STOCK TITAN

Compass Pathways (CMPS) gains Q1 profit, boosts cash to $466M and speeds COMP360 NDA

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Compass Pathways reported a strong start to 2026, combining major regulatory progress for its COMP360 psilocybin treatment in treatment-resistant depression with a sharp improvement in reported results. The FDA granted a rolling New Drug Application submission and review, which is already underway, and a Commissioner’s National Priority Voucher that may shorten review timelines.

Part B 26-week data from the COMP006 Phase 3 trial are expected in early Q3 2026, with final NDA submission still targeted for Q4 and launch readiness by year-end. Cash and cash equivalents rose to $466.0 million as of March 31, 2026, supporting a runway into 2028. For the quarter, research and development expenses were $26.5 million and general and administrative expenses were $16.4 million, while a non-cash $130.9 million warrant fair value gain drove net income of $91.2 million versus a prior-year net loss.

Positive

  • Regulatory acceleration for COMP360: Rolling NDA submission is underway and a Commissioner’s National Priority Voucher has been awarded, supporting the company’s plan to complete filing in Q4 2026 and potentially shorten FDA review timelines.
  • Strengthened cash position and runway: Cash and cash equivalents increased to $466.0 million as of March 31, 2026, and management expects this to fund operating and capital needs into 2028, reducing near-term financing risk during the transition toward potential commercialization.

Negative

  • None.

Insights

Regulatory acceleration for COMP360 plus a fortified balance sheet mark a pivotal quarter.

Compass Pathways advanced COMP360 in treatment-resistant depression with an FDA-accepted rolling NDA and a Commissioner’s National Priority Voucher. These tools can concentrate review into a shorter window once the filing is complete, aligning with a planned Q4 2026 final submission.

The company expects 26-week Part B data from the COMP006 Phase 3 trial in early Q3 2026, an important confirmation step for durability of effect. Commercial preparations are underway, with plans to be launch-ready by year-end and to leverage more than 7,300 multi-hour treatment centers already in place.

Financially, cash and cash equivalents of $466.0 million at March 31, 2026 and guidance that this funds operations into 2028 reduce near-term financing pressure. Net income of $91.2 million in Q1 2026 is driven largely by a non-cash $130.9 million warrant fair value gain, so ongoing operating performance still depends on managing R&D and commercial build-out as regulatory milestones and launch timing unfold.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash and cash equivalents $466.0 million As of March 31, 2026; funds operations into 2028
Net income $91.2 million Three months ended March 31, 2026
Non-cash warrant fair value gain $130.9 million Q1 2026 other income from warrant liabilities
Research and development expense $26.5 million Three months ended March 31, 2026
General and administrative expense $16.4 million Three months ended March 31, 2026
Total assets $531.7 million Balance sheet as of March 31, 2026
Total debt $50.5 million As of March 31, 2026
Treatment centers cited Over 7,300 centers Existing multi-hour treatment centers suitable for COMP360
rolling New Drug Application (NDA) submission regulatory
"NDA rolling submission underway"
Commissioner’s National Priority Voucher (CNPV) regulatory
"CNPV awarded for COMP360, Compass’ proprietary formulation"
treatment-resistant depression (TRD) medical
"COMP360 in TRD, further accelerating momentum"
Treatment-resistant depression (TRD) is a form of major depression that does not improve after trying two or more standard therapies such as common antidepressants or talk therapy; think of it as a lock that doesn’t open with the usual keys. It matters to investors because patients with TRD represent a large, unmet medical need that drives demand for new drugs and devices, but developing effective treatments often involves longer, riskier and more expensive clinical testing and regulatory review — which can mean bigger potential rewards and bigger risks.
warrant liabilities financial
"Warrant liabilities | 131,882 | | | 203,726"
Warrant liabilities are the financial obligations a company records when it grants warrants—special rights allowing someone to buy shares at a set price in the future. If the warrants are expected to be exercised, they are treated as a liability because the company might need to deliver shares or cash later. This matters to investors because it affects the company’s reported financial health and the potential dilution of existing shares.
Breakthrough Therapy designation regulatory
"COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
Net income $91.2 million
Research and development expense $26.5 million
General and administrative expense $16.4 million
Cash and cash equivalents $466.0 million
Guidance

Current cash position is expected to fund operating expenses and capital expenditure requirements into 2028.

false000181659000018165902026-05-132026-05-13

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 13, 2026
COMPASS PATHWAYS PLC
(Exact Name of Registrant as Specified in Its Charter)
England and Wales001-39522Not applicable
(State or other Jurisdiction of Incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)

33 Broadwick Street
London W1F 0DQ
United Kingdom
(Address of Principal Executive Offices; Zip Code)
+1 (716) 676-6461
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:

Title of each class 
Trading
Symbol(s)
 Name of each exchange on which registered
American Depositary Shares, each representing one ordinary share, nominal value £0.008 per share CMPS The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 




Item 2.02Results of Operation and Financial Condition

On May 13, 2026, COMPASS Pathways plc (the “Company”) issued a press release announcing the Company's financial results for the three months ended March 31, 2026. A copy of this press release is furnished herewith as Exhibit 99.1.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01Financial Statements and Exhibits.
(d)Exhibits.
The following exhibits are filed herewith:
Exhibit No.Description
99.1
Press Release dated May 13, 2026
104Cover page interactive data file (embedded within Inline XBRL document)




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
COMPASS PATHWAYS PLC
Date: May 13, 2026By:/s/ Teri Loxam
Teri Loxam
Chief Financial Officer






compasspicture.jpg

Compass Pathways Announces First Quarter 2026 Financial Results and Business Highlights
FDA granted Compass NDA rolling submission and review request, based on strength of Phase 3 data

CNPV awarded for COMP360 in TRD, further accelerating momentum

26-week (Part B) data from COMP006, expected in early Q3 2026

Final NDA submission on track for Q4, aligned with Company’s previously defined accelerated timing to be launch ready by end of year

Successful financing and warrant exercises resulted in strong cash position of $466 million at end of first quarter, providing cash runway well beyond launch and into 2028

LONDON & NEW YORK, May 13, 2026
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported first quarter 2026 financial results and business highlights.

“With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today. Its transformative clinical profile has the potential to change what patients can expect in terms of both rapid and durable relief, and we are ready to deliver for those who have waited far too long for better options.”

Business Highlights

Accelerated regulatory path
Approval timelines are tracking to Compass’ fastest projected expectations, supported by regulatory acceleration including a rolling New Drug Application (NDA) submission and the Commissioner’s National Priority Review Voucher (CNPV).
NDA rolling submission underway:
oFDA granted Compass NDA rolling submission and review request, based on strength of positive Phase 3 data.
oRolling submission and review are underway, with sections of the NDA already submitted.
o26-week (Part B) data from COMP006, expected in early Q3 2026.
oThe final NDA submission remains on track for Q4, aligned with the Company’s previously defined accelerated timing.












Post-NDA filing momentum:
oCNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin for TRD, which has the potential to accelerate filing review time to be completed within 1-2 months.
oWhite House Executive Order on psychedelics treatments directs the Drug Enforcement Administration (DEA) to initiate and complete review of psychedelic treatment that has successfully completed Phase 3 trials so that rescheduling may proceed as quickly as possible.
Advancing toward commercial launch
Launch readiness:
oCompass will be launch ready by the end of the year and has assembled a highly experienced commercial leadership team.
oThe team is advancing comprehensive launch preparedness efforts, including KOL and HCP education, payer engagement, and ongoing initiatives to support a timely federal and state rescheduling process.
Delivery infrastructure readiness:
oCOMP360 is expected to fit seamlessly across diverse healthcare settings within the current infrastructure of over 7,300 centers1 offering multi-hour treatments
oTreatment centers are growing rapidly, and existing centers are already scaling in anticipation of a COMP360 launch and additional multi-hour psychedelic treatments coming to market.

COMP360’s transformative clinical profile
COMP360 has the potential to offer a highly differentiated, transformative clinical profile and is expected to be a blockbuster opportunity.
COMP360 is the first classic psychedelic2 to consistently achieve a highly statistically significant result and clinically meaningful effect in 3 large late-stage trials involving more than 1,000 participants living with TRD, with a generally well-tolerated and safe profile.
COMP360 demonstrates effects as quickly as within one day after administration with durability lasting at least through 6 months for those who achieve a clinically meaningful response after one or two doses.

Financial Highlights
Research and development expenses were $26.5 million for the three months ended March 31, 2026, compared with $30.9 million during the same period in 2025. The decrease was primarily driven by lower development expenses, reflecting reduced clinical trial costs as our Phase 3 program for COMP360 psilocybin therapy in TRD progresses toward completion, as well reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the related contract terminations in 2025.









General and administrative expenses were $16.4 million for the three months ended March 31, 2026, compared with $18.7 million during the same period in 2025. The decrease was primarily due to lower legal and professional fees, driven by higher financing-related costs in 2025, including those associated with warrant issuances, which were expensed as incurred, whereas a greater portion of such costs in 2026 were capitalized. This decrease was partially offset by increased consulting and legal advisory expenses.
Net income for the three months ended March 31, 2026, was $91.2 million, or $0.71 net income per share (basic) and $0.30 net loss per share (diluted), compared with a net loss of $17.9 million, or $0.20 net loss per share (basic) and $0.24 net loss per share (diluted), during the same period in 2025. The increase in net income was primarily driven by a $130.9 million non-cash gain on fair value adjustment related to our warrants, compared with $19.5 million during the same period in 2025. As the fair value of the warrants fluctuates with our share price, this adjustment can result in significant variability in our reported net income or net loss.
Cash and cash equivalents were $466.0 million as of March 31, 2026, compared with $149.6 million as of December 31, 2025.
Debt was $50.5 million as of March 31, 2026, compared with $31.6 million as of December 31, 2025.

Financial Guidance
The current cash position 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 for the release of data from Part B of the COMP006 Phase 3 trial for TRD; any implication that past results will be predictive of future results; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our expectations regarding potential commercial launch timelines and our commercial readiness; our efforts and 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; that the rolling review process and/or the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, 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.Data on file
2.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

Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324









COMPASS PATHWAYS PLC
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
March 31,December 31,
20262025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$466,010 $149,608 
Restricted cash379 379 
Prepaid expenses and other current assets44,478 41,503 
Total current assets510,867 191,490 
NON-CURRENT ASSETS:
Operating lease right-of-use assets2,861 3,424 
Deferred tax assets4,098 3,751 
Long-term prepaid expenses and other assets13,913 11,684 
Total assets$531,739 $210,349 
LIABILITIES AND SHAREHOLDERS' EQUITY/(DEFICIT)
CURRENT LIABILITIES:
Accounts payable$10,877 $15,222 
Accrued expenses and other liabilities8,984 9,214 
Debt, current portion
— 17,523 
Operating lease liabilities - current2,054 2,110 
Warrant liabilities
131,882 203,726 
Total current liabilities153,797 247,795 
NON-CURRENT LIABILITIES:
Debt, non-current portion
50,476 14,110 
Operating lease liabilities - non-current779 1,292 
Total liabilities$205,052 $263,197 
SHAREHOLDERS' EQUITY/(DEFICIT):
Ordinary shares, £0.008 par value; 134,923,295 and 96,085,785 shares authorized, issued and outstanding at March 31, 2026 and December 31, 2025, respectively1,393 973 
Additional paid-in capital1,071,481 783,562 
Accumulated other comprehensive loss(14,795)(14,789)
Accumulated deficit(731,392)(822,594)
Total shareholders' equity/(deficit)326,687 (52,848)
Total liabilities and shareholders' equity/(deficit)$531,739 $210,349 






COMPASS PATHWAYS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)

Three Months ended March 31,
20262025
OPERATING EXPENSES:
Research and development$26,480 $30,880 
General and administrative16,424 18,736 
Total operating expenses
42,904 49,616 
Loss from operations:(42,904)(49,616)
OTHER INCOME (EXPENSE), NET:
Fair value change of warrant liabilities
130,916 19,460 
Benefit from R&D tax credit2,477 8,448 
Interest income2,419 2,386 
Interest expense(1,465)(1,124)
Foreign exchange (losses) gains
(736)2,133 
Other income
484 803 
Total other income, net134,095 32,106 
Income (loss) before income taxes91,191 (17,510)
Income tax benefit (expense)
11 (354)
Net income (loss)$91,202 $(17,864)
Net income (loss) per share attributable to ordinary shareholders: basic$0.71 $(0.20)
Weighted average ordinary shares outstanding: basic110,064,58189,192,252
Net loss per share attributable to ordinary shareholders: diluted$(0.30)$(0.24)
Weighted average ordinary shares outstanding: diluted
130,266,69398,642
Net income (loss)$91,202 $(17,864)
Other comprehensive income (loss):
Foreign exchange translation adjustment(6)(117)
Comprehensive income (loss)$91,196 $(17,981)




        

FAQ

What key regulatory milestones did Compass Pathways (CMPS) achieve in Q1 2026?

Compass secured FDA agreement for a rolling NDA submission and review for COMP360 in treatment-resistant depression and received a Commissioner’s National Priority Voucher. These steps may help concentrate the FDA review period once the NDA is fully submitted, supporting the company’s accelerated approval timeline.

What is Compass Pathways’ cash position and runway after Q1 2026?

Compass reported cash and cash equivalents of $466.0 million as of March 31, 2026. Management expects this cash balance to cover operating expenses and capital expenditures into 2028, supporting ongoing Phase 3 activities, regulatory work, and commercial launch preparations for COMP360 if approved.

How did Compass Pathways’ profitability change in the first quarter of 2026?

Compass reported net income of $91.2 million for the three months ended March 31, 2026, versus a net loss of $17.9 million a year earlier. The swing primarily reflects a $130.9 million non-cash gain from fair value changes in warrant liabilities, which can make results volatile quarter to quarter.

What were Compass Pathways’ R&D and G&A expenses in Q1 2026?

Research and development expenses were $26.5 million and general and administrative expenses were $16.4 million for Q1 2026. Both categories declined versus the same quarter in 2025, mainly due to lower clinical and financing-related costs, partially offset by higher consulting and legal advisory expenses.

When does Compass Pathways expect key COMP360 Phase 3 data and NDA completion?

The company expects 26-week Part B data from the COMP006 Phase 3 trial in early Q3 2026. It continues to target final submission of the COMP360 NDA for treatment-resistant depression in Q4 2026, consistent with plans to be launch-ready by the end of the year if approval is obtained.

How much debt does Compass Pathways have following the first quarter of 2026?

Compass reported total debt of $50.5 million as of March 31, 2026, up from $31.6 million at December 31, 2025. This debt level is modest relative to total assets of $531.7 million and the company’s reported cash and cash equivalents of $466.0 million.

Filing Exhibits & Attachments

4 documents