Alzinova AB (publ) ("Alzinova" or "the Company") today announces that it has entered into a non-binding Letter of Intent ("LoI") with Fujirebio, a global provider of in vitro diagnostic solutions, regarding the potential development and commercialization of a blood-based diagnostic test for Alzheimer's disease based on Alzinova's proprietary Aß42CC oligomer technology. The parties intend to evaluate a broader collaboration following the outcome of the ongoing validation work conducted together with Amsterdam UMC, with initial results expected during the third quarter of 2026.
The contemplated collaboration concerns the further development, optimization, validation and potential commercialization of a blood-based diagnostic test designed to measure naturally occurring (endogenous) antibodies against toxic amyloid-ß oligomers. The test is based on Alzinova's proprietary Aß42CC oligomer technology, which is also the foundation of the Company's therapeutic vaccine candidate ALZ-101.
Under the Letter of Intent, the parties have agreed to establish a framework for continued discussions regarding a potential future collaboration. Any definitive agreement remains subject to satisfactory confirmation of the data generated through Alzinova's ongoing research collaboration with Amsterdam UMC, where the Company is currently working to validate previous findings in a larger patient cohort and further assess the clinical performance of the assay.
Should the validation data support continued development, the parties intend to enter negotiations regarding a definitive collaboration and licensing agreement. Such an agreement may include an exclusive license or other commercial rights for Fujirebio to develop, manufacture and commercialize the test, as well as customary financial terms such as upfront payments, development milestones and royalties.
Fujirebio is expected to contribute expertise in assay development, clinical validation, regulatory strategy and commercialization of the diagnostic test on a global scale. Alzinova is expected to contribute its proprietary peptide technology, biological know-how and supporting scientific data.
The ongoing collaboration with Amsterdam UMC is progressing according to plan, with initial results expected during the third quarter of 2026. The work is conducted independently of the clinical development of ALZ-101 but has the potential to create significant long-term synergies between diagnostics and therapy within the same disease-modifying platform.
Christian Fermer, CEO of Fujirebio Diagnostics AB, comments:
"As a recognized leader in Alzheimer's disease diagnostics and at the forefront of innovation in neurodegenerative diseases, Fujirebio continuously evaluates novel approaches that can improve disease management and support better clinical decision-making. We see potential in Alzinova's differentiated technology and look forward to assessing the results from the ongoing validation work as a basis for a possible future collaboration."
Tord Labuda, CEO of Alzinova, comments:
"The signing of this Letter of Intent confirms that our diagnostic program is attracting interest from leading players in the global diagnostics industry. Establishing a framework with Fujirebio at this stage is highly encouraging and reinforces our belief that the unique biology behind our oligomer technology has the potential to create value not only through therapeutics, but also through diagnostics. We now look forward to completing the ongoing validation work and taking the next steps towards a potential commercial partnership."
About Fujirebio
Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and in vitro diagnostics (IVD) partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE G platform, Fujirebio's open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.
Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio's flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster-driving better decisions, treatments, and patient outcomes. Lumipulse is a registered trademark of Fujirebio Inc.
For more information, please contact:
Tord Labuda, CEO
E-mail: info@alzinova.com
About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AßCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com
