OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced the interim report for the second quarter of 2025. The Company's Phase III program has moved into execution. Preparations are now underway for manufacturing of BupiZenge clinical trial material. The European site feasibility study is progressing according to plan with positive responses from 12 hospitals in four countries.
Summary of the Second Quarter
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 planned share issues were subscribed by the investor during the second quarter. Proceeds were received after the reporting period and are accounted for in the interim report as an ongoing share issue. The company's financing depends on the completion of the remaining directed share issues, which are planned for the fourth quarter of 2025 to the first quarter of 2026.
In March, a commercialization agreement was signed with Molteni Farmaceutici S.P.A. regarding the European territory. The first milestone payment was received during the second quarter.
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 is currently performing a European site feasibility study in preparation for site selection.
| Second Quarter (Apr-Jun) 2025 | Reporting Period (Jan-Jun) 2025 |
|---|---|
| Net sales: SEK 0 thousand (0) | Net sales: SEK 2,664 thousand (0) |
| Operating result: SEK -2,605 thousand (-2,049) | Operating result: SEK -2,561 thousand (-4,422) |
| Earnings per share before and after dilution: SEK -0.22 (-0.18) | Earnings per share before and after dilution: SEK -0.22 (-0.38) |
The company's net sales consist of milestone payments from licensees.
Key figures
| 2025 Apr-Jun | 2024 Apr-Jun | 2025 Jan-Jun | 2024 Jan-Jun | 2024 Jan-Dec | |
|---|---|---|---|---|---|
| Net sales, SEK thousand | - | - | 2 664 | - | - |
| Operating result, SEK thousand | - 2 605 | - 2 049 | - 2 561 | - 4 422 | - 8 685 |
| Profit after tax, SEK thousand | - 2 607 | - 2 053 | - 2 563 | -4 425 | - 8 688 |
| Total assets, SEK thousand | 15 266 | 14 937 | 15 266 | 14 937 | 11 434 |
| Cash flow for the period, SEK thousand | 263 | - 2 093 | - 2 306 | - 5 058 | - 8 764 |
| Cash flow per share for the period (SEK) | 0.02 | - 0.18 | - 0.20 | - 0.43 | - 0.75 |
| Cash and cash equivalents, SEK thousand | 1 557 | 7 569 | 1 557 | 7 569 | 3 863 |
| Earnings per share before and after dilution (SEK) | - 0.22 | - 0.18 | - 0.22 | - 0.38 | - 0.74 |
| Equity per share (SEK) | 1.09 | 1.21 | 1.09 | 1.21 | 0.63 |
| Equity ratio, % | 84.02% | 95.15% | 84.02% | 95.15% | 87.02% |
CEO comments
Dear Shareholder,
I am pleased to report on the significant progress OncoZenge has made in the second quarter of 2025, as we advance toward our mission of bringing BupiZenge to patients and making a very meaningful impact to their quality of life and cancer supportive care.
Having secured SEK 46.7 million in additional funding marks a pivotal milestone, fully financing our Phase III project targeting European approval. This achievement, coupled with our strategic partnerships, expert sponsor team and refined trial design, positions us for a planned commercial launch in Europe and adjacent markets in 2027.
Key to our progress is the partner-led strategy launched in September 2023. Molteni Farmaceutici, our pan-European licensee, has shown additional commitment to our collaboration by accelerating milestone payments in support of a fully European trial. This together with the strategic investment by Yangtian Pharma, and financial support from Linc AB, has enabled us to take the next steps in executing our Phase III program.
Notably, Meribel Pharma is now preparing for manufacturing of BupiZenge lozenges in the coming weeks and LINK Medical has been very effective in the European site feasibility study this summer. To date, we have positive responses and patient recruitment inputs from 12 candidate hospitals in Norway, Sweden, Denmark and Germany. It is very motivating to see our Phase III project take shape.
Looking ahead, we are focused on executing our Phase III trial, targeting patient enrollment in early to mid-2026. And our priorities for value creation beyond that are clear; We are exploring new commercial partnerships in global markets that can leverage a European approval and our improved intellectual property position. Together with our new strategic investor, Yangtian Pharma, we are actively discussing paths to approval and launch in China. And, in line with our commitment in the recent 'Market and Strategy Update' we are increasing USA business development and partnering efforts this fall and formulating our strategy for re-approaching the FDA. On the horizon we see significant opportunities in other indications, such as dentistry.
We invite you to join us at our upcoming Capital Markets Day in Stockholm on September 18th where we will discuss in more detail our commercial opportunity, execution plans, and answer your questions.
Together, we can redefine the standard of care for millions of cancer patients suffering from oral pain. Considering the scope of our opportunity we remain convinced our shareholders will be rewarded too, in pace with our fundamental developments being recognized.
Thank you for your continued support on our journey.
Sincerely,
Stian Kildal
Chief Executive Officer
To read the full report please refer to the enclosed file or oncozenge.se/investors/.?
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
Michael Owens, CFO, mobile: +46 73 324 4988, e-mail: michael.owens@oncozenge.se
About this release
The information in this release was submitted for publication, through the agency of the contact persons set out above, at 08:00 CEST on August 21, 2025.
Attached file: OncoZenge AB Interim Report January - June 2025 [LINK]
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About OncoZenge
Headquartered in Stockholm, Sweden, OncoZenge is dedicated to developing better treatments for oral pain in conditions with significant unmet needs. BupiZenge, its lead candidate, leverages decades of clinical experience with bupivacaine to offer a safe, effective, non-opioid and well-tolerated alternative to current therapies. OncoZenge is publicly traded on Nasdaq First North Growth Market (Ticker: ONCOZ).
