ATAI Life Sciences(ATAI) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company's Q3 operating cash use was $28 million, aligning with expectations, and no surprises were reported [4] - At the end of Q3, the company had $304 million in cash, supplemented by a debt facility with Hercules providing access to up to $175 million, ensuring a strong capital position and a cash runway extending into 2025 [4] Business Line Data and Key Metrics Changes - Atai has 8 drug development programs in clinical stages and 4 enabling technologies, all targeting major neuropsychiatric indications [6] - Positive initial Phase 1 results were reported for GRX-917 and KUR-101, indicating promising pharmacokinetic and pharmacodynamic results [6] Market Data and Key Metrics Changes - The company is focused on treatment-resistant depression (TRD) with its PCN-101 program, which has completed enrollment in a Phase 2a proof-of-concept study [7] Company Strategy and Development Direction - Atai aims to achieve clinically meaningful and sustained behavioral change in mental health patients, with a focus on at-home administration of treatments [6][9] - The company is positioning itself to leverage upcoming efficacy datasets as potential value inflection points [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving objectives based on existing preclinical and clinical data, emphasizing the importance of demonstrating a greater therapeutic index compared to other approved treatments [25] - The anticipated data readout for PCN-101 is expected to be a significant event for the company, targeting at-home therapy for TRD [47] Other Important Information - The company is exploring the integration of digital therapeutics to enhance treatment scalability and standardization, aiming to harness behavioral plasticity for durable responses [38] Q&A Session Summary Question: Can you provide a summary of recent progress and upcoming milestones? - The company has 8 drug development programs and 4 enabling technologies, with several programs having achieved proof of concept or a path to efficacy data within the next two years [6] Question: What is the target clinical profile for PCN-101? - The plan is for unsupervised at-home administration with rapid onset of effect and an intermittent dosing regimen [9] Question: How did you decide on the efficacy bar for PCN-101? - The target was based on triangulating data from other trials, aiming for a 5-point improvement compared to placebo at hour 24 [20][21] Question: What would cause a reassessment of moving forward with PCN-101? - Efficacy below clinically meaningful thresholds would lead to a reassessment of the clinical development plan [25] Question: How did you select the doses for the Phase 2a trial of RL007? - Doses were selected based on previous biomarker studies showing clinically meaningful pro-cognitive effects [43]