Analyst Conference Summary

biotechnology

conference date: August 4, 2017 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2017 (second quarter 2017, Q2)

Forward-looking statements

Overview: Clinical company continues therapy development, with Phase 2 enrollment complete for two studies.

Basic data (GAAP):

Revenue was $10.0 million, up sequentially from $0.0 million, and up from $0.5 million in the year-earlier quarter.

Net loss was $28.0 million, up sequentially from a loss of $32.5 million, and down from a $28.0 million loss year-earlier.

EPS was negative $0.48, up sequentially from negative $0.56, and up from negative $0.49 year-earlier.

Guidance:

none

Conference Highlights:

Robert Bazemore, president and CEO said "Our focus throughout 2017 has been on executing important clinical and regulatory milestones across our tazemetostat program to enable us to bring this first-in-class agent to patients as quickly as we can. In addition, we have continued to pursue avenues to accelerate patient enrollment in our studies, including the recently established collaboration with US Oncology Research to support recruitment for our NHL study. We are also pleased to have reached key milestones in our solid tumor program, including completing enrollment in both our Phase 2 mesothelioma study and the epithelioid sarcoma cohort in our Phase 2 INI1-negative solid tumor study, and establishing the recommended dose in our Phase 1 study in children. We believe we have a significant opportunity with tazemetostat in hematological malignancies and solid tumors."

Epizyme has now reported "positive interim data in three different cancer indications from our ongoing Phase 2 clinical trials."

On May 4 Epizyme announced it had earned a $10 million milestone payment from GlaxoSmithKline for a novel methyltransferase inhibitor initiation of toxicology studies.

Epizyme has a global development plan for tazemetostat (an EZH2 inhibitor), which includes a phase 2 study in patients with NHL which has completed enrolling three of five cohorts. Interim data from all 5 cohorts was presented at ICML on June 14. Tazemetostat in combination with prednisolone in relapsed/refractory DLBCL, was added as the sixth cohort of the Phase 2 NHL study. Also added a follicular lymphoma cohort in January.

In June positive interim data, grouped by EZH2 status, was presented from the Phase 2 trial for FL (follicular lymphoma) and DLBCL, showing safety and activity. Single agent for patients with EZH2 status had a 92% response rate for FL. Even the wild type (normal EZH2) FL cohort had a 26% objective response rate. R/R DLBCL with mutant EZH@ had a 29% objective response rate, and may evolve as time on treatment increases.

Tazemetostat is also in a three-arm phase 2 study in adult patients with certain genetically defined, InI1-negative solid tumors. The pediatric recommended dose was established in a Phase 1 study.

A new Tazemetostat study for pediatric patients with genetically defined solid tumors or NHL was started by the NCI in July.

Enrollment was completed in the mesothelioma with BAP1 loss of function Phase 2 trial. Data expected in 2018.

Data was presented at ASCO. Tazemetostat is a first-in-class orally administered EZH2 inhibitor. The interim data is from the Phase 2 trial for INI1-negative epithelioid sarcoma. The regulatory meeting for this indication was held and a registration path for accelerated approval was determined. Three other arms of the trial, for different solid cancers.

For epithelioid sarcoma, which is rare and aggressive and characterized by the loss of INI1 protein, the results were positive. 31 patients were in the study group, ranging in stage of the disease and in number of lines of prior therapy. Current treatment has limited benefit. 13% of patients had objective responses (2 first line, 2 5th line) and 19% had stable disease, but there were no complete responses. So 32% had disease control, the primary endpoint of the study. Median progression free survival has reached 5.7 months.

Two patients from the Phase 1 trial have gone without disease progression for over two years.

Safety in the trial was about the usual: lots of low-grade adverse events, only a few grade three or greater, and those appeared to be related to disease progression.

Epizyme plans to meet with regulatory authorities, beginning with the FDA in mid-2017, to review data to be presented at a meeting in June and to discuss registration strategies based on the NHL and solid tumor studies. Received Fast Track designation for DLBCL with EZH2 activating mutations.

A Phase 1b study of tazemetostat with Tecentriq for patients with with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) was continuing by Genentech/Roche. Also planned is a similar trial in non-small cell long cancer.

Epizyme continued 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 in collaboration with the Lymphoma Study Association in France.

Two new combination studies with tazemetostat will be initiated in 2017.

A dose-escalation study of pinometostat in pediatric patients with MLL-r acute leukemia is continuing 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 that are planned for introduction into the clinic by 2020.

Three programs are partnered with GSK and three with Celgene.

Cash and equivalents ended at $193 million, down sequentially from $211 million. Epizyme believes it has sufficient funding though at least the third quarter of 2018. Longer if milestone payments are received or new partnership revenue comes in.

Operating expenses of $38.5 million consisted of $22.3 million for R&D and $11.2 million for general and administrative. Loss from operations was $28.5 million. Other income was $0.4 million.

Still on track to introduce the newest product candidate from the platform later this year.

Q&A:

Enrollment in mutated EZH2 mutated arm? We have seen an uptick this year. We put in screening earlier this year. We are pleased to have to collaboration with U.S. oncology. With the enhanced activity data the clinics are more interested in screening patients.

Mesothelioma study, could it be registrational? Study enrolled faster than expected. Disease control at 12 weeks is the primary endpoint. It is an extemely aggressive disease. We will see if results are sufficient for accelerated approval, or if it guides us to combination studies.

Combination strategy for NHL? We have had an aggressive approach. Three studies were initiated in 2015 and we should make a call on that data in 2018. We will add FL combo by end of this year. We think about the safety profile, which looks favorable for Taz. Non-small cell combo study opens up more possibilities.

CAR-T with tazemetostat? We don't have data on what patients go on to after tazemetostat. We do have data showing some enrolled after CAR-T therapies. We have seen too few of these patients to form any conclusions.

Pricing? It is encouraging that the market still supports and rewards novel therapies. It is premature to talk about a price for tazemetostat.

GSK's EZH2 inhibitor? We have no insight into their decision.

ES prevalence statement? INI1 testing is fairly recent for ES patients. These tumors tend to be histologically undifferentiated. Now with INI1 testing it is easier to make a diagnosis.

Cash versus timeline? We have cash through Q3 2018, plus possible milestone payments. With have a path to submitting for ES in 2018. We have a pipeline we could license, or access capital markets if that makes sense.

Non-small cell lung cancer, markers to look for? In the Roche study it is not directed at a particular signal. It is more about enhancing an immunotherapy effect like neoantigen expression. We are looking at both hot and cold tumors in this space, for NSCLC is more directed at hot tumors.

Maintenance setting for tazemetostat? We would be very excited about that. We are looking for the right clinical setting for that.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: