RNS Number:2719F
YM BioSciences Inc.
16 November 2004
YM BIOSCIENCES REPORTS FIRST QUARTER OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, Canada - November 15th, 2004 - 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
- NorelinTM: 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.
Enquiries:
James Smith, the Equicom Group Inc. YM BioSciences Inc.
Tel. +1-416-815-0700 x 229 Tel. +1-905-629-9761
Fax +1-416-815-0080 Fax +1-905-629-4959
Email: jsmith@equicomgroup.com Email: ir@ymbiosciences.com
Summary financial statements attached:
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
37,778,834 20,871,411
Capital assets 10,597 11,381
$ 37,789,431 $ 20,882,792
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 861,475 $ 993,272
Accrued liabilities 288,678 170,439
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)
36,639,278 19,719,081
Commitments
Subsequent event
$ 37,789,431 $ 20,882,792
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
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
2,581,736 887,679 48,291,494
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)
Loss before income taxes (2,268,699) (836,072) (46,363,865)
Income taxes - - 7,300
Loss for the period $ (2,268,699) $ (836,072) $ (46,371,165)
Basic and diluted loss
per common share $ (0.08) $ (0.05)
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
(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)
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)
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 -
Cash and cash equivalents,
end of period $ 37,349,984 $ 6,901,807 $ 37,349,984
This information is provided by RNS
The company news service from the London Stock Exchange
END
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