OncoZenge AB (publ) ("OncoZenge" or "the Company") today announced the interim report for the first quarter of 2026. The company reports progress with European authorities expecting regulatory approval to initiate the planned Phase III trial for BupiZenge, 'BEAM-Pain', latest by May 29th, 2026.
Summary of the First Quarter
OncoZenge submitted its Phase III Clinical Trial Application (CTA) to the European Medicines Agency (EMA) in December 2025 for the company's pharmaceutical candidate BupiZenge. During the first quarter of 2026, the Company addressed questions raised by the EMA and provided clarifications on the application for the registrational trial. The company has received regulatory acceptance of the proposed trial, and now awaits full approval by the EMA to initiate patient recruitment, expected no later than May 29, 2026. Operationally the company remains positioned to enroll the first patient in Q2 2026.
During the first quarter of 2026 the third investment tranche made by Sichuan Yangtian Bio-Pharmaceutical Co. Ltd. (Yangtian Pharma), was received. In addition, CTA approval will trigger key contractual milestones; namely the fourth and final tranche by Yangtian Pharma and the €550,000 CTA achievement milestone by Molteni Farmaceutici. Together these transactions will have increased the Company's liquidity by approximately SEK 30 million from the start of the year. Shareholder Linc AB has supported the company with bridge financing solutions leading up to the CTA approval, in order to manage liquidity requirements and maintain operational readiness to initiate the Phase III trial on schedule.
First quarter (Jan-Mar) 2026
Net sales: SEK 0 thousand (2 713)
Operating result: SEK -6 802 thousand (44)
Earnings per share before and after dilution: SEK -0.54 (0.00)
Key Figures
| 000's | 2026 Jan-Mar | 2025 Jan-Mar | 2025 Jan-Dec |
| Net sales | - | 2 713 | 2 664 |
| Operating result | -6 802 | 44 | -15 787 |
| Result after tax | -7 132 | 44 | -15 940 |
| Total assets | 11 801 | 11 743 | 24 401 |
| Cash flow for the period | -2 779 | -2 569 | -149 |
| Cash flow per share (SEK) | -0.21 | -0.22 | -0.01 |
| Cash | 935 | 1 294 | 3 714 |
| Result per share prior to and after dilution (SEK) | -0.54 | 0.00 | -1.31 |
| Shareholders equity per share (SEK) | 0.03 | 0.85 | 0.67 |
| Equity ratio, % | 3.03% | 85.11 | 34.74 |
CEO comments
Dear Shareholders,
OncoZenge continues to advance BupiZenge toward regulatory approval and commercial launch in Europe and markets where a European approval can support market access.
Following submission of the Phase III Clinical Trial Application (CTA) in December 2025, we engaged with European regulatory authorities throughout Q1 2026 to address questions and provide clarifications on the proposed registrational trial. All significant elements of the trial have been accepted, and we now await full regulatory approval. The authorities have confirmed a decision will be made no later than May 29th.
Operationally, we remain on-track to begin patient enrollment in Q2. After more than two years of intense effort, we are now, with good probability, just weeks away from initiating patient recruitment - and with it, the opportunity to test at scale the true merits of BupiZenge versus today's inadequate standard of care. This achievement is a testament to the dedication of our team, our strategic focus, the robustness of our trial application, and the commitment of our partners Molteni, Meribel, PharmaRelations, and LINK Medical.
I want to express my sincere gratitude to our core team members, our Chairman, our extended team members and partners, past and present board members, members of our Advisory Board, as well as our investors Linc AB and Yangtian Pharma. Each of you have contributed to this turn-around story in different ways - firmly positioning OncoZenge to deliver very meaningful quality of life improvements for millions of cancer patients, and the significant commercial opportunity that comes with it.
Stian Kildal, CEO
Stockholm May 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
Redeye Nordic Growth AB is the company's Certified Adviser.
