Two Successive Tazemetostat NDA Submissions for Epithelioid Sarcoma and Follicular Lymphoma on Track for 2019
Productive FDA Meeting Supports Planned Accelerated Approval Submission for Relapsed/Refractory Follicular Lymphoma Patients with or without EZH2 Mutations
Operating Runway into Second Quarter of 2020
Conference Call to be Held Today, Feb. 26 at 8:30 a.m. ET
Epizyme, Inc. (Nasdaq: EPZM), a late-stage company developing novel epigenetic therapies, today provided business and pipeline updates and reported fourth quarter and full year 2018 financial results.
“We made tremendous progress last year, leading into what is poised to be one of our most meaningful and value-creating years as a company in 2019, with two successive NDA submissions planned for tazemetostat and a robust clinical expansion strategy,” said Robert Bazemore, president and chief executive officer of Epizyme. “Following our meeting with FDA late last year, we are confident in the submission path for accelerated approval for all patients with follicular lymphoma, regardless of EZH2 mutation status, who have been previously treated with two or more therapies. We believe tazemetostat, based on its ongoing safety and efficacy data, would be well-suited to address the unmet need and treatment goals for patients with this indolent disease. Our first NDA submission for tazemetostat for epithelioid sarcoma remains on track to be submitted in the second quarter, and if successful, would make tazemetostat the first commercially available EZH2 inhibitor and the first treatment specifically indicated for epithelioid sarcoma patients. We look forward to submitting both regulatory applications so that we may bring tazemetostat to patients who need it.”
2019 Tazemetostat Program Outlook
Pipeline Progress
Financial Guidance
Fourth Quarter and Full Year 2018 Financial Results
Conference Call Information
Epizyme will host a conference
call today, Feb. 26, at 8:30 a.m. ET. To participate in the conference
call, please dial (877) 844-6886 (domestic) or (970) 315-0315
(international) and refer to conference ID 1088195. A live webcast will
be available in the investor section of the company's website at www.epizyme.com.
The webcast and slides will be archived for 60 days following the call
and presentation.
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) | |||||||
|
December 31, 2018 |
December 31, 2017 |
||||||
| Consolidated Balance Sheet Data: | |||||||
| Cash, cash equivalents, and marketable securities | $240,304 | $276,439 | |||||
| Total assets | 275,501 | 289,359 | |||||
| Current portion of deferred revenue | 13,300 | - | |||||
| Deferred revenue, net of current portion | 3,806 | 28,809 | |||||
| Total stockholders’ equity | 233,009 | 235,371 | |||||
|
EPIZYME, INC. |
|||||||||||||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) |
|||||||||||||||||||||
|
(Amounts in thousands except per share data) |
|||||||||||||||||||||
|
Three Months Ended |
Twelve Months Ended |
||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||||||||
| Collaboration revenue | $ | 9,700 | $ | - | $ | 21,700 | $ | 10,000 | |||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Research and development | 21,838 | 28,933 | 105,833 | 109,661 | |||||||||||||||||
| General and administrative | 12,170 | 8,431 | 43,972 | 37,181 | |||||||||||||||||
| Total operating expenses | 34,008 | 37,364 | 149,805 | 146,842 | |||||||||||||||||
| Loss from operations | (24,308 | ) | (37,364 | ) | (128,105 | ) | (136,842 | ) | |||||||||||||
| Other income, net | 1,420 | 862 | 4,532 | 2,197 | |||||||||||||||||
| Loss before income taxes | (22,888 | ) | (36,502 | ) | (123,573 | ) | (134,645 | ) | |||||||||||||
| Income tax (provision) benefit | (57 | ) | 336 | (57 | ) | 336 | |||||||||||||||
| Net loss | $ | (22,945 | ) | $ | (36,166 | ) | $ | (123,630 | ) | $ | (134,309 | ) | |||||||||
| Loss per share allocable to common stockholders: | |||||||||||||||||||||
| Basic | $ | (0.29 | ) | $ | (0.52 | ) | $ | (1.72 | ) | $ | (2.18 | ) | |||||||||
| Diluted | $ | (0.29 | ) | $ | (0.52 | ) | $ | (1.72 | ) | $ | (2.18 | ) | |||||||||
| Weighted average shares outstanding: | |||||||||||||||||||||
| Basic | 78,962 | 69,287 | 71,864 | 61,471 | |||||||||||||||||
| Diluted | 78,962 | 69,287 | 71,864 | 61,471 | |||||||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190226005203/en/
Media:
Erin Graves, (617) 500-0615
Epizyme, Inc.
media@epizyme.com
Investors:
Monique Allaire, (617) 895-9511
THRUST Strategic
Communications
monique@thrustsc.com