Epizyme Provides Update on Execution of Clinical Program and Reports Third Quarter 2016 Financial Results
Robust Clinical Program Underway for Tazemetostat in Multiple Cancer Indications and Treatment Settings as Both Monotherapy and Combination Agent
Conference Call to Be Held Today at
"Throughout 2016, we have made substantial progress toward achieving our vision, which includes advancing the clinical development of tazemetostat and expanding its therapeutic benefit into new indications and treatment settings," said
Execution of Clinical Programs
- Enrollment in Phase 2 Programs in
NHLand Solid Tumors Progressing: The Company's Phase 2 studies of tazemetostat in non-Hodgkin lymphoma (NHL) and genetically defined solid tumors are progressing and continue to enroll patients. Epizymeplans to report efficacy, safety and biomarker data from both studies in the first half of 2017. The Company is also preparing for intended regulatory engagement, beginning first with the United States Food and Drug Administration(FDA) in mid-2017 to determine potential registration paths for its genetically defined solid tumor program in adult patients. In addition, Epizymeis preparing for FDAengagement on its NHLprogram, also in 2017, to determine potential registration paths in various subtypes of NHL.
- Immuno-oncology Combination Study Initiated: The Phase 1b study is evaluating tazemetostat in combination with Tecentriq™
(atezolizumab), in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Tecentriq is the first and only anti-PD-L1 cancer immunotherapy approved by
FDA. This study is being conducted by Genentech, a member of the Roche Group, under Epizyme's collaboration agreement with Roche.
- Front-line Combination Study Initiated: The first study of tazemetostat in the front-line treatment setting has been initiated. The Phase 1b/2 study is evaluating tazemetostat in combination with R-CHOP, a chemotherapy regimen, as a first-line treatment for newly diagnosed elderly, high-risk patients with DLBCL. This study is being conducted under the Company's collaboration with the
Lymphoma Study Association.
- Mesothelioma Study Initiated: Patient enrollment is underway in Epizyme's global Phase 2 study evaluating tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. This study marks the expansion of tazemetostat development as a monotherapy into a new cancer indication.
- CRADAs Established with NCI on Tazemetostat and Pinometostat:
Epizymerecently entered into separate Cooperative Researchand Development Agreements (CRADAs) with the National Cancer Institute(NCI) to evaluate tazemetostat in clinical trials in multiple cancer indications and to evaluate Epizyme's novel DOT1L inhibitor, pinometostat, in multiple combination regimens. These CRADAs further expand the clinical evaluation of tazemetostat in both adults and children, while also exploring the potential for pinometostat as a combination therapy for certain kinds of acute leukemia.
- Collaboration Established with Foundation Medicine:
Epizymeentered into a collaboration agreement with Foundation Medicine, Inc. to support patient identification and enrollment for Epizyme'songoing Phase 2 clinical trial of tazemetostat in patients with NHL. Foundation Medicine's SmartTrials™ Precision Enrollment Program and FoundationOne® Heme panel will assist in identifying a population of individuals with NHLwho harbor EZH2 mutations, which constitute specific cohorts in the Epizymetrial.
Strengthening of Epizyme Team
- The Company made two, recent key hires to prepare for the intended regulatory engagement and determination of potential registration pathways in 2017.
Pamela Strodewas appointed to the position of Vice President of Regulatory Affairs and Quality Assurance, and Ray Mankoski, M.D., Ph.D. was appointed as Vice President of Medical Affairs.
Third Quarter 2016 Financial Results and Guidance
- Cash Position: Cash, cash equivalents and marketable securities were
$263.3 millionas of September 30, 2016, as compared to $208.3 millionas of December 31, 2015.
- Revenue: Collaboration revenue was
$6.6 millionand $7.5 millionfor the three and nine months ended September 30, 2016, respectively, compared to $0.4 millionand $2.0 millionfor the three and nine months ended September 30, 2015, respectively. The increase was driven predominantly by the recognition of the $6.0 millionmilestone earned upon GlaxoSmithKline's (GSK) initiation of patient dosing in a Phase 1 clinical trial of GSK3326595, a PRMT5 inhibitor invented by Epizymeand licensed to GSK. GSK holds worldwide rights to the compound, and Epizymemay receive significant additional payments from GSK if future milestones are met for the program, plus up to double digit royalties on worldwide net sales should this product candidate progress through the clinic to commercialization.
- R&D Expenses: Research and development (R&D) expenses were
$23.9 millionand $63.1 millionfor the three and nine months ended September 30, 2016, respectively, compared to $16.8 millionand $94.4 millionfor the three and nine months ended September 30, 2015, respectively. The increase in R&D expenses for the three months ended September 30, 2016, is primarily due to the expansion of the tazemetostat clinical development program, increased spending on tazemetostat preclinical activities, and increased discovery and spending on high-priority, earlier-stage programs. The period-over-period decrease from the nine months ended September 30, 2015was driven by the inclusion of the $40.0 million payment to Eisai for the reacquisition of the tazemetostat worldwide rights, excluding Japan, in R&D expenses in the first quarter of 2015. The Company expects that research and development expenses will continue to increase in the fourth quarter of 2016.
- G&A Expenses: General and administrative (G&A) expenses were
$7.5 millionand $20.8 millionfor the three and nine months ended September 30, 2016, respectively, as compared to $6.7 millionand $17.9 millionfor the three and nine months ended September 30, 2015, respectively. The increase is primarily due to the staffing of key leadership roles in the first half of 2016. G&A expenses were flat compared to the second quarter of 2016, and we expect G&A expenses to remain relatively constant through the fourth quarter of 2016.
- Net Loss: Net loss was
$24.3 millionand $75.2 millionfor the three and nine months ended September 30, 2016, respectively, compared to a net loss of $23.1 millionand $110.2 millionfor the three and nine months ended September 30, 2015, respectively.
- Financial Guidance:
Epizymereiterates its belief that its cash, cash equivalents and marketable securities of $263.3 millionas of September 30, 2016will be sufficient to fund the Company's planned operations into at least the second quarter of 2018.
Conference Call Information
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
Tecentriq™ is a trademark of
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
|Cash and cash equivalents||$||66,028||$||208,323|
|Total stockholders' equity||233,796||169,532|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
|Three Months Ended ||Nine Months Ended |
|Research and development||23,888||16,788||63,078||94,390|
|General and administrative||7,522||6,676||20,792||17,883|
|Total operating expenses||31,410||23,464||83,870||112,273|
|Loss from operations||(24,826||)||(23,106||)||(76,341||)||(110,268||)|
|Other income, net||490||41||1,145||118|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Julie DiCarlo, Epizyme, Inc.email@example.com (617) 401-0721 Investors Monique Allaire, THRUST IR firstname.lastname@example.org (617) 895-9511
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