YM BioSciences reports fiscal year end 2010 operational and financial results
MISSISSAUGA, ON, Sept. 23 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today reported operational and financial results for its fiscal year end, ended June 30, 2010.
"This has been a transformative year for YM. Our most notable development was the merger of the public Australian company, Cytopia, into YM BioSciences, completed in January, from which we gained two important clinical stage drug candidates, CYT387 and CYT997, as well as a library of more than 4,000 novel compounds in addition to the ongoing advancement of nimotuzumab by us and our four licensees," said David Allan, Chairman and CEO of YM BioSciences. "Work on CYT387, a potent, orally-administered JAK1/JAK2 inhibitor, has resulted in favorable biological activity and safety data observed in recent months and as such have announced the expansion of our current Phase I/II program in myelofibrosis initiated at Mayo Clinic from 60 to up to 120 patients and the inclusion of up to six centers in the United States, Canada and Australia. We also look forward to the American Society of Hematology (ASH) meeting in Orlando, Florida, in early December 2010, where detailed safety and preliminary activity data for CYT387 are expected to be presented."
"During the fiscal period we raised an additional $20 million in two financings that brought in a number of highly regarded life-sciences investors as shareholders and we also recently announced the appointment of Dr. Nick Glover as President and COO of YM. By strengthening both our balance sheet and leadership team we have positioned YM to seize the significant new opportunities that our expanded pipeline presents," added Mr. Allan.
Highlights from Fiscal 2010:
CYT387
- Pivotal preclinical efficacy data for CYT387 in myeloproliferative
neoplasms were published in Blood, the Journal of the American
Society of Hematology (Blood, 24 June 2010, Vol. 115, No. 25, pp.
5232-5240).
- Subsequent to quarter end, Mayo Clinic concluded dose-escalation in
the Phase I portion of the Phase I/II clinical trial of CYT387 in
patients with myelofibrosis, a chronic debilitating condition where
the patient's bone marrow is replaced by scar tissue. In total, 21
patients were treated in Phase I, with no voluntary withdrawals
reported. CYT387 showed significant activity in reducing spleen size
and controlling constitutional symptoms in these patients. To date,
27 patients have been enrolled into the Phase II tranche bringing the
total number in the study to 48. Given the favorable biological
activity and safety data, the Company intends to expand enrolment for
the trial and include centers in the US, Canada and Australia,
subject to regulatory approval.
- Subsequent to quarter end, CYT387 was granted Orphan Drug Designation
by the US FDA. Orphan Drug Designation is granted to novel drugs or
biologics that treat a rare disease or condition affecting fewer than
200,000 patients in the US.
Nimotuzumab
- Wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) received a
license from the US Department of the Treasury's Office of Foreign
Assets Control (OFAC) to further develop its humanized monoclonal
antibody, nimotuzumab, for patients with solid tumor cancers in the
US. YM-USA subsequently received FDA clearance to enroll patients
from US clinical sites into two ongoing randomized, double-blind
Phase II trials of its product, nimotuzumab. Subsequent to quarter
end, YM enrolled the first US patient in its randomized, double-blind
trial evaluating nimotuzumab in patients with brain metastases from
non-small-cell lung cancer (NSCLC) at the Florida Cancer Institute -
New Hope.
- YM reported that its licensee for nimotuzumab, Daiichi Sankyo Co.,
Ltd. in Japan advised that it has completed enrollment of a Phase II
trial evaluating nimotuzumab in combination with radiation
therapy/cisplatin/vinorelbine in first-line curative intent patients
with Stage III NSCLC. YM further anticipates that Daiichi Sankyo will
be in possession of data from its Phase II gastric cancer trial
evaluating nimotuzumab in combination with irinotecan in calendar
2010.
- YM reported in an oral presentation at the American Society for
Therapeutic Radiology and Oncology (ASTRO) 2009 Annual Meeting
positive 48-month survival data for its product, nimotuzumab. The
"BEST" trial was a randomized four-arm study treating patients with
inoperable, locoregionally-advanced, Stage III/IVa head and neck
cancer with radiation alone, chemoradiation alone, or radiation or
chemoradiation in combination with nimotuzumab.
- YM was advised that nimotuzumab had been approved for marketing in
Mexico, the 20th country to have approved the drug.
- YM anticipates reporting data from its North American Phase II
pediatric glioma trial in calendar 2010; that its licensee for
Europe, Oncoscience AG, will be in possession of European Phase III
adult glioma data for nimotuzumab in calendar 2010; and that it will
continue to support the scale-up and process enhancement for
manufacturing of nimotuzumab which are required for increased late-
stage clinical activity and in anticipation of requirements for
commercial volumes of product.
CYT997
- A poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets
and Cancer Therapeutics conference in Boston, Massachusetts,
demonstrated CYT997's potent vascular disrupting effects and enhanced
antitumor effects in combination with cisplatin in preclinical
models. In August 2010, Phase I clinical trial results of CYT997 were
published in the premier cancer journal, the British Journal of
Cancer, demonstrating that CYT997 was well tolerated at doses that
were associated with changes in plasma and imaging biomarkers
consistent with vascular disruption in tumors.
Corporate Highlights
- Created YM Australia from the merger into YM of an Australian
biotechnology company, Cytopia Ltd., a company focused on the
discovery and development of new drugs to treat cancer and other
diseases.
- Raised US$17.5 million in March 2010, followed by a subsequent
investment of US$3.2 million made in June by a leading international
health-care-specific investment fund management company specifically
in support of the CYT387 program.
- Appointed Dr. Nick Glover to the newly created position of President
and Chief Operating Officer. Dr. Glover will provide broad leadership
to the Company and have primary responsibility for its operations and
infrastructure, in particular the development and commercialization
of YM's pipeline. The Company also announces that Mr. Robert Watson
has resigned as a director of YM BioSciences effective September
2010, that Mr. Sean Thompson, Vice President, Corporate Development,
has left YM BioSciences, effective August 2010, and that Ms. Wendy
Chapman and Dr. Ernest Wong have been appointed as Vice President,
Clinical Operations and Vice President, Business Development
respectively.
- Terminated all further expenditures related to the AeroLEF(R)
program.
Financial Results (CDN dollars)
Total revenue (out-licensing revenue and interest income) for the fiscal year ended June 30, 2010 was $2.7 million compared to $5.6 million for fiscal 2009. Total revenue for the fourth quarter of fiscal 2010 was $0.5 million compared to $0.8 million for the fourth quarter of fiscal 2009. Revenue from out-licensing was $2.6 million for fiscal 2010 compared to $4.5 million for fiscal 2009. The decrease is mainly attributable to the full recognition of all contracts related to the development of tesmilifene because all of YM's obligations under the licensing agreement have been met.
Licensing and product development expenses were $17.0 million for the fiscal year ended June 30, 2010 compared with $14.2 million for fiscal 2009. Licensing and product development expenses were $7.6 million for the fourth quarter of fiscal 2010 compared to $2.6 million for the fourth quarter of fiscal 2009. The increases were almost entirely the consequence of non-cash write-off of the AeroLEF intangible assets and the amortization of the Cytopia intangible asset.
Costs associated with development activities for nimotuzumab were $5.6 million for the fiscal year ended June 30, 2010 compared to $6.0 million for the previous year. Costs associated with development activities for nimotuzumab were $1.8 million for the fourth quarter of fiscal 2010, compared with $1.3 million for the same quarter of the previous year. The minor differences mainly relate to two clinical trials, one for brain metastases from non-small cell lung cancer (NSCLC) and the other for NSCLC patients ineligible for radical chemotherapy. Recruitment into both trials lags expectations and the targeted recruitment period is under review as a consequence. Total development expenses decreased as result of the conclusion of the Phase II pediatric pontine glioma and colorectal trials.
Costs associated with development activities for AeroLEF were $0.6 million for the fiscal year ended June 30, 2010 compared to $1.7 million for the previous year. Costs associated with development activities for AeroLEF were $0.1 million for the fourth quarter of fiscal 2010, compared to $0.2 million the previous year. In June 2010, the Company decided to no longer pursue the AeroLEF program, and to terminate the development program associated with the product. Accordingly, the net asset remaining on the balance sheet was written off in Q4 of fiscal 2010.
General and administrative expenses were $6.9 million for the fiscal year ended June 30, 2010 compared to $4.8 million for the previous year with the majority of the increase accounted for by acquisition costs and non-cash expenses. General and administrative expenses for the fourth quarter of fiscal 2010 were $1.8 million compared to $1.3 million for the same quarter in the prior year. This increase is largely attributable to increased travel and salaries with the acquisition of YM Australia.
Net losses for the fiscal year and fourth quarter ended June 30, 2010 were $21.0 million ($0.33 per share) and $8.6 million ($0.11 per share) respectively, compared to $13.1 million ($0.23 per share) and $3.3 million ($0.06 per share) for the same periods last year.
As at June 30, 2010 the Company had cash and short-term deposits totalling $45.6 million and accounts payables and accrued liabilities totalling $2.8 million compared to $42.1 million and $0.9 million respectively at June 30, 2009. Management believes that the cash and short-term deposits at June 30, 2010 are sufficient to support the Company's activities for at least the next twelve months.
As at June 30, 2010 the Company had 80,359,623 common shares and 8,166,480 warrants outstanding.
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 November 18, 2010 at 4:00 p.m. at the offices of Ogilvy Renault, 200 Bay Street, Suite 3800, Toronto, Ontario
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company focused in oncology. Together with the products from YM BioSciences Australia (formerly Cytopia Limited), the Company is currently developing three clinical-stage products: CYT387, a JAK1/2 small molecule inhibitor; nimotuzumab, a humanized monoclonal antibody; and CYT997, a potent, vascular disrupting agent (VDA). 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.
The products discovered by YM's recently acquired Australian subsidiary, YM BioSciences Australia, include the JAK1/2 inhibitor CYT387 and the novel VDA molecule CYT997. Both were discovered through Cytopia's internal medicinal chemistry program, based on research led by Dr. Andrew Wilks, who identified the JAK1/2 kinase enzymes. Both products are currently in clinical development. Nimotuzumab is a humanized monoclonal antibody in development worldwide, targeting multiple tumor types. It is importantly differentiated from other currently marketed EGFR-targeting agents due to its benign side-effect profile. Nimotuzumab's anti-tumor activity has led to its approval for marketing in 23 countries. In more than 9,000 patients reported as having been treated with nimotuzumab worldwide to date, incidents of severe rash have been only rarely observed and reports of the other severe side-effects that are typical of EGFR-targeting molecules have been equally rare. Nimotuzumab is licensed to YM's majority-owned, Canadian subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was developed at the Center of Molecular Immunology.
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 JAK1/2 and the VDA molecule will generate positive efficacy and safety data in future clinical trials; that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. Except as required by applicable securities laws, 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, 2010 and 2009
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2010 2009
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Assets
Current assets:
Cash and cash equivalents $ 19,460,141 $ 2,337,716
Short-term deposits 26,184,991 39,713,042
Accounts receivable 161,184 564,584
Prepaid expenses 237,962 352,850
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46,044,278 42,968,192
Property and equipment 84,775 96,876
Intangible asset 11,645,714 3,004,868
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$ 57,774,767 $ 46,069,936
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 699,277 $ 431,028
Accrued liabilities 2,085,824 486,723
Deferred revenue 1,523,916 2,549,568
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4,309,017 3,467,319
Deferred revenue 1,650,909 2,898,292
Shareholders' equity:
Share capital 203,498,239 172,921,153
Share purchase warrants 1,473,246 -
Contributed surplus 14,088,671 13,035,123
Deficit (167,245,315) (146,251,951)
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51,814,841 39,704,325
Basis of presentation
Commitments
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$ 57,774,767 $ 46,069,936
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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,
2010 2009 2008
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Out-licensing revenue $ 2,610,560 $ 4,543,280 $ 4,859,085
Interest income 84,391 1,070,264 2,584,080
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2,694,951 5,613,544 7,443,165
Expenses:
Licensing and product
development 16,974,790 14,172,845 15,631,550
General and
administrative 6,898,209 4,839,870 6,831,955
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23,872,999 19,012,715 22,463,505
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Loss before the undernoted (21,178,048) (13,399,171) (15,020,340)
Gain on foreign exchange 194,036 67,075 32,463
Gain (loss) on short-term
deposits (9,352) (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 (20,993,364) (13,065,156) (14,885,744)
Current income taxes - 4,310 -
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Loss and comprehensive loss
for the year (20,993,364) (13,069,466) (14,885,744)
Deficit, beginning of year (146,251,951) (133,182,485) (118,296,741)
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Deficit, end of year $(167,245,315) $(146,251,951) $(133,182,485)
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Basic and diluted loss
per common share $ (0.33) $ (0.23) $ (0.27)
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Weighted average number
of common shares
outstanding 63,607,316 55,835,356 55,835,356
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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,
2010 2009 2008
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Cash provided by (used in):
Operating activities:
Loss for the year $ (20,993,364) $ (13,069,466) $ (14,885,744)
Items not involving cash:
Amortization of
property and equipment 63,837 91,896 125,271
Amortization of
intangible asset 2,938,891 1,060,541 1,060,541
Impairment of intangible
asset 1,944,317 - -
Loss on disposal of
property and equipment - - 70,143
Unrealized loss on
short-term deposits 9,352 41,912 -
Stock-based
compensation 983,242 760,760 2,063,973
Change in non-cash
operating working capital:
Accounts receivable and
prepaid expenses 705,474 (138,930) (61,483)
Accounts payable, accrued
liabilities and deferred
revenue (2,395,174) (4,694,597) (5,844,790)
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(16,743,425) (15,947,884) (17,472,089)
Financing activities:
Issuance of common shares
on exercise of options 89,139 - -
Net proceeds from issuance
of shares and warrants 19,389,596 - -
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19,478,735 - -
Investing activities:
Short-term deposits, net 13,518,699 15,226,783 14,742,701
Additions to property and
equipment (41,163) (60,372) (37,770)
Proceeds from sale of
property and equipment - - 38,996
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13,477,536 15,166,411 14,743,927
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Increase (decrease) in cash
and cash equivalents 16,212,846 (781,473) (2,728,162)
Net cash assumed on
acquisition 909,579 - -
Cash and cash equivalents,
beginning of year 2,337,716 3,119,189 5,847,351
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Cash and cash equivalents,
end of year $ 19,460,141 $ 2,337,716 $ 3,119,189
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Supplemental disclosure of
non-cash transactions:
Issuance of common shares
on acquisition of
Cytopia Limited $ 12,515,903 $ - $ -
Issuance of stock
options on acquisition
of Cytopia Limited 126,000 - -
Issuance of broker
warrants 175,371 - -
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%SEDAR: 00004652E
For further information: James Smith, the Equicom Group Inc., Tel. +1-416-815-0700 x 229, Email: [email protected]; Thomas Fechtner, the Trout Group LLC, Tel. +1-646-378-2931, Email: [email protected]
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