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SMALL BUSINESS
BioMS Medical announces second quarter 2009 results
Toronto Stock Exchange Symbol: MS
"The pivotal phase III MAESTRO-01 trial has completed the last patient last visit, and we are expecting results from this study within the second half of this year. This is the first of our two pivotal trials evaluating dirucotide in patients with secondary progressive multiple sclerosis and with a positive outcome, our drug could represent a valuable new treatment for MS patients," said
Currently, BioMS is conducting two pivotal clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):
- MAESTRO-01: This pivotal phase III trial is being conducted in Canada
and Western Europe, involving 611 SPMS patients at 47 trial sites in
ten countries. The primary clinical endpoint for MAESTRO-01 (and
MAESTRO-03) is defined as a statistically and clinically significant
increase in the time to progression of the disease as measured by the
Expanded Disability Status Scale (EDSS), in patients with HLA-DR2
and/or HLA-DR4 immune response genes.
- MAESTRO-02: Eligible patients who have successfully completed
MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in
this open-label follow-on study regardless of whether they were
previously on placebo or drug. To date, approximately 95% of the
eligible patients who have successfully completed the MAESTRO-01
trial have enrolled in this follow-on study.
- MAESTRO-03: Enrollment was initiated in June 2007 and completed on
August 1, 2008 for this pivotal U.S. phase III trial of approximately
510 SPMS patients at 67 sites across the U.S. To date, the DSMB has
conducted four reviews of the data from this trial and recommended it
continue.
Financial Results
The consolidated net income for the three months ended
Revenue earned from the collaboration agreement was
Total consolidated expenses for the three months ended
As at
As at
About BioMS Medical Corp.
-------------------------
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in
This press release may contain forward-looking statements, which reflect the Corporation'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 Corporation'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 dirucotide will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the 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.
BioMS Medical Corp.
(A Development Stage Corporation)
Interim Consolidated Balance Sheets
(Unaudited)
-------------------------------------------------------------------------
(expressed in thousands of Canadian dollars)
June 30, December 31,
2009 2008
$ $
(Unaudited)
Assets
Current assets
Cash and cash equivalents 64,864 87,826
Short-term investments 2,652 2,614
Goods and services tax recoverable 65 299
Prepaid clinical trial costs 1,914 2,227
Other current assets 664 321
---------------------------
70,159 93,287
Prepaid clinical trial costs 495 790
Licensing costs 5,174 5,910
Property and equipment 438 517
---------------------------
76,266 100,504
---------------------------
---------------------------
Liabilities
Current liabilities
Accounts payable and accrued liabilities 10,564 12,015
Deferred revenue 20,615 45,605
---------------------------
31,179 57,620
---------------------------
Shareholders' Equity
Share capital 175,714 175,714
Contributed surplus 10,937 8,839
Accumulated deficit (141,564) (141,669)
---------------------------
45,087 42,884
---------------------------
76,266 100,504
---------------------------
---------------------------
BioMS Medical Corp.
(A Development Stage Corporation)
Interim Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
-------------------------------------------------------------------------
(expressed in thousands of Canadian dollars and shares, except per share
amounts)
Cumulative
from Six-month Three-month
inception to period ended period ended
June 30, June 30, June 30,
--------- -------------------- --------------------
2009 2009 2008 2009 2008
$ $ $ $ $
Revenue earned from
collaboration
partner 77,551 24,990 24,000 11,933 11,231
Less: Research and
development
expenses (171,732) (19,647) (22,482) (8,138) (9,339)
--------- -------------------- --------------------
(94,181) 5,343 1,518 3,795 1,892
General and
administrative
expenses (47,215) (4,610) (10,388) (1,762) (1,693)
Amortization of
licensing costs (12,491) (736) (736) (368) (368)
Amortization of
property and
equipment (602) (85) (43) (42) (31)
--------- -------------------- --------------------
Income (loss) from
operations (154,489) (88) (9,649) 1,623 (200)
--------- -------------------- --------------------
Other income
(expense)
Investment income 9,045 266 1,323 96 594
Foreign exchange
gain (loss) 5,507 (73) 1,239 (215) (796)
--------- -------------------- --------------------
14,552 193 2,562 (119) (202)
--------- -------------------- --------------------
Net income (loss)
and comprehensive
income (loss) (139,937) 105 (7,087) 1,504 (402)
--------- -------------------- --------------------
--------- -------------------- --------------------
Basic and diluted
net income (loss)
per common share 0.00 (0.08) 0.02 0.00
-------------------- --------------------
-------------------- --------------------
Basic weighted
average number of
common shares
outstanding 91,009 91,311 91,009 91,217
-------------------- --------------------
-------------------- --------------------
Diluted weighted
average number of
common shares
outstanding 91,563 91,311 91,356 91,217
-------------------- --------------------
-------------------- --------------------
BioMS Medical Corp.
(A Development Stage Corporation)
Interim Consolidated Statements of Cash Flows
(Unaudited)
-------------------------------------------------------------------------
(expressed in thousands of Canadian dollars)
Cumulative
from Six-month Three-month
inception to period ended period ended
June 30, June 30, June 30,
--------- -------------------- --------------------
2009 2009 2008 2009 2008
$ $ $ $ $
Cash provided by
(used in)
Operating activities
Net income (loss) (139,937) 105 (7,087) 1,504 (402)
Items not involving
cash
Stock-based
compensation 10,976 2,098 2,168 - 264
Amortization of
licensing costs 12,491 736 736 368 368
Amortization of
property and
equipment 602 85 43 42 31
Loss on disposal
of property and
equipment 11 - 7 - 2
--------- -------------------- --------------------
(115,857) 3,024 (4,133) 1,914 263
Net change in
non-cash working
capital items 23,628 (27,491) 61,986 (14,135) (10,317)
--------- -------------------- --------------------
(92,229) (24,467) 57,853 (12,221) (10,054)
--------- -------------------- --------------------
Investing activities
Purchase of property
and equipment (1,052) (7) (29) (6) (29)
Net (purchase of)
proceeds from
short-term
investments (2,652) (38) 2,205 (19) 1,093
Licensing costs (6,467) - - - -
--------- -------------------- --------------------
(10,171) (45) 2,176 (25) 1,064
--------- -------------------- --------------------
Financing activities
Proceeds from
issuance of share
capital 178,729 - 91 - 91
Repurchase of
share capital (3,552) - (989) - (953)
Share issue costs (12,312) - - - -
--------- -------------------- --------------------
162,865 - (898) - (862)
--------- -------------------- --------------------
Foreign exchange
gain on cash and
cash equivalents
held in foreign
currency 4,399 1,550 1,239 1,381 (796)
--------- -------------------- --------------------
(Decrease) increase
in cash and cash
equivalents 64,864 (22,962) 60,370 (10,865) (10,648)
Cash and cash
equivalents -
Beginning of
period - 87,826 35,428 75,729 106,446
--------- -------------------- --------------------
Cash and cash
equivalents -
End of period 64,864 64,864 95,798 64,864 95,798
--------- -------------------- --------------------
--------- -------------------- --------------------
Cash and cash
equivalents
consists of
Bank accounts 1,282 1,282 1,261 1,282 1,261
Interest bearing
deposits and
securities 63,582 63,582 94,798 63,582 94,537
--------- -------------------- --------------------
64,864 64,864 95,798 64,864 95,798
--------- -------------------- --------------------
--------- -------------------- --------------------
SOURCE BioMS Medical Corp.