8-K
false 0001571498 0001571498 2019-10-30 2019-10-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported):

October 30, 2019

 

EPIZYME, INC.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

001-35945

 

26-1349956

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

     

400 Technology Square,

Cambridge, Massachusetts

 

02139

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (617) 229-5872

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

symbol

 

Name of each exchange

on which registered

Common stock, $0.0001 par value

 

EPZM

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 


Item 2.02 Results of Operations and Financial Condition

On October 30, 2019, Epizyme, Inc., a Delaware corporation (the “Company”) announced its financial results for the quarter ended September 30, 2019. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information provided under Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits
         
 

99.1

   

Press release issued by the Company on October 30, 2019*

         
 

104

   

Cover Page Interactive Data File (embedded within the Inline XBRL document)

* The exhibit shall be deemed to be furnished, and not filed.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

EPIZYME, INC.

             

Date: October 30, 2019

 

 

By:

 

/s/ Robert B. Bazemore

 

 

 

Robert B. Bazemore

 

 

 

President and Chief Executive Officer

EX-99.1

Exhibit 99.1

 

LOGO

Epizyme Announces Positive Pre-NDA Meeting for Tazemetostat for Follicular

Lymphoma, Pipeline Updates and Third Quarter 2019 Results

Pre-NDA Meeting Supports Registration Strategy for Tazemetostat for Follicular Lymphoma Patients with and without EZH2 Activating Mutations and Planned NDA Submission in December 2019

Updated Phase 2 Follicular Lymphoma Data Selected for Oral Presentation at ASH

Finalized U.S. Launch Readiness for Epithelioid Sarcoma with January 23, 2020 PDUFA Date

CAMBRIDGE, Mass., Oct. 30, 2019Epizyme, 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

 

   

Pre-NDA Meeting Supports Planned NDA Submission for FL: During a recent pre-NDA meeting, Epizyme gained alignment with the FDA that the proposed data package is sufficient to support a submission for accelerated approval of tazemetostat as a monotherapy for relapsed or refractory FL patients, both with EZH2 activating mutations and wild-type EZH2, who have received at least two prior systemic therapies. Epizyme is on track to submit the NDA for this indication in December 2019.

 

   

Mature Phase 2 Data to be Reported in Oral Presentation at ASH: Epizyme’s abstract on data from its ongoing Phase 2 trial in FL as of a June 7, 2019 data cutoff has been selected for an oral presentation on Saturday, Dec. 7 at the 2019 American Society of Hematology (ASH) Annual Meeting. Updated data, as assessed by both investigators and independent reviewers from a later data cutoff than the abstract submission, will be presented and will serve as the basis for the planned FL NDA submission.


   

Gained Alignment with FDA on Single Confirmatory Trial for FL: Epizyme gained alignment with FDA on a single confirmatory trial to support a submission for full approval. This global, randomized, adaptive trial will evaluate the combination of tazemetostat with “R2” (Revlimid® plus Rituxan®), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. Site initiation is underway and the safety run-in portion of the trial is on track to begin in the fourth quarter of 2019.

 

   

Preparing for Epithelioid Sarcoma (ES) U.S. Commercial Launch with Jan. 23, 2020 PDUFA Date: Priority Review was granted by FDA for Epizyme’s NDA for accelerated approval of tazemetostat for patients with metastatic or locally advanced ES who are not eligible for curative surgery. To support a potential early 2020 approval and launch, the company’s go-to-market strategy has been finalized. An experienced commercial and medical affairs team is now in place to expand the knowledge and awareness of ES among the treating and patient communities and ensure seamless patient access to tazemetostat, if approved.

 

   

ES Confirmatory Trial Ready to Begin in Fourth Quarter: Epizyme has begun initiating sites for its confirmatory trial to support a submission for full approval of tazemetostat for ES. This global, randomized, controlled trial will assess the combination of tazemetostat plus doxorubicin, a commonly used systemic treatment, compared with doxorubicin alone as a front-line treatment. The trial is expected to enroll approximately 150 patients, with the safety run-in portion to begin in the fourth quarter of 2019.

 

   

Combination Trial Open for Castration-Resistant Prostate Cancer (CRPC): Epizyme is conducting a Phase 1b/2 clinical trial in chemo-naïve patients with metastatic CRPC, assessing tazemetostat with enzalutamide or with abiraterone, the standard-of-care treatments for this patient population. Epizyme recently presented preclinical data at the AACR-NCI-EORTC International Conference on Molecular Targets, which demonstrated that tazemetostat in combination with an androgen signaling inhibitor (ASI) increased tumor growth inhibition more than either agent alone. Site initiation is underway and the dose-escalation Phase 1b portion of the trial is on track to begin in the fourth quarter of 2019.

G9a Program Update

 

   

Epizyme has decided to refocus its preclinical program targeting G9a on other potential development candidates and discontinue development of EZM-8266. This decision was made after a review of development path implications of a preclinical toxicology finding of EZM-8266. The company is evaluating next steps for its G9a program to develop an oral, disease-modifying approach to treating a variety of hemoglobinopathies, including sickle cell disease.

Leadership Team Expansion

 

   

Epizyme further strengthened its management team with the appointment of Mark De Rosch, Ph.D., to chief regulatory officer. Dr. De Rosch joined Epizyme from Nightstar Therapeutics, where he served as senior vice president, regulatory affairs and quality assurance, and brings more than 25 years of global regulatory strategy and operations experience, including having successfully led the regulatory strategy and marketing approval of KalydecoTM, the first disease-modifying treatment for people with cystic fibrosis when at Vertex Pharmaceuticals. Dr. De Rosch earned a B.S. in chemistry/biochemistry from the University of Wisconsin, and an M.S. and Ph.D. in inorganic chemistry from the University of California, San Diego.

 

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“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

 

   

Cash Position: Cash, cash equivalents and marketable securities were $292.9 million as of Sept. 30, 2019.

 

   

Revenue: Collaboration revenue for the third quarter of 2019 was $5.7 million, compared to no revenue for the third quarter of 2018. This collaboration revenue was earned as part of the Company’s Boehringer Ingelheim collaboration, which includes a $1.25 million quarterly installment in connection with the Company’s research activities.

 

   

R&D Expenses: Research and development (R&D) expenses were $26.6 million for the third quarter of 2019, compared to $27.0 million for the third quarter of 2018. The decrease primarily relates to decreases in clinical trial expenses and tazemetostat manufacturing costs, offset by an increase in discovery research activities related to tazemetostat in other indications.

 

   

G&A Expenses: General and administrative (G&A) expenses were $17.1 million for the third quarter of 2019, compared to $11.5 million for the third quarter of 2018. The increase is due primarily to pre-commercialization activities and staffing, as well as increased personnel related expenses.

 

   

Net Loss Attributed to Common Stockholders: Net loss attributable to common stockholders was $36.1 million, or $0.40 per share, for the third quarter of 2019, compared to $37.5 million, or $0.54 per share, for the third quarter of 2018.

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,”

 

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“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

Contacts

Media:

Media:

Erin Graves, Epizyme, Inc.

media@epizyme.com

(617) 500-0615

Investors:

Alicia Davis, THRUST Strategic Communications

alicia@thrustsc.com

(910) 620-3302

 

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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  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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