BIOMS MEDICAL ANNOUNCES SECOND QUARTER 2007 RESULTS
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Edmonton, Alberta, August 14th, 2007 – BioMS Medical Corp (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, 2007.
“We are excited by the continued momentum of our global late-stage clinical trials of MBP8298 for the treatment of MS,” said Kevin Giese, President and CEO of BioMS. “During this quarter, we completed patient recruitment in MINDSET-01, our phase II trial for relapsing-remitting MS, and we initiated enrollment of patients in MAESTRO-03, our pivotal phase III U.S. trial for the treatment of secondary-progressive MS, a form of MS for which there is currently no viable treatment.”
Second Quarter 2007 Highlights:
- Announced that the independent Data Safety Monitoring Board (DSMB) for the MAESTRO-01 trial had completed a safety analysis and recommended that the trial continue as per protocol. The Company remains on track to receive interim data in mid-2008 from the first 200 patients enrolled, when they have completed the 24 months of treatment.
- Announced Dr. Clyde E. Markowitz, Director of the Multiple Sclerosis Center at the Hospital of the University of Pennsylvania in Philadelphia as the lead investigator for MAESTRO-03 trial and enrolled the first patients in the trial.
- Completed patient recruitment for MINDSET-01, a randomized, double-blind phase II trial evaluating MBP8298 for the treatment of relapsing remitting MS. Approximately 215 patients have been enrolled at 24 trial sites in 6 countries across Europe.
- Completed a public offering for total gross proceeds of $44,275,000.
- Subsequent to the end of the quarter, the company announced that the independent Data Safety Monitoring Board (DSMB) for the MINDSET-01 trial had completed a safety analysis and recommended that the trial continue as per protocol.
- The Corporation has contracted the services of Quintiles Inc. as the clinical research organization for the phase III clinical trial in the United States. Quintiles is a global leader in pharmaceutical services improving healthcare worldwide and is known for providing innovative, quality professional expertise in the pharmaceutical, biotechnology and healthcare industries.
Financial Results
The consolidated net loss for the three months ended June 30, 2007 was $11.8 million or ($0.14) per share, compared to a consolidated net loss of $9.1 million or ($0.14) per share for the second quarter of 2006. For the first six months ended June 30, 2007, the consolidated net loss was $24.6 million or ($0.31) per share compared to $17.6 million or ($0.28) per share for the corresponding period in 2006. The increase in the loss was the result of larger research and development expenditures and an increase in general and administrative expenses. It is expected that research and development expenses will increase over the next two years as the MBP8298 clinical trials (MAESTRO-01, MAESTRO-02, MAESTRO-03 and MINDSET-01) continue.
Total consolidated expenses for the second quarter of 2007 were $12.2 million compared to $9.3 million for the second quarter of 2006. Total consolidated expenses for the first six months of 2007 were $25.5 million compared to $18.1 million for the same period in 2006. Research and development expenditures totaled $10.4 million for the second quarter of 2007 compared to $7.9 million for the second quarter of 2006 and totaled $20.7 million for the first six months of 2007 compared to $14.6 million for the same period in 2006. General and administration expenditures totaled $1.5 million for the second quarter of 2007 compared to $1.0 million for the second quarter of 2006 and totaled $4.1 million for the first six months of 2007 compared to $2.7 million for the same period in 2006.
Investment income earned on funds invested was $0.5 million for the three months ended June 30, 2007, compared to $0.1 million for the three months ended June 30, 2006. For the six months ended June 30, 2007, investment income was $0.9 million compared to $0.5 million for the six months ended June 30, 2006. Investment income is earned from the short-term investment of cash reserves in low-risk term deposits and high-quality low-risk funds.
On May 23, 2007 the Company completed a prospectus financing with an issue of 16,100,000 units at a price of $2.75 per unit for total gross proceeds to the Corporation of $44,275,000.
As at June 30, 2007, cash and short-term investments totaled $58.6 million as compared to $43.1 million at December 31, 2006. As at June 30, 2007, the Company had working capital of $56.3 million as compared to $37.4 million at December 31, 2006. Management estimates that the current working capital is sufficient for the Company to meet its obligations in respect of the currently initiated clinical trials through to the end of 2008.
As at June 30, 2007 there were 91,356,923 Class “A” common shares of the Company issued and outstanding.
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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 Director Investor Relations Phone: 780-413-7152 astadel@biomsmedical.com |
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