CMND
Clearmind MedicineFDocument history
Earnings documents stored for CMND.
Investor releaseQuarter not tagged2026-04-20Clearmind Medicine Announced Positive Top-Line Safety Results: CMND-100 Proprietary Psychedelic Treatment Meets Primary Endpoint in AUD Trial
GlobeNewswire
Clearmind Medicine Announced Positive Top-Line Safety Results: CMND-100 Proprietary Psychedelic Treatment Meets Primary Endpoint in AUD Trial
Vancouver, Canada, April 20, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation psychedelic, neuroplastogen-derived therapeutics to solve major under-treated health problems, recently announced that CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD) has met the primary endpoint in its FDA-approved Phase I/IIa clinical trial. Results from the third cohort of the trial indicated a high safety profile for CMND-100, even at the higher dosage administered to date. The data demonstrated that the drug candidate was well tolerated, with no serious adverse events reported in the third cohort and continued favorable overall tolerability, consistent with the safety outcomes observed in prior cohorts. The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Meeting the primary safety and tolerability endpoint in this dose-escalation stage, including at the higher dosage in the third cohort, supports continued advancement of CMND-100 as a potential novel, non-hallucinogenic treatment option for AUD. About Clearmind Medicine Inc. Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements. The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND." For further information, visit: https://www.clearmindmedicine.com or contact: Investor Relations [email protected] www....
Investor releaseQuarter not tagged2026-03-11Clearmind Medicine Advances Recruitment for CMND-100 Trial's Third Cohort at Yale, Johns Hopkins and Tel Aviv Sites Following Recent Positive Topline Results
GlobeNewswire
Clearmind Medicine Advances Recruitment for CMND-100 Trial's Third Cohort at Yale, Johns Hopkins and Tel Aviv Sites Following Recent Positive Topline Results
Vancouver, Canada, March 11, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the continuation of participant enrollment for the third cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). The recruitment follows the positive topline results recently reported from the second cohort, which demonstrated continued safety and tolerability, building on the favorable outcomes from prior cohorts. The Company’s Data and Safety Monitoring Board (DSMB) has reviewed the data and provided unanimous approval to proceed, enabling enrollment in this next phase. The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Participant recruitment for the third cohort at leading sites, including Yale University, Johns Hopkins University, and Tel Aviv Sourasky Medical Center, reflecting strong momentum and confidence in CMND-100 as a potential breakthrough therapy for AUD. “Building on the encouraging results from our first and second cohort, we are excited on progressing with the clinical trial at these prestigious institutions,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “The positive data we continue to receive from our clinical trial, reinforce CMND-100’s potential as a safe and well tolerated, non-hallucinogenic treatment option that addresses the critical unmet needs in alcohol use disorder, without requiring adjunct psychotherapy, making this treatment accessible and discrete. We remain committed to progressing this trial to bring innovative, safe and affordable solutions to patients in need.” About Clearmind Medicine Inc. Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary o...
Investor releaseQuarter not tagged2026-03-06Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
TipRanks
Psychedelic: Helus Pharma reports HLP004 Phase 2 signal detection study results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on study results, FDA alignment and a DSMB recommendation. Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential HELUS PHARMA REPORTS PHASE 2 HLP004 RESULTS: Helus Pharma (HELP) announced Thursday topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. At six months, the pooled study population showed 67% responders and 39% remitters. Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6. The study also found a short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics. Additionally, results show a favorable tolerability p...
Investor releaseQuarter not tagged2026-02-09Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial
GlobeNewswire
Clearmind Medicine Announces Additional Topline Positive Safety Results Reinforcing Favorable Profile of CMND-100 in Ongoing Phase I/IIa Clinical Trial
Vancouver, Canada, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced additional positive safety topline results from the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). These further safety data points, emerging following the successful completion of treatment in another six patients of the second cohort, previously announced January 14, 2026, continue to strengthen the encouraging safety and tolerability profile previously established in the first cohort. The results reinforce no serious adverse events and overall good tolerability, consistent with the favorable results reported from the first cohort, support the rapid progression enabled by the Company’s Data and Safety Monitoring Board’s (DSMB) unanimous approval to advance for the second cohort. The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. The second cohort, conducted across leading sites, including Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center, achieved full treatment completion shortly after DSMB clearance, underscoring continued confidence in CMND-100’s safety profile as a potential innovative therapy for AUD. “These additional topline safety results from the second cohort further validate and reinforce the positive profile we observed in the first cohort,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “With no serious adverse events emerging and strong tolerability maintained, we are continuing to build compelling evidence for CMND-100 as a potentially safe, non-hallucinogenic, not adjunct to psychotherapy, treatment to address the significant unmet needs in alcohol use disorder.” About Clearmind Medicine Inc. Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeu...
Investor releaseQuarter not tagged2026-01-21Clearmind Medicine Inc. Files Annual Report on Form 20-F for the Fiscal Year Ended October 31, 2025
GlobeNewswire
Clearmind Medicine Inc. Files Annual Report on Form 20-F for the Fiscal Year Ended October 31, 2025
Vancouver, Canada, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced that it has filed its Annual Report on Form 20-F for the fiscal year ended October 31, 2025, with the U.S. Securities and Exchange Commission (the 'SEC'). The report is available on the SEC's website, at www.sec.gov and Clearmind’s Investor Relations website, at https://www.clearmindmedicine.com/investors. Shareholders can obtain copies of Galmed's Annual Report on Form 20-F, free of charge, by making a request within a reasonable period of time to Clearmind’s Investor Relations Department at [email protected]. About Clearmind Medicine Inc. Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements. The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY0.” For further information, visit: https://www.clearmindmedicine.com or contact: Investor Relations [email protected] Telephone: (604) 260-1566 US: [email protected] General Inquiries [email protected] www.Clearmindmedicine.com Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Forward-looking statements are not historical fac...
Investor releaseQuarter not tagged2025-11-18Clearmind Medicine Announces Positive Top-Line Results from First Cohort of its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
GlobeNewswire
Clearmind Medicine Announces Positive Top-Line Results from First Cohort of its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Vancouver, Canada, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced positive top-line results from the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD). The top-line data from the first cohort demonstrate a favorable safety profile, with no serious adverse events reported and the treatment generally well-tolerated across all participants. Additionally, the cohort showed strong treatment observance, with high adherence to the dosing regimen and protocol requirements, underscoring the feasibility and patient acceptability of CMND-100 in a clinical setting. These encouraging early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions worldwide where effective treatments remain limited. These results build on the Company’s previous announcement on October 30, 2025, regarding the successful completion of dosing in the first cohort, where six patients were enrolled and treated—two at Johns Hopkins University School of Medicine and four at Yale School of Medicine’s Department of Psychiatry. The multinational, multicenter trial, conducted under the U.S. Food and Drug Administration (FDA)-approved clinical protocol, is designed as a single- and multiple-dose study to assess the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in participants with heavy binge drinking or AUD. “We are thrilled with these initial top-line results from the first cohort, which “indicate an encouraging safety profile and excellent treatment observance of CMND-100,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine. “Building on our recent milestone of completing dosing at premier institutions like Johns Hopkins and Yale, these data provide strong momentum as we advance toward full data readout and subsequent cohorts. Our goal remains to pioneer neuroplastogen -derived therapies that offer real hope to those battling addiction, and these results bring us one step closer to that v...
Investor releaseQuarter not tagged2025-03-21Psychedelic: atai Life Sciences, NRx report quarterly results
TipRanks
Psychedelic: atai Life Sciences, NRx report quarterly results
In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a collaboration LOI and a study publication. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. EARNINGS: On Monday, atai Life Sciences (ATAI) reported a fourth quarter loss per share of (24c) on revenue loss of ($5,000), which compared to analyst estimates of a loss per share of (15c) and revenue of $18,000 for the same period last year. As of December 31, the company had cash, cash equivalents, restricted cash and short-term securities of $72.3M compared to $154.2M as of December 31, 2023. In February, the company completed an equity offering with net proceeds of $59.2M and now expects its cash, short-term securities, and public equity holdings to be sufficient to fund operations into 2027. “We are beginning the year in a strong financial position, thanks to the recent capital raise, which extends our runway into 2027, beyond when we expect the topline data readouts from the Phase 2 clinical trials of our two core programs, VLS-01 and EMP-01, in 1Q26” stated Srinivas Rao, CEO. “Our team is focused on executing these trials rigorously and efficiently to drive forward our mission to transform patient outcomes in mental health. We also look forward to several key milestones this year, notably Beckley Psytech’s BPL-003 Phase 2b topline results in patients with treatment-resistant depression as well as RL-007 in patients with cognitive impairment associated with schizophrenia, both expected mid-2025.” Additionally on Monday, NRx Pharmaceuticals (NRXP) reported a FY24 loss per share of ($2.36), which compared to a loss per share of ($3.98) for the same period last year. As of December 31, the company had approximately $1.4M in cash and cash equivalents. In January, the company completed two financings with aggregate gross proceeds of approximately $8.5M. Management believes that current available cash resources will be sufficient to support ongoing operations through at least the end of 2025. “Our work in the fourth quarter of 2024 and into 2025 has driven significant advances for our company and investors. We have retired debt that was impeding the launch of HOPE Therapeutics and brought new investors into the Company who are aligned with our objectives. We launched the fili...

