Press release from PR Newswire
YM BioSciences Reports Operational and Financial Results for the Second Quarter of Fiscal 2012
Thursday, February 09, 2012
YM BioSciences Reports Operational and Financial Results for the Second Quarter of Fiscal 201207:03 EST Thursday, February 09, 2012
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.For further information: <p> James Smith<br/> VP Corporate Communications<br/> YM BioSciences Inc.<br/> Tel. +1 905.361.9518<br/> <a href="mailto:jsmith@ymbiosciences.com">jsmith@ymbiosciences.com</a> </p>
