Continued constructive dialogue with the FDA
During the period, we continued our interactions with the U.S. Food and Drug Administration (FDA). In February 2026, IBT sent a synopsis for a clinical study that could be carried out as a post-marketing study. During April, this proposal as well as other clinical study alternatives have been discussed with the authority. The focus of the discussions has been on whether the existing evidence shows that IBP-9414 reduces mortality in premature infants.

On the 1st May, IBT received a letter from the FDA that opened up for IBT’s study together with other available scientific information being considered as sufficient for FDA to accept a submission for market approval. This could mean an application without the requirement for a post-marketing study. IBT will continue the dialogue with the FDA during the spring and summer. The next step planned is for FDA and IBT to have a pre-BLA meeting and that IBT, after that meeting and as soon as the manufacturing validation work at our German and Dutch commercial manufacturers is documented, submits a BLA (“Biologics License Application”).

Our goal remains the same: IBT plans to submit an application to the FDA during 2026.

Validation is proceeding according to plan
The analytical work is now complete. It has taken much longer than we had anticipated, although this has not in itself delayed our project. IBT has modified the analytical methods to make them even more robust, and we are pleased that these new analytical methods are now validated in a manner consistent with FDA requirements. This means that the laboratory work is complete, as all analyses required for the development of IBP-9414 are now validated.

The PPQ – work (“Process Performance Qualification”) for the drug substance is proceeding as planned at Recipharm, our manufacturing partner. We have manufactured several batches of drug substance and these are now in the freezer. The next step is analysis and report writing as well as to perform the corresponding validation work at the facility that manufactures the finished product. These PPQ runs are scheduled to take place in June/July at our other manufacturing partner, BioConnection, in the Netherlands.

Once these steps are completed, the direct product development work for IBP-9414 will be finished. This marks an important transition—from development to regulatory completion and preparations for commercialization.

Parallel Work in Europe
In parallel with the work in the U.S., we are continuing with registration in Europe. This work is in line with our ambition to enable access to IBP-9414 outside the U.S. as well.

Preparations for Launch
IBT is evaluating various alternative routes to market by selecting a supplier for the packaging of IBP-9414 and distribution partners in both the U.S. and Europe.
 
Scientific forums
Earlier this year, the results from our Phase III study “The Connection Study” were published in an article in Pediatric Research titled “Live biotherapeutic product IBP-9414 (L. reuteri) in very low birth weight infants.”

In late April, IBT participated in the PAS (Pediatric Academic Societies) conference in Boston, one of the most important scientific conferences in pediatrics and neonatal care. We had a large number of valuable meetings with clinical investigators, researchers, and other stakeholders.

The meeting was marked by strong interest in our data and a clearly positive response to IBP-9414 and its potential. These types of dialogues are central to a successful launch of our product—they strengthen both the scientific foundation and the understanding of the medical need.

Summary
Following the planned final PPQ work in June/July, the IBP-9414 product will be fully developed. We are very pleased and proud to have reached this milestone. We are now focusing on regulatory work and the market to help ensure that more premature babies survive and have the opportunity for a better life.

Stockholm May 6 2026

Staffan Strömberg, CEO

Financial overview for the period

*Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the first quarter, these amounted to KSEK 339 (3,652).

Significant events during the first quarter (January-March)

• In February 2026, the results of “The Connection Study” were published in Pediatric Research.

Summary of selected financial data