The Company has signed a non-binding offer from Pharmanovia for a commercial partnership to introduce BupiZenge™ in Europe, the Middle East and Northern Africa. The parties will now enter a period of exclusivity to complete detailed due diligence and joint detailed planning, with the goal to sign a definite agreement by November 30th, 2024. The intended agreement includes potential milestone payments, up to €7 million in support of the Phase 3 program and commercialization for BupiZenge™. Furthermore, the agreement will include commercial milestone payments and royalties on product sales.

Pharmanovia is a global pharmaceutical company with a presence in 160 countries, that commercializes novel medicines and revitalizes, extends and expands the lifecycle of established medicines. If the partnership is successful, Pharmanovia will play a key role in providing important regulatory- and market access expertise to help ensure a successful clinical program and subsequent market introduction.

Stian Kildal, CEO of OncoZenge, comments: "Today marks the beginning of a new chapter for OncoZenge where we obtain a clear path to market for BupiZenge. We are thrilled at the prospect of working with Pharmanovia, whose team, capabilities and market reach make them an ideal partner for us. This partnership will provide important support to the program and deliver an ambitious and cohesive launch plan for commercialization across the EMENA region. Together we will make a significantly positive impact in the lives of millions of cancer patients who deserve better pain relief during their treatments, while realizing the full commercial potential of BupiZenge across the 63 countries covered by this agreement."

James Burt, CEO of Pharmanovia, adds: "Cancer supportive care is critically important to millions of cancer patients and a strategic priority for Pharmanovia. Oral mucositis pain is a very common and debilitating side effect of cancer treatments and a large unmet need, making this project a great fit for our portfolio. We look forward to working with OncoZenge towards a definite agreement and on our mutual plans to ensure a successful clinical program and market introduction. Together we aim to redefine the standard of care, as BupiZenge is uniquely positioned to improve patients' quality of life and cancer treatment adherence, leading to better health outcomes."

Daniel Ehrenstråhle, Chairman of OncoZenge, comments: "This partnership is further validation of our strategy and dedicated efforts to focus on a European launch, as a first step towards a global rollout. In Pharmanovia we have found a partner with strong regulatory, clinical development and market access capabilities that share our vision for the market opportunity and potential. Pharmanovia are uniquely positioned to drive both broad and rapid adoption."

OncoZenge will now proceed to appoint a CDMO and initiate technology transfer for the manufacture of lozenges required for the Phase 3 clinical trial to be initiated as early as possible in 2025. OncoZenge and Pharmanovia will also move to jointly finalize the Phase 3 study protocol, whereafter OncoZenge will appoint a CRO for the development and execution of the study plan.

The company will provide timely updates to the market as developments occur.
 

This information is such that OncoZenge AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication, through the agency of the contact persons set out below, at 10:00 CEST on October 18, 2024.

For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Michael Owens, CFO, mobile: +46 73 324 4988, e-mail: michael.owens@oncozenge.se
Daniel Ehrenstråhle, Chairman, mobile: +46 72 724 2069, e-mail: daniel.ehrenstrahle@oncozenge.se

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OncoZenge's Certified Adviser is Redeye AB.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

About OncoZenge
OncoZenge is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options fall short, often due to insufficient pain relief or significant side effects. BupiZenge™ is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge™ is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to severe physical and psychological distress, representing a significant unmet medical need for an effective, opioid-sparing treatment. In Phase 2 trials, BupiZenge™ demonstrated substantially better pain relief compared to the standard of care.

OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.