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METHYLGENE REPORTS SECOND QUARTER 2009 FINANCIAL RESULTS
Montreal, Quebec. July 31, 2009 – MethylGene Inc. (TSX:MYG) today announced financial results for the second quarter ended June 30, 2009.
During the quarter, the Company continued to progress its clinical programs while managing costs. The second quarter of 2009 was highlighted by continuing enrollment in the two Phase I trials evaluating MGCD265 in solid tumors, with favorable data from the trials presented in May at the American Society of Clinical Oncology’s (ASCO) annual meeting. Preparation for the Phase II program for MGCD265, which is expected to commence in the third quarter of 2009, was also underway during the quarter and included continuing scale-up and product optimization efforts. In addition, MethylGene continued to enroll healthy adult volunteers into the multiple Phase I studies evaluating MGCD290 in fungal infections; and interactions continued with the U.S. Food and Drug Administration (FDA) regarding MGCD0103 with the goal of lifting the partial clinical hold.
Financial Results Reported in Canadian Dollars
Total revenues for the second quarter ended June 30, 2009 were $388,000 compared to $4.3 million for the same period last year. This reduction in revenue was primarily due to the termination of our collaboration agreement with Celgene Corporation which was partially offset by revenues from our collaboration with Otsuka Pharmaceutical Co. Ltd.
Offsetting the decline in revenue, were savings in net research and development of $4.6 million and in general and administrative expenses of $320,000, reductions of 45.5 percent and 23.2 percent respectively, compared to the second quarter of 2008. Net research and development expenditures in the second quarter of 2009 were $5.5 million compared to $10.1 million in the second quarter of 2008. This decrease relates primarily to lower expenses for MGCD0103, MGCD290 and discovery research which was partially offset by higher clinical trial expenditures for MGCD265, which included scale-up and optimization efforts for clinical supply. General and administrative expenses in the second quarter of 2009 were $1.1 million compared to $1.4 million in the same period last year due to reduction in salaries, professional fees and office expenses.
The favorable impact of the lower research and development and general and administrative expenses were partially offset by a loss in foreign exchange of $726,000 in the second quarter of 2009 versus a loss of $126,000 in the second quarter of 2008; and lower interest income which was $24,000 in the second quarter of 2009 versus $419,000 in the second quarter of 2008. As a result, the net loss for the second quarter ended June 30, 2009 was $6.9 million or ($0.19) per share compared to a net loss of $7.4 million or ($0.20) per share for the corresponding period last year.
At June 30, 2009 the Company had cash, cash equivalents and short-term investments totaling $25.9 million. The Company believes that its current cash and investments, plus expected tax credits, interest income and projected revenues from our ongoing collaborations will be sufficient to carry out its currently planned research and development activities into the third quarter of 2010. The Company continues to evaluate various options to extend its financial resources.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics with a focus on cancer. The Company’s product candidates include: MGCD265, an oral, multi-targeted kinase inhibitor targeting the c-Met, VEGF, Ron and Tie-2 receptor tyrosine kinases that is in Phase I clinical trials for solid tumor cancers; MGCD290, a fungal Hos2 (HDAC) inhibitor being developed for use in combination with fluconazole for serious fungal infections that is also in Phase I clinical studies; and MGCD0103, an oral, isoform-selective HDAC inhibitor which has been in multiple clinical trials for solid tumors and hematological malignancies and is licensed to Taiho Pharmaceutical Co. Ltd. A fourth compound discovered using MethylGene’s HDAC platform, EVP-0334 - a potential cognition enhancing agent, is in a Phase I study sponsored by EnVivo Pharmaceuticals Inc. MethylGene also has a funded collaboration with Otsuka Pharmaceutical Co. Ltd. for applications in ocular diseases using the Company’s proprietary kinase inhibitor chemistry. Please visit our website at www.methylgene.com.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene’s control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD0103, MGCD265 or MGCD290. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, which you are urged to read, as described in MethylGene’s Annual Information Form for the fiscal year ending December 31, 2008, under the heading ‘risk factors and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.
Contacts:
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
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