Andrew Tsai

Ritu Baral

Charles Duncan

Judah Frommer

Brian Abrahams

Neena Bitritto-Garg

Patrick Trucchio

Sumant Kulkarni

- ATAI Life Sciences announced positive Phase 2b data for **BPL-003** in Treatment-Resistant Depression (TRD), demonstrating a **MADRS difference of 6.3** versus subclinical control at day 29.  **[1840904_2146205_0]** 
- The company will proceed with the **8 milligram dose** of BPL-003 for further development, citing similar efficacy but a less favorable safety profile for the 12 milligram dose.  **[1840904_2146205_7]** 
- An end-of-Phase 2 meeting with the FDA for BPL-003 is scheduled for submission this quarter, with Phase 3 study initiation targeted for **early next year** and patient enrollment around mid-next year.  **[1840904_2146205_1]** **[1840904_2146205_3]** 
- The VLS-01 program is facing delays in site activation and recruitment due to limited psychedelic experience sites and challenges with Schedule I license approvals.  **[1840904_2146205_6]** 
- ATAI is exploring EMP-01 for social anxiety disorder, an indication representing a **market of over 13 million individuals**.  **[1840904_2146205_7]**

ATAI Life Sciences (ATAI)