Clearmind to Evaluate Intranasal Delivery of Its Psychedelic Drug Combination
Clearmind Medicine (Nasdaq: CMND) has signed a non-binding Letter of Intent with Polyrizon (Nasdaq: PLRZ) to develop a novel intranasal formulation for its psychedelic-based treatments. The collaboration aims to enhance the delivery of Clearmind's proprietary drug candidate, 5-Methoxy-2-aminoindane (MEAI), alone or combined with Palmitoylethanolamide (PEA).
The partnership focuses on developing an intranasal delivery system that could offer several advantages including:
- Faster absorption and onset of action
- Higher bioavailability for increased therapeutic effects
- Enhanced patient compliance through non-invasive administration
Under the agreement, Clearmind will fund the R&D process, while Polyrizon will advance formulation development using its proprietary intranasal drug delivery platform. Upon successful proof of concept, the parties plan to negotiate a definitive agreement covering IP rights, commercialization, and financial terms.
Clearmind Medicine (Nasdaq: CMND) ha firmato una Lettera di Intenti non vincolante con Polyrizon (Nasdaq: PLRZ) per sviluppare una nuova formulazione intranasale per i suoi trattamenti a base di psichedelici. La collaborazione mira a migliorare la somministrazione del candidato farmaco proprietario di Clearmind, 5-Metossido-2-aminoindano (MEAI), da solo o in combinazione con Palmitoiletanolamide (PEA).
Il partenariato si concentra sullo sviluppo di un sistema di somministrazione intranasale che potrebbe offrire diversi vantaggi, tra cui:
- Assorbimento e inizio d'azione più rapidi
- Maggiore biodisponibilità per effetti terapeutici aumentati
- Migliore aderenza del paziente grazie a una somministrazione non invasiva
In base all'accordo, Clearmind finanzierà il processo di R&D, mentre Polyrizon porterà avanti lo sviluppo della formulazione utilizzando la sua piattaforma proprietaria di somministrazione intranasale. Una volta dimostrato con successo il concetto, le parti prevedono di negoziare un accordo definitivo riguardante i diritti di proprietà intellettuale, la commercializzazione e i termini finanziari.
Clearmind Medicine (Nasdaq: CMND) ha firmado una Carta de Intención no vinculante con Polyrizon (Nasdaq: PLRZ) para desarrollar una nueva formulación intranasal para sus tratamientos basados en psicodélicos. La colaboración tiene como objetivo mejorar la administración del candidato a fármaco propietario de Clearmind, 5-Metoxido-2-aminoindano (MEAI), solo o combinado con Palmitoiletanolamida (PEA).
La asociación se centra en desarrollar un sistema de entrega intranasal que podría ofrecer varias ventajas, incluyendo:
- Absorción más rápida y inicio de acción
- Mayor biodisponibilidad para efectos terapéuticos incrementados
- Mejor cumplimiento del paciente a través de una administración no invasiva
Según el acuerdo, Clearmind financiará el proceso de I+D, mientras que Polyrizon avanzará en el desarrollo de la formulación utilizando su plataforma propietaria de entrega intranasal de fármacos. Tras una prueba de concepto exitosa, las partes planean negociar un acuerdo definitivo que cubra los derechos de propiedad intelectual, la comercialización y los términos financieros.
Clearmind Medicine (Nasdaq: CMND)은 Polyrizon (Nasdaq: PLRZ)와 비구속적인 의향서를 체결하여 정신활성 물질 기반 치료를 위한 새로운 비강 투여 제형을 개발합니다. 이 협력의 목표는 Clearmind의 독점 약물 후보인 5-메톡시-2-아미노인단 (MEAI)의 전달을 개선하는 것입니다. 이는 Palmitoylethanolamide (PEA)와 단독 또는 결합하여 사용될 수 있습니다.
파트너십은 여러 가지 이점을 제공할 수 있는 비강 투여 시스템의 개발에 초점을 맞추고 있습니다:
- 더 빠른 흡수 및 작용 시작
- 치료 효과 증가를 위한 더 높은 생체이용률
- 비침습적 투여를 통한 환자 순응도 향상
계약에 따라 Clearmind는 R&D 프로세스를 자금 지원하고 Polyrizon은 자사의 비강 약물 전달 플랫폼을 사용하여 제형 개발을 진행합니다. 개념 증명이 성공적으로 이루어진 후, 양 당사자는 지적 재산권, 상업화 및 재무 조건을 포함하는 최종 계약을 협상할 계획입니다.
Clearmind Medicine (Nasdaq: CMND) a signé une Lettre d'Intention non contraignante avec Polyrizon (Nasdaq: PLRZ) pour développer une nouvelle formulation intranasale pour ses traitements basés sur des psychédéliques. La collaboration vise à améliorer l'administration du candidat médicament propriétaire de Clearmind, 5-Méthoxy-2-aminoindane (MEAI), seul ou en combinaison avec la Palmitoylethanolamide (PEA).
Le partenariat se concentre sur le développement d'un système de délivrance intranasale qui pourrait offrir plusieurs avantages, notamment :
- Absorption plus rapide et début d'action
- Meilleure biodisponibilité pour des effets thérapeutiques accrus
- Amélioration de la conformité des patients grâce à une administration non invasive
En vertu de l'accord, Clearmind financera le processus de R&D, tandis que Polyrizon fera avancer le développement de la formulation en utilisant sa plateforme propriétaire de délivrance intranasale de médicaments. Après une preuve de concept réussie, les parties prévoient de négocier un accord définitif concernant les droits de propriété intellectuelle, la commercialisation et les conditions financières.
Clearmind Medicine (Nasdaq: CMND) hat eine nicht verbindliche Absichtserklärung mit Polyrizon (Nasdaq: PLRZ) unterzeichnet, um eine neuartige intranasale Formulierung für seine psychedelisch basierten Behandlungen zu entwickeln. Ziel der Zusammenarbeit ist es, die Abgabe des proprietären Arzneimittelkandidaten von Clearmind, 5-Methoxy-2-aminoindane (MEAI), allein oder in Kombination mit Palmitoylethanolamid (PEA) zu verbessern.
Die Partnerschaft konzentriert sich auf die Entwicklung eines intranasalen Abgabesystems, das mehrere Vorteile bieten könnte, darunter:
- Schnellere Absorption und Wirkungseintritt
- Höhere Bioverfügbarkeit für gesteigerte therapeutische Effekte
- Verbesserte Patientencompliance durch nicht-invasive Verabreichung
Im Rahmen der Vereinbarung wird Clearmind den Forschungs- und Entwicklungsprozess finanzieren, während Polyrizon die Formulierungsentwicklung mit seiner proprietären intranasalen Arzneimitteldeliver-Plattform vorantreiben wird. Nach erfolgreichem Nachweis des Konzepts planen die Parteien, eine endgültige Vereinbarung über geistige Eigentumsrechte, Kommerzialisierung und finanzielle Bedingungen zu verhandeln.
- Development of potentially more effective drug delivery system
- Partnership with established biotech company specializing in intranasal delivery
- Potential for improved patient compliance and treatment efficacy
- Non-binding nature of the LOI indicates uncertainty in deal completion
- Additional R&D costs for Clearmind as sole funding provider
- Potential conflict of interest with overlapping board members between companies
Insights
Clearmind's strategic partnership with Polyrizon represents a calculated enhancement to its drug delivery strategy, focused on improving the administration of its psychedelic compound MEAI. The non-binding LOI establishes a framework to explore intranasal delivery, which could potentially address key limitations in psychedelic therapeutics.
From a pharmacokinetic perspective, intranasal delivery offers significant advantages over traditional routes - notably faster absorption directly to the brain via the olfactory pathway, potentially avoiding first-pass metabolism and enabling more precise dosing. For psychedelic compounds, where onset time and bioavailability directly impact therapeutic efficacy, this delivery method could meaningfully enhance MEAI's clinical profile.
This collaboration leverages complementary expertise - Clearmind's psychedelic compounds paired with Polyrizon's specialized intranasal hydrogel technology. However, investors should note several important considerations: 1) This remains a non-binding agreement at the proof-of-concept stage; 2) The overlapping board membership between companies (Oz Adler and Assaf Itzhaik) creates potential governance considerations; 3) No financial terms or development timelines were disclosed.
While representing an incremental R&D advance rather than a transformative catalyst, this initiative aligns with broader industry trends toward optimizing delivery mechanisms for CNS therapeutics, particularly for compounds where controlled administration significantly impacts safety and efficacy profiles.
The announced non-binding LOI with Polyrizon represents a measured R&D-focused initiative that appears strategically sound but comes with near-term financial implications for Clearmind. The company has committed to funding the research activities, though specific investment amounts remain undisclosed.
This collaboration follows a common development pathway in biotech: exploring alternative delivery mechanisms to potentially enhance existing intellectual property and extend product lifecycles. Intranasal delivery systems can command premium pricing if they demonstrate meaningful improvements in bioavailability or patient compliance, potentially enhancing commercial viability of Clearmind's MEAI compound.
However, several factors warrant investor caution. First, the significant board overlap between Clearmind and Polyrizon raises governance questions about deal terms and valuation. Second, the company's current market capitalization of $5.16 million underscores the importance of capital allocation discipline. Third, this remains a non-binding agreement subject to proof-of-concept validation before progressing to formal terms.
Fundamentally, while novel delivery technologies can enhance drug value propositions, they rarely compensate for deficiencies in underlying compound efficacy. The agreement primarily represents a prudent technological enhancement rather than a paradigm shift in Clearmind's development trajectory. Given the early-stage nature and absence of financial details, this announcement represents a modest strategic development rather than a material financial catalyst.
Aiming to improve bioavailability and optimize the therapeutic effect of Clearmind’s psychedelic-based treatments
Vancouver, Canada, March 19, 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, announced today that it has signed a non-binding Letter of Intent (LOI) with Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon”), a development stage biotech company specializing in the development of innovative intranasal hydrogels, 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 (MEAI), alone or in combination with Palmitoylethanolamide (PEA), 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 non-binding 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 Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “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.”
As part of the non-binding LOI, Clearmind will fund the research and development process, including feasibility studies to validate intranasal delivery effectiveness. Polyrizon will advance formulation development, using its proprietary intranasal drug delivery platform to enhance the absorption and efficacy of Clearmind’s drug candidates. If successful, the parties intend to negotiate a definitive agreement, outlining intellectual property rights, commercialization terms, and financial arrangements.
Mr. Oz Adler, serves as a member of the board of directors of Clearmind, also serves as the chairman of the board of directors of Polyrizon. In addition, Mr. Assaf Itzhaik, who serves as a member of the board of directors of Clearmind, also serves as a member of the board of directors of Polyrizon.
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
invest@clearmindmedicine.com
Telephone: (604) 260-1566
US: CMND@crescendo-ir.com
General Inquiries
About Polyrizon Ltd.
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.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 execution of definitive agreements with Polyrizon Ltd., how this collaboration represents an exciting step forward in our efforts to continue innovating psychedelic-based treatments, its belief that intranasal administration has the potential to improve patient outcomes by providing a faster-acting, more efficient, and user-friendly treatment option and its commitment to developing innovative and accessible solutions for mental health and addiction treatment. 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 filed 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.
FAQ
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