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 ...

Financial Performance and Losses - Total net losses for the year ended December 31, 2024, were $155.1 million, compared to $118.5 million for the year ended December 31, 2023, resulting in an accumulated deficit of $534.7 million as of December 31, 2024[274]. - The company expects to incur significant losses for the foreseeable future due to ongoing research and development, clinical trials, and regulatory compliance activities[275]. - The company has incurred significant operating losses primarily from research and development activities and general administrative costs[274]. - The company anticipates requiring substantial additional funding to complete the development and commercialization of its investigational COMP360 psilocybin treatment and any future therapeutic candidates[280]. - The company may need to seek additional funding sooner than planned due to changing circumstances, including fluctuating inflation and interest rates[281]. - The company’s ability to raise additional funds will depend on market conditions and may be adversely affected by economic factors such as inflation and potential recession[286]. - The company has accumulated trading losses for carry forward in the UK of $339.7 million and $252.3 million as of December 31, 2024 and December 31, 2023, respectively[422]. Funding and Capital Requirements - As of December 31, 2024, the company had cash and cash equivalents of $165.1 million, which, along with net proceeds of $140.4 million raised in Q1 2025, is expected to fund operations through the planned 26-week data read-out from the COMP006 study in the second half of 2026[281]. - The company may need to seek additional funding sooner than anticipated due to changing circumstances, including fluctuating inflation and interest rates[292]. - The company has a financial covenant requiring a minimum cash balance of $22.5 million, which may necessitate raising additional funds or reducing operating expenses to maintain compliance[301]. - If all outstanding PIPE Warrants and 2025 ADS Warrants were exercised, the company would issue 47,384,148 ADSs, leading to significant dilution for shareholders[298]. - The company has 12,324,700 outstanding PIPE Warrants with an exercise price of $9.93, which is higher than the current trading price of its ADSs, potentially limiting the likelihood of these warrants being exercised[289]. Regulatory and Compliance Challenges - The investigational COMP360 psilocybin treatment is subject to comprehensive regulation by the FDA, DEA, EMA, MHRA, and other foreign regulatory authorities, which will impact its commercialization[307]. - Regulatory approvals are necessary for conducting planned clinical trials, and any delays in these approvals could significantly harm the company's business[311]. - The DEA classifies psilocybin as a Schedule I controlled substance, which imposes strict regulations on its manufacturing, distribution, and prescription[313]. - The company may face heightened regulatory scrutiny, which could negatively impact its ability to raise capital and conduct business operations[288]. - The company is subject to anti-corruption laws, and non-compliance could result in civil or criminal penalties affecting its operations[410]. - The company is exposed to potential product liability risks related to its investigational COMP360 psilocybin treatment, which could adversely affect its market prospects[400]. Clinical Development and Market Readiness - The company plans to initiate a late-stage development program in PTSD and continue advancing its Phase 3 program for COMP360 psilocybin treatment in TRD[275]. - Successful completion of clinical trials, including the Phase 3 program in Treatment-Resistant Depression (TRD), is critical for the approval of COMP360[309]. - The company is conducting a Phase 3 program for COMP360 in treatment-resistant depression (TRD) and has received Breakthrough Therapy Designation from the FDA[340]. - Clinical trials are lengthy and expensive, with uncertain outcomes, and the company has limited experience in managing late-stage trials[333]. - The company may need to conduct additional studies if changes are made to COMP360, potentially delaying the clinical development plan[330]. - The company faces risks of regulatory delays and increased costs due to potential adverse events in research related to depression and mental health diseases[322]. Market and Competitive Landscape - The company currently has no approved treatments for commercial sale and is dependent on the successful development and regulatory approval of the COMP360 psilocybin treatment[306]. - The company may face significant competition in securing collaborative partnerships, which could impact its ability to develop therapeutic candidates[396]. - Market acceptance of COMP360 will depend on factors such as safety, effectiveness, cost-effectiveness, and the willingness of healthcare professionals and patients to use the treatment[375]. - The company currently has no product authorized for marketing, and the future commercial success of COMP360 is uncertain[374]. - The company lacks experience in commercializing therapeutic candidates, which may hinder its ability to successfully launch and market treatments[369]. Reimbursement and Pricing Challenges - The investigational COMP360 psilocybin treatment is currently classified as a Schedule I substance, which limits its coverage and reimbursement options in the U.S.[459]. - Market acceptance and sales of COMP360 will significantly depend on adequate coverage and reimbursement from third-party payors[462]. - Third-party payors are increasingly challenging drug prices, which may affect the reimbursement status of COMP360 if cheaper alternatives are available[463]. - Obtaining and maintaining reimbursement status is a time-consuming and costly process, with no uniform policy among third-party payors[465]. - Local governments are implementing regulations to control pharmaceutical pricing, which could negatively impact the company's business[466]. Data Privacy and Compliance - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose additional data privacy rights and operational requirements, potentially increasing compliance costs[445][447]. - The General Data Protection Regulation (GDPR) imposes strict rules on the processing of personal data, with potential fines of up to €20 million or 4% of annual global revenue for violations[453]. - The company may face challenges in transferring personal data from the UK and EEA to third countries, which could adversely affect operations and financial position[455]. - The evolving regulatory environment related to personal data and health information may require the company to modify data collection practices and incur substantial compliance costs[448]. Strategic Collaborations and Research Initiatives - The company established a Discovery Center in collaboration with the University of the Sciences Philadelphia to enhance research capabilities[394]. - The company announced the establishment of its first Center of Excellence in collaboration with The Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics in January 2021[398]. - A strategic collaboration with King's College London and South London and Maudsley NHS Foundation Trust was announced in March 2022 to accelerate research in psychedelic treatments[398]. - The company aims to gather evidence to optimize treatment delivery and conduct clinical trials through its Centers of Excellence[399].

Financial Data and Key Metrics - Cash used in operations in Q3 2024 was $22.2 million, including a $13.6 million R&D tax credit received in full during the quarter Excluding the tax credit, cash used in operations would have been $35.8 million, within the guidance range of $32 million to $38 million [24] - Cash and cash equivalents stood at $207 million as of September 30, 2024, compared to $228.6 million at the end of Q2 2024 [25] - Debt under the Hercules loan facility was $29.8 million at the end of Q3 2024 [25] - The company expects net cash used in operations to increase to between $37 million and $43 million in Q4 2024, resulting in full-year 2024 cash usage between $114 million and $120 million [24] Business Line Data and Key Metrics - The company is focusing on completing its Phase III trials for COMP360, with significant resources dedicated to ensuring successful recruitment and trial integrity [8][10] - The COMP005 trial, a 52-week study, is now expected to disclose 6-week data in Q2 2025 due to recruitment challenges [8] - The COMP006 trial, with a 26-week blinded portion, is expected to disclose data in the second half of 2026 [16] - The company is reducing its workforce by approximately 30% and externalizing non-COMP360 preclinical efforts to preserve cash and focus on COMP360 trials [26] Market Data and Key Metrics - The company is preparing for the commercialization of COMP360, focusing on establishing billing codes, DEA rescheduling, and health economics research [19] - Strategic collaborations with interventional psychiatry networks are providing insights into optimizing patient flow and scaling the COMP360 operating model [20] - There is significant enthusiasm among healthcare providers for COMP360, with a focus on managing demand and monitoring requirements similar to Spravato [21] Company Strategy and Industry Competition - The company is prioritizing the completion of its Phase III trials for COMP360, with a focus on maintaining trial integrity and ensuring regulatory success [8][16] - COMPASS Pathways is the first company to conduct large-scale psychedelic trials, facing unique challenges due to the complexity of the trials and lack of prior comparable Phase III timelines [9] - The company is leveraging insights from the Lykos AdCom and FDA feedback to refine its regulatory strategy and maintain blinding in its trials [13][14] Management Commentary on Operating Environment and Future Outlook - Management acknowledges the challenges in recruitment and trial complexity but remains confident in the potential impact of COMP360 for patients with treatment-resistant depression (TRD) [16][29] - The company is taking steps to preserve cash, including workforce reduction and externalizing digital tools, to ensure sufficient runway into 2026 [26] - Management emphasizes the importance of maintaining the integrity of the trials and the potential for COMP360 to be a paradigm-changing treatment for TRD [17][29] Other Important Information - The company is exploring externalizing its digital tools and technology to a new company established by its co-founders, with a final decision expected by Q1 2025 [26] - The restructuring and cost-cutting measures are expected to extend the company's cash runway and ensure focus on COMP360's success [26][28] Q&A Session Summary Question: Was the decision to move the top-line readout made after additional FDA correspondence or a face-to-face meeting? [30] - Answer: The decision was made internally by COMPASS out of caution, influenced by observations from the Lykos process and the need to maintain blinding in the 006 trial [31] Question: How do trial recruitment complexities impact real-world use of COMP360? [33] - Answer: Clinical trial settings differ from commercial settings, but the company is learning from trial sites and collaborations to optimize patient flow for commercialization [34][35] Question: Has the regulatory strategy changed for COMP005 and COMP006? [39] - Answer: No changes to the regulatory strategy, with both trials still needed for filing [40] Question: How is the washout of antidepressant medications affecting enrollment? [41] - Answer: The washout rate is over 90%, with no significant logistical obstacles observed [42] Question: What is the expected cash runway given the trial delays? [45] - Answer: The company has $207 million in cash, expected to last into 2026, with restructuring savings aimed at offsetting increased trial costs [45] Question: What needs to be done between final data readouts and launch? [47] - Answer: Focus areas include increasing TRD awareness, educating on COMP360 data, state rescheduling, optimizing patient flow, and preparing for payer discussions [54] Question: Will data from both COMP005 and COMP006 be needed for the NDA submission? [68] - Answer: Yes, data from both trials will be required, and an advisory committee is expected given the Schedule 1 status of the product [69] Question: What is considered a positive outcome in terms of MADRS improvement in Phase III TRD trials? [73] - Answer: Success is defined as detecting a clinically relevant difference in TRD, with adequate power in the studies to show such differences [77] Question: Are dropout rates tracking as expected, and is the company adding patients? [78] - Answer: Attrition rates are below plan, and no changes to sample size are being made [78] Question: What percentage of trial participants will have completed 26 weeks at the 6-week data announcement? [79] - Answer: The company has always guided for releasing 6-week data for COMP005, with no change in this approach [80] Question: Does the Phase III program provide enough data for pretreatment schedules and pricing? [81] - Answer: The company believes the Phase III program will provide important data relevant to payers and dosing schedules [82]

Clinical Trials and Data - Top-line data for the COMP005 trial in the COMP360 phase 3 program for treatment-resistant depression is now expected in Q2 2025[1] - The company will announce COMP006 data after the 26-week time point, expected in the second half of 2026[3] Financial Performance - The net loss for Q3 2024 was $38.5 million, or $0.56 loss per share, compared to a net loss of $33.4 million, or $0.67 loss per share in Q3 2023[5] - Comprehensive loss for Q3 2024 was $38,163, compared to $34,127 in Q3 2023, indicating a 8.9% increase in comprehensive losses[19] - Net loss for Q3 2024 was $38,502, compared to a net loss of $33,389 in Q3 2023, reflecting a 6.3% increase in losses[19] - Net loss per share attributable to ordinary shareholders was $0.56 in Q3 2024, an improvement from $0.67 in Q3 2023[19] Research and Development Expenses - Research and development expenses for Q3 2024 were $32.9 million, up from $21.5 million in Q3 2023, primarily due to late-stage trial advancements[5] - Research and development expenses rose to $32,928 in Q3 2024, up 52.9% from $21,526 in Q3 2023[19] - The benefit from R&D tax credit was $4,084 in Q3 2024, up from $2,685 in Q3 2023, marking a 52.1% increase[19] Cash and Assets - Cash and cash equivalents stood at $207 million as of September 30, 2024, down from $220.2 million at the end of 2023[5] - The total assets decreased to $247.3 million as of September 30, 2024, from $276.0 million at the end of 2023[17] - Full-year 2024 net cash used in operating activities is expected to be between $114 million and $120 million[6] Workforce and Strategic Focus - A strategic reorganization will reduce the workforce by approximately 30% to focus on the COMP360 program[4] - The company is exploring potential externalization for its digital health tools as part of its strategic focus[4] Operating Expenses - Total operating expenses for Q3 2024 were $47,896, a 40.5% increase from $34,062 in Q3 2023[19] Other Income and Gains - The company reported a total other income of $9,567 in Q3 2024, significantly higher than $735 in Q3 2023[19] - Interest income for Q3 2024 was $1,977, compared to $1,015 in Q3 2023, reflecting a 95.0% increase[19] - Foreign exchange gains for Q3 2024 were $4,452, a significant recovery from a loss of $1,997 in Q3 2023[19] Shareholder Information - The weighted average ordinary shares outstanding increased to 68,395,343 in Q3 2024 from 49,633,104 in Q3 2023[19]

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

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