* COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on

    track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial
    top-line data expected mid-2025
  * Compass announces positive phase 2 COMP360 data in post-traumatic stress
    disorder (PTSD)
  * Michael Gold to join Compass as Head of R&D
  * Compass enters into additional commercial collaborations, including with
    Reliant Medical Group, part of Optum Care
  * Cash position of $262.9 million at March 31, 2024
  * Conference call May 8 at 8:00 am ET (1:00 pm UK)

LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- 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 first quarter 2024 and provided an update on recent business progress.
Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and
limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in
PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial
data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."
Business highlights
COMP360 psilocybin treatment in treatment-resistant depression (TRD):

  * Phase 3 program ongoing, composed of two pivotal trials with an integrated,
    long-term outcomes component

* Pivotal trial 1 (COMP005): single dose monotherapy, n=255, top-line data

        expected Q4 2024
      * Pivotal trial 2 (COMP006): 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

* Additional research collaborations with Reliant Medical Group (a part of

        Optum Care), Mindful Health Solutions, and Journey Clinical launched to
        explore and develop multiple commercial delivery templates for COMP360
        psilocybin treatment, if approved

COMP360 psilocybin treatment in post-traumatic stress disorder (PTSD):

  * 22 patient, multi-center open label study, single administration of 25mg
    COMP360 with psychological support

* COMP360 was well tolerated with no treatment emergent serious adverse events

    reported
  * Early and durable change from baseline in CAPS-5 observed at week 4 (29.9
    points) and week 12 (29.5 points)
  * Improvement over time in Sheehan Disability Scale (SDS) measure of
    functional impairment over 12 weeks from a mean total score of 22.7 at
    baseline to a 11.7 point reduction at week 4 and a 14.4 point reduction at
    week 12
  * High and sustained rates of response and remission relative to baseline,
    with early onset of symptom improvement, accompanied by increasing
    functional improvement at 4 and 12 weeks
  * Based on results, Compass is exploring the optimal path forward for PTSD

Management update
* Michael Gold, MD, will join Compass as Chief Research and Development
Officer, effective May 20, 2024. Previously Chief Medical Officer at Neumora

    Therapeutics, Gold brings more than 25 years of experience across all
    aspects of drug development in neuroscience, with extensive therapeutic
    experience in neurological disorders and psychiatric disorders, including
    depression. Gold will work with Guy Goodwin, Compass's Chief Medical

Officer, to continue developing COMP360 in TRD and other indications, and to

    explore and advance other potential pipeline opportunities.
  * Trevor Mill, Chief Development Officer, will leave Compass to pursue other
    opportunities. Trevor led the development of the COMP360 program in TRD,
    launched programs in PTSD and anorexia nervosa, and was instrumental in
    guiding the exploration of additional early pipeline opportunities.

Financial highlights
* Net loss for the three months ended March 31, 2024, was $35.2 million, or
$0.55 loss per share (including non-cash share-based compensation expense of $5.1 million), compared with $24.2 million, or $0.57 loss per share, during
the same period in 2023 (including non-cash-share-based compensation expense

    of $4.1 million).
  * Research and development expenses were $24.9 million for the three months
    ended March 31, 2024, compared with $19.0 million during the same period in
    2023. The increase was primarily attributable to development expenses,

associated with advancing our COMP360 phase 3 clinical trials, and increased

    personnel expenses due to increased R&D headcount.
  * General and administrative expenses were $13.7 million for the three months
    ended March 31, 2024, compared with $12.8 million during the same period in
    2023. The increase was primarily attributable to increases in non-cash
    share-based compensation, and legal and professional fees.

* Cash and cash equivalents were $262.9 million as of March 31, 2024, compared

    with $220.2 million as of December 31, 2023.
  * Long term debt was $29.1 million as of March 31, 2024, compared with $28.8
    million as of December 31, 2023.
  * Additional $63.5 million net cash raised in first quarter 2024 through ATM
    facility and proceeds from exercise of warrants

Financial Guidance
Second quarter 2024 net cash used in operating activities is expected to be in the range of $32 million to $38 million. The full-year 2024 net cash used in operating activities is expected to be in the range of $110 million to $130 million and assumes the 2023 R&D tax credit is received in 4Q 2024. The cash position at March 31, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2026.
Conference call
The Compass Pathways management team will host a conference call at 8:00am ET
(1:00pm UK) on May 8, 2024. Please register in advance here
(https://ir.compasspathways.com/events/event-details/compass-pathways-first-
quarter-2024-investor-call) 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 2024 Financial Results (https://ir.compasspathways.com/news-
events/events). 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