Financial Performance - The company reported net losses of $111.8 million and $85.9 million for the nine months ended September 30, 2024, and 2023, respectively, with an accumulated deficit of $491.4 million as of September 30, 2024[73]. - The company has not generated any revenue to date and does not expect to do so in the foreseeable future[76]. - Accumulated trading losses for carry forward in the UK amounted to $252.3 million as of December 31, 2023, compared to $176.9 million in 2022[87]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $77.4 million, compared to $69.6 million in 2023, a change of $7.8 million[100]. - Net cash provided by financing activities decreased to $26.2 million during the nine months ended September 30, 2024, down from $28.1 million in the same period of 2023[102]. Research and Development - The Phase 2b clinical trial for COMP360 psilocybin treatment showed that 29.1% of participants were in remission by week 3 after receiving a single 25mg dose, achieving a statistically significant treatment difference (p<0.001) compared to the 1mg dose[67]. - The company commenced a Phase 3 program in early 2023, consisting of two pivotal trials, with top-line data expected in Q2 2025 for the first trial (n=255) and in the second half of 2026 for the second trial (n=568)[68][69]. - The company is conducting a Phase 2 study (n=102) to investigate the safety and tolerability of COMP360 psilocybin treatment in patients with major depressive disorder, with results expected to be included in the submission package for TRD approval[71]. - The company anticipates significant increases in research and development expenses as it continues to develop its investigational COMP360 psilocybin treatment for TRD[77]. - 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[92]. Expenses - Research and development expenses for the three months ended September 30, 2024, increased to $32.9 million from $21.5 million in 2023, a change of $11.4 million[89]. - General and administrative expenses for the nine months ended September 30, 2024, rose to $42.9 million from $38.1 million in 2023, an increase of $4.8 million[92]. - The company expects to incur significant costs associated with operating as a public company, including legal, accounting, and investor relations expenses[82]. - The company anticipates significant increases in expenses related to advancing its Phase 3 program for COMP360 psilocybin treatment in TRD and associated clinical activities[103]. Funding and Capital - As of September 30, 2024, the company had cash and cash equivalents of $207.0 million, which is expected to fund operations into 2026[74]. - The company entered into a Hercules Loan Agreement with maximum borrowings of up to $50.0 million, including a term loan of $30.0 million funded on June 30, 2023[73]. - The company sold 5,491,836 ADSs under its ATM offering program, resulting in $54.8 million in net proceeds through September 30, 2024[73]. - The company anticipates receiving up to approximately $122.4 million in gross proceeds if the PIPE Warrants are fully exercised[97]. - Future funding requirements may increase significantly due to the progress and regulatory approval processes for the COMP360 program and potential new therapeutic candidates[106]. Strategic Plans - The company plans to establish a sales, marketing, and distribution infrastructure to commercialize therapeutic candidates, including COMP360, if approved[104]. - The company may pursue additional research and development programs for preclinical stage therapeutic candidates and discovery-stage programs in the future[103]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, with potential dilution of current ownership interests[108]. - The company is a "smaller reporting company" with annual revenues of less than $100.0 million, allowing it to take advantage of scaled disclosures[110]. Other Income - Total other income, net, for the three months ended September 30, 2024, was $9.6 million, up from $735,000 in 2023, reflecting an increase of $8.8 million[95]. - The increase in other income was primarily due to higher R&D expenditures and an increase in interest income from higher interest rates on cash deposits[95].

Core Insights - The psychedelic medicine sector is experiencing significant developments, particularly with Lykos Therapeutics and its MDMA therapy, which faced a setback from the FDA advisory panel's negative recommendation [3][4] - Other companies like MindMed, COMPASS Pathways, and Cybin are now positioned to compete for market leadership in psychedelic therapies following Lykos' challenges [5][6] Industry Overview - The psychedelic sector has seen a shift in focus, with companies like MindMed, COMPASS, and Cybin advancing their clinical trials while Lykos has fallen behind [5][6] - The FDA has granted breakthrough therapy designations to multiple companies, indicating a positive trend for psychedelic therapies despite the recent setback for Lykos [4][5] Company Developments - MindMed has shown strong Phase 2b results with 50% of patients in remission at 12 weeks, positioning it favorably for Phase 3 trials [6] - COMPASS Pathways is targeting treatment-resistant depression and has received breakthrough therapy designation, making it a strong contender in the market [6] - Cybin has developed a novel form of psilocybin with a shorter duration of effect, which may enhance its scalability and marketability [6] Regulatory Landscape - The FDA's recent actions indicate a cautious but supportive approach to psychedelic therapies, with ongoing discussions about the complexities of clinical trials, particularly regarding blinding issues [4][5] - The advisory panel's recommendation against Lykos' MDMA therapy highlights the challenges that psychedelic companies face in navigating regulatory hurdles [4][5] Future Outlook - The upcoming Phase 3 trials for MindMed, COMPASS, and Cybin are critical milestones that could reshape the competitive landscape in the psychedelic sector [6] - Investors should monitor the cash reserves of these companies, as financial stability is crucial for advancing through the lengthy clinical trial process [6]

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]