Synaptogenix Inc (SNPX)

[SF Wolf]

My transcribed quotes from Dr. Wilke and Dr. Alkon’s presentation at the Oppenheimer 27th Annual Healthcare Conference 03/21/17 (please feel free to add other transcribed portions of this presentation): https://www.veracast.com/webcasts/opco/healthcare2017/79104510713.cfm

Dr. Wilke:
4:10 “(NTRP) expects to either halt or to reverse Alzheimer’s disease in advanced patients”

5:25 “the Neurotrope difference is that we have a uniquely regenerative approach that has the potential to reverse AD even in advanced patients”

5:35 “we also believe that synaptic loss is an independent event that can be reversed”

Dr. Alkon:

16:08 “if you look at every major aspect of the (AD) disease process, the patho-physiology, it‘s regulated by PKC epsilon, in turn activated by Byrostatin. Then ultimately even the plaques and tangles are prevented”

17:20 (discussing transgenic animal disease model) “if you treat even two or three months after that mouse model has actually progressed into those pathologic changes with Byrostatin or similar compounds in our portfolio, you can actually prevent and reverse all of those (pathological) changes. The PKC epsilon is stimulated to be activated, the synthesis goes up, the a-beta oligomers go down, the synapses are restored, and the cognitive deficit is remediated.”

19:45 “you can actually see that Byrostatin (in animal models) and similar compounds totally restore the ability to acquire new information and then even restore the ability to recall old information”

20:15 “if within 24 hours of that stroke (in an animal model) you give Byrostatin or a comparable member of our platform you completely prevent that (loss of memory)…the animal can recall the information he gained 4 months earlier, he can learn new information, and if you look 4 months latter you can see that the information is still stored.”

21:10 “this experiment was reproduced by another laboratory (speaking of the effect of PKS epsilon) where they had a double transgenic (animal model), they genetically increased PKC epsilon and genetically prevented all of the amyloid plaque”

21:36 “our clinical trial program began with experiments we didn’t do ourselves, Phase 1 studies by the Cancer Institute, 1500 patients showed well tolerated capacity even up to two and a half years of Byrostatin, even at higher dosages, we use much lower dosages.”

22:01 “we did Phase 2a studies where we could monitor the drug itself, we could see target engagement with certain highly sensitive assays and we even showed with a single dose cognitive enhancement that could be measured with the Mini Mental Status Exam 3 hours afterwards…that motivated us to go to Compassionate Use studies where we took very severe patients…we could reverse (some of) those (severe) symptoms…

That experience with Compassionate Use patients encouraged us to go after a niche which the industry has had the approach of advoiding and the reason is their philosophy has been if you come too late you can’t treat the disease. Well we have gone after that niche - severe patients with a mean Mini Mental of 10 and that is our current P2b study with 150 patients…we are looking for something that hasn’t been seen before, a reversal of the disease, a positive change not just a reduction in the rate of decline which is what the industry has been looking, not too successfully, in my view.

We hope to get Breakthrough Status if we get the kind of improvement we are looking for. We hope to then look at Phase 3 with 300 to 400 patients…we also are looking at other diseases that have synaptic loss since this seems to be a universal aspect of many degenerative diseases. One of these examples is Fragile X in kids, which is a par excellence example…the synapses are completely wiped out.”

Q&A:

28:20 (Stanford) “has developed a new synthesis an accelerated economical synthesis …NTRP has an exclusive license, IP license, for all neurologic psychiatric disorders from Stanford. So we have a synthetic version of Byrostatin that is going to be practical, economic, easy to scale up, so we will have an unlimited supply.”

30:01 “Has anything happened since (the trial began) then to encourage or discourage you as to the outcome of Phase 2?” Dr. Alkon: “We are very pleased that our data safety monitoring board, which has met several times, has not had any occasion to stop any trial so the patients are tolerating the drug well.” As (Dr. Wilke) said we have had this anecdotal report back that they would like to continue with the trial and to respond to that we plan to do an open label extension for all 150 patients where we will bring them back in addition to the Phase 3 trial.”