Core Viewpoint - Clearmind Medicine Inc. has signed a non-binding Letter of Intent with Polyrizon Ltd. to develop a novel intranasal formulation for its psychedelic-based treatments, aiming to enhance bioavailability and optimize therapeutic effects [1][2][3] Group 1: Collaboration Details - The collaboration will focus on Clearmind's proprietary drug candidate, 5-Methoxy-2-aminoindane (MEAI), either alone or in combination with Palmitoylethanolamide (PEA), administered intranasally [2] - Research and development efforts will aim to achieve proof of concept for an intranasal formulation of MEAI and MEAI-PEA combinations, assessing the feasibility of intranasal drug delivery [3] - The agreement allows Clearmind to fund the R&D process, while Polyrizon will advance formulation development using its proprietary intranasal drug delivery platform [4] Group 2: Company Background - Clearmind is a clinical-stage biotech company focused on developing psychedelic-derived therapeutics to address major under-treated health issues, including alcohol use disorder [6] - The company holds a portfolio of nineteen patent families, including 31 granted patents, and aims to seek additional patents for its compounds [7] - Clearmind's shares are traded on Nasdaq under the symbol "CMND" and on the Frankfurt Stock Exchange under "CWY0" [7] Group 3: Polyrizon Overview - Polyrizon specializes in developing innovative intranasal hydrogels that create a barrier in the nasal cavity to protect against viruses and allergens [8] - The company is advancing its proprietary Capture and Contain TM hydrogel technology, which functions as a "biological mask" for nasal drug delivery [8]

Core Insights - Clearmind Medicine Inc. has initiated its Phase I/IIa clinical trial for CMND-100, targeting Alcohol Use Disorder (AUD), marking a significant milestone in the company's development of psychedelic-derived therapeutics [1][3] - The trial aims to evaluate the safety, tolerability, and pharmacokinetics of CMND-100, with preliminary efficacy assessments to reduce alcohol cravings and consumption [3][4] - The global prevalence of AUD is a major health concern, with approximately 400 million people affected, highlighting the urgent need for innovative treatment solutions [5][6] Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel psychedelic-derived therapeutics to address under-treated health issues, including AUD [7] - The company's intellectual property portfolio includes nineteen patent families and 31 granted patents, with plans to seek additional patents as necessary [8] Clinical Trial Details - The first trial site is located at IMCA in Israel, led by Prof. Mark Weiser, with additional sites at Yale School of Medicine and Johns Hopkins University [2][4] - CMND-100 is a MEAI-based oral drug candidate designed to modulate reward mechanisms associated with addictive behavior, offering a novel approach compared to traditional treatments [4]

Financial Performance - Total assets decreased from $7,255,414 on October 31, 2024, to $6,584,957 on January 31, 2025, representing a decline of approximately 9.2%[2] - Cash and cash equivalents decreased from $6,573,813 to $5,781,196, a reduction of about 12.1%[2] - Total operating expenses increased to $1,496,174 for the three months ended January 31, 2025, compared to $1,383,991 for the same period in 2024, marking an increase of approximately 8.1%[3] - Net loss for the period was $1,071,621, a decrease from the net loss of $1,367,800 in the prior year, reflecting an improvement of about 21.6%[3] - The accumulated deficit increased to $25,094,362 as of January 31, 2025, compared to $24,022,741 on October 31, 2024[5] - The company reported no revenues for the three months ended January 31, 2025, continuing its trend of no revenue generation[7] Cash Flow and Operating Activities - Cash used in operating activities was $1,265,435 for the three months ended January 31, 2025, compared to $1,461,996 in the same period of 2024, indicating a decrease of approximately 13.4%[6] - The company’s total current liabilities decreased from $4,131,446 to $3,724,378, a reduction of about 9.8%[2] Share Capital and Equity - Share capital and share premium increased to $24,758,901 as of January 31, 2025, from $24,168,256 on October 31, 2024, an increase of approximately 2.4%[2] - The weighted average number of shares for basic and diluted loss per share increased to 4,488,514 for the three months ended January 31, 2025, compared to 1,517,459 in the prior year[3] - As of January 31, 2025, the company had 4,693,623 common shares issued and outstanding, an increase from 4,265,186 shares as of October 31, 2024[36] Research and Development - For the three months ended January 31, 2025, the Company incurred research and development expenses of $12,746, a significant increase from $502 for the same period in 2024[27] Consulting and Fees - The Company reported consulting fees to officers of $84,000 for the three months ended January 31, 2025, down from $160,688 in the same period of 2024[25] Derivative Liabilities and Warrants - The company recorded a gain of $514,750 on the revaluation of total derivative warrant liabilities during the three months ended January 31, 2025[34] - The balance of derivative warrant liabilities decreased from $4,310,379 on October 31, 2023, to $2,983,031 on January 31, 2025[33] - The company issued 1,500,000 January 2024 Warrants with an exercise price of $1.60, which includes cashless exercise provisions[32] - The company issued 7,500,000 September 2023 Warrants, which were recorded at their fair value as a derivative liability at the time of grant[29] - The exercise price of the April 2023 Warrants was reduced to $1.077 following the January 2024 Public Offering, allowing each warrant to be exercisable into 0.724 common shares[29] Investments and Assets - The total fair value of derivative warrant liabilities is $2,983,031, while short-term investments in Polyrizon Warrants amount to $134,723[45] - The fair value of Polyrizon Warrants was $134,723, based on the Black-Scholes option pricing model with a risk-free rate of 4.36% and expected volatility of 92%[23] - The Company sold all shares of Polyrizon for total proceeds of $82,960 during November 2024[22] Foreign Currency and Financial Risk - The company's total foreign currency financial assets and liabilities amount to $(93,049), with a potential impact of a 10% strengthening or weakening of foreign exchange rates affecting the net loss by $9,305[47] - The company is exposed to foreign currency risk due to monetary assets and liabilities denominated in foreign currencies, particularly in New Israeli Shekel and CAD[46] Financial Obligations - The total contractual maturities of financial liabilities as of January 31, 2025, amount to $748,250, with $654,187 due within one year[48] Licensing Agreements - The company has entered into a license agreement with BIRAD, requiring royalties of 1.5% of net sales for the development of products for cocaine addiction[55] - The company has also signed a license agreement with Yissum for PTSD treatment, with royalties set at 3.0% of net sales and annual maintenance fees ranging from $25,000 to $50,000 starting from the fifth anniversary[55] Operational Status - The Company’s operations have not been adversely affected by the ongoing war in Israel as of the date of the financial statements[8] - The Company’s clinical trials and manufacturing operations have continued without disruption despite regional hostilities[8] Capital Management - The company manages its capital structure to ensure sufficient liquidity to meet financial obligations, relying on raising debt or equity financing[49] Share Consolidation - The company completed a 1-for-30 share consolidation on November 28, 2023, retroactively restating all share amounts for all periods presented[36] Stock Options - The total fair value of stock options expensed during the three months ended January 31, 2025, was $3,264, a decrease from $33,578 in the same period of 2024[40] - The expected volatility for stock options was between 112.20% and 134.44% for the three months ended January 31, 2025[40] Restricted Share Units - During the three months ended January 31, 2025, the company issued 296,122 Restricted Share Units (RSUs) with a fair value of $377,474[41] - On February 20, 2025, the company issued 441,163 common shares in respect of RSUs that had a fair value of $594,306 at the time of issuance[56]

Core Viewpoint - Clearmind Medicine Inc. has announced the publication of a patent for its innovative combination therapy of MEAI and N-Acylethanolamines aimed at treating cocaine addiction, marking a significant advancement in the field of psychedelic-derived therapeutics [1][4]. Group 1: Patent and Research Developments - The patent was published by the Korean Intellectual Property Office and is based on preclinical trial results from Bar-Ilan University, showing that MEAI significantly reduces cocaine-induced cravings in animal models [1][2]. - Further studies indicated that MEAI's effects on drug-seeking behavior do not impair responses to natural rewards, suggesting a targeted approach to drug-related compulsions rather than a general impact on the reward system [3]. Group 2: Collaboration and Intellectual Property - Clearmind is collaborating with SciSparc Ltd. to combine MEAI with SciSparc's PEA, enhancing the development of therapies for addiction and mental health disorders [4]. - The company's intellectual property portfolio includes nineteen patent families with 31 granted patents, and it plans to pursue additional patents to strengthen its position in the market [6].

Core Insights - Clearmind Medicine Inc. has announced a patent publication for a combination therapy involving MEAI and N-Acylethanolamines, targeting binge behaviors such as alcohol consumption and shopping [1][2] - The patent is a result of collaboration with SciSparc Ltd., focusing on integrating psychedelic compounds with N-Acylethanolamines [2] - Clearmind's intellectual property portfolio includes 19 patent families and 31 granted patents, with plans to seek additional patents as opportunities arise [4] Company Overview - Clearmind is a clinical-stage biotech company dedicated to developing psychedelic-derived therapeutics aimed at addressing significant health issues, including alcohol use disorder [3] - The company aims to commercialize its psychedelic-based compounds as regulated medicines, foods, or supplements [3] Collaboration Details - The partnership with SciSparc Ltd. is centered on researching innovative therapies that combine psychedelic compounds with the N-Acylethanolamines family, including Palmitoylethanolamide [2] - SciSparc Ltd. focuses on cannabinoid pharmaceuticals and is involved in various drug development programs targeting central nervous system disorders [5]

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Vancouver, Canada, Jan. 07, 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 psychedelic-derived therapeutics to solve major under-treated health problems, is pleased to announce that all of the matters put forward before shareholders for consideration and approval at its meeting held on January 6, 2025 (the “Meeting”), as set out in the Company’s Management Information ...

Vancouver, Canada, Jan. 06, 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 psychedelic-derived therapeutics to solve major under-treated health problems, today announced the publication of a European patent application with the European Patent office for its innovative combination therapy of MEAI and N-Acylethanolamines, addressing binge behavior, including alcohol con ...

Company recently signed a non-binding term sheet with Dr Glitter Pty Ltd for mutual development in ActivCrystal™ Format Vancouver, Canada, Dec. 26, 2024 (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 psychedelic-derived therapeutics to solve major under-treated health problems, recently announced that it signed a non-binding term sheet with Dr. Glitter Pty Ltd, a health te ...

Vancouver, Canada, Dec. 24, 2024 (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 psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, targeting alcohol use disorder (AUD). The trial will be led at Yale School of Medicine’s Depart ...