Compass Pathways Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Highlights
LONDON & NEW YORK--( BUSINESS WIRE)--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.
Compass is rapidly advancing commercial readiness efforts to be launch-ready by the end of 2026.
“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
COMP360’s differentiated profile and commercial opportunity
COMP360 in Post Traumatic Stress Disorder (PTSD)
Financial Highlights
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
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
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time periods the release of data from Part B of the COMP006 Phase 3 trial for TRD; our expectations regarding discussions with the FDA, including discussions regarding potential NDA acceleration strategies, including potential for rolling NDA submission and review for COMP360 psilocybin treatment in TRD; our expectations regarding timing for our NDA submission; our expectations regarding potential commercial launch timelines and our commercial readiness; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our acceleration strategies for our NDA submission may not be successful; FDA may ultimately disagree with our proposal for a rolling NDA submission and may not permit us to utilize the rolling review process; our efforts to obtain marketing approval from FDA or regulatory authorities in any other jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof.
References
1. For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138
2. Data on file
3. Data on file
4. Data on file
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
COMPASS PATHWAYS PLC
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
149,608
$
165,081
Restricted cash
379
389
Prepaid expenses and other current assets
41,503
35,821
Total current assets
191,490
201,291
NON-CURRENT ASSETS:
Operating lease right-of-use assets
3,424
2,006
Deferred tax assets
3,751
3,774
Long-term prepaid expenses and other assets
11,684
6,595
Total assets
$
210,349
$
213,666
LIABILITIES AND SHAREHOLDERS' (DEFICIT)/EQUITY
CURRENT LIABILITIES:
Accounts payable
$
15,222
$
12,283
Accrued expenses and other liabilities
9,214
14,495
Debt, current portion
17,523
5,513
Operating lease liabilities - current
2,110
1,725
Warrant liabilities
203,726
—
Total current liabilities
247,795
34,016
NON-CURRENT LIABILITIES:
Debt, non-current portion
14,110
24,652
Operating lease liabilities - non-current
1,292
303
Total liabilities
263,197
58,971
SHAREHOLDERS' (DEFICIT)/EQUITY:
Ordinary shares, £0.008 par value; 96,085,785 and 68,552,215 shares authorized, issued and outstanding at December 31, 2025 and 2024, respectively
973
702
Additional paid-in capital
783,562
704,919
Accumulated other comprehensive loss
(14,789
)
(16,194
)
Accumulated deficit
(822,594
)
(534,732
)
Total shareholders' (deficit)/equity
(52,848
)
154,695
Total liabilities and shareholders' (deficit)/equity
$
210,349
$
213,666
COMPASS PATHWAYS PLC
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2025
2024
2025
2024
OPERATING EXPENSES:
Research and development
$
29,906
$
32,141
$
118,436
$
119,039
General and administrative
16,046
16,273
60,601
59,166
Total operating expenses
45,952
48,414
179,037
178,205
LOSS FROM OPERATIONS:
(45,952
)
(48,414
)
(179,037
)
(178,205
)
OTHER (EXPENSE) INCOME, NET:
Fair value change of warrant liabilities
(38,163
)
—
(122,561
)
—
(Expense) Benefit from R&D tax credit
(12,912
)
10,203
3,747
21,097
Interest income
1,310
1,623
7,182
8,268
Interest expense
(1,137
)
(1,132
)
(4,517
)
(4,479
)
Foreign exchange (losses) gains
(128
)
(4,926
)
3,471
(1,032
)
Other income
370
337
1,380
823
Total other (expense) income, net
(50,660
)
6,105
(111,298
)
24,677
Loss before income taxes
(96,612
)
(42,309
)
(290,335
)
(153,528
)
Income tax benefit (expense)
2,734
(1,023
)
2,473
(1,594
)
Net loss
$
(93,878
)
$
(43,332
)
$
(287,862
)
$
(155,122
)
Net loss per share attributable to ordinary shareholders—basic and diluted
$
(1.00
)
$
(0.63
)
$
(3.08
)
$
(2.30
)
Weighted average ordinary shares outstanding—basic and diluted
93,636,285
68,395,343
93,504,836
67,482,902
Net loss
$
(93,878
)
$
(43,332
)
$
(287,862
)
$
(155,122
)
Other comprehensive loss:
Foreign exchange translation adjustment
398
348
1,405
732
Comprehensive loss
$
(93,480
)
$
(42,984
)
$
(286,457
)
$
(154,390
)