-
Reacquired global rights to EPZ-6438 from Eisai, gaining full
control of development, manufacturing and commercialization outside of
Japan
-
Data from ongoing Phase 1 dose escalation study of EPZ-6438 in
B-cell non-Hodgkin lymphoma (NHL) and advanced solid tumors presented
at EORTC-NCI-AACR Symposium; as of October 20, 2014 data cut-off:
-
Three of five evaluable diffuse large B-cell lymphoma (DLBCL)
patients achieved a partial response or better, including one
patient with a complete response
-
One of four evaluable follicular lymphoma patients achieved a
partial response
-
One of two evaluable INI1-deficient solid tumor patients
achieved a complete response; this patient had a malignant
rhabdoid tumor (MRT)
-
Updates on Phase 1 dose escalation patients previously reported on
at EORTC-NCI-AACR presented at Targeted Anticancer Therapies meeting
on March 3, 2015:
-
Four of 10 evaluable NHL patients remain on study in dose
escalation
-
Range of time on study for four NHL patients remaining on
study: seven months to 14 months
-
MRT patient with complete response remains on study at nearly
nine months
-
Fully enrolled 800 mg dose escalation expansion cohort (six
patients) and on track to complete enrollment in 1600 mg cohort (five
of six patients enrolled)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Epizyme,
Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company
creating novel epigenetic therapeutics for cancer patients, today
reported business highlights and operating and financial results for
2014. In addition, the Company highlighted upcoming milestones.
"We made tremendous progress in 2014 and continued our pioneering work
in epigenetic therapies. We are particularly excited by the safety
profile, tolerability and durable responses we have seen with EPZ-6438
as a monotherapy in NHL patients and an MRT patient. Based on these
impressive data in a broader patient population than originally
anticipated, we approached our partner Eisai about acquiring broader
rights to the drug," said Robert Gould, Ph.D., President and Chief
Executive Officer, Epizyme. "We believe that regaining full operational
control of EPZ-6438 outside of Japan represents a game-changing
milestone in our goal to build an independent, fully integrated oncology
company. With the opportunity to lead global development of EPZ-6438
outside of Japan, we look forward to aggressively advancing the
compound. We intend to initiate a five-arm Phase 2 study in NHL patients
in Europe in the second quarter of this year, and studies in adult and
pediatric INI1-deficient tumor patients in the second half of 2015. We
also expect to present updated data from the completed Phase 1 dose
escalation study in the middle of the year and new data from the ongoing
Phase 1 dose expansion study before the end of the year. Additionally,
we plan to provide an update on several new targets from our pipeline at
the AACR annual meeting next month and to present data from the 54 mg/m2
dose expansion cohort of the Phase 1 study of EPZ-5676 in adult acute
leukemia patients before the end of the year."
"Epizyme has made significant strides in advancing as an independent
oncology company," said Andrew Singer, Executive Vice President and
Chief Financial Officer, Epizyme. "We began 2014 with $123.6 million in
cash and cash equivalents and ended the year with $190.1 million in cash
and cash equivalents, which reflects the proceeds from our public
offering in 2014 and collaborator non-equity funding. As we move
forward, we will continue to evaluate our operating plan to ensure that
we are carefully monitoring our spend and providing for appropriate
capital to be devoted to the aggressive development of EPZ-6438."
Upcoming Milestones
EPZ-6438:
-
Updated data from the Phase 1 dose escalation study in patients with
B-cell lymphomas or advanced solid tumors to be disclosed at a medical
meeting in mid-2015
-
Data from the Phase 1 expansion cohorts to be disclosed at a medical
meeting before the end of 2015
-
Expected initiation of a five-arm Phase 2 clinical study in NHL
patients in Europe in the second quarter of 2015
-
Expected initiation of a Phase 1 clinical study in pediatric
INI1-deficient tumor patients in the second half of 2015
-
Expected initiation of a Phase 2 clinical study in adult
INI1-deficient tumor patients in the second half of 2015
-
Data expected from the first two arms of the Phase 2 NHL study in
mid-2016 (germinal center DLBCL with wild-type EZH2 and non-germinal
center DLBCL)
EPZ-5676:
-
Data from the 54 mg/m2 expansion cohort in adult acute
leukemia patients to be disclosed before the end of 2015
-
Expected completion of enrollment in Phase 1 study in pediatric acute
leukemia patients in the second half of 2015
Pipeline:
-
Presentation of discovery research on pipeline HMT targets at AACR
annual meeting in April 2015: CARM1, SETDB1, SMYD3 and PRMT6
2014 Financial Results
Collaboration Revenue: Collaboration revenue was $41.4 million in
2014, compared to $68.5 million in 2013. The decline in collaboration
revenue in 2014 reflects a decline in milestone revenue, partially
off-set by increased research and development services revenue.
R&D Expenses: Research and development expenses were $75.6
million, including non-cash expenses of $4.0 million, in 2014, compared
to $57.6 million, including non-cash expenses of $1.7 million in 2013.
The increase was largely driven by the expansion of Epizyme's product
platform and the advancement of the Company's preclinical pipeline.
Epizyme expects research and development expenses to increase
significantly in 2015 as the Company assumes responsibility for the
global development of EPZ-6438 outside of Japan.
G&A Expenses: General and administrative expenses were $20.9
million, including non-cash expenses of $3.6 million, in 2014, compared
to $14.0 million, including non-cash expenses of $1.8 million, in 2013.
The increase was largely driven by additional professional fees,
insurance and other costs associated with public company operations as
well as increased stock-based compensation expense, intellectual
property-related legal services and other costs to support Epizyme's
growing organization.
Net Loss: Net loss was $55.0 million in 2014, compared to a net
loss of $3.5 million in 2013.
Cash and Cash Equivalents: Cash and cash equivalents as of
December 31, 2014, were $190.1 million, compared to $123.6 million as of
December 31, 2013. The increase was driven by Epizyme's follow-on public
offering in February 2014, with $101 million in net proceeds, and
collaborator non-equity funding of $53.2 million in 2014. The Company
expects that these funds, together with expected research funding under
the Company's collaborations, will fund the Company through the first
quarter of 2016 prior to including any potential future milestone
payments.
Shares Outstanding: Shares outstanding as of December 31, 2014,
were 34.4 million, following the sale of 3.7 million shares of common
stock in the Company's February 2014 follow-on public offering. Weighted
average shares outstanding were 33.0 million for the year ended December
31, 2014.
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 7:30
a.m. ET to discuss full year 2014 financial results and provide a
corporate update, including the development plans for EPZ-6438. To
participate in the conference call, please dial 1-877-844-6886
(domestic) or 1-970-315-0315 (international) and refer to conference ID
1428077. 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.
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 filed with the SEC on November
6, 2014, and in our other filings from time to time with the SEC,
including our Form 10-K for the year ended December 31, 2014, that will
be filed 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.
|
|
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
|
|
(Amounts in thousands)
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
2014
|
|
2013
|
|
Cash and cash equivalents
|
|
$
|
190,095
|
|
$
|
123,564
|
|
Total assets
|
|
|
199,203
|
|
|
162,988
|
|
Deferred revenue
|
|
|
23,151
|
|
|
46,872
|
|
Stockholders' equity
|
|
|
160,282
|
|
|
104,313
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPIZYME, INC.
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
|
|
(Amounts in thousands except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
|
Year Ended December 31,
|
|
|
|
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
|
$
|
10,349
|
|
|
$
|
36,317
|
|
|
$
|
41,411
|
|
|
$
|
68,482
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
20,505
|
|
|
|
15,685
|
|
|
|
75,595
|
|
|
|
57,567
|
|
|
General and administrative
|
|
|
|
4,935
|
|
|
|
4,378
|
|
|
|
20,866
|
|
|
|
14,042
|
|
|
Total operating expenses
|
|
|
|
25,440
|
|
|
|
20,063
|
|
|
|
96,461
|
|
|
|
71,609
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations
|
|
|
|
(15,091
|
)
|
|
|
16,254
|
|
|
|
(55,050
|
)
|
|
|
(3,127
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
|
47
|
|
|
|
25
|
|
|
|
154
|
|
|
|
(7
|
)
|
|
Income tax (benefit) expense
|
|
|
|
(9
|
)
|
|
|
349
|
|
|
|
109
|
|
|
|
349
|
|
|
Net (loss) income
|
|
|
$
|
(15,035
|
)
|
|
$
|
15,930
|
|
|
$
|
(55,005
|
)
|
|
$
|
(3,483
|
)
|
|
Less: accretion of redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
to redemption value
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
264
|
|
|
Less: income allocable to participating securities
|
|
|
|
-
|
|
|
|
4
|
|
|
|
-
|
|
|
|
-
|
|
|
(Loss) income allocable to common stockholders
|
|
|
$
|
(15,035
|
)
|
|
$
|
15,926
|
|
|
$
|
(55,005
|
)
|
|
$
|
(3,747
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings per share allocable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
(0.44
|
)
|
|
$
|
0.56
|
|
|
$
|
(1.67
|
)
|
|
$
|
(0.22
|
)
|
|
Diluted
|
|
|
$
|
(0.44
|
)
|
|
$
|
0.52
|
|
|
$
|
(1.67
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
34,273
|
|
|
|
28,434
|
|
|
|
33,027
|
|
|
|
17,049
|
|
|
Diluted
|
|
|
|
34,273
|
|
|
|
30,901
|
|
|
|
33,027
|
|
|
|
17,049
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investors/Media:
Epizyme, Inc.
Manisha Pai, 617-229-7560
mpai@epizyme.com
Source: Epizyme, Inc.
News Provided by Acquire Media
