Infant Bacterial Therapeutics (IBT) Q2 2025 earnings summary

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.