By Patrick Crutcher
Shares of Neoprobe (NEOP.OB) rose from $3 to a high of $3.71 on Wednesday after the company announced on Monday that they had been approved to list their shares on the NYSE AMEX. Neoprobe had been trading on the OTC Bulletin Board, but will now trade on the NYSE Amex on Thursday, February 10, 2011.
As we told premium subscribers on Monday, Neoprobe's ticker symbol will change to “NEOP” from “OTCBB:NEOP”. This development is a significant milestone in their history and should attract the interest of more investors, specifically institutional ones. When shares were trading at $2.15 we told our readers that pivotal catalysts will shape the company this year. We continue to believe that management has executed well on their promises and there is more potential upside in the coming months.
President and CEO David C. Bupp noted that the,“Enhanced investor visibility will be important to our ongoing business strategy and to building shareholder value as Neoprobe achieves upcoming development and commercial milestones, including completion of enrollment in our Lymphoseek NEO3-09 Phase 3 clinical study conducted in subjects with breast cancer or melanoma, disclosure of the NEO3-09 clinical study data, the filing of our Lymphoseek NDA, the completion of our FDA pre-IND meeting for RIGScan, and additional progress milestones on RIGScan development. We believe this sequential line-up of achievements over the coming months represents important progress and will continue to add value for the Company and its shareholders.”
Management has put their money where there mouth is in 2010. Insiders at Neoprobe purchased roughly 360K shares throughout 2010. Neoprobe’s radiopharmaceutical, Lymphoseek, is being developed as a tracing agent for identifying cancerous lymph nodes in patients with breast cancer and melanoma. Essentially, Lymphoseek is designed to identify sentinel lymph nodes that may be predictive of determining whether a patient’s cancer has spread into the lymphatic system. Currently, they are running a superiority trial of Lymphoseek over currently used dyes in Breast and Melanoma cancers (NEO3-09). Additionally, they are concurrently running a study in head and neck cancers (NEO3-06), which will eventually be used to support an expanded label. Neoprobe anticipates completion of their NEO3-09 study in early-to-mid February and announcing top-line results soon after.
Management has noted that the performance in NEO3-09 has remained consistent with previous successful results seen in the NEO3-05 trial (Breast & Melanoma trial).
It is an open-label study, so Neoprobe has a very good idea how the trial is progressing. We fully expect to see results consistent with the NEO3-05 results and their data should be highly supportive of approval.
Management also anticipates filing for FDA approval sometime in early 2Q 2011. Many are expecting a priority 6-month review, which could see Lymphoseek approved by the FDA in late 2011. Neoprobe currently estimates Lymphoseek’s worldwide market at $450-500 million annually. Once Lymphoseek is approved, Neoprobe has the advantage of having a revenue sharing agreement with the dominant player in the radiopharmaceutical market, Cardinal Health (CAH). Neoprobe will receive a 50% share of each patient dose sold. Lymphoseek revenue will be essential to supporting the development of their RIGScan CR. NEOP’s RIGScan CR is designed to identify and evaluate potentially tumor-associated tissue in patients with colon or rectal cancer. It is a monoclonal antibody-based radiopharmaceutical tracer that binds to metastatic tissue. Neoprobe hopes to nail down a joint FDA-EMEA proposal for a pivotal study sometime in 3Q/4Q 2011. RIGScan CR has the potential to generate $2-3 billion in revenues.
We have been supporters of Neoprobe since Septemeber 2010 and continue to expect multiple positive developments in 2011. Taglich Brothers, TriPoint Global Research and WBB Securities have them rated as "BUY" with a $4, $5 and $6. With news expected anytime on the NEO3-09 study completion and top-line data, we expect that the uplisting to the AMEX will attract significant new investors interest. Positive results with Lymphoseek will certainly help fuel the rumors of a potential acquisition of Neoprobe that started back in the fall by Uri Landesman, President of Platinum Partners. We’ll continue to keep you updated on their progress.
Disclosure: Long NEOP