Precious Metals

[gfp927z]

>>> VistaGen Therapeutics, Inc.


https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt=fea5bc64-af05-423d-9493-24f68d605c6e&mime=pdf&co=maxim&id=[e-mail]&source=mail


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Stay Focused on ELEVATE, The Target is Adjunctive
Therapy

Summary

• VTGN shares are trading down ~45% this morning following announcement
of data from the P2 monotherapy study of AV-101 in treatment resistant
depression (TRD). Overreaction? We think so and we need to look at both
the trial, the differences from the ELEVATE study and the NMDA space in
depression to understand why.

• The monotherapy trial was a small, N=19 patient exploratory study in TRD.
TRD patients are very difficult to treat having tried essentially everything
and nothing has helped. Remember, even J&J's (JNJ - NR) Spravato, which
ushered in the NMDA class of antidepressant, is an adjunctive therapy.

• ELEVATE is targeting adjunctive therapy in patients who have had an
inadequate response to approved antidepressants, not TRD. Let's compare
the trials; monotherapy TRD vs. ELEVATE:
? Size- N=19 vs. N=180.
? Duration of depressive episode- Average 8.6 years vs. less than 2 years.
? Population- TRD vs. inadequate response.
? Treatment- Patients in ELEVATE come in already on their FDA-approved
antidepressant.
? Number of prior therapy attempts: Average of 7.8 vs. ~1-3.

• Conclusion: The monotherapy was exploratory and it would have been nice
to see some separation from placebo, but even then, it likely would have been
viewed as a trial too small to demonstrate definitive proof of concept, in our
view. VistaGen though does gain additional safety data, which is a positive,
given that it does not have the ketamine-like side effects which could limit
utility of a Spravato. Stay focused on the ELEVATE study; data is expected
late 3Q19 and the company is funded though the data. We would be buyers of
VTGN shares on today's weakness.
Details
VistGen's AV-101 is an NMDA receptor modulator. Its mechanism allows it to have
ketamine-like efficacy and fast onset of action without ketamine's psychotomimetic
side effects or safety issues. Spravato (J&J, JNJ - NR) is a nasal spray that must be
administered in a clinical setting, and due to possible side effects, is not suitable for
long-term use. AV-101 is an oral, at-home therapy that may be ideal for long-term
use in depression and/or as a step-down from intranasal or injection approaches
and/or adjunctive therapy for MDD.
Phase II ELEVATE, Adjunctive Setting in MDD- In 2Q18, VistaGen initiated
the ELEVATE Phase IIb trial of AV-101 in MDD as an adjunct to FDA-approved
antidepressants in patients who have not responded adequately to them. The
ELEVATE Phase IIb trial is a multi-center, randomized, double-blind, placebocontrolled safety and efficacy study. The trial was designed using a Sequential
Parallel Comparison Design (SPCD) in order to minimize placebo response by
generating a cohort of placebo non-responders, and then randomizing these
patients into the trial. This approach is increasingly common in CNS studies. Target
enrollment is ~180 patients. The trial will evaluate a 1440mg of oral AV-101 dosed 1x
a day for 14 days. Patients in the study will also be taking their regular antidepressant
regimen. The primary endpoint will be efficacy as measured by a decrease on the
Montgomery-Asberg Depression Rating Scale 10-item version (MADRS-10) scale
at two weeks; data late 3Q19.

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