Lactobacillus reuteri

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.

Message from the CEO This quarter, IBT completed the global Phase 3 clinical trial “The Connection Study” for the drug candidate IBP-9414. On July 8, we reported that the last patient was treated. On August 30, we reported topline data to the market. Since then, we have continued to analyze the data with our experts. Our conclusion is that our drug candidate IBP-9414 meets the requirements for a pharmaceutical product, meaning we have now documented both the potency and safety of IBP-9414. We see that IBP-9414's safety profile is generally very good, in line with, or in some areas even better, than placebo. When we look at the causes of death in infants, we see a clear reduction in the number of deaths in the cardiopulmonary and gastrointestinal areas after IBP-9414 administration when compared to the children receiving placebo. See figure 1. Figure 1: Reported causes of death grouped by organ class in “The Connection Study” If we look at survival as a function of time, we see an clear effect of IBP-9414 after two weeks of treatment. See figure 2 (in attachment) on the Y-axis we see survival and on the X-axis we see the number of days after the first dose is administered. The overall reduction in mortality of 27% in the IBP-9414 treatment group compared to the placebo group for all preterm infants in the phase 3 study is clinically relevant. In addition, when examining deaths occurring after 14 days of treatment, the relative risk of death is further reduced to 46%. These are fantastic results and as there is no treatment alternative on the market, we at IBT are highly motivated to continue our work to register our product. After further analysis of the study data, scientifically accepted reasons have emerged as to why it has been difficult to measure our primary endpoints in the study. There are different pathways for how a product can be registered as a medicine. We will therefore have a meeting with the FDA, which is scheduled for December 2024. Then we will update timetables for the remaining parts of IBP-9414's development work. In parallel with our communication with the authorities, we are ensuring that we can produce large volumes of IBP-9414 to a high standard of quality. We are expanding our supplier network for manufacturing and product analysis. The first commercial batches are planned to be produced in 2025. Another ongoing activity is the publication of the full results from “The Connection study”, IBT's data from the study will be presented at Hot Topics in Neonatology, December 9, by Professor Josef Neu who is also the principal investigator of the study. IBT also aims to publish the results in several scientific publications as soon as possible. On October 25th, IBT was the only company invited to participate in a one-day meeting organized by the US authorities in Washington DC. The purpose of the meeting was to bring together academia, government and industry to discuss the Live Biotheapeutic Products class of drugs and how such products can be developed to prevent NEC. Clinical results for IBP-9414 were also presented during the meeting. In conclusion, I would like to thank all the staff in the 95 hospitals around the world who collected data for the infants. I would also like to extend a very big thank you to the IBT staff who executed the largest randomized study ever conducted on preterm infants in a very professional manner. We now look to the future with confidence, as IBT has no doubt that the results of our phase 3 study demonstrate that premature babies do better with IBP-9414 than without it. Stockholm November 13, 2024 Staffan Strömberg, CEO Financial overview for the period * Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the third quarter amounting to KSEK -4 280 (-448) and during the reporting period amounting to SEK -108 (7 313) Significant events during the third quarter (Jul-Sep) 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. 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 phase III study didn´t showed significant effects on the primary endpoints but a significant reduction in the secondary endpoint, all-cause mortality. Significant events during the reporting period (Jan-Sep) 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. Results from “The Connection Study” were expected Q3 2024. Selected financial data Contacts Staffan Strömberg, CEO Maria Ekdahl, CFO info@ibtherapeutics.com +46 76 219 37 38 About Us Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBTB). IBT is a pharmaceutical company whose purpose is to develop and commercialize drugs for diseases affecting premature babies. During the 12 years of drug development IBT has gained unique expertise in the field of drugs using live bacteria as active substances. This is a key competitive factor for our development programs. IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. The drug development of IBP-9414 is currently in its final stages for this important product for premature babies. The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections. Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.