Bear Stearns Conf summary -
1) While Dr. Stoll wasn't able to discuss the details of the new animal tox data, reading the tea leaves, it sounds like they didn't see a repeat of the histo "finding". Slide 26 stated that Cortex is very positive about the new data filed with the FDA, so barring any ulterior agenda at the FDA, it looks like there's a good chance of getting the clinical hold lifted on the first try (approx mid-October).
2) The cash level at year end is estimated at only $9-10 mil, so as Daviddal suggested, a post-FDA decision PIPE might be in the cards. However, there are still 8.5 mil unexcercised warrants outstanding (average excercise price $3.02), and some of these should get excercised if the FDA decision is positive ($4-6 range), which could reduce/eliminate the need for a pre-BP deal PIPE. Those 8.5 mil outstanding warrants represent approx $25 mil in potential cash proceeds to Cortex, and if a third are excercised following the FDA decision, that would bring in an additional $8 mil or so.
3) A new IND needs to be submitted to the FDA in order to start a larger ADHD Phase 2b (the Phase 2a was apparently done under the Alzheimer's IND, which was obtained from the FDA's "Neurological Division", instead of the FDA's "Psychiatric Division"). If Neuro is out there, I'm wondering how the ADHD Phase 2a trial could have been done that way (without a Psychiatric Division IND)? Could this have been an oversight that conceivably contributed to/precipitated the clinical hold?
4) In-licensing strategy - it looks like Cortex is looking at Phase 2 programs rather than Phase 3 (targeting orphan indications).
5) One possible correction - Dr. Stoll said that Org-24448 was in 2 Schizo trials and 1 Depression trial, but I think it's 2 Depression and 1 Schizo (there are 2 different NIMH Depression trials).
6) CX-717's ADHD results compared very favorably with Strattera, with similar improvements seen in only 3 weeks of dosing vrs 4-8 weeks with Strattera. CX-717 also has the potential to be a non-scheduled drug, and the advantage of very few/no systemic side effects (heart rate, blood pressure, etc).
7) Lilly's LY-503430 (slide 10)- I think this was the first time Dr. Stoll had a presentation slide showing Lilly's phenomenal preclinical Parkinson's results with their AMPA upmodulator. 23 days of dosing showed a dramatic improvement in this preclinical model, demonstrating the huge potential of the high impact approach.
8) CX-701 - this backup compound to CX-717 should be in tox studies in the 4th quarter (1 month tox in 2 species), and in the clinic in early 2nd qtr 2007 (Phase 1). Cortex is also advancing a third promising low impact compound.
