Epizyme, Inc. (EPZM)

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Epizyme, Inc. (EPZM)

Q1 2014 Earnings Conference Call

May 13, 2014 4:30 PM ET


Manisha Pai - Senior Director of Corporate Communications

Robert Gould - CEO

Jason Rhodes - President and CFO

Eric Hedrick - Chief Medical Officer


Howard Liang - Leerink Swann

Eric Joseph - JMP Securities



Good day ladies and gentlemen and welcome to Epizyme Incorporated First Quarter 2014 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions). As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Senior Director of Corporate Communications, Manisha Pai, you may begin.

Manisha Pai

Thank you. Good afternoon. This is Manisha Pai with Epizyme Corporate Communications, and welcome to Epizyme's first quarter 2014 conference call. The news release with our first quarter financial results and company update became available at 4 PM today and can be found on our website at epizyme.com. You can listen to a live web cast including a set of slides or a replay of today's call by going to the Investor Center section of the web site.

The agenda for today is, Robert Gould, CEO will discuss highlights of the quarter and will provide an update on the company's clinical progress and plans and plans for 2014. Jason Rhodes, President and CFO will review the company's financial position and collaboration. He will then make closing remarks and open the call for Q&A. Eric Hedrick, CMO, will also be available for Q&A at the end. Robert Copeland, CSO, is attending the Cancer Advance Conference in New York this week, and will not be able to participate in today's call.

Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements, as a result of various important factors including those discussed in the Risk Factor section of Annual Report on Form 10-K filed the SEC on February 28, 2014.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

Now, I will turn the call over to Robert Gould.

Robert Gould

Thanks Manisha and welcome to Epizyme. Manisha joined us this month as our Senior Director of Corporate Communications. She was most recently with Pharmacyclics, and previously was with Millennium TK [ph]. We are very glad to have her onboard, and good afternoon and thank you all for joining us on this call.

The first quarter of 2014 was another highly productive period for Epizyme. We continue to make significant progress across the entire company, as we work to create innovative personalized therapeutics for patients with genetically defined cancers, by targeting a class of epigenetic enzymes called histone methyltransferase or HMT.

I will begin with EPZ-5676, our clinical program for the treatment of genetically defined acute leukemia. 5676 is a first in class inhibitor with a DOT1L HMT. We are developing it with our collaborator Celgene for the treatment of adults in pediatric patients with one of two genetically defined acute leukemia, MLL-r or MLL-PTD.

In the Celgene collaboration, Epizyme retains a 100% of U.S. commercial rights for 5676 and we are currently developing the program on a global basis together. 5676 clinical development began in September 2012 and we are currently enrolling patients at sites in U.S., the Netherlands and Germany. We now have proof-of-concept studies ongoing for 5676 in three genetically defined acute leukemias, adult MLL-r, adult MLL-PTD, and pediatric MLL-r.

In January, we announced that we had completed enrolment in the dose escalation stage of the adult Phase 1 study, achieving objective responses in two MLL-r patients through the fourth dose cohort in that study and earning a $25 million proof-of-concept milestone payment from Celgene.

The expansion stage of the Phase 1 study is ongoing and enrolling adult patients with MLL-r and MLL-PTD for being treated with 90 milligrams per meter squared per day with uninterrupted administration. We are pleased with continued safety of 5676 and there have been no drug related treatment discontinuations in the study to-date. We are on track to report data from a dose escalation and expansion stage of the adult Phase 1 study in the second half of this year and look forward to sharing this update with you.

We are very pleased to have announced the initiation of the Phase 1b study in pediatric patients with MLL-r leukemia earlier this month. MLL-r comprises approximately 15% pediatric acute leukemia and is considered to be the last remaining subtype of pediatric acute leukemia for which current treatment is inadequate. This pediatric Phase 1b is designed to evaluate the safety pharmacokinetics and pharmacodynamics of escalating doses of 5676 in patients between the ages of three months and 18 years, and to also provide a preliminary assessment of efficacy. Doses are starting at 45 milligrams per meter squared for patients less than 12 months of age and at 70 milligrams per meter squared for patients older than 12 months.

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