Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced operating and financial results for the three months ended
March 31, 2009. For the first quarter of 2009, EpiCept’s loss from
operations, before other expense and income taxes, was $4.1 million
compared with a loss from operations of $6.0 million for the first
quarter of 2008.
During the first quarter of 2009, EpiCept recorded other expense, net of
$18.4 million consisting primarily of interest expense incurred as a
result of the conversion during the quarter of $22.5 million of the
Company’s 7.5556% convertible subordinated notes due 2014 into
approximately 25.0 million shares of its common stock. Under the terms
of the notes, the holders received a make-whole payment in an amount
equal to the interest payable through the scheduled maturity of the
converted notes, and this payment was funded from restricted cash. As a
result, EpiCept’s net loss for the first quarter of 2009 was $22.5
million, or $0.23 per share, compared with a net loss of $6.1 million,
or $0.13 per share, for the first quarter of 2008. As of March 31, 2009,
EpiCept had cash and cash equivalents of $10.1 million and 115.9 million
shares outstanding.
"During the first quarter we continued with preparations for the market
launch of Ceplene® in Europe, including manufacturing initial drug
inventory and working to engage a corporate partner,” stated Jack
Talley, President and Chief Executive Officer. "We also advanced the
regulatory process for Ceplene® in the U.S. and in Canada via
discussions with relevant governing bodies, and reported positive Phase
II results with EpiCept™ NP-1 in patients suffering from Post-herpetic
Neuralgia (PHN). We shored up our financial position, raising funds and
reducing our burn rate with a workforce reduction and rationalization of
our drug discovery efforts. Importantly, cash available to fund our
operations was not impacted by the interest expense incurred during the
first quarter on the convertible notes, as it was funded from a
restricted cash escrow account established at the time of issuing the
notes.”
EpiCept today provided an update on several of its key product
candidates:
-
Ceplene® - approved in the European Union for the remission
maintenance and prevention of relapse of patients with Acute Myeloid
Leukemia (AML) in first remission; AML is the most common type of
leukemia in adults. EpiCept is in advanced negotiations with a
prospective partner to license the European marketing rights to Ceplene®.
Drug inventory was manufactured and shipped to the European Union in
preparation for the commercial launch of Ceplene later this year. The
Company held a pre-New Drug Application (NDA) meeting with the U.S.
FDA in January 2009 and is preparing to file an NDA with the FDA and a
New Drug Submission with Health Canada during 2009. EpiCept is also
making preparations to initiate the post-approval single arm clinical
study that is required under the marketing authorization with the
European Commission. This study is expected to commence in the second
quarter of 2009 and will enroll approximately 150 patients in at least
20 leading European hematology centers.
-
EpiCeptTM 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 United
States alone. In January 2009 EpiCept reported positive results from a
360-patient Phase IIb trial of NP-1 in PHN patients, where NP-1
achieved statistically significant pain relief as compared to placebo
and was statistically similar in pain relief to market leader
gabapentin, yet had fewer CNS side effects. EpiCept is seeking a
strategic partner to share the Phase III development costs of NP-1 and
to market the product in the U.S.
-
Crinobulin (EPC2407) - a vascular disruption agent (VDA) which has
demonstrated potent anti-tumor activity in both preclinical and early
clinical studies. In preclinical in vitro and in vivo
studies, crinobulin has been shown to induce tumor cell apoptosis and
selectively inhibit growth of proliferating cell lines, including
multi-drug resistant cell lines. In April 2008 EpiCept announced
positive clinical data from a Phase I study of crinobulin in patients
with solid tumors and is making preparations to initiate a Phase Ib
combination trial for the compound with other chemotherapeutic agents
in the second half of 2009.
-
Azixa™ - a compound discovered by EpiCept and licensed to Myriad
Genetics, Inc. as part of an exclusive, worldwide development and
commercialization agreement. Myriad Genetics is currently conducting
Phase II trials for Azixa. If successful these results could lead to
Phase III registration trials for the compound, which would trigger a
milestone payment for EpiCept.
Financial and Operating Highlights - First Quarter 2009 vs. First
Quarter 2008
General and Administrative Expense
General and administrative expense decreased by 22%, or $0.6 million,
from $2.6 million in the first quarter of 2008 to $2.0 million in
the first quarter of 2009. The decrease was primarily attributable to
lower facility, legal and investor relations costs.
Research and Development (R&D) Expense
Research and development expense decreased by 38%, or $1.2 million, from
$3.4 million in the first quarter of 2008 to $2.2 million
in the
first quarter of 2009. The decrease was primarily attributable to lower
clinical, consulting and patent costs. R&D activity during the first
quarter of 2009 was focused on the initiation of an open-label trial of
Ceplene® that will meet EpiCept’s post-approval requirements with the
European Commission and a Phase Ib clinical trial for crinobulin, as
well as preparations for the commercial launch of Ceplene® in Europe. As
a result of EpiCept’s decision to close its facility in San Diego, the
Company expensed $0.2 million during the first quarter of 2009. EpiCept
expects to incur an additional expense of approximately $2.3 million
later this year once it vacates the premises.
Other Income (Expense)
Other income (expense) during the first quarter of 2009 amounted to net
expense of $18.4 million, compared with net expense of $0.1 million in
2008. The first quarter of 2009 included $18.1 million of interest
expense, which included $9.6 million in amortization of debt issuance
costs and debt discount related to the conversion of $22.5 million of
the Company’s 7.5556% convertible subordinated notes due 2014 into
approximately 25.0 million shares of its common stock. As only $2.5
million of the notes remained outstanding as of March 31, 2009 the
balance of the interest expense to be recognized over the remaining life
of the notes will be approximately $2.0 million.
Net Cash Used in Operating Activities
Net cash used in operating activities for the first quarter of 2009 was
$15.2 million compared with $3.9 million for the first quarter of 2008.
During the first quarter of 2009, cash was used primarily to fund the
Company’s loss from operations, expenses related to our convertible debt
financing and payment of accounts payable and accrued expenses. Cash
used for the first quarter of 2009 included interest expense of $8.5
million as a result of the conversion of $22.5 million of the Company’s
7.5556% convertible subordinated notes due 2014 into approximately 25.0
million shares of EpiCept’s common stock, which was paid from escrowed
cash established from the proceeds of the financing to make interest
payments. Accounts payable and accrued expenses decreased by
approximately $2.4 million as a result of paying vendors, including
certain vendors to which EpiCept had previously delayed payment. The
2009 net loss was partially offset by non-cash charges of $9.6 million
of amortization of deferred financing costs and discount on loans, $0.4
million of FAS 123R stock-based compensation and $0.1 million of
depreciation and amortization expenses.
Net Cash Used in Investing Activities
Net cash used in investing activities for the first quarter of 2009 was
$0.9 million compared with $21,000 for the first quarter of 2008. During
the first quarter of 2009, cash was used to establish restricted cash
for a $9.4 million make-whole interest payment resulting from the
issuance of $25.0 million principal aggregate amount of 7.5556%
convertible senior subordinated notes. As the result of the conversion
of $22.5 million in aggregate principal amount of the 7.5556% notes, the
Company released $8.5 million from restricted cash to pay the interest
on these notes.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the first quarter of 2009
was $25.5 million compared to $3.7 million for the first quarter of
2008. During the first quarter of 2009, the Company issued $25.0 million
principal aggregate amount of 7.5556% convertible senior subordinated
notes, netting the Company $14.0 million after $1.6 million in
transaction costs and establishing an escrow account for $9.4 million in
make-whole interest. The Company also received proceeds of $2.9 million
related to the exercise of approximately 8.5 million common stock
warrants in the first quarter of 2009.
Liquidity
EpiCept’s existing cash and cash equivalents should be sufficient to
meet its projected operating and debt service requirements into the
fourth quarter of 2009. Additional funding for the Company’s operations
is anticipated to be derived from sales of Ceplene® in
Europe, fees from the Company’s strategic partners including a marketing
partner for Ceplene® in Europe, strategic relationships for
other product candidates including NP-1 or other financing arrangements.
See our Quarterly Report on Form 10-Q for the quarter ended March 31,
2009 for a further discussion of the Company’s liquidity and cash
position.
Conference Call
EpiCept will host a conference call to discuss these results on May 7,
2009 at 9:00 a.m. Eastern time.
To participate in the live call, please dial from the U.S. or Canada
(877) 809-8594 or from international locations (706) 758-9407 (please
reference access code 97888197). The conference call will also be
broadcast live on the Internet and may be accessed at www.epicept.com.
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 U.S. and Canada (800) 642-1687 or from international
locations (706) 645-9291 (please reference reservation number 97888197).
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer.
The Company's broad portfolio of pharmaceutical product candidates
includes Ceplene®, a cytokine immunomodulator that recently
received marketing authorization in Europe for the remission maintenance
of AML patients, and pain therapies that are in clinical development.
Two oncology drug candidates currently in clinical development that were
discovered using in-house technology have also been shown to act as
vascular disruption agents in a variety of solid tumors.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release, contains 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 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 our
securities may be delisted by The Nasdaq Capital Market or the OMX
Nordic Exchange and that any appeal of the delisting determination may
not be successful, the risk that Ceplene® will not receive
regulatory approval or marketing authorization in the United States or
Canada, the risk that Ceplene® will not be launched in Europe
in the second half of 2009 or achieve significant commercial success,
the risk that we are unable to find a suitable marketing partner for
Ceplene® on attractive terms, a timely basis or at all, 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 its
final regulatory approval or marketing authorization for Ceplene®,
the risk that Myriad's development of AzixaTM will not be
successful, the risk that AzixaTM will not receive regulatory
approval or achieve significant commercial success, the risk that we
will not receive any significant payments under our agreement with
Myriad, the risk that the development of our other apoptosis product
candidates will not be successful, the risk that we will not be able to
find a buyer for our ASAP technology, the risk that clinical trials for
EpiCeptTM NP-1 or crinobulin will not be successful, the risk
that EpiCeptTM NP-1 or crinobulin 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 EpiCeptTM NP-1 on attractive terms or a timely basis 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 other product
candidates, the risks associated with our 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 its 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
or at www.epicept.com.
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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
Selected financial information follows:
|
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EpiCept Corporation and Subsidiaries
|
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|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Balance Sheet Data
|
|
|
|
|
|
(in $000s)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,143
|
|
|
$
|
790
|
|
|
Restricted cash
|
|
|
1,015
|
|
|
|
—
|
|
|
Property and equipment, net
|
|
|
472
|
|
|
|
502
|
|
|
Total assets
|
|
$
|
12,873
|
|
|
$
|
2,271
|
|
|
|
|
|
|
|
|
Accounts payable and other accrued liabilities
|
|
$
|
3,572
|
|
|
$
|
5,995
|
|
|
Deferred revenue
|
|
|
9,895
|
|
|
|
9,990
|
|
|
Notes and loans payable
|
|
|
4,380
|
|
|
|
3,552
|
|
|
Total stockholders’ deficit
|
|
|
(5,273
|
)
|
|
|
(17,730
|
)
|
|
Total liabilities and stockholders’ deficit
|
|
$
|
12,873
|
|
|
$
|
2,271
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Statement of Operations Data
|
|
|
|
(in $000s except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
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|
|
March 31,
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
115
|
|
|
$
|
49
|
|
|
Operating expenses:
|
|
|
|
|
|
General and administrative
|
|
|
2,027
|
|
|
|
2,588
|
|
|
Research and development
|
|
|
2,170
|
|
|
|
3,472
|
|
|
Total operating expenses
|
|
|
4,197
|
|
|
|
6,060
|
|
|
Loss from operations
|
|
|
(4,082
|
)
|
|
|
(6,011
|
)
|
|
Other income (expense):
|
|
|
|
|
|
Interest income
|
|
|
6
|
|
|
|
14
|
|
|
Foreign exchange gain
|
|
|
(289
|
)
|
|
|
395
|
|
|
Interest and amortization of discount and expense
|
|
|
(18,119
|
)
|
|
|
(473
|
)
|
|
Other income (expense), net
|
|
|
(18,402
|
)
|
|
|
(64
|
)
|
|
Net loss before income taxes
|
|
|
(22,484
|
)
|
|
|
(6,075
|
)
|
|
Income taxes
|
|
|
(3
|
)
|
|
|
(2
|
)
|
|
Net loss
|
|
|
(22,487
|
)
|
|
|
(6,077
|
)
|
|
Basic and diluted loss per common share
|
|
$
|
(0.23
|
)
|
|
$
|
(0.13
|
)
|
|
Weighted average common shares outstanding
|
|
|
98,684,465
|
|
|
|
47,421,064
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Statement of Cash Flows Data
|
|
|
|
(in $000s)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
$
|
(15,180
|
)
|
|
$
|
(3,889
|
)
|
|
Net cash used in investing activities
|
|
|
(948
|
)
|
|
|
(21
|
)
|
|
Net cash provided by financing activities
|
|
|
25,487
|
|
|
|
3,749
|
|
|
Effect of exchange rate changes on cash
|
|
|
(6
|
)
|
|
|
27
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
9,353
|
|
|
|
(134
|
)
|
|
Cash and cash equivalents at beginning of period
|
|
|
790
|
|
|
|
4,943
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
10,143
|
|
|
$
|
4,809
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Statement of Stockholders Deficit Data
|
|
(in $000s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
Stockholders’ deficit at beginning of period
|
|
$
|
(17,730
|
)
|
|
$
|
(14,177
|
)
|
|
|
|
|
|
|
|
Net loss for the period
|
|
|
(22,487
|
)
|
|
|
(6,077
|
)
|
|
Stock-based compensation expense
|
|
|
381
|
|
|
|
620
|
|
|
Foreign currency translation adjustment
|
|
|
386
|
|
|
|
(569
|
)
|
|
Share, option and warrant issuance
|
|
|
11,677
|
|
|
|
4,633
|
|
|
Issuance of common stock as payment of loan
|
|
|
22,500
|
|
|
|
—
|
|
|
|
|
|
|
|
|
Stockholders’ deficit at end of period
|
|
$
|
(5,273
|
)
|
|
$
|
(15,570
|
)
|
|
|
|
|
|
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EPCT-GEN
