Q2 2025 COMPASS Pathways PLC Earnings Call
If you'd like to ask a question during that time. Please press star followed by one on your telephone keypad. Thank you I'd now like to hand, the call over to Steven Schwartz Senior Vice President of Investor Relations. You May now go ahead. Please.
Welcome all of you and thank you for joining us today for our second quarter 'twenty twenty-five results conference call.
Again, my name is Steve Schultz Senior Vice President of Investor Relations at Compass pathways.
Today I'm joined by Kabir Nath, our Chief Executive Officer, and Terry Lux, and our Chief Financial Officer, who will have prepared remarks.
In addition, Dr Guide Goodwin, our Chief Medical Officer, Dr. Steve Levine, our Chief patient Officer, and Lori Engelberg, our chief commercial officer will 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.
<unk>, we begin let me remind everyone that during the call today the team will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095 as amended you should not place undue reliance on these forward looking statements.
Actual events or results could differ materially from those expressed or implied in any forward looking statements. As a result of various risks uncertainties and other factors, including those risks and uncertainties described under the heading risk factors in our most recent quarterly report on Form 10-Q filed with the U S security.
He's an exchange commission and in subsequent filings made by Compass with the SEC.
Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date we.
We specifically disclaim any obligation to update or revise any forward looking statements, even if our estimates or assumptions change.
I will now hand, the call over to <unk>. Thank.
Thank you Steve.
Good day, everyone and thank you for joining us.
Let me begin by welcoming Justin go over to the Compass Board of directors.
Justin was the CEO and one of the founders of GW Pharmaceuticals, and we're truly excited to have access to his expertise.
Under Justin's leadership at the dialects. The first cannabis plant derived medicine to be approved by the FDA had a successful commercial launch.
Look forward to leveraging his expertise as we embark on a similar path to gain FDA approval and launched 360 for TRT.
In addition to announcing the addition of Justin to the board earlier this week.
We announced the Doctor Linda Mcgoldrick will be retiring from the board at the end of October after a transition period.
I'd like to thank Linda for her service on the board over the last five years.
She was instrumental in supporting the growth of the company through the IPO and subsequent developments.
Turning now to our operations. This has been an exciting quarter for compass.
In late June we announced the successful achievement of the primary endpoint of the 365 trial. The first about two pivotal phase III trials.
Positive results were highly statistically significant demonstrating a clinically meaningful reduction in depression and no unexpected safety findings based on the latest data reviewed by the independent the SMB.
This assessment included all data reviewed by the SMB to date from both the <unk> six trials going beyond the six week time point.
Five below.
There was a three six point difference in change from baseline in mattress between the 25 milligram and the placebo arms at six weeks.
Exceeding the three point difference that is both clinically meaningful and commercially viable.
While cross trial comparisons are always challenging this difference sustained to six weeks with a single administration of <unk> 360 is similar to the different seen at four weeks and the pivotal trials for the blockbuster drugs for boto rich required eight administrations.
We believe the result that we have seen it six weeks with cop 360 is both clinically and commercially compelling.
With this positive data compass has delivered to put two announcing positive highly statistically significant results from two robust late stage studies of over 230 patients each and a very difficult to treat patient population in depression.
Given the track record of previous studies in psychiatry, particularly in severe depression, our achievement of two positive late stage studies is remarkable.
Provides important clinical validation for <unk> treatment potential in CRD.
We plan to meet with the FDA to discuss these results and exploring next steps in getting comp 360 to patients as rapidly as possible patients.
Patients, who so desperately need new treatment options.
Second pivotal phase III trial com or six continues to recruit well and we confirm that we're on track to disclose the 26 week data in the second half of next year.
As a reminder, the protocol for this trial has a second dose after three weeks with a six week primary endpoint assessment. Therefore, only three weeks after the second administration.
We should also get some good information on the effects of a second dose as part of the 26 week <unk> five data.
On that subject to specific re treatment criteria participants can get another dose in part B, which runs from the six week time point through 26 weeks.
To prepare for a potential commercial launch our team continues to work with a broad array of mental health care providers, both through our strategic collaborations and through our field medical team to refine our understanding of how comp 360 treatments will fit into existing settings of care.
We are frequently asked by investors how come 360 will be viewed by providers, who we used to the approximately three hours per bartow treatment window.
Through our discussions with these providers, we know the patient preference will be a driving factor and treatment selection.
As you're well aware has provided patients need to be driven to the clinic frequently which is a burden for the patient and caregiver and generally they're not able to return to work that day.
In addition, we believe that the added administrative burden and the work required to turn a room potentially multiple times may actually favor comp 360, <unk> from a practice standpoint.
Finally, the CPT three code specific to psychedelics that were put in place back in early 2024 provide for hourly reimbursement so regardless of the length of the administration for country sector. The provider will be covered Steve.
Stephen Laurie can go into much more detail on all of this.
Beyond <unk>. We're also excited about the potential for 360 in PTSD.
We're in the final steps of designing a late stage clinical program in PTSD and we look forward to updating you when that design is finalized and once we have reviewed it with the FDA.
Given the high unmet need and limited current treatment options, we see a significant commercial opportunity in PTSD.
In addition, as you know we had been running a small phase II study and anorexia.
This was a double blind randomized controlled phase II clinical trial investigating the safety and efficacy of cop 360, psilocybin treatments in participants with anorexia nervosa.
It was a multicenter study, which enrolled 32 participants with.
The study has now completed and we recently received the data.
From an efficacy standpoint that was an encouraging positive signal and the reduction of eating disorder in depressive symptoms in the 25 milligram arm, which was sustained through 12 weeks.
However, the low overall numbers of participants at the high number of dropouts in the control arm limited statistical power.
The safety profile was aligned with the high risk patient population and anorexia and no unexpected safety signals were reported.
As we've discussed before this is a difficult condition to study we're proud of the data that we've been able to generate and we will.
Published will present, the full dataset in future.
With that let me now hand, the call to Terry to go through some financial updates before we move on to Q&A.
Thank you it could be air at the end of June we had cash and cash equivalents of 222 million, which we expect to fund our operations into 2027.
This compares with $260 million that we had at the end of the first quarter.
Debt under the Hercules loan facility with $30 9 million at the end of the second quarter.
Cash used in operations for the second quarter was $38 7 million and we expect net cash used in operations for the full year 2025 can be within the range of $120 million to $145 million.
We're energized by the positive Oh, five primary resolved, which we believe has derisked the company from a regulatory and commercial perspective and.
And we look forward to the upcoming 26 week data from both phase III trials.
We are finalizing a PTSD study and look forward to updating you soon on that design and timeline.
2025 has already been an important year for the company and the remainder of this year and 2020 is shaping up to be even more exciting.
We are heads down focused on continuing to execute on our pivotal program, while exploring all opportunities to get concrete 60 to patients suffering from hard to treat depression and PTSD as quickly as possible.
As mentioned in the beginning of the call. Dr Guide Goodwin, Dr. Steve Levine and Lori Inglebert will also be available for Q&A.
Thank you and I'll now turn the call over to the operator for Q&A.
Now opening the floor for a question and answer session. If you'd like to ask a question. Please press star followed by one on your telephone Keypad next five followed by one on your telephone keypad to your first question comes from the line of Paul Mckenna Keith.
Your line is now open.
Hey, good morning. Thanks.
Thanks for taking my question I was curious if you could expand upon the engagement you've had with the FDA.
Since the data.
What do you think the scenarios that you could have an accelerated path for filing and scenarios I guess.
You actually can move quickly enough, where the second phase III study would read out.
Before you submit during the review I guess like is there a real way to actually move ahead of that data or are we going to ultimately of course that that data before there's any sort of regulatory decision in any scenario. Thank you.
Thanks, very much Paul it's goodbye and just checking you can hear me clearly.
Yes. Thank you.
Thanks, Bill so thank you for the question. So as we've said we have requested and we will be meeting with the FDA in this quarter.
As we said on the call. We are two for two now in treatment resistant depression. So the phase <unk> with over 230 patients. This phase III with the primary endpoint data 250 patients and importantly, consistent data across the trials, while the to be of course the <unk>.
Mary endpoint was at three weeks as you know at six weeks, we did see a statistically significant difference and actually it's a pretty similar difference to what we've seen here in the phase III. So we are two for two we believe in a very hard to treat patient population one in urgent need of new interventions.
So to your point it clearly is the right thing to off load accelerated pathways may be available and Thats exactly what we are planning to do.
I would note at this stage going to handicap, the chances and obviously, we need to have that meeting with the agency in quarter, three and see what their view is we're obviously encouraged by the fact that there are other leaders within the administration more broadly who seem to share all of you in the central and share our views of that ground to move.
This more quickly, but in terms of specifically, which elements of our five or whether part of over six will be needed that really depends on discussions with the agency.
Just on your last comment there.
Understanding your question meeting and meet the folks.
Psychiatry division are there plans or expectations, neither engaging with others that are more senior at the FDA or within HHS as well.
Yes.
Got it go into the details of those but yes, absolutely we recognize that this needs to be.
Could a concerted approach using whatever levers, we can but I might just ask Laurie to comment on some of the work we have been doing around a broader engagement with stakeholders not just in the administration, but actually in the political environment as well because we recognize that sports are a critical part of this.
Yes, Thanks, <unk> and Hi, Paul.
So obviously, we are very encouraged by statements that have been made by secretary Kennedy as well as the commissioner. They escalate your stated they are very clearly.
Yes, dealing psychedelics as a potential to treat these patients who have otherwise.
Limited option.
Yes, we've seen that through examples of them appointing Matt.
Good morning, Mike Davis, It seems all very positive for the industry in and of itself.
We also have been spending quite a bit of time in D. C. As the potential first to market.
Company and psychedelic space to find.
Take it very seriously that we want to make sure that everyone is.
Well educated.
And forms and so we are spending quite a bit of time, there and what we're finding is that members of Congress are also highly receptive not only to the VA sector, which of course.
No.
They care very much about and it gets a lot of commentary but also.
For the broader patient population that we are encouraged by the conversations that we're having and continue to want to continue our efforts there.
One thing I Should've said and to add you'll be aware that last week. The formal application process for the commission is national priority review voucher or the one that promises a very accelerated timeline open. So we have submitted our application for that alone I'm sure with many other companies, but we did do that as well.
Yeah.
Okay very good mentioned, taking the questions.
Sure.
Your next question comes from the line of Patrick Twitchell.
H C Wainwright your line.
Awesome.
Hello. Good morning, this is Alicia for Patrick.
We'd like to ask a little bit on the.
Collaborations. This opinion collaborations that you are putting in place for the interventional psychiatry treatment centers how are they progressing what feedback have you received about readiness for accomplished 60 delivery is approved and how confident that's the.
Listing network of centers that you've already engaged with will support the delivery of 360 triples. Thank you so much.
Lisa and I will pass to Steve to answer that.
Hi, Louise Thanks for the question, Yes, we have been engaged in the work with these collaborations for the past couple of years. As a reminder, they are representative of the broad swath of sites that mental health care delivery in this country, including hospital system intervention Psychiatry networks community behavioral health and others.
And what we're finding in this work and as a reminder, some of them deliver provider today.
And those that you are highly representative of the 6000 centers that are currently delivering provider around the country.
And one thing is abundantly clear that this work is reinforcing our conviction that <unk> hundred 60, if approved fits directly into the infrastructure that is delivering <unk> provided today.
If you look at it is to provide a room it looks like what is necessary for comp 360. The staffing of these centers is what we believe will be required to deliver $3 60.
And so we are we are very confident that the network is ready if and when we get approval and even if that approval has accelerated it is weighted.
Thank you.
Our next question comes from the line of Gavin Gartner Evercore ISI. Your line is now open.
Hey, guys congrats on the progress and thanks for taking the question.
First I was just curious if you've seen a pickup in Ohio six enrollment following the <unk> five data and then secondly, just following off of your last point on the commercial side of things do you have an estimate for what percent of <unk> is given in a single room for some kind of group room settings, where multiple people can be monitored at the same time.
Thank you.
Thanks, Kevin So I'll take the first one so.
Oh five data has been viewed very positively by investigators known anti IL five and six we're now in that kind of the really steep ascent.
The Olympics recruitment and it's going extremely well, which is why we are able to reconfirm our guidance the data in the second half of next year, but yes, I would say in general the reception from investigators to the data has been very positive.
Of course, I believe in the potential of <unk> six.
The derisking, both from a clinical and regulatory perspective.
Steve So the second question.
Hi, Kevin regarding your question about whether it's provided was currently delivered an individual rooms versus in group settings. It is primarily an individual rooms and that is another reason why we believe that infrastructure is in place there is.
The likelihood that as these products mature in the market and they are commonly delivered sites may look at various models to deliver them, but again currently today, it's primarily individual rooms, and ready to deliver cop 361 available.
Question comes from the mining of the tube.
TD Cowen Your line is now open.
Hi, guys. Thanks for taking my question. This is Dan Hansen on for the Cooper all.
Are you guys pursuing the commissioners national priority voucher and what is your understanding of the criteria to meet eligibility. Thank you.
Yes, I did actually just confirm that in an earlier question. We did submit our application. We also do as part of our briefing book for the meeting with the FDA raised that question.
In terms of the criteria.
Believe our five priorities listed.
And they include significantly aid public health crisis, both of which we clearly.
Innovative treatments also there are also ones around manufacturing and global pricing, which are less relevant to us but it is clear that the criteria that would expect a company to hit all five of those and we believe on three of them. We very clearly ticks those boxes. It also requires you to be ready to start submitting element. So the filing package when we clear.
We are in terms of CMC and some of our preclinical and some were in very good shape with that so we think we're a great candidate we recognize that there are in theory only five pilots that we would take in food.
We also recognize that the decisions were due to be made by the CMO, but it appears that the CMO at the FDA is currently a vacant position Hasnt Monday night.
Of the processes.
Don't know, but we believe we absolutely meet the criteria and that's why we've submitted.
Understood. Thanks again.
Yeah.
Next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.
Yeah, Hi, Thanks for taking the question just following up on kind of your commentary regarding interactions with the agency and it seems like there is some high level connectivity, but are you able to comment on consistency of interaction with kind of mid and lower level members at the agency just just curious.
If theres been consistency within team makeup.
And in the teams that you were talking to you. Thank you.
Thanks, Peter and nice to meet you and the answer is absolutely so.
As a reminder, we have breakthrough designation and as we've always said we have consistently had excellent engagement with the Psychiatry Division currently we see no change to either stopping the level of engagement the responsiveness and so on so.
Day to day level with the FDA we remain.
Very tightly aligned with our good relationships with no changes.
Thanks.
Churn comes from the line of will you need cash.
No.
VC capital markets. Your line is now open.
Hey, guys. Thanks for taking my question I had one on safety, especially as it relates to read those things. So I guess, how are you guys thinking about the risk.
It's modality or any elevations in suicidal ideation.
I think that after that kind of craft with every dose of comfort 60 or potentially reduce the placebo or is it just something that occurs after the first dose on the study I guess do you have any data that you.
With respect to that and then Relatedly I know in the interactive study you said there were no unexpected safety signals I Wonder if you could just talk a little bit more about what you saw in terms of safety from the interactive study, especially on fidelity.
Thanks, Leah and I will pass the guy in a moment, but first just as we've always said the statement. We made last month from the SMB did refer to old data they were seen to date from both or.
So including the study.
Second does it but let me hand to guys are more of a broader.
Broader discussion about guide base.
Yes.
I think we have to be a bit weak.
Don't have the detail on the time course of the suicide RFP that is being seen in 00006, what we know is that there is no imbalance between the arms. So I can't really comment on directly to your question, except to sort of be reassuring about the fact that there isn't to clear.
The effect of the drug this much more likely to be an effect of the illness and that will depend obviously on how people have responded and how the response is maintained so.
We will certainly have all that information in due course, but not at the moment.
It's a good question about the anorexia group. This was a small study remember, but it was clear that we saw higher rates of suicidology than we are used to see just measured as events in that group.
That was true in both the arm receiving one milligram and the arm receiving 25 milligrams. So again, we had no imbalance between the arms, but higher overall rates, reflecting the fact that it's.
It's a more dangerous condition from the point of view of mortality. It has the highest mortality of any psychiatric disorder and suicide is one of the leading causes along with the physical problems of patients also encountered so the safe relative safety of our treatment in this high risk group is again a reassuring.
Thing really for the whole program.
Okay.
Next question comes from the line of two months.
<unk> of Canaccord Genuity. Your line is now open.
Thanks for taking our questions.
What is the earliest that you could find a new drug application for complete 60, and how should we think about when you might announce a timeline for reporting from.
From the comparable five trial, and then I will follow up.
Thanks, so much so.
Again I'll refer you to my earlier answer until we've met with the agency, it's premature to speculate on exactly what that could be because we really need to reach alignment on what days that they would like to see.
Process for that.
As we have said before we will in due course announce full enrollment of six <unk>.
When we do that will be deployed into which we can all look at all Canada project forward because as a reminder, we have said.
26 weeks of <unk> five coffee about five we will only release once all patients all through cost.
Six in order to avoid any potential suggestion that there is a compound between those two.
Got it and how long is the process to submit an application for the commission is piloting a new program in terms of any trial data necessity and is that any safety related efficacy our durability data in that application on a briefing book that investors have not seen yet.
So in terms of what was required to submit for it. It's a 350 worth abstract so I could safely say that there was no data included Atlanta and again I think as we're all aware it's unclear what the selection criteria are actually going to be for the pilots.
No to confirm I mean, we have no more phase III data.
<unk> is out in the public domain and that we have already released.
Yeah.
Thanks.
I'd now like to hand back the call over to the management for final remarks.
Thank you very much so thanks, everyone for your attention this morning.
We're excited about the progress we have made and the progress we're continuing to make we've delivered to positive late stage studies in treatment resistant depression, which is remarkable.
Likely a unique achievements with that we're also very encouraged by the signals. We are hearing from within the administration on more broadly about them sharing our belief in the potential for these transformative treatments for patients who have so few options and we're committed to working with the appropriate regulatory and administration.
Authority to see what we can do to advance <unk> 360 for treatment resistant depression in.
In addition, we will be in vehicles announcing the design of the PTSD study I think particularly with recent events again at the agency. It's very clear that there is an urgent need for new treatments for PTSD and we're excited to move comp 360 food in that as well. So thanks again for your attention. This morning, I wish everyone a good day.
This concludes today's call you may now disconnect Goodbye.