Biosergen

BSG005 Demonstrates Therapeutic Effect in High-Risk Patients: Cohort 2 Completed
2025 will be the year we focus on expanding the clinical path for BSG005 beyond India—by preparing for FDA pre-IND meeting and establishing a future-proof production setup for BSG005—while also progressing toward Phase 2 planning in India. These activities are already in motion, driven by the strong proof-of-concept results confirmed with the successful completion of our second clinical cohort in February 2025. What began with a great deal of uncertainty in a high-risk patient group has evolved into a program demonstrating real therapeutic potential. Combined with increasing regulatory visibility, we believe 2025 will be another year in which we make meaningful strides toward positioning BSG005 as a truly novel antifungal candidate with broad-spectrum potential—capable of addressing some of the most urgent unmet needs in infectious disease.

Summary of the interim report for Q1 2025

HIGHLIGHTS DURING Q1 2025

• On February 4, Biosergen successfully completed the second cohort of BSG005 clinical trial, gaining conclusive proof-of-concept data, and confirming 2025 objectives. With the completion of the second cohort, we now have compelling proof-of-concept data on BSG005, further reinforcing its potential as a life-saving treatment for patients with invasive fungal infections who have no remaining medical treatment options. In short, across cohort 1 and 2, every patient who completed BSG005 treatment experienced clinical benefits, with multiple complete recoveries and significant improvements - all without severe side effects.

HIGHLIGHTS AFTER THE PERIOD

• Proposal of electing Dr. Marco Taglietti, M.D., as a new member of the Board of Directors ahead of the upcoming Annual General Meeting. Dr. Taglietti has an extensive and successful track record in anti-infective drug development, securing regulatory approvals for multiple therapies, and experience with significant licensing deals.

CEO STATEMENT
We entered 2025 with solid momentum. In February, we announced the successful completion of the second patient cohort in our ongoing proof-of-concept trial for BSG005, following on from the encouraging results in the first cohort. Across both groups, BSG005 continued to demonstrate a favorable safety profile and strong signals of clinical efficacy in patients suffering from life-threatening fungal infections who had no remaining treatment options. These results represent conclusive proof-of-concept and mark a key step forward in our clinical development program. This strong foundation enables us to focus our energy this year on three essential priorities for 2025.

First, we are actively preparing a new batch of BSG005 to support future trials. This new supply will be manufactured to meet the regulatory GMP standards required by agencies such as the U.S. FDA, European Medicines Agency (EMA), and India’s CDSCO. This process is already underway and, while time-intensive, is a necessary step to ensure uninterrupted development, to initiate our third cohort as planned later in 2025, and to support subsequent trial activities.

Second, we are initiating regulatory discussions with Indian authorities to outline the most efficient path to a Phase 2 trial in India. The successful completion of our first two cohorts has provided a strong basis for these conversations, and we expect to engage in more detailed interactions with CDSCO over the coming months.

Third, we are preparing for substantial regulatory engagement in the United States. This year, we expect to initiate formal discussions with the FDA aimed at securing an Investigational New Drug (IND) application—an essential step toward conducting clinical trials in the U.S. We will base these interactions on our preclinical data, Phase 1 safety data from healthy volunteers, and supplementary insights from our ongoing trial in India.

Both these processes represent meaningful progress in positioning BSG005 for international development and partnering discussions.

One aspect that continues to strengthen our confidence is the sustained engagement and initiative shown by our clinical investigators. Their willingness to explore extended treatment durations and increased dosing levels reflects growing confidence in BSG005’s safety profile and therapeutic potential. While the higher-than-expected dosing in the second cohort required us to delay the initiation of the third cohort, this has no impact on our broader development or regulatory objectives. We are managing the program efficiently and remain fully focused on maintaining momentum across all tracks of our clinical and regulatory strategy.

As we proceed through 2025, we continue to position Biosergen for long-term progress. This includes pursuing additional funding through strategic partnerships. Although global attention to antimicrobial resistance (AMR) still lags what we believe is warranted, we believe momentum is ticking upwards, and BSG005 stands out as a novel anti-fungal candidate with broad-spectrum potential that could play an important role in addressing this growing threat. Notably, BSG005 has demonstrated preclinical efficacy against Candida auris, one of the most dangerous drug-resistant fungal strains identified by the WHO.

On behalf of the entire Biosergen team, I would like to thank our shareholders, collaborators, and clinical partners for your continued support. Our path ahead is ambitious, but we move forward with confidence, purpose, and a shared belief in the urgent value of what we are developing.

Sincerely,

Tine Olesen
CEO Biosergen