LONDON, Feb. 29, 2024 (GLOBE NEWSWIRE) --
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|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 Guidance
First 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 (https://protect- us.mimecast.com/s/g5yaCADQM0I7o2P9c2HX-9?domain=register.vevent.com) 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 (https://protect- us.mimecast.com/s/KUNYCzpB7LFJB9yRfwIRjx?domain=edge.media-server.com). The webcast will also be available on the Investors section (https://ir.compasspathways.com/news-events/events) 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 Pathways
Compass 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 (pÂ