atai Life Sciences (NASDAQ:ATAI, ETR:9VC) has provided an update on its research activities and told investors it has cash, marketable securities, and committed term loan funding available which is expected to fund its operations into 2026.
In addition to announcing its second quarter financial results, atai on Tuesday unveiled positive preliminary Phase 1b trial results for VLS-01, its proprietary oral transmucosal film formulation of N,N-dimethyltryptamine (DMT) that is applied to the buccal surface.
The trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of VLS-01 when compared to intravenous DMT.
VLS-01 reached peak plasma concentration within 30 to 45 minutes and was shown to induce a short psychedelic experience, with the effects generally resolving within 90 to 120 minutes, the company reported.
The drug demonstrated a favorable safety profile and was well tolerated. All adverse events were classified as either mild or moderate, with most resolving on the day of dosing.
atai expects to commence a Phase 2 study of VLS-01 to assess the efficacy, safety and durability of response of repeated doses in patients with treatment-resistant depression (TRD) around year-end 2024.
“In this trial, the 120mg dose was found to strike a balance between psychedelic effect intensity and safety as well as tolerability,” atai co-CEO Dr Srinivas Rao said in a statement.
“These encouraging findings, if replicated in Phase 2, suggest that VLS-01 could become a best-in-class treatment for TRD, one that offers a well-tolerated, convenient oral dosing and a short psychedelic experience that fits into the two-hour in-clinic commercial paradigm established within interventional psychiatry.”
The co-CEO highlighted that atai has made “significant strides” to advance its pipeline during the second quarter, with key updates from its VLS-01 and EMP-01 programs.
Clinical development plans for EMP-01, atai’s oral formulation of R-MDMA, are advancing, with a Phase 2 study in Social Anxiety Disorder set to begin at the year-end, Dr Rao said.
“This follows encouraging Phase 1 results, where EMP-01 demonstrated a unique subjective profile compared to racemic MDMA and classical psychedelics. With no novel molecules approved for SAD in over 20 years, it remains an area of critical unmet need,” Dr Rao said.
“Looking ahead, our team is focused on several important readouts and study initiations in the second half of the year. As such, we continue to establish our position as a leader in mental health innovation, with a robust set of high potential programs aimed at addressing the areas of most significant unmet need.”
During the second quarter, the clinical-stage biopharmaceutical company invested $12.6 billion in research and development, compared to $15.5 million for the year-ago quarter.
General and administrative expenses decreased year-over-year due to a decrease in personnel-related and professional services and other administrative expenses, to $13.4 million from $16.6 million.
Its net loss increased to $57.3 million from $33 million in Q2 2023.