On January 6, 2020 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that it exercised its option to sell $50 million of its common stock to Royalty Pharma, pursuant to the terms of the companies’ recent funding agreements announced on November 4, 2019 (Press release, Epizyme, JAN 6, 2020, View Source [SID1234552704]). The company notified Royalty Pharma that it was exercising the prespecified option when the trailing average share price reached the $20 per share cap. The closing of the sale and issuance of the shares is subject to the satisfaction or waiver of customary conditions.
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Epizyme expects that this additional capital, combined with its existing cash, cash equivalents and marketable securities on December 31, 2019 of approximately $381 million (preliminary and unaudited), will further support the company’s current operating runway into 2022, which includes the planned epithelioid sarcoma and follicular lymphoma launch activities for tazemetostat, as well as other potential value-creating initiatives.
"2020 is set to be a transformational year as we complete our evolution to a commercial enterprise," said Robert Bazemore, president and chief executive officer of Epizyme. "Our top priorities this year include successfully launching tazemetostat for the first two indications upon approvals, advancing life-cycle development for tazemetostat to support its potential utility in additional treatment settings and combinations, and progressing our research efforts to expand our pipeline. With a strong balance sheet and an exceptional team in place, I am confident in our ability to execute these activities and to realize our mission of rewriting treatment for people with cancer."
Epizyme has outlined the following key milestones for 2020:
Gain U.S. Food and Drug Administration (FDA) approval for and launch tazemetostat for patients with metastatic or locally advanced epithelioid sarcoma in the U.S.;
Gain FDA approval for and launch tazemetostat for patients in the U.S. with relapsed or refractory follicular lymphoma (FL), both with and without EZH2 activating mutations, who have received at least two prior lines of systemic therapy;
Complete the safety evaluation of tazemetostat in combination with doxorubicin and advance the confirmatory trial in the front-line epithelioid sarcoma treatment setting;
Complete the safety evaluation of tazemetostat in combination with "R2" (Revlimid plus Rituximab) and advance the confirmatory trial in the second-line FL treatment setting;
Expand clinical investigation of tazemetostat in combination with R-CHOP in the front-line treatment setting for patients with FL;
Initiate the Phase 2 efficacy portion of the ongoing Phase 1b/2 clinical trial exploring tazemetostat in combination with standard-of-care treatments for chemo-naïve patients with metastatic castration-resistant prostate cancer;
Initiate clinical investigation of tazemetostat in combination with a PARP inhibitor for certain platinum-resistant solid tumors;
Support investigator-sponsored studies designed to evaluate clinical activity of tazemetostat in various combinations for multiple tumor types; and
Pursue additional development candidates for its preclinical programs.
Epizyme’s figure for cash, cash equivalents and marketable securities as of December 31, 2019 is based on preliminary unaudited information and is subject to change as the company has not yet completed its financial closing procedures and its auditors have not reviewed this information.