Financial Performance - The net loss for Q3 2025 was $137.7 million, or $1.44 per share, compared to a net loss of $38.5 million, or $0.56 per share, in Q3 2024 [12]. - Net loss for Q3 2025 was $137,717,000, compared to a net loss of $38,502,000 in Q3 2024, indicating a significant increase in losses [20]. - Loss before income taxes for Q3 2025 was $137,947,000, compared to $38,329,000 in Q3 2024, representing a substantial increase in operational losses [20]. - Comprehensive loss for Q3 2025 was $138,322,000, compared to a comprehensive loss of $38,163,000 in Q3 2024 [20]. - Total other income, net for Q3 2025 was a loss of $97,411,000, contrasting with a gain of $9,567,000 in Q3 2024 [20]. - Net loss per share attributable to ordinary shareholders for Q3 2025 was $1.44, compared to $0.56 in Q3 2024 [20]. Cash Position and Assets - The cash position as of September 30, 2025, was $185.9 million, an increase from $165.1 million as of December 31, 2024 [12]. - Full year 2025 net cash used in operating activities is expected to be between $120 million and $145 million, with sufficient cash to fund operations into 2027 [9]. - The total assets as of September 30, 2025, were $255.6 million, compared to $213.7 million as of December 31, 2024 [18]. - The accumulated deficit increased to $728.7 million as of September 30, 2025, from $534.7 million at the end of 2024 [18]. Research and Development - Research and development expenses for Q3 2025 were $27.3 million, down from $32.9 million in Q3 2024, primarily due to decreased development expenses related to the termination of discovery programs [8]. - Research and development expenses decreased to $27,325,000 in Q3 2025 from $32,928,000 in Q3 2024, reflecting a reduction of 17% [20]. - Benefit from R&D tax credit for Q3 2025 was $3,924,000, slightly down from $4,084,000 in Q3 2024 [20]. - The second Phase 3 trial, COMP006, has completed enrollment with 585 participants, and data from this trial is expected in Q1 2026 [6]. - Compass Pathways accelerated its commercial launch plans for COMP360 in Treatment Resistant Depression (TRD) by 9-12 months following the completion of the COMP006 trial enrollment and positive discussions with the FDA [3][5]. - The company plans to disclose 9-week data from COMP006 and 26-week data from COMP005 in Q1 2026 [5][6]. Operating Expenses - General and administrative expenses for Q3 2025 were $13.2 million, down from $15.0 million in Q3 2024, due to decreased personnel and non-cash share-based compensation expenses [8]. - Total operating expenses for Q3 2025 were $40,536,000, a decrease of 15.4% from $47,896,000 in Q3 2024 [20]. - Interest income for Q3 2025 was $1,588,000, a decrease from $1,977,000 in Q3 2024 [20]. - Weighted average ordinary shares outstanding for Q3 2025 were 95,337,993, an increase from 68,395,343 in Q3 2024 [20].

Core Insights - NeuroKaire has initiated a research and development collaboration with Compass Pathways to enhance the understanding of psychedelic compounds for mental health therapies [1][4] - The collaboration will utilize patient-derived neurons to study the structure and connectivity of neurons, particularly focusing on treatment-resistant depression and major depressive disorder [2][5] Company Overview - NeuroKaire specializes in precision medicine solutions aimed at optimizing treatments for psychiatric and neurological diseases by leveraging biological data [6] - Compass Pathways is a biotechnology company focused on accelerating access to evidence-based mental health innovations, particularly through the development of synthetic psilocybin treatments [7] Research Methodology - The study will employ NeuroKaire's proprietary platform, which integrates advanced biology and AI-powered image analysis to investigate the effects of various compounds on neuronal communication [3][5] - The research aims to provide insights into the cellular mechanisms of potential treatments, thereby guiding future therapeutic developments [5] Strategic Importance - This collaboration represents a significant shift in psychiatry, merging human biology with machine learning to improve the transition from preclinical research to real-world patient outcomes [5] - Both companies express optimism about the potential for this partnership to lead to more effective and personalized mental health treatments [4][5]

Core Insights - Compass Pathways plc has appointed Dr. Jeffrey Jonas to its Board of Directors, effective immediately, bringing over 30 years of experience in pharmaceutical research and development, particularly in neuroscience [1][3][4] - Thomas Lönngren will retire from the Board at the end of December after more than six years of service, having contributed significantly to the company's achievements, including the advancement of the COMP360 program [2][3] Company Overview - Compass Pathways is a biotechnology company focused on accelerating patient access to evidence-based innovations in mental health, particularly through its investigational COMP360 synthetic psilocybin treatment [6][7] - The company aims to address the growing mental health crisis by developing transformative treatments for conditions that are not adequately addressed by existing therapies [5][6] Product Development - COMP360 has received Breakthrough Therapy designation from the US FDA and Innovative Licensing and Access Pathway designation in the UK for treatment-resistant depression [7] - The company is pioneering a new treatment paradigm aimed at achieving rapid and durable responses for patients with serious mental health conditions [6][7] Leadership and Expertise - Dr. Jonas has held various leadership roles in life sciences, including CEO of Sage Therapeutics and President of the Regenerative Medicine Division at Shire Pharmaceuticals, and has a strong background in psychiatric disorders and neuropsychopharmacology [3][4] - His extensive experience is expected to be beneficial as Compass Pathways works towards bringing COMP360 to market, pending regulatory approval [3][5]

Core Insights - Compass Pathways plc is set to announce its third quarter financial results for the period ending September 30, 2025, on November 4, 2025, and will provide updates on recent developments [1][2] Company Overview - Compass Pathways is a biotechnology company focused on improving patient access to evidence-based innovations in mental health, particularly for those with serious mental health conditions unresponsive to existing treatments [3][4] - The company is developing COMP360, a synthesized psilocybin treatment, which has received Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway designation in the UK for treatment-resistant depression [3] Upcoming Events - Management will host a conference call on November 4, 2025, at 8:00 am ET (1:00 pm UK), with a live webcast available on the company's website [2] - Compass Pathways is participating in several investor conferences, including the Cantor Global Healthcare Conference and the Morgan Stanley 23rd Annual Global Healthcare Conference in September 2025 [8][9]

Group 1 - The session is part of the Morgan Stanley Global Healthcare Conference, featuring discussions on biotech companies [1] - COMPASS Pathways team is represented by key members including Kabir, Teri, Steve, and Guy, indicating a collaborative approach to the discussion [2] - The discussion aims to provide a comprehensive overview of the company and its COMP360 program, highlighting its significance in the biotech sector [2]

Company Overview - COMPASS Pathways is a leading company in the field of psychedelics, which has transitioned from a fringe area to a mainstream focus [1] - The management team includes Kabir Nath (CEO), Guy Goodwin (CMO), and Steve Levine (CPO), indicating a strong leadership presence in the industry [1] Industry Perspective - The psychedelics industry requires a new approach to communication and understanding, reflecting its growing acceptance and potential [1] - There is a discussion on the terminology used in the industry, questioning whether to continue using the term "psychedelic" or to adopt alternative language [1]

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]

Core Insights - Compass Pathways Plc reported strong clinical progress with its lead drug candidate, COMP360 psilocybin, achieving its primary goal in a Phase 3 trial for treatment-resistant depression (TRD) [1][5] - The company posted a GAAP net loss of $0.41 per share for Q2 2025, slightly better than the consensus estimate of $0.43 per share, with no revenue generated as expected for a pre-commercial entity [1][6] - The financial position improved, with cash and cash equivalents increasing to $221.9 million, expected to support operations into 2027 [7] Financial Performance - Q2 2025 GAAP EPS was $(0.41), an improvement of 26.8% from $(0.56) in Q2 2024 [2] - Research and Development expenses were $30.3 million, up 4.1% from $29.1 million in Q2 2024 [2] - General and Administrative expenses decreased by 11.9% year-over-year to $12.6 million [2] Clinical Developments - COMP360 demonstrated a statistically significant reduction in symptom severity in the COMP005 Phase 3 trial for TRD after six weeks [5] - The independent Data Safety Monitoring Board reported no unexpected safety issues during the trial [5] - The company is also advancing COMP360 into post-traumatic stress disorder (PTSD) with late-stage clinical trial design being finalized [8] Strategic Focus - Compass Pathways aims to provide clear evidence of clinical benefit and safety for COMP360, with priorities on late-stage clinical trials and regulatory submissions [4] - The company is preparing for commercialization, contingent on positive trial results and effective patient treatment planning post-approval [4] Future Outlook - Management did not provide formal revenue or earnings guidance but reaffirmed a target for full-year 2025 net cash used in operating activities of $120 to $145 million [9] - Key upcoming data releases include 26-week durability and long-term safety data from ongoing trials, expected by late 2026 [10] - The company is monitoring regulatory discussions and competitive landscape developments in the psychedelic treatment space [10]

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]

Second Quarter 2025 Business Highlights The company announced positive Phase 3 results for COMP360 in TRD and is advancing its PTSD clinical program [COMP360 Psilocybin Treatment in TRD (Treatment Resistant Depression)](index=1&type=section&id=COMP360%20psilocybin%20treatment%20in%20TRD%20%28Treatment%20Resistant%20Depression%29) The company announced positive primary endpoint results from its first Phase 3 trial (COMP005) for COMP360 in treatment-resistant depression, demonstrating a statistically significant and clinically meaningful reduction in symptoms at 6 weeks with no unexpected safety findings. The second Phase 3 trial (COMP006) is enrolling well, with 26-week data anticipated in the second half of 2026, and the company is exploring pathways for an accelerated regulatory filing - Achieved a **positive primary endpoint** in the first COMP360 Phase 3 trial (COMP005), showing a **highly statistically significant and clinically meaningful reduction** in depression symptoms at **6 weeks** after a single administration[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The second pivotal Phase 3 trial (COMP006) is continuing to enroll, with **26-week data** expected in the **second half of 2026**[5](index=5&type=chunk)[6](index=6&type=chunk) - A Data Safety Monitoring Board (DSMB) review found **no unexpected safety findings** and **no clinically meaningful imbalance in suicidal ideation** in either Phase 3 study[6](index=6&type=chunk) - The company is exploring options for a **potential accelerated filing** of COMP360 for TRD based on the positive Phase 3 data[5](index=5&type=chunk) [COMP360 Psilocybin Treatment in PTSD (Post Traumatic Stress Disorder)](index=2&type=section&id=COMP360%20psilocybin%20treatment%20in%20PTSD%20%28Post%20Traumatic%20Stress%20Disorder%29) Following a positive Phase 2 open-label study announced in May 2024, which showed COMP360 was well-tolerated and demonstrated rapid, durable symptom improvement, the company is now finalizing the design for a late-stage clinical trial for PTSD - The company is **finalizing the design for a late-stage clinical trial** for COMP360 in PTSD[7](index=7&type=chunk) - The trial design is informed by a Phase 2 study where a single administration of COMP360 was **well-tolerated and showed rapid and durable symptom improvement** from baseline[7](index=7&type=chunk) Corporate and Financial Highlights Key corporate developments include board changes, a review of financial performance, and updated financial guidance [Board of Directors Update](index=2&type=section&id=Board%20of%20Directors%20update) Justin Gover, the former CEO of GW Pharmaceuticals, has been appointed to the Compass Pathways Board of Directors. Concurrently, Dr. Linda McGoldrick will retire from her board position at the end of October after more than five years of service - **Justin Gover**, former CEO of GW Pharmaceuticals, was **appointed to the Board of Directors**[9](index=9&type=chunk) - **Dr. Linda McGoldrick** is set to **retire from the Board** at the end of October after over 5 years of service[9](index=9&type=chunk) [Financial Highlights](index=2&type=section&id=Financial%20Highlights) For Q2 2025, Compass reported a net loss of $38.4 million, slightly up from $38.1 million in Q2 2024, influenced by a non-cash loss on warrant liabilities. For the first six months of 2025, the net loss decreased to $56.3 million from $73.3 million year-over-year, primarily due to a significant non-cash gain on warrant liabilities. R&D expenses rose due to advancing Phase 3 trials, while G&A expenses declined. The company ended the quarter with a strong cash position of $221.9 million | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net Loss** | $38.4M | $38.1M | $56.3M | $73.3M | | **Net Loss Per Share** | $0.41 | $0.56 | $0.62 | $1.11 | | **R&D Expenses** | $30.3M | $29.1M | $61.2M | $54.0M | | **G&A Expenses** | $12.6M | $14.3M | $31.3M | $27.9M | - The **significant variability in reported net loss** was primarily driven by **non-cash fair value adjustments related to warrant liabilities**, which resulted in a **$2.5 million loss** in **Q2 2025** and a **$16.9 million gain** in **H1 2025**[9](index=9&type=chunk)[14](index=14&type=chunk) - **Cash and cash equivalents** were **$221.9 million** as of **June 30, 2025**, compared to **$165.1 million** as of **December 31, 2024**[14](index=14&type=chunk) [Financial Guidance](index=3&type=section&id=Financial%20Guidance) The company projects its full-year 2025 net cash used in operating activities to be in the range of $120 million to $145 million. Its cash position of $221.9 million as of June 30, 2025, is expected to be sufficient to fund operations and capital expenditures into 2027 - **Full year 2025 net cash used in operating activities** is expected to be between **$120 million and $145 million**[11](index=11&type=chunk) - The cash position as of **June 30, 2025**, is expected to provide a **cash runway into 2027**[5](index=5&type=chunk)[11](index=11&type=chunk) Financial Statements Detailed financial statements provide an overview of the company's balance sheet and operational performance [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets grew to $293.5 million from $213.7 million at year-end 2024, driven by an increase in cash to $221.9 million. Total liabilities rose substantially to $131.0 million from $59.0 million, primarily due to the recognition of $74.4 million in warrant liabilities. Consequently, total shareholders' equity increased modestly to $162.6 million | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $221,881 | $165,081 | | **Total assets** | $293,536 | $213,666 | | **Warrant liabilities** | $74,398 | $0 | | **Total liabilities** | $130,981 | $58,971 | | **Total shareholders' equity** | $162,555 | $154,695 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the second quarter of 2025, the company reported a net loss of $38.4 million, nearly flat compared to a $38.1 million loss in Q2 2024. For the six months ended June 30, 2025, the net loss improved to $56.3 million from $73.3 million in the prior-year period. This improvement was largely due to a $16.9 million non-cash gain from the change in fair value of warrant liabilities. Operating expenses for the six-month period increased to $92.5 million from $81.9 million, driven by higher research and development costs | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $30,325 | $29,069 | | General and administrative | $12,608 | $14,253 | | Loss from operations | $(42,933) | $(43,322) | | Fair value change of warrant liabilities | $(2,540) | $0 | | **Net loss** | **$(38,403)** | **$(38,101)** | | Statement of Operations (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $61,205 | $53,970 | | General and administrative | $31,344 | $27,925 | | Loss from operations | $(92,549) | $(81,895) | | Fair value change of warrant liabilities | $16,920 | $0 | | **Net loss** | **$(56,267)** | **$(73,288)** | Company Information and Disclosures This section provides an overview of Compass Pathways and standard forward-looking statement disclosures [About Compass Pathways](index=3&type=section&id=About%20Compass%20Pathways) Compass Pathways is a biotechnology company dedicated to advancing mental health treatments. Its primary focus is the development of COMP360, an investigational synthetic psilocybin therapy. This therapy has received Breakthrough Therapy designation from the U.S. FDA and an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) - The company is a **biotechnology firm** focused on accelerating patient access to evidence-based innovation in mental health[12](index=12&type=chunk) - Its lead program is the development of investigational COMP360 synthetic psilocybin treatment, which has received **FDA Breakthrough Therapy** and **UK ILAP designations** for **treatment-resistant depression (TRD)**[12](index=12&type=chunk) [Forward-looking Statements](index=3&type=section&id=Forward-looking%20statements) This section provides a standard safe harbor statement, cautioning that the press release includes forward-looking statements concerning financial guidance, clinical trial timelines, regulatory approval prospects, and commercialization plans. These statements are subject to significant risks and uncertainties, such as clinical development outcomes, funding availability, and regulatory challenges, which could cause actual results to differ materially from expectations - The press release contains **forward-looking statements** regarding financial guidance, clinical trial timelines (including Phase 3 TRD data), potential for regulatory filings, and commercialization plans[15](index=15&type=chunk) - These statements are **not guarantees and involve known and unknown risks**, including **uncertainties in clinical development**, the **need for additional funding**, and potential for **unsuccessful marketing approval efforts**[16](index=16&type=chunk)