Biosergen's CEO on preparations for the next clinical phase

Biosergen develops BSG005, a first-in-class polyene macrolide that targets invasive fungal infections – conditions with high mortality and limited treatment options. Unlike existing antifungal drugs, BSG005 is designed to combine the proven efficacy of polyenes with an improved safety profile, potentially filling a major gap in the treatment landscape. The drug has already received orphan drug designation from FDA (orphan drug designation, ODD) for invasive aspergillosis, highlighting its potential for rare conditions with significant medical needs.

Infections such as Candida and Aspergillus now claim an estimated 2,5 million lives each year – a figure that has risen sharply due to more patients with compromised immune systems and growing drug resistance. BSG005 stands out for its antifungal activity (killing fungi directly, rather than simply inhibiting them), broad spectrum coverage and lower toxicity, as demonstrated in preclinical and early clinical data.

Clinical advances and regulatory initiatives

In its Q2 2025 report, published yesterday, August 20, Biosergen reported progress in its ongoing proof-of-concept clinical trial in patients with serious fungal infections, including mucormycosis (black fungus), aspergillosis and candidiasis. Cohorts 1 and 2 – which included the first 10 patients who had not responded to, or were intolerant of, standard treatments – have been completed with encouraging results. Two patients achieved complete recovery, six showed significant improvement and safety remained strong with no serious drug-related issues.

The manufacturing of a new GMP-compliant batch of BSG005 is progressing to enable study implementation with cohort 3, which will include up to five additional patients. This study positions BSG005 as a potential salvage therapy (a last resort) for patients intolerant to amphotericin B, the current last-line treatment option known for its renal toxicity.

In parallel, Biosergen has been in dialogue with regulatory authorities to prepare for upcoming clinical phases. Preparations are underway for a US IND (Investigational New Drug) application to the FDA later this year, as well as work with the EMA to secure orphan drug designation for invasive aspergillosis and mucormycosis also in Europe. The company is also planning global phase II/III studies in mucormycosis and aspergillosis, where the already positive results from India can be used as a basis for further development.

Financial position

The company reported an operating loss of SEK 11,0 million in the second quarter, mainly due to research and development efforts and manufacturing costs. Cash and cash equivalents amounted to SEK 33,3 million, which is considered sufficient for the immediate plans – including continued manufacturing, cohort 3 and regulatory applications.

Although the company is not yet generating revenue, its financial position provides scope to achieve its set milestones. Management is also emphasizing the importance of strict cost control combined with a focus on delivering clinical advances that create value.

Looking ahead

Biosergen's strategy is to advance BSG005 through clinical development with the goal of demonstrating its potential as a safer and more effective treatment for fungal infections. This work includes developing nano-formulations for lung-targeted treatment (for example, aspergillosis) as well as oral versions for preventive use or home monitoring.

The company aims to submit applications for marketing approval (NDA) by 2029. The team has also been strengthened with key recruitments, including Dr. Dora Corzo Leon as consultative medical director, Gijs Crone BSc as a commercial manager and Dr. Marco Taglietti to the board – all with extensive experience in antifungals and licensing. If successful, BSG005 could become an important new treatment option against resistant fungal strains and meet a major medical need in a market valued at over USD 16 billion.

CEO comments

We turned to the CEO Tine Olesen for a comment on how the latest clinical progress towards cohort 3 and the new leadership appointments will shape Biosergen's path forward.

What are the key regulatory milestones, such as the US IND filing and EMA orphan drug applications, that you anticipate in the next year?

- We will apply for orphan drug designation in the USA for mucor mycosis, we already have invasive aspergillosis. In Europe we will apply for both indications for the first time this will happen in 2025 and the feedback on these applications should be ready in 2025. In parallel we approach both agencies to get permission to start clinical trials in patients with life threatening fungal disease. By FDA the next steps will be to request a pre_IND meeting, have the meeting, compile the IND with their suggested changes, submit the IND and hopefully get permission to start a global clinical trial. On the critical path is the data on the manufacturing which are due in December. We prepare everything in advance including the discussion and then we add critical data in the end. The same process applies for EMA, the two processes will run almost in parallel. There are official timelines from both agencies. This means in essence that the submission of the IND will be Q1 2026 and an approval is scheduled 2-3 months later.

With the current cash position, how will resources be prioritized between clinical manufacturing, regulatory preparations, and long-term planning like nano-formulations?

- We are diligently following our forecasting and hope to achieve the goals we set out at the beginning of the year ie 2025. To achieve near term progress and to ensure a global reach. We need to succeed in manufacturing, regulatory interaction and finalize our clinical trial. We are in the positive situation that our nano-formulation is covered by a grant from the Norwegian Research Counsel. An organization that has been very supportive during the years. Biosergen will continue to pursue financial support from major institutions.