to the same period in the prior year is mainly as a result of the above mentioned extension and the ending of monthly revenue recognition for one other deferred revenue contract, partially offset by a milestone payment received this year from one of the Company's licensees. The Company also began receiving royalty payments from a limited sales program in Europe initiated in the fourth quarter of fiscal 2008. Interest income decreased as the Company draws on its cash balances to fund its operations and due to lower interest rates.

General and administrative expenses were $1.2 million for the third quarter of fiscal 2009 compared with $1.4 million for the third quarter of fiscal 2008. General and administrative expenses were $3.5 million for the first nine months of fiscal 2009 compared with $5.5 million for the first nine months of fiscal 2008. These decreases were mainly a result of stock option expenses decreasing as well as decreases in legal fees, salaries, consulting and investor relations expenditures.

Licensing and product development expenses were $3.3 million for the third quarter of fiscal 2009 compared with $4.3 million for the third quarter of fiscal 2008. Licensing and product development expenses were $11.5 million for the first nine months of fiscal 2009 compared with $12.1 million for the first nine months of fiscal 2008.

Costs associated with development activities for nimotuzumab remained at $1.5 million in the quarter compared to a year ago and increased by $1.1 million to $4.7 million for the nine months ended March 31, 2009. The increase in expenses is primarily related to preparation for the two new Phase II trials.

Costs associated with development activities for AeroLEF(TM) decreased by $0.2 million to $0.4 million for the three month period ended March 31, 2009 compared to the same period in the prior year. For the nine month period ended March 31, 2009 costs were $1.6 million, similar to the same period in the prior year.

Net loss for the third quarter of fiscal 2009 was $3.5 million ($0.06 per share) compared to $3.8 million ($0.07 per share) for the same period last year. Net loss for the first nine months of fiscal 2009 was $9.8 million ($0.18 per share) compared to $11.9 million ($0.21 per share) for the same period last year.

As at March 31, 2009 the Company had cash and cash equivalents and short-term deposits totaling $46.6 million and payables and accrued liabilities totaling $1.9 million compared to $58.1 million and $2.0 million respectively at June 30, 2008.

As at March 31, 2009 the Company had 58,216,309 common shares outstanding, of which 2,380,953 common shares are held in escrow to be released contingent upon the completion of certain milestones.

About YM BioSciences

YM BioSciences Inc. is a life sciences product development company that identifies and advances a portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.

Nimotuzumab is a humanized monoclonal antibody in development worldwide, targeting multiple tumor types primarily in combination with radiation and chemoradiation. It is significantly differentiated from all other currently marketed EGFR-targeting agents due to its remarkably benign side-effect profile. Nimotuzumab's anti-tumor activity has led to its approval for marketing in more than 12 countries. In more than 3,500 patients reported as having been treated with nimotuzumab worldwide to date, no Grade IV incidents of radiation dermatitis have been described, severe rash has not been observed and reports of the other severe side-effects that are typical of EGFR-targeting molecules have been rare. Nimotuzumab is licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was developed at the Center of Molecular Immunology. YM is developing AeroLEF for the treatment of moderate to severe acute pain. The product is differentiated from other approaches using fentanyl because patients can individually control the analgesia required for their differing intensities of pain. AeroLEF met all endpoints in a randomized Phase II trial and is currently being prepared for late-stage development internationally.

This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    YM BIOSCIENCES INC.
    Interim Consolidated Balance Sheets
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                                                    March 31,        June 30,
                                                        2009            2008
    -------------------------------------------------------------------------
                                                  (Unaudited)

    Assets

    Current assets:
      Cash and cash equivalents                $   8,917,872   $   3,119,189
      Short-term deposits                         37,688,943      54,981,737
      Accounts receivable                            280,479         403,371
      Prepaid expenses                               543,664         375,133
    -------------------------------------------------------------------------
                                                  47,430,958      58,879,430

    Property and equipment                           105,268         128,400

    Intangible assets                              3,270,003       4,065,409

    -------------------------------------------------------------------------
                                               $  50,806,229   $  63,073,239
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------
    Liabilities and Shareholders' Equity

    Current liabilities:
      Accounts payable                         $     636,680   $     307,588
      Accrued liabilities                          1,302,123       1,715,024
      Deferred revenue                             2,562,696       4,623,340
    -------------------------------------------------------------------------
                                                   4,501,499       6,645,952

    Deferred revenue                               3,522,556       4,414,256

    Shareholders' equity:
      Share capital                              172,921,153     172,921,153
      Share purchase warrants                              -       3,150,539
      Contributed surplus                         12,848,942       9,123,824
      Deficit                                   (142,987,921)   (133,182,485)
    -------------------------------------------------------------------------
                                                  42,782,174      52,013,031

    Basis of presentation
    Commitments
    -------------------------------------------------------------------------
                                               $  50,806,229   $  63,073,239
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Operations and Comprehensive Income
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                         Three months ended             Nine months ended
                              March 31,                     March 31,
                           2009            2008          2009           2008
    -------------------------------------------------------------------------
                            (Unaudited)                   (Unaudited)
    Out-licensing
     revenue      $     776,127  $   1,155,835  $   3,823,296  $   3,438,601
    Interest
     income             201,635        622,029      1,009,323      2,039,663
    -------------------------------------------------------------------------
                        977,762      1,777,864      4,832,619      5,478,264

    Expenses:
      General and
       adminis-
       trative        1,190,039      1,416,872      3,530,626      5,526,388
      Licensing
       and product
       development    3,259,177      4,286,792     11,525,789     12,052,278
    -------------------------------------------------------------------------
                      4,449,216      5,703,664     15,056,415     17,578,666
    -------------------------------------------------------------------------

    Loss before
     the undernoted  (3,471,454)    (3,925,800)   (10,223,796)   (12,100,402)

    Gain on
     foreign
     exchange            51,122         15,584        143,009         29,716

    Gain (loss)
     on short-
     term deposits      (54,507)        91,569        (31,789)       217,985

    Loss on
     disposal
     of property and
     equipment                -              -              -        (70,143)

    Other income              -              -        307,140              -

    -------------------------------------------------------------------------
    Loss and
     comprehensive
     loss for
     the period   $  (3,474,839) $  (3,818,647) $  (9,805,436) $ (11,922,844)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------

    Basic and
     diluted loss
     per common
     share        $       (0.06) $       (0.07) $       (0.18) $       (0.21)

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

    Weighted
     average
     number of
     common
     shares
     outstanding     55,835,356     55,835,356     55,835,356     55,835,356

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



    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Deficit
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                         Three months ended             Nine months ended
                              March 31,                     March 31,
                           2009            2008          2009           2008
    -------------------------------------------------------------------------
                            (Unaudited)                   (Unaudited)

    Deficit,
     beginning
     of period    $(139,513,082) $(126,400,938) $(133,182,485) $(118,296,741)

    Loss for
     the period      (3,474,839)    (3,818,647)    (9,805,436)   (11,922,844)

    -------------------------------------------------------------------------
    Deficit, end
     of period    $(142,987,921) $(130,219,585) $(142,987,921) $(130,219,585)
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------



    YM BIOSCIENCES INC.
    Interim Consolidated Statements of Cash Flows
    (Expressed in Canadian dollars)

    -------------------------------------------------------------------------
                         Three months ended             Nine months ended
                              March 31,                     March 31,
                           2009            2008          2009           2008
    -------------------------------------------------------------------------
                            (Unaudited)                   (Unaudited)

    Cash provided
     by (used in):

    Operating
     activities:
      Loss for
       the period $  (3,474,839) $  (3,818,647) $  (9,805,436) $ (11,922,844)
      Items not
       involving
       cash:
        Amortiza-
         tion of
         property
         and
         equipment       19,806         20,781         57,282        106,364
        Amortiza-
         tion of
         intangible
         assets         265,135        265,135        795,406        795,406
        Loss on
         disposal
         of property
         and
         equipment            -              -              -         70,143
        Unrealized
         loss
         (gain) on
         short-term
         deposits        56,219        (98,443)        33,501        (91,569)
        Stock-based
         compensation   195,023        324,704        574,579      1,827,991
      Change in
       non-cash
       operating
       working
       capital:
        Accounts
         receivable
         and
         prepaid
         expenses       255,258        257,614        (45,639)      (152,916)
        Accounts
         payable,
         accrued
         liabili-
         ties and
         deferred
         revenue       (767,508)      (849,632)    (3,036,153)    (4,204,800)
    -------------------------------------------------------------------------
                     (3,450,906)    (3,898,488)   (11,426,460)   (13,572,225)

    Investing
     activities:
      Short-term
       deposits,
       net            4,233,479     (4,980,923)    17,259,293     10,362,066
      Additions
       to property
       and
       equipment
       and
       intangible
       assets           (19,114)             -        (34,150)       (35,933)
      Proceeds
       from sale
       of property
       and
       equipment              -              -              -         38,996
    -------------------------------------------------------------------------
                      4,214,365     (4,980,923)    17,225,143     10,365,129
    -------------------------------------------------------------------------

    Increase
     (decrease)
     in cash and
     cash
     equivalents        763,459     (8,879,411)     5,798,683     (3,207,096)

    Cash and
     cash
     equivalents,
     beginning
     of period        8,154,413     11,519,666      3,119,189      5,847,351

    -------------------------------------------------------------------------
    Cash and
     cash
     equivalents,
     end of
     period       $   8,917,872  $   2,640,255  $   8,917,872  $   2,640,255
    -------------------------------------------------------------------------
    -------------------------------------------------------------------------


'/>"/>
SOURCE YM BioSciences Inc.
Copyright©2009 PR Newswire.
All rights reserved


Related biology technology :

1. Frost & Sullivan Awards Precision Biosciences for Technology Innovation and Molecular Design Process in the Genomics Market
2. Neurocrine Biosciences to Present at the Deutsche Bank 34th Annual Health Care Conference
3. MichBio Leader Cites New Senate Biosciences Task Force and House Subcommittee as Evidence of States Growing Awareness of Industrys Economic Importance
4. Neurocrine Biosciences Reports First Quarter 2009 Results
5. Sangamo BioSciences Receives $100,000 Grand Challenges Explorations Grant for Innovative Global Health Research
6. Sangamo BioSciences Announces Publication in Nature of the Use of Zinc Finger Nucleases to Accelerate Precision Trait Stacking in Commercial Crop Species
7. ImQuest BioSciences and Arisyn Therapeutics Announce Strategic Partnership to Develop Infectious Disease and Cancer Drugs
8. LaVoie Group Selected by Vaccine Developer, Profectus BioSciences, as Agency of Record
9. Former GE Healthcare Director, Per Foss Appointed CEO for HUNT Biosciences
10. Sangamo BioSciences Announces First Quarter 2009 Conference Call and Webcast
11. Cell Biosciences Launches Next-Generation Protein Characterization System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 A person commits a crime, and the ... track the criminal down. An outbreak of foodborne ... Administration (FDA) uses DNA evidence to track down the bacteria ... far-fetched? It,s not. The FDA has increasingly used a complex, ... foodborne illnesses. Put as simply as possible, whole genome sequencing ...
(Date:6/23/2016)... Calif. , June 23, 2016  The Prostate Cancer Foundation ... increasingly precise treatments and faster cures for prostate cancer. Members of the Class ... across 15 countries. Read More About the Class of ... ... ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... announced the launch of the Supplyframe Design Lab . Located in Pasadena, ... explore the future of how hardware projects are designed, built and brought to ...
(Date:6/23/2016)... LOUISVILLE, Ky. , June 23, 2016 /PRNewswire/ ... from two Phase 1 clinical trials of its ... double-blind, placebo-controlled, single and multiple ascending dose studies ... and pharmacodynamics (PD) of subcutaneous injection in healthy ... APL-2 subcutaneously (SC) either as a single dose ...
Breaking Biology Technology:
(Date:4/28/2016)... 2016 First quarter 2016:   ... with the first quarter of 2015 The gross margin ... (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) , ... unchanged, SEK 7,000-8,500 M. The operating margin for 2016 ...
(Date:4/15/2016)... , April 15, 2016 ... "Global Gait Biometrics Market 2016-2020,"  report to their ... ) , ,The global gait biometrics market ... 13.98% during the period 2016-2020. Gait ... which can be used to compute factors that ...
(Date:3/29/2016)... 2016 LegacyXChange, Inc. (OTC: ... SelectaDNA/CSI Protect are pleased to announce our successful effort ... variety of writing instruments, ensuring athletes signatures against counterfeiting ... from athletes on LegacyXChange will be assured of ongoing ... Bill Bollander , CEO states, "By ...
Breaking Biology News(10 mins):