OncoZenge is developing BupiZenge, a lozenge based on bupivacaine intended for pain relief in patients suffering from oral mucositis – a severe side effect of radiation and chemotherapy.
The project rests on solid ground; in phase II, BupiZenge demonstrated statistically significant and clinically meaningful pain relief compared to standard of care, along with a favorable safety profile.
Now, OncoZenge has formally submitted the application for the phase III study BZ003, a randomized trial that will recruit 150 patients across Sweden, Norway, Denmark, and Germany. The goal is to compare the efficacy and safety of BupiZenge against the standard of care, i.e. lidocaine treatment.
CTA submission unlocks capital
The submission of the Clinical Trial Application (CTA) to the European Medicines Agency (EMA) was the specific condition required to trigger the next phase of funding. Consequently, the Board of Directors has resolved on a directed share issue of 1 shares to the strategic investor Sichuan Yangtian Bio-Pharmaceutical.
Through the issue, OncoZenge receives approximately 9,1 MSEK before transaction costs. The subscription price was set at 6,47 SEK per share. Notably, this corresponds to a premium of approximately 4,7 per cent compared to the volume-weighted average price (VWAP) on December 18, and a premium of roughly 40 per cent compared to the VWAP when the original agreement was signed in January 2025.
Daniel Ehrenstråhle, Chairman of the Board, comments on the synergy between the team’s effort and the partnership:
– I am very proud of the immense effort over the last few months across the OncoZenge team and our partners Meribel Pharma Solutions and LINK Medical to prepare and submit our Clinical Trial Application according to plan. This achievement now triggers the next tranche of investment from our strategic investor Sichuan Yangtian Bio-Pharmaceutical Co.
Funding the path to the first patient
The proceeds from this tranche are explicitly allocated to prepare for the trial start. This includes finalizing CDMO activities, sourcing the comparator drug (lidocaine), and securing CRO resources for the execution phase.
Stian Kildal, CEO of OncoZenge, emphasised the significance of the submission itself:
– The submission of our clinical trial application marks a major milestone in OncoZenge’s history, and it brings us significantly closer to delivering BupiZenge to the millions of cancer patients who suffer from debilitating oral pain with limited effective treatment options today.
Roadmap for 2026
With the CTA submitted and the finances secured, OncoZenge has a clear path for the first half of 2026. The coming months will be dedicated to the regulatory review process, where the company will address potential queries.
Approval of the CTA is anticipated in March or April 2026. This approval will serve as the trigger for the fourth and final tranche of the investment agreement (remaining 50 per cent), ensuring the company is funded to dose the first patient in Q2 2026 as planned.
Following this latest transaction, Sichuan Yangtian Bio-Pharmaceutical holds approximately 16,6 per cent of the shares in OncoZenge, a stake expected to rise to approximately 28,5 per cent upon completion of the full investment program.
Improved quality of life in sight
The milestones achieved this week lay the foundation for what Chairman Daniel Ehrenstråhle describes as an eventful year ahead.
Beyond the financial and regulatory technicalities, the primary driver remains the potential clinical benefit. By advancing BZ003, OncoZenge moves closer to offering a solution that could not only alleviate severe pain but also reduce the reliance on opioids for cancer patients – improving their ability to eat, drink, and complete their treatments.
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