EpiCept Corporation Reports First Quarter 2011 Financial Results and
Provides Business Update
Conference Call Begins at 9:00 A.M. Eastern Time Today
TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced operating and financial results for the three months
ended March 31, 2011, and provided an update with respect to the
Company's key business initiatives.
“EpiCept made substantial progress with its most important clinical
projects during the first quarter of 2011,” stated Jack Talley,
President and Chief Executive Officer of EpiCept. “We were delighted
with the excellent clinical results for AmiKet™, formerly known as
EpiCept™ NP-1, in the treatment of chemotherapy-induced neuropathy,
particularly with respect to its activity in relieving the suffering of
cancer patients who have undergone taxane therapy. We were also pleased
to have received the support of key opinion leaders concerning the
design of the Ceplene® Phase III confirmatory clinical trial.” Mr.
Talley added, “With the recent submission of the application for Special
Protocol Assessment with the FDA along with a strengthened cash
position, we believe we are well positioned to meet our important
objectives for the rest of 2011.”
Business Update
• Ceplene® - approved in the European Union (EU) and Israel
for administration with low-dose interleukin-2 (IL-2) for the remission
maintenance and prevention of relapse of patients with Acute Myeloid
Leukemia (AML) in first remission; AML is the deadliest form of leukemia
in adults. The product has been licensed to Meda AB of Sweden to market
and sell in Europe and certain Pacific Rim countries, and to MegaPharm
Ltd. to market and sell in Israel.
During the first quarter of 2011, Ceplene® was officially
added to the list of reimbursed products in Italy, permitting
reimbursement for one year, following which permanent reimbursement
approval is expected. Reimbursement has been approved in Sweden and is
being negotiated in France, while talks remain in a pre-negotiation
phase in Spain. Reimbursement negotiations in several other European
countries are ongoing. Sales of Ceplene® were not material in the first
quarter of 2011 and are not expected to grow significantly until 2012.
The Company recently filed its protocol for a Phase III
confirmatory clinical trial for Ceplene® with the U.S. Food and Drug
Administration (FDA). The protocol will be reviewed under the FDA's
Special Protocol Assessment (SPA) program under which the FDA will
provide formal guidance regarding the trial's design, clinical
endpoints, statistical analysis and labeling claims. As part of its
submission, EpiCept has proposed a two-arm trial comparing the efficacy
of maintenance therapy with Ceplene® in conjunction with low-dose IL-2
to investigator's choice, which is often no treatment. The target
population is AML patients in first complete remission who have received
consolidation therapy. The primary endpoint will be overall survival. To
ensure that the study design is both clinically rigorous and feasible
from an enrollment standpoint, EpiCept worked closely with key opinion
leaders to develop the protocol. EpiCept believes the results of this
Phase III study, if positive, will provide the basis for the filing of a
New Drug Application for Ceplene® in the U.S. Ceplene® has been granted
orphan drug status in the United States, which provides seven years of
market exclusivity from the approval date.
EpiCept is continuing patient enrollment for its European
post-approval clinical study of Ceplene®. Approximately 50 patients have
been enrolled to date. Data from the first 75 patients enrolled are
expected to be reported beginning in late 2011. Thirty centers across
Europe are participating in this study, with sites in Sweden, Belgium,
France, the U.K., Spain, Germany and Italy. The Company intends to use
the data from this single-arm, open-label trial to meet its
post-approval commitment and to seek a refinement of Ceplene's EU
labeling. The data also is expected to have value to prescribing
hematologists.
In early March 2011, EpiCept announced that it had
submitted additional U.S. and global provisional patent applications
based on the discoveries of the efficacy of Ceplene® plus IL-2 in AML of
monocyte origin. The Company believes that these provisional patents, if
granted, would provide an additional 20 years of market exclusivity for
Ceplene® from the date of patent filing.
• AmiKet™ (formerly known as EpiCept™ NP-1) - a
prescription topical analgesic cream designed to provide long-term
relief from the pain of peripheral neuropathies, which affect more than
15 million people in the U.S. alone. EpiCept has filed for registration
“AmiKet” as the trade name for NP-1. During the first quarter of 2011,
EpiCept announced positive results from a Phase IIb trial evaluating the
efficacy and safety of AmiKet™ in chemotherapy-induced peripheral
neuropathy (CIPN). The multi-center, double-blind, randomized,
placebo-controlled study was conducted by the National Cancer Institute
(NCI)-funded Community Clinical Oncology Program. More than 460 cancer
survivors suffering from painful CIPN were enrolled in the six-week
study. The results of the trial in the intent to treat (ITT) population
demonstrated that the change in average daily neuropathy intensity
scores in the AmiKet™ group achieved a statistically significant
reduction in CIPN intensity versus placebo (p<0.001), which was the
trial's primary endpoint. Additionally, a pre-specified subgroup of the
ITT population, those patients who previously received taxane
chemotherapy, also showed a statistically significant reduction in
average daily neuropathy intensity scores (p=0.034). This subgroup
constituted more than 50% of the ITT population. Secondary efficacy
endpoints confirmed the superiority of AmiKet™ vs. placebo. Furthermore,
the safety profile of AmiKet™ was comparable to placebo.
The NCI estimates that 30%-40% of cancer patients treated
with chemotherapy experience symptoms of CIPN, which impairs their
quality of life and ability to function. The debilitating, chronic pain
of CIPN is one of the most common reasons why cancer patients
discontinue their treatment prematurely. More than one million breast
cancer survivors in the United States alone suffer from this disease,
for which there is no effective therapy.
The results of this trial build upon EpiCept's clinical
development of AmiKet™ in both diabetic and post-herpetic neuropathies.
The Company has enrolled more than 1,600 patients into clinical trials
of AmiKet™, including a 360-patient trial that studied AmiKet™'s
efficacy compared with gabapentin and placebo in post-herpetic
neuropathy, for which positive results were previously reported. EpiCept
intends to partner AmiKet™ prior to the commencement of the Phase III
program in order to share the costs and development risk, and ultimately
to have that partner market the product globally upon approval. Partner
discussions are continuing.
• CrolibulinTM - a vascular disruption agent that has
demonstrated potent anti-tumor activity in both preclinical and early
clinical studies. In December 2010, the NCI initiated a Phase Ib/II
trial for crolibulinTM to assess safety and efficacy in combination with
cisplatin in patients with anaplastic thyroid cancer (ATC). Trial
enrollment has commenced and data from this trial could be available as
early as the fourth quarter of 2011.
• Azixa™ - a compound discovered by EpiCept and licensed to
Myrexis, Inc. as part of an exclusive, worldwide development and
commercialization agreement. AzixaTM has received orphan drug status in
the United States for the treatment of glioblastoma multiforme (GBM).
Phase II data from a sub-group of patients with recurrent GBM who are
naïve to Avastin is expected to be reported in the first half of 2011.
In December 2010, Myrexis began a Phase IIb clinical study of AzixaTM to
treat GBM. The study will enroll as many as 120 patients in the U.S. and
India in order to evaluate AzixaTM combination therapy as a first-line
GBM treatment. The dosing of the first patient in a Phase III trial for
Azixa™ triggers a milestone payment to EpiCept.
Financial and Operating Highlights
EpiCept's net loss for the first quarter of 2011 was $2.5 million, or
$0.04 per share, compared with a net loss of $4.5 million, or $0.10 per
share, for the first quarter of 2010. As of March 31, 2011, EpiCept had
cash and cash equivalents of $10.2 million.
First Quarter 2011 vs. First Quarter 2010
Revenue
The Company recognized revenue of $0.2 million during each of the first
quarters of 2011 and 2010. For each of the first quarters of 2011 and
2010, revenue consisted primarily of the recognition of license fee
payments previously received from the Company's partners.
Cost of Goods Sold
Cost of goods sold in the first quarter of 2011 was $0.1 million,
consisting primarily of a $0.1 million expense for Ceplene® inventory
the Company believes will not be sold prior to reaching its product
expiration date.
Selling, General and Administrative Expense
Selling, general and administrative expense in the first quarter of 2011
decreased by 32%, or $0.7 million, to $1.4 million compared with $2.1
million in the first quarter of 2010. The decrease was primarily related
to lower selling expenses and marketing salaries.
Research and Development (R&D) Expense
R&D expense in the first quarter of 2011 decreased by approximately 17%,
or $0.3 million, to $1.7 million compared with $2.0 million in the first
quarter of 2010. The decrease was primarily related to lower regulatory
fees and clinical trial expenses for Ceplene®.
Other Income (Expense)
Other income (expense) during the first quarter of 2011 amounted to net
income of $0.5 million, compared with net expense of $0.6 million in the
first quarter of 2010. The primary component of other income (expense)
in both quarters is interest expense and foreign exchange gain (loss).
Liquidity
As of March 31, 2011 EpiCept had $10.2 million in cash and cash
equivalents. In February 2011, the Company received approximately $6.6
million in net proceeds from the issuance of approximately 8.9 million
shares of its common stock at $0.80 per share, and five-year warrants to
purchase up to approximately 3.6 million shares of common stock at an
exercise price of $0.75 per share. In March 2011, the Company received
approximately $4.3 million in net proceeds from the issuance of
approximately 7.1 million shares of its common stock at $0.65 per share,
and five-year warrants to purchase up to approximately 5.3 million
shares of common stock at an exercise price of $0.72 per share. The
Company believes that its current cash is sufficient to fund operations
into 2012.
The Company continues its efforts to secure a non-equity financing
transaction that, if completed, will support its current operations
through 2012. The Company may decide to seek additional or alternative
sources or types of financing should the transaction not close or the
proceeds be less than anticipated. The Company also may receive cash
from certain licensing activities during 2011.
Conference Call
EpiCept will host a conference call to discuss these results and answer
questions today beginning at 9:00 a.m. Eastern Daylight Time.
To participate in the live call and be able to participate in the
question and answer session, please dial from the United States or
Canada (877) 809-8594 or from international locations (706) 758-9407
(please reference access code 65652513) prior to the start of the
conference. The conference call will also be broadcast live in
listen-only mode on the Internet and may be accessed at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http
%3A%2F%2Fwww.epicept.com&esheet=6716827&lan=en-US&anchor=www.epicept.com
&index=1&md5=957a177794794932a62062483e45fb63). The web cast will be
archived for 90 days.
A telephone replay of the call will be available for seven days by
dialing from the United States or Canada (800) 642-1687 or from
international locations (706) 645-9291 (please reference reservation
number 65652513).
About EpiCept Corporation
EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of cancer and pain. The
Company's lead product is Ceplene®, approved in the EU and Israel for
the remission maintenance and prevention of relapse in adult patients
with Acute Myeloid Leukemia (AML) in first remission. In the United
States, a pivotal trial is scheduled to commence in 2011. The Company
has two other oncology drug candidates currently in clinical development
that were discovered using in-house technology and have been shown to
act as vascular disruption agents in a variety of solid tumors. The
Company's pain portfolio includes AmiKet™, a prescription topical
analgesic cream in late-stage clinical development designed to provide
effective long-term relief of pain associated with peripheral
neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
which express plans, anticipation, intent, contingency, goals, targets,
future development and are otherwise not statements of historical fact.
These statements are based on our current expectations and are subject
to risks and uncertainties that could cause actual results or
developments to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Factors that may cause actual results or developments to
differ materially include: the risk that our securities may be delisted
from The Nasdaq Capital Market, the risks associated with the adequacy
of our existing cash resources and our ability to continue as a going
concern, the risks associated with our ability to continue to meet our
obligations under our existing debt agreements, the risk that Ceplene®
will not receive regulatory approval or marketing authorization in the
United States or Canada, the risk that Ceplene® will not achieve
significant commercial success, the risk that any required post-approval
clinical study for Ceplene® will not be successful, the risk that we
will not be able to maintain our final regulatory approval or marketing
authorization for Ceplene®, the risk that Azixa™ will not receive
regulatory approval or achieve significant commercial success, the risk
that we will not receive any significant payments under our agreement
with Myrexis, the risk that the development of our other apoptosis
product candidates will not be successful, the risk that clinical trials
for AmiKet™ or crolibulinTM will not be successful, the risk that
AmiKet™ or crolibulinTM will not receive regulatory approval or achieve
significant commercial success, the risk that we will not be able to
find a partner to help conduct the Phase III trials for AmiKet™ on
attractive terms, a timely basis or at all, the risk that our other
product candidates that appeared promising in early research and
clinical trials do not demonstrate safety and/or efficacy in
larger-scale or later stage clinical trials, the risk that we will not
obtain approval to market any of our product candidates, the risks
associated with dependence upon key personnel, the risks associated with
reliance on collaborative partners and others for further clinical
trials, development, manufacturing and commercialization of our product
candidates; the cost, delays and uncertainties associated with our
scientific research, product development, clinical trials and regulatory
approval process; our history of operating losses since our inception;
the highly competitive nature of our business; risks associated with
litigation; and risks associated with our ability to protect our
intellectual property. These factors and other material risks are more
fully discussed in our periodic reports, including our reports on Forms
8-K, 10-Q and 10-K and other filings with the U.S. Securities and
Exchange Commission. You are urged to carefully review and consider the
disclosures found in our filings which are available at
www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2F%2Fus.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3o
DMTEzM2pvaWgxBHBvcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15
t064n6f%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlin
k%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526esheet%3D6170045%25
26lan%3Den_US%2526anchor%3Dwww.sec.gov%2526index%3D2%2526md5%3D61ec7b720
44301e411e3335754ee5c07&esheet=6716827&lan=en-US&anchor=www.sec.gov&inde
x=2&md5=c5b65fbcb3b2f6c66de153a0e838f63d) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http
%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3
DX3oDMTE2OGhhcWs4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2F
SIG%3D1659oglun%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3D
smartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.epicept.com%2526esheet%
3D6170045%2526lan%3Den_US%2526anchor%3Dwww.epicept.com%2526index%3D3%252
6md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6716827&lan=en-US&anchor=
www.epicept.com&index=3&md5=81535d7e60c1d35b43ee42571cb21c1f). You are
cautioned not to place undue reliance on any forward-looking statements,
any of which could turn out to be wrong due to inaccurate assumptions,
unknown risks or uncertainties or other risk factors.
Selected financial information follows:
EpiCept Corporation and Subsidiaries
(Unaudited)
Selected Consolidated Balance Sheet Data
(in $000s)
March 31,
December 31,
2011
2010
Cash and cash equivalents $ 10,212 $
2,435
Inventory 922
1,004
Property and equipment, net 193
222
Total assets $ 12,353 $
4,689
Accounts payable and other accrued liabilities $ 3,224 $
3,389
Deferred revenue 13,603
13,826
Notes and loans payable 979
972
Total stockholders' deficit (6,023 )
(14,135 )
Total liabilities and stockholders' deficit $ 12,353 $
4,689
EpiCept Corporation and Subsidiaries
(Unaudited)
Selected Consolidated Statement of Operations Data
(in $000s except share and per share data)
Three Months Ended
March 31,
2011
2010
Revenue $ 238
$ 195
Operating expenses:
Cost of goods sold 90
28
Selling, general and administrative 1,394
2,057
Research and development 1,684
2,039
Total operating expenses 3,168
4,124
Loss from operations (2,930 )
(3,929 )
Other income (expense):
Interest income 2
3
Foreign exchange gain (loss) 504
(516 )
Interest expense (39 )
(61 )
Other income (expense), net 467
(574 )
Net loss before income taxes (2,463 )
(4,503 )
Income taxes (3 )
(5 )
Net loss (2,466 )
(4,508 )
Basic and diluted loss per common share $ (0.04 )
$ (0.10 )
Weighted average common shares outstanding * 60,102,966
44,160,266
* Reflects a 1:3 reverse split effected in January 2010.
EpiCept Corporation and Subsidiaries
(Unaudited)
Selected Consolidated Statement of Cash Flows Data
(in $000s)
Three Months
Ended March 31,
2011
2010
Net cash used in operating activities $ (3,420 )
$ (1,518 )
Net cash (used in) provided by investing activities (1 )
27
Net cash provided by (used in) financing activities 11,200
(74 )
Effect of exchange rate changes on cash (2 )
2
Net increase (decrease) in cash and cash equivalents 7,777
(1,563 )
Cash and cash equivalents at beginning of period 2,435
5,142
Cash and cash equivalents at end of period $ 10,212
$ 3,579
EpiCept Corporation and Subsidiaries
(Unaudited)
Selected Consolidated Statement of Stockholders Deficit Data
(in $000s)
Three Months Ended
March 31,
2011
2010
Stockholders' deficit at beginning of period $ (14,135 )
$ (9,079 )
Net loss for the period (2,466 )
(4,508 )
Stock-based compensation expense 236
203
Foreign currency translation adjustment (531 )
603
Share, option and warrant issuance 10,873
—
Exercise of warrants —
39
Stockholders' deficit at end of period $ (6,023 )
$ (12,742 )
As of May 6, 2011 EpiCept had 70,989,292 common shares outstanding.
# # #
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com (rcook@epicept.com)
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com (gregory.kelley@fkhealth.com)
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com (kgolodetz@lhai.com)
or
Bruce Voss, 310-691-7100
bvoss@lhai.com (bvoss@lhai.com)
EpiCept Corporation Reports First Quarter 2011 Financial Results and Provides Business Update
| Source: Immune Pharmaceuticals Inc
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