EmpathBio Inc. is developing EMP-01, a novel compound, which comprises the R- enantiomer of the racemic S,R(+/-)-3,4-methylenedioxymethamphetamine (MDMA). EMP-01 (R-MDMA) is a psychoactive compound with effects on mood, perception and pro-social feelings, similar to racemic MDMA, a compound that has been found to exhibit therapeutic efficacy in psychiatric populations. EMP-01 was selected for development because of its greater serotonergic activity, specifically increasing serotonin release and acting as a partial agonist at 5-HT2A, compared to racemic MDMA. It was also selected for development based on its lower activity at biological targets related to some of the side effects observed with racemic MDMA. Based on the ease of manufacture, much of the research around entactogens has been conducted using racemic MDMA, which is often considered the prototype entactogen. Clinical experience with racemic MDMA indicates that it produces subjective effects distinct from classical psychostimulants and hallucinogens, that include compassion for self and others, reduced defenses, reduced fear of emotional injury, and making unpleasant memories less disturbing while enhancing communication and capacity for introspection. Racemic MDMA inhibits the serotonergic, dopaminergic and noradrenergic neurotransmitters, stimulates 5-HT (serotonin) release and activates the 5-HT2A, B and C receptors (with 50% effective concentrations in the nanomolar to low micromolar range). Previous PBO-controlled randomized studies investigating racemic MDMA in post-traumatic stress disorder, life-threatening illness-related anxiety, and SAD support the therapeutic potential of racemic MDMA. Based on the similarities in pharmacologic activity, the findings of therapeutic benefit or potential for racemic MDMA can be extrapolated to EMP-01. Social anxiety disorder has an estimated lifetime prevalence rate of approximately 12% and an estimated 12-month prevalence of approximately 7%, with approximately 70% of patients suffering from moderate-to-severe impairments in functioning, with low recovery rates. The 3 Food and Drug Administration approved pharmacotherapies do not work for all SAD patients as approximately 30 to 50% of patients do not respond to treatment. A complete program of nonclinical drug metabolism and pharmacokinetics and safety as defined by ICH M3(R2) "non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - scientific guideline" has been completed with EMP-01, including all requirements to support a Phase 2a clinical trial. The first-in-human Phase 1 study of EMP-01 conducted by the Sponsor (Study EMP-01-101) was a single-center, randomized, double-blind, PBO-controlled trial with single-ascending doses of orally administered EMP-01 or matching PBO. This study characterized the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of EMP-01. The study enrolled 32 healthy participants who received 75 mg, 125 mg, 175 mg or 225 mg of EMP-01 or PBO in a 6+2 design. EMP-01 was safe and well-tolerated at all dose levels up to 225 mg following single-dose administration. EMP-01 was associated with increased emotional breakthrough experiences, suggested greater introspective awareness, increased self-compassion scores and produced subjective experiences and altered states that were similar to those of classic psychedelics. This data suggests that EMP-01 could significantly aid in the treatment of SAD, thus supporting further development and progression to a Phase 2a trial. This Phase 2a study (Study EMP-01-201) will explore the safety, tolerability, and efficacy of EMP-01 treatment in patients with SAD.