Icagen Reports First Quarter 2006 Financial Results.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Icagen, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ICGN ICGN International Corporate Governance Network ) reported today its financial results for the first quarter ended March 31, 2006. Revenues for the first quarter of 2006 totaled $1.9 million. Net loss for the first quarter of 2006 was $6.7 million. As of March 31, 2006, cash and cash equivalents totaled $41.3 million. P. Kay Wagoner, Ph.D., Chief Executive Officer, noted, "Icagen continued to make excellent progress in our lead program for sickle cell disease sickle cell disease or sickle cell anemia, inherited disorder of the blood in which the oxygen-carrying hemoglobin pigment in erythrocytes (red blood cells) is abnormal. during the first quarter of 2006. During the quarter we met the midpoint mid·point n. 1. Mathematics The point of a line segment or curvilinear arc that divides it into two parts of the same length. 2. A position midway between two extremes. of enrollment in our pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial of ICA-17043. Additionally, the data monitoring committee met for the first planned periodic safety review and recommended that the trial continue without modification. We are also on track to begin a pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. pharmacokinetic and safety study, in which we expect to enroll the first patient during the second quarter. We also continue to advance our broad portfolio of earlier stage preclinical and research programs." Pipeline Update ICA-17043 for Sickle Cell Disease --During the first quarter of 2006, the Company continued patient enrollment in its pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of ICA-17043. ICA-17043 has both orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation and fast-track status. This trial is a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled study in 300 patients. The primary endpoint is vaso-occlusive crisis vaso-occlusive crisis Painful crisis Hematology A 'crisis' common in sickle cell anemia, in which 'sludged' sickled RBCs cause capillary stasis and infarction, and incapacitating musculoskeletal pain or 'referral'-type organ pain, hemoptysis, hematuria, melena, CNS rate in the ICA-17043 arm versus vaso-occlusive crisis rate in the placebo arm. The Company is conducting the study at approximately 65 sites across the U.S. and in selected other countries. The study design includes an interim efficacy analysis by an independent data monitoring committee ("DMC DMC Devil May Cry (video game) DMC Detroit Medical Center DMC Darryl McDaniels (rapper) DMC Destination Management Company DMC Del Mar College (Corpus Christi, TX) "), which is expected to occur during the third quarter of 2006. The Company's target timeframe for the completion of patient enrollment in this trial is the second half of 2006. --In January 2006, the Company reported that following the first per protocol interim safety review, the DMC recommended continuation of the pivotal Phase III clinical trial of ICA-17043 as planned. The DMC meets approximately every six months to review unblinded safety data from the pivotal Phase III clinical trial. --In March 2006, the Company reported that it had reached the midpoint of enrollment in its Phase III clinical trial of ICA-17043 on schedule, with 150 of the total expected study population of 300 patients enrolled at that time. --Results from the Company's open label extension study to the Phase II trial of ICA-17043, which had previously been reported, were recently presented by Dr. Paul Swerdlow, M.D., interim chief of the department of hematology and oncology at Wayne State University School of Medicine The Wayne State University School of Medicine (WSUSOM) is the largest single-campus medical school in the United States with more than 1,000 medical students. In addition to undergraduate medical education, the school offers master’s degree, Ph.D. and M.D.-Ph.D. , at the annual sickle cell disease meeting of the National Institutes of Health in Memphis, Tennessee For the ancient Egyptian capital, see . Memphis is a city in the southwest corner of Tennessee, and the county seat of Shelby County. Memphis rises above the Mississippi River on the 4th Chickasaw Bluff just below the mouth of the Wolf River. . --The Company continues preparations for two additional clinical trials for ICA-17043 in the treatment of sickle cell disease. The first of these studies, expected to begin during the second quarter, is a safety and pharmacokinetic study of ICA-17043 in the pediatric population. The second of these studies, expected to begin in the second half of 2006, will involve sickle cell disease patients who have secondary pulmonary hypertension Pulmonary Hypertension Definition Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right , a common and serious complication of this illness. Other Clinical and Preclinical Programs --Development continued on the Company's internal preclinical program in epilepsy and neuropathic neuropathic /neu·ro·path·ic/ (-path´ik) pertaining to or characterized by neuropathy. neuropathic pertaining to disease of the nervous system. pain, as well as the Company's research programs in pain, inflammation and glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). . --Bristol-Myers Squibb Company ("BMS BMS abbr. Bachelor of Marine Science "), the Company's collaborator in its atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. program, has notified the Company that it has decided to discontinue development of the compound for which an initial Phase I safety study had been completed. BMS is evaluating a backup compound for which it is conducting further preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. . --The Company's collaboration with Astellas Pharma Astellas Pharma Inc. (アステラス製薬株式会社 , Inc. ("Astellas"), the research phase of which was completed during 2003, allows for the selection of compounds generated by the collaboration by Astellas for certain specified indications and by Icagen for certain other specified indications. Astellas is evaluating compounds generated by the collaboration for potential further development in dementia, including Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . In addition, Icagen is evaluating certain other compounds with potential utility in the treatment of other central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , including attention deficit/hyperactivity disorder Attention deficit/hyperactivity disorder A persistent pattern of inattention, hyperactivity and/or impulsiveness; the pattern is more frequent and severe than is typically observed in people at a similar level of development. ("ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or "). Financials Revenues for the first quarter of 2006 totaled $1.9 million, as compared to $2.0 million during the same period in 2005, a decrease of 7%. The decrease in revenues for the first quarter of 2006, as compared to the same period in 2005, was primarily due to decreased revenues from the Company's collaboration with Abbott Laboratories Abbott Laboratories (NYSE: ABT) is a diversified pharmaceuticals and health care company. It has over 65,000 employees and operates in 130 countries. The corporate headquarters are in Abbott Park, Illinois, a neighborhood of North Chicago, Illinois. which concluded at year-end 2005, partially offset by increased cost sharing reimbursement from the Company's collaboration with the McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. ("McNeil") for the further clinical development of ICA-17043. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the first quarter of 2006 were $9.0 million, as compared to $7.6 million for the same period in 2005, an increase of 19%. The increase in operating expenses for the first quarter of 2006, as compared to the same period in 2005, was primarily due to increased research and development expenses related to the development of ICA-17043 as well as to an increase in general and administrative expenses. The adoption of FAS-123R as of January 1, 2006 resulted in stock-based compensation expense of approximately $0.5 million during the first quarter of 2006, as compared to approximately $0.3 million under APB-25 during the first quarter of 2005. Net loss for the first quarter of 2006 totaled $6.7 million, as compared to $5.3 million during the same period in 2005, an increase of 27%. The increase in net loss for the first quarter of 2006, as compared to the same period in 2005, was primarily due to higher research and development expenses and general and administrative expenses. 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: --800-683-1585 (United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Canada) --973-935-2107 (International) The access code for the call is 7326426. A webcast of this conference call 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 call. A playback of the call will be available from approximately 1:00 p.m. ET on May 9 through May 18, 2006 and may be accessed by dialing: --877-519-4471 (United States and Canada) --973-341-3080 (International) The access code for the call is 7326426. About Icagen Icagen, Inc. is a biopharmaceutical company based in Research Triangle Park, North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures Area, 52,586 sq mi (136,198 sq km). Pop. , focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate To insert a data signal into a carrier wave or direct current. See modulation. ion channel ion channel n. See 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's four most advanced programs are: --ICA-17043 for sickle cell disease, for which the Company is conducting a pivotal Phase III clinical trial; --lead compounds for epilepsy and neuropathic pain, for which the Company is conducting preclinical studies; --a compound for atrial fibrillation, for which the Company's collaborator Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were Company is conducting preclinical studies; --lead compounds for dementia, including Alzheimer's disease, for which the Company's collaborator Astellas Pharma Inc. is conducting preclinical studies, and lead compounds for attention deficit/hyperactivity disorder, which were derived from the collaboration and for which the Company is conducting preclinical studies; and Icagen is also conducting ongoing drug discovery programs focused on new therapeutics for pain disorders pain disorder Somatiform pain disorder, see there , inflammatory disorders and glaucoma. Forward Looking Statements This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , filed with the Securities and Exchange Commission on March 15, 2006. These risk factors include risks as to 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 ICA-17043, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , and for which indications, and if such products receive approval, whether they will be successfully marketed; the Company's history of net losses and how long the Company will be able to operate on its existing capital resources; 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
March 31,
----------------------
2006 2005
----------------------
Collaborative research and development revenues:
Research and development fees $468 $1,074
Reimbursed research and development costs 1,414 949
----------------------
Total collaborative research and development
revenues 1,882 2,023
Operating expenses:
Research and development 7,491 6,528
General and administrative 1,556 1,043
----------------------
Total operating expenses 9,047 7,571
----------------------
Loss from operations (7,165) (5,548)
Other income, net 416 237
----------------------
Net loss $(6,749) $(5,311)
======================
Net loss per share - basic and diluted $(0.31) $(0.40)
======================
Weighted average common shares outstanding -
basic and diluted 22,092,491 13,136,228
======================
Pro forma net loss per share assuming conversion
of preferred stock - basic and diluted $(0.27)
===========
Pro forma weighted average common shares
outstanding -
basic and diluted 19,393,588
===========
Unaudited pro forma basic and diluted net loss per share is computed
using the weighted average number of common shares outstanding,
including the pro forma effects of the automatic conversion of all
outstanding preferred stock into shares of the Company's common stock
effective upon the completion of the Company's initial public offering
as if such conversion had occurred at the date of the original
issuance. The following table sets forth the computation of unaudited
basic and diluted, and unaudited pro forma basic and diluted, net loss
per share.
Icagen, Inc.
Reconciliation of Historical and Proforma Results
(in thousands, except share and per share data)
(Unaudited)
Three Months Ended
March 31,
----------------------
2006 2005
----------------------
Historical:
Numerator:
Net loss $(6,749) $(5,311)
======================
Denominator:
Weighted-average common shares outstanding -
basic and diluted 22,092,491 13,136,228
======================
Net loss per share - basic and diluted $(0.31) $(0.40)
======================
Pro Forma:
Numerator:
Net loss, as reported $(5,311)
===========
Denominator:
Shares used above 13,136,228
Pro forma adjustments to reflect assumed
conversion of preferred stock, on a
weighted-average basis 6,257,360
-----------
Shares used to compute pro forma basic and
diluted net loss per share 19,393,588
===========
Pro forma net loss per share - basic and diluted $(0.27)
===========
Icagen, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
March 31, December 31,
2006 2005
------------------------
Assets
Cash and cash equivalents $41,295 $47,763
Other current assets 2,308 1,328
Property and equipment, net 1,965 2,130
Technology licenses and related costs, net 2,322 2,368
Other long-term assets 804 804
------------------------
Total assets $48,694 $54,393
========================
Liabilities and stockholders' equity
Current liabilities $7,458 $6,697
Deferred revenue, less current portion 12,260 12,510
Equipment debt financing, less current portion 1,026 1,194
Stockholders' equity 27,950 33,992
------------------------
Total liabilities and stockholders' equity $48,694 $54,393
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