YM BIOSCIENCES REPORTS FISCAL YEAR END 2009 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON,
"Just weeks ago we received clearance from the US Treasury Department to extend our US clinical program for nimotuzumab, permitting us to conduct trials in any cancer indication. Obtaining this clearance will be a transformative event for nimotuzumab and highlights the significant efforts made by YM staff in fiscal 2009 to advance our lead drug in an aligned effort with our licensees," said
Nimotuzumab is being advanced globally on multiple fronts supported by a network of cooperative relationships. In total, 32 Phase II and III clinical trials are currently ongoing, 11 of which are being conducted by YM's majority owned subsidiary, CIMYM BioSciences Inc., or its licensees.
- Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan,
and YM's licensee in Korea, Kuhnil Pharmaceutical Co., are currently
collaborating on a Phase II randomized, open-label trial they are
conducting that is evaluating nimotuzumab plus irinotecan compared to
irinotecan alone in patients with advanced or recurrent gastric
cancer refractory to 5-FU-containing regimens which is designed to
complete recruitment in calendar 2009. Daiichi has also launched a
Phase II trial in first-line NSCLC bringing to three the number of
NSCLC indications being investigated by our direct consortium.
- Randomized, Phase II, double-blind trials in brain metastases from
non-small cell lung cancer (NSCLC) and in NSCLC patients ineligible
for radical chemotherapy were initiated in Canada; recruitment
commenced in March 2009 for NSCLC and in September for the brain
metastases trial. A Phase II, second-line, single-arm trial in
children with progressive diffuse intrinsic pontine glioma (DIPG) is
ongoing at multiple sites in the US, Canada, and Israel.
- Oncoscience AG (OSAG), CIMYM's licensee for Europe, reports that it
continues to recruit for a Phase III trial in adult glioma and a
Phase II/III trial in pancreatic cancer.
- Innogene Kalbiotech PTE Ltd. (IGK), a subsidiary of Kalbe Farma, the
largest public Southeast Asian pharmaceutical company and a CIMYM
licensee, reported marketing approval in the Philippines and
Indonesia, bringing to 21 the number of countries that are now
reported as having approved the drug for sale in specific
indications. In January 2009, the National Cancer Centre of Singapore
announced that it was launching a worldwide Phase III, 710-patient
trial of nimotuzumab in the adjuvant setting in head and neck cancer
in cooperation with IGK. This trial is in addition to the on-going
investigator-initiated Phase II trial in locally advanced head and
neck cancer and the initiation of a Phase II trial in cervical
cancer.
- Subsequent to the end of the fiscal year, YM received a license from
the US Department of the Treasury's Office of Foreign Assets Control
(OFAC) to further develop its lead product, nimotuzumab, for patients
in the United States. YM's first priority is discussion with the FDA
on its two IND submissions to include US citizens in the randomized,
double-blind Phase II trial of nimotuzumab in NSCLC patients
ineligible for radical chemotherapy and the parallel Phase II trial
in patients with brain metastases from NSCLC, both of which YM
initiated in Canada during the 2009 fiscal year. Development plans
may also include extending one of the Phase III trials being
conducted worldwide into the US, such as the multinational
710-patient Phase III trial of nimotuzumab in the adjuvant setting in
head and neck cancer.
YM continues to prepare its second late-stage product, AeroLEF(R), for further development internationally. After consulting with regulatory bodies in
The Company continues to evaluate opportunities to amplify and diversify its development portfolio through potential licensing, acquisition or M&A activity. YM filed and received clearance for a "shelf" prospectus in
Cancellation of AIM Listing
YM also announces that trading of the Company's Common Shares on the AIM market of the
Following the cancellation of the Company's Common Shares on AIM, shareholders may continue to hold their shares and continue to trade such shares on either the TSX under the symbol 'YM' or the NYSE Amex under the symbol 'YMI'. YM does not expect the liquidity or marketability of its common shares to be materially affected by the AIM delisting.
Financial Results (CDN dollars)
Total revenue for the fiscal year ended
Licensing and product development expenses were
Costs associated with development activities for nimotuzumab were
Costs associated with development activities for AeroLEF(TM) were
General and administrative expenses were
Net losses for the fiscal year and fourth quarter ended
The Company received an audit opinion for the fiscal year ended
As at
The Company's annual financial statements and management's discussion and analysis will be available on www.sedar.com, www.edgar.com and at www.ymbiosciences.com.
AGM Announcement
YM BioSciences' Annual Meeting of Shareholders will be held on
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 20 countries. In more than 5,000 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.
Consolidated Balance Sheets
(Expressed in Canadian dollars, unless otherwise noted)
June 30, 2009 and 2008
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2009 2008
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Assets
Current assets:
Cash $ 2,337,716 $ 3,119,189
Short-term deposits 39,713,042 54,981,737
Accounts receivable 564,584 403,371
Prepaid expenses 352,850 375,133
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42,968,192 58,879,430
Property and equipment 96,876 128,400
Intangible assets 3,004,868 4,065,409
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$ 46,069,936 $ 63,073,239
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 431,028 $ 307,588
Accrued liabilities 486,723 1,715,024
Deferred revenue 2,549,568 4,623,340
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3,467,319 6,645,952
Deferred revenue 2,898,292 4,414,256
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants - 3,150,539
Contributed surplus 13,035,123 9,123,824
Deficit (146,251,951) (133,182,485)
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39,704,325 52,013,031
Basis of presentation
Commitments
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$ 46,069,936 $ 63,073,239
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YM BIOSCIENCES INC.
Consolidated Statements of Operations and Comprehensive Loss and Deficit
(Expressed in Canadian dollars, unless otherwise noted)
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Years ended June 30,
2009 2008 2007
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Out-licensing revenue $ 4,543,280 $ 4,859,085 $ 4,407,890
Interest income 1,070,264 2,584,080 3,239,540
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5,613,544 7,443,165 7,647,430
Expenses:
Licensing and product
development 14,172,845 15,631,550 28,758,469
General and
administrative 4,839,870 6,831,955 6,978,336
Impairment of
intangible assets - - 1,829,538
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19,012,715 22,463,505 37,566,343
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Loss before the undernoted (13,399,171) (15,020,340) (29,918,913)
Gain (loss) on foreign
exchange 67,075 32,463 (142,552)
Gain (loss) on short-term
deposits (40,200) 172,276 -
Loss on disposal of
property and equipment - (70,143) -
Other income 307,140 - -
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Loss before income taxes (13,065,156) (14,885,744) (30,061,465)
Current income taxes 4,310 - 1,668,775
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Loss and comprehensive
loss for the year (13,069,466) (14,885,744) (31,730,240)
Deficit, beginning of year (133,182,485) (118,296,741) (86,566,501)
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Deficit, end of year $(146,251,951) $(133,182,485) $(118,296,741)
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Basic and diluted loss
per common share $ (0.23) $ (0.27) $ (0.57)
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Weighted average number of
common shares outstanding 55,835,356 55,835,356 55,804,674
Excludes common shares
held in escrow for
contingent additional
payment related to the
acquisition of Delex
Therapeutics Inc. 2,380,953 2,380,953 2,380,953
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YM BIOSCIENCES INC.
Consolidated Statements of Cash Flows
(Expressed in Canadian dollars, unless otherwise noted)
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Years ended June 30,
2009 2008 2007
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Cash provided by (used in):
Operating activities:
Loss for the year $ (13,069,466) $ (14,885,744) $ (31,730,240)
Items not involving cash:
Amortization of
property and equipment 91,896 125,271 107,107
Amortization of
intangible assets 1,060,541 1,060,541 1,913,040
Impairment of
intangible assets - - 1,829,538
Loss on disposal of
property and equipment - 70,143 -
Unrealized loss on
short-term deposits 41,912 - -
Stock-based compensation 760,760 2,063,973 1,716,913
Change in non-cash
operating working capital:
Accounts receivable
and prepaid expenses (138,930) (61,483) 1,816,092
Accounts payable,
accrued liabilities
and deferred revenue (4,694,597) (5,844,790) 11,604,460
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(15,947,884) (17,472,089) (12,743,090)
Financing activities:
Issuance of common shares
on exercise of options - - 11,232
Issuance of common shares
on exercise of warrants - - 89,375
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- - 100,607
Investing activities:
Short-term deposits, net 15,226,783 14,742,701 15,881,679
Additions to property
and equipment (60,372) (37,770) (127,162)
Proceeds from sale of
property and equipment - 38,996 -
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15,166,411 14,743,927 15,754,517
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Increase (decrease) in
cash and cash equivalents (781,473) (2,728,162) 3,112,034
Cash and cash equivalents,
beginning of year 3,119,189 5,847,351 2,735,317
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Cash and cash equivalents,
end of year $ 2,337,716 $ 3,119,189 $ 5,847,351
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%SEDAR: 00004652E
For further information: James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Email: [email protected]; Thomas Fechtner, the Trout Group LLC, Tel. (646) 378-2931, Email: [email protected]; Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
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