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Neoprobe looks to file for Lymphoseek approval early next year

Neoprobe Corp.’s (OTCBB:NEOP) third-quarter loss narrowed, but more importantly, the company remains on track to file for regulatory approval of its cancer-detecting drug Lymphoseek early next year.

Neoprobe Corp.‘s (OTCBB:NEOP) third-quarter loss narrowed, but more importantly, the company remains on track to file for regulatory approval of its cancer-detecting drug Lymphoseek early next year.

Neoprobe reported a net loss attributable to common stockholders of $2.4 million, or 3 cents per share, compared to a net loss attributable to common stockholders of $25.1 million, or 34 cents per share, for the third quarter of 2009. In last year’s third quarter, the company took about $22 million in charges related to “non-cash losses.”

The company hopes to complete patient enrollment by early next year in a key clinical trial of Lymphoseek, a tracing agent that identifies cancerous lymph nodes in patients with breast cancer and melanoma. The company estimates Lymphoseek’s market at $450 million.

Assuming the company achieves its patient enrollment goals on time, it’d likely to file for regulatory approval of Lymphoseek around the end of next year’s first quarter. Neoprobe had previously planned to file for approval in October but pushed the timeline back at the request of federal regulatory who wanted more data in the company’s application.

The company also is looking to move ahead with clinical trials of RIGScan. This tracing agent works by attaching itself to cancerous cells in the body, which can then be identified by a handheld radiation-detection device. A cancer patient is injected with the drug before surgery, and the radiation scanner directs the surgeon to cancerous tissue in the patient’s body. The drug is likely years away from commercialization.

Third-quarter revenues dropped 11 percent to $2.3 million because revenues in last year’s third quarter were “unreasonably high,” due to initial stocking orders for new products, the company said. Currently, the company draws its sales from gamma detection devices, which are used to evaluate the potential spread of cancer to lymph nodes and organs.

As of Sept. 30, the company had $2.7 million in cash on its balance sheet, compared with $5.6 million at the end of 2009.

Neoprobe still is seeking to be listed on the New York Stock Exchange’s AMEX market. The company applied for a listing in August but must achieve a share price of $2, among other financial targets, to qualify, CEO David Bupp said.

Neoprobe’s shares, which are listed on NASDAQ’s Over-The-Counter Bulletin Board, closed flat Wednesday at $1.73.