Financial Performance - The company reported net losses of $73.3 million and $52.5 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of $452.9 million as of June 30, 2024[74]. - The net loss for the six months ended June 30, 2024, was $73.3 million, compared to a net loss of $52.5 million for the same period in 2023, reflecting an increase of $20.8 million or 40%[92]. - For the six months ended June 30, 2024, total operating expenses increased to $81.9 million from $64.5 million in the same period of 2023, representing a change of $17.4 million or 27%[92]. - General and administrative expenses for the six months ended June 30, 2024, rose to $27.9 million from $25.6 million in the same period of 2023, an increase of $2.3 million or 9%[95]. - Research and development expenses for the three months ended June 30, 2024, were $29.1 million, up from $19.8 million in the same period of 2023, an increase of $9.3 million or 47%[93]. - Net cash used in operating activities for the six months ended June 30, 2024, was $55.2 million, compared to $52.5 million in the same period of 2023, an increase of $2.7 million or 5%[102]. - The company recorded a benefit from R&D tax credit of $6.8 million for the six months ended June 30, 2024, compared to $6.8 million in the same period of 2023, showing no significant change[98]. - Net cash used in operating activities increased by $20.8 million due to a net loss, offset by favorable working capital activities of $13.4 million[103]. - The company raised $63.7 million from financing activities during the six months ended June 30, 2024, compared to $57.0 million in the same period of 2023, an increase of $6.7 million or 12%[102]. - Net cash provided by financing activities increased to $63.5 million, driven by $26.2 million from ordinary shares issuance through the ATM facility and $37.3 million from warrants exercised[104]. Clinical Trials and Research - The Phase 2b clinical trial of COMP360 psilocybin treatment for treatment-resistant depression (TRD) showed that 29.1% of participants were in remission by week 3 after receiving a 25mg dose[68]. - The company commenced a Phase 3 program in 2023, consisting of two pivotal trials, with top-line data expected in Q4 2024 for the first trial and mid-2025 for the second trial[69]. - The primary endpoint for both pivotal trials in the Phase 3 program is the change from baseline in MADRS total score at week 6[71]. - The company is conducting a Phase 2 study to investigate the safety and tolerability of COMP360 psilocybin treatment in patients with major depressive disorder, with 102 participants enrolled[71]. - The company expects research and development costs to continue to increase substantially through the completion of its Phase 3 program for COMP360 psilocybin therapy in TRD[93]. - The company anticipates significant increases in expenses related to advancing its Phase 3 clinical program for COMP360 in TRD and other ongoing activities[105]. Funding and Cash Position - As of June 30, 2024, the company had cash and cash equivalents of $228.6 million, which is expected to fund operations into 2026[78]. - The company sold 5,491,836 ADSs under its at-the-market offering program, resulting in $54.8 million in net proceeds[73]. - The company entered into a Securities Purchase Agreement to sell 16,076,750 ADSs at approximately $7.78 per ADS, with potential additional proceeds of $122.4 million if PIPE Warrants are fully exercised[73]. - The Hercules Loan Agreement allows for maximum borrowings of up to $50.0 million, of which $30.0 million has been funded as of June 30, 2024[100]. - Future funding requirements may increase significantly due to various factors, including the progress of clinical programs and regulatory approvals[108]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, with potential dilution of current ownership interests[111]. Operational and Market Considerations - The company has not generated any revenue to date and does not expect to do so in the foreseeable future[80]. - The company has incurred significant costs associated with operating as a public company, including legal, accounting, and investor relations expenses[85]. - There have been no material changes in market risk exposures affecting disclosures since the last annual report[115]. - The company plans to expand operations in the U.S. and Europe and invest in sales, marketing, and distribution infrastructure for potential commercialization[106]. - The company is a "smaller reporting company," allowing it to take advantage of scaled disclosures and exemptions under the Securities Exchange Act[113].

Core Insights - Compass Pathways plc is advancing its phase 3 clinical program for COMP360 psilocybin treatment in treatment-resistant depression, with top-line data expected in Q4 2024 [3][12] - The company has appointed Gino Santini as Chairman and Lori Englebert as Chief Commercial Officer, enhancing its leadership team [2][5][7] - The financial position shows a cash balance of $228.6 million as of June 30, 2024, with a net loss of $38.1 million for Q2 2024 [8][9] Business Highlights - The COMP360 psilocybin treatment program is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted [3] - Positive results were reported from a phase 2 study on post-traumatic stress disorder (PTSD), indicating safety and tolerability with significant symptom improvement [4][12] Leadership Updates - Gino Santini will join as Chairman effective September 3, 2024, bringing extensive board leadership experience [5] - Lori Englebert has joined as Chief Commercial Officer, previously serving at Axsome Therapeutics [7] Financial Highlights - For Q2 2024, the net loss was $38.1 million, compared to $28.3 million in Q2 2023, with R&D expenses increasing to $29.1 million [8][18] - Cash and cash equivalents increased to $228.6 million from $220.2 million at the end of 2023 [8][9] - The company expects to use $32 million to $38 million in operating activities for Q3 2024, with a full-year estimate of $110 million to $130 million [9] Conference Call - A conference call is scheduled for August 1, 2024, at 8:00 am ET to discuss the financial results and business updates [10]

Company Overview - Compass Pathways plc (NASDAQ:CMPS) is a biotechnology company focused on enhancing patient access to evidence-based innovations in mental health [4][8] - The company is pioneering a new model of psilocybin treatment, utilizing its proprietary formulation of synthetic psilocybin, COMP360, alongside psychological support [8] - COMP360 has received Breakthrough Therapy designation from the US FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) [8] Clinical Developments - Compass Pathways has initiated a phase 3 clinical program for COMP360 psilocybin treatment in TRD, marking it as the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted [6] - A previous phase 2b study demonstrated a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support [6] - The company has also completed an open-label phase 2 study for COMP360 psilocybin treatment in post-traumatic stress disorder (PTSD) and is currently conducting a phase 2 clinical study in anorexia nervosa [6] Upcoming Events - The management team will host a conference call on August 1, 2024, at 8:00 am ET to discuss the financial results for the second quarter of 2024 and provide updates on recent business developments [4][5] - A live webcast of the call will be available on the Compass Pathways website, and the webcast will be archived for 30 days [5][8]

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 ...

COMPASS Pathways plc (NASDAQ:CMPS) Q1 2024 Results Conference Call May 8, 2024 8:00 AM ET Company Participants Stephen Schultz - SVP, IR Kabir Nath - CEO Guy Goodwin - Chief Medical Officer Teri Loxam - CFO Conference Call Participants Vikram Purohit - Morgan Stanley Ritu Baral - TD Cowen Charles Duncan - Cantor Patrick Trucchio - H.C. Wainwright & Co. Tom Shrader - BTIG Sumant Kulkarni - Canaccord Genuity Elemer Piros - Rodman Operator Thank you for standing by, and welcome to the COMPASS Pathways' First Q ...

Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights • Cash position of $262.9 million at March 31, 2024 London, UK – May 8, 2024 Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress. COMP360 psilocybin treatment in treatment-resistant depression (TRD): ...

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 ...