LONDON, May 11, 2023 (GLOBE NEWSWIRE)
COMP360 Phase 3 pivotal program underway, patients have been treated in both trials
CPT® III code for in-person psychedelic therapy support accepted by the American Medical Association
Cash position at 31 March 2023 of $117.1 million, additional $26.9 million net cash raised through ATM facility to date in the second quarter
COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, reported its financial results for the first quarter 2023 and gave an update on recent progress across its business.
Kabir Nath, Chief Executive Officer, said, “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.”
COMP360 psilocybin therapy in treatment-resistant depression (TRD):
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
Additional COMP360 development activities:
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.
Conference callThe COMPASS Pathways management team will host a conference call at 8.00am ET (1:00pm UK) on May 11, 2023.Please register in advance here to access the call and obtain a local or toll-free phone number and personal pin.A live webcast of the call will be available on COMPASS Pathway’s website at: First Quarter 2023 Financial Results. The webcast will also be available on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days. The call will also be webcast on the COMPASS Pathways website and archived for 30 days. For more information, please visit the COMPASS Pathways website (ir.compasspathways.com).
About COMPASS PathwaysCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com
Availability of other information about COMPASS PathwaysInvestors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.