Epizyme Reports First Quarter 2017 Results and Provides Corporate Update
Interim Phase 2 Data of Tazemetostat in Molecularly Defined Solid Tumors and NHL to be Presented at Scientific Meetings in June
Conference Call on Interim Solid Tumor Data to be Held on
Conference Call on Interim NHL Data to be Held on
Upcoming Tazemetostat Clinical Data Presentations
- Phase 2 in Molecularly Defined Solid Tumors: Interim efficacy and safety data from study cohorts in Epizyme's ongoing Phase 2
clinical trial of tazemetostat in adult patients with molecularly defined solid tumors that have reached futility assessment by the Independent Data Monitoring Committee will be reported in two poster presentations at the
American Society of Clinical Oncology(ASCO) Annual Meeting taking place June 2-6, 2017in Chicago. The Company will host a conference call to discuss the data on Thursday, May 18at 8:30 a.m. ET, after ASCO abstracts have been released.
To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 12186629. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company's website at www.epizyme.com.
- Phase 2 in Non-Hodgkin Lymphoma: Interim efficacy and safety data from all five monotherapy study cohorts in Epizyme's ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) has been selected for a plenary session on
Wednesday, June 14, 2017at 2:00 p.m. CET( 8:00 a.m. ET) at the International Conference on Malignant Lymphoma(ICML) in Lugano, Switzerland. Data from a 62-gene panel biomarker study of tazemetostat in patients with NHL will also be presented in a poster session during ICML. The Company plans to hold a conference call to discuss these clinical findings on Wednesday, June 14at 10:30 a.m. ET.
To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 15855261. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company's website at www.epizyme.com.
"Already in 2017, we have made progress in our novel epigenetic pipeline, led by tazemetostat," stated
May 2017, the Company earned a $10 millionmilestone payment from GlaxoSmithKline (GSK). The milestone payment follows GSK's initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizymeand licensed to GSK.
April 2017, the U.S. Food and Drug Administration(FDA) granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory FL, including patients whose tumors have wild type EZH2 or EZH2 activating mutations. Fast Track designation is intended to provide expedited processes for the development and FDAreview of drugs that may reduce development time and costs associated with bringing a drug to market.
March 2017, Epizymeinitiated clinical investigation of tazemetostat in combination with prednisolone in relapsed or refractory patients with DLBCL, based on observed preclinical synergy of the agents. This combination regimen is being conducted as the sixth cohort in the ongoing Phase 2 NHL study.
January 2017, Epizymecompleted enrollment of all wild type EZH2 cohorts in its ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory FL and DLBCL.
First Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$211.2 millionas of March 31, 2017, as compared to $242.2 millionas of December 31, 2016.
- Revenue: No revenue was recognized in the first quarter of 2017, compared to
$0.5 millionfor the first quarter of 2016.
- R&D Expenses: Research and development (R&D) expenses were
$24.7 millionfor the first quarter of 2017, compared to $17.7 millionfor the first quarter of 2016. The increase is primarily due to the expansion of the tazemetostat clinical program and advancement of our proprietary research pipeline.
Expenses: General and administrative (G&A) expenses were
$8.3 millionfor the first quarter of 2017, compared to $5.8 millionfor the first quarter of 2016. The increase is primarily due to higher pre-commercial, intellectual property, business development and product planning expenses.
- Net Loss: Net loss was
$32.5 millionfor the first quarter of 2017, compared to $22.9 millionfor the first quarter of 2016.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
|Cash and cash equivalents||$||64,381||$||77,895|
|Total stockholders' equity||174,521||201,700|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
|Three Months Ended |
|Research and development||24,695||17,740|
|General and administrative||8,269||5,846|
|Total operating expenses||32,964||23,586|
|Other income, net||442||235|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Cheya Pope, Epizyme, Inc.email@example.com 617-229-7561 Monique Allaire, THRUST IR firstname.lastname@example.org (617) 895-9511
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