MethylGene Reports Third Quarter 2012 Financial Results and Provides Corporate Update
Highlights
• On November 12, 2012 we announced the appointment of Dr. Charles Baum M.D., Ph.D. as the President and Chief Executive Officer of the Company and that Dr. Baum joined the Board of Directors. On the same date, we announced that Mr. Louis Lacasse and Mr. Colin Mallet had resigned from the Board of Directors.
• On November 12, 2012 the Company announced the intent to complete a private placement for gross proceeds of $26.1 million. Under the terms of the private placement the Company will issue 179,690,970 units at a price of $0.145 per unit, each unit comprising of one common share and thirty one-hundreths (30/100) of a common share purchase warrant. The closing of the private placement is subject to regulatory and shareholder approvals as well as customary closing conditions.
• At the end of the quarter the Company had $18 million of cash and cash equivalents. Including the proceeds from the proposed private placement the cash runway is expected to extend into the second half of 2014.
• Over 180 patients have now been recruited in the Phase II trial of the antifungal agent MGCD290. Topline results from this trial are anticipated in Q1 2013.
• The Met/VEGFR kinase inhibitor MGCD265 continues to exhibit a favorable safety profile and encouraging indications of activity in ongoing dose escalation trials.
• Data on the two lead programs were presented at major scientific and medical conferences: ICAAC, IDWeekTM, ESMO and EORTC-NCI-AACR.
MGCD290 Clinical Program Update
The Phase II randomized, placebo-controlled, double-blind multicenter trial in vulvovaginal candidiasis (VVC) (290-005) is active at nineteen sites in North America. Over 180 patients have now been recruited and this trial is anticipated to complete accrual in 2012. The trial is designed to evaluate MGCD290 plus fluconazole versus fluconazole alone in patients with moderate-to-severe VVC. Topline data from this trial is expected in Q1 2013 and to date there have been no serious adverse events reported in this blinded study.
MGCD265 Clinical Program Update
Enrollment is ongoing in the Phase I/II trials MGCD265-101 (monotherapy) and MGCD265-103 (combination therapy with docetaxel or erlotinib). In monotherapy studies, MGCD265 has been well tolerated with no grade 4 adverse events. Treatment-related grade 3-4 adverse events were infrequent. Long term stable disease (over 12 months in duration) has been observed in patients with bladder, renal cell and neuroendocrine cancer. One patient with squamous cell cancer achieved a partial response (PR), as determined by RECIST criteria, after ten cycles of monotherapy with MGCD265. The PR was based on one target axillary lesion, but the non-target bone lesions remained stable.
MGCD265 in combination with docetaxel continues to be well tolerated. Non-hematologic grade 3-4 adverse events occurring in more than one patient were infrequent and hematologic toxicities of grade 3-4 were as expected with docetaxel therapy. Objective responses have been observed in NSCLC, prostate cancer and endometrial cancer patients. Of twelve evaluable NSCLC patients, two achieved partial remission and eleven achieved disease control (partial remission or stable disease) at the first tumor assessment.
In the MGCD265 plus erlotinib combination studies there were no grade 4 toxicities and grade 3-4 adverse events were infrequent. Five of nine gastro-esophageal (GE) patients achieved stable disease at the first scan (disease control rate of 56%). Of these four patients remained stable for greater than 4 months and two remained stable for greater than 1 year. Enrollment will continue in the 265-101 monotherapy and 265-103 combination trials with docetaxel or erlotinib until a maximum tolerated dose (MTD) is reached. Once the MTD is reached, we will define the optimal dose for Phase II studies and the product will advance into multiple Phase I/II expansion cohorts. Indications of interest include renal cell, gastric and hepatocellular cancer patients who are c-Met positive. Plans are also underway to initiate a study in NSCLC patients who express Axl.
Third Quarter 2012 Financial Results Reported in Canadian Dollars
Click here to view our Q3 financial statements.
The Company’s financial statements for the period ended September 30, 2012 have been prepared in accordance with IAS 34, Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB).
The Company reported no revenues in the third quarter September 30, 2012, versus $67,000 for the third quarter of 2011. The decline in revenues was due to recognizing the remaining deferred revenues under the Taiho Pharmaceutical Co. Ltd. agreement in 2011.
Research and development expenditures, net of investment tax credits, for the third quarter of 2012 were $4.2 million versus $2.1 million in the third quarter of 2011. This increase was primarily due to the ongoing Phase II trial with MGCD290, the continued enrollment in MGCD265 studies, and API production for MGCD265. General and administrative expenses in the third quarter of 2012 were $1.7 million, an increase of $526,000 versus the third quarter of 2011. The increase relates to the departure of the Company’s President and CEO on September 21, 2012.
Financial income of $49,000, relating primarily to interest income, in the third quarter of 2012 was $40,000 lower compared to the third quarter of 2011 due to lower cash balances in the third quarter of 2012 versus the prior year. The Company recorded a foreign exchange loss of $15,000 in the third quarter of 2012 compared to a gain of $35,000 in the third quarter of 2011.
The net loss and comprehensive loss for the third quarter ended September 30, 2012 was $5.9 million, or ($0.02) per share, compared to a net loss and comprehensive loss of $3.1 million, or ($0.01) per share, for the same period last year. The increased loss per share relates to the higher net loss and comprehensive loss for the quarter relating to the higher operating costs.
Cash, cash equivalents, marketable securities and restricted cash totaled $18.0 million as at September 30, 2012 compared to $29.6 million on December 31, 2011. Including the proceeds of the proposed private placement the Company believes it has sufficient financial resources to carry forward its current clinical development and operating plans into the second half of 2014.
About MethylGene
MethylGene Inc. (TSX:MYG) is a drug development company that is advancing 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 in Phase II trials for vulvovaginal candidiasis, and MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase I/II clinical trials for patients with solid tumors. 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 Contacts
Joseph Walewicz, CFA
Vice President, Business & Corporate Development
MethylGene Inc.
Phone: 514-337-3333 ext. 373
ir@methylgene.com
www.methylgene.com
Thomas Hoffmann
Vice President
The Trout Group LLC
Phone: 646-378-2931
thoffmann@troutgroup.com
www.troutgroup.com