February 10, 2026: Biosergen AB ("Biosergen" or the "Company") hereby publishes the interim report for the fourth quarter 2025. The interim report is available as an attached document and on the company website (www.biosergen.net)
Advancing BSG005 Toward Cohort 3 and Strengthening Key Program Foundations
Progress in GMP Manufacturing of BSG005 and Successful Pre-IND meeting with good guidance from FDA
"During the fourth quarter, our primary operational focus remained on preparing the BSG005 program for its next phase of advancement. In particular finalization of drug supply to ensure clinical trial material has been in focus. This activity has enabled us to further strengthen the manufacturing process for BSG005. Our objective is to ensure that the new drug substance meets the requirements associated with upcoming Phase 2 clinical trials, as well as future regulatory expectations. Manufacturing activities remain ongoing, and we continue to work toward release of the new batch. In parallel, we held our first in-depth regulatory advice meeting with FDA in the form of a pre-IND meeting. The guidance received provides a clearer roadmap for the next development step.
'It has been a pleasure to see how the company continues to mature in its readiness for a later-stage development phase. We are gaining increasing insight into how to further strengthen and streamline our manufacturing process, and we have also received strong interest from the FDA, who have given guidance to the development program and a willingness to provide further guidance. In October 2025, we welcomed Bianca Rosengarten to the team. She brings a wealth of clinical trial experience combined with a strong chemistry background and will serve as our Global Senior Project Director.." -Tine Olesen, CEO Biosergen
CONSOLIDATED FINANCIAL HIGHLIGHTS AND RATIOS
2025 | 2024 | 2025 | 2024 | |
TSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
Profit/loss | ||||
Other income | - | 380 | 2,088 | 1,940 |
Profit/loss before depreciation (EBITDA) | -12,490 | -2,326 | -40,857 | -19,203 |
Net financials | 27 | 86 | 39 | 8 |
Net profit/loss for the period | -12,463 | -2,240 | -40,817 | -19,195 |
Earnings per share (SEK) | -5,31 | -0,95 | -17,38 | -8,17 |
Highlights during Q4 2025
- Successful Pre-IND meeting with FDA with good guidance
- Reverse share split of ratio 1:100 executed on December 2, 2025
CEO STATEMENT
As we closed the fourth quarter of 2025 and entered 2026, Biosergen continued to execute with discipline on the priorities that we believe will drive long-term value: advancing BSG005, strengthening manufacturing readiness, and positioning the company for its next phase of development.
2025 represented a year of solid progress for Biosergen. Following completion of the second cohort in the BSG005 proof-of-concept trial earlier in the year, the company advanced into the next phase of preparation to support further development of the program. A key milestone was the successful Pre-IND meeting with the U.S. Food and Drug Administration, which provided clear regulatory guidance on the requirements to advance BSG005 for the treatment of life-threatening fungal infections, including expectations for upcoming clinical studies.
During the fourth quarter, our primary operational focus remained on finalizing new drug supply to support continued clinical development. While this has resulted in delays relative to our initial timeline, the pause has also enabled us to further strengthen the manufacturing process for BSG005. Our objective is to ensure that the new drug batch meets the quality and regulatory requirements needed to support future clinical trials. Manufacturing activities are ongoing, and we continue to work toward release of the new batch.
Cost discipline remained a key focus, and company continues to rationalise expenses. Biosergen reports a cash holding of 15.3 MSEK per December 31, 2025. At the same time, as we look ahead and take into account the extended timelines related to manufacturing, we recognize that the company will need to further strengthen its financial position to support continued progress. For the time being it is challenging times to raise funding, however we are evaluating several financing alternatives in order to secure the resources required to execute on our development plan.
The disease area we are focused on does not receive significant media attention. However, the medical need is substantial and growing. During the fourth quarter, an important report was published by the European Centre for Disease Prevention and Control, documenting more than 4,000 reported cases of colonisation or infection with Candidozyma auris (formerly Candida auris) across the EU/EEA between 2013 and 2023. Candidozyma auris is a uniquely persistent organism. It forms biofilms on medical devices and surfaces, can survive for weeks outside the body and is notoriously difficult to eradicate once established in healthcare settings. The report shows that case numbers have increased steadily since 2020, reaching 1,346 reported cases in 2023 alone. Several countries - including Greece, Italy, Romania and Spain - now describe C. auris as regionally endemic rather than outbreak-driven. ECDC further cautioned that reported figures likely represent only part of the true burden due to incomplete surveillance and gaps in national preparedness.
The rapid spread of C. auris is not limited to Europe. In January 2026, the Missouri Department of Health and Senior Services reported a continued and geographically expanding increase in C. auris detections across healthcare facilities statewide. Since cases were first identified in late 2023, Missouri has documented hundreds of clinical and screening detections across acute-care hospitals, long-term acute-care facilities, skilled nursing facilities, and rehabilitation centers.
Such trends were also discussed in our recent video fireside chat, where our medical consultant Dr. Dora Corzo-León was joined by Professor Luis Ostrosky-Zeichner to discuss the increasing changing risk profile for invasive fungal infections and antimicrobial resistance. The recording is available on our website.
Looking ahead, our priorities remain unchanged: to complete release of the new BSG005 drug batch, to maintain relevant regulatory interactions in India, Europe, and the United States, and to resume our trial in India together with our local partners.
I would like to thank our investigators, partners, and shareholders for their continued support. Biosergen remains focused on steady progress as we work toward our goal of addressing life-threatening fungal infections with limited treatment options.
Sincerely,
Tine Olesen
CEO Biosergen
For further information about Biosergen, please contact:
Tine Kold Olesen, CEO Telephone: +45 3135 5707
E-mail: tine.olesen@biosergen.net
Mark Beveridge, CFO Telephone: +46 76 805 8288
Email: mark.beveridge@biosergen.net
The Company's Certified Adviser is Carnegie Investment Bank AB (publ).
ABOUT BIOSERGEN
Biosergen is a biotechnology company in the clinical stage within the therapeutic field of life-threatening fungal diseases. Biosergen' s mission is to develop the drug candidate BSG005, into a new first line treatment choice for resistant and/or difficult to treat invasive fungal infections, to save thousands of lives of immune-compromised cancer- transplant- and AIDS patients every year.
