EDMONTON, July 17 /PRNewswire-FirstCall/ -- BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the three and six months ended June 30, 2009.
"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 Kevin Giese, President and CEO of BioMS Medical.
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 June 30, 2009 was $1.5 million or $0.02 per share compared with a consolidated net loss of ($0.4) million or ($0.00) per share for the previous year. The consolidated net income for the six months ended June 30, 2009 was $0.1 million or $0.00 per share compared with a consolidated net loss of ($7.1) million or ($0.08) per share for the same period in 2008.
Revenue earned from the collaboration agreement was $11.9 million for the three months and $25.0 million for the six months ended June 30, 2009 compared to $11.2 million and $24.0 million for the three and six months ended June 30, 2008. This revenue is the result of the amortization of the upfront payment and development milestone payment received from Lilly, associated with the positive interim analysis of the MAESTRO-01 clinical trial.
Total consolidated expenses for the three months ended June 30, 2009 were $10.3 million compared with $11.4 million for the three months June 30, 2008. Expenses related to direct research and development efforts accounted for $8.1 million or 79% of all expenses for the three months ended June 30, 2009 compared with $9.3 million or 82% for this period in 2008. Total consolidated expenses for the six months ended June 30, 2009 were $25.1 million as compared with $33.6 million in the six months June 30, 2008. Expenses related to direct research and development efforts accounted for $19.6 million or 78% of all expenses for the six months ended June 30, 2009 compared with $22.5 million or 67% for this period in 2008.
As at June 30, 2009, cash and cash equivalents and short-term investments totaled $67.5 million as compared to $90.4 million at December 31, 2008. As at June 30, 2009, the Company had working capital of $59.8 million as compared to $81.3 million at December 31, 2008. Management estimates that the current working capital is sufficient for the Company to meet its obligations in respect of the currently initiated clinical trials.
As at June 30, 2009 there were 91,008,923 Class "A" common shares of the Company issued and outstanding.
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 Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com/
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 --------- -------------------- -------------------- --------- -------------------- --------------------
BioMS Medical Corp.
CONTACT: Tony Hesby, Ryan Giese, Amanda Stadel, BioMS Medical Corp.,
(780) 413-7152, (780) 408-3040 Fax, E-mail: info@biomsmedical.com, Internet:
http://www.biomsmedical.com/; James Smith, Investor Relations, (416) 815-0700
ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com
