Latest news with #COMP005
Yahoo
27-06-2025
- Business
- Yahoo
Psychedelic: Compass Pathways achieves primary endpoint in COMP360 trial
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a primary endpoint achievement, a clinical site addition and additional development candidate data. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter COMPASS PATHWAYS ACHIEVES PRIMARY ENDPOINT IN COMP360 TRIAL: Compass Pathways (CMPS) announced Monday the achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression. The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration, which has not yet reviewed the data. The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD. KBased on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study. "The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way," said Kabir Nath, CEO. "We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses. We remain focused on our goal of transforming the landscape of mental health treatment." Following the report, Evercore ISI downgraded Compass Pathways (MNMD) initiation, durability is a key component for commercial success and this will remain a question with relatively unclear durability in the Phase 2b and a weaker effect at 6 weeks here, the analyst said. Meanwhile, H.C. Wainwright said that meeting the primary endpoint in the Phase 3 COMP005 trial in treatment-resistant depression marks 'a historic first for a psychedelic therapy.' In addition to this readout representing the first-ever positive Phase 3 efficacy data for a classic psychedelic, it positions COMP360 as 'a potential first-in-class treatment in a large, underserved depression market,' said the analyst, who reiterated a Buy rating and $45 price target on the shares. Stifel acknowledged that the 3.6 point MADRS delta between drug-vs-placebo for COMP360 was 'a little lighter than expected,' but argued that the magnitude of the stock reaction is 'significantly overdone'. The COMP360 data represents 'a clearly positive result from a regulatory perspective,' and the effect-size is 'actually pretty good for a treatment-resistant population,' according to the analyst, who added that it is 'simply not clear' that effect size is a major driver of commercial success in neuropsychiatry. The firm has a Buy rating and $11 price target on Compass shares. Additionally, Canaccord said the weakness in Compass Pathways following the release of top-line results from its eagerly-awaited COMP005 Phase 3 trial is a buying opportunity. Canaccord believes updates from the FDA could eventually move the stock and there is no change to their model pending additional data. Canaccord reiterated its Buy rating and $15 price target on Compass Pathways shares. BTIG lowered the firm's price target on Compass Pathways to $7 from $12 but kept a Buy rating on the shares. The firm noted that COMP360 represents the 'very careful development of a mediocre drug' relative to other options in the psychedelic and neuro-plastic pipeline, the analyst said. CLEARMIND ADDS ISRAELI CLINICAL SITE TO AUD TRIAL: Clearmind Medicine (CMND) announced Monday the addition of Tel Aviv Sourasky Medical Center in Tel Aviv, Israel, as an additional clinical site for its ongoing Phase I/IIa clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. This expansion follows the recent enrollment of the first patient in the trial. The study at Tel Aviv Sourasky Medical Center will be led by Dr. David Zeltser, Director of the Emergency Medicine Department. Tel Aviv Sourasky Medical Center joins other institutions participating in the trial, including Yale School of Medicine's Department of Psychiatry and Johns Hopkins University School of Medicine. The inclusion of Tel Aviv Sourasky Medical Center further strengthens Clearmind's clinical network, enhancing the trial's capacity to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also exploring its potential to reduce alcohol cravings and consumption in patients with AUD. 'We are pleased to welcome Tel Aviv Sourasky Medical Center to our Phase I/IIa clinical trial, alongside esteemed partners like Yale and Johns Hopkins,' said Adi Zuloff-Shani, CEO. 'The enrollment of our first patient earlier this month was a pivotal moment, and expanding our clinical trial to additional leading clinical sites like TASMC underscores our commitment to addressing the global burden of AUD, which affects millions and accounts for 2.6M deaths annually.' ENVERIC REPORTS ADDITIONAL DATA ON EB-003: On Tuesday, Enveric Biosciences (ENVB) unveiled additional data indicating that its lead development candidate, EB-003, acts as an agonist of the serotonin receptor 5-HT1B, in addition to its other previously disclosed receptor engagement activities. The 5-HT1B receptor is a recognized therapeutic target for treating several central nervous system conditions, including major depressive disorder, Parkinson's disease, migraines, and cluster headaches. The study results demonstrated agonism of 5-HT1B by EB-003 and added to the existing receptor engagement data supporting that EB-003 acts as a partial agonist of the 5-HT2A receptor, which is key to the compound's potential ability to elicit neuroplastogenic effects without inducing adverse hallucinogenic outcomes. EB-003 is currently in preclinical development, with IND-enabling activities planned to continue through 2025. 'The 5-HT1B receptor, found predominantly in the frontal cortex, basal ganglia and hippocampus, is a validated therapeutic target of some well-known CNS drugs,' said Joseph Tucker, CEO. 'Enveric previously announced positive pharmacology, in vitro safety and oral bioavailability data of EB-003, including achieving therapeutically relevant brain exposure in rodent models. The newly revealed ability to target 5-HT1B illustrates EB-003's differentiated and multifaceted mechanism of action and broadens its utility and the range of potential target indications to pursue in future development.' SILO PHARMA ENTERS LOI FOR JV WITH HOTH: Silo Pharma (SILO) announced Wednesday that it has entered into a non-binding letter of intent to form a strategic 50:50 joint venture with Hoth Therapeutics (HOTH) to develop and commercialize a potential treatment for obesity and metabolic disease based on technology Hoth has exclusively licensed from the U.S. Department of Veterans Affairs that was co-developed by the VA and Emory University. The novel therapeutic platform centers on glial cell line-derived neurotrophic factor, a VA-invented biologic with demonstrated anti-obesity effects and metabolic regulation in preclinical models. The platform is protected under U.S. Patent No. 10,052,362 and targets multiple high-burden conditions, including non-alcoholic fatty liver disease, type 2 diabetes, and central obesity. 'With obesity at epidemic levels and no curative therapies available, we believe the VA's biologic GDNF is potentially a game-changer,' said Eric Weisblum, CEO. 'We believe that our potential JV collaboration with Hoth aligns with our mission to accelerate groundbreaking science into human trials.' HOPE THERAPEUTICS TO ACQUIRE INTEREST IN COHEN: HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals (NRXP), announced Thursday the signing of a binding Letter of Intent to purchase a 49% interest in Cohen and Associates, founded by Dr. Rebecca Cohen. Cohen is expected to serve as a foundational clinic for HOPE in the Sarasota-Bradenton region of western Florida. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, including ketamine, Spravato, Transcranial Magnetic Stimulation as well as medication management. 'We are delighted to welcome Rebecca and her team to the HOPE family. Her extensive experience with neuroplastic therapies, combined with compassionate patient care exemplify our culture of bringing HOPE to life,' said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE. Additionally on Monday, NRx Pharmaceuticals announced filing for the newly-announced FDA Commissioner's National Priority Voucher program on behalf of NRX-100, its patent-pending, preservative-free formulation of ketamine for intravenous use. Concurrent with the CNPV process, the company is preparing a citizen petition to seek withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. The company has also filed a patent on its preservative-free manufacturing process. 'NRx is highly encouraged by the newly-announced Commissioner's National Priority Voucher Program, and believes that NRX-100 meets each of the criteria for acceptance,' said Jonathan Javitt, CEO. 'As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD, and address an unmet medical need. We will be seeking New Drug Approval for NRX-100 in the treatment of suicidal depression and PTSD. The FDA's announcement has now validated our company's focus on manufacturing and CMC by identifying CMC as a pre-requisite to the CNPV program. The timelines announced for the CNPV program are consistent with NRx's previous guidance of FDA decisions by year-end 2025. Our application under the CNPV program is accretive to the Abbreviated New Drug Application filed last week for preservative-free ketamine, for which we are seeking priority review.' OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds (DRUG), Cybin (CYBN), Entheon Biomedical (ENTBF), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Mike Davis to become CDER deputy director, Pink Sheet's Gingery says Compass Pathways price target lowered to $7 from $12 at BTIG Compass Pathways weakness a buying opportunity, says Canaccord Compass Pathways Achieves Phase 3 Trial Success Compass Pathways downgraded to In Line from Outperform at Evercore ISI Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
23-06-2025
- Business
- Business Wire
Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression
LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint is the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6. A single dose of COMP360 25 mg versus placebo demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint. The Company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data. The ongoing Phase 3 COMP005 trial is the first study of an investigational, synthetic psilocybin, and the first classic psychedelic to report Phase 3 efficacy data. This randomized, double-blind, placebo-controlled study, which dosed 258 participants with TRD across 32 sites in the United States, aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD. Key COMP005 Findings: Efficacy Data (MADRS): Single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points, 95% CI [-5.7, -1.5]; p<0.001 Safety Data (statement provided by the DSMB chair): Based on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study. 4 'The positive top-line results at week 6 from the COMP005 trial underscore the innovative potential of psilocybin treatment in mental health care for which Compass Pathways continues to pave the way,' said Kabir Nath, Chief Executive Officer of Compass Pathways. 'We are proud of this significant progress, which reflects our scientific rigor, operational excellence and steadfast commitment to serving patients living with TRD. We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses. We remain focused on our goal of transforming the landscape of mental health treatment.' 'As we continue our Phase 3 program, we are very encouraged by the initial positive results and the highly statistically significant and clinically meaningful change in the MADRS score between the arms of the study 6 weeks after a single administration of COMP360,' said Guy Goodwin, MD, Chief Medical Officer of Compass Pathways. 'This progress marks an important milestone for patients living with TRD and highlights the groundbreaking work Compass Pathways is doing to bring innovative treatments to those who have been failed by multiple currently approved available treatment options. This achievement provides hope that they can finally receive appropriate care and live the life they deserve. We are incredibly grateful to the participants, investigators and clinical sites for their invaluable contributions to this study.' About the COMP360 Phase 3 Program The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD). The ongoing COMP005 trial is a randomized, double-blind, placebo-controlled study, which has dosed 258 participants with treatment-resistant depression across 32 sites in the United States and aims to assess the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD. The trial is comprised of three parts: Part A, which has recently concluded and was blinded through 6 weeks; Part B, which remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52. The COMP006 trial, running in parallel to the COMP005 trial, is a randomized, double-blind study with 568 planned participants from North America and Europe and aims to compare the safety and efficacy of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360. The trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52. Compass Pathways anticipates sharing 26-week data for COMP005 once all participants in the COMP006 trial have completed part A of the COMP006 trial. The 26-week data from COMP006 is expected in the second half of 2026. About treatment resistant depression (TRD) The United States is in a mental health crisis, and depression is one of the most common mental health disorders. Depression significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030. An estimated 21 million adults in the United States suffer from major depression, and approximately 9 million are drug treated. Due to the limitations of approved existing MDD medications, approximately one-third of patients with MDD will develop TRD. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as 'may', 'might', 'will', 'could', 'would', 'expect', 'intend', 'plan', 'objective', 'anticipate', 'believe', 'contemplate', 'estimate', 'predict', 'potential', 'continue' and 'ongoing,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our plans and expectations regarding our Phase 3 trials in TRD, including our expectations regarding the time periods during which the 26-week results of the two Phase 3 trials will become available; the potential for the pivotal Phase 3 program in TRD to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our expectations regarding the enrollment of our Phase 3 COMP006 trial; any implication that past results will be predictive of future results; and statements related to the innovative potential of psilocybin treatment in mental health care. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from this Phase 3 study in TRD or the results and safety data from our second Phase 3 study in TRD, COMP006, may not be consistent with the preliminary results to date; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading 'Risk Factors' in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. Securities and Exchange Commission ('SEC'), which are available on the SEC's website at Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof. References Data on file For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55 (03), pp.121-138.
Business Wire
08-05-2025
- Business
- Business Wire
Compass Pathways Announces First Quarter 2025 Financial Results and Business Highlights
LONDON & NEW YORK--(BUSINESS WIRE)--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 first quarter 2025 and provided an update on recent progress across its business. 'We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.' said Kabir Nath, Chief Executive Officer. 'Our continued progress reinforces Compass' leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.' Business Highlights COMP360 psilocybin treatment in TRD (Treatment Resistant Depression) The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program. All participants have completed dosing in part A of the COMP005 phase 3 trial for TRD and top-line 6-week (primary endpoint) data are expected in late June. 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. COMP006 26-week data is expected in the second half of 2026. Recent 52-week data from an observational follow-up study published on COMP360 demonstrated a durable treatment response and a median time to depressive event of 92 days (n=252) on a single 25mg administration and 189 days (n=58) for the 25mg subgroup that continued into the COMP004 long-term extension COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder) Company designing late-stage clinical trial program Phase 2 open label 12-week safety and tolerability study (n=22) announced in May 2024, showed COMP360 was well tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration. Financial highlights Net loss for the three months ended March 31, 2025, was $17.9 million, or $0.20 net loss per share: basic, $0.24 net loss per share: diluted, compared with $35.2 million, or $0.55 loss per share basic and diluted, during the same period in 2024. The decrease in net loss for the quarter was primarily driven by a $19.5 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. Non-cash share-based compensation for the three months ended March 31, 2025 was $3.9 million compared with $5.1 million for the same period in 2024. Research and development expenses were $30.9 million for the three months ended March 31, 2025, compared with $24.9 million during the same period in 2024. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials partially offset by decreased personnel and non-cash share-based compensation expenses due to decreased staffing levels associated with the strategic reorganization that took place in the fourth quarter of 2024. General and administrative expenses were $18.7 million for the three months ended March 31, 2025, compared with $13.7 million during the same period in 2024. The increase was primarily attributable to issuance costs related to the 2025 Financing as well as expenses associated with consulting, accounting and legal advice. Gain on change in fair value of warrants for the three months ended March 31, 2025, was $19.5 million compared with $0.0 million during the same period in 2024. Cash and cash equivalents were $260.1 million as of March 31, 2025, compared with $165.1 million as of December 31, 2024. An additional $140.4 million net cash raised in the first quarter of 2025. Financial Guidance Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. The cash position at March 31, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. Conference call The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025. A live webcast of the call will be available on the Compass Pathways website at First Quarter 2025 Financial Results. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as 'may', 'might', 'will', 'could', 'would', 'should', 'expect', 'intend', 'plan', 'objective', 'anticipate', 'believe', 'contemplate', 'estimate', 'predict', 'potential', 'continue' and 'ongoing,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company's future cash needs and financial results; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; and those risks and uncertainties described under the heading 'Risk Factors' in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ('SEC'), which are available on the SEC's website at Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof. COMPASS PATHWAYS PLC Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) Three Months ended March 31, 2025 2024 OPERATING EXPENSES: Research and development $ 30,880 $ 24,901 General and administrative 18,736 13,672 Total operating expenses 49,616 38,573 Loss from operations: (49,616 ) (38,573 ) OTHER INCOME (EXPENSE), NET: Fair value change of warrant liabilities 19,460 — Benefit from R&D tax credit 8,448 3,101 Interest income 2,386 2,260 Foreign exchange gains (losses) 2,133 (783 ) Interest expense (1,124 ) (1,098 ) Other income 803 128 Total other income, net 32,106 3,608 Loss before income taxes (17,510 ) (34,965 ) Income tax expense (354 ) (222 ) Net loss $ (17,864 ) $ (35,187 ) Net loss per share attributable to ordinary shareholders: basic $ (0.20 ) $ (0.55 ) Weighted average ordinary shares outstanding: basic 89,192,252 64,222,178 Net loss per share attributable to ordinary shareholders: diluted $ (0.24 ) $ (0.55 ) Weighted average ordinary shares outstanding: diluted 98,641,624 64,222,178 Net loss $ (17,864 ) $ (35,187 ) Other comprehensive loss: Foreign exchange translation adjustment (117 ) (36 ) Comprehensive loss $ (17,981 ) $ (35,223 ) Expand
Yahoo
25-04-2025
- Business
- Yahoo
Why Compass Pathways Stock Was a Double-Digit Winner This Week
The field of psychedelic medicine is relatively new, and because of this, certain investors consider it to be loaded with potential. That's why even minor events in companies specializing in this can be greeted with notable share price pops. Such a dynamic was in evidence with U.K.-based Compass Pathways (NASDAQ: CMPS) this week. On news about a step completed in a clinical trial, the company's shares rose by 13% over the period, according to data compiled by S&P Global Market Intelligence. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » Compass Pathways, which focuses on psilocybin -- the psychoactive compound found in "magic" mushrooms -- announced Tuesday that it had completed dosing in a late-stage clinical trial. The biotech is currently putting its synthesized psilocybin treatment, COMP005, through its paces in a phase 3 trial. Participants are to receive either a 25-milligram dose of the medication or a placebo. Promisingly, we should have a readout before long, as Compass Pathways said it is on pace to publish six-week primary endpoint results toward the end of June. The study comprises 258 patients currently afflicted with moderate to severe depression and who have not responded to a minimum of two previous treatments. The dosing took place at 32 sites in the U.S. In the press release marking the milestone, Compass Pathways quoted CEO Kabir Nath as saying that it "marks a critical milestone in our mission to address the pressing unmet need in treatment resistant depression." It also further establishes once-taboo psychoactive substances as legitimate potential therapies for serious psychological disorders. Investors will be crossing their fingers for success with this late-stage round of testing. Before you buy stock in Compass Pathways Plc, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Compass Pathways Plc wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $591,533!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $652,319!* Now, it's worth noting Stock Advisor's total average return is 859% — a market-crushing outperformance compared to 158% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of April 21, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Why Compass Pathways Stock Was a Double-Digit Winner This Week was originally published by The Motley Fool Sign in to access your portfolio
