Epizyme Announces Second Quarter 2016 Financial Results and Progress Against Corporate Objectives
Company Updates Financial Guidance Extending Runway into At Least Second Quarter of 2018
Conference Call to Be Held Today at
"We are pleased with our continued momentum in the clinical development of tazemetostat in non-Hodgkin lymphoma, or
Advancing the Clinical Development of Tazemetostat for the Treatment of Non-Hodgkin Lymphoma (NHL) and Genetically Defined Solid Tumors
- In June,
Epizymepresented positive, early findings from its ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory NHLat the American Society of Hematology Meeting on Lymphoma Biology. As of the data cutoff date in late May, approximately 30 percent of the planned 270 patients were enrolled into the study. Tazemetostat demonstrated clinical activity, including objective responses, in all five arms of the study and a favorable safety profile in a heavily pre-treated, multiply relapsed and highly refractory patient population. Overall patient enrollment is proceeding according to internal projections, and the study is now open for enrollment in the U.S.
- Overall patient enrollment is also on-track in the Company's ongoing Phase 2 clinical study in adult patients and Phase 1 study in pediatric patients with INI-1 negative tumors or synovial sarcoma.
Epizymeplans to provide data on the efficacy and safety of tazemetostat from both the NHLand solid tumor Phase 2 studies in the first half of 2017. The Company plans to meet with regulatory authorities, beginning with the U.S. Food and Drug Administration(FDA) in mid-2017, to review data from all cohorts of its Phase 2 solid tumor study and discuss registration strategies based on these data. Epizymealso expects to meet with FDAto review Phase 2 NHLdata and discuss registration strategies in 2017.
- In June,
Epizymeparticipated in FDA's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee(ODAC) meeting, which reviewed select novel, targeted agents for the treatment of pediatric cancer. Epizymewas one of five invited innovators, and presented on its ongoing pediatric clinical program. The Company received valuable feedback and support from Committee members on the development of tazemetostat as a treatment for rare and extremely aggressive cancers in pediatric patients.
Broadening Scope of Tazemetostat Clinical Program
- In August,
Epizymeinitiated a global study of tazemetostat in patients with mesothelioma. This is a multi-center Phase 2 study evaluating tazemetostat as a monotherapy treatment for patients with mesothelioma characterized by BAP1 loss-of-function. The study is open for enrollment in the U.S., with an accepted Investigational New Drug application, and is expected to open in international sites shortly. This study marks the first of five new indications into which the Company plans to expand tazemetostat in the clinic by the end of 2020.
- In June,
Epizymeentered into a collaboration agreement with Genentech, a member of the Roche Group, to conduct a clinical trial to investigate tazemetostat and Genentech'srecently approved anti-PD-L1 cancer immunotherapy, Tecentriq™ (atezolizumab), when used in combination for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. The study will be conducted by Genentechand is expected to begin in the second half of 2016.
- In May,
Epizymeentered into a collaboration agreement with the Lymphoma Study Association(LYSA), a premier cooperative group in Francededicated to clinical and translational research for lymphoma, to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in elderly, high-risk patients with DLBCL. The study will be conducted by LYSA and is expected to be initiated in the second half of 2016.
Second Quarter 2016 Financials Results and Guidance
- Collaboration revenue was
$0.5 millionand $0.9 millionfor the three and six months ended June 30, 2016, respectively, compared to $0.7 millionand $1.6 millionfor the three and six months ended June 30, 2015, respectively. The period-over-period decreases reflect decreased recognition of deferred revenue from upfront payments and research and development revenue related to the Company's collaboration with GlaxoSmithKline, partially offset by increased recognition of deferred revenue from upfront payments from its Celgene collaboration.
- Research and development (R&D) expenses were
$21.5 millionand $39.2 millionfor the three and six months ended June 30, 2016, respectively, compared to $20.6 millionand $77.6 millionfor the three and six months ended June 30, 2015, respectively. During the three months ended June 30, 2016, R&D expenses increased due to external and internal costs associated with the expansion of the tazemetostat program, which more than offset the period-over-period reduction of pinometostat-related costs. The period-over-period decrease from the six months ended June 30, 2015was driven by the first quarter 2015 payment to Eisai of $40.0 millionfor the reacquisition of the worldwide rights, excluding Japan, to tazemetostat. Epizymeexpects that R&D expenses will increase significantly in the remainder of 2016. This will be driven by the planned expansion of clinical trial activity for tazemetostat, including initiation of the mesothelioma study, initiation of the two combination trials in DLBCL, and expansion of the Company's ongoing studies in NHLand solid tumors. In addition, discovery and preclinical research costs are expected to increase as Epizymeadvances its wholly owned small molecule programs against multiple novel epigenetic targets and continues its research efforts under its Celgene collaboration.
- General and administrative (G&A) expenses were
$7.4 millionand $13.3 millionfor the three and six months ended June 30, 2016, respectively, as compared to $6.0 millionand $11.2 millionfor the three and six months ended June 30, 2015, respectively. The period-over-period increases in G&A expenses were largely due to staffing key leadership roles in the second quarter. Epizymeexpects that G&A spend will increase modestly over the remainder of 2016.
- Net loss was
$28.0 millionand $50.9 millionfor the three and six months ended June 30, 2016, respectively, compared to a net loss of $25.8 millionand $87.1 millionfor the three and six months ended June 30, 2015, respectively.
- Cash, cash equivalents and
marketable securities were
$288.6 millionas of June 30, 2016, as compared to $208.3 millionas of December 31, 2015.
Conference Call Information
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Cash and cash equivalents||$||89,480||$||208,323|
|Total stockholders' equity||255,164||169,532|
|CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||21,450||20,551||39,190||77,602|
|General and administrative||7,424||5,970||13,270||11,207|
|Total operating expenses||28,874||26,521||52,460||88,809|
|Loss from operations||(28,401||)||(25,785||)||(51,515||)||(87,162||)|
|Other income, net||420||26||655||77|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Monique Allaire, 617-895-9511 THRUST Investor Relations Monique@thrustir.com Media: Michael Lampe, 484-575-5040 Scient Public Relations firstname.lastname@example.org
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