Montreal, Quebec. July 30, 2010 - MethylGene Inc. (TSX:MYG) today announced financial results for the second quarter ended June 30, 2010. In addition, the Company provided a clinical trial update for its multi-targeted (Met) kinase oncology inhibitor, MGCD265.
Financial Results Reported in Canadian Dollars
Total revenues for the second quarter ended June 30, 2010 were $512,000 compared to $388,000 for the same period last year due to increased collaboration revenue from Otsuka and final revenue reconciliation from the termination of the Celgene collaboration reflected in the second quarter of 2009.
Gross research and development expenditures in the second quarter of 2010 were $2.9 million, down 49 percent, compared to $5.8 million in the second quarter of 2009. This decrease is primarily due to lower research and development expenses as we continue to focus development on our key programs. General and administrative expenses in the second quarter of 2010 were $1.2 million, an increase of $176,000 compared to the second quarter of 2009. The increase was due primarily to higher professional fees which were partially offset by lower compensation expenses. MethylGene incurred a foreign exchange gain of $54,000 in the second quarter of 2010 versus a loss of $726,000 in the second quarter of 2009. The magnitude of the second quarter gain in 2010 versus the loss in the second quarter of 2009 is the result of lower average U.S. denominated assets and a higher average exchange rate for the Canadian dollar versus the U.S. dollar in the second quarter of 2010 versus the second quarter of 2009. The net loss for the second quarter ended June 30, 2010 was $3.4 million or ($0.09) per share compared to a net loss of $6.9 million or ($0.19) per share for the corresponding period last year. These results reflect continued lower operating expenses due to cost control efforts and our focus on key clinical development projects.
As of June 30, 2010, the Company had $14.9 million of cash, cash equivalents, marketable securities and restricted cash. Based on our current assumptions, the Company believes that its current cash, cash equivalents, marketable securities, interest income, projected revenues from current collaborations, projected timing of clinical trials and refundable investment tax credits should be sufficient to carry out its currently planned research and development plans and operations into the second quarter of 2011.
MGCD265 Update (Preliminary Data)
MethylGene continued to enroll patients into the ongoing MGCD265 clinical trials (Trials 101, 102 and 103), which are evaluating the compound in solid tumor patients. The Company has begun BID (twice a day) dosing in all three trials. For the MGCD265-docetaxel combination arm of Trial 103, 16 patients have been enrolled of which six patients are ongoing including four metastatic Stage IV non-small cell lung cancer (NSCLC) patients. Five of the six patients have been treated for four cycles or more including one NSCLC patient who has an objective partial response (PR) and four patients (three NSCLC and one pancreatic) who have experienced stable disease (SD). The NSCLC patients have received three to six prior therapies, including treatment with taxanes and all were smokers. The current treatment duration for these patients (as of July 28, 2010) ranges from 24 to 46 weeks and all four patients experienced tumor shrinkage, as well as a 98 percent decrease in carcinoembryonic antigen (CEA) levels in the patient experiencing a PR. These four NSCLC patients exceed the time to disease progression (TDP) of approximately 12 weeks reported for second-line NSCLC patients treated with docetaxel as described in the Taxotere® label (TAX317 study). The current progression-free survival (PFS) mean and median for these four patients following administration of the MGCD265-docetaxel combination is 34 and 33 weeks respectively.
In the MGCD265-erlotinib arm of Trial 103, 21 patients have been enrolled of which six patients are ongoing. Seven patients experiencing SD were treated for more than four cycles. One of these patients with gastric cancer experienced significant clinical benefit demonstrated by the removal of an indwelling catheter to drain ascites and a decrease in the thickening of the gastric wall. This patient has now been on study for over six cycles. Another patient with metastatic medulloblastoma (an aggressive form of brain cancer) experienced stable disease and was on study for approximately six cycles.
The Company’s current goal for all MGCD265 trials is to identify a recommended Phase II dose and schedule in preparation for a randomized, placebo-control, double-blind MGCD265 Phase II trial (Trial 104) in refractory NSCLC patients with the selected comparator agent (erlotinib or docetaxel). There is a current bias to the docetaxel combination based on safety and efficacy data to date.
Current Objectives
• Complete the two ongoing Phase I clinical trials (Trials 101 and 102) evaluating MGCD265 in patients with solid tumors;
• Complete MGCD265 Trial 103 in solid tumor patients to identify a recommended Phase II dose and regimen in combination with two comparator agents (Tarceva® or Taxotere®) in preparation for a randomized trial with the chosen comparator agent in NSCLC patients (Trial 104);
• Continue to enroll refractory or relapsed follicular lymphoma patients in the mocetinostat Phase II trial (Trial 008);
• Report updated clinical trial data at appropriate scientific venues for MGCD265 and the completed Phase I studies for MGCD290 a fungal Hos2 inhibitor; and
• Continue to seek and evaluate partnerships, collaborations, strategic relationships and other alternatives, as well as monetize assets to enhance clinical outcomes for the Company’s development stage compounds and to provide additional resources to the Company.
About MethylGene
MethylGene Inc. (TSX:MYG) is a publicly-traded, clinical stage biopharmaceutical company focused on the 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 Met, VEGF, Ron and Tie-2 receptor tyrosine kinases that is in multiple clinical trials for cancer; MGCD290, a fungal Hos2 inhibitor for use in combination with fluconazole for serious fungal infections which has completed Phase I clinical studies; and mocetinostat (MGCD0103), an oral, isoform-selective HDAC inhibitor for cancer which has been in multiple Phase II clinical trials and is currently in a Phase II trial in refractory or relapsed follicular lymphoma. Mocetinostat is licensed to Taiho Pharmaceutical Co. Ltd in certain Asian countries. A fourth compound discovered using MethylGene’s HDAC platform, EVP-0334 - a potential cognition enhancing agent for neurodegenerative diseases has successfully completed Phase I trials 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.
Investor Relations Contacts
Rhonda Chiger Rx Communications Group, LLC Phone: 917-322-2569 rchiger@rxir.com Donald F. Corcoran President & CEO MethylGene Inc. Phone: 514-337-3333 ext. 373 mctavishk@methylgene.com
