Tazemetostat NDA Submissions for Epithelioid
Sarcoma and Follicular Lymphoma on Track for Second Quarter and
Fourth Quarter 2019, Respectively
Updated Data from Tazemetostat Development
Program to be Presented in the Second Quarter
First Research Milestone Achieved in Worldwide
Collaboration with Boehringer Ingelheim to Develop Novel Epigenetic
Oncology Therapies
Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical
company developing novel epigenetic therapies, today provided
business and pipeline updates and reported first quarter 2019
financial results.
“This is an incredibly exciting time for our company, and 2019
is slated to be one of the most important years in Epizyme’s
evolution,” said Robert Bazemore, president and chief executive
officer of Epizyme. “Our team is on track to submit two NDAs for
tazemetostat this year, first for epithelioid sarcoma in the second
quarter, which, if successful, would make tazemetostat the first
commercially available EZH2 inhibitor, and then a second submission
for follicular lymphoma in the fourth quarter. We are preparing for
multiple clinical trials starting mid-year designed to expand the
utility of tazemetostat, and to initiate clinical development of
our novel G9a inhibitor in the second half of 2019. In addition, we
have achieved the first milestone in our partnership with
Boehringer Ingelheim, which further validates our research
expertise and our collaboration strategy in epigenetic target
discovery and drug development. With each milestone accomplished,
we are one step closer to fulfilling our mission of bringing new
treatments to patients with cancer and other serious diseases.”
Tazemetostat Program Updates and Progress
- NDA Submission for Epithelioid
Sarcoma (ES) on Track for Second Quarter: Epizyme is well
underway with its preparations to submit its first New Drug
Application (NDA) for accelerated approval to the U.S. Food and
Drug Administration (FDA) in the second quarter of 2019 for
tazemetostat in patients with ES. This is an ultra-rare and
difficult-to-treat sarcoma, and if approved, tazemetostat would be
the first treatment specifically indicated for patients with ES.
Updated data from the company’s ongoing Phase 2 trial in ES will be
presented at the 2019 American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago; details will be disclosed at a future
date.
- NDA Submission for All-Comer
Follicular Lymphoma (FL) Population Planned for Fourth Quarter:
Epizyme plans to submit an NDA for accelerated approval of
tazemetostat for patients with FL, regardless of their EZH2
mutational status, who have been previously treated with two or
more systemic therapies. The ongoing Phase 2 study has completed
enrollment, and the company is working toward the submission of an
NDA for accelerated approval in the fourth quarter of 2019 for this
patient population. Updated data from the Phase 2 trial will be
presented at a medical meeting in the second quarter of 2019.
Details will be disclosed at a future date.
Planned Tazemetostat Clinical Studies in 2019
Epizyme is planning for multiple clinical trials designed to
expand the benefit of tazemetostat into earlier treatment lines in
follicular lymphoma, and to explore new combinations and potential
indications in both FL and solid tumors. Planned clinical trials
include:
- a combination study of tazemetostat
with the chemo-free treatment regimen “R2” (Revlimid® plus
Rituxan®) for patients with relapsed/refractory FL who have
received at least one prior therapy;
- a combination study of tazemetostat
with Rituxan for patients with relapsed/refractory FL;
- a combination study of tazemetostat
with R-CHOP for front-line patients with FL in collaboration with
the Lymphoma Study Association (LYSA);
- a combination study of tazemetostat
with the standards-of-care for patients with castration-resistant
prostate cancer; and
- a combination study of tazemetostat
with a PARP inhibitor for patients with platinum-resistant solid
tumors, such as small-cell lung cancer, triple-negative breast
cancer and ovarian cancer.
Initiation of Clinical Development of EZM8266 for Sickle Cell
Disease
- Upon approval of an Investigational New
Application (IND) for EZM8266 for the treatment of patients with
sickle cell disease, Epizyme anticipates beginning clinical
development in the second half of 2019 with a Phase 1 trial of
EZM8266, a novel, first-in-class G9a inhibitor.
Business Updates
- Epizyme recently earned a $5.5 million
milestone payment from Boehringer Ingelheim, following the
selection of a lead optimization candidate for the shared program
targeting an enzyme within the helicase family. The companies are
jointly researching and developing this program, with both parties
sharing U.S. commercialization responsibilities and Boehringer
Ingelheim assuming responsibility for commercialization outside the
U.S. The companies will also share research responsibilities for a
histone acetyltransferase (HAT) program that is under
development.
- In March of this year, Epizyme raised
$172.50 million in aggregate gross proceeds, before deducting
underwriting discounts and offering expenses, from two concurrent
underwritten public offerings.
First Quarter 2019 Financial Results
- Cash Position: Cash, cash
equivalents and marketable securities were $371.1 million as
of March 31, 2019, as compared to $247.9 million as
of March 31, 2018.
- Revenue: Collaboration
revenue for the first quarter of 2019 was $7.9 million. There was
no collaboration revenue recognized for the first quarter of 2018.
The increase in collaboration revenue is due to the company’s
collaboration with Boehringer Ingelheim, which was initiated in
November 2018.
- R&D Expenses: Research
and development (R&D) expenses were $26.9 million for
the first quarter of 2019, compared to $25.6 million for
the first quarter of 2018. The increase is primarily due to greater
tazemetostat manufacturing costs and costs incurred in preparation
for two NDA submissions offset by decreases in clinical trial
expenses.
- G&A Expenses: General and
administrative (G&A) expenses were $12.0 million for
the first quarter of 2019, compared to $9.4 million for
the first quarter of 2018. The increase is primarily due to a rise
in medical affairs and commercial costs as a result of
organizational development in preparation for tazemetostat
commercialization.
- Net Loss Attributed to Common
Stockholders: Net loss attributable to common stockholders
was $32.3 million, or $0.39 per share, for the first
quarter of 2019, compared to $34.1 million, or $0.49 per
share, for the first quarter of 2018.
Financial Guidance
Following its March financing, and based on its current
operating plan, Epizyme expects its cash runway to extend into at
least the first quarter of 2021.
The company will not hold a conference call in conjunction with
these results.
About the Epizyme-Boehringer Ingelheim Collaboration
Epizyme and Boehringer Ingelheim established a worldwide
collaboration agreement in November 2018 to develop novel
epigenetic oncology therapies. Under the terms of the agreement,
Boehringer Ingelheim and Epizyme will jointly research and develop
a helicase program, with both parties sharing U.S.
commercialization responsibilities and Boehringer Ingelheim
assuming responsibility for commercialization outside the U.S.
Epizyme and Boehringer Ingelheim will also share research
responsibilities for a histone acetyltransferase (HAT) program,
with Boehringer Ingelheim assuming responsibility for worldwide
development and commercialization. Epizyme received an upfront
payment of $15 million and will receive an additional $5 million in
research funding in 2019, and is eligible to receive up to $280.5
million in research, development and commercialization milestones.
For the helicase program, Epizyme will fund a portion of the global
development costs, retain a share of U.S. profits and receive
tiered royalties on ex-U.S. sales. For the HAT program, Epizyme is
eligible to receive tiered royalties on worldwide sales.
About Epizyme, Inc.
Epizyme, Inc. is a late-stage biopharmaceutical company
committed to rewriting treatment for cancer and other serious
diseases 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. The company
also is developing a novel G9a program with its next development
candidate, EZM8266, which is targeting sickle cell disease. By
focusing on the genetic drivers of disease, Epizyme's science seeks
to match targeted medicines with the patients who need them. For
more information, visit www.epizyme.com.
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 Designation and Orphan Drug Designations will
provide the benefits for which tazemetostat is eligible;
expectations for regulatory approvals, including accelerated
approval, 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.
EPIZYME, INC. CONDENSED CONSOLIDATED BALANCE SHEET
DATA (UNAUDITED)
(Amounts in thousands)
March 31,2019 December
31,2018 Consolidated Balance Sheet Data: Cash,
cash equivalents, and marketable securities $ 371,146 $
240,304 Total assets 412,722 275,501 Current portion of
deferred revenue 5,409 13,300 Deferred revenue, net of current
portion 3,806 3,806 Total stockholders’ equity 368,353 233,009
EPIZYME, INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands
except per share data) Three Months
Ended March 31, 2019 2018
Collaboration revenue $ 7,891 $ — Operating expenses: Research and
development 26,896 25,622 General and administrative 11,986
9,360 Total operating expenses 38,882 34,982
Operating loss (30,991) (34,982) Other income, net: Interest
income, net 1,658 899 Other (expense) income, net (6)
18 Other income, net 1,652 917 Net loss $ (29,339) $
(34,065) Reconciliation of net loss to net
loss attributable to common stockholders: Net loss $ (29,339) $
(34,065) Accretion of convertible preferred stock (2,940)
- Net loss attributable to common stockholders $ (32,279) $
(34,065) Net loss per share attributable to common stockholders -
basic and diluted $ (0.39) $ (0.49) Weighted-average common shares
outstanding used in net loss per share attributable to common
stockholders - basic and diluted 82,424 69,386
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version on businesswire.com: https://www.businesswire.com/news/home/20190506005077/en/
Media:Erin Graves, (617) 500-0615Epizyme,
Inc.media@epizyme.comInvestors:Chelcie Lister, (919) 777-3049THRUST
Strategic Communicationschelcie@thrustsc.com
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