>>> Cortex the comeback kid <<<
Yes, though I'd like to get more info on how they intend to pay for the two RD trials next year.
In the presentation, Dr. Lippa said that Central SA will need a partner in order to proceed further clinically, but the ongoing Dronabinol Phase 2b is already fully funded by the NIH ($5 mil), and the injectable CX-1942 preclinical study has funding from the NIH/SBIR.
So that leaves the two RD Phase 2a trials to fund, plus operating cash to keep the company going thru next year. He didn't mention finances much in the presentation so we'll need to get a fuller picture in that regard.
Concerning the Central Sleep Apnea indication (CSA), it's considerably bigger than I realized, since 40% of Heart Failure patients have CSA and 70% of chronic opioid users have CSA. Doing a Phase 2a with CX-1739 focusing specifically on CSA prior to partnering might make sense since the previous SA trial only had a small CSA subset (with extremely dramatic efficacy shown in that subset).
Another area to get more info on concerns additional compounds they'll need for partnering. Partnering CSA separately from RD would be tough since CX-1739 will be in the RD trials and have to be part of a future RD deal. They'll also need backup compounds. CX-1763 is on one of the slides, which is the oral version of the injectable/water soluble prodrug CX-1942, but these two may have to be partnered together (?) So getting several more compounds thru tox and Phase 1 should be a goal over the next year.
Anyway, lots of questions, but the important thing is that Ampakines are finally moving forward again, and on multiple fronts. The way Lippa et al cleaned up the balance sheet, settled with the various creditors, ousted and replaced previous management, etc demonstrates more business savvy than Cortex has had in the past. Should be an interesting 2015 for ole (new) Cor.
