Summary of COMPASS Pathways (CMPS) FY Conference Call - August 12, 2025 Company Overview - **Company**: COMPASS Pathways - **Focus**: Mental health treatments, specifically in the psychedelic space - **Product**: COMM 360, aimed at treating treatment-resistant depression (TRD) Key Points and Arguments 1. **Regulatory Landscape**: - Political and regulatory support for psychedelic treatments is seen as neutral to positive, with endorsements from various government leaders acknowledging the unmet needs in mental health care [7][10] - The FDA's psychiatry division remains engaged and responsive, having granted breakthrough therapy designation to COMPASS [9][30] 2. **Clinical Trials**: - A large Phase 2b study for TRD involved 233 patients across 22 sites in 10 countries, achieving statistically significant results [11] - The Phase 3 trial (COM005) demonstrated a significant separation of the 25 mg dose from placebo at week six after a single administration, which is a notable advantage over existing treatments like esketamine (SPRAVATO) [16][17] 3. **Market Positioning**: - COMPASS believes it is well-positioned to commercialize COMM 360 in the U.S., differing from traditional big pharma approaches [14] - There is interest from major pharmaceutical companies in the psychedelic space, which validates the science behind these treatments [13][15] 4. **Safety and Efficacy**: - The Data Safety Monitoring Board (DSMB) issued a clean safety statement for the Phase 3 trials, indicating no new safety signals [18][22] - Comparability of COMPASS's data with SPRAVATO has been emphasized, with a focus on achieving clinically meaningful reductions in depression scales [23] 5. **Investor Perception**: - Initial misunderstandings regarding the Phase 3 data have been addressed, clarifying the trial designs and the implications for future studies [19][20] - The reception from the neuropsychiatric community has been enthusiastic, with many psychiatrists viewing COMM 360 as approvable [24] 6. **Future Developments**: - A meeting with the FDA is scheduled to discuss the data and potential for accelerated filing based on the evidence gathered [25][26] - Plans for a PTSD trial are in development, with a focus on addressing the significant unmet need in this area [48][49] 7. **Commercial Considerations**: - Pricing strategies will depend on the full profile of COMM 360, with expectations of less frequent administration compared to SPRAVATO [39] - Payer policies are anticipated to align closely with those for SPRAVATO, focusing on patients who meet the definition of treatment-resistant depression [40] 8. **Market Size and Demand**: - Approximately 3 million U.S. adults are living with TRD, with only a small fraction currently receiving effective treatment [43] - The company aims to address the high unmet need in mental health, particularly for patients who have not responded to existing therapies [48] Additional Important Content - The company does not view other psychedelic treatments as direct competitors due to the vast unmet need in the market [52] - The potential for positive data from other psychedelic programs is seen as beneficial for the overall field and patient outcomes [53]

Financial Data and Key Metrics Changes - As of June, the company had cash and cash equivalents of $222 million, down from $260 million at the end of the first quarter, which is expected to fund operations into 2027 [15] - Cash used in operations for the second quarter was $38.7 million, with an expected net cash usage for the full year 2025 in the range of $120 million to $145 million [15] Business Line Data and Key Metrics Changes - The company announced the successful achievement of the primary endpoint of the COMT360-5 trial, showing a statistically significant reduction in depression symptoms [7] - The second pivotal Phase III trial, COMP006, continues to recruit well, with data expected in the second half of next year [9] Market Data and Key Metrics Changes - The company is exploring the potential for COMT360 in PTSD, with a late-stage clinical program design in the final steps [12] - A small Phase II study in anorexia showed encouraging signals in reducing eating disorder and depressive symptoms, although the statistical power was limited due to low participant numbers [13] Company Strategy and Development Direction - The company is focused on executing its pivotal program while exploring opportunities to expedite the delivery of COMT360 to patients with treatment-resistant depression and PTSD [16] - The addition of Justin Gover to the board is expected to leverage his expertise in gaining FDA approval for COMT360 [5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the positive results from the trials, which they believe de-risk the company from a regulatory and commercial perspective [15] - The company is encouraged by the engagement with the FDA and the potential for accelerated pathways for filing [22][29] Other Important Information - The company has submitted an application for the commissioner's national priority review voucher, which promises an accelerated timeline for review [29] - The safety profile of COMT360 in the anorexia study was aligned with the high-risk patient population, with no unexpected safety signals reported [13][61] Q&A Session Summary Question: Can you expand upon the engagement with the FDA since the data? - Management confirmed they will meet with the FDA this quarter and are exploring accelerated pathways for filing [22][24] Question: What feedback have you received about readiness for COMT360 delivery? - The company is confident that the existing network of centers is ready to deliver COMT360 if approved, as they align with the infrastructure currently delivering SPRAVATO [38] Question: Have you seen a pickup in enrollment following the five data? - The company reported that the reception from investigators has been very positive, reinforcing their belief in the potential of the ongoing trial [42] Question: Are you pursuing the commissioner's national priority voucher? - Yes, the company has submitted an application and believes it meets the eligibility criteria [46][48] Question: What is the earliest that you could file a new drug application for COM360? - Management stated it is premature to speculate on the timeline until they meet with the FDA [65]

COMP360 psilocybin treatment in TRD (Treatment Resistant Depression) • Positive primary endpoint achieved in first COMP360 Phase 3 trial with high statistical significance, clinically meaningful reduction in depression at 6 weeks, and no unexpected safety findings • Second ongoing pivotal Phase 3 trial continues to enroll well, with 26-week data expected in the second half of 2026 • Compass exploring options for potential accelerated COMP360 filing for TRD • Cash position of $221.9 million at June 30, 2025; ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ⊠ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-39522 COMPASS Pathways plc (Exact name of registrant as specified in its charter) England and Wales Not Applicable (State ...

Core Viewpoint - The biotechnology industry presents significant investment opportunities, particularly in pre-revenue companies with high price targets set by analysts, indicating potential for dramatic gains in a short time [1][4]. Group 1: Compass Pathways - Compass Pathways is developing a treatment for depression using synthetic psilocybin, with a current market cap of approximately $363 million, down from a peak of over $2 billion during the COVID-19 pandemic [5][10]. - Analysts have set a consensus price target of $15.78 for Compass Pathways, suggesting a potential gain of over 300% from current prices [5]. - The company reported positive results from the COMP005 trial for treatment-resistant depression (TRD), showing a 3.6-point improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) compared to the placebo group [8][9]. - The upcoming COMP006 study will further evaluate the efficacy of COMP360, with expectations that stronger results could significantly increase the stock's value [10]. Group 2: Viking Therapeutics - Viking Therapeutics, another clinical-stage drugmaker, has seen its market cap drop to approximately $3.6 billion from a peak of over $9 billion, with analysts projecting a price target of $90.26, indicating a potential increase of 181% [12]. - The company's lead candidate, VK2735, has shown promising results in weight loss, achieving a placebo-adjusted weight loss of 13% after 13 weeks of treatment [13]. - Viking Therapeutics is positioned to compete with established products like Zepbound, which generated $9.3 billion in annualized sales in the first quarter of this year [14]. - The company is currently conducting a phase 3 study to support a new drug application, which carries risks if tolerability issues arise [15].

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][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Recent Performance of COMPASS Pathways - Over the past three months, the Zacks Consensus Estimate for COMPASS Pathways has increased by 22.6%, reflecting a positive trend in earnings estimates [8]. - The company is expected to earn -$1.48 per share for the fiscal year ending December 2025, with no year-over-year change anticipated [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - COMPASS Pathways' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10].

Core Viewpoint - Compass Pathways' disappointing Phase III trial results for psilocybin treatment of treatment-resistant depression (TRD) led to a significant decline in stock prices across the psychedelic drug sector, with Compass's stock dropping by 49% [1][2]. Group 1: Trial Results and Market Reaction - The Phase III trial (COMP005) for COMP360 showed a MADRS score improvement of only 3.6 points compared to placebo, which, while statistically significant, fell short of analysts' expectations of at least 5 points and was lower than the company's previous Phase II data of 6.6 points [2][3]. - The underwhelming results raised concerns about the efficacy, sustainability, and commercial potential of psilocybin, leading to a broader sell-off in the psychedelic drug sector [2][3]. - Other companies in the psychedelic space, such as atai Life Sciences, MindMed, Cybin, and GH Research, experienced stock declines ranging from 5% to over 15% following the news [2][3]. Group 2: Impact on Other Companies - atai Life Sciences, with its DMT oral film in Phase II trials for TRD, saw its stock drop by over 15% [3]. - MindMed, which is in Phase III trials for an LSD derivative targeting major depressive disorder, experienced a stock decline of approximately 6% [3]. - Cybin's stock, which is developing an oral psilocin treatment for depression in Phase II trials, fell by about 5% [3]. - GH Research, with its inhaled mebufotenin candidate in Phase II for TRD, also saw a stock decrease of around 5% [3]. - Other psychedelic stocks, including Clearmind Medicine, Enveric Biosciences, and Bright Minds Biosciences, faced significant declines on the same day [4].

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]