Summary of COMPASS Pathways (CMPS) Conference Call Company Overview - **Company**: COMPASS Pathways (CMPS) - **Focus**: Development of psilocybin therapy for treatment-resistant depression (TRD) and PTSD Key Points Trial Design and Patient Enrollment - The ongoing trial, COMP-five, involves a single dose of 25 mg of COM360 compared to a placebo, with primary endpoint data expected next month at six weeks [2][13] - The trial design is consistent with Phase 2b, with a slight increase in patients with prior psychedelic experience [3][5] - Enrollment challenges were addressed by utilizing third-party vendors to gather necessary medical and pharmacy records, significantly shortening recruitment time [7][10] - The study is 100% U.S.-based, which has presented unique challenges compared to previous international trials [9][10] Efficacy Expectations - A clinically meaningful difference of at least 3 points on the MADRS scale at six weeks is anticipated for the TRD population [13][14] - The only marketed pharmacologic treatment for TRD currently is esketamine, which shows a similar efficacy range [14] Safety Profile - The Data Safety Monitoring Board (DSMB) has not raised any concerns regarding safety or protocol changes [17][21] - The population studied has a high risk of suicidality, with 70% having a history of suicidal ideation [20] - A black box warning for suicidality is expected, similar to other antidepressants, but the nature of psilocybin's rapid action may differ from traditional treatments [22][23] Durability of Treatment - Recent data indicates a time to depressive event of 92 days for the 25 mg dose, suggesting significant durability [26][28] - The study is also examining longer-term durability and effective retreatment strategies [30] Regulatory and Commercial Strategy - The company is preparing for a commercial launch by establishing collaborations with mental health care providers and developing reimbursement frameworks [39][41] - The infrastructure for delivering interventional psychiatry has significantly improved since the launch of SPRAVATO, providing confidence for the launch of COM360 [43][44] Workforce Considerations - The FDA does not regulate therapy, allowing for a broader range of healthcare providers to administer psilocybin treatments, which could include nurses and licensed social workers [46][48] Future Directions - COMPASS is designing a robust late-stage study for PTSD, building on promising efficacy signals from earlier studies [50][51] - There is a recognition of the high comorbidity between PTSD and TRD, which may facilitate treatment pathways [52] Additional Insights - The company is committed to maintaining trial blinding and has implemented strategies to ensure data integrity [31][32] - The evolving regulatory landscape may provide opportunities for faster patient access to psilocybin treatments [36] This summary encapsulates the critical aspects of the COMPASS Pathways conference call, highlighting the company's focus on psilocybin therapy for mental health conditions, trial progress, safety considerations, and commercial strategies.

COMPASS Pathways PLC Sponsored ADR (CMPS) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked ...

COMPASS Pathways (CMPS) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Steve Schultz - Senior Vice President, Investor RelationsKabir Nath - Chief Executive OfficerTeri Loxam - CFO, Principal Financial Officer & Principal Accounting OfficerGuy Goodwin - Chief Medical OfficerPaul Matteis - Managing Director, Head of Therapeutics ResearchCharles Duncan - Managing DirectorSteve Levine - Chief Patient OfficerSumant Kulkarni - Managing DirectorPatrick Trucchio - Managing Director Conference ...

COMPASS Pathways (CMPS) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Ladies and gentlemen, thank you for standing by, and welcome to the Compass Pathways First Quarter twenty twenty five Earnings Call. Please note that this call is being recorded. After the speakers' prepared remarks, there will be a question and answer session. Thank you. I'd now like to hand the call over to Steve Senior Vice President of Investor Relations. You may now begin, sir. Speaker1 Welcome all of you and thank you for ...

Compass Pathways Announces First Quarter 2025 Financial Results and Business Highlights Highlights: LONDON & NEW YORK - May 8, 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 first quarter 2025 and provided an update on recent progress across its business. "We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ⊠ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-39522 COMPASS Pathways plc (Exact name of registrant as specified in its charter) England and Wales Not Applicable (Stat ...

Core Insights - The field of psychedelic medicine is emerging, attracting investor interest due to its potential for growth and innovation [1] - Compass Pathways experienced a 13% increase in share price following the announcement of a completed step in its clinical trial [1] Company Developments - Compass Pathways has completed dosing in a late-stage clinical trial for its psilocybin treatment, COMP005 [2] - The phase 3 trial involves 258 patients with moderate to severe depression who have not responded to at least two prior treatments, with dosing conducted at 32 sites in the U.S. [3][4] - The company is expected to publish six-week primary endpoint results by the end of June [3] Industry Context - The CEO of Compass Pathways emphasized the milestone as critical in addressing the unmet need in treatment-resistant depression, highlighting the legitimacy of psychedelics as potential therapies for serious psychological disorders [5]

Transforming Mental Health Care Investor Presentation February 2025 Disclaimer Cautionary Note Regarding Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, you can identify forward-looking statements by terms such as "believe," "continue," "could," "estimate," "expect," "may," "might," "plan," "potential," "project," "should," "target," "will," "would," or the negative of th ...

COMPASS Pathways plc (NASDAQ:CMPS) Q4 2024 Earnings Conference Call February 27, 2025 8:00 AM ET Company Participants Stephen Schultz - Senior Vice President of Investor Relations Kabir Nath - Chief Executive Officer Lori Englebert - Chief Commercial Officer Teri Loxam - Chief Financial Officer Michael Gold - Chief Research & Development Officer Guy Goodwin - Chief Medical Officer Steve Levine - Chief Patient Officer Conference Call Participants Gavin Clark-Gartner - Evercore ISI Paul Matteis - Stifel Ritu ...

Compass Pathways Announces Fourth Quarter and Full-Year 2024 Financial Results and Business Highlights Highlights: LONDON & NEW YORK - February 27, 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 fourth quarter and full year 2024 and provided an update on recent progress across its business. "We are excited that the first data readout from our pivotal phase ...