-- COMP360 is the first classic psychedelic1 to consistently achieve a
highly statistically significant result and clinically meaningful effect
in treatment resistant depression (TRD), with a generally well-tolerated
and safe profile
-- Across three large trials in TRD, including two positive Phase 3
studies, COMP360's differentiated profile is redefining rapidity and
durability for TRD patients and demonstrating a consistent level of
clinical effect that has never been achieved before
-- Compass will meet with the FDA to confirm alignment on a rolling
submission and review, and expects to complete the NDA submission in Q4
-- Compass is rapidly advancing commercial readiness plans and expects
COMP360 will fit seamlessly across diverse healthcare settings at launch
-- Phase 2b/3 trial in PTSD initiating, following FDA acceptance of IND
application
-- Successful $150 million financing in February and exercise of $200
million in warrants extends cash runway into 2028
LONDON & NEW YORK--(BUSINESS WIRE)--March 24, 2026--
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported the fourth quarter and full-year 2025 financial results and business highlights.
"COMP360 is shaping the future of mental healthcare, and we are moving the field of psychiatric medicine forward for the millions of people urgently needing better options. As the potential first classic psychedelic approved by the FDA, COMP360 is redefining rapidity and durability with response as early as the day after dosing and lasting through at least 6 months with just one or two doses -- an unmatched clinical profile and important advancement for those living with TRD," said Kabir Nath, Chief Executive Officer of Compass Pathways. "We look forward to our upcoming FDA meeting to confirm our NDA submission strategy, and we continue to advance our commercial readiness to be launch-ready by the end of this year. We are also initiating our late-stage PTSD study, reinforcing our commitment to advancing innovative, science driven treatments for people facing the most challenging mental health conditions."
Business Highlights
COMP360 in Treatment Resistant Depression (TRD)
FDA approval pathway
-- Compass is scheduled to meet with the FDA to confirm the NDA submission
strategy, including a rolling submission and review
-- 26-week (Part B) data from COMP006 in early Q3 2026 is expected to be
the final dataset for NDA submission
-- Compass is rapidly advancing commercial readiness efforts to be
launch-ready by the end of 2026
COMP360's differentiated profile and commercial opportunity
-- Of the approximately 4 million2 TRD patients in the U.S., it is
estimated that fewer than 200,000 (5%) of patients3 receive an
FDA-approved treatment indicated for TRD
-- Across three robust late-stage clinical trials in more than 1,000
participants, COMP360 has consistently achieved highly statistically
significant results at the primary endpoint and demonstrated clinically
meaningful efficacy in a patient population that has historically been
failed by other treatment options
-- COMP360 has the potential to redefine rapidity and durability for
patients with TRD, offering a highly differentiated and transformative
clinical profile unlike any other treatment available for this patient
population today. As announced in February, the data demonstrate the
following:
-- Extremely rapid onset of action with reduction in depressive
symptoms as quickly as the day following administration at the
first measured timepoint
-- The first pivotal, placebo-controlled trial COMP005 demonstrated
extensive durability that lasts at least through 6 months after
only 1 or 2 administrations for those participants in the 25 mg
arm who achieved a clinically meaningful reduction in MADRS (>=
25%) at Week 6
-- A generally well-tolerated safety profile with a significant
majority of treatment-emergent adverse events (TEAEs) being mild
or moderate in severity, and the vast majority resolving within 24
hours
-- Compass' strategic collaborations are generating valuable insights into
future implementation opportunities for COMP360 within the current
infrastructure
-- COMP360 is expected to fit seamlessly across diverse healthcare
settings within the current infrastructure of over 7,300 centers4
offering multi hour treatments
-- Treatment centers are growing rapidly, and existing centers are
already scaling in anticipation of a COMP360 launch and additional
psychedelic treatments coming to market
-- COMP360 will potentially offer a highly differentiated, patient
friendly dosing schedule, compelling clinical profile and is
expected to be a blockbuster opportunity
COMP360 in Post Traumatic Stress Disorder (PTSD)
-- FDA accepts Investigational New Drug $(IND)$ Application for COMP360 for the treatment of post-traumatic stress disorder (PTSD), enabling initiation of Phase 2b/3 trial -- Previous Phase 2 open-label, safety and tolerability study in PTSD with 22 participants showed COMP360 is generally safe and well-tolerated, with no serious adverse events observed, and demonstrated both rapid and durable improvement in symptoms observed following a single administration of COMP360 out to 12 weeks. The results of this study were published in the September 2025 issue of the Journal of Psychopharmacology -- Affecting 13 million people in the U.S. each year, PTSD remains an underserved condition. There are currently only two FDA-approved medications for PTSD. This limited pharmacological landscape underscores the urgent need to advance care for patients experiencing this debilitating condition
Financial Highlights
-- Research and development expenses were $29.9 million for the three
months ended December 31, 2025, compared with $32.1 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
-- Research and development expenses were broadly stable at $118.4 million
for the year ended December 31, 2025, compared with $119.0 million during
the same period in 2024
-- General and administrative expenses were broadly stable at $16.0
million for the three months ended December 31, 2025, compared with $16.3
million during the same period in 2024
-- General and administrative expenses were $60.6 million for the year
ended December 31, 2025, compared with $59.2 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 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
-- Net loss for the three months ended December 31, 2025, was $93.9
million, or $1.00 net loss per share: basic and diluted, compared with
$43.3 million, or $0.63 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 $38.2 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 for the year ended December 31, 2025, was $287.9 million, or
$3.08 net loss per share: basic and diluted, compared with $155.1 million,
or $2.30 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
$122.6 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
-- Cash and cash equivalents were $149.6 million as of December 31, 2025,
compared with $165.1 million as of December 31, 2024
-- Debt was $31.6 million as of December 31, 2025, compared with $30.2
million as of December 31, 2024 (and $50.4 million as of March 24, 2026)
Financial Guidance
The cash position at March 24, 2026 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028.
About Compass Pathways
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