Epizyme Reports 2016 Financial Results and Provides 2017 Pipeline Goals
Data from Tazemetostat Phase 2 Programs in NHL and Molecularly Defined Solid Tumors Planned for Medical Meetings in Second Quarter
Conference Call to Be Held Today at
"2016 was a year of tremendous progress across all aspects of
- Tazemetostat Combination with Prednisolone Initiated:
Epizymehas initiated clinical investigation of tazemetostat in combination with prednisolone in relapsed/refractory patients with DLBCL, based on observed preclinical synergy of the agents. This combination regimen is being conducted as the sixth cohort to the ongoing Phase 2 NHL study. Epizymealso anticipates initiating a new combination study in patients with follicular lymphoma in 2017.
- Enrollment Completed in Three of Five NHL Study Cohorts:
Epizymehas completed enrollment in three of the five cohorts of its ongoing, global Phase 2 study of tazemetostat in patients with relapsed/refractory non-Hodgkin lymphoma (NHL): the two cohorts enrolling patients with diffuse large B-cell lymphoma (DLBCL) with wild-type EZH2 and a third enrolling patients with follicular lymphoma with wild-type EZH2.
- Follicular Lymphoma Enrollment Initiated in
U.S.: In January 2017, following a positive written response from the U.S. Food and Drug Administration(FDA) to the company's written request, Epizymeopened enrollment to patients with follicular lymphoma in the United Statesas part of the Company's Phase 2 study in NHL.
- Fast Track Designation Granted for DLBCL with EZH2 Mutations: In
December 2016, the U.S. FDAgranted Fast Track designation to tazemetostat for the treatment of patients with DLBCL whose tumors carry an EZH2 activating mutation. DLBCL is the most common form of NHL. The Fast Track designation provides expedited processes that may reduce development time and costs associated with bringing a drug to market.
- Epithelioid Sarcoma Cohort Expanded in Phase 2 Solid Tumor Study: In late 2016,
Epizymeexpanded the epithelioid sarcoma cohort of its ongoing Phase 2 trial of tazemetostat in adult patients with certain molecularly defined solid tumors, following review by the Independent Data Monitoring Committee. This expansion was based on encouraging early activity, including confirmed objective responses, and surpassing the pre-specified futility hurdle in the cohort. This cohort will enroll up to 60 patients, or double the initial cohort size of 30 patients.
- Synovial Sarcoma Cohort
Completed Enrollment in Phase 2 Solid Tumor Study: The synovial sarcoma cohort of the Phase 2 trial in patients with molecularly defined solid tumors was fully enrolled in
November 2016. This arm surpassed its pre-specified futility hurdle; however, the Company concluded that the activity was insufficient to continue further investigation of tazemetostat as a monotherapy. Epizymeis focusing its efforts on the remaining four cohorts of INI1-negative tumors.
Key 2017 Milestones and Goals
- Interim Phase 2 Data Presentations Anticipated in the Second Quarter:
Epizymeplans to report efficacy, safety and biomarker data from all five arms of the ongoing Phase 2 study in NHL, and from the study cohorts that have reached their futility analysis in the ongoing Phase 2 study in molecularly defined solid tumors. Pending abstract approval, the Company plans to present interim solid tumor data at the American Society of Clinical Oncology(ASCO) Annual Meeting. Pending abstract submission and approval, the Company anticipates presenting interim data from all five arms of the ongoing Phase 2 NHL trial at The International Conference on Malignant Lymphoma(ICML).
- Preparing for Regulatory Engagement beginning Mid-Year:
Epizymeis preparing for regulatory engagement around its Phase 2 studies, beginning with the United States Food and Drug Administration(FDA) in mid-2017 on its molecularly defined solid tumor program. The Company is also preparing for FDAengagement on its NHL program in the second half of the year. These interactions are intended to determine registration paths for tazemetostat in each disease area.
- Combination Studies Progressing: The combination studies of tazemetostat in front-line DLBCL with R-CHOP and in relapsed/refractory DLBCL with atezolizumab (Tecentriq™) are continuing to enroll patients globally.
Epizymeexpects the optimal dose of tazemetostat in these combinations will be established this year, and for enrollment to continue to evaluate the safety and efficacy profile of both combinations.
- Mesothelioma Study Progressing:
Epizymeis continuing to enroll patients in its global Phase 2 study of tazemetostat in patients with mesothelioma characterized by BAP1 loss-of-function. The Company anticipates completing enrollment in this trial in 2017.
- Next Development Candidate to be Named:
Epizymeis progressing a pipeline of next-generation small molecules against novel epigenetic targets, and plans to name the next epigenetic development candidate from its pipeline in 2017. This is part of the Company's goal of bringing three new product candidates into the clinic by 2020.
Fourth Quarter and Full-Year 2016 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$242.2 millionas of December 31, 2016, as compared to $208.3 millionas of December 31, 2015.
- Revenue: Collaboration revenue was
$0.5 millionfor the fourth quarter of 2016 and $8.0 millionfor the full year ended December 31, 2016, compared to $0.6 millionfor the fourth quarter of 2015 and $2.6 millionfor the full year ended December 31, 2015. The year-over-year increase was driven predominantly by the achievement of a $6.0 millionmilestone under the Company's agreement with GSK during 2016.
- R&D Expenses: Research and development (R&D) expenses were
$28.4 millionfor the fourth quarter of 2016 and $91.5 millionfor the full year ended December 31, 2016, compared to $16.8 millionfor the fourth quarter of 2015 and $111.2 millionfor the full year ended December 31, 2015. R&D spending on discovery research programs and tazemetostat clinical development increased in both the quarter ended December 31, 2016and, excluding the impact of the $40.0 millionupfront payment to Eisai in the first quarter of 2015 to acquire worldwide rights, excluding Japan, to tazemetostat, in the year ended December 31, 2016.
- G&A Expenses: General and administrative (G&A) expenses were
$7.6 millionfor the fourth quarter of 2016 and $28.4 millionfor the full year ended December 31, 2016, compared to $6.0 millionfor the fourth quarter of 2015 and $23.9 millionfor the full year ended December 31, 2015. The increase was primarily due to higher compensation-related expenses associated with expansion of the senior leadership team in the first half of 2016 to support the Company's operational growth, as well as increased investment in business development activities and tazemetostat-related pre-commercial activities.
- Net Loss: Net loss was
$35.0 millionfor the fourth quarter of 2016 and $110.2 millionfor the full year ended December 31, 2016, compared to $22.2 millionfor the fourth quarter of 2015 and $132.4 millionfor the full year ended December 31, 2015.
Conference Call Information
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Any statements in this press release about future expectations, plans and prospects for
Tecentriq™ is a trademark of
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Cash and cash equivalents||$||77,895||$||208,323|
|Total stockholders' equity||201,700||169,532|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended ||Twelve Months Ended |
|Research and development||28,383||16,819||91,461||111,209|
|General and administrative||7,580||6,017||28,372||23,900|
|Total operating expenses||35,963||22,836||119,833||135,109|
|Other income, net||469||55||1,614||173|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Monique Allaire, THRUST IR firstname.lastname@example.org (617) 895-9511
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