COMPASS Pathways Plc American Depository Shares 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thanks very much, Josh, and it's great to be here. Just a reminder, we will be making some forward-looking statements right now. COMPASS Pathways is the leading company in psychedelics. We have started a rolling submission for COMP360 for treatment-resistant depression, and these are patients with chronic, recurring refractory depression. That will be important to bear in mind as we go on to talk about the opportunity here. The rolling submission is underway. The FDA has commenced its review. We will complete that submission in Q4 of this year. We were awarded an executive order, through the executive order, post that executive order, a National Priority Voucher for an accelerated review. With that, with a filing due to complete in Q4 of this year, with the potential for an accelerated review, we are expecting to launch in the first half of 2027.

COMP360 in TRD, there is only one drug approved today, SPRAVATO, esketamine from Johnson & Johnson. COMP360 is clearly highly differentiated from that in terms of rapidity of onset, durability, and the just very limited number of doses needed to sustain that effect. We are extremely excited about the year ahead of us, about being potentially the first psychedelic to come to market. We have also just started, and it is now underway, a late-stage, potentially registrational study in PTSD, where we also see a very, very significant opportunity, and again, just like TRD, a very underserved market.

We now have all the data required for it in hand. Today, we put out the 52-week data from the first study and that safety database, and that was consistent with everything we have seen. That safety data will go into the filing. Right now, we are actually finalizing the integration of the two studies, the ISS. The team is working very hard on that, and that will be the last piece of the clinical module to go in. Pre-clinical, CMC, others are already in, already under review. We are already getting information requests on those.

I'll hand to Lori to talk about what it really means for the commercial profile and how it really, again, strengthens what we're already seeing for COMP360.

Yeah, we're really excited about the data that came out today for our open label portion of Part C for COMP005. That data really does help in three ways as we prepare specifically for the commercial launch. First and foremost is that it helps us start to understand what the average number of doses will be on an annualized basis. This becomes important because this is how we will likely price the product on a per dose basis on an annualized price. This really does help us construct the profile that we will put in front of payers as we start initiating our negotiations with payers. The other piece that's important to this is that it really does help us guide physicians in terms of what to expect for redosing.

That becomes important because open label data is extremely important for physicians because physicians like to take a look at what happens in open label data from clinical trials to have an analog as to what will happen in the real world. Of course, they understand, and they look at the double-blind piece when they're trying to understand the rigor that was applied and the scientific integrity that went into the clinical trials. But the open label portion of data really is more indicative of what real-world looks like. So we're pretty excited about the data that came out today.