Financial Data and Key Metrics Changes - Cash used in operations for Q2 2024 was $34.4 million, within the guidance range of $32 million to $38 million [12] - Cash and cash equivalents stood at $228.6 million as of June 30, 2024, down from $262.9 million at March 31, 2024 [12] - The company expects cash used in operations for the full year to be between $110 million and $130 million [12] Business Line Data and Key Metrics Changes - The company is progressing in recruitment for its COMP360 Phase 3 trials, with expectations for top-line data readout from the 005 trial in Q4 2024 [6][13] - Recruitment is trending towards the end of the year, with a possibility of data readout extending into January [6] Market Data and Key Metrics Changes - The commercial marketplace for interventional psychiatry treatments continues to grow, validating the company's approach [13] Company Strategy and Development Direction - The company is focused on completing its COMP360 Phase 3 clinical trials and building commercial capabilities [5] - The management team has been strengthened with the addition of a Chief Commercial Officer and a new Chairman of the Board [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pivotal program delivering what the FDA requires for effective evaluation of COMP360 treatment [11] - The company is well-positioned for continued success in treatment-resistant depression (TRD) and beyond [14] Other Important Information - The company is collecting a range of safety data expected in any pharmaceutical clinical development program, including positive side effect data [11] - The company maintains a strong financial position with a cash runway expected to fund operations into 2026 [12] Q&A Session Summary Question: What is the status of the ongoing 005 trial and suicidality rates? - The DSMB meeting indicated that both 005 and 006 trials should continue as planned with no changes to procedures [17] Question: Were there any impacts on enrollment rates due to the AdCom proceedings? - There has been no significant impact on enrollment rates for either trial following the AdCom [20] Question: Can you provide insights on site performance and quality? - The company is maintaining close contact with sites to ensure quality and has not identified any anomalies post-AdCom [23] Question: What are the key questions being asked in the 005 and 006 trials? - The 005 trial aims to demonstrate separation from placebo, while the 006 trial seeks to replicate previous efficacy results and assess durability [34][35] Question: What are the next steps for PTSD and bipolar disorder in the pipeline? - The company is developing designs and protocols for PTSD but currently prioritizes TRD [39][40] Question: How is the company ensuring that patients do not use other treatment modalities post-dosing? - The company is collecting data on co-administration of other drugs but actively preventing such use is challenging [48][49] Question: What are the findings regarding suicidality in recreational users of psilocybin? - Studies suggest a reduction in psychological distress and suicidal thoughts among recreational users, but the focus remains on clinical efficacy [51] Question: How does the company view the FDA's commentary on psychotherapy in trials? - The company believes it is in a different category as it does not provide psychotherapy, making the efficacy assessment simpler [46]

[Q2 2024 Performance and Outlook](index=1&type=section&id=Q2%202024%20Performance%20and%20Outlook) Compass Pathways' Q2 2024 performance highlights clinical advancements, leadership changes, and financial results with forward-looking guidance [Business Highlights](index=1&type=section&id=Business%20highlights) The company is advancing its clinical programs, with top-line data for the COMP360 phase 3 pivotal trial in treatment-resistant depression (TRD) expected in Q4 2024, and positive phase 2 results for PTSD - Top-line data from the pivotal COMP005 trial for COMP360 in treatment-resistant depression is expected in **Q4 2024**, with data from the COMP006 trial expected in **mid-2025**[3](index=3&type=chunk) - A phase 2 study of COMP360 for post-traumatic stress disorder (PTSD) showed that a single **25mg** dose was well-tolerated with no serious adverse events, observing meaningful and sustained symptom improvement with high rates of response and remission[4](index=4&type=chunk) [Leadership Updates](index=1&type=section&id=Leadership%20updates) Compass Pathways strengthened its leadership with Gino Santini appointed Chairman and Lori Englebert as Chief Commercial Officer - Gino Santini will join the Board of Directors as **Chairman**, bringing over a decade of board leadership experience from companies like Collegium Pharmaceuticals and Eli Lilly[5](index=5&type=chunk) - Lori Englebert was appointed **Chief Commercial Officer** in July, having previously served as head of commercial and business development at Axsome Therapeutics[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20highlights) The company reported an increased net loss of **$38.1 million** in Q2 2024 due to higher R&D expenses, maintaining a strong cash position of **$228.6 million** [Q2 2024 Financial Results](index=2&type=section&id=Q2%202024%20Financial%20Results) Net loss increased to **$38.1 million** in Q2 2024, primarily driven by a **47.0%** rise in R&D expenses to **$29.1 million** for late-stage clinical trials | Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | Net Loss ($M) | $38.1M | $28.3M | Increased Loss | | Loss Per Share ($) | $0.56 | $0.62 | Decreased Loss/Share | | R&D Expenses ($M) | $29.1M | $19.8M | +47.0% | | G&A Expenses ($M) | $14.3M | $12.8M | +11.7% | | Metric | H1 2024 | H1 2023 | Change | | :--- | :--- | :--- | :--- | | Net Loss ($M) | $73.3M | $52.5M | Increased Loss | | Loss Per Share ($) | $1.11 | $1.19 | Decreased Loss/Share | | R&D Expenses ($M) | $54.0M | $38.9M | +38.8% | | G&A Expenses ($M) | $27.9M | $25.6M | +9.0% | - The increase in R&D expenses was primarily attributable to development costs for advancing late-stage COMP360 phase 3 clinical trials and increased R&D headcount[7](index=7&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of June 30, 2024, the company's cash and cash equivalents increased to **$228.6 million**, with total assets at **$278.5 million** and liabilities at **$52.3 million** | Metric | June 30, 2024 ($M) | Dec 31, 2023 ($M) | | :--- | :--- | :--- | | Cash and cash equivalents | $228.6M | $220.2M | | Total Assets | $278.5M | $276.0M | | Long-term debt | $29.4M | $28.8M | | Total Liabilities | $52.3M | $50.2M | | Total Shareholders' Equity | $226.3M | $225.7M | [Financial Guidance](index=2&type=section&id=Financial%20Guidance) The company projects Q3 2024 net cash used in operations between **$32 million** and **$38 million**, with full-year 2024 guidance of **$110 million** to **$130 million**, sufficient to fund operations into 2026 - Q3 2024 net cash used in operating activities is projected to be in the range of **$32 million** to **$38 million**[8](index=8&type=chunk) - Full-year 2024 net cash used in operating activities is expected to be between **$110 million** and **$130 million**[8](index=8&type=chunk) - The cash position as of June 30, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements into **2026**[8](index=8&type=chunk)

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 ...

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 ...