Compass Pathways Announces Fourth Quarter 2023 Financial Results and Business Highlights 

Published

LONDON, Feb. 29, 2024 (GLOBE NEWSWIRE) --

Highlights:
  • COMP360 phase 3 pivotal program ongoing; COMP005 trial top-line data now expected in fourth quarter 2024, COMP006 remains on track for top-line data in mid-2025
  • Teri Loxam to assume Chief Financial Officer role on March 1, 2024
  • Cash position of $220.2 million at December 31, 2023, additional $31.4 million net cash raised to date in first quarter 2024
  • Conference call February 29 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter 2023 and provided an update on recent progress across its business.

Kabir Nath, Chief Executive Officer, said, “We continue to progress our two phase 3 trials of COMP360 in treatment-resistant depression with top-line data expected this year and next. While our overall Phase 3 trial completion remains on track with the ‘006 study expected in mid-2025, we are experiencing some enrollment delays in the ‘005 trial, resulting in a slight delay to our guidance for that trial. In parallel, we are actively preparing for commercialization and have commenced a number of collaborations with mental health providers in the US to understand the patient care experience and to investigate models for the delivery of scalable COMP360 psilocybin treatment within various care settings, if approved by the FDA. We are also excited to provide a full data set from our phase 2 study in individuals living with post-traumatic stress disorder this Spring after an initial safety data readout late last year.”

Business highlights

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 in fourth quarter 2024
    • Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568, top-line data expected in mid-2025
    • Long-term follow-up in each trial will generate data on duration of response and potential effect of retreatment

Additional COMP360 development activities:

  • Research collaborations with Greenbrook TMS and Hackensack Meridian Health launched to explore and develop multiple potential commercial delivery templates for COMP360 psilocybin treatment if approved
  • Phase 2 study in patients with post-traumatic stress disorder (PTSD) initial safety data reported, COMP360 well tolerated, full data set expected in Spring 2024
  • Phase 2 study in anorexia nervosa ongoing
  • Publication of results of COMP360 treatment in bipolar II depression published in JAMA Psychiatry showing a significant number of patients experience relief from their bipolar II depression symptoms after a single 25mg dose of COMP360 psilocybin treatment

Leadership Update

  • Teri Loxam to start as Chief Financial Officer on March 1, 2024

Financial highlights

  • Net loss for the year ended December 31, 2023, was $118.5 million, or $2.32 loss per share (including non-cash share-based compensation expense of $17.3 million), compared with $91.5 million, or $2.16 loss per share, during the same period in 2022 (including non-cash-share-based compensation expense of $13.1 million).
  • Net loss for the three months ended December 31, 2023, was $32.5 million, or $0.53 loss per share (including non-cash share-based compensation expense of $4.2 million), compared with $30.9 million, or $0.73 loss per share, during the same period in 2022 (including non-cash-share-based compensation expense of $3.3 million).
  • Research and development (R&D) expenses were $87.5 million for the year ended December 31, 2023, compared with $65.1 million during the same period in 2022. Of this increase, $14.0 million related to an increase in external development expenses as we continue to investigate COMP360 psilocybin treatment in clinical trials and preclinical studies. A further $6.9 million and $1.6 million were attributable to personnel expenses and non-cash share-based compensation respectively, to support the expansion of the digital, preclinical and clinical teams in late 2022 and 2023. Other expenses increased by $0.1 million.
  • R&D expenses were $27.1 million for the three months ended December 31, 2023, compared with $19.8 million during the same period in 2022. Of this increase, $3.6 million related to an increase in external development expenses as we continue to investigate COMP360 psilocybin treatment in clinical trials and preclinical studies. A further $2.1 million was attributable to personnel expenses due to increased headcount.  Other expenses increased by $1.2 million, which primarily related to an increase in external consulting fees and non-cash share-based compensation increased by $0.4 million.
  • General and administrative (G&A) expenses were $49.4 million for the year ended December 31, 2023, compared with $45.4 million during the same period in 2022. The increase was partially attributable to an increase of $2.6 million in non-cash share-based compensation, with a further increase of $2.0 million and $1.0 million in facilities and other expenses and personnel expenses respectively. The increases were partially offset by a decrease of $1.6 million in legal and professional fees.
  • G&A expenses were $11.3 million for the three months ended December 31, 2023, compared with $12.4 million during the same period in 2022. This was attributable to a decrease of $1.5 million in personnel expenses, partially offset by an increase of $0.5 million in non-cash share-based compensation. There was a further decrease of $0.1 million in legal and professional fees.
  • Cash and cash equivalents were $220.2 million as of December 31, 2023, compared with $143.2 million as of December 31, 2022
  • Long term debt was $28.8 million as of December 31, 2023, compared with $0 million as of December 31, 2022
  • Additional $31.4 million net cash raised to date in first quarter of 2024

Financial GuidanceFirst quarter 2024 net cash used in operating activities is expected to be in the range of $17 million to $23 million. This range includes the amount receivable in respect of the 2022 R&D tax credit in the UK, confirmed by HMRC to be paid in full, but the timing for which is uncertain. The full-year 2024 net cash used in operating activities is expected to be in the range of $110 million to $130 million. The cash position at December 31, 2023, together with the net cash raised to date in the first quarter, is expected to be sufficient to fund operating expenses and capital expenditure requirements into late 2025.

Conference call The Compass Pathways management team will host a conference call at 8.00am ET (1:00pm UK) on February 29, 2024. 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 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 treatment, 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 treatment in TRD, the largest randomised, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p

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