First Tazemetostat NDA Submission for Epithelioid Sarcoma Targeted for Fourth Quarter of 2018; Second Tazemetostat NDA Submission for Follicular Lymphoma Targeted for 2019
Multiple Phase 2 Study Data Readouts Planned in 2018
Conference Call to be Held Today at 8:30 a.m. ET
CAMBRIDGE, Mass., March 13, 2018 (GLOBE NEWSWIRE) -- Epizyme, Inc. (NASDAQ: EPZM) today reported key pipeline progress and 2018 milestones, as well as operating results for the quarter and year ended December 31, 2017.
“2017 was truly a transformational year for Epizyme as we moved several steps closer to bringing tazemetostat to patients with both solid tumors and hematological malignancies,” said Robert Bazemore, president and chief executive officer of Epizyme. “These efforts have positioned Epizyme for one of the most milestone-rich years in the company’s history. We plan to submit our first NDA for tazemetostat for the treatment of patients with epithelioid sarcoma in the fourth quarter and are targeting a second NDA submission for the treatment of follicular lymphoma in 2019. We plan to present updated data from both of these programs this year, as well as from our studies in mesothelioma, diffuse large B-cell lymphoma, and other adult INI1-negative tumors. In addition, Epizyme will be readying its next product candidate, EZM8266, for the clinic. I am proud of our team’s many accomplishments and am confident in our ability to continue building momentum as we transition into a fully-integrated, commercial organization.”
Pipeline Progress in Recent Months
Key 2018 Milestones
Fourth Quarter and Full Year 2017 Financial Results
Financial Guidance
Epizyme continues to expect that its existing cash, cash equivalents and marketable securities as of December 31, 2017 will be sufficient to fund its planned operations into the third quarter of 2019.
Conference Call Reminder
Management will host a conference call and webcast today at 8:30 a.m. ET to discuss the company’s fourth quarter and full year 2017 financial results and other business highlights. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 7299537. A live webcast will be available in the investor section of the company’s website at http://www.epizyme.com. The webcast also will be archived on the website for 60 days.
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 certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); mesothelioma; and combination studies in DLBCL and NSCLC.
About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases 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 in relapsed and front-line disease. The company is also developing a novel G9a program and its next development candidate, EZM8266, is targeting sickle cell disease. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. For more information, visit www.epizyme.com.
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-K 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. | ||||||
CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) | ||||||
(Amounts in thousands) | ||||||
December 31, 2017 | December 31, 2016 | |||||
Cash, cash equivalents, and marketable securities | $ | 276,439 | $ | 242,192 | ||
Total assets | 289,359 | 252,441 | ||||
Deferred revenue, net of current portion | 28,809 | 28,809 | ||||
Total stockholders’ equity | 235,371 | 201,700 | ||||
EPIZYME, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands except per share data) | ||||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Collaboration revenue | $ | - | $ | 478 | $ | 10,000 | $ | 8,007 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 28,933 | 28,383 | 109,661 | 91,461 | ||||||||||||
General and administrative | 8,431 | 7,580 | 37,181 | 28,372 | ||||||||||||
Total operating expenses | 37,364 | 35,963 | 146,842 | 119,833 | ||||||||||||
Loss from operations | (37,364 | ) | (35,485 | ) | (136,842 | ) | (111,826 | ) | ||||||||
Other income, net | 862 | 469 | 2,197 | 1,614 | ||||||||||||
Loss before income taxes | (36,502 | ) | (35,016 | ) | (134,645 | ) | (110,212 | ) | ||||||||
Income tax benefit | 336 | - | 336 | - | ||||||||||||
Net loss | $ | (36,166 | ) | $ | (35,016 | ) | $ | (134,309 | ) | $ | (110,212 | ) | ||||
Loss per share allocable to common stockholders: | ||||||||||||||||
Basic | $ | (0.52 | ) | $ | (0.60 | ) | $ | (2.18 | ) | $ | (1.93 | ) | ||||
Diluted | $ | (0.52 | ) | $ | (0.60 | ) | $ | (2.18 | ) | $ | (1.93 | ) | ||||
Weighted average shares outstanding: | ||||||||||||||||
Basic | 69,287 | 58,016 | 61,471 | 57,126 | ||||||||||||
Diluted | 69,287 | 58,016 | 61,471 | 57,126 |
Contacts
Media:
Cheya Pope, Epizyme, Inc.
[email protected]
(617) 229-7561
Investors:
Jason Fredette, Epizyme, Inc.
[email protected]
(617) 500-0623
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