Gastroschisis

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.

The last patient in IBT’s global phase 3 clinical program “The Connection Study” has finished treatment. IBP-9414 is being developed to prevent serious diseases in premature infants. The study evaluates the safety and clinical efficacy of IBP-9414. As planned, the work to generate the results is underway. This marks the achievement of another important milestone in the largest randomized controlled study ever conducted on premature infants. It means that the clinical development program is now complete and the next milestone will be to generate the study’s results. The study involved 2,158 premature infants in 10 countries at approximately 100 hospitals. “Having now completed the clinical development program, we look forward to seeing the results of our important phase III study for this vulnerable patient group. The medical needs of premature infants are enormous, and establishing healthy gut function is crucial to prevent serious illness,” says Staffan Strömberg, CEO of IBT. “During the past 5 years we have successfully conducted this study and look forward to presenting the study results in Q3 2024,” adds Staffan. 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. The development program is designed to show a reduced incidence of necrotizing enterocolitis ("NEC") and improved gastrointestinal function ("SFT"). IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. Upon approval, it would be the first product to prevent NEC and improve Sustained Feeding Tolerance (“SFT”) in newborns. The drug development of IBP-9414 is currently in its final stages and IBT expects to receive regulatory approval in 2025 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. 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 2024-07-08 16:40 CEST.

Term Infants Fed Human Milk-Based Fortifier Achieved Full Enteral Feeds 30 Days Sooner and Experienced Better Weight Gain Compared to Infants Fed Cow Milk-Based Fortifier DUARTE, Calif., May 15, 2024 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, announced today that data demonstrating the benefits of Prolacta's Exclusive Human Milk Diet (EHMD) for term infants recovering from gastroschisis repair surgery will be presented at the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) meeting in Milan, Italy, taking place May 15-18. Gastroschisis is a birth defect in which the intestines, and sometimes other organs, protrude through a hole in the abdominal wall. Infants recovering from gastroschisis repair, especially those with complex disease and comorbidities (e.g., heart or lung disease), require high macronutrient intake for optimal growth.1 Clinicians are increasingly addressing this nutritional need through human milk fortification, which means adding a fortifier to mother's own milk or donor milk to provide additional calories and protein. Until recently, fortification was primarily with cow milk-based fortifiers or formula. These fortifiers have been associated with feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants.2-4 The ESPGHAN poster presentation "Human Milk-Based Fortifiers Associated With Improved Growth and Shorter Time to Full Enteral Feeds in Term Infants After Gastroschisis Repair" includes data from a case-control study showing: Term infants who received an EHMD with Prolacta's human milk-based fortifier formulated for term infants achieved full enteral feeds 30 days sooner than infants who received cow milk-based fortifiers or formula (adjusted p = 0.004). The EHMD-fed cohort also experienced higher weight gain velocity (adjusted p = 0.049) and less NEC, with no adverse events reported. "Term infants who require surgery often experience poor growth and significant morbidities when a cow milk-based nutritional fortifier is used," said study lead author Dr. Heidi Karpen of the Emory University School of Medicine. "Safe and early postsurgical fortification with an EHMD helps address the specific feeding challenges impacting these infants. It also supports growth and decreases the risk of NEC, which may translate into improved long-term neurodevelopmental outcomes." "This pioneering study for infants with gastroschisis reaffirms the critical importance of optimal nutrition for the growth and health of medically fragile infants," noted Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. "It is well-established in the medical community and in hospitals across the country that Prolacta's EHMD is beneficial for extremely low birth weight premature infants. This data demonstrates that the benefits extend to term infants who require surgery for gastroschisis repair." The ESPGHAN annual meeting is at the forefront of education provision and knowledge exchange. To register for the ESPGHAN meeting, click here. About Prolacta's Human Milk-Based Nutritional Products Available to hospitals since 2006, Prolacta's human milk-based fortifiers changed the standard of care for critically ill, premature infants by providing a proven alternative to cow milk-based fortifiers in the NICU.4-6 The naturally occurring bioactive components in human milk are thought to support infants' immunity, development, growth, and long-term health.7 Prolacta's products have the highest bioactivity in the human milk industry8 and are clinically proven to significantly boost human milk bioactive proteins and antioxidant activity.9 The company's proprietary processing ensures pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible, compared to other human milk processing methods.8,10,11 About Prolacta Bioscience Prolacta Bioscience® is a global life sciences company dedicated to Advancing the Science of Human Milk® to improve health outcomes for critically ill and premature infants. As the world's leading provider of human milk-based nutritional products for hospitals, Prolacta has touched the lives of more than 100,000 premature infants worldwide.12 Prolacta's human milk-based products have been evaluated in more than 20 peer-reviewed clinical studies, and hospitals adopting Prolacta's Exclusive Human Milk Diet realize up to a 3X dollar-for-dollar return on investment.13 Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity. Learn more at , on X, Instagram, Facebook, and LinkedIn. Media Contact: Loren Kosmont [email protected] 310-721-9444 References 1. Riddle S, Karpen H. Special populations-surgical infants. Clin Perinatol. 2023;50(3):715-728. doi:10.1016/j.clp.2023.04.008 2. Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134 3. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168 4. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567.e1. doi:10.1016/j.jpeds.2009.10.040 5. Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024 6. Cristofalo EA, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. December 2013. 163(6):1592-1595. doi: 10.1016/j.jpeds.2013.07.011 7. Gila-Diaz A, Arribas SM, Algara A, Martín-Cabrejas MA, López de Pablo ÁL, Sáenz de Pipaón M, Ramiro-Cortijo D. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307 8. Liang N, Koh J, Kim BJ, Ozturk G, Barile D, Dallas DC. Structural and functional changes of bioactive proteins in donor human milk treated by vat-pasteurization, retort sterilization, ultra-high-temperature sterilization, freeze-thawing and homogenization. Front. Nutr. 2022;9. 9. Philip RK, Romeih E, Bailie E, et al. Exclusive human milk diet for extremely premature infants: a novel fortification strategy that enhances the bioactive properties of fresh, frozen, and pasteurized milk specimens. Breastfeed Med. April 2023;18(4):279-290. 10. Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635 11. Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438 12. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023. 13. Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs. BMC Pediatr. 2023;23(1). doi.org/10.1186/s12887-023-04047-5 SOURCE Prolacta Bioscience