Epizyme, Inc.
Aug 4, 2017

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
Tumor Types

Conference Call to be Held Today at 8:00 a.m. ET

CAMBRIDGE, Mass., Aug. 04, 2017 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today reported operating results for the second quarter 2017 and highlighted recent business and clinical progress.

"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 Robert Bazemore, president and chief executive officer of Epizyme. "In addition, we have continued to pursue avenues to accelerate patient enrollment in our studies, including the recently established collaboration with US Oncology Research to support recruitment for our NHL study. We are also pleased to have reached key milestones in our solid tumor program, including completing enrollment in both our Phase 2 mesothelioma study and the epithelioid sarcoma cohort in our Phase 2 INI1-negative solid tumor study, and establishing the recommended dose in our Phase 1 study in children. We believe we have a significant opportunity with tazemetostat in hematological malignancies and solid tumors, and look forward to further evaluating its monotherapy and combination potential and engaging with FDA for our NHL program in the second half of the year."

Tazemetostat Clinical Program Updates

Recent Business Highlights

             
Upcoming 2017 Milestones

Second Quarter 2017 Financial Results

2017 Financial Guidance
Epizyme believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of $193.0 million as of June 30, 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 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 U.S. Food and Drug Administration for FL regardless of EZH2 mutation status and for DLBCL with EZH2-activating mutations, as well as Orphan Drug designation for soft tissue sarcoma and 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 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.

TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; whether fast track and orphan drug designations will provide the benefits for which tazemetostat is eligible; 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) 
  
  June 30,
2017
  December 31,
2016
 
  (In thousands) 
Consolidated Balance Sheets Data :        
Cash, cash equivalents and marketable securities $ 193,004  $ 242,192 
Total assets  205,310   252,441 
Deferred revenue   28,809   28,809 
Total stockholders' equity  150,040   201,700 



EPIZYME, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
 
                 
  Three Months Ended June 30,  Six Months Ended June 30, 
  2017  2016  2017  2016 
Collaboration revenue $10,000  $473  $10,000  $945 
Operating expenses:                
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 
Net loss $(28,024) $(27,981) $(60,546) $(50,860)
Loss per share allocable to common stockholders:                
Basic $(0.48) $(0.49) $(1.04) $ (0.90)
Diluted $(0.48) $(0.49) $(1.04) $ (0.90)
Weighted average shares outstanding:                
Basic  58,377   57,352   58,298    56,250 
Diluted  58,377   57,352   58,298   56,250 

 

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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