Thursday, February 04, 2016 11:19:52 PM
CX-1739 - They should be hearing back from the FDA concerning the additional tox studies before long, so this is a key event. If no further requirements from the FDA, then CX-1739 can proceed into the Respiratory Depression trial, subject to funding.
Financing - The recent financing (up to $2.5 mil) is available to prospective investors until Feb 29, but looks like they've only issued $100 K of that amount so far, so hopefully more investors will step up to the plate by the end of Feb. Obtaining funding will be critical for moving Ampakines back into the clinic as planned, although the ongoing Dronabinol Phase 2b is already fully funded by the NIH.
In the last financing offer that ran from Aug-Dec 31st last year, it looks like they issued $721 K of the possible $3 mil, with Dr. Manuso providing $250 K of the funding.
Dronabinol Phase 2b - The results of the 120 patient Sleep Apnea trial are due in Q3-16, so interest should start ramping up as we get into the Spring/Summer. From what was said at the recent investor presentation it sounds like they may want to do a reverse split before too long (VP Margolis said the capital structure and .02 cent share price will be dealt with soon, so 'stay tuned'), and a good time to do these is when there is some big transformational news coming, and the Dronabinol Phase 2b results would qualify.
In his recent presentation, Dr. Manuso said the Phase 2b results might be pivotal/registrational and allow for an accelerated NDA. So the lead up to the Dronabinol Phase 2b results, and the return of Ampakines to the clinic, will hopefully provide the spark to raise funding, get the capital structure back to reasonable levels, and allow more institutional investment into the company. It'll take considerable salesmanship and hustle, plus some luck, but they have an energetic team and a renewed focus, so should be interesting.
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