I read it. Still have a buy rating. Price target lowered to 17 bucks, essentially because they think the company is a little behind schedule of what Aegis had previously based numbers off of. Felt the trial a success. Here's the basics. Sorry for formatting issues.
Neurotrope, Inc.
Rating: Buy
NTRP: Clinical Trial Data Presentation Consistent
With Expectations
Investment Highlights:
Summary The clinical trial data from the first test of Bryostatin-1 to treat
moderate to severe Alzheimer's disease was presented at the Alzheimer's Association
International Conference 2017 in London on July 19, 2017. The presentation
provided new data and a more extensive analysis that added to the top-line results
presented in May 2017.
The lead investigator concluded that the 20 microgram (µg) dose of Bryostatin-1
achieved its primary safety endpoints with a dose-response relationship that is
consistent with its theorized mechanism of action. The 20µg dose showed a treatment
effect, tolerability, and justified further study, while the 40µg dose did not. It
acts through several mechanisms that enhance synaptogeneisis, reduce formation
of amyloid beta and its plaques, and prevents phosphorylation of tau proteins.
These effects enhanced memory and spacial learning. The efficacy measures had a
consistent treatment effect for endpoints of SIB & ADCS-ADL-SIV at 13 weeks at
the 20 µg dose level. Additional studies are warranted to determine the optimal dosing
schedule, durability of the treatment effect, and to prove statistically significant
efficacy.
Discussion of Trial Results This was first Bryostatin-1 trail in which the drug was
administered as a multiple dose regimen. The trial compared dose levels of 20µg and
40µg against placebo. The primary investigator presented the trial data and discussed
the statistical analysis, both points that had been questioned after the top-line data was
presented. When top-line results were released, the company included its conclusions
with only some data points for the 20µg dose and not all comparable points for the
40µg dose. The press release had to balance its obligation to release its material
conclusions with its obligation to the researchers to present the full data set in a
scientific forum after peer-review. Although investors prefer to see all the data at
once, we believe this was the proper scientific way to present the data.
The full data set was consistent with our expectations from the top-line data. The
20µg dose showed improvements in learning and memory, while the placebo showed
a decline. The 40µg dose had higher side effects and patient dropouts, with less
efficacy. Bryostatin-1 activity levels were effected by negative feedback at higher
doses which reduced its biological effect. This is consistent with pharmcokinetic
profiles for molecules that act through this mechanism. More is not necessarily better,
and the 20µg dose was considered both safe and efficacious for further studies.
Conclusion We found these results consistent with our expectations from the
previous data release. The trial was designed to determine if there was sufficient
safety with a signal of efficacy to move to a larger trial, and to determine the doseresponse
for future dosing schedules. It was not intended to show clinical proof of
efficacy, and its objectives were achieved.
We believe investor expectations may have been too high, and believe the stock sold
off when the size and duration of the study was presented. In addition, the small
size and short duration of the study justified use of a statistical analysis with one-tailed test and a significance
threshold of p<0.10, rather than the two-tailed test with a statistical significance of p<0.05 that is typical for
late stage clinical testing.
We believe investors should view the data as the first successful trial in a drug that uses a novel mechanism to
improve learning and restore memory. We also point out that the trial tested moderate to severe Alzheimer''s
patients, a more advanced and difficult stage of disease that most other drugs currently in clinical testing. The
drug has several important benefits and can be used with the two current standard of care drugs, cholinesterase
inhibitors and memantine. Additional studies with a larger number of patients an longer duration of treatment
are planned. We continue to rate the stock BUY with a price target of $17 per share, based on our FY2023 EPS
of $5.35, discounted at 30% per year with a multiple of 15X
Price Target
Our price target is $17 per share.
Valuation Methodology
We base our price target on our estimated FY2023 EPS of $5.35, discounted at 30% with a multiple of 15X.
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