Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today provided business and pipeline updates and reported first quarter 2019 financial results.
“This is an incredibly exciting time for our company, and 2019 is slated to be one of the most important years in Epizyme’s evolution,” said Robert Bazemore, president and chief executive officer of Epizyme. “Our team is on track to submit two NDAs for tazemetostat this year, first for epithelioid sarcoma in the second quarter, which, if successful, would make tazemetostat the first commercially available EZH2 inhibitor, and then a second submission for follicular lymphoma in the fourth quarter. We are preparing for multiple clinical trials starting mid-year designed to expand the utility of tazemetostat, and to initiate clinical development of our novel G9a inhibitor in the second half of 2019. In addition, we have achieved the first milestone in our partnership with Boehringer Ingelheim, which further validates our research expertise and our collaboration strategy in epigenetic target discovery and drug development. With each milestone accomplished, we are one step closer to fulfilling our mission of bringing new treatments to patients with cancer and other serious diseases.”
Tazemetostat Program Updates and Progress
Planned Tazemetostat Clinical Studies in 2019
Epizyme is planning for multiple clinical trials designed to expand the benefit of tazemetostat into earlier treatment lines in follicular lymphoma, and to explore new combinations and potential indications in both FL and solid tumors. Planned clinical trials include:
Initiation of Clinical Development of EZM8266 for Sickle Cell Disease
Business Updates
First Quarter 2019 Financial Results
Financial Guidance
Following its March financing, and based on its current operating plan, Epizyme expects its cash runway to extend into at least the first quarter of 2021.
The company will not hold a conference call in conjunction with these results.
About the Epizyme-Boehringer Ingelheim Collaboration
Epizyme and Boehringer Ingelheim established a worldwide collaboration agreement in November 2018 to develop novel epigenetic oncology therapies. Under the terms of the agreement, Boehringer Ingelheim and Epizyme will jointly research and develop a helicase program, with both parties sharing U.S. commercialization responsibilities and Boehringer Ingelheim assuming responsibility for commercialization outside the U.S. Epizyme and Boehringer Ingelheim will also share research responsibilities for a histone acetyltransferase (HAT) program, with Boehringer Ingelheim assuming responsibility for worldwide development and commercialization. Epizyme received an upfront payment of $15 million and will receive an additional $5 million in research funding in 2019, and is eligible to receive up to $280.5 million in research, development and commercialization milestones. For the helicase program, Epizyme will fund a portion of the global development costs, retain a share of U.S. profits and receive tiered royalties on ex-U.S. sales. For the HAT program, Epizyme is eligible to receive tiered royalties on worldwide sales.
About Epizyme, Inc.
Epizyme, Inc. is a late-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 also is developing a novel G9a program with its next development candidate, EZM8266, which 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 Designation and Orphan Drug Designations will provide the benefits for which tazemetostat is eligible; expectations for regulatory approvals, including accelerated approval, 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. | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) | |||||||||
(Amounts in thousands) |
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March 31, 2019 |
December 31, 2018 |
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Consolidated Balance Sheet Data: | |||||||||
Cash, cash equivalents, and marketable securities | $ | 371,146 | $ | 240,304 | |||||
Total assets | 412,722 | 275,501 | |||||||
Current portion of deferred revenue | 5,409 | 13,300 | |||||||
Deferred revenue, net of current portion | 3,806 | 3,806 | |||||||
Total stockholders’ equity | 368,353 | 233,009 | |||||||
EPIZYME, INC. | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||
(Amounts in thousands except per share data) | |||||||
Three Months Ended March 31, |
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2019 | 2018 | ||||||
Collaboration revenue | $ | 7,891 | $ | — | |||
Operating expenses: | |||||||
Research and development | 26,896 | 25,622 | |||||
General and administrative | 11,986 | 9,360 | |||||
Total operating expenses | 38,882 | 34,982 | |||||
Operating loss | (30,991) | (34,982) | |||||
Other income, net: | |||||||
Interest income, net | 1,658 | 899 | |||||
Other (expense) income, net | (6) | 18 | |||||
Other income, net | 1,652 | 917 | |||||
Net loss | $ | (29,339) | $ | (34,065) | |||
Reconciliation of net loss to net loss attributable to common stockholders: | |||||||
Net loss | $ | (29,339) | $ | (34,065) | |||
Accretion of convertible preferred stock | (2,940) | - | |||||
Net loss attributable to common stockholders | $ | (32,279) | $ | (34,065) | |||
Net loss per share attributable to common stockholders - basic and diluted | $ | (0.39) | $ | (0.49) | |||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted | 82,424 | 69,386 |
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Media:
Erin Graves, (617) 500-0615
Epizyme, Inc.
[email protected]
Investors:
Chelcie
Lister, (919) 777-3049
THRUST Strategic Communications
[email protected]