Atai Beckley NV Q4 FY2021 earnings call

Strategic Pillars

• Three strategic pillars: rapid acting intervention, ongoing digital support, biomarker driven precision mental health.

Achievements in 2021

• Launched eight new programs including three drug discovery programs, total drug discovery and development programs at 13.
• Positive Phase IIb data for COMP360, increased stake in Compass Pathways to 22.8%.
• Positive Phase IIa proof of mechanism data for RL-007.
• Initiated Phase IIa proof of concept trial with PCN-101 in TRD, received IND clearance from FDA for first clinical study with PCN-101 in US.
• Collaboration with Otsuka Pharmaceuticals for PCN-101.

Philanthropic Efforts

• atai Impact launched atai Fellowship Fund at MGH's center for the neuroscience of psychedelics, made donations to MAPS and for humanitarian support in Ukraine.

No specific financial performance data for product segments in terms of absolute revenue and contribution percentages provided in the transcript.

Forward-Looking Statements

• Anticipate at least 14 R&D catalysts in the upcoming two years.
• Year-end 2021 cash balance of $362.3 million provides cash runway for approximately two years, funding operations into 2024.
• Expect R&D and G&A operating expenses to increase year-on-year as multiple clinical trials are initiated.

Risks

• Uncertainties around clinical trial outcomes, including safety and tolerability concerns for compounds.
• Regulatory challenges in obtaining approvals and meeting requirements for commercialization.

Q: Andrew Tsai at Jefferies asked about what would be a deal breaker in the GRX-917 Phase I dataset and if PCN-101 is free of unwanted side effects of ketamine.

A: Florian Brand said safety and tolerability concern would be a deal breaker for GRX-917, and for PCN-101, doses picked were associated with minimal dissociative effects, using lorcaserin as an example of a compound with some psychedelic effect but approved for obesity.

Q: Neena Bitritto-Garg at Citi asked about FDA's view on studying PCN-101 in an at-home setting and formulation details.

A: Florian Brand said FDA review will be based on data, therapeutic index is important, and subcutaneous formulation is being developed for better control and potential at-home use.

Q: Charles Duncan at Cantor Fitzgerald asked about defining good vs great results for PCN-101 and RL-007 dosing.

A: Florian Brand said hitting primary endpoint like substantial and statistically significant improvement on MADRS is key for PCN-101, and Srinivas Rao mentioned RL-007 has an inverted U-shaped dose response with most robust benefits in 20-40mg range.

Q: Ritu Baral at Cowen asked about biomarkers in precision mental health and GRX-917 qEEG beta band shift.

A: Florian Brand said it's both biological and digital biomarkers, Srinivas Rao mentioned psy products focus on mitochondrial metabolism and GRX-917 has a different mechanism with no expectation of same magnitude beta band shift as other GABA PAMs.

Q: Judah Frommer at Credit Suisse asked about cash priorities and biomarker strategy.

A: Greg Weaver said cash is sufficient for clinical/preclinical programs and business development, Srinivas Rao mentioned biomarker strategy for patient enrichment and potential label inclusion.

Q: Brian Abrahams at RBC Capital Markets asked about learnings from COMP360 for trial design and GRX-917 confidence.

A: Srinivas Rao said COMP360 trial was similar to R-ketamine in single administration for duration of efficacy, Srinivas Rao expressed confidence in GRX-917 based on pre-clinical data and etifoxine's long use history but Phase I data is preliminary.

Q: Patrick Trucchio at H.C. Wainwright asked about underappreciated catalysts and Compass Phase III meeting.

A: Srinivas Rao and Florian Brand mentioned diverse pipeline and key outcomes for Compass Phase III meeting, Srinivas Rao discussed how different TRD programs complement each other.

Q: Sumant Kulkarni at Canaccord Genuity asked about DMX-1002 dose selection and first mover advantage/clinics.

A: Srinivas Rao discussed DMX-1002 dose selection based on ibogaine data, Florian Brand talked about first mover advantage in assembling pipeline and no immediate plans for running clinics but considering scaling with infrastructure providers.