Medicus Pharma Announces MoU With Helix Nanotechnologies to Develop Thermostable Infectious Disease Vaccines

Medicus Pharma Ltd. and Helix Nanotechnologies Inc. recently announced they have entered into a non-binding memorandum of understanding (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 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,” said Dr. Raza Bokhari, Executive Chairman and CEO.

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.

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.

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.

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.

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.

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.

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.