[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]

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]

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]