Invasive fungal infections pose a severe risk, particularly for immunocompromised patients, such as those undergoing cancer treatment, organ transplants, or living with HIV/AIDS. The World Health Organization recognizes these infections as a global health priority, with an estimated 6,5 million cases annually and 2,5 million deaths directly attributable to fungal diseases, a 66 percent increase from 2017 estimates, regardless of underlying conditions. Mortality rates can soar to 90 percent within the first two weeks if untreated, underscoring the urgent need for effective therapies.
Kills broad spectrum of fungi
Biosergen’s lead candidate, BSG005, is a polyene macrolide antifungal designed to kill a broad spectrum of fungi, offering a fungicidal effect that minimizes the risk of resistance development – an advantage over fungistatic treatments like azoles and echinocandins. Unlike its main competitor, Amphotericin B, which is limited by significant kidney toxicity, BSG005 has demonstrated a favorable safety profile in preclinical studies and a phase I trial, with no severe adverse effects reported.
This safety profile, combined with its efficacy against resistant strains like Candida auris, Mucor mycosis (black fungus) and Aspergillus, supports BSG005’s potential as a potential first-line treatment for invasive fungal infections. Its broad-spectrum activity could also enable its use in patients with unspecified fungal infections, including those with conditions like diabetes or chronic obstructive pulmonary disease (COPD).
Clinical progress paves the way for expansion
In 2024, Biosergen initiated its first clinical proof-of-concept program in India, targeting patients suffering from life-threatening fungal infections with no available treatment options. The patients have failed already marketed medicine. Early results from the first two patient cohorts are encouraging: eight out of ten patients completed the treatment, all showing clinical improvement, with several achieving full recovery. This is unique in a population that otherwise had no other option as current therapy induce severe side effect so the patients have to stop or they have formed resistance to current therapy.
The strong tolerability profile also allowed for a dose escalation – from 1.5 to 2.0 mg/kg/day – at the request and approval of investigators, a decision that CEO Tine Olesen noted was telling:
– Such an investigator-request is uncommon and underscores the strong safety profile BSG005 has demonstrated thus far. The investigators’ desire to treat patients longer and at higher doses speaks to their confidence in BSG005’s tolerability and potential.
A third patient cohort is expected to begin treatment in the fourth quarter of 2025, once new drug supply has been manufactured to meet the higher dosing needs identified in cohort two.
Strategic priorities for 2025
Following the ongoing study, Biosergen aims to expand BSG005’s use for similar patient groups in the US and EU via pivotal trials.
Regulatory preparations are progressing, including interactions with India’s CDSCO for a phase II pathway and a planned Pre-IND meeting with the US FDA to pave the way for US trials. Exploratory preparations for a European phase II trial are also underway. Additionally, Biosergen is developing nano-formulations to enhance lung delivery and enable oral administration.
To support these efforts, the company will pursue additional fundraising activities and non-dilutive opportunities such as grants, alongside strengthening its partnering strategy to drive long-term growth. Biosergen also plans to broaden stakeholder engagement, aiming to raise awareness of fungal infections as a significant but often underrecognized global health threat.
Financial position
During 2024, Biosergen raised SEK 26 million through a rights issue in March and SEK 45 million via the full subscription of TO3 warrants in November, ending the year with a cash position of SEK 50.6 million. These funds support ongoing clinical trials and operational needs.
However, additional capital will be required to fully finance the upcoming phase II trials and regulatory submissions. The company is pursuing a dual strategy combining capital raises and strategic partnerships to ensure long-term financial stability and continuity of development.
Comments from the CEO
In the 2024 annual report, CEO Tine Olesen points to the clinical validation of BSG005 and outlines the company’s next steps toward realizing its market potential:
– 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. As BSG005 has a unique profile, it will be positioned with a price premium that reflects its exceptional therapeutic value potential. The market potential is significant.
BioStock reached out to Tine to learn more.
Tine, how would you describe Biosergen’s position today compared to a year ago?
— Our situation today is much better, we have confirmed what we saw in animal studies, thereby we have increased the probability of success tremendously.
Why do you believe BSG005 could stand out in the competitive anti-fungal space?
— To be a safe, effective and broadspectrum is a unique beneficial profile. It gives confidence and trust by physicians. In an emergency setting where you do not have time to wait for a firm diagnose and the identity of the fungal strain. You can immediately start with a broadspectrum, effective, safe treatment.
How do you view the regulatory landscape for new anti-fungal therapies today?
— Life-threatening fungal diseases are a global concern, addressing an urgent unmet medical need across all countries. However, due to recent shifts in the political landscape, we may need to adapt our regulatory plans accordingly.
