Summary of Atai Life Sciences FY Conference Call Company Overview - **Company**: Atai Life Sciences (NasdaqGM: ATAI) - **Event**: FY Conference on September 17, 2025 - **Key Speakers**: CEO Srinivas Rao, Chief Medical Officer Kevin Craig Key Industry and Company Insights Recent Developments - Atai Life Sciences reported positive Phase 2b data for BPL-003, a treatment for treatment-resistant depression (TRD) in partnership with Beckley Psytech Limited, which has now been acquired by Atai [1][2] Phase 2b Trial Results - The eight-milligram dose of BPL-003 showed a significant MADRS (Montgomery-Åsberg Depression Rating Scale) difference of 6.3 compared to a subclinical control of 0.3 at day 29 [2] - The trial demonstrated good response rates at four weeks, with durability extending to eight weeks [2][4] - Expectations for the open-label data include confirmation of durability and potential incremental improvement with a second dose, aiming for remission rates of 40% to 50% [4][5] Additional Analyses - The trial also assessed anxiety and anhedonia, with interest in how these comorbid conditions respond to treatment [5][8] - Patient-reported outcomes were collected using GAD-7 for anxiety and SHAPS for anhedonia, focusing on the absence of positive enjoyment in life [8][9] Regulatory Considerations - Atai plans to submit a request for an end-of-phase two meeting with the FDA within the current quarter [11] - The company is considering applying for breakthrough therapy designation, having gathered sufficient double-blind placebo-controlled data [12][14] Treatment Paradigm - BPL-003 is positioned as a treatment option with less frequent dosing compared to Spravato, targeting patients who are relatively high functioning and require less commitment to treatment [17] - The ideal patient profile includes those needing to return to daily life with less frequent treatment visits [17] Safety and Monitoring - Similar safety profiles are expected between BPL-003 and Spravato, with attention to cardiovascular effects and psychiatric comorbidities [18] - Monitoring requirements post-dosing are being refined to ensure safety while maintaining a reasonable approach [19] Phase 3 Trial Design - The design for the Phase 3 trial is evolving, with a preference for using a true placebo as a control arm and a middle dose that is psychedelic but less effective [21][23] - The anticipated timeline for the Phase 3 trial initiation is early next year, with patient dosing expected around mid-next year [30] Market Opportunities - Atai is also developing VLS-01, an oral transmucosal DMT for TRD, which has shown a favorable safety profile in early trials [47][51] - The company is exploring EMP-01 for social anxiety disorder, targeting a market of over 13 million individuals, which is larger than the TRD market [59][60] Challenges - Recruitment for trials has been slower than expected due to a limited number of psychedelic experience sites and variability in Schedule I approval timelines [55][56] Conclusion Atai Life Sciences is making significant strides in the development of psychedelic treatments for mental health conditions, with promising data from BPL-003 and plans for future trials. The company is navigating regulatory landscapes and market opportunities while addressing challenges in recruitment and site activation.

Financial Data and Key Metrics Changes - As of March, the company had cash and cash equivalents of $260 million, an increase from $165 million at the end of 2024, indicating a strong financial position following recent financing [12] - Cash used in operations for the first quarter was $45.7 million, with an expected net cash usage for the full year 2025 projected to be between $120 million to $145 million [13] Business Line Data and Key Metrics Changes - The company announced the completion of dosing for all participants in Part A of its pivotal Phase III trial for treatment-resistant depression (TRD), with top-line results expected in late June [5] - The Phase III program aims to confirm the durability and safety profile of COMM360, which could provide a groundbreaking treatment option for TRD patients if successful [9] Market Data and Key Metrics Changes - The company is focusing on the commercialization of COMM360 by developing relationships with various provider types through strategic collaborations, including a new partnership with HealthPort to enhance access to innovative mental health treatments [10] Company Strategy and Development Direction - The company is preparing for the commercialization of COMM360 by understanding the commercial opportunity and ensuring broad delivery across various care settings [9] - The strategic collaboration with HealthPort aims to address the needs of underserved populations, reflecting the company's commitment to equitable access to mental health treatments [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III data readout, emphasizing the potential of COMM360 to be a clinically differentiated treatment option for TRD [13] - The company is also working on the final design for a late-stage clinical program in PTSD, indicating a significant commercial opportunity in this area due to high unmet needs [13] Other Important Information - The independent Data Safety Monitoring Board (DSMB) is regularly reviewing unblinded safety data, with a focus on suicidality, which remains a critical concern in the context of TRD [6][39] Q&A Session Summary Question: Key takeaways from the long-term follow-up data on durability and appropriate dosing - Management noted that while the data is not definitive, it suggests that patients receiving 25 mg can experience effects lasting up to six months, indicating this dose may be preferred moving forward [21] Question: Efficacy delta on MADRS and placebo effect considerations - Management acknowledged the variability in placebo effects in psychedelic trials and estimated a clinically significant effect size of over three on the MADRS scale [29] Question: Concerns regarding suicidality signals - Management clarified that suicidality is a core feature of depression and must be included in study designs, with ongoing monitoring to ensure safety [36] Question: Current delivery of esketamine by HealthPort - HealthPort has experience delivering SPRAVATO and is motivated to ensure access to new treatment options for underserved populations [42] Question: Manufacturing supply chain and FDA inspections - The company is currently manufacturing in the UK and plans to add US manufacturing capabilities, with multiple inspections conducted over the years [49] Question: Patient enrollment in COMM-five and comparison to Phase 2b - Management confirmed that recruitment criteria remain consistent, suggesting similar patient profiles across studies [55] Question: Interest in large pharma partnerships - The company is committed to commercializing COMM360 independently in the US, with no current plans for large pharma partnerships [58] Question: Optimal time frame for assessing suicidality risk post-treatment - Management indicated that predictions are difficult, and they will rely on data to inform their understanding of suicidality risk [61] Question: Changes in FDA interactions regarding psychedelic therapies - Management reported no significant changes in FDA interactions, maintaining routine discussions around event reporting [63]