Icagen reports revenues of $1.5M, net loss of $3.2M for first-quarter 2010

May 7 2010

Icagen, Inc. (Nasdaq:ICGN) reported today its financial results and operational highlights for the first quarter ended March 31, 2010. For the first quarter of 2010, the Company reported revenues of $1.5 million and a net loss of $3.2 million. As of March 31, 2010, the Company's cash and cash equivalents totaled $14.3 million.

"The first quarter of 2010 has been important in the progression of our lead compound, ICA-105665, along its clinical development path for epilepsy and pain.  We were pleased to recently report positive results in our Phase IIa study in patients with photosensitive epilepsy and to have these results presented at the Tenth Eilat Conference on New Antiepileptic Drugs in Israel. Based upon the efficacy demonstrated in that study, as well as the safety profile in all clinical studies to date, we were pleased that the FDA was supportive of our plan to investigate higher doses of ICA-105665. These studies, the combined cost of which is expected to be approximately $1.0 million, will position us to optimize dose selection for potential future clinical trials," noted P. Kay Wagoner, CEO of Icagen, Inc.

Pipeline Update

ICA-105665 for Epilepsy and Pain: The Company recently reported positive results in its Phase IIa study in patients with photosensitive epilepsy. Based upon the efficacy demonstrated in this study, coupled with a favorable clinical safety profile, consistent pharmacokinetics and the lack of a maximal tolerated dose in all clinical studies to date, the Company proposed, and the FDA approved, a study of up to two additional cohorts of photosensitive epilepsy patients at higher doses of ICA-105665. In addition, subject to review of a finalized protocol, the FDA agreed to a second study of higher doses of ICA-105665 in a multiple ascending dose trial of healthy volunteers. The objective of both of these studies is to evaluate higher doses of ICA-105665 in order to optimize dose selection for subsequent larger clinical trials.

If these studies are successful, the Company plans to initiate, subject to available funding, a Phase IIb study in patients with treatment-resistant, partial-onset epilepsy. As currently planned, the Phase IIb trial is expected to be a double blind, placebo controlled study in patients who have seizures despite treatment with optimal medical therapy. The primary endpoint is expected to be a reduction in seizure frequency. The Phase IIb trial will be designed with input from the FDA and is expected to be similar to other studies that have been utilized at this stage of the development of other antiepileptics.

During the quarter, the Company also reported results of a Phase Ib pain study of ICA-105665.   At the single dose tested, ICA-105665 did not reduce the pain elicited in the capsaicin or sunburn models. The compound was well tolerated with no serious adverse events and with similar numbers of adverse events across treatment groups. Pharmacokinetic parameters were consistent with expectations. Following completion of the planned multiple ascending dose and photosensitive epilepsy studies at higher doses, the Company plans to consider additional studies in pain at higher doses.

Results of the photosensitive epilepsy study were recently presented at the Tenth Eilat Conference on New Antiepileptic Drugs in Eilat, Israel. The presentation was delivered by Dorothee Kasteleijn-Nolst Trenite, MD, University Medical Centre Utrecht and Universita di Roma Sapienza II, Rome, Italy. Dr. Kasteleijn-Nolst Trenite is an internationally recognized expert on studies of photosensitivity as proof of concept for new antiepileptic drugs and served as the central electroencephalogram (EEG) reviewer for the study.  

Research Programs: The Company's collaboration with Pfizer continues to make progress as it focuses on the identification of novel compounds targeting three specific sodium channels, including Nav1.7, for the treatment of pain. In addition, the Company has ongoing research efforts directed at several other ion channel targets focused primarily on pain and inflammatory disorders.   

Financial Results

Revenues for the first quarter of 2010 were $1.5 million, as compared to $3.0 million during the same period in 2009, a decrease of 51%. The decrease in revenues for the first quarter of 2010, as compared to the same period in 2009, was due primarily to a decrease in amortization of the initial upfront payment from Pfizer which became fully amortized during the third quarter of 2009.

Operating expenses for the first quarter of 2010 were $4.7 million, as compared to $6.6 million during the same period in 2009, a decrease of 29%. This decrease in operating expenses was primarily due to decreased research and development costs as a result of the Company's decision to terminate the development of senicapoc for asthma, as well as decreased operating expenses resulting from the Company's ongoing cost reduction efforts. 

Net loss for the first quarter of 2010 was $3.2 million, as compared to $3.6 million during the same period in 2009, a decrease of 11%. The decrease in net loss for the first quarter of 2010, as compared to the same period in 2009, was primarily due to reduced operating expenses as noted above, partially offset by reduced revenues. As of March 31, 2010, the Company had cash and cash equivalents of $14.3 million.