-
Reacquired global rights to EPZ-6438 from Eisai, gaining full
control of development, manufacturing and commercialization outside of
Japan
-
Completed successful public offering of shares of common stock,
raising $130.7 million before expenses, including the April exercise
of the underwriters' option to purchase additional shares
-
Completed enrollment in 800 mg BID and 1600 mg BID dose expansion
cohorts in ongoing EPZ-6438 Phase 1 study
-
Updated data from the dose escalation cohorts of the ongoing Phase
1 study of EPZ-6438 to be presented at the International Conference on
Malignant Lymphoma on June 20, 2015
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 the
first quarter of 2015. In addition, the Company highlighted upcoming
milestones.
"The reacquisition of global rights to EPZ-6438 and our recent
successful follow-on offering have laid the groundwork for Epizyme's
continued growth as a pioneering company in the field of epigenetic
cancer therapies," said Robert Gould, Ph.D., President and Chief
Executive Officer, Epizyme. "We look forward to presenting updated data
from the ongoing Phase 1 study of EPZ-6438 at the International
Conference on Malignant Lymphoma in June. We expect to present
additional data from the ongoing clinical studies of EPZ-6438 and
EPZ-5676 toward the end of this year. Beyond our clinical programs, we
are very pleased with the productivity of our platform, most recently
evidenced by the presentations on four new HMT targets at the AACR
meeting earlier this month."
Anticipated Upcoming Milestones
EPZ-6438:
-
Updated data from the ongoing Phase 1 study in patients with B-cell
lymphomas or advanced solid tumors to be disclosed at the
International Conference on Malignant Lymphoma in Lugano, Switzerland
on June 20
-
Data from the Phase 1 expansion cohorts expected 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-negative or INI1-deficient tumor patients in the second half of
2015
-
Expected initiation of a Phase 2 clinical study in adult INI1-negative
or INI1-deficient tumor patients in the second half of 2015
-
Initial data expected from the Phase 2 NHL study in mid-2016
EPZ-5676:
-
Data from the 54 mg/m2/day expansion cohort in adult acute
leukemia patients expected to be disclosed before the end of 2015
-
Expected completion of enrollment in ongoing Phase 1 study in
pediatric acute leukemia patients in the second half of 2015
First Quarter 2015 Financial Results
Collaboration Revenue: Collaboration revenue was $0.9 million in
the three months ended March 31, 2015, compared to $13.4 million in the
three months ended March 31, 2014. The decline in collaboration revenue
primarily reflects the substantial completion of certain components of
the Company's research obligations under its collaborations.
R&D Expenses: Research and development expenses were $57.1
million in the three months ended March 31, 2015, including the $40.0
million upfront payment made to Eisai in connection with Company's
reacquisition of worldwide rights to its EZH2 program and non-cash
expenses of $1.6 million, compared to $15.3 million, including non-cash
expenses of $0.8 million in the three months ended March 31, 2014.
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 $5.2
million, including non-cash expenses of $1.1 million, in the three
months ended March 31, 2015, compared to $5.0 million, including
non-cash expenses of $0.8 million, in the three months ended March 31,
2014. The increase was largely driven by increased stock-based
compensation expense.
Net Loss: Net loss was $61.3 million in the three months ended
March 31, 2015, compared to a net loss of $6.9 million in the three
months ended March 31, 2014.
Cash and Cash Equivalents: Cash and cash equivalents as of March
31, 2015, were $244.5 million, compared to $190.1 million as of December
31, 2014. The increase was driven by Epizyme's follow-on public offering
in March 2015, with $117 million in proceeds before expenses, partly
offset by the $40.0 million upfront payment made to Eisai in March 2015.
The Company expects that these funds will fund the Company through at
least the end of 2016 prior to including any potential option exercise
fees or future milestone payments.
Shares Outstanding: Shares outstanding as of March 31, 2015, were
40.5 million, following the sale of 6.0 million shares of common stock
in the Company's March 2015 follow-on public offering. Weighted average
shares outstanding were 35.0 million for the three months ended March
31, 2015.
Conference Call Information
Epizyme will host a conference call and live audio webcast today at 4:30
p.m. ET to discuss first quarter 2015 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 32270626. 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-K filed with the SEC on March 12,
2015, 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.
|
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
|
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
December 31,
|
|
|
|
|
2015
|
|
|
|
2014
|
Cash and cash equivalents
|
|
|
$
|
244,504
|
|
|
|
$
|
190,095
|
Total assets
|
|
|
|
253,266
|
|
|
|
|
199,203
|
Deferred revenue
|
|
|
|
22,220
|
|
|
|
|
23,151
|
Stockholders' equity
|
|
|
|
218,372
|
|
|
|
|
160,282
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EPIZYME, INC.
|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
|
(Amounts in thousands except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
|
$
|
911
|
|
|
|
|
$
|
13,391
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
57,051
|
|
|
|
|
|
15,347
|
|
General and administrative
|
|
|
|
5,237
|
|
|
|
|
|
4,956
|
|
|
Total operating expenses
|
|
|
|
62,288
|
|
|
|
|
|
20,303
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
(61,377
|
)
|
|
|
|
|
(6,912
|
)
|
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
|
51
|
|
|
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(61,326
|
)
|
|
|
|
$
|
(6,884
|
)
|
|
|
|
|
|
|
|
|
|
Loss per share allocable to common stockholders:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
(1.75
|
)
|
|
|
|
$
|
(0.22
|
)
|
|
Diluted
|
|
|
$
|
(1.75
|
)
|
|
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
34,992
|
|
|
|
|
|
30,959
|
|
|
Diluted
|
|
|
|
34,992
|
|
|
|
|
|
30,959
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|

Investors/Media:
Epizyme, Inc.
Manisha Pai, 617-229-7560
mpai@epizyme.com
Source: Epizyme, Inc.
News Provided by Acquire Media