8/5/2026

speaker
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Compass Pathways second quarter 2026 conference call. At this time, all participants are in listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Stephen Schultz. You may begin.

speaker
Steve Schultz
Senior Vice President of Investor Relations

Thank you, operator. I welcome all of you and thank you for joining us today for this conference call. Again, my name is Steve Schultz, Senior Vice President of Investor Relations at Compass Pathways. And today I'm joined by Kabir Nath, our Chief Executive Officer, and Lori Englebert, our Chief Commercial Officer. Teri Loxam, our Chief Financial Officer, will also be available for the Q&A. The call is being recorded and will be available on the Compass Pathways Investor Relations website shortly after the conclusion of the call and will be available for a period of 30 days. Before we begin, let me remind everyone that during the call today, we will be making statements about our future plans and prospects that constitute forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. including those risks and uncertainties described under the heading risk factors in our most recent filings with the U.S. Securities and Exchange Commission. These forward-looking statements represent our views only as of today and we specifically disclaim any obligation to update or revise any forward-looking statement even if our estimates or assumptions change. I'll now hand the call to Kabir Nath. Thank you, Steve.

speaker
Kabir Nath
Chief Executive Officer

and thank you all for joining us today. The first half of this year has been an exciting time for Compass. Now that we have highly statistically significant positive phase three primary endpoint readouts, as well as demonstrated durability through six months from both our trials, we believe we have largely de-risked the clinical and regulatory profile of Comp360. In addition to confirming its rapid onset and durability, The totality of data from the program so far shows it has a generally well tolerated and safe profile. Taken together, these data reinforce our belief that Comp360 has the potential to fundamentally change how mental health is managed. With these data sets in hand, we continue to make significant progress towards our NDA filing for the treatment of TRD. Our rolling submission and review process allows us to submit data in waves to the FDA, and they have started to review some modules that we've already submitted. We continue to expect to complete the NDA filing in the fourth quarter. With the potential for an accelerated approval following our final submission, we are advancing our commercial readiness. We built a fantastic commercial team with incredible experience, and we're executing on all fronts to be prepared to get Comp 360 to the millions of patients living with CRD who urgently need new treatment options. We're also well positioned with our strong balance sheet with $433 million of cash on hand as of June the 30th, which carries us well through launch and into 2028. Let me now hand the call to Lori to talk through in more detail how we're preparing to transform treatment options for these patients.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-

Investor presentation