EDMONTON, Nov. 6 /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 third quarter ended September 30, 2008. BioMS Medical, in partnership with Eli Lilly and Company (Lilly), is developing dirucotide (MBP8298), a drug for the treatment of MS undergoing pivotal trials in Canada, Europe and the U.S.
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"The third quarter saw positive developments in the dirucotide development plan, with completion of the interim analysis resulting in a significant milestone payment from our partner Lilly," said Kevin Giese, President and CEO of BioMS Medical. "Dirucotide was also granted fast track designation by the U.S. FDA, another important achievement which could potentially accelerate the development and review process for this important MS drug."
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Currently, BioMS is conducting three clinical trials and one open-label follow-on trial for dirucotide (MBP8298):
Financial Results
The consolidated net income for the three months ended September 30, 2008 was $6.3 million or $0.07 per share compared with a net loss of $10.9 million or ($0.12) per share for the three months ended September 30, 2007. The consolidated net loss for the nine months ended September 30, 2008 was $0.8 million or ($0.01) per share compared with a loss of $35.5 million or ($0.43) per share for the same period in 2007.
Revenue for the three months ended September 30, 2008 was $16.1 million compared to $nil for the same period of 2007. Revenue for the nine months ended September 30, 2008 was $40.1 million compared to $nil for the same period of 2007. The revenue is the result of recognizing a portion of the upfront payment and development milestone for the positive interim analysis related to the MAESTRO-01 clinical trial received from the licensing agreement with Lilly.
Total consolidated expenses for the three months ended September 30, 2008 were $11.8 million compared to $10.6 million for the same period of 2007. Total consolidated expenses for the nine months ended September 30, 2008 were $45.4 million compared to $36.0 million for the period of 2007.
Research and development expenses for the three months ended September 30, 2008 totaled $10.1 million compared to $9.1 million for the three months ended September 30, 2007. Research and development expenses for the nine months ended September 30, 2008 totaled $32.6 million compared to $29.6 million for the same period of 2007. It is expected that total research and development expenses will remain constant over the next two years as the MAESTRO-01 and MINDSET-01 clinical trials near completion and MAESTRO-02 and MAESTRO-03 increase in number of patients under treatment. General and administrative expenses were $1.3 million for the three months ended September 30, 2008 compared to $1.1 million for the three months ended September 30, 2007. General and administrative expenses were $11.6 million for the nine months ended September 30, 2008 compared to $5.2 million for the same period of 2007.
As at September 30, 2008, cash and short-term investments totaled $98.8 million compared to $38.0 million at December 31, 2007. As at September 30, 2008, the Company had working capital of $94.0 million (excluding the current portion of deferred revenue which does not represent a cash obligation) compared to $34.8 million at December 31, 2007. Management estimates that the current working capital is sufficient for the Company to meet its obligations in respect of the currently initiated clinical trials for which it is responsible under the Lilly agreement.
As at September 30, 2008 there were 91,086,323 common shares, 26,021,528 warrants and 9,161,500 stock options of the Corporation issued and outstanding.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, dirucotide (MBP8298), 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. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at 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.
- MAESTRO-01: A randomized, double-blind pivotal phase II/III trial in Canada and Europe evaluating dirucotide (MBP8298) for the treatment of secondary progressive MS (SPMS). The study has completed full recruitment of 611 patients at 47 trial sites in 9 countries. To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB). Full analysis of this trial is expected in the second half of 2009. - MAESTRO-02: An open-label follow-on study to the MAESTRO-01 pivotal trial. Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial may choose to receive dirucotide (MBP8298) on an un-blinded basis. To date, approximately 95% of patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02. - MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide (MBP8298) for the treatment of SPMS. The trial is fully recruited with approximately 510 patients enrolled at 68 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and has recommended it continue. - MINDSET-01: A phase II clinical trial evaluating dirucotide (MBP8298) for the treatment of relapsing-remitting MS (RRMS). The randomized, double-blind study has completed recruitment with 218 patients enrolled at 24 trial sites in six countries across Europe. The DSMB has completed six safety reviews to date and recommended that the trial continue as per the protocol. Completion of the double-blind phase of the trial is expected at the end of 2008 with results anticipated in the first quarter of 2009.
SOURCE BioMS Medical Corp.
