Core Insights - Cumberland Pharmaceuticals reported a 31% increase in fourth quarter 2025 net revenues, totaling $13.7 million, compared to the same period last year [1] - For the full year 2025, net revenues reached $44.5 million, an 18% increase year-over-year, achieving the company's goal of double-digit revenue growth [1] - The company ended 2025 with total assets of $76.8 million, liabilities of $52.3 million, and shareholders' equity of $24.9 million [1] Financial Performance - The net loss for 2025 was $2.9 million, an improvement of $3.6 million from the previous year [1] - Adjusted earnings for the year were $1.7 million, reflecting a $2.7 million improvement over 2024 [1] - Cash flow from operations was $4.9 million in 2025, representing a $5.5 million increase compared to 2024 [1] International Expansion - In February 2025, Cumberland's Vibativ® received approval in China, with SciClone Pharmaceuticals granted exclusive rights for registration and distribution [1] - The launch of Vibativ in Saudi Arabia occurred in September 2025, following an agreement with Tabuk Pharmaceutical Manufacturing Company [1] - In October 2025, Cumberland's ibuprofen injection product received regulatory approval in Mexico, with PiSA Farmaceutica obtaining exclusive distribution rights [1] Expanded Commercial Portfolio - Cumberland announced a co-commercialization agreement with RedHill Biopharma Ltd. for Talicia®, an FDA-approved treatment for H. pylori infection [1] - Talicia is now recommended as a first-line therapy in the American College of Gastroenterology clinical guidelines and is patent protected until 2042 [1] Reimbursement Milestones - Caldolor® received a permanent J-code (J1741) in December 2025, facilitating a defined reimbursement pathway for healthcare providers [1] - This milestone supports the adoption of Caldolor as a non-opioid option for pain management, enhancing access for patients [1] Clinical Developments - Cumberland announced positive top-line results from the FIGHT DMD clinical trial for ifetroban, a treatment for Duchenne muscular dystrophy heart disease [1] - The trial showed significant improvements in left ventricular ejection fractions (LVEF) for patients treated with high-dose ifetroban compared to controls [1] - Ifetroban received Orphan Drug and Rare Pediatric Disease designations from the FDA, along with Fast Track Designation for further development [1]

Core Insights - The full sales and operational launch of Talicia, a leading H. pylori therapy, has commenced under a joint commercialization agreement between Talicia Holdings Inc. and Cumberland Pharmaceuticals, aiming for accelerated market penetration and expanded reach [1][2] - Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy for H. pylori, addressing antibiotic resistance and recommended as a first-line treatment in the 2024 ACG Clinical Guideline [1][2] - H. pylori infection affects approximately 35% of the U.S. adult population, with an estimated 1.6 million patients treated annually, highlighting the significant market potential for Talicia [1][2] 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 [2] - The company has entered a co-commercialization agreement with Cumberland Pharmaceuticals to promote Talicia in the U.S. market [1][2] - Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation and is patent protected until 2042 [1][2] Market Context - H. pylori is classified as a Group 1 carcinogen by the WHO and is a major risk factor for gastric cancer, with approximately 11,000 related deaths in the U.S. annually [1][2] - The increasing antibiotic resistance of H. pylori complicates treatment, with current therapies failing in 25-40% of patients, emphasizing the need for effective solutions like Talicia [1][2] - The company is also exploring potential new market entries in the UK and the Middle East to expand patient access to Talicia globally [1][2]

Core Viewpoint - Cumberland Pharmaceuticals Inc. will announce its 2025 financial results and provide a company update on March 3, 2026, after market close, followed by a conference call to discuss the results [1] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products for hospital acute care, gastroenterology, and oncology market segments [1] - The company’s portfolio includes several FDA-approved products such as Talicia®, Vibativ®, Vaprisol®, Sancuso®, Kristalose®, Caldolor®, and Acetadote® [1] Product Details - Talicia® is an oral capsule for treating H. pylori infection - Vibativ® is an injection for serious bacterial infections, including hospital-acquired pneumonia - Vaprisol® is an injection used to raise serum sodium levels in hospitalized patients - Sancuso® is a transdermal system for preventing nausea and vomiting in chemotherapy patients - Kristalose® is a prescription laxative for treating constipation - Caldolor® is an injection for pain and fever management - Acetadote® is an injection for treating acetaminophen poisoning [1] Clinical Programs - The company is conducting Phase II clinical programs for its ifetroban product candidate, targeting conditions such as Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis [1]

Israel 2834 Not Applicable (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on January 22, 2026 Registration No. 333-292528 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REDHILL BIOPHARMA LTD. (Exact name of Registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) (State or other jurisdiction o ...

Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 As filed with the Securities and Exchange Commission on December 31, 2025 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REDHILL BIOPHARMA LTD. (Exact name of Registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) (Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices) RedHill Biopharma In ...

Core Points - The New York Supreme Court awarded RedHill approximately $1.82 million in legal costs and expenses, in addition to a prior summary judgment of approximately $8.25 million in favor of RedHill against Kukbo Co. Ltd [1][2] - Both awards include a 9% ongoing statutory interest accrual [2] - RedHill successfully obtained an attachment grant from Korea's Incheon District Court against Kukbo, allowing for the seizure of Kukbo's assets [2] 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 [4] - The company promotes the FDA-approved gastrointestinal drug Talicia® for treating Helicobacter pylori infection in adults [4] - Key clinical late-stage development programs include: - Opaganib (ABC294640), targeting multiple indications including COVID-19 and prostate cancer [4] - RHB-204, aimed at Crohn's disease and pulmonary nontuberculous mycobacteria [4] - RHB-107 (upamostat), in late-stage development for non-hospitalized symptomatic COVID-19 and other diseases [4] - RHB-102, with potential applications for chemotherapy-induced nausea and vomiting [4]

Core Insights - The article discusses the initiation of a Phase 2 study evaluating the combination of opaganib and darolutamide in patients with advanced prostate cancer, sponsored by ANZUP and supported by Bayer and Ramsay Hospital Research Foundation [1][2] - Prostate cancer is a significant global health issue, with approximately 1.5 million new cases and nearly 400,000 deaths annually, representing a market worth around $12 billion [1][5] Study Overview - The Phase 2 study will involve 60 participants and is designed to assess the efficacy of opaganib in overcoming resistance to standard androgen receptor pathway inhibitors [2][3] - The study will utilize the PCPro lipid biomarker test to identify patients with poor prognosis who may benefit from the treatment combination [3][5] - The primary endpoint of the study is to improve 12-month radiographic progression-free survival (rPFS), with several secondary and exploratory endpoints also being evaluated [3] Prostate Cancer Context - Prostate cancer is the second most diagnosed cancer globally, with a significant increase in cases, nearly 120% from 1990 to 2019 [6] - The survival rates for prostate cancer vary significantly by stage, with a 100% five-year survival rate for Stage 1, dropping to 28% for Stage 4 [7] Androgen Receptor Pathway Inhibitors (ARPI) - ARPI is a key therapeutic strategy for treating castration-resistant prostate cancer, targeting male hormones that promote cancer cell growth [8] - Darolutamide is one of the key therapeutic options in this category, alongside enzalutamide and apalutamide [8] Opaganib Profile - Opaganib is an investigational drug with anticancer, anti-inflammatory, and antiviral properties, targeting multiple indications including various cancers [9][10] - The drug works by inhibiting multiple pathways and has shown potential in enhancing the efficacy of androgen receptor signaling inhibitors [4][10] Company Background - RedHill Biopharma is focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology, with opaganib being a key part of its late-stage development programs [18]

Core Points - RedHill Biopharma Ltd. has secured a court ruling in its favor against Kukbo Co. Ltd., with a summary judgment amounting to approximately $8.25 million plus legal fees and costs [1][3] - The New York Supreme Court dismissed all counterclaims made by Kukbo, reinforcing RedHill's position in the legal dispute [1] - An attachment petition in South Korea has been granted, preventing Kukbo from disposing of its assets prior to enforcement of the judgment [1][2] Financial Implications - The summary judgment includes approximately $1.75 million in accrued interest at a rate of 9%, due to Kukbo's failure to adhere to the terms of subscription and licensing agreements [3] - Legal fees and costs are also recoverable as per the court's ruling, indicating potential additional financial recovery for RedHill [3] Legal Context - Kukbo has filed a notice of appeal against the judgment, with a six-month window to perfect its appeal, which may be extended [4] - The outcome of the appeal process could impact the enforcement of the judgment and the collection of the awarded amount [4] Company Overview - RedHill Biopharma is focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [5] - The company promotes the FDA-approved drug Talicia® for treating H. pylori infection and has several late-stage clinical development programs targeting various diseases [5]