CMND

Vancouver, Canada, Aug. 11, 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, non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve major under-treated health problems, such as addictions and weight-loss, today announced positive permeation study results from its ongoing intranasal MEAI development program. The new findings confirm that the enhanced nasal residence time previously demonstrated with the proprietary intranasal MEAI formulation does not compromise the permeation characteristics of Clearmind's proprietary MEAI (5-Methoxy-2-aminoindane). Clearmind’s early-stage studies of its intranasal MEAI formulation have generated highly promising results, supporting the continued development of this innovative treatment approach. The positive data generated to date supports the company’s development strategy and provide compelling support for the continued advancement of the intranasal program. Together, these findings provide additional support for the continued evaluation of MEAI  as a differentiated therapeutic candidate for mental-health disorders, including alcohol use disorder (AUD), as well as for weight management, obesity, and metabolic conditions. The permeation study builds on recently reported ex vivo mucoadhesion results demonstrating that intranasal MEAI remains associated with nasal tissue substantially longer than a conventional MEAI solution. These findings show markedly enhanced retention of MEAI on nasal mucosa reinforcing its potential to achieve extended nasal residence time within the nasal cavity. Together, the data further supports the continued development of Clearmind’s intranasal program and highlights the formulation’s potential as a differentiated intranasal delivery approach for MEAI. To evaluate whether the enhanced retention of intranasal MEAI influences its release and membrane transport, permeation studies were performed using Franz diffusion cells, a widely accepted model for assessing intranasal drug delivery performance. The experiments used a cellulose dialysis membrane and simulated nasal electrolyte solution under physiologically relevant conditions. Equivalent MEAI doses were applied as either the intranasal formulation or a conventional reference solution, enabling a direct head-to-head comparison of permeation behavior over time. The results showed rapid and extensive permeation for both formulations. While intranasal MEAI displayed a slightly more gradual early‑phase release profile, overall permeation was highly comparable to the reference solution. By 180 minutes, both formulations achieved near- complete permeation with cumulative permeation reaching 97.35% for intranasal MEAI and 98.34% for the conventional formulation. This data indicates that incorporating MEAI into the mucoadhesive intranasal delivery system does not materially impair drug transport. When combined with previously reported mucoadhesion results, the findings suggest that Clearmind's intranasal strategy may successfully extend nasal residence time while maintaining efficient permeation - two essential attributes for effective intranasal drug delivery. Together, the results demonstrate three key development achievements supporting the advancement of the intranasal MEAI development program: Formulation compatibility: MEAI successfully integrated into the intranasal platform as a stable, fully soluble formulation. Enhanced mucoadhesion and prolonged nasal residence: the intranasal MEAI formulation demonstrated substantially longer nasal retention compared with a MEAI saline solution. Preserved permeation kinetics: extended residence time was achieved without compromising MEAI transport across the tested membrane. “These results represent an important milestone in our efforts to advance MEAI as a differentiated therapeutic candidate for alcohol use disorder,” said Dr. Adi Zuloff Shani, Chief Executive Officer of Clearmind Medicine. “The significantly enhanced nasal retention demonstrated by intranasal MEAI underscores the  potential advantages of intranasal delivery as a promising administration route for MEAI. We are encouraged by the formulation’s ability to maintain prolonged contact with nasal tissue while demonstrating permeation characteristics comparable to a conventional MEAI formulation, and believe these findings further support the overall development program.” 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 32 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: 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. For example, the Company is using forward-looking statements when it discusses the timing and progress of its clinical studies, the company’s development strategy, the continued advancement of the intranasal program and advancing MEAI as a differentiated therapeutic candidate for alcohol use disorder. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites. Investor Relations: [email protected] www.Clearmindmedicine.com

Vancouver, Canada, July 16, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), a clinical-stage biotechnology company pioneering non‑hallucinogenic neuroplastogen‑derived treatments for Alcohol Use Disorder (AUD), addiction, and weight management, announced today compelling ex vivo mucoadhesion results for its intranasal formulation of MEAI (5‑Methoxy‑2‑aminoindane). Leveraging a nasal drug‑delivery system, the new formulation demonstrated markedly improved nasal residence characteristics compared with a standard MEAI solution. Enhanced nasal retention is a critical step toward maximizing MEAI absorption and therapeutic potential. These results reinforce Clearmind’s strategy of developing differentiated, next‑generation treatments for AUD and other high‑need indications. The study forms a core component of Clearmind’s intranasal MEAI development program, designed to overcome the limitations of rapid mucociliary clearance and deliver more consistent, effective dosing. The study was conducted as part of Clearmind’s development program focused on the development of an intranasal formulation of MEAI for the treatment of AUD. A key objective of the program is to improve the residence time of MEAI within the nasal cavity, potentially increasing the opportunity for absorption before mucociliary clearance removes the formulation from the nasal surface. Ex Vivo Nasal Residence Time Evaluation The ex vivo mucoadhesion study was designed to evaluate the ability of its intranasal MEAI formulation to remain associated with nasal tissue over time compared with a non‑mucoadhesive MEAI solution. Using freshly isolated rabbit nasal mucosa, both formulations were applied to the tissue surface and allowed to interact with the mucosa before exposure to a simulated nasal electrolyte solution. The amount of formulation retained on the tissue was measured over a 30‑minute period to generate comparative residence time profiles. The intranasal MEAI formulation consistently maintained a greater proportion of its initially adhered dose throughout the entire evaluation period, demonstrating a clear retention advantage over the reference solution. These results highlight the contribution of the mucoadhesive polymer system incorporated into the intranasal MEAI formulation and provide further validation of Clearmind’s nasal drug‑delivery platform, which is engineered to increase formulation residence at mucosal surfaces and enhance overall delivery performance. Extended residence time within the nasal cavity is widely recognized as a key factor in effective intranasal drug administration, as prolonged contact with the nasal mucosa increases the opportunity for absorption and may improve therapeutic efficiency. The observed retention profile suggests that Clearmind’s intranasal MEAI formulation may offer meaningful advantages over conventional non‑mucoadhesive approaches. 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 32 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.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. For example, the Company is using forward-looking statements when it discusses the potential of MEAI, the ability to improve the residence time of MEAI within the nasal cavity, potentially increasing the opportunity for absorption, the company’s intention to seek additional patents for its compounds whenever warranted and that it will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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.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. For example, the Company is using forward-looking statements when it discusses the timing and progress of its clinical trials. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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 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] 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. For example, the Company is using forward-looking statements when it discusses the timing and progress of its clinical trials, advancing to patient enrollment for the fourth cohort, CMND-100’s potential as a safe, non-hallucinogenic treatment option that addresses the critical unmet needs in alcohol use disorder, without requiring adjunct psychotherapy and its commitment to progressing its clinical trial to bring innovative, safe and affordable solutions to patients in need. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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 profile with no drug-related serious adverse events or suicidality-related safety signals. Michael Cola, CEO, said, “Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments. We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients. The Company’s broad intellectual property portfolio has been leveraged once again to create what we feel are best in class products and we are further excited to release the data on HLP003 targeted at major depressive disorder in the fourth quarter of 2026.” ATAIBECKLEY ALIGNS WITH FDA ON BPL-003 PHASE 3 DESIGN: AtaiBeckley (ATAI) announced on Tuesday results of an End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration regarding the development of BPL‑003, the company’s proprietary intranasal formulation of mebufotenin benzoate, for treatment‑resistant depression. Minutes from the meeting show that the FDA indicated support for AtaiBeckley’s proposed BPL-003 pivotal program and the compound’s advancement into Phase 3 studies in adults with TRD. The FDA also provided constructive feedback on the overall design and key components of the proposed program, including the overall size of the safety database for this chronic indication. The Phase 3 program is designed to include two pivotal studies, ReConnection 1 and ReConnection 2, conducted in parallel. Both will include a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension in which participants may receive individualized retreatment with BPL-003, subject to pre-specified eligibility criteria. The core study will enroll approximately 350 participants and will evaluate a single-dose of BPL-003 across three treatment arms – 8 mg, 4 mg, and placebo. This trial is designed to replicate and extend the treatment response observed in the Phase 2b study and to further characterize the dose–response relationship for BPL-003. ReConnection 2 will enroll approximately 300 participants and will evaluate BPL-003 administered on Day 1 and Day 15 across two arms – 8 mg BPL-003 and placebo. This trial is designed to investigate a two-dose induction model of BPL-003 as a potential treatment option to increase magnitude and durability of initial response. The primary endpoint in both pivotal trials will be the change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 4 of the response in the 8 mg BPL-003 treatment arm compared to placebo. In the OLE, participants may receive 8 mg BPL-003 at 8‑ or 12‑week intervals, subject to certain conditions for re-treatment eligibility, with the goal of maintaining remission and assessing long‑term safety, durability of effects, and treatment patterns. “Receiving clear guidance from the FDA at this stage is a major milestone for AtaiBeckley and for the BPL‑003 program,” said Srinivas Rao, CEO. “This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 in October 2025 and firmly positions us to advance a robust Phase 3 clinical program designed to maximize the probability of regulatory and commercial success. With this development, we maintain our conviction that BPL-003 has the potential to offer a rapid, durable and convenient treatment option for the millions of people living with treatment-resistant depression.” CLEARMIND GETS DSMB RECOMMENDATION FOR TRIAL CONTINUATION: Clearmind Medicine (CMND) announced Wednesday that its independent Data and Safety Monitoring Board has completed the second scheduled interim review of the company’s ongoing FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary, non-hallucinogenic neuroplastogen, in the treatment of Alcohol Use Disorder. Based on the additional top-line data from the second cohort, which demonstrated a favorable safety profile, the DSMB recommended that the clinical trial continue. The results of the second cohort, in which twice the dose was administered compared to a single dose in the first cohort, reinforce no serious adverse events and overall good tolerability, consistent with the results reported from the first cohort. The results support the rapid progression enabled by the DSMB’s unanimous approval to advance for the third cohort, for which the dose is 80 mg per administration, which is double the dose administered in the second cohort. GH RESEARCH REPORTS Q4 EARNINGS: GH Research (GHRS) reported FY25 loss per share of (79c) on Thursday, which compared to analyst estimates of a loss per share of (82c). Cash, cash equivalents and marketable securities were $280.7M as of December 31. In 2025, the company completed its Phase 2b trial of GH001 in treatment-resistant depression and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology Congress in Amsterdam. GH Research is now actively seeking FDA alignment on the design of its global Phase 3 pivotal program, which is intended to replicate the Phase 2b study. The Phase 2b trial met its primary endpoint with a placebo-adjusted MADRS reduction of -15.5 points at Day 8. In the double-blind portion, 57.5% of patients on GH001 achieved remission at Day 8 versus 0% on placebo. The open-label extension confirmed durable efficacy, with a 73% remission rate at six months achieved with infrequent retreatment visits and no mandated psychotherapy. The median duration of psychoactive experience was ~11 minutes, with 99% of patients deemed discharge-ready within one hour of dosing. Safety was favorable, with no treatment-related serious adverse events and no treatment emergent suicidal intent or behavior. “Our Phase 2b results reinforce our conviction that GH001 has the potential to be a practice-changing therapy for patients with TRD,” said Dr. Velichka Valcheva, CEO. “We look forward to aligning with the FDA on our global Phase 3 program, replicating phase 2b design, and advancing this innovative program with initiation targeted for 2026.” PHARMALA SIGNS SUPPLY, DATA AGREEMENT WITH NAUTILUS SANCTUARY: PharmAla Biotech Holdings (MDXXF) announced Tuesday that it has executed a supply and data agreement with Nautilus Sanctuary of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States. Under the agreement, PharmAla will supply its LaNeo MDMA to Nautilus Sanctuary for use in an open-label clinical trial entitled “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”. In consideration for the supply of LaNeo MDMA, Nautilus Sanctuary will grant PharmAla a perpetual, non-exclusive license to the clinical trial data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally. “This agreement represents a continuation of our innovative supply-for-data model, which we believe creates significant value for both parties,” said Nicholas Kadysh, CEO. “Frontline healthcare workers and first responders bear an enormous mental health burden, and we are proud to support Nautilus Sanctuary in their efforts to bring MDMA-assisted therapy to these critical populations. The clinical data generated in the United States under this agreement will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo MDMA.” PSYENCE BIOMED REPORTS PSILOCYBIN EXPORT: Psyence Biomedical (PBM) announced Tuesday the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia. The product was manufactured at the Psyence Labs GMP-controlled production facility, supporting pharmaceutical-grade psychedelic development. The exported NPX-5 product will now be used in Psyence BioMed’s ongoing Phase IIb clinical trial in Australia, a double-blind, randomized, low-dose comparator-controlled, multi-center study evaluating natural psilocybin for the treatment of Adjustment Disorder in patients with cancer in a palliative care context. The trial is enrolling 87 participants across multiple Australian sites, including Melbourne and Perth/ Patient dosing is underway, with initial participants having been dosed in late 2025, and all newly enrolled patients will be dosed with NPX-5. “This export demonstrates more than regulatory clearance – it validates the operational readiness of our vertically integrated model,” said Jody Aufrichtig, CEO. “The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.” PRICE TARGET RAISES: Maxim raised the firm’s price target on Definium Therapeutics (DFTX) to $40 from $18 and kept a Buy rating on the shares after its Q4 results. The company’s cash on the balance sheet should provide sufficient funding into 2028, through a busy 2026 with three Phase 3 pivotal readouts for DT120, the analyst said. As the readout in major depressive disorder approaches, the firm is factoring in revenues for MDD in 2029, Maxim added. H.C. Wainwright raised the firm’s price target on Bright Minds (DRUG) to $145 from $115 and kept a Buy rating on the shares. The firm says the BREAKTHROUGH Phase 2 data “de-risks” BMB-101 and establishes 5-HT2C agonist as potentially best-in-class. H.C. Wainwright increased its probability of success for the absence epilepsy program to 60% from 25%, reflecting what it believes is a “significant efficacy signal and validation from the trial.” H.C. Wainwright also raised the firm’s price target on NRx Pharmaceuticals (NRXP) to $45 from $40 and kept a Buy rating on the shares. The firm said the Type C FDA meeting “provides a clear” application pathway for NRX-100. This is “supported by real-world evidence and a broader proposed indication, significantly de-risking the program,” the analyst said. H.C. Wainwright expanded the addressable population for NRX-100 and increased its risk-adjusted NRX-100 valuation to $15 per share from $10. OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Health (AGNPF), BetterLife (BETRF), Compass Pathways (CMPS), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), MIRA Pharmaceuticals (MIRA), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmaTher (PHRRF), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF) and Silo Pharma (SILO). 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 HELP: Disclaimer & DisclosureReport an Issue Cybin’s Helus Pharma Posts Strong Phase 2 Data for HLP004 in Hard-to-Treat Anxiety Helus Pharma announces results in Phase 2 signal detection study of HLP004 Cybin Corrects Exhibit References in Form 6-K to Align With Active F-10 Shelf Psychedelic: AtaiBeckley reports EMP-01 met primary objective in Phase 2a trial Helus Pharma Names Former Pfizer CMO Freda Lewis-Hall to Board and Scientific Advisory Role

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 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. For example, the Company is using forward-looking statements when it discusses CMND-100’s safety profile as a potential innovative therapy for alcohol use disorder and how it is 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. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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 facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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 vision.” 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. For example, the Company is using forward-looking statements when it discusses the ongoing evaluation and clinical development of its product candidates, advancing toward full data readout and subsequent cohorts, pioneering neuroplastogen -derived therapies, and seeking additional patents for its compounds. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

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 filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx.  We also moved NRX-101 toward it’s NDA for Accelerated Approval in bipolar depression in patients at risk of akathisia, and made meaningful progress building HOPE’s best-in-class network of Interventional Psychiatry Clinics.  Additionally, two potential strategic transactions that are under negotiation could further accelerate our progress.  These accomplishments advance our mission of preventing and treating suicide: work that is critical to our patients, their families and our country,” said Jonathan Javitt, CEO. CLEARMIND SIGNS LOI WITH POLYRIZON: Clearmind Medicine (CMND) announced Wednesday that it has (PLRZ) to develop a novel intranasal formulation for its psychedelic-based treatment applications. The collaboration will explore the potential of Clearmind’s proprietary drug candidate, 5-Methoxy-2-aminoindane, alone or in combination with Palmitoylethanolamide, through intranasal administration. This initiative aims to enhance bioavailability and optimize the therapeutic effect of Clearmind’s psychedelic-based treatments. Under the terms of the LOI, Clearmind and Polyrizon will conduct research and development efforts to achieve a proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations. The companies will assess the feasibility of intranasal drug delivery, which offers several potential advantages over traditional administration methods, including faster absorption and onset of action, high bioavailability for increased therapeutic effects and enhanced patient compliance due to non-invasive administration. “This collaboration represents an exciting step forward in our efforts to continue innovating psychedelic-based treatments,” said Adi Zuloff-Shani, CEO. “We believe intranasal administration has the potential to improve patient outcomes by providing a faster-acting, more efficient, and user-friendly treatment option. This agreement aligns with our commitment to developing innovative and accessible solutions for mental health and addiction treatment.” Additionally on Tuesday, Clearmind Medicine announced that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its treatment, CMND-100, in Alcohol Use Disorder patients. This study is the first clinical application of the company’s proprietary CMND-100 platform. The first site to be initiated is IMCA in Israel and will be led by Prof. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center. “Transitioning to a clinical stage pharmaceutical company is a major milestone for our Company, enabling us to evaluate whether the promising results from our animal studies will translate to human clinical trial participants with AUD,” said Zuloff-Shani. “Previously announced preclinical data on alcohol curb supports the potential ofCMND-100 as a novel and effective treatment approach for alcoholism, addressing a significant unmet medical need.” COMPASS REPORTS PUBLICATION OF COMP004 RESULTS: Compass Pathways (CMPS) announced Tuesday the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression. The COMP004 study’s findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of antidepressant effects compared to the 1 mg and 10 mg doses. The results of COMP004 build upon previous findings from the Phase 2b trial COMP001, which showed that a single 25mg dose of COMP360 psilocybin was associated with a rapid and highly statistically significant reduction in depressive symptoms compared to COMP360 1mg dose after three weeks, with durable response for up to 12 weeks. “Treatment-resistant depression is a major public health challenge, affecting approximately 100 million people worldwide, and it is well understood that there is an urgent need for differentiated treatment options,” said Guy Goodwin, CMO. “This study together with the Phase 2b suggest the potential of COMP360 to provide rapid and durable clinical benefits from a single administration. We continue to explore the full profile of COMP360 in our ongoing Phase 3 clinical development program and we look forward to seeing the first phase 3 data from our COMP005 trial in the second quarter.” FILAMENT REPORTS PHASE 2 PEX010 DATA: Filament Health (FLHLF) announced Monday data from an open-label phase 2 clinical trial studying the effects of its botanical psilocybin drug candidate, PEX010, for the treatment of alcohol use disorder at Psychiatric Centre Copenhagen. The results were published in the Journal of Psychopharmacology and found that a single 25mg dose of PEX010 was safe and effective in reducing alcohol consumption in AUD patients. The open-label phase 2 study investigated single-dose psilocybin therapy in 10 treatment-seeking adults with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session, and two integration sessions. Alcohol consumption significantly decreased over the 12 weeks following the administration of PEX010. The percentage of heavy drinking days was reduced from 53.6% before receiving PEX010 to 16.1% at week 12 and drinks per day decreased by an average of 3.4 drinks over the 12-week follow up period. This was corroborated by reports of rapid and sustained reductions in craving and temptation and significant increases in self-efficacy. All participants completed the therapy course, and the safety profile was favourable with no serious adverse events. “We are thrilled to announce positive results which support the efficacy of PEX010,” said Benjamin Lightburn, CEO. “These data reinforce our confidence in the potential of botanical psilocybin to help the millions of people suffering from substance use disorders like AUD. We look forward to advancing to the next stage of development.” NUMINUS RECEIVES STATE CERTIFICATION APPROVAL: Numinus Wellness (NUMIF) announced Thursday that its Psychedelic-Assisted Therapy Training Program has been officially approved by the state of Colorado. This approval comes as part of Colorado’s Natural Medicine Health Act, which establishes a legal framework for the facilitation of psilocybin services by trained and licensed professionals. Numinus’ state-approved certification pathway includes coursework in psychedelic-assisted therapy fundamentals, psilocybin-specific training, trauma-informed care, and practical applications, along with clinical practicum placements to ensure hands-on experience. “This is an exciting step forward for both Numinus and for the future of psychedelic-assisted therapy in Colorado,” said Michael Tan, CEO of Numinus Wellness. “We are committed to ensuring that practitioners receive the highest standard of training so they can provide safe, ethical, and transformative psilocybin-assisted therapy in accordance with Colorado’s regulations.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Incannex Healthcare (IXHL), Mind Medicine (MNMD), MIRA Pharmaceuticals (MIRA), Mydecine Innovations (MYCOF), 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 today’s best-performing stocks on TipRanks >> Read More on ATAI: Questions or Comments about the article? Write to [email protected] ATAI Life Sciences Diversifies Treasury with Bitcoin Investment ATAI Life Sciences: Positioned for Growth in Psychedelic and Neuropsychiatric Treatments with Strong Pipeline and Upcoming Catalysts ATAI Life Sciences: Strong Financial Position and Promising Pipeline Drive Buy Rating Atai Life Sciences reports Q4 EPS (24c), consensus (15c) Psychedelic: atai reports dosing of first patient in Phase 2 VLS-01 trial