MISSISSAUGA,
ON, Feb. 9, 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 second quarter of fiscal 2012, ended December 31, 2011.
"JAK inhibitors may ultimately prove valuable in
the treatment of a wide range of blood disorders, cancers and
inflammatory diseases, representing an immense opportunity for this
emerging drug class. We recently reported multicenter data for our
lead JAK inhibitor, CYT387, establishing its competitive safety and
efficacy profile in patients with myelofibrosis," said Dr.
Nick Glover, President and CEO of YM
BioSciences. "The strength of our data positions us well to select
the optimal course to further advance this opportunity."
Updated results from the Phase I/II study of
CYT387 in 166 patients with myelofibrosis were presented in a
poster session at the 53rd Annual Meeting of the American Society
of Hematology held in San Diego in
December 2011. CYT387 demonstrated
an ability to render and maintain anemic myelofibrosis
patients transfusion independent for clinically-relevant periods
while also producing significant and durable improvements in their
splenomegaly and constitutional symptoms. CYT387 was generally safe
and well tolerated in myelofibrosis patients for dosing periods up
to and exceeding two years, with minimal treatment-related
myelosuppression observed.
Financial Results (CDN dollars)
The interim consolidated financial statements and comparative
information for the second 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 from out-licensing for the second
quarter of fiscal 2012, ended December 31,
2011, was $0.4 million
compared with $0.3 million for the
second quarter of fiscal 2011. Revenue from out-licensing for the
first six months of fiscal 2012 was $0.6
million and comparable to $0.6
million for the first six months of fiscal 2011.
Net finance income was $1.5 million for the second quarter of fiscal
2012 compared to net finance costs of $4.6
million for the second quarter of fiscal 2011. Net finance
income was $9.0 million for the first
six months of fiscal 2012 compared to net finance costs of
$8.3 million for the first six months
of fiscal 2011. 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. The change in net finance income
during the second fiscal quarter is primarily attributed to a
change of $6.0 million in the fair
value adjustment for USD warrants. For the first six months of
fiscal 2012, the Company incurred a gain of $7.3 million compared to a loss of $7.5 million for the six months ended
December 31, 2010 on the revaluation
of warrants.
Licensing and product development expenses were
$7.3 million for the second quarter
of fiscal 2012 compared with $5.2
million for the second quarter of fiscal 2011. Licensing and
product development expenses were $13.7
million for the first six months of fiscal 2012 compared
with $10.9 million for the first six
months of fiscal 2011. 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. Expenses for nimotuzumab
continued to decrease.
General and administrative expenses were
$1.2 million for the second quarter
of fiscal 2012 compared to $2.7
million for the second quarter of fiscal 2011. General and
administrative expenses were $3.3
million for the first six months of fiscal 2012 compared to
$5.0 million for the first six months
of fiscal 2011, primarily due to severance and restructuring costs
in 2010.
Net loss for the second quarter of fiscal 2012
was $6.6 million ($0.06 per share) compared to $12.3 million ($0.14 per share) for the same period last
year.
As at December 31,
2011 the Company had cash and short-term deposits totaling
$67.9 million and accounts payables
and accrued liabilities totaling $3.7
million compared to $79.7
million and $4.4 million
respectively at June 30, 2011.
Management believes that the cash and short-term deposits at
December 31, 2011 are sufficient to
support the Company's activities for at least the next 18
months.
As at December 31,
2011 the Company had 116,711,448 common shares and 7,366,418
warrants outstanding.
About YM BioSciences
YM BioSciences Inc. is a drug development company advancing three
products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2
kinases; nimotuzumab, an EGFR-targeting monoclonal antibody; and
CYT997, a vascular disrupting agent (VDA).
CYT387 is 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. Nimotuzumab is 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.
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Financial Position
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
|
|
|
|
|
December 31,
2011 |
June 30,
2011 |
July 1,
2010
|
Assets |
Current assets: |
Cash and cash
equivalents |
$ 21,538,285 |
$ 32,046,630 |
$ 19,460,141 |
Short-term
deposits |
46,410,762 |
47,611,922 |
26,184,991 |
Accounts
receivable |
284,435 |
205,900 |
161,184 |
Prepaid expenses |
491,612 |
731,676 |
237,962 |
Total current
assets |
68,725,094 |
80,596,128 |
46,044,278 |
Non-current assets: |
Property and
equipment |
68,406 |
91,320 |
84,775 |
Intangible
assets |
4,883,690 |
7,137,698 |
11,645,714 |
Total non-current
assets |
4,952,096 |
7,229,018 |
11,730,489 |
|
|
|
|
Total assets |
$ 73,677,190 |
$ 87,825,146 |
$ 57,774,767 |
Liabilities and
Equity |
Current liabilities: |
Accounts
payable |
$ 1,537,001 |
$ 1,718,893 |
$ 699,277 |
Accrued
liabilities |
2,170,038 |
2,652,511 |
2,085,824 |
Share purchase
warrants |
7,212,460 |
14,476,681 |
6,358,480 |
Deferred
revenue |
594,072 |
594,072 |
1,523,916 |
Total current
liabilities |
11,513,571 |
19,442,157 |
10,667,497 |
Non-current
liabilities: |
Deferred
revenue |
1,534,686 |
1,831,722 |
1,650,909 |
Total non-current
liabilities |
1,534,686 |
1,831,722 |
1,650,909 |
Equity: |
Share capital
|
264,586,651 |
264,548,643 |
203,498,239 |
Contributed
surplus |
16,636,188 |
15,144,062 |
14,232,353 |
Deficit |
(220,593,906) |
(213,141,438) |
(172,274,231) |
Total
equity |
60,628,933 |
66,551,267 |
45,456,361 |
|
|
|
|
Total liabilities and
equity |
$ 73,677,190 |
$ 87,825,146 |
$ 57,774,767 |
Approved by the Board and authorized for issue
on February 8, 2012:
Tryon Williams,
Director
David G.P. Allan, Director
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Comprehensive
Income
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
|
|
|
|
Three months ended
December 31, |
Six months ended
December 31, |
|
2011 |
2010 |
2011 |
2010 |
Revenue: |
|
|
|
|
Out-licensing |
$ 380,117 |
$ 251,417 |
$ 630,845 |
$ 593,773 |
Expenses: |
|
|
|
|
Licensing and product
development |
7,260,481 |
5,246,698 |
13,748,328 |
10,938,754 |
General and administrative |
1,154,883 |
2,742,199 |
3,315,031 |
4,954,611 |
|
8,415,364 |
7,988,897 |
17,063,359 |
15,893,365 |
Loss before the undernoted |
(8,035,247) |
(7,737,480) |
(16,432,514) |
(15,299,592) |
Finance income |
2,058,174 |
86,892 |
8,980,046 |
149,498 |
Finance costs |
(580,705) |
(4,679,605) |
- |
(8,498,335) |
Other income |
- |
24,916 |
- |
24,916 |
|
|
|
|
|
Net loss for the period and
comprehensive loss |
$ (6,557,778) |
$ (12,305,277) |
$ (7,452,468) |
$ (23,623,513) |
Basic and diluted loss per common
share |
$ (0.06) |
$ (0.14) |
$ (0.06) |
$ (0.29) |
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, July 1, 2010 |
80,359,623 |
$ 203,498,239 |
$ 14,232,353 |
$ (172,274,231) |
$ 45,456,361 |
Net loss for the period |
- |
- |
- |
(23,623,513) |
(23,623,513) |
Transactions with owners of the
Company,
recognized directly in equity: |
|
|
|
|
|
Share-based
compensation |
- |
- |
1,044,198 |
- |
1,044,198 |
Shares issued on
exercise of options |
319,309 |
425,589 |
(171,780) |
- |
253,809 |
Shares issued on
exercise of warrants |
527,343 |
1,599,312 |
- |
- |
1,599,312 |
Shares issued
pursuant to prospectus offering |
28,750,000 |
43,334,523 |
- |
- |
43,334,523 |
Total transactions with owners of the
Company |
29,596,652 |
45,359,424 |
872,418 |
- |
46,231,842 |
Balance, December 31, 2010 |
109,956,275 |
$ 248,857,663 |
$ 15,104,771 |
$ (195,897,744) |
$ 68,064,690 |
|
|
|
|
|
|
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 |
- |
- |
- |
(7,452,468) |
(7,452,468) |
Transactions with owners of the
Company,
recognized directly in equity: |
|
|
|
|
|
Share-based
compensation |
- |
- |
1,507,684 |
- |
1,507,684 |
Shares issued on
exercise of options |
29,500 |
38,008 |
(15,558) |
- |
22,450 |
Total transactions with owners of the
Company |
29,500 |
38,008 |
1,492,126 |
- |
1,530,134 |
Balance, December 31, 2011 |
116,711,448 |
$ 264,586,651 |
$ 16,636,188 |
$ (220,593,906) |
$ 60,628,933 |
YM BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Cash Flows
(Expressed in Canadian dollars, unless otherwise noted)
(Unaudited)
|
|
|
|
|
|
Three months ended
December 31, |
|
|
Six months ended
December 31,
|
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the period |
$ |
|
(6,557,778) |
$ |
|
(12,305,277) |
$ |
|
(7,452,468) |
$ |
|
(23,623,513) |
Items
not involving cash: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of
property and equipment |
|
|
16,550 |
|
|
19,789 |
|
|
33,134 |
|
|
39,147 |
Amortization of
intangible assets |
|
|
1,127,004 |
|
|
1,127,004 |
|
|
2,254,008 |
|
|
2,254,008 |
Interest
earned |
|
|
(154,692) |
|
|
(82,740) |
|
|
(309,168) |
|
|
(138,375) |
Unrealized (gain)
loss on cash and cash equivalents |
|
|
576,919 |
|
|
601,654 |
|
|
(1,406,658) |
|
|
1,010,362 |
Gain on disposal of
property and equipment |
|
|
- |
|
|
- |
|
|
- |
|
|
(10,744) |
Share-based
compensation |
|
|
442,030 |
|
|
408,145 |
|
|
1,507,684 |
|
|
1,044,198 |
Change in fair
value of share purchase warrants |
|
|
(1,903,482) |
|
|
4,076,077 |
|
|
(7,264,221) |
|
|
7,487,973 |
Changes in non-cash
working capital balances: |
|
|
|
|
|
|
|
|
|
|
|
|
Short-term
deposits |
|
|
(139,972) |
|
|
(66,524) |
|
|
(305,277) |
|
|
(106,367) |
Accounts receivable
|
|
|
(17,069) |
|
|
(37,156) |
|
|
(78,535) |
|
|
(41,979) |
Prepaid
expenses |
|
|
64,352 |
|
|
(370,250) |
|
|
240,064 |
|
|
(256,716) |
Accounts
payable |
|
|
(319,915) |
|
|
718,772 |
|
|
(181,892) |
|
|
712,684 |
Accrued liabilities
|
|
|
(393,750) |
|
|
631,723 |
|
|
(482,473) |
|
|
1,528,885 |
Deferred
revenue |
|
|
(148,518) |
|
|
(148,518) |
|
|
(297,036) |
|
|
(451,995) |
Net cash used in
operating activities |
|
|
(7,408,321) |
|
|
(5,427,301) |
|
|
(13,742,838) |
|
|
(10,552,432) |
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of
short-term deposits |
|
|
33,988,017 |
|
|
20,202,541 |
|
|
35,806,437 |
|
|
48,854,217 |
Purchase of short-term
deposits |
|
|
(33,500,000) |
|
|
(48,514,540) |
|
|
(34,300,000) |
|
|
(76,014,540) |
Interest
earned |
|
|
154,692 |
|
|
82,740 |
|
|
309,168 |
|
|
138,375 |
Additions to property and
equipment |
|
|
(5,920) |
|
|
- |
|
|
(10,220) |
|
|
(52,694) |
Net cash provided by
(used in) investing activities |
|
|
636,789 |
|
|
(28,229,259) |
|
|
1,805,385 |
|
|
(27,074,642) |
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares
on exercise of options |
|
|
- |
|
|
238,809 |
|
|
22,450 |
|
|
253,809 |
Issue of common shares on
exercise warrants |
|
|
- |
|
|
850,159 |
|
|
- |
|
|
850,159 |
Net proceeds from
issuance of shares |
|
|
- |
|
|
43,334,523 |
|
|
- |
|
|
43,334,523 |
Net cash provided by
financing activities |
|
|
- |
|
|
44,423,491 |
|
|
22,450 |
|
|
44,438,491 |
Impact of foreign exchange rates on
cash |
|
|
(576,919) |
|
|
(601,654) |
|
|
1,406,658 |
|
|
(1,010,362) |
Increase (decrease) in cash and cash
equivalents |
|
|
(7,348,451) |
|
|
10,165,277 |
|
|
(10,508,345) |
|
|
5,801,055 |
Cash and cash equivalents, beginning
of period |
|
|
28,886,736 |
|
|
15,095,919 |
|
|
32,046,630 |
|
|
19,460,141 |
Cash and cash equivalents, end of
period |
$ |
|
21,538,285 |
$ |
|
25,261,196 |
$ |
|
21,538,285 |
$ |
|
25,261,196 |
SOURCE YM BioSciences Inc.