Compass Pathways scores first Phase 3 win in TRD with COMP360 psilocybin

Rhea-AI Filing Summary

Compass Pathways plc (CMPS) filed an 8-K to disclose that its pivotal Phase 3 COMP005 study met its primary endpoint in treatment-resistant depression (TRD). In the randomized, double-blind trial (n = 258 across 32 U.S. sites), a single 25 mg dose of COMP360 psilocybin produced a statistically significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores versus placebo at week 6 (mean difference −3.6 points; 95% CI [−5.7, −1.5]; p < 0.001). Safety, reviewed by the independent DSMB on 19 June 2025, was consistent with prior studies and showed no new or unexpected adverse signals, including suicidality.

COMP005 has three parts, with Parts A (through week 6) now unblinded, Part B blinded to week 26, and Part C open-label through week 52. The parallel COMP006 trial (planned n = 568) compares two fixed dosing regimens and remains blinded. The company expects to release 26-week data for COMP005 after all COMP006 participants complete Part A; 26-week COMP006 data are targeted for H2 2026.

The positive read-out strengthens CMPS’s regulatory pathway, but the FDA has not yet reviewed the data, full safety assessments are pending, and additional capital will likely be required to complete development and pursue commercialization. Forward-looking statements highlight clinical, regulatory, and financing risks.

Positive

• Primary endpoint met in pivotal Phase 3 COMP005 with p < 0.001, materially increasing regulatory probability of success.
• No new safety concerns reported by DSMB, reducing perceived psychedelic risk profile.
• Large, multi-site randomized design (258 patients, 32 U.S. centers) enhances data credibility and external validity.

Negative

• Only 6-week data; durability through 26 and 52 weeks remains unknown.
• Regulatory approval still contingent on positive COMP006 results and FDA review.
• High cash burn implies likely future equity raises, creating dilution risk for shareholders.

Insights

Biotech Clinical-Trials Analyst

TL;DR: First Phase 3 win in TRD is clinically meaningful; de-risks program but regulatory and funding hurdles remain.

Efficacy: A −3.6 MADRS difference with p < 0.001 in a 258-patient, placebo-controlled trial is robust; effect size is within the 2–4-point range often viewed as clinically important in depression registrational studies.
Safety: DSMB confirmation of no new safety issues, specifically suicidality, removes a key FDA concern with psychedelics.
Regulatory Pathway: With one positive pivotal trial, CMPS now needs a confirmatory COMP006 win; FDA typically requires two adequate and well-controlled studies. The single-dose design of COMP005 also complements the multiple-dose arm in COMP006, potentially strengthening labeling discussions.
Valuation Impact: Probability-of-success for COMP360 in TRD should rise materially (e.g., from ~30 % to ~50 % in many DCF models), providing potential multi-hundred-million-dollar uplift to NPV.
Risks: Full 26-week durability data are not yet available; any attenuation could temper payer uptake. Cash burn remains high; additional equity or partnership financing is probable in 2025-26.

Portfolio Risk Manager

TL;DR: Event is positive but still preliminary; execution, cash, and regulatory timing drive risk-reward.

Impact to shares is likely favorable near-term given scarcity of late-stage psychedelic assets. However, catalysts gap until COMP006 read-outs (H2 2026) could re-introduce volatility. Cash runway (~$200 m at last report) covers < 18 months of operations; equity dilution risk is high. FDA could request additional safety data, notably on cardiovascular and psychiatric adverse events, extending timelines. Position sizing should reflect binary regulatory outcomes and liquidity constraints.

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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): June 23, 2025

COMPASS PATHWAYS PLC

(Exact Name of Registrant as Specified in Its Charter)

England and Wales			001-39522			Not 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 8.01 Other Events.

Compass Pathways plc (the “Company”) announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of p<0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The Company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA) which has not yet reviewed the data.

Key COMP005 Findings:

•Efficacy Data (MADRS): Single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points, 95% CI[ -5.7, -1.5]; p<0.001

•Safety Data (statement dated June 19, 2025 provided by the DSMB chair): Based on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study.

The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD).

The ongoing COMP005 trial is a randomized, double-blinded, placebo-controlled study, which has dosed 258 participants with moderate-to-severe depression across 32 sites in the United States and aims to assess the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD. The trial is comprised of three parts: Part A - which has recently concluded – and was blinded through 6 weeks; Part B, which remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.

The COMP006 trial, running in parallel to COMP005, is a randomized, double-blinded study with 568 planned participants from North America and Europe and aims to compare the safety and efficacy of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360. The trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52.

Compass Pathways anticipates sharing 26-week data for COMP005 once all participants in the COMP006 trial have completed part A of the COMP006 trial. The 26-week data from COMP006 is expected in the second half of 2026.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Any statements, other than statements of historical fact, including statements regarding the Company’s plans and expectations regarding the Company’s Phase 3 trials in TRD, including the Company’s expectations regarding the time periods during which the 26-week results of the two Phase 3 trials will become available; the potential for the pivotal Phase 3 program in TRD to support regulatory filings and approvals; any implication that past results will be predictive of future results; and any other statements containing the words “expects,” “anticipates,” “plans,” and similar expressions, are forward-looking statements. These forward-looking statements are based on the Company’s current intentions, beliefs and expectations regarding future events. The Company cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from the Company’s expectations, including uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore the Company’s clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from this Phase 3 study in TRD or the results and safety data from the Company’s second Phase 3 study in TRD,

COMP006, may not be consistent with the preliminary results to date; the Company’s need for substantial additional funding to achieve its business goals and if the Company is unable to obtain this funding when needed and on acceptable terms, the Company could be forced to delay, limit or terminate its clinical trials; the Company’s efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for the Company’s investigational COMP360 psilocybin treatment may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports the Company has filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this Form 8-K, and, except as required by law, the Company does not undertake to update any forward-looking statement to reflect new information, events or circumstances.

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: June 23, 2025

By:

/s/ Teri Loxam

Teri Loxam

Chief Financial Officer

FAQ

What did Compass Pathways (CMPS) announce in its 8-K?

The company reported that Phase 3 trial COMP005 met its primary MADRS endpoint with a statistically significant −3.6 point benefit at week 6.

How significant was the COMP005 efficacy result for CMPS?

The 25 mg dose achieved p < 0.001 versus placebo, indicating a highly statistically significant improvement in depression symptoms.

Were there any new safety issues in the COMP005 trial?

No; the DSMB found safety consistent with prior studies, with no unexpected adverse events or suicidality imbalance.

What are the next milestones for Compass Pathways' Phase 3 program?

CMPS expects 26-week data from COMP005 after COMP006 Part A completion and COMP006 26-week data in H2 2026.

Does Compass Pathways have sufficient funding to reach commercialization?

The filing notes the need for substantial additional funding; without new capital CMPS may have to delay or scale back trials.