LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following December investor conferences: A live audio webcast of these events will be accessible from the "Events†page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Com ...

Core Insights - Compass Pathways plc is a biotechnology company focused on mental health innovation, particularly through its investigational treatment COMP360, which has received Breakthrough Therapy designation from the FDA and ILAP designation in the UK for treatment-resistant depression [2][8]. Company Participation in Conferences - Compass Pathways will participate in two investor conferences in December 2025: the 8th Annual Evercore Healthcare Conference on December 2, 2025, and the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1][4]. Financial and Business Updates - The company reported its third quarter 2025 financial results, highlighting an acceleration of its commercial launch plans for COMP360 by 9-12 months due to positive discussions with the FDA and completion of COMP006 enrollment [8]. Leadership Changes - Dr. Jeffrey Jonas has been appointed to the Board of Directors of Compass Pathways, bringing over 30 years of experience in pharmaceutical research and development, particularly in neuroscience [9].

Summary of COMPASS Pathways Conference Call Company Overview - **Company**: COMPASS Pathways (NasdaqGS:CMPS) - **Focus**: Development of synthetic psilocybin for treatment-resistant depression (TRD) and PTSD - **Current Status**: Nearing completion of phase three trials with significant milestones achieved [1][2] Key Updates and Milestones - **Phase Three Trials**: Enrollment for the second phase three trial (006) has been completed, marking a significant milestone [1][2] - **FDA Interaction**: A Type B meeting with the FDA was granted, resulting in a positive and collaborative discussion, which has accelerated timelines for potential rolling submission and review [2][3] - **Data Disclosure**: Upcoming disclosures include: - Q1 2026: Nine-week data from part A of trial 006 and both parts A and B of trial 005 [3][6] - Early Q3 2026: Completion of part B data for trial 006 [3][4] - **Launch Timeline**: The launch has been accelerated by approximately 9-12 months due to the progress in trials and data collection [3][4] Efficacy and Safety Data - **Efficacy**: The initial results from trial 005 showed a highly statistically significant outcome at week six, comparable to existing treatments like Spravato [10][11] - **Durability of Response**: Data from previous studies suggest that patients may require treatment 2 to 5 times per year, with ongoing assessments of durability and response rates [11][12] - **Safety Profile**: The safety data from the DSMB has been clean, and ongoing trials are expected to provide more granularity on adverse events [28][29] PTSD Development - **PTSD Trials**: Positive data from a phase two A study in PTSD has encouraged the company to finalize a design for a late-stage trial, with details to be announced soon [31] Commercial Strategy - **Market Positioning**: COMPASS aims to be the first approved psychedelic treatment, with a focus on scalability and efficient delivery of treatments [4][32] - **Billing and Economics**: New CPT codes effective January 2024 will allow for hourly billing for psychedelic treatments, making it economically favorable for treatment sites [35] - **Prescriber Targeting**: The company is focusing on high-potential prescribers, with an estimated 5,000 prescribers currently for Spravato, where 80% of volume comes from less than 1,000 prescribers [44] Future Outlook - **Excitement for Launch**: The company expresses strong confidence in the upcoming launch and the potential impact of COMP360 on patients with TRD and PTSD [47][48] - **Strategic Collaborations**: Ongoing work with medical science liaisons and strategic collaborations is aimed at preparing for a successful market entry [43][44] Additional Insights - **Integration of Therapy**: While there is no requirement for therapy during the administration of COMP360, follow-up safety assessments will be conducted to monitor patient well-being [41][42] - **Patient Experience**: The treatment experience is designed to be calm and supportive, allowing for potential efficiencies in patient management over time [36][40] This summary encapsulates the key points discussed during the COMPASS Pathways conference call, highlighting the company's advancements, strategic plans, and future expectations in the psychedelic treatment landscape.

Core Viewpoint - Compass Pathways plc is focused on enhancing patient access to evidence-based innovations in mental health, indicating a commitment to advancing the biotechnology sector in this area [1] Company Participation - Management of Compass Pathways will participate in the Stifel 2025 Healthcare Conference scheduled for November 11, 2025, at 10:40 am ET [1] - A live audio webcast of the conference will be available on the company's website, allowing investors and stakeholders to access the event [1]

Transforming Mental Health Care Investor Presentation November 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," "target," "will," "would," or the negative of these terms, ...

Financial Data and Key Metrics Changes - At the end of September, the company had cash and cash equivalents of $186 million, down from $222 million at the end of the second quarter, indicating disciplined spending to maintain cash runway into 2027 [9] - Cash used in operations for the third quarter was $35 million, with an expected net cash used in operations for the full year 2025 to be between $120 million and $145 million [9] Business Line Data and Key Metrics Changes - The first phase 3 trial, COMP005, demonstrated a highly statistically significant result for the primary endpoint, marking an important de-risking event for the company [4] - Enrollment for the second phase 3 trial, COMP006, continued to accelerate, with completion of enrollment announced [5] Market Data and Key Metrics Changes - The company is encouraged by the increase in interventional psychiatry infrastructure, driven by existing treatments and the potential for psychedelic treatments like COMP360 [7][8] - The company is focused on understanding the commercial landscape and provider dynamics to differentiate COMP360 from current and future treatment options [6] Company Strategy and Development Direction - The company plans to accelerate its launch readiness based on significant progress made over the past few years, with strategic collaborations and insights into patient preferences and provider economics [6][8] - The company is finalizing the design for a late-stage PTSD trial, following positive interactions with the FDA [8] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential 9-12 month acceleration of launch plans, supported by positive FDA interactions regarding the filing strategy for COMP360 [4][5] - The company is confident in the emerging profile for COMP360 and its potential to transform treatment options for patients with TRD and PTSD [10] Other Important Information - The company has added resources to its regulatory team to expedite NDA filing activities and has pulled forward select commercial activities to meet new accelerated timelines [10] - The company is committed to broad and equitable access for COMP360, enabling access in a variety of treatment sites [53] Q&A Session Summary Question: Selection of specialty pharma partner for patient access - The company has not made a selection yet, as it is still early in the process, but will narrow down options in the coming months [14] Question: Administration of COMP360 at sites delivering Spravato - Any site delivering Spravato today is expected to be capable of delivering COMP360 if approved, with ongoing assessments to understand any incremental changes needed [17] Question: FDA engagement and data granularity - The company anticipates another meeting with the FDA after significant data readouts in Q1, to align on the plan going forward [21] Question: Commercialization preparation for COMP360 - The company has made significant progress in understanding the marketplace and is pulling forward traditional commercial activities like marketing and sales force structuring [41] Question: Change in FDA's tone regarding COMP360 - The company has noted a positive change in tone from the FDA, indicating recognition of the potential in psychedelics and the need for new treatment options [46] Question: Readiness of interventional psychiatry centers for COMP360 - A high representation of interventional psychiatry centers capable of administering COMP360 is expected at launch, with ongoing support for these sites [52]

Financial Data and Key Metrics Changes - The company has accelerated its timeline for commercialization by nine to twelve months due to successful enrollment in clinical trials and positive dialogue with the FDA [59][63] - The 26-week data from the O6 trial is now expected to be available in early Q3, which is earlier than previously guided [59] Business Line Data and Key Metrics Changes - The company is preparing for the launch of COMM-360, which is expected to be administered at sites currently delivering SPRAVATO, indicating a smooth transition for existing treatment centers [9][10] - The company has made significant progress in strategic collaborations and market access work to ensure a solid understanding of the marketplace landscape [40][41] Market Data and Key Metrics Changes - The company anticipates that a significant number of the approximately 6,000 interventional psychiatry centers capable of administering multi-hour treatments will be certified to deliver COMM-360 at launch [50][55] Company Strategy and Development Direction - The company is focused on building a strong commercial strategy, including marketing, messaging, and payer discussions, to ensure successful market entry [41][42] - The company is also exploring broader access to treatment beyond interventional psychiatry sites, reflecting a commitment to equitable access [55] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for accelerated timelines and the positive relationship with the FDA, which is crucial for the development of psychedelic treatments [48][63] - The company is preparing for an advisory committee meeting with the FDA and is confident in its data collection and risk-benefit characterization for COMM-360 [52][51] Other Important Information - The company has finalized the protocol for PTSD studies and is looking forward to initiating the first patient in Q1 of the following year [64] - The company is actively engaging with the VA to ensure access to treatments upon approval [26] Q&A Session Summary Question: Selection of specialty pharma partner for patient access - The company has not yet selected a partner but is working on understanding distribution pathways and will narrow down options in the coming months [6][7] Question: Administration of COMM-360 at SPRAVATO sites - Any site delivering SPRAVATO today is expected to be capable of delivering COMM-360 if approved, although some incremental changes may be needed [9][10] Question: FDA engagement and data expectations - The company expects to have another meeting with the FDA after releasing significant data in Q1, which will help align on the plan going forward [15][61] Question: Commercialization preparation for March - The company has pulled forward traditional commercial activities and is ready to engage in payer discussions based on upcoming data [41][42] Question: Change in FDA's tone regarding COMM-360 - The company noted a positive change in tone from the FDA, indicating a supportive relationship while maintaining high standards [48][49] Question: Readiness of SPRAVATO infrastructure for COMM-360 - The company is leveraging existing collaborations to ensure that interventional psychiatry sites are prepared to deliver COMM-360 at launch [55]

Core Insights - Compass Pathways is accelerating the launch of its experimental psilocybin-based depression therapy by 9 to 12 months [1] Company Summary - The company is focused on developing innovative treatments for depression using psilocybin, a compound found in certain mushrooms [1]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Performance - The company has not generated any revenue to date and does not expect to do so in the near future from therapeutic candidates[94] - As of September 30, 2025, the company reported net losses of $194.0 million and $111.8 million for the nine months ended September 30, 2025 and 2024, respectively[88] - The company has an accumulated deficit of $728.7 million as of September 30, 2025[88] - The net loss for Q3 2025 was $137.7 million, compared to a net loss of $38.5 million in Q3 2024, reflecting an increase of 357%[108] - For the nine months ended September 30, 2025, total operating expenses were $133.1 million, an increase of 3% from $129.8 million in the same period of 2024[108] - For the nine months ended September 30, 2025, net cash used in operating activities was $119.5 million, an increase of $42.0 million compared to the same period in 2024[119] Cash and Funding - The company had cash and cash equivalents of $185.9 million as of September 30, 2025, which is expected to fund operations into 2027[89] - The company reported a net cash provided by financing activities of $140.5 million for the nine months ended September 30, 2025, an increase of $76.9 million compared to the same period in 2024[121] - The company has funded $30.0 million of the $50.0 million available under the Hercules Loan Agreement[115] - The company has sold 5,491,836 ADSs under its ATM offering program, resulting in $54.8 million in net proceeds[115] Research and Development - The company received Breakthrough Therapy designation from the FDA for its COMP360 psilocybin treatment for treatment-resistant depression (TRD) in 2018[76] - The Phase 2b clinical trial for COMP360 demonstrated a statistically significant reduction in depressive symptom severity with a 25mg dose compared to a 1mg dose, achieving a p-value of p<0.001[79] - The company commenced its Phase 3 program for COMP360 in TRD at the beginning of 2023, consisting of two pivotal trials[77] - The first pivotal trial (COMP005) has enrolled 258 participants and achieved its primary endpoint[79] - The second pivotal trial (COMP006) has completed enrollment with 585 participants and is designed to investigate the effects of a second dose on therapeutic response[81] - The company expects to continue incurring significant R&D costs through the completion of its Phase 3 program for COMP360 psilocybin therapy[110] - The benefit from R&D tax credit increased to $16.7 million for the nine months ended September 30, 2025, compared to $10.9 million in the same period of 2024, reflecting higher R&D expenditures[114] - Research and development expenses for Q3 2025 were $27.3 million, a decrease of 17% from $32.9 million in Q3 2024[109] Operating Expenses - Total operating expenses for Q3 2025 were $40.5 million, down 15% from $47.9 million in Q3 2024[108] - General and administrative expenses for Q3 2025 were $13.2 million, a decrease of 12% from $15.0 million in Q3 2024[111] - The company anticipates ongoing increases in expenses associated with operating as a public company, including legal and accounting costs[122] - The company expects to incur significant commercialization expenses related to product manufacturing and pre-commercial activities as it advances its Phase 3 program for COMP360 in TRD[122] Market and Regulatory Status - The company qualifies as a "smaller reporting company" under the Securities Exchange Act of 1934, allowing it to utilize scaled disclosures[132] - Annual revenues are reported to be less than $100.0 million, which exempts the company from certain reporting requirements[132] - The company is not required to provide an attestation report on internal control over financial reporting due to its status as a smaller reporting company[132] - The threshold for non-affiliate voting and non-voting shares is set at less than $250.0 million for continued scaled disclosures[132] - There have been no material changes in market risk exposures affecting disclosures since the last Annual Report[133] Other Financial Metrics - The company recorded a fair value change of warrant liabilities amounting to $(101.3) million in Q3 2025, compared to no such expense in Q3 2024[108] - The benefit from R&D tax credit for Q3 2025 was $3.9 million, slightly down from $4.1 million in Q3 2024[108] - Accumulated trading losses for carry forward in the UK were $339.7 million as of December 31, 2024[106] - The company anticipates reduced personnel expenses in 2025 compared to 2024 due to a reorganization undertaken in Q4 2024[98]