RESEARCH TRIANGLE PARK, N.C., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN) reported today its financial results and operational highlights for the third quarter ended September 30, 2008. For the third quarter of 2008, the Company reported revenues of $3.1 million and a net loss of $3.6 million. As of September 30, 2008, the Company's cash and cash equivalents totaled $38.7 million.
"Initiating our Phase II study for senicapoc in allergic asthma represents the first of several exciting milestones that we anticipate in the coming months," said P. Kay Wagoner, Ph.D., Chief Executive Officer. "We expect to report Phase II results from this first asthma study and to potentially initiate additional development work in our asthma program in 2009. In addition, provided that our Phase I program for ICA-105665, our novel KCNQ compound, is successful, we plan to initiate our Phase II program in epilepsy in the first half of 2009. We believe that these programs, along with the progress in our research programs, demonstrate the value creation potential of our broad-based ion channel technology platform."
Pipeline Update
Senicapoc for Asthma: In October, the Company initiated a Phase II
proof-of-concept clinical trial to evaluate the safety and efficacy
of senicapoc, the Company's novel orally available small molecule
inhibitor of the KCa3.1 potassium ion channel, in patients with
allergic asthma. Results from a preclinical study demonstrated the
ability of senicapoc to reverse antigen-induced increases in airway
resistance and airway hyper-reactivity. The objective of the current
trial is to confirm these positive results in a clinical setting.
This Phase II trial is a double-blind, placebo-controlled, parallel
group study that is designed to assess the safety and efficacy of
senicapoc, administered once a day for two weeks, on pulmonary
function in patients with allergic asthma following exposure to a
known allergen. The study will enroll approximately 30 patients
randomized in a 1:1 ratio to senicapoc or placebo at sites in the
United Kingdom. The primary efficacy analysis of this Phase II study
is the comparison between treatment arms of the late asthmatic
response caused by inhalation of allergen, measured by percent
change in Forced Expiratory Volume 1 (FEV1), the amount of air that
can be forcefully exhaled in one second. FEV1 is a standard,
commonly used test to measure lung function.
ICA-105665 for Epilepsy and Neuropathic Pain: During the second
quarter, the Company initiated a multiple ascending dose Phase I
trial of ICA-105665, a selective opener of KCNQ potassium channel
subtypes, to further assess the safety, tolerability and
pharmacokinetics of this novel compound. In nonclinical studies,
ICA-105665 has demonstrated a broad spectrum of activity in a wide
range of seizure models, including models of treatment-resistant
seizures, as well as activity in certain models of chronic pain.
Following the completion of the first two cohorts of healthy
volunteers in the multiple ascending dose Phase I study, the FDA
approved the Company's request to study an additional cohort of
healthy volunteers at a higher dose, 200 mg bid, than those
previously studied. Dosing for this additional cohort has now been
completed. Additionally, the trial was expanded to include a cohort
of patients with epilepsy to further study the safety, tolerability
and pharmacokinetics of ICA-105665 in the target population.
Results of this Phase I trial are expected in late 2008 or early
2009. Provided that results are supportive, the Company plans to
initiate the Phase II clinical trial program of ICA-105665 during
the first half of 2009.
Pfizer Collaboration: The Company's collaboration with Pfizer is
focused on three sodium channels for the treatment of pain and
related disorders. A series of leading compounds for one of the
targets has been selected for additional testing. Lead optimization
is in progress for each of the other two targets. The two companies
are targeting the identification of one or more clinical candidates
in the next six to nine months.
Astellas Collaboration: In August 2008, the Company was notified
by Astellas Pharma, Inc. ("Astellas"), that, following further
evaluation of certain compounds discovered in collaboration with the
Company for the chronic treatment of memory loss associated with
aging, such as occurs in dementia, including Alzheimer's disease, it
has decided not to pursue their further development. As a result of
this decision, the Company's collaboration with Astellas has now
concluded.
Financial Results
Revenues for the third quarter of 2008 totaled $3.1 million, as compared to $12.9 million during the same period in 2007, a decrease of 76%. The decrease in revenues for the third quarter of 2008, as compared to the same period in 2007, was due to the termination of the McNeil collaboration, partially offset by an increase in revenue associated with the Pfizer collaboration. As a result of the termination of the McNeil collaboration during the third quarter of 2007, the remaining balance of $10.4 million of deferred revenue associated with the collaboration as of June 30, 2007 was recognized as revenue during the third quarter of 2007.
Operating expenses for the third quarter of 2008 were $6.9 million, as compared to $7.7 million during the same period in 2007, a decrease of 11%. The decrease in operating expenses for the third quarter of 2008, as compared to the same period in 2007, was due primarily to a decrease in research and development expenses related to the development of senicapoc for sickle cell disease, partially offset by an increase in research and development expenses related to the development of senicapoc for asthma and ICA-105665 for epilepsy and neuropathic pain.
Net loss for the third quarter of 2008 totaled $3.6 million, as compared to net income of $5.6 million during the same period in 2007. The net loss for the third quarter of 2008, as compared to the net income generated during the same period in 2007, was primarily due to a decrease in revenues as noted above.
Revenues for the first nine months of 2008 totaled $9.3 million, as compared to $18.2 million during the same period in 2007, a decrease of 49%. The decrease in revenues for the first nine months of 2008, as compared to the same period in 2007, was due to the termination of the McNeil collaboration, partially offset by an increase in revenue associated with the Pfizer collaboration. As noted above, as a result of the termination of the McNeil collaboration during the third quarter of 2007, the remaining balance of $10.4 million of deferred revenue associated with the collaboration as of June 30, 2007 was recognized as revenue during the third quarter of 2007.
Operating expenses for the first nine months of 2008 were $21.0 million, as compared to $26.8 million for the same period in 2007, a decrease of 22%. The decrease in operating expenses for the first nine months of 2008, as compared to the same period in 2007, was due primarily to a decrease in research and development expenses related to the development of senicapoc for sickle cell disease and the complete write-off during 2007 of a capitalized license payment that had previously been made to Children's Medical Center Corporation in connection with the Company's collaboration with McNeil due to the termination of this collaboration. This decrease was partially offset by an increase in research and development expenses related to the development of senicapoc for asthma and ICA-105665 for epilepsy and neuropathic pain.
Net loss for the first nine months of 2008 totaled $10.9 million, as compared to $7.3 million during the same period in 2007, an increase of 49%. The increase in net loss for the first nine months of 2008, as compared to the same period in 2007, was primarily due to a decrease in revenues as noted above.
Conference Call
Icagen will host a conference call to discuss these results today at 10:00 a.m. Eastern Time.
Date: Thursday, November 6, 2008 Time: 10:00 a.m. Eastern Time Dial-in (U.S. and Canada): 866-831-6234 Dial-in (International): 617-213-8854 Access code: 13430145 Web cast: www.icagen.com
An archived version of the webcast will also be available on Icagen's website for at least two weeks following the call. A playback of the call will be available from approximately 1:00 p.m. Eastern Time on November 6, 2008 for seven days and may be accessed by dialing:
Access number (U.S. and Canada): 888-286-8010 Access number (International): 617-801-6888 Access code: 78125144
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 a number of disease areas, including epilepsy, pain and inflammation. The Company has clinical stage programs in epilepsy and asthma.
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 Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2008. These risk factors include risks as to the Company's history of net losses and how long the Company will be able to operate on its existing capital resources; the Company's ability to raise additional funding; the Company's ability to maintain compliance with NASDAQ's continued listing requirements; whether the Company's product candidates 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 product candidates, including ICA-105665 and the Company's other lead compounds for epilepsy and neuropathic pain and senicapoc for asthma, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and if such product candidates receive approval, whether such products will be successfully marketed; and the Company's dependence on third parties, including manufacturers, suppliers and collaborators. 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
(in thousands, except share and per share data)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------- ----------------------
2008 2007 2008 2007
---------- ---------- ---------- ----------
Collaborative research
and development
revenues:
Research and
development fees $ 2,944 $ 11,953 $ 8,768 $ 14,508
Reimbursed research
and development costs 185 917 513 3,734
---------- ---------- ---------- ----------
Total collaborative
research and
development revenues 3,129 12,870 9,281 18,242
Operating expenses:
Research and
development 5,624 6,395 16,717 22,456
General and
administrative 1,254 1,329 4,289 4,393
---------- ---------- ---------- ----------
Total operating
expenses 6,878 7,724 21,006 26,849
---------- ---------- ---------- ----------
(Loss) income from
operations (3,749) 5,146 (11,725) (8,607)
Other income, net 177 466 795 1,280
---------- ---------- ---------- ----------
Net (loss) income $ (3,572) $ 5,612 $ (10,930) $ (7,327)
========== ========== ========== ==========
Net (loss) income per
share:
Basic $ (0.08) $ 0.14 $ (0.24) $ (0.20)
========== ========== ========== ==========
Diluted $ (0.08) $ 0.13 $ (0.24) $ (0.20)
========== ========== ========== ==========
Weighted average
common shares
outstanding-
Basic 46,885,500 39,245,452 45,920,399 36,298,526
========== ========== ========== ==========
Diluted 46,885,500 41,623,856 45,920,399 36,298,526
========== ========== ========== ==========
Icagen, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
Sept. 30, Dec. 31,
2008 2007
------- -------
Assets
Cash and cash equivalents $38,702 $43,513
Other current assets 1,082 827
Property and equipment, net 2,748 1,736
Technology licenses and related costs, net 429 465
Other long-term assets 105 116
------- -------
Total assets $43,066 $46,657
======= =======
Liabilities and stockholders' equity
Current liabilities $ 9,924 $11,444
Deferred revenue, less current portion 113 3,710
Equipment debt financing, less current portion 1,086 757
Other non-current liabilities 378 62
Stockholders' equity 31,565 30,684
------- -------
Total liabilities and stockholders' equity $43,066 $46,657
======= =======