MethylGene Reports Second Quarter 2011 Financial Results and Provides Clinical Update
(firmenpresse) - MONTREAL, QUEBEC -- (Marketwire) -- 08/11/11 -- MethylGene Inc. (TSX: MYG) today reported financial results for the second quarter ended June 30, 2011. In addition, the Company provided a clinical update for its product candidates MGCD265 and MGCD290.
Financial Results Reported in Canadian Dollars
The Company's financial statements for the period ended June 30, 2011 have been prepared in accordance with IAS 34, Interim Financial Reporting, for International Financial Reporting Standards (IFRS). The financial impact of adopting IFRS was minimal with no material impact in the restatement of the second quarter of 2010 and no material impact for the 2011 second quarter results.
The Company closed its private placement on April 4, 2011 raising $34.5 million including the convertible debentures which converted at closing.
Total revenues for the second quarter ended June 30, 2011 were $1.3 million compared to $512,000 for the same period last year due to the conclusion of the research component of the research and license collaboration agreement with Otsuka Pharmaceutical Co. Ltd. ("Otsuka") on June 30, 2011, which resulted in the accelerated amortization of deferred revenues as the Company's substantive obligations to Otsuka ended.
Gross research and development expenditures in the second quarter of 2011 were $1.9 million, a decrease of 34.3 percent compared to $2.9 million in the second quarter of 2010. This decrease is due to lower compensation costs, lower facility costs and lower clinical development expenses for MGCD265 and MGCD290. General and administrative expenses in the second quarter of 2011 were $1.1 million, a decrease of 12.8 percent compared to the second quarter of 2010, reflecting lower compensation and lease costs and lower professional fees. MethylGene incurred a foreign exchange gain of $27,000 in the second quarter of 2011 versus a gain of $116,000 in the second quarter of 2010 due primarily to lower net U.S. dollar denominated assets in the second quarter of 2011. The net loss and comprehensive loss for the second quarter ended June 30, 2011 was $1.5 million or ($0.005) per share compared to a net loss and comprehensive loss of $3.3 million or ($0.08) per share for the corresponding period last year due to the higher average number of shares outstanding, higher revenues and lower operating expenses in the second quarter of 2011.
As of June 30, 2011, the Company had $36.0 million of cash, cash equivalents, marketable securities and restricted cash. The Company believes it has sufficient financial resources to carry forward its current clinical development and operating plans into 2014.
MGCD265 Clinical Development - Met / VEGF Inhibitor for Cancer
MethylGene continues to pursue the evaluation of MGCD265 in three cancer indications: non-small cell lung (NSCLC), gastric and prostate. The amended protocols for trials 265-101 and 265-103, which include expansion cohorts and an optimized formulation, have been approved at most sites and patient enrollment has begun.
In the Phase 1/2 docetaxel-arm of Trial 265-103 (MGCD265 in combination with full-dose docetaxel), which will focus on patients with NSCLC and prostate cancer, eight patients with NSCLC were enrolled. Six of the NSCLC patients were on study for more than three months. Two of the eight patients experienced partial responses (PRs) and six patients experienced prolonged stable disease for durations ranging from four to thirteen months. All of these patients are now off study. Six out of the eight patients with NSCLC were previously exposed to a prior line of therapy containing a taxane. One prostate patient with bone metastasis who had failed prior docetaxel therapy experienced a PR after four months of treatment. The most frequent treatment-related toxicities grade 2 and above in this combination arm include neutropenia, elevated lipase, infusion reaction, nausea, anorexia, diarrhea and fatigue.
In the erlotinib-arm of Trial 265-103 (MGCD265 in combination with full-dose erlotinib), three patients with gastric cancer have been enrolled, two of which were on study for six and eleven months, respectively, and one who experienced complete resolution of ascites and a decrease in gastric wall thickness has been on study for 16 months. Molecular profiling of the archived tumor biopsy from this patient showed high levels of Met and phospho-Met protein expression in the absence of MET and EGFR gene amplification or detectable mutations. The most frequent treatment-related toxicities grade 2 and above in this combination arm include diarrhea, rash and fatigue.
"We are pleased to advance the development of MGCD265 and look forward to learning more about the activity of the compound in its intended population of gastric, non-small cell lung and prostate cancer patients," said Charles Grubsztajn, President and Chief Executive Officer of MethylGene. "We remain on track to report data from these trials in 2012."
MGCD290 Clinical Development- Hos2 Inhibitor for Fungal Infections
The Company has completed four Phase 1 clinical trials in healthy adult volunteers evaluating MGCD290 as a single-agent and in combination with fluconazole. MethylGene is planning to initiate a Phase 2 clinical trial with MGCD290 in combination with fluconazole in acute vulvovaginal candidiasis (VVC) in the fourth quarter of this year. This trial will begin following the filing of a U.S. investigational new drug (IND) application and will be conducted in the U.S. MethylGene is also planning a Phase 2 clinical trial in recurrent vulvovaginal candidiasis (RVCC) and details of this trial will be released at a later time.
About MethylGene
MethylGene Inc. (TSX: MYG) is a clinical-stage biopharmaceutical company that develops novel therapeutics for cancer and infectious disease. The Company's lead product candidates include: MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers and MGCD290, a fungal Hos2 inhibitor, for use in combination with fluconazole for fungal infections, which has completed Phase 1 clinical studies. The Company's partners include Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc.
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 MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, 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 MGCD265, MGCD290 or mocetinostat. 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, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2010, under the heading "Risk Factors" which you are urged to read and all other documents filed by the Company that can be found at . 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:
Charles Grubsztajn
President & CEO
MethylGene Inc.
514-337-3333 ext. 373
Thomas Fechtner
Vice President
The Trout Group LLC
646-378-2931
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Datum: 11.08.2011 - 14:30 Uhr
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