-- Company accelerating commercialization readiness plans by 9-12 months,
following completion of COMP006 trial enrollment and positive meeting
with FDA on NDA submission strategies for COMP360 in TRD, including
potential rolling submission
-- Company now plans to disclose 9-week data (Part A) from COMP006
together with 26-week data (Part B) from COMP005 in Q1 2026
-- Disclosure of 26-week (Part B) COMP006 data expected in early Q3 2026
-- Cash position of $185.9 million as of September 30, 2025
-- Conference call on November 4 at 8 am ET (1 pm UK)
LONDON & NEW YORK--(BUSINESS WIRE)--November 04, 2025--
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2025 and provided an update on recent progress across its business.
"With the completion of COMP006 enrollment and our recent positive discussions with the FDA, we are excited about pulling forward our expected launch timing for COMP360 in TRD by 9-12 months," said Kabir Nath, Chief Executive Officer at Compass Pathways. "We are accelerating commercial launch plans to match this new expected timeline with the goal of advancing our mission of transforming the mental health landscape and how patients living with depression are treated."
Business Highlights
COMP360 psilocybin treatment in TRD (Treatment Resistant Depression)
-- Second Phase 3 trial, COMP006, has completed enrollment (n=585)
-- In June 2025, we announced achievement of the 6-week primary endpoint
in the first of two phase 3 studies (COMP005), where a single
administration of COMP360 demonstrated a highly statistically significant
and clinically meaningful reduction in symptom severity at six weeks and
no unexpected safety findings
-- Positive Type B meeting with the FDA in September 2025 to discuss the
Company's NDA submission strategy for COMP360 in TRD and potential
acceleration scenarios, including rolling submission
-- Second phase 3 trial (COMP006) 9-week (Part A) data and COMP005 26-week
(Part B) data are expected in Q1 2026
-- 26-week (Part B) data from COMP006 is expected in early Q3 2026
COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder)
-- Late-stage clinical trial design being finalized taking FDA comments
into consideration
-- Phase 2 open label 12-week safety and tolerability study (n=22) in PTSD
announced in May 2024, showed COMP360 was generally well tolerated and
demonstrated both rapid and durable improvement in symptoms from baseline
observed following a single administration
-- Phase 2 PTSD findings published in the September 2025 issue of Journal
of Psychopharmacology
Board of Directors Update
-- Dr. Jeffrey Jonas, who brings three decades of leadership experience in
psychiatry and biotech, appointed to the Compass Pathways Board of
Directors
-- Thomas Lönngren will retire from his position on the Board at the
end of December after more than 6 years of service
Financial Highlights
-- Research and development expenses were $27.3 million for the three
months ended September 30, 2025, compared with $32.9 million during the
same period in 2024. The decrease was primarily attributable to a
decrease in development expenses related to the termination of our
discovery programs associated with the reorganization that took place in
the fourth quarter of 2024 and a decrease in non-cash share-based
compensation expenses due to decreased staffing levels associated with
the reorganization that took place in the fourth quarter of 2024.
-- Research and development expenses were $88.5 million for the nine
months ended September 30, 2025, compared with $86.9 million during the
same period in 2024. The increase was primarily attributable to
development expenses associated with advancing our late-stage COMP360
phase 3 clinical trials partially offset by decreased personnel and
non-cash share-based compensation expenses due to decreased staffing
levels associated with the reorganization that took place in the fourth
quarter of 2024.
-- General and administrative expenses were $13.2 million for the three
months ended September 30, 2025, compared with $15.0 million during the
same period in 2024. The decrease was primarily attributable to a
decrease in personnel and non-cash share-based compensation expenses due
to decreased staffing levels associated with the reorganization that took
place in the fourth quarter of 2024 as well as decreased facilities and
other expenses as a result of lower insurance premiums and banking fees.
-- General and administrative expenses were $44.6 million for the nine
months ended September 30, 2025, compared with $42.9 million during the
same period in 2024. The increase was primarily attributable to an
increase in legal and professional fees primarily due to issuance costs
related to our January 2025 Financing as well as expenses associated with
consulting, accounting and legal advice, partially offset by decreased
facilities and other expenses as a result of lower insurance premiums and
banking fees as well as decreased personnel expenses due to decreased
staffing levels associated with the reorganization that took place in the
fourth quarter of 2024.
-- Net loss for the three months ended September 30, 2025, was $137.7
million, or $1.44 net loss per share: basic and diluted, compared with
$38.5 million, or $0.56 loss per share basic and diluted, during the same
period in 2024. The increase in net loss for the quarter was primarily
driven by a $101.3 million non-cash loss on fair value adjustment related
to our warrant liabilities, compared with $0.0 million during the same
period in 2024. As the fair value of the warrants fluctuates with our
share price and other market inputs, this adjustment can result in
significant variability in our reported net loss. Net loss also includes
non-cash shared-based compensation of $3.2 million for the three months
ended September 30,2025 compared with $5.0 million for the same period in
2024.
-- Net loss for the nine months ended September 30, 2025, was $194.0
million, or $2.09 net loss per share: basic and diluted, compared with
$111.8 million, or $1.67 loss per share basic and diluted, during the
same period in 2024. The increase in net loss for the period was
primarily driven by a $84.4 million non-cash gain on fair value
adjustment related to our warrant liabilities, compared with $0.0 million
during the same period in 2024. As the fair value of the warrants
fluctuates with our share price and other market inputs, this adjustment
can result in significant variability in our reported net loss. Net loss
also includes non-cash share-based compensation of $10.7 million for the
nine months ended September 30, 2025 compared with $15.0 million for the
same period in 2024.
-- Cash and cash equivalents were $185.9 million as of September 30, 2025,
compared with $165.1 million as of December 31, 2024.
-- Debt was $31.3 million as of September 30, 2025, compared with $30.2
million as of December 31, 2024.
Financial Guidance
Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. This range includes the amount receivable in respect of the R&D tax credit in the UK, the timing for which is uncertain. The cash position at September 30, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2027.
Conference Call
The management team will host a conference call at 8:00 am ET (1:00 pm UK) on November 4, 2025. A live webcast of the call will be available on the Compass Pathways website at https://events.q4inc.com/attendee/698442687
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
Forward-looking statements
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