-
Initiated 5-arm phase 2 study of tazemetostat in NHL
-
Presenting updated data from solid tumor patients in the ongoing
phase 1 study of tazemetostat at ESMO's European Cancer Congress in
Vienna, Austria on September 26, 2015
-
As of June 30, 2015, Epizyme had cash and cash equivalents of $237
million, sufficient to fund planned operations through at least the
end of the second quarter of 2017
-
Announced appointment of Rob Bazemore as President and Chief
Executive Officer, effective September 10
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company
creating novel epigenetic therapies for cancer patients, today reported
business highlights and operating and financial results for the second
quarter of 2015.
"As we enter the third quarter of 2015, Epizyme is in a strong position.
Having regained global rights ex-Japan to tazemetostat, our lead
clinical candidate, we are actively moving the program forward and
expanding our clinical development activities," said Robert Gould,
Ph.D., President and Chief Executive Officer, Epizyme. "The company made
significant progress advancing tazemetostat during the quarter.
Importantly, we initiated the phase 2 NHL study and completed the
transition of development-related transition activities from Eisai.
Beyond tazemetostat, we look forward to working with Celgene on the
three HMT targets defined under our renewed collaboration agreement. We
are on strong financial footing and are well positioned to advance the
development of our clinical programs and platform. As we announced
yesterday, we have selected Rob Bazemore to succeed me as President and
Chief Executive Officer, positioning us for continued success into the
future."
Program Summaries
Tazemetostat (EPZ-6438):
In the second quarter of 2015, Epizyme initiated a phase 2 monotherapy
trial of its lead clinical candidate, tazemetostat, in patients with
relapsed or refractory non-Hodgkin lymphoma (NHL). This five-arm study
will enroll up to 150 patients with germinal center diffuse large B cell
lymphoma (DLBCL) or follicular lymphoma, stratified by those expressing
mutant EZH2 and those expressing wild type EZH2, as well as patients
with non-germinal center DLBCL. The initial data from this study is
expected in mid-2016.
The phase 1 study in relapsed or refractory NHL and advanced solid
tumors is ongoing, with enrollment complete in the dose escalation and
dose expansion cohorts. Enrollment in the clinical pharmacology portion
of the study is ongoing. Epizyme will present updated data from patients
with advanced solid tumors in the phase 1 study at ESMO's European
Cancer Congress in Vienna, Austria on September 26. Additional data from
patients with NHL in the phase 1 study are expected to be presented at a
medical meeting before the end of 2015. Results from the phase 1 trial
presented at the International Congress on Malignant Lymphoma on June 20
showed tazemetostat as a monotherapy produced durable objective
responses in heavily pre-treated patients with relapsed or refractory
NHL, with an acceptable safety and tolerability profile.
Epizyme intends to initiate a phase 1 clinical study in pediatric
patients with INI1-negative tumors or synovial sarcoma and a phase 2
clinical study in adult patients with INI1-negative tumors or synovial
sarcoma in the second half of 2015.
Pinometostat (EPZ-5676):
Epizyme will voluntarily cease patient enrollment into the phase 1 study
of pinometostat in adult patients with MLL-rearranged acute leukemia in
the third quarter of 2015. The decision, made together with Celgene, is
based on insufficient efficacy seen to date with monotherapy treatment
in this population. The company expects to present final study results
after all patients conclude treatment and data analyses are complete. A
separate dose-escalation study of pinometostat in pediatric patients is
ongoing and enrollment is expected to be completed in the second half of
2015.
Epizyme and Celgene plan to explore pinometostat in combination with
other agents based on encouraging preclinical data.
Celgene collaboration update
Subsequent to the second quarter, Epizyme amended and restated its
agreement with Celgene Corporation to extend the research collaboration
between the two companies for at least three additional years. Epizyme
received a $10 million upfront payment in exchange for an extension of
Celgene's option rights to individually license global rights for two
histone methyltransferase (HMT) targets and ex-US rights for a third HMT
target. Celgene may exercise its option with respect to each of the
targets at the time of the IND filing for a pre-specified license
payment. Following the completion of phase 1, if Celgene chooses to
continue its license for a specific target, it may do so by making an
additional pre-specified license payment.
Epizyme will be responsible for leading and funding development for each
target candidate through phase 1 clinical trials. Epizyme may earn total
potential milestones of up to $610 million on the three targets,
including up to $75 million in development milestones and license fees,
$365 million in regulatory milestones, and $170 million in sales
milestones. Epizyme also may earn a royalty of up to a low double-digit
percentage on worldwide net product sales relating to two of the
targets, and on ex-US annual net sales relating to the third target.
Epizyme retains global rights to the remainder of its preclinical
pipeline.
Second Quarter 2015 Financial Results
Collaboration Revenue: Collaboration revenue was $0.7 million in
the second quarter of 2015 and $1.6 million for the six months ended
June 30, 2015 compared with $9.5 million and $22.9 million in the
comparable periods of 2014. The decline in collaboration revenue
primarily reflects the completion of our research obligations under the
Eisai agreement by the end of 2014 and under the GSK agreement by
January 2015, as well as a decrease in revenue recognized under the
Celgene agreement due to the Company's satisfaction of certain of its
performance obligations under the agreement during Q4 2014.
R&D Expenses: Research and development expenses were $20.6
million for the second quarter 2015 and $77.6 million for the six months
ended June 30, 2015 compared to $17.5 million and $32.8 million for the
comparable periods of 2014. The expansion of tazemetostat clinical
trials and related EZH2 activities and the $40.0 million upfront payment
to Eisai in the first quarter of 2015 drove the increase in spending in
comparison to the three and six months ended June 30, 2014. Epizyme
expects development expenses will continue to increase in 2015 as
compared to 2014 since the Company is now solely responsible for funding
tazemetostat clinical trials and related development costs outside of
Japan.
G&A Expenses: General and administrative expenses were $6.0
million for the second quarter 2015 and $11.2 million for the six months
ended June 30, 2015 compared with $5.3 million and $10.3 million in the
comparable periods in 2014. The increase in G&A expense was largely
related to the increased infrastructure to support the expanding
clinical development program and an increase in patent filings. We
expect G&A expense to increase slightly as compared to current spending
levels for the remainder of 2015.
Net Loss: Net loss was $25.8 million in the second quarter 2015
and $87.1 million for the six months ended June 30, 2015 compared with
$13.4 million and $20.3 million in the comparable periods in 2014.
Cash and Cash Equivalents: Cash and cash equivalents as of June
30, 2015 were $236.7 million, compared with $190.1 million as of
December 31, 2014. Epizyme's follow-on public offering in March 2015
raised $117.0 million in proceeds before expenses and the exercise of
the underwriters' over-allotment option provided an additional $13.7
million in proceeds before expenses. The company received an upfront
payment of $10.0 million under the amended and restated collaboration
and license agreement with Celgene in July 2015. The company expects
that, based on its current operating plan, cash and equivalents will be
sufficient to fund its operating expenses and capital expenditure
requirements through at least the end of the second quarter of 2017
prior to including any potential license fees or future milestone
payments.
Shares Outstanding: Shares outstanding as of June 30, 2015 were
41.2 million. Weighted average shares outstanding were 41.1 million and
38.1 million for the three and six months ended June 30, 2015
respectively and 33.2 million and 32.1 million for the comparable
periods in 2014.
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 7:30
a.m. ET to discuss second quarter 2015 financial results and provide a
corporate update. To participate in the conference call, please dial
(877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to
conference ID 90027895. The live webcast can be accessed under "Events
and Presentations" in the Investor Relations section of the Company's
website at www.epizyme.com
The archived webcast will be available on the Company's website
beginning approximately two hours after the event.
About Epizyme, Inc.
Epizyme, Inc. is a clinical stage biopharmaceutical company creating
novel epigenetic therapeutics for cancer patients. Epizyme has built a
proprietary product platform that the Company uses to create small
molecule inhibitors of a 96-member class of enzymes known as histone
methyltransferases, or HMTs. HMTs 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 HMTs,
making them oncogenic (cancer-causing). By focusing on the genetic
drivers of cancers, Epizyme's targeted science seeks to match the right
medicines with the right patients.
For more information, visit www.epizyme.com
and connect with us on Twitter at @EpizymeRx.
About EZH2 in Cancer
EZH2 is a histone methyltransferase (HMT) that is increasingly
understood to play a potentially oncogenic role in a number of cancers.
These include non-Hodgkin lymphomas, INI1-negative cancers such as
malignant rhabdoid tumors, epithelioid sarcomas, synovial sarcoma, and a
range of other solid tumors.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of non-Hodgkin
lymphoma patients, patients with INI1-negative tumors or synovial
sarcoma. Tazemetostat is a first-in-class small molecule inhibitor of
EZH2 created by Epizyme using its proprietary product platform. In many
human cancers, aberrant EZH2 enzyme activity results in misregulation of
genes that control cell proliferation resulting in the rapid and
unconstrained growth of tumor cells. Tazemetostat is the WHO
International Non-Proprietary Name (INN) for compound EPZ-6438.
Tazemetostat is the second HMT inhibitor to enter human clinical
development (following Epizyme's DOT1L inhibitor, pinometostat, also
known as EPZ-5676). The phase 1 and phase 2 portions of the clinical
study of tazemetostat are ongoing, with additional data from the phase 1
portion expected to be reported later in 2015.
Additional information about this program, including clinical trial
information, may be found here: https://clinicaltrials.gov/ct2/show/NCT01897571.
About Pinometostat
Epizyme is developing pinometostat, a small molecule inhibitor of DOT1L
created with Epizyme's proprietary product platform, for the treatment
of patients with acute leukemia in which the MLL gene is rearranged due
to a chromosomal translocation (MLL-r). Due to these rearrangements,
DOT1L is misregulated, resulting in the increased expression of genes
causing leukemia. Pinometostat is the WHO International Non-Proprietary
Name (INN) for compound EPZ-5676.
Epizyme believes that pinometostat was the first HMT inhibitor to enter
human clinical development. Epizyme is currently conducting a two-stage
phase 1 study in adult MLL-r patients and in May 2014, initiated a phase
1b study of pinometostat in pediatric patients with rearrangements of
the MLL gene. Additional information about this ongoing phase 1 study
can be found here:
https://clinicaltrials.gov/ct2/show/NCT01684150.
Pinometostat has been granted orphan drug designation for the treatment
of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML)
by the Food and Drug Administration in the U.S. and by the European
Commission in Europe.
Epizyme retains all U.S. rights to pinometostat and has granted Celgene
an exclusive license to pinometostat outside of the U.S.
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 or expansion of ongoing clinical
studies, 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 or the results of future trials, expectations
for regulatory approvals, development progress of the Company's
companion diagnostics, availability of funding sufficient for 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 or companion diagnostics and other factors discussed in the
"Risk Factors" section of our Form 10-Q most recently filed with the
SEC, and in our 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. 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. These
forward-looking statements should not be relied upon as representing the
Company's views as of any date subsequent to the date hereof.
|
|
|
|
|
|
|
|
|
|
|
EPIZYME, INC.
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|
|
|
(Amounts in thousands except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
|
December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
236,695
|
|
|
$
|
190,095
|
|
|
Accounts receivable
|
|
|
|
|
723
|
|
|
|
2,075
|
|
|
Property and equipment, net
|
|
|
|
|
4,856
|
|
|
|
3,620
|
|
|
Other assets
|
|
|
|
|
2,720
|
|
|
|
3,413
|
|
|
Total Assets
|
|
|
|
$
|
244,994
|
|
|
$
|
199,203
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Accounts payable, accrued expenses, and other liabilities
|
|
|
|
|
12914
|
|
|
|
15770
|
|
|
Capital lease obligations
|
|
|
|
|
1551
|
|
|
|
|
|
Deferred revenue
|
|
|
|
|
21623
|
|
|
|
23151
|
|
|
Total stockholder's equity
|
|
|
|
|
208906
|
|
|
|
160282
|
|
|
Total Liabilities and Stockholders' Equity
|
|
|
|
$
|
244,994
|
|
|
$
|
199,203
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPIZYME, INC.
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
|
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
|
|
$
|
736
|
|
|
|
$
|
9,494
|
|
|
|
$
|
1,647
|
|
|
|
$
|
22,885
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
20,551
|
|
|
|
|
17,499
|
|
|
|
|
77,602
|
|
|
|
|
32,846
|
|
|
|
|
General and administrative
|
|
|
|
|
5,970
|
|
|
|
|
5,306
|
|
|
|
|
11,207
|
|
|
|
|
10,262
|
|
|
|
Total operating expenses
|
|
|
|
|
26,521
|
|
|
|
|
22,805
|
|
|
|
|
88,809
|
|
|
|
|
43,108
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(25,785
|
)
|
|
|
|
(13,311
|
)
|
|
|
|
(87,162
|
)
|
|
|
|
(20,223
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
|
|
26
|
|
|
|
|
38
|
|
|
|
|
77
|
|
|
|
|
66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
|
|
(25,759
|
)
|
|
|
|
(13,273
|
)
|
|
|
|
(87,085
|
)
|
|
|
|
(20,157
|
)
|
|
|
Income tax expense
|
|
|
|
|
-
|
|
|
|
|
113
|
|
|
|
|
-
|
|
|
|
|
113
|
|
|
|
Net loss
|
|
|
|
|
$
|
(25,759
|
)
|
|
|
$
|
(13,386
|
)
|
|
|
$
|
(87,085
|
)
|
|
|
$
|
(20,270
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share allocable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted
|
|
|
|
$
|
(0.63
|
)
|
|
|
$
|
(0.40
|
)
|
|
|
$
|
(2.29
|
)
|
|
|
$
|
(0.63
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted
|
|
|
|
|
41,087
|
|
|
|
|
33,156
|
|
|
|
|
38,056
|
|
|
|
|
32,064
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20150806005475/en/
Media/Investors:
Epizyme, Inc.
Andrew Singer,
617-500-0712
Executive Vice President and Chief Financial Officer
asinger@epizyme.com
Source: Epizyme, Inc.
News Provided by Acquire Media