Epizyme Reports Third Quarter 2017 Operating Results and Company Updates
Company Scheduled for First FDA Interaction for Tazemetostat in
Chief Medical Officer, Dr.
Recent Financing Extends Operating Runway into at Least 3Q19
Conference Call to be Held Today at
“2017 has been a year of tremendous progress, with additional important milestones remaining this quarter, including our scheduled interaction with the
Due to the company’s transition,
Bazemore added, “Based on our planned transformation in 2018 and his passion for early-stage drug development, Peter will be transitioning from
Tazemetostat NHL Program Updates
Epizymeis on-track to hold the first interaction with the FDAin the fourth quarter of 2017 to discuss its NHLprogram, and plans to provide an update in early 2018.
- The ongoing Phase 2 study in patients with follicular lymphoma and diffuse large B-cell lymphoma continues to enroll patients with EZH2 mutations. As a result of Epizyme’s efforts to accelerate enrollment of these patients, which includes the recently initiated collaboration with
US Oncology, August and September were the highest screening months to date for the study.
Tazemetostat Solid Tumor Program Updates
- Phase 2 Mesothelioma Study: Epizyme’s ongoing Phase 2 study designed to evaluate tazemetostat as a treatment for adults with mesothelioma characterized by BAP1 loss-of-function has surpassed the futility assessment and achieved the primary endpoint of at least a 30 percent disease control rate at 12 weeks. The company expects to report data from this study in 2018. In addition, the
FDAhas granted Orphan Drug designation to tazemetostat for the treatment of patients with mesothelioma.
- Pediatric Phase 1 INI1-Negative Tumor Study: Data from the completed dose-escalation portion of Epizyme’s Phase 1 study of tazemetostat in pediatric patients with INI1-negative solid tumors were presented 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. Enrollment in the dose-expansion portion of the study is ongoing.
- Adult Phase 2 INI1-Negative Tumor Study: The malignant rhabdoid tumor cohort and other INI1-negative tumor cohort of the company’s ongoing Phase 2 study in molecularly defined solid tumors have both surpassed their futility assessment with objective responses observed in both populations.
Epizymeis continuing to enroll and monitor patients in these arms, and plans to present updated data from this study in 2018. The company has also added a separate cohort to enroll adults with chordoma, due to the high rate of enrollment of these patients in the other INI1-negative cohort and the observed clinical activity with tazemetostat in this tumor type in both adults and children so far.
Upcoming Data Presentations
- Previously announced data on adult and pediatric epithelioid sarcoma patients in the company’s ongoing INI1-negative solid tumor studies will be presented during a plenary session at the
Connective Tissue Oncology Society(CTOS) Annual Meeting at 1:00 p.m.HAST on Thursday, Nov. 9, 2017. The adult data were originally presented at the American Society of Clinical Oncology( ASCO) 2017 Annual Meeting and the pediatric data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Epizymewill introduce the next development program in its pipeline, which addresses G9a, a novel target for the potential treatment of sickle cell disease (SCD), during a plenary presentation at the 2017 American Society of Hematology(ASH) Annual Meeting at 7:30 a.m. ETon Monday, Dec. 11, 2017. This is the first of three internally discovered programs expected to enter the clinic by the end of 2020.
- New patient data from the company’s 62-gene panel biomarker study of tazemetostat in patients with
NHLwill also be presented in a poster session at the ASH Annual Meeting.
Third Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$307.2 millionas of September 30, 2017, as compared to $263.3 millionas of September 30, 2016. The increase is mainly driven by the $151.3 millionin net proceeds following the company’s underwritten public offering of 10,557,000 shares of common stock.
- Revenue: There was no revenue recognized in the third quarter of 2017, compared to
$6.6 millionfor the third quarter of 2016, as there were no collaboration milestones during the quarter.
- R&D Expenses: Research and development (R&D) expenses were
$28.7 millionfor the third quarter of 2017, compared to $23.9 millionfor the third quarter of 2016. The increase is primarily due to increased tazemetostat manufacturing activities, tazemetostat clinical development and research activities related to advancing the company’s next development program.
- G&A Expenses: General and administrative (G&A) expenses were
$9.3 millionfor the third quarter of 2017, compared to $7.5 millionfor the third quarter of 2016. The increase is primarily due to increased personnel-related expenses to support the company’s growth and pre-commercial activities.
- Net Loss: Net loss was
$37.6 millionfor the quarter ended September 30, 2017, compared to $24.3 millionfor the quarter ended September 30, 2016.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (
About Orphan Drug Designation
The FDA Orphan Drug designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
|Consolidated Balance Sheets Data :|
|Cash, cash equivalents and marketable securities||$||307,228||$||242,192|
|Total stockholders’ equity||268,189||201,700|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||28,741||23,888||80,728||63,078|
|General and administrative||9,311||7,522||28,750||20,792|
|Total operating expenses||38,052||31,410||109,478||83,870|
|Loss from operations||(38,052||)||(24,826||)||(99,478||)||(76,341||)|
|Other income, net||455||490||1,335||1,145|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
Source: Epizyme, Inc.