Connect with us

Psilocybin

COMPASS Pathways Announces Fourth Quarter and Year-End 2022 Financial Results and Business Highlights

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health,…

Published

on

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2022 and gave an update on recent progress across its business.

“During this past quarter, we commenced our COMP360 phase 3 pivotal program in treatment-resistant depression, a significant milestone for our area of science as these are the first ever phase 3 trials of psilocybin. We have also announced important updates to this program that accelerate the placebo-controlled trial pivotal data read out and streamline the long-term follow up as an integrated component of the pivotal trials. We are confident that this phase 3 program should generate the evidence to support a regulatory filing and to support broad patient access through integration into healthcare systems.”

Kabir Nath, Chief Executive Officer

Business highlights
COMP360 psilocybin therapy in treatment-resistant depression (TRD):

  • Phase 3 program underway, program 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
      • Updates to 005 accelerate data read out
    • Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568, top line data expected mid-2025
    • Long term outcome component includes a single 25 milligram retreatment option for all qualifying patients
  • Phase 2b trial published in The New England Journal of Medicine

Additional COMP360 development activities:

  • Phase 2 trials in anorexia nervosa and post-traumatic stress disorder (PTSD) ongoing
  • Investigator-initiated studies across numerous additional indications including:
    • Bipolar disorder type II: data presented at ACNP showing treatment was well tolerated with 12 of 14 patients in remission at three months following a single 25 milligram administration of COMP 360 psilocybin therapy, and no subject having manic or hypomanic symptoms or an increase in suicidal ideation
    • Anorexia nervosa: 6 of 10 participants in remission from Eating Disorder Psychopathology following a single 25 milligram administration of COMP 360, treatment was well tolerated and 9 of 10 participants endorsed the experience as meaningful and therapeutic; data presented at the Society of Biological Psychiatry annual meeting in April 2022.
    • Major depressive disorder in adults: data from the University of Zurich published in The Lancet in December. This randomized blinded study enrolled 52 patients, comparing a weight-based dose of COMP360 to true placebo, and demonstrated compelling efficacy results with no new safety signal.

Financial highlights

  • Net loss for the year ended 31 December 2022 was $91.5 million, or $2.16 loss per share (including non-cash share-based compensation expense of $13.1 million), compared with $71.7 million, or $1.79 loss per share, during the same period in 2021 (including non-cash share-based compensation expense of $8.6 million).
  • Net loss for the three months ended 31 December 2022 was $30.9 million, or $0.73 loss per share (including non-cash share-based compensation expense of $3.3 million), compared with $25.7 million, or $0.61 loss per share, during the same period in 2021 (including non-cash share-based compensation expense of $2.8 million).
  • Research and development (R&D) expenses were $65.1 million for the year ended 31 December 2022, compared with $44.0 million during the same period in 2021. Of this increase, $6.7 million relates to an increase in external development expenses as the Company continues to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. $6.1 million relates to an increase in personnel expenses, due to increased headcount. A further $5.4 million was attributable to increased other expenses primarily related to an increase in external consulting expenses. In addition, non-cash share-based compensation increased by $2.8 million, due to increased headcount.
  • R&D expenses were $19.8 million for the three months ended 31 December 2022, compared with $13.6 million during the same period in 2021. Of this increase, $2.7 million was attributable to an increase in other expenses, which primarily related to an increase in external consulting expenses. A further $2.3 million was attributable to an increase in external development expenses. Personnel expenses and non-cash share-based compensation increased by $1.0 million and $0.2 million respectively.
  • General and administrative (G&A) expenses were $45.4 million for the year ended 31 December 2022, compared with $39.2 million during the same period in 2021. The increase was attributable to an increase of $3.2 million in personnel expenses, due to increased headcount. A further $2.8 million and $1.7 million were attributable to legal and professional fees and non-cash share-based compensation respectively. The increases were offset by a decrease of $1.5 million in facilities and other expenses.
  • G&A expenses were $12.4 million for the three months ended 31 December 2022, compared with $14.7 million during the same period in 2021. The decrease was attributable to a decrease of $2.6 million and $1.0 million in facilities and other expenses and legal and professional fees respectively. This was partially offset by an increase of $1.0 million in personnel expenses and an increase of $0.3 million in non-cash share-based compensation expense, due to increased headcount.
  • Cash and cash equivalents were $143.2 million as of 31 December 2022, compared with $273.2 million as of 31 December 2021.

Financial Guidance

  • First quarter 2023 net cash used in operating activities is expected to be in the range of $24 million to $32 million and the full-year 2023 to be in the range of $85 million to $110 million.

Conference call
The COMPASS Pathways management team will host a conference call at 8.00am ET (1:00pm UK) on February 28, 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: Fourth Quarter and Year End 2022 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.

COMPASS PATHWAYS PLC
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)

COMPASS PATHWAYS PLC
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)

About COMPASS Pathways

COMPASS Pathways plc 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.

Read More

Trending