Our company
Nanexa is a Swedish pharmaceutical company creating long-acting injectable medicines with the potential to make treatment simpler and more convenient. At the heart of our work is PharmaShell® – our proprietary drug delivery platform based on Atomic Layer Deposition. PharmaShell applies an ultra-thin, precisely engineered coating around active pharmaceutical ingredient particles. By tailoring the composition and thickness of the coating, we can control how the medicine is released after injection.
The platform combines controlled release with a high proportion of active pharmaceutical ingredient, supporting low injection volumes and fine-gauge needles. PharmaShell has been evaluated across small molecules and biological medicines, including peptides, proteins, monoclonal antibodies, oligonucleotides and mRNA. Its breadth creates opportunities to develop long-acting formulations across multiple therapeutic areas without modifying the underlying drug molecule.
From our facilities in Uppsala, we bring together formulation and analytical development, PharmaShell process expertise, clinical development, intellectual property and in-house GMP manufacturing of investigational medicinal products. PharmaShell has achieved clinical proof of concept with controlled liraglutide exposure for up to 36 days following a single injection. More recent preclinical work has generated PharmaShell-based semaglutide candidates for monthly and quarterly dosing.
Our progress is also reflected in collaborations with global pharmaceutical companies. Nanexa has experience from projects with companies including Novo Nordisk and has entered into a multi-asset license and option agreement with Moderna. Together with a broad and continually developing patent portfolio, these programs strengthen our position as a development and technology partner for the next generation of long-acting injectable medicines.
Our business model
Nanexa operates a dual business model built around the PharmaShell® platform. We develop proprietary product candidates while also working with pharmaceutical partners to apply PharmaShell to their active substances. The two pathways reinforce one another: internal programs generate scientific and clinical evidence for the platform, while partner programs expand its use across additional molecules, therapeutic areas and product opportunities.
In our proprietary programs, we identify product opportunities where a long-acting formulation can provide meaningful differentiation and patient benefit. We advance selected candidates through formulation, preclinical and clinical development, typically to clinical proof of concept, before determining the route that offers the strongest value: continued internal development, co-development or licensing to a partner with the capabilities required for later-stage development and commercialisation.
In partner-driven programs, Nanexa contributes PharmaShell formulation expertise, analytical development, manufacturing know-how and clinical-supply capabilities. Collaborations may begin with feasibility and evaluation work and progress towards product or technology licenses. Depending on the program, Nanexa’s revenue can include funded development work, upfront or option payments, development and commercial milestones, and royalties on future product sales.
This model allows Nanexa to retain significant value in selected proprietary assets while extending PharmaShell through multiple externally funded programs. The license and option agreement with Moderna, covering an initial compound and options for up to four additional compounds, demonstrates how an evaluation and development relationship can evolve into a broader commercial opportunity.
Quality control
Quality is integrated into Nanexa’s work from the outset. Our pharmaceutical quality system connects formulation and analytical development with manufacturing, quality control, quality assurance and clinical supply. It is designed to support reliable and traceable data, consistent product quality and compliance with the regulatory requirements applicable to each stage of development.
At our Uppsala site, investigational medicinal products are manufactured under GMP conditions. Nanexa performs chemical and physical quality-control testing and has in-house Qualified Person certification and release capabilities. Our quality-control work includes visual and packaging-material inspection, identity, assay, purity, particle-size analysis and in-vitro dissolution testing using qualified analytical equipment. Analytical methods used for product release are validated, with qualified external laboratories supporting specialist microbial and selected chemical analyses.
Our quality system extends beyond testing. It includes supplier and contractor qualification, analytical method development and validation, stability studies, controlled documentation, change control, deviation and CAPA management, risk-based decision-making and independent quality oversight. Preclinical and clinical activities are conducted in accordance with applicable regulatory approvals and recognised standards, including GLP where required and GCP for clinical studies.
By combining development, analytical and GMP capabilities within a single organisation, Nanexa can maintain close control of PharmaShell-based products as they move from formulation work to clinical supply. For partners, this provides a transparent and dependable development environment built around scientific rigour, data integrity and continual improvement.
