8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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): March 11, 2022

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, 4th Floor

Cambridge, Massachusetts

02139

(Address of Principal Executive Offices)

(Zip Code)

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

Not applicable

(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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 15, 2022, Epizyme, Inc. (the “Company”) issued a press release announcing the appointment of Jerald Korn as its Chief Operating Officer, effective upon commencement of his employment with the Company on or about March 21, 2022 (the “Commencement Date”).

Mr. Korn most recently served as Chief Operating Officer and General Counsel of Kaleido Biosciences, Inc. (“Kaleido”) from July 2021 to March 2022 after having been hired as General Counsel and Corporate Secretary in July 2019 and promoted to General Counsel and Chief Administrative Officer in January 2021. Prior to joining Kaleido, Mr. Korn served in various roles of increasing responsibility at TESARO, Inc. (“TESARO”) from April 2015 to July 2019, including General Counsel and Chief Administrative Officer, Global Chief Compliance Officer and Deputy General Counsel, and Assistant General Counsel and Compliance Officer. Prior to TESARO, Mr. Korn served in a variety of legal and compliance roles at other pharmaceutical companies, including Cubist Pharmaceuticals, Inc. from August 2013 to March 2015, Millennium Pharmaceuticals from July 2011 to August 2013 and AMAG Pharmaceuticals, Inc. from August 2008 to July 2011. Prior to AMAG Pharmaceuticals, he was an associate in the law firm of Ropes & Gray LLP. Mr. Korn holds a bachelor’s degree in economics from Harvard University and a J.D. from Boston University School of Law.

There are no arrangements or understandings between Mr. Korn and any other person, or with the Company, pursuant to which Mr. Korn was appointed to serve as an officer of the Company. Mr. Korn has no family relationships with any of the executive officers or directors of the Company, and there are no related party transactions of the kind described in Item 404(a) of Regulation S-K in which Mr. Korn was a participant.

Mr. Korn has entered into an employment offer letter with the Company (the “Offer Letter”). Under the Offer Letter, Mr. Korn’s annual base salary is $475,000 and his annual target bonus opportunity will be 40% of his annual base salary. Although Mr. Korn will be employed by the Company for a partial year in 2022, he will be eligible for the full year target bonus for 2022. Mr. Korn will also receive a one-time sign-on bonus payment of $100,000; provided, however, that in the event of Mr. Korn’s voluntary departure or resignation from the Company for any reason or the Company’s termination of Mr. Korn’s employment for cause within twelve months of the Commencement Date, Mr. Korn will repay the full amount of such sign-on bonus within thirty days after the termination of his employment with the Company. Additionally, as a material inducement to Mr. Korn’s acceptance of employment with the Company, and pursuant to Nasdaq Listing Rule 5635(c)(4), on April 1, 2022 (the “Grant Date”) Mr. Korn will be granted inducement stock options to purchase 800,000 shares of the Company’s common stock, exercisable at a price per share equal to the closing market price of the Company’s common stock on the Grant Date. The stock options will vest as to 25% of the underlying shares on the first anniversary of the Grant Date and as to an additional 2.0833% of the shares at the end of each successive month following the first anniversary of the Grant Date until the fourth anniversary of the Grant Date.

Under the Company’s Executive Severance and Change in Control Plan (the “Severance Plan”), if the Company terminates Mr. Korn’s employment without cause (as defined in the Severance Plan), prior to or more than twelve months following a change in control (as defined in the Severance Plan), he will be entitled to receive his monthly base salary and medical benefits for nine months following the date of such termination or, if the Company terminates Mr. Korn’s employment without cause or he terminates his employment for good reason (as defined in the Severance Plan) within twelve months following a change in control, he will be entitled to receive his monthly base salary and medical benefits for twelve months following the date of such termination and 100% of his target bonus, and any unvested stock options or restricted stock unit awards (or, in the case of restricted stock awards, any such awards that remain subject to repurchase by the Company) Mr. Korn may have as of his termination date shall immediately vest, in either case subject to Mr. Korn signing a severance agreement and release of claims.

The foregoing descriptions of the Offer Letter and the Severance Plan do not purport to be complete and are qualified in their entirety by reference to the Offer Letter, a copy of which will be filed with the Securities and Exchange Commission (the “SEC”) as an exhibit to the Company’s next Quarterly Report on Form 10-Q, and the Severance Plan, a copy of which was filed as Exhibit 10.11 to the Company’s Annual Report on Form 10-K filed with the SEC on February 26, 2019 and is incorporated herein by reference.

Also in connection with Mr. Korn’s appointment as Chief Operating Officer of the Company, Mr. Korn will enter into the Company’s standard form of indemnification agreement, a copy of which was filed as Exhibit 10.16 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 (File No. 333-187982) filed with the SEC on April 26, 2013 and is incorporated herein by reference. Pursuant to the terms of the indemnification agreement, the Company may be required, among other things, to indemnify Mr. Korn for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by him in any action or proceeding arising out of his service as Chief Operating Officer.

Item 7.01 Regulation FD Disclosure

On March 15, 2022, the Company issued a press release announcing Mr. Korn’s appointment as the Company’s Chief Operating Officer as well as dosing of the first patient in the Phase 3 randomized portion of SYMPHONY-1 (EZH-302), the Company’s Phase 1b/3 confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R²) compared with R²plus placebo in patients with relapsed or refractory follicular lymphoma. A copy of this press release is furnished as Exhibit 99.1 to this current report on Form 8-K.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits


99.1		Press release issued by the Company on March 15, 2022*

104		Cover Page Interactive Data File (embedded within 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: March 15, 2022	By:	/s/ Grant Bogle
		Grant Bogle
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

LOGO

Epizyme Announces Executive Appointment and Provides Tazemetostat Clinical Update

Appointment of Jerald Korn as Chief Operating Officer

First Patient Dosed in the Randomized Portion of SYMPHONY-1 (EZH-302), Epizyme’s Phase 1b/3 Confirmatory Study of Tazemetostat in Combination with R²

CAMBRIDGE, Mass., March 15, 2022 – Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, today announced a clinical update as well as the appointment of Jerald Korn as Chief Operating Officer, reporting to President and Chief Executive Officer, Grant Bogle.

“We are excited to welcome Jerald to Epizyme at a pivotal time for the organization,” said Mr. Bogle. “Jerald’s breadth of experience leading a wide range of functions and working in biotech companies at our stage of development will be a welcomed addition to our senior executive team as we look to drive growth for TAZVERIK^® (tazemetostat) as a monotherapy, as well as advance the tazemetostat clinical development program across both hematologic and solid tumor malignancies.”

“I am thrilled to be joining Epizyme at such an important time for the company,” said Mr. Korn. “I have a passion for working in the oncology space and am excited by the opportunity to help execute on the continued launch of TAZVERIK and to fulfill Epizyme’s vision of developing transformative epigenetic medicines. I look forward to working alongside this incredible team as we focus on the strategic priorities where we believe we can make a meaningful impact for people living with cancer.”

With more than 15 years in the biotech industry, Mr. Korn most recently served as the Chief Operating Officer and General Counsel at Kaleido Biosciences, where he oversaw legal, human resources, program management, quality, regulatory and other operations, as well as supporting the company with corporate strategy, including two financings, a pipeline prioritization and transition to a new laboratory and manufacturing facility. Prior to Kaleido, Mr. Korn held several leadership positions at TESARO, as well as senior positions at Cubist Pharmaceuticals, Millennium Pharmaceuticals (part of Takeda) and AMAG Pharmaceuticals. Mr. Korn began his career as an associate at the law firm Ropes & Gray and holds a bachelor’s degree with honors in economics from Harvard University and a J.D. with honors from Boston University School of Law.

SYMPHONY-1 Clinical Update

Epizyme also reported today that the first patient has been dosed in the Phase 3 portion of the SYMPHONY-1 (EZH-302) study, a confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R²) compared with R² plus placebo in patients with relapsed or refractory follicular lymphoma (R/R FL) previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have experienced progression of disease within two years.

“Dosing the first patient in the Phase 3 portion of the SYMPHONY-1 study is an important milestone for Epizyme and our clinical development of tazemetostat in R/R FL,” said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. “As we enroll patients in the Phase 3 randomized portion of the study, we plan to continue to report longer term follow-up data from the Phase 1b safety run-in portion of the study as well as data from other combination studies of tazemetostat in both hematological and solid tumor malignancies that we are conducting.”

LOGO

Epizyme previously announced the completion of the 30-day waiting period for its protocol amendment submitted to the U.S. Food and Drug Administration in December 2021 with 800 mg twice-daily as the recommended Phase 3 dose. The Company is now engaged in global start-up activities, including sites in greater China with its collaboration partner HUTCHMED. The latest results of the Phase 1b safety run-in portion of the study were presented at the American Society of Hematology (ASH) Annual Meeting in December 2021 and can be accessed here.

About TAZVERIK^® (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

•

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

•

Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.

•

Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com

About Epizyme, Inc.

Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer through novel epigenetic medicines. The Company is focused on creating medicines that are targeted at specific causes of diseases, that are orally administered, tolerable, easy to take and based on a deep understanding of the patients that may benefit from them. The Company aspires to change the standard-of-care for patients and physicians by developing medicines with fundamentally new mechanisms of action. 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: whether commercial sales of TAZVERIK for epithelioid sarcoma and follicular lymphoma in the approved indications will be successful or will increase to the levels anticipated or at all; whether the prioritization of the company’s

LOGO

development activities and cost reductions will achieve the company’s objectives or forecasted cost savings; whether tazemetostat will receive marketing approval for epithelioid sarcoma or follicular lymphoma in other jurisdictions, full approval in the United States or approval in any other indication; uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; whether results from preclinical studies or earlier clinical studies of the company’s product candidates will be predictive of the results of future trials, such as the ongoing confirmatory trials of TAZVERIK; 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 the company will receive regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company’s collaborations and licensing agreements with third parties will be successful; uncertainties as to the impact of the COVID-19 pandemic on the company’s business, results of operations and financial condition; 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 success of tazemetostat; and other factors discussed in the “Risk Factors” section of the company’s most recent Form 10-K or 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.

TAZVERIK^® is a registered trademark of Epizyme, Inc.

Revlimid + Rituximab (R²) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.

For More Information Contact:

Media: Erin Graves

media@epizyme.com

(617) 500-0615

Investors: Caitlin Stern

cstern@realchemistry.com