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Biotech / Medical : Neurobiological Tech (NTII) -- Ignore unavailable to you. Want to Upgrade?

To: BRAVEHEART who wrote (702)	11/10/1999 10:36:00 AM
From: BRAVEHEART	Read Replies (1) \| Respond to of 1494

NTII BREAKOUT, We are above the annual high people. Something big is gonna break. Charts like this don't make mistakes. clearstation.com Best Wishes Jeffrey

To: BRAVEHEART who wrote (702)	11/12/1999 2:42:00 AM
From: JMarcus	Read Replies (2) \| Respond to of 1494

Here are my complete notes from the stockholders meeting. Bits and pieces I've already posted earlier today, but I'm too tired to try and edit them out. Also, I'm too tired to change all "?" symbols back to apostrophes. Paul Freiman: During the course of his presentation, Paul showed three cartoons to depict his perception of the company?s past, present, and future. The first cartoon, representing the condition of the company a year ago, showed Paul (a very dapper looking fellow, with his white hair and mustache) sitting inside a pot of boiling water; the second cartoon, representing the present, showed the pot still cooking, but with Paul no longer inside it; the third cartoon, representing the company one year from now, showed Paul with the cooked meal on his plate. In an August meeting with AIDS Clinical Trial Group, the decision was made to proceed with the Phase II AIDS-related dementia trial. Paul considered that decision an important indicator that the trial is going well. Merz (which they pronounce as ?Merzzzzzz? and not ?Mertz?) is a challenging company for NTII to work with as a partner. Merz is privately owned and very private and conservative in its approach to publicity. Paul is working with them to put together a selling presentation to American companies. He?s trying to get Merz to behave more like an aggressive biotech company, but this is not an easy task. Merz earmarked the $1.2M in loans to NII, so that the money could not be used for corporate overhead but had to be spent solely for Memantine trials. $1.2M of the $4.2M raised in the new private placement will be used to repay the Merz loans. This will put Paul on more of an even footing with Merz?s management. Also, repayment of the loan will remove the restriction that the first proceeds of Memantine sales would go to Merz. Non-Memantine burn rate has been reduced to $120K per month. Stabilized work force at 9 employees. Lisa Carr 60% of the patients in the AIDS-related dementia trial are also being studied for the effect on neuropathic pain. Enrollment of 375 evaluable patients in Phase IIB diabetic neuropathy trial was completed two months ahead of schedule. 421 patients were enrolled, but not all were evaluable. NTII will issue a press release in December re the unblinded results. This Phase IIB trial is really more of a Phase IIB/III trial, because the FDA has preliminarily indicated that just one more trial might be required before the NDA. Duration: one week screening, 8 weeks on study drug, and 4 weeks follow up. Primary evaluation was week 8 nocturnal pain. Patients evaluate their own pain subjectively. The patient locates the severity of his pain by marking it on a line extending from no pain to worst pain possible. This is recorded twice daily. The trial is still blinded, but Lisa has looked at the overall data. Overall, the prior Phase II trial was at 37.8 (average score on the pain ranking scale) at week 8. The overall score for the Phase IIB trial (which has a higher percentage of patients on Memantine rather than Placebo) is 36.5. This suggests that the modeling is on target. Starting at week 0 patients are at 60. Pain intensity returns to about 45 three weeks after dosing stops in week 8. 80% of the patients in the Phase IIB trial were on Memantine and just 20% on placebo. In the prior Phase II trial there was a 19.4% rate of early terminations due to dizziness. For the Phase IIB trial, this rate has dropped to just 7.7%. This suggests that the lower dosing (half of the Memantine patients are receiving dosing at 50% of the dose used in the prior Phase II trial) is have a profound effect in eliminating this side effect. Procedures for collecting adverse event data were more standardized in this most recent trial. Gabapentin is the biggest competitor drug in diabetic neuropathy. Lisa predicts that Memantine will have superior adverse event profile. Enrollment was completed on Sept. 8th. In the first quarter of 2000 they expect to meet with FDA to review the data and discuss the design of the Phase III trial. AIDS-related dementia and neuropathy trial is a Phase II double-blind placebo controlled trial run by NIH. 70 pts on Memantine (10-40 mg/d) 70 pts on placebo. 16 weeks blind, 4 weeks washout, 60 weeks open. They?ll do a cut on the data once the last enrolled patient completes the 16-week blind period. 131 of the 140 patients have been rolled. DSMB increased the patient numbers from 120 to 140 (I didn?t catch what significance Lisa attributed to that). Last patient in should be this Month. Last patient out March 2000 Internal results Sept. 2000 Public announcement Oct 2000 Merz controls what NTII can make public about Merz?s Memantine trials. Merz will present at the April 2000 Symposium on Advances in Alzheimer?s Therapy in Stockholm. Merz currently has 3 large Memantine trials in process. April 2000 NTII should learn more about Merz?s vascular dementia trial. By July we should hear about Merz?s AD trials. Xerecept: Enrollment was suspended in April 1999 after 31 of 90 patients enrolled. The shelf life of the drug was approaching expiration and patient enrollment was painfully slow. Analysis was done at 2 weeks and 4 weeks. Signal neurological symptoms and NCI neurological exam were the primary efficacy variables. Patients receiving 1 mg dosing consistently showed a better response than those receiving a 0.5 mg. dose, which produced no better response than placebo. They will present their Xerecept findings at a conference this April. The startup cost for another Xerecept trial would be $1M, the cost of a toxicology study plus the cost of the drug itself. They will not start another trial unless they can find a partner to fund it. Barry Cohen, the Chairman of the Board, said that good results from the Phase IIB diabetic neuropathy trial would make finding a big pharma partner as easy as ?rolling off a log,? because the market for this disease is huge. Paul Freiman: Unfortunately, NIH controls the pace of the AIDS trial. NTII would like to speed them up, but that is difficult. There is currently no competing treatment for AIDS-related dementia. NTII will therefore negotiate aggressively with the FDA to obtain a fast track designation. NTII and Merz expect to consummate a relationship with a big pharma company to be their marketing partner for Memantine during the first or second quarter of 2000. This task will be Paul?s central goal for the next couple of months. Now that he has the private offering behind him, he can really concentrate on this partnering task. Paul estimates that the Phase III trial for diabetic neuropathy will cost $5M. He needs the partner to fund those costs. Their office lease expires in April 2000. Now that they are down to just 9 employees, they won?t need a large space. The company that brokered the private placement, AmeriCal, is run by a couple of physicians. They have underwritten the growth of 5-6 small biotech companies. The $.80/share price for the stock issued in the private placement was determined in August, when NTII?s stock was selling at around $.86. Paul tried to renegotiate the price downward after the stock started rapidly appreciating, but the investors threatened to back out if he changed the price. In order to get relisted on the NASDAQ, they will need at least $4M cash on the day of filing, plus the ability to retain at least $2M on an ongoing basis. They will look into the possibility of relisting once they sign up a partner for Memantine. EOM Marc