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Epizyme Announces Positive Pre-NDA Meeting for Tazemetostat for Follicular Lymphoma, Pipeline Updates and Third Quarter 2019 Results

October 30, 2019 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct 30, 2019--

Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced recent tazemetostat program updates, including successfully completing a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for its tazemetostat program for follicular lymphoma (FL), G9a program updates and third quarter 2019 financial results.

“We are very pleased with the outcome of our recent pre-NDA meeting and the continued alignment with FDA on our registration strategy for FL patients, regardless of their EZH2 status, who have received at least two prior systemic therapies,” said Dr. Shefali Agarwal, chief medical officer of Epizyme. “FL remains an incurable disease, and we believe strongly in the potential of tazemetostat to make a difference for these patients. We are on track to submit our FL NDA for accelerated approval in December and look forward to continuing to engage with FDA as we work to bring tazemetostat to both FL and epithelioid sarcoma patients in the U.S. next year.”

Tazemetostat Program Updates

G9a Program Update

Leadership Team Expansion

“Over the course of 2019, we’ve made significant progress building out critical functions, advancing and expanding tazemetostat development, and continuing our evolution toward becoming a commercial company,” said Robert Bazemore, president and chief executive officer of Epizyme. “I am proud of what we have achieved thus far, with much more to come in the next several months. We have multiple trials to initiate, a second NDA to submit and a first U.S. commercial launch to execute, if approved. We are thrilled to be on the cusp of delivering tazemetostat to patients and look forward to continued progress.”

Third 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.

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, an oral, 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 exploring additional molecules in its novel G9a inhibitor program. 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; 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.

Revlimid® and Rituxan® are registered trademarks of Celgene Corporation and Biogen Idec, Inc., respectively

CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)

(Amounts in thousands)

 

September 30,
2019

December 31,
2018

Consolidated Balance Sheet Data:

Cash, cash equivalents, and marketable securities

$

292,861

$

240,304

Total assets

 

334,197

 

275,501

Current portion of deferred revenue

 

1,794

 

13,300

Deferred revenue, net of current portion

 

3,806

 

3,806

Total stockholders’ equity

 

293,738

 

233,009

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)

 

Three Months Ended
September 30,

Nine Months Ended
September 30,

2019

2018

2019

2018

Collaboration revenue

$ 5,715

$ —

$ 19,506

$ 12,000

Operating expenses:

Research and development

26,579

27,027

94,382

83,994

General and administrative

17,089

11,528

44,773

31,801

Total operating expenses

43,668

38,555

139,155

115,795

Operating loss

(37,953)

(38,555)

(119,649)

(103,795)

Other income, net:

Interest income, net

1,879

1,069

5,790

3,121

Other (expense), net

(15)

(6)

(34)

(11)

Other income, net

1,864

1,063

5,756

3,110

Net loss

$ (36,089)

$ (37,492)

$ (113,893)

$ (100,685)

Other comprehensive income (loss):

Unrealized (loss) gain on available-for-sale securities

(99)

3

203

26

Comprehensive loss

$ (36,188)

$ (37,489)

$ (113,690)

$ (100,659)

 
 

Reconciliation of net loss to net loss attributable to common stockholders:

Net loss

$ (36,089)

$ (37,492)

$ (113,893)

$ (100,685)

Accretion of convertible preferred stock

(2,940)

Net loss attributable to common stockholders

$ (36,089)

$ (37,492)

$ (116,833)

$ (100,685)

Net loss per share attributable to common stockholders - basic and diluted

$ (0.40)

$ (0.54)

$ (1.33)

$ (1.45)

Weighted-average common shares outstanding used in net loss per share attributable to
common stockholders - basic and diluted

91,044

69,539

88,145

69,472

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20191030005187/en/

CONTACT: Media:

Erin Graves, (617) 500-0615

Epizyme, Inc.

media@epizyme.com

Investors:

Alicia Davis, (910) 620-3302

THRUST Strategic Communications

alicia@thrustsc.com

KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL ONCOLOGY

SOURCE: Epizyme, Inc.

Copyright Business Wire 2019.

PUB: 10/30/2019 06:30 AM/DISC: 10/30/2019 06:30 AM

http://www.businesswire.com/news/home/20191030005187/en