Epizyme Announces First Quarter 2016 Financial Results and Provides Update on Execution Against Multi-Year Company Vision
Presentation of early safety and efficacy data from the tazemetostat phase 2 non-Hodgkin lymphoma study planned for ASH Meeting on Lymphoma Biology
Conference call to be held today at
"We have made significant progress in our clinical development program
for tazemetostat and all four areas of our multi-year vision," said
Accelerate Tazemetostat Program in Non-Hodgkin Lymphoma and Solid Tumors
Epizymehas submitted an abstract to present a study update from its phase 2 program in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) at the 2016 American Society of Hematology(ASH) Meeting on Lymphoma Biology in June. This presentation will include a progress update on the study enrollment, safety experience for all patients enrolled and an early look at clinical activity in the patient populations that have surpassed their futility hurdle as confirmed by the Independent Data Monitoring Committee (IDMC). The three arms confirmed to have surpassed the futility hurdle are: germinal center diffuse large B-cell lymphoma (DLBCL) with an EZH2 mutation; germinal center DLBCL with wild-type EZH2; and non-germinal center DLBCL. Futility in each of the DLBCL arms is based on observing at least one objective response in the first ten patients enrolled. Responses have been observed in the two arms enrolling patients with follicular lymphoma; however, neither arm has yet reached its futility hurdle, which is at least two objective responses out of the first ten patients enrolled.
IDMCrecently approved Epizyme's planned expansion of enrollment in all five arms of the phase 2 study in patients with NHL. The total population will increase to 270 patients from 150. The three arms enrolling patients with DLBCL will now enroll 60 patients each, and the two arms enrolling patients with follicular lymphoma will now enroll 45 patients each. This expansion will enable more precision around the level of activity in each patient population, which will provide guidance for determining next steps in each population and the statistical design of potential subsequent studies. Pending abstract submission and acceptance, the Company plans to present a second study update at the ASH Annual Meeting in late 2016.
Epizymerecently expanded the number of arms in the phase 2 study in adult patients with certain genetically defined solid tumor (INI1-negative tumors, SMARCA4-negative tumors or synovial sarcomas) to five arms from three due to a higher accrual of patients with certain types of INI1-negative tumors than it anticipated. The two arms enrolling patients with rhabdoid tumors and synovial sarcomas remain unchanged. A third arm will continue to enroll patients with other INI1-negative tumors, and the Company has now separated out two specific INI1-negative cohorts from the third arm. One arm will enroll patients with renal medullary carcinoma and another will enroll patients with epithelioid sarcoma. Pending abstract submission and acceptance, the Company plans to present preliminary data from the phase 2 adult solid tumor study at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in late 2016.
- The phase 1 dose-escalation and expansion study of tazemetostat in pediatric patients with certain INI1-negative tumors, including rhabdoid tumors and synovial sarcomas, is enrolling well, and the study has escalated to the second dose level.
Expand Tazemetostat Program
In May, the
U.S. Food and Drug Administration(FDA) accepted the Company's Investigational New Drug (IND) application for tazemetostat for the treatment of adult patients with mesothelioma characterized by BAP1 loss-of-function. The Company plans to initiate a phase 2 trial in patients with mesothelioma in the third quarter of 2016.
Epizymeannounced that it has entered into a collaboration agreement with the Lymphoma Academic Research Organisation(LYSARC) for the first planned combination trial of tazemetostat. LYSARC is the operational arm of the Lymphoma Study Association, a premier cooperative French lymphoma group. This phase 1b/2 study will evaluate tazemetostat administered together with R-CHOP as a front-line therapy for elderly, high-risk patients with DLBCL, and is expected to begin in mid-2016.
Data presented at the
American Association for Cancer Research(AACR) conference in April further characterized the dosing and administration of tazemetostat. The findings show that tazemetostat is only a weak inducer of CYP3A-mediated metabolism, suggesting a low potential interaction with other treatments metabolized through this pathway. Pharmacokinetic data presented at that meeting also show that tazemetostat can be dosed with or without food. These findings further guide tazemetostat development as a monotherapy and in combination regimens.
Growth Discovery Pipeline
Epizymescientists continue to advance the development of small molecule inhibitors against five targets that have been selected and prioritized for research.
Maintain Established Leadership Position
Epizymeadded strength to its leadership team with new hires: Matthew Rosas Chief Operating Officer, Susan Grafas Chief Business Officer, Jeannie Chuas Vice President of Program and Portfolio Management and Michael Boretti, Ph.D. as Vice President of Business Development.
Q1 2016 Financials Results and Guidance
Collaboration revenue was
$0.5 millionfor the quarter ended March 31, 2016, compared to $0.9 millionfor the same period last year. The period-over-period decrease reflects increased recognition of deferred revenue from upfront payments from the Celgene collaboration in the first quarter of 2016 offset by decreased recognition of deferred revenue from upfront payments and research and development revenue related to the GlaxoSmithKline collaboration compared to the first quarter of 2015 as no revenue was recognized with respect to the GSK collaboration in the first quarter of 2016.
Research and development (R&D) expenses were
$17.7 millionfor the quarter ended March 31, 2016, compared to $57.1 millionfor the first quarter of 2015. The period-over-period decrease was driven by the first quarter 2015 payment to Eisai of $40.0 millionrelated to the reacquisition of the worldwide rights, excluding Japan, to tazemetostat, and was partially offset by increased spending on the tazemetostat clinical development program. Epizymeexpects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily related to the development costs of tazemetostat, including Epizyme's trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the Company advances its wholly owned small molecule programs against five novel targets and continues the research efforts under its Celgene collaboration.
General and administrative (G&A) expenses were
$5.8 millionfor the quarter ended March 31, 2016, compared to $5.2 millionfor the same period last year. The increase in G&A expense was largely due to higher professional services costs and personnel-related expenses associated with the expansion of Epizyme's operations. Epizymeexpects that G&A spend will increase in 2016 as compared to 2015 due to increases in staffing and infrastructure to support expanded clinical trial activities, increased research investment and other expanded operational activities, including increased intellectual property costs.
Net loss was
$22.9 millionfor the quarter ended March 31, 2016, compared to a net loss of $61.3 millionfor the quarter ended March 31, 2015.
Cash and cash equivalents were
$312.7 millionas of March 31, 2016, compared with $208.3 millionas of December 31, 2015. This increase in cash was driven by the Company's January 2016financing.
Financial guidance from
Epizymestates that the Company believes its cash and cash equivalents as of March 31, 2016will be sufficient to fund the Company's planned operations through at least the end of 2017.
Conference Call Information
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Consolidated Balance Sheets Data:|
|Cash and cash equivalents||$||312,656||$||208,323|
|Total stockholders' equity||279,010||169,532|
|CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
|Three Months Ended|
|Research and development||17,740||57,051|
|General and administrative||5,846||5,237|
|Total operating expenses||23,586||62,288|
|Loss from operations||(23,114||)||(61,377||)|
|Other income, net||235||51|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
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