BIOMS MEDICAL ANNOUNCES SECOND QUARTER 2006 RESULTS
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More than 300 patients enrolled in pivotal phase II/III multiple sclerosis trial
Edmonton, Alberta, August 14, 2006 – BioMS Medical Corp (“BioMS” or the “Corporation”) (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the second quarter ended June 30, 2006.
Second Quarter 2006 Highlights:
- Enrolled more than 200 patients in the pivotal phase II/III clinical trial for secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they complete 24 months of the clinical trial
- Received a fourth positive safety review from the Data Safety Monitoring Board for the pivotal SPMS trial
- Expanded the pivotal SPMS trial into Denmark and the Netherlands.
- Initiated a phase II clinical trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial will be conducted in several countries across Europe.
- Completed a private placement for gross proceeds of more than $15 million.
- 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 an unprecedented five year delay in disease progression in a HLA-defined subgroup of MS patients (up to 75% of MS patients) treated with the drug.
"We continue to make excellent progress developing MBP8298 on multiple fronts,” said Kevin Giese , President and CEO of BioMS. “We currently have enrolled more than 300 patients in our pivotal phase II/III SPMS trial and remain on track to achieve full enrolment by year-end. In addition, we anticipate commencing enrollment for our European Phase II RRMS trial in the second half of 2006 and we continue to prepare for an anticipated pivotal SPMS trial in the U.S. ”
Financial Results
The consolidated net loss for the three months ended June 30, 2006 was $9.1 million or ($0.14) per share, compared to a consolidated net loss of $3.5 million or ($0.06) per share for the second quarter of 2005. For the first six months ended June 30, 2006 the consolidated net loss was $17.6 million compared to $6.9 million for the corresponding period in 2005.
Total consolidated expenses for the second quarter of 2006 were $9.3 million compared to $3.9 million for the second quarter of 2005. Total consolidated expenses for the first six months of 2006 were $18.1 million compared to $7.3 million for the same period in 2005.
Research and development expenditures totaled $7.9 million for the second quarter of 2006 compared to $1.8 million for the second quarter of 2005 and totaled $14.4 million for the first six months of 2006 compared to $2.8 million for the same period in 2005. The increase in expenses was the result of the increased number of clinical trial sites and patients participating in the phase II/III SPMS trial in Canada and Europe . The Corporation also incurred expenses of $2.8 million in the second quarter related to preparation for the anticipated start of a U.S. SPMS trial and a European RRMS trial, including the expenditure of approximately $2.1 million towards obtaining a significant supply of MBP8298 product for use in these clinical trials over the course of the next few years. For the first six months of 2006, preparation costs for these new trials resulted in added expenses of approximately $5.2 million.
General and administration expenditures totaled $1.0 million for the second quarter of 2006 compared with $1.0 million for the second quarter of 2005 and totaled $2.1 million for the first six months of 2006 compared with $2.0 million for the same period in 2005.
As at June 30, 2006 the Corporation had cash and short-term investments totaling $39.8 million compared to $38.0 million as at December 31, 2005. At June 30, 2006 the Corporation had working capital of $34.7 million compared to $37.2 million as at December 31, 2005. Management estimates that the current working capital is adequate to fund the expected costs of the research and development and clinical trial process through to the second half of 2007.
The Corporation has adjusted stock-based compensation expense of prior periods to record the compensation as an expense over the period in which the options vested. Previously, the compensation was recorded as an expense over the es tim ated life of the options. This change has been made retroactively and prior periods have been restated. The Corporation extended the life of a total of 1,082,000 options. The incremental value associated with this modification has been calculated as the difference between the fair value of the options as calculated on the date of modification and the fair value of the original options as calculated on the date immediately preceding the modification. The Corporation uses the Black-Scholes option pricing model for valuation of the options.
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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 (MBP8298) 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.
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| Ryan Giese VP Corporate Communications Phone: 780-413-7152 rgiese@biomsmedical.com |
Tony Hesby Executive VP Corporate Affairs Phone: 780-413-7152 thesby@biomsmedical.com |
Amanda Stadel Investor Relations Manager Phone: 780-413-7152 astadel@biomsmedical.com |