ENCALM: a Study of ENX-102 As a Monotherapy Treatment in Patients with Generalized Anxiety Disorder

Key Inclusion Criteria:

• Male or female at birth, inclusive of any gender identity, aged 18 to 65 years,inclusive, at Screening

• Diagnosed with GAD according to the Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition (DSM-5), confirmed by a Mini-International NeuropsychiatricInterview (MINI) version 7.0.2

• Experiencing clinically significant generalized anxiety in need of treatment asmeasured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 andat least moderately severe score symptoms of anxious mood and tension as measured byHAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

Key Exclusion Criteria:

• Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI

• Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychoticdisorder, or any current diagnosis of posttraumatic stress disorder, obsessivecompulsive disorder or bipolar disorder confirmed by independent adjudication

• Reports moderately severe to severe symptoms of depression

• Ingested psychotropic medication within 5 half-lives or 21 days (whichever islonger) prior to Day 1, including THC and CBD, and unwillingness to refrain fromtheir use for the entire duration of the trial

• Recent suicidal ideation or behavior

• Current or recent moderate to severe substance use disorder as assessed by the MINI

• Clinically significant abnormal findings in safety assessments

• Has significant progressive disorders or unstable medical conditions

• Unable to comply with the requirements of the study or, in the opinion of theInvestigator or Sponsor, is unsuitable for the study