Lori's appointment follows that of Teri Loxam as Chief Financial Officer in March 2024 and Dr. Michael Gold as Chief Research & Development Officer in May 2024. All three executive team members bring decades of successful strategic leadership and highly relevant experience in drug development. Forward-looking statements Enquiries LONDON, June 26, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in ...

Financial Data and Key Metrics Changes - Cash used in operations for Q1 2024 was $20.8 million, within the guidance range of $17 million to $23 million, and the company received a $15 million R&D tax credit from HMRC [69] - Cash and cash equivalents increased to $262.9 million at March 31, 2024, compared to $220.2 million at December 31, 2023, indicating a strong financial position [69] - The company expects net cash used in operations to be between $32 million and $38 million for Q2 2024 and between $110 million and $130 million for the full year [69] Business Line Data and Key Metrics Changes - The company is on track to deliver top-line data for the COMP 005 single-dose placebo-controlled study in Q4 2024 and for the COMP 006 fixed repeat dose trial in mid-2025 [47][49] - The Phase II exploratory study in PTSD showed a mean CAPS-5 total score reduction of 29.9 points at week four and 29.5 points at week twelve, indicating significant symptom improvement [68] Market Data and Key Metrics Changes - The company announced collaborations with leading mental health care providers to develop scalable delivery models for COMP360 psilocybin treatment, which is aimed at treatment-resistant depression [47] - The PTSD study included 22 patients, with a mean CAPS-5 total score at baseline of 47.5, indicating severe PTSD symptoms [48][68] Company Strategy and Development Direction - The company is focusing on expanding the application of COMP360 into PTSD, leveraging similarities in patient profiles with treatment-resistant depression (TRD) [4] - The appointment of Dr. Mike Gold as Chief Research and Development Officer is expected to enhance the development of COMP360 and explore additional pipeline opportunities [4] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early and durable improvement in PTSD symptoms observed in the study, indicating potential for COMP360 to provide meaningful clinical benefits [68] - The company is preparing for a meeting with the FDA to discuss potential next steps for COMP360, emphasizing the importance of the upcoming Phase III results [4][68] Other Important Information - The company has maintained a strong cash runway, expected to fund operations into 2026, allowing for continued advancement of pivotal programs [69] - The study reported no serious adverse events, and the administration of COMP360 was well tolerated among participants [2][68] Q&A Session Summary Question: What are the implications of the recent FDA Ad Comm meeting for MDMA-assisted therapy for PTSD? - Management noted that the FDA's interest in MDMA therapy could influence the broader market landscape for COMP360, but specific implications remain to be seen [70] Question: How does the company plan to mitigate risks associated with suicidal ideation in trials? - Management emphasized the importance of patient preparation and support during treatment sessions to minimize risks, noting no serious adverse events reported [101] Question: Can you provide insights on the trial design for the Phase II study in PTSD? - Management indicated that the Phase II study was designed to avoid recruiting actively suicidal patients, focusing instead on those with a history of suicidality but not currently suicidal [102]

Financial Position - Cash position of $262.9 million as of March 31, 2024, compared to $220.2 million as of December 31, 2023, representing a 19% increase[10] - Long-term debt increased slightly to $29.1 million as of March 31, 2024, from $28.8 million as of December 31, 2023[10] - Total assets as of March 31, 2024, were $308.993 million, up from $275.987 million as of December 31, 2023[15] - Compass raised an additional $63.5 million in net cash during Q1 2024 through an ATM facility and warrant exercises[10] - The cash position as of March 31, 2024, is expected to be sufficient to fund operating expenses and capital expenditures into 2026[31] Operating Performance - Net loss for Q1 2024 was $35.2 million, or $0.55 loss per share, compared to a net loss of $24.2 million, or $0.57 loss per share in Q1 2023[4] - Total operating expenses for Q1 2024 were $38.6 million, up from $31.8 million in Q1 2023, reflecting a 21% increase[16] - Research and development expenses increased to $24.9 million in Q1 2024 from $19.0 million in Q1 2023, a rise of 31%[16] - Research and development expenses for Q1 2024 were $24.9 million, up from $19.0 million in Q1 2023, reflecting increased development activities[31] - The expected net cash used in operating activities for Q2 2024 is projected to be between $32 million and $38 million[31] - Full-year 2024 net cash used in operating activities is anticipated to be in the range of $110 million to $130 million, contingent on receiving the 2023 R&D tax credit in Q4 2024[31] Clinical Development - The COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) is on track for top-line data from the first trial expected in Q4 2024[23] - Positive phase 2 data for COMP360 in post-traumatic stress disorder (PTSD) showed a 29.9 point reduction in CAPS-5 scores at week 4[24] - COMP360 has been designated as a Breakthrough Therapy by the FDA and received ILAP designation in the UK for treatment-resistant depression[27] - The company has initiated a phase 3 clinical program for COMP360 psilocybin treatment in treatment-resistant depression, marking the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted[27] - A phase 2b study previously showed a statistically significant improvement in depressive symptom severity (p<0.001) after three weeks for patients receiving a single dose of COMP360[27] Strategic Initiatives - Compass is exploring additional commercial collaborations to develop delivery models for COMP360 psilocybin treatment[25] - The company is focused on establishing research facilities and innovation labs, which involves significant costs and resources[29] - There are risks associated with research collaborations and obtaining coverage and reimbursement for the investigational COMP360 treatment[29] - The company encourages stakeholders to review material information posted on its investor relations website and other communication channels regularly[28]

England and Wales Not Applicable (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 33 Broadwick Street London W1F 0DQ United Kingdom (Address of principal executive offices, zip code) Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was ...

COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)Michael Gold to join Compass as Head of R&DCompass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care Cash position of $262.9 million at March 31, 2024 Conference call May 8 at 8:00 am E ...

Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12 Measures of symptom scores relative t ...

LONDON, May 03, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (NASDAQ:CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the first quarter 2024 ending March 31, 2024, and provide an update on recent business developments, on May 8, 2024. The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2024. To access the call, please register in advance here to o ...

LONDON, May 02, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (NASDAQ:CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Mindful Health Solutions (MHS), one of the US's leading providers of innovative behavioral health care, today announced that they have entered into a research collaboration agreement to inform the development of a scalable and cost-effective delivery model for COMP360 psilocybin treatment, if approved for ...

LONDON, April 29, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (NASDAQ:CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Journey Clinical, a leading psychedelic-assisted psychotherapy platform with the largest network of licensed therapists focused on psychedelics in the US, today announced they have entered into a research collaboration agreement to inform the development of a scalable and practical delivery and healthcar ...

COMPASS Pathways plc (NASDAQ:CMPS) Q4 2023 Earnings Conference Call February 29, 2024 8:00 AM ET Company Participants Stephen Schultz - Senior Vice President, Investor Relations Kabir Nath - Chief Executive Officer Mary-Rose Hughes - Interim Financial Officer Teri Loxam - Incoming Chief Financial Officer Dr. Guy Goodwin - Chief Medical Officer Conference Call Participants Patrick Trucchio - H.C. Wainright Charles Duncan - Cantor François Brisebois - Oppenheimer Neena Bitritto-Garg - Deutsche Bank Ritu Baral ...