Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2018 Financial Results
Two Successive Tazemetostat NDA Submissions for Epithelioid Sarcoma and Follicular Lymphoma on Track for 2019
Productive FDA Meeting Supports Planned Accelerated Approval Submission for Relapsed/Refractory Follicular Lymphoma Patients with or without EZH2 Mutations
Operating Runway into Second Quarter of 2020
Conference Call to be Held Today,
“We made tremendous progress last year, leading into what is poised to
be one of our most meaningful and value-creating years as a company in
2019, with two successive NDA submissions planned for tazemetostat and a
robust clinical expansion strategy,” said
2019 Tazemetostat Program Outlook
- Tazemetostat NDA Submission for Epithelioid Sarcoma (ES) on Track
for Second Quarter:
Epizymeis well underway with its preparations to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration( FDA) for accelerated approval of tazemetostat for patients with ES in the second quarter of 2019 based on the ongoing Phase 2 study. ES is an ultra-rare and difficult-to-treat sarcoma with no specifically indicated FDA-approved therapies today. If approved, tazemetostat could be the first treatment specifically indicated for patients with ES and could enhance regulatory efficiencies of future tazemetostat submissions for additional indications. The company anticipates reporting updated data from the Phase 2 study at a medical meeting in mid-2019.
- NDA Submission Planned for Fourth Quarter for All-Comer Follicular
Lymphoma (FL) Population Based on Fully Enrolled Study: In late
Epizymemet with the FDAto review its planned registration strategy for tazemetostat for patients with FL who have been previously treated with two or more systemic therapies. Based on this interaction, the company has identified a path to a submission for accelerated approval for FL patients with EZH2 activating mutations and those with wildtype EZH2, based on the ongoing, fully enrolled Phase 2 study. The company anticipates reporting updated data from the study at a medical meeting in mid-2019 and submitting an NDA for accelerated approval for this patient population in the fourth quarter of 2019.
- Plans Established to Expand Tazemetostat into Earlier FL Treatment
Epizymeis planning to initiate a combination study in mid-2019 of tazemetostat with the chemo-free treatment regimen “R2” (Revlimid® plus Rituxan®) for the treatment of patients with relapsed/refractory FL who have received at least one prior therapy. The company is also finalizing plans for a trial of tazemetostat in combination with Rituxan for the treatment of patients with relapsed/refractory FL. Further, Epizymeis exploring the opportunity to expand the combination assessment of tazemetostat with R-CHOP into front-line, high-risk patients with FL.
- Studies in Prostate Cancer and Platinum-Resistant Solid Tumors to
Begin in 2019: Based on strong scientific rationale, as well as
research and biomarker data,
Epizymeanticipates initiating a combination study in patients with castration-resistant prostate cancer in mid-2019, followed by a combination study with a PARP inhibitor in patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer, in the second half of 2019.
- EZM8266 on Track to
Begin Clinical Development: Following the completion of IND-enabling studies, the company is on track to begin clinical development of its first-in-class G9a inhibitor, EZM8266, for the treatment of sickle cell disease in the second half of 2019 with a dose-finding and safety study.
- Two Research Programs to Be Advanced under Boehringer Ingelheim
November 2018, Epizymeentered a strategic collaboration with Boehringer Ingelheim focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. Specifically, these targets are enzymes within the helicase and histone acetyltransferase (HAT) families. The company received an upfront payment of $15 millionand will receive an additional $5 millionin research funding in 2019. Epizymeis eligible to receive a total of up to $280 millionin additional payments for research, development, regulatory and commercial milestones.
- Milestone Payment Earned from GSK: In
December 2018, Epizymeearned an $8 millionmilestone payment from its partner GlaxoSmithKline (GSK) following initiation of patient dosing in a Phase 1 clinical trial of GSK3368715, a first-in-class protein arginine methyltransferase1 (PRMT1) inhibitor discovered by Epizymeand the second program to enter the clinic under the collaboration. The company has earned an aggregate of $89 millionin up-front, research and milestone payments to date, and may earn up to an additional $375 millionfrom GSK if all remaining milestones are met.
Based on current operating plans,
Epizymeexpects its current cash runway to extend into the second quarter of 2020.
Fourth Quarter and Full Year 2018 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities
$240.3 millionas of December 31, 2018, as compared to $276.4 millionas of December 31, 2017. The decrease is primarily due to operating expenditures for the year off set by milestones received through collaborations and the company’s public offering of common stock that closed in October 2018.
- Revenue: Collaboration revenue for the fourth quarter of
$9.7 millionand $21.7 millionfor the full year ended December 31, 2018, compared to no revenue for the fourth quarter of 2017 and $10.0 millionfor the full year ended December 31, 2017. The increase in annual collaboration revenue is due to the company’s collaboration with Boehringer Ingelheim, which was initiated in November 2018, and a milestone payment earned from GSK for the initiation of clinical development of a PRMT1 inhibitor discovered at Epizyme.
- R&D Expenses: Research and development (R&D) expenses
$21.8 millionfor the fourth quarter of 2018 and $105.8 millionfor the full year ended December 31, 2018, compared to $28.9 millionfor the fourth quarter of 2017 and $109.7 millionfor the full year ended December 31, 2017. The reductions in expenses are primarily due to decreases in our discovery research expenses and decreases in clinical trial expenses, offset by greater tazemetostat manufacturing costs.
- G&A Expenses: General and administrative (G&A) expenses
$12.2 millionfor the fourth quarter of 2018 and $44.0 millionfor the full year ended December 31, 2018, compared to $8.4 millionfor the fourth quarter of 2017 and $37.2 millionfor the full year ended December 31, 2017. The increase is primarily due to an rise in medical affairs and commercial costs as a result of organizational development in preparation for tazemetostat commercialization.
- Net Loss: Net loss was
$22.9 million, or $0.29per share, for the fourth quarter of 2018 and $123.6 million, or $1.72per share, for the full year ended December 31, 2018, compared to was $36.2 million, or $0.52per share, for the fourth quarter of 2017 and $134.3 million, or $2.18per share, for the full year ended December 31, 2017.
Conference Call Information
Epizyme will host a conference call today,
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents, and marketable securities||$240,304||$276,439|
|Current portion of deferred revenue||13,300||-|
|Deferred revenue, net of current portion||3,806||28,809|
|Total stockholders’ equity||233,009||235,371|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
Three Months Ended
Twelve Months Ended
|Research and development||21,838||28,933||105,833||109,661|
|General and administrative||12,170||8,431||43,972||37,181|
|Total operating expenses||34,008||37,364||149,805||146,842|
|Loss from operations||(24,308||)||(37,364||)||(128,105||)||(136,842||)|
|Other income, net||1,420||862||4,532||2,197|
|Loss before income taxes||(22,888||)||(36,502||)||(123,573||)||(134,645||)|
|Income tax (provision) benefit||(57||)||336||(57||)||336|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Erin Graves, (617) 500-0615
Monique Allaire, (617) 895-9511
THRUST Strategic Communications