Epizyme Reports Fourth Quarter and Full Year 2017 Operating Results and 2018 Milestones
First Tazemetostat NDA Submission for Epithelioid Sarcoma Targeted for Fourth Quarter of 2018; Second Tazemetostat NDA Submission for Follicular Lymphoma Targeted for 2019
Multiple Phase 2 Study Data Readouts Planned in 2018
Conference Call to be Held Today at
“2017 was truly a transformational year for
Epizymehad a positive interaction with the FDAin the fourth quarter of 2017 regarding its registration strategy for tazemetostat for the treatment of patients with follicular lymphoma, and the company believes that it has an opportunity to submit for accelerated approval. Epizymeis targeting a New Drug Application (NDA) submission in 2019. Epizymereported that a Phase 1b/2 clinical study evaluating tazemetostat in combination with atezolizumab (TECENTRIQ®) for the treatment of metastatic non-small cell lung cancer was opened for enrollment. The study is part of MORPHEUS, Genentech's open-label, multi-center, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in solid tumors. Epizymepresented data from the completed dose-escalation portion of its Phase 1 study of tazemetostat in pediatric patients with INI1-negative solid tumors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Objective responses were observed in patients with epithelioid sarcoma (n=1), poorly differentiated chordoma (n=2) and atypical teratoid rhabdoid tumors (n=1) at dose levels ranging from 520 to 900 mg/m2 twice daily. Epizymereported that its ongoing Phase 2 study designed to evaluate tazemetostat as a treatment for adults with mesothelioma characterized by BAP1 loss-of-function surpassed the futility assessment, achieving the primary endpoint of ≥35 percent disease control rate at 12 weeks. Epizymenamed its next product candidate, EZM8266, a novel first-in-class G9a inhibitor being developed for the treatment of sickle cell disease (SCD). The company reported preclinical data at the 59th Annual Meeting & Exposition of the American Society of Hematology(ASH) demonstrating the potential of EZM8266 to treat SCD.
Key 2018 Milestones
- Submit First Tazemetostat NDA for Epithelioid Sarcoma: Following engagement with the
FDAin 2017, Epizymehas identified a path to submit for accelerated approval for tazemetostat for the treatment of patients with epithelioid sarcoma. The company completed enrollment of patients in the expansion cohort of its Phase 2 study in 2017 and plans to present updated data from all patients in the second half of 2018. These data will inform the planned NDA submission for tazemetostat for this indication in the fourth quarter of 2018. In addition, the company is preparing for a confirmatory study in epithelioid sarcoma to support its registration strategy.
- Continue Regulatory Engagement on Follicular Lymphoma Program: Following its initial interaction with the
FDAin late 2017, the company plans to continue its engagement with the Agency throughout 2018 to further refine the registration strategy for accelerated approval of tazemetostat for the treatment of follicular lymphoma. Epizymealso plans to initiate a tazemetostat combination study in follicular lymphoma in the second half of 2018, designed to support its registration strategy.
- Complete Follicular Lymphoma Patient Enrollment and Present Updated Data:
Epizymeplans to complete enrollment in the cohort of patients with relapsed or refractory follicular lymphoma with an EZH2 mutation in its ongoing Phase 2 study of tazemetostat as a monotherapy in 2018; enrollment in the cohort of patients with wild-type EZH2 was completed in early 2017. The company expects to present updated data from the ongoing study at a medical meeting in mid-to-second half of 2018.
- Complete Phase 2 DLBCL Enrollment and Present Monotherapy and Combination Data:
Epizymeplans to complete enrollment of patients with relapsed or refractory DLBCL with an EZH2 mutation in its ongoing Phase 2 study of tazemetostat as a monotherapy in 2018; enrollment of patients with wild-type EZH2 was completed in early 2017. The company expects to present updated monotherapy data and announce next steps for the program in mid-to-second half of the year. Epizymealso plans to begin reporting initial data on tazemetostat as a combination treatment for DLBCL in 2018.
- Present Mesothelioma Data and Next Development Steps: The company plans to present data from its Phase 2 study of tazemetostat in patients with relapsed or refractory mesothelioma at a medical meeting and to communicate next steps for this tumor type in mid-2018.
- Advance Clinical Studies in Adults and Children with INI1-Negative Tumors:
Epizymeis advancing its ongoing Phase 2 study of tazemetostat in adult patients with INI1-negative tumors. In the second half of 2018, the company plans to present data from cohorts that have surpassed futility, which currently includes epithelioid sarcoma, malignant rhabdoid tumor and other INI1-negative tumor cohorts. The company is also advancing its Phase 1 clinical study in pediatric patients with INI1-negative tumors and expects to complete enrollment in the dose-expansion portion of the study in 2018.
- Prepare EZM8266 for Clinical Initiation in Early 2019:
Epizymeplans to complete IND-enabling studies for EZM8266, its G9a inhibitor designed to treat patients with sickle cell disease, in 2018 and prepare for a Phase 1 study in early 2019.
Fourth Quarter and Full Year 2017 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$276.4 millionas of December 31, 2017, as compared to $242.2 millionas of December 31, 2016. The increase is primarily the result of the company’s public offering of common stock that closed in September 2017, offset by operating expenditures for the year.
- Revenue: There was no collaboration revenue for the fourth quarter of 2017 and
$10.0 millionfor the full year ended December 31, 2017, compared to $0.5 millionfor the fourth quarter of 2016 and $8.0 millionfor the full year ended December 31, 2016. The increase in annual collaboration revenue is primarily due to greater milestone contribution from the company’s agreement with GSK in 2017.
- R&D Expenses: Research and development (R&D) expenses were
$28.9 millionfor the fourth quarter of 2017 and $109.7 millionfor the full year ended December 31, 2017, compared to $28.4 millionfor the fourth quarter of 2016 and $91.5 millionfor the full year ended December 31, 2016. The increase is primarily due to higher costs for tazemetostat manufacturing and clinical trial activities in 2017.
- G&A Expenses: General and administrative (G&A) expenses were
$8.4 millionfor the fourth quarter of 2017 and $37.2 millionfor the full year ended December 31, 2017, compared to $7.6 millionfor the fourth quarter of 2016 and $28.4 millionfor the full year ended December 31, 2016. The increase is primarily due to increased consulting services and preparations for tazemetostat commercialization.
- Net Loss: Net loss 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, compared to $35.0 million, or $0.60per share, for the fourth quarter of 2016 and $110.2 million, or $1.93per share, for the full year ended December 31, 2016.
Conference Call Reminder
Management will host a conference call and webcast today at
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
|CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|Cash, cash equivalents, and marketable securities||$||276,439||$||242,192|
|Deferred revenue, net of current portion||28,809||28,809|
|Total stockholders’ equity||235,371||201,700|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
|Three Months Ended
|Twelve Months Ended
|Research and development||28,933||28,383||109,661||91,461|
|General and administrative||8,431||7,580||37,181||28,372|
|Total operating expenses||37,364||35,963||146,842||119,833|
|Loss from operations||(37,364||)||(35,485||)||(136,842||)||(111,826||)|
|Other income, net||862||469||2,197||1,614|
|Loss before income taxes||(36,502||)||(35,016||)||(134,645||)||(110,212||)|
|Income tax benefit||336||-||336||-|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Source: Epizyme, Inc.