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Epizyme, Inc. (EPZM)
Q3 2013 Earnings Call
October 22, 2013 4:30 PM ET
Stephanie Ascher – IR
Jason Rhodes – President and CEO
Eric Hedrick – Chief Medical Officer
Bob Copeland – EVP and Chief Scientific Officer
Jonathan Eckard – Citi
Simos Simeonidis – Cowen and Company
Howard Laing – Leerink Swann
Mike King – JMP Securities
Greg Wade – Wedbush Securities
Simos Simeonidi – Cowen and Company
» Bristol-Myers Squibb Company Discusses Q4 2013 Results (Webcast)
» Thermo Fisher Scientific Inc. Discusses Q3 2013 Results (Webcast)
I would now like to turn the call over to Epizyme’s team. Please proceed.
Good afternoon. This is Stephanie Ascher with Stern Investor Relations. And welcome to Epizyme’s third quarter 2013 conference call. The news release with our third 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 webcast including a set of slides or a replay of today’s call by going to the Investor Center section of the website.
The agenda for today’s call is, Jason Rhodes, Epizyme’s President and CFO will discuss highlights of the third quarter and other recent updates; Eric Hedrick, Epizyme’s CMO will provide an update on the company’s clinical progress and plans; Robert Copeland, Epizyme’s EVP and CSO will discuss the company’s R&D efforts including expansion indication plans for 2014. Jason Rhodes will review the company’s financial position and collaborations. He will then make closing remarks and open the call for Q&A.
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 our 10-Q filed with the SEC on August 1, 2013.
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’ll turn the call over to Epizyme’s President and CFO, Jason Rhodes.
Thanks Stephanie. Good afternoon everyone and thank you for joining us today. Robert Gould, our CEO won’t be on the call today because he had surgery this morning to repair the mitral valve in his heart. Robert had originally planned to share this news with you on this call with his surgery scheduled for tomorrow. However, yesterday morning his surgeon moved the surgery to today because of a change in the surgeon’s schedule. This change had nothing to do with Robert’s health. So you have me here to share this news with you instead.
The very good news is that I’m able to tell you that the surgery was successfully completed this morning. He is doing well and while we promised to his family that we won’t bother him over the next few weeks. He will be available to us by phone and email while he is recovering at home. We are looking forward to having him back here at Epizyme very soon. In the meantime, the Epizyme leadership team including myself, Bob Copeland and Eric Hedrick will continue to lead the organization.
2013 has been an enormously important year so far for Epizyme as we translate the science of epigenetics into innovative personalized therapeutics for patients with genetically defined cancer. A year ago, Epizyme was a private company initiating its first dose escalation study. Today we are a public company with two ongoing clinical programs, EPZ-5676, a DOT1L inhibitor for the treatment of acute leukemias with the rearrangements of the MLL gene referred to as MLL-r and EPZ-6438 and EZH2 inhibitor for the treatment of non-Hodgkin lymphoma patients with oncogenic point mutations in EZH2. To our knowledge, these are the first and only histone methyltransferase where HMT inhibitors to enter human clinical development.
On today’s call, we will provide an update on our clinical and research progress this year and highlight an important clinical expansion that we are currently planning for 2014.
For 5676, we anticipate completion of the dose escalation stage of the Phase 1 study this year. There had been no dose-limiting toxicities to-date and we are highly encouraged by the tolerability thus far and believe this represents a significant step forward for this first in class epigenetic therapeutic program as well as for the entire field of histone methyltransferase inhibitors. This quarter we will share top-line data from the dose escalation stage and plan to initiate an expansion cohort that will only enroll MLL-r patients.
The expansion cohort will provide an initial assessment of therapeutic effect of 5676 in this population. For 6438, Epizyme along with our partner Eisai initiated a Phase 1, 2 clinical trial in June of 2013. The Phase 1 dose escalation study is ongoing and while we are early in the study no dose-limiting toxicities have been observed to-date. We plan to initiate the Phase 2 part of the study in 2014 in which only non-Hodgkin lymphoma patients with point mutations in EZH2 will be enrolled.