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Sep 30, 2022
Atai Q3 2022 Earnings Report
Atai reported financial results and business update for Q3 2022.
Key Takeaways
Atai Life Sciences reported its Q3 2022 financial results, highlighting advancements in its clinical programs, including the dosing of the final patient in the Phase 2a trial of PCN-101 for TRD and positive results from Phase 1 studies of GRX-917 and KUR-101. The company ended the quarter with $304.1 million in cash and is anticipated to have cash runway into 2025.
Last patient dosed in the Phase 2a proof-of-concept trial of PCN-101 for treatment-resistant depression (TRD), with topline results expected around year-end 2022.
Announced positive preliminary pharmacokinetics and pharmacodynamics results in a Phase 1 study of GRX-917 being developed for generalized anxiety disorder (GAD).
Announced positive preliminary results of the single ascending dose (SAD) portion of the Phase 1 study of KUR-101 being developed for opioid use disorder (OUD).
Ended quarter with $304M in cash, which combined with the non-dilutive funding facility from Hercules provides anticipated runway into 2025.
Atai
Atai
Forward Guidance
atai Life Sciences is advancing its clinical programs and anticipates additional clinical milestones for the remainder of 2022 and beyond. Eight compounds are now in clinical development.
Positive Outlook
- PCN-101 Phase 2a topline results expected around year-end 2022.
- Phase 1 relative bioavailability bridging study of PCN-101 expected to initiate H1 2023.
- Compass Pathways Phase 3 program is expected to commence by the end of 2022.
- RL-007 Phase 2b dose finding trial to be initiated by the end of this year.
- GRX-917 efficacy study in healthy volunteers is anticipated in H2 2022.
Challenges Ahead
- DemeRx – DMX-1002 (ibogaine) for OUD Cohort 3 expected to begin in the first half of 2023
- Safety data from the Phase 1 portion of the DemeRx trial are expected in the first half of 2023
- Viridia Life Sciences - VLS-01 (dimethyltryptamine) for TRD topline results expected in the first half of 2023
- EmpathBio - EMP-01 (MDMA derivative) for PTSD Topline results for this Phase 1 study anticipated in mid 2023
- InnarisBio – Nasal spray drug-delivery technology Phase 1 proof-of-concept trial results expected in the first half of 2023