In vitro studies, undertaken by two leading microbiology centers, confirm RHB-204's killing capability on Mycobacterium avium subspecies paratuberculosis (MAP) and its MAP-killing comparability to RedHill's RHB-104 in both long-term intracellular culture and spot and phage assays The two sets of studies, showing confirmed MAP-killing effect and comparability to RHB-104, led by Professor Tim Bull from City St George's University of London , and Prof Irene Grant , Professor of Microbiology and Food Safety, Queen's University Belfast and Dr Hannah Dane , further support development of RHB-204's potential in MAP-related Crohn's disease In its positive Phase 3 study, RHB-104 met the primary endpoint with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone in treating Crohn's disease, compared to the placebo (standard of care only) group (p = 0.0048) 1 RHB-204 2 , a proprietary next-generation oral optimized formulation of RHB-104 3 , designed for reduced toxicity and side effects and enhanced patient adherence, employs a differentiated, MAP-targeted approach to the treatment of Crohn's disease RALEIGH, N.C. and TEL AVIV, Israel , Nov. 2, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (" RedHill " or the "Company"), a specialty biopharmaceutical company, today announced the confirmation of RHB-204's killing capability on Mycobacterium avium subspecies paratuberculosis (MAP), and RHB-204's comparability to RHB-104 MAP-killing, following two sets of in vitro studies, undertaken by leading microbiology centers, in both long-term intracellular culture and spot and phage assays. The two sets of studies led by Professor Tim Bull from City St George's University of London , and Prof Irene Grant , Professor of Microbiology and Food Safety, Queen's University Belfast and Dr Hannah Dane , support the potential for RHB-204's role in MAP-related Crohn's disease (CD) through demonstrated RHB-204 comparability to RedHill's RHB-104, which met the primary endpoint with statistical significance of its positive Phase 3 clinical trial, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048). In vitro studies, undertaken by Professor Tim Bull , confirm RHB-204's MAP-killing capability MAP in long term intracellular culture4 and further demonstrate RHB-204's comparability to RedHill's RHB-104's MAP-killing effect. The positive results were seen across a range of MAP strains, taken from both human Crohn's disease patients and animal carriers of Johne's disease, sometimes referred to as "animal Crohn's", which were suggestive of both potential human and veterinary utility. The studies also showed that RHB-204 did not induce tolerance in the strains during the short exposure periods used in the studies (6 days max), suggesting that further consecutive dosing could add to the effect. Tim Bull , Professor of Cell and Molecular Biology at City St George's University of London said : "RHB-204 demonstrated a significant MAP-killing effect, similar to RHB-104, against multiple strains of MAP, both human and animal, whilst intracellularly persistent. MAP is remarkably difficult to kill and test against due to its unique biological structure, intracellular lifestyle, and slow growth rate. This data gives a valuable insight into the potential of RHB-204 to treat MAP-related Crohn's disease involving either human or animal derived MAP strains." Prof. Bull's work adds to the in vitro work undertaken by Rapid-myco Technologies, a world leader in the field and developer of a transformative diagnostic platform for the rapid detection of important and often life-threatening mycobacterial infections of humans and livestock. This work, led by Prof Irene Grant , Professor of Microbiology and Food Safety at Queen's University Belfast and Dr Hannah Dane , showed in vitro that RHB-204 demonstrated comparable MAP killing to RHB-104 in both spot and phage assays. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects5. "We know from previous published positive Phase 3 clinical testing that RHB-104 delivered a statistically significant 64% improvement over placebo in efficacy in treating Crohn's disease using a MAP-targeted approach. In vitro confirmation of RHB-204's MAP-killing effect and comparability to RHB-104 is another step forward in the development of RHB-204 for MAP-related CD," said Reza Fathi , PhD, Senior VP, R&D at RedHill . "We believe Phase 2-ready RHB-204 could be among the first treatments to be evaluated in an adequately controlled study in a specifically defined MAP-positive Crohn's disease patient population." There is a significant body of peer reviewed published research supporting the scientific rationale that MAP may be a root cause of