Summary of COMPASS Pathways Update Webinar Company Overview - **Company**: COMPASS Pathways (NasdaqGS:CMPS) - **Focus**: Development of COMP360, a treatment for treatment-resistant depression (TRD) Key Industry Insights - **Market Need**: Over 4 million adults in the U.S. suffer from TRD annually, with a significant burden compared to major depressive disorder (MDD) [4][34] - **Current Treatments**: Only one approved medication for TRD (Spravato), which requires multiple treatments to achieve similar effects to COMP360 [6][35] - **Economic Burden**: Medication-treated MDD costs nearly $100 billion annually, with TRD patients accounting for almost 50% of these costs due to ineffective treatments [35] Clinical Trial Results - **Trials Conducted**: COMP005 and COMP006, both phase 3 trials for COMP360 - **Primary Endpoint Achievement**: COMP360 met primary endpoints with high statistical significance in three consecutive trials [5][6] - **Efficacy**: - In COMP005, 25% of patients achieved a clinically meaningful reduction in symptoms by week six, sustained through 26 weeks [5][21] - In COMP006, this figure increased to 39% [5][19] - **Rapid Onset**: Patients typically respond within one day of treatment, with durable effects observed [5][6][37] - **Safety Profile**: COMP360 demonstrated a well-tolerated safety profile, with serious adverse events (SAEs) of suicidal ideation below 1% [27][32] Regulatory and Commercial Strategy - **FDA Interaction**: Submitted data to the FDA and requested a meeting to discuss NDA filing strategy, including potential for rolling submission and expedited review [7][42] - **Launch Readiness**: Plans to be launch-ready by the end of the year, with ongoing preparations for commercial rollout [33][39] - **Market Positioning**: COMP360 is positioned to be a leading treatment option for TRD, with a differentiated profile compared to existing therapies [33][38] Additional Insights - **Patient Population**: Trials focused on a highly symptomatic, treatment-resistant population, with a mean MADRS score of 32 [12][13] - **Retreatment Rates**: Approximately 70% of patients in the 25 mg arm of COMP005 opted for retreatment, indicating a strong interest in ongoing treatment [85] - **Commercial Potential**: If approved, COMP360 could significantly change the treatment landscape for TRD, with potential blockbuster revenue given the current market dynamics [38][40] Conclusion - COMPASS Pathways is on track to potentially revolutionize the treatment of TRD with COMP360, addressing a significant unmet need in the mental health space while preparing for a strategic market entry.

Company Overview - GH Research PLC (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for mental health disorders, specifically advancing GH001, an inhalable bufotenin product candidate for treatment-resistant depression (TRD) [1][6] - Competitors include other biopharmaceutical companies such as Compass Pathways and MindMed [1] Recent Developments - On January 5, 2026, Eddie Hickman from Guggenheim set a price target of $29 for GHRS, indicating a potential upside of approximately 83.5% from the current stock price of $15.80, with a Buy rating reiterated following a management call [2] - The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on GH Research's Investigational New Drug Application (IND) for GH001, allowing the company to advance its global pivotal program in 2026 [3] - In February 2025, GH Research announced that its Phase 2b trial for GH001 successfully met its primary endpoint, showing a significant reduction of 15.2 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline on Day 8, compared to an increase of 0.3 points in the placebo group [4] Stock Performance - The stock for GHRS is currently priced at $15.78, reflecting a significant increase of 19.18% with a change of $2.54, and has fluctuated between a low of $15.59 and a high of $19 today [5] - Over the past year, GHRS has reached a high of $20.50 and a low of $7.98, with a market capitalization of approximately $978.8 million and a trading volume of 4,619,702 shares [5]

Core Insights - The FDA has lifted the clinical hold on GH Research PLC's Investigational New Drug Application for GH001, allowing U.S. subject enrollment and advancing the company's development plans [1][2][8] - GH001 is positioned as a potential ultra-rapid and durable treatment option for patients with treatment-resistant depression (TRD), with a global pivotal program expected to initiate in 2026 [2][8] - The Phase 2b trial results indicate a significant reduction in depression symptoms, with a placebo-adjusted MADRS reduction of -15.5 points on Day 8, and 57.5% of patients achieving ultra-rapid remission [6][9] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing innovative treatments for depression, specifically targeting treatment-resistant depression [5] - The lead product candidate, GH001, utilizes a proprietary inhalation method for mebufotenin administration, aiming to change the treatment landscape for TRD [6] Clinical Trial Highlights - The Phase 2b trial (GH001-TRD-201) met its primary endpoint, demonstrating a statistically significant reduction in depression symptoms [6][9] - Key findings from the trial include a 73% remission rate at 6 months with an average of approximately 4 treatments, a median psychoactive experience duration of ~11 minutes, and 99% of patients being discharge-ready within 1 hour of dosing [9]

Core Viewpoint - GH Research PLC is set to provide an update on its Investigational New Drug Application (IND) for GH001 and its global pivotal Phase 3 program in treatment-resistant depression (TRD) on January 5, 2026 [1] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing transformative treatments for depression, specifically targeting treatment-resistant depression (TRD) [2] Product Information - GH001 is the lead product candidate of the company, utilizing a proprietary inhalation method for mebufotenin administration. The Phase 2b GH001-TRD-201 trial demonstrated significant clinical activity, achieving a mean reduction of 15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo on Day 8 (p<0.0001), indicating its potential to change TRD treatment [3]

Core Insights - GH Research PLC is focused on developing innovative treatments for treatment-resistant depression (TRD) and has announced a presentation at the 38th Annual European College of Neuropsychopharmacology Congress [1][3] Group 1: Clinical Data and Presentations - A Novel Therapies Symposium Presentation will feature long-term clinical data on the safety and efficacy of GH001 from a Phase 2b clinical trial for TRD [1][4] - Two posters will present additional safety and tolerability data from the open-label extension of the same trial, as well as psychoactive effects of GH001 [2][5] Group 2: Unmet Medical Need and Treatment Efficacy - There is a significant unmet medical need for TRD, as many patients do not achieve adequate relief with existing therapies [3] - GH001 has shown a favorable safety and tolerability profile, with no serious adverse events or treatment-emergent suicidal intent reported during the 6-month open-label extension [3][5] Group 3: Product Information - GH001 is a proprietary formulation of mebufotenin administered via inhalation, which has demonstrated a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) by 15.5 points compared to placebo on Day 8 in the Phase 2b trial [8]

Core Insights - GH Research PLC is focused on developing innovative treatments for depression, particularly treatment-resistant depression (TRD) [15][16] - The company reported significant progress in its clinical trials, particularly with its lead product candidate GH001, which demonstrated a substantial reduction in depression scores [4][16] Business Updates - The FDA has communicated regarding the clinical hold on the Investigational New Drug Application (IND) for GH001, with only one topic remaining to be addressed [2] - A Phase 1 clinical trial for GH001 using a proprietary aerosol delivery device is ongoing in the UK, aimed at supporting the global program for GH001 [3] - The Phase 2b trial for GH001 in TRD met its primary endpoint with a significant placebo-adjusted reduction of -15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) [4][16] - An open-label extension analysis confirmed a 73% remission rate at 6 months with no serious adverse events reported [5][6][8] Financial Highlights - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $308.7 million, an increase from $182.6 million at the end of 2024 [11] - Research and development expenses for Q2 2025 were $9.0 million, a decrease from $9.8 million in the same quarter of 2024 [12] - General and administrative expenses rose to $5.7 million in Q2 2025 from $3.5 million in Q2 2024, primarily due to increased professional fees and employee expenses [13] - The net loss for Q2 2025 was $9.3 million, or $0.15 loss per share, compared to a net loss of $10.4 million, or $0.20 loss per share, in Q2 2024 [14] Future Plans - The company is on track to initiate its global pivotal program for GH001 in 2026 [10][8] - Plans for submitting an IND for GH002, another product candidate, are expected in Q4 2025 following a successful Phase 1 trial [9]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - GH Research PLC is focused on developing innovative treatments for depression, particularly targeting treatment-resistant depression (TRD) [12] GH001 Update - The company submitted a complete response to the FDA regarding the clinical hold on its Investigational New Drug Application (IND) for GH001, with only one hold topic remaining related to respiratory tract histology findings in rats [2][3] - The primary endpoint of the Phase 2b clinical trial for GH001 was met, showing a significant placebo-adjusted reduction of -15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8 (p<0.0001) [4][12] - The full analysis of the open-label extension (OLE) phase confirmed a 73% remission rate at 6 months, with 57.5% of patients achieving remission by Day 8 and 90% of those remaining in remission at month 6 [5][10] - Safety analysis indicated that 100% of patients from the double-blind part continued in the OLE, with no treatment-related serious adverse events reported [6][10] GH002 Update - GH Research PLC completed a Phase 1, dose-ranging clinical pharmacology trial of GH002, which was well-tolerated with no severe adverse events and demonstrated ultra-rapid psychoactive effects [8] - The pharmacokinetic profile of GH002 was found to be equivalent to that of GH001, with plans to submit an IND for GH002 in Q4 2025 [8] Global Pivotal Program Plans - The company is on track to initiate its global pivotal program in 2026, with planning ongoing since Q1 2025 [11][10] - A steering committee with key opinion leaders (KOLs) has been established to review Phase 2b results and assist in the design of the pivotal program [14]

Clinical Trial Results - A nasal spray for treatment-resistant depression has delivered strong clinical results [1] Market Sentiment - The strong clinical results have rekindled investor hopes [1]

Core Insights - GH Research PLC announced the acceptance of a Pharmaceutical Pipeline Presentation at the ASCP Annual Meeting, where clinical data from a Phase 2b trial of GH001 for treatment-resistant depression will be presented [1][7] - The Phase 2b trial results indicate robust evidence of GH001's efficacy and safety, potentially transforming treatment for patients with treatment-resistant depression [2][10] - Additional late-breaking posters will present safety and tolerability data from the Phase 2b trial and a proof-of-concept trial for postpartum depression [3][4] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing innovative treatments for depression, particularly targeting treatment-resistant depression with its lead product candidate, GH001 [9][10] - GH001 is administered via a proprietary inhalation method and has shown promising clinical activity in trials, meeting primary endpoints with significant reductions in depressive symptoms [10] Clinical Trial Highlights - The Phase 2b trial (GH001-TRD-201) demonstrated a mean reduction of 15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo on Day 8, with a p-value of less than 0.0001, indicating strong efficacy [10] - In a proof-of-concept trial for postpartum depression, all ten participants achieved remission by Day 8, highlighting GH001's potential as an effective treatment option [4][8] - A separate Phase 2a trial for bipolar II disorder showed a 52% mean reduction in depressive symptoms by Day 8, suggesting rapid onset and substantial efficacy [6][9]