atai Life Sciences (NASDAQ:ATAI, ETR:9VC), a biopharmaceutical company targeting mental health disorders, advanced its pipeline of innovative therapies during the third quarter of 2024.
Notably, the US Food and Drug Administration approved an investigational new drug application for for VLS-01, atai’s buccal film formulation of DMT.
atai plans to initiate a Phase 2 study of VLS-01 in treatment-resistant depression by the year-end.
The company remains on track to kick off its Phase 2 study of EMP-01 (oral R-MDMA) for social anxiety disorder by the end of 2024.
It also completed its acquisition of IntelGenx Corp, a drug delivery company specializing in innovative oral thin film products for pharmaceuticals. IntelGenx manufactures VLS-01.
“As we approach the end of 2024, we continue to see progress and momentum across our pipeline, both with our wholly owned programs and strategic investments,” atai co-CEO and co-founder Dr Srinivas Rao commented.
“We are on track to initiate Phase 2 trials for VLS-01 and EMP-01 around year-end and we look forward to topline Phase 2b data from Beckley Psytech’s BPL-003 in the second quarter of 2025.”
The CEO concluded: “Our team is focused on executing these trials with the utmost scientific rigor and is driven by our goal of being the leader in developing new psychedelic treatment options to mental health patients in need of innovative, safe and effective solutions.”
atai exited Q3 with cash, marketable securities and committed term loan funding of $101 million, which is expected to fund its operations into 2026.
The company spent $12.4 million on research and development, compared to $13.3 million for the year-ago period. The decrease of $0.9 million was attributed to a $2.7 million decrease in personnel-related costs partially offset by $1.7 million more in program-specific expenses.
General and administrative expenses decreased to $10.3 million from $13.6 million in the year-ago quarter due to reduced personal-related expenses and administrative costs.
atai reported a net loss of $26.3 million for Q3 2024, impacted by $2.0 million in non-cash adjustments on investments and $5.0 million in share-based compensation. This compares to a net income of $44.2 million in Q3 2023, with the difference largely due to a $69.0 million non-cash gain from an accounting adjustment on its investment in Compass Pathways (NASDAQ:CMPS).