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Biotech / Medical : ICOS Corporation -- Ignore unavailable to you. Want to Upgrade?

To: Robert Scott who wrote (615)	2/2/1999 12:30:00 AM
From: Lel H	Read Replies (2) \| Respond to of 1139

Here's a review of the Jan. 25 conference call which I posted on the Yahoo! message board. George Rathmann started off with a review of 1998 goals and how ICOS did. The only major miss was that he had hoped that IC351 would be in phase III by year end, and this clearly didn't happen. My impression was that he was rather disappointed in this (and so am I). ICOS now has 163 patents, and is receiving them at a rate of about 20-30/year. Tom St. John then started the clinical trials discussion: LeukArrest (LA) in MS: the multi-dose study enrollment is complete (45 patients). As we all know, the first single dose study was a bust. Data from the current study should be available 2Q99. The future of LA in MS will depend on these two studies. Personally, I think LA will fail in this indication. LA in MI: enrollment is continuing, with a 420 pt target. Data should come in a year. LA in stroke: an 800 pt phase III trial has been started. It is a three-arm-to-two-arm study, in which two doses will be tested and after an interim review of data the more efficacious dose will be continued. The trial might take a statistical hit because of the interim analysis, but design of this trial has the full approval of the FDA. If successful, this is unlikely to be a registration trial; i.e. it won't be used alone to file for FDA approval, unless the data is very compelling. It is clear that ICOS expects to run at least one additional trial. LA in shock: 150 pt phase II will complete enrollment soon; data expected in mid-1999. Pafase in ERCP-pancreatitis: a 600 pt trial was initiated Feb. 98, data expected 1Q00. Pafase in ARDS: 240 pt phase II started Aug. 98, data also expected 1Q00 Pafase in severe acute pancreatitis: 600 pt phase II trial initiated 4Q98. I didn't catch an estimated completion date. Pafase in asthma: this was discussed during Q&A. The trial was unsuccessful, you may recall, and ICOS expressed disappointment in the trial design - the challenge may not have been severe enough to determine effect. It does not sound like they are moving forward aggressively on this indication. ICM3 in severe psoriasis: US and European multi-dose phase I/II trials were announced earlier this month. Enrollment is 80% complete. ICM3 in Crohn's disease: this will be the second indication for ICM3. A trial is expected to begin enrollment before the end of 2Q99. IC14 in septic shock: European phase I trial began late 98. Two phase II efficacy trials in normal and septic patients may possibly be initiated later this year. IC351 in MED: three phase II trials are complete, which enrolled a total of 520 pt. All 3 reported efficacy with p < 0.001. Endpoints were exactly the same as those used in the Viagra studies. A phase III trial will hopefully be initiated mid to late 99. In light of drug interactions that exist with Viagra, ICOS intends to conduct separate trials to study IC351's effect in nitrate users and in patients with renal and hepatic disease. They will also test for any visual disturbances. Because ICOS and Lilly are co-developing and marketing IC351, data from these trials may not be as forthcoming as in the past, because Lilly is not in the habit of releasing data of their investigational drugs. North American and European profits are split equally between the two companies. This year, ICOS hopes to initiate a phase I trial of an orally-active small molecule. This is a goal carried over from last year. This may be related to ICOS's extensive expertise in the phosphodiesterase, but may also deal with cell adhesion. No clues were offered. Mike Gallatin spoke next about ICOS's high-throughput screening and medicinal chemistry platforms. He discussed some of ICOS's internal and collaborative approaches to target optimization. Howard Mendelsohn discussed financials. I won't bore you with specific numbers, since you can look up the 10Q yourself. Bottom lines: ICOS has $78M cash, and ICOS doesn't expect to have to worry about financing for some time to come. A little over 6 million warrants have yet to be exercised, which would provide and additional $63M. Remember, this is a sale of stock, which represents a dilution. Additional funding will come in the form of cost reimbursements from previously-established clinical partnerships, and will vary with expenditures. Incidentally, the cost of the recent phase II trials for IC351 as well as the startup costs for the phase III stroke trial, phase I IC14, and phase II severe pancreatitis trials were all realized in 4Q98, which may partially account for the missed estimates and increased operating costs.