Infant Bacterial Therapeutics

The US Food and Drug Administration (FDA) has granted IBP-9414 “Breakthrough Therapy Designation.” This means that the FDA and IBT will work together to bring the new drug to market as soon as possible. The FDA's Breakthrough Designation is intended to expedite the development and regulatory review of potential new drugs that are intended to treat serious conditions and address significant medical needs. The drug must have achieved preliminary clinical results that demonstrate significant improvements on a clinically significant efficacy measure compared to available drugs. For IBT, it is positive in itself that we are likely to reduce the time to a potential market approval, but in our case it means more than just a time gain. This is because “The Connection Study,” our large Phase III study in premature infants, did not show what we expected, but the results of the study nevertheless form the basis for the FDA's decision to grant “Breakthrough Therapy Designation.” The Connection Study supports the hypothesis that IBP-9414 is safe and has the potential to improve intestinal maturation and thereby reduce serious consequences of intestinal damage, such as NEC and gastrointestinal mortality, in premature infants. IBP-9414 has the potential to address this unmet medical need in a vulnerable population in need of new treatment options.

IBT now has a new compass course to follow. We will now intensify our work towards the market, and IBT has hired a person who will be tasked with identifying global distribution partners for IBP-9414. In April this year, Professor Neu presented results from “The Connection Study” at the Pediatric Academic Societies' annual conference in Hawaii. Communication with healthcare providers will be further intensified. IBT will also conduct additional market research to prepare for the launch of IBP-9414. Another important area is production, and in the first quarter, the analytical methods were validated with good results. The analytical methods are used to release the product when it is produced to ensure its quality. The development of additional production-related documentation is planned for 2025.

In April, we completed our clinical study report for “The Connection Study.” This report, together with additional information, will now be submitted to the FDA as soon as possible in accordance with their recommendation.

IBT's liquidity is such that the activities we are currently planning will be sufficient until sometime in mid-2026.

Finally, a big thank you to everyone at IBT; all the hard work has paid off. IBT's IBP-9414 product has completed Phase III and received “Breakthrough” status based on our Phase III results. These are exciting times for IBT.

Stockholm May 7, 2025

Staffan Strömberg, CEO

Financial overview for the period

First quarter (January - March) 2025

• Net sales KSEK 0 (0)
• Operating income KSEK -17 495* (-29 798)
• Earnings per share before and after dilution SEK -1.24 (-2.06)
* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the first quarter amounting to KSEK -3,652 (5,323).

Significant events during the reporting period (January - March)

• On March 28, 2025, IBT announced that the FDA had granted IBP-9414 “Breakthrough Therapy Designation” for its potential to reduce gastrointestinal-related mortality.

Summary of selected financial data