Joint U.S. Commercialization of RedHill's Talicia® Commences [Accessibility Statement] Skip NavigationThe full sales and operational launch of Talicia, under the joint commercialization agreement between Talicia Holdings Inc. (THI), a jointly controlled entity of RedHill and Cumberland has started and is now being rolled out to support accelerated market penetration and expanded reachFocused on unlocking the full market potential of Talicia, the #1 branded U.S. gastroenterologist-prescribed H. pylori therap ...

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 ...

Core Viewpoint - Redhill Biopharma Ltd's stock experienced a decline following a significant rally, attributed to profit-taking after a 36% increase on the previous day, coinciding with the announcement of development progress for RHB-102 in various gastrointestinal indications [1] Group 1: Product Development - RHB-102 is a patent-protected bimodal, immediate and extended-release oral formulation of the 5HT3 antagonist ondansetron, designed to enhance titration success and mitigate early discontinuation of GLP-1/GIP-based diabetes and weight loss therapies [2] - The company is pursuing potential U.S. FDA approval for RHB-102 for oncology support, with additional applications for post-operative nausea and vomiting (PONV) [3] Group 2: Clinical Data and Market Impact - Extensive clinical and non-clinical data will support the potential FDA approval of RHB-102 for various gastrointestinal conditions, including gastroenteritis, IBS-D, and GLP-1/GIP receptor agonist therapy-associated GI side effects [4] - Results from the Phase 3 GUARD gastroenteritis study and the positive Phase 2 IBS-D study, both meeting their primary endpoints, will bolster the evidence for RHB-102's approval [5] - Over 2% of Americans are currently using GLP-1 receptor agonists, with estimates indicating that up to 50% of patients discontinue these therapies within three months due to GI side effects, which significantly impacts market valuations [6][7]

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 Insights - Resistance to venetoclax, a $2.5 billion therapy for Chronic Lymphocytic Leukemia (CLL), is becoming a significant therapeutic challenge as leukemic cells persist despite combination therapies [1][3] - New in vivo studies indicate that the addition of opaganib, a potent sphingosine kinase 2 (SPHK2) inhibitor, to venetoclax can reduce CLL cell counts by 50% compared to controls, suggesting its potential as an add-on therapy for venetoclax-resistant CLL [1][2] - Opaganib has demonstrated a favorable safety and tolerability profile in over 470 clinical trials and is being evaluated for multiple indications, including oncology and viral infections [1][9] 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 drug Talicia for treating Helicobacter pylori infections and is advancing several late-stage clinical programs, including opaganib [12][13] - Opaganib is currently undergoing a Phase 2 clinical trial in combination with darolutamide for advanced prostate cancer, highlighting its broad therapeutic potential [1][7] Product Insights - Venetoclax, approved by the FDA in 2016, is a first-in-class BCL-2 inhibitor that has become a cornerstone of CLL therapy, achieving sales of approximately $2.5 billion in 2024 [3] - Opaganib is a first-in-class, orally administered drug with anticancer, anti-inflammatory, and antiviral activities, targeting multiple indications including various cancers and viral diseases [6][10] - The drug has received orphan-drug designations from the FDA for cholangiocarcinoma and neuroblastoma, indicating its potential in treating rare diseases [7]

Core Insights - RedHill Biopharma Ltd. has regained compliance with Nasdaq's stockholders' equity requirement, confirming that its stockholders' equity exceeds the minimum requirement of $2.5 million [1][7]. Group 1: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on the U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [3]. - The company promotes Talicia, an FDA-approved drug for treating Helicobacter pylori infection in adults, and has a co-commercialization agreement with Cumberland Pharmaceuticals [3][2]. Group 2: Strategic Initiatives - In 2025, RedHill is pursuing strategic initiatives, including the partnership for Talicia and a focus on operational efficiency [2]. - The company is advised by Donohoe Advisory in its compliance process with Nasdaq [2]. Group 3: Clinical Development Programs - RedHill's key late-stage clinical development programs include: - Opaganib (ABC294640), targeting multiple indications including COVID-19 and prostate cancer [3]. - RHB-204, aimed at Crohn's disease and pulmonary nontuberculous mycobacteria disease [3]. - RHB-102, with positive results for acute gastroenteritis and potential submissions for chemotherapy-induced nausea [3]. - RHB-107 (upamostat), in late-stage development for non-hospitalized symptomatic COVID-19 and other diseases [3].

Core Viewpoint - RedHill Biopharma Ltd. has achieved a favorable summary judgment from the New York Supreme Court against Kukbo Co. Ltd, resulting in a total award exceeding $10.5 million, which is now eligible for enforcement and foreign recognition [1][2]. Financial Summary - The court awarded RedHill approximately $8.6 million as the main judgment, which is now final and enforceable [2]. - Additionally, RedHill was awarded approximately $1.9 million for legal fees and expenses, which remains subject to appeal until March 13, 2026 [2]. - A 9% annual statutory interest continues to accrue on both awards [2]. Legal Developments - RedHill has secured a court attachment in Korea against Kukbo to prevent asset disposal prior to the enforcement of the judgment [3]. Company Overview - RedHill Biopharma Ltd. focuses on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [4]. - The company promotes the FDA-approved drug Talicia for treating Helicobacter pylori infection in adults, co-commercialized with Cumberland Pharmaceuticals [4]. - Key clinical programs include: - Opaganib, targeting multiple indications including COVID-19 and prostate cancer [4]. - RHB-204, aimed at Crohn's disease and pulmonary nontuberculous mycobacteria [4]. - RHB-107, in late-stage development for symptomatic COVID-19 and other diseases [4]. - RHB-102, with positive results for chemotherapy-induced nausea and vomiting [4].

Core Insights - Cumberland Pharmaceuticals Inc. has announced a strategic partnership with RedHill Biopharma Ltd. to jointly commercialize Talicia, an FDA-approved therapy for Helicobacter pylori infection, which is a significant risk factor for gastric cancer [1][2][3] Company Overview - Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on improving patient care through high-quality products, with a portfolio that includes various FDA-approved brands [7] - RedHill Biopharma is a specialty biopharmaceutical company primarily focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [9] Partnership Details - The agreement involves forming a new jointly owned company where RedHill will contribute all Talicia assets, including international licenses and revenues, while Cumberland will invest $4 million and manage distribution and sales [2][4] - Talicia generated net revenues of $8 million in 2024, and both companies will share these revenues equally while collaborating on operational aspects such as sales, marketing, and supply chain [2][4] Product Information - Talicia is a unique all-in-one oral capsule combining omeprazole, amoxicillin, and rifabutin, with a high eradication rate of over 90%, simplicity of use, and low resistance [3][6] - The product is recognized as a first-line treatment option in the updated American College of Gastroenterology guidelines for H. pylori infections [3] Market Position - Talicia is patent-protected until 2042 and has received eight years of U.S. market exclusivity under the Qualified Infectious Disease Product (QIDP) designation [4][6] - The product has broad U.S. insurance coverage, with 70% of American lives covered by commercial plans and 60% by government plans, and is available at 1,700 CVS pharmacies [5]

Core Insights - The licensing agreement for Talicia aims to enhance its market presence in the Middle East, with a total potential value of $1.8 million plus sales royalties [1][2]. Financial Terms - RedHill will receive $500,000 in guaranteed payments, which includes a $250,000 upfront payment and another $250,000 in fixed payments due within 18 months [2]. - There is a potential for a minimum of $1.3 million in near-term milestone payments, along with tiered royalties that could reach mid-teens percentage on Talicia's net sales [2]. Product Overview - Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy specifically targeting H. pylori antibiotic resistance [1][4]. - It is the leading branded therapy prescribed by U.S. gastroenterologists for H. pylori and is recognized as a first-line treatment in the American College of Gastroenterology Clinical Guidelines [4]. Market Need - H. pylori infection affects over 50% of the global adult population, with rates nearing 80% in certain Middle Eastern regions, and is classified as a Group 1 carcinogen by WHO, significantly increasing the risk of gastric cancer [1][6]. - Effective treatment for H. pylori is critical, especially given the rising antibiotic resistance, which complicates treatment regimens that include clarithromycin [3][6]. Clinical Efficacy - Talicia has demonstrated an efficacy rate of up to 90% in eradicating H. pylori, with a significant advantage over traditional therapies that may fail in 25-40% of cases due to antibiotic resistance [3][6]. - The eradication of H. pylori can lead to a 75% reduction in gastric cancer risk, highlighting the importance of effective treatment options [3]. Intellectual Property - Talicia is protected by patents until 2042 and has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product designation [5][9].

Core Points - The New York Supreme Court upheld its ruling in favor of RedHill Biopharma, dismissing Kukbo Co. Ltd's defense and confirming Kukbo's breach of agreements [1][2] - RedHill has been awarded approximately $10 million, which includes an original award of $8.25 million and an additional $1.82 million for legal costs and expenses [1][2] - RedHill also secured an attachment grant from Korea's Incheon District Court, allowing for the seizure of Kukbo's assets to prevent disposal before judgment enforcement [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 [3] - The company promotes the FDA-approved drug Talicia for treating H. pylori infections in adults [3] - Key clinical programs include opaganib for various indications, RHB-204 for Crohn's disease, RHB-107 for symptomatic COVID-19, and RHB-102 for chemotherapy-induced nausea [3]