Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Compass Pathways PLC (CMPS, Financial) has appointed new leaders with strong, relevant experience, including Lori Englebert as Chief Commercial Officer and Gino Santini as Chairman of the Board.
- Progress is being made on recruitment for the COMP360 Phase III trials, with a readout for the six-week primary endpoint expected by the end of the fourth quarter.
- The company maintains a strong financial position with cash and cash equivalents of $228.6 million as of June 30, 2024, and expects its cash runway to fund operations into 2026.
- Retention rates in the trials have been better than expected, indicating strong patient engagement and adherence.
- The company is confident that its pivotal program will meet FDA requirements for evaluating COMP360 treatment, based on the insights gained from the Lykos advisory committee meeting.
Negative Points
- Increased time and resources are needed to support clinical sites for recruitment, which may delay data readout into January.
- The issue of unblinding in trials remains a concern, as it could affect the integrity of the results.
- The company is spending significant resources on ensuring the highest level of quality in trials, which could impact financials.
- There is uncertainty around the impact of the Lykos AdCom proceedings on enrollment rates and placebo rates in the trials.
- The long-term follow-up data from the trials will not be available until several months after the primary endpoint data, delaying comprehensive insights into the treatment's durability.
Q & A Highlights
Q: Could you provide an update on the conduct of the ongoing 005 trial and the overall suicidality rate given the high background rate of suicides in the TRD population?
A: We recently had a DSMB meeting for both 005 and 006 trials, and the feedback was to continue the trials as planned with no changes to procedures. (Guy Goodwin, Chief Medical Officer)
Q: Have you seen any impact on your enrollment rates for 005 or 006 based on the AdCom proceedings?
A: There has been no suggestion that one trial influences another in terms of enrollment rates. We haven't received feedback from sites or patients indicating any impact on enrollment rates post-AdCom. (Guy Goodwin, Chief Medical Officer)
Q: Can you talk about how sites have been performing with respect to screen-in or screen-out periods and maintaining site quality?
A: We are continuing to recruit successfully into both 005 and 006. The additional resources for confirming TRD diagnosis have been helpful. We are in close touch with sites to ensure quality, and retention rates have been better than expected. (Kabir Nath, Chief Executive Officer; Guy Goodwin, Chief Medical Officer)
Q: What might be an acceptable amount of suicidal ideation in the TRD population, given that SSRIs have some elevated risk on the label?
A: Clinicians treating depressed patients live with suicidality as a core symptom. The key observation will be the differential rate between different arms of the study. We will have sufficient data to make a conclusion once the studies are completed. (Guy Goodwin, Chief Medical Officer)
Q: Do you plan to announce the completed enrollment in 005?
A: We haven't yet determined whether we will make that announcement. (Kabir Nath, Chief Executive Officer)
Q: Were there any surprises in the Lykos AdCom, and did it change the FDA's perspective?
A: There were no surprises in the AdCom. The issues discussed were anticipated, and there was no detectable change in the FDA's perspective. (Guy Goodwin, Chief Medical Officer)
Q: What are the key questions being asked in the 005 and 006 trials?
A: For 005, we aim to see separation from placebo and demonstrate safety. For 006, we hope to replicate the dose-response effect seen in Phase II and assess the impact of a second treatment on remission and response rates. Durability is also a key element. (Guy Goodwin, Chief Medical Officer; Kabir Nath, Chief Executive Officer)
Q: When might the longer-term follow-up data from 005 and 006 be communicated publicly?
A: We haven't specifically confirmed the dates, but you can project the additional five to six months of data collection. (Kabir Nath, Chief Executive Officer)
Q: What are the next steps and development plans for PTSD and bipolar disorder?
A: We are developing designs and protocols for PTSD, taking external advice. The current runway does not contemplate additional studies in PTSD. Bipolar disorder remains of interest but is a lower priority compared to PTSD. (Kabir Nath, Chief Executive Officer; Guy Goodwin, Chief Medical Officer)
Q: How is COMPASS ensuring that patients don't use other treatment modalities post-dosing in the Phase III trials?
A: We collect data on co-administration of other drugs throughout the follow-up phase. Patients commit to no subsequent use of psychedelics as part of the informed consent. (Guy Goodwin, Chief Medical Officer; Kabir Nath, Chief Executive Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
