09.05.2007 12:30:00
|
Icagen Reports First Quarter 2007 Financial Results
Icagen, Inc. (NASDAQ: ICGN) reported today its financial results for the
first quarter of 2007. For the first quarter of 2007, the Company
reported revenues of $2.0 million and a net loss of $6.5 million. As of
March 31, 2007, cash and cash equivalents totaled $40.3 million.
Seth Hetherington, M.D., SVP of Clinical and Regulatory Affairs noted,
"We have experienced both accomplishments and challenges in the early
part of 2007. While making excellent progress in several of our
programs, as earlier reported we terminated our Phase III study of
senicapoc for the reduction of crisis rate in patients with sickle cell
disease ("SCD") on the basis of our independent Data Monitoring Committee’s
("DMC”)
recommendation that there was a low probability of achieving the primary
endpoint of the study. When the data are available to us, we will
complete a full evaluation and discuss our findings with experts in the
field, as we consider potential future studies of senicapoc in other
indications in sickle cell disease."
P. Kay Wagoner, Ph.D., Chief Executive Officer, noted, "Beyond sickle
cell disease, in animal studies we and others have demonstrated that
senicapoc and related compounds decrease signs of inflammation and the
abnormal proliferation of certain cell types. Given that senicapoc has
thus far been generally well tolerated in approximately 200 volunteers,
we intend to explore the potential utility of this drug candidate in
other disease areas in which modulation of inflammatory and
proliferative responses would be therapeutically beneficial."
Dr. Wagoner noted further, "We have continued
to make strong progress in our preclinical programs. Most notably,
provided that the results of final preclinical studies are favorable, we
plan to file an IND and begin Phase I studies in our epilepsy and
neuropathic pain program in 2007. This program, which targets the
opening of a specific potassium channel, has produced compounds,
including the current lead, with broad-spectrum efficacy in multiple
models of epilepsy and neuropathic pain. We are also pleased with the
progress of our pain programs, which primarily target sodium and calcium
channels, and are fully committed to pursuing these and other
opportunities, all of which have been generated by our core ion channel
technology platform."
Pipeline Update
As previously reported, the Company recently terminated its Phase III
clinical trial of senicapoc for the treatment of sickle cell disease
in adults, in accordance with the recommendation of the DMC. This
recommendation was based upon the low probability of achieving a
reduction in crisis rate, the primary endpoint of the study. The DMC
noted that data from the trial indicated the expected changes in
hematologic parameters, consistent with an improvement in the
hemolytic anemia that characterizes this disease. Among the available
data, there were no statistically significant differences in safety
measurements between the senicapoc and placebo treatment groups. The
Company will analyze final data when available and consider future
options for the development of senicapoc in SCD. Other therapeutic
indications outside of SCD are also under consideration for this drug
candidate.
Progress continued on the Company’s
potassium channel program in epilepsy and neuropathic pain, with the
advancement of a lead compound into final preclinical studies.
Provided that these studies are favorable, the Company expects to file
an Investigational New Drug ("IND") application during 2007.
In the Company’s multi-target sodium channel
and multi-target calcium channel programs, hits, leads and advanced
leads focused on several novel ion channel targets have been
identified with potential utility in the treatment of neuropathic and
inflammatory pain.
The Company's collaborator Bristol-Myers Squibb Company ("BMS”)
is evaluating data from recently completed preclinical formulation and
toxicology studies on a lead compound for the treatment of atrial
fibrillation in order to determine next steps.
The Company’s collaborator Astellas Pharma,
Inc. ("Astellas”)
continues to evaluate a compound in preclinical studies with potential
utility in the treatment of dementia, including Alzheimer's disease.
In addition, Icagen continues to evaluate in preclinical studies
certain other compounds from the Astellas collaboration with potential
utility in the treatment of other central nervous system disorders,
including attention deficit/hyperactivity disorder ("ADHD”).
Corporate Developments
In February 2007, the Company announced the completion of a $22
million private placement. Principal investors in the financing
included Greenway Capital, Walker Smith Capital, QVT, Venrock
Associates, Alta Partners and NovaQuest, an affiliate of Quintiles
Transnational Corp, as well as other institutional and other
accredited investors.
During April 2007, the Company announced the formation of a drug
discovery and development expert panel with the initial appointment of
two distinguished pharmaceutical industry executives, Christopher
Cimarusti, Ph.D. and Ian Skidmore, Ph.D. Icagen's drug discovery and
development expert panel, which will include individuals from both the
pharmaceutical industry and academia, is being formed in order to
provide ongoing advice and guidance on key scientific and clinical
development issues related to the Company's portfolio of drug
discovery and development programs.
Richard D. Katz, M.D., SVP of Finance and Corporate Development, and
Chief Financial Officer, noted, "We were pleased to complete a $22
million private placement during the first quarter with a broad group of
highly regarded investors. This financing will provide the capital
needed to drive the continued advancement of our pipeline and to further
capitalize on our strengths in ion channel drug discovery and
development."
Financials
Revenues for the first quarter of 2007 totaled $2.0 million, as compared
to $1.9 million during the same period in 2006, an increase of 6%. The
increase in revenues for the first quarter of 2007, as compared to the
same period in 2006, was due to increased cost sharing reimbursement
from the Company’s collaboration with the
McNeil Pediatrics Division (formerly McNeil Consumer & Specialty
Division) of McNeil-PPC, Inc. ("McNeil”)
for the clinical development of senicapoc.
Operating expenses for the first quarter of 2007 were $8.9 million, as
compared to $9.0 million for the same period in 2006, a decrease of 2%.
The decrease in operating expenses for the first quarter of 2007, as
compared to the same period in 2006, was due to decreases in both
research and development expenses and general and administrative
expenses.
Net loss for the first quarter of 2007 totaled $6.5 million, as compared
to $6.7 million during the same period in 2006, a decrease of 4%. The
decrease in net loss for the first quarter of 2007, as compared to the
same period in 2006, was due to higher revenues and lower research and
development expenses and general and administrative expenses.
Financial Guidance
As a result of the changes noted above in the Company's sickle cell
disease program, the Company is providing revised financial guidance for
2007. This revised financial guidance reflects costs incurred during the
first quarter as well as expected wind-down costs related to the
termination of the Company's Phase III clinical trial of senicapoc.
The Company's original expectation for revenues had been in the range of
$7 to $9 million. Due to decreased expenses and thus decreased cost
sharing reimbursement from McNeil in connection with the Company's
sickle cell disease program, the Company now expects revenues to be in
the range of $4 to $5 million. The revised revenue guidance is based
upon expected revenues from the Company’s
collaboration with McNeil, and does not include any additional revenues
from any new collaborations. The Company's original expectation for
research and development expense had been in the range of $29 to $33
million. R&D expense is now expected to be in the range of $22 to $26
million. The Company's expectation for general and administrative
expense is unchanged at approximately $5 to $6 million. The Company's
original expectation for the operating loss had been in the range of $26
to $30 million. The operating loss is now expected to be in the range of
$21 to $25 million.
The guidance provided above includes the effect of stock-based
compensation expense in accordance with FAS-123R. For 2007, the Company’s
expectation for stock-based compensation expense is unchanged at
approximately $2.5 million.
Conference Call
Icagen will host a conference call to discuss these results today at
10:00 a.m. ET.
To listen to the conference call, please dial:
877-715-5282 (United States and Canada)
973-582-2850 (International)
Please reference reservation number 8723171.
A webcast of this conference will be available on Icagen’s
website at www.icagen.com. An
archived version of the webcast will also be available on Icagen’s
website for at least two weeks following the meeting.
A playback of the call will be available from approximately 1:00 p.m. ET
on May 9 through May 18, 2007 and may be accessed by dialing:
877-519-4471 (United States and Canada)
973-341-3080 (International)
Please reference reservation number 8723171.
About Icagen
Icagen, Inc. is a biopharmaceutical company based in Research Triangle
Park, North Carolina, focused on the discovery, development and
commercialization of novel orally-administered small molecule drugs that
modulate ion channel targets. Utilizing its proprietary know-how and
integrated scientific and drug development capabilities, Icagen has
identified multiple drug candidates that modulate ion channels. The
Company is conducting research and development activities, in some cases
in collaboration with major pharmaceutical companies, in a number of
disease areas, including epilepsy; pain; inflammation; sickle cell
disease; atrial fibrillation; dementia, including Alzheimer's disease;
and attention deficit / hyperactivity disorder.
Forward Looking Statements
This press release contains forward-looking statements that involve a
number of risks and uncertainties. For this purpose, any statements
contained herein that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the foregoing,
the words "believes,” "anticipates,” "plans,” "expects,” "intends,”
and similar expressions are intended to identify forward-looking
statements. Important factors that could cause actual results to differ
materially from the expectations described in these forward-looking
statements are set forth under the caption "Risk
Factors” in the Company’s
most recent Annual Report on Form 10-K, filed with the SEC on March 6,
2007 and amended on April 27, 2007. These risk factors include risks as
to the Company’s ability to raise additional
funding; the Company’s ability to maintain
compliance with NASDAQ’s continued listing
requirements; the Company’s history of net
losses and how long the Company will be able to operate on its existing
capital resources; whether the Company’s
products will advance in the clinical trials process; the timing of such
clinical trials; whether the results obtained in preliminary studies
will be indicative of results obtained in clinical trials; whether the
clinical trial results will warrant continued product development;
whether and when, if at all, the Company’s
products, including senicapoc, will receive approval from the U.S. Food
and Drug Administration or equivalent regulatory agencies, and for which
indications, and if such products receive approval, whether they will be
successfully marketed; and the Company’s
dependence on third parties, including manufacturers, suppliers and
collaborators, including McNeil, the Company's collaborator for its
sickle cell disease program. We disclaim any intention or obligation to
update any forward-looking statements as a result of developments
occurring after the date of this press release.
Icagen, Inc. Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended March 31, 2007
2006
Collaborative research and development revenues:
Research and development fees
$ 492
$ 468
Reimbursed research and development costs
1,498
1,414
Total collaborative research and development revenues
1,990
1,882
Operating expenses:
Research and development
7,387
7,491
General and administrative
1,467
1,556
Total operating expenses
8,854
9,047
Loss from operations
(6,864)
(7,165)
Other income, net
379
416
Net loss
$ (6,485)
$ (6,749)
Net loss per share - basic and diluted
$ (0.20)
$ (0.31)
Weighted average common shares outstanding - basicand diluted
31,637,662
22,092,491
Icagen, Inc. Condensed Balance Sheets
(in thousands)
March 31, December 31, 2007
2006
(Unaudited)
Assets
Cash and cash equivalents
$ 40,252
$ 25,131
Other current assets
3,616
921
Property and equipment, net
1,387
1,566
Technology licenses and related costs, net
2,137
2,183
Other long-term assets
52
1,014
Total assets
$ 47,444
$ 30,815
Liabilities and stockholders’ equity
Current liabilities
$ 7,546
$ 6,481
Deferred revenue, less current portion
11,264
11,513
Equipment debt financing, less current portion
645
774
Stockholders’ equity
27,989
12,047
Total liabilities and stockholders’ equity
$ 47,444
$ 30,815
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