LONDON, Aug. 03, 2023 (GLOBE NEWSWIRE) --
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|Highlights: | | | | * COMP360 Phase 3 pivotal program ongoing and on track | | * CPT(®) III code for in-person psychedelic therapy support accepted by the | | American Medical Association | | * Cash position at June 30, 2023 of $148.2 million | | * Term loan facility up to $50 million secured | | * Conference call today 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, reported its financial results for the second quarter 2023 and gave an update on recent progress across its business.
Kabir Nath, Chief Executive Officer, said, "This has been another quarter of steady, strong progress across the business, including the continued execution of our COMP360 phase 3 trials in treatment-resistant depression, important progress in laying the commercial groundwork for COMP360 with the recent acceptance by the American Medical Association of a CPT III code to describe the
support services required during administration of psychedelic drugs, and the FDA's recently issued guidance on psychedelic drug development that represents an important validation of our area of science. Further, the cash received from the draw down from our debt facility with Hercules and sales of equity through our ATM program lengthened our cash runway significantly and allows us to continue to invest in our COMP360 development programs at full speed."
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
  * Current Procedural Terminology (CPT®) III code language for in-person

support services during psychedelic therapy approved by the American Medical Association and aligns with expected COMP360 treatment support requirements. Additional COMP360 development activities:
* Phase 2 trials in anorexia nervosa and post-traumatic stress disorder (PTSD) ongoing
* Investigator-initiated study data in depression in cancer patients following

    single dose of COMP360 psilocybin presented at ASCO 2023
  * Investigator-initiated study demonstrating the potential for COMP360
    psilocybin treatment in female patients with anorexia nervosa published in
    Nature Medicine
  * Opinion paper on the definition of "psychedelic-assisted psychotherapy"
    using psilocybin published in American Journal of Psychiatry
  * Data from an open-label study that suggest that the use of selective

serotonin reuptake inhibitor (SSRI) anti-depressants does not interfere with

    the potential therapeutic effect of COMP360 published in
    Neuropsychopharmacology

Financial highlights

  * Cash and cash equivalents were $148.2 million as of 30 June 2023, compared
    with $143.2 million as of 31 December 2022.
      * Runway lengthened through term loan facility and sales of shares under
        the At the Market ("ATM") facility
  * Long-term debt was $28.1 million as of 30 June 2023, compared with $0
    million as of 31 December 2022.
  * Received $26.9 million in net proceeds through our ATM facility in second
    quarter and entered into a term loan agreement with Hercules Capital,
    Inc. (NYSE: HTGC

(https://www.globenewswire.com/Tracker?data=IopYN4mhq8kSo65VpGOKFZQ5IlFcz3B7 7HI3IdBeUhXFkIPAqNcc3h_R8QrEzZb3UyT4Smgx1rHiFldcwDGEsSSfmzga2me0f0WOt1Ha6y39 kCvg6v7Vlv9v8wiBU3OI4otwHUxKvQVy5rKBbDlfwYIdIhYQkIOFcJrnw6BPVftqXOAfORh1CFKZ 0z92POxcCqyakesAdAHLPJKAaFS7ud0W6kqduAzILUB9j9BvzVJ68aI7WG46mL596Dy3WTw7zOSp

    cw4qIIcGfE4nx7unQLfON3-ZJ6mLn_dRem27h0yAyU5-E-
    Q65OziXD3mPkrNqzXL9NYPQhVoJXj08zlxwPJMgUT0wm-2ScKuVHJDD8Q=)) in June 2023
    for up to $50 million, with net proceeds after issuance costs of $28.8

million received in the second quarter. Total net cash provided by financing of $55.9 million in the second quarter.
* Net loss for the three months ended 30 June 2023 was $28.3 million, or $0.62

    loss per share (including non-cash share-based compensation expense of $4.6
    million), compared with $21.0 million, or $0.50 loss per share, during the
    same period in 2022 (including non-cash-share-based compensation expense of
    $3.2 million).
  * Net loss for the six months ended 30 June 2023 was $52.5 million, or $1.19
    loss per share (including non-cash share-based compensation expense of $8.6
    million), compared with $42.2 million, or $1.00 loss per share, during the
    same period in 2022 (including non-cash-share-based compensation expense of
    $6.3 million).
  * Research and development (R&D) expenses were $19.8 million for the three
    months ended 30 June 2023, compared with $15.9 million during the same
    period in 2022. Of this increase, $2.7 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 $1.8
    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 $1.0 million, which primarily related to a
    decrease in external consulting expenses.
  * R&D expenses were $38.9 million for the six months ended 30 June 2023,
    compared with $31.3 million during the same period in 2022. Of this
    increase, $4.1 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 $3.0 million and $0.8 million
    were attributable to personnel expenses and non-cash share-based
    compensation respectively, due to increased headcount. Other expenses

decreased by $0.3 million, which primarily related to a decrease in external

    consulting expenses.
  * General and administrative (G&A) expenses were $12.8 million for the three
    months ended 30 June 2023, compared with $11.3 million during the same

period in 2022. The increase was attributable to an increase of $1.0 million and $0.5 million in non-cash share-based compensation and personnel expenses

    respectively, due to increased headcount. There was a further increase of
    less than $0.1 million in facilities and other expenses and a decrease of
    $0.1 million in legal and professional fees.
  * G&A expenses were $25.6 million for the six months ended 30 June 2023,

compared with $21.4 million during the same period in 2022. The increase was

    attributable to an increase of $2.8 million and $1.5 million in personnel
    expenses and non-cash share-based compensation respectively, due to
    increased headcount. There was a further increase of $0.9 million in
    facilities and other expenses and a decrease of $1.0 million in legal and
    professional fees.

Financial Guidance
Third quarter 2023 net cash (provided by)/used in operating activities is expected to be in the range of ($2 million) to $18 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 expect the full-year 2023 net cash used in operating activities to be in the range of $80 million to $90 million.
Conference call
The COMPASS Pathways management team will host a conference call at 8.00am ET (1:00pm UK) on August (3), 2023.
Please register in advance here (https://register.vevent.com/register/BI4b7b60ee092744a2a1bb4f1aadc06a38) 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: Second Quarter 2023 Financial Results (https://edge.media- server.com/mmc/p/nqex7duv). 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 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