Biosergen (BIOSGN) Q1 2025 earnings summary

Executive summary

• BSG005 demonstrated therapeutic effect in high-risk patients, with all completing patients in cohorts 1 and 2 experiencing clinical benefits and no severe side effects, supporting its potential as a novel antifungal therapy.

• 2025 priorities include preparing for FDA pre-IND meetings, establishing GMP-compliant production, and advancing toward Phase 2 trials in India and the US.

• Strategic partnership with Alkem Laboratories supports clinical development and future commercialization in India, with Alkem funding local trials and receiving exclusive marketing rights.

• BSG005 has orphan drug status for aspergillosis in the US and plans to seek QIDP designation for additional market exclusivity.

Financial highlights

• Q1 2025 operating loss was SEK 5.1 million, an improvement from SEK 6.8 million in Q1 2024.

• Net loss for the period was SEK 5.1 million, compared to SEK 6.9 million in Q1 2024.

• Cash and cash equivalents at March 31, 2025, were SEK 44.7 million, up from SEK 1.7 million a year earlier.

• Equity at period end was SEK 43.4 million, up from SEK 21.4 million in Q1 2024.

• Cash flow from operating activities was SEK -5.9 million, compared to SEK -26.4 million in Q1 2024.

Outlook and guidance

• Focus remains on regulatory engagement in India and the US, with plans to initiate Phase 2 trials and prepare for FDA IND application.

• New batch of BSG005 is being manufactured to support future trials and regulatory requirements.

• Additional funding is being pursued through strategic partnerships.