EpiCept Corporation Reports Second Quarter 2008 Operating and Financial Results Monday, August 11, 2008 12:02 AM
Symbols: EPCT
Ceplene Launch Plans for EU Progressing
Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced operating and financial results for the second quarter and six
months ended June 30, 2008. For the second quarter of 2008, EpiCept’s
net loss attributable to common stockholders was $7.8 million, or $0.15
per share, compared with a net loss attributable to common stockholders
of $7.0 million, or $0.22 per share, for the second quarter of 2007. For
the six months ended June 30, 2008, EpiCept’s
net loss attributable to common stockholders was $13.8 million, or $0.28
per share, compared to $14.7 million, or $0.45 per share, for the six
months ended June 30, 2007. As of June 30, 2008, EpiCept had
approximately 59.3 million shares outstanding.
“The second quarter was challenging for the
Company as we filed and then prepared to present the grounds for the
re-examination of the negative opinion of Ceplene®
issued by the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMEA) in March,”
stated Jack Talley, President and CEO of EpiCept. “Our
liquidity was negatively affected by the earlier decision on Ceplene®.
This required us to reduce expenses and renegotiate our loan with our
senior secured lender. However, with the overwhelming support for
Ceplene we received from key opinion leaders in hematology across Europe
we were able to successfully prevail in our appeal, and as a result we
believe we are now in a much more favorable position to improve the
Company’s liquidity while we simultaneously
make preparations to launch Ceplene in Europe through a marketing
partner.”
EpiCept today provided an update on several of its key product
candidates:
-
Ceplene® - is
intended for the remission maintenance and prevention of relapse of
patients with Acute Myeloid Leukemia (AML) in first remission, the
most common type of leukemia in adults. In July 2008, the CHMP issued
a positive opinion regarding the marketing authorization application
(MAA) for Ceplene®.
EpiCept is working with the EMEA to finalize the product labeling, the
package insert or SPC, the risk management plan and the
phamacovigilance plan for post introduction monitoring of adverse
reactions. EpiCept expects final marketing authorization to occur in
September/October 2008. Several marketing partners are under
consideration for the licensing of the European marketing rights to
Ceplene at this time. First commercial introduction of Ceplene is
expected to occur in Europe in the first quarter of 2009.
-
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. In February
2008, EpiCept reported encouraging results from a Phase II trial for
NP-1 in Diabetic Peripheral Neuropathy (DPN), which the Company
believes support the advancement of NP-1 to a pivotal Phase III trial
in DPN. EpiCept NP-1 is currently being studied in two additional
clinical trials: a Phase III trial in chemotherapy-induced peripheral
neuropathy (CPN) being conducted by the National Cancer Institute
(NCI)-funded Community Clinical Oncology Program, and a Phase II
comparative trial versus gabapentin and placebo in post-herpetic
neuralgia (PHN). Enrollment for the PHN trial is complete and top line
results are expected in the fourth quarter of 2008.
-
EPC2407 - a vascular disruption agent (VDA) that also has potent
direct apoptotic activity on cancer cells. In April 2008, the Company
announced that it is evaluating the pharmacodynamic effects of EPC2407
with different dosage schedules and expects to initiate a Phase Ib
combination trial for the compound with other chemotherapeutic agents
in 2009.
-
Azixa™ - a compound discovered by EpiCept
and licensed to Myriad Genetics, Inc. as part of an exclusive,
worldwide development and commercialization agreement. EpiCept
received a milestone payment in March 2008 as a result of Myriad’s
dosing of the first patient in the first of its three Phase II trials.
EpiCept will earn an additional milestone payment upon the dosing of
the first patient in the first Phase III trial.
Financial and Operating Highlights
General and Administrative Expense
General and administrative expense decreased by 33%, or $1.1 million,
from $3.3 million in the second quarter of 2007 to $2.2 million
in the second quarter of 2008. The decrease was primarily attributable
to lower personnel, accounting, public reporting and investor relations
costs for the second quarter of 2008 as compared to the same period in
2007. In addition, for the second quarter of 2007, we incurred a $0.4
million charge for liquidating damages as a result of a registration
statement not being declared effective by the required date and a $0.3
million charge relating to a release and settlement agreement with our
senior secured lender. General and administrative expense decreased by
27%, or $1.8 million from $6.6 million for the six months ended June 30,
2007 to $4.8 million for the six months ended June 30, 2008.
Research and Development (R&D) Expense
Research and development expense was $3.3 million in the second quarter
of 2008, unchanged from the second quarter of 2007. During the second
quarter of 2008, EpiCept’s clinical efforts
were focused primarily on the completion of the clinical trials of NP-1
and preparation for the reexamination of the negative determination
issued by the CHMP regarding EpiCept’s MAA
for Ceplene®. During the second quarter of
2007, EpiCept commenced two clinical trials of NP-1 and continued our
Phase I clinical trial of EPC 2407. EpiCept also reviewed the Day 80
report and the Day 120 List of Questions related to the Ceplene MAA, and
commenced preparation of our response to the EMEA. For the six months
ended June 30, 2008, research and development expenses decreased by 3%,
or $0.2 million from $7.0 million for the six months ended June 30, 2007
to $6.8 million for the six months ended June 30, 2008.
Other Expense, Net
Other expense, net increased by $1.7 million to $2.2 million in the
second quarter of 2008 from $0.5 million in the second quarter of 2007.
The increase in other expense, net was primarily attributable to a $2.0
million non-cash loss on the extinguishment of debt recorded in the
second quarter of 2008. In June 2008, EpiCept entered into a second
amendment to the original debt agreement with its senior secured lender,
which was considered a substantial modification. As a result of the
modification to the original debt agreement, EpiCept recorded the new
debt at its fair value and recorded a loss on the extinguishment of the
original debt of $2.0 million.
Cash from Operations
Net cash used in operating activities for the first six months of 2008
was $7.8 million as compared to $10.5 million in the first six months of
2007. During the first six months of 2008, cash was used primarily to
fund EpiCept’s net loss for the period,
partially offset by non-cash charges of $1.7 million related to the
extinguishment of debt, $1.3 million of FAS 123R stock-based
compensation and $0.1 million of depreciation and amortization expenses.
Deferred revenue increased by $1.0 million as a result of receiving a
$1.0 million milestone payment from Myriad.
Nasdaq Listing Update
On August 6, 2008, the Company received a letter from the Nasdaq Office
of the General Counsel stating that the Nasdaq Hearings Panel had
granted the Company’s request for continued
listing on The Nasdaq Stock Market, subject to the Company’s
ability to (i) maintain a market value of listed securities above $35
million for ten (10) consecutive trading days, on or before August 29,
2008, and (ii) comply with all requirements for continued listing on The
Nasdaq Stock Market. The market value of the Company’s
listed securities has exceeded $35 million for each of the six
consecutive trading days ending August 8, 2008. The Company has until
October 13, 2008 to regain compliance with Marketplace Rule
4320(e)(2)(E)(ii), which requires that the closing bid price of the
Company’s common stock be a minimum of $1.00.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and pain.
The Company's broad portfolio of pharmaceutical product candidates
includes Ceplene®, a
cytokine immunomodulator that recently received a positive opinion from
the CHMP in Europe for the remission maintenance of AML patients, and
several pain therapies in clinical development. In addition, EpiCept's
ASAP technology, a proprietary live cell high-throughput caspase-3
screening technology, can efficiently identify new cancer drug
candidates and molecular targets that selectively induce apoptosis in
cancer cells. Two oncology drug candidates currently in clinical
development that were discovered using this 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 EpiCept's 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, our need to raise additional financing to
continue to meet our capital needs 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 or that we may
default on our loans or that our lenders may declare the Company in
default or that our secured lender would seek to sell our assets, the
risk that the Company’s securities may be
delisted by The Nasdaq Capital Market or the OMX Nordic Exchange, the
risk that we do not receive final regulatory marketing approval by the
European Commission for Ceplene®,
the risk that Ceplene®,
if approved, will not be launched in the first quarter 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 Myriad’s
development of Azixa™ will not be successful,
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 Myriad, the risk that the development of our other apoptosis
product candidates will not be successful, the risk that our ASAP
technology will not yield any successful product candidates, the risk
that clinical trials for NP-1 or EPC2407 will not be successful, the
risk that NP-1 or EPC2407 will not receive regulatory approval or
achieve significant commercial success, 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; risks
associated with prior material weaknesses in our internal controls; and
risks associated with our ability to protect our intellectual property.
These factors and other material risks are more fully discussed in
EpiCept’s 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 EpiCept’s
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.
EPCT-GEN
*Azixa is a registered trademark of Myriad Genetics, Inc.
Selected financial information follows:
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Balance Sheet Data
|
|
|
|
|
|
(in $000s)
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ 1,326
|
|
$ 4,943
|
|
Property and equipment, net
|
|
581
|
|
599
|
|
Total assets
|
|
3,093
|
|
7,398
|
|
|
|
|
|
|
|
Accounts payable and other accrued liabilities
|
|
6,552
|
|
4,028
|
|
Deferred revenue
|
|
7,765
|
|
6,837
|
|
Notes and loans payable
|
|
7,719
|
|
9,928
|
|
Total stockholders’ deficit
|
|
(19,505)
|
|
(14,177)
|
|
Total liabilities and stockholders’
deficit
|
|
$ 3,093
|
|
$ 7,398
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
Selected Consolidated Statement of Operations Data
|
|
(in $000s except share and per share data)
|
|
|
|
|
|
|
|
|
|
For Three Months Ended
|
|
For Six Months Ended
|
|
|
June 30,
|
|
June 30,
|
|
June 30,
|
|
June 30,
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
$ 42
|
|
$ 100
|
|
$ 91
|
|
$ 259
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
General and administrative
|
2,248
|
|
3,354
|
|
4,837
|
|
6,648
|
|
Research and development
|
3,314
|
|
3,280
|
|
6,786
|
|
7,012
|
|
Total operating expenses
|
5,562
|
|
6,634
|
|
11,623
|
|
13,660
|
|
Loss from operations
|
(5,520)
|
|
(6,534)
|
|
(11,532)
|
|
(13,401)
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest income
|
5
|
|
18
|
|
20
|
|
64
|
|
Foreign exchange gain
|
(11)
|
|
63
|
|
384
|
|
108
|
|
Interest expense
|
(377)
|
|
(591)
|
|
(850)
|
|
(1,207)
|
|
Loss on extinguishment of debt
|
(1,975)
|
|
—
|
|
(1,975)
|
|
—
|
|
Change in value of warrants and derivatives
|
113
|
|
—
|
|
113
|
|
(278)
|
|
Other income (expense), net
|
(2,245)
|
|
(510)
|
|
(2,308)
|
|
(1,313)
|
|
Net loss before income taxes
|
(7,765)
|
|
(7,044)
|
|
(13,840)
|
|
(14,714)
|
|
Income taxes
|
—
|
|
—
|
|
(2)
|
|
(4)
|
|
Net loss
|
$ (7,765)
|
|
$ (7,044)
|
|
$ (13,842)
|
|
$ (14,718)
|
|
Basic and diluted loss per common share
|
$ (0.15)
|
|
$ (0.22)
|
|
$ (0.28)
|
|
$ (0.45)
|
|
Weighted average common shares outstanding
|
52,012,245
|
|
32,404,185
|
|
49,703,971
|
|
32,399,800
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
(Unaudited)
|
|
|
|
|
Selected Consolidated Statement of Cash Flows Data
|
|
|
(in $000s)
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
Net cash used in operating activities
|
$ (7,790)
|
|
$ (10,546)
|
|
Net cash provided by (used in) investing activities
|
297
|
|
(137)
|
|
Net cash provided by (used in) financing activities
|
3,818
|
|
(1,528)
|
|
Effect of exchange rate changes on cash
|
58
|
|
(1)
|
|
Net decrease in cash and cash equivalents
|
(3,617)
|
|
(12,212)
|
|
Cash and cash equivalents at beginning of period
|
4,943
|
|
14,097
|
|
Cash and cash equivalents at end of period
|
$ 1,326
|
|
$ 1,885
|
|
EpiCept Corporation and Subsidiaries
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Selected Consolidated Statement of Stockholders Deficit Data
|
|
(in $000s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Stockholders’ deficit at beginning of
period
|
|
$ (14,177)
|
|
$ (9,373)
|
|
|
|
|
|
|
|
Net loss for the period
|
|
(13,842)
|
|
(14,718)
|
|
Stock-based compensation expense
|
|
1,313
|
|
1,203
|
|
Foreign currency translation adjustment
|
|
(558)
|
|
(157)
|
|
Share, option and warrant issuance
|
|
7,759
|
|
1,028
|
|
Financing Costs
|
|
—
|
|
(63)
|
|
Reclassification of warrants from liability to equity, net
|
|
—
|
|
794
|
|
|
|
|
|
|
|
Stockholders’ deficit at end of period
|
|
$ (19,505)
|
|
$ (21,286)
|
EPCT-GEN
EpiCept Corporation: Robert W. Cook, 914-606-3500 rcook@epicept.com or Media: Feinstein
Kean Healthcare Greg Kelley, 617-577-8110 gregory.kelley@fkhealth.com or Investors: Lippert/Heilshorn
& Associates Kim Sutton Golodetz, 212-838-3777 kgolodetz@lhai.com or Bruce
Voss, 310-691-7100 bvoss@lhai.com
(Source: Business Wire )
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