OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced the interim report for the second quarter of 2026. The company reports receipt of regulatory approval to initiate patient recruitment for the Phase III trial for BupiZenge, 'BEAM-Pain', with the 1st patient enrolled shortly after quarter close, on July 7th, 2026.
Summary of the Quarter
On May 26, the Company received full European regulatory approval to initiate its pivotal Phase III "BEAM-Pain" trial of BupiZenge. The first patient was enrolled on July 7. As of this report, five hospitals in Norway, Sweden, and Denmark are actively recruiting; 12 of 150 patients have been enrolled.
The regulatory approval triggered a 5.8 MSEK milestone payment from the Company's European commercialization partner, Molteni Farmaceutici, as well as the fourth and final contractual milestone of 15 MSEK under the investment agreement with Sichuan Yangtian-Bio Pharmaceutical. The Company received 5 MSEK on July 10, with the remaining 10 MSEK still pending.
On August 25, the Company resolved on a rights issue of approximately SEK 33.3 million with preferential rights for OncoZenge shareholders. The objective of the rights issue is to secure funding to extend the Company's runway well beyond readout of the Phase III program and finance the development of the Marketing Authorization Application (MAA) dossier to optimize the lead-time to BupiZenge approval, launch and royalties.
| Second Quarter (Apr-Jun) 2026 | Reporting Period (Jan-Jun) 2026 |
| Net sales: SEK 5 840 thousand (0) | Net sales: SEK 5 840 thousand (2 664) |
| Operating result: SEK -5 441 thousand (-2 605) | Operating result: SEK -12 433 thousand (-2 561) |
| Earnings per share before and after dilution: SEK -0.40 (-0.22) | Earnings per share before and after dilution: SEK -0.94 (-0.22) |
Key figures
| 2026 Apr-Jun | 2025 Apr-Jun | 2026 Jan-Jun | 2025 Jan-Jun | 2025 Jan-Dec | |
| Net sales, SEK thousand | 5 840 | - | 5 840 | 2 664 | 2 664 |
| Operating result, SEK thousand | - 5 441 | - 2 605 | - 12 433 | - 2 561 | - 15 787 |
| Profit after tax, SEK thousand | - 5 667 | - 2 607 | - 12 789 | - 2 563 | - 15 940 |
| Total assets, SEK thousand | 26 832 | 15 266 | 26 832 | 15 266 | 24 401 |
| Cash flow for the period, SEK thousand | -186 | 263 | - 2 965 | - 2 306 | - 149 |
| Cash flow per share for the period (SEK) | -0.01 | 0.02 | - 0.22 | - 0.20 | - 0.01 |
| Cash and cash equivalents, SEK thousand | 749 | 1 557 | 749 | 1 557 | 3 714 |
| Earnings per share before and after dilution (SEK) | - 0.40 | - 0.22 | - 0.94 | - 0.22 | - 1.31 |
| Equity per share (SEK) | 0.70 | 1.09 | 0.70 | 1.09 | 0.67 |
| Equity ratio, % | 36.54% | 84.02% | 36.54% | 84.02% | 34.74% |
CEO comments
Dear Shareholders,
The second quarter of 2026 marked a significant milestone in OncoZenge's history. On May 26, we received full regulatory approval to initiate our Phase III trial of BupiZenge. Shortly after the close of the quarter, on July 7, we enrolled our first patient.
Since then, progress has continued steadily. Five hospitals in Norway, Sweden, and Denmark are now recruiting patients. As of today, 12 of the planned 150 patients have been enrolled, with several already randomized and receiving either BupiZenge or the comparator, lidocaine. Given that this ramp-up is taking place during the summer holiday period, we are pleased with the pace. Site activations in Denmark and Germany will continue over the coming weeks, and by early October we expect to have meaningful recruitment metrics that we can compare against the hospitals' earlier estimates, giving us a view of the timeline to readout.
Financially, the regulatory approval triggered another milestone payment from our European commercialization partner, Molteni Farmaceutici, as well as the fourth and final tranche of the investment from Yangtian Pharma. Currency exchange administration has, however, significantly delayed these proceeds. The delay has increased both our bridge financing costs and our overall financial risk. With patient recruitment now underway the Board of Directors concluded that the delayed proceeds, and thus the financial risk, had to be mitigated. The Board therefore decided to carry out a new share issue on August 25.
The financing is structured to give our existing shareholders the opportunity to participate on attractive terms, while securing the required capital through guarantees and participation from a select group of long-term investors. These include Jan Poulsen of Life Science Invest Fund (LSIF), John Haurum, Erik Selin, family offices with a life-science focus, and our long-term shareholder Linc AB. We are honored by their trust and by their recognition of both what we have delivered so far and the significant potential ahead of us.
We believe this solution addresses market concerns regarding our financing and allows attention to return to the underlying value of the opportunity.
Some of the new investment proceeds will be directed toward preparing the Marketing Authorization Application (MAA) dossier, with as much data and documentation as possible ready by the time the trial is completed. Given our confidence in a positive trial result, this approach will shorten the timeline for MAA submission in Europe, provide prospective global licensees with useful documentation sooner for their local registrations, and ultimately optimize our path to launch and royalty revenues. To help us and Molteni deliver on these objectives, we hired Linda Nord as our new Head of Regulatory Affairs during the quarter. We welcome Linda to the team and again thank Christina Junvik for her efforts in helping secure the clinical trial approval.
Business development has continued, with several regional pharma companies now working through due diligence and business-case modeling for their markets. Feedback from their local key opinion leaders mirrors what we hear directly: oral mucositis pain in cancer care remains a large unmet need and a compelling commercial opportunity. Our national patent filing activities are now focused on supporting these prospective licensees, and we will provide updates as we progress.
We have made significant progress this year on many fronts, and we remain determined to deliver on the opportunity to bring BupiZenge to market - for the benefit of the millions of cancer patients who need it, for our commercial partners, and for you, our shareholders.
Thank you for your continued trust and support.
Stian Kildal
CEO
Stockholm, August 27, 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. The Company recently received European regulatory approval to initiate its pivotal Phase III study 'BEAM-Pain'. The first patient has been enrolled in the trial and site activations are currently ongoing. 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
Redeye Nordic Growth AB is the company's Certified Adviser.
