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Biosergen (BIOSGN) investor relations material
Biosergen Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Advanced BSG005 development with GMP manufacturing for Cohort 3 and Phase 2, targeting global regulatory standards and commercial readiness in key regions.
IND submission to the U.S. FDA planned for early next year, supported by positive Phase 1 and proof-of-concept results.
Mark Beveridge appointed as CFO in July 2025, strengthening the leadership team.
BSG005 demonstrated strong efficacy and safety in patients with life-threatening, drug-resistant fungal infections, with all treated patients showing recovery or improvement and no severe side effects.
Financial highlights
Net loss for Q3 2025 was SEK -12.2 million, compared to SEK -4.3 million in Q3 2024, reflecting increased R&D and regulatory preparation.
Cash and cash equivalents at period end were SEK 22.7 million, up from SEK 10.2 million a year earlier.
Operating loss for Jan–Sep 2025 was SEK -28.4 million, compared to SEK -16.9 million for the same period in 2024.
Earnings per share for Jan–Sep 2025 was SEK -0.12, compared to SEK -0.18 for Jan–Sep 2024.
Outlook and guidance
New GMP batch of BSG005 expected to be released in early 2026, enabling resumption of clinical trials.
IND submission to the FDA targeted for early 2026, with expanded regulatory engagement in Europe and the U.S.
Focus remains on advancing BSG005 through clinical development and securing additional funding.
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