Epizyme Reports 2016 Financial Results and Provides 2017 Pipeline Goals
March 09 2017 - 6:32AM
Data from Tazemetostat Phase 2 Programs in NHL
and Molecularly Defined Solid Tumors Planned for Medical Meetings
in Second Quarter
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapies, today reported
financial results for the fourth quarter and full year 2016. In
addition, the Company reviewed recent highlights and provided
guidance on its clinical and research pipeline in 2017.
“2016 was a year of tremendous progress across all aspects of
Epizyme, which set the stage for 2017 to be a transformational year
for the company,” said Robert Bazemore, president and chief
executive officer of Epizyme. “We have a broad clinical development
program with tazemetostat in multiple tumor types and treatment
settings. We plan to present data from both our ongoing, global
Phase 2 studies in both molecularly defined solid tumors and
non-Hodgkin lymphoma in June, and to initiate discussions with
regulators to define registration pathways for tazemetostat. We are
advancing our ongoing monotherapy and combination studies and plan
to announce the next development candidate from our preclinical
pipeline this year. As we look ahead, we are on our way to
achieving our vision of rewriting cancer treatment through novel
epigenetic medicines.”
Recent Achievements
- Tazemetostat Combination with Prednisolone
Initiated: Epizyme has initiated clinical investigation of
tazemetostat in combination with prednisolone in
relapsed/refractory patients with DLBCL, based on observed
preclinical synergy of the agents. This combination regimen is
being conducted as the sixth cohort to the ongoing Phase 2 NHL
study. Epizyme also anticipates initiating a new combination study
in patients with follicular lymphoma in 2017.
- Enrollment Completed in Three of Five NHL Study
Cohorts: Epizyme has completed enrollment in three of the
five cohorts of its ongoing, global Phase 2 study of tazemetostat
in patients with relapsed/refractory non-Hodgkin lymphoma (NHL):
the two cohorts enrolling patients with diffuse large B-cell
lymphoma (DLBCL) with wild-type EZH2 and a third enrolling patients
with follicular lymphoma with wild-type EZH2.
- Follicular Lymphoma Enrollment Initiated in
U.S.: In January 2017, following a positive written
response from the U.S. Food and Drug Administration (FDA) to the
company’s written request, Epizyme opened enrollment to patients
with follicular lymphoma in the United States as part of the
Company’s Phase 2 study in NHL.
- Fast Track Designation Granted for DLBCL with EZH2
Mutations: In December 2016, the U.S. FDA granted Fast
Track designation to tazemetostat for the treatment of patients
with DLBCL whose tumors carry an EZH2 activating mutation. DLBCL is
the most common form of NHL. The Fast Track designation provides
expedited processes that may reduce development time and costs
associated with bringing a drug to market.
- Epithelioid Sarcoma Cohort Expanded in Phase 2 Solid
Tumor Study: In late 2016, Epizyme expanded the
epithelioid sarcoma cohort of its ongoing Phase 2 trial of
tazemetostat in adult patients with certain molecularly defined
solid tumors, following review by the Independent Data Monitoring
Committee. This expansion was based on encouraging early activity,
including confirmed objective responses, and surpassing the
pre-specified futility hurdle in the cohort. This cohort will
enroll up to 60 patients, or double the initial cohort size of 30
patients.
- Synovial Sarcoma Cohort Completed Enrollment in Phase 2
Solid Tumor Study: The synovial sarcoma cohort of the
Phase 2 trial in patients with molecularly defined solid tumors was
fully enrolled in November 2016. This arm surpassed its
pre-specified futility hurdle; however, the Company concluded that
the activity was insufficient to continue further investigation of
tazemetostat as a monotherapy. Epizyme is focusing its efforts on
the remaining four cohorts of INI1-negative tumors.
Key 2017 Milestones and Goals
- Interim Phase 2 Data Presentations Anticipated in the
Second Quarter: Epizyme plans to report efficacy, safety
and biomarker data from all five arms of the ongoing Phase 2 study
in NHL, and from the study cohorts that have reached their futility
analysis in the ongoing Phase 2 study in molecularly defined solid
tumors. Pending abstract approval, the Company plans to present
interim solid tumor data at the American Society of Clinical
Oncology (ASCO) Annual Meeting. Pending abstract submission and
approval, the Company anticipates presenting interim data from all
five arms of the ongoing Phase 2 NHL trial at The International
Conference on Malignant Lymphoma (ICML).
- Preparing for Regulatory Engagement beginning
Mid-Year: Epizyme is preparing for regulatory engagement
around its Phase 2 studies, beginning with the United States Food
and Drug Administration (FDA) in mid-2017 on its molecularly
defined solid tumor program. The Company is also preparing for FDA
engagement on its NHL program in the second half of the year. These
interactions are intended to determine registration paths for
tazemetostat in each disease area.
- Combination Studies Progressing: The
combination studies of tazemetostat in front-line DLBCL with R-CHOP
and in relapsed/refractory DLBCL with atezolizumab (Tecentriq™) are
continuing to enroll patients globally. Epizyme expects the optimal
dose of tazemetostat in these combinations will be established this
year, and for enrollment to continue to evaluate the safety and
efficacy profile of both combinations.
- Mesothelioma Study Progressing: Epizyme is
continuing to enroll patients in its global Phase 2 study of
tazemetostat in patients with mesothelioma characterized by BAP1
loss-of-function. The Company anticipates completing enrollment in
this trial in 2017.
- Next Development Candidate to be Named:
Epizyme is progressing a pipeline of next-generation small
molecules against novel epigenetic targets, and plans to name the
next epigenetic development candidate from its pipeline in 2017.
This is part of the Company’s goal of bringing three new product
candidates into the clinic by 2020.
Fourth Quarter and Full-Year 2016 Financial
Results
- Cash Position: Cash, cash equivalents and
marketable securities were $242.2 million as of December 31, 2016,
as compared to $208.3 million as of December 31, 2015.
- Revenue: Collaboration revenue was $0.5
million for the fourth quarter of 2016 and $8.0 million for the
full year ended December 31, 2016, compared to $0.6 million for the
fourth quarter of 2015 and $2.6 million for the full year ended
December 31, 2015. The year-over-year increase was driven
predominantly by the achievement of a $6.0 million milestone under
the Company’s agreement with GSK during 2016.
- R&D Expenses: Research and development
(R&D) expenses were $28.4 million for the fourth quarter of
2016 and $91.5 million for the full year ended December 31, 2016,
compared to $16.8 million for the fourth quarter of 2015 and $111.2
million for the full year ended December 31, 2015. R&D spending
on discovery research programs and tazemetostat clinical
development increased in both the quarter ended December 31, 2016
and, excluding the impact of the $40.0 million upfront payment to
Eisai in the first quarter of 2015 to acquire worldwide rights,
excluding Japan, to tazemetostat, in the year ended December 31,
2016.
- G&A Expenses: General and administrative
(G&A) expenses were $7.6 million for the fourth quarter of 2016
and $28.4 million for the full year ended December 31, 2016,
compared to $6.0 million for the fourth quarter of 2015 and $23.9
million for the full year ended December 31, 2015. The increase was
primarily due to higher compensation-related expenses associated
with expansion of the senior leadership team in the first half of
2016 to support the Company’s operational growth, as well as
increased investment in business development activities and
tazemetostat-related pre-commercial activities.
- Net Loss: Net loss was $35.0 million for the
fourth quarter of 2016 and $110.2 million for the full year ended
December 31, 2016, compared to $22.2 million for the fourth quarter
of 2015 and $132.4 million for the full year ended December 31,
2015.
2017 GuidanceEpizyme believes that its cash,
cash equivalents and marketable securities of $242.2 million as of
December 31, 2016 will be sufficient to fund the Company's planned
operations into at least the third quarter of 2018.
Conference Call Information Epizyme will host a
conference call and audio webcast today at 8:30 a.m. Eastern Time
to discuss its fourth quarter and full year 2016 financial results
and 2017 pipeline goals. To participate in the conference call,
please dial (877) 844-6886 (domestic) or (970) 315-0315
(international) and refer to conference ID 79789689. The webcast
can be accessed under "Events and Presentations" in the Investor
Relations section of the company's website at www.epizyme.com.
About Epizyme, Inc. Epizyme, Inc. is a
clinical-stage biopharmaceutical company committed to rewriting
cancer treatment through novel epigenetic medicines. Epizyme is
broadly developing its lead product candidate, tazemetostat, a
first-in-class EZH2 inhibitor, with studies underway in both solid
tumors and hematological malignancies as a monotherapy and
combination therapy and in relapsed and front-line disease. Using
the Company’s proprietary platform, Epizyme has pioneered the
identification and development of small molecule inhibitors of
histone methyltransferases and other chromatin modifying proteins
(CMPs), such as tazemetostat. CMPs are part of the system of gene
regulation, referred to as epigenetics, that controls gene
expression. Genetic alterations can result in changes to the
activity of CMPs, which can allow cancer cells to grow and
proliferate. By focusing on the genetic drivers of cancers,
Epizyme's science seeks to match targeted medicines with the
specific patients that need it. For more information, visit
www.epizyme.com and connect with us on Twitter at
@EpizymeRx.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Epizyme, Inc. and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: uncertainties inherent in the initiation of
future clinical studies and in the availability and timing of data
from ongoing clinical studies; whether interim results from a
clinical trial will be predictive of the final results of the
trial; whether results from preclinical studies or earlier clinical
studies will be predictive of the results of future trials; whether
results from clinical studies will warrant meetings with regulatory
authorities or submissions for regulatory approval; expectations
for regulatory approvals to conduct trials or to market products;
whether the Company's cash resources will be sufficient to fund the
Company's foreseeable and unforeseeable operating expenses and
capital expenditure requirements; other matters that could affect
the availability or commercial potential of the Company's
therapeutic candidates; and other factors discussed in the "Risk
Factors" section of the Company's most recent Form 10-Q filed with
the SEC and in the Company's other filings from time to time with
the SEC. In addition, the forward-looking statements included in
this press release represent the Company's views as of the date
hereof and should not be relied upon as representing the Company's
views as of any date subsequent to the date hereof. The Company
anticipates that subsequent events and developments will cause the
Company's views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do
so.
Tecentriq™ is a trademark of Genentech, Inc., (South San
Francisco, CA, USA), a member of the Roche Group.
|
EPIZYME, INC. |
CONSOLIDATED BALANCE SHEET DATA
(UNAUDITED) |
(Amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016 |
|
|
December 31, 2015 |
|
|
|
|
Cash and cash
equivalents |
|
$ |
77,895 |
|
|
$ |
208,323 |
|
Marketable
securities |
|
|
164,297 |
|
|
|
— |
|
Total assets |
|
|
252,441 |
|
|
|
217,903 |
|
Deferred revenue |
|
|
28,809 |
|
|
|
30,709 |
|
Total stockholders’
equity |
|
|
201,700 |
|
|
|
169,532 |
|
|
EPIZYME, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED) |
(Amounts in thousands except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Twelve
Months Ended December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Collaboration
revenue |
|
$ |
478 |
|
|
$ |
555 |
|
|
$ |
8,007 |
|
|
$ |
2,560 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
28,383 |
|
|
|
16,819 |
|
|
|
91,461 |
|
|
|
111,209 |
|
General
and administrative |
|
|
7,580 |
|
|
|
6,017 |
|
|
|
28,372 |
|
|
|
23,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
35,963 |
|
|
|
22,836 |
|
|
|
119,833 |
|
|
|
135,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(35,485 |
) |
|
|
(22,281 |
) |
|
|
(111,826 |
) |
|
|
(132,549 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
469 |
|
|
|
55 |
|
|
|
1,614 |
|
|
|
173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(35,016 |
) |
|
$ |
(22,226 |
) |
|
$ |
(110,212 |
) |
|
$ |
(132,376 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share
allocable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.60 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.93 |
) |
|
$ |
(3.32 |
) |
Diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.93 |
) |
|
$ |
(3.32 |
) |
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
58,016 |
|
|
|
41,725 |
|
|
|
57,126 |
|
|
|
39,839 |
|
Diluted |
|
|
58,016 |
|
|
|
41,725 |
|
|
|
57,126 |
|
|
|
39,839 |
|
Contacts:
Monique Allaire, THRUST IR
monique@thrustir.com
(617) 895-9511
Epizyme (NASDAQ:EPZM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Epizyme (NASDAQ:EPZM)
Historical Stock Chart
From Apr 2023 to Apr 2024