To: Cacaito who wrote (709 ) 11/11/1999 3:46:00 PM From: JMarcus Respond to of 1494
I took lots of notes that the SH meeting today. No time to go through them all just yet (maybe this evening). Lisa Carr presented the blinded data from the diabetic neuropathy trial and reaffirmed that the unblinded data will be published sometime in December. The blinded data (70% or 80% of the patients received Memantine rather than placebo) showed the trends they were expecting, so hopes are very high. Lisa mentioned that because of the size of the Phase IIB trial, the excellent safety profile, and the status of diabetic neuropathy as huge unmet medical need, they will be asking the FDA to treat it as a Phase IIB/III trial, so that only one more trial (not two) should be required before the NDA. The Phase III trial will cost about $6 million and there is no way that they'd undertake on their own. But their Chairman, Barry Cohen, a former Sr. VP of Merck, said that if the Phase IIB results turn out as hoped, finding a major partner for the diabetic neuropathy market would be "like rolling off a log" because the market potential is so great. >> 375 subjects, but final enrollment was 421 subjects.<< Not all the patients who enrolled were "evaluable." That accounts for the difference between 421 and 375, according to Ms. Carr. I asked Paul Freiman about the new financing and the prospects for getting relisted on Nasdaq. About the new financing, he said that the deal, setting the share price at $.80, was set in August when the market price was $.86. He tried to renegotiate the price upward when the market price took off, but met a brick wall with the investors. His only options were to stick with the offered price or start over on the search for funding. He felt very strongly that the new investors are in this for long term appreciation with venture-capital returns and will not be tempted to flip the stock in order to earn a quick 100% profit. Given how thinly traded the stock is, any attempt to flip their shares would quickly drive the price down, to their disadvantage. Paul expects a major cash infusion from a big pharma company when they partner Memantine for diabetic neuropathy. That will allow them to think about getting relisted. They need $4M in cash and prospects for maintaining a minimum cash balance of $2M. Because they are using $1.2M of the $4M in proceeds from the new financing to repay the Merz loans, they won't be able to meet those requirements until they sign up a partner. Marc