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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- Summit Participation: Clearmind Medicine's CEO, Dr. Adi Zuloff-Shani, was appointed as a delegate to the 2026 Federal Policy Summit held on May 14 in Washington, D.C., aimed at fostering dialogue between the biopharma industry and policymakers to advance the responsible development of psychedelic therapies.
- Clinical Trial Progress: Clearmind is advancing its non-hallucinogenic psychedelic candidate, currently undergoing Phase IIa clinical trials at leading institutions like Johns Hopkins and Yale, which not only showcases the company's commitment to innovative drug development but also addresses significant unmet health needs.
- Intellectual Property Strategy: Clearmind holds 19 patent families and 31 granted patents, with plans to seek additional patents as warranted, indicating a proactive approach to intellectual property that aims to enhance its market competitiveness and technological barriers.
- Industry Collaboration and Impact: The summit brought together key figures from the U.S. Congress and global biopharma CEOs, emphasizing the importance of cross-sector collaboration, and Clearmind's participation may pave the way for future policy support and market access.

- Clinical Trial Progress: Clearmind Medicine is evaluating its candidate CMND-100 for eligibility for the FDA's Breakthrough Therapy Designation based on positive results from its ongoing Phase I/IIa clinical trial for Alcohol Use Disorder, indicating significant therapeutic potential that could open new market opportunities for the company.
- Policy Support: The recent Executive Order signed by President Trump accelerates FDA review processes for certain breakthrough therapies, providing favorable conditions for CMND-100's application and further enhancing Clearmind's strategic position in the competitive biotech market.
- Market Demand: Alcohol Use Disorder represents a serious health issue affecting millions globally with limited treatment options, and the successful development of CMND-100 could address this substantial unmet medical need, potentially yielding significant economic benefits for the company.
- Intellectual Property Strategy: Clearmind currently holds 19 patent families and 31 granted patents, with plans to continue expanding its intellectual property portfolio to support drug development and commercialization strategies, ensuring a competitive edge in future market dynamics.

- ClearMind Medicine Update: ClearMind Medicine has not submitted or received FDA breakthrough therapy designation for its treatment.
- Therapy Designation Status: The company is currently awaiting further developments regarding its therapy designation.

- Clinical Trial Milestone: Clearmind's CMND-100 successfully met its primary endpoint of safety and tolerability in the FDA-approved Phase I/IIa trial, with no serious adverse events observed in the highest dose tested, indicating significant potential as a non-hallucinogenic treatment for Alcohol Use Disorder.
- Regulatory Support: President Trump's Executive Order aims to accelerate psychedelic innovation and expand access to mental health care for veterans, which Clearmind describes as a historic step that reflects growing recognition of non-hallucinogenic neuroplastogens as potential therapies for conditions like PTSD and depression.
- Intellectual Property Expansion: Clearmind holds 19 patent families and 31 granted patents, with plans to further expand its intellectual property portfolio, demonstrating the company's commitment to ensuring breakthrough treatments reach patients responsibly and efficiently.
- Market Reaction: Following a 1-for-40 reverse stock split, CMND's stock price rose 58.42% to $1.14 during Monday's trading, although it fell 8.77% to $1.04 in overnight trading, reflecting positive market response to the company's developments alongside short-term volatility.
- Funding Support: Trump signed an executive order allocating $50 million for psychedelic research aimed at accelerating studies on PTSD treatments, potentially paving the way for future drug reclassification.
- Clearmind Drug Progress: Clearmind Medicines' CMND-100 met its primary goal in early-stage trials, demonstrating strong safety with no serious side effects reported at higher doses, likely enhancing its market competitiveness.
- Market Reaction: Clearmind's shares surged nearly 65% in pre-market trading, marking its largest intraday gain since August 2022, reflecting strong investor interest in the therapeutic potential of psychedelics.
- Silo Pharma Development: Silo Pharma is developing SPC-15, a nasal spray designed to prevent PTSD, utilizing a fast nose-to-brain delivery method, and is expected to benefit from a more favorable regulatory environment.
- Clinical Trial Success: Clearmind Medicine Inc.'s CMND-100 drug has met the primary safety and tolerability endpoints in its FDA-approved Phase I/IIa clinical trial, indicating promising prospects for treating Alcohol Use Disorder (AUD).
- Safety Data: Results from the third cohort show that CMND-100 exhibited a high safety profile even at higher doses, with no serious adverse events reported, further validating the drug's tolerability across different dosages.
- Multinational Study: The clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD, supporting its potential as a novel non-hallucinogenic treatment option.
- Intellectual Property Strategy: Clearmind currently holds 19 patent families, including 31 granted patents, and plans to continue seeking additional patents to enhance its competitive position in the psychedelic drug market.






