Lactobacillus reuteri

Message from CEO IBT's plan to apply for marketing approval in the US through a so-called accelerated application remains unchanged. The development program for IBP-9414 is “Breakthrough Designated,” which gives us the opportunity to submit the marketing authorization application in several parts, rather than all at once. IBT has made use of this opportunity, and so the FDA reviewed the clinical documentation already in the summer of 2025. During the fall, we held meetings with the FDA where IBT answered clinical questions about the results of our Phase III study, “The Connection Study.” We are therefore very pleased that the FDA is encouraging IBT to work towards market approval. What remains can be summarized in two parts: The first is to ensure continued documentation of the clinical effects of IBP-9414, with a focus on its ability to reduce mortality in premature babies. At a meeting on 19th December 2025, IBT and the FDA agreed that IBT would develop a proposal for a study intended to be conducted after the launch of IBP-9414. The study proposal is being developed with clinical and statistical experts. The study design is based on the following four principles: Feasibility – To ensure that the study is feasible. Equipoise – To ensure that healthcare professionals do not withhold a treatment that is believed to help the patient. Ethics: To ensure that good morals are upheld. Meeting “CBER Standards”: To ensure that legal requirements are met in the manner deemed appropriate by the FDA The second part we are working on is the validation of production at the companies that will manufacture the commercial volumes of IBP-9414. The plan is for our German manufacturer of the drug substance to be ready in April 2026. The product will then be further processed into a drug by filling vials and freeze-drying them at our manufacturer in the Netherlands. Despite a somewhat tight schedule, I consider our timetable to be realistic, based on the cooperation with suppliers and working methods we have today. Shortly after the drug is manufactured, IBT intends to submit an application for marketing approval in the US. Most of the documents required for the application have been completed, and the remainder are expected to be ready once we have completed the two steps above. Discussions are continuing with several partners regarding sales partnerships and distribution of IBP-9414. For the US market, IBT intends to register IBP-9414 with the FDA itself and handle distribution and sales. At the same time, we are working with potential partners in other parts of the world, with the request that the partner convert the US/EU-adapted registration to local requirements. In January 2026, IBT received the welcome news that the clinical results from “The Connection Study” will be published in the scientific journal Pediatric Research shortly. This is the first publication of study results from “The Connection Study,” which showed that IBP-9414 is safe and reduces mortality by 27% in premature infants. IBP-9414 has Rare Pediatric Disease Designation, which means that IBT can be awarded a Priority Review Voucher (“PRV”) upon market approval. The program, that previously had an end date of 30th September 2026, has now been extended to 30th September 2029. The last known sale value for a PRV was 200MUSD. At the end of Q4 2025, IBT had cash reserves of SEK 144 million. The company has very low fixed costs and is therefore a sustainable company. Stockholm February 5, 2026 Staffan Strömberg, CEO *Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the fourth quarter, these amounted to KSEK -1,162 (5,552) and during the reporting period to KSEK -7,043 (5,445). Significant events during the fourth quarter (October – December) On November 20, 2025, IBT announced that it had entered into a partnership with Recipharm Advanced Bio for the production of drug substance. On November 25, 2025, IBT announced that it had decided to proceed with an accelerated approval process for IBP-9414. On December 11, 2025, IBT announced that it had entered into a partnership with BioConnection for the production of drugs. Significant events during the reporting period (January – December) On March 28, 2025, IBT announced that the FDA had granted IBP-9414 “Breakthrough Therapy Designation” for its potential to reduce gastrointestinal-related mortality. On May 8, IBT announced that the Clinical Study Report (CSR) for “The Connections Study” had been submitted to the FDA. The report contains data from the Phase 3 clinical trial that was completed in 2024. Summary of selected financial data

Recipharm Advanced Bio, part of global contract development and manufacturing organization Recipharm, and pharma company Infant Bacterial Therapeutics AB (IBT) announced the initiation of Process Performance Qualification (PPQ) for IBT’s lead product, IBP-9414, which targets mortality and gastrointestinal injury in premature infants. The PPQ program will be conducted at Recipharm’s microbial manufacturing facility in Cuxhaven, Germany, which offers integrated bacterial capabilities covering the full product lifecycle from pre-clinical development through commercial supply, according to Recipharm. The Cuxhaven site provides comprehensive support including viral and bacterial cell bank production, development, scale-up, as well as production of virus-based therapies and vaccines (AAV, lentivirus, oncolytic virus), sterile fill-finish, analytical services, recombinant proteins, and monoclonal antibodies. “Partnering with Infant Bacterial Therapeutics on this breakthrough therapy underscores our shared commitment to addressing critical unmet needs in vulnerable patient populations,” Vikas Gupta, president of Recipharm Advanced Bio, said in a statement. “By combining IBT’s innovative approach with Recipharm Advanced Bio’s microbial expertise and accelerated path to manufacturing, we are ensuring PPQ and commercial readiness are delivered on a fast and reliable timeline, bringing this lifesaving treatment for premature infants fast to market.” In October, Recipharm announced that its Cuxhaven facility has been designated as the company’s Center of Excellence for Analytical Services tailored to advanced modalities. With more than 15 years of experience in analytical method development and qualification, Cuxhaven’s team specializes in both compendial and non-standard assays, including microbiological and viral assay validation, nucleic acid quantification, and advanced molecular techniques such as ddPCR, qPCR, and Western blot. According to Recipharm, these capabilities make the site a key asset for biologics and advanced therapy medicinal products (ATMPs). The facility in Cuxhaven provides support in viral and bacterial cell bank production, development, scale-up, and production of virus-based therapies and vaccines (AAV, lentivirus, oncolytic virus), sterile fill and finish, analytical services, recombinant proteins and monoclonal antibodies (mAbs). "IBP-9414 will be the first LBP (Live Biotherapeutic Product) globally, and after careful consideration, we now proceed to Process validation for Drug substance with Recipharm Advanced Bio in Cuxhaven,” says Staffan Strömberg, CEO at IBT. “With the possibility of Recipharm Advanced Bio being a future drug substance supplier, we are strengthening our commercial supply chain possibilities. We feel that we are in good hands for this work, given Recipharm Advanced Bio's deep expertise and understanding of pharmaceutical quality requirements for scalable commercial manufacturing." Recipharm Advanced Bio has the ability to enable comprehensive and accelerated manufacturing via its network of advanced therapy medicinal products facilities, along with its centers of excellence, in order to support partners from early development through commercial supply. In October, Recipharm announced the inauguration of newly commissioned parenteral development and sterility laboratories at its Bengaluru, India site, according to the company. The purpose-built facilities are designed to enhance Recipharm’s sterile pharmaceutical development and testing capabilities, expand its analytical services function and build on its established strengths in oral dosage and advanced therapies.