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|Highlights: | | | | * COMP360 Phase 3 pivotal program ongoing with expanding European clinical | | sites | | * Secured up to $285 million private placement financing with $125 million | | upfront | | * Cash position at September 30, 2023 of $248.0 million | | * Conference call on November 2 at 8:00 am ET (12:00 pm UK) | +------------------------------------------------------------------------------+
LONDON, Nov. 02, 2023 (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 third quarter 2023 and provided an update on recent progress across its business.
Kabir Nath, Chief Executive Officer, said, "We continue to make progress in our COMP360 phase 3 program, most recently with the authorization to commence recruitment in a number of European clinical trial sites. Both phase 3 trials, COMP005 and COMP006, are on track, and we expect to have initial top-line data in less than a year for COMP005. We also expect to see top-line data in our phase 2 study in PTSD by the end of this year. The August financing, led by specialist biotech investors, provides a strong financial foundation that permits COMPASS to move forward confidently with our clinical programs, as well as all supporting studies for a potential new drug application filing with the FDA. We also continue to invest in our pre-commercial work to ensure we are prepared for a successful COMP360 launch, if approved."
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, topline data

        expected summer 2024
      * Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568,
        topline data expected mid-2025
      * Long-term follow up in each trial will generate data on duration of
        response and potential effect of retreatment
      * Both phase 3 trials ongoing and on track

Additional COMP360 development activities:

  * Phase 2 study in post-traumatic stress disorder (PTSD) top-line data
    expected by the end of 2023
  * Phase 2 study in anorexia nervosa ongoing
  * Publication of a paper in Psychopharmacology showing the potential of AI
    technologies to support investigational COMP360 psilocybin treatment in TRD

Team Updates

  * Daphne Karydas appointed to the COMPASS Board of Directors
  * Mary-Rose Hughes assumed the role of interim CFO after Mike Falvey
    departure; search for a permanent Chief Financial Officer commenced

Financial highlights
In August, COMPASS completed a private placement pursuant to which it issued and
sold to a select group of specialist biotech investors 16,076,750 American Depositary Shares ("ADSs") and warrants to purchase up to 16,076,750 ADSs (the "PIPE Warrants") at a purchase price of approximately $7.78 per ADS and accompanying warrant to purchase one ADS. At closing, COMPASS received $125 million in gross proceeds, before deducting placement agent commissions and offering expenses. COMPASS will receive up to an additional approximately $160 million in gross proceeds if the PIPE Warrants are fully exercised. The PIPE Warrants have an exercise price of $9.93 per ADS, which represented a 30%
premium to the last sale price prior to the financing, and will be exercisable at the election of the investors beginning in February 2024 for a three-year period.

  * Cash and cash equivalents were $248.0 million as of September 30, 2023,
    compared with $143.2 million as of December 31, 2022.
      * Runway lengthened to late 2025 through term loan facility, sales of
        shares under the At the Market ("ATM") facility and private placement
        transaction (the "PIPE)".
  * Long-term debt was $28.4 million as of September 30, 2023, compared with $0
    million as of December 31, 2022.
  * Received $116.9 million in net proceeds through our PIPE offering in third
    quarter.

* Net loss for the three months ended September 30, 2023 was $33.4 million, or $0.67 loss per share (including non-cash share-based compensation expense of $4.4 million), compared with $18.4 million, or $0.43 loss per share, during
the same period in 2022 (including non-cash-share-based compensation expense

    of $3.5 million).
  * Net loss for the nine months ended September 30, 2023 was $85.9 million, or

$1.81 loss per share (including non-cash share-based compensation expense of $13.1 million), compared with $60.6 million, or $1.43 loss per share, during the same period in 2022 (including non-cash-share-based compensation expense

    of $9.8 million).
  * Research and development (R&D) expenses were $21.5 million for the three

months ended September 30, 2023, compared with $14.0 million during the same

    period in 2022. Of this increase, $6.2 million related to an increase in
    external development expenses as we continue to investigate COMP360
    psilocybin treatment in clinical and pre-clinical trials. A further $1.7
    million and $0.4 million were attributable to personnel expenses and non-
    cash share-based compensation respectively, due to increased headcount.
    Other expenses decreased by $0.8 million, which primarily related to a
    decrease in external consulting fees.
  * R&D expenses were $60.4 million for the nine months ended September
    30, 2023, compared with $45.3 million during the same period in 2022. Of
    this increase, $10.4 million related to an increase in external development
    expenses as we continue to investigate COMP360 psilocybin treatment in
    clinical and pre-clinical trials. A further $4.7 million and $1.2 million
    were attributable to personnel expenses and non-cash share-based
    compensation respectively, due to increased headcount. Other expenses

decreased by $1.1 million, which primarily related to a decrease in external

    consulting fees.
  * General and administrative (G&A) expenses were $12.5 million for the three

months ended September 30, 2023, compared with $11.6 million during the same

    period in 2022. This was attributable to an increase of $1.1 million in
    facilities and other expenses and $0.6 million in non-cash share-based
    compensation, partially offset by a decrease of $0.2 million in personnel
    expenses, primarily due to reductions in travel and employee benefit
    expenses. There was a further decrease of $0.5 million in legal and
    professional fees.
  * G&A expenses were $38.1 million for the nine months ended September
    30, 2023, compared with $33.0 million during the same period in 2022. The

increase was attributable to an increase of $2.6 million and $2.1 million in personnel expenses and non-cash share-based compensation respectively. There

    was a further increase of $2.0 million in facilities and other expenses and
    a decrease of $1.5 million in legal and professional fees.

Financial Guidance
Fourth quarter 2023 net cash used in operating activities is expected to be in the range of $9 million to $15 million. This range includes the amount receivable in respect of the R&D tax credit in the UK, the timing for which is uncertain. We are adjusting the full-year 2023 cash burn guidance downward and expect net cash used in operating activities to be in the range of $79 million to $85 million, which assumes the R&D tax credit is received in full in the fourth quarter.
Conference call
The COMPASS Pathways management team will host a conference call at 8.00am ET (12:00pm UK) on November 2, 2023.
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: Third 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