Synaptogenix Inc (SNPX)

[SF Wolf]

AEGIS Capital Update:

Neurotrope, Inc. Rating: Buy NTRP: Bryostatin-1 Trial Data Justifies Additional Studies

Investment Highlights:

Summary Results from the Neurotrope Phase II study show that Alzheimer's disease (AD) patients receiving Bryostatin-1 had an improvement in their cognitive abilities compared with a decline in the placebo patients. The primary endpoint in the study was the Severe Impairment Battery (SIB), a clinical tool testing cognitive function. The data showed statistically significance on the completer analysis, with a trend toward significance in the modified intent to treat (mITT) analysis. As the first study using Bryostain-1 for only 12-weeks of treatment, we see the results as encouraging. In our opinion, these data justify moving the drug into a larger study with a longer treatment period.

Trial Details Byrostain-1 was tested at the 20 microgram and 40 microgram dose levels against placebo. Patients entering the trial had moderate-to-severe Alzheimer's disease with mental status scores (MMSE) ranging from 4 to 15. Patients received an initial dose, followed by a dose every other week for 12 weeks, for a total of 7 doses.

Untreated AD patients are expected show a decline in their SIB score, while preliminary data for Bryostain-1 has shown an improvement in SIB scores. Based on the size of enrollment and expected single directional change for each group, the analysis used a one-tailed t-test with a p-value of 0.1 as a test of significance. Using the one-tailed test increased the statistical power for the small sample size over the more common two-tailed test with a p-value of 0.05.

Data was reported for the modified intent to treat (mITT) analysis as well as a completer analysis using only the patients who completed the full 12-week study. The mITT group had 135 patients while the 20 microgram group had 113 patients. In the 20 microgram group, the completer analysis showed (p<0.07) while the mITT group showed (p<0.134).

Interpretation This was the first study testing Bryostatin-1 with repeated doing for AD. Given the small enrollment and short treatment period, we believe the statistical analysis was appropriate. This may not be what investors were expecting, and we expect some to view the p-values as a failure. However, in a study with a treatment period of six months, the decline in the placebo patients would be expected to widen the difference between the two groups, showing greater treatment effect and statistical significance. In a field where universal failure is expected, Bryostatin-1 showed an improvement in memory. Our opinion, the study met its objective of showing that the drug has sufficient activity to move to a larger study with a longer treatment period.

Valuation Based on these developments, we are reviewing our estimates and price target. In our view, the drug has sufficient activity and data that justifies moving to a larger trial with a longer treatment period. Our valuation of for NTRP is based on estimated earnings for the first year of profitability. We assume first revenues in 2020, and base our estimates on a cost of $1,500 per month. We use a probability adjustment of 75% of revenues to allow for the high risk of failure in clinical trials for Alzheimer’s disease. We further discount FY2021 EPS of $5.96 by 30% per year, with a multiple of 15X for a price target of $31 per share. See Risk Factors on page 2.

2 AEGIS CAPITAL CORP.
Required Disclosures
Price Target
Our price target is $31 per share.
Valuation Methodology
We base our price target on our estimated FY2021 EPS of $5.96, discounted at 30% with a multiple of 15X.
 
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