Core Insights - RedHill Biopharma plans to submit a UK Marketing Authorisation Application (MAA) for Talicia, targeting H. pylori infection, with potential approval by Q4 2025 [1][4] - Talicia is recognized as a first-line treatment option by the American College of Gastroenterology (ACG) and is the leading branded therapy for H. pylori in the U.S. [2][4] - H. pylori infection represents a significant market opportunity, affecting approximately 40% of the UK adult population and over 50% globally [1][3] Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [7] - Talicia, approved by the FDA in November 2019, is a fixed-dose combination therapy that includes two antibiotics and a proton pump inhibitor [5] - The company is exploring commercialization partnerships to expand Talicia's market presence following approvals in the U.S. and UAE [4][5] Market Opportunity - H. pylori infection is a billion-dollar market, with significant prevalence in both the UK and globally, impacting treatment strategies and market dynamics [1][3] - The World Health Organization classifies H. pylori as a Group 1 carcinogen, linking it to a high incidence of gastric cancer and peptic ulcer disease [3][4] - Talicia's unique formulation addresses antibiotic resistance, a growing concern in H. pylori treatment, with efficacy rates reported as high as 90% [4][12]

Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [12] - The company promotes the FDA-approved gastrointestinal drug Talicia® for the treatment of Helicobacter pylori infection in adults [12] Product Development - The company plans to advance its late-stage program for Crohn's disease (CD) with the initiation of a Phase 2 study of RHB-204, targeting Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD [1][3] - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and adherence, with a 40% reduction in pill burden [2][10] - The Phase 2 study will be the first clinical trial in CD patients who are all MAP-positive, correlating mucosal healing with MAP eradication [1][3] Clinical Study Insights - The primary endpoints of the Phase 2 study will include mucosal healing, MAP status, and clinical remission, following FDA guidance [3] - Insights from the successful Phase 3 study of RHB-104 indicate that RHB-204 could be efficiently conducted with a small patient population and decisive endpoints, potentially reducing program costs [4][6] - The Phase 3 study of RHB-104 demonstrated a 64% improvement in efficacy compared to standard of care, with significant mucosal healing data [2][7] Market Potential - The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033, indicating significant commercial potential for new FDA-approved therapies [1][5] - There is a strong need for effective new therapies due to high treatment failure rates and approximately 1.6 million diagnosed cases of CD globally [6][8] Regulatory Designations - RHB-204 is patent protected until 2041 and is expected to receive pediatric orphan designation, subject to FDA approval [2][10] - The company intends to explore additional regulatory designations, such as breakthrough therapy and fast track designations, to enhance exclusivity and expedite the review process [6]

Core Insights - RedHill Biopharma has entered into an exclusive worldwide licensing agreement with Hyloris Pharmaceuticals for RHB-102 (Bekinda®), which includes an upfront payment, potential milestone payments of up to $60 million, and mid-20s percent royalties on revenues for territories outside the U.S., Canada, and Mexico [1][2] - RHB-102 is positioned to be the first oral 24-hour extended-release ondansetron for treating chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV) if approved by the UK MHRA [1][4] - The global antiemetics drugs market was valued at approximately $7.5 billion in 2023 and is projected to grow at a CAGR of around 6% from 2024 to 2030 [5] Company Overview - RedHill Biopharma focuses on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology, with key products including Talicia® for H. pylori infection [8] - Hyloris Pharmaceuticals specializes in innovating and optimizing existing medications to meet healthcare needs [7] Product Development - RHB-102 is a proprietary, once-daily, bimodal extended-release oral tablet formulation of ondansetron, targeting oncology support, acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D) at doses of 12 mg and 24 mg [3][6] - Positive results from U.S. Phase 2 and Phase 3 studies for RHB-102 have been published, indicating its efficacy in treating IBS-D and acute gastroenteritis [5][6]

Core Insights - The Phase 2 study aims to evaluate the efficacy of opaganib in combination with darolutamide for men with metastatic castrate-resistant prostate cancer (mCRPC) [1][2] - The study is financially supported by Bayer and the Ramsay Hospital Research Foundation, led by Professor Lisa Horvath [1][2] - Prostate cancer is the second most diagnosed cancer globally, with approximately 1.5 million new cases and nearly 400,000 deaths annually [1][5] Study Design - The study is a double-blind, placebo-controlled trial involving 80 patients, focusing on those with poor prognosis as defined by the PCPro lipid biomarker test [1][4] - The primary endpoint is improved 12-month radiographic progression-free survival (rPFS), with several secondary and exploratory endpoints also evaluated [2][4] Market Context - The prostate cancer market is valued at approximately $12 billion in 2023, highlighting the potential commercial significance of successful treatment options [3][5] - Men with mCRPC have limited treatment options, making the development of new therapies critical for improving patient outcomes [3][5] Mechanism of Action - Opaganib is a sphingosine kinase-2 (SPHK2) inhibitor that may enhance the efficacy of androgen receptor signaling inhibitors like darolutamide [3][7] - The drug targets multiple pathways, potentially overcoming resistance to standard treatments [3][8] Clinical Implications - The study's findings could represent a significant breakthrough in managing advanced treatment-resistant mCRPC, improving outcomes for patients with poor prognosis [3][4] - The combination therapy may provide a new avenue for treatment in a patient population that currently faces high mortality rates [3][5]

Core Insights - Talicia is now covered by Humana's Part D Plan, expanding access to over eight million Medicare lives for H. pylori therapy without prior therapeutic steps or authorizations [1][2] - The American College of Gastroenterology (ACG) Clinical Guideline has updated Talicia as a first-line treatment option for H. pylori infection, reinforcing its position as the most prescribed branded therapy by U.S. gastroenterologists [1][2] - New data published in the Journal of Clinical Pharmacology supports Talicia's recent FDA-approved label change to a more convenient three-times daily dosing regimen, enhancing patient adherence [1][3] Group 1: Talicia's Market Position - Talicia is the only FDA-approved low-dose rifabutin-based therapy for H. pylori eradication, highlighting its unique market position [2][7] - The drug demonstrated an 84% eradication rate in the pivotal Phase 3 study, significantly outperforming the 58% rate in the active comparator arm [8][29] - Talicia's pharmacokinetic profile remains consistent across dosing regimens, supporting its simplified TID dosing schedule [3][4] Group 2: H. pylori Infection Context - H. pylori infection affects approximately 35% of the U.S. adult population, with around two million patients treated annually [5][6] - The World Health Organization classifies H. pylori as a Group 1 carcinogen, making it a significant risk factor for gastric cancer and peptic ulcer disease [5][6] - Current therapies fail in approximately 25-40% of patients due to high resistance rates, particularly to clarithromycin, underscoring the need for effective treatments like Talicia [6][7] Group 3: Company Overview - RedHill Biopharma Ltd. focuses on the commercialization and development of drugs for gastrointestinal diseases, infectious diseases, and oncology [19] - The company is committed to enhancing patient experience and outcomes through innovative therapies like Talicia [3][4] - Talicia is eligible for eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation, with patent protection extending until 2034 [9]

Core Viewpoint - RedHill Biopharma has been awarded approximately $8 million in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd, with the court dismissing all of Kukbo's counterclaims and ruling in favor of RedHill's good faith commitment to the agreements [1][2]. Group 1: Legal Proceedings - The judgment includes $6.5 million plus approximately $1.5 million in interest, along with costs [1]. - The case stems from Kukbo's failure to make agreed payments to RedHill under a Subscription Agreement and an Exclusive License Agreement [2]. - RedHill intends to pursue its attorneys' fees and collection of the judgment, while Kukbo has the right to seek an appeal [3]. Group 2: Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the commercialization and development of drugs for gastrointestinal diseases, infectious diseases, and oncology [4]. - The company promotes Talicia®, a drug for treating Helicobacter pylori infection in adults [4]. - Key clinical late-stage development programs include opaganib, RHB-107, RHB-102, RHB-104, and RHB-204, targeting various diseases and conditions [4].

Core Viewpoint - RedHill Biopharma has been selected to present opaganib's potential to U.S. government representatives at the JPEO-CBRND "Host Directed Therapeutics Industry Day" scheduled for October 29-30, 2024, highlighting its capabilities in treating viral, bacterial, and toxin exposures [1][3]. Group 1: Opaganib Overview - Opaganib is a novel, host-directed, orally administered small molecule drug with demonstrated safety and efficacy, being developed for various indications including oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection [1][4]. - It is a first-in-class sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory, and antiviral activity, targeting multiple potential indications such as cancers, COVID-19, and Ebola [4][9]. Group 2: Government Collaboration and Evaluation - Opaganib has been selected for evaluation in several U.S. government countermeasures and pandemic preparedness programs, including those led by NIAID and BARDA [6]. - The JPEO-CBRND manages U.S. government investments in CBRN defense and has selected therapeutics that demonstrate capability in prophylaxis and treatment of exposures to various pathogens [2]. Group 3: Clinical Efficacy and Research Findings - Opaganib has shown antiviral activity against SARS-CoV-2 and other viruses, with significant increases in survival time in Ebola studies and improved outcomes in COVID-19 patients [7][8]. - In Phase 2/3 clinical trials, opaganib demonstrated improved viral RNA clearance and reduced mortality in hospitalized COVID-19 patients compared to placebo [8]. Group 4: Future Development and Designations - Opaganib has received orphan-drug designations from the FDA and has ongoing studies in advanced cholangiocarcinoma and prostate cancer, with a Phase 1 study protocol ready for FDA-IND submission [9]. - The drug is expected to maintain efficacy against emerging viral variants based on its host-targeted mechanism [8].

Core Viewpoint - RedHill Biopharma has signed a collaborative research agreement with Duke University School of Medicine to conduct in vivo studies on opaganib as a potential treatment for phosgene inhalation injury, aiming for further development under the FDA's Animal Rule pathway to approval [1][2][4] Group 1: Phosgene Inhalation Injury - Phosgene is a toxic, colorless chemical used in industrial processes, identified by the EPA at 123 sites in the U.S. that could expose millions to potential harm [2][4] - Inhalation of phosgene can lead to severe respiratory injuries, including acute respiratory distress syndrome (ARDS), with no known approved antidote currently available [2][3][4] Group 2: Opaganib Overview - Opaganib is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with potential applications in oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection [5][10] - The drug has shown antiviral activity against various viruses, including SARS-CoV-2 and Ebola, and has demonstrated safety and efficacy in multiple clinical studies [7][8] Group 3: Government Collaborations and Funding - Opaganib is being evaluated by several U.S. government programs for its potential as a medical countermeasure against various threats, including Acute Radiation Syndrome and Ebola [6][10] - Funding for these evaluations comes from agencies such as the National Institute of Allergy and Infectious Diseases (NIAID) and the Administration for Strategic Preparedness and Response (ASPR) [6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September 2024 Commission File No.:001-35773 REDHILL BIOPHARMA LTD. 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F ☒ Form 40-F ☐ Indicate by ...

Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates th ...