YM Biosciences reports first quarter 2007 operational and financial results
MISSISSAUGA, ON, Nov. 10 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today reported operational and
financial results for the first quarter of fiscal 2007, ended September 30,
2006.
"Our pivotal Phase III trial for tesmilifene is nearing completion, with
the third of a number of interim analyses anticipated shortly. We continue to
expect the complete set of mature data for our lead anti-cancer drug will be
available in calendar 2007," said David Allan, Chairman and CEO of
YM BioSciences. "For Nimotuzumab we were pleased to report that, during the
quarter, the Office of Foreign Assets Control (OFAC) of the U.S. Treasury
Department issued us a license that allows YM to import nimotuzumab into the
U.S. for the purpose of a clinical trial in children with inoperable brain
cancer. The OFAC license is a key achievement in our efforts to make
nimotuzumab available in the U.S. while we concurrently advance the drug
through a broad multi-national development program internationally with
numerous partners."
"We also made progress in the development of AeroLEF(TM), our unique,
inhaled-delivery composition of free and liposome encapsulated fentanyl for
the treatment of moderate to severe acute pain, including cancer pain," added
David Allan. "Recently presented results of the open-label portion of our
Phase IIb study demonstrated that patients are able to successfully
self-titrate AeroLEF(TM) for managing acute pain and we intend to further
expand the product's clinical development into patients with cancer pain."
Highlights for the first quarter (July 1, 2006 - September 30, 2006):
Tesmilifene:
- The independent Data Safety Monitoring Board (DSMB) made its second
recommendation that the tesmilifene pivotal trial proceed as planned.
The Company believes that this demonstrates that the product
continues to be safe and indicates that the data have the prospect of
becoming positive as they mature.
Nimotuzumab:
- Received clearance from OFAC to import nimotuzumab for specific
clinical research in the U.S.
- Licensed the drug to Daiichi Pharmaceutical Co., Ltd., a wholly owned
subsidiary of Daiichi Sankyo Company, Limited, for Japan.
- Enrollment of patients in a Phase III trial in pediatric glioma in
Europe continues by YM partner Oncoscience AG and recruitment is
expected to be completed in the first half of calendar 2007.
- A multi-center Phase I/II trial comparing the effects of the
combination of nimotuzumab with radiation against radiation alone in
patients with non-small-cell lung cancer (NSCLC) unfit for
chemotherapy is also underway, with recruitment anticipated to be
completed by the end of 2007, or early 2008. This trial is being
conducted by YM and is expected to be expanded into South Korea
through YM partner Kuhnil Pharmaceutical Company of Seoul, Korea.
AeroLEF(TM):
- Results of the open-label portion of the Phase IIb study with
AeroLEF(TM) for the treatment of moderate to severe acute pain in
post-surgical patients were presented at the American Society of
Anesthesiologists Annual Meeting in October 2006. The data
demonstrated that clinically meaningful analgesia was achieved in
81%, 100% and 87.5% of treated pain episodes during doses 1, 2 and 3
respectively in the multi-dose study. Differences in median time to
effective analgesia, with shorter dosing times for doses 2 and 3,
suggests that patients were capable of safely self-limiting dosing to
uniquely match each distinct pain episode. Achievement of effective
analgesia was the reason for patients stopping dosing in 88% of
treated pain episodes. Multiple doses were well tolerated with all
treatment emergent events reported at mild ((greater than)70%) or
moderate.
- Interim results from the randomized, placebo-controlled portion of
Phase IIb trial were announced. That analysis of data from the first
67 patients from the trial indicated that AeroLEF(TM) provided
benefit when comparing the treatment arm to placebo, but not the
degree of difference that would permit an early stopping. Since the
study was powered to detect benefit at full recruitment it will
continue as planned to enroll the original target of 99 randomized
patients. The full data is anticipated early in calendar 2007.
Corporate highlights:
- YM BioSciences was declared, for the second year in a row, a finalist
of Canada's Top 10 Life Science Companies Competition subsequent to
the end of the quarter. In particular, the Company was again declared
one of Canada's top five Later Stage Companies within the
competition.
Financial Results (CDN dollars)
Total revenue for the quarter ended September 30, 2006 was $1.7 million
compared to $243,000 for the same period last year. Revenue was generated from
out-licensing agreements and interest income. The increase in licensing
revenue is due to the licenses for nimotuzumab to Innogene Kalbiotech Private
Limited (January 2006) for countries in Southeast Asia and Africa and Daiichi
Pharmaceutical Co., Ltd. (July 2006) for Japan.
Total operating expenditures for the quarter ended September 30, 2006
were $9.7 million compared to $6.2 million for the same period last year.
General and administrative expenses for the first quarter of the fiscal year
were $1.9 million compared to $1.4 million for the same period in the prior
year. Licensing and product development expenses were $7.9 million for the
first quarter of the fiscal year compared to $4.8 million for the first
quarter of last year. The increases were due mainly to the addition of a
senior management team with the acquisition of Eximias in May and increased
expenditures on nimotuzumab.
Net loss for the fiscal first quarter was $8.1 million ($0.15 per share)
compared to $5.9 million ($0.15 per share) for the same period last year.
As at September 30, 2006 the Company had cash, cash equivalents and
short-term deposits totaling $93.9 million and current liabilities of
$1.6 million compared to $88.3 million and $3.7 million respectively at June
30, 2006.
As at September 30, 2006 the Company had 55,782,023 common shares
outstanding, 2,380,953 common shares held in escrow for contingent additional
payment related to the acquisition of DELEX Therapeutics Inc., and 9,022,277
warrants and 4,790,955 options outstanding.
AGM Announcement
YM BioSciences' Annual and Special Meeting of Shareholders will be held
on November 28th, 2006 at 4:00 p.m. at the Gallery of the TSX Broadcast &
Conference Centre, The Exchange Tower, 130 King Street West, Toronto, Ontario.
About YM BioSciences
YM BioSciences, Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
three late-stage products: tesmilifene, a novel small molecule that
selectively targets multiple-drug resistant tumor cells and sensitizes them to
chemotherapy, under investigation for metastatic breast cancer,
hormone-refractory prostate cancer and gastric cancer; nimotuzumab, a
humanized monoclonal antibody that targets the epidermal growth factor
receptor (EGFR) and is approved in several countries for treatment of various
types of head and neck cancer; and AeroLEF(TM), a unique, inhaled-delivery
composition of free and liposome-encapsulated fentanyl in development for the
treatment of moderate to severe pain, including cancer pain.
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 the pivotal tesmilifene Phase III trial will be completed
on schedule and yield mature data in calendar 2007; that the DSMB's
recommendations to continue the pivotal trial for tesmilifene based on two
early analyses implies that the trial continues to have the prospect of
meeting its primary endpoint; that nimotuzumab will continue to demonstrate a
competitive safety profile in ongoing and future clinical trials; 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.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
September 30, June 30,
2006 2006
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 42,285,660 $ 2,735,317
Short-term deposits 51,646,532 85,606,117
Accounts receivable 1,264,120 2,214,775
Prepaid expenses 400,739 318,338
-------------------------------------------------------------------------
95,597,051 90,874,547
Capital assets 281,267 304,985
Intangible assets 8,235,477 8,868,528
-------------------------------------------------------------------------
$ 104,113,795 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 873,747 $ 2,367,042
Accrued liabilities 721,468 1,350,923
Deferred revenue 4,389,361 738,297
-------------------------------------------------------------------------
5,984,576 4,456,262
Deferred revenue 11,004,382 844,275
Shareholders' equity:
Share capital 172,773,599 172,771,544
Share purchase warrants 4,597,808 4,597,988
Contributed surplus 4,463,706 3,944,492
Deficit accumulated during the
development stage (94,710,276) (86,566,501)
-------------------------------------------------------------------------
87,124,837 94,747,523
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 104,113,795 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2006 2005 2006
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Revenue $ 793,085 $ 88,508 $ 2,692,240
Interest income 894,712 154,499 5,784,561
-------------------------------------------------------------------------
1,687,797 243,007 8,476,801
Expenses:
General and administrative 1,880,889 1,427,899 30,989,088
Licensing and product
development 7,864,866 4,776,009 69,902,780
-------------------------------------------------------------------------
9,745,755 6,203,908 100,891,868
-------------------------------------------------------------------------
Loss before the undernoted (8,057,958) (5,960,901) (92,415,067)
Gain (loss) on foreign exchange (85,817) 37,055 (306,447)
Loss on marketable securities - - (1,191,329)
-------------------------------------------------------------------------
Loss before income taxes (8,143,775) (5,923,846) (93,912,843)
Income taxes - - 7,300
-------------------------------------------------------------------------
Loss for the period $ (8,143,775) $ (5,923,846) $ (93,920,143)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.15) $ (0.15)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of
common shares outstanding,
excluding 2,380,953 common
shares held in escrow for
contingent additional payment
related to the Delex
acquisition 55,781,996 38,788,715
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2006 2005 2006
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit, beginning of period $ (86,566,501) $ (60,751,894) $ -
Cost of purchasing shares for
cancellation in excess of
book value - - (790,133)
Loss for the period (8,143,775) (5,923,846) (93,920,143)
-------------------------------------------------------------------------
Deficit, end of period $ (94,710,276) $ (66,675,740) $ (94,710,276)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2006 2005 2006
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (8,143,775) $ (5,923,846) $ (93,920,143)
Items not involving cash:
Depreciation of capital
assets 25,348 12,564 357,029
Amortization of intangible
assets 633,051 228,528 2,039,969
Loss on marketable
securities - - 1,191,329
Stock-based employee
compensation 519,214 286,919 4,955,777
Stock-based consideration - 100,000 292,750
Warrants-based
consideration - - 54,775
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses 868,254 (249,049) (636,137)
Accounts payable, accrued
liabilities and deferred
revenue 11,688,421 (265,032) 13,747,316
-------------------------------------------------------------------------
5,590,513 (5,809,916) (71,917,335)
Financing activities:
Repayment of debentures - - (1,469,425)
Issue of common shares on
exercise of options - 162,500 2,505,014
Issue of common shares on
exercise of warrants 1,875 - 4,284,055
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - - (1,029,679)
Net proceeds from issuance
of shares and warrants - - 123,276,729
-------------------------------------------------------------------------
1,875 162,500 124,936,322
Investing activities:
Short-term deposits, net 33,959,585 29,882,472 (51,452,607)
Proceeds on sale of
marketable securities - - 1,404,450
Additions to capital and
intangible assets (1,630) (6,631) (451,783)
-------------------------------------------------------------------------
33,957,955 29,875,841 (50,499,940)
-------------------------------------------------------------------------
Increase in cash and cash
equivalents 39,550,343 24,228,425 2,519,047
Net cash assumed on acquisition - - 39,766,613
Cash and cash equivalents,
beginning of period 2,735,317 686,373 -
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 42,285,660 $ 24,914,798 $ 42,285,660
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares from
escrow on Delex
acquisition $ - $ 1,464,284 $ 11,326,981
Issuance of common shares
on Eximias acquisition - - 35,063,171
Issuance of common shares
in exchange for licensed
patents - 100,000 100,000
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For further information: Thomas Fechtner, The Trout Group LLC, Tel. (212)
477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com
(YMBA)
END
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