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]

Financial Data and Key Metrics Changes - Cash used in operations for Q2 2024 was $34.4 million, within the guidance range of $32 million to $38 million [12] - Cash and cash equivalents stood at $228.6 million as of June 30, 2024, down from $262.9 million at March 31, 2024 [12] - The company expects cash used in operations for the full year to be between $110 million and $130 million [12] Business Line Data and Key Metrics Changes - The company is progressing in recruitment for its COMP360 Phase 3 trials, with expectations for top-line data readout from the 005 trial in Q4 2024 [6][13] - Recruitment is trending towards the end of the year, with a possibility of data readout extending into January [6] Market Data and Key Metrics Changes - The commercial marketplace for interventional psychiatry treatments continues to grow, validating the company's approach [13] Company Strategy and Development Direction - The company is focused on completing its COMP360 Phase 3 clinical trials and building commercial capabilities [5] - The management team has been strengthened with the addition of a Chief Commercial Officer and a new Chairman of the Board [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pivotal program delivering what the FDA requires for effective evaluation of COMP360 treatment [11] - The company is well-positioned for continued success in treatment-resistant depression (TRD) and beyond [14] Other Important Information - The company is collecting a range of safety data expected in any pharmaceutical clinical development program, including positive side effect data [11] - The company maintains a strong financial position with a cash runway expected to fund operations into 2026 [12] Q&A Session Summary Question: What is the status of the ongoing 005 trial and suicidality rates? - The DSMB meeting indicated that both 005 and 006 trials should continue as planned with no changes to procedures [17] Question: Were there any impacts on enrollment rates due to the AdCom proceedings? - There has been no significant impact on enrollment rates for either trial following the AdCom [20] Question: Can you provide insights on site performance and quality? - The company is maintaining close contact with sites to ensure quality and has not identified any anomalies post-AdCom [23] Question: What are the key questions being asked in the 005 and 006 trials? - The 005 trial aims to demonstrate separation from placebo, while the 006 trial seeks to replicate previous efficacy results and assess durability [34][35] Question: What are the next steps for PTSD and bipolar disorder in the pipeline? - The company is developing designs and protocols for PTSD but currently prioritizes TRD [39][40] Question: How is the company ensuring that patients do not use other treatment modalities post-dosing? - The company is collecting data on co-administration of other drugs but actively preventing such use is challenging [48][49] Question: What are the findings regarding suicidality in recreational users of psilocybin? - Studies suggest a reduction in psychological distress and suicidal thoughts among recreational users, but the focus remains on clinical efficacy [51] Question: How does the company view the FDA's commentary on psychotherapy in trials? - The company believes it is in a different category as it does not provide psychotherapy, making the efficacy assessment simpler [46]

Financial Performance - Net loss for Q2 2024 was $38.1 million, or $0.56 loss per share, compared to $28.3 million, or $0.62 loss per share, in Q2 2023[7] - Net loss for the six months ended June 30, 2024, was $73.288 million, compared to $52.543 million in the same period in 2023[21] - Net loss per share for the six months ended June 30, 2024, was $1.11, compared to $1.19 in 2023[20] - Comprehensive loss for the six months ended June 30, 2024, was $73.243 million, compared to $52.404 million in 2023[21] Operating Expenses - Research and development expenses for Q2 2024 were $29.1 million, up from $19.8 million in Q2 2023, primarily due to advancing COMP360 phase 3 clinical trials[7] - General and administrative expenses for Q2 2024 were $14.3 million, up from $12.8 million in Q2 2023, primarily due to increased personnel expenses[7] - Total operating expenses for the six months ended June 30, 2024, increased to $81.895 million from $64.452 million in 2023[22] - Research and development expenses for the six months ended June 30, 2024, rose to $53.970 million from $38.853 million in 2023[22] - General and administrative expenses for the six months ended June 30, 2024, increased to $27.925 million from $25.599 million in 2023[22] Cash and Debt Position - Cash position of $228.6 million as of June 30, 2024[1] - Long-term debt as of June 30, 2024, was $29.4 million, compared to $28.8 million as of December 31, 2023[7] - Full-year 2024 net cash used in operating activities expected to be in the range of $110 million to $130 million[8] Clinical Trials and Research - Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression expected in Q4 2024[1] - COMP360 phase 2 study in post-traumatic stress disorder showed meaningful and sustained symptom improvement in 22 patients with no serious adverse events reported[4] Tax and Other Financial Items - Benefit from R&D tax credit for the six months ended June 30, 2024, was $6.810 million, slightly down from $6.836 million in 2023[22] - Interest income for the six months ended June 30, 2024, surged to $4.668 million from $1.342 million in 2023[22] - Foreign exchange losses for the six months ended June 30, 2024, were $558,000, compared to gains of $4.061 million in 2023[22] Shareholder Information - Weighted average ordinary shares outstanding for the six months ended June 30, 2024, increased to 66,296,658 from 44,153,772 in 2023[20] Leadership Changes - Gino Santini to join Board of Directors as Chairman effective September 3, 2024[5] - Lori Englebert appointed as Chief Commercial Officer in July 2024[6]