A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of Anxiety in Adult Subjects With Social Anxiety Disorder (SAD)
Phase: PHASE3
Conditions: Social Anxiety Disorder
Sponsor: VistaGen Therapeutics, Inc.

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PROTOCOL AMENDMENT 1
PH94B Nasal Spray 
PH94B-CL030 
061332
NCT05030350
3
PRODUCT NAME/NUMBER: 
PROTOCOL NUMBER: 
IND NUMBER: 
NCT:
DEVELOPMENT PHASE: 
PROTOCOL TITLE:
A Phase 3 Open-label Safety Trial of PH94B Nasal Spray 
in the Acute Treatment of Anxiety in Adult Subjects with 
Social Anxiety Disorder (SAD)
Version 1.0, 12-Aug-2021
Version 2.0, 14-Mar-2022
VistaGen Therapeutics, Inc.
343 Allerton Avenue
South San Francisco, CA 94080, USA
PROTOCOL DATE: 
AMENDMENT 1 DATE: 
SPONSORED BY:
CONTRACT RESEARCH 
ORGANIZATION:
This study will be performed in compliance with ICH Good Clinical Practices and applicable 
regulatory requirements, including the archiving of essential documents. Information contained in 
this protocol is confidential in nature, and may not be used, divulged, published, or otherwise 
disclosed to others except to the extent necessary to obtain approval of the institutional review 
board or independent ethics committee, or as required by law. Persons to whom this information 
is disclosed should be informed that it is confidential and may not be further disclosed without the 
express permission of VistaGen Therapeutics, Inc.

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1.
APPROVAL SIGNATURES
PROTOCOL NUMBER:
PH94B-CL030
PROTOCOL TITLE:
A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the 
Acute Treatment of Anxiety in Adult Subjects with Social Anxiety 
Disorder (SAD)
AMENDMENT 1 DATE:
Version 2.0, 14-Mar-2022
I, the undersigned, have read this protocol and confirm that to the best of my knowledge it 
accurately describes the planned conduct of the study.
SIGNATURE
DATE:
VistaGen Therapeutics, Inc.
VistaGen Therapeutics, Inc.
 
VistaGen Therapeutics, Inc.

VistaGen Therapeutics, Inc
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Sponsor:
VistaGen Therapeutics, Inc., a Nevada corporation (VistaGen)
343 Allerton Avenue
South San Francisco, CA 94080
Medical Monitor:
 
Phone: +1 650-577-3647
Medical Director:
 
VistaGen Therapeutics, Inc
 

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2.
PROTOCOL SUMMARY
2.1.
Synopsis
PRODUCT 
NAME/NUMBER
PH94B Nasal Spray
PROTOCOL 
NUMBER
PH94B-CL030
DEVELOPMENT 
PHASE
3
PROTOCOL TITLE
A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the Acute Treatment of 
Anxiety in Adult Subjects with Social Anxiety Disorder (SAD)
INDICATION
Social anxiety disorder
OBJECTIVES
Primary: 
The primary objective of the study is to evaluate the safety and tolerability of repeated 
dosing of PH94B over a period of up to 12 months as assessed by documenting adverse 
events (AEs), standard clinical measurements (physical examination, vital signs, clinical 
chemistry, hematology, suicidality, level of depression, and 12-lead electrocardiogram 
[ECG]), and 
.
 
 
 
 
 
 
 
RATIONALE
The study is designed to evaluate the safety and tolerability of the long-term 
administration of 3.2 µg of PH94B as needed, up to 4 times a day, in adult subjects with 
SAD prior to acute anxiety-provoking social situations in daily life.

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STUDY DESIGN
This is a multicenter, open-label, multiple dose study in adult subjects diagnosed with 
SAD. Subjects diagnosed with SAD by Mini-International Neuropsychiatric Interview 
(MINI) and with a Liebowitz Social Anxiety Scale (LSAS)
50 are to be 
enrolled.
The study will enroll subjects who have previously participated in any PH94B SAD study
(for example, PALISADE-1 [PH94B-CL026] or PALISADE-2 [PH94B-CL032]) who
meet requirements of the inclusion and exclusion criteria for the present study.
Procedures:
Subject participation in the study will last up to approximately 12 to 13 months, 
depending on the duration of the screening period and intervals between visits. Upon 
signing the informed consent form, subjects will begin participation in the present study 
at Visit 1 or Visit 2, depending on when they finished participation in their antecedent 
study:
Subjects who finished participation in their antecedent PH94B SAD study more 
than 14 days before entering the present study will complete Visit 1 and enter a 
screening period lasting between 7 and 35 days. Subjects who meet all eligibility 
criteria will return to the clinic to complete Visit 2 (Baseline)
Subjects who finished participation in their antecedent PH94B SAD study 
within the last 14 days will enter the present study at Visit 2 (Baseline)
At Visit 2 (Baseline, Day 0), all subjects will undergo baseline measurements of clinical 
laboratory assessments (clinical chemistry, hematology, urinalysis, pregnancy test [if 
female and of childbearing potential], and urine drug screening), 12-lead ECG, vital 
signs, physical examination, Hamilton Rating Scale for Depression (HAM-D17), 
Hamilton Rating Scale for Anxiety (HAM-A), LSAS, Columbia-Suicide Severity Rating 
Scale (C-SSRS), and Clinical Global Impression Scale of Severity (CGI-S). At Visit 2
(Baseline), subjects will be trained on how to use and store PH94B Nasal Spray, and how 
to use an electronic diary (eDiary) application each day to record their dosing of PH94B 
(including a record of days when PH94B was not used) and any health problems they 
experienced that day. Adverse events (AEs) and concomitant medications will be 
reported and recorded. The subject will receive a 1-month supply of PH94B for use (up 
to 4
Subjects will be instructed to return to the clinic for Visit 3 after 30 days (±3 days). At 
Visit 3, subjects will undergo clinical laboratory assessments (clinical chemistry, 
hematology, urinalysis, pregnancy test, and urine drug screening), vital signs, 12-lead 
ECG, physical examination (limited to nasal passage and oropharynx examination unless 
any AEs are reported), HAM-D17, HAM-A, LSAS, C-SSRS, CGI-S, Clinical Global 
Impression Scale of Improvement (CGI-I), and self-evaluation by Patient Global 
Impression of Change (PGI-C). At Visit 3, PH94B use and any daily reports of health 
problems that have been recorded in the eDiary will be reviewed, and AEs and 
concomitant medications will be reported and recorded. Subjects will receive a 1-month 
supply of PH94B.
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4 to 13), and will 
repeat the same assessments as those performed at Visit 3. PH94B use and any daily 
reports of health problems that have been recorded in the eDiary application will be 
reviewed, AEs and concomitant medications will be reported and recorded. Subjects will 
receive a 1-month supply of PH94B at each monthly visit.
At Visit 14 (12 months±2 weeks), treatment will conclude, and subjects will undergo 
clinical laboratory assessments (clinical chemistry, hematology, urinalysis, pregnancy 
test, and urine drug screening), vital signs, 12-lead ECG, physical examination, 
HAM-D17, HAM-A, LSAS, C-SSRS, CGI-S, CGI-I, PGI-C, and the Penn Physician 
Withdrawal Checklist (PWC-20). Also, PH94B use and any daily reports of health 

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problems that have been recorded in the eDiary application will be reviewed and AEs and 
concomitant medications will be recorded and reported. Subjects will also be informed 
of their follow-up visit (Visit 15).
Subjects will return to the clinic for a follow-up visit (Visit 15, 54 weeks ±3 days), 
approximately 2 weeks after the last PH94B administration, to undergo C-SSRS,
PWC-20, and vital signs assessments, and record AEs.
Subjects who discontinue study treatment without completing 12 months of treatment 
will attend an Early Termination Visit (Visit 14) as soon as possible after discontinuing 
treatment, and return to the clinic for a follow-up visit (Visit 15) approximately 2 weeks 
later.
Safety Considerations: 
4 doses per day up to 12 months in up to 
600 subjects) will be assessed and summarized through changes from Visit 2 (Baseline) 
to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical 
examinations, suicidality, level of depression, vital sign assessments, and withdrawal 
symptoms following exposure to PH94B.
PLANNED NUMBER 
OF SUBJECTS
A sufficient number of subjects from previous PH94B SAD studies will be screened or 
rolled over to obtain up to 600 subjects to receive up to 12 months of PH94B treatment.
STUDY ENTRY 
CRITERIA
Subjects who have participated in a previous PH94B SAD study will be enrolled in the 
present study if they meet the following eligibility criteria.
INCLUSION CRITERIA
To be considered eligible to participate in the study, all subjects must meet the following 
inclusion criteria:
1.
Subject must have participated in a previous PH94B SAD study.
Note: Subjects who have not participated in a prior PH94B SAD study may be 
permitted to enroll following approval by the sponsor on a case-by-case basis.
2.
Written informed consent provided prior to conducting any study-specific 
assessment.
3.
Male and female adults, 18 through 65 years of age, inclusive.
4.
Women of childbearing potential must be able to commit to the consistent and 
correct use of an effective method of birth control throughout the study and must 
also have a negative urine pregnancy test result at both Screening (Visit 1) (for 
subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. 
Effective methods of contraception include: condoms with spermicide, diaphragm 
with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or 
implantable contraceptive devices.
5.
Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of 
Mental Disorders, 5th Edition, and confirmed by the Mini-International 
Neuropsychiatric Interview (MINI). 
6.
Clinician-rated HAM-D17 total score < 18 at study entry (Screening [Visit 1] or 
Visit 2 [Baseline] as applicable).
7.
Negative COVID-19 test for subjects with COVID-19 symptoms or those who had 
direct exposure to someone with a positive COVID-19 test, and/or completion of 
quarantine period consistent with requirements at the study site as determined by the 
investigator.

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EXCLUSION CRITERIA
To be considered eligible for entry into the study, a subject must not meet any of the 
following exclusion criteria at study entry. 
1.
Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, 
psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum 
disorder, obsessive-compulsive disorder, or treatment-refractory major depressive 
disorder.
Any other current Axis I disorder, other than SAD, which is the primary focus of 
treatment. Note that subjects with concurrent Generalized Anxiety Disorder are 
eligible for the study provided that Generalized Anxiety Disorder is not the primary 
diagnosis.
2.
In the opinion of the Investigator, the subject has a significant risk for suicidal 
behavior during the course of their participation in the study, or
a.
on items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide 
Severity Rating Scale (C-SSRS) with reference to a 6-month period 
prior to screening; or
b.
At Screening (for subjects who attend Visit 1): the subject has had 1 or 
more suicidal attempts with reference to a 2-year period prior to 
screening; or
c.
At Baseline (Visit
Suicidal Ideation section of the C-SSRS with reference to last visit; or
d.
The subject is considered to be an imminent danger to themself or 
others.
3.
Subjects using the following psychotropic medications at enrollment or within 
30 days before study entry: antidepressants (including monoamine oxidase
inhibitors), anxiolytics, stimulants, anticonvulsants, mood stabilizers, antipsychotic 
medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine.
Eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or anti-histamines 
prescribed for insomnia are allowed.
4.
Use of benzodiazepines or unapproved treatments such as beta blockers, within 
30 days before study entry and during the study. Use of beta blockers for treatment 
of hypertension or cardiac conditions is allowed. Subjects who have been taking 
benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to 
participate.
5.
Use of any over-the-counter product or herbal preparation for treatment of the 
symptoms of anxiety or social anxiety within 30 days before study entry; 
concomitant use is prohibited during the study.
6.
Clinically significant nasal pathology or history of significant nasal trauma, nasal 
surgery, total anosmia, or nasal septum perforation that may have damaged the nasal 
chemosensory epithelium.
7.
Subjects who meet criteria for moderate or severe alcohol or substance use disorder 
within the 1 year prior to entry into the study.
8.
Subjects with a positive urine drug screen at study entry
 
9.
An acute or chronic condition, including an infectious illness, uncontrolled seasonal 
allergies at the time of the study, or significant nasal congestion that potentially could 
affect drug delivery to the nasal chemosensory epithelium.
10. Any current clinically significant and/or uncontrolled medical condition, based on 
medical history or as evidenced in screening assessments, such as COVID-19, HIV, 
cancer, stroke, congestive heart failure, uncontrolled diabetes mellitus, or any other 
medical condition or disease that, in the clinical judgment of the Investigator, could 

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place the subject at undue risk, interfere with study participation, or confound the 
results of the study. 
11. Women who have a positive urine pregnancy test prior to IP administration. Women 
who are currently breastfeeding are not eligible.
12. History of cancer or malignant tumor not in remission for at least 2 years. Basal cell 
skin cancers are not exclusionary.
13. Subjects with clinically significant abnormalities in hematology, blood chemistry, 
urinalysis, 12-lead ECG, or physical examination identified at study entry or during 
the legacy study which, in the clinical judgment of the Investigator, could place the 
subject at undue risk, interfere with study participation, or confound the results of 
the study.
TEST PRODUCT
Name: PH94B Nasal Spray
Dose, route, frequency: 3.2 µg administered as an intranasal (i.n.) solution (a 1.6-µg spray 
to each nostril per dose), up to 4 times a day.
CONTROL 
PRODUCT
Not applicable
TREATMENT 
REGIMENS
Treatment will be administered as needed at 3.2
4 doses per 
day) from Visit 2 (Baseline) to Visit 14 (End of Treatment).
Treatment with PH94B should be self-administered as needed approximately 15 minutes 
prior to or during an anxiety-provoking social situation or event. Consecutive nasal 
administrations of IP should be 
, with no more than 4 administrations 
per day. Treatment does not need to be administered every day.
PLANNED STUDY 
SITES
The study is designed as a multicenter study conducted in the USA with approximately
40 clinical study sites.
CRITERIA FOR 
EVALUATION
The primary outcome variable for the study is the change from Baseline (Visit 2) in AEs 
after the administration of PH94B prior to anxiety-provoking social situations in daily 
life for subjects with SAD. In addition to the primary outcome variable, the change from 
Baseline (Visit 2) in standard clinical measurements and behavioral assessment scores 
(LSAS, CGI-S, CGI-I, and PGI-C) in response to anxiety-provoking social situations in 
daily life after the administration of PH94B will be evaluated in subjects with SAD.
Safety endpoints: 
Incidence and severity of AEs, AEs leading to discontinuation, and SAEs
Changes in vital signs results
Changes in clinical laboratory evaluation (hematology, chemistry, and 
urinalysis) results
Changes in 12-lead ECG results
Changes in physical examination findings
Changes in HAM-D17 scores
Changes in C-SSRS scores
PWC-20 scores after termination of PH94B
: 
Change in total LSAS scores over time with use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time with use of 
PH94B

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Change in proportion of subjects with CGI-I scores of 1 (Very much improved)
or 2 (Much improved) over time with use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very much improved) 
or 2 (Much improved) over time with use of PH94B
 
 
 
STATISTICAL 
METHODS
Analysis Populations:
Safety population: All subjects who receive IP.
All analyses will be performed using the Safety population.
Safety Analyses:
Safety and tolerability implications are best addressed by applying descriptive statistical 
methods to the data, supplemented by calculation of confidence intervals wherever this 
aids interpretation. The incidence of AEs for defined periods of exposure (e.g., 3 months, 
6 months, 9 months, 12 months, and overall) will be evaluated in the form of a proportion 
relating number of subjects experiencing events to number of subjects at risk for AEs by 
organ, relatedness, severity of reported AE, and by frequency of AE. In addition, 
frequency-type of reported AEs (once, continuous, or adaptability to treatment) by time 
of occurrence after Visit 2 dispensation may be tabulated. These data will be summarized 
and tabulated, including confidence intervals when appropriate, for descriptive purposes,
and may serve as nonparametric endpoints. Time series analysis will be used where 
warranted to determine whether frequency of AEs changes with increased duration of 
exposure.
Efficacy Analyses:
Exploratory endpoints address efficacy using patient- and clinician-rated scales and will 
be evaluated for significant changes from baseline using a generalized linear model for 
repeated measures.
SAMPLE SIZE 
DETERMINATION
Based on feedback from the FDA, the sample size for this study (up to 600 subjects) has 
been selected to attain a PH94B safety database per the ICH E1 Guideline.
STUDY AND 
TREATMENT 
DURATION
The sequence and maximum duration of the study periods will be as follows:
1.
Screening and washout (if applicable): From 7 to 35 days
2.
12-Month treatment period: From Visit 2 (Baseline) through Visit 14 (End of 
Treatment)
3.
Follow-up period: Follow-up visit (Visit 15) conducted approximately 2 weeks
after last treatment
The maximum study duration for each subject is approximately 59 weeks.
The maximum treatment duration for each subject is 12 months.

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2.2.
Schedule of Events
Table 2-1:
Schedule of Events
Assessment/Evaluation
Study Periods
Visit 1
Visit 2
Visit 3
Visits 4 to 13
Visit 14 / ET
Visit 15
Screening
Baseline 
1st Month
Monthly
End of Treatment
Follow-up
Informed Consent Form 
Xa
Xa
Subject Demographics
X
Urine Drug Screen
X
X
X
X
X
Pregnancy Testb
X
X
X
X
X
MINI 7.0.2
X
Medical and Psychiatric History
X
Record Concomitant 
Medication Use
X
X
X
X
X
 
LSAS
X
X
X
X
X
HAM-D17
C-SSRS
X
X
X
X
X
X
Physical Examinationc,d
X
X
X
X
X
Vital Signs
X
X
X
X
X
X
12-Lead Electrocardiograme
X
X
X
X
X
Clinical Chemistry, 
Hematology, and Urinalysis
X
X
X
X
X
Review Inclusion/Exclusion 
Criteria
X
Xf
CGI-S
X
X
X
X
X
CGI-I
X
X
X
PGI-C
X
X
X
PWC-20
X
X

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Assessment/Evaluation
Study Periods
Visit 1
Visit 2
Visit 3
Visits 4 to 13
Visit 14 / ET
Visit 15
Screening
Baseline 
1st Month
Monthly
End of Treatment
Follow-up
Day -35 to
Day -7
Day 0
Day 30
±3 days
±7 days
52 Weeks
±2 weeks
54 Weeks
± 3 days
Training on Use of PH94B
X
Storage Instructions
X
X
X
Training on eDiary App to 
Record PH94B Use and Health 
Problems
X
Adverse Event Recording
X
X
X
X
X
Dispense PH94B to Subject 
X
X
X
eDiary Review
X
X
X
Abbreviations: C-SSRS = Columbia-Suicide Severity Rating Scale; CGI-I = Clinical Global Impression Scale of Improvement; CGI-S = Clinical Global 
Impression Scale of Severity; eDiary = electronic diary; ET = Early Termination; HAM-A = Hamilton Rating Scale for Anxiety; HAM-D17 = Hamilton 
Rating Scale for Depression (17 items); LSAS = Liebowitz Social Anxiety Scale; MINI = Mini-International Neuropsychiatric Interview; PGI-C = Patient 
Global Impression of Change; PWC-20 = Penn Physician Withdrawal Checklist; SAD = social anxiety disorder
a
Subjects will sign an informed consent form for the present study at either Visit 1 or Visit 2, depending on when they enter the study.
b
Pregnancy tests will only be given to female subjects of childbearing potential and not post-menopausal females. 
c
Physical examination will include measurement of weight and an examination of the nasal passages. Height will be measured at Screening and at Visit 14. The 
physical examinations done at Visit 1, Visit 2 and Visit 14 will be comprehensive. The physical examinations done at Visit 3 to Visit 13 will be focused but 
must include examination of the nasal passages and oropharynx. Other organ systems should be examined at Visit 3 to Visit 13 if the subject reports AEs or if 
the investigator has specific concerns.
d
.
e
12-Lead electrocardiograms will be administered in a supine position after the subject has rested for 5 minutes.
f
For all subjects, a review of inclusion and exclusion criteria will be conducted at Visit 2 to confirm eligibility.
Note: Long-term C-SSRS will be administered at screening. All other C-SSRS evaluations
Since Last Visit.
Note: If central laboratory urine drug screen testing is positive for a subject
, then the participation of the 
subject in the study may have to be discontinued. The Medical Monitor should be consulted on these cases. An unscheduled repeat urine drug screen may be 
obtained to investigate whether drug use is continuing.

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3.
TABLE OF CONTENTS
1. 
APPROVAL SIGNATURES ...................................................................................................2 
2. 
PROTOCOL SUMMARY........................................................................................................4 
2.1. Synopsis ..........................................................................................................................4 
2.2. Schedule of Events........................................................................................................10 
3. 
TABLE OF CONTENTS .......................................................................................................12 
3.1. List of In-Text Tables....................................................................................................16 
REASONS FOR AMENDMENT .................................................................................................17 
AMENDED PROTOCOL .............................................................................................................19 
4. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS...........................................20 
5. 
INTRODUCTION..................................................................................................................22 
5.1. Background and Rationale............................................................................................22 
5.1.1 Social Anxiety Disorder....................................................................................22 
5.1.2 Nasal Chemosensory Systems...........................................................................22 
5.1.3 PH94B ...............................................................................................................23 
5.2. Clinical Experience.......................................................................................................24 
5.2.1 Phase 1 Studies..................................................................................................24 
5.2.2 Phase 2 Studies..................................................................................................25 
5.3. Summary of Potential Risks and Benefits.....................................................................25 
6. 
OBJECTIVES.........................................................................................................................26 
6.1. Primary Objective .........................................................................................................26 
6.2. Exploratory Objectives..................................................................................................26 
6.3. Endpoint Mapping.........................................................................................................26 
7. 
STUDY DESIGN ...................................................................................................................29 
7.1. Overall Study Design and Plan .....................................................................................29 
7.2. Rationale and Discussion of Study Design...................................................................30 
7.3. Selection of Doses in the Study ....................................................................................30 
7.4. Study Sites.....................................................................................................................31 
7.5. End of Study Definition ................................................................................................31 
8. 
SUBJECT POPULATION .....................................................................................................32 
8.1. Selection of Study Population.......................................................................................32 
8.2. Study Entry Criteria ......................................................................................................32 
8.2.1 Inclusion Criteria...............................................................................................32 
8.2.2 Exclusion Criteria..............................................................................................32 
8.3. Premature Subject Withdrawal .....................................................................................34 
8.4. Subject Replacement Criteria........................................................................................35 
9. 
TREATMENTS......................................................................................................................36 
9.1. Identification of Investigational Product.......................................................................36 

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9.2. Selection of Timing of Dose for Each Subject..............................................................36 
9.3. Dose Adjustment Criteria..............................................................................................36 
9.4. Treatment Compliance..................................................................................................36 
9.4.1 eDiary ................................................................................................................37 
9.5. Method of Assigning Subjects to Treatment Groups....................................................37 
9.6. Blinding and Unblinding Treatment Assignment .........................................................37 
9.7. Permitted and Prohibited Therapies..............................................................................37 
9.7.1 Permitted Therapies...........................................................................................38 
9.7.2 Prohibited Therapies..........................................................................................38 
9.8. Treatment After End of Study.......................................................................................39 
9.9. Dispensing and Storage.................................................................................................39 
9.9.1 Dispensing.........................................................................................................39 
9.9.2 Storage...............................................................................................................40 
9.10. Drug Accountability......................................................................................................40 
9.11. Labeling and Packaging................................................................................................40 
9.11.1 Labeling.............................................................................................................40 
9.11.2 Packaging ..........................................................................................................41 
10. STUDY PROCEDURES........................................................................................................42 
10.1. Study Duration ..............................................................................................................43 
10.2. Study Periods and Visits ...............................................................................................43 
10.2.1 Screening and Washout.....................................................................................43 
10.2.1.1 Screening (Visit 1) ................................................................................43 
10.2.1.2 Washout Period.....................................................................................45 
10.2.2 Treatment Period ...............................................................................................45 
10.2.2.1 Visit 2 (Baseline)...................................................................................45 
10.2.2.2 Visit 3 (First Month in Clinic, ±3 Days)...............................................47 
10.2.2.3 Visit 4 Through Visit 13 (Monthly Visits, ±7 Days) ............................48 
10.2.3 Visit 14 End of Treatment (or Early Termination) Visit...................................48 
10.2.4 Visit 15 (Follow-up, 54 weeks ±3 Days) ..........................................................49 
10.3. Assessments ..................................................................................................................49 
10.3.1 Safety Variables ................................................................................................49 
10.3.1.1 Clinical Laboratory Safety Assessments...............................................49 
10.3.1.2 Clinical Examinations...........................................................................51 
10.3.1.3 Adverse Events......................................................................................52 
10.3.2 Efficacy Variables .............................................................................................52 
10.3.2.1 Liebowitz Social Anxiety Scale............................................................52 
10.3.2.2 Hamilton Rating Scale for Anxiety.......................................................52 
10.3.2.3 Hamilton Rating Scale for Depression (17 Items) ................................53 

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10.3.2.4 Clinical Global Impression Scales ........................................................53 
10.3.2.5 Patient Global Impression of Change ...................................................53 
11. ADVERSE EVENTS..............................................................................................................54 
11.1. Definitions.....................................................................................................................54 
11.1.1 Adverse Events..................................................................................................54 
11.1.2 Unexpected Adverse Event ...............................................................................55 
11.1.3 Serious Adverse Events.....................................................................................55 
11.1.4 Significant Adverse Events ...............................................................................56 
11.1.5 Treatment-emergent Adverse Events ................................................................56 
11.2. Event Assessment and Follow-up of Adverse Events ..................................................56 
11.2.1 Assessment ........................................................................................................56 
11.2.2 Evaluation..........................................................................................................57 
11.2.2.1 Severity of Adverse Events...................................................................57 
11.2.2.2 Seriousness............................................................................................57 
11.2.2.3 Actions Taken .......................................................................................57 
11.2.2.4 Outcome at the Time of Last Observation ............................................57 
11.2.2.5 Adverse Event Relationship to Investigational Product........................58 
11.2.3 Documentation ..................................................................................................58 
11.2.4 Treatment of Adverse Events............................................................................58 
11.2.5 Follow-up ..........................................................................................................59 
11.2.6 Reporting...........................................................................................................59 
11.2.6.1 Serious Adverse Events.........................................................................59 
11.2.6.2 Nonserious Adverse Events ..................................................................60 
11.3. Special Considerations..................................................................................................60 
11.3.1 Pregnancy ..........................................................................................................60 
12. DATA SAFETY MONITORING BOARD ...........................................................................62 
13. STATISTICS ..........................................................................................................................63 
13.1. Statistical Analysis........................................................................................................63 
13.1.1 Analysis Populations.........................................................................................63 
13.1.2 Study Subjects and Demographics....................................................................63 
13.1.2.1 Disposition and Withdrawals................................................................63 
13.1.2.2 Protocol Deviations...............................................................................64 
13.1.2.3 Demographics and Other Baseline Characteristics...............................64 
13.1.3 Exposure and Compliance.................................................................................64 
13.1.4 Safety and Tolerability Analyses ......................................................................64 
13.1.4.1 Adverse Events......................................................................................65 
13.1.4.2 Clinical Laboratory Evaluations ...........................................................66 
13.1.4.3 Vital Signs.............................................................................................66 

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13.1.4.4 Twelve-lead Electrocardiograms ..........................................................66 
13.1.4.5 Penn Physician Withdrawal Checklist ..................................................66 
13.1.4.6 Physical Examination Findings.............................................................66 
13.1.5 Efficacy Analysis ..............................................................................................67 
13.1.5.1 Exploratory Endpoints ..........................................................................67 
13.1.6 Interim Analysis ................................................................................................67 
13.2. Sample Size Determination...........................................................................................67 
14. STUDY CONDUCT...............................................................................................................68 
14.1. Sponsor and Investigator Responsibilities ....................................................................68 
14.1.1 Sponsor Responsibilities ...................................................................................68 
14.1.2 Investigator Responsibilities .............................................................................68 
14.1.3 Confidentiality and Privacy...............................................................................68 
14.2. Site Initiation.................................................................................................................69 
14.3. Screen Failures..............................................................................................................69 
14.4. Study Documents ..........................................................................................................69 
14.4.1 Informed Consent..............................................................................................70 
14.4.2 
...............................................................70 
14.4.3 Case Report Forms ............................................................................................70 
14.4.4 Source Documents.............................................................................................71 
14.5. Data Quality Control.....................................................................................................71 
14.5.1 Monitoring Procedures......................................................................................71 
14.5.2 Data Management..............................................................................................72 
14.5.3 Quality Assurance/Audit ...................................................................................72 
14.6. Study Termination.........................................................................................................72 
14.6.1 Premature Study Termination ...........................................................................72 
14.7. Study Site Closure.........................................................................................................73 
14.7.1 Record Retention...............................................................................................73 
14.7.2 Sample Retention ..............................................................................................73 
14.8. Changes to the Protocol ................................................................................................74 
14.9. Use of Information and Publication..............................................................................74 
15. FINAL CLINICAL STUDY REPORT ..................................................................................75 
16. ETHICAL AND LEGAL CONSIDERATIONS....................................................................76 
16.1. Good Clinical Practice ..................................................................................................76 
16.2. Subject Information and Informed Consent..................................................................76 
16.3. Approval by Institutional Review Board ......................................................................76 
16.4. Finance and Insurance...................................................................................................76 
17. REFERENCES .......................................................................................................................77 
18. ATTACHMENTS...................................................................................................................81 

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18.1. 
..............................................................................................81 
19. APPENDICES ........................................................................................................................82 
A. 
Liebowitz Social Anxiety Scale....................................................................................83 
B. 
............................................................................................84 
C. 
....................................................................................89 
D. 
Hamilton Depression Rating Scale ...............................................................................90 
E. 
Clinical Global Impression Scale of Improvement.......................................................94 
F. 
Clinical Global Impression of Severity.........................................................................95 
G. 
Patient Global Impression of Change ...........................................................................96 
H. 
Penn Physician Withdrawal Checklist ..........................................................................97 
I. 
Regulations and Good Clinical Practice Guidelines .....................................................98 
J. 
Summary of Amended Sections....................................................................................99 
3.1.
List of In-Text Tables
Table 2-1: 
Schedule of Events ............................................................................................10 

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REASONS FOR AMENDMENT
1. The study entry criteria were modified such that only subjects who have participated in a 
previous SAD study with PH94B (e.g., PALISADE-1 or PALISADE-2) can participate.
2. The number of potential study sites was modified to 40, to more accurately reflect the
number of sites that are likely to be involved based on the PALISADE-1 and PALISADE-2
studies.
3. The estimate of 800 subjects to be screened to provide 600 subjects was removed, and 
replaced by text stating that a sufficient number of subjects would be screened.
4. The eligibility criteria were changed such that the use of anxiolytics in the 30 days before 
study is now exclusionary; their use is also prohibited during the study, with the exception 
of buspirone.
5. The eligibility criteria were changed such that the use of stimulants in the 30 days before 
study is now exclusionary; their use is also prohibited during the study.
6. The eligibility criteria were changed to exclude subjects who are using low-dose 
antipsychotics (rather than allowing their inclusion on a case-by-case basis).
7. The eligibility criteria were changed such that the use of antidepressants in the 30 days 
before study is now exclusionary. Treatment with antidepressants (except MAO inhibitors
and ketamine) or buspirone can be initiated during the study provided that the 
antidepressant has been approved for the treatment of SAD or major depressive disorder 
by the FDA.
8. The eligibility criteria were changed to exclude women who are currently breastfeeding 
since it is not yet known whether PH94B can pass to an infant through breast milk.
9. The inclusion criterion concerning COVID-19 was modified to provide additional 
clarification.
10. Text describing prohibited therapies was updated to explain that legitimate use of 
prohibited medications for a short period will not necessarily lead to exclusion, but should 
be discussed on a case-by-case basis with the Medical Monitor.
11. The maximum duration of the screening period was increased from 30 days to 35 days.
12. Modify the rationale to clarify that acute symptoms of anxiety are being investigated.
13. Language was added to indicate that subjects are to complete the eDiary even on days when
they have not used any PH94B, and to record details of any health problems they 
experience.
14. The order in which assessments should be carried out during the screening visit was 
updated.
15. Physical examination updated.
16. The Penn Physician Withdrawal Checklist was added to safety assessments, to be 
conducted at Visit 14/ET visit and Visit 15 (Follow-up visit); relevant descriptions of the 
assessment and the analysis were added.
17. The analysis population definitions were simplified.
18. Removed text stating that a physician is required to see subjects at each visit, since this is 
not necessary.

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20. Text was added to advise male subjects with partners of childbearing potential to use 
contraception throughout their participation in the study, although this is not mandatory.
21. Text was added to clarify that ECGs should be performed in a supine position after the 
subject has rested for 5 minutes, to ensure consistency in the way ECG is measured.
22. Information on sample retention was updated.
23. Text describing the investigational product was clarified, including the addition of a 
description of monthly kits that will be provided.
24. Text describing the subject identification numbers was clarified.
25. Contact details for the study medical monitor were added.
26. New appendices were added to provide investigators with the 
 
 Hamilton Depression Rating Scale, Clinical Global 
Impression Scale of Improvement, Clinical Global Impression Scale of Severity, Patient 
Global Impression of Change, and the PWC-20.
A
APPENDIX J.

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AMENDED PROTOCOL
The following are the amended protocol and appendices, including all revisions specified above
APPENDIX J).

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4.
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ABBREVIATION
EXPLANATION
AE
adverse event
C-SSRS
Columbia-Suicide Severity Rating Scale
CFR
Code of Federal Regulations
CGI-I
Clinical Global Impression Scale of Improvement
CGI-S
Clinical Global Impression Scale of Severity
CI
confidence interval
COVID-19
coronavirus disease 2019
CRA
clinical research associate
CSR
clinical study report
EC50
concentration giving half-maximal response
ECG
electrocardiogram
eCRF
electronic case report form
EDC
electronic data capture
FDA
Food and Drug Administration
GABA
gamma aminobutyric acid
GCP
Good Clinical Practice
HAM-D17
Hamilton Depression Scale (17 items)
IB
investigator brochure
ICF
informed consent form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
i.n.
intranasal
IND
Investigational New Drug
IP
investigational product
IRB
institutional review board
LSAS
Liebowitz Social Anxiety Scale
MAO
monoamine oxidase
MINI
Mini-International Neuropsychiatric Interview
PGI-C
Patient Global Impression of Change
PWC-20
Penn Physician Withdrawal Checklist
SAD
social anxiety disorder
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation

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ABBREVIATION
EXPLANATION
SUDS
Subjective Units of Distress Scale
UAE
unanticipated adverse event
UDS
urine drug screen

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5.
INTRODUCTION
This document is a protocol for a Phase 3 human research study. This study is to be conducted 
according to United States and international standards of Good Clinical Practice (GCP) (Food and 
Drug Administration [FDA] Title 21 part 312 and International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use [ICH] guidelines), applicable 
government regulations, and institutional research policies and procedures.
5.1.
Background and Rationale
5.1.1
Social Anxiety Disorder
The essential features of social anxiety disorder (SAD) are defined as intense, marked, and 
persistent fear of social or performance situations, in which the subject believes embarrassment, 
humiliation, judgment, or rejection could occur as a consequence of exposure to unfamiliar people 
or possible scrutiny by others in the social or performance (e.g., public speaking) situation. The 
anxiety or fear resulting from the social or performance situation is profound. The avoidance, fear, 
ily routine, 
having a marked impact on occupational functioning and social life. The disorder has a lifetime 
prevalence estimated at up to 13%, with onset typically in the mid-teens or earlier, and it is 
diagnosed slightly more frequently in females than in males. Social anxiety tends to be a chronic 
disorder with periods of exacerbation, and a reported mean duration of illness of approximately 
20 years.1,2
Two subtypes of social anxiety are described in Diagnostic and Statistical Manual of Mental 
Disorders, 5th Edition: (i) social anxiety (formerly called generalized subtype) in which fear and 
avoidance extend to a wide range of social situations, and (ii) performance subtype only, in which 
the subject fears only one or a few circumscribed situations. Public speaking is by far the most 
prevalent of social fears.1
Social anxiety disorder has a lifetime comorbidity rate of approximately 81% with other 
psychiatric disorders (particularly affective disorders, other anxiety disorders, and substance abuse 
disorders), as well as being associated with increased non-psychiatric medical difficulties. People 
with SAD identify themselves as struggling with social impairment, inadequate social support, 
overall role impairment, specific impairment in education, work, and other activities, as well as 
interference in their efforts at self-improvement. Unfortunately, for these subjects, there is a strong 
consensus that SAD is one of the least commonly recognized and treated mental disorders.1,2
Current treatments for SAD include both psychosocial and pharmacologic measures. Psychosocial 
treatments include exposure therapy and cognitive behavioral therapy. Pharmacological measures 
vary widely and include antidepressants (monoamine oxidase inhibitors, selective serotonin 
reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors), benzodiazepines, beta 
blockers, and alpha-2-delta voltage gated calcium channel modulators.
5.1.2
Nasal Chemosensory Systems
In humans, as in other mammals, the olfactory system is a rostral projection of the telencephalon 
and it is the only sensory system with direct neural connections to the limbic system without a 
relay in the thalamus. Therefore, the limbic amygdala is the only brain structure that receives rapid 
afferent neural inputs from peripheral nasal chemosensory receptors.3,4 Chemical cues acting on 

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nasal chemosensory neurons trigger sensory inputs that reach the limbic amygdala through a rapid 
(oligosynaptic) neural path.
The relevance of the olfactory system in behavior is revealed by the serious behavioral impairment 
that occurs after bilateral olfactory bulbectomy in laboratory animals,5,6 and the development of 
anxiety and depression in humans with congenital anosmia.7,8
Stimulation of human olfactory chemosensory cells with primary odors produces olfactory 
awareness via the main olfactory neural circuits,9,10 but in humans chemosensory cues also engage 
nasal chemosensory receptors and induce behavioral and neuroendocrine responses, without 
olfactory awareness.11-16
In most mammals, odorless chemosignals induce activation of accessory olfactory neural 
circuits.17-22 However, some mammals including humans do not have an accessory olfactory 
system, and there are instead neural connections arising in nasal chemosensory neurons that 
connect with a subset of neurons in the main olfactory bulb. These main olfactory bulb neurons in 
turn project directly to the cortical and the medial amygdala and trigger an important contingent 
of forward inhibitory GABAergic neural circuits in the central amygdala involved in the 
modulation of fear and anxiety.21-26
These olfactory-limbic neural circuits play an important role in social behavior and 
emotions.11-13,19,27,28 The independent sensory contribution of the olfactory system projections to 
the limbic amygdala on social behavior has been also confirmed in molecular biology/behavioral 
studies, in studies using knockout mouse lines with loss of function in different zones of the 
olfactory bulbs,20 in human functional magnetic resonance imaging studies,12,29 in clinical studies 
in human subjects with isolated congenital anosmia,7,30 and in subjects with congenital 
hypogonadotropic hypogonadism.31
It has been suggested that olfactory receptor repertoires differ significantly across species.32 Since 
these receptors have different roles in different behaviors (e.g., social behavior, fear, reproductive 
behavior) the rapid evolutionary divergences may have contributed to behavior differentiation and 
speciation. Therefore, the action of chemosignals on nasal chemosensory neurons differs 
significantly across species.33-35
Pherines are a family of synthetic neuroactive steroid molecules that engage specifically with 
human nasal chemosensory receptors. Pherines stimulate receptor neurons in the human nasal 
chemosensory epithelium14,36 that activate olfactory bulb neurons and in turn trigger neural circuits 
in the limbic amygdala. This leads to activation of the anterior gyrus, hypothalamus, hippocampus 
and prefrontal cortex, and it is different from the brain areas activated by primary olfactory 
stimuli.12,29 Pherines are odorless, and brain activation by pherines does not produce olfactory 
awareness12,14 and can modulate brain autonomic and psychophysiologic response.11,13,15,29,37-39
5.1.3
PH94B
-androsta-4,16-dien-3-ol) is a synthetic neuroactive steroid discovered and initially 
developed at Pherin Pharmaceuticals that targets human nasal chemosensory cells11,36 and has been 
demonstrated in Phase 2 clinical studies to have benefits for the acute treatment of SAD.40
Pherines induce calcium ion entry in human nasal chemosensory neurons.37,41 Pherines such as 
PH94B target G-protein-coupled receptor chemosensory receptors that are expressed in human 
nasal chemosensory neurons.32,42

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In vitro screening studies using isolated, living, human nasal chemosensory neurons have shown 
that picomolar quantities of PH94B can selectively induce inward currents in a concentration-
dependent and reversible fashion.43 These membrane currents are carried by calcium ions.41
 
 
 
 
 
 
PH94B exerts its activity by stimulation of neural circuits involving 
the limbic amygdala, and it does not require systemic uptake and distribution to produce its 
anxiolytic pharmacological effects. PH94B is being investigated as a potential acute treatment for 
the alleviation of anxiety symptoms in adult patients with SAD. While PH94B may regulate 
gamma aminobutyric acid (GABA) circuits in the limbic amygdala, electrophysiological 
experiments in vitro show that PH94B does not directly bind to or modulate GABA receptors at 
concentrations of 10 µM or lower, which differentiates its mechanism of action from 
benzodiazepines.44 PH94B had no significant effect on GABA potentiation at doses up to 10 µM, 
compared to the 300% potentiation induced by diazepam, a commonly-prescribed benzodiazepine. 
The concentration of PH94B that gives the half-maximal response (EC50) could not be calculated 
50 was 72 nM (0.072 µM).
5.2.
Clinical Experience
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5.2.2
Phase 2 Studies
Two completed Phase 2 clinical studies had similar population and efficacy endpoints as the 
Phase 3 study PH94B-CL026 (PALISADE-1), currently in progress. These double-blind, 
randomized, placebo-controlled Phase 2 clinical studies
, included a 
total of 91 female subjects who met criteria for SAD (generalized subtype) as defined by the 
Diagnostic and Statistical Manual of Mental Disorders 4th edition. PH94B (1.6 µg) was 
administered i.n. (in spray form) 15 minutes prior to both a performance (public speaking) 
challenge and a social interaction challenge simulation which took place at the clinical sites. The 
2 challenges were separated by a 30-minute rest period. The primary outcome measures were the 
Clinical Global Impression Scale of Improvement (CGI-I) and the Subjective Units of Distress 
Scale (SUDS). The CGI-I rating is based on a 7-point scale in response to treatment ranging from 
very much improved (1), much improved (2), minimally improved (3), no change (4), minimally 
worse (5), much worse (6), and to very much worse (7). The SUDS scores range from 0 to 100, 
with higher scores indicating greater levels of anxiety. Subjects receiving PH94B were more likely 
to show improvement on the CGI-I following treatment than those who received placebo. In the 
PH94B group, 34 of 45 subjects (75.6%) were rated very much improved or much improved 
compared to only 17 of 46 subjects (37%) in the placebo group (p < 0.001).40
During the public speaking challenge, subjects randomized to PH94B (n = 45) showed an 
improvement of 26.7 points in the mean score on the SUDS at Visit 3 (initial treatment visit) as 
compared to Visit 2 (Baseline visit, at which all subjects received placebo). In comparison, subjects 
randomized to placebo (n = 46) showed an improvement of only 14.0 in the mean SUDS score 
ficantly exceeded the 
= 3.16, p = 0.002) on this challenge.40 No
SAEs were reported and no subjects were terminated prematurely from the study due to AEs.
5.3.
Summary of Potential Risks and Benefits
The potential benefits of study participation are that subjects with SAD may experience a reduction 
in their symptoms when they encounter anxiety-provoking situations in daily life as a result of 
treatment with PH94B. No other benefits of participation are anticipated.
Based on previous clinical studies conducted with PH94B, it is believed to be safe and well 
tolerated, and risks to subjects are considered minimal. Intranasal administration of PH94B may 
increase the risk of local site reactions including itching, burning, runny nose, sneezing and 
soreness inside the nose. In completed clinical studies, the most commonly reported AE was 
headache. None of these effects was reported in more subjects receiving PH94B than in subjects 
receiving placebo. In a nonclinical long-term safety study, no toxic effects were observed in rats 
administered repeated daily doses of PH94B for 6 months, suggesting that prolonged exposure to 
PH94B is safe; no toxic effects are expected with prolonged exposure in humans.
A summary of the pharmaceutical properties and known potential risks of PH94B is provided in 
the current version of the investigator brochure (IB). The Investigator must become familiar with 
all sections of the PH94B IB before the start of the study.

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6.
OBJECTIVES
6.1.
Primary Objective
The primary objective of the study is to evaluate the safety and tolerability of repeated dosing of 
PH94B over a period of up to 12 months as assessed by documenting AEs, standard clinical
measurements (physical examination, vital signs, clinical chemistry, hematology, suicidality, level 
of depression, and 12-lead electrocardiogram [ECG]), and withdrawal symptoms.
 
 
 
 
 
 
 
6.3.
Endpoint Mapping
Endpoints are mapped to study objectives as follows:

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Objectives
Endpoints
Primary
The primary objective of the study is to
evaluate the safety and tolerability of repeated 
dosing of PH94B over a period of up to 
12 months as assessed by documenting AEs,
standard clinical measurements (physical 
examination, vital signs, clinical chemistry, 
hematology, suicidality, level of depression,
and 12-lead ECG), and withdrawal symptoms
Incidence and severity of AEs, AEs leading 
to discontinuation, and SAEs
Changes in vital signs results
Changes in clinical laboratory evaluation 
(hematology, chemistry, and urinalysis) 
results
Changes in 12-lead ECG results
Changes in physical examination findings
Changes in HAM-D17 scores
Changes in C-SSRS scores
PWC-20 scores after termination of PH94B
 
 
 
 
anxiety and avoidance of common SAD 
triggers in daily life over the course of the 
study
Change in total LSAS scores over time with 
use of PH94B
 
 
 
 
 
To assess changes in subject perception of 
change in overall severity of their SAD 
symptoms over the course of the study
Change in proportion of subjects with PGI-C
scores of 1 (Very much improved) or 
2 (Much improved) over time with use of
PH94B
 
 
 
 
 
 
 
 
 
 

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Objectives
Endpoints
 
 
 
Abbreviations: AE = adverse event; C-SSRS = Columbia-Suicide Severity Rating Scale; CGI-I = Clinical Global 
Impression 
Scale 
of 
Improvement; 
CGI-S = Clinical 
Global 
Impression 
Scale 
of 
Severity; 
ECG = electrocardiogram; 
; HAM-D17 = Hamilton Rating Scale 
for Depression (17 items); LSAS = Liebowitz Social Anxiety Scale; PGI-C = Patient Global Impression of 
Change; PWC-20 = Penn Physician Withdrawal Checklist; SAD = social anxiety disorder; SAE = serious adverse 
event

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7.
STUDY DESIGN
Prevention of missing data is central to this study design. All subjects will be counseled at 
enrollment on the importance of completing the study and communicating all issues and concerns 
to the study staff.
A sufficient number of subjects from previous PH94B SAD studies will be screened or rolled over 
to obtain up to 600 subjects to receive up to 12 months of PH94B treatment.
7.1.
Overall Study Design and Plan
Subject participation in the study will last up to approximately 12 to 13 months, depending on the 
duration of the screening period and intervals between visits. Upon signing the informed consent 
form (ICF), subjects will begin participation in the present study at Visit 1 or Visit 2, depending 
on when they finished participation in their antecedent study:
Subjects who finished participation in their antecedent PH94B SAD study more than 
14 days before entering the present study will complete Visit 1 and enter a screening period 
lasting between 7 and 35 days. Subjects who meet all eligibility criteria will return to the 
clinic to complete Visit 2 (Baseline)
Subjects who finished participation in their antecedent PH94B SAD study within the last 
14 days will enter the present study at Visit 2 (Baseline)
At Visit 2 (Baseline, Day 0), all subjects will undergo baseline measurements of clinical laboratory 
assessments (clinical chemistry, hematology, urinalysis, pregnancy test [if female and of 
childbearing potential], and urine drug screening), 12-lead ECG, vital signs, physical examination, 
Hamilton Rating Scale for Depression (HAM-D17), 
 
Liebowitz Social Anxiety Scale (LSAS), Columbia-Suicide Severity Rating Scale (C-SSRS), and 
Clinical Global Impression Scale of Severity (CGI-S). At Visit 2 (Baseline), subjects will be 
trained on how to use and store PH94B Nasal Spray, and how to use an electronic diary (eDiary) 
application each day to record their dosing of PH94B (including a record of days when PH94B 
was not used) and any health problems they experienced that day. Adverse events (AEs) and 
concomitant medications will be reported and recorded. The subject will receive a 1-month supply 
Subjects will be instructed to return to the clinic for Visit 3 after 30 days (±3 days). At Visit 3, 
subjects will undergo clinical laboratory assessments (clinical chemistry, hematology, urinalysis, 
pregnancy test, and urine drug screening), vital signs, 12-lead ECG, physical examination (limited 
to nasal passage and oropharynx examination unless any AEs are reported), HAM-D17, 
 
LSAS, C-SSRS, CGI-S, CGI-I, and self-evaluation by the patient-reported outcome measure, 
Patient Global Impression of Change (PGI-C). At Visit 3, PH94B use and any daily reports of 
health problems that have been recorded in the eDiary application will be reviewed and AEs and 
concomitant medications will be reported and recorded. Subjects will receive a 1-month supply of
PH94B.
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4 to 13), and will repeat the 
same assessments as those performed at Visit 3. PH94B use and any daily reports of health 
problems that have been recorded in the eDiary application will be reviewed, AEs and concomitant 
medications will be reported and recorded at each visit. Subjects will receive a 1-month supply of
PH94B at each monthly visit.

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At Visit 14 (12 months±2 weeks), treatment will conclude, and subjects will undergo clinical 
laboratory assessments (clinical chemistry, hematology, urinalysis, pregnancy test, and urine drug
screening), vital signs, 12-lead ECG, physical examination, HAM-D17, 
 LSAS, C-SSRS 
CGI-S, CGI-I, PGI-C, and the Penn Physician Withdrawal Checklist (PWC-20). Also, PH94B use
and any daily reports of health problems that have been recorded in the eDiary application will be 
reviewed, and AEs and concomitant medications will be recorded and reported. Subjects will also 
be informed of their follow-up visit (Visit 15).
Subjects will return to the clinic for a follow-up visit (Visit 15, 54 weeks ±3 days), approximately 
2 weeks after the last PH94B administration, to undergo C-SSRS, PWC-20, and vital signs 
assessments, and record AEs.
Subjects who discontinue study treatment without completing 12 months of treatment will attend 
an Early Termination Visit (Visit 14) as soon as possible after discontinuing treatment, and return 
to the clinic for a follow-up visit (Visit 15) approximately 2 weeks later.
Safety Considerations: 
Sa
4 doses per day up to 12 months in up to 600 subjects) will be 
assessed and summarized through changes from baseline (Visit 2) to end of treatment (Visit 14) in 
AEs, laboratory values, 12-lead ECGs, physical examinations, suicidality, level of depression, vital 
sign assessments, and withdrawal symptoms following exposure to PH94B.
7.2.
Rationale and Discussion of Study Design
The present study has been designed to evaluate the safety and tolerability of PH94B with repeated 
dosing over a period of up to 12 months, in subjects who have participated in previous PH94B 
SAD studies. Participating subjects will use PH94B up to 4 times a day when they encounter 
anxiety-provoking social situations in daily life. Formal evaluation of the efficacy of PH94B is 
being conducted in 2 Phase 3 studies, which have been designed and powered to assess its efficacy 
in reducing anxiety in a public speaking challenge. In the present study, evaluation of the efficacy 
of PH94B over the 12-month treatment period is an exploratory objective.
Given that evaluation of long-term safety is the primary objective of this study, an open-label study 
with no comparator is considered to be an appropriate design.
Safety assessments in this study are standard for the evaluation of an investigational medicinal 
product, and include collection of AEs and SAEs, and evaluation of vital signs, safety laboratory 
tests, 12-lead ECGs, and physical examinations; given the use of the i.n. route of administration, 
the physical examination will include an examination of the nasal passages. Given that subjects 
are patients with a confirmed diagnosis of SAD, the C-SSRS will be used at each study visit as a 
precautionary measure. Withdrawal symptoms will also be assessed.
The exploratory evaluation of efficacy of PH94B with long-term use will use clinician-rated tools 
such as the LSAS, CGI-I and CGI-S, and a patient-reported outcome measure, the PGI-I. These 
are commonly used in clinical studies of psychiatric disorders, including SAD, and are considered 
appropriate for the present study.
7.3.
Selection of Doses in the Study
PH94B is an investigational new drug that has shown statistically significant efficacy, rapid onset 
of effect, and an excellent safety profile in the treatment of performance anxiety and social 

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interaction anxiety in subjects diagnosed with SAD. A 
 formulation has been used i.n. 
in Phase 1 and Phase 2 clinical studies. The i.n. route of administration is required for the small 
quantities of PH94B to engage directly with nasal chemosensory neurons interspersed in the nasal 
olfactory epithelium.
Nonclinical and clinical studies with PH94B are summarized in the IB. Nonclinical studies on
chronic exposure to PH94B and clinical Phase 2 studies have shown that PH94B is safe for use in 
human subjects 
. PH94B could not be quantified in blood samples 
of human subjects administered 
 i.n. in a Phase 1 study. No SAEs associated with the 
administration of PH94B have been observed in any clinical study to date. Safety margin based 
no-observed-adverse-effect levels for toxicity have indicated that the proposed doses are safe. The 
profile of physiological and behavioral responses to PH94B was similar for males and females, 
but the magnitude of effect is slightly reduced for males at the 1.6-µg dose. Based on Phase 1 and 
Phase 2 study outcomes after a single dose of PH94B of 3.2 µg (one 1.6-µg spray per nostril) and
observations made in study PH94B-CL019, this study proposes the self-administration of repeat 
dosing of PH94B 3.2 µg (one 1.6-µg spray per nostril), for males and females. PH94B, the 
investigational product (IP), will be self-administered i.n. up to 4 times per day in an open-label 
study. The objective of the study is to evaluate the safety and tolerability of PH94B use, and 
incidence of AEs in subjects with SAD over a 12-month observation period. Monthly clinic-based 
visits will be used to monitor subjects throughout the course of the study.
7.4.
Study Sites
The study is designed as a multicenter study conducted in the USA with approximately 40 clinical 
study sites.
7.5.
End of Study Definition
A clinical study is considered completed when the last 
last study visit has occurred.

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8.
SUBJECT POPULATION
8.1.
Selection of Study Population
Eligibility for participation in the study will be determined from demographic information, medical 
and psychiatric history, physical and psychiatric examination, 12-lead ECG, clinical laboratory 
findings, and clinical rating scale assessments.
Any information to be disseminated to potential subjects (handouts, brochures, etc.), as well as 
direct advertisements (including direct electronic or digital advertising), must be approved by 
VistaGen and by the appropriate IRB prior to use and implementation.
8.2.
Study Entry Criteria
Subjects who do not meet all of the eligibility criteria will not be enrolled.
8.2.1
Inclusion Criteria
To be considered eligible to participate in the study, all subjects must meet the following inclusion 
criteria:
1. Subject must have participated in a previous PH94B SAD study.
Note: Subjects who have not participated in a prior PH94B SAD study may be permitted 
to enroll following approval by the sponsor on a case-by-case basis.
2. Written informed consent provided prior to conducting any study-specific assessment.
3. Male and female adults, 18 through 65 years of age, inclusive.
4. Women of childbearing potential must be able to commit to the consistent and correct use 
of an effective method of birth control throughout the study and must also have a negative 
urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and 
Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: 
condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents 
(oral, transdermal, or injectable), or implantable contraceptive devices.
5. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental 
Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric 
Interview (MINI). 
6. Clinician-rated HAM-D17 total score < 18 at study entry (Screening [Visit 1] or Visit 2 
[Baseline] as applicable).
7. Negative COVID-19 test for subjects with COVID-19 symptoms or those who had direct 
exposure to someone with a positive COVID-19 test, and/or completion of quarantine 
period consistent with requirements at the study site as determined by the investigator. 
8.2.2
Exclusion Criteria
To be considered eligible for entry into the study, a subject must not meet any of the following 
exclusion criteria at study entry.
1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, 
anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum disorder, 
obsessive-compulsive disorder, or treatment-refractory major depressive disorder.

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Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. 
Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study 
provided that Generalized Anxiety Disorder is not the primary diagnosis.
2. In the opinion of the Investigator, the subject has a significant risk for suicidal behavior 
during the course of their participation in the study, or
a.
4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating 
Scale (C-SSRS) with reference to a 6-month period prior to screening; or
b. At Screening (for subjects who attend Visit 1): the subject has had 1 or more 
suicidal attempts with reference to a 2-year period prior to screening; or
c.
ms 4 or 5 in the Suicidal 
Ideation section of the C-SSRS with reference to last visit; or
d. The subject is considered to be an imminent danger to themself or others.
3. Subjects using the following psychotropic medications at enrollment or within 30 days 
before study entry: antidepressants (including monoamine oxidase [MAO] inhibitors), 
anxiolytics, stimulants, anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine. Eszopiclone, 
ramelteon, melatonin, zaleplon, zolpidem, or anti-histamines prescribed for insomnia are 
allowed.
4. Use of benzodiazepines or unapproved treatments such as beta blockers, within 30 days 
before study entry and during the study. Use of beta blockers for treatment of hypertension 
or cardiac conditions is allowed. Subjects who have been taking benzodiazepines daily for 
1 month or longer at the time of Visit 1 are not eligible to participate.
5. Use of any over-the-counter product or herbal preparation for treatment of the symptoms 
of anxiety or social anxiety within 30 days before study entry; concomitant use is 
prohibited during the study.
6. Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, 
total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory 
epithelium.
7. Subjects who meet criteria for moderate or severe alcohol or substance use disorder within 
the 1 year prior to entry into the study.
8. Subjects with a positive urine drug screen at study entry
.
9. An acute or chronic condition, including an infectious illness, uncontrolled seasonal 
allergies at the time of the study, or significant nasal congestion that potentially could affect 
drug delivery to the nasal chemosensory epithelium. 
10. Any current clinically significant and/or uncontrolled medical condition, based on medical 
history or as evidenced in screening assessments, such as COVID-19, HIV, cancer, stroke, 
congestive heart failure, uncontrolled diabetes mellitus, or any other medical condition or 
disease that, in the clinical judgment of the Investigator, could place the subject at undue 
risk, interfere with study participation, or confound the results of the study. 

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11. Women who have a positive urine pregnancy test prior to IP administration. Women who 
are currently breastfeeding are not eligible.
12. History of cancer or malignant tumor not in remission for at least 2 years. Basal cell skin 
cancers are not exclusionary.
13. Subjects with clinically significant abnormalities in hematology, blood chemistry, 
urinalysis, 12-lead ECG, or physical examination identified at study entry or during the 
legacy study which, in the clinical judgment of the Investigator, could place the subject at 
undue risk, interfere with study participation, or confound the results of the study.
8.3.
Premature Subject Withdrawal
All subjects will be advised that they are free to withdraw from participation in this study at any 
time, for any reason, and without prejudice. The Investigator should make every reasonable 
attempt to keep subjects in the study; however, subjects must be withdrawn from the study if they 
withdraw consent to participate. Investigators must attempt to contact subjects who fail to attend 
scheduled visits by telephone or other means to exclude the possibility of an AE being the cause 
of withdrawal. Should this be the cause, the AE must be documented, reported, and followed as 
described in Section 11.2.
The sponsor reserves the right to request the withdrawal of a subject due to protocol deviations or
other reasons.
The Investigator also has the right to withdraw subjects from the study at any time for the following 
reasons:
reason)
Any AE, laboratory abnormality, positive pregnancy test, positive urine drug screen, any 
of the inclusion/exclusion criteria not met during the study or concomitant illness which, 
in the opinion of the Investigator, indicates that continued treatment with IP or any other 
aspect of the study is not in the best interest of the subject
Note: If central laboratory urine drug screen testing is positive for a subject after 
enrollment, then the participation of the subject in the study may have to be discontinued. 
The Medical Monitor should be consulted on these cases. An unscheduled repeat urine 
drug screen may be obtained to investigate whether drug use is continuing.
Disease progression that, in the I
participation in the study
Significant noncompliance with the requirements of the protocol or treatment
Two consecutive missing visits and failure to contact the Investigator within a period of 
2 weeks (during the Screening and Baseline visits) or 1 month (during treatment) with no
reason for missing visit
The subject requires use of a medication prohibited by the protocol. The Investigator 
should discuss these cases with the medical monitor before withdrawing the subject, to 
determine whether the subject can continue in the study or not. 
Termination of the study by VistaGen

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At the discretion of the Investigator or VistaGen
Pregnancy
If a subject is withdrawn before completing the study, the reason for withdrawal and the date of 
discontinuation will be recorded on the appropriate page of the electronic case report form (eCRF). 
All attempts will be made to have subjects return to the clinic to complete the assessments or 
procedures performed at the Early Termination visit (see Section 10.2.3) in the event of early 
withdrawal after Visit 2 or any visit other than Visit 14 after IP administration. All attempts to
contact the subject, including phone or email, must be recorded in the source documents. Data will 
be collected from subjects on treatment only.
8.4.
Subject Replacement Criteria
Withdrawn subjects will not be replaced. If a substantial number of subjects are withdrawn from 
the study, the sponsor will evaluate the need for developing replacement criteria. Rescreening will 
be permitted on a case-by-case basis after discussion with the medical monitor.
The subject number for a withdrawn subject will not be reassigned to another subject.

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9.
TREATMENTS
All IP should be refrigerated prior to use but administered only at room temperature. 
Site personnel will instruct the subject to self-administer the IP by 1 spray into each nostril (right 
and left nasal passages), for 2 total sprays per dose.
9.1.
Identification of Investigational Product
The IP (PH94B Nasal Spray) is supplied in a 10-mL amber glass vial with a spray actuator. The 
spray actuator has a clear protective cover.
PH94B is odorless and contains propylene glycol, ethyl alcohol, polysorbate 80, water (q.s. to 
100%), and benzalkonium chloride as a preservative, in a phosphate buffer.
PH94B will be supplied in monthly kits consisting of a sufficient number of 10-mL amber glass 
vials, where each vial contains 8 mL of PH94B. Each metered dose spray delivers 1.6 µg 
per 100 µL spray. There is sufficient volume in each vial to deliver at least 60 sprays of PH94B.
Use of the i.n. route is essential given the site of action of PH94B on nasal sensory chemoreceptors 
(see Section 5.1).
PH94B will be supplied by 
New vials should be allowed to come to room temperature for 30 minutes and primed before use
according to the instructions provided.
9.2.
Selection of Timing of Dose for Each Subject
The IP will be administered once in each nostril. Men and women will be treated with the same 
3.2-µg dose of PH94B. Each nasal spray delivers 100 µL containing 1.6 µg PH94B. 
 
 
 
Treatment with PH94B should be self-administered approximately 15 minutes prior to or during 
an anxiety-provoking social situation or event. Consecutive nasal administrations of IP should be 
at least 1 hour apart, with no more than 4 administrations per day.
Site personnel will instruct the subject to self-administer the IP by 1 spray into each nostril (right 
and left nasal passages), for 2 total sprays per dosing event.
Subjects are instructed to record all PH94B administrations in the provided eDiary, even if they 
have not used PH94B that day (see Section 9.4.1).
9.3.
Dose Adjustment Criteria
Dose adjustment is not allowed in this study.
9.4.
Treatment Compliance
Study personnel will weigh each vial of IP prior to dispensing to subjects and upon return of used
or unused vials of IP from subjects to the study personnel. Vial weights will be documented in the 
eCRF. Subjects will record their use of the IP in an eDiary during the study (see Section 9.4.1).
Subjects will self-administer the IP up to 4 times per day between visits. The study personnel will 
be responsible for reviewing the self-administration of the IP in the eDiary.

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9.4.1
eDiary
Subjects participating in the study will be instructed to record their use of PH94B in an eDiary 
lication
and used on their smartphone or a similar device.
Subjects will be instructed to complete the eDiary at the end of each day even if zero doses are 
taken that day. They will be instructed to provide information on the number of doses they 
self-administered that day and the approximate time of each dose. 
After the subject has completed the dosing section, the eDiary will prompt the subject to answer if 
they have experienced any health problems that day. If they answer yes, the subject is asked to 
write a brief summary text in the eDiary. The Investigator or a delegate will review these summary 
texts at each visit and determine whether they are to be recorded in the EDC system as AEs, with
their severity, duration, and relationship to the study drug.  
A nominal payment will be made to subjects for each day that they complete the eDiary. This will 
be made available to the subject at the end of the study.
entries. Additional training on the use of the eDiary may be administered if necessary (see 
Section 9.4).
9.5.
Method of Assigning Subjects to Treatment Groups
In this open-label, single-treatment study, all subjects will receive the same treatment.
Subject numbers will be allocated by the IRT. Subjects will be sequentially assigned 6-digit 
numbers as shown below. The subject number will include the site number. Instructions on subject 
number assignments will be included in the IRT manual.
Sourcea
Site Number
Subject ID
Example
New Subjectsb
001
Starting with 001
001-001
001-002
PALISADE-1 Study (Completers)
001
Starting with 101
001-101
001-102
PALISADE-2 Study (Completers)
001
Starting with 501
001-501
001-502
a
Participants from other antecedent studies will follow a similar systematic numbering convention.
b
Subjects who have not participated in a prior PH94B SAD study may be permitted to enroll following approval 
by the sponsor on a case-by-case basis.
9.6.
Blinding and Unblinding Treatment Assignment
Not applicable this is an open-label study with all subjects receiving PH94B.
9.7.
Permitted and Prohibited Therapies
All medications taken by or administered to the subject during the month prior to Screening 
(Visit 1) should be recorded in the eCRF. All concomitant medication taken during the study will 
be recorded on appropriate pages of the eCRF.

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In order to ensure that appropriate concomitant therapy is administered, it is essential that subjects 
be instructed not to take any medication (either self-administered non-prescription drugs or 
prescription therapy prescribed by another physician) without prior consultation with the 
Investigator. The Investigator should examine the acceptability of all concomitant medications not 
explicitly prohibited. Sites should contact the Medical Monitor when uncertain about the 
acceptability of concomitant medications. All concomitant medication taken during the study will 
be recorded on appropriate pages of the eCRF.
9.7.1
Permitted Therapies
With the exception of those noted in Section 9.7.2, all medications (prescription or over-the-
counter) that were started prior to Screening may be continued during the course of the study.
During the course of the study, subjects should stay on stable doses of their usual allowable 
medication regimens. Medications for treatment of minor concurrent illnesses that arise after 
Screening may be allowed at the discretion of the Investigator, with the exception of the prohibited 
therapies specified in Section 9.7.2.
The use of eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or anti-histamines as 
concomitant medications for the treatment of insomnia is permitted.
 
 
 
Investigators may allow concomitant use of over-the-counter nasal decongestants as needed for 
seasonal allergies. Subjects may self-administer over-the-counter nasal decongestants at a 
minimum of 15 minutes prior to the use of IP during the study.
In general, starting treatment with antidepressants and buspirone during the study is allowed but 
the investigator should inform the Medical Monitor of this decision; for antidepressants, initiating 
treatment is permitted provided that the antidepressant has been approved for the treatment of SAD 
or major depressive disorder by the FDA. However, while subjects may begin treatment with 
antidepressants, use of MAO inhibitors or ketamine is not permitted.
9.7.2
Prohibited Therapies
At Screening (Visit 1), the Investigator may consider checking the local Prescription Drug 
Monitoring Database to confirm that subjects are not using scheduled central nervous system 
active drugs, such as benzodiazepines, if appropriate.
For subjects who use a prohibited medication (see below) during the study, Investigators should 
discuss the subject with the Medical Monitor. Such treatment might not be a cause for 
discontinuing the subject from the study. In particular, one-time use or very short-term use 
( 3 days) of prohibited medications, e.g., in cases of legitimate medical requirement such as minor 
surgeries or procedures, will not necessarily lead to exclusion from the study. These subjects 
should be discussed on a case-by-case basis with the Medical Monitor.
Prohibited medications are as follows:
Prior use of PH94B is not permitted, except for subjects who have participated in a PH94B 
SAD study.

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Use of the following psychotropic medications is prohibited: anxiolytics, anticonvulsants, 
mood stabilizers, antipsychotic medications, stimulants, gabapentin, pregabalin, opioids, 
naltrexone, esketamine, and ketamine.
o
Use of antidepressants is prohibited at enrollment or within 30 days before the 
study. However, treatment with antidepressants or buspirone can be initiated during 
the study (see Section 9.7.1).
Note: Treatment with MAO inhibitors or ketamine is prohibited at all times.
Use of benzodiazepines and unapproved anxiety treatments such as beta blockers is not 
permitted within 30 days before study entry (Visit 2), or during the study.
o
Subjects requiring daily treatment with benzodiazepines are excluded from the 
study. If a subject develops the need to use benzodiazepines for management of 
anxiety, their participation in the study will be discontinued and the subject will be 
excluded from the study.
o
Use of beta blockers for treatment of hypertension or cardiac conditions is allowed.
Use of any over-the-counter product or herbal preparation for treatment of the symptoms 
of anxiety or social anxiety is not permitted within 30 days before study entry, or during 
the study.
Where washout of prohibited medications is required before Visit 2 (Baseline), tapering rates are 
at the discretion of the Investigator and are to be determined on an individual basis, with 
consideration to subject state, dose, and known pharmacokinetics of the medication being 
discontinued. The subject must be consented before any tapering is started.
9.8.
Treatment After End of Study
After the end of the study, each subject will be treated according to standard clinical practice.
9.9.
Dispensing and Storage
The IP supplied by
 is to be used exclusively in the clinical study according 
to the instructions of this protocol. The Investigator is responsible for dispensing the IP according 
to the dosage scheme and for ensuring proper storage of the IP.
The Investigator must confirm the receipt of the IP.
9.9.1
Dispensing
At each visit from Visit 2 (Baseline) through the final monthly visit (Visit 13), subjects will be 
dispensed a monthly kit containing a sufficient number of PH94B Nasal Spray vials from the 
respective clinical site. Each study site will be provided with an appropriate supply of IP, and each 
vial will be individually numbered with a unique identification code. 
Prior to the subject receiving the IP at each in-clinic visit, the Investigator or study staff will use a
vial from their assigned kit to instruct the subject on how to ensure the IP is primed before use 
according to instruction. At least 1 vial of the IP will be primed at each clinic visit following Visit 2
(Baseline) as needed. The IP will be weighed prior to priming, and again when returned to study 
staff. Once primed the IP must be stored at room temperature.

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Subjects should use a fresh vial at the start of each week. Subjects will be instructed to remove the 
new vial from their home refrigerator, bring it to room temperature and prime the spray actuator
before use as needed. The clinic will dispense a kit of vials with unique serialized vial identification 
codes at each visit.
If the IP supply is lost or depleted prior to next in-clinic visit, subjects may notify the study site
through the provided study site phone number to secure additional supply of IP.
9.9.2
Storage
All IP supplied to each site by the sponsor will be maintained in a safe and secure (locked) area, 
stored upright in a refrigerator between 2°C (36°F) and 8°C (46°F), until dispensed, and away 
from direct sunlight and ultraviolet light. Access should be restricted to the designated responsible 
member(s) of t
neither he/she nor any of the study staff will supply IP to any person other than subjects enrolled 
in the study. 
Secure access to the storage area is the responsibility of the Investigator and designated staff.
New (unused) IP should be stored in the refrigerator. The spray actuator of the IP should be primed 
before use according to the instructions provided.
9.10. Drug Accountability
Upon receipt of each IP shipment, an inventory must be performed, and a drug receipt log filled
out and signed by the person accepting the shipment. The IP will be provided with each vial 
assembled individually to its spray actuator. It is important that the designated study staff count 
and verify that the shipment contains all the items noted in the shipment inventory. Any damaged 
or unusable IP in each shipment (active drug) will be documented in the study files.
Current and accurate inventory and dispensing records will be kept for all IP. Upon study 
completion a final inventory of all clinical supplies will be compiled. The Investigator or an 
assistant will instruct subjects to return spray vials to the clinical site, whether empty or containing 
unused IP, at study visits prior to subjects receiving additional supplies of IP. A copy of the Drug 
If the subject reports the IP as being lost or stolen this will be recorded in the eCRF.
9.11. Labeling and Packaging
Labeling and packaging of the IP will be performed by 
 
9.11.1 Labeling
The vials will have a label affixed that meets the applicable regulatory requirements and may 
include the following: IP name, dosage strength, lot number, protocol number, specified volume 
of contents,
information, vial identification code, and the 
.
The vial identification codes will be recorded in the drug dispensing record and the eCRF.

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Investigators must save all empty packaging or packaging containing unused vials for final 
disposition by the sponsor or contract pharmacy.
9.11.2 Packaging
PH94B will be supplied in subject kits containing a sufficient number of individual PH94B Nasal 
Spray dosage units.
PH94B Nasal Spray dosage units are not childproof and should be stored out of reach of children.

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10. STUDY PROCEDURES
Subjects must provide written informed consent for the present study before any study-related 
procedures are initiated, including the cessation of prohibited concomitant therapy.
The required safety and tolerability endpoints for subject evaluation are outlined in Section 13.1.4,
with a comprehensive schedule of events in Table 2-1. Every effort should be made to complete 
all required procedures and evaluations at the designated visits. A trained designated rater must 
see the subject at every visit. If available, the rater should be the same for a subject for each visit 
from Visit 2 (Baseline) to Visit 14, however, all raters will be trained for consistency.
Throughout the study, every reasonable effort should be made by study personnel to follow the 
timing of assessments and procedures in the schedule of events for each subject. If a subject misses 
a study visit for any reason, the visit should be rescheduled as soon as possible.
Subjects who have participated in a previous PH94B SAD study will be enrolled in this study and 
attend Visit 1 or Visit 2 depending on the interval since they finished participation in their 
antecedent study, as follows: 
>14 Days Since Antecedent Study: Subjects who finished participation in their antecedent PH94B 
SAD study more than 14 days before entering the present study will attend Visit 1 of the long-term 
safety study and complete all necessary screening assessments as shown in the schedule of events 
(Table 2-1).
For the purposes of enrollment,
Days Since Antecedent Study: Subjects who enter the present study within 14 days after 
finishing participation in their antecedent PH94B SAD study without meeting any of the exclusion 
criteria of this long-term safety study will enter the present study at Visit 2 (see Table 2-1).
While these subjects enter the long-term safety study at Visit 2, Investigators must
transcribe the following screening data (Visit 1) from the antecedent study to the 
present long-term safety study: demographics, the MINI, medical and psychiatric 
history, and the SAD Diagnostic Criteria checklist. If there have been any changes,
these details should be updated. This data from the antecedent study must be 
re-entered into the Visit 1 eCRF for the present study. All other assessments 
scheduled for Visit 2 must be performed as indicated in the schedule of events (see 
Table 2-1).
If the subject enters the present study on the same day as the last visit of their 
antecedent study, results from the assessments on that day may be used to enter data 
into the eCRFs for the antecedent study and for Visit 2 of the present study without 
repeating them.
o
For example, 
 assessment completed for the last visit of the
antecedent study may be transcribed for this long-term safety study 
provided that the last visit occurred on the same day as Visit 2 for the 
present study. Details on preparing a certified copy of the results will be 
provided in the eCRF completion guidelines. 

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For clinical laboratory assessments, 2 sets of blood and urine samples should be
obtained and sent to the lab for analysis: one for the antecedent study and one for the
long-term study. Note that these can be collected at the same time to avoid
unnecessary needlesticks.
Subjects who have not participated in a prior PH94B SAD study may be permitted to enroll 
following approval by the sponsor on a case-by-case basis. For the purposes of enrollment, these 
10.1. Study Duration
The study comprises a 7- to 35-day screening period and a treatment period of up to 12 months, 
and a follow-up visit at 2 weeks after the last visit.
10.2. Study Periods and Visits
A comprehensive schedule of study assessments is presented in Table 2-1 and described in the 
following sections. Every effort should be made to complete all required procedures and 
evaluations at the designated visits. A window of ±3 days is permitted for Visit 3 and the follow-up 
visit (Visit 15), with a window of ±7 days permitted for Visits 4 through 13, and ±2 weeks for 
Visit 14.
10.2.1 Screening and Washout
10.2.1.1 Screening (Visit 1)
Screening begins after written informed consent has been obtained. The purpose of the screening 
phase is to:
Ensure that appropriate subjects are entered into the study
Determine that the subject meets all eligibility criteria
o
Subjects who enter this study more than 14 days after finishing participation in their
antecedent study must undergo all the screening procedures at Visit 1 to ensure they
meet eligibility
Collect demographic and medical data permitting characterization of the subject
To meet these objectives, the duration of screening must be tailored to the individual subject and 
may last from a minimum of 7 to a maximum of 35 days. Subjects continuing to meet all eligibility 
requirements at Visit 2 (Baseline) will undergo treatment with IP (PH94B) up to Visit 14. 
Generally, subjects who have participated in an antecedent PH94B SAD study will be informed 
about the study, the IP, required visits and scheduling, and asked whether they wish to participate. 
All subjects agreeing to participate must give written informed consent using the IRB-approved 
ICF before any study-related procedures are performed (including tapering of prohibited 
medications, see Section 
). The ICF will be signed and dated by the subject and Investigator 
or other appropriate site staff, and a copy of the signed ICF will be given to the subject. The 
informed consent process will be documented in the source records for each subject. 

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After the informed consent process is complete, the signed ICF will be obtained, and the Screening 
visit (Visit 1) occurs.
The following numbered procedures should be performed in a block fashion as per the order 
indicated. Assessments within a block, except for the first block, may be conducted in any order 
as per clinical judgement at Screening, which is to occur at least 7 days, but no more than 35 days 
prior to Visit 2:
1. ICF will be reviewed and completed before any other assessments. Collect demographic 
information; and assign subject number.
2. Urine sample for drug screen and pregnancy test (if appropriate) will be collected early in 
the screening visit to determine eligibility and to guide diagnostic interviews, especially 
with regards to substance use assessment. The urine sampling is to include:
a.
Obtain urine sample for urine drug screen (UDS): Instant Exam to be performed on 
site, with results thoroughly documented in the source; urine sample to be sent to 
central laboratory for confirmation if on-site UDS is positive 
 
.
b. For females of child-bearing potential, obtain urine sample and complete on-site 
urine pregnancy test.
3. Medical and psychiatric history and diagnosis (usually starting with MINI) to include:
a.
Administer MINI (7.0.2).
b. Obtain medical history (including nicotine, alcohol use, and menstrual information 
on women of childbearing potential) and psychiatric history.
c.
Record prior and concomitant treatment and medication use (medication name, 
dose, and frequency).
d. Complete SAD diagnostic criteria checklist.
4. Standardized assessments (usually starting with LSAS but per investigator judgement 
based on the MINI) to include:
a.
Administer LSAS.
b. Administer HAM-D17.
c.
d. Administer C-SSRS (Baseline).
e.
Complete CGI-S with a recall period of 1 week (by the trained clinician).

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5. Physical assessments (recommend blood draw last to avoid any potential impact on vitals
and ECG assessment) to include:
a.
Perform physical examination, including height (inches) and body weight (pounds).
The physical examination includes a review of the nasal passages. If total anosmia
is suspected, Quick Olfactory Test (QOT) is to be administered.
b. Measure vital signs after the subject has rested for 5 minutes: seated systolic and
diastolic blood pressure, heart rate, respiratory rate, and body temperature (°F).
c.
Obtain 12-lead ECG in supine position after the subject has rested for 5 minutes.
d. Obtain blood and urine samples for evaluation by the central clinical laboratory,
including hematology, chemistry, thyroid functioning, and urinalysis (refer to
Section 10.3.1.1.1 for complete list).
6. After these assessments are complete, review all inclusion and exclusion criteria.
Procedures for rescreening subjects who initially fail to meet study entry criteria are described in
Section 14.3.
10.2.1.2 Washout Period 
In accordance with the study entry criteria (Section 8.2), the use of certain psychotropic 
medications, anxiolytics, or other preparations for the treatment of anxiety or social anxiety is
prohibited within 30 days before study entry (considered as Visit 2, Baseline). 
Where washout of prohibited medications (see Section
) is required before Visit 2
(Baseline), tapering rates are at the discretion of the Investigator and are to be determined on 
an individual basis, with consideration to subject state, dose, and known pharmacokinetics of 
the medication being discontinued. The subject must be consented before any tapering is started. 
10.2.2 Treatment Period
10.2.2.1 Visit 2 (Baseline)
Subjects entering the study within 14 days of their antecedent PH94B SAD study will enter this 
study at Visit 2. These subjects will sign an ICF for the present study at this visit and complete all 
Visit 2 assessments as noted in the schedule of events (Table 2-1) and detailed in this section.
All subjects will complete the following Visit 2 assessments:
Obtain urine sample for urine drug screen: Instant Exam to be performed on site, with
results thoroughly documented in the source; urine samples will be sent to the central
laboratory for confirmation as needed if on-site urine drug screen is positive. If the central
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, the subject may have to be excluded from the study; the Medical 
Monitor should be consulted on these cases
For females of childbearing potential, obtain urine sample and complete on-site urine 
pregnancy test
Record concomitant medication use 
Perform physical examination, including body weight (pounds). The physical examination 
includes a review of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: seated systolic and diastolic 
blood pressure, heart rate, respiratory rate, and body temperature (°F) 
Obtain 12-lead ECG in supine position after the subject has rested for 5 minutes
Obtain blood and urine samples for evaluation by the central clinical laboratory, including 
hematology, chemistry, thyroid functioning, and urinalysis
Review all inclusion and exclusion criteria
For subjects meeting all study inclusion criteria and no study exclusion criteria, the following 
Visit 2 procedures will be performed:
Administer the LSAS
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained clinician)
Train subjects on the use, dosing, and storage of IP. The subject will be given instructions 
on:
o
how to position the actuator nozzle in the nasal passages and self-administer IP
o
the number of sprays per nostril per dose (1 per nostril)
o
how to store the nasal spray
o
Treatment with PH94B should be self-administered approximately 15 minutes prior 
to or during an anxiety-provoking social situation or event. 
 
, with no more than 
4 administrations per day. Treatment does not need to be administered every day.
Train subjects on how to record study drug use on the eDiary application (see Study 
Procedures Manual for training on the eDiary application)
Record any AEs 
All prior, ongoing, or resolved AEs reported by subjects at the time of study entry will be 
considered as medical history during this study. Adverse events that become aggravated, 
accelerated, or exacerbated will be reported and considered as new AEs. Adverse events 
that recur will be considered as new AEs during this study.

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Dispense IP to subjects (1-month supply)
Subjects will be instructed to call a designated phone number provided by the study site to report 
any unusual or severe AEs or hospitalizations that may occur in between in-clinic visits.
Visit 3 will be scheduled 30 days (±3 days) from Baseline (Visit 2) for subjects.
10.2.2.2 Visit 3 (First Month in Clinic, ±3 Days)
At Visit 3, subjects should return to the study site and the following assessments will be completed:
Conduct urine drug screen (Instant Exam, to be performed on site, with results documented 
in the source. If urine drug screen result is positive 
, then urine sample will be sent to central laboratory for 
confirmation as needed). If the urine drug screen is confirmed as positive, a repeat 
unscheduled urine drug screen may be obtained to investigate whether drug use is 
continuing. The Medical Monitor should be consulted regarding these cases.
For females of childbearing potential, obtain urine sample and complete on-site urine 
pregnancy test
Record concomitant medication use
Administer the LSAS
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Perform focused physical examination, including body weight (pounds). The physical 
examination includes a review of the nasal passages and oropharynx but other organ 
systems should be examined only if the subject has symptoms or the investigator is 
concerned.
Measure vital signs after the subject has rested for 5 minutes: seated systolic and diastolic 
blood pressure, heart rate, respiratory rate, and body temperature (°F) 
Obtain 12-lead ECG in supine position after the subject has rested for 5 minutes
Obtain blood and urine samples for evaluation by the central clinical laboratory, including 
hematology, chemistry, thyroid functioning, and urinalysis (refer to Section 10.3.1.1.1 for 
complete list)
Complete the CGI-S with a recall period of 1 week (by the trained clinician)
Complete the CGI-I as compared to baseline visit (Visit 2), with a recall period of 1 week
(by the trained clinician)
Complete the PGI-C as compared to baseline visit (Visit 2), with a recall period of 1 week
(by the subject)
Dispense study medication and provide the subject with the storage instructions of the IP 
(1-month supply of IP) 

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Review and record AEs
Review the use of IP and any health problems they experienced as reported in the eDiary 
(by study staff)
10.2.2.3 Visit 4 Through Visit 13 (Monthly Visits, ±7 Days)
At Visit 4 through Visit 13, study assessments will be the same as those conducted at Visit 3 (see 
Section 10.2.2.2). Visits 4 through 13 will be conducted on a monthly basis, with a ±7-day window.
10.2.3 Visit 14 End of Treatment (or Early Termination) Visit
At Visit 14, subjects should return to the study site for an End of Treatment visit, and undergo the 
assessments shown in the schedule of events.
In addition, subjects who discontinue from the study early (for any reason other than loss to 
follow-up) should return to the study site for an Early Termination Visit. Similarly, if the subject
is attending a scheduled visit when the decision to discontinue is made, the investigator should 
perform the assessments indicated for Visit 14/Early Termination Visit in the schedule of events 
(Table 2-1).
The following assessments will be completed at Visit 14/Early Termination:
Record concomitant medication use
Obtain blood and urine samples for evaluation by the central clinical laboratory, including
hematology, chemistry, thyroid functioning, and urinalysis (refer to Section 10.3.1.1.1 for 
complete list)
Conduct urine drug screen (Instant Exam, to be performed on site, with results documented 
in the source. If urine drug screen result is positive
, then then urine sample will be sent to central laboratory 
for confirmation as needed).
For females of childbearing potential, obtain urine sample and complete on-site urine 
pregnancy test
Obtain 12-lead ECG in supine position after the subject has rested for 5 minutes
Perform physical examination, including height (inches) and body weight (pounds). Also 
includes an examination of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: seated systolic and diastolic 
blood pressure, heart rate, respiratory rate, and body temperature (°F)
Administer the LSAS
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained clinician)

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Complete the CGI-I as compared to baseline visit (Visit 2), with a recall period of 1 week
(by the trained clinician)
Complete the PGI-C as compared to baseline visit (Visit 2), with a recall period of 1 week
(by the subject)
Complete PWC-20
Review the use of IP and any health problems they experienced as reported in the eDiary 
(by the trained clinician)
Review and record AEs (by the trained clinician)
10.2.4 Visit 15 (Follow-up, 54 weeks ±3 Days)
At Visit 15, subjects should return to the study site and the following assessments will be 
completed:
Measure vital signs after the subject has rested for 5 minutes: seated systolic and diastolic 
blood pressure, heart rate, respiratory rate, and body temperature (°F)
Administer C-SSRS (Since Last Visit)
Complete PWC-20
Review and record AEs
10.3. Assessments
10.3.1 Safety Variables
Safety assessments will include the evaluation of AEs, clinical laboratory assessments, vital signs, 
12-lead ECGs, physical examinations, HAM-D17, C-SSRS evaluations, and the PWC-20.
10.3.1.1 Clinical Laboratory Safety Assessments
10.3.1.1.1 Clinical Laboratory Tests to be Performed 
Samples for the following laboratory tests will be collected at the time points specified in the 
schedule of events (Table 2-1).
The following laboratory tests will be performed on site during the study:
Urine pregnancy test (for all female subjects of childbearing potential)
Urine drug screen
The following laboratory tests will be performed by the central laboratory during the study:
Hematology Panel:
hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular 
concentration, mean corpuscular volume, platelets, red blood cell count, 
white blood cell count with differential, red blood cell morphology
Hematology 
Differential Panel:
basophils, eosinophils, lymphocytes, monocytes, neutrophils

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Serum Chemistry
Panel:
alanine aminotransferase, aspartate aminotransferase, albumin, calcium, 
chloride, alkaline phosphatase, bicarbonate, cholesterol, creatine kinase, 
creatinine, direct bilirubin, lactate dehydrogenase, magnesium, globulin, 
glucose, gamma-glutamyl transferase, indirect bilirubin, phosphorous, 
potassium, sodium, total bilirubin, total protein, triglycerides, urea 
nitrogen, uric acid
Urinalysis
Macroscopic 
Panel:
bilirubin, blood, clarity, color, glucose, ketones, leucocyte esterase, nitrite, 
pH, protein, specific gravity, urobilinogen
Urine Drug 
Screen:
If on-site urine drug screen is positive, urine sample will be submitted to 
central laboratory for confirmatory urine drug screen to be performed:
opiates, 
cocaine, 
amphetamines, 
barbiturates, 
benzodiazepines, 
cannabinoids, 
methadone, 
phencyclidine, 
propoxyphene, 
methamphetamine, buprenorphine, ecstasy, and oxycodone
 
Other:
thyroid stimulating hormone
free thyroxine (T4) will automatically be performed if thyroid stimulating 
hormone level is above the upper or below the lower normal limits
The central laboratory should be used for any unscheduled and follow-up labs, if needed.
Additional urine and blood samples may be collected for further evaluation of safety as warranted 
by the I
judgment.
Results and reports from the central laboratory should be filed with the source documents for each 
subject. The central laboratory will provide laboratory results to the study site as soon as they are 
available; results will also be provided to the sponsor or designated data manager within agreed 
upon timelines.
Any laboratory value outside the normal range will be flagged for the attention of the Investigator, 
who must indicate whether or not the value is of clinical significance. If the result of any laboratory
test performed during Screening is clinically significant, the subject should not be advanced to 
Visit 2 (Baseline) before discussing with the Medical Monitor. However, any abnormal result may 
be repeated to confirm the finding before excluding the subject from potential inclusion in the 
study. In addition, subjects should be excluded if they have any other abnormal laboratory test at
Screening that, in the I
judgment, is medically significant in that it would impact the 
safety of the subject, the conduct of the study, or the interpretation ofthe study results.
Follow-up/unscheduled laboratory tests may be performed on clinically significant abnormalities 
as indicated by the Investigator. Unscheduled laboratory tests may be repeated at any time at the
discretion of the Investigator for appropriate medical care.
10.3.1.1.2 Specimen Handling Requirements 
The transmission of infectious agents may occur through contact with contaminated needles and 
blood or blood products. Consequently, appropriate blood and body fluid precautions should be 

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employed by all study personnel involved in the collection of blood and handling of specimens in 
both the clinic and laboratory settings. Refer to current recommendations of the appropriate 
authorities.
In addition to appropriate handling of subject samples, specific regulations exist regarding the 
shipment of biologic/etiologic samples. Procedures and regulations for the packaging and shipping 
of infectious samples are outlined in the study laboratory manual or other appropriate reference. 
The Investigator is responsible for ensuring that all study samples that are to be transported to 
another location are packed and shipped appropriately according to the applicable regulations. 
10.3.1.1.3 Evaluation of Clinical Laboratory Values 
The normal ranges of values for the clinical laboratory assessments in this study will be provided 
by the responsible laboratory and submitted to VistaGen Therapeutics, Inc. prior to the beginning 
of the study. They will be regarded as the reference ranges on which decisions will be made.
If a laboratory value is out of the reference range, it is not necessarily clinically relevant. The 
Investigator must evaluate the out-of-range values and record his or her assessment of the clinical 
relevance in the appropriate eCRF.
All clinical laboratory values that in the I
r
pathological changes during or after termination of treatment must be reported as AEs and 
followed, as described in Section 11.2.5.
All measurements described in this section are recognized standard methods.
10.3.1.2 Clinical Examinations
10.3.1.2.1 Vital Signs 
Vital signs, including heart rate, respiratory rate, and seated systolic and diastolic blood pressure 
will be measured after the subject has been in a seated position for 5 minutes. Temperature will 
also be measured.
10.3.1.2.2 Twelve-lead Electrocardiogram 
A standard 12-lead ECG will be performed in a supine position after the subject has rested for 
5 minutes. All ECG recordings will be identified with the subject number, initials, date, and time 
of the recording.
All abnormal ECGs will be submitted for a secondary evaluation by a physician with expertise in 
clinical pharmacology and ECG interpretation. The expert
EDC system. The external expert will follow-up with the site as needed. Teleconferences can be 
arranged between the external expert and the site to discuss difficult cases and reach a consensus.
10.3.1.2.3 Physical Examination 
A complete physical examination (excluding the genitourinary examination) will be performed as 
indicated in the schedule of events (Table 2-1). The physical examination will include 
measurement of weight and height, and an examination of the nasal passages.

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A focused physical examination will be performed at certain visits as per the schedule of events, 
but must include examination of the nasal passages and oropharynx; other organ systems should 
be examined if the subject has symptoms or if the investigator has specific concerns.
10.3.1.2.4 Columbia-Suicide Severity Rating Scale 
The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency 
of suicide-related thoughts and behaviors during the assessment period. The interview includes 
definitions and suggested questions to solicit the type of information needed to determine if a 
suicide-related thought or behavior has occurred. The C-
Since Last V
visits. There are a maximum of 19 items to be completed: 7 that are required, 10 potential 
additional items if there is a positive response to a required item, and 2 items for suicide/suicide 
behavior present during the interview. The C-SSRS uses dichotomous scales (i.e., yes or no), 
Likert scales, and text or narrative to further describe the thoughts or behaviors.
10.3.1.2.5 Penn Physician Withdrawal Checklist 
The PWC-20 is a 20-item simple instrument for assessing anxiolytic discontinuation symptoms. It 
should be administered by a suitably qualified physician or advanced practice provider.
The PWC-20 consists of 20 questions related to withdrawal from benzodiazepines or other 
anti-anxiety compounds (see APPENDIX H). The symptoms measured are based on those that are 
potentially related to anxiolytic withdrawal: gastrointestinal, mood, sleep, motor, somatic, 
perception, and cognition. The questions will cover any symptoms that might occur during the 
week following discontinuation of PH94B.
10.3.1.3 Adverse Events
The definitions and management of AEs, and any special considerations for AEs, are provided in 
Section 11.
10.3.2 Efficacy Variables
10.3.2.1 Liebowitz Social Anxiety Scale
The LSAS is a clinician-rated scale that has been shown to be sensitive to treatment-related change 
in social anxiety symptoms. The time frame for rating symptomatology is the past week. The scale 
consists of 24 items. Each item is given 2 ratings: fear or anxiety on scale of 0 to 3 and avoidance 
on a scale of 0 to 3, with a total maximum overall score of 144 (see APPENDIX A). The items in 
the scale can be divided into performance and social interaction items, and corresponding 
subscores can be derived.
10.3.2.2
 
 
 

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10.3.2.3 Hamilton Rating Scale for Depression (17 Items)
The HAM-D17 scale is a 17-item clinician-rated scale to measure the severity of depression, 
addressing symptoms experienced in the past week, with the total score ranging from 0 to 68 (see 
APPENDIX D). A score of 0 to 7 is considered to be within the normal range, while a score of 20 
or more indicates at least moderate depression. The time frame for rating symptomatology is the 
past week.
10.3.2.4 Clinical Global Impression Scales
The Clinical Global Impression Scale (CGI) is a clinician-
view of the 
global health prior to and after participation in a clinical study. The scale 
history, psychosocial circumstances, 
symptoms, behavior and the effect of these parameters on the 
capability to function since 
the last visit with the subject. The CGI consists of 2 components, severity (CGI-S) and 
improvement (CGI-I). A recall period of 1 week is used.
The severity component (CGI-S) consists of 1 question that assesses the disease severity of the 
patient population and is on a scale of 1 to 7 ranging from normal (1) to extremely ill (7).
The improvement component (CGI-I) evaluates the change of the 
condition from the 
Baseline and is on a scale of 1 to 7 ranging from very much improved (1) to very much worse (7).
In this study the disease severity refers to the severity of SAD. The scale scoring is anchored with 
reference to the severity of symptoms and functional impairment caused by SAD.
10.3.2.5 Patient Global Impression of Change
The Patient Global Impression of Change (PGI-C) is a self-administered instrument that measures 
=
=
(see APPENDIX G). The time frame for rating is compared 
to the baseline visit (Visit 2).
Very Much Improved
1
Much Improved
2
Minimally Improved
3
No Change
4
Minimally Worse
5
Much Worse
6
Very Much Worse
7

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11. ADVERSE EVENTS
It is the responsibility of the Investigator at the site to oversee the safety of the study at his/her site. 
This safety monitoring will include careful assessment and appropriate reporting of SAEs as noted
below. Medical monitoring will include a regular assessment of the number and type of SAEs.
The Investigator will record all reportable events with start dates occurring any time after informed 
consent is obtained until 14 days after the last day of study participation.
11.1. Definitions
11.1.1 Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product that does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an
abnormal laboratory finding, for example), symptom, or disease temporally associated with the 
use of a medicinal product, whether or not related to the medicinal product.
Pre-existing diseases or conditions will not be considered AEs unless there is an increase in the 
frequency or severity, or a change in the quality, of the disease or condition. (Worsening of a 
preexisting condition is considered an AE.) A pre-existing condition is one that is present at the 
start of the study. A pre-existing condition should be recorded as an AE if the frequency, intensity, 
or the character of the condition worsens during the study period (after signing the ICF up to
Visit 14 and Visit 15/Follow-up).
For subjects who enter the present study within 14 days of their antecedent PH94B SAD study,
AEs ongoing at the time of enrollment into the present study will be recorded in the medical history 
section of the present study. 
Abnormal results of diagnostic procedures are considered to be AEs if the abnormality:
results in study withdrawal and is associated with an SAE
is associated with clinical signs or symptoms
leads to additional treatment or to further diagnostic tests
is considered by the Investigator to be of clinical significance
In addition, a clinical laboratory abnormality must be documented as an AE if any 1 of the 
following conditions is met:
The laboratory abnormality is not otherwise refuted by a repeat test to confirm the 
abnormality
The abnormality suggests a disease and/or organ toxicity
The abnormality is of a degree that requires active management, e.g., change of dose, 
discontinuation of the drug, more frequent follow-up assessments, further diagnostic 
investigation, etc.
Pregnancy is not considered an AE, but it is an important medical event, which must be followed 
up as described in Section 11.3.1.

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11.1.2 Unexpected Adverse Event
An expected AE is one for which the nature or severity is consistent with the known AE profile of 
the product. For a pre-approval test product, the known information is contained in the IB. For a 
marketed product, the known information is contained in the current package insert for the product.
An unexpected adverse event (UAE) is one for which the nature or severity of which is not 
consistent with the applicable product information (e.g., IB for an unapproved investigational 
product or package insert/summary of product characteristics for an approved product). For
example, hepatic necrosis would be unexpected (greater severity) if the IB only listed elevated 
hepatic enzymes or hepatitis. Likewise, cerebral thromboembolism and cerebral vasculitis would 
be unexpected (greater specificity) if the IB only listed cerebral vascular accidents.
Furthermore, reports that add significant information on specificity or severity of a known, already 
documented adverse reaction constitute unexpected events. Examples would be (a) acute renal 
failure as an expected adverse reaction with a subsequent new occurrence of interstitial nephritis 
(interstitial nephritis would be unexpected) and (b) hepatitis with a first occurrence of fulminant 
hepatitis (fulminant hepatitis would be unexpected.)
11.1.3 Serious Adverse Events
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
results in death
is life-threatening
-
the subject was at risk of death at the time of the event; it does not refer to an event that
hypothetically might have caused death if it were more severe.
requires inpatient hospitalization or prolongation of existing hospitalization
An elective hospital admission to treat a condition present before exposure to the IP, or a 
hospital admission for a diagnostic evaluation of an AE, does not qualify the condition or 
event as an SAE
results in persistent or significant disability/incapacity
is a congenital anomaly
NOTE: A congenital anomaly in an infant born to a mother who was exposed to the IP 
during pregnancy is an SAE. However, a newly diagnosed pregnancy in a subject that has 
received an IP is not considered an SAE unless it is suspected that the IP(s) interacted with
a contraceptive method and led to the pregnancy. 
is an important medical event
NOTE: Medical and scientific judgment should be exercised in deciding whether it is 
appropriate to consider other situations serious, such as important medical events that may 
not be immediately life-threatening or result in death or hospitalization but may jeopardize 
the subject or may require intervention to prevent one of the other outcomes listed in the 
definition above. Examples of such events are intensive treatment in an emergency room 
or at home for allergic bronchospasm, blood dyscrasias, or convulsions that do not result 
in hospitalization, development of drug dependency, or drug abuse.

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11.1.4 Significant Adverse Events
Other significant AEs are defined as marked hematological and other laboratory abnormalities 
(other than those meeting the definition of serious) and any events that led to an intervention, 
including withdrawal of test drug, dose reduction, or significant additional concomitant therapy.
11.1.5 Treatment-emergent Adverse Events
Treatment-emergent AEs are defined as:
AEs with onset at the time of or following the start of treatment with IP through the 
Follow-up Visit, or
AEs starting prior to the start of treatment but increasing in severity or relationship at the 
time of, or following, the start of treatment with IP through the Follow-up Visit
11.2. Event Assessment and Follow-up of Adverse Events
The Investigator will record all reportable events with start dates occurring any time after informed 
consent is obtained until 14 days after the last day of study participation. At each study visit, the 
Investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be 
followed for outcome information until resolution or stabilization.
The occurrence of an AE or SAE may come to the attention of study personnel during study visits 
and interviews of a study subject presenting for medical care, or upon review by a study monitor.
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured 
on the appropriate eCRF. Information to be collected includes event description, time of onset, 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All 
AEs occurring while on study must be documented appropriately regardless of relationship. All 
AEs will be followed to adequate resolution.
Any medical condition that is present at the time that the subject is screened will be considered as 
time during the study, it will be recorded as an AE.
Changes in the severity of an AE will be documented to allow an assessment of the duration of the 
event at each level of severity to be performed. Adverse events characterized as intermittent require 
documentation of onset and duration of each episode.
11.2.1 Assessment
The Investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or SAE described previously. At each visit, the subject will be allowed 
time to spontaneously report any issues since the last visit or evaluation. The Investigator will then 
monitor and/or ask about or evaluate AEs using nonleading questions, such as
Any clinically relevant observations made during the visit will also be considered AEs.

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In addition, the Investigator will review the eDiary summary text for health problems and 
determine whether they are to be recorded in the EDC system as AEs.
11.2.2 Evaluation
11.2.2.1 Severity of Adverse Events
The clinical severity of an AE will be classified as:
Mild
An event that is easily tolerated by the subject, causing minimal discomfort and 
not interfering with everyday activities
Moderate
An event that is sufficiently discomforting to the extent of interfering with 
normal everyday activities
Severe
An event that prevents the subject from performing normal everyday activities
It is important to distinguish between severe AEs and SAEs. Severity is a classification of intensity 
whereas an SAE is an AE that meets serious criteria, as described in Section 11.1.3.
11.2.2.2 Seriousness
The Investigator is to evaluate whether the AE meets serious criteria, as described in 
Section 11.1.3.
11.2.2.3 Actions Taken
Actions taken may consist of:
Dose not changed
An indication that a medication schedule was maintained.
Drug withdrawn
An indication that a medication schedule was modified through 
termination of a prescribed regimen of medication.
Not applicable
Determination of a value is not relevant in the current context.
Unknown
Not known, not observed, not recorded, or refused.
11.2.2.4 Outcome at the Time of Last Observation
The outcome at the time of last observation will be classified as:
Recovered/resolved
Recovered/resolved with sequelae
Recovering/resolving
Not recovered/not resolved

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Fatal*
Unknown
*Investigators should only select fatal as an outcome when the AE results in death. If more than 
one AE is judged to be 
death should be 
indicated for each such AE. 
death or unexplained death should be reported as SAEs.
11.2.2.5 Adverse Event Relationship to Investigational Product
The Investigator must make an asses
classifying the I
as follows:
Related
A reasonable possibility exists of a relationship between the AE and IP.
Not related
No reasonable possibility exists of a relationship between the AE and IP.
Medical judgment should be used to determine the relationship, considering all relevant factors, 
including pattern of reaction, temporal relationship, relevant medical history, and confounding 
factors such as co-medication or concurrent diseases.
11.2.3 Documentation
All AEs that occur within the period of observation for the study must be documented in the eCRF 
with the following information, where appropriate. (The period of observation for the study is 
described in Section 11.2).
AE name or term
When the AE first occurred (start date and time)
When the AE stopped (stop date and time or an indicati
Severity of the AE
Seriousness (hospitalization, death, etc.)
Actions taken
Outcome
Investigator opinion regarding the AE relationship to the IP
11.2.4 Treatment of Adverse Events
Adverse events that occur during the study will be treated, if necessary, by established standards 
of care. If such treatment constitutes a deviation from the protocol, the subject should be withdrawn 
from the study and the reason must be documented in the eCRF. The decision about whether the 
subject may continue in the study will be made by the sponsor after consultation with the 
Investigator and/or Medical Monitor.
If AEs occur in a subject that are not tolerable, the Investigator must decide whether to stop the
study and/or treat the subject. Special procedures may be 

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recommended for the specific IP, such as the collection of a serum sample for determining blood 
concentrations of IP, specific tapering procedures, or treatment regimens, as appropriate.
11.2.5 Follow-up
Any AE will be followed up to a satisfactory resolution, until it becomes stable, or until it can be 
explained by another known cause(s) (i.e., concurrent condition or medication) and clinical 
judgment indicates that further evaluation is not warranted. All findings relevant to the final 
and recorded on the eCRF
page.
11.2.6 Reporting
11.2.6.1 Serious Adverse Events
The Investigator or designee must report all SAEs promptly to 
 within 24 hours 
of first becoming aware of the event by completing, signing, and dating the Serious Adverse Event 
Report Form, verifying the accuracy of the information recorded in the form with the source 
documents and eCRF, and sending the SAE Report Form to 
 by one of the 
following methods: 
email: 
Fax number (back-up): 
This written report should be submitted on the SAE form provided for this purpose. At the time of 
first notification, the Investigator or designee should provide the following information, if 
available:
Protocol number
Reporter (study site and Investigator)
date of birth
Date of first dose of IP
Date of last dose of IP, if applicable
Adverse event term
Date of occurrence of the event
A brief description of the event, outcome to date, and any actions taken
The seriousness criteria(on) that were met
Concomitant medication at onset of the event
Relevant medical history information

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Relevant laboratory test findings
IP 
Whether and when the I
assignment 
Any missing or additional relevant follow-up information concerning the SAE should be sent to 
the sponsor/sponsor representative via the same contact details above as soon as possible, and 
within 7 days, on a follow-up SAE Report Form, together with the following minimal information 
(initial report, AE, date of occurrence, subject identification [ID], study ID, IP, and site number); 
this will allow the follow-up information to be linked to the initial SAE report. 
Specific information may be requested by the 
 Pharmacovigilance Department 
using a follow-up request form sent via email communication.
The Investigator is required to comply with applicable regulations (including local laws and 
guidances) regarding the notification of his or her health authorities, IRB, principal and 
coordinating investigators, study investigators, and institutions. Each investigator is obligated to
learn about the reporting requirements for investigators in his/her country. The study monitor may 
be able to assist with this.
11.2.6.2 Nonserious Adverse Events
Nonserious AEs will be recorded in the eCRF and reported by 
 to the sponsor in 
accordance with the study-specific safety management plan.
11.3. Special Considerations
11.3.1 Pregnancy
All women of childbearing potential who participate in the study should be counseled on the need 
to practice adequate birth control and on the importance of avoiding pregnancy during study 
participation. Women should be instructed to contact the investigator or study staff immediately if 
pregnancy occurs or is suspected.
Pregnancy testing will be conducted prior to administration of the IP on every woman of 
childbearing potential. A woman who is found to be pregnant at the Screening visit will be 
excluded from the study and considered to be a screening failure.
A woman who becomes pregnant during IP treatment or within 14 days of discontinuing the IP 
will be immediately discontinued from study participation. The Investigator must report the 
pregnancy within 48 hours of learning of the pregnancy, to 
 Pharmacovigilance 
using the Pregnancy Data Collection Form via the same fax number and/or email address as for 
SAE reporting (see Section 11.2.6.1). The Investigator should contact the designated individual(s) 
who receive SAE notification and record information related to the pregnancy on an Exposure in 
Utero form provided by the sponsor or its designee.
Early Termination Visit assessments are required as soon as possible after learning of the 
pregnancy. The Investigator is also responsible for following the pregnancy until delivery or 
termination. These findings must be reported on the Exposure in Utero form and forwarded to the 

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designated individual(s). The event meets the SAE criterion only if it results in a spontaneous 
abortion or a congenital anomaly.
Male subjects with partners of childbearing potential should be advised to use contraception 
throughout their participation in the study. If the partner of a male subject becomes pregnant during 
his IP treatment or within 14 days of his discontinuing the IP, the Investigator must report the 
pregnancy within 48 hours of learning of the pregnancy, to 
 Pharmacovigilance, 
as described above.

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12. DATA SAFETY MONITORING BOARD
A data safety monitoring board will not be used in this study. 

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13. STATISTICS
An interim safety analysis will be performed when approximately 100 subjects have completed 
12 months of PH94B dosing up to 4 times per day and approximately 300 subjects have completed 
6 months of PH94B dosing up to 4 times per day. All subjects who have received at least 1 dose 
of PH94B at this point will be included in this analysis. A final analysis will be performed after 
the last subject has completed or discontinued from the study.
13.1. Statistical Analysis
This section presents a summary of the planned statistical analyses. 
Safety, tolerability, and efficacy variables will be summarized using descriptive statistics. 
Descriptive summaries for categorical variables will include count and percentage. Descriptive 
summaries for continuous variables will include number of subjects (n), mean, standard deviation 
(SD), median, minimum, and maximum. Where appropriate, 95% confidence intervals (CIs) may 
be reported. Summaries will be presented by time point. All CIs will be 95%, unless stated 
otherwise.
Unless specified otherwise, all data recorded, will be listed by subject. A comprehensive 
description of planned analyses and statistical considerations will be described in the statistical 
analysis plan (SAP).
Summary statistics will be reported based upon observed data. Should a determination of treatment 
period be required for an AE or concomitant medication when the corresponding date is missing, 
or is a partial date, the event/medication will be considered 
on-treatment unless the portions 
of the date that are available indicate that this is not possible.
Details of the planned analyses, including strategies if needed to assess and address consequences 
of the COVID-19 pandemic on study conduct and study data, will be provided in the SAP that will 
be finalized before the database is locked.
13.1.1 Analysis Populations
A single analysis population is planned for this study:
Safety population: All subjects who receive IP.
All analyses will be performed using the Safety population.
Primary and exploratory endpoints may be summarized by subgroups of interest including age, 
sex, concomitant medications, and SAD severity. Analysis of subgroups not pre-defined in the 
final SAP will be labeled as such in the clinical study report (CSR).
13.1.2 Study Subjects and Demographics
13.1.2.1 Disposition and Withdrawals
The numbers of subjects randomized, completing, and withdrawing, along with reasons for 
withdrawal, will be tabulated. Details on the number of subjects participating in the individual 
antecedent PH94B SAD studies will also be provided.

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13.1.2.2 Protocol Deviations
A protocol deviation is any noncompliance with the clinical study protocol or ICH GCP 
requirements. The noncompliance may be either on the part of the subject, the Investigator, or the 
study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
Documentation of the deviations and corrective actions will be included in the data quality 
assessment during review.
It is the responsibility of the site Investigator to use continuous vigilance to identify and report 
deviations within 2 working days of identification of the protocol deviation, or within 2 working 
days of the scheduled protocol-required activity. All deviations must be addressed in study source 
documents and reported to the sponsor. Protocol deviations must be sent to the reviewing IRB per 
their policies. The site Investigator is responsible for knowing and adhering to the reviewing IRB 
requirements. Further details about the handling of protocol deviations will be included in the 
protocol deviation guidance plan.
13.1.2.3 Demographics and Other Baseline Characteristics
For all participating subjects, baseline is defined as Visit 2. For subjects who enter the present 
study within 14 days of their antecedent PH94B SAD study, Visit 2 assessments should be 
conducted as described in the schedule of events (Table 2-1). Demographics, medical and 
psychiatric history, MINI findings, SAD Diagnostic Criteria Checklists,
and baseline 
characteristics such as gender, age, race, weight, height and baseline physical examination reports, 
and vital signs will be carried over.
Demographic variables will include age, sex, height, and weight. Information on race and ethnicity 
will be collected for any eventual analysis of differences in response to the IPs, in accordance with 
local regulatory requirements. Baseline subject characteristics will include medical and psychiatric 
history, MINI findings, and physical examination findings.
Prior and concomitant medications will be summarized, by the number and percentage of subjects 
taking each medication, classified using World Health Organization Drug Dictionary (WHO-DD) 
Anatomical Therapeutic Chemical (ATC) classes and preferred terms.
13.1.3 Exposure and Compliance
Investigational product administration will be summarized in terms of total number of doses 
received and average number of daily doses.
Descriptive statistics will be provided overall and for each 3-month period of exposure 
(0-3 months, 4-6 months, 7-9 months, and 10-12 months).
13.1.4 Safety and Tolerability Analyses
Safety analyses will be conducted using data from the safety population (as defined in 
Section 13.1.1). Safety variables include treatment-emergent AEs, clinical laboratory values, vital 
signs, changes in suicidality (C-SSRS), level of depression (HAM-D17), PWC-20 results, ECG
readings, and physical examination results. No formal inferential analyses will be conducted for 
safety variables, unless otherwise noted.

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The incidence of AEs for defined periods of exposure (e.g., 3 months, 6 months, 9 months,
12 months, and overall) will be evaluated in the form of a proportion relating number of subjects 
experiencing events to number of subjects at risk for AEs by organ, relatedness, severity of 
reported AE, and by frequency of AE. In addition, frequency-type of reported AEs (once, 
continuous, or adaptability to treatment) by time of occurrence after Visit 2 dispensation may be 
tabulated. These data will be summarized and tabulated, including CIs when appropriate, for 
descriptive purposes. Abnormal laboratory values, vital signs, 12-lead ECGs and findings from 
physical evaluations that are logged as AEs are included. 
For each AE category (organ, relatedness, severity, frequency, etc.) the number of subjects 
reporting 1 or more AEs during the specified time period divided by the number of subjects 
exposed to the IP during that time period may serve as a nonparametric endpoint, and be subject 
to evaluation using time series analysis to investigate whether frequency of AEs changes with 
increased duration of exposure.
Descriptive statistics will be used to portray safety and tolerability of PH94B as measured by reports 
of AEs and SAEs, changes in laboratory values, 12-lead ECGs, physical examination, vital signs, 
and withdrawal symptoms.
Safety endpoints are as follows:
Incidence and severity of AEs, AEs leading to discontinuation, and SAEs
Changes in vital signs results
Changes in clinical laboratory evaluation (hematology, chemistry, and urinalysis) results
Changes in 12-lead ECG results
Changes in physical examination findings
Changes in HAM-D17 scores
Changes in C-SSRS scores
PWC-20 scores after termination of PH94B
13.1.4.1 Adverse Events
All AEs will be coded using the most recent version of Medical Dictionary for Regulatory 
Activities (MedDRA).
Treatment-emergent AEs are defined as:
AEs with onset at the time of or following the start of treatment with IP through the 
Follow-up Visit or Early Termination Visit, whichever occurs first, or
AEs starting prior to the start of treatment but increasing in severity or relationship at the 
time of, or following, the start of treatment with IP through the Follow-up Visit or Early 
Termination Visit, whichever occurs first.
The number and percentage of subjects with AEs will be displayed by system organ class and 
preferred term. Summaries of AEs by severity and relationship to IP will also be provided. Serious 
adverse events and AEs resulting in discontinuation of IP will be summarized separately in a 

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similar manner. Subject listings of AEs, SAEs, and AEs causing discontinuation of IP will be 
produced.
13.1.4.2 Clinical Laboratory Evaluations
Descriptive summaries (mean, SD, median, minimum, and maximum) of actual (absolute) values 
and changes from baseline values will be presented for clinical laboratory values for each time 
point.
The number of subjects with clinical laboratory values categorized as below, within, or above 
normal ranges will be tabulated showing change from baseline (shift tables) for each clinical 
laboratory analyte by study visit.
Laboratory values that are outside the normal range will also be flagged in the data listings and 
presented with the corresponding normal ranges. Any out-of-range values that are identified by 
the Investigator as being clinically significant will also be shown in a data listing.
13.1.4.3 Vital Signs
Descriptive summaries (mean, SD, median, minimum, and maximum) of actual values and 
changes from baseline will be calculated for systolic blood pressure, diastolic blood pressure, heart 
rate, respiratory rate, and body temperature.
The number of subjects with vital signs values categorized as below, within, or above normal 
ranges will be tabulated showing change from baseline (shift tables) for each parameter by study 
visit. Pre- and post-treatment values may also be presented with an analysis of mean changes from 
baseline.
13.1.4.4 Twelve-lead Electrocardiograms
The number and percentage of subjects with normal and abnormal ECG findings will be 
summarized for each time point. Abnormal results will be grouped as clinically significant and not 
clinically significant. A comparison of QT results will be presented. Summary statistics, for 
baseline values at Screening and each subsequent evaluation, will be displayed by treatment group 
for QT and the QT interval corrected for heart rate (QTc). In addition, the number and percent of 
subjects who experienced a change >30 ms or a change >60 ms will be presented.
Descriptive summaries (mean, SD, median, minimum, and maximum) will be presented for ECG 
measures of PR interval, QRS interval, QT interval, QTcF interval, and heart rate for each time 
point.
13.1.4.5 Penn Physician Withdrawal Checklist
Descriptive summaries (mean, SD, median, minimum, and maximum) will be presented for scores 
from the PWC-20 checklist, completed at Visits 14 and 15.
13.1.4.6 Physical Examination Findings
The number and percentage of subjects with normal and abnormal findings in the complete 
physical examination, including nasal passages examination, will be displayed.

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13.1.5 Efficacy Analysis
Efficacy variables will be summarized and analyzed using the safety population.
13.1.5.1 Exploratory Endpoints
Overall
-S, CGI-I, and the 
rating of the PGI-C from Screening (Visit 1) through Follow-up (Visit 15) will be 
summarized, including changes from baseline where appropriate. The change in LSAS, CGI-I, and 
PGI-C scores from Baseline to Visit 14 may also be explored using generalized linear model for 
repeated measures. 
In addition, overall change in the pattern in the frequency of PH94B use (frequent users; 3 or 
4 times a day and less 
2 times a day), change in medication use as documented 
by the clinician and the subject between Screening (Visit 1) and Follow-up (Visit 15) will be 
summarized.
Full details on this exploratory analysis will be provided in the SAP.
The exploratory endpoints are as follows:
Change in total LSAS scores over time with use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time with use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very much improved) or 2 (Much 
improved) over time with use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very much improved) or 2 (Much 
improved) over time with use of PH94B
 
 
 
13.1.6 Interim Analysis
Data cuts for interim data summaries are planned to support regulatory filings. An interim safety 
analysis will be performed when approximately 100 subjects have completed 12 months of PH94B 
dosing up to 4 times per day and approximately 300 subjects have completed 6 months of PH94B 
dosing up to 4 times per day. The study will remain ongoing until the last subject has been 
discontinued from the study and the database has been locked.
13.2. Sample Size Determination
Based on feedback from the FDA, the sample size for this study (up to 600 subjects) has been
selected to attain a PH94B safety database per the ICH E1 Guideline.45

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14. STUDY CONDUCT
Steps to ensure the accuracy and reliability of data include the selection of qualified investigators 
and appropriate study sites, review of protocol procedures with the Investigator and associated 
personnel before the study, periodic monitoring visits, and meticulous data management.
14.1. Sponsor and Investigator Responsibilities
14.1.1 Sponsor Responsibilities
The sponsor is obligated to conduct the study in accordance with strict ethical principles 
(Section 16). The sponsor reserves the right to withdraw a subject from the study (Section 8.3), to 
terminate participation of a study site at any time (Section 14.7), and/or to discontinue the study 
(Section 14.6).
VistaGen Therapeutics, Inc. agrees to provide the Investigator with sufficient material and support 
to permit the Investigator to conduct the study according to the study protocol.
14.1.2 Investigator Responsibilities
18.1), the Investigator indicates that he or she 
has read the protocol carefully, fully understands the requirements, and agrees to conduct the study 
in accordance with the procedures and requirements described in this protocol.
The study will be conducted in accordance with ICH GCP and applicable United States Code of 
Federal Regulations (CFR). The Principal Investigator will assure that no deviation from, or 
changes to, the protocol will take place without prior agreement from the Investigational New 
Drug (IND) sponsor, funding agency and documented approval from the IRB, except where 
necessary to eliminate an immediate hazard(s) to the study subjects. All personnel involved in the 
conduct of this study have completed Human Subjects Protection and ICH GCP training.
Investigators should ensure that all persons who are delegated study-related responsibilities are 
adequately qualified and informed about the protocol, the IP(s), and their specific duties within the 
context of the study. Investigators are responsible for providing VistaGen Therapeutics, Inc. with
documentation of the qualifications, GCP training, and research experience for themselves and 
their staff as required by the sponsor and the relevant governing authorities.
To ensure compliance with the guidelines, the study may be audited by an independent person. 
The Investigator agrees, by written consent to this protocol, to cooperate fully with compliance 
checks by allowing access to all study documentation by authorized individuals.
14.1.3 Confidentiality and Privacy
Subject confidentiality and privacy are strictly held in trust by the participating investigators, their 
staff, and the sponsor and their staff. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to subjects. Therefore, the 
study protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any unauthorized 
third party without prior written approval of the sponsor. 
All research activities will be conducted in as private a setting as possible.
The study monitor, other authorized representatives of the sponsor, representatives of the IRB, 
regulatory agencies, or pharmaceutical company supplying study product may inspect all 

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documents and records required to be maintained by the Investigator, including, but not limited to, 
medical records (office, clinic, or hospital) and pharmacy records for the subjects in this study. 
The clinical study site will permit access to such records.
ely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location 
for as long a period as dictated by the reviewing IRB, institutional policies, or sponsor 
requirements.
Study subject research data, which is for purposes of statistical analysis and scientific reporting, 
or identifying information. Rather, individual subjects and their research data will be identified by 
a unique study identification number. The study data entry and study management systems used 
by clinical sites and by 
 staff will be secured and password protected. At the end 
of the study, all study databases will be de-identified and archived at 
14.2. Site Initiation
Study personnel may not screen or enroll subjects into the study until after receiving notification 
from the sponsor or its designee that the study can be initiated at the study site. The study site will 
not be authorized for study initiation until:
1. The study site has received the appropriate IRB approval for the protocol and the 
appropriate ICF.
2. All regulatory documents have been submitted to and approved by the sponsor or its 
designee.
3. The study site has a Clinical Trial Agreement in place.
4. Study site personnel, including the Investigator, have participated in a study initiation 
meeting.
14.3. Screen Failures
Subjects who fail inclusion and/or exclusion criteria may be rescreened for the study on a 
case-by-case basis after discussion with the medical monitor. Subjects may only be rescreened 
once 30 days or more after the original Screening visit. If a subject is eligible to enter the study 
after having previously failed screening, the subject will be assigned a new subject identification 
number.
Screen failures are defined as subjects who consent to participate in the clinical study but are not 
subsequently entered in the study. A minimal set of screen failure information is required to ensure 
transparent reporting of screen failure subjects to meet the Consolidated Standards of Reporting 
Trials (CONSORT) publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure details, eligibility criteria, and any SAE.
14.4. Study Documents
All documentation and material provided by VistaGen Therapeutics, Inc. for this study is to be 
retained in a secure location and treated as confidential material.

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14.4.1 Informed Consent
Informed consent forms describing in detail the study intervention, study procedures, and risks are 
given to the subject and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.
Informed consent is
approved and the subject will be asked to read and review the document. The Investigator will 
explain the research study to the subject and answer any questions that may arise. A verbal 
procedures, and potential risks of the study and of their rights as research participants. Subjects 
will have the opportunity to carefully review the written ICF and ask questions prior to signing. 
The subject should have the opportunity to discuss the study with their family or surrogates or 
think about it prior to agreeing to participate. The subject will sign the informed consent document 
prior to any procedures being done specifically for the study. Subjects must be informed that 
participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the ICF will be given to the subjects for their records. The informed consent 
process will be conducted and documented in the source document (including the date) and the 
ICF signed before the subject undergoes any study-specific procedures. The rights and welfare of 
the subjects will be protected by emphasizing to them that the quality of their medical care will 
not be adversely affected if they decline to participate in this study.
14.4.2
Documents
The regulatory documents are listed in the 
 study plans.
The regulatory documents must be received from the Investigator and reviewed and approved by 
VistaGen Therapeutics, Inc. or its designee before the study site can initiate the study and before 
VistaGen Therapeutics, Inc. will authorize shipment of IP to the study site. Copies of the 
I
Additional documents, including a copy of the protocol and applicable amendment(s), the PH94B 
IB, eCRF completion guidelines, copies of regulatory references, copies of IRB correspondence, 
and IP accountability records should also be retained as part of the I
documents. It is the I
responsibility to ensure that copies of all required regulatory 
documents are organized, current, and available for inspection.
14.4.3 Case Report Forms
Electronic case report forms (eCRFs) will be designed to capture all relevant background 
information as well as objective reasons for early discontinuation when it cannot be prevented.
18.1), the Investigator agrees to maintain 
accurate eCRFs and source documentation as part of the case histories for all subjects who sign an 
ICF.
Case report forms are considered confidential documents and should be handled and stored 
accordingly. The sponsor or its designee will provide the necessary training on the use of the 
specific eCRF system used during the study to ensure that the study information is captured 
accurately and appropriately.

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To ensure data accuracy, eCRF data for individual subject visits should be completed as soon as 
possible after the visit. All requested information must be entered in the EDC system according to 
the completion guidelines provided by the sponsor or its designee.
The eCRFs must be signed by the Investigator. These signatures serve to attest that the information 
contained in the eCRF is accurate and true.
14.4.4 Source Documents
Information recorded in the EDC system should be supported by corresponding source 
documentation. Examples of acceptable source documentation include, but are not limited to, a
record of obtaining informed consent, hospital records, clinic and office charts, laboratory notes, 
and recorded data from automated instruments, memoranda, and pharmacy dispensing records.
14.5. Data Quality Control
VistaGen Therapeutics, Inc. and its designees will perform quality control checks on this clinical 
study.
14.5.1 Monitoring Procedures
VistaGen Therapeutics, Inc. and/or its designee will conduct site visits to monitor the study and 
ensure compliance with the protocol, GCP, and applicable regulations and guidelines. The 
assigned clinical research associate(s) (CRA[s]) will visit the Investigator and study site at periodic 
intervals and maintain periodic communication. The Investigator agrees to allow the CRA(s) and 
other authorized VistaGen Therapeutics, Inc. personnel access. The CRA(s) will maintain current 
personal knowledge of the study through observation, review of study records and source 
documentation, and discussion of the conduct of the study with the Investigator and staff. While 
on site, the CRA(s) will review
regulatory documents, directly comparing entries in the EDC system with the source 
documents
consenting procedures
AE procedures
storage and accountability of IP and study materials
The CRA will ask for clarification and/or correction of any noted inconsistencies. Procedures for 
correcting eCRFs are described in the 
 study plans. As representatives of the 
sponsor, CRAs are responsible for notifying project management of any noted protocol deviations.
By signing the 
18.1), the Investigator agrees to meet with the 
CRA(s) during study site visits; to ensure that study staff is available to the CRA(s) as needed; to 
provide the CRA(s) access to all study documentation, to the clinical supplies dispensing and 
storage area; and to assist the monitors in their activities, if requested. Further, the Investigator 
agrees to allow VistaGen Therapeutics, Inc. or designee auditors or inspectors from regulatory 
agencies to review records and to assist the inspectors in their duties, if requested. 
Additional details on monitoring will be described in the clinical monitoring plan.

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14.5.2 Data Management
VistaGen Therapeutics, Inc. or designee will be responsible for activities associated with the data 
management of this study. The standard procedures for handling and processing records will be 
management plan will be developed, including a data management overview, description of 
database contents, annotated eCRF, and consistency checks.
Study site personnel will be responsible for providing resolutions to all data queries. The 
Investigator will be required to document electronic data review to ensure the accuracy of the 
corrected and/or clarified data. Procedures for soliciting and documenting resolution to data 
queries are described in the 
 study plans.
14.5.3 Quality Assurance/Audit
This study will be subject to audit by VistaGen Therapeutics, Inc., or its designee. Audits may be 
performed to check compliance with GCP guidelines and can include:
site audits
Trial Master File audits
database audits
document audits (e.g., protocol and/or CSR)
VistaGen Therapeutics, Inc. or its designee may conduct additional audits on a selection of study 
sites, requiring access to subject notes, study documentation, and facilities or laboratories used for 
the study.
The study site, facilities, all data (including source data), and documentation will be made available 
for audit by quality assurance auditors and for IRB or regulatory authorities according to GCP 
guidelines. The Investigator agrees to cooperate with the auditor during the visit and will be 
available to supply the auditor with eCRFs or other files necessary to conduct that audit. Any 
findings will be strictly confidential.
If a regulatory authority informs the Investigator that it intends to conduct an inspection, the 
Investigator shall notify VistaGen Therapeutics, Inc. immediately.
14.6. Study Termination
reason.
14.6.1 Premature Study Termination
The study may be temporarily suspended or terminated prematurely if there is sufficient reasonable 
cause at any time by VistaGen Therapeutics, Inc., IRBs, or regulatory authorities. 
Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study subjects, Principal Investigators, the IND sponsor, 
and regulatory authorities. If the study is prematurely terminated or suspended, the Principal 
Investigator will promptly inform study subjects and the IRB; the sponsor will provide the reasons 
for the termination or suspension. Study subjects will be contacted, as applicable, and be informed 
of changes to study visit schedule.

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Circumstances that may warrant termination or suspension include, but are not limited to:
Determination of unexpected, significant, or unacceptable risk to subjects
Demonstration of efficacy that would warrant stopping
Insufficient compliance to protocol requirements
Data that are not sufficiently complete and/or evaluable
Determination that the primary endpoint has been met
Determination of futility
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor, IRB, and/or FDA. 
In the case of study termination, study sites may be asked to have all subjects currently 
participating in the study complete all of the assessments for Visit 14/Early Termination.
14.7. Study Site Closure
At the end of the study, all study sites will be closed. VistaGen Therapeutics, Inc. may terminate 
participation of a study site at any time. Examples of conditions that may require premature 
termination of a study site include, but are not limited to, the following:
Noncompliance with the protocol and/or applicable regulations and guidelines
Inadequate subject enrollment
14.7.1 Record Retention
The Investigator shall retain and preserve one copy of all data generated in the course of the study, 
specifically including, but not limited to, those defined by GCP as essential until:
Notified by VistaGen Therapeutics, Inc. that records no longer need to be retained
At least 2 years following the date a marketing application for the IP has been approved 
in this indication (SAD), or the sponsor has discontinued its research with the IP, or
At least 2 years have elapsed since the formal discontinuation of clinical development of 
the IP
These documents should be retained for a longer period, however, if required by the applicable 
regulatory requirement(s) or if needed by the sponsor.
At the end of such period, the Investigator shall notify the sponsor in writing of his or her intent to 
destroy all such material. The sponsor has 30 days to respond to the I
sponsor has
14.7.2 Sample Retention
Samples may be used for purposes related to this research. The samples will be destroyed after 
testing is complete. In addition, identifiable samples can be destroyed at any time at the request of 
the subject.

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14.8. Changes to the Protocol
This protocol cannot be altered or changed except through a formal protocol amendment, which 
requires the written approval of VistaGen Therapeutics, Inc. The protocol amendment must be 
signed by the Investigator and approved by the IRB before it may be implemented. Protocol 
amendments will be filed with the appropriate regulatory agency(s) having jurisdiction over the 
conduct of the study.
14.9. Use of Information and Publication
manufacturing processes, basic scientific data, and formulation information supplied by VistaGen 
Therapeutics, Inc. or its designee to the Investigator, and not previously published, is considered 
confidential and remains the sole property of VistaGen Therapeutics, Inc. Case report forms also 
remain the property of VistaGen Therapeutics, Inc. The Investigator agrees to use this information 
for purposes of study execution through finalization.
The information developed in this study will be used by VistaGen Therapeutics, Inc. in connection 
with the continued development of PH94B and thus may be disclosed as required to other clinical 
investigators or government regulatory agencies.
The information generated by this study is the property of VistaGen Therapeutics, Inc. Publication 
or other public presentation of PH94B data resulting from this study requires prior review and 
written approval of VistaGen Therapeutics, Inc. Abstracts, manuscripts, and presentation materials 
should be provided to VistaGen Therapeutics, Inc. for review at least 30 days prior to the relevant 
submission deadline.
It is agreed that the results of the study will not be submitted for presentation, abstract, poster 
exhibition, or publication by the Investigator until VistaGen Therapeutics, Inc. has reviewed and 
commented on such a presentation or manuscript for publication. If applicable, this study will be 
registered at ClinicalTrials.gov, and results information from this study will be submitted to 
ClinicalTrials.gov.

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15. FINAL CLINICAL STUDY REPORT
VistaGen Therapeutics, Inc. will retain ownership of the data.
The final CSR will be written within 1 year of completion of the clinical part of the study. This 
report will include a summary of the study results based on a statistical evaluation and clinical 
assessment of the protocol-defined endpoints.
The final CSR may be submitted to the regulatory authorities.

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16. ETHICAL AND LEGAL CONSIDERATIONS
16.1. Good Clinical Practice
This study will be conducted in compliance with the April 1996 ICH Guidance for Industry GCP 
E6 (including archiving of essential study documents), the Integrated Addendum to ICH E6 (R2) 
of November 2016, and the applicable regulations of the country(ies) in which the study is 
conducted.
16.2. Subject Information and Informed Consent
A properly constituted, valid IRB must review and approve the protocol, the I
and related subject information and recruitment materials before the start of the study.
It is the responsibility of the Investigator to ensure that written informed consent is obtained from 
the subject before any activity or procedure is undertaken that is not part of routine care.
16.3. Approval by Institutional Review Board
For IND studies, the minimum standards of conduct and requirements for informed consent are 
defined in the FDA regulations.
A valid IRB must review and approve this protocol before study initiation. Written notification of 
approval is to be provided by the I
mpleted 
 
 form, IRB Approval Form, or written documentation from the IRB containing the same 
information.
Until written approval by the IRB has been received by the Investigator, no subject may undergo 
any procedure not part of routine care 
Protocol amendments must also be reviewed and approved by the IRB. Written approval from the 
IRB, or a designee, must be received by VistaGen Therapeutics, Inc. before implementation. This 
written approval will consist of a completed Approval form or written documentation from the 
IRB containing the same information.
16.4. Finance and Insurance
Details on finance and insurance will be provided in a separate agreement between the Investigator 
and the sponsor.

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17. REFERENCES
1. Lang AJ, Stein MB. Social phobia: prevalence and diagnostic threshold. J Clin Psychiatry. 
2001;62(Suppl 1):5-10.
2. Katzelnick DJ, Greist JH. Social anxiety disorder: an unrecognized problem in primary 
care. J Clin Psychiatry. 2001;62 (Suppl 1):11-15.
3. Papez 
JW. 
A 
proposed 
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4. Maclean PD. The limbic system ( visceral brain ) and emotional behavior. AMA Arch 
Neurol Psychiatry. 1955;73(2):130-134.
5. Cairncross. Olfactory bulbectomy as a model for depression. N.W. Bond ed. In: Animal 
models in psychophysiology. New York. Academic Press, 1976:99-128.
6. Song C, Leonard B. Effects of olfactory bulbectomy in the rat, alone or in combination 
with antidepressants and endogenous factor, an immune function. Hum Psychopharmacol 
Clin Exp. 1995;10(1):7-18.
7. Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life-an updated review. 
Chem Senses. 2014;39(3):185-194.
8. Croy I, Negoias S, Novakova L, Landis BN, Hummel T. Learning about the Functions of 
the Olfactory System from People without a Sense of Smell. 2012. Plos One.
9. Kevetter GA, Winans SS. Connections of the corticomedial amygdala in the golden 
hamster. II. Efferents of the olfactory amygdala . J Comp Neurol. 1981;197(1):99-111.
10. Sosulski DL, Bloom ML, Cutforth T, Axel R, Datta SR. Distinct representations of 
olfactory information in different cortical centres. Nature. 2011;472(7342):213-216.
11. Monti-Bloch L, Jennings-White C, Dolberg DS, Berliner DL. The human vomeronasal 
system. Psychoneuroendocrinology. 1994;19(5-7):673-686.
12. Sobel N, Prabhakaran V, Hartley CA, Desmond JE, Glover GH, Sullivan EV, et al. Blind 
smell: brain activation induced by an undetected air-borne chemical. Brain. 1999;122 
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13. Grosser BI, Monti-Bloch L, Jennings-White C,
Berliner DL. Behavioral and 
electrophysiological 
effects 
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pheromone. 
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14. Monti-Bloch L, Grosser BI. Effect of putative pheromones on the electrical activity of the 
human vomeronasal organ and olfactory epithelium. J Steroid Biochem Mol Biol. 
1991;39(4B):573-582.
15. Monti-Bloch L, Diaz-Sanchez V, Jennings-White C, Berliner DL. Modulation of serum 
testosterone and autonomic function through stimulation of the male human vomeronasal 
organ (VNO)
with pregna-4,20-diene-3,6-dione. J Steroid Biochem Mol Biol. 
1998;65(1-6):237-242.

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16. Monti L, Liebowitz M. Neural Circuits of Anxiolytic and Antidepressant Pherine 
Molecules. Epub ahead of print. CNS Spectrums. 2020;23:1-7.
17. Kevetter GA, Winans SS. Connections of the corticomedial amygdala in the golden 
hamster. I. Efferents of the "vomeronasal amygdala". J Comp Neurol. 1981;197(1):81-98.
18. Swanson LW, Petrovich GD. What is the amygdala? Trends Neurosci. 1998;21(8):323-
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19. Dorries KM, Adkins-Regan E, Halpern BP. Sensitivity and behavioral responses to the 
pheromone androstenone are not mediated by the vomeronasal organ in domestic pigs. 
Brain Behav Evol. 1997;49(1):53-62.
20. Hagino-Yamagishi K. Diverse systems for pheromone perception: multiple receptor 
families in two olfactory systems. Zoolog Sci. 2008;25(12):1179-1189.
21. Kang N, Baum MJ, Cherry JA. A direct main olfactory bulb projection to the 'vomeronasal' 
amygdala in female mice selectively responds to volatile pheromones from males. Eur J 
Neurosci. 2009;29(3):624-634.
22. Pape HC, Jungling K, Seidenbecher T, Lesting J, Reinscheid RK. Neuropeptide S: a 
transmitter system in the brain regulating fear and anxiety. Neuropharmacology. 
2010;58(1):29-34.
23. Pro-Sistiaga P, Mohedano-Moriano A, Ubeda-Banon I, Del Mar Arroyo-Jimenez M, 
Marcos P, Artacho-Perula E, et al. Convergence of olfactory and vomeronasal projections 
in the rat basal telencephalon. J Comp Neurol. 2007;504(4):346-362.
24. Mohedano-Moriano A, de la Rosa-Prieto C, Saiz-Sanchez D, Ubeda-Banon I, Pro-Sistiaga 
P, de Moya-Pinilla M, et al. Centrifugal telencephalic afferent connections to the main and 
accessory olfactory bulbs. Front Neuroanat. 2012;6:19.
25. Sokolowski K, Corbin JG. Wired for behaviors: from development to function of innate 
limbic system circuitry. Front Mol Neurosci. 2012;5:55.
26. Tovote P, Fadok JP, Luthi A. Neuronal circuits for fear and anxiety. Nat Rev Neurosci. 
2015;16(6):317-331.
27. Schaal B, Coureaud G, Langlois D, Ginies C, Semon E, Perrier G. Chemical and 
behavioural 
characterization 
of 
the 
rabbit 
mammary 
pheromone. 
Nature. 
2003;424(6944):68-72.
28. Nuss P. Anxiety disorders and GABA neurotransmission: a disturbance of modulation. 
Neuropsychiatr Dis Treat. 2015;11:165-175.
29. Savic I, Berglund H, Gulyas B, Roland P. Smelling of odorous sex hormone-like 
compounds causes sex-differentiated hypothalamic activations in humans. Neuron. 
2001;31(4):661-668.
30. Smeets MAM, Veldhuizen MG, Galle S, Gouweloos J, de Haan AJA, Vernooij J, et al. 
Sense of smell disorder and health-related quality of life. Rehabil Psychol. 2009;54(4):404-
412.
31. Aydogan U, Aydogdu A, Akbulut H, Sonmez A, Yuksel S, Basaran Y, et al. Increased 
frequency of anxiety, depression, quality of life and sexual life in young hypogonadotropic 

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hypogonadal males and impacts of testosterone replacement therapy on these conditions. 
Endocr J. 2012;59(12):1099-1105.
32. Rodriguez I, Greer CA, Mok MY, Mombaerts P. A putative pheromone receptor gene 
expressed in human olfactory mucosa. Nat Genet. 2000;26(1):18-19.
33. Grus WE, Shi P, Zhang YP, Zhang J. Dramatic variation of the vomeronasal pheromone 
receptor gene repertoire among five orders of placental and marsupial mammals. Proc Natl 
Acad Sci U S A. 2005;102(16):5767-5772.
34. Yoder AD, Larsen PA. The molecular evolutionary dynamics of the vomeronasal receptor 
(class 1) genes in primates: a gene family on the verge of a functional breakdown. Front 
Neuroanat. 2014;8:153.
35. Francia S, Pifferi S, Menini A, Tirindelli R. Vomeronasal Receptors and Signal 
Transduction in the Vomeronasal Organ of Mammals. C. Mucignat-Caretta ed. In: 
Neurobiology of Chemical Communication. Chapter Chapter 10, Boca Raton, FL. CRC 
Press/Taylor & Francis, 2014.
36. Monti-Bloch L. Patch recorded isolated adult human vomeronasal organ cells are 
electrically excitable and respond to skin steroidal substances androsta-4,16-dien-3-one 
and estra-1,3,5(10),16-tetraen-3-ol. Chemical Senses. 1995;20(6):745.
37. Monti-Bloch L, Jennings-White C, Berliner DL. The human vomeronasal system. A 
review. Ann N Y Acad Sci. 1998;855:373-389.
38. Liebowitz MR, Salmán E, Rosenthal N, Nicolini H, Monti L. Evaluation of a Unique 
Nanogram-Dose Intranasal Aerosol for the Acute Management of the Symptoms of Social 
Anxiety Disorder. in New Clinical Drug Evaluation Unit Conference. 2011. Boca Raton, 
FL.
39. Liebowitz MR, Hanover R, Draine A, Lemming R, Careri J, Monti L. Effect of as-needed 
use of intranasal PH94B on social and performance anxiety in individuals with social 
anxiety disorder. Depress Anxiety. 2016;33(12):1081-1089.
40. Liebowitz MR, Salman E, Nicolini H, Rosenthal N, Hanover R, Monti L. Effect of an acute 
intranasal aerosol dose of PH94B on social and performance anxiety in women with social 
anxiety disorder. Am J Psychiatry. 2014;171(6):675-682.
41. Winegar B, Monti L. Pherines increase cytosolic Ca in isolated living human vomeronasal 
chemosensory neurons. ACHEMS abstract. 2003.
42. Herman R, Monti-Bloch L. Human VNO cDNA libraries: Pertussis toxin blockade of 
human VNO receptors (R1). Pherin Pharmaceuticals, Inc.; Los Altos, CA: Pherin Report 
MB 007; 1997.
43. Monti L. Dose dependent effect of pherine PH94B in isolated female human vomeronasal 
organ cells. Pherin Study Report # CL009; Report date: May 18, 1999.
44. Monti L, Liebowitz M, Smith M. PH94B: A new intranasal neuroactive steroid with rapid 
onset of anxiolytic activity but a mechanism of action different from benzodiazepines. 
ADAA, 2021.

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45. ICH Topic E 1: Note for Guidance on Population Exposure: The Extent of Population 
Exposure to Assess Clinical Safety (CPMP/ICH/375/95). June 1995.

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18. ATTACHMENTS
18.1.
PROTOCOL 
NUMBER:
PH94B-CL030
PROTOCOL TITLE:
A Phase 3 Open-label Safety Trial of PH94B Nasal Spray in the 
Acute Treatment of Anxiety in Adult Subjects with Social Anxiety 
Disorder (SAD)
FINAL PROTOCOL:
12-Aug-2021
AMENDMENT 1
14-Mar-2022
I have read this protocol and agree to conduct this clinical study as outlined herein. I will ensure 
that all subinvestigators and other study staff members have read and understand all aspects of this 
protocol. I agree to cooperate fully with VistaGen Therapeutics, Inc. and 
 during 
the study. I will adhere to all FDA, ICH, and other applicable regulations and guidelines regarding 
clinical studies on an IP during and after study completion.
Principal Investigator:
Printed Name:
Signature:
Date:

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19. APPENDICES
A. Liebowitz Social Anxiety Scale
B.
C.
D. Hamilton Depression Rating Scale
E. Clinical Global Impression Scale of Improvement
F. Clinical Global Impression Scale of Severity
G.
H.
I.
Regulations and Good Clinical Practice Guidelines
J.
Summary of Amended Sections

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A. Liebowitz Social Anxiety Scale

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B.

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C.

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D. Hamilton Depression Rating Scale

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lOl 
Vista Gen® 
Therapeutics 
,, 
PALISADE LTS 
Subject Initials 
Subject ff 
Source Document: Protocol PH94B-CL030 
Hamilton Depression Rating Scale (HAM-0) 
Dale 
Visit If 
Check the appropriate response for each item according to how the subject has felt during the past week. 
7. 
WORK AND ACTIVITIES 
DO No difficulty. 
0 1 Thoughts and feelings of incapacity, fatigue or weakness related to activities, work, or hobbies. 
02 Loss of interest in activity, hobbies or work - either directly reported by patient. or indirect 
listlessness, indecision and vacillation (feels he/she has to push self to work or activities} . 
03 Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient 
does not spend at least three hours a day in activities (job or hobbies) excluding routine 
chores. 
04 Stopped working because of present illness. Rate 4 if patient engages in no activities except 
routine chores. or if patient fails to complete routine chores unassisted. 
8. 
RETARDATION (slowness of thought and speech, impaired ability to concentrate, decreased motor 
activity) 
DO Normal speech and thought. 
0 1 Slight retardation during the interview. 
02 Obvious retardation during the interview. 
0 3 Interview difficult. 
04 Complete stupor. 
9. 
AGITATION 
DO None. 
0 1 Fidgetiness. 
02 Playing with hands, hair. etc. 
03 Moving about, can't sit still. 
04 Hand wringing, nail-biting, hair pulling, biting of lips. 
10. ANXIETY PSYCHIC 
DO No difficulty. 
0 1 Subjective tension and irritability. 
02 Worrying about minor matters. 
0 3 Apprehensive attitude apparent in face or speech. 
04 Fears expressed without questioning. 
Rater Signature: __________________ 
_ 
Initials: ______ 
_ 
Date: ___J___J __ 
Page 2 of 4 
Version: 16 November 2021 

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LrOl 
Vista Gen® 
Therapeutics 
'' 
PALISADE LTS 
Subjec t Initials 
Subject# 
Source Document: Protocol PH94B-CL030 
Hamilton Depression Rating Scale (HAM-D) 
Dale 
Visit# 
Check the appropriate response for each item according to how the subject has felt during the past week. 
l l. ANXIETY SOMATIC (Physiological concomitants of anxiety), such as: 
Gastrointestinal - dry mouth. wind. indigestion. diarrhea, stomach cramps, belching 
Cardiovascular - palpitations. headaches 
Respiratory - hyperventilation. sighing. sweating 
Urinary frequency 
Sweating 
DO Absent. 
0 1 Mild. 
02 Moderate. 
03 Severe. 
1:1 4 Incapacitating. 
12. SOMATIC SYMPTOMS GASTROINTESTINAL 
DO None. 
0 1 Loss of appetite but eating without encouragement. Heavy feelings in abdomen. 
02 Difficulty eating without urging. Requires laxatives or medication for bowels or medication for 
gastrointestinal symptoms. 
13. GENERAL SOMATIC SYMPTOMS 
1:10 None. 
1:1 1 Heaviness in limbs. back or head. Backaches. headaches. muscle aches. Loss of energy and 
fatigability. 
1:12 Any clear-cut symptom rates 2. 
14. GENITAL SYMPTOMS (symptoms such as loss of libido. menstrual disturbances) 
DO Absent. 
0 1 Mild. 
02 Severe. 
15. HYPOCHONDRIASIS 
1:10 Not present. 
1:1 1 Self-absorption (bodily). 
1:12 Preoccupation with health. 
1:13 Frequent complaints. requests for help, etc . 
1:14 Hypochondriacal delusions. 
16. Loss OF WEIGHT (according to the patient) 
1:10 No weight loss. 
1:11 
Probable weight loss associated with present illness. 
0 2 Definite (according to patient) weight loss. 
03 Not assessed. 
Rater Signature: __________________ 
_ 
lnllials: ______ 
_ 
Dale: __J__J __ 
Page 3 of 4 
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lOl 
Vista Gen® 
Therapeutics 
,, 
PALISADE LTS 
Subject Initials 
Subject# 
Source Document: Protocol PH94B-CL030 
Hamilton Depression Rating Scale (HAM-D) 
Dale 
Visit# 
Check the appropriate response for each item according to how the subject hos felt during the past week. 
17. INSIGHT 
DO Acknowledges being depressed and ill. 
D l 
Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc. 
02 Denies being ill at all. 
Total (17 Items}: 
Rater Signature: __________________ 
_ 
Version: 16 November 202 1 
Initials: ______ 
_ 
Date: ___} __ ! __ 
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E. Clinical Global Impression Scale of Improvement

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F. Clinical Global Impression of Severity

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G.

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H.

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I.
Regulations and Good Clinical Practice Guidelines
1. Regulations
Refer to the following United States CFR:
FDA Regulations 21 CFR, Parts 50.20 50.27
Subpart B Informed Consent of Human Subjects
FDA Regulations 21 CFR, Parts 56.107 56.115
Part 56 Institutional Review Boards
Subpart B Organization and Personnel
Subpart C IRB Functions and Operations
Subpart D Records and Reports
FDA Regulations 21 CFR, Parts 312.50 312.70
Subpart D Responsibilities of Sponsors and Investigators
2. Good Clinical Practice Guidelines
ICH GCP guidelines can be found at the following URLs:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_G
uideline.pdf
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__
Step_4.pdf

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J. Summary of Amended Sections
In addition to editorial changes throughout, the following changes have been made:
Section 1.
Approval Signatures
New:
Medical Monitor:
 
VistaGen Therapeutics, Inc
Text formerly read:
Now reads:
Section 2.1.
Synopsis
Text formerly read:
Objectives: The primary objective of the study is to evaluate the safety 
and tolerability of repeated dosing of PH94B over a period of up to 
12 months as assessed by documenting adverse events (AEs) and 
standard clinical measurements (physical examination, vital signs, 
clinical chemistry, hematology, and 12-lead electrocardiogram 
[ECG]).
Now reads:
Objectives: The primary objective of the study is to evaluate the safety 
and tolerability of repeated dosing of PH94B over a period of up to 
12 months as assessed by documenting adverse events (AEs), standard 
clinical measurements (physical examination, vital signs, clinical 
chemistry, hematology, suicidality, level of depression, and 12-lead 
electrocardiogram [ECG]), and withdrawal symptoms.
Text formerly read:
Rationale: The study is designed to evaluate the safety and tolerability 
of the long-term administration of 3.2 µg of PH94B as needed, up to 
4 times a day, in adult subjects with SAD prior to anxiety-provoking 
situations in daily life.
Now reads:
Rationale: The study is designed to evaluate the safety and tolerability 
of the long-term administration of 3.2 µg of PH94B as needed, up to 
4 times a day, in adult subjects with SAD prior to acute
anxiety-provoking social situations in daily life.
Text formerly read:
Study Design: 
participated in a PH94B Phase 3 SAD study will be given the option to 
enroll in this study if they meet requirements of the inclusion and 
exclusion criteria.
Now reads:
Study Design: The study will enroll subjects who have previously 
participated in any PH94B SAD study (for example, PALISADE-1
[PH94B-CL026] or PALISADE-2 [PH94B CL032]) who meet 

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requirements of the inclusion and exclusion criteria for the present 
study.
Text formerly read:
Study Design (Procedures): Subject participation in the study will last 
up to approximately 12 to 13 months, depending on the duration of the 
screening period and intervals between visits. Upon signing the 
informed consent form, subjects will complete Visit 1 and enter a 
screening period lasting between 7 and 30 days. Subjects who meet all 
eligibility criteria will return to the clinic to complete Visit 2
(Baseline, Day 0) and undergo baseline measurements of clinical 
laboratory assessments (clinical chemistry, hematology, urinalysis, 
pregnancy test [if female and of childbearing potential], and urine drug 
screening), 12-lead ECG, vital signs, physical examination, Hamilton 
Rating Scale for Depression (HAM-D17), 
 
 LSAS, Columbia-Suicide Severity Rating Scale 
(C-SSRS), and Clinical Global Impression Scale of Severity (CGI-S). 
At Visit 2 (Baseline), subjects will be trained on how to use and store 
the PH94B nasal spray delivery device, and how to use an electronic 
diary (eDiary) application; subjects will be instructed to record each 
incidence of PH94B use in the eDiary. Adverse events (AEs) and 
concomitant medications will be reported and recorded. The subject 
will receive a 1-month supply of PH94B (6 vials) for use (up to 
4
anxiety. 
Subjects will be instructed to return to the clinic for Visit 3 after 
30 days (±3 days). At Visit 3, subjects will undergo clinical laboratory 
assessments (clinical chemistry, hematology, urinalysis, pregnancy 
test, and urine drug screening), vital signs, 12-lead ECG, physical 
examination, HAM-D17, 
LSAS, C-SSRS, CGI-S, Clinical
Global Impression Scale of Improvement (CGI-I), and self-evaluation 
by Patient Global Impression of Change (PGI-C). At Visit 3, PH94B 
use recorded in the eDiary application will be reviewed, and AEs and 
concomitant medications will be reported and recorded. Subjects will 
receive a 1-month supply of PH94B (6 vials). 
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4
to 13), and will repeat the same assessments as those performed at 
Visit 3. PH94B use recorded in the eDiary application will be 
reviewed, AEs and concomitant medications will be reported and 
recorded, and at each visit subjects will receive a 1-month supply of 
PH94B (6 vials). 
At Visit 14 (1 year ±2 weeks), treatment will conclude, and subjects 
will undergo clinical laboratory assessments (clinical chemistry, 
hematology, urinalysis, pregnancy test, and urine drug screening), vital 
signs, 12-lead ECG, physical examination, HAM-D17, 
LSAS, C-SSRS, CGI-S, CGI-I, and PGI-C. Also, PH94B use recorded 
in the eDiary application will be reviewed and AEs and concomitant 

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medications will be recorded and reported. Subjects will also be 
informed of their follow-up visit (Visit 15).
Subjects will return to the clinic for a follow-up visit (Visit 15, 
54 weeks ±3 days), approximately 2 weeks after the last PH94B 
administration, to undergo C-SSRS and vital signs assessments, and 
record AEs.
Now reads:
Study Design (Procedures): Subject participation in the study will last 
up to approximately 12 to 13 months, depending on the duration of the 
screening period and intervals between visits. Upon signing the 
informed consent form, subjects will begin participation in the 
present study at Visit 1 or Visit 2, depending on when they 
finished participation in their antecedent study:
Subjects who finished participation in their antecedent PH94B 
SAD study more than 14 days before entering the present study 
will complete Visit 1 and enter a screening period lasting between 
7 and 35 days. Subjects who meet all eligibility criteria will return to 
the clinic to complete Visit 2 (Baseline)
Subjects who finished participation in their antecedent PH94B 
SAD study within the last 14 days will enter the present study at 
Visit 2 (Baseline)
At Visit 2 (Baseline, Day 0), all subjects will undergo baseline 
measurements of clinical laboratory assessments (clinical chemistry, 
hematology, urinalysis, pregnancy test [if female and of childbearing 
potential], and urine drug screening), 12-lead ECG, vital signs, 
physical examination, Hamilton Rating Scale for Depression 
(HAM-D17), 
 LSAS, 
Columbia-Suicide Severity Rating Scale (C-SSRS), and Clinical 
Global Impression Scale of Severity (CGI-S). At Visit 2 (Baseline), 
subjects will be trained on how to use and store PH94B Nasal Spray,
and how to use an electronic diary (eDiary) application each day to
record their dosing of PH94B (including a record of days when 
PH94B was not used) and any health problems they experienced 
that day. Adverse events (AEs) and concomitant medications will be 
reported and recorded. The subject will receive a 1-month supply of 
needed for social anxiety. 
Subjects will be instructed to return to the clinic for Visit 3 after 
30 days (±3 days). At Visit 3, subjects will undergo clinical laboratory 
assessments (clinical chemistry, hematology, urinalysis, pregnancy 
test, and urine drug screening), vital signs, 12 lead ECG, physical 
examination (limited to nasal passage and oropharynx examination 
unless any AEs are reported), HAM-D17, 
LSAS, C-SSRS, 
CGI-S, Clinical Global Impression Scale of Improvement (CGI-I), and 
self-evaluation by Patient Global Impression of Change (PGI-C). At 
Visit 3, PH94B use and any daily reports of health problems that 
have been recorded in the eDiary will be reviewed, and AEs and 

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concomitant medications will be reported and recorded. Subjects will 
receive a 1-month supply of PH94B. 
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4
to 13), and will repeat the same assessments as those performed at 
Visit 3. PH94B use and any daily reports of health problems that 
have been recorded in the eDiary application will be reviewed, AEs 
and concomitant medications will be reported and recorded. Subjects
will receive a 1-month supply of PH94B at each monthly visit.
At Visit 14 (12 months±2 weeks), treatment will conclude, and 
subjects will undergo clinical laboratory assessments (clinical 
chemistry, hematology, urinalysis, pregnancy test, and urine drug 
screening), vital signs, 12-lead ECG, physical examination, 
HAM-D17, 
 LSAS, C-SSRS, CGI-S, CGI-I, PGI-C, and the 
Penn Physician Withdrawal Checklist (PWC-20). Also, PH94B use 
and any daily reports of health problems that have been recorded
in the eDiary application will be reviewed and AEs and concomitant 
medications will be recorded and reported. Subjects will also be 
informed of their follow-up visit (Visit 15).
Subjects will return to the clinic for a follow-up visit (Visit 15,
54 weeks ±3 days), approximately 2 weeks after the last PH94B 
administration, to undergo C-SSRS, PWC-20, and vital signs 
assessments, and record AEs.
Subjects who discontinue study treatment without completing 
12 months of treatment will attend an Early Termination Visit 
(Visit 14) as soon as possible after discontinuing treatment, and 
return to the clinic for a follow-up visit (Visit 15) approximately 
2 weeks later.
Text formerly read:
Study Design (Safety Considerations): Safety and tolerability of 
be assessed and summarized through changes from Visit 2 (Baseline) 
to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, 
physical examinations, and vital sign assessments following exposure 
to PH94B.
Now reads:
Study Design (Safety Considerations): Safety and tolerability of 
be assessed and summarized through changes from Visit 2 (Baseline) 
to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, 
physical examinations, suicidality, level of depression, vital sign 
assessments, and withdrawal symptoms following exposure to 
PH94B.
Text formerly read:
Planned Number of Subjects: An estimated 800 subjects will be 
screened or rolled over from previous PH94B Phase 3 studies to obtain 
up to 600 subjects to receive up to 1 year of PH94B treatment.
Now reads:
Planned Number of Subjects: A sufficient number of subjects from 
previous PH94B SAD studies will be screened or rolled over to 

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obtain up to 600 subjects to receive up to 12 months of PH94B 
treatment.
Text formerly read:
o have 
participated in a previous PH94B Phase 3 SAD study, either 
PALISADE-1 (PH94B-CL026) or PALISADE-2 (PH94B CL032), 
will be given the option to enroll in the present study.
New Subjects: Subjects with no prior experience in a PH94B 
study, and those who participated in either PALISADE-1 or 
PALISADE-2 more than 14 days before entry in the present study
P1/P2 Completers: Subjects who enter the present study within 
14 days after completing Visit 2, 3, or 4 of either PALISADE-1 (P1) 
or PALISADE-2 (P2) without meeting any of the exclusion criteria of 
PALISADE-1/ PALISADE-2, with the exception of SUDS < 75 at 
Visit 2.
Now reads:
Study Entry Criteria: Subjects who have participated in a previous 
PH94B SAD study will be enrolled in the present study if they 
meet the following eligibility criteria.
Text formerly read:
Inclusion Criteria:
All Subjects
To be considered eligible to participate in the study, all subjects must 
meet the following inclusion criteria:
1. Written informed consent provided prior to conducting any study-
specific assessment.
2. Male and female adults, 18 through 65 years of age, inclusive.
3. Women of childbearing potential must be able to commit to the 
consistent and correct use of an effective method of birth control 
throughout the study, and must also have a negative urine pregnancy 
test result at both Screening (Visit 1) (for subjects who attend Visit 1) 
and Baseline (Visit 2), prior to IP administration. Effective methods of 
contraception include: condoms with spermicide, diaphragm with 
spermicide, hormonal contraceptive agents (oral, transdermal, or 
injectable), or implantable contraceptive devices.
4. Current diagnosis of SAD as defined in the Diagnostic and 
Statistical Manual of Mental Disorders, 5th Edition, and confirmed by 
the Mini-International Neuropsychiatric Interview (MINI). 
5. Clinician-rated HAM-D17 total score < 18 at study entry 
(Screening [Visit 1] or Visit 2 [Baseline] as applicable).
6. Negative COVID-19 test for subjects with COVID-19 symptoms 
or who had direct exposure to someone with a positive COVID-19 test, 
as determined by the investigator. 
New Subjects
In order to qualify for participation in this study, new subjects must 
7. Clinician-
P1/P2 Completers

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all the following criteria.
7. Have participated in PALISADE-1 or PALISADE-2 and 
completed Visit 2, 3, or 4 within the last 14 days without meeting any 
of the exclusion criteria of PALISADE-1/ PALISADE-2 with the 
exception of SUDS < 75 at Visit 2.
8. Clinician-rated LSAS total score requirement does not apply.
Now reads:
Inclusion Criteria: 
To be considered eligible to participate in the study, all subjects must 
meet the following inclusion criteria:
1. Subject must have participated in a previous PH94B SAD 
study.
Note: Subjects who have not participated in a prior PH94B SAD 
study may be permitted to enroll following approval by the 
sponsor on a case-by-case basis.
2. Written informed consent provided prior to conducting any study-
specific assessment.
3. Male and female adults, 18 through 65 years of age, inclusive.
4. Women of childbearing potential must be able to commit to the 
consistent and correct use of an effective method of birth control 
throughout the study and must also have a negative urine pregnancy 
test result at both Screening (Visit 1) (for subjects who attend Visit 1) 
and Baseline (Visit 2), prior to IP administration. Effective methods of 
contraception include: condoms with spermicide, diaphragm with 
spermicide, hormonal contraceptive agents (oral, transdermal, or 
injectable), or implantable contraceptive devices.
5. Current diagnosis of SAD as defined in the Diagnostic and 
Statistical Manual of Mental Disorders, 5th Edition, and confirmed by 
the Mini-International Neuropsychiatric Interview (MINI). 
6. Clinician-rated HAM-D17 total score < 18 at study entry 
(Screening [Visit 1] or Visit 2 [Baseline] as applicable).
7. Negative COVID-19 test for subjects with COVID-19 symptoms 
or those who had direct exposure to someone with a positive 
COVID-19 test, and/or completion of quarantine period consistent 
with requirements at the study site as determined by the 
investigator.
Text formerly read:
Exclusion Criteria:
All Subjects
To be considered eligible for entry into the study, a subject must not 
meet any of the following exclusion criteria at study entry. 
1. Women who have a positive urine pregnancy test prior to IP 
administration.
2. Subjects with a positive urine drug screen at study entry 
 
3. Any current clinically significant and/or uncontrolled medical 
condition, based on medical history or as evidenced in screening 

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assessments, such as COVID-19, HIV, cancer, stroke, congestive heart 
failure, uncontrolled diabetes mellitus, or any other medical condition 
or disease that, in the clinical judgment of the Investigator, could place 
the subject at undue risk, interfere with study participation, or 
confound the results of the study. 
4. History of cancer or malignant tumor not in remission for at least 
2 years. Basal cell skin cancers are not exclusionary.
New Subjects
New subjects will be excluded from the present study if they meet any 
of the exclusion criteria in this section.
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, autism-
spectrum disorder, or obsessive-compulsive disorder.
Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to study entry.
3. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
5 in 
the Suicidal Ideation section of the C-SSRS with reference to a 
6-month period prior to screening; or
b. At Screening (Visit 1): the subject has had 1 or more suicidal 
attempts with reference to a 2-year period prior to screening; or
c.
At Baseline (V
the Suicidal Ideation section of the C-SSRS with reference to 
screening; or
d. The subject is considered to be an imminent danger to themself or 
others.
4. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
5. An acute or chronic condition, including an infectious illness, 
uncontrolled seasonal allergies at the time of the study, or significant 
nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium. 
6. Subjects using the following psychotropic medications: 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine 
at enrollment. 
Subjects using lower doses of atypical antipsychotics at Screening may 
be eligible after discussion with the Medical Monitor (e.g., quetiapine 
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In general, subjects using antidepressants or buspirone can continue to 
receive these provided that they have been taking them for a minimum 
of 2 months, and have been on a stable dose for a minimum of 
1 month.
7. Use of anxiolytics, such as benzodiazepines or unapproved 
treatments such as beta blockers, within 30 days before study entry; 
concomitant use is prohibited during the study. Subjects who have 
been taking benzodiazepines daily for 1 month or longer at the time of 
Visit 1 are not eligible to participate.
8. Use of any over-the-counter product, prescription product, or 
herbal preparation for treatment of the symptoms of anxiety or social 
anxiety within 30 days before study entry; concomitant use is 
prohibited during the study.
9. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at the Screening visit or Baseline visit that in the clinical 
judgment of the Investigator, could place the subject at undue risk, 
interfere with study participation, or confound the results of the study.
P1/P2 Completers 
P1/P2 completers will be excluded from the present study if they meet 
any of the exclusion criteria in this section.
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, autism-
spectrum disorder, or obsessive-compulsive disorder as determined at 
the time of entry into the legacy study.
Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to entry into the legacy 
study.
3. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
At Baseline (Visit 2):
the Suicidal Ideation section of the C-SSRS with reference to last visit; 
or
b. The subject is considered to be an imminent danger to themself or 
others.
4. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
5. An acute or chronic condition, including an infectious illness, 
uncontrolled seasonal allergies at the time of the study, or significant 

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nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium. 
6. Subjects using the following psychotropic medications: 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine 
at enrollment.
Subjects using lower doses of atypical antipsychotics at Screening may 
be eligible after discussion with the Medical Monitor (e.g., quetiapine 
< 100 mg).
In general, subjects using antidepressants or buspirone can continue to 
receive these provided that they have been taking them for a minimum 
of 2 months, and have been on a stable dose for a minimum of 
1 month.
7. Use of anxiolytics, such as benzodiazepines or unapproved 
treatments such as beta blockers, within 30 days before study entry; 
concomitant use is prohibited during the study. Subjects who have 
been taking benzodiazepines daily for 1 month or longer at the time of 
study entry are not eligible to participate.
8. Use of any over-the-counter product, prescription product, or 
herbal preparation for treatment of the symptoms of anxiety or social 
anxiety within 30 days before study entry; concomitant use is 
prohibited during the study.
9. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at study entry or during the legacy study which, in the 
clinical judgment of the Investigator, could place the subject at undue 
risk, interfere with study participation, or confound the results of the 
study.
Now reads:
Exclusion Criteria:
To be considered eligible for entry into the study, a subject must not 
meet any of the following exclusion criteria at study entry. 
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, 
premenstrual dysphoric disorder, autism-spectrum disorder, 
obsessive-compulsive disorder, or treatment-refractory major 
depressive disorder.
Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
At Screening (for subjects who attend Visit 1): the subject scores 
-

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Suicide Severity Rating Scale (C-SSRS) with reference to a 6-month 
period prior to screening; or
b. At Screening (for subjects who attend Visit 1): the subject has 
had 1 or more suicidal attempts with reference to a 2-year period prior 
to screening; or
c.
the Suicidal Ideation section of the C-SSRS with reference to last visit; 
or
d. The subject is considered to be an imminent danger to themself or 
others.
3. Subjects using the following psychotropic medications at
enrollment or within 30 days before study entry: antidepressants 
(including monoamine oxidase inhibitors), anxiolytics, stimulants, 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine. 
Eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or 
anti-histamines prescribed for insomnia are allowed.
4. Use of benzodiazepines or unapproved treatments such as beta 
blockers, within 30 days before study entry and during the study. Use 
of beta blockers for treatment of hypertension or cardiac
conditions is allowed. Subjects who have been taking 
benzodiazepines daily for 1 month or longer at the time of Visit 1 are 
not eligible to participate.
5. Use of any over-the-counter product or herbal preparation for 
treatment of the symptoms of anxiety or social anxiety within 30 days 
before study entry; concomitant use is prohibited during the study.
6. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
7. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to entry into the study.
8. Subjects with a positive urine drug screen at study entry 
 
.
9. An acute or chronic condition, including an infectious illness, 
uncontrolled seasonal allergies at the time of the study, or significant 
nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium.
10. Any current clinically significant and/or uncontrolled medical 
condition, based on medical history or as evidenced in screening 
assessments, such as COVID-19, HIV, cancer, stroke, congestive heart 
failure, uncontrolled diabetes mellitus, or any other medical condition 
or disease that, in the clinical judgment of the Investigator, could place 
the subject at undue risk, interfere with study participation, or 
confound the results of the study. 

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11. Women who have a positive urine pregnancy test prior to IP 
administration. Women who are currently breastfeeding are not 
eligible.
12. History of cancer or malignant tumor not in remission for at least 
2 years. Basal cell skin cancers are not exclusionary.
13. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at study entry or during the legacy study which, in the 
clinical judgment of the Investigator, could place the subject at undue 
risk, interfere with study participation, or confound the results of the 
study.
Text formerly read:
Treatment Regimens: Treatment with PH94B should be 
self-administered approximately 15 minutes prior to an 
anxiety-provoking situation or event. Consecutive nasal 
administrations of IP should be at least 1 hour apart, with no more than 
4 administrations per day.
Now reads:
Treatment Regimens: Treatment with PH94B should be 
self-administered as needed approximately 15 minutes prior to or 
during an anxiety-provoking social situation or event. Consecutive 
nasal administrations of IP should be at least 1 hour apart, with no
more than 4 administrations per day. Treatment does not need to be 
administered every day.
Text formerly read:
Planned Study Sites: The study is designed as a multicenter study 
conducted in the USA with 20-30 clinical study sites, with each site 
enrolling approximately 25 to 34 subjects.
Now reads:
Planned Study Sites: The study is designed as a multicenter study 
conducted in the USA with approximately 40 clinical study sites.
Text formerly read:
Criteria for Evaluation: The primary outcome variable for the study is 
the change from Baseline (Visit 2) in AEs after the administration of 
PH94B prior to anxiety-provoking situations in daily life for subjects 
with SAD. In addition to the primary outcome variable, the change 
from Baseline (Visit 2) in standard clinical measurements and 
behavioral assessment scores (LSAS, CGI-S, CGI-I, and PGI-C) in 
response to anxiety-provoking situations in daily life after the 
administration of PH94B will be evaluated in subjects with SAD.
Now reads:
Criteria for Evaluation: The primary outcome variable for the study is 
the change from Baseline (Visit 2) in AEs after the administration of 
PH94B prior to anxiety-provoking social situations in daily life for 
subjects with SAD. In addition to the primary outcome variable, the 
change from Baseline (Visit 2) in standard clinical measurements and 
behavioral assessment scores (LSAS, CGI-S, CGI-I, and PGI-C) in 
response to anxiety-provoking social situations in daily life after the 
administration of PH94B will be evaluated in subjects with SAD.
New:
Criteria for Evaluation (Safety endpoints):
PWC-20 scores after termination of PH94B

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Text formerly read:
Criteria for Evaluation (Exploratory endpoints): 
Change in total LSAS scores over time with daily use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time 
with daily use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very 
much improved) or 2 (Much improved) over time with daily use of 
PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very 
much improved) or 2 (Much improved) over time with daily use of 
PH94B
Changes in patterns of PH94B use (daily frequency and dosing 
interval) over time 
Change in patterns of PH94B use (daily frequency and dosing 
interval) in designated subgroups over time 
Now reads:
Criteria for Evaluation (Exploratory endpoints): 
Change in total LSAS scores over time with use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time 
with use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very 
much improved) or 2 (Much improved) over time with use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very 
much improved) or 2 (Much improved) over time with use of PH94B
Changes in patterns of PH94B use (frequency and dosing interval) 
over time 
Change in patterns of PH94B use (frequency and dosing interval) 
in designated subgroups over time 
Text formerly read:
Statistical Methods (Analysis Populations): 
Safety Population: All subjects who are dispensed IP will be included 
in the safety population.
Now reads:
Statistical Methods (Analysis Populations):
Safety Population: All subjects who receive IP.
Text formerly read:
Study Treatment and Duration: 
1. Screening and washout: From 7 to 30 days
Now reads:
Study Treatment and Duration: 
1. Screening and washout (if applicable): From 7 to 35 days
Text formerly read:
Study Treatment and Duration: 
The maximum study duration for each subject is approximately 
54 weeks.
Now reads:
Study Treatment and Duration: 
The maximum study duration for each subject is approximately 
59 weeks. 

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Section 2.2
Schedule of Events
The order of assessments in the Schedule of Events was adjusted to 
match the order defined in Section 10.2
Text formerly read:
Screening visit window: Day -30 to Day -7
Now reads:
Screening visit window: Day -35 to Day -7
New:
PWC-20 added to list of assessments at Visits 14 and 15
Text formerly read:
Assessment/Evaluation: Training on use of Spray Device
Now reads:
Assessment/Evaluation: Training on use of PH94B
Text formerly read:
Assessment/Evaluation: Training on eDiary App to Record PH94B 
Use
Now reads:
Assessment/Evaluation: Training on eDiary App to Record PH94B 
Use and Health Problems
New:
Abbreviations: PWC-20 = Penn Physician Withdrawal Checklist
Text formerly read:
Footnotes: 
a
Subjects entering the study having participated in a previous 
PH94B Phase 3 SAD study will sign an informed consent form for the 
present study at either Visit 1 or Visit 2, depending on when they enter 
the study (see Table 2-2).
b
For subjects entering the study having participated in a previous 
PH94B Phase 3 SAD study, a review of inclusion and exclusion 
criteria will be conducted at either Visit 1 or Visit 2, depending on 
when they enter the study (see Table 2-2).
c
Pregnancy tests will only be given to female subjects of 
childbearing potential and not post-menopausal females. 
d
12-Lead electrocardiograms will be administered to subjects at the 
Screening and Baseline visits and then every month during the study. 
e
Physical examination will include measurement of weight and an 
examination of the nasal passages. Height will be measured at 
Screening and at Visit 14.
f
If total anosmia is suspected during review of the nasal passages at 
Visit 1, the Quick Olfactory Test (QOT) is to be administered.
Note: Long-term C-SSRS will be administered at screening. All other 
C-
Note: If central laboratory urine drug screen testing is positive for a 
subject, then the participation of the subject in the study may have to 
be discontinued. The Medical Monitor should be consulted on these 
cases. An unscheduled repeat urine drug screen may be obtained to 
investigate whether drug use is continuing.
Now reads:
Footnotes: 
a
Subjects will sign an informed consent form for the present study 
at either Visit 1 or Visit 2, depending on when they enter the study.
b
Pregnancy tests will only be given to female subjects of 
childbearing potential and not post-menopausal females. 
c
Physical examination will include measurement of weight and an 
examination of the nasal passages. Height will be measured at 
Screening and at Visit 14. The physical examinations done at 

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Visit 1, Visit 2 and Visit 14 will be comprehensive. The physical 
examinations done at Visit 3 to Visit 13 will be focused but must 
include examination of the nasal passages and oropharynx. Other 
organ systems should be examined at Visit 3 to Visit 13 if the 
subject reports AEs or if the investigator has specific concerns.
d
If total anosmia is suspected during review of the nasal passages at 
Visit 1, the Quick Olfactory Test (QOT) is to be administered.
e
12-Lead electrocardiograms will be administered in a supine 
position after the subject has rested for 5 minutes.
f
For all subjects, a review of inclusion and exclusion criteria 
will be conducted at Visit 2 to confirm eligibility.
Note: Long-term C-SSRS will be administered at screening. All other 
C-SSRS evaluations
Note: If central laboratory urine drug screen testing is positive for a 
subject
,
then the participation of the subject in the study may have to be 
discontinued. The Medical Monitor should be consulted on these 
cases. An unscheduled repeat urine drug screen may be obtained to 
investigate whether drug use is continuing.
Deleted:
Table 2-2: Enrollment of Subjects From Previous PH94B Phase 3 
SAD Studies Management of Visit 1 and Visit 2
(references to this table were removed throughout the protocol)
Section 4.
List of Abbreviations and Definitions of Terms
New:
MAO: monoamine oxidase
PWC-20: Penn Physician Withdrawal Checklist
UDS: urine drug screen
Section 6.1.
Primary objective
Text formerly Read:
The primary objective of the study is to evaluate the safety and 
tolerability of repeated dosing of PH94B over a period of up to 
12 months as assessed by documenting AEs and standard clinical 
measurements (physical examination, vital signs, clinical chemistry, 
hematology, and 12-lead electrocardiogram [ECG]).
Now reads:
The primary objective of the study is to evaluate the safety and 
tolerability of repeated dosing of PH94B over a period of up to 
12 months as assessed by documenting AEs, standard clinical 
measurements (physical examination, vital signs, clinical chemistry, 
hematology, suicidality, level of depression, 12-lead 
electrocardiogram [ECG]), and withdrawal symptoms.
Section 6.3.
Endpoint mapping
Text formerly read:
Objectives (Primary): The primary objective of the study is to evaluate 
the safety and tolerability of repeated dosing of PH94B over a period 
of up to 12 months as assessed by documenting AEs and standard 

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clinical measurements (physical examination, vital signs, clinical 
chemistry, hematology, and 12-lead ECG)
Now reads:
Objectives (Primary): The primary objective of the study is to evaluate 
the safety and tolerability of repeated dosing of PH94B over a period 
of up to 12 months as assessed by documenting AEs, standard clinical 
measurements (physical examination, vital signs, clinical chemistry, 
hematology, suicidality, level of depression, 12-lead ECG), and 
withdrawal symptoms.
New:
Endpoints (Primary): PWC-20 scores after termination PH94B
Text formerly read:
Endpoints (Exploratory): 
Change in total LSAS scores over time with daily use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time with 
daily use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very much 
improved) or 2 (Much improved) over time with daily use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very much 
improved) or 2 (Much improved) over time with daily use of PH94B
Change in patterns of PH94B use (daily frequency and dosing interval) 
over time
Change in patterns of PH94B use (daily frequency and dosing interval) 
in designated subgroups over time
Now reads:
Endpoints (Exploratory): 
Change in total LSAS scores over time with use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time with 
use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very much
improved) or 2 (Much improved) over time with use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very much
improved) or 2 (Much improved) over time with use of PH94B
Change in patterns of PH94B use (frequency and dosing interval) over 
time
Change in patterns of PH94B use (frequency and dosing interval) in 
designated subgroups over time
New:
Abbreviations: PWC-20 = Penn Physician Withdrawal Checklist
Section 7.
Study Design
Text formerly read:
An estimated 800 subjects will be screened or rolled over from 
previous PH94B Phase 3 studies to obtain up to 600 subjects to receive 
up to 1 year of PH94B treatment.
Now reads:
A sufficient number of subjects from previous PH94B SAD studies 
will be screened or rolled over to obtain up to 600 subjects to receive 
up to 12 months of PH94B treatment.

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Section 7.1.
Overall Study Design and Plan
Text formerly read:
Subject participation in the study will last up to approximately 12 to 
13 months, depending on the duration of the screening period and 
intervals between visits. Upon signing the informed consent form 
(ICF), subjects will complete Visit 1 and enter a screening period 
lasting between 7 and 30 days. Subjects who meet all eligibility 
criteria will return to the clinic to complete Visit 2 (Baseline, Day 0) 
and undergo baseline measurements of clinical laboratory assessments 
(clinical chemistry, hematology, urinalysis, pregnancy test [if female 
and of childbearing potential], and urine drug screening), 12-lead 
ECG, vital signs, physical examination, Hamilton Rating Scale for 
Depression (HAM-D17), 
 
 Liebowitz Social Anxiety Scale (LSAS), Columbia Suicide 
Severity Rating Scale (C-SSRS), and Clinical Global Impression Scale 
of Severity (CGI-S). At Visit 2 (Baseline), subjects will be trained on 
how to use and store the PH94B nasal spray delivery device, and how 
to use an electronic diary (eDiary) application; subjects will be 
instructed to record each incidence of PH94B use in the eDiary 
application. Adverse events (AEs) and concomitant medications will 
be reported and recorded. The subject will receive a 1-month supply of 
discretion, as needed for social anxiety. 
Subjects will be instructed to return to the clinic for Visit 3 after 
30 days (±3 days). At Visit 3, subjects will undergo clinical laboratory 
assessments (clinical chemistry, hematology, urinalysis, pregnancy 
test, and urine drug screening), vital signs, 12-lead ECG, physical 
examination, HAM-D17, 
 LSAS, C-SSRS, CGI-S, CGI-I, and
self-evaluation by the patient-reported outcome measure, Patient 
Global Impression of Change (PGI-C). At Visit 3, PH94B use 
recorded in the eDiary application will be reviewed and AEs and 
concomitant medications will be reported and recorded. Subjects will
receive a 1-month supply of PH94B (6 vials).
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4
to 13), and will repeat the same assessments as those performed at 
Visit 3. PH94B use recorded in the eDiary application will be 
reviewed, AEs and concomitant medications will be reported and 
recorded, and at each visit subjects will receive a 1-month supply of 
PH94B (6 vials).
At Visit 14 (1 year ±2 weeks), treatment will conclude, and subjects 
will undergo clinical laboratory assessments (clinical chemistry, 
hematology, urinalysis, pregnancy test, and urine drug screening), vital 
signs, 12-lead ECG, physical examination, HAM-D17, HAM-A,
LSAS, C-SSRS CGI-S, CGI-I, and PGI-C. Also, PH94B use recorded 
in the eDiary application will be reviewed, and AEs and concomitant 
medications will be recorded and reported. Subjects will also be 
informed of their follow-up visit (Visit 15).

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Subjects will return to the clinic for a follow-up visit (Visit 15, 
54 weeks ±3 days), approximately 2 weeks after the last PH94B 
administration, to undergo C-SSRS and vital signs assessments, and 
record AEs.
Safety Considerations: 
up to 600 subjects) will be assessed and summarized through changes 
from baseline (Visit 2) to end of treatment (Visit 14) in AEs, 
laboratory values, 12-lead ECGs, physical examinations, and vital sign 
assessments following exposure to PH94B.
Now reads:
Subject participation in the study will last up to approximately 12 to 
13 months, depending on the duration of the screening period and 
intervals between visits. Upon signing the informed consent form 
(ICF), subjects will begin participation in the present study at 
Visit 1 or Visit 2, depending on when they finished participation in 
their antecedent study:
Subjects who finished participation in their antecedent PH94B 
SAD study more than 14 days before entering the present study 
will complete Visit 1 and enter a screening period lasting between 7 
and 35 days. Subjects who meet all eligibility criteria will return to the 
clinic to complete Visit 2 (Baseline)
Subjects who finished participation in their antecedent PH94B 
SAD study within the last 14 days will enter the present study at 
Visit 2 (Baseline)
At Visit 2 (Baseline, Day 0), all subjects will undergo baseline 
measurements of clinical laboratory assessments (clinical chemistry, 
hematology, urinalysis, pregnancy test [if female and of childbearing 
potential], and urine drug screening), 12-lead ECG, vital signs, 
physical examination, Hamilton Rating Scale for Depression 
(HAM-D17), 
Liebowitz 
Social Anxiety Scale (LSAS), Columbia Suicide Severity Rating Scale 
(C-SSRS), and Clinical Global Impression Scale of Severity (CGI-S). 
At Visit 2 (Baseline), subjects will be trained on how to use and store 
PH94B Nasal Spray, and how to use an electronic diary (eDiary) 
application each day to record their dosing of PH94B (including a 
record of days when PH94B was not used) and any health 
problems they experienced that day. Adverse events (AEs) and 
concomitant medications will be reported and recorded. The subject 
will receive a 1-month supply of PH94B for use (up to 4 times per 
al anxiety. 
Subjects will be instructed to return to the clinic for Visit 3 after 
30 days (±3 days). At Visit 3, subjects will undergo clinical laboratory 
assessments (clinical chemistry, hematology, urinalysis, pregnancy 
test, and urine drug screening), vital signs, 12 lead ECG, physical 
examination (limited to nasal passage and oropharynx examination 
unless any AEs are reported), HAM-D17, 
, LSAS, C-SSRS, 

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CGI-S, CGI-I, and self-evaluation by the patient-reported outcome 
measure, Patient Global Impression of Change (PGI-C). At Visit 3, 
PH94B use and any daily reports of health problems that have 
been recorded in the eDiary application will be reviewed and AEs and 
concomitant medications will be reported and recorded. Subjects will 
receive a 1-month supply of PH94B.
Subjects will return to the clinic at monthly intervals (±7 days, Visits 4
to 13), and will repeat the same assessments as those performed at 
Visit 3. PH94B use and any daily reports of health problems that 
have been recorded in the eDiary application will be reviewed, AEs 
and concomitant medications will be reported and recorded at each 
visit. Subjects will receive a 1-month supply of PH94B at each 
monthly visit.
At Visit 14 (12 months±2 weeks), treatment will conclude, and 
subjects will undergo clinical laboratory assessments (clinical 
chemistry, hematology, urinalysis, pregnancy test, and urine drug 
screening), vital signs, 12-lead ECG, physical examination, 
HAM-D17, HAM-A, LSAS, C-SSRS CGI-S, CGI-I, PGI-C, and the 
Penn Physician Withdrawal Checklist (PWC-20). Also, PH94B use 
and any daily reports of health problems that have been recorded 
in the eDiary application will be reviewed, and AEs and concomitant 
medications will be recorded and reported. Subjects will also be 
informed of their follow-up visit (Visit 15).
Subjects will return to the clinic for a follow-up visit (Visit 15, 
54 weeks ±3 days), approximately 2 weeks after the last PH94B 
administration, to undergo C-SSRS, PWC-20, and vital signs 
assessments, and record AEs.
Subjects who discontinue study treatment without completing 
12 months of treatment will attend an Early Termination Visit 
(Visit 14) as soon as possible after discontinuing treatment, and 
return to the clinic for a follow-up visit (Visit 15) approximately 
2 weeks later.
Safety Considerations: 
12 months in 
up to 600 subjects) will be assessed and summarized through changes 
from baseline (Visit 2) to end of treatment (Visit 14) in AEs, 
laboratory values, 12-lead ECGs, physical examinations, suicidality, 
level of depression, vital sign assessments, and withdrawal 
symptoms following exposure to PH94B.
Section 7.1.1.
Enrollment From PALISADE-1 (PH94B-CL026) and PALISADE-2
(PH94B-CL032) Studies
Section deleted:
Subjects who have participated in a previous PH94B Phase 3 SAD 
study, either PALISADE-1 (PH94B-CL026) or PALISADE-2
(PH94B-CL032), will be given the option to enroll in this study. 
Subjects who enter the present study within 14 days after completing 

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Visit 2, 3, or 4 of either PALISADE-1 (P1) or PALISADE-2 (P2) 
without meeting any of the exclusion criteria of PALISADE-1/
PALISADE-2, with the exception of SUDS < 75 at Visit 2, will be 
Visit 2 (see Table 2-2).
Subjects who participated in PALISADE-1 or PALISADE-2 more 
than 14 days before entry into the present study will be considered as 
he present study at Visit 1 (see 
Table 2-2).
Irrespective of whether they enroll in the present study at Visit 1 or 
Visit 2, all subjects entering from PALISADE-1 or PALISADE-2 must 
sign an ICF for the present study before receiving study treatment or 
undergoing any study-specific assessment.
Section 7.2.
Rationale and Discussion of Study Design
Text formerly read:
The present study has been designed to evaluate the safety and 
tolerability of PH94B with repeated dosing over a period of up to 
12 months. Participating subjects will use PH94B up to 4 times a day 
when they encounter anxiety-provoking situations in daily life. Formal 
evaluation of the efficacy of PH94B is being conducted in 2 Phase 3
studies that have been designed and powered to assess its efficacy in 
reducing anxiety in a public speaking challenge. In the present study, 
evaluation of the efficacy of PH94B over the 12-month treatment 
period is an exploratory objective.
Given that evaluation of long-term safety is the primary objective of 
this study, an open-label study with no comparator is considered to be 
an appropriate design.
Safety assessments in this study are standard for the evaluation of an 
investigational medicinal product, and include collection of AEs and 
SAEs, and evaluation of vital signs, safety laboratory tests, 12-lead 
ECGs, and physical examinations; given the use of the i.n. route of 
administration, the physical examination will include an examination 
of the nasal passages. Given that subjects are patients with a confirmed 
diagnosis of SAD, the C-SSRS will be used at each study visit as a 
precautionary measure.
Now reads:
The present study has been designed to evaluate the safety and 
tolerability of PH94B with repeated dosing over a period of up to 
12 months, in subjects who have participated in previous PH94B 
SAD studies. Participating subjects will use PH94B up to 4 times a 
day when they encounter anxiety-provoking social situations in daily 
life. Formal evaluation of the efficacy of PH94B is being conducted in 
2 Phase 3 studies, which have been designed and powered to assess its 
efficacy in reducing anxiety in a public speaking challenge. In the 
present study, evaluation of the efficacy of PH94B over the 12-month 
treatment period is an exploratory objective.

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Given that evaluation of long-term safety is the primary objective of 
this study, an open-label study with no comparator is considered to be 
an appropriate design.
Safety assessments in this study are standard for the evaluation of an 
investigational medicinal product, and include collection of AEs and 
SAEs, and evaluation of vital signs, safety laboratory tests, 12-lead 
ECGs, and physical examinations; given the use of the i.n. route of 
administration, the physical examination will include an examination 
of the nasal passages. Given that subjects are patients with a confirmed 
diagnosis of SAD, the C-SSRS will be used at each study visit as a 
precautionary measure. Withdrawal symptoms will also be assessed.
Section 7.4.
Study Sites
Text formerly read:
The study is designed as a multicenter study conducted in the USA 
with 20-30 clinical study sites, with each site enrolling approximately 
25 to 34 subjects.
Now reads:
The study is designed as a multicenter study conducted in the USA 
with approximately 40 clinical study sites.
Section 8.1.
Selection of Study Population
Deleted:
-
referring physicians, direct advertisement, or other lead generation 
sources. 
PH94B Phase 3 SAD study will be given the option to enroll in this 
study.
New Subjects: Subjects with no prior experience in a PH94B 
study, and those who participated in either PALISADE-1 or 
PALISADE-2 more than 14 days before entry in the present study
P1/P2 Completers: Subjects who enter the present study within 
14 days after completing Visit 2, 3, or 4 of either PALISADE-1 (P1) 
or PALISADE-2 (P2) without meeting any of the exclusion criteria of 
PALISADE-1/PALISADE-2, with the exception of SUDS < 75 at 
Visit 2.
Section 8.2.1.
Inclusion Criteria.
Text formerly read:
8.2.1.1   All Subjects
To be considered eligible to participate in the study, all subjects must 
meet the following inclusion criteria:
1. Written informed consent provided prior to conducting any study-
specific assessment.
2. Male and female adults, 18 through 65 years of age, inclusive.
3. Women of childbearing potential must be able to commit to the 
consistent and correct use of an effective method of birth control 
throughout the study, and must also have a negative urine pregnancy 

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test result at both Screening (Visit 1) (for subjects who attend Visit 1) 
and Baseline (Visit 2), prior to IP administration. Effective methods of 
contraception include: condoms with spermicide, diaphragm with 
spermicide, hormonal contraceptive agents (oral, transdermal, or 
injectable), or implantable contraceptive devices.
4. Current diagnosis of SAD as defined in the Diagnostic and 
Statistical Manual of Mental Disorders, 5th Edition, and confirmed by 
the Mini-International Neuropsychiatric Interview (MINI). 
5. Clinician-rated HAM-D17 total score < 18 at study entry 
(Screening [Visit 1] or Visit 2 [Baseline] as applicable).
6. Negative COVID-19 test for subjects with COVID-19 symptoms 
or who had direct exposure to someone with a positive COVID-19 test, 
as determined by the investigator. 
8.2.1.2   New Subjects
In order to qualify for participation in this study, new subjects must 
7. Clinician-
8.2.1.3   P1/P2 Completers
all the following criteria.
7. Have participated in PALISADE-1 or PALISADE-2 and 
completed Visit 2, 3, or 4 within the last 14 days without meeting any 
of the exclusion criteria of PALISADE-1/ PALISADE-2 with the 
exception of SUDS < 75 at Visit 2.
8. Clinician-rated LSAS total score requirement does not apply.
Now reads:
Inclusion Criteria: 
To be considered eligible to participate in the study, all subjects must 
meet the following inclusion criteria:
1. Subject must have participated in a previous PH94B SAD 
study.
Note: Subjects who have not participated in a prior PH94B SAD 
study may be permitted to enroll following approval by the 
sponsor on a case-by-case basis.
2. Written informed consent provided prior to conducting any study-
specific assessment.
3. Male and female adults, 18 through 65 years of age, inclusive.
4. Women of childbearing potential must be able to commit to the 
consistent and correct use of an effective method of birth control 
throughout the study and must also have a negative urine pregnancy 
test result at both Screening (Visit 1) (for subjects who attend Visit 1)
and Baseline (Visit 2), prior to IP administration. Effective methods of 
contraception include: condoms with spermicide, diaphragm with 
spermicide, hormonal contraceptive agents (oral, transdermal, or 
injectable), or implantable contraceptive devices.

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5. Current diagnosis of SAD as defined in the Diagnostic and 
Statistical Manual of Mental Disorders, 5th Edition, and confirmed by 
the Mini-International Neuropsychiatric Interview (MINI). 
6. Clinician-rated HAM-D17 total score < 18 at study entry 
(Screening [Visit 1] or Visit 2 [Baseline] as applicable).
7. Negative COVID-19 test for subjects with COVID-19 symptoms 
or those who had direct exposure to someone with a positive 
COVID-19 test, and/or completion of quarantine period consistent 
with requirements at the study site as determined by the 
investigator.
Section 8.2.2.
Exclusion Criteria.
Text formerly read:
8.2.2.1 All Subjects
To be considered eligible for entry into the study, a subject must not 
meet any of the following exclusion criteria at study entry. 
1. Women who have a positive urine pregnancy test prior to IP 
administration.
2. Subjects with a positive urine drug screen at study entry 
 
3. Any current clinically significant and/or uncontrolled medical 
condition, based on medical history or as evidenced in screening 
assessments, such as COVID-19, HIV, cancer, stroke, congestive heart 
failure, uncontrolled diabetes mellitus, or any other medical condition 
or disease that, in the clinical judgment of the Investigator, could place 
the subject at undue risk, interfere with study participation, or 
confound the results of the study. 
4. History of cancer or malignant tumor not in remission for at least 
2 years. Basal cell skin cancers are not exclusionary.
8.2.2.2 New Subjects
New subjects will be excluded from the present study if they meet any 
of the exclusion criteria in this section.
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, autism-
spectrum disorder, or obsessive-compulsive disorder.
Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to study entry.
3. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
the Suicidal Ideation section of the C-SSRS with reference to a 
6-month period prior to screening; or

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b. At Screening (Visit 1): the subject has had 1 or more suicidal 
attempts with reference to a 2-year period prior to screening; or
c.
the Suicidal Ideation section of the C-SSRS with reference to 
screening; or
d. The subject is considered to be an imminent danger to themself or 
others.
4. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
5. An acute or chronic condition, including an infectious illness, 
uncontrolled seasonal allergies at the time of the study, or significant 
nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium. 
6. Subjects using the following psychotropic medications: 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine 
at enrollment. 
Subjects using lower doses of atypical antipsychotics at Screening may 
be eligible after discussion with the Medical Monitor (e.g., quetiapine 
< 100 mg).
In general, subjects using antidepressants or buspirone can continue to 
receive these provided that they have been taking them for a minimum 
of 2 months, and have been on a stable dose for a minimum of 
1 month.
7. Use of anxiolytics, such as benzodiazepines or unapproved 
treatments such as beta blockers, within 30 days before study entry; 
concomitant use is prohibited during the study. Subjects who have 
been taking benzodiazepines daily for 1 month or longer at the time of 
Visit 1 are not eligible to participate.
8. Use of any over-the-counter product, prescription product, or 
herbal preparation for treatment of the symptoms of anxiety or social 
anxiety within 30 days before study entry; concomitant use is 
prohibited during the study.
9. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at the Screening visit or Baseline visit that in the clinical 
judgment of the Investigator, could place the subject at undue risk, 
interfere with study participation, or confound the results of the study.
8.2.2.3 P1/P2 Completers 
P1/P2 completers will be excluded from the present study if they meet 
any of the exclusion criteria in this section.
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, autism-
spectrum disorder, or obsessive-compulsive disorder as determined at 
the time of entry into the legacy study.

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Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to entry into the legacy 
study.
3. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
the Suicidal Ideation section of the C-SSRS with reference to last visit; 
or
b. The subject is considered to be an imminent danger to themself or 
others.
4. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
5. An acute or chronic condition, including an infectious illness,
uncontrolled seasonal allergies at the time of the study, or significant 
nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium. 
6. Subjects using the following psychotropic medications: 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine 
at enrollment.
Subjects using lower doses of atypical antipsychotics at Screening may 
be eligible after discussion with the Medical Monitor (e.g., quetiapine 
< 100 mg).
In general, subjects using antidepressants or buspirone can continue to 
receive these provided that they have been taking them for a minimum 
of 2 months, and have been on a stable dose for a minimum of 
1 month.
7. Use of anxiolytics, such as benzodiazepines or unapproved 
treatments such as beta blockers, within 30 days before study entry; 
concomitant use is prohibited during the study. Subjects who have 
been taking benzodiazepines daily for 1 month or longer at the time of
study entry are not eligible to participate.
8. Use of any over-the-counter product, prescription product, or 
herbal preparation for treatment of the symptoms of anxiety or social 
anxiety within 30 days before study entry; concomitant use is 
prohibited during the study.
9. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at study entry or during the legacy study which, in the 
clinical judgment of the Investigator, could place the subject at undue 

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risk, interfere with study participation, or confound the results of the 
study.
Now reads:
Exclusion Criteria:
To be considered eligible for entry into the study, a subject must not 
meet any of the following exclusion criteria at study entry. 
1. Any history of bipolar disorder (I or II), schizophrenia, 
schizoaffective disorder, psychosis, anorexia or bulimia, 
premenstrual dysphoric disorder, autism-spectrum disorder, 
obsessive-compulsive disorder, or treatment-refractory major 
depressive disorder.
Any other current Axis I disorder, other than SAD, which is the 
primary focus of treatment. Note that subjects with concurrent 
Generalized Anxiety Disorder are eligible for the study provided that 
Generalized Anxiety Disorder is not the primary diagnosis.
2. In the opinion of the Investigator, the subject has a significant risk 
for suicidal behavior during the course of their participation in the 
study, or
a.
At Screening (for subjects who attend Visit 1): the subject scores 
on items 4 or 5 in the Suicidal Ideation section of the Columbia-
Suicide Severity Rating Scale (C-SSRS) with reference to a 6-month 
period prior to screening; or
b. At Screening (for subjects who attend Visit 1): the subject has 
had 1 or more suicidal attempts with reference to a 2-year period prior 
to screening; or
c.
the Suicidal Ideation section of the C-SSRS with reference to last visit; 
or
d. The subject is considered to be an imminent danger to themself or 
others.
3. Subjects using the following psychotropic medications at
enrollment or within 30 days before study entry: antidepressants 
(including monoamine oxidase inhibitors), anxiolytics, stimulants, 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine. 
Eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or 
anti-histamines prescribed for insomnia are allowed.
4. Use of benzodiazepines or unapproved treatments such as beta 
blockers, within 30 days before study entry and during the study. Use 
of beta blockers for treatment of hypertension or cardiac 
conditions is allowed. Subjects who have been taking 
benzodiazepines daily for 1 month or longer at the time of Visit 1 are 
not eligible to participate.
5. Use of any over-the-counter product or herbal preparation for 
treatment of the symptoms of anxiety or social anxiety within 30 days 
before study entry; concomitant use is prohibited during the study.

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6. Clinically significant nasal pathology or history of significant nasal 
trauma, nasal surgery, total anosmia, or nasal septum perforation that 
may have damaged the nasal chemosensory epithelium.
7. Subjects who meet criteria for moderate or severe alcohol or 
substance use disorder within the 1 year prior to entry into the study.
8. Subjects with a positive urine drug screen at study entry 
 
9. An acute or chronic condition, including an infectious illness, 
uncontrolled seasonal allergies at the time of the study, or significant 
nasal congestion that potentially could affect drug delivery to the nasal 
chemosensory epithelium.
10. Any current clinically significant and/or uncontrolled medical 
condition, based on medical history or as evidenced in screening 
assessments, such as COVID-19, HIV, cancer, stroke, congestive heart 
failure, uncontrolled diabetes mellitus, or any other medical condition 
or disease that, in the clinical judgment of the Investigator, could place 
the subject at undue risk, interfere with study participation, or 
confound the results of the study. 
11. Women who have a positive urine pregnancy test prior to IP 
administration. Women who are currently breastfeeding are not 
eligible.
12. History of cancer or malignant tumor not in remission for at least 
2 years. Basal cell skin cancers are not exclusionary.
13. Subjects with clinically significant abnormalities in hematology, 
blood chemistry, urinalysis, 12-lead ECG, or physical examination 
identified at study entry or during the legacy study which, in the 
clinical judgment of the Investigator, could place the subject at undue 
risk, interfere with study participation, or confound the results of the 
study.
Section 8.4
Subject Replacement Criteria
Text formerly read:
Withdrawn subjects will not be replaced. If a substantial number of 
subjects are withdrawn from the study, the sponsor will evaluate the 
need for developing replacement criteria.
Now reads:
Withdrawn subjects will not be replaced. If a substantial number of 
subjects are withdrawn from the study, the sponsor will evaluate the 
need for developing replacement criteria. Rescreening will be
permitted on a case-by-case basis after discussion with the medical 
monitor.
Section 9.1.
Identification of Investigational Product
Text formerly read:
The IP is defined as the spray delivery device containing PH94B 
(PH94B Nasal Spray). 
 
 

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PH94B will be supplied 
. Each spray from the 
metered dose spray nozzle delivers 1.6 µg per 100 µL spray. There is 
sufficient volume in each vial to deliver at least 60 sprays of PH94B.
The spray delivery device consists of an 
 
 which contains 8 mL of PH94B. 
Use of the i.n. route is essential given the site of action of PH94B on 
nasal sensory chemoreceptors (see Section 5.1).
PH94B and placebo will be supplied by 
 
When needed, a new device should be primed and allowed to come to 
room temperature for 30 minutes before use. The IP spray delivery 
device should be primed 5 times per vial before use.
Now reads:
The IP (PH94B Nasal Spray) is 
 
 
 
 
PH94B will be supplied in monthly kits consisting of a 
 
 
 Each metered dose spray delivers 1.6 µg per 100 µL spray. 
There is 
 
Use of the i.n. route is essential given the site of action of PH94B on 
nasal sensory chemoreceptors (see Section 5.1).
PH94B will be supplied by 
New vials should be allowed to come to room temperature for 
30 minutes and primed before use according to the instructions 
provided.
Section 9.2.
Selection of Timing of Dose for Each Subject
Text formerly read:
Treatment with PH94B should be self-administered approximately 
15 minutes prior to an anxiety-provoking situation or event. 
Consecutive nasal administrations of IP should be at least 1 hour apart, 
with no more than 4 administrations per day.
Site personnel will instruct the subject to self-administer the IP by 
1 spray into each nostril (right and left nasal passages), for 2 total 
sprays per dosing event.
Subjects must record all PH94B administrations in the provided 
eDiary (see Section 9.4.1).
Now reads:
Treatment with PH94B should be self-administered approximately 
15 minutes prior to or during an anxiety-provoking social situation or 
event. Consecutive nasal administrations of IP should be at least 
1 hour apart, with no more than 4 administrations per day.

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Site personnel will instruct the subject to self-administer the IP by 
1 spray into each nostril (right and left nasal passages), for 2 total 
sprays per dosing event.
Subjects are instructed to record all PH94B administrations in the 
provided eDiary, even if they have not used PH94B that day (see 
Section 9.4.1).
Section 9.4.
Treatment Compliance
Text formerly read:
Subjects will self-administer the IP up to 4 times per day between 
visits. The study personnel will be responsible for recording the self-
administration of the IP in the eCR
documented use of the IP in the eDiary application. If a discrepancy is 
observed between the measured weight of IP used and the expected 
weight based on reported use by a subject, the study staff should 
question the subject during their in-clinic visit on whether there was a 
malfunction of the pump, improper administration of IP, or inaccurate 
eDiary entries. Depending on the reason for the discrepancy, subjects 
may be retrained on the proper use and administration of the IP to 
maintain compliance.
Now reads:
Subjects will self-administer the IP up to 4 times per day between 
visits. The study personnel will be responsible for reviewing the
self-administration of the IP in the eDiary.
Section 9.4.1.
eDiary for Dosing Record (now read
Text formerly read:
Subjects participating in the study will be required to record their use 
of PH94B in an eDiary application. The eDiary will be made available 
smartphone or a similar device.
Subjects will be instructed to complete the eDiary at the end of each 
day, providing information on the number of doses they 
self-administered that day and the approximate time of each dose. The 
eDiary will also be used to prompt the subject to start a new vial of 
PH94B.
Now reads:
Subjects participating in the study will be instructed to record their 
use of PH94B in an eDiary application. The eDiary will be made 
their smartphone or a similar device.
Subjects will be instructed to complete the eDiary at the end of each 
day even if zero doses are taken that day. They will be instructed 
to provide information on the number of doses they self-administered 
that day and the approximate time of each dose. 
After the subject has completed the dosing section, the eDiary will 
prompt the subject to answer if they have experienced any health 
problems that day. If they answer yes, the subject is asked to write 
a brief summary text in the eDiary. The Investigator or a delegate 
will review these summary texts at each visit and determine 

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whether they are to be recorded in the EDC system as AEs, with 
their severity, duration, and relationship to the study drug.
Section 9.5.
Method of Assigning Subjects to Treatment Groups
Text formerly read:
Subject numbers will be allocated by the study site. Subject numbers 
will be sequentially assigned 4-digit numbers, will include the site 
number and will not be sex-specific. Instructions on subject number 
assignments will be included in the Study Procedures Manual.
Now reads:
Subject numbers will be allocated by the IRT. Subjects will be 
sequentially assigned 6-digit numbers as shown below. The subject 
number will include the site number. Instructions on subject number 
assignments will be included in the IRT manual.
Sourcea
Site Number
Subject ID
Example
New Subjectsb
001
Starting with 001
001-001
001-002
PALISADE-1 Study (Completers)
001
Starting with 101
001-101
001-102
PALISADE-2 Study (Completers)
001
Starting with 501
001-501
001-502
a
Participants from other antecedent studies will follow a similar systematic numbering convention.
b
Subjects who have not participated in a prior PH94B SAD study may be permitted to enroll following 
approval by the sponsor on a case-by-case basis.
Section 9.7.1.
Permitted Therapies
Deleted:
Subjects who are receiving stimulant medications may enroll in the 
study provided that there is documentation of their prolonged daily use 
and that the dose has been stable. The Investigator should discuss these 
cases with the Medical Monitor before enrolling the subject in the 
study.
Text formerly read:
In general, subjects using antidepressants (e.g., serotonin selective 
re-uptake inhibitors, serotonin/nor-epinephrine reuptake inhibitors, 
bupropion, mirtazapine) or buspirone can continue to receive these, 
provided that they have been taking them for a minimum of 2 months, 
and have been on a stable dose for a minimum of 1 month at the time 
of enrollment. The antidepressant must have been approved for 
treatment of SAD or major depressive disorder by the FDA. Use of 
low doses of atypical antipsychotics (e.g., quetiapine < 100 mg) should 
be discussed with the Medical Monitor. In general, starting an 
antidepressant during the study is allowed but the investigator should 
inform the Medical Monitor of this decision.
Now reads:
In general, starting treatment with antidepressants and buspirone 
during the study is allowed but the investigator should inform the 
Medical Monitor of this decision; for antidepressants, initiating 
treatment is permitted provided that the antidepressant has been 
approved for the treatment of SAD or major depressive disorder 
by the FDA. However, while subjects may begin treatment with 

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antidepressants, use of MAO inhibitors or ketamine is not 
permitted.
Section 9.7.2.
Prohibited Therapies
Text formerly read:
For subjects who use a prohibited medication (see below) during the 
study, or who require a change in the dose of their antidepressant 
treatment, Investigators should discuss the subject with the Medical 
Monitor. Such treatment might not be a cause for discontinuing the 
subject from the study immediately; this will be discussed on a case-
by-case basis.
Now reads:
For subjects who use a prohibited medication (see below) during the 
study, Investigators should discuss the subject with the Medical 
Monitor. Such treatment might not be a cause for discontinuing the 
subject from the study. In particular, one-time use or very short 
legitimate medical requirement such as minor surgeries or 
procedures, will not necessarily lead to exclusion from the study. 
These subjects should be discussed on a case-by-case basis with the 
Medical Monitor.
Text formerly read:
Prior use of PH94B is not permitted, except for subjects who have 
participated in a PH94B Phase 3 SAD study
Use of the following psychotropic medications is prohibited: 
anticonvulsants, mood stabilizers, antipsychotic medications, 
gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine
Use of anxiolytics such as benzodiazepines and unapproved 
anxiety treatments such as beta blockers 
o
Subjects requiring daily treatment with benzodiazepines are 
excluded from the study. If a subject develops the need to use 
benzodiazepines for management of anxiety, their participation in the 
study will be discontinued and the subject will be excluded from the 
study. 
o
One-time use or very short-
lead to exclusion from the study. These subjects should be discussed
on a case-by-case basis with the Medical Monitor
Now reads:
Prior use of PH94B is not permitted, except for subjects who have 
participated in a PH94B SAD study.
Use of the following psychotropic medications is prohibited: 
anxiolytics, anticonvulsants, mood stabilizers, antipsychotic 
medications, stimulants, gabapentin, pregabalin, opioids, naltrexone, 
esketamine, and ketamine.
o
Use of antidepressants is prohibited at enrollment or within 
30 days before the study. However, treatment with antidepressants 
or buspirone can be initiated during the study (see Section 9.7.1).
Note: Treatment with MAO inhibitors or ketamine is prohibited 
at all times. 

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Use of benzodiazepines and unapproved anxiety treatments such as 
beta blockers is not permitted within 30 days before study entry 
(Visit 2), or during the study. 
o
Subjects requiring daily treatment with benzodiazepines are 
excluded from the study. If a subject develops the need to use 
benzodiazepines for management of anxiety, their participation in the 
study will be discontinued and the subject will be excluded from the 
study. 
o
Use of beta blockers for treatment of hypertension or cardiac 
conditions is allowed.
Use of any over-the-counter product or herbal preparation for 
treatment of the symptoms of anxiety or social anxiety is not 
permitted within 30 days before study entry, or during the study.
Section 9.9.1.
Dispensing
Text formerly read:
At each visit from Visit 2 (Baseline) through the final monthly visit 
(Visit 13), subjects will be dispensed the appropriate number of vials 
of IP from the respective clinical site: a 
 
 The vial numbers of the dispensed vials will be recorded 
in the eCRF for each subject. Each study site will be provided with an 
appropriate supply of IP, and each vial will be individually numbered 
with a unique identification code. 
Prior to the subject receiving the IP at each in-clinic visit, the 
Investigator or study staff will use an identified vial to instruct the 
subject how to prime the spray vial (push actuator 5 times), how to 
adequately position the spray nozzle in each nasal passage, and to 
ensure the IP is used at room temperature. At least 1 vial of the IP will 
be primed at each clinic visit following Visit 2 (Baseline) as needed. 
The IP will be weighed prior to priming, and again when returned to 
study staff. 
Subjects should use a fresh vial at the start of each week. Subjects will 
be instructed to 
 
 
 The clinic will provide vials with unique serialized vial 
identification codes. Each vial will be dispensed to the subject in order 
from the lowest to highest serial number.
Now reads:
At each visit from Visit 2 (Baseline) through the final monthly visit 
(Visit 13), subjects will be dispensed a monthly kit containing a 
sufficient number of PH94B Nasal Spray vials from the respective 
clinical site. Each study site will be provided with an appropriate 
supply of IP, and each vial will be individually numbered with a 
unique identification code. 
Prior to the subject receiving the IP at each in-clinic visit, the 
Investigator or study staff will use a vial from their assigned kit to
instruct the subject on how to ensure the IP is 
 
At least 1 vial of the IP will be primed at 
each clinic visit following Visit 2 (Baseline) as needed. The IP will be 

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weighed prior to priming, and again when returned to study staff. 
 
 
 
 
 The clinic will dispense a kit of vials with unique 
serialized vial identification codes at each visit.
Section 9.9.2.
Storage
Text formerly read:
All IP supplied to each site by the sponsor will be maintained in a safe 
and secure (locked) area, 
 
 
. Access should be restricted to the designated 
monitor. The Investigator agrees that neither he/she nor any of the 
study staff will supply IP to any person other than subjects enrolled in 
the study. 
Secure access to the storage area is the responsibility of the 
Investigator and designated staff.
New (unused) IP spray delivery devices should be stored in the 
refrigerator. The IP spray delivery device should be primed 5 times per 
vial before use. 
room temperature. New devices stored in the refrigerator have a shelf 
life of 6 months from the date of manufacture.
Now reads:
All IP supplied to each site by the sponsor will be maintained in a safe 
and secure (locked) area, stored upright in a refrigerator between 2°C 
(36°F) and 8°C (46°F), until dispensed, and away from direct sunlight 
and ultraviolet light. Access should be restricted to the designated 
monitor. The Investigator agrees that neither he/she nor any of the 
study staff will supply IP to any person other than subjects enrolled in 
the study.
Secure access to the storage area is the responsibility of the 
Investigator and designated staff.
New (unused) IP should be stored in the refrigerator. The spray 
actuator of the IP should be primed before use according to the 
instructions provided.
Section 9.10.
Drug Accountability
Text formerly read:
Upon receipt of each IP shipment, an inventory must be performed, 
and a drug receipt log filled out and signed by the person accepting the 
shipment. The IP will be provided with each vial assembled 
individually to its pump device. It is important that the designated 
study staff count and verify that the shipment contains all the items 
noted in the shipment inventory. Any damaged or unusable IP in each 
shipment (active drug) will be documented in the study files.

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Now reads:
Upon receipt of each IP shipment, an inventory must be performed, 
and a drug receipt log filled out and signed by the person accepting the 
shipment. 
 
 It is important that the designated 
study staff count and verify that the shipment contains all the items 
noted in the shipment inventory. Any damaged or unusable IP in each 
shipment (active drug) will be documented in the study files.
Section 9.11.1.
Labeling
Text formerly read:
The vials will have a label affixed that meets the applicable regulatory 
requirements and may include the following: IP name, dosage 
strength, lot number, protocol number, specified volume of contents, 
Limited by United States Law to 
information, date of expiration, vial identification code, user 
.
Now reads:
The vials will have a label affixed that meets the applicable regulatory 
requirements and may include the following: IP name, dosage 
strength, lot number, protocol number, specified volume of contents, 
Limited by United States Law to 
.
Section 9.11.2.
Packaging
Text formerly read:
PH94B will be supplied in 
. 
 
 
 
 
PH94B Nasal Spray dosage units are not childproof and should be 
stored out of reach of children.
Section 10.
Study Procedures
Text formerly read:
Subjects must provide written informed consent before any 
study-related procedures are initiated, including the cessation of 
prohibited concomitant therapy.
Now reads:
Subjects must provide written informed consent for the present study 
before any study-related procedures are initiated, including the 
cessation of prohibited concomitant therapy.
Section 10.
Study Procedures
Text formerly read:
Subjects who have participated in a previous PH94B Phase 3 SAD 
study will be given the option to enroll in this study, as follows:
Subjects who enter the present study within 14 days after 
completing Visit 1, 2, 3, or 4 of either PALISADE-1 (PH94B-CL026) 
or PALISADE-2 (PH94B CL032) without meeting any of the 

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exclusion criteria of PALISADE-1/PALISADE-2, with the exception 
of SUDS <
and will enter the present study at Visit 2 (see Table 2-2). For these 
subjects, Investigators can use the data from Visit 1 of the legacy study 
for demographics, the MINI and SAD Diagnostic Criteria checklist, 
and medical and psychiatric history, but if there have been changes 
these details should be updated.
Now reads:
Subjects who have participated in a previous PH94B SAD study will 
be enrolled in this study and attend Visit 1 or Visit 2 depending on 
the interval since they finished participation in their antecedent 
study, as follows: 
: Subjects who finished 
participation in their antecedent PH94B SAD study more than 
14 days before entering the present study will attend Visit 1 of the 
long-term safety study and complete all necessary screening 
assessments as shown in the schedule of events (Table 2-1).
For the purposes of enrollment, these subjects are referred to as 
: Subjects who enter the present 
study within 14 days after finishing participation in their 
antecedent PH94B SAD study without meeting any of the 
exclusion criteria of this long-term safety study will enter the 
present study at Visit 2 (see Table 2-1).
For the purposes of enrollment, these subjects are referred to as 
While these subjects enter the long-term safety study at Visit 2, 
Investigators must transcribe the following screening data (Visit 1)
from the antecedent study to the present long-term safety study: 
demographics, the MINI, medical and psychiatric history, and the 
SAD Diagnostic Criteria checklist. If there have been any changes, 
these details should be updated. This data from the antecedent 
study must be re-entered into the Visit 1 eCRF for the present 
study. All other assessments scheduled for Visit 2 must be 
performed as indicated in the schedule of events (see Table 2-1).
If the subject enters the present study on the same day as the 
last visit of their antecedent study, results from the assessments on 
that day may be used to enter data into the eCRFs for the 
antecedent study and for Visit 2 of the present study without 
repeating them.
o
For example,
 completed for the last visit 
of the antecedent study may be transcribed for this long-term 
safety study provided that the last visit occurred on the same day 
as Visit 2 for the present study. Details on preparing a certified 

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copy of the results will be provided in the eCRF completion 
guidelines. 
For clinical laboratory assessments, 2 sets of blood and urine 
samples should be obtained and sent to the lab for analysis: one 
for the antecedent study and one for the long-term study. Note 
that these can be collected at the same time to avoid unnecessary
needlesticks. 
Subjects who have not participated in a prior PH94B SAD study 
may be permitted to enroll following approval by the sponsor on a 
case-by-case basis. For the purposes of enrollment, these subjects 
Section 10.1
Study Duration
Text formerly read:
The study comprises a 7- to 30-day screening period and a treatment 
period of up to 12 months, and a follow-up visit at 54 weeks.
Now reads:
The study comprises a 7- to 35-day screening period and a treatment 
period of up to 12 months, and a follow-up visit at 2 weeks after the 
last visit.
Section 10.2
Study Periods and Visits
Text formerly read:
A comprehensive schedule of study assessments is presented in 
Table 2-1 and described in the following sections. Every effort should 
be made to complete all required procedures and evaluations at the 
designated visits. A physician must see the subject at every visit. A 
window of ±3 days is permitted for Visit 3 and the follow-up visit 
(Visit 15), with a window of ±7 days permitted for Visits 4 through 13, 
and ±2 weeks for Visit 14.
Now reads:
A comprehensive schedule of study assessments is presented in 
Table 2-1 and described in the following sections. Every effort should 
be made to complete all required procedures and evaluations at the 
designated visits. A window of ±3 days is permitted for Visit 3 and the 
follow-up visit (Visit 15), with a window of ±7 days permitted for 
Visits 4 through 13, and ±2 weeks for Visit 14.
Section 10.2.1.1
Screening (Visit 1)
Text formerly read:
o
have not participated in a previous PH94B Phase 3 study) will be 
required to undergo all the screening procedures to ensure they meet 
eligibility
o
Similarly, subjects who have participated in a PH94B Phase 3 
SAD study more than 14 days before entry into the present study must 
undergo all the screening procedures at Visit 1 to ensure they meet 
eligibility (see Table 2-2)

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Now reads:
o
Subjects who enter this study more than 14 days after finishing 
participation in their antecedent study must undergo all the 
screening procedures at Visit 1 to ensure they meet eligibility
Text formerly read:
To meet these objectives, the duration of screening must be tailored to 
the individual subject and may last from a minimum of 7 to a 
maximum of 30 days. Subjects continuing to meet all eligibility 
requirements at Visit 2 (Baseline) will undergo treatment with IP 
(PH94B) up to Visit 14.
Now reads:
To meet these objectives, the duration of screening must be tailored to 
the individual subject and may last from a minimum of 7 to a 
maximum of 35 days. Subjects continuing to meet all eligibility 
requirements at Visit 2 (Baseline) will undergo treatment with IP 
Text formerly read:
Generally, healthy subjects who are thought to meet inclusion and 
exclusion criteria and express an interest in participating will be 
informed about the study, the IP, required visits and scheduling, and 
asked whether they wish to participate.
Now reads:
Generally, subjects who have participated in an antecedent PH94B 
SAD study will be informed about the study, the IP, required visits and 
scheduling, and asked whether they wish to participate.
Text formerly read:
The following procedures will be performed in the order below at 
Screening, which is to occur at least 7 days, but no more than 30 days 
prior to Visit 2:
Obtain informed consent
Review all inclusion and exclusion criteria
Collect demographic information
Assign subject number determined by study site 
Obtain medical history (including nicotine, alcohol use, and 
menstrual information on women of childbearing potential) and 
psychiatric history
Record prior and concomitant treatment and medication use 
(medication name, dose, and frequency)
Complete SAD diagnostic criteria checklist
Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list)
Obtain urine sample for urine drug screen: Instant Exam to be 
performed on site, with results thoroughly documented in the source; 
urine sample to be sent to central laboratory for confirmation if on-site 
urine drug screen is positive. If the central laboratory urine drug screen 
result is positive, the subject in the study may have to be excluded 
from the study; the Medical Monitor should be consulted on these 
cases
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Obtain 12-lead ECG

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Perform physical examination, including height (inches) and body 
weight (pounds). The physical examination includes a review of the 
nasal passages. If total anosmia is suspected, Quick Olfactory Test 
(QOT) is to be administered.
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F) 
Administer MINI 7.0.2
Administer LSAS
Administer HAM-D17
Administer C-SSRS (Long Term)
Complete CGI-S
Now reads:
The following numbered procedures should be performed in a block 
fashion as per the order indicated. Assessments within a block, 
except for the first block, may be conducted in any order as per 
clinical judgement at Screening, which is to occur at least 7 days, but 
no more than 35 days prior to Visit 2:
1. ICF will be reviewed and completed before any other 
assessments. Collect demographic information; and assign subject 
number.
2. Urine sample for drug screen and pregnancy test (if 
appropriate) will be collected early in the screening visit to 
determine eligibility and to guide diagnostic interviews, especially 
with regards to substance use assessment. The urine sampling is to 
include:
a. Obtain urine sample for urine drug screen (UDS): Instant Exam to 
be performed on site, with results thoroughly documented in the 
source; urine sample to be sent to central laboratory for confirmation if 
on-site UDS is positive
 
.
b. For females of child-bearing potential, obtain urine sample and 
complete on-site urine pregnancy test.
3. Medical and psychiatric history and diagnosis (usually starting 
with MINI) to include:
a. Administer MINI (7.0.2).
b. Obtain medical history (including nicotine, alcohol use, and 
menstrual information on women of childbearing potential) and 
psychiatric history.
c.
Record prior and concomitant treatment and medication use 
(medication name, dose, and frequency).
d. Complete SAD diagnostic criteria checklist.
4. Standardized assessments (usually starting with LSAS but per 
investigator judgement based on the MINI) to include:
a. Administer LSAS.
b. Administer HAM-D17.

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c.
d. Administer C-SSRS (Baseline).
e.
Complete CGI-S with a recall period of 1 week (by the trained 
clinician).
5. Physical assessments (recommend blood draw last to avoid any 
potential impact on vitals and ECG assessment) to include:
a.
Perform physical examination, including height (inches) and body 
weight (pounds). The physical examination includes a review of the 
nasal passages. If total anosmia is suspected, Quick Olfactory Test 
(QOT) is to be administered.
b. Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F). 
c.
Obtain 12-lead ECG in supine position after the subject has 
rested for 5 minutes.
d. Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list).
6. After these assessments are complete, review all inclusion and 
exclusion criteria.
Section 10.2.2.1.
Visit 2 (Baseline)
Text formerly read:
Section 10) will enter this study at Visit 2 (see Table 2-2). These 
subjects will sign an ICF for the present study at this visit and complete 
all Visit 2 assessments as noted in the schedule of events (Table 2-1) 
and detailed in this section.
Now reads:
Subjects entering the study within 14 days of their antecedent PH94B 
SAD study will enter this study at Visit 2. These subjects will sign an 
ICF for the present study at this visit and complete all Visit 2
assessments as noted in the schedule of events (Table 2-1) and detailed 
in this section.
NOTE: In the text describing the assessments to be conducted at this visit, the order of assessments 
was modified to match the Schedule of Events this rearrangement is not captured in this section 
to allow specific changes in text to be identified.
Text formerly read:
Obtain urine sample for urine drug screen: Instant Exam to be 
performed on site, with results thoroughly documented in the source; 
urine samples will be sent to the central laboratory for confirmation as 
needed if on-site urine drug screen is positive. If the central laboratory 
urine drug screen result is positive, the subject may have to be 
excluded from the study; the Medical Monitor should be consulted on 
these cases
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test

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Obtain 12-lead ECG
Perform physical examination, including body weight (pounds). 
The physical examination includes a review of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F) 
For subjects meeting all study inclusion criteria and no study exclusion 
criteria, the following Visit 2 procedures will be performed:
Administer the LSAS 
t
Administer the HAM-D17 (by the trained clinician)
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Train subjects on the use, dosing, and storage of IP. The subject 
will be given instructions on:
o
how to position the nozzle in the nasal passages and self-
administer IP
o
o
how to store the nasal spray
Now reads:
Obtain urine sample for urine drug screen: Instant Exam to be 
performed on site, with results thoroughly documented in the source; 
urine samples will be sent to the central laboratory for confirmation as 
needed if on-site urine drug screen is positive. If the central laboratory 
urine drug screen result is positive 
 
, the subject may have to be 
excluded from the study; the Medical Monitor should be consulted on 
these cases
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Record concomitant medication use 
Perform physical examination, including body weight (pounds). 
The physical examination includes a review of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F) 
Obtain 12-lead ECG in supine position after the subject has 
rested for 5 minutes
Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis
Review all inclusion and exclusion criteria
For subjects meeting all study inclusion criteria and no study exclusion 
criteria, the following Visit 2 procedures will be performed:

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Administer the LSAS 
Administer the HAM-D17 
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Train subjects on the use, dosing, and storage of IP. The subject 
will be given instructions on:
o
how to position the actuator nozzle in the nasal passages and self-
administer IP
o
the number of sprays per nostril per dose (1 per nostril)
o
how to store the nasal spray
o
Treatment with PH94B should be self-administered 
approximately 15 minutes prior to or during an anxiety-provoking 
social situation or event. Consecutive nasal administrations of IP 
should be at least 1 hour apart, with no more than 
4 administrations per day. Treatment does not need to be 
administered every day.
Train subjects on how to record study drug use on the eDiary 
application (see Study Procedures Manual for training on the eDiary 
application) 
Record any AEs 
All prior, ongoing, or resolved AEs reported by subjects at the time of 
study entry will be considered as medical history during this study. 
Adverse events that become aggravated, accelerated, or exacerbated 
will be reported and considered as new AEs. Adverse events that recur 
will be considered as new AEs during this study.
Dispense IP to subjects (1-month supply)
Section 10.2.2.2.
Visit 3 (First Month in Clinic, ±3 Days)
NOTE: In the text describing the assessments to be conducted at these visits, the order of 
assessments was modified to match the Schedule of Events this rearrangement is not captured in 
this section to allow specific changes in text to be identified.
Text formerly read:
Record concomitant medication use
Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list)
Conduct urine drug screen (Instant Exam, to be performed on site, 
with results documented in the source. If urine drug screen result is 
positive, then urine sample will be sent to central laboratory for 
confirmation as needed). If the urine drug screen is confirmed as 
positive, a repeat unscheduled urine drug screen may be obtained to 
investigate whether drug use is continuing. The Medical Monitor 
should be consulted regarding these cases.

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For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Obtain 12-lead ECG
Perform physical examination, including body weight (pounds). 
The physical examination includes a review of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F) 
Administer the LSAS (by the trained clinician)
Administer the HAM-D17 (by the trained clinician)
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Complete the CGI-I with a recall period of 1 week (by the trained 
clinician)
Complete the PGI-C with a recall period of 1 week (by the subject)
Review and record AEs
Dispense study medication and provide the subject with the storage 
instructions of the IP (1-month supply of IP [6 vials]) 
Review and record use of IP in eDiary (by study staff)
Now reads:
Conduct urine drug screen (Instant Exam, to be performed on site, 
with results documented in the source. If urine drug screen result is 
positive 
 
 then urine sample will be sent to central 
laboratory for confirmation as needed). If the urine drug screen is 
confirmed as positive, a repeat unscheduled urine drug screen may be 
obtained to investigate whether drug use is continuing. The Medical 
Monitor should be consulted regarding these cases.
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Record concomitant medication use
Administer the LSAS 
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Perform focused physical examination, including body weight 
(pounds). The physical examination includes a review of the nasal 
passages and oropharynx but other organ systems should be 
examined only if the subject has symptoms or the investigator is 
concerned
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F) 
Obtain 12-lead ECG in supine position after the subject has 
rested for 5 minutes

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Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Complete the CGI-I as compared to baseline visit (Visit 2), with 
a recall period of 1 week (by the trained clinician)
Complete the PGI-C as compared to baseline visit (Visit 2), with 
a recall period of 1 week (by the subject)
Dispense study medication and provide the subject with the storage 
instructions of the IP (1-month supply of IP) 
Review and record AEs
Review the use of IP and any health problems they experienced 
as reported in the eDiary (by study staff)
Section 10.2.3.
Visit 14 End of Treatment (or Early Termination) Visit
Text formerly read:
At Visit 14, or upon early termination of study participation, subjects 
should return to the study site and the following assessments will be 
completed:
Record concomitant medication use
Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list)
Conduct urine drug screen (Instant Exam, to be performed on site, 
with results documented in the source. If urine drug screen result is 
positive, then then urine sample will be sent to central laboratory for 
confirmation as needed) 
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Obtain 12-lead ECG
Perform physical examination, including height (inches) and body 
weight (pounds). Also includes an examination of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F)
Administer the LSAS (Last Visit)
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Complete the CGI-I with a recall period of 1 week (by the trained 
clinician)
Complete the PGI-C with a recall period of 1 week (by the subject)

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Review and record use of IP in eDiary (by the trained clinician)
Now reads:
At Visit 14, subjects should return to the study site for an End of 
Treatment visit, and undergo the assessments shown in the schedule 
of events.
In addition, subjects who discontinue from the study early (for any 
reason other than loss to follow up) should return to the study site 
for an Early Termination Visit. Similarly, if the subject is 
attending a scheduled visit when the decision to discontinue is 
made, the investigator should perform the assessments indicated 
for Visit 14/Early Termination Visit in the schedule of events 
(Table 2-1).
The following assessments will be completed at Visit 14/Early 
Termination:
Record concomitant medication use
Obtain blood and urine samples for evaluation by the central 
clinical laboratory, including hematology, chemistry, thyroid 
functioning, and urinalysis (refer to Section 10.3.1.1.1 for complete 
list)
Conduct urine drug screen (Instant Exam, to be performed on site, 
with results documented in the source. If urine drug screen result is 
positive 
 
 then then urine sample will be sent to central 
laboratory for confirmation as needed) 
For females of childbearing potential, obtain urine sample and 
complete on-site urine pregnancy test
Obtain 12-lead ECG in supine position after the subject has 
rested for 5 minutes
Perform physical examination, including height (inches) and body 
weight (pounds). Also includes an examination of the nasal passages
Measure vital signs after the subject has rested for 5 minutes: 
seated systolic and diastolic blood pressure, heart rate, respiratory rate, 
and body temperature (°F)
Administer the LSAS 
Administer the HAM-D17
Administer the C-SSRS (Since Last Visit)
Complete the CGI-S with a recall period of 1 week (by the trained 
clinician)
Complete the CGI-I as compared to baseline visit (Visit 2), with 
a recall period of 1 week (by the trained clinician)
Complete the PGI-C as compared to baseline visit (Visit 2), with 
a recall period of 1 week (by the subject)
Complete PWC-20
Review the use of IP and any health problems they experienced 
as reported in the eDiary (by the trained clinician)

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Section 10.2.4.
Visit 15 (Follow-up, 54 weeks ±3 Days)
New:
Complete PWC-20
Section 10.3.1.
Safety Variables
Text formerly read:
Safety assessments will include the evaluation of AEs, clinical 
laboratory assessments, vital signs, 12-lead ECGs, physical 
examinations, and C-SSRS evaluations.
Now reads:
Safety assessments will include the evaluation of AEs, clinical 
laboratory assessments, vital signs, 12-lead ECGs, physical 
examinations, HAM-D17, C-SSRS evaluations, and the PWC-20.
Section 10.3.1.1.1.
Clinical Laboratory Tests to be Performed
Text formerly read:
Urine Drug Screen: If on-site urine drug screen is positive, urine 
sample must be submitted to central laboratory for confirmatory urine 
drug screen to be performed:
opiates, cocaine, amphetamines, barbiturates, cannabinoids, 
methadone, phencyclidine, propoxyphene, methamphetamine, 
buprenorphine, ecstasy, and oxycodone
Now reads:
Urine Drug Screen: If on-site urine drug screen is positive, urine 
sample will be submitted to central laboratory for confirmatory urine 
drug screen to be performed:
opiates, cocaine, amphetamines, barbiturates, benzodiazepines,
cannabinoids, methadone, phencyclidine, propoxyphene, 
methamphetamine, buprenorphine, ecstasy, and oxycodone
 
Section 10.3.1.2.2
Twelve-lead Electrocardiogram
Text formerly read:
A standard 12-lead ECG will be performed after the subject has been 
seated for at least 5 minutes.
Now reads:
A standard 12-lead ECG will be performed in a supine position after 
the subject has rested for 5 minutes.
Section 10.3.1.2.3
Physical Examination
New:
A focused physical examination will be performed at certain visits 
as per the schedule of events, but must include examination of the 
nasal passages and oropharynx; other organ systems should be 
examined if the subject has symptoms or if the investigator has
specific concerns.
Section 10.3.1.2.5.
Penn Physician Withdrawal Checklist
New:
10.3.1.2.5 Penn Physician Withdrawal Checklist
The PWC-20 is a 20-item simple instrument for assessing 
anxiolytic discontinuation symptoms. It should be administered by 
a suitably qualified physician or advanced practice provider. 

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The PWC-20 consists of 20 questions related to withdrawal from 
benzodiazepines or other anti-anxiety compounds (see 
APPENDIX H). The symptoms measured are based on those that 
are potentially related to anxiolytic withdrawal: gastrointestinal, 
mood, sleep, motor, somatic, perception, and cognition. The 
questions will cover any symptoms that might occur during the 
week following discontinuation of PH94B.
Section 10.3.2.1.
Liebowitz Social Anxiety Scale
Text formerly read:
The LSAS is a clinician-rated scale that has been shown to be sensitive 
to treatment-related change in social phobia symptoms. 
Now reads:
The LSAS is a clinician-rated scale that has been shown to be sensitive 
to treatment-related change in social anxiety symptoms. 
Section 10.3.2.2.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 10.3.2.3.
Hamilton Rating Scale for Depression (17 Items)
Text formerly read:
The HAM-D17 scale is a 17-item clinician-rated scale to measure the 
severity of depression, addressing symptoms experienced in the past 
week, The 17 items are scored on a scale from 0 (not present) to 
4 (severe), with the total score ranging from 0 to 68. A score of 0 to 7 
is considered to be within the normal range, while a score of 20 or 
more indicates at least moderate depression.
Now reads:
The HAM-D17 scale is a 17-item clinician-rated scale to measure the 
severity of depression, addressing symptoms experienced in the past 
week, with the total score ranging from 0 to 68 (see APPENDIX D).
A score of 0 to 7 is considered to be within the normal range, while a 
score of 20 or more indicates at least moderate depression. The time 
frame for rating symptomatology is the past week.

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Section 10.3.2.4.
Clinical Global Impression Scales
Text formerly read:
The Clinical Global Impression Scale (CGI) is a clinician-rated scale 
to and after participation in a clinical study. The scale assesses the 
circumstances, symptoms, behavior and the effect of these parameters 
ith the 
subject. The CGI consists of 2 components, severity (CGI-S) and 
improvement (CGI-I). The severity component consists of 1 question 
that assesses the disease severity of the patient population and is on a 
scale of 1 to 7 ranging from normal (1) to extremely ill (7). The 
condition from the Baseline and is on a scale of 1 to 7 ranging from 
very much improved (1) to very much worse (7). The time frame for 
rating is the past week.
Now reads:
The Clinical Global Impression Scale (CGI) is a clinician-rated scale 
to and after participation in a clinical study. The scale assesses the 
, psychosocial 
circumstances, symptoms, behavior and the effect of these parameters 
subject. The CGI consists of 2 components, severity (CGI-S) and 
improvement (CGI-I). A recall period of 1 week is used.
The severity component (CGI-S) consists of 1 question that assesses 
the disease severity of the patient population and is on a scale of 1 to 7 
ranging from normal (1) to extremely ill (7). 
The improvement component (CGI-I) evaluates the change of the 
ranging from very much improved (1) to very much worse (7). 
In this study the disease severity refers to the severity of SAD. The 
scale scoring is anchored with reference to the severity of 
symptoms and functional impairment caused by SAD.
Section 10.3.2.5.
Patient Global Impression of Change
Text formerly read:
The Patient Global Impression of Change (PGI-C) is a self-
overall 
Now reads:
The Patient Global Impression of Change (PGI-C) is a self-
improvement with treatment on a scale 
(see APPENDIX G). The time 
frame for rating is compared to the baseline visit (Visit 2).

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Section 11.1.1.
Adverse Events
Text formerly read:
For P1/P2 completers, AEs ongoing at a time of enrollment into the 
present study will be recorded in the medical history section of the 
present study.
Now reads:
For subjects who enter the present study within 14 days of their 
antecedent PH94B SAD study, AEs ongoing at the time of 
enrollment into the present study will be recorded in the medical 
history section of the present study.
Section 11.2.1.
Assessment
New:
In addition, the Investigator will review the eDiary summary text 
for health problems and determine whether they are to be 
recorded in the EDC system as AEs.
Section 11.2.2.3.
Actions Taken
Deleted:
Dose increased: An indication that a medication schedule was 
modified by addition; either by changing the frequency, strength, or 
amount.
Dose reduced: An indication that a medication schedule was modified 
by subtraction, either by changing the frequency, strength, or amount.
Dose interrupted: An indication that a medication schedule was 
modified by temporarily terminating a prescribed regimen of 
medication.
Section 11.3.1.
Pregnancy
Text formerly read:
If the partner of a male subject becomes pregnant during his IP 
treatment or within 14 days of his discontinuing the IP, the 
Investigator must report the pregnancy within 48 hours of learning of 
the pregnancy, to 
 Pharmacovigilance, as described 
above.
Now reads:
Male subjects with partners of childbearing potential should be 
advised to use contraception throughout their participation in the 
study. If the partner of a male subject becomes pregnant during his IP 
treatment or within 14 days of his discontinuing the IP, the 
Investigator must report the pregnancy within 48 hours of learning of 
the pregnancy, to 
 Pharmacovigilance, as described 
above.
Section 13.1.1.
Analysis Populations
Text formerly read:
Safety: All subjects who are dispensed IP will be included in the safety 
population.
Now reads:
Safety population: All subjects who receive IP.

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Section 13.1.2.1.
Disposition and Withdrawals
Text formerly read:
The numbers of subjects randomized, completing, and withdrawing, 
along with reasons for withdrawal, will be tabulated. Details on the 
number of subjects participating in previous PH94B Phase 3 SAD 
studies will also be provided.
Now reads:
The numbers of subjects randomized, completing, and withdrawing, 
along with reasons for withdrawal, will be tabulated. Details on the 
number of subjects participating in the individual antecedent PH94B 
SAD studies will also be provided.
Section 13.1.2.2.
Protocol Deviations
Text formerly read:
Documentation of the deviations and corrective actions will be 
included in the data quality assessment during blinded review.
Now reads:
Documentation of the deviations and corrective actions will be 
included in the data quality assessment during review.
Section 13.1.2.3.
Demographics and Other Baseline Characteristics 
Text formerly read:
For all participating subjects, baseline is defined as Visit 2. For 
subjects coming from previous PH94B studies (PALISADE-1
[PH94B-CL026] or PALISADE-2 [PH94B CL032]), Visit 2 
assessments should be conducted as described in the schedule of 
events (Table 2-1). Demographics, medical and psychiatric history, 
MINI findings, SAD Diagnostic Criteria Checklists, and baseline 
characteristics such as gender, age, race, weight, height and baseline 
physical examination reports, and vital signs will be carried over.
Now reads:
For all participating subjects, baseline is defined as Visit 2. For 
subjects who enter the present study within 14 days of their 
antecedent PH94B SAD study, Visit 2 assessments should be 
conducted as described in the schedule of events (Table 2-1).
Demographics, medical and psychiatric history, MINI findings, SAD 
Diagnostic Criteria Checklists, and baseline characteristics such as 
gender, age, race, weight, height and baseline physical examination 
reports, and vital signs will be carried over.
Section 13.1.4.
Safety and Tolerability Analyses
Text formerly read:
Safety analyses will be conducted using data from the safety 
population (as defined in Section 13.1.1). Safety variables include 
treatment emergent AEs, clinical laboratory values, vital signs, ECG 
readings, and physical examination results. No formal inferential 
analyses will be conducted for safety variables, unless otherwise 
noted.
Now reads:
Safety analyses will be conducted using data from the safety 
population (as defined in Section 13.1.1). Safety variables include 
treatment emergent AEs, clinical laboratory values, vital signs, 
changes in suicidality (C-SSRS), level of depression (HAM-D17),
PWC-20 results, ECG readings, and physical examination results. No 

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formal inferential analyses will be conducted for safety variables, 
unless otherwise noted.
Text formerly read:
Descriptive statistics will be used to portray safety and tolerability of 
PH94B as measured by reports of AEs and SAEs, changes in 
laboratory values, 12-lead ECGs, and physical examination.
Now reads:
Descriptive statistics will be used to portray safety and tolerability of 
PH94B as measured by reports of AEs and SAEs, changes in 
laboratory values, 12-lead ECGs, physical examination, vital signs, 
and withdrawal symptoms.
New text:
PWC-20 scores after termination of PH94B
Section 13.1.4.5.
Penn Physician Withdrawal Checklist
New:
13.1.4.5
Penn Physician Withdrawal Checklist
Descriptive summaries (mean, SD, median, minimum, and 
maximum) will be presented for scores from the PWC-20
checklist, completed at Visits 14 and 15.
Section 13.1.5.1.
Exploratory Endpoints
Text formerly read:
The change in LSAS, CGI-I, and PGI-C scores from the Baseline 
Visit 2 to Visit 14 may also be explored using generalized linear model 
for repeated measures.
Now reads:
The change in LSAS, CGI-I, and PGI-C scores from Baseline to 
Visit 14 may also be explored using generalized linear model for 
repeated measures.
Text formerly read:
Change in total LSAS scores over time with daily use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time 
with daily use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very 
much improved) or 2 (Much improved) over time with daily use of 
PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very 
much improved) or 2 (Much improved) over time with daily use of 
PH94B
Changes in patterns of PH94B use (daily frequency and dosing 
interval) over time 
Change in patterns of PH94B use (daily frequency and dosing 
interval) in designated subgroups over time 
Now reads:
Change in total LSAS scores over time with use of PH94B
Change in proportion of subjects with CGI-S scores >4 over time 
with use of PH94B
Change in proportion of subjects with CGI-I scores of 1 (Very 
much improved) or 2 (Much improved) over time with use of PH94B
Change in proportion of subjects with PGI-C scores of 1 (Very 
much improved) or 2 (Much improved) over time with use of PH94B

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Protocol PH94B-CL030
14-Mar-2022
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Changes in patterns of PH94B use (frequency and dosing interval) 
over time 
Change in patterns of PH94B use (frequency and dosing interval) 
in designated subgroups over time 
Section 14.3.
Screen Failures
Text formerly read:
Subjects who fail inclusion and/or exclusion criteria may be 
rescreened for the study. Subjects may only be rescreened once 
30 days or more after the original Screening visit. If a subject is 
eligible to enter the study after having previously failed screening, the 
subject will be assigned a new subject identification number.
Now reads:
Subjects who fail inclusion and/or exclusion criteria may be 
rescreened for the study on a case-by-case basis after discussion 
with the medical monitor. Subjects may only be rescreened once 
30 days or more after the original Screening visit. If a subject is 
eligible to enter the study after having previously failed screening, the 
subject will be assigned a new subject identification number.
Section 14.7.2.
Sample Retention
Text formerly read:
Samples may be used for purposes related to this research. The 
samples will be stored until the sponsor has determined that specimens 
are no longer needed, and the decision has been made that none of the 
samples needs to be reanalyzed. In addition, identifiable samples can 
be destroyed at any time at the request of the subject.
Now reads:
Samples may be used for purposes related to this research. The 
samples will be destroyed after testing is complete. In addition, 
identifiable samples can be destroyed at any time at the request of the 
subject.
New appendices were added (not shown here): 
SAD Diagnostic Checklist
Hamilton Depression Rating Scale
Clinical Global Impression Scale of Improvement
Clinical Global Impression Scale of Severity
Patient Global Impression of Change
Penn Physician Withdrawal Checklist