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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Epizyme Inc | NASDAQ:EPZM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.47 | 1.61 | 1.40 | 0 | 01:00:00 |
Interim Phase 2 Data of Tazemetostat in Molecularly Defined Solid Tumors and NHL to be Presented at Scientific Meetings in June
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 GuidanceEpizyme 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 ProgramTazemetostat, 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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