Neurizon Enters into Global License with Elanco to Accelerate Commercialisation of NUZ-001

Rhea-AI Summary

Neurizon Therapeutics has entered into an exclusive global licensing agreement with Elanco Animal Health (NYSE:ELAN) for Monepantel, the key ingredient in NUZ-001, their lead investigational therapy for ALS and other neurodegenerative diseases.

The agreement includes exclusive worldwide rights to Elanco's intellectual property, access to non-clinical studies and manufacturing data, and outlines terms for a future GMP-compliant Monepantel supply agreement. Financial terms include a nominal upfront fee, development milestone payments of $9.75 million for initial products and $5.2 million for subsequent products, sales milestones up to $65 million, and single-digit royalties on global net sales.

A formal supply agreement is expected to be finalized in H2 2025, which will provide Neurizon with a long-term source of GMP-compliant monepantel for clinical development and commercialization.

Positive

• Exclusive global rights secured for Monepantel development in neurodegenerative diseases
• Access to extensive non-clinical studies and manufacturing data reduces development costs and timeline
• Favorable financial terms with nominal upfront payment and milestone-based structure
• Agreement significantly de-risks future global regulatory approval process

Negative

• Additional milestone payments of up to $80 million may strain future cash flows
• Ongoing royalty obligations will impact future profit margins
• Supply agreement terms not yet finalized, creating uncertainty in manufacturing arrangements

Insights

Biotechnology Industry Analyst

Neurizon's exclusive global license with Elanco significantly accelerates NUZ-001's development pathway while reducing costs and regulatory risks.

This licensing agreement represents a strategic milestone for Neurizon Therapeutics in its development of NUZ-001, a potential treatment for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. By securing exclusive global rights to Elanco's intellectual property for Monepantel (the active ingredient in NUZ-001), Neurizon gains immediate access to extensive non-clinical studies and manufacturing data that would otherwise require significant time and capital to generate.

The deal structure is notably favorable for Neurizon, requiring only a nominal upfront payment while deferring the bulk of financial obligations to regulatory and commercial milestones. The agreement includes $9.75 million in development milestones for initial products and $5.2 million for subsequent ones, plus up to $65 million in sales-based milestones and single-digit royalties on global net sales.

The most valuable component of this transaction is how it substantially de-risks Neurizon's regulatory pathway. Access to Elanco's existing safety and manufacturing data eliminates the need to duplicate expensive and time-consuming studies, potentially accelerating NUZ-001's path to market by years while significantly reducing development costs. This could potentially save tens of millions in development expenses.

The announcement also mentions a forthcoming supply agreement expected in H2 2025, which would secure Neurizon's access to GMP-compliant Monepantel—a critical component for clinical trials, regulatory submissions, and eventual commercialization. This integrated approach to both intellectual property and manufacturing creates a more robust foundation for Neurizon's development program.

For a clinical-stage biotech company, this type of agreement represents classic risk mitigation by leveraging existing data and manufacturing capabilities rather than building everything internally. The modest financial terms suggest Elanco sees value in repurposing their animal health compound for human applications without disrupting their core business.

Highlights:

• Neurizon^® Therapeutics and Elanco Animal Health enter into an exclusive global licensing agreement
• Provides worldwide rights for Neurizon to utilise Elanco's intellectual property, providing exclusive access to an extensive package of non-clinical studies and manufacturing data and outlines key terms for a future supply agreement for GMP-compliant Monepantel
• Provides a clear pathway for accelerated global commercialisation of NUZ-001^[1] and significantly de-risks future global regulatory approval processes
• The license agreement represents the first step in formalising Neurizon's relationship with Elanco, with the next step focused on finalising a supply agreement expected H2 CY 2025

MELBOURNE, Australia, July 2, 2025 /PRNewswire/ -- Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce it has executed an exclusive global license agreement with Elanco Animal Health Incorporated (Elanco; NYSE: ELAN) and affiliates for Monepantel, the active pharmaceutical ingredient in NUZ-001, Neurizon's lead investigational therapy in development for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases in humans.

This license agreement represents a critical inflection point for Neurizon, further strengthening the Company's strategic outlook for the development, manufacturing and potential future commercialisation of NUZ-001. It also significantly supports the Company's regulatory foundations, providing ongoing access to critical animal safety data and manufacturing data, key pillars required to support future clinical trials, potential regulatory approvals and global market entry.

Dr. Michael Thurn, Managing Director and Chief Executive Officer, commented: "This license agreement with Elanco marks a watershed moment in Neurizon's journey to become a leader in the accelerated development of treatments for neurodegenerative diseases. This strategic milestone provides exclusive access to a comprehensive package of non-clinical studies and manufacturing data, dramatically reducing near-term development costs and accelerating development timelines. All of this is in exchange for a nominal up-front payment, small back-ended regulatory approval and commercial sale milestones and single-digit royalty payments on future global net sales. Neurizon is now well-positioned to accelerate the path to market and advance new treatment options for people affected by devastating neurodegenerative diseases."

Mr. Sergio Duchini, Non-Executive Chairman, commented: "On behalf of the Board, I am pleased to endorse this landmark agreement with Elanco, which represents a strategically significant step forward for Neurizon. This agreement not only strengthens our clinical and regulatory position but also reflects our strong commitment to accelerating the development of meaningful therapies for people living with neurodegenerative diseases. We are also very happy to be making this important step in formalising our relationship with Elanco and look forward to building on this foundation as we progress towards finalising a supply agreement later this year."

Key Terms of the Licensing Agreement:

• Exclusive Global Rights: Neurizon is granted exclusive global rights to Elanco's data package and related intellectual property for monepantel to develop and commercialise NUZ-001 and its related compounds for the treatment, palliation, prevention, or cure of neurodegenerative diseases in humans.
• Upfront Payment: A nominal upfront licensing fee is payable to Elanco upon execution of the agreement^[2].
• Milestone Payments: Total Development milestone payments for the initial and subsequent licensed products, indications, or presentations of US$9.75 million and US$5.2 million, respectively. Elanco will also be eligible for milestone payments of up to US $65 million based on sales milestones^[3].
• Royalties: Elanco will receive tiered single-digit royalties on global net sales of licensed products.
• Supply: The agreement outlines certain key terms, including duration and price, for the conclusion of a Supply Agreement.

Supply Agreement

Neurizon and Elanco remain focused on finalising a supply agreement, with a follow-up announcement anticipated in H2 CY 2025.

This next phase of the collaboration is expected to provide Neurizon with long-term, scalable source of GMP-compliant monepantel to support ongoing clinical development, regulatory submissions, and future global commercialisation of NUZ-001.

-ENDS-   

This announcement has been authorized for release by the Board of Neurizon Therapeutics Limited.

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 NUZ-001's potential 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.

Neurizon^® is a registered trademark of Neurizon Therapeutics Limited

[1] NUZ-001 is Neurizon Therapeutics formulation of monepantel for use in neurodegeneration applications. [2] The amount is not material to Neurizon's current cash position [3] If triggered, the sales milestone payments will not fall due until six months after the first commercial sale.  The remaining regulatory and commercial milestone payments will become due 30 days after the relevant milestone is met.

 

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SOURCE Neurizon Therapeutics Limited

FAQ

What are the key terms of Elanco's (NYSE:ELAN) licensing agreement with Neurizon?

The agreement includes exclusive global rights, a nominal upfront fee, development milestone payments of $9.75M for initial products and $5.2M for subsequent ones, sales milestones up to $65M, and single-digit royalties on global net sales.

How does the Elanco licensing deal benefit Neurizon's NUZ-001 development?

The deal provides access to extensive non-clinical studies and manufacturing data, significantly reducing development costs and accelerating timelines while de-risking the global regulatory approval process.

When will Elanco (NYSE:ELAN) and Neurizon finalize their supply agreement?

The supply agreement is expected to be finalized in the second half of 2025, providing long-term access to GMP-compliant monepantel.

What is NUZ-001 being developed for?

NUZ-001 is being developed as a treatment for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases in humans.

What milestone payments is Elanco (NYSE:ELAN) eligible for under the agreement?

Elanco is eligible for $9.75M in development milestones for initial products, $5.2M for subsequent products, and up to $65M in sales-based milestones.