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]

[UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS](index=3&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20INTERIM%20FINANCIAL%20STATEMENTS) This section presents the unaudited interim financial statements, detailing comprehensive loss, financial position, equity, and cash flows [Condensed Consolidated Interim Statements of Comprehensive Loss](index=3&type=section&id=Condensed%20consolidated%20interim%20statements%20of%20comprehensive%20loss) For the six months ended June 30, 2025, RedHill Biopharma Ltd. reported increased net revenues but also a higher comprehensive loss compared to the same period in 2024, primarily driven by changes in financial income and expenses | Metric (U.S. dollars in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | NET REVENUES | 4,079 | 2,572 | | GROSS PROFIT | 2,472 | 1,168 | | OPERATING LOSS | (4,378) | (8,448) | | FINANCIAL INCOME, net | 245 | 5,360 | | LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | (4,133) | (3,088) | | LOSS PER ORDINARY SHARE, basic and diluted | 0.00 | 0.00 | - Net revenues increased by **58.2%** from **$2,572 thousand** in H1 2024 to **$4,079 thousand** in H1 2025[5](index=5&type=chunk) - Operating loss significantly improved from **$(8,448) thousand** in H1 2024 to **$(4,378) thousand** in H1 2025[5](index=5&type=chunk) - Net financial income decreased substantially from **$5,360 thousand** in H1 2024 to **$245 thousand** in H1 2025, contributing to a higher comprehensive loss[5](index=5&type=chunk) [Condensed Consolidated Interim Statements of Financial Position](index=4&type=section&id=Condensed%20consolidated%20interim%20statements%20of%20financial%20position) As of June 30, 2025, the company's total assets slightly increased compared to December 31, 2024, while total liabilities also saw a minor increase, and the capital deficiency improved | Metric (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | TOTAL ASSETS | 18,375 | 18,043 | | TOTAL LIABILITIES | 22,787 | 22,726 | | TOTAL CAPITAL DEFICIENCY | (4,412) | (4,683) | | Cash and cash equivalents | 2,866 | 4,617 | | Trade receivables | 5,350 | 2,539 | | Allowance for deductions from revenue | 10,541 | 9,288 | - Cash and cash equivalents decreased by approximately **37.8%** from **$4,617 thousand** at December 31, 2024, to **$2,866 thousand** at June 30, 2025[8](index=8&type=chunk) - Trade receivables increased significantly by approximately **110.7%** from **$2,539 thousand** to **$5,350 thousand**[8](index=8&type=chunk) - Allowance for deductions from revenue increased by approximately **13.5%** from **$9,288 thousand** to **$10,541 thousand**[8](index=8&type=chunk) [Condensed Consolidated Interim Statements of Changes in Equity (Capital Deficiency)](index=5&type=section&id=Condensed%20consolidated%20interim%20statements%20of%20changes%20in%20equity%20(capital%20deficiency)) The statements show a reduction in the total capital deficiency from $(4,683) thousand at January 1, 2025, to $(4,412) thousand at June 30, 2025, primarily influenced by share issuances and share-based compensation, partially offset by the comprehensive loss for the period | Metric (U.S. dollars in thousands) | January 1, 2025 | June 30, 2025 | January 1, 2024 | June 30, 2024 | | :--------------------------------- | :-------------- | :------------ | :-------------- | :------------ | | BALANCE AT BEGINNING OF PERIOD | (4,683) | N/A | 2,069 | N/A | | Share-based compensation | N/A | 815 | N/A | 766 | | Issuance of ordinary shares | N/A | 3,589 | N/A | 314 | | Comprehensive loss | N/A | (4,133) | N/A | (3,088) | | BALANCE AT END OF PERIOD | N/A | (4,412) | N/A | 61 | - Issuance of ordinary shares (net of costs) contributed **$3,589 thousand** to equity in H1 2025, a significant increase from **$314 thousand** in H1 2024[11](index=11&type=chunk) - Comprehensive loss for H1 2025 was **$(4,133) thousand**, worsening from **$(3,088) thousand** in H1 2024[11](index=11&type=chunk) [Condensed Consolidated Interim Statements of Cash Flows](index=6&type=section&id=Condensed%20consolidated%20interim%20statements%20of%20cash%20flows) For the six months ended June 30, 2025, the company continued to use cash in operating activities, albeit at a lower rate than the prior year, while cash provided by financing activities decreased, leading to an overall decrease in cash and cash equivalents | Metric (U.S. dollars in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | (5,015) | (6,185) | | Net cash used in investing activities | (4) | (1) | | Net cash provided by financing activities | 3,259 | 7,900 | | INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (1,760) | 1,714 | | BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | 2,866 | 7,277 | - Net cash used in operating activities improved by **18.9%** from **$(6,185) thousand** in H1 2024 to **$(5,015) thousand** in H1 2025[14](index=14&type=chunk) - Net cash provided by financing activities decreased by **58.7%** from **$7,900 thousand** in H1 2024 to **$3,259 thousand** in H1 2025[14](index=14&type=chunk) - Cash and cash equivalents at the end of the period decreased by **60.6%** from **$7,277 thousand** in H1 2024 to **$2,866 thousand** in H1 2025[14](index=14&type=chunk) [NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS](index=7&type=section&id=NOTES%20TO%20THE%20CONDENSED%20CONSOLIDATED%20INTERIM%20FINANCIAL%20STATEMENTS) This section provides explanatory notes to the interim financial statements, detailing general context, accounting policies, significant events, and financial instruments [NOTE 1 - GENERAL](index=7&type=section&id=NOTE%201%20-%20GENERAL) RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on GI and infectious diseases, commercializing Talicia® in the U.S., facing significant going concern uncertainties due to insufficient funding and accumulated deficit, despite actively pursuing strategic transactions and additional financing, with immaterial impact from the war in Israel to date - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on gastrointestinal ("GI") diseases and infectious diseases, commercializing Talicia® for Helicobacter pylori infection in adults in the U.S.[15](index=15&type=chunk)[18](index=18&type=chunk) - The Company has an accumulated deficit and negative working capital through June 30, 2025, and its current cash resources are not sufficient to fund operations until sustainable positive cash flows[17](index=17&type=chunk)[18](index=18&type=chunk) - Management believes there is insufficient funding to cover activities for a period exceeding one year from the filing date, indicating a material uncertainty about the Company's ability to continue as a going concern[21](index=21&type=chunk)[22](index=22&type=chunk) - The Company is actively pursuing strategic transactions, including potential asset divestment, and plans to fund future operations through commercialization, out-licensing, and equity/debt financing[17](index=17&type=chunk) - The impact of the war in Israel on the Company's results and financial condition was immaterial during the six months ended June 30, 2025, but such impact may increase[22](index=22&type=chunk) [NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND MATERIAL ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202%20-%20BASIS%20OF%20PREPARATION%20OF%20THE%20CONDENSED%20CONSOLIDATED%20INTERIM%20FINANCIAL%20STATEMENTS%20AND%2

Core Insights - RedHill Biopharma has undergone a significant strategic, financial, and operational overhaul, leading to strong progress in its business operations and financial results for the first half of 2025 [4][3]. Commercial Highlights - Talicia generated net revenues of $3.8 million in the first half of 2025, an increase from $3.5 million in the same period of 2024, with U.S. net revenues of $3.3 million compared to $3.0 million in the prior year [5][20]. - The commercial team has achieved formulary wins securing an additional 8 million covered lives, bringing the total to over 204 million lives [20]. - The company is pursuing geographic expansion with a potential UK Marketing Authorization Application approval expected this year [21]. - Talicia surpassed 100,000 prescriptions, reflecting a positive patient experience with minimal refunds claimed [21]. R&D Highlights - The Bayer-supported Phase 2 study of opaganib in combination with darolutamide for advanced prostate cancer has commenced patient recruitment [8][32]. - The FDA has provided positive feedback on the pathway to approval for the RHB-204 Crohn's disease program, which aims to be the first clinical trial in a defined MAP-positive patient population [8][33]. - RedHill's pipeline includes multiple externally funded programs targeting significant market opportunities in oncology, infectious diseases, and gastrointestinal disorders [23][35]. Financial Highlights - Net revenues for the first half of 2025 were $4.1 million, a 59% increase from $2.6 million in the first half of 2024 [5][12]. - Gross profit doubled to $2.5 million compared to $1.2 million in the same period of 2024, driven by higher revenues and cost-free royalty contributions [7][10]. - Operating loss decreased to $4.4 million from $8.4 million in the first half of 2024, primarily due to higher gross profit and reduced operating expenses [10][12]. - The company reported a net loss of $4.1 million for the first half of 2025, compared to a net loss of $3.1 million in the same period of 2024 [12]. Liquidity and Financing - As of June 30, 2025, the cash balance was $3 million, with a reduction in cash burn by 19% following a previous year's 74% reduction [8][14]. - The company has secured up to $60 million in an out-licensing deal for RHB-102 with Hyloris Pharma [4][8]. - Enhanced liquidity was achieved through an Any Market Purchase Agreement, allowing the company to sell up to $10 million of American Depositary Shares [15][16].

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 - RedHill Biopharma has received its first sales milestone payment and royalties totaling approximately $1.1 million for Talicia following its first ex-U.S. commercial launch in 2024 [1] - Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), which affects over 50% of the global adult population and is a significant risk factor for gastric cancer and peptic ulcer disease [1][2] - Talicia is recognized as the leading first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection and has been granted a Qualified Infectious Disease Product (QIDP) designation, providing eight years of U.S. market exclusivity [1][7] 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 [16] - The company promotes Talicia for the treatment of H. pylori infection in adults and is engaged in discussions with potential partners to secure additional non-dilutive ex-U.S. licensing revenue streams [2][16] Product Details - Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) [6] - In clinical studies, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients, significantly outperforming traditional clarithromycin-based therapies [3][6] - Talicia is patent protected until 2042, with additional patents pending in various territories worldwide [7][8] Market Context - H. pylori infection is classified by the WHO as a Group 1 carcinogen, with over 27,000 Americans diagnosed with gastric cancer annually [4][12] - Current clarithromycin-based therapies show declining effectiveness, with eradication rates dropping to 32% in patients with resistant H. pylori strains [3][4] - The increasing resistance of H. pylori to antibiotics, particularly clarithromycin, highlights the urgent need for effective first-line therapies like Talicia [5][16]

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]