OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced its full year report for 2025, a year of significant progress culminating in the submission of the Phase III Clinical Trial Application for BupiZenge (BZ003) to the European Medicines Agency (EMA) in December. With trial sites selected across Norway, Sweden, Denmark and Germany, and GMP-manufactured clinical trial material ready, the Phase III program is on track to dose its first patient in Q2 2026, following regulatory approval.
Summary of the Fourth Quarter
OncoZenge has during the fourth quarter submitted the Clinical Trial Application (CTA) for its pivotal Phase III trial (BZ003) of BupiZenge to the European Medicines Agency (EMA).
The company is currently working towards achieving market approval and commercial launch of BupiZenge in Europe and adjacent markets where a European approval can be used for market access. In light of the confirmed financing, the company has signed Meribel Pharma Solutions for manufacturing of lozenges for the Phase III trial and LINK Medical has been retained as CRO preparing site initiation with selected hospitals in Norway, Sweden, Denmark and Germany. Molteni Farmaceutici has acquired the pan-European license for commercialization of BupiZenge in Europe. In addition to financial support and committing to secure an efficient market introduction in Europe, Molteni offers valuable R&D support to the Phase III program, and has contractually committed to establish a scalable volume supply chain in time for launch.
In January, an investment agreement worth SEK 30.2 million was signed with the new strategic investor Sichuan Yangtian Bio-Pharmaceutical Co. Ltd, to be executed through directed share issues. The first two share issues were subscribed by the investor during the second quarter. Proceeds were received and the new share issue was reported in the third quarter. The third share issue was subscribed by the investor and is reported as a pending new share issue in the fourth quarter. Proceeds were received in February of 2026. The company's financing depends on the completion of the remaining directed share issue, which is planned to be consummated in the second quarter of 2026 upon the anticipated Clinical Trial Application approval.
| Fourth Quarter (Oct-Dec) 2025 | Reporting Period (Jan-Dec) 2025 |
| Net sales: SEK 0 thousand (0) Operating result: SEK -9,748 thousand (-2,501) Earnings per share before and after dilution: SEK -0.78 (-0.21) | Net sales: SEK 2,664 thousand (0) Operating result: SEK -15,787 thousand (-8,685) Earnings per share before and after dilution: SEK -1.31 (-0.74) |
Selected Financial Data
| 000's | 2025 Oct-Dec | 2024 Oct-Dec | 2025 Jan-Dec | 2024 Jan-Dec |
| Net sales | - | - | 2 664 | - |
| Operating result | -9 748 | -2 501 | -15 787 | -8 685 |
| Result after tax | -9 886 | -2 501 | -15 940 | -8 688 |
| Total assets | 24 401 | 11 434 | 24 401 | 11 434 |
| Cash flow for the period | -7 876 | -1 967 | -149 | -8 764 |
| Cash flow per share (SEK) | -0.62 | -0.17 | -0.01 | -0.75 |
| Cash | 3 714 | 3 863 | 3 714 | 3 863 |
| Result per share prior to and after dilution (SEK) | -0.78 | -0.21 | -1.31 | -0.74 |
| Shareholders equity per share (SEK) | 0.67 | 0.85 | 0.67 | 0.85 |
| Equity ratio, % | 34.74 | 87.02 | 34.74 | 87.02 |
CEO comments
Dear shareholders,
2025 closed on a high note for OncoZenge building on the investment funds secured last summer. We achieved a major milestone by submitting our Phase III Clinical Trial Application (CTA) to European authorities in December, right on schedule.
First and foremost, I'd like to extend my sincere thanks to our internal team, as well as partner teams, for their dedication and commitment. Our submission is comprehensive, well-prepared and acknowledged complete and in-review by the European Medicines Agency (EMA). We will now address any questions from EMA as part of their standard process. Barring any major revisions, we anticipate CTA approval in the second half of April or early May at the latest. This timeline aligns with our objective of dosing the first patient in Q2 2026.
Key achievements
• Successful manufacturing of BupiZenge lozenges at Meribel Pharma.
• Site selection in Norway, Sweden, Denmark, and Germany, supported by LINK Medical.
• Extensive work on CTA documentation, including refining details of the study protocol, endpoints, patient safety, and more.
• Molteni Farmaceutici has committed to establish a scalable volume supply chain for the European launch.
• Conclusion of the patient study at UCLA, where 40% of head & neck cancer patients reported pain of 9-10, and 74% of patients reported pain of 7-10, on a 10-point scale, despite use of any and all available pain medications, including opioids.
In addition, we participated in several external events, which strengthened our dialogues with potential partners and investors. These interactions not only reconfirmed BupiZenge's potential but also opened doors to new collaboration opportunities.
Opportunity and risks
As we approach 1st patient in our Phase III trial, our opportunity is both significant and meaningful. BupiZenge promises to redefine the standard of care and thereby the quality of life for millions of patients. That prospect is both motivating and a large market opportunity.
While we await CTA approval this is also a good time to remind ourselves about the inherent risks in drug development, particularly regarding regulatory feedback and manufacturing. Specifically to our project, our selected hospitals have provided their patient recruitment goals, but also reminded us that summer staffing levels create uncertainty in recruitment. The trial has been scoped to mitigate for this and aim for "last patient out" by year-end 2026. We will provide updates on progress and timelines when we see the actual recruitment pace during the summer.
Unlocking future value creation
The confirmation of the European trial will serve as an important enabler for unlocking other opportunities. As we look into 2026 our strategic priorities have not changed;
1) Ensure successful execution of the European Phase III trial,
2) Secure additional commercial partnerships where EMA approval can be leveraged,
3) Refine the China market entry strategy and finalize a collaboration agreement with Yangtian Pharma,
4) Assess options for USA market entry and the optimal path to a US FDA approval, and
5) Explore new indications for BupiZenge that effectively increases potential for use, and thereby our addressable market, such as in dental.
Looking forward
2026 promises to be a defining year for OncoZenge. We enter it with a mix of anticipation but also confidence, with a strong submission behind us, a great team and supportive partners.
Thank you again for your trust and support on our journey.
Sincerely,
Stian Kildal
Chief Executive Officer
Stockholm February 26, 2026
BupiZenge - Potential to be the leading treatment for oral pain.
Contacts
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
About
OncoZenge AB (publ) is a clinical-stage pharmaceutical company developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options are insufficient, such as oral mucositis from cancer therapy. Its lead candidate, BupiZenge, represents a novel formulation of bupivacaine in a lozenge form, aimed at providing rapid and sustained local pain relief without the risks associated with systemic opioids. OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ. For more information, please visit www.oncozenge.se.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
Certified Adviser
OncoZenge's Certified Adviser is Redeye Sweden AB.
