Medicus Pharma Ltd. Announces a Memorandum of Understanding (MOU) with Helix Nanotechnologies Inc. to Develop Thermostable Infectious Disease Vaccines
Medicus Pharma (NASDAQ: MDCX) has signed a non-binding Memorandum of Understanding (MOU) with Helix Nanotechnologies to develop thermostable infectious disease vaccines. The collaboration aims to combine HelixNano's proprietary mRNA vaccine platform with Medicus' Microneedle array (MNA) delivery platform.
The companies plan to form a joint venture for co-development and commercialization of thermostable mRNA-based vaccines. Initially, they will collaborate on producing clinical-grade mRNA vaccine-loaded MNAs for a Phase 1 clinical bridging study comparing intramuscular injection versus intradermal MNA delivery of HelixNano's vaccine candidate HN-0001.
The partnership includes a Sponsored Research Agreement with the University of Pittsburgh under Dr. Lou Falo's direction. HelixNano will supply the mRNA-LNP formulated vaccine material, while Medicus and the University will handle MNA loading and optimization.
Medicus Pharma (NASDAQ: MDCX) ha firmato un Memorandum of Understanding (MOU) non vincolante con Helix Nanotechnologies per sviluppare vaccini contro le malattie infettive termostabili. La collaborazione mira a combinare la piattaforma proprietaria di vaccini mRNA di HelixNano con la piattaforma di somministrazione a matrice di microaghi (MNA) di Medicus.
Le aziende prevedono di costituire una joint venture per lo sviluppo congiunto e la commercializzazione di vaccini mRNA termostabili. Inizialmente, collaboreranno per produrre MNAs caricati con vaccini mRNA di grado clinico per uno studio clinico di fase 1 di confronto tra iniezione intramuscolare e somministrazione intradermica tramite MNA del candidato vaccino HN-0001 di HelixNano.
La partnership include un Accordo di Ricerca Sponsorizzata con la University of Pittsburgh sotto la direzione del Dr. Lou Falo. HelixNano fornirà il materiale vaccinale formulato mRNA-LNP, mentre Medicus e l’Università si occuperanno del caricamento e dell’ottimizzazione delle MNA.
Medicus Pharma (NASDAQ: MDCX) ha firmado un Memorando de Entendimiento (MOU) no vinculante con Helix Nanotechnologies para desarrollar vacunas termostables contra enfermedades infecciosas. La colaboración busca combinar la plataforma propietaria de vacunas mRNA de HelixNano con la plataforma de administración de matriz de microagujas (MNA) de Medicus.
Las compañías planean formar una empresa conjunta para el co-desarrollo y la comercialización de vacunas mRNA termostables. Inicialmente, colaborarán en la producción de MNAs cargadas con vacunas mRNA de grado clínico para un estudio clínico de fase 1 que compara la inyección intramuscular versus la administración intradérmica mediante MNA del candidato a vacuna HN-0001 de HelixNano.
La asociación incluye un Acuerdo de Investigación Patrocinada con la University of Pittsburgh bajo la dirección del Dr. Lou Falo. HelixNano suministrará el material vacunal formulado mRNA-LNP, mientras que Medicus y la Universidad se encargarán de la carga y optimización de las MNA.
Medicus Pharma (NASDAQ: MDCX)는 Helix Nanotechnologies와 비구속적 양해각서(MOU)를 체결하여 열에 안정한 감염병 백신을 개발하기로 했습니다. 이번 협력은 HelixNano의 독자적인 mRNA 백신 플랫폼과 Medicus의 마이크로니들 배열(MNA) 전달 플랫폼을 결합하는 것을 목표로 합니다.
양사는 열에 안정한 mRNA 기반 백신의 공동 개발 및 상용화를 위해 합작 회사를 설립할 계획입니다. 초기에는 HelixNano의 백신 후보물질 HN-0001의 근육 내 주사와 피부 내 MNA 전달을 비교하는 1상 임상 브리징 연구를 위해 임상 등급 mRNA 백신 탑재 MNA를 공동 생산할 예정입니다.
이번 파트너십에는 Dr. Lou Falo가 이끄는 University of Pittsburgh와의 후원 연구 계약도 포함되어 있습니다. HelixNano는 mRNA-LNP 조성 백신 물질을 제공하며, Medicus와 대학은 MNA 적재 및 최적화를 담당합니다.
Medicus Pharma (NASDAQ : MDCX) a signé un protocole d'accord non contraignant (MOU) avec Helix Nanotechnologies pour développer des vaccins thermostables contre les maladies infectieuses. Cette collaboration vise à combiner la plateforme propriétaire de vaccins à ARNm de HelixNano avec la plateforme de délivrance par matrice de micro-aiguilles (MNA) de Medicus.
Les entreprises prévoient de créer une coentreprise pour le co-développement et la commercialisation de vaccins thermostables à base d'ARNm. Dans un premier temps, elles collaboreront pour produire des MNAs chargées de vaccins à ARNm de qualité clinique pour une étude clinique de phase 1 comparant l'injection intramusculaire à la délivrance intradermique par MNA du candidat vaccin HN-0001 de HelixNano.
Le partenariat inclut un accord de recherche sponsorisée avec l'Université de Pittsburgh sous la direction du Dr Lou Falo. HelixNano fournira le matériau vaccinal formulé mRNA-LNP, tandis que Medicus et l'Université se chargeront du chargement et de l'optimisation des MNAs.
Medicus Pharma (NASDAQ: MDCX) hat ein unverbindliches Memorandum of Understanding (MOU) mit Helix Nanotechnologies unterzeichnet, um thermostabile Impfstoffe gegen Infektionskrankheiten zu entwickeln. Die Zusammenarbeit zielt darauf ab, die proprietäre mRNA-Impfstoffplattform von HelixNano mit der Microneedle-Array-(MNA)-Verabreichungsplattform von Medicus zu kombinieren.
Die Unternehmen planen die Gründung eines Joint Ventures zur gemeinsamen Entwicklung und Vermarktung thermostabiler mRNA-basierter Impfstoffe. Zunächst werden sie gemeinsam klinisch hochwertige mRNA-Impfstoff-beladene MNAs für eine Phase-1-Studie zur Vergleichsanalyse der intramuskulären Injektion versus intradermale MNA-Verabreichung des Impfstoffkandidaten HN-0001 von HelixNano herstellen.
Die Partnerschaft umfasst eine gesponserte Forschungsvereinbarung mit der University of Pittsburgh unter der Leitung von Dr. Lou Falo. HelixNano liefert das mRNA-LNP formulierte Impfstoffmaterial, während Medicus und die Universität das Laden und die Optimierung der MNAs übernehmen.
- None.
- MOU is non-binding with no guarantee of definitive agreement
- Joint venture formation still subject to negotiations and conditions
- Clinical trial outcomes and timeline uncertainties
- Early-stage development with no immediate revenue potential
Insights
Medicus-HelixNano MOU combines mRNA and microneedle technologies for thermostable vaccines, potentially disrupting cold-chain dependent vaccine distribution.
This MOU between Medicus Pharma and HelixNano represents a strategic move to address one of the vaccine industry's most persistent challenges: thermostability. The potential joint venture aims to combine HelixNano's mRNA vaccine platform with Medicus' microneedle array (MNA) delivery technology to create vaccines that don't require cold-chain storage—a significant innovation in the
The technical approach is particularly noteworthy. Current mRNA vaccines typically require ultra-cold storage (as low as -70°C), creating enormous logistical barriers for global distribution. The microneedle array technology could theoretically preserve thermosensitive mRNA constructs in a dried state while simultaneously offering needle-free delivery—solving two major problems simultaneously.
Importantly, this partnership has progressed beyond conceptual discussions to concrete research steps. The companies have outlined specific development milestones, including a Sponsored Research Agreement with the University of Pittsburgh under Dr. Lou Falo, a recognized authority in transdermal delivery systems. The planned Phase 1 clinical bridging study comparing intramuscular versus intradermal MNA delivery of HelixNano's HN-0001 vaccine candidate represents a clear development pathway.
However, investors should recognize that this remains a non-binding MOU with significant execution risks ahead. The technical challenges of stabilizing mRNA in microneedle arrays while maintaining potency and shelf-life are substantial. Additionally, no financial terms or timeline for the definitive joint venture agreement were disclosed, making valuation impact difficult to quantify at this stage.
The MOU intends to combine proprietary mRNA vaccine platform of HelixNano with proprietary Microneedle array (MNA) delivery platform of Medicus.
Philadelphia, Pennsylvania--(Newsfile Corp. - August 4, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus") and Helix Nanotechnologies Inc. ("HelixNano"), a Boston-based biotech company focused on developing an advanced mRNA platform to create vaccines and therapies to augment the immune system's power to fight disease, announced today that they have entered into a non-binding memorandum of understanding (the "MoU") in respect of their shared mutual interest in the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus' proprietary MNA delivery platform.
Subject to the certain conditions noted in the MoU, Medicus and HelixNano are currently engaged in good faith negotiations with the aim of forming a joint venture (the "Joint Venture") for the co-development and commercialization of thermostable mRNA-based vaccines utilizing their respective proprietary technologies.
In parallel with such ongoing negotiations, Medicus and HelixNano have formalized their mutual intent to collaborate on the research, development and production of a batch of clinical-grade mRNA vaccine-loaded MNAs (the "Project"), which are intended for use in a Phase 1 clinical bridging study to compare the safety and preliminary efficacy of intramuscular injection vs. intradermal MNA delivery of HelixNano's vaccine candidate HN-0001, through the proposed Joint Venture.
"The potential of combining HelixNano's potent mRNA vaccine platform with our uniquely formulated dissolvable microneedle array (MNA) technology, is designed to unlock next generation vaccination paradigm," stated Dr. Raza Bokhari, Executive Chairman & CEO, "aiming to develop needle-free, thermostable vaccines that could eliminate cold-chain logistics, reduce distribution costs, improve patient access and offer global scale, which could potentially position us at the forefront of ground-breaking opportunities to prevent, rather than treat, infectious diseases. The Company is exploring numerous possibilities offered by microneedle arrays."
The purpose of the MoU is to memorialize the mutual intention of the parties to proceed with preliminary collaborative efforts towards the Project while the terms of the contemplated Joint Venture are being finalized.
In addition, Medicus and HelixNano have agreed to engage in the following preliminary joint development activities for the purpose of evaluating the feasibility and desirability of pursuing the proposed Joint Venture. The parties acknowledge and agree that these activities do not constitute a binding commitment to proceed with the Joint Venture, which remains subject to the negotiation and execution of definitive agreements.
Sponsored Research Agreement: HelixNano and Medicus will enter into a Sponsored Research Agreement with the University of Pittsburgh (the "University") to conduct parts of the Project under the direction of Dr. Lou Falo, Professor and Chair, Department of Dermatology, University of Pittsburgh, School of Medicine.
Supply of Clinical Material: HelixNano will supply clinical drug product HN-0001, consisting of mRNA-LNP formulated vaccine material, in sufficient quantities and conditions suitable for use in the Project.
Loading into Microneedle Arrays: The University will test and optimize the incorporation of the HN-0001 mRNA-LNP drug product into microneedle arrays (MNAs). Once all parties agree that sufficient loading conditions have been achieved, Medicus and/or the University will complete the loading of HN-0001 drug product at an agreed upon dosage/concentration into a batch of sterile, clinical-grade MNAs provided by Medicus for use in the Project. The HN-0001-loaded, clinical MNAs are intended for future use in a human clinical study after creation of the Joint Venture.
No Binding Obligation to Transact
Except as expressly provided in certain sections, the MoU is non-binding and shall not be construed to obligate either party to proceed with the Joint Venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in UAE.
In June 2025, the Company announced its entry into a definitive agreement to acquire Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate. The transaction with Antev is subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the proposed transaction on the terms or timeframe currently contemplated or at all.
About Helix Nanotechnologies, Inc:
Helix Nanotechnologies Inc, is a biotechnology company headquartered in Boston, MA. HelixNano is focused on building a universal interface to the immune system to tap into the innate power of the human body to fight disease and is currently developing mRNA-based drug products in infectious disease, solid organ transplant, oncology, and other indications.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the MOU, including the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus' proprietary microneedle array (MNA) delivery platform, the commencement of the Project and potential results thereof, the formation of the Joint Venture and potential benefits thereof, the commencement and successful completion of the joint development activities and the benefits thereof, the design of the MOU and the Joint Venture to unlock next generation vaccination paradigm, successfully develop needle-free and thermostable vaccines that could eliminate cold-chain logistics, reduce distribution costs, improve patient access and offer global scale, the Company being positioned at the forefront of ground-breaking opportunities to prevent infectious diseases, the Company's aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the Antev transaction, including the closing of the transaction or the timing thereof, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on EDGAR and on SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are cautioned that the foregoing list is not exhaustive, and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca . Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
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