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Business Wire 9-Aug-2019 6:30 AM
Tazemetostat NDA Submission Accepted for Priority Review for Epithelioid Sarcoma
Industry Veteran Paolo Tombesi Appointed as Chief Financial Officer
Epizyme, Inc. (NASDAQ:EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today provided business and pipeline highlights and reported second quarter 2019 financial results.
"Over the course of the first half of 2019, we made tremendous progress across all aspects of Epizyme's business, and the second half of the year holds even greater opportunities as we transition to a commercial-stage company and work to achieve our Vision 2020," said Robert Bazemore, president and chief executive officer of Epizyme. "Our vision is to bring tazemetostat to both epithelioid sarcoma and follicular lymphoma patients, while also expanding its development in the future to additional tumor types and combinations, to advance research efforts to bring EZM8266 and other early programs into the clinic, and to further enhance our leadership in the field of epigenetic drug discovery and development. The milestones we have achieved so far this year, along with the anticipated clinical and regulatory catalysts over the next several months, position this to be our most significant year yet. We look forward to continuing our progress in an effort to impact the lives of as many people as we can."
Leadership Team Expansion
Tazemetostat for Epithelioid Sarcoma (ES)
Tazemetostat for Follicular Lymphoma (FL)
Tazemetostat for Additional Solid Tumors
EZM8266 for Sickle Cell Disease
Second Quarter 2019 Financial Results
Financial Guidance Based on its current operating plan, Epizyme continues to expect its cash runway to extend into the first quarter of 2021.
The company will not hold a conference call in conjunction with these results.
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 ) |
||||||||
June 30, 2019 |
December 31, 2018 |
|||||||
Consolidated Balance Sheet Data: |
||||||||
Cash, cash equivalents, and marketable securities |
$ |
330,980 |
$ |
240,304 |
||||
Total assets |
|
371,412 |
|
275,501 |
||||
Current portion of deferred revenue |
|
6,259 |
|
13,300 |
||||
Deferred revenue, net of current portion |
|
3,806 |
|
3,806 |
||||
Total stockholders' equity |
|
325,685 |
|
233,009 |
EPIZYME, INC. |
|||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) |
|||||||||||||||||
(Amounts in thousands except per share data) |
|||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|||||||||||||||
2019 |
|
2018 |
|
2019 |
|
2018 |
|||||||||||
Collaboration revenue |
$ |
5,900 |
|
$ |
12,000 |
|
$ |
13,791 |
|
$ |
12,000 |
|
|||||
Operating expenses: |
|||||||||||||||||
Research and development |
|
40,907 |
|
|
31,346 |
|
|
67,803 |
|
|
56,968 |
|
|||||
General and administrative |
|
15,698 |
|
|
10,914 |
|
|
27,684 |
|
|
20,274 |
|
|||||
Total operating expenses |
|
56,605 |
|
|
42,260 |
|
|
95,487 |
|
|
77,242 |
|
|||||
Operating loss |
|
(50,705 |
) |
|
(30,260 |
) |
|
(81,696 |
) |
|
(65,242 |
) |
|||||
Other income, net: |
|||||||||||||||||
Interest income, net |
|
2,253 |
|
|
1,143 |
|
|
3,911 |
|
|
2,042 |
|
|||||
Other (expense) income, net |
|
(13 |
) |
|
(11 |
) |
|
(19 |
) |
|
7 |
|
|||||
Other income, net |
|
2,240 |
|
|
1,132 |
|
|
3,892 |
|
|
2,049 |
|
|||||
Net loss |
$ |
(48,465 |
) |
$ |
(29,128 |
) |
$ |
(77,804 |
) |
$ |
(63,193 |
) |
|||||
Other comprehensive income (loss): |
|||||||||||||||||
Unrealized gain (loss) on available-for-sale securities |
|
216 |
|
|
46 |
|
|
302 |
|
|
23 |
|
|||||
Comprehensive loss |
$ |
(48,249 |
) |
$ |
(29,082 |
) |
$ |
(77,502 |
) |
$ |
(63,170 |
) |
|||||
Reconciliation of net loss to net loss attributable to common stockholders: |
|||||||||||||||||
Net loss |
$ |
(48,465 |
) |
$ |
(29,128 |
) |
$ |
(77,804 |
) |
$ |
(63,193 |
) |
|||||
Accretion of convertible preferred stock |
— |
— |
|
(2,940 |
) |
— |
|||||||||||
Net loss attributable to common stockholders |
$ |
(48,465 |
) |
$ |
(29,128 |
) |
$ |
(80,744 |
) |
$ |
(63,193 |
) |
|||||
Net loss per share attributable to common stockholders - basic and diluted |
$ |
(0.53 |
) |
$ |
(0.42 |
) |
$ |
(1.04 |
) |
$ |
(0.91 |
) |
|||||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted |
|
90,876 |
|
|
69,490 |
|
|
77,315 |
|
|
69,438 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190809005013/en/