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)

[PART I - FINANCIAL INFORMATION](index=9&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=9&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2025 financial statements reflect increased assets and liabilities, a reduced net loss, and substantial financing inflows [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets at **$293.5 million** and total liabilities at **$131.0 million**, driven by cash and warrant liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $221,881 | $165,081 | | Total current assets | $276,403 | $201,291 | | **Total assets** | **$293,536** | **$213,666** | | **Liabilities & Equity** | | | | Total current liabilities | $31,328 | $34,016 | | Warrant liabilities | $74,398 | $— | | **Total liabilities** | **$130,981** | **$58,971** | | **Total shareholders' equity** | **$162,555** | **$154,695** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For H1 2025, the company reported a **net loss of $56.3 million**, an improvement from 2024, primarily due to warrant fair value changes and R&D tax credits Statement of Operations Highlights (in thousands, except per share data) | Metric | 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 | | Total operating expenses | $92,549 | $81,895 | | Loss from operations | $(92,549) | $(81,895) | | Fair value change of warrant liabilities | $16,920 | $— | | Benefit from R&D tax credit | $12,735 | $6,810 | | **Net loss** | **$(56,267)** | **$(73,288)** | | **Net loss per share** | **$(0.62)** | **$(1.11)** | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) H1 2025 saw **$84.3 million** net cash used in operations, offset by **$140.5 million** from financing, resulting in a **$56.8 million** net cash increase Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(84,346) | $(55,244) | | Net cash provided by financing activities | $140,525 | $63,722 | | Effect of exchange rate changes | $611 | $(99) | | **Net increase in cash** | **$56,790** | **$8,379** | | **Cash, cash equivalents and restricted cash, end of period** | **$222,260** | **$229,017** | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's COMP360 development, a **$149.8 million** January 2025 financing, and sufficient cash to fund operations for at least twelve months - The company is a clinical-stage biotechnology company developing its investigational COMP360 psilocybin treatment for treatment-resistant depression[32](index=32&type=chunk) - In January 2025, the company completed a financing that raised aggregate proceeds of **$149.8 million** through the issuance of ADSs, Pre-funded Warrants, and 2025 ADS Warrants[36](index=36&type=chunk)[63](index=63&type=chunk) - Management believes the cash and cash equivalents of **$221.9 million** as of June 30, 2025, will be sufficient to fund operations and capital expenditures for at least the next twelve months[38](index=38&type=chunk) - Warrants issued in the January 2025 financing are classified as liabilities and measured at fair value, with changes recognized in the statement of operations. As of June 30, 2025, the total fair value of these warrant liabilities was **$74.4 million**[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses COMP360's clinical progress, including positive Phase 3 TRD data, and the financial impact of increased R&D and G&A expenses [Overview and Clinical Development](index=23&type=section&id=Overview%20and%20Clinical%20Development) The company's COMP360 treatment for TRD achieved its primary endpoint in Phase 3 trial 1, with **$221.9 million** cash expected to fund operations into 2027 - The pivotal Phase 3 trial 1 (COMP005) for TRD achieved its primary endpoint, with a single 25 mg dose of COMP360 demonstrating a highly statistically significant reduction in symptom severity versus placebo at six weeks (p<0.001)[80](index=80&type=chunk) - The second pivotal Phase 3 trial (COMP006) is ongoing, and 26-week data is expected to be reported in the second half of 2026[82](index=82&type=chunk) - Following positive Phase 2 results in PTSD, the company is designing a late-stage program for this indication[83](index=83&type=chunk) - As of June 30, 2025, the company had **$221.9 million** in cash and cash equivalents, which is expected to fund operations into 2027[89](index=89&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) H1 2025 operating expenses increased to **$92.5 million** due to clinical trials and financing-related fees, partially offset by significant other income Operating Expenses Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $61,205 | $53,970 | $7,235 | | General and administrative | $31,344 | $27,925 | $3,419 | | **Total operating expenses** | **$92,549** | **$81,895** | **$10,654** | - The increase in R&D expenses was primarily due to advancing late-stage COMP360 clinical trials, partially offset by decreased personnel costs from a Q4 2024 reorganization[111](index=111&type=chunk)[112](index=112&type=chunk) - The increase in G&A expenses for the six-month period was driven by higher legal and professional fees related to the 2025 Financing[114](index=114&type=chunk) - Total other income, net, increased by **$27.8 million** for the six-month period, driven by a **$16.9 million** gain on fair value of warrant liabilities, a **$5.9 million** increase in R&D tax credit benefits, and a **$5.0 million** increase in foreign exchange gains[115](index=115&type=chunk)[119](index=119&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Operations are funded by equity and debt, with **$221.9 million** cash expected to last into 2027, but future funding depends on clinical trial progress - The company has primarily funded operations through equity offerings (including an ATM program), a loan agreement with Hercules, and a private placement (PIPE)[117](index=117&type=chunk) - Net cash used in operating activities increased to **$84.3 million** for the six months ended June 30, 2025, from **$55.2 million** in the prior year period, mainly due to unfavorable working capital changes[120](index=120&type=chunk)[121](index=121&type=chunk) - Net cash provided by financing activities increased to **$140.5 million** for the six months ended June 30, 2025, primarily from the 2025 Financing[120](index=120&type=chunk)[122](index=122&type=chunk) - Future expenses are expected to increase with the advancement of the Phase 3 program in TRD, initiation of a late-stage program in PTSD, and commercial preparedness activities[123](index=123&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 have occurred since the December 31, 2024, Annual Report on Form 10-K - There have been no material changes in market risk exposures since the last Annual Report on Form 10-K for the year ended December 31, 2024[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[134](index=134&type=chunk) - No changes in internal control over financial reporting occurred during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II - OTHER INFORMATION](index=37&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings expected to adversely affect its business or financial condition - The company is not currently a party to any material litigation or legal proceedings[137](index=137&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Numerous risks include a history of losses, need for additional funding, dependence on COMP360, complex regulatory processes, and controlled substance challenges - The company is a clinical-stage entity with a history of significant losses (**$591.0 million** accumulated deficit as of June 30, 2025) and expects to incur losses for the foreseeable future[139](index=139&type=chunk) - Substantial additional funding is required to complete development and commercialization of COMP360, and failure to obtain it could force delays or termination of programs[144](index=144&type=chunk) - The company's business is highly dependent on the successful development, regulatory approval, and commercialization of its only clinical-stage candidate, COMP360 psilocybin treatment[172](index=172&type=chunk)[173](index=173&type=chunk) - COMP360 is subject to strict controlled substance laws (Schedule I in the U.S.), which creates significant regulatory hurdles for clinical development and potential commercialization, including the need for DEA rescheduling[179](index=179&type=chunk)[181](index=181&type=chunk) [Item 5. Other Information](index=142&type=section&id=Item%205.%20Other%20Information) The company amended its Hercules loan agreement, completed a Phase 2 anorexia nervosa trial with encouraging signals, and reported no 10b5-1 plan changes - On July 30, 2025, the company amended its Loan and Security Agreement with Hercules, removing a **$10.0 million** tranche and increasing a separate, discretionary tranche by **$10.0 million** to an aggregate of **$20.0 million**[560](index=560&type=chunk) - The Phase 2 trial of COMP360 in anorexia nervosa (COMP401) was completed. While there was a positive signal in the 25mg arm, high dropout rates in the control arm limited the study's statistical power. The safety profile was consistent with the patient population[561](index=561&type=chunk) [Item 6. Exhibits](index=143&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and the amended loan agreement with Hercules Capital

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

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

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

Summary of COMPASS Pathways (CMPS) Conference Call Company Overview - **Company**: COMPASS Pathways (CMPS) - **Focus**: Development of psilocybin therapy for treatment-resistant depression (TRD) and PTSD Key Points Trial Design and Patient Enrollment - The ongoing trial, COMP-five, involves a single dose of 25 mg of COM360 compared to a placebo, with primary endpoint data expected next month at six weeks [2][13] - The trial design is consistent with Phase 2b, with a slight increase in patients with prior psychedelic experience [3][5] - Enrollment challenges were addressed by utilizing third-party vendors to gather necessary medical and pharmacy records, significantly shortening recruitment time [7][10] - The study is 100% U.S.-based, which has presented unique challenges compared to previous international trials [9][10] Efficacy Expectations - A clinically meaningful difference of at least 3 points on the MADRS scale at six weeks is anticipated for the TRD population [13][14] - The only marketed pharmacologic treatment for TRD currently is esketamine, which shows a similar efficacy range [14] Safety Profile - The Data Safety Monitoring Board (DSMB) has not raised any concerns regarding safety or protocol changes [17][21] - The population studied has a high risk of suicidality, with 70% having a history of suicidal ideation [20] - A black box warning for suicidality is expected, similar to other antidepressants, but the nature of psilocybin's rapid action may differ from traditional treatments [22][23] Durability of Treatment - Recent data indicates a time to depressive event of 92 days for the 25 mg dose, suggesting significant durability [26][28] - The study is also examining longer-term durability and effective retreatment strategies [30] Regulatory and Commercial Strategy - The company is preparing for a commercial launch by establishing collaborations with mental health care providers and developing reimbursement frameworks [39][41] - The infrastructure for delivering interventional psychiatry has significantly improved since the launch of SPRAVATO, providing confidence for the launch of COM360 [43][44] Workforce Considerations - The FDA does not regulate therapy, allowing for a broader range of healthcare providers to administer psilocybin treatments, which could include nurses and licensed social workers [46][48] Future Directions - COMPASS is designing a robust late-stage study for PTSD, building on promising efficacy signals from earlier studies [50][51] - There is a recognition of the high comorbidity between PTSD and TRD, which may facilitate treatment pathways [52] Additional Insights - The company is committed to maintaining trial blinding and has implemented strategies to ensure data integrity [31][32] - The evolving regulatory landscape may provide opportunities for faster patient access to psilocybin treatments [36] This summary encapsulates the critical aspects of the COMPASS Pathways conference call, highlighting the company's focus on psilocybin therapy for mental health conditions, trial progress, safety considerations, and commercial strategies.

Core Viewpoint - COMPASS Pathways PLC has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for COMPASS Pathways for the fiscal year ending December 2025 is projected at -$1.82 per share, reflecting a 20.9% change from the previous year's reported figure [9]. - Over the past three months, the Zacks Consensus Estimate for COMPASS Pathways has increased by 13%, indicating a trend of rising earnings estimates [9]. Zacks Rating System - The Zacks rating system is based on changes in earnings estimates, which are crucial for determining stock price movements. It classifies stocks into five groups, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [2][10][11]. - The Zacks Rank 2 upgrade places COMPASS Pathways in the top 20% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term due to favorable earnings estimate revisions [11]. Market Impact - Rising earnings estimates and the corresponding rating upgrade for COMPASS Pathways suggest an improvement in the company's underlying business, which could lead to increased investor interest and a higher stock price [6]. - The influence of institutional investors, who adjust their valuations based on earnings estimates, contributes to the stock price movements, reinforcing the importance of earnings revisions [5].

Financial Data and Key Metrics Changes - As of March, the company had cash and cash equivalents of $260 million, an increase from $165 million at the end of 2024, indicating a strong financial position following recent financing [12] - Cash used in operations for the first quarter was $45.7 million, with expectations for net cash used in operations for the full year 2025 to be between $120 million and $145 million [13] Business Line Data and Key Metrics Changes - The company announced the completion of dosing for all participants in Part A of its pivotal Phase III trial for treatment-resistant depression (TRD), with top-line results expected in late June [6] - The Phase III program is designed to confirm the durability and safety profile of COMP360, which could provide a groundbreaking treatment option for TRD patients if successful [9] Market Data and Key Metrics Changes - The company is focusing on the commercialization of COMP360 by developing relationships with various provider types through strategic collaborations, including a new partnership with HealthPort to enhance access to innovative mental health treatments [10][11] Company Strategy and Development Direction - The company aims to ensure broad and equitable access to COMP360, particularly for underserved populations, and is working on understanding the commercial opportunity for its treatment in various care settings [10] - The company is also planning for a late-stage clinical program in PTSD, recognizing the significant unmet need in this area [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III data readout, emphasizing the potential of COMP360 to be a clinically differentiated treatment option with rapid action and meaningful durability [14][76] - The management noted that the FDA is not concerned about the likelihood of suicidality in the Phase III trial, understanding that it is a core feature of the disease [39] Other Important Information - The company is working on adding manufacturing capabilities in the US for commercial supply, with plans already underway [48] - The company has had multiple inspections of its manufacturing sites, indicating a robust compliance history [48] Q&A Session Summary Question: Key takeaways from the longer-term follow-up data from the Phase II trial - The data showed a difference in durability among the three doses, with patients receiving 25 mg lasting as long as six months following treatment, suggesting it is the preferred dose for the Phase III program [21] Question: Efficacy delta on MADRS and placebo effect - The company expects a clinically significant effect size over three on the MADRS scale, with a typical placebo response anticipated in well-conducted trials [28] Question: Concerns about suicidality in the study design - Suicidality is a core feature of depression, and the company must include patients with some degree of suicidality to maintain a representative population [36] Question: Current delivery of esketamine by HealthPort - HealthPort has experience delivering SPRAVATO and is motivated to ensure access to new treatment options for underserved populations [42] Question: Manufacturing supply chain and FDA inspections - The company is adding US manufacturing capabilities and has a straightforward manufacturing process with a small quantity of material, mitigating risks [50] Question: Patient enrollment in COMM-five compared to Phase IIb - The recruitment criteria remain the same, and the company expects no significant differences in patient profiles between the studies [55] Question: Interest in large pharma partnerships - The company is committed to commercializing COMP360 independently in the US and select geographies, with no current plans for large strategic partnerships [57] Question: Optimal time to assess suicidality risk post-treatment - The management indicated that predictions are difficult, and they will wait for data to inform their understanding of suicidality risk [60]

Financial Data and Key Metrics Changes - As of March, the company had cash and cash equivalents of $260 million, an increase from $165 million at the end of 2024, indicating a strong financial position following recent financing [12] - Cash used in operations for the first quarter was $45.7 million, with an expected net cash usage for the full year 2025 projected to be between $120 million to $145 million [13] Business Line Data and Key Metrics Changes - The company announced the completion of dosing for all participants in Part A of its pivotal Phase III trial for treatment-resistant depression (TRD), with top-line results expected in late June [5] - The Phase III program aims to confirm the durability and safety profile of COMM360, which could provide a groundbreaking treatment option for TRD patients if successful [9] Market Data and Key Metrics Changes - The company is focusing on the commercialization of COMM360 by developing relationships with various provider types through strategic collaborations, including a new partnership with HealthPort to enhance access to innovative mental health treatments [10] Company Strategy and Development Direction - The company is preparing for the commercialization of COMM360 by understanding the commercial opportunity and ensuring broad delivery across various care settings [9] - The strategic collaboration with HealthPort aims to address the needs of underserved populations, reflecting the company's commitment to equitable access to mental health treatments [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III data readout, emphasizing the potential of COMM360 to be a clinically differentiated treatment option for TRD [13] - The company is also working on the final design for a late-stage clinical program in PTSD, indicating a significant commercial opportunity in this area due to high unmet needs [13] Other Important Information - The independent Data Safety Monitoring Board (DSMB) is regularly reviewing unblinded safety data, with a focus on suicidality, which remains a critical concern in the context of TRD [6][39] Q&A Session Summary Question: Key takeaways from the long-term follow-up data on durability and appropriate dosing - Management noted that while the data is not definitive, it suggests that patients receiving 25 mg can experience effects lasting up to six months, indicating this dose may be preferred moving forward [21] Question: Efficacy delta on MADRS and placebo effect considerations - Management acknowledged the variability in placebo effects in psychedelic trials and estimated a clinically significant effect size of over three on the MADRS scale [29] Question: Concerns regarding suicidality signals - Management clarified that suicidality is a core feature of depression and must be included in study designs, with ongoing monitoring to ensure safety [36] Question: Current delivery of esketamine by HealthPort - HealthPort has experience delivering SPRAVATO and is motivated to ensure access to new treatment options for underserved populations [42] Question: Manufacturing supply chain and FDA inspections - The company is currently manufacturing in the UK and plans to add US manufacturing capabilities, with multiple inspections conducted over the years [49] Question: Patient enrollment in COMM-five and comparison to Phase 2b - Management confirmed that recruitment criteria remain consistent, suggesting similar patient profiles across studies [55] Question: Interest in large pharma partnerships - The company is committed to commercializing COMM360 independently in the US, with no current plans for large pharma partnerships [58] Question: Optimal time frame for assessing suicidality risk post-treatment - Management indicated that predictions are difficult, and they will rely on data to inform their understanding of suicidality risk [61] Question: Changes in FDA interactions regarding psychedelic therapies - Management reported no significant changes in FDA interactions, maintaining routine discussions around event reporting [63]

[Overview and Business Highlights](index=1&type=section&id=Overview%20and%20Business%20Highlights) This section provides an overview of Compass Pathways' Q1 2025 performance, highlighting significant clinical advancements and financial stability [Q1 2025 Highlights](index=1&type=section&id=Q1%202025%20Highlights) Compass Pathways reported significant progress in its pivotal phase 3 COMP360 program for treatment-resistant depression (TRD), with key 6-week data expected in late June 2025. The company ended the first quarter with a strong cash position of $260.1 million, bolstering its financial runway - CEO Kabir Nath emphasized the anticipation for the upcoming topline 6-week data from the pivotal phase 3 COMP360 program in treatment-resistant depression, expected in **late June**[2](index=2&type=chunk) Key Milestones and Financial Status | Metric | Status / Value | | :--- | :--- | | COMP005 Phase 3 (TRD) 6-week data | On track for late June | | COMP006 Phase 3 (TRD) 26-week data | Expected H2 2026 | | Cash Position (Mar 31, 2025) | $260.1 million | [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) The company is advancing its COMP360 psilocybin treatment programs for both Treatment-Resistant Depression (TRD) and Post-Traumatic Stress Disorder (PTSD). The TRD program is noted as the largest randomized, controlled, double-blind psilocybin clinical program to date, while the PTSD program is moving towards a late-stage trial design following positive phase 2 results [COMP360 in Treatment-Resistant Depression (TRD)](index=1&type=section&id=COMP360%20in%20Treatment-Resistant%20Depression%20%28TRD%29) This section details the progress and key data expectations for the COMP360 pivotal phase 3 program in Treatment-Resistant Depression - The pivotal phase 3 program for COMP360 in TRD is the **largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program**[5](index=5&type=chunk) - Key data readouts are scheduled, with top-line 6-week data from the COMP005 trial expected in **late June** and 26-week data from the COMP006 trial expected in the **second half of 2026**[5](index=5&type=chunk) - A recent 52-week observational follow-up study demonstrated a **durable treatment response** from a single 25mg administration of COMP360[5](index=5&type=chunk) [COMP360 in Post-Traumatic Stress Disorder (PTSD)](index=1&type=section&id=COMP360%20in%20Post-Traumatic%20Stress%20DIsorder%20%28PTSD%29) This section outlines the advancement of the COMP360 program for Post-Traumatic Stress Disorder, following promising phase 2 results - Following positive phase 2 results, the company is now designing a **late-stage clinical trial program** for COMP360 in PTSD[5](index=5&type=chunk) - A phase 2 open-label study (n=22) showed that a single administration of COMP360 was **well-tolerated** and resulted in **rapid and durable improvement in PTSD symptoms**[5](index=5&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) This section provides a comprehensive review of the company's financial results, position, and future guidance [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) For Q1 2025, Compass Pathways reported a net loss of $17.9 million, a significant reduction from $35.2 million in Q1 2024. This improvement was primarily driven by a $19.5 million non-cash gain on the fair value of warrant liabilities. Operating expenses increased year-over-year, with R&D expenses rising to $30.9 million due to advancing phase 3 trials, and G&A expenses increasing to $18.7 million, partly due to costs from a recent financing Q1 2025 vs Q1 2024 Key Financials (in thousands) | Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Net Loss | $17,900 | $35,200 | $19,500 non-cash gain on warrant liabilities | | Net Loss Per Share (basic) | $0.20 | $0.55 | - | | R&D Expenses | $30,900 | $24,900 | Advancing Phase 3 trials | | G&A Expenses | $18,700 | $13,700 | 2025 Financing issuance costs | [Financial Position and Cash Flow](index=2&type=section&id=Financial%20Position%20and%20Cash%20Flow) The company significantly strengthened its balance sheet, ending Q1 2025 with $260.1 million in cash and cash equivalents, a substantial increase from $165.1 million at the end of 2024. This was primarily due to raising an additional $140.4 million in net cash from financing activities during the quarter Cash Position Comparison (in thousands) | Date | Cash and Cash Equivalents | | :--- | :--- | | March 31, 2025 | $260,100 | | December 31, 2024 | $165,100 | - The company raised an additional **$140.4 million** in net cash during the first quarter of 2025[9](index=9&type=chunk) [Financial Guidance](index=2&type=section&id=Financial%20Guidance) Compass Pathways projects its full-year 2025 net cash used in operating activities to be between $120 million and $145 million. The company's cash position as of March 31, 2025, is expected to be sufficient to fund operations and capital expenditures at least through the second half of 2026, covering the period of the planned COMP006 study data readout - Full year 2025 net cash used in operating activities is projected to be in the range of **$120 million to $145 million**[6](index=6&type=chunk) - The current cash position is expected to provide a financial runway at least through the planned 26-week data readout from the COMP006 study in the **second half of 2026**[6](index=6&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including the Balance Sheets as of March 31, 2025, and December 31, 2024, and the Statements of Operations for the three-month periods ending March 31, 2025, and 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position through its condensed consolidated balance sheets Condensed Consolidated Balance Sheets (in thousands) | | 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's financial performance over specific periods through its condensed consolidated statements of operations Condensed Consolidated Statements of Operations (in thousands) | | Three Months ended Mar 31, 2025 | Three Months ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $30,880 | $24,901 | | General and administrative | $18,736 | $13,672 | | **Loss from operations** | **($49,616)** | **($38,573)** | | Fair value change of warrant liabilities | $19,460 | $0 | | **Net loss** | **($17,864)** | **($35,187)** | | **Net loss per share: basic** | **($0.20)** | **($0.55)** |