COMPASS Pathways Announces First Quarter 2023 Financial Results and Business Highlights

“Our phase 3 pivotal trials in treatment-resistant depression are now underway and on track, with treatment being administered to patients across numerous sites. This is significant progress, indicating that with the necessary approvals and licenses in place, these sites can now focus completely on training and recruitment. We have also made important progress in laying the commercial groundwork for COMP360, with the recent acceptance by the American Medical Association of a CPT III code to describe the support services required in its administration. It has been a quarter of steady, strong progress, including productive, ongoing dialogue about the design of our pivotal trials with FDA.”

Kabir Nath, Chief Executive Officer

• Phase 3 program underway, composed of two pivotal trials with an integrated, long-term outcomes component
  • Pivotal trial 1 (COMP 005): single dose monotherapy, n=255, top line data expected summer 2024
  • Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568, top line data expected mid-2025
  • Long-term follow up in each trial will generate data on duration of response and potential effect of retreatment
• As expected, FDA feedback received on the COMP 005 and COMP 006 trials and the phase 3 program is continuing in accordance with previously announced study design
• Current Procedural Terminology (CPT^®) III code for in-person support services during psychedelic therapy accepted by the American Medical Association – code expected to go into effect when published on January 1, 2024

• Phase 2 trials in anorexia nervosa and post-traumatic stress disorder (PTSD) ongoing
• Investigator-initiated studies ongoing across a number of additional indications

• Net loss for the three months ended 31 March 2023 was $24.2 million, or $0.57 loss per share (including non-cash share-based compensation expense of $4.1 million), compared with $21.2 million or $0.50 loss per share, during the same period in 2022 (including non-cash-share-based compensation expense of $3.1 million).
• R&D expenses were $19.0 million for the three months ended 31 March 2023, compared with $15.4 million during the same period in 2022. Of this increase, $1.4 million was attributable to an increase in external development expenses as the company continues to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. $1.2 million relates to an increase in personnel expenses, due to increased headcount. A further $0.6 million was attributable to an increase in other expenses primarily related to an increase in external consulting expenses. In addition, non-cash share-based payment compensation increased by $0.5 million, due primarily to increased headcount.
• G&A expenses were $12.8 million for the three months ended 31 March 2023 compared with $10.1 million during the same period in 2022. The increase was attributable to an increase of $2.2 million in personnel expenses, due to increased headcount. $0.9 million relates to an increase in facilities and other expenses. A further $0.5 million was attributable to an increase in non-cash share-based compensation, due primarily to increased headcount. This was partially offset by a decrease of $0.9 million in legal and professional fees.
• Cash and cash equivalents were $117.1 million as of 31 March 2023, compared with $143.2 million as of 31 December 2022.
• Additional $26.9 million net cash raised through ATM facility to date in the second quarter

• Second quarter 2023 net cash used in operating activities is expected to be in the range of $22 million to $30 million and the full-year 2023 to be in the range of $85 million to $110 million.