AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) could see increased investor attention as it approaches Phase IIb data for its oral DMT-based therapy VLS-01, according to Jefferies analysts, who highlighted the program’s potential to add value to the company’s psychedelic medicine pipeline.
The analysts wrote that VLS-01’s completed Phase IIb enrollment in treatment-resistant depression (TRD) sets up a fourth quarter 2026 topline data readout, which could serve as a potential de-risking event for the program.
Jefferies estimated a positive outcome could support a 25% to 50% move in AtaiBeckley’s stock, while a negative outcome could result in a 10% to 20% decline. Shares of AtaiBeckley traded hands at about $5 on Tuesday afternoon, up about 24% in the year to date.
Jefferies wrote that investor expectations for VLS-01 remain low, but the program could gain greater valuation support if it produces positive placebo-controlled results and advances into Phase III studies for major depressive disorder (MDD) and generalized anxiety disorder (GAD).
The analysts wrote that VLS-01 could complement AtaiBeckley’s lead asset BPL-003, an intranasal 5-MeO-DMT therapy being developed for TRD. Jefferies noted that shifting VLS-01’s future development toward MDD and GAD could broaden the opportunity for the program while reducing potential overlap with BPL-003.
They added that VLS-01 may offer differentiation through its oral buccal film delivery approach, which is designed to provide a longer psychedelic experience than traditional DMT administration while maintaining a short in-clinic treatment period. Both VLS-01 and BPL-003 could fit within the two-hour monitoring model established by Spravato, Johnson & Johnson (NYSE:JNJ)’s intranasal esketamine treatment for depression.
The analysts also highlighted that sentiment toward psychedelic therapies continues to improve, citing positive clinical developments across the sector, evolving regulatory support and Spravato’s commercial performance as evidence of growing acceptance of psychedelic-based treatments.
Jefferies wrote that VLS-01’s Phase IIb results could provide additional support for AtaiBeckley’s pipeline as investors await Phase III data for BPL-003, which the analysts expect in early 2029.