Analyst Conference Summary


conference date: November 9, 2015 at 5:00 AM Pacific Time
for quarter ending: September 30, 2015 (third quarter 2015, Q3)

Forward-looking statements

Overview: Epizyme is a clinical-stage oncology therapy company with a platform based on small molecule inhibitors of chromatin modifying proteins (CMPs). All revenue is from collaborations as therapy candidates are moved towards FDA approvals.

Basic data (GAAP):

Revenue was $358 thousand, down from $8.2 million in the year-earlier quarter.

Net loss was $23.1 million, down from $19.7 million year-earlier.

EPS was negative $0.56, up from negative $0.58 year-earlier.


None given.

Conference Highlights:

Epizyme is conducting a Phase 2 trial of tazemetostat for relapsed or refractory B-cell NHL (Non-Hodgkin Lymphoma), stratified by cell of origin and EZH2 mutation status. In June positive data was presented from the Phase 1 study, which showed a 60% response rate. In September the data from solid tumor patients in the study was released showing a 55% disease control rate in a subset of patients with INI1-negative or SMARCA4-negative at 800 mg or above oral doses.

Epizyme plans to initiate two registration-supporting clinical trials in patients with INI1-negative tumors or synovial sarcoma, including a registration-supporting phase 2 study of tazemetostat in adult patients, and a proof-of-concept phase 1 trial in pediatric patients, in the fourth quarter of 2015.

Robert Bazemore is the new CEO of Epizyme. "Epizyme is executing on our strategic goal of bringing tazemetostat to patients as quickly as possible, and we are operating from a sound financial position. Our vision is to build Epizyme into a multi-product oncology company bringing targeted epigenetic therapies to patients."

"In the first half of 2016, Epizyme plans to initiate additional clinical evaluations of tazemetostat as a combination therapy, including a phase 1/2 study with R-CHOP in front-line high-risk patients with diffuse large B-cell lymphoma and a combination study with a B-cell signaling agent or immuno-oncology agent in B-cell lymphoma."

A dose-escalation study of pinometostat in pediatric patients with MLL-r acute leukemia is is expected to complete enrollment in the fourth quarter of 2015. Epizyme is partnering with Celgene for potential clinical development of pinometostat in combination with other agents.

Cash and equivalents ended at $229.9 million. In July $10 million was received from Celgene. Believes cash will cover operations through Q2 2017.

Operating expenses of $23.5 million consisted of $16.8 million for R&D and $6.7 million for general and administrative. Loss from operations was $23.1 million.


How is your understanding of which EZH2 patients respond to tazemetostat? 11 presentation at the Molecular Targets meeting this weekend. We are deepening our understanding of the role of EZH2 and of HMT inhibitor mechanisms. We presented on novel small molecule inhibitors of new HMTs. The data points to EZH2 as a critical B-cell state gateway.

We are talking with regulators about expanding the NHL program to the U.S. It is currently being tested in Europe. We believe EZH2 mutations respond well to tazemetostat, but wild (normal) EZH2 also shows a response, so we want to test both types.

Lymphoma safety issue? We are in discussions with the agency and continue to investigate the mechanism. There are many ways to go forward with NHL, and we want to include U.S. patients in the program.

NHL Phase 2 study futility hurdle? We have not revealed that, but we are looking for sufficient activity.

Enrollment in trial arms? Each arm is treated separately, and we will release data as it comes in for each arm. There will be about 4 times as many wild type patients as mutant patients. We will provide an update on all 5 arms at a medical conference mid 2016.

We have a five year strategy and need to clarify our pathway to move to being a late stage clinical company. We have seen new pre-clinical signals indicating there may be more paths to take tazemetostat forward.

No particular issues have been brought to us by the European regulators.

GSK partnership? Three programs, but it is up to GSK to release information.

Combination therapy rational? We have a variety of chromatin remodeling candidates that could become therapies. We have identified quite a number of interesting targets and have used a platform to validate some of those studies. We want to get to registration quickly with our monotherapy studies. Now that we are in that position, we are looking at combinations. Our data shows synergy between RCHOP and tazemetostat. We also have so pre-clinical data with B-cell signaling agents. We are looking an immune oncology agents too.

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Disclaimer: My analyst call summaries may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is investment journalism, not financial advice.

Copyright 2015 William P. Meyers