MISSISSAUGA,
ON, May 11, 2012 /PRNewswire/
- YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a drug
development company advancing a diverse portfolio of hematology and
cancer related products, today reported operational and financial
results for its third quarter of fiscal 2012, ended March 31, 2011.
"In the past few months we delivered robust
Phase I/II results for our JAK1/JAK2 inhibitor, CYT387, in patients
with myelofibrosis and we raised an additional $80 million principally to support the further
advancement of this drug," said Dr. Nick
Glover, President and CEO of YM BioSciences. "Our current
focus is on confirming our Phase III clinical strategy for CYT387
with both North American and European regulators with the
expectation that, subject to these regulatory discussions, we will
begin enrolling patients in pivotal trials in the second half of
calendar 2012."
CYT387 Next Steps:
- Subject to regulatory clearance, pivotal trials for CYT387 in
myelofibrosis are targeted to begin in the second half of calendar
2012.
- Final nine-month data from the ongoing 166-patient Phase I/II
Core trial are expected to be reported by the end of calendar
2012.
- Interim data from the Phase I/II Extension trial, in which
patients who have completed the Core trial are able to continue
long-term treatment with CYT387, are expected to be reported by the
end of calendar 2012.
- Interim data from the BID (twice-daily dosing) Phase II trial
of CYT387 are expected to be reported by the end of calendar
2012.
- YM may evaluate CYT387's effectiveness in additional clinical
indications and is currently in the process of designing clinical
trials for these indications.
- YM will entertain strategic discussions with other companies
for the next stages of development for CYT387 and will weigh any
opportunities against the prospect of retaining full commercial
economics by advancing CYT387 further into pivotal trials on its
own.
Financial Results (CDN dollars)
The interim consolidated financial statements and comparative
information for the third quarter of fiscal 2012 have been prepared
in accordance with International Financial Reporting Standards
("IFRS"). Previously, up to June 30,
2011, the Company prepared its Interim and Annual
Consolidated Financial Statements in accordance with Canadian
Generally Accepted Accounting Principles ("Canadian GAAP").
Revenue, primarily from out-licensing, for the
third quarter of fiscal 2012 ended March 31,
2012, was $0.1 million
compared with $0.2 million for the
third quarter of fiscal 2011. Revenue from out-licensing for the
first nine months of fiscal 2012 was $0.7
million compared with $0.8
million for the first nine months of fiscal 2011. The
decreases were due to a two-year increase in the period over which
the deferred revenue is being recognized.
Net finance income was $0.3 million for the third quarter of fiscal 2012
compared to net finance costs of $1.5
million for the third quarter of fiscal 2011. Net finance
income was $9.3 million for the first
nine months of fiscal 2012 compared to net finance costs of
$9.8 million for the first nine
months of fiscal 2011. The changes in net finance income are
primarily attributable to changes in the fair value adjustment for
USD warrants. Under IFRS, warrants denominated in a different
currency than the Company's functional currency must be classified
as a financial liability and measured at fair value, with changes
reflected in profit or loss. For the third quarter of fiscal 2012,
the Company incurred a loss of $0.4
million on the revaluation of warrants, compared to a loss
of $1.1 million for the third quarter
of fiscal 2011. For the first nine months of fiscal 2012, the
Company incurred a gain of $6.8
million on the revaluation of warrants, compared to a loss
of $8.6 million for the first nine
months of fiscal 2011.
Licensing and product development expenses were
$5.8 million for the third quarter of
fiscal 2012 compared with $5.5
million for the third quarter of fiscal 2011. Licensing and
product development expenses were $19.5
million for the first nine months of fiscal 2012 compared
with $16.4 million for the first nine
months of fiscal 2011. For the third quarter of fiscal 2012, core
expenses for licensing and product development remained constant at
$3.0 million compared to the three
months ended March 31, 2011, costs
associated with development activities for CYT387 increased by
$1.0 million to $2.5 million, and costs associated with
development activities for nimotuzumab decreased by $0.7 million to $0.2
million. Development expenses for CYT387 increased due to
the expansion of the Phase I/II clinical trial in myelofibrosis,
start-up costs associated with the BID (twice-daily dosing) study,
pre-clinical development activities, and manufacturing of drug for
these programs.
General and administrative expenses were
$1.4 million for the third quarter of
fiscal 2012 compared to $1.6 million
for the third quarter of fiscal 2011. General and administrative
expenses were $4.7 million for the
first nine months of fiscal 2012 compared to $6.6 million for the first nine months of fiscal
2011, primarily due to severance and restructuring costs incurred
in fiscal 2011.
Net loss for the third quarter of fiscal 2012
was $6.8 million ($0.05 per share) compared to $8.3 million ($0.08
per share) for the same period last fiscal year. Net loss for the
first nine months of fiscal 2012 was $14.2
million ($0.12 per share)
compared to $32.0 million
($0.35 per share) for the same period
last fiscal year. Under IFRS, net loss has been volatile, caused by
the requirement to adjust the carrying value of liabilities such as
USD warrants and stock appreciation rights to fair value at each
measurement date, with changes being reflected in net loss for the
quarter.
During the third quarter of fiscal 2012, the
Company completed a prospectus offering of 40,250,000 shares for
gross proceeds of $79.4 million (U.S.
$80.5 million) resulting in a net
cash proceeds of $74.2 million.
As at March 31,
2012 the Company had cash and short-term deposits totaling
$137.2 million and accounts payables
and accrued liabilities totaling $3.1
million compared to $79.7
million and $4.4 million
respectively at June 30, 2011.
As at March 31,
2012 the Company had 157,402,353 common shares and 7,366,418
warrants outstanding.
About YM BioSciences
YM BioSciences Inc. is a drug development company primarily focused
on advancing CYT387, an orally administered inhibitor of both the
JAK1 and JAK2 kinases, which have been implicated in a number of
immune cell disorders including myeloproliferative neoplasms and
inflammatory diseases as well as certain cancers. Positive interim
results have been reported from a Phase I/II trial of CYT387 in 166
patients with myelofibrosis. This trial has completed enrollment
while a 60 patient Phase II twice-daily dose escalation trial is
currently recruiting patients. YM's portfolio also includes
nimotuzumab, a humanized monoclonal antibody targeting EGFR with an
enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and
III trials worldwide. CYT997 is an orally-available small molecule
therapeutic with dual mechanisms of vascular disruption and
cytotoxicity, and has completed a Phase II trial in glioblastoma
multiforme. In addition to YM's three products, the Company has
several preclinical research programs underway with candidates from
its library of novel compounds identified through internal research
conducted at YM BioSciences Australia.
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 or the ability to obtain drug product in
sufficient quantity or at standards acceptable to health regulatory
authorities to complete clinical trials or to meet commercial
demand; 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 CYT387, nimotuzumab and CYT997 will
generate positive efficacy and safety data in ongoing and future
clinical trials, and that YM and its various licensees will
complete their respective clinical trials and disclose data 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.
|
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YM BIOSCIENCES
INC. |
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|
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|
Condensed Consolidated
Interim Statements of Financial Position |
|
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|
|
|
(Expressed in Canadian
dollars, unless otherwise noted) |
|
|
|
|
|
|
(Unaudited) |
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March 31,
2012 |
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|
June 30,
2011 |
|
July 1,
2010 |
|
|
|
|
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|
|
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|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
90,830,767 |
|
|
$ |
32,046,630 |
$ |
19,460,141 |
|
Short-term deposits |
|
46,362,847 |
|
|
|
47,611,922 |
|
26,184,991 |
|
Accounts receivable |
|
248,738 |
|
|
|
205,900 |
|
161,184 |
|
Prepaid
expenses |
|
428,114 |
|
|
|
731,676 |
|
237,962 |
|
Total current assets |
|
137,870,466 |
|
|
|
80,596,128 |
|
46,044,278 |
|
|
|
|
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
|
|
|
|
Property and equipment |
|
62,157 |
|
|
|
91,320 |
|
84,775 |
|
Intangible assets |
|
3,756,686 |
|
|
|
7,137,698 |
|
11,645,714 |
|
Total non-current assets |
|
3,818,843 |
|
|
|
7,229,018 |
|
11,730,489 |
|
|
|
|
|
|
|
|
|
Total assets |
$ |
141,689,309 |
|
|
$ |
87,825,146 |
$ |
57,774,767 |
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|
|
|
|
|
|
|
|
Liabilities and
Equity |
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|
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|
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|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
$ |
1,287,062 |
|
|
$ |
1,718,893 |
$ |
699,277 |
|
Accrued liabilities |
|
1,783,598 |
|
|
|
2,652,511 |
|
2,085,824 |
|
Share purchase warrants |
|
7,630,176 |
|
|
|
14,476,681 |
|
6,358,480 |
|
Deferred
revenue |
|
381,270 |
|
|
|
594,072 |
|
1,523,916 |
|
Total current liabilities |
|
11,082,106 |
|
|
|
19,442,157 |
|
10,667,497 |
|
|
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
|
|
|
|
Deferred
revenue |
|
1,652,170 |
|
|
|
1,831,722 |
|
1,650,909 |
|
Total non-current liabilities |
|
1,652,170 |
|
|
|
1,831,722 |
|
1,650,909 |
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|
|
|
|
|
|
|
|
Equity: |
|
|
|
|
|
|
|
|
|
Share capital |
|
339,867,098 |
|
|
|
264,548,643 |
|
203,498,239 |
|
Contributed surplus |
|
16,478,999 |
|
|
|
15,144,062 |
|
14,232,353 |
|
Deficit |
|
(227,391,064) |
|
|
|
(213,141,438) |
|
(172,274,231) |
|
Total equity |
|
128,955,033 |
|
|
|
66,551,267 |
|
45,456,361 |
|
|
|
|
|
|
|
|
|
Total liabilities and
equity |
$ |
141,689,309 |
|
|
$ |
87,825,146 |
$ |
57,774,767 |
|
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|
|
Approved by the Board and authorized for issue on May 10,
2012: |
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|
"Tryon Williams" |
Director |
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"David G.P. Allan" |
Director |
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|
YM BIOSCIENCES
INC. |
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|
|
|
|
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|
|
Condensed Consolidated
Interim Statements of Comprehensive Income |
|
|
|
|
|
(Expressed in Canadian
dollars, unless otherwise noted) |
|
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|
|
|
|
|
(Unaudited) |
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|
|
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|
|
|
|
|
|
|
|
Three months
ended March 31, |
Nine months
ended March 31, |
|
|
2012 |
|
|
2011 |
|
2012 |
|
2011 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
Out-licensing |
$ |
109,107 |
|
$ |
217,489 |
$ |
739,952 |
$ |
811,262 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
Licensing and product
development |
|
5,755,426 |
|
|
5,493,790 |
|
19,503,754 |
|
16,432,545 |
|
General
and administrative |
|
1,433,113 |
|
|
1,606,297 |
|
4,748,144 |
|
6,560,907 |
|
|
7,188,539 |
|
|
7,100,087 |
|
24,251,898 |
|
22,993,452 |
|
|
|
|
|
|
|
|
|
|
Loss before the
undernoted |
|
(7,079,432) |
|
|
(6,882,598) |
|
(23,511,946) |
|
(22,182,190) |
|
|
|
|
|
|
|
|
|
|
Finance income |
|
699,990 |
|
|
170,437 |
|
9,262,320 |
|
319,935 |
Finance costs |
|
(417,716) |
|
|
(1,642,363) |
|
- |
|
(10,140,698) |
Other income |
|
- |
|
|
9,528 |
|
- |
|
34,444 |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
Net loss for the
period and
comprehensive loss |
$ |
(6,797,158) |
|
$ |
(8,344,996) |
$ |
(14,249,626) |
$ |
(31,968,509) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share |
$ |
(0.05) |
|
$ |
(0.08) |
$ |
(0.12) |
$ |
(0.35) |
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|
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|
|
YM BIOSCIENCES
INC. |
|
|
|
|
|
|
|
Condensed Consolidated
Interim Statements of Changes in Equity |
|
|
|
|
(Expressed in Canadian
dollars, unless otherwise noted) |
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
Contributed |
|
|
|
|
|
Number |
|
Amount |
|
surplus |
|
Deficit |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30,
2011 |
116,681,948 |
$ |
264,548,643 |
$ |
15,144,062 |
$ |
(213,141,438) |
$ |
66,551,267 |
|
|
|
|
|
|
|
|
|
|
Net loss for the
period |
- |
|
- |
|
- |
|
(14,249,626) |
|
(14,249,626) |
|
|
|
|
|
|
|
|
|
|
Transactions with
owners of the Company,
recognized directly in equity: |
|
|
|
|
|
|
|
|
|
|
Shares issued
pursuant to prospectus offering |
40,250,000 |
|
74,232,207 |
|
- |
|
- |
|
74,232,207 |
|
Share-based compensation |
- |
|
- |
|
1,880,899 |
|
- |
|
1,880,899 |
|
Shares
issued on exercise of options |
470,405 |
|
1,086,248 |
|
(545,962) |
|
- |
|
540,286 |
|
Total transactions
with owners of the Company |
40,720,405 |
|
75,318,455 |
|
1,334,937 |
|
- |
|
76,653,392 |
|
|
|
|
|
|
|
|
|
|
Balance, March 31,
2012 |
157,402,353 |
$ |
339,867,098 |
$ |
16,478,999 |
$ |
(227,391,064) |
$ |
128,955,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
Contributed |
|
|
|
|
|
Number |
|
Amount |
|
surplus |
|
Deficit |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, July 1,
2010 |
80,359,623 |
$ |
203,498,239 |
$ |
14,232,353 |
$ |
(172,274,231) |
$ |
45,456,361 |
|
|
|
|
|
|
|
|
|
|
Net loss for the
period |
- |
|
- |
|
- |
|
(31,968,509) |
|
(31,968,509) |
|
|
|
|
|
|
|
|
|
|
Transactions with
owners of the Company,
recognized directly in equity: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
- |
|
- |
|
1,436,442 |
|
- |
|
1,436,442 |
|
Shares issued on exercise of
options |
824,160 |
|
1,427,213 |
|
(576,909) |
|
- |
|
850,304 |
|
Shares issued on exercise of
warrants |
660,529 |
|
2,131,506 |
|
- |
|
- |
|
2,131,506 |
|
Shares
issued pursuant to prospectus offering |
29,250,000 |
|
44,499,915 |
|
- |
|
- |
|
44,499,915 |
|
Total transactions with owners of
the Company |
30,734,689 |
|
48,058,634 |
|
859,533 |
|
- |
|
48,918,167 |
|
|
|
|
|
|
|
|
|
|
Balance, March 31,
2011 |
111,094,312 |
$ |
251,556,873 |
$ |
15,091,886 |
$ |
(204,242,740) |
$ |
62,406,019 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YM BIOSCIENCES
INC. |
|
|
|
|
|
|
|
|
Condensed Consolidated
Interim Statements of Cash Flows |
|
|
|
|
|
|
(Expressed in Canadian
dollars, unless otherwise noted) |
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended March 31, |
|
Nine months
ended March 31, |
|
|
2012 |
|
2011 |
|
2012 |
|
2011 |
|
|
|
|
|
|
|
|
|
Cash provided by (used
in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
activities: |
|
|
|
|
|
|
|
|
|
Net loss for the
period |
$ |
(6,797,158) |
$ |
(8,344,996) |
$ |
(14,249,626) |
$ |
(31,968,509) |
|
Items not involving
cash: |
|
|
|
|
|
|
|
|
|
|
|
Depreciation of
property and equipment |
|
12,521 |
|
20,598 |
|
45,655 |
|
59,745 |
|
|
|
Amortization of intangible
assets |
|
1,127,004 |
|
1,127,004 |
|
3,381,012 |
|
3,381,012 |
|
|
|
Interest earned |
|
(178,400) |
|
(170,437) |
|
(487,568) |
|
(308,812) |
|
|
|
Unrealized (gain)
loss on cash and cash equivalents |
|
506,775 |
|
505,016 |
|
(899,883) |
|
1,515,378 |
|
|
|
Gain on disposal
of property and equipment |
|
- |
|
- |
|
- |
|
(10,744) |
|
|
|
Share-based compensation |
|
373,215 |
|
392,244 |
|
1,880,899 |
|
1,436,442 |
|
|
|
Change in fair value of share
purchase warrants |
|
417,716 |
|
1,137,347 |
|
(6,846,505) |
|
8,625,320 |
|
Changes in non-cash
working capital balances: |
|
|
|
|
|
|
|
|
|
|
|
Short-term deposits |
|
(144,981) |
|
(156,223) |
|
(450,258) |
|
(262,590) |
|
|
|
Accounts receivable |
|
35,697 |
|
(91,833) |
|
(42,838) |
|
(133,812) |
|
|
|
Prepaid expenses |
|
63,498 |
|
104,128 |
|
303,562 |
|
(152,588) |
|
|
|
Accounts payable |
|
(249,939) |
|
(437,564) |
|
(431,831) |
|
275,121 |
|
|
|
Accrued liabilities |
|
(386,440) |
|
(809,927) |
|
(868,913) |
|
718,958 |
|
|
|
Deferred
revenue |
|
(95,318) |
|
(148,518) |
|
(392,354) |
|
(600,513) |
|
Net cash used in
operating activities |
|
(5,315,810) |
|
(6,873,161) |
|
(19,058,648) |
|
(17,425,592) |
|
|
|
|
|
|
|
|
|
Investing
activities: |
|
|
|
|
|
|
|
|
|
Proceeds from sale of
short-term deposits |
|
12,192,896 |
|
13,721,647 |
|
47,999,333 |
|
62,575,864 |
|
Purchase of short-term
deposits |
|
(12,000,000) |
|
(12,500,000) |
|
(46,300,000) |
|
(88,514,540) |
|
Interest received |
|
178,400 |
|
170,437 |
|
487,568 |
|
308,812 |
|
Additions to property and equipment |
|
(6,272) |
|
(16,267) |
|
(16,492) |
|
(68,961) |
|
Net cash provided by
(used in) investing activities |
|
365,024 |
|
1,375,817 |
|
2,170,409 |
|
(25,698,825) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing
activities: |
|
|
|
|
|
|
|
|
|
Issuance of common
shares on exercise of options |
|
517,836 |
|
596,495 |
|
540,286 |
|
850,304 |
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares
on exercise warrants |
|
- |
|
135,058 |
|
- |
|
985,217 |
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of shares |
|
74,232,207 |
|
1,165,392 |
|
74,232,207 |
|
44,499,914 |
|
Net cash provided by
financing activities |
|
74,750,043 |
|
1,896,945 |
|
74,772,493 |
|
46,335,435 |
|
|
|
|
|
|
|
|
|
Impact of foreign
exchange rates on cash |
|
(506,775) |
|
(505,016) |
|
899,883 |
|
(1,515,378) |
|
|
|
|
|
|
|
|
|
Increase (decrease) in
cash and cash equivalents |
|
69,292,482 |
|
(4,105,415) |
|
58,784,137 |
|
1,695,640 |
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents, beginning of period |
|
21,538,285 |
|
25,261,196 |
|
32,046,630 |
|
19,460,141 |
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents, end of period |
$ |
90,830,767 |
$ |
21,155,781 |
$ |
90,830,767 |
$ |
21,155,781 |
SOURCE YM BioSciences Inc.