Company Scheduled for First FDA Interaction for
Tazemetostat in NHL in 4Q17
Epizyme, Inc. (NASDAQ:EPZM) today reported operating results for
the third quarter 2017, recent progress in its clinical development
programs for tazemetostat in non-Hodgkin’s lymphoma (NHL) and solid
tumors, and company updates.
“2017 has been a year of tremendous progress, with additional
important milestones remaining this quarter, including our
scheduled interaction with the FDA to begin discussing the
registration strategy for tazemetostat in NHL,” said Robert
Bazemore, president and chief executive officer of Epizyme. “Our
experienced management team is executing well on the drivers for
both short and long-term Epizyme growth. Our clinical organization
is delivering on a comprehensive tazemetostat clinical program
according to our plans; our research team has named G9a as the
target for the next program in our pipeline; and our business
operations team completed a capital raise that meaningfully
extended our runway. I am confident in our ability to build on this
momentum as we begin the transition into a commercial company, with
our first NDA submission targeted for 2018 and the potential launch
of tazemetostat to follow.”
Due to the company’s transition, Peter T.C. Ho, M.D., Ph.D.,
chief medical officer, has decided to leave the company at the end
of 2017. Throughout the rest of this year, Dr. Ho will continue to
oversee all clinical programs, upcoming clinical milestones and
preparation of medical congress presentations, as well as support
the scheduled interaction with the U.S. Food and Drug
Administration (FDA) in the fourth quarter. Epizyme is conducting
an active search for a seasoned clinical executive and is in the
process of securing an interim CMO to serve in a consultative
capacity during the transition.
Bazemore added, “Based on our planned transformation in 2018 and
his passion for early-stage drug development, Peter will be
transitioning from Epizyme at the end of the year. Since joining in
2014, Peter has been instrumental in building our clinical team and
bringing the tazemetostat program to where it is today. We are very
thankful to Peter for his many contributions and wish him all the
best in the future. This transition allows us the opportunity to
add new strength to the team with a seasoned clinical executive
with extensive late-stage drug development experience and a track
record of driving new treatments to approval.”
Tazemetostat NHL Program Updates
- Epizyme is on-track to hold the first interaction with the FDA
in the fourth quarter of 2017 to discuss its NHL program, and plans
to provide an update in early 2018.
- The ongoing Phase 2 study in patients with follicular lymphoma
and diffuse large B-cell lymphoma continues to enroll patients with
EZH2 mutations. As a result of Epizyme’s efforts to accelerate
enrollment of these patients, which includes the recently initiated
collaboration with US Oncology, August and September were the
highest screening months to date for the study.
Tazemetostat Solid Tumor Program Updates
- Phase 2 Mesothelioma Study: Epizyme’s ongoing
Phase 2 study designed to evaluate tazemetostat as a treatment for
adults with mesothelioma characterized by BAP1 loss-of-function has
surpassed the futility assessment and achieved the primary endpoint
of at least a 30 percent disease control rate at 12 weeks. The
company expects to report data from this study in 2018. In
addition, the FDA has granted Orphan Drug designation to
tazemetostat for the treatment of patients with mesothelioma.
- Pediatric Phase 1 INI1-Negative Tumor Study:
Data from the completed dose-escalation portion of Epizyme’s Phase
1 study of tazemetostat in pediatric patients with INI1-negative
solid tumors were presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics. Objective
responses were observed in patients with epithelioid sarcoma (n=1),
poorly differentiated chordoma (n=2) and atypical teratoid rhabdoid
tumors (n=1) at dose levels ranging from 520 to 900 mg/m2 twice
daily. Enrollment in the dose-expansion portion of the study is
ongoing.
- Adult Phase 2 INI1-Negative Tumor Study: The
malignant rhabdoid tumor cohort and other INI1-negative tumor
cohort of the company’s ongoing Phase 2 study in molecularly
defined solid tumors have both surpassed their futility assessment
with objective responses observed in both populations. Epizyme is
continuing to enroll and monitor patients in these arms, and plans
to present updated data from this study in 2018. The company has
also added a separate cohort to enroll adults with chordoma, due to
the high rate of enrollment of these patients in the other
INI1-negative cohort and the observed clinical activity with
tazemetostat in this tumor type in both adults and children so
far.
Upcoming Data Presentations
- Previously announced data on adult and pediatric epithelioid
sarcoma patients in the company’s ongoing INI1-negative solid tumor
studies will be presented during a plenary session at the
Connective Tissue Oncology Society (CTOS) Annual Meeting at 1:00
p.m. HAST on Thursday, Nov. 9, 2017. The adult data were originally
presented at the American Society of Clinical Oncology (ASCO) 2017
Annual Meeting and the pediatric data at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics.
- Epizyme will introduce the next development program in its
pipeline, which addresses G9a, a novel target for the potential
treatment of sickle cell disease (SCD), during a plenary
presentation at the 2017 American Society of Hematology (ASH)
Annual Meeting at 7:30 a.m. ET on Monday, Dec. 11, 2017. This is
the first of three internally discovered programs expected to enter
the clinic by the end of 2020.
- New patient data from the company’s 62-gene panel biomarker
study of tazemetostat in patients with NHL will also be presented
in a poster session at the ASH Annual Meeting.
Third Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $307.2 million as of September 30, 2017,
as compared to $263.3 million as of September 30, 2016. The
increase is mainly driven by the $151.3 million in net proceeds
following the company’s underwritten public offering of 10,557,000
shares of common stock.
- Revenue: There was no revenue recognized in
the third quarter of 2017, compared to $6.6 million for the third
quarter of 2016, as there were no collaboration milestones during
the quarter.
- R&D Expenses: Research and development
(R&D) expenses were $28.7 million for the third quarter of
2017, compared to $23.9 million for the third quarter of 2016. The
increase is primarily due to increased tazemetostat manufacturing
activities, tazemetostat clinical development and research
activities related to advancing the company’s next development
program.
- G&A Expenses: General and administrative
(G&A) expenses were $9.3 million for the third quarter of 2017,
compared to $7.5 million for the third quarter of 2016. The
increase is primarily due to increased personnel-related expenses
to support the company’s growth and pre-commercial activities.
- Net Loss: Net loss was $37.6 million for the
quarter ended September 30, 2017, compared to $24.3 million for the
quarter ended September 30, 2016.
Financial GuidanceEpizyme provides financial
guidance that the company believes that its existing cash, cash
equivalents and marketable securities as of September 30, 2017 will
be sufficient to fund its planned operations into at least the
third quarter of 2019.
About the Tazemetostat Clinical Trial
ProgramTazemetostat, a first-in-class EZH2 inhibitor, is
currently being studied as a monotherapy in ongoing Phase 2
programs in both follicular lymphoma (FL) and diffuse large B-cell
lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); certain
molecularly defined solid tumors, including epithelioid sarcoma and
other INI1-negative tumors; mesothelioma; and combination studies
in DLBCL. Tazemetostat has been granted Fast Track designation by
the U.S. Food and Drug Administration for FL regardless of EZH2
mutation status and for DLBCL with EZH2-activating mutations, as
well as Orphan Drug designation for mesothelioma, soft tissue
sarcoma and malignant rhabdoid tumors.
About Orphan Drug Designation The FDA Orphan
Drug designation program provides a special status to drugs and
biologics intended to treat, diagnose or prevent so-called orphan
diseases and disorders that affect fewer than 200,000 people in the
U.S. This designation provides for a seven-year marketing
exclusivity period against competition, as well as certain
incentives, including federal grants, tax credits and a waiver of
PDUFA filing fees.
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 in relapsed and front-line disease. Using the
Company's proprietary platform, Epizyme has pioneered the
identification and development of small molecule inhibitors of
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, submissions for regulatory approval or review by
governmental authorities under the accelerated approval process;
whether fast track and orphan drug designations will provide the
benefits for which tazemetostat is eligible; 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.
Contacts
Media:Cheya Pope, Epizyme,
Inc.media@epizyme.com(617) 229-7561
Investors:Monique Allaire, THRUST
monique@thrustir.com(617) 895-9511
EPIZYME, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
|
|
September 30, 2017 |
|
|
December 31, 2016 |
|
Consolidated
Balance Sheets Data : |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
307,228 |
|
|
$ |
242,192 |
|
Total assets |
|
|
320,546 |
|
|
|
252,441 |
|
Deferred revenue |
|
|
28,809 |
|
|
|
28,809 |
|
Total stockholders’
equity |
|
|
268,189 |
|
|
|
201,700 |
|
EPIZYME,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)(Amounts in thousands except per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September
30, |
|
|
Nine Months Ended September
30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Collaboration
revenue |
|
$ |
- |
|
|
$ |
6,584 |
|
|
$ |
10,000 |
|
|
$ |
7,529 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
28,741 |
|
|
|
23,888 |
|
|
|
80,728 |
|
|
|
63,078 |
|
General
and administrative |
|
|
9,311 |
|
|
|
7,522 |
|
|
|
28,750 |
|
|
|
20,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
38,052 |
|
|
|
31,410 |
|
|
|
109,478 |
|
|
|
83,870 |
|
Loss from
operations |
|
|
(38,052 |
) |
|
|
(24,826 |
) |
|
|
(99,478 |
) |
|
|
(76,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
455 |
|
|
|
490 |
|
|
|
1,335 |
|
|
|
1,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(37,597 |
) |
|
$ |
(24,336 |
) |
|
$ |
(98,143 |
) |
|
$ |
(75,196 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share
allocable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.63 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.32 |
) |
Diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.32 |
) |
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
59,899 |
|
|
|
57,970 |
|
|
|
58,837 |
|
|
|
56,828 |
|
Diluted |
|
|
59,899 |
|
|
|
57,970 |
|
|
|
58,837 |
|
|
|
56,828 |
|
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