Clearmind Completes Second Cohort Enrollment for CMND-100 Trial
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on an enrollment completion, a CDMO selection and a listing transfer.CLEARMIND COMPLETES SECOND COHORT ENROLLMENT FOR CMND-100 TRIAL:Clearmind Medicineannounced Tuesday thein its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100, the company's proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder. The cohort consists of six patients, who were recruited rapidly across three clinical sites: Johns Hopkins University, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The enrollment follows the recent completion of the first cohort, which demonstrated encouraging top-line safety and efficacy data, including a favorable safety profile and preliminary signals of reduced cravings and withdrawal symptoms. The multinational Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD. Dosing for the second cohort is expected to commence shortly, with topline results anticipated in the coming months."We are thrilled with the accelerated pace of enrollment for our second cohort, which reflects the high level of interest from both patients and leading clinical sites in CMND-100's potential to transform AUD treatment," stated Adi Zuloff-Shani, CEO. "Building on the excellent results from the first cohort, we believe that this rapid progress positions us to generate additional valuable data, bringing us closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile."PHARMALA SELECTS CDMO FOR ALA-002 MANUFACTURING:PharmAla Biotechannounced Monday that its wholly-owned subsidiary, PharmAla Biotech Australia, hasto execute manufacture of its ALA-002 drug substance. ALA-002 is PharmAla's patented, novel, non-racemic MDMA formulation. PharmAla has publicly announced that it will be initiating Phase 2a/2b clinical research into the formulation exploring Social Anxiety Disorder in 2026."PharmAla Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA-002 drug product components," said Nick Kadysh, CEO. "This is an important and necessary step to us executing our ALA-002 Phase 2 clinical trial in 2026, and the first time since 2022 that PharmAla will be developing a wholly new Active Pharmaceutical Ingredient for human use."Additionally, PharmAla announced that it has completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Center for Psychedelic Healing at Mount Sinai. The material is scheduled to be used in clinical research.CYBIN TO TRANSFER LISTING TO NASDAQ:Cybinannounced Thursday that it will voluntarilyfrom the NYSE American. The company expects that its common shares will cease trading on the NYSE American at market close on January 4, 2026 and commence trading on Nasdaq at market open on January 5, 2026. Concurrent with the commencement of trading on Nasdaq, the company will no longer trade under the ticker symbol "CYBN" and instead will trade under the ticker symbol "HELP". The company will continue to be listed on the Cboe Canada and will also trade under the new "HELP" ticker symbol commencing on January 5, 2026."We are pleased to join the community of global pharmaceutical companies listed on Nasdaq and thank the NYSE American for supporting the company over the last four years since our initial listing," said Eric So, interim CEO. "The transfer to Nasdaq marks the next step in the evolution of Cybin into a global pharmaceutical company."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Algernon Health, Atai Beckley, BetterLife, Bright Minds, Compass Pathways, Enveric Biosciences, Filament Health, GH Research, Incannex, Mind Medicine, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Relmada Therapeutics, Revive Therapeuticsand Silo Pharma.
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- Therapeutic Progress: Clearmind Medicine's MEAI drug has made significant strides in obesity treatment, with preclinical studies indicating a potential 20% weight reduction while prioritizing muscle preservation, showcasing its promise as a next-generation neuroplastogen that could transform obesity management.
- Innovative Mechanism: MEAI targets the brain's monoaminergic system to modulate reward and addiction pathways, addressing psychological roots of obesity such as compulsive eating and emotional overeating, potentially offering a more holistic treatment approach compared to traditional GLP-1 drugs, thereby enhancing long-term patient adherence.
- Market Potential: According to Goldman Sachs, the obesity market is projected to exceed $100 billion in the coming years, positioning Clearmind to potentially lead the next era of weight loss therapeutics if MEAI fulfills its promise, addressing the urgent global demand for effective weight loss solutions.
- Strategic Partnerships and Patents: Clearmind has recently filed new patent applications targeting obesity and metabolic disorders, collaborated with Polyrizon to develop an intranasal formulation for improved delivery, and is advancing its FDA-approved Phase I/IIa trial for alcohol use disorder, demonstrating its ongoing commitment to innovative drug development.
- Therapeutic Progress: Clearmind Medicine's MEAI drug has demonstrated approximately 20% weight reduction in preclinical studies while preserving lean mass, indicating its potential to provide a more effective alternative in obesity treatment, which is crucial in a multi-billion dollar market.
- Innovative Mechanism: MEAI targets the brain's monoaminergic system to disrupt rigid behavioral patterns and promote cognitive flexibility, potentially addressing psychological factors like binge eating and emotional overeating, thus offering a more holistic treatment approach for obesity.
- Market Potential: Goldman Sachs projects the obesity market to exceed $100 billion in the coming years, positioning Clearmind to potentially lead the next generation of weight loss therapeutics if MEAI fulfills its promise, thereby driving long-term growth for the company.
- Strategic Partnerships: Clearmind's collaboration with Polyrizon to develop an intranasal formulation aims to enhance MEAI's delivery, while its FDA-approved Phase I/IIa trial progresses smoothly, reflecting the company's ongoing advancements in obesity and metabolic disorders.
- Clinical Trial Progress: Clearmind Medicine Inc. announced additional positive safety topline results from the second cohort of its FDA-approved Phase I/IIa clinical trial for CMND-100, reinforcing the encouraging safety and tolerability profile established in the first cohort, indicating the drug's potential in treating Alcohol Use Disorder.
- Therapeutic Potential: CMND-100 is viewed as a potentially safe, non-hallucinogenic treatment that does not require adjunct psychotherapy, aiming to address significant unmet needs in the Alcohol Use Disorder space, potentially offering new options for patients.
- Market Reaction: In pre-market trading, CMND shares are priced at $1.36, up 0.76% from the previous trading day, reflecting market recognition of the company's positive clinical results, which may attract more investor interest.
- Future Plans: Backed by these positive clinical results, Clearmind Medicine plans to gather further evidence to support the safety and efficacy of CMND-100, thereby advancing its application in the treatment of Alcohol Use Disorder.
- Clinical Trial Progress: Clearmind Medicine has completed treatment for six patients in the second cohort of its FDA-approved CMND-100 trial, further confirming the drug's safety and tolerability with no serious adverse events, indicating its potential as a treatment for Alcohol Use Disorder (AUD).
- Multicenter Study: The trial is conducted at leading institutions such as Johns Hopkins University and Tel Aviv Sourasky Medical Center, emphasizing CMND-100's global research capabilities and enhancing the company's competitiveness in the psychedelic pharmaceutical sector.
- Support from Data Monitoring Board: The unanimous approval from the Data and Safety Monitoring Board (DSMB) to advance the second cohort reflects confidence in CMND-100's safety and efficacy, potentially accelerating the progression to subsequent clinical phases.
- Intellectual Property Strategy: Clearmind currently holds 19 patent families and 31 granted patents, with plans to seek additional patents as needed, demonstrating the company's long-term strategic positioning and market competitiveness in psychedelic drug development.
- Aurora Financial Performance: Aurora Cannabis reported net revenue of $94.2 million for Q3 2026, a 7% year-over-year increase, with global medical cannabis sales reaching $76.2 million, accounting for over 80% of total sales, indicating strong growth potential in the high-margin medical market.
- Strategic Transformation Plan: Aurora announced plans to gradually exit select Canadian consumer cannabis markets to reduce sales and marketing costs, which is expected to significantly improve overall profit margins in the coming quarters.
- Canopy Growth Results: Canopy Growth reported net revenue of $90.4 million for Q3 2026, with a nearly 50% reduction in net loss despite weak international performance, reflecting positive progress in cost control and market integration.
- Cronos Brand Expansion: Cronos Group launched its premium Lord Jones brand in Israel, marking a significant step in its global expansion strategy aimed at meeting local market demands with high-quality products while enhancing brand recognition in international markets.
- Compliance Restoration: Clearmind Medicine confirmed on December 30, 2025, that its common shares have maintained a closing price above $1 for the last 10 consecutive trading days, successfully regaining compliance with Nasdaq Listing Rule 5550(a)(2), indicating positive progress in stock price stability.
- Price Volatility Context: Previously, Clearmind was notified on December 4, 2025, of non-compliance due to its share price being below $1 for over 30 consecutive trading days, and this compliance restoration is expected to enhance investor confidence and attract more capital inflow.
- Market Reaction Expectations: With the restoration of compliance, Clearmind is likely to improve its market image and bolster investor confidence in its future growth potential, particularly in light of its commitment to developing novel psychedelic treatment solutions.
- Strategic Development Focus: Clearmind is currently focused on developing neuroplastic drugs targeting under-treated health issues and will continue to seek patent protection to enhance its intellectual property portfolio, further strengthening its competitiveness in the biotech sector.










