Analyst Conference Summary


conference date: March 9, 2016 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2015 (fourth quarter 2015, Q4)

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 $0.6 million, up sequentially from $0.4 million, and down from $10.3 million in the year-earlier quarter.

Net loss was $22.2, up sequentially from a loss of $23.1 million, and down from $15.0 million loss year-earlier.

EPS was negative $0.53, up sequentially from negative $0.56, and down from negative $0.44 year-earlier.


Believes cash will cover operations through the end of 2017. But the R&D spend will increase meaningfully to accelerate the tazemetostat program.

Conference Highlights:

By 2020 goals are to have launched tazemetostat in NHL and genetically defined solid tumors, thus transitioning into a commercial stage organization. A broader tazemetostat program to expand its use should be in place by then. At least 3 other oncology molecules should be in clinical development by then.

Epizyme initiated a global development plan for tazemetostat, which includes a five-arm, phase 2 study in patients with NHL, a three-arm phase 2 study in adult patients with certain genetically defined solid tumors which initiated dosing in the quarter, and a dose-escalation and dose-expansion phase 1 study in pediatric patients with certain genetically defined solid tumors.

Some interim NHL tazemetostat data could be released in mid-2016. Believes has already passed the futility hurdle in 3 of the 5 arms. Hopes to get FDA permission to follow an accelerated path in some subtypes. Solid tumor interim data could come before the end of 2016.

In the first half of 2016, Epizyme will 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 (PD1 or PDL1) in B-cell lymphoma. "Partnering discussions are well underway" for the combination studies.

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

Epizyme has preclinical work underway with five new targets. The first of these is BAP1 loss-of-function mesothelioma. A prioritized set of HMT and CMP targets has been identified and prioritized.

Three programs are partnered with GSK and three with Celgene.

Cash and equivalents ended at $208.3 million, down $21.6 million sequentially from $229.9 million. . After the quarter ended Epizyme raised $130.1 from the sale of common shares.

Operating expenses of $22.8 million consisted of $16.8 million for R&D and $6.0 million for general and administrative. Loss from operations was $22.3 million.


When could we see the results of the futility analysis? We need to take the data to the independent monitoring committee. We plan to present the NHL trial data midyear at a science conference, at least for the arms that have passed futility.

Has pinometostat be de-prioritized? We are continuing the pediatric study and plan to present the data later in the year. We are looking for paths forward in combination studies for both adult and pediatric leukemia.

We are still looking at B-cell signaling agents, but that trial could start later than the PD1/PDL1 trial.

Can you tell us which 3 arms met the hurdle, and nature of hurdle? The NHL hurdle was prespecified. The hurdles differ according to indication. Not disclosing which arms yet.

Biomarker and patient response work with tazemetostat? We have a proprietary 62-gene panel we are using with the study. We don't expect that data to be ready with the mid year data, but will tie it in later.

Could you file off the Phase 2 trial data? There would be an opportunity to file with the data. It would be more likely in patients with the EZH2 marker. There is no current standard of care, so doing a controlled trial against another agent would not be likely.

The prior poster of the second EZH2 inhibitor with AML? We have identified a large pool of targets that look really exciting. We choose 5 targets for focus on. We expect 3 of 5 will come to INDs in the 2020 time frame, but are not disclosing which 3 yet. The poster you mentioned is a compound closely related to tazemetostat, if is just one of many we are working on, with academic communities.

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Disclaimer: My analyst call summaries may include both 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 2016 William P. Meyers