YM BIOSCIENCES REPORTS FISCAL FIRST QUARTER 2010 OPERATIONAL AND FINANCIAL
RESULTS
MISSISSAUGA, ON,
"During our first fiscal quarter, we continued to advance our lead drug nimotuzumab, which is being developed globally through a network of cooperative relationships. We enrolled the first patients in our YM-sponsored multinational, randomized, Phase II double-blind trial evaluating nimotuzumab in patients with brain metastases from non-small-cell lung cancer (NSCLC) and continued to enroll patients in our randomized Phase II trial of nimotuzumab in NSCLC patients ineligible for radical chemotherapy. The US Treasury Department cleared YM's subsidiary, YM BioSciences USA Inc., of any limitations in clinical trials in the US for nimotuzumab in cancer indications and we are proposing to add US centers to these trials and potentially other trials being conducted by our licensees if and when cleared by the FDA," said
Subsequent to the end of the quarter we announced our proposal to merge Cytopia Ltd., an Australian clinical-stage drug development company, into YM. We believe Cytopia's lead products hold significant unrecognized potential and will benefit from YM's clinical and regulatory expertise and our access to the US capital markets," added
Nimotuzumab
Nimotuzumab is currently being evaluated in 32 Phase II and III clinical
trials, 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 randomized, open-label Phase II trial evaluating
nimotuzumab plus irinotecan compared to irinotecan alone in patients
with advanced or recurrent gastric cancer refractory to 5-FU-
containing regimens which is reportedly expected to complete
recruitment in calendar 2009. Daiichi Sankyo is also conducting a
Phase II trial in first-line NSCLC for which completion of
recruitment is reportedly expected in the first half of 2010.
- YM initiated randomized, double-blind Phase II, trials in patients
with brain metastases from non-small cell lung cancer (NSCLC) and in
NSCLC patients ineligible for radical chemotherapy. Recruitment
commenced in Canada in March 2009 for palliative 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, reported
completion of recruitment in a single-arm, Phase III trial of
nimotuzumab as first-line therapy for DIPG in August 2007, and the
preliminary data from this trial that was released at ASCO in 2008
was expanded on at the annual international pediatric oncology forum,
SIOP, held in São Paulo, Brazil in October 2009. OSAG advises that,
based on the data it plans to submit a Pediatric Investigation Plan
(PIP) to the EMEA forthwith which, if approved by the Pediatric
Committee (PDCO) would support a submission for marketing
authorization. OSAG reports that it continues to recruit in a Phase
III trial in adult glioma patients and a Phase IIb/III trial in
pancreatic cancer patients.
- Innogene Kalbiotech PTE Ltd. (IGK), CIMYM's licensee in South East
Asia, has reportedly received marketing approval for nimotuzumab in
the Philippines and Indonesia and 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 post-
operative or adjuvant setting in head and neck cancer. 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 being conducted by IGK.
- Nimotuzumab reportedly received approval for marketing in Mexico,
bringing to 23 the number of countries that are now reported as
having approved the drug for sale in specific indications.
For calendar 2010, YM BioSciences anticipates an extensive roll-out of important data concerning nimotuzumab's clinical utility and continued differentiation from the other marketed drugs in its class. Anticipated clinical data for calendar 2010 include:
- Final Phase III pediatric glioma data (Europe)
- Phase III adult glioma data (Europe)
- Phase II pediatric glioma data (North America)
- Phase II gastric cancer data (Japan)
- Phase II first-line non-small cell lung cancer data (Japan)
- Phase II esophageal data (Brazil)
AeroLEF(R)
YM continues to prepare its second late-stage product, AeroLEF(R), for further development internationally. After consulting with regulatory bodies in
Financial Results (CDN dollars)
Total revenue for the first quarter of fiscal 2010, ended
The majority of YM's out-licensing revenue comes from five out-licensing agreements with third party licensees. Revenue decreased mainly because the recognition period for the initial payments for the Daiichi Pharmaceutical Co., Ltd. and Kuhnil Pharmaceuticals Co., Ltd. contracts were extended by 12 months effective
Licensing and product development expenses were
Costs associated with development activities for nimotuzumab were
Costs associated with development activities for AeroLEF(R) were
General and administrative expenses were
Net loss for the first quarter of fiscal 2010 was
As at
As at
Notice of AGM and mailing
YM BioSciences' Annual and Special Meeting of Shareholders will be held on
The management proxy circular documents and annual financial documents have been mailed to shareholders and are available online at www.ymbiosciences.com, www.edgar.com and www.sedar.com.
Cancellation of AIM Listing
YM also announced 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 may 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.
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 23 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 opioids because patients are able to 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.
Summary financial statements attached:
YM BIOSCIENCES INC.
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars,
unless otherwise noted)
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September 30, June 30,
2009 2009
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(Unaudited)
Assets
Current assets:
Cash $ 34,269,093 $ 2,337,716
Short-term deposits 5,205,955 39,713,042
Accounts receivable 439,911 564,584
Prepaid expenses 231,488 352,850
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40,146,447 42,968,192
Property and equipment 84,187 96,876
Intangible assets 2,739,732 3,004,868
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$ 42,970,366 $ 46,069,936
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 674,216 $ 431,028
Accrued liabilities 878,174 486,723
Deferred revenue 2,557,955 2,549,568
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4,110,345 3,467,319
Deferred revenue 2,250,416 2,898,292
Shareholders' equity:
Share capital 172,940,340 172,921,153
Contributed surplus 13,424,004 13,035,123
Deficit (149,754,739) (146,251,951)
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36,609,605 39,704,325
Basis of presentation
Commitments
Subsequent event
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$ 42,970,366 $ 46,069,936
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YM BIOSCIENCES INC.
Interim Consolidated Statements of
Operations and Comprehensive Loss and Deficit
(Expressed in Canadian dollars, unless otherwise noted)
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Three months ended
September 30,
2009 2008
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(Unaudited)
Out-licensing revenue $ 727,538 $ 1,214,945
Interest income 19,119 442,621
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746,657 1,657,566
Expenses:
Licensing and product development 2,436,048 3,845,184
General and administrative 1,784,432 1,147,378
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4,220,480 4,992,562
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Loss before the undernoted (3,473,823) (3,334,996)
Gain (loss) on foreign exchange (26,747) 12,203
Loss on short-term deposits (2,218) (140,559)
Other income - 307,140
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Loss and comprehensive
loss for the period (3,502,788) (3,156,212)
Deficit, beginning of period (146,251,951) (133,182,485)
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Deficit, end of period $(149,754,739) $(136,338,697)
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Basic and diluted loss per common share $ (0.06) $ (0.06)
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Weighted average number of common
shares outstanding 55,844,505 55,835,356
Excludes common shares held in
escrow for contingent additional
payment related to the acquisition
of Delex Therapeutics Inc. 2,380,953 2,380,953
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YM BIOSCIENCES INC.
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars, unless otherwise noted)
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Three months ended
September 30,
2009 2008
-------------------------------------------------------------------------
(Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (3,502,788) $ (3,156,212)
Items not involving cash:
Amortization of property and equipment 16,252 18,631
Amortization of intangible assets 265,136 265,136
Loss on short-term deposits 2,218 140,559
Stock-based compensation 396,644 190,333
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses 246,035 (109,840)
Accounts payable, accrued liabilities
and deferred revenue (4,850) (683,008)
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(2,581,353) (3,334,401)
Financing activities:
Issue of common shares on
exercise of options 11,424 -
Investing activities:
Short-term deposits, net 34,504,869 13,200,126
Additions to property and equipment (3,563) (12,704)
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34,501,306 13,187,422
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Increase in cash 31,931,377 9,853,021
Cash, beginning of period 2,337,716 3,119,189
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Cash, end of period $ 34,269,093 $ 12,972,210
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%SEDAR: 00004652E
For further information: Enquiries: 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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