OncoZenge AB Interim Report January 1 – September 30, 2025
OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced the interim report for the third quarter of 2025. The Company reports receipt of investment funds for its European Phase III program, and strong operational progress.
Summary of the Third Quarter
In Q3 2025, OncoZenge secured funding for its planned Phase III trial targeting European approval of BupiZenge™ lozenges. Manufacturing preparations and site selection for the trial are currently underway, with the first patient expected to be enrolled in Q2 2026.
The SEK 30.2 million investment agreement with Sichuan Yangtian Bio-Pharmaceutical Co. Ltd., signed in January 2025, is now active. The first two tranches, totaling SEK 6.0 million, were received in Q3, with the remaining tranches anticipated in Q4 2025 and Q1 2026. Additionally, Molteni Farmaceutici S.P.A. paid a Q2 commercial milestone of SEK 2.8 million and, in Q3, agreed to accelerate a second milestone payment of SEK 6.2 million upon EMA trial application approval. Linc AB, a major investor, also committed to a SEK 7.5 million convertible note in Q3.
OncoZenge appointed Meribel Pharma Solutions (formerly Recipharm) to manufacture BupiZenge™ lozenges for the Phase III trial. LINK Medical AB, appointed as the CRO, is currently managing site selection for the trial to be executed in Norway, Sweden, Denmark and Germany during 2026.
| Third Quarter (Jul-Sep) 2025 | Reporting Period (Jan-Sep) 2025 |
| Net sales: SEK 0 thousand (0) | Net sales: SEK 2,664 thousand (0) |
| Operating result: SEK -3,479 thousand (-1,755) | Operating result: SEK -6,040 thousand (-6,184) |
| Earnings per share before and after dilution: SEK -0.28 (-0.15) | Earnings per share before and after dilution: SEK -0.51 (-0.53) |
The company’s net sales consist of milestone payments from licensees.
Key figures
| 2025 Jul-Sep | 2024 Jul-Sep | 2025 Jan-Sep | 2024 Jan-Sep | 2024 Jan-Dec | |
| Net sales, SEK thousand | - | - | 2 664 | - | - |
| Operating result, SEK thousand | - 3 479 | - 1 755 | - 6 040 | - 6 184 | - 8 685 |
| Profit after tax, SEK thousand | - 3 491 | - 1 759 | - 6 054 | - 6 187 | - 8 688 |
| Total assets, SEK thousand | 19 838 | 13 653 | 19 838 | 13 653 | 11 434 |
| Cash flow for the period, SEK thousand | 10 033 | - 1 739 | 7 727 | - 6 797 | - 8 764 |
| Cash flow per share for the period (SEK) | 0.81 | - 0.15 | 0.65 | - 0.58 | - 0.75 |
| Cash and cash equivalents, SEK thousand | 11 590 | 5 830 | 11 590 | 5 830 | 3 863 |
| Earnings per share before and after dilution (SEK) | - 0.28 | - 0.15 | - 0.51 | - 0.53 | - 0.74 |
| Equity per share (SEK) | 0.74 | 1.06 | 0.74 | 1.06 | 0.85 |
| Equity ratio, % | 46.90% | 91.22% | 46.90% | 91.22% | 87.02% |
CEO comments
Dear Shareholder,
I am pleased to share the progress OncoZenge has achieved during the third quarter of 2025, as we continue to execute on our mission to deliver BupiZenge™ to patients suffering from severe oral pain, transforming supportive care in oncology.
A major milestone this quarter was completing the regulatory process for the directed share issue to Yangtian Bio- Pharmaceutical, with receipt of the initial tranches of their investment. Combined with Molteni Farmaceutici’s accelerated milestone payments and a convertible note from Linc AB, we have secured SEK 46.7 million to fund our European Phase III program. To mark this new chapter in OncoZenge’s journey, we released a comprehensive Market and Strategy Update in late July and hosted our first Capital Markets Day in September. We trust these initiatives provide current and prospective investors with a clear view of our strategy, project plans, and path to commercialization in global markets.
Operationally, we appointed LINK Medical as our Contract Research Organization (CRO) to lead the Phase III trial. Site feasibility studies have generated very good interest from over a dozen hospitals across Scandinavia and Germany, with formal site selection under way. Manufacturing preparations with Meribel Pharma are progressing, ensuring availability of clinical trial material. Additionally, we entered a collaboration with UCLA for a patient engagement study on oral mucositis, which has now enrolled its first 20 participants, promising valuable insights ahead of our pivotal trial. We have also strengthened our team with experts in CMC, medical oncology, pediatrics, GCP QA, and biostatistics to support robust submissions for our Pediatric Investigation Plan (PIP) and Clinical Trial Application (CTA). A GMP audit has been scheduled, labeling and distribution services are being procured, and a detailed schedule of document delivery is keeping internal and external team members aligned. We are on-track.
Partnering efforts have continued in parallel, including discussions with Yangtian Pharma for China market entry, a renewed focus on U.S. business development to identify the best path to a future US IND, and continued engagement in other markets. On the horizon we see substantial value creation potential as we explore these markets and label expansion beyond oncology, such as in dentistry.
In summary, Q3 2025 has been a quarter of execution, transforming plans into actionable progress. I extend my deep gratitude to our team and partners for their dedication. We have firm line of sight to Clinical Trial Application submission this year and our first patient in Q2 next year.
Thank you also to our shareholders for your trust. Together, we are not just developing a product—we are taking critical steps to pioneer a better standard of care for millions of patients worldwide. I look forward to keeping you updated on our progress.
Sincerely,
Stian Kildal
Chief Executive Officer
To read the full report please refer to the enclosed file or oncozenge.se/investors/