Axsome Therapeutics, Inc 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thanks for having us, Pete.

Mark Jacobson. Nick Pizzie, CFO.

Axsome, CNS-focused biopharma. We have three commercial products, which we'll of course focus on with the flagship at the moment, and all eyes are on AUVELITY, which is approved for major depressive disorder and recently Alzheimer's disease agitation, which we are launching. We've done expansion around that, and right now it's all commercial performance for that product and the two others, Symbravo for migraine and Sunosi for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. Behind those products, we have a very deep and broad balanced pipeline of programs that are NDA stage. That's AXS-12 for narcolepsy. We have a PDUFA date of May 1st there, and multiple phase III programs, either with one positive phase III trial or that we've just initiated and are looking through various readouts. We can touch on those. It's an incredible time for the company.

The company's better positioned, and the fundamentals are better than they ever have been, and right now it's all about execution on the commercial and pipeline side of the house.

Remainder of 2026 from a pipeline perspective, we've recently initiated a number of phase III trials. We'll get into those, but looking towards between now and the end of the year, we have the ENGAGE phase III trial of solriamfetol, that's Sunosi, in binge eating disorder. We've guided to top-line results in the fourth quarter. We're looking forward to that. We like that program and the three other label expansion efforts or potential label expansion efforts that are ongoing now. Those are, real quick, major depressive disorder with symptoms of excessive daytime sleepiness, shift work disorder, and ADHD. That's the next pipeline event. Then looking to next year, I've touched on the NDA, the PDUFA date for AXS-12 and narcolepsy. Again, that's May 1st, and then we also have guided to top line from the shift work trial of solriamfetol in 2027.

Sure. I will touch on the recent initiations, which I alluded to. We have AXS-05 in smoking cessation. We just initiated the SUMMIT phase III trial. That is AXS-05 versus placebo and versus bupropion. Again, that we just started. We haven't guided to top line yet, and enrollment is underway, and stay tuned for updates there. Just prior to that initiation, we initiated 2 trials with solriamfetol and ADHD. We have a positive phase III trial in adults with solriamfetol and ADHD, and we saw a substantial improvement in adults in symptoms of ADHD, and now we need to complete studies in children and adolescents. Those are ongoing. We will provide updates there and top-line guidance once enrollment is really underway and we have a sense of how that's tracking.

The other trials that are underway, we have, again, I touched on the shift work disorder trial, and then there's the trial in major depressive disorder with solriamfetol. We haven't guided there yet either. That study enrollment has now been underway for a number of months. Looking at AXS-14, that is esreboxetine, so the S enantiomer of reboxetine in fibromyalgia. That trial we initiated a number of months ago now, and is enrolling there too. We will have updates for all of these programs. We're really excited about them, and if you look even earlier in the pipeline, there's AXS-17 and AXS-20, both of which are our programs that are relatively new to the pipeline, which we added last year and early this year, and tech transfer activities are underway.

Those are programs that were AXS-17 we're looking at for epilepsy and AXS-20 we plan to start a phase III trial in schizophrenia as the next program there, and we're also interested in exploring that for Tourette's syndrome. Just a lot going on, different therapeutic categories, all highly complementary and have leveraged the clinical expertise that we've built over the years, and we will look forward to keeping you posted on them.

I'm surprised you can keep all of that in Yeah, no, it's there.

I'm sure I forgot something.