Infant Bacterial Therapeutics

IBT has announced the crucial results from the global clinical phase 3 study “The Connection Study” for our drug project IBP-9414 are expected in Q3 2024. On the 8th of July, we reported that the last patient had completed treatment. During the summer, our focus has been on ensuring the transfer of all study data to IBT’s database, comprising over half a million entries in so-called CRFs (case report forms). The database must then be converted into a result through the work of statisticians. It is of utmost importance that the database is accurate, therefore IBT is carefully scrutinizing the CRF data to detect any discrepancies. In August, we completed the review and implemented the next step called “database lock”. By locking our database it means that we are satisfied with the data quality and have passed the baton to the statisticians. The results will be analyzed to understand the medical benefits for premature infants. We plan to collaborate with international clinical experts for this analysis, after which we will publicly announce the results through a press release. It is not long now before we will finally know the effectiveness and safety of IBP-9414.

Regardless of whether we obtain the good results we expect from the study, I want to express my gratitude to all of IBT's employees in Sweden, Europe and the United States. Under Anders Kronström's excellent leadership, they have handled this extensive clinical study brilliantly. There have been major challenges, such as a Covid pandemic, but through determination combined with innovative thinking, we have managed to complete the study. Many thanks from me.

This spring, the regulatory work began to prepare IBT's drug application for IBP-9414. The work has intensified, and more sections are ready. As soon as we have received results from “The Connection Study” IBT intends to contact the FDA and discuss how they want us to submit our data with the objective of reaching the market as soon as possible.

There is still a lot of interest in our study and what IBP-9414 will mean for the treatment of premature infants. IBT is further developing its interactions with Key Opinion Leaders in the US as well as in Europe. We will also increase the pace of our commercial work and will continue work to ensure commercial production after we have received the results of our study.

The recent approval of IBT's patent application for IBP-9414 in the US strengthens intellectual property protection in this crucial market, complementing its existing orphan drug designation and biological drug classification. It is worth mentioning that we have continued to work on IBP-1122 and IBP-1118 and that we are planning to meet the FDA to discuss development programs this autumn.

It will not be long until we can hopefully show that IBT can help premature infants while also creating value for IBT’s shareholders. Expect to hear soon how the largest randomized study ever conducted in preterm infants turns out.

Stockholm August 27, 2024

Staffan Strömberg, CEO

Financial overview for the period
Second quarter (Apr-Jun) 2024

• Net sales KSEK 0 (0)
• Operating income KSEK -44 279* (-30 952)
• Earnings per share before and after dilution SEK -3.17 (-2.57)

Reporting period (Jan-Jun) 2024

• Net sales KSEK 0 (0)
• Operating income KSEK -74 077* (-55 247)
• Earnings per share before and after dilution SEK -5.70 (-4.57)

* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the second quarter amounting to KSEK -1 150 (8 412) and during the reporting period amounting to SEK 4 173 (7 760)

Significant events during the second quarter (Apr-Jun)

• On April 4, 2024, IBT announced that the last patient out of a total of 2,158 premature infants has been enrolled in the global Phase 3 clinical program (“The Connection Study”) for the development of IBP-9414. Results from “The Connection study” are expected Q3 2024.

Significant events after the reporting period

• On July 8, 2024, IBT announced that the last patient in the global Phase 3 clinical program “The Connection Study” has been treated. This means that the clinical development program is completed.8
• On August 15, 2024, IBT announced that they had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the drug candidate IBP-9414.

Selected financial data