Synaptogenix Inc (SNPX)

[F1ash]

March 3 2016. The Life Sciences Report:


"ER: Alzheimer's disease is a significant unmet medical need. We also know that it's been a graveyard for drug developers as the cadavers of failed trials are everywhere. There hasn't been a drug approved for Alzheimer's since 2003. Current products on the market are not disease-modifying agents—all they do is provide symptomatic relief.

Another dominant approach is to use antibodies to cross the blood-brain barrier and break up the amyloid beta protein plaque. That, too, has been a graveyard, but that is the approach that Biogen Idec Inc. (BIIB:NASDAQ) and Eli Lilly and Co. (LLY:NYSE) are taking. Axovant Sciences Ltd. (AXON:NYSE) has RVT-101, a selective 5-hydroxytryptamine receptor antagonist, in Phase 3, and H. Lundbeck A/S (LUN:CPH) is taking a similar approach to promote the release of the neurotransmitter acetylcholine.

But I have come across a micro-cap company called Neurotrope BioScience Inc. (NTRP:OTCQB), and find it intriguing. The company has a drug called bryostatin-1, which crosses the blood-brain barrier to activate protein kinase C-epsilon and upregulate brain-derived neurotrophic factor, which has been associated with synaptogenesis, or synaptic regrowth. There was such activity seen in a small Phase 1 study that several patients were granted an FDA-approved compassionate use protocol to continue using the drug. That's what got to me. I like the novel mechanism of action. I think this company is extremely undervalued, with a market cap of ~$20M.

TLSR: The company started a Phase 2 trial with 150 patients in November 2015. Will we see data—a catalyst—this year?

ER: Yes. The Phase 2 is double-blind and placebo-controlled, and there will be three- and six-month treatment arms. The three-month arm should read out top-line data by year-end, and the final six-month data are due mid-2017. From an investor perspective, we are not talking about a long time. A lot is already known about the safety of bryostatin-1. If the data bear out, it could prove to be a disease-modifying agent, which is the Holy Grail in Alzheimer's. This is a position that I like very much.

TLSR: With Neurotrope's very small market valuation, is this stock a significant position for you?

ER: Yes; I've been accumulating it over the last three months. The company did a private placement in November and raised $15M, which will fund the Phase 2 trial. Some warrants were included, which could provide additional funding even if the market shuts down.

TLSR: Two other indications for bryostatin-1 are in preclinical studies, for Fragile X Syndrome (FXS) and Niemann-Pick Type C (NPC) disease. Those are orphan diseases, and they seem like ideal candidates for nondilutive funding. Has there been any activity or funding from government or advocacy organizations?

ER: Not yet. But these disease indication candidates could attract nondilutive funding. This drug has been tested in humans for more than a decade, in many oncology trials. It was licensed from the Blanchette Rockefeller Neuroscience Institute, where it was in Phase 2 clinical studies in Alzheimer's patients in 2008. That's how Neurotrope knows so much about its safety, and why it thinks the drug has potential indications in Fragile X as well.

I see Neurotrope as being extremely undervalued, given the large unmet medical need. That the FDA is already familiar with the activity of bryostatin-1 and that it has allowed compassionate use for the drug is very telling for me."

https://www.equities.com/news/how-do-emerging-biotechs-stack-up-with-their-billion-dollar-counterparts