Latest news with #KabirNath
Politico
4 days ago
- Health
- Politico
Psychedelic medicine CEO eyes chances under MAHA
THE NEXT CURES As CEO of the psychedelic medicine company Compass Pathways, Kabir Nath has had a front-row seat to a dramatic year in the field of psychedelics. Once an industry darling, Compass' competitor Lykos Therapeutics was brought to its knees last summer when the Food and Drug Administration turned down the drugmaker's application for the psychedelic drug MDMA combined with talk therapy as a treatment for post-traumatic stress disorder. Lykos quickly shed staff and top leadership following the decision, including board member Rick Doblin, who spent decades campaigning for FDA approval of the drug. The rejection also had a chilling effect on the industry at large. Compass delayed results from its late-stage psychedelics trials and laid off 30 percent of its staff. But the environment has started to thaw in recent months. President Donald Trump's appointees, including HHS Secretary Robert F. Kennedy Jr. and VA Secretary Doug Collins, have sparked excitement among psychedelics proponents by touting psychedelic therapy's promise as a treatment for veterans with mental illness. In June, Kennedy offered a progress update on psychedelic therapies. 'We are working very hard to make sure that that happens within 12 months,' he told members of Congress. In late June, Compass released topline results from its Phase III trial of a synthetic form of psilocybin, which is derived from psychedelic mushrooms, as a therapy for treatment-resistant depression. While full findings won't be released until later this year, preliminary results found that after six weeks, a single dose of synthetic psilocybin reduced participants' depression scores by 3.6 points compared with a placebo group in a randomized trial of 258 people. Erin caught up with Nath to learn more about what's next for Compass and how the company is positioning itself under the new administration. This conversation has been edited for length and clarity. How are you feeling about your chances of FDA approval since Trump took office? We plan to meet with the FDA to discuss that and to talk about any potential for accelerating the filing. Right now, our base case continues to be that we will need both of the Phase III studies. The second one reads out at the second half in 2026, so that continues to be our base case, because that's the existing alignment we have with the agency. We're encouraged by the fact that there are voices in the administration at different levels who seem to share our view of the potential for psychedelics and share an interest in trying to get them accelerated, subject to doing the right rigorous studies and getting the science right. Which voices in the administration are you thinking of? What's in the public domain is that both RFK Jr. and Secretary Collins have talked about trying to find a way to make psychedelics available within 12 months. That has to be defined. Does that mean a full approval? Does that mean some sort of framework of early access? What we're excited to do is to find opportunities to partner if we can, so that whether it's earlier access, or whether it's some sort of pilot program, we could participate in that. But crucially, we want to respect the integrity of the FDA approval process. That's fundamental to us, because that is the gold standard for assuring safety and effectiveness. FDA Commissioner Marty Makary has also spoken publicly about psychedelics. There are a number of people who are on record saying they see the potential. But to be clear, we're not asking for psychedelic exceptionalism. We're not asking for a different standard. We've done two very large studies in patients with treatment-resistant depression, and we are two for two in showing highly statistically significant positive results after a single dose. In this population of really hard-to-treat depression, we think that is probably a unique achievement, but we'll call it remarkable. WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. Researchers at the University of Basel have reconstructed the 1918 Spanish flu virus from a 107-year-old lung, New Atlas reports. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: CarmenP.82, RuthReader.02 or ErinSchumaker.01. TECH MAZE Bruce Siegel, the outgoing president and CEO of America's Essential Hospitals, which represents hospitals that serve low-income patients, is retiring at the end of the year — after leading the group for 15 years and spending a nearly four-decade career in health policy and hospital administration. In an extended conversation with POLITICO's Kelly Hooper, he spoke about the impact of the tax legislation recently signed into law — containing more than $1 trillion in health care cuts — including new limits on provider taxes, work requirements and provisions that target Medicaid-directed payments and a $50 billion rural hospital fund Republicans included in the law to mitigate the impact on safety-net hospitals. Siegel also addressed the impact of technology on the health care sector. What might the future look like as new technology is increasingly integrated into care? I don't know how [artificial intelligence] plays out going forward. There's huge opportunities with AI to improve care, to predict what will happen to patients, to better communicate with patients. That's great. I also think that there's dangers in AI. Will AI increase disparities for some populations? It could. Could AI be used to redline communities or redline groups of patients? 'Hey, they're too risky.' Yeah, it could. There could be negative uses, and we're going to have to have some guardrails and a serious conversation about that. I was asked recently at a conference how I felt about the use of large data systems and AI to understand and inform how we treat the individual patient based on their genetics. And my response to that was that it could be very exciting, that level of personalized care, but would it also mean that my health data is now being bought and sold out there? And that's really valuable data. It's incredibly valuable data for underwriters, insurers, developers, all kinds of people. So we need to have some pretty firm understanding and some pretty firm guardrails around whose data is this and how it gets used. Read Siegel's full interview with Kelly on POLITICO Pro.
Business Wire
31-07-2025
- Business
- Business Wire
Compass Pathways Announces Second 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 second quarter 2025 and provided an update on recent progress across its business. 'With the recent positive 6-week primary endpoint from our first COMP360 Phase 3 study and the prior positive Phase 2b study, we have now delivered clinically meaningful and highly statistically significant top-line results after a single dose of COMP360 in two late-stage studies in treatment-resistant depression, a considerable achievement in psychiatry,' said Kabir Nath, Chief Executive Officer of Compass Pathways. 'As we look forward to the 006 data, our second phase 3 study, we are excited to see the efficacy of two fixed doses with the 6-week primary endpoint measurement only three weeks after the second dose. Given our recent positive phase 3 data, we are highly focused on solidifying our commercialization efforts and exploring pathways to get this potential paradigm changing treatment option to patients as quickly as possible.' Business Highlights COMP360 psilocybin treatment in TRD (Treatment Resistant Depression) First study of an investigational, synthetic psilocybin, and the first classic psychedelic 1, to report Phase 3 efficacy data A single administration of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity at six weeks, in the first of two phase 3 studies (COMP005) Based on its latest review of the data, DSMB safety review found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation in either phase 3 study (COMP005/COMP006) 2 COMP005 26-week 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 COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder) Late-stage clinical trial design being finalized taking into consideration the results from the phase 2 open label 12-week safety and tolerability study (n=22) that was announced in May 2024, which showed COMP360 was well tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration Board of Directors update Justin Gover, prior CEO of GW Pharmaceuticals, appointed to the Compass Pathways Board of Directors Dr. Linda McGoldrick will retire from her position on the Board at the end of October after more than 5 years of service Financial Highlights Net loss for the three months ended June 30, 2025, was $38.4 million, or $0.41 net loss per share: basic and diluted, compared with $38.1 million, or $0.56 loss per share basic and diluted, during the same period in 2024. The increase in net loss for the quarter was primarily driven by a $2.5 million non-cash loss on fair value adjustment related to our warrant liabilities partially offset by $2.1 million related to foreign exchange gains. 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. Net loss for the six months ended June 30, 2025, was $56.3 million, or $0.62 net loss per share: basic and diluted, compared with $73.3 million, or $1.11 loss per share basic and diluted, during the same period in 2024. The decrease in net loss for the period was primarily driven by a $16.9 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 June 30, 2025 was $3.6 million compared with $4.9 million for the same period in 2024. Non-cash share-based compensation for the six months ended June 30, 2025 was $7.5 million compared with $10.1 million for the same period in 2024. Research and development expenses were $30.3 million for the three months ended June 30, 2025, compared with $29.1 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 reorganization that took place in the fourth quarter of 2024. Research and development expenses were $61.2 million for the six months ended June 30, 2025, compared with $54.0 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 reorganization that took place in the fourth quarter of 2024. General and administrative expenses were $12.6 million for the three months ended June 30, 2025, compared with $14.3 million during the same period in 2024. The decrease was primarily attributable to decreased staffing levels associated with the reorganization that took place in the fourth quarter of 2024 as well as decreased facilities and other expenses as a result of lower insurance premiums and banking fees. General and administrative expenses were $31.3 million for the six months ended June 30, 2025, compared with $27.9 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, partially offset by decreased facilities and other expenses as a result of lower insurance premiums and banking fees as well as decreased personnel expenses due to decreased staffing levels associated with the reorganization that took place in the fourth quarter of 2024. Loss on change in fair value of warrants for the three months ended June 30, 2025, was $2.5 million compared with $0.0 million during the same period in 2024. Gain on change in fair value of warrants for the six months ended June 30, 2025, was $16.9 million compared with $0.0 million during the same period in 2024. Cash and cash equivalents were $221.9 million as of June 30, 2025, compared with $165.1 million as of December 31, 2024. Debt was $30.9 million as of June 30, 2025, compared with $30.2 million as of December 31, 2024. 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 June 30, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2027. Conference Call The management team will host a conference call at 8:00 am ET (1:00 pm UK) on July 31, 2025. A live webcast of the call will be available on the Compass Pathways website at this link: 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 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 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 ongoing Phase 3 trials in TRD, including our expectations regarding the time periods during which the 26-week results of the two ongoing 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; any implication that past results will be predictive of future results; our expectations regarding the enrollment of our Phase 3 COMP006 trial; 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 full results and safety data from our first Phase 3 study in TRD, COMP005, 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; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment in PTSD may not be predictive of the results of our planned late-stage clinical trial in PTSD; 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. References 1. 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. 2. Statement on file from the DSMB Chair, dated June 19, 2025 COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) June 30, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 221,881 $ 165,081 Restricted cash 379 389 Prepaid expenses and other current assets 54,143 35,821 Total current assets 276,403 201,291 NON-CURRENT ASSETS: Operating lease right-of-use assets 4,341 2,006 Deferred tax assets 4,290 3,774 Long-term prepaid expenses and other assets 8,502 6,595 Total assets $ 293,536 $ 213,666 LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 10,925 $ 12,283 Accrued expenses and other liabilities 10,370 14,495 Debt, current portion 7,982 5,513 Operating lease liabilities - current 2,051 1,725 Total current liabilities 31,328 34,016 NON-CURRENT LIABILITIES Debt, non-current portion 22,951 24,652 Operating lease liabilities - non-current 2,304 303 Warrant liabilities 74,398 — Total liabilities $ 130,981 $ 58,971 SHAREHOLDERS' EQUITY: Ordinary shares, £0.008 par value; 93,586,348 and 68,552,215 shares authorized, issued and outstanding at June 30, 2025 and December 31, 2024, respectively 946 702 Additional paid-in capital 767,190 704,919 Accumulated other comprehensive loss (14,582 ) (16,194 ) Accumulated deficit (590,999 ) (534,732 ) Total shareholders' equity 162,555 154,695 Total liabilities and shareholders' equity $ 293,536 $ 213,666 Expand 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 June 30, Six months ended June 30, 2025 2024 2025 2024 OPERATING EXPENSES: Research and development $ 30,325 $ 29,069 $ 61,205 $ 53,970 General and administrative 12,608 14,253 31,344 27,925 Total operating expenses 42,933 43,322 92,549 81,895 Loss from operations: (42,933 ) (43,322 ) (92,549 ) (81,895 ) OTHER INCOME (EXPENSE), NET: Fair value change of warrant liabilities (2,540 ) — 16,920 — Benefit from R&D tax credit 4,287 3,709 12,735 6,810 Interest income 1,898 2,408 4,284 4,668 Foreign exchange gains (losses) 2,349 225 4,482 (558 ) Interest expense (1,151 ) (1,112 ) (2,275 ) (2,210 ) Other (expense) income (176 ) 167 627 295 Total other income, net 4,667 5,397 36,773 9,005 Loss before income taxes (38,266 ) (37,925 ) (55,776 ) (72,890 ) Income tax expense (137 ) (176 ) (491 ) (398 ) Net loss $ (38,403 ) $ (38,101 ) $ (56,267 ) $ (73,288 ) Net loss per share attributable to ordinary shareholders: basic and diluted $ (0.41 ) $ (0.56 ) $ (0.62 ) $ (1.11 ) Weighted average ordinary shares outstanding: basic and diluted 93,341,594 68,371,139 91,278,385 66,296,658 Other comprehensive loss: Foreign exchange translation adjustment 1,729 81 1,612 45 Comprehensive loss $ (36,674 ) $ (38,020 ) $ (54,655 ) $ (73,243 ) Expand
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.
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09-05-2025
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Psychedelic: Compass, GH Research, MindMed report quarterly earnings
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent grant and study results. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Q1 EARNINGS: On Thursday, Compass Pathways (CMPS) reported a first quarter loss per share of (24c), which compared to analyst estimates of a loss per share of (49c). The company said cash and cash equivalents were $260.1M as of March 31, compared with $165.1M as of December 31. Compass also guided to full year 2025 net cash used in operating activities in the range of $120M to $145M. The cash position at March 31 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. '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, CEO. '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.' GH Research (GHRS) also reported Q1 results Thursday with a loss per share of (19c), which compared to analyst consensus of a loss per share of (20c). Cash, cash equivalents, other financial assets and marketable securities were $315.3M as of March 31, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31. Gross proceeds from public offering in Q1 were $150M. Additionally on Thursday, Mind Medicine (MNMD) reported a Q1 loss per share of (35c), which compared to analyst estimates of a loss per share of (37c). Cash, cash equivalents and investments totaled $245.5M as of March 31. The company believes that its cash, cash equivalents, and investments as of March 31 will be sufficient to fund the company's operations into 2027. Based on the company's current operating plan and anticipated R&D milestones, the company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in General Anxiety Disorder. 'We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,' said Rob Barrow, CEO. 'We're on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we're delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.' CYBIN ANNOUNCES U.S. PATENT GRANT: Cybin (CYBN) announced Thusday that the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in Major Depressive Disorder. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the company's proprietary deuterated psilocin analog program, CYB003. 'Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline,' said Doug Drysdale, CEO. 'Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders.' MIRA REPORTS KETAMIR-2 NEUROTOXICITY RESULTS: On Tuesday, MIRA Pharmaceuticals (MIRA) announced results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes included no adverse clinical signs or mortality in any Ketamir-2-treated animals; No microscopic or macroscopic brain lesions detected at any dose; MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. 'These results represent a key milestone in the development of Ketamir-2,' said Erez Aminov, CEO. 'The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2's potential as a safe next-generation, oral candidate for CNS disorders.' Additionally on Thursday, MIRA announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, following the completion of independent valuation reports on both companies. The merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5M, based on a risk-adjusted net present value of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30M. As outlined in the previously announced binding letter of intent for the merger, upon the closing, SKNY must hold at least $5M in cash or other assets, to be transferred at closing, and the company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. BRIGHT MINDS INITIATED WITH BUY: On Wednesday, Chardan initiated coverage of Bright Minds (DRUG) with a Buy rating and $80 price target. The firm cites the potential of the company's lead asset BMB-101 for the treatment of epilepsy for the Buy rating. Bright Minds is an 'interesting story even at current valuation: as BMB-101 could be differentiated verses other 5-HT2C agonists with its unique binding profile, and it could potentially achieve greater than $1B peak sales in epilepsy, the analyst said. NRXP FILES PATENT APPLICATION: NRx Pharmaceuticals (NRXP) announced Monday the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the U.S. Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. 'We are committed to delivering safer, more effective treatments for patients with suicidal depression,' said Jonathan Javitt, CEO. 'NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.' OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), 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), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). 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 Compass Pathways reports Q1 EPS (24c), consensus (49c) Compass Pathways enters strategic collaboration with HealthPort Psychedelic: Clearmind completes clinical site initiations for AUD trial Compass Pathways completes dosing in Part A of Phase 3 psilocybin trial COMPASS Pathways Amends Executive Employment Agreements
