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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| YM Bio.'b'ser1 | LSE:YMB | London | Ordinary Share | CA9842382041 | CLASS B PFD SHS SER 1 NPV |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0.00 | - |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
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YM BIOSCIENCES REPORTS FIRST QUARTER 2008 OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, Nov. 12 /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 2008, ended September 30,
2007.
"We launched into our 2008 fiscal year by further increasing the level of
clinical activity for our lead drug, nimotuzumab," said David Allan, Chairman
and CEO of YM BioSciences. "In July 2007, we initiated patient enrollment for
our colorectal cancer trial - the first trial using nimotuzumab with
chemotherapy in a bulky tumor. Data from this trial could provide important
evidence supporting the observations to date that nimotuzumab can deliver
efficacy without the debilitating side effects common to other EGFR-targeting
drugs. In August 2007, YM-USA received clearance from the FDA to initiate a
44-patient clinical trial in children with diffuse, intrinsic pontine glioma
(DIPG), an inoperable progressive brain cancer."
"More recently our licensee in Europe, Oncoscience AG, recruited its
first patients into a randomized Phase III trial in first line adult
glioblastoma grade IV and a Phase IIb/IIIa randomized, placebo controlled
trial in patients with advanced pancreatic cancer for which YM has received
clearance to extend into Canada. Moreover, Daiichi-Sankyo, our licensee in
Japan, has advised us that it has completed its preliminary trials with
nimotuzumab, permitting it to advance into more advanced trials in 2008,"
added Mr. Allan. "We also continued to progress the development of AeroLEF(TM)
and the FDA have scheduled an end-of-Phase II meeting to discuss the Phase III
trial design. The first US trial for AeroLEF(TM) has been cleared to proceed
by the FDA and is pending clearance with the relevant Investigator Review
Boards."
Nimotuzumab:
Nimotuzumab, a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR), is currently in varying stages of development
in a number of trials, including colorectal cancer, adult and pediatric
glioma, non-small-cell lung cancer and pancreatic cancer. During the first
quarter of fiscal 2008:
- YM initiated enrollment for a Phase II colorectal cancer trial in
Canada. As of today, 30 patients have been enrolled in the first 50-
patient cohort, with recruitment of this cohort expected to be
completed by the end of calendar 2007 and data from this cohort are
expected to be reported in early calendar 2008. The endpoints of the
trial include Objective Response Rate (ORR), Progression Free
Survival (PFS), Overall Survival (OS) and the rates and durations of
Stable Disease (SD), as well as safety.
- YM USA was cleared by the US FDA to expand its second-line clinical
trial in children with DIPG into the US.
- YM reported positive preliminary results of a Phase I/II trial of
nimotuzumab in combination with radiation for the treatment of non-
small-cell lung cancer (NSCLC).
- Oncoscience AG reported completion of patient enrollment in the
Phase III, first-line, pediatric DIPG trial.
- Oncoscience AG reported initiation of late-stage trials designed to
be supportive of registration in adult glioma and pancreatic cancer.
- Subsequent to the end of the quarter:
- YM received clearance from Health Canada to extend into Canada the
188-patient multi-centre randomized, placebo controlled
Phase IIb/IIIa study in chemotherapy-naive patients with locally
advanced or metastatic pancreatic cancer initiated by Oncoscience.
- Daiichi-Sankyo Co., Ltd. advised YM that it had completed enrollment
in a nimotuzumab safety trial. There were no limiting toxicities.
AeroLEF(TM):
AeroLEF(TM) is a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. AeroLEF(TM) uniquely permits patients to
identify and select the appropriate dose in real-time for each pain episode to
achieve both rapid onset and extended duration of analgesia. During the first
quarter of fiscal 2008:
- YM announced the clearance by the FDA for the first IND in the US for
AeroLEF(TM).
- A request to the FDA for an End-of-Phase II meeting prior to calendar
year-end 2007 to discuss Phase III trial designs was submitted. YM
has been notified by the FDA that this meeting has been scheduled.
- YM received clearance from the FDA to initiate a Phase II trial in
the US in opioid-tolerant or opioid-naïve patients. This trial is not
rate-limiting to the Phase III timeline but a successful trial would
further extend the utility and medical breadth of the product if and
when approved. Enrollment in the 50-patient trial is expected to
start in calendar Q4, 2007.
Financial Results (CDN dollars)
Total revenue for the first quarter of fiscal 2008, ended September 30,
2007 was $1.8 million compared with $1.8 million for the first quarter of
fiscal 2007, ended September 30, 2006. Revenue from out-licensing was
$1.1 million for first quarter of fiscal 2008 compared with $0.9 million for
the first quarter of fiscal 2007. Interest income for the first quarter of
fiscal 2008 was $0.7 million compared with $0.9 million for the first quarter
of fiscal 2007.
Total operating expenditures for the first quarter of fiscal 2008 were
$5.6 million compared to $9.7 million for the first quarter of fiscal 2007.
General and administrative expenses were $2.0 million for the first quarter of
fiscal 2008 compared with $1.9 million for the first quarter of fiscal 2007.
Licensing and product development expenses decreased to $3.5 million for the
first quarter of fiscal 2008 compared to $7.9 million for the first quarter of
fiscal 2007. The change is mainly the result of reduced development activity
for tesmilifene, for which a Phase III trial was terminated in January 2007,
and reduced clinical development costs for nimotuzumab and AeroLEF(TM), for
both of which certain trials have finished and others are just starting up.
Net loss for the first quarter of fiscal 2008 was $3.6 million ($0.06 per
share) compared to $9.7 million ($0.17 per share) for the same period last
year.
As at September 30, 2007 the Company had cash and cash equivalents and
short-term deposits totaling $71.1 million and payables and accrued
liabilities totaling $2.2 million compared to $75.6 million and $3.3 million
respectively at June 30, 2007.
As at September 30, 2007 the Company had 58,216,309 common shares
outstanding, of which 2,380,953 common shares are held in escrow for
contingent additional payment related to the acquisition of Delex Therapeutics
Inc., 5,799,765 warrants, and 6,155,662 options.
AGM Announcement
YM BioSciences' Annual Meeting of Shareholders will be held on
November 28th, 2007 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
two late-stage products: 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 proprietary, 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 nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that AeroLEF(TM) 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.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
September 30, June 30,
2007 2007
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 20,615,398 $ 5,847,351
Short-term deposits 50,500,118 69,724,438
Accounts receivable 419,152 370,011
Prepaid expenses 280,877 347,010
-----------------------------------------------------------------------
71,815,545 76,288,810
Capital assets 290,893 325,040
Intangible assets 4,860,815 5,125,950
-------------------------------------------------------------------------
$ 76,967,253 $ 81,739,800
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 1,009,731 $ 1,169,211
Accrued liabilities 1,195,302 2,103,755
Deferred revenue 4,623,340 4,702,132
-----------------------------------------------------------------------
6,828,373 7,975,098
Deferred revenue 7,881,759 8,929,900
Shareholders' equity:
Share capital 172,921,153 172,921,153
Share purchase warrants 4,553,308 4,553,308
Contributed surplus 6,703,710 5,657,082
Deficit accumulated during the
development stage (121,921,050) (118,296,741)
-----------------------------------------------------------------------
62,257,121 64,834,802
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 76,967,253 $ 81,739,800
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations and Comprehensive Income
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Period from
inception on
August 17,
Three months ended 1994 to
September 30, September 30,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Revenue $ 1,126,933 $ 860,698 $ 7,433,978
Interest income 690,392 894,712 8,819,781
-------------------------------------------------------------------------
1,817,325 1,755,410 16,253,759
Expenses:
General and administrative 2,034,010 1,880,889 38,120,545
Licensing and product
development 3,544,859 7,864,866 94,341,242
Impairment - - 1,829,538
-----------------------------------------------------------------------
5,578,869 9,745,755 134,291,325
-------------------------------------------------------------------------
Loss before the undernoted (3,761,544) (7,990,345) (118,037,566)
Gain (loss) on foreign
exchange 43,905 (85,817) (319,277)
Gain on short-term deposits 93,330 - 93,330
Loss on marketable securities - - (1,191,329)
-------------------------------------------------------------------------
Loss before income taxes (3,624,309) (8,076,162) (119,454,842)
Income taxes - 1,622,695 1,676,075
-------------------------------------------------------------------------
Loss and comprehensive loss
for the period $ (3,624,309) $ (9,698,857) $(121,130,917)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.06) $ (0.17)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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 55,835,356 55,781,996
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit, beginning of period $(118,296,741) $ (86,566,501) $ -
Cost of purchasing shares for
cancellation in excess of
book value - - (790,133)
Loss for the period (3,624,309) (9,698,857) (121,130,917)
-------------------------------------------------------------------------
Deficit, end of period $(121,921,050) $ (96,265,358) $(121,921,050)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (3,624,309) $ (9,698,857) $(121,130,917)
Items not involving cash:
Amortization of capital
assets 34,147 25,348 472,936
Amortization of intangible
assets 265,135 633,051 3,585,093
Impairment of intangible
asset - - 1,829,538
Loss on marketable
securities - - 1,191,329
Unrealized gain on
financial instruments (70,377) - (70,377)
Stock-based employee
compensation 1,046,628 519,214 7,200,104
Stock-based consideration - - 292,750
Warrants-based
consideration - - 54,775
Change in non-cash operating
working capital:
Accounts receivable and
prepaid expenses 16,992 868,254 328,693
Accounts payable, accrued
liabilities and deferred
revenue (2,194,866) 13,243,503 11,468,488
-----------------------------------------------------------------------
(4,526,650) 5,590,513 (94,777,588)
Financing activities:
Issuance of common shares on
exercise of warrants - 1,875 4,371,555
Repayment of debenture - - (1,469,425)
Net proceeds from issuance
of shares and warrants - - 123,276,729
Issuance of common shares on
exercise of options - - 2,516,246
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - - (1,029,679)
-----------------------------------------------------------------------
- 1,875 125,035,054
Investing activities:
Purchase of short-term
deposits, net 19,294,697 33,959,585 (50,235,816)
Proceeds on sale of
marketable securities - - 1,404,450
Additions to capital and
intangible assets - (1,630) (577,315)
-----------------------------------------------------------------------
19,294,697 33,957,955 (49,408,681)
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents 14,768,047 39,550,343 (19,151,215)
Net cash assumed on
acquisition - - 39,766,613
Cash and cash equivalents,
beginning of period 5,847,351 2,735,317 -
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 20,615,398 $ 42,285,660 $ 20,615,398
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow
information:
Non-cash items:
Issuance of shares from
escrow on Delex
acquisition $ - $ - $ 11,326,981
Issuance of common shares
on Eximias acquisition - - 35,063,171
Issuance of common shares
in exchange for licensed
patents - - 100,000
-------------------------------------------------------------------------
-------------------------------------------------------------------------
%SEDAR: 00004652E
For further information: Thomas Fechtner, the Trout Group LLC, Tel. (646)
378-2931, Email: tfechtner(at)troutgroup.com; James Smith, the Equicom Group
Inc., Tel. (416) 815-0700 x 229, Email: jsmith(at)equicomgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
(YMBA)
END
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