Compass Pathways (NASDAQ:CMPS) reported first-quarter financial results on Wednesday. The transcript from the company’s first-quarter earnings call has been provided below.
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Access the full call at https://events.q4inc.com/attendee/144892287
Summary
Compass Pathways PLC reported a productive quarter with positive data from both Phase 3 studies of COM360, which demonstrated rapid and durable efficacy for treatment-resistant depression (TRD).
The company is preparing for a potential accelerated launch of COM360, with plans to be launch-ready by the end of the year, supported by strong financials that extend into 2028.
Strategic initiatives include ongoing collaboration with the FDA for a rolling NDA submission and engagement with the DEA for potential rescheduling of COM360, as well as advancing trials for PTSD.
Operational highlights include building out a commercial team, leveraging strategic collaborations for market readiness, and securing CPT3 codes for psychedelic treatment reimbursements.
Management expressed high confidence in the regulatory process and the potential market impact of COM360, noting strong interest and readiness among treatment centers.
Full Transcript
OPERATOR
Good day ladies and gentlemen and welcome to The Compass Pathways 1st Quarter Results Conference call. At this time, all participants are in listen only mode. As a reminder, this call is being recorded. Now, I’d like to introduce your host for today’s call, Stephen Schultz. You may begin. Welcome all of you and thank you
Stephen Schultz (Senior Vice President Investor Relations)
for joining us today for this conference call. I’m Steve Schultz, Senior Vice President Investor Relations at Compass Pathways and today I’m joined by Kabir Nath, our Chief Executive Officer, and Lori Engelbert, our Chief Commercial Officer. Terry Loxam, our Chief Financial Officer and Dr. Steve Levine, our Chief Patient Officer will be available for the Q and 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 Nat.
Kabir Nath
Thank you Steve. And thank you all for joining us today. It has been a very exciting and productive quarter for Compass. The company continues to lead the way in psychedelic science, validated by the confirmation of a rolling NDA submission and review and the award of a Commissioner’s national priority voucher or CNPV. With our 005 and 006 data announcement in February, we have delivered positive data from Both our Phase 3 studies. COMP360 has therefore demonstrated what no approved drug for TRD offers. Clinically meaningful efficacy with both rapid onset and extended durability. In fact, these extraordinary results redefine rapidity and durability for TRD patients with only one drug approved and actually used for TRD today, we are confident that COMF360, with its differentiated and compelling profile, will be an important option for the millions of patients that have been failed by the many approved treatments for MDD. After we announced results of our first positive phase 3 trial last year and based on discussions with the FDA, we began preparing for a potential accelerated launch. As we’ve said before, we will be launch ready by the end of this year. We’ve aligned with the FDA on our rolling submission and review plan and have begun submitting modules for the COMP360 NDA. We will continue to submit additional modules on a rolling basis over the coming months. Part B data from 006, which we continue to expect in early Q3, will be the final data set to complete the submission. Given the award of the cmpv. We are already working closely with the FDA to enable as much efficiency and acceleration as possible. In addition, based on the Executive Order, we are accelerating our engagement with the DEA since there is the potential for federal rescheduling to be completed sooner than the current statutory 90 days post FDA approval. Our two large phase 3 trials, blinded to an unprecedented 26 weeks for psychiatry trials supported by our large phase 2b trial, has resulted in over 1000 patients in the program with comprehensive and strong preclinical toxicology, safety and CMC data. We are confident that we will have a robust NDA submission that supports a COMP360 approval. We’ve also continued to make great progress in our commercial preparedness which Laurie will cover in detail. Our strategic collaborations across diverse settings of care, including the interventional psychiatry infrastructure, have provided significant learnings together with our foresight in establishing CPT Category III codes specifically for providers to get fully reimbursed for psychedelic monitoring. This has set us up well for a potential near term launch. We are ramping up rapidly building out the commercial team with outstanding highly motivated talent and initiating all activities in anticipation of approval. In addition to TRD, we are also progressing our program in PTSD which affects 13 million Americans. PTSD is another significant area of unmet need and an opportunity to expand COMP360 to individuals that have few medical options. We believe COMP360 can be an important new treatment for PTSD and it is a very logical next target indication for compass. Our work with the Contract Research Organization (CRO) and sites for our late stage PTSD trial is underway and we look forward to updating you as it progresses. With both the successful financing and warrant exercises in the first quarter, we have a strong balance sheet with cash that carries us well beyond launch and into 2028. Let me now hand the call to Laurie for more on our commercial preparations.
Lori Engelbert
Thank you Kabir hi everyone and thank you for joining today. There are 4 million patients with MDD who are considered treatment resistant. Spravato (esketamine), the only drug indicated and used for TRD, is expected to reach 3 billion in revenue by 2027 and as of 2025 was treating less than 2% of the TRD patient population. We believe that if approved, COMP360 will reach blockbuster potential by offering a transformative new treatment for the millions of patients who deserve more options. As Kabir noted, we are pleased to have been selected for the Commissioner’s Priority Review Voucher. One benefit of being selected for the voucher includes the potential for an ultra accelerated review timeline of one to two months after final NDA submission. This provides helpful clarity on timing expectations and allows for more thoughtful and focused planning efforts based on the current timelines for data and submission. We remain focused on being launch ready by the end of the year. Last month the White House also issued an Executive order recognizing the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA approved psychedelics could have. In that executive order, timely rescheduling of approved treatments was stated as a priority. As a Schedule 1 product, COMP360 will need to be rescheduled at both the federal and state level after approval in order to be prescribed. We are accelerating work with the DEA to ensure rescheduling at the federal level goes as rapidly and smoothly as possible. We have also been working at the state level with the past two years to ensure that the states follow the federal rescheduling decision in a timely manner. Over the past two years we have made significant progress and today almost 90% of the US population live in a state that intends to reschedule COMP360 within 30 days after FDA approval and DEA rescheduling. Through this work we have markedly reduced the timeline to launch and for patients to access COMP360 after approval. Enabling broad and equitable access includes ensuring that both COMP360 and provider monitoring time are adequately reimbursed. Kabir mentioned earlier the work we did a few years ago on securing psychedelic specific CPT Category III codes which will ensure that sites are reimbursed fully for the time required for psychedelic treatment monitoring. These codes are billable by the hour and were designed to cover clinical work and practice expenses incurred with multi hour psychedelic treatments. We are also accelerating reimbursement and formulary discussions for COMP360 with payers. TRD has a significantly greater impact on individuals lives and accounts for a disproportionate share of health care costs versus MDD. TRD patients accrue 62% more mental health care costs and experience 41% higher work related cost costs than MDD patients. COMP360 has consistently demonstrated through three late stage trials, clinical effects and a well tolerated safety profile in a TRD patient population and we expect payers to respond favorably to the emerging clinical profile and potential value that COMP360 can bring to the healthcare system. Along with enabling access to COMP360, we want to ensure that the clinical experience for the patient is the site of care is positive. This requires thoughtful consideration of how we deploy the field force and how we educate, train and prepare patients and the sites that will be administering COMP360. Through the insights generated through our growing Medical Science Liaison team, through market research and through continued close work with our strategic collaborations, we have a deep understanding of what is required to enable a well prepared and well supported COP360 experience. Lastly, but notably, we have been rapidly building the commercial organization in preparation for launch. This includes bringing an extremely experienced commercial leadership team that has collectively launched over 50 products. This level of experience is remarkable and we are privileged to have such an impressive team leading launch preparation for COMP360. COMP360 has the potential to fundamentally change the way that patients living with depression are cared for. A COMPASS is committed to helping as many patients as possible. With COMP360 expected to be first to market in a highly anticipated new class for mental health, COMPASS is at the forefront of shaping the future of psychiatric patient care. We are strongly positioned to successfully launch COMP360 and I look forward to updating you more on our progress. Thank you and let me hand the call back to Kabir for closing remarks.
Kabir Nath
Thank you Laurie. This is an incredibly exciting and defining time for patients and compass. We are confident in the rigor and robustness of our development program to demonstrate the benefit of COMP360. We have conducted our program to the highest standards which we believe must be paramount in this new field of psychedelic science. We now have data from three robust, well controlled clinical trials that enrolled over 1,000 participants, including over 800 from two successful pivotal phase three trials. I do want to underscore the difficulty of establishing efficacy in Treatment-Resistant Depression (TRD) with only two medicines ever having been approved. Despite multiple efforts that COMP360 has consistently demonstrated a clinically meaningful, rapid and durable effect and a generally safe and well tolerated profile is a remarkable achievement and one that promises to be a transformative new offering for those living with trd. I want to sincerely thank our investigators, trial site teams and most importantly the participants whose commitment and trust has made this progress possible. Thank you and let me now pass the call to the operator for Q and A.
OPERATOR
Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Your first question comes from the line of Andrew Tsai of Jefferies. Your line is open. Hi, good morning. Congrats on the great progress and the great news. I had two questions. The first one is, you know, based on your guys ongoing FDA discussions, has the FDA given you any inclination whether there will be an ADCOM or not for comp360? Because on one hand the review timelines could be really accelerated and you know, FDA does, but then FDA does seem to be doing away adcoms and then I can’t help but think that Lyco’s got one and maybe it could be prudent for the FDA to hold one. So I’d be curious to know what you guys, where you guys lean here. Thank you.
Kabir Nath
Thank you. Andrew, it’s Kabir. I’m just checking that you can hear us clearly. I can hear you. Yeah. Great, thanks. So, thank you. Yes. So it is the FDA’s decision and the FDA’s decision only around whether or not to hold an advisory committee. They will only make that determination once they see the totality of the data we’ve submitted. We will be prepared for one and that is in our planning if necessary. But at the moment we do not have an indication of whether or not that’s likely to happen.
Andrew Tsai (Equity Analyst)
Got it. And then secondly, when you share the 26-week Part B data from COMP360, the second one in early Q3, would you consider sharing a cut of the additional 26 week long Part C portion of the 005 study,, your first study in conjunction with that top line release? If not in early Q3, then can we expect maybe a cut before you’re possibly approved? I figure it’s open label and then sharing additional long term data could be helpful or important for pricing or labeling discussions..
Kabir Nath
So. Thanks Andrew. Yes. So I mean from a timing perspective you’re right that the 52 weeks of 005 clearly run in parallel with that. We haven’t made a final determination of what we’ll share at one point, but I hear you clearly in terms of the Value potentially for payers and for commercial purposes. So that’s a decision we will come to in due course.
Andrew Tsai (Equity Analyst)
Great, thank you. Thanks.
Francois Brisebois (Equity Analyst)
Your next question comes from the line of Francois Brisebois of LifeSci Capital LLC. Your line is open. Yep, thank you. Very well said on the. Francois. Yeah, that’s great. So just quickly here in terms of the third-quarter data for implications, can you help us understand maybe what the expectations are and you know, why is it still a gating factor to complete the filing based on the developments that have happened recently, I just want to kind of better understand what that data is and how important it is for launch here.
Kabir Nath
Thanks. And Francois, may I call you Frank, please. Frank is totally fine. Thanks. Thanks for the question, Frank. So, yeah, clearly and just for complete clarity, we had already aligned on our rolling submission plan with the FDA before the executive order and the award of the cmpv. So we had already fully aligned with the psychiatry division on what we were going to do and the timeframes in which we were going to do it. That hasn’t changed. And I think it’s really important to note that the CMPV potentially accelerates the end part of this process, the final review. But it’s been very clear in our discussions with the agency that in no way does it change the evidentiary basis needed for approval. So from our perspective, we remain on track with the filing strategy we laid out with a rolling submission, and that does Indeed include the 26 weeks of 06, which we see as significant in terms of really finalizing the profile and again for commercial purposes.
Francois Brisebois (Equity Analyst)
Okay, great. Thank you. And then can you give us a little more color on the reimbursement and maybe the CPT Category III codes where maybe the evolution of it. Is there anything else that we need from the CPT angle between now and approval and after. And then just a little more color on. There’s a lot of discussions about the support, the psychological support, and kind of the prep. And then, you know, maybe the amount of people that you would expect to be in a room and their qualifications. Just on the commercial side, you know, thoughts around those, those ideas. Thank you.
Kabir Nath
I’ll hand that question to Steve.
Steve Levine (Chief Patient Officer)
Thanks, Kabir. Hi, Frank. On the CPT portion of the question, in terms of the work remaining for the CPT Category III codes, they are in a Category 3 form at the moment, which is their tracking form. As those codes are reported more and they have started to be reported in a limited number of cases, it really will require our approval and launch for them to be reported in greater quantity. But as they’re reported, that will enable the American Medical association with their RUC (Relative Value Scale Update Committee), which is an acronym for the Relative Value Unit Update Committee with representation from American Psychiatric Association (APA), to do their work to understand the work involved in delivering this treatment and the practice expenses in order for them to …
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