The strategic decision to centralize the Phase 3 clinical trial within Europe offers several key benefits, including:


• 100% European patient recruitment for the Phase 3 trial aligning with the prioritized market approval in Europe.
• Engagement with a broader set of Key Opinion Leaders (KOLs) in Europe to build awareness and ensure an efficient market introduction post-approval.
• Streamline project coordination and reduce regulatory complexity and risk, within a European framework.

"This amendment is further evidence of the deep strategic alignment and collaboration between our companies," said Stian Kildal, CEO of OncoZenge. "By accelerating these milestone payments, and together with our recent announcement of convertible note financing from Linc AB, we are positioned to deliver a European-centric Phase 3 project for BupiZenge. This approach will not only optimize our clinical development and regulatory process but also ensure a more efficient and impactful market entry, in line with our shared goal to bring BupiZenge to the patients who need it as soon as possible."

"We are delighted to deepen our commitment to BupiZenge and its potential to significantly improve the lives of patients suffering from oral mucositis," commented Gianluca Corbinelli, CEO of Molteni Farmaceutici. "Focusing the Phase 3 execution in Europe aligns perfectly with our strategic priority to introduce this innovative treatment across our markets in Europe. We believe this streamlined approach will yield substantial benefits for both our companies and, most importantly, for patients."

In light of recent progress, OncoZenge intends to issue a market and strategy update in the coming weeks to provide current and new shareholders with an up-to-date view of its progress in securing partnerships and funding for a clear path to market for BupiZenge™. Additionally, OncoZenge is planning a Capital Markets Day in September 2025 to showcase the Company's market potential, execution, and growth plan. An invitation with the event's date, location and agenda will be issued separately.
 

BupiZenge™ - Potential to be the leading treatment for oral pain. 

For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se


Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

About this release
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 above, at 08:45 CEST on July 17, 2025.

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.

About Molteni Farmaceutici
Molteni Farmaceutici is an Italian pharmaceutical company, a specialty pharma leader in therapeutics solutions for pain management and drug addiction. Founded in 1892 and headquartered in Florence, Italy. With its own Manufacturing, R&D, Regulatory, Supply Chain and Commercial capabilities it is able to serve a broad distribution reach in Europe and across the globe, with operations in over 40 countries.