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Infant Bacterial Therapeutics (IBT) investor relations material

Infant Bacterial Therapeutics Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary20 Aug, 2025

Executive summary

  • Preparations for the launch of IBP-9414, a drug for preventing NEC in premature infants, are ongoing, with regulatory submissions to the FDA completed and review underway.

  • The FDA granted Breakthrough Therapy Designation to IBP-9414 in March 2025, recognizing its potential to reduce gastrointestinal-related mortality.

  • The company is restructuring, reducing clinical staff and reallocating resources to marketing and business development in anticipation of product launch.

  • Manufacturing validation is nearly complete, with the final analytical method expected to be validated by October 2025.

Financial highlights

  • Net sales were SEK 0 for both Q2 and the first half of 2025, unchanged from the previous year.

  • Operating loss for Q2 2025 was SEK -20.1 million, an improvement from SEK -44.3 million in Q2 2024; for H1 2025, operating loss was SEK -37.6 million, improved from SEK -74.1 million year-over-year.

  • Earnings per share before and after dilution were SEK -1.42 for Q2 2025 and SEK -2.67 for H1 2025, both improved from the prior year.

  • Cash flow for H1 2025 was SEK -43.9 million, compared to SEK -60.7 million in H1 2024.

  • Cash balance at June 30, 2025, was SEK 176.3 million, down from SEK 223.4 million at year-end 2024.

Outlook and guidance

  • The FDA review of IBP-9414 is ongoing, with initial feedback expected in September 2025; launch timing will be clarified after feedback.

  • Capital is considered sufficient to fund operations through the marketing authorization application process.

  • The company is focused on cautious spending and is actively preparing for commercialization, including hiring for business development.

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Frequently asked questions

Infant Bacterial Therapeutics is a Sweden-based pharmaceutical company focused on developing microbiome-based treatments for diseases affecting premature infants and children. Its primary focus is on preventing necrotizing enterocolitis and other serious conditions using live bacterial therapies. Infant Bacterial Therapeutics is headquartered in Stockholm, Sweden, and its shares are listed on the NASDAQ Stockholm.

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