Infant Bacterial Therapeutics AB (publ) Interim report January 1 – March 31, 2024

Message from the CEO

IBT has successfully completed the recruitment of infants for our Phase III study (The Connection Study), which is the final clinical trial planned according to the IBP-9414 development program. It all began with defining the clinical development plan for IBP-9414 with the FDA and the European equivalent, EMA, over 10 years ago. Once the plan was established, we built a small and highly efficient organization tasked with converting this plan into action. It is fantastic to note that we have succeeded. From a small office in the heart of Stockholm, we have managed to conduct the largest study ever in premature infants. Some companies choose to out-license their development projects in early stages to avoid responsibility for implementation or funding of the laborious development work and to reduce project risk. IBT has chosen to perform this work and decline early out-licensing opportunities, as we believe we will create greater long-term value for shareholders. We retain control and decide how and what should be done while maintaining good cost control. That is why reaching this milestone is truly extraordinary; 100% recruitment of 2158 infants. I also want to take this opportunity to thank the individuals behind this achievement, our team in Stockholm as well as those in the USA and Europe.

The last patient participating in "The Connection Study" will leave the study no later than July 2024. We expect to receive the results sometime during Q3 2024. IBT has initiated the demanding work to compile regulatory documentation and validation of the production process in order to submit the application for market approval (BLA) to the FDA as soon as possible. During the first quarter, we have also started preparing for the next stage. We have conducted several expert panel meetings with Key Opinion Leaders in the USA as well as in the EU. It is very stimulating to discuss IBP-9414, and there is no doubt that we will meet a clear medical need where treatments are currently lacking. We are convinced that if our study results show the expected effect, our product will contribute to less suffering and death. The medical experts share the same expectations.

During this quarter, the Canadian regulatory authority warned against using probiotic supplements as a treatment for premature infants. Therefore, Canada is choosing to follow the FDA's stance on the issue. The warning concerns several infants who have died after treatment with non-regulated products. IBT expects that EU regulatory authorities will act similarly and warn or prohibit the inappropriate use of available supplements when an approved medication is available.

Finally, I want to mention that we are now conducting something called PPQ (Product Process Qualification), which means we are documenting our manufacturing of IBP-9414 in a way that authorities can obtain the necessary documentation for approval of a medicinal product. IBT has also strengthened during the quarter by expanding our staff with more talented individuals, including a Head of Regulatory and a Supply Chain Director based in our Stockholm office to tackle the future challenges awaiting IBT.

We have entered a new stage at IBT, and we look forward to an exciting near future.

Stockholm May 7, 2024

Staffan Strömberg, CEO

* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the first quarter amounting to KSEK 5 323 (-652).

Significant events during the reporting period (Jan-Mar)

• No significant events during the first quarter

Significant events after the reporting period

• On April 4th 2024, IBT announced that the last patient of a total of 2 158 premature babies has been enrolled in the global phase 3 clinical program (“The Connection Study” for the development of IBP-9414. The results from the study are anticipated during Q3 2024.

Selected financial data