Infant Bacterial Therapeutics

The risk of death decreased by 27% for children who received our drug candidate IBP-9414 compared to placebo in our Phase 3 study. It is difficult for me to put into words the significance of the 27% medical effect; it is about death, and not just death, it is about children dying. During the last quarter, I have met parents who have lost their children, as well as many doctors and nurses around the world. When I show the results from our Phase 3 study, it brings hope for a better future, as IBP-9414 can save thousands of children's lives.

IBT continues its intensive work towards market approval of IBP-9414. During the period, we have interacted with Europe (EMA) and the US (FDA). Earlier this year we registered as a Small Medium Enterprises (SME) with the EMA and during this quarter, announced that IBT intends to seek central marketing approval in Europe in 2026. In March this year, IBP-9414 was granted Breakthrough Therapy Designation in the US. In early summer, we followed this up by submitting the “totality of evidence”, i.e. the clinical information as a supplement to our Investigational New Drug (IND) application. During the period from July 1 to today, the FDA and IBT have communicated in writing several times. Among other things, IBT has received statistical and medical questions about the clinical data. We receive questions and follow-up questions, and the FDA wants answers within 24 or 48 hours. US law requires a formal Biological License Application (BLA) from IBT for the FDA to communicate the results of its review. The FDA can thus review under an IND, but in order for the FDA to approve IBP-9414, a BLA is required. IBT plans therefore to submit a BLA during first half of 2026.

The manufacture of IBP-9414 requires the use of several analytical methods to verify the products’ quality. Work to validate analysis methods and the full-scale manufacturing process continues. The work to prepare the market for the launch of IBP-9414 is primarily focused on the US. We are also in contact with potential partners for the distribution of IBP-9414 in other parts of the world.

Financial overview for the period

Third quarter (July - September) 2025

• Net sales KSEK 0 (0)
• Operating income KSEK -10,836* (-33,821)
• Earnings per share before and after dilution SEK -0.75 (-2.42)

Reporting period (January - September) 2025

• Net sales KSEK 0 (0)
• Operating income KSEK -48,457* (-107,897)
• Earnings per share before and after dilution SEK -3.41 (-7.66)

*Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the third quarter, these amounted to KSEK -2,694 (-4,280) and during the reporting period to KSEK -5,881 (-108).

Significant events during the reporting period (January - September)
● On March 28, 2025, IBT announced that the FDA had granted IBP-9414 “Breakthrough Therapy Designation” for its potential to reduce gastrointestinal-related mortality.
● On May 8, IBT announced that the Clinical Study Report (CSR) for “The Connections Study” had been submitted to the FDA. The report contains data from the Phase 3 clinical trial that was completed in 2024.

Summary of selected financial data