On May 6, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported business and pipeline updates and reported first quarter 2019 financial results (Press release, Epizyme, MAY 6, 2019, View Source [SID1234535736]).
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"This is an incredibly exciting time for our company, and 2019 is slated to be one of the most important years in Epizyme’s evolution," said Robert Bazemore, president and chief executive officer of Epizyme. "Our team is on track to submit two NDAs for tazemetostat this year, first for epithelioid sarcoma in the second quarter, which, if successful, would make tazemetostat the first commercially available EZH2 inhibitor, and then a second submission for follicular lymphoma in the fourth quarter. We are preparing for multiple clinical trials starting mid-year designed to expand the utility of tazemetostat, and to initiate clinical development of our novel G9a inhibitor in the second half of 2019. In addition, we have achieved the first milestone in our partnership with Boehringer Ingelheim, which further validates our research expertise and our collaboration strategy in epigenetic target discovery and drug development. With each milestone accomplished, we are one step closer to fulfilling our mission of bringing new treatments to patients with cancer and other serious diseases."
Tazemetostat Program Updates and Progress
NDA Submission for Epithelioid Sarcoma (ES) on Track for Second Quarter: Epizyme is well underway with its preparations to submit its first New Drug Application (NDA) for accelerated approval to the U.S. Food and Drug Administration (FDA) in the second quarter of 2019 for tazemetostat in patients with ES. This is an ultra-rare and difficult-to-treat sarcoma, and if approved, tazemetostat would be the first treatment specifically indicated for patients with ES. Updated data from the company’s ongoing Phase 2 trial in ES will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago; details will be disclosed at a future date.
NDA Submission for All-Comer Follicular Lymphoma (FL) Population Planned for Fourth Quarter: Epizyme plans to submit an NDA for accelerated approval of tazemetostat for patients with FL, regardless of their EZH2 mutational status, who have been previously treated with two or more systemic therapies. The ongoing Phase 2 study has completed enrollment, and the company is working toward the
submission of an NDA for accelerated approval in the fourth quarter of 2019 for this patient population. Updated data from the Phase 2 trial will be presented at a medical meeting in the second quarter of 2019. Details will be disclosed at a future date.
Planned Tazemetostat Clinical Studies in 2019
Epizyme is planning for multiple clinical trials designed to expand the benefit of tazemetostat into earlier treatment lines in follicular lymphoma, and to explore new combinations and potential indications in both FL and solid tumors. Planned clinical trials include:
a combination study of tazemetostat with the chemo-free treatment regimen "R2" (Revlimid plus Rituxan) for patients with relapsed/refractory FL who have received at least one prior therapy;
a combination study of tazemetostat with Rituxan for patients with relapsed/refractory FL;
a combination study of tazemetostat with R-CHOP for front-line patients with FL in collaboration with the Lymphoma Study Association (LYSA);
a combination study of tazemetostat with the standards-of-care for patients with castration-resistant prostate cancer; and
a combination study of tazemetostat with a PARP inhibitor for patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer.
Initiation of Clinical Development of EZM8266 for Sickle Cell Disease
Upon approval of an Investigational New Application (IND) for EZM8266 for the treatment of patients with sickle cell disease, Epizyme anticipates beginning clinical development in the second half of 2019 with a Phase 1 trial of EZM8266, a novel, first-in-class G9a inhibitor.
Business Updates
Epizyme recently earned a $5.5 million milestone payment from Boehringer Ingelheim, following the selection of a lead optimization candidate for the shared program targeting an enzyme within the helicase family. The companies are jointly researching and developing this program, with both parties sharing U.S. commercialization responsibilities and Boehringer Ingelheim assuming responsibility for commercialization outside the U.S. The companies will also share research responsibilities for a histone acetyltransferase (HAT) program that is under development.
In March of this year, Epizyme raised $172.50 million in aggregate gross proceeds, before deducting underwriting discounts and offering expenses, from two concurrent underwritten public offerings.
First Quarter 2019 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $371.1 million as of March 31, 2019, as compared to $247.9 million as of March 31, 2018.
Revenue: Collaboration revenue for the first quarter of 2019 was $7.9 million. There was no collaboration revenue recognized for the first quarter of 2018. The increase in collaboration revenue is due to the company’s collaboration with Boehringer Ingelheim, which was initiated in November 2018.
R&D Expenses: Research and development (R&D) expenses were $26.9 million for the first quarter of 2019, compared to $25.6 million for the first quarter of 2018. The increase is
primarily due to greater tazemetostat manufacturing costs and costs incurred in preparation for two NDA submissions offset by decreases in clinical trial expenses.
G&A Expenses: General and administrative (G&A) expenses were $12.0 million for the first quarter of 2019, compared to $9.4 million for the first quarter of 2018. The increase is primarily due to a rise in medical affairs and commercial costs as a result of organizational development in preparation for tazemetostat commercialization.
Net Loss Attributed to Common Stockholders: Net loss attributable to common stockholders was $32.3 million, or $0.39 per share, for the first quarter of 2019, compared to $34.1 million, or $0.49 per share, for the first quarter of 2018.
Financial Guidance
Following its March financing, and based on its current operating plan, Epizyme expects its cash runway to extend into at least the first quarter of 2021.
The company will not hold a conference call in conjunction with these results.
About the Epizyme-Boehringer Ingelheim Collaboration
Epizyme and Boehringer Ingelheim established a worldwide collaboration agreement in November 2018 to develop novel epigenetic oncology therapies. Under the terms of the agreement, Boehringer Ingelheim and Epizyme will jointly research and develop a helicase program, with both parties sharing U.S. commercialization responsibilities and Boehringer Ingelheim assuming responsibility for commercialization outside the U.S. Epizyme and Boehringer Ingelheim will also share research responsibilities for a histone acetyltransferase (HAT) program, with Boehringer Ingelheim assuming responsibility for worldwide development and commercialization. Epizyme received an upfront payment of $15 million and will receive an additional $5 million in research funding in 2019, and is eligible to receive up to $280.5 million in research, development and commercialization milestones. For the helicase program, Epizyme will fund a portion of the global development costs, retain a share of U.S. profits and receive tiered royalties on ex-U.S. sales. For the HAT program, Epizyme is eligible to receive tiered royalties on worldwide sales.