- Top-line data for Phase 1 study of EPZ-5676 expected in fourth quarter -
- Significant clinical expansion planned for DOT1L and EZH2 programs in 2014 -
CAMBRIDGE, Mass., Oct. 22, 2013 /PRNewswire/ -- Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today provided a corporate update and reported financial results for the quarter ended September 30, 2013.
"2013 has been an important year for Epizyme as we translate the science of epigenetics into personalized therapeutics," said Robert Gould, Ph.D., chief executive officer. "We currently have two ongoing clinical programs, which to our knowledge are the only histone methyltransferase (HMT) inhibitor programs to have entered human clinical development. EPZ-5676, an inhibitor of the HMT DOT1L, is being developed as a treatment for patients with acute leukemias with rearrangements of the MLL gene (MLL-r). The dose escalation stage of the Phase 1 study of EPZ-5676 is proceeding and no dose-limiting toxicities have been observed to date. We have been highly encouraged by the tolerability thus far and believe this represents a significant step forward for this first-in-class epigenetic program and for the entire field. We anticipate completion of this stage by the end of the year. In the fourth quarter of 2013, we will share top-line dose escalation data and, based on data from the dose escalation stage, plan to initiate an expansion cohort stage that will be limited to patients with MLL-r. This expansion cohort is expected to provide an initial assessment of therapeutic effect in this population in 2014."
Dr. Gould continued, "In addition, for EPZ-6438, an inhibitor of the HMT EZH2 being developed as a treatment for non-Hodgkin lymphoma patients with oncogenic point mutations in EZH2, Epizyme, with our partner Eisai, initiated a Phase 1/2 clinical trial in June 2013. This Phase 1 dose escalation study is ongoing and no dose-limiting toxicities have been observed to date."
"Looking ahead to 2014, we plan to pursue additional clinical studies for both candidates in genetically defined cancers beyond the primary indications, including MLL-PTD for EPZ-5676 and synovial sarcoma and other INI1-deficient tumors for EPZ-6438," said Gould. "We are in a strong position to invest in Epizyme's internally generated pipeline and look forward to continued progress with multiple proof of concept studies in 2014."
EPZ-5676 Clinical Development – Progress and Plans
EPZ-6438 Clinical Development – Progress and Plans
Additional Business Highlights
Third Quarter 2013 Financial Results & Financial Guidance
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 4:30 p.m. EDT to discuss the quarter and provide a corporate update. To participate in the conference call, please dial 1-877-303-9053 (domestic) or 1-970-315-0464 (international) and refer to conference ID 85846372. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of the Company's website at www.epizyme.com.
The archived webcast will be available on the Company's website beginning approximately two hours after the event.
About Epizyme, Inc.
Epizyme, Inc. is a clinical stage biopharmaceutical company creating personalized therapeutics for patients with genetically defined cancers. Epizyme has built a proprietary product platform that the company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme's targeted science seeks to match the right medicines with the right patients for a personalized approach to cancer treatment.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
Cash and cash equivalents
Redeemable convertible preferred stock (Series A, B and C)
Stockholders' equity (deficit)
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
Three Months Ended September 30,
Nine Months Ended September 30,
Research and development
General and administrative
Total operating expenses
(Loss) income from operations
Other income (expense), net
Net (loss) income
Less: accretion of redeemable convertible preferred stock
to redemption value
Less: income allocable to participating securities
(Loss) income allocable to common stockholders - basic
Undistributed income re-allocated to common stockholders
(Loss) income allocable to common stockholders - diluted
(Loss) earnings per share allocable to common stockholders:
Weighted average shares outstanding:
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, expectations regarding the sufficiency of the Company's cash balance to fund operating expenses and capital expenditures, milestone or royalty payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, development progress of the Company's companion diagnostics, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates or companion diagnostics and other factors discussed in the "Risk Factors" section of the Company's 10-Q filed with the Securities and Exchange Commission on August 1, 2013. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof
SOURCE Epizyme, Inc.
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