Incara Announces Results for Third Quarter of Fiscal 2002
RESEARCH TRIANGLE PARK, N.C., Aug. 13 /PRNewswire-FirstCall/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - News) today announced the financial results for its third quarter of fiscal 2002, the three-month period ended June 30, 2002. The company also included recent progress from its research and development programs and financing activities.
During the third and current fiscal quarter, Incara highlights include:
* Allowance of Incara's Investigational New Drug Application (IND) by the FDA to begin Phase 1 clinical trials of cryopreserved human liver cells for the treatment of patients with cirrhosis and end-stage liver disease. Assuming adequate financial resources, the company intends to initiate clinical trials this fall.
* $3 million equity investment in Incara was made in May 2002 by an affiliate of Elan Corporation, plc to enable the development of Incara's catalytic antioxidant compounds as adjunctive agents to cancer treatment. Specifically, the compounds might reduce therapy-limiting side effects and improve outcome of radiation therapy.
* Enrollment reached 138 patients in a Phase 2/3 multicenter clinical trial for deligoparin, an ultra-low molecular weight heparin being developed by Incara in a business venture with Elan Corporation for treatment of ulcerative colitis. Results of this pivotal trial should be available around March 2003.
"With the ongoing clinical trial for deligoparin in its 20th month, and now a clinical trial for the liver cell therapy program scheduled for this fall, we have made significant progress despite a very harsh financial environment," stated Clayton I. Duncan, Chairman and CEO of Incara. "Furthermore, if all goes according to plan, we will also have one or more clinical programs for our catalytic antioxidants within the next year."
Incara reported a net loss attributable to common stockholders of $3,383,000, or $.26 per share basic and diluted, for the three months ended June 30, 2002, and a net loss attributable to common stockholders of $9,449,000, or $.74 per share basic and diluted, for the nine months ended June 30, 2002. In comparison, the Company reported a net loss of $3,237,000, or $.40 per share, for the three months ended June 30, 2001, and a net loss of $19,499,000, or $2.59 per share, for the nine months ended June 30, 2001. The net loss for the nine month period ended June 30, 2001, included an immediate expense of Incara's $12,015,000 investment in Incara Development, Ltd., a company that was formed by Incara and Elan Corporation to develop deligoparin (previously named OP2000).
Incara is currently considering various financial alternatives regarding its need for additional capital. These alternatives could include additional sales of stock, the sale of one or more of the company's programs, or the sale of the entire company. Without additional capital, the company expects to run out of cash around the end of the current fiscal year.
Incara also announced it has restated its balance sheet as of the year ended September 30, 2001, to reclassify its Series C redeemable convertible exchangeable preferred stock outside of permanent stockholders' equity to the mezzanine section. This reclassification did not affect the net loss for any period, or affect the company's cash flow or cash position for any period. The Series C preferred stock is convertible by Elan into Incara Pharmaceuticals equity, or exchangeable by Elan for an additional 30.1% interest in Incara Development, Ltd. If the Series C preferred stock has not been exchanged or converted by Elan by December 21, 2006, it will be redeemed at Incara's option for either cash or equity of Incara Pharmaceuticals having the then fair market value of the Series C preferred stock plus dividends. The Series C preferred stock was reclassified because of its exchange feature, which allows the Series C preferred stock to be exchanged for certain assets (the additional 30.1% interest in Incara Development, Ltd.).
Incara Pharmaceuticals Corporation (www.incara.com) is focused on disease therapies based on tissue protection, repair and regeneration. The company has received allowance for an IND for the study of cryopreserved human liver cells for treatment of patients with severe liver disease and also is investigating the use of liver stem cells. Incara is developing a series of catalytic antioxidants as treatments for protection of cells from damage occurring in stroke and cancer radiation therapy, and for protection of cells in transplantation. In addition, in a business venture with Elan Corporation, Incara is conducting a Phase 2/3 multicenter clinical trial for deligoparin, an ultra-low molecular weight heparin being developed for treatment of ulcerative colitis. |