Infant Bacterial Therapeutics AB

The 2024 Annual General Meeting resolved that the Chairman of the Board shall convene the three largest shareholders in the company in terms of voting rights, who may each appoint a member who, together with the Chairman of the Board, shall form the Nomination Committee. For the composition of the Nomination Committee, the ownership structure as of 30 June 2024 shall determine who are the largest shareholders in terms of voting rights. The member appointed by the largest shareholder in terms of voting rights on the Nomination Committee at that date shall be the Chairman of the Nomination Committee. If any of the three largest shareholders waives its right to appoint a member to the Nomination Committee, the next largest shareholder shall be given the opportunity to appoint a member to the Nomination Committee. The Nomination Committee for the Annual General Meeting 2025 has been formed in accordance with the decision of the Annual General Meeting. The Nomination Committee consists of David Dangoor (Chairman of the Nomination Committee), appointed by the largest shareholder Annwall & Rothschild Investments AB, Sebastian Jahreskog, who through direct and indirect ownership is the company's second largest shareholder, and Jannis Kitsakis, appointed by the third largest shareholder, Fjärde AP-fonden. In addition, Peter Rothschild is a member of the Nomination Committee in his capacity as Chairman of the Board. Shareholders wishing to submit proposals to the Nomination Committee are welcome to contact the Chairman of the Nomination Committee by e-mail at derd@derdangoor.com ,or by letter: Infant Bacterial Therapeutics AB Att: Valberedningen Bryggargatan 10 111 21 Stockholm, Sweden For further information, please contact: Maria Ekdahl, CFO Email: maria.ekdahl@ibtherapeutics.com

IBT has conducted a phase III study comprising 2153 premature infants for five years. The objective of the study has been to show that the company's drug candidate IBP-9414, a bacterial strain found naturally in human breast milk, can improve the health of premature infants by preventing necrotizing enterocolitis (NEC) and improve premature infants' gastrointestinal function (measured as time to Sustained Feeding Tolerance, SFT) and, as a secondary objective, reduce death. The results of the study have now been analyzed according to the pre-specified statistical analysis plan. Although these analysis showed positive trends, there were no statistical significance for the two primary endpoints: prevention of necrotizing enterocolitis (NEC), active group: 8.7% vs placebo group: 10.2% (p=0.24) and SFT, active group: 16 days vs placebo group: 17 days (p=0.07). Importantly, there was a significant reduction in the secondary endpoint of all-cause mortality, active group: 6.2% vs placebo group: 8.5% (p=0.04), corresponding to a significant risk reduction of 27%, which meant that in reality 23 infants’ lives were spared by the administration of IBP-9414 in the study. IBT will continue the development towards pharmaceutical registration, considering that the study showed statistical significance on all-cause mortality. The previous communicated timeline for the registration might be affected and IBT will revert with an update if any changes will occur. The risk reduction of 27% in mortality is a substantial effect size and comparable to currently available pharmaceutical products, for example, surfactants used in the neonatal intensive care units. The effect of IBP-9414 could potentially save the lives of thousands of infants per year and is the only Live Biopharmaceutical candidate that has shown a strong advantage in saving premature infants’ lives. Furthermore the study shows that giving IBP-9414 to these very vulnerable premature infants does not cause any safety issues, including the risk of sepsis which has been a concern expressed by the FDA for the use of probiotic products in preterm infants. “It is becoming clear to the scientific community that NEC is a poorly defined diagnosis representing several different processes. This is the likely reason for the results obtained on the NEC endpoint. Regarding the SFT endpoint, feeding patterns between intensive care units differed more than expected, which could explain the SFT results. The observed difference of 27% in lowered mortality in the active group is exciting and cannot be ignored,” says Josef Neu, Professor of Pediatrics at the University of Florida and principal investigator of the study. “Over the years, neonatal intensive care has significantly improved the survival of preterm infants. Fifty years ago, only 5-10% of the smallest babies survived. Today, the corresponding survival rate is much higher at 80%. Several factors, such as mechanical ventilation and pharmaceuticals like surfactants, have significantly contributed to this positive development. With our study data, I expect that IBP-9414 could be the next major improvement targeting the gut, as it is now established that the product increases the survival rate of premature infants. I believe the extraordinary and unexpected large effect on survival is even more important than potential improvements in NEC and SFT. We are extremely grateful for all the excellent work done by our employees and the medical teams in approximately 100 hospitals involved in the study and special thank you to all families who have allowed us to include their infants in the study," says IBT’s CEO, Staffan Strömberg. “Because mortality is considerably lower in the active group, we have decided to pursue our endeavors to register IBP-9414 as a drug. IBT’s financial situation is such that we have sufficient resources to continue our development work. IBT's cash position was SEK 272 million at the end of the second quarter. I am confident our competent staff led by Staffan Strömberg will spare no effort to register the product as a pharmaceutical thereby helping many premature infants in the future,” says Peter Rothschild, IBT’s chairman. This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-30 18:38 CEST.

Message from the CEO 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 This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-28 08:30 CEST.