atai Life Sciences (NASDAQ:ATAI, ETR:9VC) CEO Dr Srinivas Rao talked with Proactive about the company's upcoming clinical milestones and strategic focus in 2025.
Rao outlined four major clinical readouts across atai’s pipeline of short-duration psychedelics, including updates on VLS-01, BPL-003, RL-007 and EMP-01.
Proactive: Hello you’re watching Proactive. Joining me is atai Life Sciences CEO and co-founder, Dr Srinivas Rao. Srinivas, very good to speak with you. There's lots of exciting updates announced as a part of your year-end results. Could you give us a rundown on the key things investors should know?
Dr Srinivas Rao: Absolutely. Well, first of all, thank you for having me on. Yes, there's quite a bit that we reported on. I think the most important things are emphasizing the fact that we've got four readouts coming up over the course of the next year, give or take. So we've got the VLS-01 trial in treatment-resistant depression that has kicked off. We've dosed our first patient there, anticipating results right around a year from now — so Q1 of next year.
The BPL-003 trial — we just completed enrollment on that study. So BPL-003 we're anticipating readouts in the middle of this year. RL-007 — we're anticipating readout on that one in the middle of this year. EMP-01 has been initiated, and that trial on social anxiety disorder will also be reading out about a year from now.
Obviously, we've also recently raised some cash. So that’s quite helpful. Our runway is now out into 2027, which gives us some buffer beyond the timing of these readouts for subsequent fundraisers, etc. So, yeah — a lot going on. Very exciting time.
It’s great to hear that the first patient has been dosed in your lead study VLS-01 for patients with treatment-resistant depression. Can you tell us what’s unique about this trial, Srinivas?
Our focus is, and has been for some time now, on short-duration psychedelics. We have a wonderful formulation and dosage form for a short-duration psychedelic, which we’ve talked about in the past — some of the results from our Phase 1 trial. But it’s something that’s super easy to use.
It’s basically like a little Listerine strip that’s put onto the inside cheek surface. Very easy for patients, very easy for providers. So we’re very happy about that. The trial itself is being conducted in the United States and in Canada. It is under IND, so obviously we’re happy about that.
One of the things that we’re doing that’s a little bit different here for a short-duration compound is actually looking at re-dose. So looking at two doses, in this case, with the primary endpoint at four weeks. And of course, we have a long blinded period, which goes up to twelve weeks after the second dose.
This will be the first data set that’s going to come out that really addresses the question of what is the incremental benefit of a re-dose?
We also have BPL-003. That’s a single-dose study that gives us the decay curves over an extended period of time with a short-duration compound. This one — VLS-01 — is a little bit different. Again, it’s another short-duration compound, but we’re looking at two doses, seeing what the incremental benefit is. Can we drive more people into remission? Then looking to see what that decay curve looks like from there on out.
What are the next milestones, then, Srinivas?
As I mentioned, there's quite a bit coming up. BPL-003 — large treatment-resistant depression, readout Phase 2b — that'll be in the middle of this year. RL-007 — the cognitive impairment associated with schizophrenia trial — that will also be reading out in the middle of this year.
VLS-01 — treatment-resistant depression, two doses, as I mentioned — roughly a year from now. And EMP-01 — Phase 2a study is a proof of concept in social anxiety disorder, an indication that has a huge unmet medical need and hasn’t really been the focus of many companies. That trial will also be reading out roughly one year from now. So again, very exciting period for the company.
Quotes have been lightly edited for clarity and style