Epizyme Reports Second Quarter 2017 Financial Results and Clinical and Business Progress
Key Clinical Milestones Achieved in Studies of Mesothelioma, Epithelioid Sarcoma and Pediatric Solid Tumors
Expansion of Collaborations to Accelerate Investigation of Tazemetostat Across Multiple
Conference Call to be Held Today at
"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," said
Tazemetostat Clinical Program Updates
July 2017, Epizymecompleted enrollment in the epithelioid sarcoma (ES) cohort of its ongoing, multi-arm Phase 2 study in adult patients with INI1-negative solid tumors. Following the announcement of positive interim data at the American Society of Clinical Oncology(ASCO) Annual Meeting and discussion with the U.S. Food and Drug Administration, the company has identified a path to submission for accelerated approval for the treatment of patients with ES, and is targeting the first New Drug Application for tazemetostat in this indication in 2018.
July 2017, Epizymeannounced that the National Cancer Institute(NCI) initiated its Pediatric MATCH study, which will evaluate tazemetostat in one of the study arms as a monotherapy for pediatric patients with certain genetically defined solid tumors or non-Hodgkin lymphoma. This study is part of the company's Cooperative Researchand Development Agreement (CRADA) executed between Epizymeand the NCI.
July 2017, the company established the recommended dose for tazemetostat in its study of pediatric patients with solid tumors, and initiated the dose-expansion portion of the study.
June 2017, the company completed enrollment in its ongoing Phase 2 study designed to evaluate tazemetostat as a treatment for adults with mesothelioma characterized by BAP1 loss-of-function. The company expects to report data from this study in 2018.
June 2017, Epizymeannounced that tazemetostat will be evaluated in combination with atezolizumab (TECENTRIQ®) in a Phase 1b/2 clinical study of metastatic non-small cell lung cancer as part of MORPHEUS, Genentech'sopen-label, multi-center, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in solid tumors. This study is an expansion of the company's clinical collaboration with Genentech, a member of the Roche Group, and is expected to begin enrolling patients by the end of the year.
June 2017, positive interim efficacy data, grouped by EZH2 mutational status, were presented during a plenary session at the International Conference on Malignant Lymphoma(ICML) from the ongoing Phase 2 clinical trial of tazemetostat as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). Promising clinical activity and durability were observed across all study cohorts, with enhanced efficacy in the EZH2 mutation cohorts. Importantly, tazemetostat continues to demonstrate a favorable safety profile across the clinical development program.
Recent Business Highlights
August 2017, Epizymeannounced a collaboration with US Oncology Researchto implement a separate screening protocol in 68 locations in the U.S.(including satellite locations affiliated with primary sites) to identify relapsed or refractory FL and DLBCL patients with tumors bearing EZH2 mutations who may be candidates for enrollment in Epizyme's ongoing Phase 2 clinical trial. US Oncology Researchwill direct identified patients to the tazemetostat Phase 2 clinical trial for protocol screening and potential enrollment into the trial. Sites began screening patients in July 2017.
June 2017, the U.S. FDAgranted Orphan Drug designation to tazemetostat for the treatment of patients with soft tissue sarcoma (STS). Orphan Drug designation conveys eligibility for certain development incentives and market exclusivity for STS independent from Epizyme'sintellectual property protection.
Upcoming 2017 Milestones
Epizymeanticipates engaging with the U.S. FDAin the second half of 2017 to review data from its ongoing Phase 2 study in relapsed or refractory patients with NHL and discussing potential registration paths for tazemetostat.
- The company plans to begin a clinical study evaluating tazemetostat as a combination agent for the treatment of patients with FL by the end of 2017.
Epizymeplans to announce the next development candidate from its novel, internally discovered pipeline of epigenetic programs by the end of 2017.
Second Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$193.0 millionas of June 30, 2017, as compared to $211.2 millionas of March 31, 2017.
$10.0 millionwas recognized in the second quarter of 2017, compared to $0.5 millionfor the second quarter of 2016. Revenue in the second quarter of 2017 represents a $10.0 millionmilestone payment from GlaxoSmithKline (GSK) following their initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizymeand licensed to GSK.
- R&D Expenses: Research and development (R&D) expenses were
$27.3 millionfor the second quarter of 2017, compared to $21.5 millionfor the second quarter of 2016. The increase is primarily due to the expansion of the tazemetostat clinical development program, as well as increased research activities related to Epizyme's next potential development candidate and new target families.
- G&A Expenses: General and administrative (G&A) expenses were
$11.2 millionfor the second quarter of 2017, compared to $7.4 millionfor the second quarter of 2016. The increase is primarily due to an increase in commercial-related activities and legal spending to support the company's growing intellectual property portfolio.
Loss: Net loss was
$28.0 millionfor each of the quarters ended June 30, 2017and June 30, 2016.
2017 Financial Guidance
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma and combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the
TECENTRIQ® (atezolizumab) is a registered trademark of
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Consolidated Balance Sheets Data :|
|Cash, cash equivalents and marketable securities||$||193,004||$||242,192|
|Total stockholders' equity||150,040||201,700|
|CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended June 30,||Six Months Ended |
|Research and development||27,292||21,450||51,987||39,190|
|General and administrative||11,170||7,424||19,439||13,270|
|Total operating expenses||38,462||28,874||71,426||52,460|
|Loss from operations||(28,462||)||(28,401||)||(61,426||)||(51,515||)|
|Other income, net||438||420||880||655|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Cheya Pope, Epizyme, Inc.email@example.com 617-229-7561 Monique Allaire, THRUST IR firstname.lastname@example.org (617) 895-9511
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