Highlights
- During the fourth quarter we commenced our first randomized, controlled Phase 2 study with MGCD290, and our two Phase 1 dose escalation studies with MGCD265 continued to enroll patients.
- On January 4th, 2012 we strengthened our management team with the appointment of Rachel Humphrey, MD as Executive Vice President and Chief Medical Officer.
- On November 13th, 2011 we reported final results for MGCD265 Trial 265-102 at the 2011 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference.
- We finished the quarter with over $29 million in cash and equivalents to fund our development programs.
“Last year was a very successful year for MethylGene,” said Charles Grubsztajn, President and CEO of MethylGene. “In 2011 we raised $34.5 million from thought-leading investors, made key additions to our management team and Board of Directors, reported data on MGCD265 at ASCO in June, and commenced a randomized, controlled Phase 2 trial with our first-in-class antifungal agent MGCD290. We expect continued clinical progress, and to report additional clinical data, in 2012.”
International Financial Reporting Standards
The financial statements of the Company for the year ended December 31, 2011, have been prepared for the first time in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). They have been prepared: on a historical cost basis, except for financial instruments that have been measured at fair value; in accordance with IAS 1, Presentation of Financial Statements; in accordance with IFRS 1, First-time Adoption of IFRS; and in accordance with IFRS standards and IFRIC interpretations issued and effective or issued and early adopted as at the time of preparing these statements.
Fourth Quarter 2011 Financial Results Reported in Canadian Dollars
Revenues for the fourth quarter of 2011 of $468,000 were $348,000 lower versus the fourth quarter of 2010 due to lower research collaborations and contract revenues from Otsuka Pharmaceutical Co. Ltd. (“Otsuka”), as the research component of our collaboration agreement ended in June 2011.
Research and development expenditures, net of investment tax credits, for the fourth quarter of 2011 were $3.1 million compared to $1.9 million for the fourth quarter of 2010. This increase is mainly due to higher compensation and third-party clinical costs as we increased clinical development activities related to both of our lead programs, MGCD290 and MGCD265. These increases were partially offset by lower lease-related costs.
General and administrative expenses in the fourth quarter of 2011 were $1.0 million compared to $879,000 in the fourth quarter of 2010. This increase relates to higher compensation costs partially offset by lower professional fees.
Financial income of $82,000, relating primarily to interest income, in the fourth quarter of 2011 was $67,000 higher compared to the fourth quarter of 2010 due to increased cash balances and higher average interest rates versus the prior year. The Company recorded a foreign exchange loss of $9,000 in the fourth quarter of 2011 versus a loss of $17,000 in the fourth quarter of 2010.
The net loss and comprehensive loss for the fourth quarter of 2011 was $3.6 million, or ($0.01) per share, versus a net loss and comprehensive loss of $2.0 million or ($0.05) per share for the same period last year. The improved loss per share relates to the higher average number of shares outstanding at the respective quarter ends, partially offset by the higher loss in the fourth quarter of 2011 compared to the fourth quarter of 2010.
Full Year 2011 Financial Results in Canadian Dollars
Revenues for 2011 of $3.1 million were $703,000 higher versus 2010, as higher license and up-front fees from Otsuka and Taiho Pharmaceutical Co. Ltd. offset lower research collaborations and contract revenues from Otsuka as the research component of the collaboration agreement ended in June 2011.
Research and development expenditures, net of investment tax credits, for 2011 were $8.8 million versus $10.9 million for 2010. This decrease is mainly due to lower lease-related costs and lower compensation costs. Third-party clinical development costs in connection with our lead programs MGCD290 and MGCD265 were marginally higher in 2011 as compared to 2010.
General and administrative expenses in 2011 were $4.3 million versus $6.1 million in 2010. This decrease relates primarily to the one-time costs of $1.5 million associated with the departure of the previous CEO in 2010, which was partially offset by higher non-cash stock option expenses in 2011.
Financial income of $262,000 for 2011, relating primarily to interest income, was $238,000 higher versus 2010 due to increased cash balances and higher average interest rates versus the prior year. The Company recorded a foreign exchange gain of $42,000 in 2011 compared to a loss of $72,000 in 2010.
The net loss and comprehensive loss for 2011 was $9.7 million, or ($0.04) per share, versus a net loss and comprehensive loss of $14.7 million or ($0.36) per share for the same period last year. The improved loss per share relates to the higher average number of shares outstanding at the respective year ends and the lower loss in 2011 compared to 2010.
Cash, cash equivalents, marketable securities and restricted cash totaled $29.6 million as at December 31, 2011 compared to $8.6 million as at December 31, 2010. Due to increased clinical activity, the Company believes it has sufficient financial resources to carry forward its current clinical development and operating plans only into the fourth quarter of 2013.
About MethylGene
MethylGene Inc. (TSX:MYG) is a small molecule drug development company that is advancing two novel therapeutics for cancer and infectious disease in human clinical trials. The Company’s lead product candidates are: MGCD290, an oral antifungal agent targeting the fungal Hos2 enzyme, that is currently in Phase 2 trials for vulvovaginal candidiasis and MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase 1/2 clinical trials for solid tumor cancers. MethylGene owns all rights to its lead product candidates, and has partnerships with Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc. for its other pipeline programs.
Investor Relations Contact:
Joseph Walewicz
Vice President, Business & Corporate Development
MethylGene Inc.
Phone: 514-337-3333 ext. 373
ir@methylgene.com
www.methylgene.com
Thomas Fechtner
Vice President
The Trout Group LLC
Phone: 646-378-2931
tfechtner@troutgroup.com
www.troutgroup.com
