• Cash Used in Operations (Q3 2024): $22.2 million, including a $13.6 million R&D tax credit.
• Adjusted Cash Used in Operations (Q3 2024): $35.8 million, excluding the R&D tax credit.
• Cash and Cash Equivalents (as of September 30, 2024): $207 million.
• Debt under Hercules Loan Facility (Q3 2024): $29.8 million.
• Q4 2024 Financial Guidance: Net cash used in operations expected to be between $37 and $43 million.
• Full Year 2024 Cash Guidance: Expected cash used in operations between $114 and $120 million.
• Workforce Reduction: Approximately 30% downsizing to preserve cash.
• Cash Runway: Expected to fund operations at least into 2026.

• Warning! GuruFocus has detected 2 Warning Sign with CMPS.

Release Date: October 31, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Compass Pathways PLC (NASDAQ:CMPS) has a strong executive team with the recent addition of Laurie Englebert, who brings valuable commercial experience.
• The company is making significant progress in preparing for the commercialization of COMP360, with strategic collaborations and health economics research underway.
• There is a high unmet need in the treatment-resistant depression (TRD) market, presenting a significant commercial opportunity for COMP360.
• The company has a robust financial position with $207 million in cash and cash equivalents, providing a runway into 2026.
• Compass Pathways PLC (NASDAQ:CMPS) is actively working to optimize patient flow and site efficiency, learning from both clinical trials and strategic collaborations.

Negative Points

• The anticipated disclosure of pivotal COMP360 trial data has been delayed to the second quarter of 2025, impacting timelines.
• The complexity of the phase three trials has led to recruitment challenges, affecting the speed of trial completion.
• The company is reducing its workforce by approximately 30% to preserve cash, which may impact employee morale and operations.
• There is uncertainty around the recruitment curve for the COMP006 trial, with data disclosure now expected in the second half of 2026.
• The company is de-prioritizing non-COMP360 preclinical efforts, which may limit future pipeline diversification.

Q & A Highlights

Q: Was your decision to move the business top line readout made after additional FDA correspondence or a face-to-face meeting? Do you foresee any other changes to trial operations and conduct? A: The decision was made by Compass out of an abundance of caution after observing the Lycos process. We continue to look at ways to accelerate the conduct of the 006 trial. - Kabir Nath, CEO

Q: How might the complexities in trial recruitment impact the real-world use of comp 360? A: Clinical trials are more onerous than commercial settings. We are learning from clinical sites and collaborations to optimize patient flow, which will be different in a commercial setting. - Lori Englebert, Chief Commercial Officer

Q: What has changed over the last six weeks regarding your regulatory strategy? A: Nothing about our regulatory strategy has changed. We still anticipate needing data from both 005 and 006 for a filing. - Kabir Nath, CEO

Q: How is your focus on non-TRD indications, including PTSD, impacted by these timeline delays? A: PTSD remains an area of interest, but advancing it is not in our current runway. We have plans but are not executing them at this time. - Kabir Nath, CEO

Q: What percentage of trial participants do you expect to have completed the 26 weeks at the time of the six-week data announcement for 005? A: We have always guided for releasing six-week data for 005. The designs of 005 and 006 are different, and our decision on 005 has not changed. - Kabir Nath, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.