Biosergen scales up for future wins
Biosergen is charging into 2025 with momentum, building on a transformative 2024 that showcased the life-saving potential of its antifungal drug candidate, BSG005. As the biotech company continues its mission to combat the global crisis of life-threatening fungal infections, it is focused on key strategic priorities for the year ahead expanding clinical trials, accelerating development, and strengthening its global presence.
Biosergen is advancing BSG005 as a potential treatment for patients facing life-threatening invasive fungal infections. The company runs a proof-of-concept study to assess the drug candidate as a rescue therapy specifically for patients who failed to respond to standard treatments, have shown treatment intolerance or have impaired kidney function.
This dose escalation study is focused on determining the safety, tolerability, and effectiveness of BSG005 in a group of 15 critically ill patients in intensive care units across India.
A turning point for BSG005
The final quarter of 2024 marked a pivotal moment for Biosergen. In October, the company completed the first cohort of its phase Ib clinical trial in India, testing BSG005 in five patients with severe Mucormycosis or Aspergillus infections. Results were promising: four showed significant improvement – highlighting BSG005’s promise as a rescue treatment for those with no other options. Unfortunately, one of the participants passed away, but due to causes unrelated to BSG005.
November brought further momentum as the safety committee greenlit dose escalation, allowing the second cohort to begin. By December, Biosergen increased dosing in this cohort following the preliminary data and a request from the Principal Investigator. The independent Data Safety Review Committee approved this shift, reflecting confidence in BSG005’s safety and potential at higher doses. That same month, the company secured SEK 44.9 million through exercise of warrants of series TO3, corresponding to 100 percent of the outstanding warrants.
Early 2025 – Proof of Concept
The eventful last quarter of 2024 continued into 2025 when on February 4, Biosergen announced the completion of the second cohort, delivering conclusive proof-of-concept data. The second cohort further confirmed BSG005’s potential and are consistent with those from the first cohort, where all patients who completed treatment experienced positive outcomes. A standout case involved a critically ill Mucormycosis patient who fully recovered. The results underscore BSG005’s role as a broad-spectrum antifungal and its life-saving potential.
However, the higher-than-expected drug use in cohort two, coupled with an increased maximum dose, depleted supplies. This necessitates replenishing stock before launching the third cohort in Q4 2025. According to Biosergen, the delay will not impact the company’s broader plans outside India.
Looking ahead
Biosergen’s roadmap for 2025 is ambitious, yet focused. First, the company has initiated the manufacturing of a new batch of BSG005 to meet international regulatory standards, including those of the FDA and EMA. This supply, expected to be ready by Q4, will support the third cohort and future trials. Second, Biosergen is engaging India’s Central Drugs Standard Control Organisation (CDSCO) to streamline the path to a phase II trial, leveraging its strong clinical data. Third, the company is preparing an Investigational New Drug (IND) application for the U.S. FDA – a critical step toward U.S.-based trials and global expansion.
While the increased dosing of BSG005 depleted supplies and delayed the third cohort, it gives a competitive edge and enhances its market appeal, according to Tine Olesen‘s CEO letter in the Q4 2024 interim report:
“I want to highlight a potentially overlooked aspect of the investigators’ interest in maximizing both the dose and treatment duration of BSG005 […] First, a drug that can be administered for an extended period without toxicity concerns is inherently more competitive. Second, in some markets, reimbursement is tied to drug efficiency, meaning longer effective treatments can have a positive financial impact. Therefore, the investigators’ inclination to extend BSG005 treatment should further enhance its appeal to potential commercial partners — encouraging news for all of you supporting its development.”
Additionally, Biosergen aims to leverage the growing global attention to Antimicrobial Resistance (AMR), with BSG005 demonstrating efficacy against multidrug-resistant strains like Candida auris, positioning it as a vital tool in this fight.
Key metrics
The company is also planning for the long-term future, seeking additional funding through partnerships and grants to sustain the mission.
The company posted a profit/loss before depreciation (EBITDA) of -3,6 MSEK, matching its operating profit/loss before net financials. Net financials added a further -0,12 MSEK burden, resulting in a net profit/loss of -3,7 MSEK for the period. These figures underscore Biosergen’s ongoing investment in BSG005’s development, offset by the 44.9 MSEK raised through warrants, bolstering its financial runway well through 2025.
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