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| Statement |
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| In a sign of the continuing unmet need in TRD, esketamine sold under the brand name Spravato achieved global sales of almost $700 million in 2023, which demonstrates the continued growth of interventional psychiatry and the infrastructure to deliver it, which bode well for the potential of COMP360 if approved |
| While this is a small trial, we see the results as extremely promising |
| I'm pleased that we're seeing continued enthusiasm and meaningful momentum building for both COMPASS and its area of science |
| Patient demand is strong in all geographies, which as expected, reflects the degree of unmet need in this population |
| And with a strong balance sheet and an experienced team, we are well positioned for success |
| This is a good fit with our mission for the company |
| But clearly patients who have both depression and anxiety are probably the commonest phenotype around and we think that there will be an advantage in treating that population on the basis of their depressive symptoms, but incidentally treating their anxiety |
| Separately, we're also excited by the potential for COMP360 in other indications |
| They actually fit very well with their economics and offer an attractive route |
| So, it's encouraging to see early signal that COMP360 psilocybin may have potential to help those living with these depressive conditions |
| However, now that nearly all 005 sites are open and with the addition of resources, we will see an increased pace of recruitment, which should help improve enrolment |
| In closing, with our strong balance sheet, we are focused on execution of our Phase III program in treatment resistant depression |
| We were also pleased to see the publication of COMP360 data from an investigator-initiated study in bipolar type II in JAMA Psychiatry |
| Now that I'm back at sea level, I'm really happy to be joining you in this experience and pioneering leadership team |
| COMPASS continues to maintain a strong financial position with cash and cash equivalents of $220.2 million at December 31, 2023 compared with $143.2 million at December 31, 2022 |
| We announced initial safety data in December, which demonstrated that COMP360 was well tolerated up 24 hours and the safety profile was as expected with no treatment emergent serious adverse events recorded |
| So there's a great that's a tremendous difference from what we have to say for each day |
| Let me begin by thanking Mary-Rose Hughes, our Interim Chief Financial Officer, for her tremendous support over this last quarter |
| Welcome once again, and it's great to have you join our leadership team |
| We will continue to manage our cash carefully to continue advancing our pivotal programs and to achieve important milestones that we believe will create value for our shareholders |
| This will be an exciting year for COMPASS Pathways and we look forward to updating you on our progress over the coming year |
| Her broad experience through all stages of development is precisely the expertise and leadership that COMPASS required as we progress our Phase III program in treatment-resistant depression |
| It's great to work with you again |
| We're seeing increasing interest from clinicians who plan to incorporate psilocybin treatments into their mental health offerings |
| Teri brings to COMPASS deep extensive strategic experience working for publicly traded companies in the pharmaceutical and biotech sectors |
| These collaborations will explore how to improve the patient care experience and gain a better understanding of potential commercial models for the administration of COMP360 psilocybin treatments |
| In parallel with the Phase III trial program, we continue to take the steps needed to ensure a well-developed delivery network for COMP360 if approved |
| So, a big draw for me to the company was seeing COMPASS fully embracing its mission with a thoughtful, innovative and data driven approach to tackling significant unmet need in this area |
| There are a lot of important milestones over the next 12 to 18 months for the company |
| has proved to be difficult but not impossible and we're proceeding successfully to do that in the patients we are recruiting |
| Statement |
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| This has been a challenge that medical record keeping is decentralized in the U.S |
| What I will say is, in general, split indications are enormously challenging in my experience |
| However, as Kabir has said, we are experiencing delays in recruitment in our 005 trial |
| While our overall Phase III clinical program completion remains on track with top line data from 006 study expected in the middle of 2025, we are experiencing some recruitment delays in the 005 trial, which extends our guidance for top line data from that trial into Q4 of this year |
| I should say there's no shortage of patients, but the issues around verification have been real and that those are what have caused the problem |
| Kabir Nath I mean I think that the problem in the U.S |
| Similar to many, I sadly witnessed the impact of mental health issues on people close to me |
| If I could ask one follow-up, and that is, can you help us understand the screen failure rate if you're tracking that at all? But then also, are you having any challenges with washing patients out before of standard of care, albeit ineffective, antidepressants before they enter 005? Kabir Nath I mean, there are that represents -- the washout represents a challenge, but the most of the problem has been with the verification for diagnosis |
| and has slowed the pace of screening and enrolling |
| Do the logistical hurdles in the U.S |
| And the problems of 005 are really hard to do with the fact we started 005 first in U.S |
| The challenges we have encountered are specific to U.S |
| So it's just a delay and we think we've overcome some of the factors that contributed to it now |
| We did not see the onset of a manic, hypomanic or mixed state, which is a particular concern for patients with bipolar disorder |
| For the year ended December 31, 2023, net loss was $118.5 million or $2.32 per share compared with a net loss of $91.5 million or $2.16 per share during the same period in 2022 |
| We wish them well and I think it's clearly premature to see how they're thinking through commercial reimbursement |
| And just to emphasize, one of the issues that we face is that patients conceivably or patients -- people seeking treatment maybe seeking psychedelics and that's one of the reasons why we're particularly rigorous insisting on the medical records being proven and verifiable |
| But it's enrolment that has been the issue in 005 |
| However, as I mentioned already, the timing is uncertain |
| Guy Goodwin Yeah, I don't think that the track -- I mean as you heard the vendors that we hired are there because this is a general problem, it isn't just our problem |
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