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]

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 ...

A transformed RedHill: Numerous potential catalysts Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborations Addressing substantial and underserved indicatio ...

Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths[1],[2] Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits The neuroblastoma market i ...

Core Viewpoint - RedHill Biopharma has launched Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori infection, in the UAE, which opens up eligibility for additional milestone payments and royalties for the company [1][2]. Group 1: Product Launch and Market Impact - Talicia is now available by prescription in the UAE for adults with H. pylori infection, which affects 41% of the UAE population and over 50% of the global adult population [1][3]. - The launch of Talicia triggers RedHill's eligibility for potential milestone payments, minimum sales payments, and tiered royalties up to mid-teens on net sales [1][2]. - Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori treatment [1]. Group 2: Medical Need and Efficacy - H. pylori is a significant public health concern, being a major risk factor for gastric cancer, with traditional clarithromycin-based therapies showing declining effectiveness [2][4]. - A 2021 study indicated only 68.5% eradication with clarithromycin-based therapy, which dropped to 32% in patients with resistant H. pylori [2][3]. - Talicia demonstrated an 84% eradication rate in a pivotal Phase 3 study, significantly higher than the 58% rate in the active comparator arm [5][6]. Group 3: Product Composition and Resistance - Talicia is a fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), specifically designed to combat high resistance rates of H. pylori to other antibiotics [4][5]. - Minimal to zero resistance to rifabutin was detected in the pivotal Phase 3 study, highlighting its effectiveness [5][6]. Group 4: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, promoting Talicia for H. pylori and Aemcolo for travelers' diarrhea [9]. - The company is engaged in various late-stage development programs targeting multiple indications, including COVID-19 and oncology [9].