Infant Bacterial Therapeutics

The scientific literature suggests that benign bacteria of the type found in IBT's drug product IBP-9414 can positively affect the health of premature infants. In 2024, we received the results of “The Connection Study”, our phase 3 study, the largest randomized clinical trial ever conducted in premature infants. The size of the study and the way it was conducted provides a unique opportunity to answer the question; whether the mechanisms that were already known could improve the health situation for premature infants. The short answer is yes, the health of the infants improves and they survive to a significantly higher degree after IBP-9414 has been administered.

Of course, it is not enough for IBT to claim that we have a good product. In order to sell our product, it must be approved by the pharmaceutical authorities. During the fall, IBT has therefore discussed our conclusions of the study results, which concern, for example, reduced mortality, but also NEC with the FDA. During the period October to the end of December, we have communicated intensively with the FDA, which led to a formal meeting on December 19th 2024. IBT has received several good suggestions from the FDA and it is from that perspective and with the support of relevant guidelines that IBT plans to submit all our clinical data to the FDA as soon as possible in the spring of 2025. At the same time, work is progressing to finalize the validation of the production in accordance with our previous plan. At present, we have much of the documentation required for a drug approval available, but the last parts of the validation are expected to be available in the second half of 2025. Assuming that the FDA wants 6-9 months to review the clinical material and that during that time we can add the final pieces of the required information, then an optimistic scenario is that IBP-9414 could receive an approval this year.

IBT will therefore intensify preparations for a launch of IBP-9414. We plan to conduct market research. The results from these will guide future distribution and sales activities for IBP-9414. In addition, the commercial production needs will be influenced by how the market receives our product and how quickly we reach expected peak sales. It is about building stocks of IBP-9414 in a balanced way for a launch.

Our strategy for distribution partners of IBP-9414 remains unchanged. IBT wishes to be responsible for sales and marketing in the USA, while we intend to find the best possible partners for areas outside the USA. We plan to become more active in partnering during the year and will therefore also approach authorities in regions other than the USA in 2025.

Finally, I would like to thank everyone at IBT, all consultants and Key Opinion Leaders who have done a fantastic job during the fall to find alternative paths that will hopefully lead to a quick registration of our drug that saves the lives of premature infants.

Stockholm February 12, 2025

Staffan Strömberg, CEO

Financial overview for the period

* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the fourth quarter amounting to KSEK 5,552 (-9,387) and during the reporting period amounting to SEK 5,445 (-2,074)

Significant events during the fourth quarter (October-December)

• In October, IBT was invited to present at a workshop with the title “Live Biotherapeutic Products to prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants”, organized by the FDA in the US.
• Following further analysis of the study results and dialogue with the FDA, IBT announced in December that the company is continuing to prepare a “Biologicals License Application (BLA) to obtain drug approval.

Significant events during the reporting period (January - September)

• On April 4, 2024, IBT announced that the last patient out of a total of 2,158 premature infants had been enrolled in the global Phase 3 clinical program (“The Connection Study”) for the development of IBP-9414.
• July 8, 2024, IBT announced that the last patient in the global Phase 3 clinical program “The Connection Study” had completed treatment. This meant that the clinical development program was completed.
• On August 15, 2024, IBT announced they had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the drug candidate IBP-9414.
• On August 30, 2024, IBT announced that the phase III study did not show significant effects on the primary endpoints but did show a significant reduction in the secondary endpoint, all-cause mortality.

Summary of selected financial data