Atai Beckley NV Q3 FY2022 earnings call

• Atai's goal is to achieve clinically meaningful and sustained behavioral change in mental health patients. - Has 8 drug development programs in clinics and 4 complementary enabling technologies. - Recent progress includes clinical trial initiations, positive Phase 1 results for GRX-917 (deuterated etifoxine) and KUR-101 (deuterated mitragynine), and enrollment completion in PCN-101 Phase 2a study in TRD. - PCN-101 targets unsupervised at-home administration, rapid onset within 24 hours, and intermittent dosing for TRD. - Discussed safety metrics like risk ratio for sedation/dissociation and efficacy considerations for various programs. - For RL007 Phase 2a trial in CIAS, MCCB is FDA-supported efficacy endpoint for CIAS, and VRFCAT assesses impact on daily living; doses selected based on biomarker study showing clinically meaningful pro-cognitive effects at 20 and 40 mg.

No traditional segment performance breakdown by revenue contribution provided; focus is on drug development programs with 8 in clinics and 4 enabling technologies.

• Cash runway extends into 2025. - Anticipates top line results from PCN-101 Phase 2a study around end of 2023. - Confident in achieving R&D objectives across programs based on existing preclinical and clinical data.

Forward-looking statements subject to risks and uncertainties that may cause actual results to differ; no specific detailed operational failures discussed in depth.

Q: Ritu Baral asks Florian Brand for a high level summary of recent progress and upcoming milestones.

A: Florian mentions 8 drug development programs, 4 enabling technologies, positive Phase 1 results for GRX-917 and KUR-101, and enrollment completion in PCN-101 Phase 2a study.

Q: Ritu Baral asks about PCN-101's target clinical profile.

A: Florian talks about unsupervised at-home administration, rapid onset, intermittent dosing, and targeting TRD.

Q: Ritu Baral asks about safety risk ratio of 2 for PCN-101.

A: Srini Rao explains risk ratio is based on population analysis of normal vs abnormal in MOAA/S and CADSS.

Q: Andrew Tsai asks about efficacy bar for PCN-101.

A: Srini Rao explains backtracking from final endpoint to 5-point change at hour 24 based on Phase 1 data and triangulation.

Q: Andrew Tsai asks about reassessing clinical development based on efficacy or safety.

A: Florian says single dose efficacy below meaningful would reassess, but confident based on existing data.

Q: Andrew Tsai asks about dose selection for PCN-101 trial.

A: Srini Rao says based on Phase 1, selecting sub dissociative and threshold dissociative doses.

Q: Andrew Tsai asks about Compass Phase 3 plans.

A: Srini Rao says FDA is flexible with different controls, but Compass' plans are based on their own decisions.

Q: Andrew Tsai asks about digital therapeutics.

A: Srini Rao says digital therapeutics are important for scalability and harnessing behavioral plasticity, aiming for combination therapy.

Q: Ritu Baral asks about RL007 Phase 2a trial primary endpoint.

A: Florian says MCCB is FDA-supported endpoint for CIAS, VRFCAT assesses impact on daily living.

Q: Ritu Baral asks about dose selection for RL007 study.

A: Florian says based on biomarker study showing clinically meaningful pro-cognitive effects at 20 and 40 mg.

Q: Andrew Tsai asks about Biogen's CIAS asset.

A: Srini Rao says following Biogen's path, CIAS is a challenging indication with high unmet need.