OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced the interim report for the third quarter of 2026. The Company reports that its Phase III trial of BupiZenge, 'BEAM-Pain', is now recruiting at nine hospitals, that a successful rights issue has strengthened the balance sheet, and that discussions with potential licensees have progressed to written, non-binding offers.
Summary of the Third Quarter
In the third quarter, OncoZenge moved from preparation to execution of the pivotal Phase III BEAM-Pain trial of BupiZenge, our drug candidate for pain relief in patients with oral mucositis. The first patient was enrolled on July 7, and nine hospitals are now activated in Norway, Sweden, Denmark and Germany. Preparations for the Marketing Authorization Application (MAA) have begun, and volume manufacturing is being established in Milan, Italy. Both are progressing in close collaboration with our European licensee, Molteni Farmaceutici.
OncoZenge entered the fourth quarter with a significantly stronger balance sheet. The rights issue, with preferential rights for existing shareholders, was subscribed to approximately 92% and raised gross proceeds of SEK 30.7 million, with support from long-term life science investors including Linc AB and Life Science Invest Fund (LSIF). The proceeds finance the Phase III trial and prioritized MAA preparations.
The investment agreement with Yangtian Pharma has been concluded following receipt of SEK 5.0 million of the SEK 15.1 million outstanding in the fourth and final tranche. No further payments will be made. On September 29, the SEK 2.0 million bridge loan from Linc AB was repaid, and a SEK 2.0 million bridge loan from John Haurum was settled through a directed share issue. On October 7, a further SEK 3.3 million directed issue to LSIF and Selandia Alpha Invest was completed on the same terms as the rights issue.
On September 10, the Company filed a new patent application covering dental and oral pain relief, which could extend protection to 2047. Dental remains a longer-term opportunity, to be pursued after the Phase III readout in cancer supportive care. Label expansion opportunities remain partner-driven, as the Company is fully focused on the ongoing Phase III trial.
| Third Quarter (Jul-Sep) 2026 | Reporting Period (Jan-Sep) 2026 |
| Net sales: SEK 0 thousand (0) | Net sales: SEK 5 840 thousand (2 664) |
| Operating result: SEK -8 883 thousand (-3 479) | Operating result: SEK -21 116 thousand (-6 040) |
| Earnings per share before dilution: SEK -0.63 (-0.28) | Earnings per share before dilution: SEK -1.62 (-0.51) |
| Earnings per share after dilution: SEK -0.63* (-0.28) | Earnings per share after dilution: SEK -1.62* (-0.51) |
* Dilution effects exist. Dilution is not restated when results are negative.
Selected Financial Data
| Thousands | 2026 Jul-Sep | 2025 Jul-Sep | 2026 Jan-Sep | 2025 Jan-Sep | 2025 Jan-Dec |
| Net sales | - | - | 5 840 | 2 664 | 2 664 |
| Operating result | -8 883 | -3 479 | -21 116 | -6 040 | -15 787 |
| Result after tax | -9 236 | -3 491 | -22 025 | -6 054 | -15 940 |
| Total assets | 33 801 | 19 838 | 33 801 | 19 838 | 24 401 |
| Cash flow for the period | 23 555 | 10 033 | 20 590 | 7 727 | -149 |
| Cash flow per share (SEK) | 1.60 | 0.81 | 1.47 | 0.66 | -0.01 |
| Cash | 24 304 | 11 590 | 24 304 | 11 590 | 3 714 |
| Result per share before prior to dilution (SEK) | -0.63 | -0.28 | -1.62 | -0.51 | -1.31 |
| Result per share before after dilution (SEK) | -0.63 | -0.28 | -1.62 | -0.51 | -1.31 |
| Shareholders equity per share (SEK) | 0.71 | 0.74 | 0.71 | 0.74 | 0.67 |
| Equity ratio, % | 55.28% | 46.90% | 55.28% | 46.90% | 34.74% |
CEO comments
Dear Shareholders,
The third quarter marked OncoZenge's transition from preparation to execution of our Phase III trial of BupiZenge, with the first patient enrolled on July 7. Financially, we are in a considerably stronger position than a quarter ago. A rights issue was subscribed to approximately 92%, with gross proceeds of more than SEK 30 million. We are grateful for the support from existing shareholders and from several long-term life science investors, including Linc AB and Life Science Invest Fund (LSIF). Recent bridge financing has been settled, and after quarter-end a further SEK 3.3 million was raised from LSIF and Selandia Alpha Invest on the same terms. The proceeds fund the Phase III trial and prioritized preparations for the Marketing Authorization Application (MAA).
Operationally, nine hospitals in Norway, Sweden, Denmark and Germany are now open for recruitment. Recruitment has been slower than anticipated, particularly in Germany, where site activations were delayed for practical and hospital scheduling reasons, and in Norway due to a proton study starting up at the same time. The start-up phase has given us many useful learnings, and we are working closely with our CRO, LINK Medical, to apply them across sites in order to accelerate recruitment and bring the hospitals closer to their full potential. This includes joint investigator meetings to share experiences, minor adjustments to the study protocol, and patient reporting. We aim to complete the trial as early as possible in 2027. Our adjusted operational planning remains within the Company's financial runway.
We have previously reported on the interest and discussions with potential licensees, and I am pleased to share that we have now received several written, non-binding offers for a number of countries and regions. We will assess these carefully in order to choose the most appropriate partners for OncoZenge in terms of market reach and the investment they are prepared to make to ensure a successful launch of BupiZenge. We will also consider the value of entering agreements in the near term against waiting for the Phase III readout, with maximizing shareholder value as the guiding principle.
In summary, we are making steady progress on all fronts, with exciting months ahead of us as we approach year-end and 2027.
Thank you for your continued support.
Stian Kildal, CEO
Stockholm, November 11, 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.