Infant Bacterial Therapeutics (IBT) Q1 2025 earnings summary

Executive summary

• FDA granted IBP-9414 Breakthrough Therapy Designation, expediting regulatory review for a drug targeting gastrointestinal mortality in premature infants.

• Phase III "Connection Study" completed; results support safety and potential efficacy of IBP-9414.

• IBT is intensifying market preparation, including hiring for global distribution and advancing production documentation.

• Liquidity is sufficient to support planned activities until mid-2026.

Financial highlights

• Net sales remained at KSEK 0 for the quarter, unchanged from the previous year.

• Operating loss improved to KSEK -17,495 from KSEK -29,798 year-over-year, mainly due to lower R&D costs after study completion.

• Result after tax was KSEK -16,739, compared to KSEK -27,815 in Q1 2024.

• Cash flow for the period was KSEK -27,979, with cash balance at KSEK 191,758 as of March 31, 2025.

• Earnings per share before and after dilution improved to SEK -1.24 from SEK -2.06 year-over-year.

Outlook and guidance

• IBT will focus on regulatory submission and market launch for IBP-9414 in 2025.

• Additional market research and intensified communication with healthcare providers are planned.

• Capital is considered sufficient until the application for marketing authorization.