-
Initial data from ongoing Phase 1 study of EPZ-6438 support
expanded Phase 2 study in EZH2 mutant and wild type non-Hodgkin
lymphoma (NHL), to initiate in 1Q15: More complete, updated dose
escalation data to be featured in late-breaking oral presentation at
EORTC-NCI-AACR Symposium on November 20th
-
EPZ-6438 Phase 1 trial for pediatric patients with INI1-deficient
tumors expected to initiate in 1H15 and Phase 2 trial for adult
patients with INI1-deficient tumors expected to initiate in 2015
-
Preliminary results from Phase 1 study of EPZ-5676 to be published
online today in ASH Annual Meeting abstract, and updated results to be
presented at ASH Annual Meeting on December 8th
-
Drug was generally safe and well tolerated
-
Two patients achieved complete responses, additional biological
activity was observed in several patients
-
Received Notice of Allowance of U.S. Patent Application 14/070,675
with claims covering methods of treatment of lymphoma with a variety
of EZH2 inhibitors, and Notice of Allowance of U.S. Patent Application
13/230,703 with claims covering the use of EZH2 inhibitors for
treatment of patients carrying the most common EZH2 oncogenic mutations
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Epizyme,
Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company
creating innovative personalized therapeutics for patients with
genetically defined cancers, today announced third quarter 2014
operating and financial results and confirmed 2014 guidance.
"We have made excellent clinical progress over the past quarter, with
readouts from both of our Phase 1 studies coming during the next five
weeks. For our EZH2 inhibitor EPZ-6438, in August we announced early
clinical observations from the ongoing Phase 1 study showing two
objective responses among NHL patients enrolled in the first three
cohorts of the Phase 1 study. We will present more complete, updated
results from the dose escalation study in a late-breaking oral
presentation at the EORTC-NCI-AACR Symposium on November 20th.
We intend to initiate a Phase 2 study in NHL, as well as a Phase 1 study
in pediatric INI1-deficient tumors and a Phase 2 in adult INI1-deficient
tumors, all in 2015," said Robert Gould, Ph.D., President and Chief
Executive Officer, Epizyme. "For our DOT1L inhibitor EPZ-5676,
preliminary data from the Phase 1 study will be published online in an
ASH Annual Meeting abstract this morning, with updated data to be
presented at the meeting on December 8th. EPZ-5676 appeared
to be safe and well tolerated, with two patients in the fourth dosing
cohort achieving complete responses. We are reopening this dosing cohort
to gain a better understanding of the activity of EPZ-5676. "
"Epizyme is well-positioned to continue moving its clinical programs and
pipeline forward to create value for our shareholders by bringing
innovative new therapeutics to patients in need," said Dr. Gould. "We
began 2014 with $157.2 million in cash, cash equivalents and accounts
receivable and ended the third quarter of 2014 with $213.8 million in
cash, cash equivalents and accounts receivable. This cash position
reflects our successful follow-on offering in February 2014 and
collaborator non-equity funding. We anticipate ending 2014 with more
than $170 million in cash and cash equivalents. We expect that these
funds, together with the research funding we expect to receive under our
collaborations, will fund the Company until at least mid-2016, prior to
including any potential future milestone payments."
Upcoming Clinical Milestones
EPZ-6438:
-
Updated data from the Phase 1 dose escalation study in patients with
advanced solid tumors or B-cell lymphomas to be disclosed in
late-breaking oral presentation at EORTC-NCI-AACR Symposium on
November 20th
-
Expected initiation of Phase 2 clinical study in NHL patients, both
EZH2 mutant and wild type, in first quarter of 2015
-
Expected initiation of Phase 1 POC clinical study in pediatric
INI1-deficient tumors in first half of 2015
-
Expected initiation of Phase 2 clinical study in adult INI1-deficient
tumors in 2015
EPZ-5676:
-
Preliminary data from ongoing Phase 1 clinical study in MLL-r and
MLL-PTD adult patients, as of July 15th abstract data
cut-off, to be published on ASH website today; updated data to be
presented at ASH Annual Meeting on December 8th
-
Poster on PK modeling from Phase 1 POC clinical study in MLL-r
pediatric patients to be presented at ASH Annual Meeting on December 8th
Pipeline:
-
Pre-clinical data on first-in-class PRMT5 inhibitor in mantle cell
lymphoma models to be presented at ASH Annual Meeting on December 8th
Third Quarter 2014 Financial Results and 2014
Guidance
Collaboration Revenue: Collaboration revenue was $8.2 million for
the third quarter 2014 and $31.1 million for the nine months ended
September 30, 2014, compared to $8.4 million and $32.2 million in the
comparable periods in 2013. Collaboration revenue includes amounts
recognized from deferred revenue from payments received in previous
periods as well as payments earned during the period.
R&D Expenses: Research and development expenses were $22.2
million, including non-cash expenses of $0.9 million, for the third
quarter 2014 and $55.1 million, including non-cash expenses of $2.7
million, for the nine months ended September 30, 2014, compared to $14.6
million, including non-cash expenses of $0.4 million, and $41.9 million,
including non-cash expenses of $1.0 million, in the comparable periods
in 2013. The increase was largely driven by the expansion of Epizyme's
product platform and the advancement of the Company's EPZ-5676 clinical
trials and related DOT1L programs. Epizyme continues to expect research
and development expenses in 2014 to be approximately $75 million,
including non-cash expenses of approximately $3 million.
G&A Expenses: General and administrative expenses were $5.7
million, including non-cash expenses of $0.9 million, for the third
quarter 2014 and $15.9 million, including non-cash expenses of $2.5
million, for the nine months ended September 30, 2014, compared to $3.6
million, including non-cash expenses of $0.6 million, and $9.7 million,
including non-cash expenses of $1.3 million, in the comparable periods
in 2013. The increase was largely driven by incremental expenses to
support public company operations and the Company's growing
organization. Epizyme continues to expect general and administrative
expenses in 2014 to be approximately $20 million, including non-cash
expenses of approximately $3.5 million.
Net Loss: Net loss was $19.7 million for the third quarter 2014
and $40.0 million for the nine months ended September 30, 2014, compared
to net losses of $9.7 million and $19.4 million in the comparable
periods in 2013.
Cash, Cash Equivalents and Accounts Receivable: Cash, cash
equivalents and accounts receivable as of September 30, 2014, were
$213.8 million, compared to $157.2 million as of December 31, 2013. The
increase was driven by Epizyme's successful follow-on public offering in
February 2014, with $101 million in net proceeds, and collaborator
non-equity funding of $20 million in the nine months ended September 30,
2014. Epizyme expects to end 2014 with more than $170 million in cash
and cash equivalents. The Company expects that these funds, together
with expected research funding under the Company's collaborations, will
fund the Company until at least mid-2016 prior to including any
potential future milestone payments.
Shares Outstanding: Shares outstanding as of September 30, 2014,
were 34.1 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 33.7 million for the third quarter 2014
and 32.6 million for the nine months ended September 30, 2014.
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 8:00
a.m. ET to discuss third quarter 2014 financial results and provide a
corporate update. To participate in the conference call, please dial
1-877-844-6886 (domestic) or 1-970-315-0315 (international) and refer to
conference ID 27197386. 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
personalized therapeutics for patients with genetically defined cancers.
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 a personalized
approach to cancer treatment.
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., including statements about the
Company's strategy, future operations, clinical development of the
Company's therapeutic candidates, expectations regarding ongoing or
future clinical studies, expectations regarding the sufficiency of the
Company's cash balance to fund operating expenses, expectations
regarding future financial performance and future expectations and plans
and prospects for the Company 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, expectations of expanding 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 results of early
clinical studies will be indicative of the results of future studies,
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
financial performance of the Company, 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 the Company's Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on August 13, 2014. 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.
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EPIZYME, INC.
|
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CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
|
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(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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September 30,
|
|
December 31,
|
|
|
|
|
|
|
2014
|
|
2013
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
211,669
|
|
$
|
123,564
|
|
Total assets
|
|
|
|
|
|
220,753
|
|
|
162,988
|
|
Deferred revenue
|
|
|
|
|
|
33,150
|
|
|
46,872
|
|
Stockholders' equity
|
|
|
|
|
|
172,754
|
|
|
104,313
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|
|
|
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|
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|
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EPIZYME, INC.
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
|
|
(Amounts in thousands except per share data)
|
|
|
|
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|
|
|
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|
|
|
|
|
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Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
$
|
8,177
|
|
|
$
|
8,444
|
|
|
$
|
31,062
|
|
|
$
|
32,165
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
22,244
|
|
|
|
14,584
|
|
|
|
55,090
|
|
|
|
41,882
|
|
|
|
General and administrative
|
|
|
5,669
|
|
|
|
3,587
|
|
|
|
15,931
|
|
|
|
9,664
|
|
|
Total operating expenses
|
|
|
27,913
|
|
|
|
18,171
|
|
|
|
71,021
|
|
|
|
51,546
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(19,736
|
)
|
|
|
(9,727
|
)
|
|
|
(39,959
|
)
|
|
|
(19,381
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
41
|
|
|
|
23
|
|
|
|
107
|
|
|
|
(32
|
)
|
|
Income tax expense
|
|
|
5
|
|
|
|
-
|
|
|
|
118
|
|
|
|
-
|
|
|
Net loss
|
|
$
|
(19,700
|
)
|
|
$
|
(9,704
|
)
|
|
$
|
(39,970
|
)
|
|
$
|
(19,413
|
)
|
|
Less: accretion of redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
to redemption value
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
264
|
|
|
Loss allocable to common stockholders
|
|
$
|
(19,700
|
)
|
|
$
|
(9,704
|
)
|
|
$
|
(39,970
|
)
|
|
$
|
(19,677
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share allocable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.58
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(1.23
|
)
|
|
$
|
(1.49
|
)
|
|
|
Diluted
|
|
$
|
(0.58
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(1.23
|
)
|
|
$
|
(1.49
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
33,676
|
|
|
|
28,406
|
|
|
|
32,607
|
|
|
|
13,212
|
|
|
|
Diluted
|
|
|
33,676
|
|
|
|
28,406
|
|
|
|
32,607
|
|
|
|
13,212
|
|
Epizyme, Inc.
Investors/Media:
Manisha Pai, 617-229-7560
mpai@epizyme.com
Source: Epizyme, Inc.
News Provided by Acquire Media
