LONDON & NEW YORK--(BUSINESS WIRE)---- $CMPS #Biotech--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced that tomorrow it will report new clinical data from two ongoing Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The company will be disclosing new clinical data from Part A and Part B from COMP005 and Part A from COMP006. The results ...

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Core Viewpoint - COMPASS Pathways is conducting an update webinar to provide insights into its current status and future plans [2]. Group 1 - The webinar is hosted by Stephen Schultz, Senior Vice President of Investor Relations at COMPASS Pathways [2]. - The call is being recorded and will be available on the COMPASS Pathways Investor Relations website for 30 days after the conclusion of the call [2]. Group 2 - Participants are reminded that the team will make forward-looking statements regarding future plans and prospects during the call [3].

COMPASS Pathways Update Summary Company Overview - **Company**: COMPASS Pathways (NasdaqGS:CMPS) - **Focus**: Development of COMP360 for treatment of Post-Traumatic Stress Disorder (PTSD) and Treatment-Resistant Depression (TRD) Key Points on PTSD and TRD Programs PTSD Program - **Patient Population**: Approximately 13 million individuals in the U.S. suffer from PTSD, with limited therapeutic options available [4][9] - **Economic Burden**: The annual economic cost of PTSD is estimated at $230 billion, with a significant portion attributed to civilian cases [9] - **Current Treatments**: Only two FDA-approved medications exist for PTSD, both SSRIs, which have been in use for over 25 years and show limited efficacy [10] - **COMP360 Potential**: COMP360 psilocybin is believed to offer a novel mechanism for treatment, with preliminary studies showing sustained symptom relief for up to 12 weeks after a single dose [11][12] TRD Program - **Patient Population**: Approximately 23 million adults in the U.S. experience major depression, with about 4 million classified as having TRD [19] - **Current Treatments**: Only two direct treatments are approved for TRD, with Spravato being the most commonly prescribed [27][28] - **Treatment Challenges**: Current treatments require frequent dosing and have significant logistical burdens, leading to poor adherence [28][30] - **COMP360 Advantages**: Early data suggests that COMP360 may provide rapid and durable symptom relief after a single administration, contrasting with the multiple treatments required for existing options [31][32] Clinical Trial Updates - **PTSD Trial Design**: A pivotal phase 2b/3 trial is underway, testing two doses of COMP360 against a control group [15][17] - **Efficacy Signals**: Previous studies indicated significant benefits in CAPS-5 scores, with sustained effects observed [14] - **FDA Engagement**: The IND for the PTSD program has been accepted by the FDA, and the company is preparing for patient screening [18] Commercial Readiness - **Launch Timeline**: COMPASS aims to be launch-ready by the end of 2026, with extensive pre-commercial activities already in place [62] - **Differentiation from Spravato**: COMP360 is expected to offer a less burdensome patient experience, requiring fewer visits compared to Spravato [64][65] - **Reimbursement Strategy**: New CPT codes for psychedelic treatments are designed to ensure adequate reimbursement for providers, addressing operational challenges faced with Spravato [30][69] Strategic Collaborations - **Partnerships**: Collaboration with various healthcare providers and organizations to facilitate the integration of COMP360 into existing treatment frameworks [33][46] - **Community Engagement**: Focus on ensuring equitable access to COMP360, particularly for underserved populations [47] Conclusion - **Market Potential**: COMP360 is positioned to address significant unmet needs in the treatment of PTSD and TRD, with the potential to revolutionize patient care in psychiatry [70] - **Anticipated Impact**: The launch of COMP360 is expected to be one of the most significant in recent history, with a strong emphasis on patient access and clinical efficacy [71]

Core Insights - Compass Pathways plc has received FDA acceptance for its IND application for COMP360, allowing the start of a late-stage clinical trial for PTSD [1][5] - The company aims to address the significant unmet need in PTSD and treatment-resistant depression (TRD) through innovative therapies [2][14] Late-Stage Clinical Trial for PTSD - The Phase 2b/3 clinical trial (COMP202) will evaluate the efficacy, safety, and tolerability of COMP360 in PTSD patients [5] - The trial consists of two parts: a 12-week blinded study comparing two doses of COMP360 (25 mg vs. 1 mg) and a 40-week open-label follow-up [5] - The primary efficacy endpoint is the change in CAPS-5 total severity score at Week 8 [5] Commercialization Readiness in TRD - Compass is preparing for the commercialization of COMP360 for TRD, with a focus on ensuring patient access if approved [2][12] - The company has had positive discussions with the FDA regarding its NDA submission strategy for COMP360 in TRD, including potential rolling submission scenarios [5] - The company has also expanded its collaborations to enhance the integration of COMP360 into healthcare settings [5] Financial Updates - Compass has amended its term loan facility with Hercules Capital, increasing it to $150 million, with $50 million already drawn [12] - The amendment extends the interest-only period until at least January 2029, providing financial flexibility [12] About PTSD and TRD - PTSD affects approximately 13 million adults in the U.S. annually, with limited treatment options available [10][8] - TRD impacts around 4 million patients in the U.S., characterized by inadequate response to multiple treatments [13]

Core Viewpoint - Compass Pathways plc is entering its seventh strategic collaboration with Radial Health, Inc. to enhance patient access to evidence-based innovation in interventional psychiatry [1] Group 1: Company Overview - Compass Pathways plc is a biotechnology company focused on accelerating patient access to innovative treatments [1] - Radial Health, Inc. is a national network specializing in interventional psychiatry practices, utilizing technology and operational expertise [1] Group 2: Strategic Collaboration - The collaboration aims to inform the development of scalable delivery models for psychiatric care [1]

Company Overview - COMPASS Pathways plc (NASDAQ:CMPS) is a London-based biotechnology company founded in 2020, focusing on mental health and committed to mental well-being [5]. Investment Potential - COMPASS Pathways is considered one of the best stocks for quick wealth accumulation, with a majority of analysts giving it a 'Buy' or equivalent rating. The median price target is $15, indicating an upside potential of 119.14% from the current price [1]. - Oppenheimer upgraded COMPASS Pathways to 'Outperform' from 'Perform', setting a price target of $15, driven by the potential of its psilocybin therapy for treatment-resistant depression [3]. - Gavin Clark-Gartner from Evercore ISI reaffirmed a 'Hold' rating with a price target of $8, reflecting a 16.87% upside potential from the current level [2]. Market Opportunity - Oppenheimer estimates a record sales opportunity of nearly $1.5 billion for COMPASS Pathways' psilocybin-based therapy, COMP360, which is significant compared to the company's current market capitalization of over $600 million [4]. - The company is expected to benefit from an early-mover advantage in the psychedelics space, supported by a strong financial position and adequate cash runway [4].

Group 1: Market Movements - Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after substantial losses during regular sessions, driven by fresh clinical data, FDA designations, and financing announcements [1] - Stoke Therapeutics, Inc. (STOK) saw its stock rise to $33.95 (+11.42%) in post-market hours after closing at $30.47 (-7.67%), following positive data presentations with Biogen regarding zorevunersen for Dravet syndrome [2] - Alpha Tau Medical Ltd. (DRTS) experienced a notable increase in share price, climbing to $5.30 (+25.26%) after closing at $4.23 (+8.74%), following the treatment of the first patient in its pilot study for recurrent glioblastoma multiforme [3] Group 2: Company Announcements - Absci Corp. (ABSI) rose to $3.65 (+3.69%) after hours, building on a close of $3.52 (+2.03%), with no new announcements but previously reported first volunteer dosing in its Phase 1/2a HEADLINE study of ABS-201 [4] - Senti Biosciences, Inc. (SNTI) surged to $1.60 (+3.92%) after hours, despite a sharp decline to $1.54 (-35.56%) during regular trading, driven by the FDA granting RMAT designation to its investigational CAR-NK cell therapy for AML and other hematologic malignancies [5] - TuHURA Biosciences, Inc. (HURA) edged up to $1.18 (+0.85%) after hours, following a significant decline to $1.17 (-40.91%) at the close, announcing a registered direct offering of 9.4 million shares priced at $1.65 per share [6]

Core Insights - Compass Pathways plc is hosting a webinar on January 7, 2026, to discuss its commercial preparations for treatment-resistant depression (TRD) and clinical trial plans for post-traumatic stress disorder (PTSD) [1] - The webinar will feature discussions on patient care pathways, provider economics for multi-hour treatments, and treatment model development in TRD [2][3] - The management team will review commercial readiness activities and the emerging profile of COMP360 in TRD, highlighting the unmet need in PTSD and detailing the planned late-stage program for COMP360 in this indication [3] Company Overview - Compass Pathways is a biotechnology company focused on accelerating patient access to evidence-based innovations in mental health, particularly for those with serious mental health conditions not adequately addressed by existing treatments [5] - The company is pioneering a new treatment paradigm with its investigational COMP360 synthetic psilocybin treatment, which has received Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway designation in the UK for TRD [5] Webinar Details - The webinar will include perspectives from key opinion leaders (KOLs) and industry leaders on the current treatment landscape and the significant unmet needs in TRD and PTSD [3] - Speakers at the event will include notable figures in the field of psychiatry and mental wellness [7]