• Cash Used in Operations: $119.2 million for the full year 2024, within the guidance range of $114 million to $120 million.
• Net Loss: $155.1 million or $2.30 per share for the year ended December 31, 2024, compared to $118.5 million or $2.32 per share in 2023.
• Non-Cash Share-Based Compensation: $19.5 million in 2024, up from $17.3 million in 2023.
• R&D Expenses: $119 million in 2024, compared to $87.5 million in 2023.
• G&A Expenses: $59.2 million in 2024, compared to $49.4 million in 2023.
• Debt: $30.2 million under the Hercules loan facility at the end of Q4 2024.
• Cash and Cash Equivalents: $165.1 million as of December 31, 2024.
• Recent Financing: Net proceeds of approximately $140 million in January 2025.
• 2025 Financial Guidance: Expected net cash used in operations to be within the range of $120 million to $145 million.

• Warning! GuruFocus has detected 1 Warning Sign with CMPS.

Release Date: February 27, 2025

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

Positive Points

• Compass Pathways PLC (NASDAQ:CMPS) has secured financing that positions the company to complete the COMP360 program in treatment-resistant depression (TRD) and progress the PTSD development program.
• The company has recruited over 90% of patients for the 005 trial, indicating strong progress towards completing enrollment.
• Compass Pathways PLC (NASDAQ:CMPS) is on track to report top-line results from the 005 trial in the second quarter of 2025, providing key efficacy measures.
• The recent financing provides a financial runway to fund operations through the planned 26-week data readout from the COMP006 study, expected in the second half of 2026.
• Strategic collaborations with healthcare delivery organizations are providing valuable insights into care settings, aiding in the strategy for launch and post-launch scaling.

Negative Points

• The company reported a net loss of $155.1 million for the year ended December 31, 2024, compared to a net loss of $118.5 million in 2023.
• Research and development expenses increased significantly to $119 million in 2024 from $87.5 million in the prior year.
• General and administrative expenses also rose to $59.2 million in 2024 from $49.4 million in the previous year.
• The company has debt under the Hercules loan facility amounting to $30.2 million at the end of the fourth quarter.
• There is uncertainty regarding the regulatory path and the specific requirements for the PTSD program, as discussions with the FDA are ongoing.

Q & A Highlights

Q: What is the expected benchmark for the six-week Madras delta in the COMP005 trial? A: Kabir Nath, CEO, stated that the phase 2B six-week data is being used as a benchmark for the phase three studies. The clinically meaningful effect size is lower, but the phase 2B data serves as a guide for planning the phase three trials.

Q: Can you provide details on what will be disclosed in the top line for the COMP005 readout? A: Kabir Nath, CEO, explained that the top line will include the Madras effect size difference between the arms, the P value, and confidence intervals. From a safety perspective, a statement from the DSMB will be included, particularly regarding any imbalance in suicidal ideation.

Q: How is the patient disposition and demographic shaping up in the COMP005 trial? A: Guy Goodwin, Chief Medical Officer, mentioned that while they are not looking at detailed breakdowns as the trial progresses, the number of patients in washout suggests a similar number to the phase two trial. Detailed statistics on comorbidities and drug use are not being monitored during the trial.

Q: What are the plans for the PTSD development program, and how does it compare to other indications like bipolar disorder? A: Kabir Nath, CEO, highlighted that PTSD is prioritized due to the unmet need and encouraging phase 2A results. Guy Goodwin, CMO, added that they are considering various scenarios for development and will seek FDA guidance. PTSD is prioritized over other indications like bipolar disorder due to its complexity and unmet need.

Q: How does the company view the potential competition from other psychedelic compounds with shorter clinic times? A: Steve Levine, Chief Patient Officer, emphasized that decision-making by healthcare providers will consider the economic viability of treatments. The company has secured CPT codes for psychedelic treatments, which will be reimbursed based on the duration of administration, making the treatment economically viable regardless of length.

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