Epizyme Reports First Quarter 2017 Results and Provides Corporate Update
May 08 2017 - 7:00AM
Interim Phase 2 Data of Tazemetostat in
Molecularly Defined Solid Tumors and NHL to be Presented at
Scientific Meetings in June
Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical
company creating novel epigenetic therapies, today reported
operating results for the first quarter 2017 and reiterated
timelines for its upcoming data presentations.
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, 2017
in Chicago. The Company will host a conference call to discuss the
data on Thursday, May 18 at 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, 2017 at 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 14 at
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 Robert Bazemore, president
and chief executive officer. “We have continued to advance
tazemetostat in multiple clinical trials in a range of solid tumors
and hematological malignancies, and as both a monotherapy and in
combination with other anti-cancer agents. We look forward to
reporting interim data from our Phase 2 study in molecularly
defined solid tumors in our conference call next week and from our
Phase 2 study in relapsed or refractory FL and DLBCL in June.”
Recent Achievements
- In May 2017, the Company earned a $10 million milestone payment
from GlaxoSmithKline (GSK). The milestone payment follows GSK’s
initiation of GLP toxicology studies for a first-in-class
methyltransferase inhibitor discovered by Epizyme and licensed to
GSK.
- In 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 FDA review of drugs that may reduce development
time and costs associated with bringing a drug to market.
- In March 2017, Epizyme initiated 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.
- In January 2017, Epizyme completed 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 million as of March 31, 2017, as
compared to $242.2 million as of December 31, 2016.
- Revenue: No revenue was recognized in the
first quarter of 2017, compared to $0.5 million for the first
quarter of 2016.
- R&D Expenses: Research and development
(R&D) expenses were $24.7 million for the first quarter of
2017, compared to $17.7 million for 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.
- G&A Expenses: General and administrative
(G&A) expenses were $8.3 million for the first quarter of 2017,
compared to $5.8 million for 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 million for the
first quarter of 2017, compared to $22.9 million for the first
quarter of 2016.
2017 GuidanceEpizyme believes, based on its
current operating plan, that its cash, cash equivalents and
marketable securities of $211.2 million as of March 31, 2017 will
be sufficient to fund the Company's planned operations into at
least the third quarter of 2018.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, 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
U.S. Food and Drug Administration for the treatment of patients
with relapsed or refractory FL, either wild type EZH2 or with EZH2
activating mutations, and for relapsed or refractory DLBCL with
EZH2 activating mutations, as well as Orphan Drug designation for
malignant rhabdoid tumors.
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.
EPIZYME, INC. CONSOLIDATED
BALANCE SHEET DATA (UNAUDITED)(Amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017 |
|
|
December 31, 2016 |
|
|
|
|
Cash and cash
equivalents |
|
$ |
64,381 |
|
|
$ |
77,895 |
|
Marketable
securities |
|
|
146,774 |
|
|
|
164,297 |
|
Total assets |
|
|
223,906 |
|
|
|
252,441 |
|
Deferred revenue |
|
|
28,809 |
|
|
|
28,809 |
|
Total stockholders’
equity |
|
|
174,521 |
|
|
|
201,700 |
|
EPIZYME, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)(Amounts in thousands except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2017 |
|
|
2016 |
|
Collaboration
revenue |
|
$ |
— |
|
|
$ |
472 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
24,695 |
|
|
|
17,740 |
|
General
and administrative |
|
|
8,269 |
|
|
|
5,846 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
32,964 |
|
|
|
23,586 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(32,964 |
) |
|
|
(23,114 |
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
442 |
|
|
|
235 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(32,522 |
) |
|
$ |
(22,879 |
) |
|
|
|
|
|
|
|
|
|
Loss per share
allocable to common stockholders: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.56 |
) |
|
$ |
(0.41 |
) |
Diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.41 |
) |
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
58,219 |
|
|
|
51,149 |
|
Diluted |
|
|
58,219 |
|
|
|
51,149 |
|
Contacts:
Cheya Pope, Epizyme, Inc.
media@epizyme.com
617-229-7561
Monique Allaire, THRUST IR
monique@thrustir.com
(617) 895-9511
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