Epizyme, Inc.
May 8, 2017

Epizyme Reports First Quarter 2017 Results and Provides Corporate Update

Interim Phase 2 Data of Tazemetostat in Molecularly Defined Solid Tumors and NHL to be Presented at Scientific Meetings in June

Conference Call on Interim Solid Tumor Data to be Held on May 18, 2017

Conference Call on Interim NHL Data to be Held on June 14, 2017

CAMBRIDGE, Mass., May 08, 2017 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today reported operating results for the first quarter 2017 and reiterated timelines for its upcoming data presentations.

Upcoming Tazemetostat Clinical Data Presentations

"Already in 2017, we have made progress in our novel epigenetic pipeline, led by tazemetostat," stated Robert Bazemore, president and chief executive officer. "We have continued to advance tazemetostat in multiple clinical trials in a range of solid tumors and hematological malignancies, and as both a monotherapy and in combination with other anti-cancer agents. We look forward to reporting interim data from our Phase 2 study in molecularly defined solid tumors in our conference call next week and from our Phase 2 study in relapsed or refractory FL and DLBCL in June."

Recent Achievements

First Quarter 2017 Financial Results

2017 Guidance
Epizyme believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of $211.2 million as of March 31, 2017 will be sufficient to fund the Company's planned operations into at least the third quarter of 2018.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with relapsed or refractory FL, either wild type EZH2 or with EZH2 activating mutations, and for relapsed or refractory DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.

About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting cancer treatment through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies as a monotherapy and combination therapy and in relapsed and front-line disease. Using the Company's proprietary platform, Epizyme has pioneered the identification and development of small molecule inhibitors of histone methyltransferases and other chromatin modifying proteins (CMPs), such as tazemetostat. CMPs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of CMPs, which can allow cancer cells to grow and proliferate. By focusing on the genetic drivers of cancers, Epizyme's science seeks to match targeted medicines with the specific patients that need it. 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 Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; whether results from clinical studies will warrant meetings with regulatory authorities or submissions for regulatory approval; expectations for regulatory approvals to conduct trials or to market products; whether the Company's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the Company's most recent Form 10-Q filed with the SEC and in the Company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.


EPIZYME, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
         
  March 31,
2017
  December 31,
2016
 
   
Cash and cash equivalents $64,381  $77,895 
Marketable securities  146,774   164,297 
Total assets  223,906   252,441 
Deferred revenue  28,809   28,809 
Total stockholders' equity  174,521   201,700 


EPIZYME, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
 
          
  Three Months Ended 
March 31,
 
  2017  2016 
Collaboration revenue $  $472 
Operating expenses:        
Research and development  24,695   17,740 
General and administrative  8,269   5,846 
         
Total operating expenses  32,964   23,586 
         
Operating loss  (32,964)  (23,114)
         
Other income, net  442   235 
         
Net loss $(32,522) $(22,879)
         
Loss per share allocable to common stockholders:        
Basic $(0.56) $(0.41)
Diluted $(0.56) $(0.41)
Weighted average shares outstanding:        
Basic  58,219   51,149 
Diluted  58,219   51,149 

 

Contacts:

Cheya Pope, Epizyme, Inc.

media@epizyme.com

617-229-7561



Monique Allaire, THRUST IR

monique@thrustir.com

(617) 895-9511

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Source: Epizyme, Inc.

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