Highlights for 2006:
MBP8298 - Published results in the European Journal of Neurology describing positive data from a phase II trial and long-term follow-up treatment of MS patients treated with MBP8298. The data showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes (up to 75% of MS patients). - Presented Phase II and long-term follow-up treatment results for MBP8298 at the 22nd Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and at the American Academy of Neurology (AAN). MAESTRO-01 - Achieved, in May 2006, the enrolment milestone of more than 200 patients in the MAESTRO-01 pivotal phase II/III trial. An interim safety and efficacy analysis will be performed in 15 months time on data from the first 200 patients that complete the full 24 month treatment phase of the clinical trial. - Received additional positive safety reviews by the Data Safety Monitoring Board. Six positive reviews have been given to-date. - Expanded the MAESTRO-01 trial into a total of 10 countries with 48 trial sites participating. - Reached full recruitment of approximately 550 patients in January 2007. MAESTRO-03 - Received, subsequent to the end of the year, approval from the U.S. FDA to initiate a pivotal phase III clinical trial of MBP8298 in patients with secondary progressive MS. This trial is expected to be initiated in the first half of 2007. MINDSET-01 - Initiated a phase II clinical trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting MS. The trial is being conducted in several countries across Europe, with full enrolment anticipated in the first half of 2007. Corporate - Completed two financings for gross proceeds of more than $42 million.
Financial Highlights: "While our General and Administrative expenses decreased year-over-year, our Research and Development expenses increased substantially over 2005: we dramatically increased the number of patients screened and enrolled in our MAESTRO-01 trial; initiated enrollment in the MINDSET-01 trial, incurred significant costs to manufacture our MBP8298 drug in support of the trial and regulatory programs; prepaid certain CRO's expenses associated with these trials; and incurred expenses in preparation for the filing of the MAESTRO-03 IND with the FDA," added Mr. Giese. "With these expenses behind us, we have sufficient resources to fund the expected costs of the current initiated clinical trials through to early 2008." Investment income totaled $1.3 million for the year ended December 31, 2006 compared with $1.2 million for the previous year. Total consolidated expenses for the year ended December 31, 2006 were $42.2 million compared to $18.3 million for the previous year. Research and development expenses totaled $35.2 million in 2006 compared to $10.8 million in 2005. General and administrative expenses totaled $5.4 million in 2006 compared with $5.9 million in 2005. The consolidated net loss for the year ended December 31, 2006 was $40.9 million or $0.62 per share, compared to a consolidated net loss of $17.1 million or $0.28 per share for the previous year. For the fourth quarter ended December 31, 2006, investment income was $0.4 million compared with $0.2 million for the fourth quarter of 2005. Total consolidated expenses were $14.4 million for the fourth quarter of 2006 compared to $6.6 million for the fourth quarter of 2005. Research and development expenses were $12.5 million compared to $4.6 million. General and administrative expenses in the fourth quarter of 2006 were $1.5 million compared to $1.6 million. In the fourth quarter of 2005, the Company incurred a loss of $14.1 million or $0.20 per share compared to a loss of $6.4 million or $0.10 per share in the fourth quarter of 2005. As at December 31, 2006, cash and short-term investments totaled $43.1 million compared to $38.0 million at December 31, 2005. At December 31, 2006, the Corporation had working capital of $37.4 million as compared to $37.2 million at December 31, 2005.
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, 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. For further information please visit our website at www.biomsmedical.com.
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 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 MBP8298 will continue to demonstrate a 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.
For further information: Tony Hesby, Ryan Giese, Corporate Communications, BioMS Medical Corp., (780) 413-7152, (780) 408-3040 Fax, E-mail: rgiese@biomsmedical.com, Internet: www.biomsmedical.com; James Smith, Investor Relations, (416) 815-0700 ext. 229, (416) 815-0080 Fax, E-mail: jsmith@equicomgroup.com; Mr. Barry Mire, Investor Relations, Phone: (514) 939-3989, E-mail: bmire@renmarkfinancial.com
