YM BioSciences reports first quarter operational and financial results
MISSISSAUGA, ON, Nov. 15 /CNW/ - YM BioSciences Inc. (TSX:YM, AMEX:YMI,
AIM:YMBA), the cancer drug development company with an advanced-stage
portfolio, today reported operational and financial results for the first
quarter of its 2005 fiscal year, ended September 30, 2004.
First Quarter Highlights:
- Received out-licensing revenue of $360,000 from subsidiary of
CancerVax Corporation (NASDAQ:CNVX) of San Diego.
- TheraCIM hR3 awarded Orphan Drug Designation in Europe for glioma
(brain cancer).
- Raised more than $20 million in equity.
- Listed on the American Stock Exchange (AMEX).
"With multiple late-stage clinical programs underway, additional key
trials expected to be initiated, and results for TheraCIM hR3 anticipated
during 2005, it will be an active year ahead," said David Allan, Chairman and
CEO of YM BioSciences. "A key focus for 2005 will be to enhance the market
potential of tesmilifene by undertaking to confirm its efficacy with taxanes
in metastatic breast cancer as well as to prioritize development in other
indications beyond breast and prostate cancer."
Anticipated Milestones going forward by calendar quarter:
- Ending December 31, 2004
- TheraCIM: data from nasopharyngeal Phase II trial by licensor
- TheraCIM: start of metastatic pancreatic trial - Germany
- 200 of 700 patients (86 centers) targeted enrolment for tesmilifene
international trial
- Ending March 31, 2005
- tesmilifene: regulatory submission for Taxotere study in metastatic
breast
- TheraCIM: start of staged pivotal trial in adult glioma - Germany
- TheraCIM: initiate pharmacodynamic study
- Norelin(TM): data from Phase II extension trial
- Targets for balance of calendar 2005
- Expand product pipeline
- Complete recruitment Phase III metastatic breast in Q3
- Complete recruitment Phase III glioma - Germany
- Complete recruitment Phase II Taxotere in metastatic breast
YM's lead drug, tesmilifene, continues enrolment in a registration trial
as planned. As at Nov. 8th, 2004, there are 62 active clinical sites open out
of a targeted 86 sites across 16 countries. The remaining 24 sites are
expected to become active by the end of 2004 and approximately 200 patients
are targeted to be enrolled by that date. The enrolment target is one
patient/site/month and YM management continues to anticipate completion of
enrolment in the third quarter of 2005. If enrolment targets are met and
survival results are similar to those for the initial tesmilifene phase III
trial then YM may be in position to submit the drug for FDA approval in late
2006 or early 2007.
Financial Results
During the first quarter, the Company recorded first time out-licensing
revenues of $361,378 for two pre-clinical products acquired by Taracanta, a
subsidiary of CancerVax Corporation.
Total expenditures for the three months ended September 30, 2004 were
$2,581,736 compared to $831,433 for the three months ended September 30, 2003.
Licensing and Product Development expenses were $1,323,704 for the three
months ended September 30, 2004 compared to $324,586 for the same quarter last
year. This includes $635,000 for the tesmilifene Phase III clinical trial in
metastatic and recurrent breast cancer that commenced in March 2004. General
and administrative expenses for the three months ended September 30, 2004
totaled $1,258,032 compared to $506,847 for the same period last year. The
major increases were principally due to increased investor relations expense
and the cost of obtaining a listing on the AMEX.
The net loss for the quarter ended September 30, 2004 was $2,268,699
compared to $779,826 for the same period last year.
On September 30, 2004 the Company raised $20,795,002 (net $18,611,860)
through a bought deal public offering. As at September 30, 2004 the Company
had cash and short-term deposits totaling $37,349,984 and current liabilities
of $1,150,153. The Company anticipates that it has sufficient cash to support
its current development program to beyond the end of fiscal 2006.
About YM BioSciences
YM BioSciences Inc. is a cancer drug development company. Its lead drug,
tesmilifene, is a small molecule chemopotentiator (for taxanes and
anthracyclines) currently undergoing a pivotal Phase III trial in metastatic
breast cancer. Tesmilifene has completed a previous Phase III trial with
positive results. In addition to tesmilifene, the company is developing an
EGFr humanized monoclonal antibody that has completed Phase II trials and a
GnRH anti-cancer vaccine that is in earlier stage clinical trials.
Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause 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.
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Balance Sheet
(Expressed in Canadian dollars)
September 30, 2004, with comparative figures for June 30, 2004
(Unaudited)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
September 30, June 30,
2004 2004
-------------------------------------------------------------------------
Restated -
Assets
Current assets:
Cash and cash equivalents $ 37,349,984 $ 5,493,907
Short-term deposits - 14,893,951
Marketable securities 19,715 19,715
Accounts receivable and prepaid expenses 409,135 463,838
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37,778,834 20,871,411
Capital assets 10,597 11,381
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$ 37,789,431 $ 20,882,792
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 861,475 $ 993,272
Accrued liabilities 288,678 170,439
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1,150,153 1,163,711
Shareholders' equity:
Share capital 77,280,157 59,841,914
Share and unit purchase warrants 5,208,720 3,627,239
Contributed surplus 738,367 569,195
Deficit accumulated during the
development stage (46,587,966) (44,319,267)
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36,639,278 19,719,081
Commitments
Subsequent event
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$ 37,789,431 $ 20,882,792
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Operations
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
From inception
on August 17,
Three months ended 1994 to
September 30, September 30,
2004 2003 2004
-------------------------------------------------------------------------
Restated - Restated -
Out-licencing revenue $ 361,378 $ - $ 361,378
Interest income 107,096 51,607 2,895,514
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468,474 51,607 3,256,892
Expenses:
General and administrative 1,258,032 563,093 16,091,403
Licensing and product
development 1,323,704 324,586 32,200,091
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2,581,736 887,679 48,291,494
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Loss before the undernoted (2,113,262) (836,072) (45,034,602)
Gain on sale of
marketable securities - - 638,332
Unrealized loss on foreign
exchange (155,437) - (155,437)
Unrealized loss on
marketable securities - - (1,812,158)
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Loss before income taxes (2,268,699) (836,072) (46,363,865)
Income taxes - - 7,300
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Loss for the period $ (2,268,699) $ (836,072) $(46,371,165)
-------------------------------------------------------------------------
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Basic and diluted loss
per common share $ (0.08) $ (0.05)
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-------------------------------------------------------------------------
Weighted average number of
common shares outstanding 28,689,212 17,441,894
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Deficit Accumulated During the Development
Stage
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
From inception
on August 17,
Three months ended 1994 to
September 30, September 30,
2004 2003 2004
-------------------------------------------------------------------------
Restated - Restated -
Deficit, beginning of period:
As previously reported $(43,779,888) $(36,411,810) $ -
Adjustment to reflect
change in accounting for
employee stock options (539,379) (58,855) -
-----------------------------------------------------------------------
As restated (44,319,267) (36,470,665) -
Cost of purchasing shares
for cancellation in excess
of book value - (156,704) (216,801)
Loss for the period (2,268,699) (836,072) (46,371,165)
-------------------------------------------------------------------------
Deficit, end of period $(46,587,966) $(37,463,441) $(46,587,966)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statement of Cash Flows
(Expressed in Canadian dollars)
(Unaudited)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
From inception
on August 17,
Three months ended 1994 to
September 30, September 30,
2004 2003 2004
-------------------------------------------------------------------------
Restated - Restated -
Cash provided by (used in):
Operating activities:
Loss for the period $ (2,268,699) $ (836,072) $(46,371,165)
Items not involving cash:
Depreciation 784 14,910 259,731
Gain on sale of
marketable securities - - (638,332)
Unrealized loss on
marketable securities - - 1,812,158
Stock-based compensation 169,172 56,246 738,367
Change in non-cash
operating working capital:
Accounts receivable and
prepaid expenses 54,703 3,735 (409,135)
Accounts payable and
accrued liabilities (13,558) (30,066) 1,150,153
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(2,057,598) (791,247) 43,458,223
Financing activities:
Net proceeds from issuance
of shares and warrants 18,972,307 - 80,964,645
Exercise of options 47,417 - 1,591,792
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - (5,120) (249,769)
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19,019,724 (5,120) 79,676,296
Investing activities:
Short-term deposits 14,893,951 - -
Proceeds on sale of
marketable securities - - 1,402,239
Additions to capital assets - (2,159) (270,328)
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14,893,951 (2,159) 1,131,911
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents 31,856,077 (798,526) 37,349,984
Cash and cash equivalents,
beginning of period 5,493,907 7,700,333 -
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Cash and cash equivalents,
end of period $ 37,349,984 $ 6,901,807 $ 37,349,984
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For further information: James Smith, the Equicom Group Inc.,
Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:
jsmith(at)equicomgroup.com; YM BioSciences Inc., Tel. (905) 629-9761, Fax
(905) 629-4959, Email: ir(at)ymbiosciences.com
(YM. YMI YMBA)
END
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