Core Viewpoint - RedHill Biopharma received positive FDA feedback for its RHB-204 Crohn's disease development program, indicating a promising pathway to approval for a potentially groundbreaking therapy targeting the root cause of the disease [1][2]. Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [15]. - The company is actively pursuing non-dilutive funding options for its RHB-204 program, including grant applications and discussions with external funding sources [1][10]. Product Development - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and patient adherence, with a 40% reduction in pill burden [5][13]. - The drug is patent protected until 2041 and is expected to receive pediatric orphan drug designation, along with potential breakthrough therapy and fast track designations [1][10][14]. - The Phase 2 study of RHB-204 will be the first clinical trial targeting a specific population of Mycobacterium avium subspecies paratuberculosis infected Crohn's disease patients, aiming to address both the cause and symptoms of the disease [2][6]. Clinical Study Insights - The primary endpoints of the Phase 2 study will focus on mucosal remission, which is considered a new gold standard in efficacy evaluation for Crohn's disease, correlated with MAP status and clinical remission [4]. - The study design allows for a smaller sample size, which could lead to lower costs and faster completion times [4][6]. Market Potential - The Crohn's disease market is projected to grow significantly, with sales expected to increase from $13.6 billion in 2024 to over $19 billion by 2033, representing a compound annual growth rate (CAGR) of 3.87% [9]. - Up to 40% of Crohn's disease patients do not respond to existing anti-TNF treatments, highlighting the need for new, effective therapies like RHB-204 [8]. Competitive Landscape - Current FDA-approved therapies for Crohn's disease include Abbvie's Humira, Janssen's Remicade, and others, which are often expensive and have known safety issues [11][8]. - RHB-204 aims to provide a safe and effective oral therapy alternative, potentially transforming treatment options for Crohn's disease patients [7][8].

Corporate Overview - RedHill Biopharma is an emerging U S specialty biopharmaceutical company focused on gastrointestinal, infectious diseases, and oncology[9] - The company has a streamlined U S commercial organization and a robust development pipeline with multiple near-term milestones[9] - As of December 31, 2024, RedHill Biopharma had a cash balance of $4 8 million[18] - For FY24, RedHill Biopharma reported net revenues of $8 0 million and a gross margin of 60 3%[9, 18] - The company's market capitalization is approximately $4 4 million[18] Talicia® - Talicia® is the No 1 branded U S Rx for H pylori and is listed as a first-line option in the ACG guideline[9, 28, 44] - In a Phase 3 study, Talicia® demonstrated 84% eradication of H pylori in the ITT population versus 58% with the active comparator (p<0 0001)[59] - In the confirmed adherent population, Talicia® achieved a 90% eradication rate compared to 65% with the active comparator (p<0 0001)[59] - Talicia® has broad U S managed care coverage, covering 7 out of 10 commercial lives and 6 out of 10 government lives[48] Pipeline Products - Opaganib is under U S Government collaboration for evaluation as a potential medical countermeasure for GI-ARS[12, 75] - RHB-102 has positive results from a first Phase 3 U S study for Gastroenteritis[12] - RHB-104 has positive results from the first Phase 3 "MAP US" study for Crohn's disease[12]

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 Insights - RedHill Biopharma Ltd. supports an independent medical education grant for a new two-part H. Pylori Continuing Medical Education (CME) program aimed at enhancing clinical knowledge and improving patient outcomes [1][3] - H. pylori is a significant health concern, classified as a Group 1 carcinogen by WHO, affecting nearly 50% of the global population and representing a billion-dollar market opportunity [1][5] - Talicia® is highlighted as the leading branded therapy for H. pylori, being the only FDA-approved all-in-one, low-dose rifabutin-based treatment [1][6] Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [18] - The company promotes Talicia for the treatment of H. pylori infection in adults and plans to submit a Marketing Authorisation Application (MAA) for Talicia in the UK [6][18] H. Pylori Infection Insights - H. pylori infection affects approximately 50% of the global adult population and is the strongest known risk factor for gastric cancer, causing 70% to 90% of cases [5][7] - The infection is also a major risk factor for peptic ulcer disease, with eradication becoming increasingly difficult due to high antibiotic resistance [7][8] CME Program Details - The CME program consists of two parts: - Part 1: A livestreamed expert panel on May 6, 2025, focusing on antibiotic resistance and guideline-directed therapies [3][4] - Part 2: An interactive online discussion scheduled for June 2025, addressing challenges in H. pylori diagnosis and treatment [4][5] Talicia Overview - Talicia is a fixed-dose, all-in-one oral capsule combining amoxicillin, rifabutin, and omeprazole, approved by the FDA in November 2019 [8][9] - The drug has received eight years of U.S. market exclusivity and is protected by patents extending until 2034 [8][18]

Core Insights - RedHill Biopharma has received a critical composition-of-matter patent for RHB-107, enhancing its market exclusivity in the COVID-19 therapeutic space, which is projected to exceed $3 billion by 2025 [1][2] - RHB-107 has shown promising results in a U.S. Phase 2 study, achieving a 100% reduction in hospitalization rates among treated patients compared to a 15% hospitalization rate in the placebo group [2] - The drug is designed to be a broad-acting antiviral that targets human serine proteases, potentially effective against various SARS-CoV-2 variants [3][4] Company Overview - RedHill Biopharma focuses on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology, with a notable product being Talicia for H. pylori infection [5] - The company has a diverse pipeline, including RHB-204 for Crohn's disease and opaganib for cancer and COVID-19, indicating a strong commitment to addressing multiple health challenges [5] Clinical Data - In the Phase 2 study, RHB-107 demonstrated a 100% reduction in hospitalization (0/41) versus 15% (3/20) in the placebo group, with a nominal p-value of 0.0317, and an 88% reduction in new severe COVID-19 symptoms [2] - The study also indicated faster recovery times, with a median recovery of 3 days for RHB-107 compared to 8 days for placebo [2] Patent and Market Position - The newly allowed patent in China strengthens RedHill's intellectual property portfolio and expands its presence in Asia, a significant pharmaceutical market [2] - RHB-107's unique mechanism of action, targeting host cells rather than the virus directly, positions it as a potential alternative to existing treatments like Pfizer's Paxlovid [2][3]

Core Viewpoint - RedHill Biopharma Ltd. has received a Notification Letter from Nasdaq indicating non-compliance with listing requirements due to a stockholders' deficit of $4,683,000, but this does not immediately affect its listing or operations [1][2][3]. Group 1: Compliance Status - The company is required to maintain a minimum of $2,500,000 in stockholders' equity for continued listing on the Nasdaq Capital Market [2]. - As of the fiscal year ended December 31, 2024, the company reported a stockholders' deficit of $4,683,000, leading to non-compliance with Nasdaq Listing Rule 5550(b)(1) [2]. - The company has 45 days to submit a plan to regain compliance, with a deadline of May 30, 2025, and if accepted, Nasdaq may grant an extension of up to 180 days [3][4]. Group 2: Company Operations and Plans - The company is exploring various options to regain compliance and intends to submit its compliance plan as soon as possible [4]. - There is no assurance that the company's compliance plan will be accepted or that it will successfully regain compliance with the Nasdaq listing requirements [4]. Group 3: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company 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, including opaganib, RHB-204, RHB-104, RHB-107, and RHB-102 [5].

Core Insights - Opaganib demonstrates comparable efficacy to semaglutide in promoting weight loss and improving metabolic markers in preclinical models, indicating its potential as a competitive treatment in the obesity and diabetes market [1][2] - The global obesity-diabetes drugs market is projected to reach approximately $100 billion by 2034, primarily driven by GLP-1 inhibitors [1][2] - Opaganib's unique mechanism of action as a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor may provide a significant advantage by avoiding common side effects associated with GLP-1 inhibitors [1][3] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [12] - The company is advancing multiple clinical programs, including opaganib, which targets various indications such as obesity, diabetes, and several cancers [12][10] - Opaganib has shown positive results in preclinical studies for renal fibrosis and has potential applications in multiple oncology, viral, and inflammatory diseases [11] Clinical Development - Opaganib has demonstrated safety and tolerability in over 470 subjects across various clinical studies, which may facilitate its FDA approval process [1][9] - The drug has received orphan-drug designations from the FDA for oncology and other diseases, indicating its potential for addressing unmet medical needs [10] - A Phase 2 study is underway to evaluate opaganib in combination with Bayer's darolutamide for metastatic castrate-resistant prostate cancer [7] Market Potential - The obesity-diabetes drugs market is rapidly expanding, with significant contributions from existing GLP-1 inhibitors, creating a competitive landscape for new entrants like opaganib [1][2] - Opaganib's ability to modulate multiple signaling pathways through the inhibition of sphingolipid-metabolizing enzymes positions it as a promising candidate in the multi-billion-dollar obesity and diabetes market [2][5]

For the month of April 2025 Commission File No.:001-35773 REDHILL BIOPHARMA LTD. (Translation of registrant's name into English) 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 Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel Form 20-F ☒ Form 40-F ☐ Attached ...

Core Insights - RedHill Biopharma Ltd. reported a 23% increase in net revenues for 2024, reaching $8.0 million compared to $6.5 million in 2023, driven by cost-cutting measures and strategic partnerships [4][5][12] - The company has undergone significant restructuring, focusing on maximizing value from its commercial and R&D assets, including a global licensing deal for RHB-102 worth up to $60 million [2][4] - Talicia, a key product, has been recognized as a first-line therapy for H. pylori eradication, securing formulary wins covering 25 million lives and showing promising growth potential in new markets [2][20] Financial Performance - Net revenues for the year ended December 31, 2024, were $8.0 million, up from $6.5 million in 2023, with Talicia contributing $9.0 million in revenues [5][41] - Gross profit increased to $4.9 million in 2024 from $3.1 million in 2023, attributed to higher net revenues and reduced inventory write-downs [6][41] - Operating loss for 2024 was $14.6 million, compared to an operating income of $12.6 million in 2023, influenced by the Movantik divestiture [10][41] Cost Management - Research and development expenses decreased to $1.6 million in 2024 from $3.5 million in 2023, reflecting cost-reduction measures [7][41] - Selling, marketing, and general administrative expenses were reduced to $15.5 million in 2024 from $31.0 million in 2023, primarily due to workforce downsizing and divestment of Movantik [8][41] Product Development and Pipeline - The company is advancing RHB-204 into a Phase 2 clinical study for Crohn's disease, supported by positive Phase 3 data from RHB-104 [2][28] - Opaganib is being developed for multiple indications, including a Bayer-supported Phase 2 study in metastatic castrate-resistant prostate cancer [2][22][23] - Ongoing government-supported programs for Ebola and gastrointestinal acute radiation syndrome (GI-ARS) are also part of the company's pipeline [21][30] Market Expansion - Talicia has been launched in the UAE and is preparing for a potential UK Marketing Authorisation Application (MAA) [2][4] - The company aims to leverage its partnerships and product advancements to enter additional global markets [2][20] Strategic Partnerships - The global licensing agreement with Hyloris Pharmaceuticals for RHB-102 is expected to enhance development and commercialization efforts outside North America [2][4] - The company is actively pursuing funding opportunities and partnerships to support its R&D initiatives and product advancements [28][30]

Financial Position and Cash Flow - As of December 31, 2024, the company had a cash balance of approximately $4.8 million, down from $6.5 million as of December 31, 2023[36]. - The company reported a net cash used in operating activities of $9.4 million for the year ended December 31, 2024[28]. - The company has estimated obligations of $6.7 million under the Global Termination Agreement as of December 31, 2024[28]. - The company’s current working capital is insufficient to commercialize Talicia® or complete research and development for its therapeutic candidates[35]. - The company’s current cash resources are insufficient to fully support its commercial operations until sustainable positive cash flows are generated[51]. - The company experienced a net loss of approximately $8.3 million in 2024, a net income of approximately $23.9 million in 2023, and a net loss of approximately $71.7 million in 2022, with an accumulated deficit of approximately $414.8 million as of December 31, 2024[52]. Business Viability and Strategic Plans - The company’s ability to continue as a going concern is in doubt due to insufficient resources to fund operations for the next twelve months[28]. - The company lost its primary revenue source following the sale of Movantik® in February 2023, significantly impacting its market share and operational viability[34]. - The company plans to fund future operations through the commercialization of Talicia® and other products, but will need to raise significant additional capital[36]. - The company plans to fund future operations through commercialization and out-licensing of therapeutic candidates, as well as raising significant additional capital through equity or debt financing[51]. - The company is actively pursuing strategic business transactions to raise additional capital, but there are no assurances of success[29]. Regulatory and Compliance Challenges - The company has identified a material weakness in internal control over financial reporting, which was disclosed in its Annual Report for the years ended December 31, 2022, and December 31, 2023[46]. - The company is subject to numerous regulatory requirements that govern clinical trials, manufacturing, and marketing authorization, which could impact revenue generation[120]. - Compliance with FDA regulations and guidelines is critical for the manufacturing and commercialization of Talicia® and other therapeutic candidates, with potential sanctions for non-compliance[129]. - Regulatory approvals are limited to specific indications, and the FDA may impose Risk Evaluation and Mitigation Strategies (REMS) that could restrict marketability[132]. - The company must navigate extensive regulations regarding marketing and promotional practices, with non-compliance potentially resulting in significant sanctions[194]. Market and Competitive Landscape - The healthcare industry faced challenging market conditions in 2024, which may continue to hinder the company’s ability to raise capital in the future[39]. - The pharmaceutical market is highly competitive, with significant competition from other companies developing similar therapeutic candidates and products[165][168]. - Talicia® faces competition from both branded and generic therapies extensively used for H. pylori treatment[167]. - Competitors with greater financial capabilities and resources may outperform the company in the commercialization of products[86]. - The company competes with other entities for in-license or acquisition opportunities, which may hinder growth if unable to secure favorable terms[102]. Operational Risks and Challenges - The company may face difficulties in managing growth and integrating new personnel to expand its commercialization capabilities[63]. - High turnover rates have historically affected the U.S. subsidiary, RedHill U.S., which may impact the integration of new sales personnel[66]. - The reliance on external partners for key functions such as clinical development and commercialization may affect the company's ability to achieve significant results[68]. - The company faces risks associated with potential defaults by collaborators, which could lead to renegotiation or termination of agreements[70]. - The company may need to expand its commercialization capabilities, including development, regulatory, manufacturing, sales, and marketing, to accommodate sales growth[64]. Clinical Development and Product Pipeline - The company has five therapeutic candidates in development, most of which are in clinical stage development, aiming for FDA or other foreign regulatory approvals[119]. - The ongoing Phase 2 trial for RHB-107 is at risk of termination due to funding issues, with only 100 out of a target of 300 patients enrolled[162]. - The FDA granted orphan drug designation to RHB-104 for treating Crohn's disease in pediatric patients, RHB-107 for pancreatic cancer, and RHB-204 for nontuberculous mycobacteria infections, with the latest designation for opaganib for neuroblastoma in 2024[152][153]. - Orphan drug designation provides financial incentives, including grant funding for clinical trials, tax advantages, and a seven-year exclusivity period upon first FDA approval for the designated disease[153][154]. - The company relies on contract research organizations for clinical data management, which poses risks if these organizations fail to meet contractual obligations, potentially delaying clinical studies[151]. Intellectual Property and Legal Risks - The company manages a large patent portfolio, with potential decisions to discontinue maintaining certain patents based on market viability[105]. - The ability to protect intellectual property rights is uncertain, which could lead to loss of market share and anticipated profits[217]. - Patent rights are territorial, and the company may face challenges in enforcing these rights in various jurisdictions[221]. - Litigation may be necessary to enforce patent rights, which is expensive and unpredictable, potentially impairing the company's ability to prevent competition[222]. - The lengthy development and regulatory approval process for therapeutic candidates may result in early patent expirations, diminishing market advantages[225]. Economic and Market Conditions - Global economic conditions are challenging commercialization efforts for Talicia® and future products, with patients potentially switching to generics or delaying treatments due to increased costs[203]. - Changes in foreign exchange rates and political unrest in international jurisdictions could materially affect the company's operations[111]. - Tariff policies may increase raw material costs and disrupt the supply chain, negatively impacting operational results[204]. - Federal and state proposals to constrain expenditures for medical products may adversely affect reimbursement rates for current and future products[187]. Reimbursement and Pricing Pressures - The reimbursement approval process for Talicia® and other products is time-consuming and costly, with historical limitations on reimbursement coverage impacting commercial prospects[186]. - Third-party payors may impose coverage restrictions that could limit the use of Talicia® and affect revenue[185]. - Changes in U.S. healthcare reform, such as the ACA, could significantly impact reimbursement and market dynamics for Talicia®[175]. - The Inflation Reduction Act of 2022 introduces price negotiations for certain drugs, which may significantly affect the pharmaceutical industry[183]. - Heightened scrutiny over drug pricing may lead to new legislation affecting product pricing and reimbursement methodologies, impacting revenue generation[192].