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.

Core Viewpoint - COMPASS Pathways PLC has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for COMPASS Pathways for the fiscal year ending December 2025 is projected at -$1.82 per share, reflecting a 20.9% change from the previous year's reported figure [9]. - Over the past three months, the Zacks Consensus Estimate for COMPASS Pathways has increased by 13%, indicating a trend of rising earnings estimates [9]. Zacks Rating System - The Zacks rating system is based on changes in earnings estimates, which are crucial for determining stock price movements. It classifies stocks into five groups, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [2][10][11]. - The Zacks Rank 2 upgrade places COMPASS Pathways in the top 20% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term due to favorable earnings estimate revisions [11]. Market Impact - Rising earnings estimates and the corresponding rating upgrade for COMPASS Pathways suggest an improvement in the company's underlying business, which could lead to increased investor interest and a higher stock price [6]. - The influence of institutional investors, who adjust their valuations based on earnings estimates, contributes to the stock price movements, reinforcing the importance of earnings revisions [5].

Financial Data and Key Metrics Changes - As of March, the company had cash and cash equivalents of $260 million, an increase from $165 million at the end of 2024, indicating a strong financial position following recent financing [12] - Cash used in operations for the first quarter was $45.7 million, with expectations for net cash used in operations for the full year 2025 to be between $120 million and $145 million [13] Business Line Data and Key Metrics Changes - The company announced the completion of dosing for all participants in Part A of its pivotal Phase III trial for treatment-resistant depression (TRD), with top-line results expected in late June [6] - The Phase III program is designed to confirm the durability and safety profile of COMP360, which could provide a groundbreaking treatment option for TRD patients if successful [9] Market Data and Key Metrics Changes - The company is focusing on the commercialization of COMP360 by developing relationships with various provider types through strategic collaborations, including a new partnership with HealthPort to enhance access to innovative mental health treatments [10][11] Company Strategy and Development Direction - The company aims to ensure broad and equitable access to COMP360, particularly for underserved populations, and is working on understanding the commercial opportunity for its treatment in various care settings [10] - The company is also planning for a late-stage clinical program in PTSD, recognizing the significant unmet need in this area [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III data readout, emphasizing the potential of COMP360 to be a clinically differentiated treatment option with rapid action and meaningful durability [14][76] - The management noted that the FDA is not concerned about the likelihood of suicidality in the Phase III trial, understanding that it is a core feature of the disease [39] Other Important Information - The company is working on adding manufacturing capabilities in the US for commercial supply, with plans already underway [48] - The company has had multiple inspections of its manufacturing sites, indicating a robust compliance history [48] Q&A Session Summary Question: Key takeaways from the longer-term follow-up data from the Phase II trial - The data showed a difference in durability among the three doses, with patients receiving 25 mg lasting as long as six months following treatment, suggesting it is the preferred dose for the Phase III program [21] Question: Efficacy delta on MADRS and placebo effect - The company expects a clinically significant effect size over three on the MADRS scale, with a typical placebo response anticipated in well-conducted trials [28] Question: Concerns about suicidality in the study design - Suicidality is a core feature of depression, and the company must include patients with some degree of suicidality to maintain a representative population [36] Question: Current delivery of esketamine by HealthPort - HealthPort has experience delivering SPRAVATO and is motivated to ensure access to new treatment options for underserved populations [42] Question: Manufacturing supply chain and FDA inspections - The company is adding US manufacturing capabilities and has a straightforward manufacturing process with a small quantity of material, mitigating risks [50] Question: Patient enrollment in COMM-five compared to Phase IIb - The recruitment criteria remain the same, and the company expects no significant differences in patient profiles between the studies [55] Question: Interest in large pharma partnerships - The company is committed to commercializing COMP360 independently in the US and select geographies, with no current plans for large strategic partnerships [57] Question: Optimal time to assess suicidality risk post-treatment - The management indicated that predictions are difficult, and they will wait for data to inform their understanding of suicidality risk [60]

Financial Data and Key Metrics Changes - As of March, the company had cash and cash equivalents of $260 million, an increase from $165 million at the end of 2024, indicating a strong financial position following recent financing [12] - Cash used in operations for the first quarter was $45.7 million, with an expected net cash usage for the full year 2025 projected to be between $120 million to $145 million [13] Business Line Data and Key Metrics Changes - The company announced the completion of dosing for all participants in Part A of its pivotal Phase III trial for treatment-resistant depression (TRD), with top-line results expected in late June [5] - The Phase III program aims to confirm the durability and safety profile of COMM360, which could provide a groundbreaking treatment option for TRD patients if successful [9] Market Data and Key Metrics Changes - The company is focusing on the commercialization of COMM360 by developing relationships with various provider types through strategic collaborations, including a new partnership with HealthPort to enhance access to innovative mental health treatments [10] Company Strategy and Development Direction - The company is preparing for the commercialization of COMM360 by understanding the commercial opportunity and ensuring broad delivery across various care settings [9] - The strategic collaboration with HealthPort aims to address the needs of underserved populations, reflecting the company's commitment to equitable access to mental health treatments [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III data readout, emphasizing the potential of COMM360 to be a clinically differentiated treatment option for TRD [13] - The company is also working on the final design for a late-stage clinical program in PTSD, indicating a significant commercial opportunity in this area due to high unmet needs [13] Other Important Information - The independent Data Safety Monitoring Board (DSMB) is regularly reviewing unblinded safety data, with a focus on suicidality, which remains a critical concern in the context of TRD [6][39] Q&A Session Summary Question: Key takeaways from the long-term follow-up data on durability and appropriate dosing - Management noted that while the data is not definitive, it suggests that patients receiving 25 mg can experience effects lasting up to six months, indicating this dose may be preferred moving forward [21] Question: Efficacy delta on MADRS and placebo effect considerations - Management acknowledged the variability in placebo effects in psychedelic trials and estimated a clinically significant effect size of over three on the MADRS scale [29] Question: Concerns regarding suicidality signals - Management clarified that suicidality is a core feature of depression and must be included in study designs, with ongoing monitoring to ensure safety [36] Question: Current delivery of esketamine by HealthPort - HealthPort has experience delivering SPRAVATO and is motivated to ensure access to new treatment options for underserved populations [42] Question: Manufacturing supply chain and FDA inspections - The company is currently manufacturing in the UK and plans to add US manufacturing capabilities, with multiple inspections conducted over the years [49] Question: Patient enrollment in COMM-five and comparison to Phase 2b - Management confirmed that recruitment criteria remain consistent, suggesting similar patient profiles across studies [55] Question: Interest in large pharma partnerships - The company is committed to commercializing COMM360 independently in the US, with no current plans for large pharma partnerships [58] Question: Optimal time frame for assessing suicidality risk post-treatment - Management indicated that predictions are difficult, and they will rely on data to inform their understanding of suicidality risk [61] Question: Changes in FDA interactions regarding psychedelic therapies - Management reported no significant changes in FDA interactions, maintaining routine discussions around event reporting [63]

[Overview and Business Highlights](index=1&type=section&id=Overview%20and%20Business%20Highlights) This section provides an overview of Compass Pathways' Q1 2025 performance, highlighting significant clinical advancements and financial stability [Q1 2025 Highlights](index=1&type=section&id=Q1%202025%20Highlights) Compass Pathways reported significant progress in its pivotal phase 3 COMP360 program for treatment-resistant depression (TRD), with key 6-week data expected in late June 2025. The company ended the first quarter with a strong cash position of $260.1 million, bolstering its financial runway - CEO Kabir Nath emphasized the anticipation for the upcoming topline 6-week data from the pivotal phase 3 COMP360 program in treatment-resistant depression, expected in **late June**[2](index=2&type=chunk) Key Milestones and Financial Status | Metric | Status / Value | | :--- | :--- | | COMP005 Phase 3 (TRD) 6-week data | On track for late June | | COMP006 Phase 3 (TRD) 26-week data | Expected H2 2026 | | Cash Position (Mar 31, 2025) | $260.1 million | [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) The company is advancing its COMP360 psilocybin treatment programs for both Treatment-Resistant Depression (TRD) and Post-Traumatic Stress Disorder (PTSD). The TRD program is noted as the largest randomized, controlled, double-blind psilocybin clinical program to date, while the PTSD program is moving towards a late-stage trial design following positive phase 2 results [COMP360 in Treatment-Resistant Depression (TRD)](index=1&type=section&id=COMP360%20in%20Treatment-Resistant%20Depression%20%28TRD%29) This section details the progress and key data expectations for the COMP360 pivotal phase 3 program in Treatment-Resistant Depression - The pivotal phase 3 program for COMP360 in TRD is the **largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program**[5](index=5&type=chunk) - Key data readouts are scheduled, with top-line 6-week data from the COMP005 trial expected in **late June** and 26-week data from the COMP006 trial expected in the **second half of 2026**[5](index=5&type=chunk) - A recent 52-week observational follow-up study demonstrated a **durable treatment response** from a single 25mg administration of COMP360[5](index=5&type=chunk) [COMP360 in Post-Traumatic Stress Disorder (PTSD)](index=1&type=section&id=COMP360%20in%20Post-Traumatic%20Stress%20DIsorder%20%28PTSD%29) This section outlines the advancement of the COMP360 program for Post-Traumatic Stress Disorder, following promising phase 2 results - Following positive phase 2 results, the company is now designing a **late-stage clinical trial program** for COMP360 in PTSD[5](index=5&type=chunk) - A phase 2 open-label study (n=22) showed that a single administration of COMP360 was **well-tolerated** and resulted in **rapid and durable improvement in PTSD symptoms**[5](index=5&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) This section provides a comprehensive review of the company's financial results, position, and future guidance [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) For Q1 2025, Compass Pathways reported a net loss of $17.9 million, a significant reduction from $35.2 million in Q1 2024. This improvement was primarily driven by a $19.5 million non-cash gain on the fair value of warrant liabilities. Operating expenses increased year-over-year, with R&D expenses rising to $30.9 million due to advancing phase 3 trials, and G&A expenses increasing to $18.7 million, partly due to costs from a recent financing Q1 2025 vs Q1 2024 Key Financials (in thousands) | Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Net Loss | $17,900 | $35,200 | $19,500 non-cash gain on warrant liabilities | | Net Loss Per Share (basic) | $0.20 | $0.55 | - | | R&D Expenses | $30,900 | $24,900 | Advancing Phase 3 trials | | G&A Expenses | $18,700 | $13,700 | 2025 Financing issuance costs | [Financial Position and Cash Flow](index=2&type=section&id=Financial%20Position%20and%20Cash%20Flow) The company significantly strengthened its balance sheet, ending Q1 2025 with $260.1 million in cash and cash equivalents, a substantial increase from $165.1 million at the end of 2024. This was primarily due to raising an additional $140.4 million in net cash from financing activities during the quarter Cash Position Comparison (in thousands) | Date | Cash and Cash Equivalents | | :--- | :--- | | March 31, 2025 | $260,100 | | December 31, 2024 | $165,100 | - The company raised an additional **$140.4 million** in net cash during the first quarter of 2025[9](index=9&type=chunk) [Financial Guidance](index=2&type=section&id=Financial%20Guidance) Compass Pathways projects its full-year 2025 net cash used in operating activities to be between $120 million and $145 million. The company's cash position as of March 31, 2025, is expected to be sufficient to fund operations and capital expenditures at least through the second half of 2026, covering the period of the planned COMP006 study data readout - Full year 2025 net cash used in operating activities is projected to be in the range of **$120 million to $145 million**[6](index=6&type=chunk) - The current cash position is expected to provide a financial runway at least through the planned 26-week data readout from the COMP006 study in the **second half of 2026**[6](index=6&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the Balance Sheets as of March 31, 2025, and December 31, 2024, and the Statements of Operations for the three-month periods ending March 31, 2025, and 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position through its condensed consolidated balance sheets Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $260,110 | $165,081 | | Total current assets | $305,468 | $201,291 | | **Total assets** | **$319,135** | **$213,666** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $29,999 | $34,016 | | Warrant liabilities | $71,857 | $0 | | **Total liabilities** | **$123,668** | **$58,971** | | **Total shareholders' equity** | **$195,467** | **$154,695** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's financial performance over specific periods through its condensed consolidated statements of operations Condensed Consolidated Statements of Operations (in thousands) | | Three Months ended Mar 31, 2025 | Three Months ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $30,880 | $24,901 | | General and administrative | $18,736 | $13,672 | | **Loss from operations** | **($49,616)** | **($38,573)** | | Fair value change of warrant liabilities | $19,460 | $0 | | **Net loss** | **($17,864)** | **($35,187)** | | **Net loss per share: basic** | **($0.20)** | **($0.55)** |

PART I [Item 1. Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents unaudited condensed consolidated financial statements for Q1 2025 vs Q1 2024, highlighting increased cash to **$260.1 million** and a reduced net loss of **$17.9 million** [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows cash and equivalents increased to **$260.1 million**, total assets to **$319.1 million**, and a new **$71.9 million** warrant liability Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $260,110 | $165,081 | | Total current assets | $305,468 | $201,291 | | Total assets | $319,135 | $213,666 | | **Liabilities & Equity** | | | | Total current liabilities | $29,999 | $34,016 | | Warrant liabilities | $71,857 | $0 | | Total liabilities | $123,668 | $58,971 | | Total shareholders' equity | $195,467 | $154,695 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2025 improved to **$17.9 million** from **$35.2 million** in Q1 2024, primarily due to a **$19.5 million** non-cash gain on warrant liabilities Statement of Operations Summary (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $30,880 | $24,901 | | General and administrative | $18,736 | $13,672 | | **Total operating expenses** | **$49,616** | **$38,573** | | Loss from operations | ($49,616) | ($38,573) | | Fair value change of warrant liabilities | $19,460 | $0 | | Benefit from R&D tax credit | $8,448 | $3,101 | | **Net loss** | **($17,864)** | **($35,187)** | | Net loss per share, basic | ($0.20) | ($0.55) | [Condensed Consolidated Statements of Shareholders' Equity](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) Shareholders' equity increased to **$195.5 million** by March 31, 2025, from **$154.7 million** at year-end 2024, driven by **$54.6 million** from ordinary share issuance - The company issued 24,014,728 ordinary shares, net of issuance costs, during the quarter, increasing additional paid-in capital by **$54.6 million**[26](index=26&type=chunk) - Total shareholders' equity increased to **$195.5 million** at March 31, 2025, from **$154.7 million** at December 31, 2024[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$45.7 million** in Q1 2025, with **$140.4 million** provided by financing, leading to **$260.5 million** cash at quarter-end Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($45,657) | ($20,828) | | Net cash provided by financing activities | $140,359 | $63,512 | | Net increase in cash, cash equivalents and restricted cash | $95,019 | $42,639 | | **Cash, cash equivalents and restricted cash, end of period** | **$260,489** | **$263,277** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's biotech focus on COMP360, significant January 2025 financing raising **$149.8 million** and creating warrant liabilities, and a cash runway of **$260.1 million** through H2 2026 - In January 2025, the company completed a financing by issuing ADSs, Pre-funded Warrants, and 2025 ADS Warrants, resulting in aggregate proceeds of **$149.8 million**[35](index=35&type=chunk)[64](index=64&type=chunk) - The company believes its cash and cash equivalents of **$260.1 million** as of March 31, 2025, will be sufficient to fund operations at least through the planned 26-week data read-out from the COMP006 study, expected in H2 2026[37](index=37&type=chunk) - Warrants issued in the January 2025 financing are classified as liabilities and measured at fair value. As of March 31, 2025, the total warrant liability was **$71.9 million**[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, advancing the COMP360 Phase 3 program, increased R&D and G&A expenses, a reduced net loss for Q1 2025, and a cash runway through H2 2026 - The company is advancing its Phase 3 program for COMP360 in TRD, with top-line results for the pivotal COMP005 trial expected in late June 2025[90](index=90&type=chunk) - Cash and cash equivalents of **$260.1 million** as of March 31, 2025, are expected to fund operations through the COMP006 data readout in the second half of 2026[98](index=98&type=chunk)[129](index=129&type=chunk) Q1 2025 vs Q1 2024 Results Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total operating expenses | $49,616 | $38,573 | $11,043 | | Total other income, net | $32,106 | $3,608 | $28,498 | | **Net loss** | **($17,864)** | **($35,187)** | **$17,323** | [Overview](index=24&type=section&id=Overview) The company is a biotech firm focused on COMP360 for TRD, with Phase 3 trials underway and top-line COMP005 data expected in late June 2025, supported by **$260.1 million** cash through H2 2026 - The Phase 3 program for COMP360 in TRD consists of two pivotal trials, COMP005 (n=258) and COMP006 (n=568). Top-line 6-week data for COMP005 is expected in late June 2025[90](index=90&type=chunk)[91](index=91&type=chunk) - A Phase 2 study of COMP360 in PTSD met its primary safety endpoint and showed meaningful symptom improvement, leading to the design of a late-stage PTSD program[92](index=92&type=chunk) - In January 2025, the company completed a financing selling ADSs and warrants. As of March 31, 2025, cash and cash equivalents were **$260.1 million**, with an expected cash runway through H2 2026[95](index=95&type=chunk)[98](index=98&type=chunk) [Components of Our Results of Operations](index=26&type=section&id=Components%20of%20Our%20Results%20of%20Operations) Key drivers of financial results include R&D and G&A expenses, with no revenue, and Other Income influenced by UK R&D tax credits and warrant liability fair value changes - R&D expenses are expected to continue to increase as the company completes the clinical development for its investigational COMP360 psilocybin treatment for TRD[104](index=104&type=chunk) - The UK R&D tax credit is a key component of Other Income and is not dependent on taxable income, being recorded as a benefit before income tax[108](index=108&type=chunk)[110](index=110&type=chunk) - Fair value changes in warrant liabilities, which are re-measured each period, are recognized in the statement of operations and can cause significant fluctuations[112](index=112&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Q1 2025 saw R&D expenses rise by **$6.0 million** to **$30.9 million** and G&A by **$5.1 million** to **$18.7 million**, but a **$19.5 million** gain on warrant liabilities led to a reduced net loss of **$17.9 million** R&D Expense Breakdown (in thousands) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Development expenses | $21,696 | $13,944 | $7,752 | | Personnel expenses | $6,069 | $6,604 | ($535) | | **Total R&D expenses** | **$30,880** | **$24,901** | **$5,979** | G&A Expense Breakdown (in thousands) | Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Legal and professional fees | $9,364 | $2,447 | $6,917 | | Personnel expenses | $5,061 | $5,501 | ($440) | | **Total G&A expenses** | **$18,736** | **$13,672** | **$5,064** | - Other income, net, increased by **$28.5 million**, primarily due to a **$19.5 million** gain on the change in fair value of warrant liabilities and a **$5.3 million** increase in the benefit from the R&D tax credit[120](index=120&type=chunk)[122](index=122&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$260.1 million** in cash as of March 31, 2025, sufficient to fund operations through H2 2026, with Q1 2025 seeing **$45.7 million** cash used in operations and **$140.4 million** provided by financing - The company had cash and cash equivalents of **$260.1 million** as of March 31, 2025[129](index=129&type=chunk) - The current cash balance is expected to fund operating expenses and capital requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026[129](index=129&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($45,657) | ($20,828) | | Net cash provided by financing activities | $140,359 | $63,512 | [Critical Accounting Policies and Significant Judgments and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Critical accounting policies were updated in Q1 2025 to include warrant liabilities, recorded at fair value using the Black-Scholes model, requiring significant management judgment and re-measurement each period - The company accounts for certain warrants as liabilities in accordance with ASC Topic 815-40, recording them at fair value and re-measuring them each reporting period[133](index=133&type=chunk) - The fair value of these warrant liabilities is determined using the Black-Scholes pricing model, a method that is subject to a significant degree of management's judgment[133](index=133&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes in market risk exposures were reported compared to the Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes in market risk exposures that affect the disclosures presented in the company's Annual Report on Form 10-K for the year ended December 31, 2024[137](index=137&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during Q1 2025 - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[138](index=138&type=chunk) - There were no material changes in the company's internal control over financial reporting during the first quarter of 2025[139](index=139&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any litigation or claims that would materially adversely affect its business or financial condition - The company is not currently a party to any material legal proceedings[141](index=141&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks, including financial losses, dependence on COMP360 development, regulatory hurdles for controlled substances, adverse side effects, competition, and reliance on third parties - The company is a clinical-stage entity with a history of significant losses, an accumulated deficit of **$552.6 million** as of March 31, 2025, and expects to incur losses for the foreseeable future[143](index=143&type=chunk) - The company's business is highly dependent on the success of its investigational COMP360 psilocybin treatment, which is subject to stringent controlled substance laws (Schedule I in the U.S.) and may never receive regulatory approval or be successfully commercialized[176](index=176&type=chunk)[183](index=183&type=chunk) - The company relies on third parties for the manufacturing of COMP360 and for conducting clinical trials, exposing it to risks of supply disruption, regulatory non-compliance, and delays[413](index=413&type=chunk)[418](index=418&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=36&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This sub-section details the company's history of significant operating losses, expected future losses, critical need for additional capital, and potential for dilution or restrictive terms from future financings [Risks Related to Development, Clinical Testing and Commercialization](index=46&type=section&id=Risks%20Related%20to%20Development%2C%20Clinical%20Testing%20and%20Commercialization) This sub-section outlines extensive risks in developing and commercializing COMP360, including trial failures, adverse side effects, regulatory approval for a Schedule I substance, market acceptance, and competition [Risks Related to Regulatory Compliance](index=75&type=section&id=Risks%20Related%20to%20Regulatory%20Compliance) This sub-section details risks from psilocybin's Schedule I status, requiring rescheduling for commercialization, and compliance burdens from anti-corruption, tax (Section 280E), healthcare fraud, and data privacy laws [Risks Related to Intellectual Property](index=91&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This sub-section details IP risks, including challenges in obtaining, maintaining, and defending COMP360 patents, potential invalidation, insufficient protection, third-party infringement claims, and protecting trade secrets and trademarks [Risks Related to Our Dependence on Third Parties](index=103&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This sub-section outlines reliance on third parties, including CMOs for COMP360 manufacturing and CROs for clinical trials, exposing the company to risks of failures, quality issues, supply disruptions, and delays [Risks Related to Business Operations, Managing Growth and Employee Matters](index=108&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations%2C%20Managing%20Growth%20and%20Employee%20Matters) This sub-section covers operational and personnel risks, including retaining key talent, managing growth, employee morale, misconduct, competition, cybersecurity threats, and business disruptions from external events [Risks Related to the Ownership of Our ADSs](index=118&type=section&id=Risks%20Related%20to%20the%20Ownership%20of%20Our%20ADSs) This sub-section addresses risks for ADS investors, including price volatility, no dividends, challenges in enforcing judgments, differing voting rights, and potential adverse U.S. tax consequences from PFIC or CFC classification [Risks Related to Our Controls Over Financial Reporting](index=131&type=section&id=Risks%20Related%20to%20Our%20Controls%20Over%20Financial%20Reporting) This sub-section highlights the risk of failing to maintain effective internal control over financial reporting, which could lead to inaccurate reporting, fraud, loss of investor confidence, and negative impact on ADS trading price [General Risk Factors](index=132&type=section&id=General%20Risk%20Factors) This sub-section covers broad external risks, including currency exchange rate fluctuations, unfavorable global economic and geopolitical conditions, and uncertainty from potential changes in U.S. government policies and tax laws [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=141&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section reports on the company's purchases of **26,563** ordinary shares at a weighted-average price of **$4.20** per share in Q1 2025, primarily for employee tax withholding obligations Issuer Purchases of Equity Securities (Q1 2025) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | Jan 2025 | 0 | — | | Feb 2025 | 22,095 | $4.31 | | Mar 2025 | 4,468 | $3.67 | | **Total** | **26,563** | **$4.20** | - The shares purchased represent ordinary shares surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of employee equity awards[562](index=562&type=chunk) [Item 3. Defaults Upon Senior Securities](index=141&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable, indicating no defaults upon the company's senior securities during the period - Not applicable; no defaults upon senior securities were reported[563](index=563&type=chunk) [Item 4. Mine Safety Disclosures](index=141&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business operations - Not applicable; the company has no mine safety disclosures to report[564](index=564&type=chunk) [Item 5. Other Information](index=141&type=section&id=Item%205.%20Other%20Information) During Q1 2025, no directors or executive officers adopted, terminated, or modified any Rule 10b5-1 trading plans or similar arrangements - During Q1 2025, no directors or executive officers adopted, terminated, or modified any Rule 10b5-1 trading plans or similar arrangements[565](index=565&type=chunk) [Item 6. Exhibits](index=142&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q, including amended employment agreements for key executives, a research collaboration amendment, SOX certifications, and XBRL data files - Filed exhibits include amended employment agreements for CEO Kabir Nath and CFO Teri Loxam, and an amendment to the research collaboration with King's College London[569](index=569&type=chunk) - Certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002, signed by the CEO and CFO, are included as exhibits[569](index=569&type=chunk)

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 ...