Neurizon Therapeutics (ASX:NUZ) Chair Sergio Duchini has told shareholders the company is entering a decisive phase in its mission to bring new treatments to patients with neurodegenerative diseases, describing the past year as one of disciplined execution, strengthened governance, and meaningful scientific progress.
Addressing the company’s Annual General Meeting in Melbourne, Duchini reiterated Neurizon’s central purpose “to lead the development of neurodegenerative disease treatments towards a promising new horizon for patients.” He paid tribute to the ALS community, including patients, carers, clinicians and advocates, whose “courage and resilience”, he said, remained fundamental to the company’s work.
Duchini also acknowledged the leadership of CEO Dr Michael Thurn and the executive team, praising their “tireless commitment” across regulatory, clinical, manufacturing and capital planning activities. “The Board’s ongoing challenge to strategies and continued stewardship have strengthened our decision-making through this period,” he said.
A key development for the company this year was the appointment of Justine Conway, Global Head of Business Development at Elanco, as a Board Observer. Duchini said the move strengthened the company's governance and reflected the depth of its strategic partnership with Elanco.
Conway brings more than two decades of experience across pharmaceuticals, animal health, M&A and capital markets. As Board Observer, she will contribute strategic insight as Neurizon progresses toward the commencement of the HEALEY ALS Platform Trial and prepares for global commercialisation.
Reviewing the year’s progress, Duchini highlighted several pivotal achievements across regulatory, clinical, and commercial-readiness activities. The lifting of the FDA clinical hold on Neurizon’s lead candidate NUZ-001 marked a significant inflection point, Duchini said, aligning the company to enter the HEALEY ALS Platform Trial this quarter, with protocol completion and site activations expected shortly.
The company’s preclinical program also advanced, with new data reinforcing NUZ-001’s proposed mechanism of selective mTOR modulation and autophagy enhancement. Additional studies showed neuroprotection and reductions in TDP-43–related pathology, with recently presented datasets informing the company’s biomarker strategy and Phase 2 dose rationale.
The 12-month open-label extension study met its primary safety endpoint at the intended Phase 2 dose. It showed “directional signals on function and respiration versus matched historical controls,” further supporting NUZ-001’s clinical profile.
On enablement, Duchini said the company’s global licence and data-access agreement with Elanco has strengthened manufacturing and regulatory foundations, secured GMP tablet registration batches with Catalent, and de-risked the company’s path to an eventual US FDA New Drug Application.
Duchini used the address to reaffirm Neurizon’s four-pillar strategy. The framework focuses on accelerating patient access, driving clinical progress with NUZ-001, broadening therapeutic reach across neurodegenerative diseases, and ensuring commercial readiness for international markets. Together, he said, these pillars “represent a balanced strategy that bridges our purpose with performance.”