Neurizon executes long-term supply agreement with Elanco
Released
Released
Announcement PDF
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222
Neurizon executes long-term supply agreement with Elanco strengthening
commercialisation readiness
Highlights:
• Neurizon executes long-term supply agreement with Elanco Animal Health
(Elanco), with an initial five-year term
• The agreement provides long-term access to GMP monepantel, the active pharmaceutical ingredient in
Neurizon’s lead asset, NUZ-001
• Agreement represents an important commercialisation milestone and materially strengthens Neurizon’s
long-term manufacturing and supply chain readiness
• Execution further strengthens Neurizon’s position as a clinically advanced, capital efficient
neurodegenerative disease company with a defined regulatory and commercialisation pathway
17 June 2026 – Melbourne Australia: Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF)
("Neurizon" or "the Company"), a late-stage clinical biotech company dedicated to advancing innovative treatments
for neurodegenerative diseases, is pleased to announce that it has executed a critical strategic supply agreement
with Elanco Animal Health (“Elanco”) securing long-term access to human health monepantel, the active
pharmaceutical ingredient in lead asset, NUZ-001. Importantly, the agreement provides Neurizon with access to
scalable Good Manufacturing Practise (GMP) supply.
The agreement represents a major milestone for Neurizon and demonstrates the Company’s focus on capital
efficient commercialisation readiness. The agreement furthers the Company’s collaboration with Elanco, as NUZ-
001 progresses through late-stage clinical development via the Phase 2/3 HEALEY ALS platform trial and into
commercialisation.
The agreement builds on the previously executed global license agreement (refer ASX announcement: 2 July 2025)
between the parties and reflects Neurizon’s continued confidence in the clinical development of NUZ-001 as a
potential therapy for ALS and broader neurodegenerative disease opportunities.
Interim Executive Chairman, Sergio Duchini, said: “This agreement represents a critical milestone in the continued
advancement of the NUZ-001 program and furthers our relationship with Elanco.
Importantly, the agreement strengthens Neurizon’s long-term manufacturing and supply framework, supporting
potential future commercialisation and operational scalability following completion of the Phase 2/3 program.
The agreement provides Neurizon with a long-term supply of monepantel for human use, reflecting a disciplined,
risk-managed approach to capital management.
Combined with our existing licence agreement, this supply arrangement further enhances the strategic and
commercial foundation underpinning NUZ-001 and strengthens Neurizon’s positioning as a clinically advanced and
commercially focused neurodegenerative disease company.”
Commercialisation readiness and operational scalability
The agreement provides Neurizon with long-term access to human health monepantel, establishing an important
commercial supply framework to support future clinical, regulatory and commercialisation activities for NUZ-001.
Initial orders are intended to support commercialisation and the creation of a strategic inventory holding.
The supply framework supports Neurizon’s broader commercial readiness strategy by strengthening long-term
supply certainty and supporting operational scalability.
Capital discipline and economic efficiency
The agreement also strengthens the economic and commercial profile of the NUZ-001 program by providing access
to a long-term, scalable, high-quality supply of monepantel for human use.
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222
Neurizon believes this agreement enhances the long-term commercial attractiveness and strategic flexibility of the
NUZ-001 program as the Company progresses discussions with potential pharmaceutical partners and broader
commercial stakeholders.
Regulatory and CMC infrastructure
The agreement further strengthens Neurizon’s regulatory and Chemistry, Manufacturing and Controls (CMC)
infrastructure by combining GMP manufacturing capability with the strategic foundations established under the
previously executed global licence agreement with Elanco.
The agreement provides a supply of monepantel manufactured to human pharmaceutical specifications and
supports manufacturing consistency and reproducibility across both clinical and future commercial development
activities.
Long term strategic positioning
Execution of the agreement further strengthens Neurizon’s position as a clinically advanced, commercially focused
and capital efficient neurodegenerative disease company.
Neurizon continues to advance its global regulatory development strategy and believes execution of this agreement
complements ongoing regulatory and commercial readiness activities by strengthening the long-term supply
framework supporting NUZ-001. Commercialisation of NUZ-001 remains subject to successful clinical development
and regulatory approval.
The agreement strengthens the strategic foundation underpinning the NUZ-001 program and supports Neurizon’s
continued build-out of a scalable, neurodegenerative disease development platform.
It also reinforces Neurizon’s strategic differentiation within the ALS and neurodegenerative disease sector and
enhances the long-term attractiveness of the NUZ-001 program to potential pharmaceutical partners and strategic
investors.
Material terms
The agreement has an initial term of five years and includes provisions relating to forecasting, production scheduling,
supply, confidentiality and termination. It also details the first two supplies of monepantel under the supply
agreement, with Neurizon having a right to request the deferral of supply pending the obtaining of regulatory
approval.
Neurizon will exclusively acquire monepantel from Elanco, with a right to manufacture, or acquire from a third party,
functionally equivalent active pharmaceutical ingredient to the monepantel in specifically identified circumstances.
The Supply Agreement is supported by a separate Quality Agreement that allocates the parties’ responsibilities for
GMP manufacturing, quality control, batch release, change management and related regulatory-quality matters.
Commercialisation of NUZ-001 remains subject to successful clinical development, regulatory approval and future
commercial outcomes.
-ENDS-
This announcement has been authorised for release by the Board of Neurizon Therapeutics Limited.
For any questions, comments, or further information regarding Neurizon, please email enquiries@neurizon.com
or contact:
Neurizon Therapeutics
Lidija Damjanovic
Marketing & Corporate Affairs
Email: lidija@neurizon.com
Phone: +61 (0) 425 700 504
Australia Investor
Relations
Henry Jordan
Six Degrees Investor
Relations
Email:
henry.jordan@sdir.com.au
Phone: +61 (0) 431 271 538
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222
About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing
treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the
treatment of ALS, which is the most common form of motor neurone disease. Neurizon’s strategy is to accelerate
access to effective ALS treatments for patients while exploring the potential of NUZ-001 for broader
neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is
dedicated to creating new horizons for patients and families impacted by complex neural disorders. NUZ-001 is an
investigational product and is not approved for commercial use in any jurisdiction.
About NUZ-001
NUZ-001 is an investigational oral therapy being developed for Amyotrophic Lateral Sclerosis (ALS) and other
neurodegenerative diseases characterised by impaired cellular protein clearance pathways and toxic protein
aggregation, TDP-43. The therapy is designed to target converging pathological drivers of neurodegeneration
associated with disrupted cellular protein homeostasis.
NUZ-001 has completed Phase 1 and Open-Label Extension studies, demonstrating encouraging preclinical and early
clinical findings. In a small group of patients with ALS (n=12) the therapy was found to be safe and generally well
tolerated, with signals observed across exploratory clinical measures. NUZ-001 is currently being evaluated in the
Phase 2/3 HEALEY ALS Platform Trial, a leading global clinical trial initiative for ALS.
NUZ-001 is an investigational product and has not been approved for use in any jurisdiction.
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