PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2

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. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual ofMental Disorders, 5th Edition, and confirmed by the MINI.

4. Clinician-rated LSAS total score ≥70 at Screening (Visit 1).

5. Clinician-rated Hamilton Depression Score 17-items total score <18 at Screening (Visit 1).

6. Women of childbearing-potential must be able to commit to the consistent and correctuse of an effective method of birth control throughout the study, and must also havea negative urine pregnancy test result at both Screening (Visit 1) and Baseline (Visit 2), prior to investigational product (IP) administration. Effective methodsof contraception include: condoms with spermicide, diaphragm with spermicide,hormonal contraceptive agents (oral, transdermal, or injectable), or implantablecontraceptive devices.

7. Negative COVID-19 test either in the presence of COVID-19 symptoms or after directexposure to someone with a positive COVID-19 test

Exclusion Criteria:

1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder,psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrumdisorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus oftreatment. Note that subjects with concurrent Generalized Anxiety Disorder areeligible for the study provided that Generalized Anxiety Disorder is not the primarydiagnosis.

2. Subjects who meet criteria for moderate or severe alcohol or substance use disorderwithin the 1 year prior to Study entry.

3. In the opinion of the investigator, the subject has a significant risk for suicidalbehavior during the course of their participation in the study, or

4. At Screening (Visit 1): the subject scores "yes" on items 4 or 5 in theSuicidal Ideation section of the Columbia-Suicide Severity Rating Scale (CSSRS) with reference to a 6-month period prior to screening; or

5. At Screening (Visit 1): the subject has had 1 or more suicidal attempts withreference to a 2 year period prior to screening; or

6. At Baseline (Visit 2): the subject scores "yes" on items 4 or 5 in the SuicidalIdeation section of the C-SSRS with reference to screening; or

7. The subject is considered to be an imminent danger to themself or others.

8. Clinically significant nasal pathology or history of significant nasal trauma, nasalsurgery, total anosmia, or nasal septum perforation that may have damaged the nasalchemosensory epithelium.

9. An acute or chronic condition, including an infectious illness, uncontrolledseasonal allergies at the time of the study, or significant nasal congestion thatpotentially could affect drug delivery to the nasal chemosensory epithelium.

10. Two or more documented failed treatment trials with a registered medication approvedfor SAD, at any time during the lifetime of the subject, whereby an adequatetreatment trial is defined as that described in the package insert for a particulardrug during which the subject received an adequate medication dosage (defined as thetreatment dose indicated in the package insert to obtain efficacy for thatparticular drug).

11. Use of any psychotropic medication within 30 days before study entry (other thanmedication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon,zolpidem, or antihistamines).

12. Use of any anxiolytics, such as benzodiazepines or unapproved treatments such asbeta blockers, within 30 days before study entry; concomitant use is prohibitedduring the study. Subjects who have been taking benzodiazepines daily for 1 month orlonger at the time of Visit 1 are not eligible to participate.

13. Use of any over-the-counter product, prescription product, or herbal preparation fortreatment of the symptoms of anxiety or social anxiety within 30 days before studyentry; concomitant use is prohibited during the study.

14. Prior participation in a clinical trial involving PH94B.

15. Women who have a positive urine pregnancy test prior to IP administration.

16. Subjects with clinically significant abnormalities in hematology, blood chemistry,urinalysis, electrocardiogram, or physical examination identified at the Screeningvisit or Baseline visit that in the clinical judgment of the Investigator, couldplace the subject at undue risk, interfere with study participation, or confound theresults of the study.