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Epizyme Inc (EPZM)
UBS Global Healthcare Conference Call
May 21, 2014 10:00 AM ET
Robert J. Gould – Chief Executive Officer
Matt M. Roden – UBS Securities LLC
Matt M. Roden – UBS Securities LLC
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So, we are pleased to have you with us and we are looking-forward to hearing the latest update on Epizyme. Robert?
Robert J. Gould
Thanks, Matt. Well, thank you, Matt and thank you to UBS for the invitation, and thank you to each one of you for taking the time to hear the Epizyme story. I’m very pleased to have this opportunity to give you an update on where Epizyme stands in the first half of 2014 and what we can look forward to in the future.
For those of you who don’t know Epizyme, we are a biopharmaceutical company creating personalized therapeutics for patients with genetically-defined cancers. And very specifically we make small molecule inhibitors that are discovered by the scientists at Epizyme, the target – one of a family of enzymes called histone methyltransferases or HMTs for short. This is a large family of enzymes, 96-members within the human genome comprised this family of enzymes, and a controlled gene expression via phenomenon called epigenetics and they control that by transferring small chemical groups called methyl groups on to proteins called histones hence the name histone methyltransferases.
And because of the critical role that they play in driving gene expression, when these enzymes are misregulated through genetic alterations within the enzyme itself or within associated regulatory proteins. That misregulation of the enzyme leads to misregulated gene expression and that misregulated gene expression can be the driver for a variety of hematologic and solid malignancies as well as in another diseases, but Epizyme is chosen to focus on the cancers in which histone methyltransferases are the driving mutations.
We have two such clinical programs currently and genetically-defined cancers; a compound called EPZ-5676, which is an inhibitor of one of these HMTs, and HMT called DOT1L. And during dose escalation phase this – the development of 5676, we are very pleased to see objective responses in patients that have the genetic alteration.
Second program that’s in the clinic is for a different an inhibitor of the different HMT, this compound 6438 inhibits an HMT called EZH2. The Phase 1 dose escalation is currently ongoing in this program, where we’re targeting NHL patients with specific genetic alterations. But these two programs are only the tip of a product platform is generating a pipeline of novel personalized therapeutic programs within this family of enzymes, within the HMTs. Our intellectual property is robust, we have composition of matter patents around our two lead programs 5676 and 6438 that expire in 2032.
And we have therapeutic collaborations with Celgene, Eisai, and GSK that have been an important source not only revenue for the company, but also validation of our approach and recognition of the uniqueness of our product platforms, because of the criticality of addressing patients with genetically-defined cancers, we also have companion diagnostic collaborations with Abbott and Roche. Abbott around the DOT1L program and Roche molecular around the EZH2 program.
In 2013 and 2014 to date we’ve advanced our clinical program 5676 significantly, we achieved a $25 million proof-of-concept milestone with Celgene for achieving objective responses in the dose escalation phase of that program. And we initiated a Phase 1 expansion study specifically in patients that have genetic alterations. This is a leukemia population that has chromosomal translocation, leukemia is known as MLL-r or MLL-PTD.
And additionally we started a Phase 1 study in pediatric MLL-r patients. The form of leukemia were treating occurs in two age populations, in adult population and in pediatric population and we’re very pleased based on the safety profile that we’ve seen to date with 5676 to initiate the pediatric trial.
We have an ongoing EZH2 Phase 1 dose escalation study and again in 2013 we achieved $6 million initiation milestone with Eisai in that program. We have three programs that are partnered with GSK and over the last since December we’ve achieved $10 million in milestones across those three programs with the three GSK targets. And as I’ve mentioned we’ve advanced our intellectual property position with U.S. patents that have been issued this year on 5676 and 6438 as well as therapeutic and diagnostic claims around the EZH2 programs.
We anticipate that we’ll finish 2014 with more than a $170 million in cash this cash runway extends us through at least mid 2016 and that does not consider any additional milestones from any of our three partners. More importantly than the time that it extends through our ability to do proof-of-concept trials in our two programs that are currently in the clinic.
So let me turn now and explain a little bit more about this class of enzymes and then why we chose to focus initially on the two HMTs DOT1L and EZH2. So in this within that nucleus of your cell is the DNA that it encodes the proteins that make up life. And that control of gene expression is regulated by the addition of small chemical groups on to protein called histones as depicted in this cartoon. The addition of methyl groups is a particularly important regulatory system controlling gene expression.