RDHL

2025 was a year of tenacity, strategic transactions and building traction for RedHill Talicia® business transformed: Formation of Talicia Holdings Inc. (THI) and the U.S. co-commercialization partnership with Cumberland Pharmaceuticals ("Cumberland") (Nasdaq: CPIX), including Cumberland's $4 million investment for a 30% equity interest in THI planned to drive Talicia growth, and potentially additional revenue generating products. Cumberland and Apotex1, Canadian-based global health company, have since announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex Added eight million lives with coverage by Humana®'s Part D Plan and published new data supporting Talicia's FDA-approved label change to a more convenient three-times daily Talicia dosing routine Expanded Talicia activities in the Middle East, which included licensing for new Middle East markets, generated revenue of approximately $1.9 million in 2025 within discontinued operations Targeting Talicia global market expansion in the UK with submission of fast-track Marketing Authorisation Application (MAA) imminent R&D pipeline focus and progress: RHB-204 for Crohn's disease (CD) advancing in accordance with FDA feedback on its pathway to approval as well as two new lab collaborations signed with work ongoing for MAP killing preclinical testing and development of rapid and accurate detection diagnostics Opaganib's potential as a key add-on therapy in oncology progressing with a Phase 2 combination study of opaganib and darolutamide (Bayer' fast growing blockbuster drug) in advanced prostate cancer (mCRPC), with expanded sites and ongoing recruitment; Additionally, new preclinical data supporting opaganib potential as add-on therapy in Chronic Lymphocytic Leukemia (CLL)2, neuroblastoma3 and Triple Negative Breast Cancer4 therapy was reported Discussions for further development of opaganib in neuroblastoma ongoing with Penn State University, Beat Childhood Cancer and Apogee, with potential for priority review voucher RHB-102 (Bekinda®) being advanced as a late-stage potential therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects (e.g., nausea, vomiting and diarrhea) Corporate opportunity unlocked: RHB-102 (Bekinda) licensed to Hyloris (excluding North America) for up to $60 million in potential milestone payments plus royalties $10 million line of credit agreed with Alumni Capital LP providing the right to sell up to $10,000,000 of American Depositary Shares (ADSs) to Alumni as part of the Any Market Purchase Agreement More than $10.5 million awarded to RedHill in Kukbo Co. Ltd. New York Supreme Court rulings, which are now final and eligible for enforcement, with collection remaining subject to future realization 2025 ended with positive equity of $4.3 million, compared to a capital deficiency of $4.7 million at year end 2024 Cash balance of $4.1 million as of December 31, 20255 TEL AVIV, Israel and RALEIGH, N.C., April 27, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full-year 2025 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2025. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "2025 was not an easy year in our industry, but for RedHill it was a year that demonstrates our business tenacity, the strategic transactions that we successfully accomplished and the traction we have achieved in progressing key commercial, R&D and financial objectives. Through the partnership with Cumberland, we have transformed the Talicia business creating a strong new partnership powered to drive increased sales, strengthen our balance sheet and provide a platform for future growth and market expansion." Mr. Ben-Asher continued: "We have carefully and intentionally focused our R&D pipeline: demonstrating opaganib's potential to augment current standard of care therapies across multiple oncology indications; taking major steps in a ground-breaking new approach to Crohn's disease, with the FDA providing positive feedback on RHB-204's pathway to approval and signing breakthrough collaborations in MAP detection diagnostics; and driving the emergence of RHB-102 (Bekinda) as a potential answer to GLP-1/GIP-related nausea, vomiting and diarrhea - one of the biggest growth restrictors in the $100 billion GLP-1 market." In summarizing 2025, Mr. Ben-Asher added: "We have unlocked significant opportunity for the Company through strategic transactions like the Cumberland partnership and the ex-North America licensing of RHB-102 (Bekinda) to Hyloris for up to $60 million in potential milestone payments plus royalties. We demonstrated our tenacity and clear adherence to our agreements in successfully winning and defending the New York Supreme Court's more than $10.5 million ruling against Kukbo, making it now final and eligible for enforcement, though collection remains subject to future realization. We have ended the year better positioned than we started. Having reshaped the Talicia business, improved our balance sheet, transitioned to a leaner and optimized operational footprint and sharply focused our R&D efforts, we are now on stronger footing for further growth." Financial results for the 12 months ended December 31, 20256 Following the Cumberland transaction in October 2025, RedHill's direct Talicia commercial operations were transferred to Talicia Holdings Inc. ("THI"), a 70%-owned jointly controlled venture. As a result, those operations are presented as "discontinued operations" in RedHill's 2025 financial statements for accounting purposes. The year-over-year comparison below is therefore presented on a continuing operations basis, which reflects RedHill's non-Talicia activities only. RedHill's ongoing economic participation in the Talicia franchise going forward is reflected separately as its share of results of the joint venture. Prior period results have been recast accordingly. Revenues for the year ended December 31, 2025, were $0.3 million, generated from the Hyloris license for RHB-102 (Bekinda), compared to no revenues for the year ended December 31, 2024. Research and Development Expenses for the year ended December 31, 2025, were $2.0 million, as compared to $1.6 million for the year ended December 31, 2024. The increase was mainly driven by costs related to clinical activities. General, Administrative and Business Development Expenses for the year ended December 31, 2025, were $6.2 million, compared to $4.9 million for the year ended December 31, 2024. The increase was primarily attributable to legal expenses related to the Kukbo litigation. Share of loss of joint venture for the year ended December 31, 2025, was $33 thousand, representing RedHill's 70% share of the net loss of THI, the joint venture formed in September 2025 with Cumberland Pharmaceuticals. This reflects less than three months of THI's activity post-closing. Under the joint commercialization agreement, THI is entitled to 50% of Cumberland's net revenues from Talicia sales in the U.S., and RedHill participates in that economic activity through its 70% interest in THI. Operating Loss for the year ended December 31, 2025, was $7.9 million, compared to Operating Loss of $6.5 million for the year ended December 31, 2024. The difference is primarily attributable to an increase in operating expenses, as detailed above. Financial Expenses, net for the year ended December 31, 2025, were $0.1 million, compared to Financial Income, net of $6.8 million for the year ended December 31, 2024. The income recognized in the year ended December 31, 2024, was primarily driven by the revaluation of financial instruments, partially offset by other financing expenses. Net loss from continuing operations was $8.1 million for the year ended December 31, 2025, compared to net income from continuing operations of $0.4 million for the year ended December 31, 2024. The change was primarily attributable to the absence of significant financial income recognized in 2024 from the revaluation of financial instruments, together with higher operating expenses in 2025. Net income from discontinued operations was $7.7 million for the year ended December 31, 2025, compared to net loss from discontinued operations of $8.6 million for the year ended December 31, 2024. The change was primarily attributable to the gain recognized upon loss of control of THI in 2025, and a decrease in other operating expenses. Total assets as of December 31, 2025, were $25.3 million, compared to $18.0 million as of December 31, 2024. The increase was primarily attributable to the Company's investment in a joint venture as part of the Talicia Holdings transaction. Total liabilities as of December 31, 2025, were $21.1 million, compared to $22.7 million as of December 31, 2024. The decrease was primarily attributable to a reduction in allowance for deductions from revenues and a decrease in derivative financial instrument liabilities, partially offset by an increase in lease liabilities. Net Cash Used in Operating Activities for the year ended December 31, 2025, was $9.7 million, compared to $9.4 million for the year ended December 31, 2024. The cash used in operating activities was primarily directed toward settling pre-closing liabilities related to Movantik® and other operational activities. Net Cash Provided by Investing Activities for the year ended December 31, 2025, was $1.7 million, primarily related to the proceeds from the investment in a joint venture, compared to an immaterial amount used in investing activities for the year ended December 31, 2024. Net Cash Provided by Financing Activities for the year ended December 31, 2025, was $7.3 million, primarily generated through equity offerings and exercise of certain warrants. Net Cash Provided by Financing Activities for the year ended December 31, 2024, was $8.4 million, primarily generated through equity offerings. Cash Balance as of December 31, 2025, was $4.1 million5. 2025 Corporate, Commercial and R&D Highlights: Corporate – opportunity unlocked: In 2025, RedHill successfully completed several important strategic transactions and won a significant court case against Kukbo, unlocking significant opportunity across our business: In October 2025 the Company announced it had secured a $4 million strategic investment and U.S. co-commercialization partnership deal with Cumberland Pharmaceuticals for Talicia. The $4 million investment, to acquire a 30% ownership stake in RedHill's global Talicia business, is payable in two equal tranches, $2 million of which was paid at closing and $2 million to be paid within 12 months of execution of the definitive agreements. RedHill and Cumberland have also entered into an Exclusive Joint Commercialization Agreement for Talicia in the United States with an equal sharing of the product's net revenues. Subsequent to this, in February 2026, the Company announced the full sales and operational launch of Talicia, by Talicia Holdings Inc. ("THI"), a RedHill and Cumberland jointly controlled operating entity with a 70/30 RedHill/Cumberland ownership, supporting accelerated market penetration and expanded reach. Cumberland and Apotex have since announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex. Earlier, in February 2025, the Company announced another transaction, licensing RHB-102 (Bekinda) for commercialization worldwide, excluding North America, to Hyloris Pharmaceuticals for up to $60 million in potential milestone payments plus royalties. Under the terms of the deal, Hyloris paid RedHill an upfront payment and will pay up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, contingent upon achieving specified commercial targets, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda) across all indications and territories outside the United States, Canada and Mexico. A third deal was signed in October 2025, amending the existing Middle East licensing agreement to expand Talicia's entry into additional Middle East markets. Under the terms of the amendment, RedHill will receive $500,000 in guaranteed payments, including a $250,000 upfront payment and $250,000 in fixed payments due within 18 months, plus a minimum of $1.3 million in near-term potential milestone payments, as well as tiered royalties up to mid-teens percent on Talicia net sales. In August 2025, the Company had also announced receipt of licensing payments from the original Middle East agreement totaling $1.1 million. In June 2025, the Company entered into an Any Market Purchase Agreement (the "Purchase Agreement") with Alumni Capital LP, a Delaware limited partnership (the "Purchaser"). Pursuant to the Purchase Agreement, the Company has the right, but not the obligation, to sell to the Purchaser, from time to time, up to $10,000,000 of American Depositary Shares ("ADSs"), each representing 10,000 ordinary shares ("Ordinary Shares"), par value NIS 0.01 per share, of the Company, subject to the terms and conditions set forth in the Purchase Agreement. In November 2025, the Company also announced that the New York Supreme Court's approximately $10.5 million summary judgment in favor of RedHill against Kukbo is now final and eligible for enforcement and foreign recognition, with no further appeal permissible following expiry of the appeal period. Collection of the award and associated legal fees and costs, which were also awarded to RedHill, remain subject to future realization, and no related receivable has been recognized in the financial statements. Commercial – a transformed Talicia business: Following the transaction with Cumberland, at the Talicia business level, which is distinct from RedHill's 2025 continuing operations, Talicia generated net revenues of approximately $8.9 million in the U.S. in 2025 (including Cumberland's post-closing net revenues), and approximately $1.9 million in ex-U.S. licensing, product supply and royalties. This included revenues under our October 2025 amendment to the Middle East licensing agreement, a deal worth potentially $1.8 million plus sales royalty payments. In January 2025, eight million lives were covered with Humana's addition of Talicia to its Medicare Part D Formulary. New data describing the foundations for Talicia's FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, were published in the Journal of Clinical Pharmacology. Talicia remains the leading U.S. gastroenterologist-prescribed branded H. pylori therapy. RedHill continues to pursue acquisition of additional commercial products through licensing or promotion transactions, asset purchases, joint ventures, acquisitions, mergers or other business combinations involving companies with rights to commercial GI and other relevant assets. The Company intends to pursue such opportunities in the United States and, if available, in other jurisdictions. R&D - focused on new opportunities: With multiple externally funded Government and non-governmental collaborations, RedHill's pipeline provides new and exciting opportunities in major indications, with multiple oncological indications alongside Crohn's disease, diabetes and obesity-related disorders, viral and other gastrointestinal uses: Opaganib7: A potentially broad acting, novel, oral, host-directed small molecule drug, with a demonstrated safety and efficacy profile, advancing in largely externally funded programs directed at multiple underserved oncology, viral, inflammatory and diabetes and obesity-related indications, with sizeable multi-billion-dollar markets: A new approach in the $12 billion prostate cancer market: Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths8. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them. In February 2025, the Company announced the initiation of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis. In July 2025, the Company further announced initiation of recruitment and an expansion of recruiting sites. The study will utilize a companion lipid biomarker test (PCPro) to select mCRPC patients who have a poor prognosis due to standard of care (SoC) treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The primary endpoint will be improved 12-month radiographic progression-free survival (rPFS). Additional opaganib oncology and other updates include: In April 2026 two posters outlining data showing opaganib enhances efficacy of neuroblastoma chemotherapy combination and augments anti-tumor immunity in triple-negative breast cancer in preclinical studies were presented at the American Association of Cancer Research (AACR) annual meeting. Orphan drug designation for opaganib was previously granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology) Discussions for further development of opaganib in neuroblastoma ongoing with Penn State University, Beat Childhood Cancer and Apogee, with potential for priority review voucher In December 2025, RedHill reported additional preclinical data that opaganib reduces venetoclax resistant cells in chronic lymphocytic leukemia (CLL) Positive in vivo study results supporting the potential of opaganib therapy in diabetes and obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade - were published in the journal Diabetes, Metabolic Syndrome and Obesity in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance"9. Pre-clinical testing of opaganib in metabolic disease (Obesity, T2D and Fatty Liver Disease) following prior publication of promising results continues Programs in Ebola, acute respiratory distress syndrome (ARDS, COVID-19 and Influenza continue to seek to address important markets worth multiple hundreds of millions of dollars RHB-20410: RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease (CD). Unlike existing therapies that focus on symptom relief, RHB-204 is intended to target the possible root cause of Crohn's disease, which is hypothesized to be caused by Mycobacterium avium subspecies paratuberculosis (MAP). Patent protected until at least 2041, RHB-204 is a next-generation formulation of RHB-104, which successfully completed a Phase 3 study in Crohn's disease, with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Paradigm shift in MAP-positive Crohn's disease treatment approach In March 2025, the Company announced its plans to advance its potentially groundbreaking late-stage RHB-204 Crohn's disease program, building on statistically significant positive RHB-104 Phase 3 results. In July 2025, the Company further updated that it had received positive FDA feedback on the pathway to approval of RHB-204 for CD and had initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP killing detection diagnostics - the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program. The planned innovative Phase 2 study of RHB-204 is expected to be the first clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population. The study intends to utilize novel and decisive endpoints and imaging, allowing for a study design with a relatively small sample size. RHB-204 builds upon RHB-104's successful Phase 3 study, which successfully met its Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus standard of care. It also showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes. RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment. RHB-102 (Bekinda)11 update: RHB-102 (Bekinda) is a proprietary, advanced clinical-stage, once-daily, bimodal extended-release, oral tablet formulation of 5-HT3 antagonist, ondansetron, targeting oncology support, acute gastroenteritis and gastritis, IBS-D and GLP-1/GIP-associated gastrointestinal (GI) side effects. Largely de-risked, RHB-102 (Bekinda) development is supported by published positive U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program12, plus decades of ondansetron clinical use (>22 million annual U.S. ER prescriptions)13 RHB-102 (Bekinda) is clinically aligned, if approved, to improve titration success and reduce the #1 cause of discontinuing diabetes & weight loss therapies like Mounjaro®/Zepbound® & Ozempic®/Wegovy® Development is being planned under the accelerated FDA 505(b)(2) route of RHB-102 (Bekinda) as a once-daily oral therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects. >2% of Americans take GLP-1 receptor agonist drugs14 but estimates suggest up to 50% discontinue within 3 months[15], potentially costing an estimated $35 billion in lost market value by 203016. RHB-10717 (upamostat) update: RHB-107 was included in the U.S. Government-supported PROTECT study, which was a Phase 2 adaptive, randomized, double-blind, placebo-controlled platform trial to evaluate the safety and efficacy of RHB-107 for early outpatient COVID-19 treatment. The study was conducted as part of a master protocol evaluating promising investigational products for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for COVID-19. RHB-107 was the first and only drug to enter the platform and was evaluated in the early treatment arm of the study. The study was planned for a duration of approximately 18 months, but due to challenges to enrollment and U.S. Government funding limitations, enrollment was discontinued after a total of only 92 of the planned 300 participants were enrolled. While a benefit in time to resolution of symptoms and time to viral clearance were observed regarding the efficacy of RHB-107 in this study it did not reach statistical significance. Whether the lack of significant results were due to true lack of efficacy or accrual of fewer than one third of the planned number of patients is unknown. Annual Report: A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025, has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at: https://www.redhillbio.com/investors/financial-filings/quarterly-reports/default.aspx. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at: [email protected]. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults18, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases. Visit www.redhillbio.com / X.com/RedHillBio for more information about the Company Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential success of any transactions, commercial programs or development activities and the payment of future milestone payments. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) the Company's ability to collect on its judgement against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 27, 2026. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma [email protected] Category: Financials 1 https://www.apotex.com/global/home 2 https://www.redhillbio.com/news/news-details/2025/RedHill-Biopharmas-Positive-Opaganib-Results-Indicate-Reduction-in-Venetoclax-Resistant-Cells/default.aspx 3 Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879 4 Abstract 4323: The SPHK2 inhibitor opaganib potentiates tumor-intrinsic STING activation in triple-negative breast cancer in vitro. Colette R. Worcester, Amrita Mitra, Harsh B. Pathak, Shane R. Stecklein. Cancer Res (2026) 86 (7_Supplement): 4323. https://doi.org/10.1158/1538-7445.AM2026-4323 Published: 03 April 2026 5 Including cash, cash equivalents, short-term bank deposits and restricted cash. 6 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 7 Opaganib is an investigational new drug, not available for commercial distribution. 8 Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 9 Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983 https://doi.org/10.2147/DMSO.S514548 10 RHB-204 is an investigational new drug, not available for commercial distribution 11 RHB-102 is an investigational new drug, not available for commercial distribution 12 Data on file 13 Cairns C, Kang K. National Hospital Ambulatory Medical Care Survey: 2021 emergency department summary tables. Available from: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHAMCS/doc21-ed-508.pdf. 14 FAIR Health. Obesity and GLP-1 Drugs: A Claims-Based Analysis. FAIR Health White Paper; May 27, 2025. 15 Issue Brief (Real-World Trends in GLP-1 Treatment Persistence and Prescribing for Weight Management, May 2024) 16 https://www.goldmansachs.com/insights/articles/the-anti-obesity-drug-market-may-prove-smaller-than-expected 17 RHB-107 is an investigational new drug, not available for commercial distribution 18 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-full-year-2025-financial-results-and-operational-highlights-302754141.html

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CLL) therapy, is emerging as a therapeutic challenge, with leukemic cells persisting over time, even with combination therapy1 Studies show that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previously resistant CLL cells2,3 New in vivo study shows adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduces CLL cell (CD19⁺, CD5⁺) counts by 50% compared to controls and lowered CD3+, CD4+ and CD8+ T cell counts compared to controls with lowered PD1 expression (CD8+)4 Data shows opaganib's venetoclax combination potential in CLL; builds on multiple preclinical studies demonstrating opaganib's therapeutic add-on potential in oncology; further clinical evaluation ongoing in a Phase 2 study of opaganib + darolutamide in advanced prostate cancer Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place TEL-AVIV, Israel and RALEIGH, N.C., Dec. 15, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive in vivo results, indicating that opaganib combined with venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cells by half compared to controls, and further demonstrates opaganib's potential as an add-on therapy to venetoclax in venetoclax-resistant CLL. "Understanding mechanisms of resistance to targeted therapies such as the BCL-2 inhibitor venetoclax is essential to improve current treatment strategies and may provide key insights to personalize treatment for chronic lymphocytic leukemia (CLL) patients," said Romina Gamberale, PhD, Independent Researcher at CONICET from the Institute of Experimental Medicine (IMEX, CONICET-National Academy of Medicine) in Buenos Aires, Argentina, who led the study. "Our previous ex vivo work has shown that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant CLL cells and that inhibiting SPHK2 may reduce T-cell-induced resistance and resensitize previously resistant cells. The results of this in vivo study in mice indicate that adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduced CLL cell counts by 50% compared to controls, showing that opaganib may have a significant role to play in mitigating BCL-2 inhibitor resistance." Dr. Mark Levitt, Chief Scientific Officer at RedHill, said: "Venetoclax is a key CLL therapy and finding ways to maintain its effectiveness, and to reduce the potential for resistance-related treatment failure, could represent a breakthrough in the ability to treat CLL patients. This promising data supports the hypothesis that opaganib, as a potent inhibitor of SPHK2, provides a potential route to maintaining venetoclax effects in treating CLL. Opaganib has shown potential as add-on therapy in several preclinical oncology models and is currently undergoing a Phase 2 clinical trial in combination with darolutamide in advanced prostate cancer. This new data now adds CLL to the list of potential cancer indications where opaganib has shown potential to bring additive therapeutic value." Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, medical countermeasures, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place. Approved by the FDA in 2016, venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), is a first-in-class BCL-2 inhibitor that has become a mainstay of CLL therapy, achieving sales of approximately $2.5 billion in 2024. Venetoclax works by blocking a protein called BCL-2, which is often overproduced in certain cancer cells and prevents the process of apoptosis (programmed cell death) – helping to keep the cancer cells alive and growing. By binding to, and inhibiting, the BCL-2 protein, venetoclax enables the cancer cells to undergo apoptosis and die. About Chronic Lymphocytic Leukemia (CLL) CLL is a slow-growing blood and bone marrow cancer that affects a type of white blood cell called lymphocytes. It is the most common type of leukemia in adults and has a highly variable clinical course. It is generally not considered to be curable. About Opaganib (ABC294640) Opaganib is a first-in-class, proprietary investigational host-directed and potentially broad-acting orally administered drug with anticancer, anti-inflammatory and antiviral activity. Opaganib is targeted at multiple potential oncology, radioprotection, viral, inflammatory, and gastrointestinal indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib has also shown positive preclinical results in renal fibrosis. Opaganib has received orphan-drug designations from the FDA in cholangiocarcinoma and neuroblastoma. It is currently undergoing a Phase 2 clinical trial in combination with darolutamide in advanced prostate cancer and has previously undergone studies in advanced cholangiocarcinoma (Phase 2a). Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Several U.S. government medical countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including GI-ARS, Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health, and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA). Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults5, with a recent co-commercialization agreement in the U.S. with Cumberland Pharmaceuticals. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-102, with positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America; and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential impact of Talicia. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that opaganib may not replicate its potential to mitigate resistance in CLL therapy; the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives; the risk regarding the Company's ability to maintain compliance with Nasdaq's listing requirements, including the minimum stockholders' equity requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: R&D 1 Al-Sawaf O, Stumpf J, Zhang C, Simon F, Bosch F, Feyzi E, Ghia P, Gregor M, Kater AP, Lindström V, Mattsson M, Niemann CU, Staber PB, Tadmor T, Thornton P, Wendtner CM, Janssens A, Noesslinger T, Bohn JP, da Cunha-Bang C, Poulsen CB, Ranti J, Illmer T, Schoettker B, Böttcher S, Gaska T, Vandenberghe E, Clifford R, Benjamini O, Frustaci AM, Scarfò L, Sportoletti P, Schreurs J, Levin MD, van der Straaten H, van der Klift M, Tran H, de la Serna J, Loscertales J, Lindblad O, Bergendahl Sandstedt A, Goede J, Baumann M, Fink AM, Fischer K, Ritgen M, Kreuzer KA, Schneider C, Tausch E, Stilgenbauer S, Robrecht S, Eichhorst B, Hallek M; CLL17 Trial Investigators. Fixed-Duration versus Continuous Treatment for Chronic Lymphocytic Leukemia. N Engl J Med. 2025 Dec 6. doi: 10.1056/NEJMoa2515458. Epub ahead of print. PMID: 41358601. 2 Elías EE, Almejún MB, Colado A, Cordini G, Vergara-Rubio M, Podaza E, Risnik D, Cabrejo M, Fernández-Grecco H, Bezares RF, Custidiano MDR, Sánchez-Ávalos JC, Vicente Á, Garate GM, Borge M, Giordano M, Gamberale R. Autologous T-cell activation fosters ABT-199 resistance in chronic lymphocytic leukemia: rationale for a combined therapy with SYK inhibitors and anti-CD20 monoclonal antibodies. Haematologica. 2018 Oct;103(10):e458-e461. doi: 10.3324/haematol.2018.188680. Epub 2018 May 10. PMID: 29748439; PMCID: PMC6165796. 3 Sarapura Martinez VJ, Buonincontro B, Cassarino C, Bernatowiez J, Colado A, Cordini G, Custidiano MDR, Mahuad C, Pavlovsky MA, Bezares RF, Favale NO, Vermeulen M, Borge M, Giordano M, Gamberale R. Venetoclax resistance induced by activated T cells can be counteracted by sphingosine kinase inhibitors in chronic lymphocytic leukemia. Front Oncol. 2023 Mar 20;13:1143881. doi: 10.3389/fonc.2023.1143881. PMID: 37020867; PMCID: PMC10067719. 4 Unpublished results - data on file 5 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg View original content:https://www.prnewswire.com/news-releases/redhill-biopharmas-positive-opaganib-results-indicate-reduction-in-venetoclax-resistant-cells-302642162.html

Extensive strategic, financial and operational overhaul has reshaped and refocused our business; Strong progress on multiple fronts Commercial and R&D Highlights: Recruitment initiated in the Bayer-supported Phase 2 combination study of opaganib and darolutamide in advanced prostate cancer Positive U.S. Food and Drug Administration (FDA) feedback on pathway to approval for RedHill's next-generation Crohn's disease program with RHB-204 - planned to be the first ever clinical study in a defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Increased Talicia net revenues and units sold as compared to first half 2024 - achieved with significantly reduced resources Talicia U.S. formulary wins securing 8 million additional covered lives, taking the total to more than 204 million lives UK Marketing Authorization Application (MAA) for Talicia® submission imminent and expected to be in time for potential approval this year Ex-U.S. Talicia: cash inflows from first sales milestone and from royalties, majority received post–balance sheet date Up to $60 million global (ex-North America) RHB-102 out-licensing deal signed with Hyloris Pharmaceuticals Corporate and financial highlights: Gross profit doubled compared to first half 2024 59% increase in net revenues in first half of 2025 to $4.1 million, up from $2.6 million in first half of 2024 Enhanced financial stability with up to approximately $13.5 million available to the Company through At-the-Market ("ATM") and Any Market Purchase agreements Cash balance of $3 million as of June 30, 20251 Further 19% reduction in cash burn following the previous year's 74% reduction Net cash used in operations in first half of 2025 dropped to $5 million from $6.2 million in first half of 2024 Following RedHill's approximately $8.25 million including interest New York Supreme Court summary judgment win against Kukbo (appeal to be heard this month), the Court also awarded RedHill approximately $1.82 million including interest in legal costs and expenses. RedHill also won an attachment grant in the Korean courts, preventing Kukbo asset disposal prior to enforcement TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its first half of 2025 financial results and operational highlights for the six months ended June 30, 2025. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Last year's extensive strategic, financial and operational overhaul has reshaped and refocused our business, and our first half of 2025 results show strong progress on multiple fronts. Our predominantly externally funded research and development programs are advancing positively. The Bayer-supported Phase 2 study of opaganib and darolutamide has started recruiting patients. We now have an FDA green light for our planned groundbreaking Crohn's program with RHB-204 - the first ever in a wholly MAP-positive population, presenting a new potential treatment approach - with an innovative design enabling a smaller sample size, lower study costs and faster time to completion. Commercially, the much-streamlined commercial team has achieved increased Talicia revenues with significantly reduced resources. The commercial team continues to break new ground with new Talicia formulary wins. Equally important is the progress being made with Talicia's geographic expansion with the potential for a UK Marketing Authorization Application approval this year, first ex-U.S. Talicia sales milestone and royalty payments received and active discussions to secure additional non-dilutive ex-US licensing revenue streams advancing. We have also secured an up to $60 million RHB-102 out-licensing deal to Hyloris Pharma. The significant progress we have made so far this year is largely due to our focused and committed team, and to the quality of programs we are advancing – both R&D and commercial. We have achieved important legal successes and built strong momentum and are working towards the delivery of additional key near-term catalysts to further accelerate our growth trajectory. Financial results for the six months ended June 30, 2025 (Unaudited)2 Net Revenues for the first half of 2025 were $4.1 million, compared to $2.6 million for the first half of 2024. Talicia net revenues for the first half of 2025 were $3.8 million, up from $3.5 million in the same period of 2024. This included U.S. net revenues of $3.3 million (compared to $3.0 million in the prior-year period, reflecting an increase in units sold) and $0.5 million from our partnership in the United Arab Emirates ("UAE") in product sales, with an additional $0.1 million recognized from royalties, compared to $0.5 million in product sales in the same period of 2024. In addition, $0.3 million was recorded from the Hyloris license for RHB-102 (Bekinda®), reflecting a $0.1 million upfront payment at signing and $0.2 million related to the present value of minimum annual payments due from 2027 through 2035. In the first half of 2024, Movantik® generated negative net revenues of $0.9 million, primarily due to product returns, compared to an immaterial amount of contra-revenues in the first half of 2025. Cost of Revenues for the first half of 2025 was $1.6 million, compared to $1.4 million for the first half of 2024. The 2024 figure included a reduction from Movantik® contra-revenues, while the 2025 revenue increase was only partly reflected in costs, due to royalty and license revenues with no associated COGS. Gross Profit for the first half of 2025 was $2.5 million, compared to $1.2 million for the first half of 2024 driven by higher revenues, cost-free royalty and license contributions, and the absence of Movantik® adjustments. Research and Development Expenses for the first half of 2025 were $1 million, as compared to $0.7 million for the first half of 2024. The increase was primarily driven by costs related to various clinical activities as well as regulatory work associated with Talicia. Selling, Marketing, and General and Administrative Expenses for the first half of 2025 were $5.9 million, as compared to $9 million for the first half of 2024. The decrease was mainly due to U.S. workforce downsizing, continued cost-reduction measures, and an overall lower level of commercial and administrative activity. Operating Loss for the first half of 2025 was $4.4 million, compared to $8.4 million for the first half of 2024. The decrease is primarily attributable to higher gross profit and reduced operating expenses, as detailed above. Financial Income, net for the first half of 2025 was $0.2 million, compared to Financial Income, net of $5.4 million for the first half of 2024. In both periods, net financial income was primarily attributable to the revaluation of warrants, partially offset by issuance costs in respect of warrants. Net Loss for the first half of 2025 was $4.1 million, as compared to $3.1 million for the first half of 2024. The increase in net loss was primarily driven by a significant decrease in financial income related to the revaluation of warrants, partially offset by a reduction in operating loss, as detailed above. Total Assets as of June 30, 2025, were $18.4 million, as compared to $18.0 million as of December 31, 2024, reflecting higher trade receivables partly offset by lower cash, inventory, and restricted cash. Total Liabilities as of June 30, 2025, were $22.8 million, as compared to $22.7 million as of December 31, 2024, driven by higher allowances for deductions from revenues and increased accrued expenses, partly offset by lower derivative liabilities following warrant revaluation. Net Cash Used in Operating Activities for the first half of 2025 was $5 million, compared to $6.2 million for the first half of 2024. The decrease was primarily driven by the continued impact of cost-cutting measures. Net Cash Provided by Financing Activities for the first half of 2025 was $3.3 million, driven by use of our ATM program, compared to $7.9 million for the first half of 2024, which were mainly derived from equity offerings. Cash Balance as of June 30, 2025, was $3 million1. Enhanced Liquidity: On June 25, 2025, the Company entered into an Any Market Purchase Agreement (the "Purchase Agreement") with Alumni Capital LP, whereby the Company has the right, but not the obligation, to sell to Alumni, from time to time, up to $10,000,000 of American Depositary Shares ("ADSs"), subject to the terms and conditions set forth in the Purchase Agreement. Thus far, 1,013,908 ADSs have been sold at an average price of $1.67 per ADS, for an aggregate net proceeds of approximately $1.7 million. On February 3, 2025, the Company entered into an At-the-Market Offering Agreement with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which the Company may offer and sell ADSs, from time to time, through Wainwright acting as the Company's placement agent. Pursuant to the prospectus supplement dated February 3, 2025, the Company may offer and sell ADSs having an aggregate offering price of up to $3,464,000. Thus far, 890,001 ADSs have been sold at an average price of $3.85 per ADS, for an aggregate net proceeds of approximately $3.3 million. As of September 3, 2025, the Company had 3,329,857 ADSs outstanding (equivalent to 33,298,571,000 ordinary shares), each ADS representing 10,000 ordinary shares of the Company, par value NIS 0.01 per share. These activities formed part of our plan submitted to Nasdaq in response to their deficiency letter notifying the Company that it was no longer compliant with Nasdaq Listing Rule 5550(b) (the "Rule"), requiring listed companies to maintain a minimum stockholders' equity of $2,500,000 for continued listing. On August 8, 2025, Nasdaq granted the Company an extension until October 13, 2025, to regain compliance with the Rule. Commercial and R&D First Half of 2025 Highlights: Commercial - streamlined and revenue-generating: With a streamlined commercial operation, Talicia has increased unit sales compared to the same period in 2024 and has maintained its No.1 position as the most prescribed branded H. pylori therapy by U.S. gastroenterologists. In the first half of 2025, Talicia generated net revenues of $3.3 million in the U.S. Talicia U.S. formulary wins secured 8 million additional covered lives, taking the total to more than 204 million lives, following the Medi-Cal renewal and Humana formulary wins. Talicia also generated an additional approximately $0.6 million in net revenues from our UAE partnership. Following the successful launch of Talicia in the UAE, focus on geographic expansion continues with potential for a UK MAA approval this year. The Company is also in advanced discussions to secure additional non-dilutive ex-US licensing revenue streams. Talicia has surpassed the 100,000 prescriptions milestone, with minimal refunds claimed via our innovative warranty program, reflecting a positive patient experience. R&D - focused on new opportunities: RedHill's pipeline, which is predominantly externally funded through multiple U.S. Government and non-governmental collaborations, provides new and exciting opportunities in major indications, including prostate cancer, Ebola virus disease (EBOV) and other viral and pandemic preparedness indications, gastrointestinal-acute radiation syndrome (GI-ARS), diabetes and obesity-related disorders and Crohn's disease. Opaganib3: A potentially broad-acting, novel, oral, host-directed small molecule drug, with a robust safety and tolerability database, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications. Oncology - A new approach in the $12 billion prostate cancer market: Prostate cancer is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths4. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them. On July 1, 2025, the Company announced the start of recruitment of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis. Utilizing a precision medicine approach, the unique 60-patient Phase 2 study uses the PCPro™ companion lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination. The study will utilize PCPro to select mCRPC patients who have a poor prognosis due to standard of care treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The study's primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated. Ebola Virus Disease (EBOV): Opaganib is believed to be the first host-directed molecule to show activity in vivo in EBOV, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability. GI-ARS: U.S. Government- and non-government funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for GI-ARS, undertaken as part of the U.S. Government's Radiation and Nuclear Countermeasures Program product pipeline development contract. Diabetes and obesity-related disorders: Positive in vivo study results support the potential of opaganib therapy in diabetes and obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade. Positive results from multiple in vivo studies showing the impact of opaganib on weight gain and glucose intolerance in a high fat diet (HFD) model were recently published5 in the journal Diabetes, Metabolic Syndrome and Obesity. RHB-2046: RHB-204, an orally-administered, next-generation optimized formulation of RedHill's RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104 Phase 3 safety and efficacy results7, which delivered a statistically significant 64% improvement in efficacy8. RHB-204 is patent protected through 2041. Crohn's Disease (CD) - Paradigm shift in MAP-positive CD treatment approach: On July 21, 2025, the Company announced that it had received positive feedback from the FDA, following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company's potentially groundbreaking RHB-204 Crohn's disease development program. The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in CD to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) CD patients. This groundbreaking approach, which tests MAP as a root cause of CD, could potentially make RHB-204, if approved, a paradigm-shifting new therapy treating both the suspected cause of the disease and its symptoms. As part of the planned Phase 2 study, RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection diagnostics – the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program. Innovative study design enables a smaller sample size allowing for lower study costs and faster time to completion. RHB-107 (upamostat)9: On January 30, 2025, we were notified that funding from the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination, requiring the study to cease enrollment on February 28, 2025. 92 patients have been enrolled out of a fully enrolled target patient population of 300. Due to the reduced number of patients enrolled in this study, the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial. The U.S. Army-funded Ebola development program remains ongoing, with RHB-107 having demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults10. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at www.redhillbio.com / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Financials [1] Including cash, cash equivalents, short-term bank deposits and restricted cash. [2] All financial highlights are approximate and are rounded to the nearest hundreds of thousands. [3] Opaganib is an investigational new drug, not available for commercial distribution. [4] Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 [5] Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983 https://doi.org/10.2147/DMSO.S514548 [6] RHB-204 is an investigational new drug, not available for commercial distribution. [7] RHB-104 is an investigational new drug, not available for commercial distribution in the United States. [8] Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. https://www.mdpi.com/2079-6382/13/8/694. PMID: 39199994; PMCID: PMC11350828. [9] RHB-107 is an investigational new drug, not available for commercial distribution. [10] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: https://www.talicia.com/. Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-first-half-2025-financial-results-and-operational-highlights-302547519.html SOURCE RedHill Biopharma Ltd.

Revenue-generating with an exciting, diversified, largely externally funded, advanced development pipeline and multiple upcoming catalysts. Recent highlights: Global licensing deal (excluding North America) with Hyloris Pharmaceuticals with RHB-102 for up to $60 million in potential milestone payments Approximately $8 million plus legal costs NY Supreme Court summary judgment win against Kukbo Bayer-supported Phase 2 combination study of opaganib and Bayer's darolutamide in prostate cancer initiated Talicia® advancement and geographic expansion: Planned UK MAA with potential for approval in 2025 Commercially launched in the United Arab Emirates (UAE) Formulary wins securing 25 million covered lives First-line therapy listing in the recently updated ACG Guideline Advancing next-generation development, RHB-204, into the first ever Phase 2 clinical study in Crohn's Disease (CD) patients who are all MAP-positive, supported by RHB-104's positive Phase 3 data showing a statistically significant 64% improvement in efficacy; FDA path to approval guidance expected in coming weeks Positive results from new U.S. Government funded program for gastrointestinal Acute Radiation Syndrome (GI-ARS) further confirm opaganib's nuclear radiation protective activity. Discussions ongoing regarding advanced development Cash balance of $4.8 million as of December 31, 20241 23% increase in net revenues in 2024 to $8.0 million, up from $6.5 million in 2023 Supported by extensive cost-cutting measures, the Movantik® divestiture transaction and reduced R&D spend, cash burn slashed by 74% year-over-year; Net cash used in operations dropped to $9.4M from $35.8M in 2023 TEL AVIV, Israel and RALEIGH, N.C., April 10, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full-year 2024 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2024. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have undergone an extensive overhaul reshaping ourselves financially, operationally and strategically. Major corporate and R&D moves, undertaken over the last 12 months, have resulted in new and clearer opportunities to deliver maximum value from both our commercial and R&D assets. The potential $60 million ex-North America global license of RHB-102 to Hyloris lays the groundwork for the ongoing development and commercialization in the large gastroenteritis, oncology support and IBS-D markets while enabling RedHill to maintain control of the key North American markets. The approximately $8 million plus legal costs New York Supreme Court summary judgment was a resounding win for RedHill and we are fully committed to pursuing the collection of this award. Last year's recommendation by the latest ACG Clinical Guideline for Talicia as a first-line therapeutic option for H. pylori eradication, has, we expect further enhanced Talicia's product profile as the leading branded U.S. gastroenterologist prescribed H. pylori therapy, winning additional formulary successes securing 25 million covered lives. After its successful launch in UAE, Talicia is also poised for a potential UK Marketing Authorisation Application (MAA) mid-year, presenting a promising pathway for Talicia's entry into additional markets globally." Mr. Ben-Asher continued: "Having successfully completed the Hyloris RHB-102 out-license deal, we are now advancing our next-generation candidate, RHB-204, in the $12 billion Crohn's disease space, employing a novel, groundbreaking approach, supported by RHB-104's positive Phase 3 clinical data. In parallel, opaganib continues to show its broad-acting potential and we are very excited to have initiated the innovative Bayer-supported Phase 2 study in combination with darolutamide, which may bring vital new hope to men with metastatic castrate resistant prostate cancer. Progress was also made with opaganib as a treatment for GI-ARS following positive results from new in vivo studies, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirming opaganib's radioprotective activity in models of GI-ARS. Discussions are ongoing regarding advanced development. Additionally, the ongoing U.S. Government-supported work in Ebola continues following our previously announced BARDA grant. We have started 2025 as we mean to go on – aggressively pursuing our business goals and aiming to deliver on our catalysts in a meaningful way." Financial results for the 12 months ended December 31, 20242 Net Revenues for the year ended December 31, 2024 were $8.0 million, compared to $6.5 million for the year ended December 31, 2023. Talicia net revenues for the year ended December 31, 2024, increased to $9.0 million from $8.8 million for the year ended December 31, 2023, driven by approximately $1.0 million of revenues generated from the UAE partnership with Gaelan Medical. Net revenues for the years ended December 31, 2024 and December 31, 2023 included Movantik contra-revenues of $0.9 million and $2.6 million for Movantik, respectively, mainly due to product returns. Cost of Revenues for the year ended December 31, 2024 was $3.2 million, compared to $3.5 million for the year ended December 31, 2023. The decrease was primarily due to lower inventory write-downs, which totaled $0.2 million in 2024 compared to $1.3 million in 2023. Gross Profit for the year ended December 31, 2024 was $4.9 million, compared to $3.1 million for the year ended December 31, 2023, reflecting the increase in net revenues and the lower level of inventory write-downs in 2024. Research and Development Expenses for the year ended December 31, 2024 were $1.6 million, as compared to $3.5 million for the year ended December 31, 2023. The decrease was attributable to the costs from closing the RHB-204 clinical trial, which were recognized in 2023, as well as ongoing cost-reduction measures. Selling, Marketing, and General and Administrative Expenses for the year ended December 31, 2024 were $15.5 million, as compared to $31.0 million for the year ended December 31, 2023. The reduction was primarily attributable to ongoing cost-reduction measures and the divestment of Movantik in 2023, which led to workforce downsizing and other related expense reductions. Other Expenses for the year ended December 31, 2024 were $2.3 million, recognized as part of the Global Termination Agreement3, as compared to Other Income of $44.1 million for the year ended December 31, 2023. The Other Income in 2023 was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services provided to the buyer of Movantik. Operating Loss for the year ended December 31, 2024 was $14.6 million, compared to Operating Income of $12.6 million for the year ended December 31, 2023. Both periods include items related to the Movantik divestiture, as described under Other Expenses - a $2.3 million loss in 2024 and $44.1 million income in 2023. Excluding these, the year-over-year change reflects improved operating performance driven by cost-cutting measures. Financial Income, net for the year ended December 31, 2024 was $6.3 million, compared to Financial Income, net of $11.3 million for the year ended December 31, 2023. The income recognized for the year ended December 31, 2024, was primarily driven by the revaluation of financial instruments, partially offset by other financing expenses. The income recognized in the year ended December 31, 2023, was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCRM debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred, partially offset by financial expenses related to the financial instruments and other financial expenses. Net Loss for the year ended December 31, 2024 was $8.3 million, as compared to Net Income of $23.9 million for the year ended December 31, 2023. Both periods include impacts from the Movantik divestiture, as detailed under Other Expenses and Financial Income - a $2.3 million loss in 2024 and $64.7 million in income in 2023. Excluding these, the year-over-year change reflects improved performance driven by cost cutting measures. Total Assets as of December 31, 2024 were $18.0 million, as compared to $23.0 million as of December 31, 2023. The decrease was primarily attributable to the decrease in cash balance, reduced inventory and a decline in prepaid expenses and other receivables, consistent with the Company's scaled-down operations, as well as impact of balances settled as part of the Global Terminations Agreement, and a reduction in right-of-use assets following the termination of vehicle leases during 2024. Total Liabilities as of December 31, 2024 were $22.7 million, as compared to $21.0 million as of December 31, 2023. The increase primarily reflects the impact of the Global Termination Agreement, under which the Company incurred liabilities related to Movantik that were allocatable to HCRM and its affiliates under their agreements with the Company, offset by payments made toward these liabilities during the period. Additionally, there was an increase in derivative financial instruments associated with warrant liabilities from offerings made during 2024. This was partially offset by a decrease in accounts payable and allowance from deductions from revenues, consistent with the Company's scaled-down operations, as well as a reduction in lease liabilities due to the termination of car leases. Net Cash Used in Operating Activities for the year ended December 31, 2024 was $9.4 million, compared to $35.8 million for the year ended December 31, 2023. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities. This was partially offset by proceeds received from the Global Termination Agreement, net of payments made to settle obligations arising from this agreement. Net Cash Provided by Financing Activities for the year ended December 31, 2024 was $8.4 million, primarily generated through equity offerings. Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023, July 2023, September 2023 and November 2023, and from decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchases. Cash Balance as of December 31, 2024, was $4.8 million1. Commercial and R&D Highlights: Commercial - streamlined and revenue-generating: With a significantly streamlined commercial operation, Talicia has generated net revenues of $9.0 million, supported by approximately $1.0 million of new revenues from the UAE partnership with Gaelan Medical, and remains the leading U.S. gastroenterologist-prescribed branded H. pylori therapy. Significant effort has resulted in important accomplishments with Talicia, such as the inclusion as first-line option for treatment of H. pylori infection in the recently updated 2024 American College of Gastroenterology (ACG) Clinical Guideline, the securing of 25 million covered lives following the Medi-Cal renewal and Humana formulary win, a successful launch in the UAE and the potential for opening up new markets with the recently announced plan for a Talicia UK MAA. Talicia has now surpassed the 100,000 prescriptions milestone and our innovative warranty program, with minimal refunds claimed, reflects a positive patient experience. R&D - focused on new opportunities: Largely externally funded, with multiple U.S. Government and non-governmental collaborations, RedHill's pipeline provides new and exciting opportunities in major indications: Crohn's disease, prostate cancer, diabetes and obesity-related disorders, Ebola and other viral and pandemic preparedness indications as well as for gastrointestinal-acute radiation syndrome (GI-ARS) and other medical/chemical countermeasure uses: Opaganib4: A potentially broad acting, novel, oral, host-directed small molecule drug, with a demonstrated safety and efficacy profile, advancing in predominantly U.S. Government-supported, externally funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including prostate cancer, COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection, including GI-ARS: A new approach in the $12 billion prostate cancer market: Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths5. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them. In February 2025, the Company announced the initiation of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis. The study will utilize a companion lipid biomarker test (PCPro) to select mCRPC patients who have a poor prognosis due to standard of care (SoC) treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The primary endpoint will be improved 12-month radiographic progression-free survival (rPFS). Other opaganib programs/updates include: U.S. Army and BARDA-grant funded program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability U.S. Government- and non-government funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for GI-ARS and Phosgene inhalation injury. On December 10, 2024, the Company announced positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. Government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract. These results further confirm opaganib's protective activity in models of GI-ARS and discussions are ongoing regarding advanced development. Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade. 'Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance' was recently published6 in the journal Diabetes, Metabolic Syndrome and Obesity Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology) ARDS, COVID-19 and Influenza programs continue to seek to address multi-hundreds of millions of dollars markets RHB-204: RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease (CD). Unlike existing therapies that focus on symptom relief, RHB-204 is intended to target the possible root cause of Crohn's disease, which is hypothesized to be caused by Mycobacterium avium subspecies paratuberculosis (MAP). Patent protected until at least 2041, RHB-204 is a next-generation formulation of RHB-104, which successfully completed a Phase 3 study in Crohn's disease, with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Paradigm shift in MAP-positive CD treatment approach In March 2025, the Company announced its plans to advance its potentially groundbreaking late-stage RHB-204 Crohn's disease program, building on statistically significant positive RHB-104 Phase 3 results. FDA guidance on pathway to approval is anticipated in the coming weeks. RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment. The planned innovative Phase 2 study of RHB-204 is planned to be the first ever clinical study in CD patients who are all MAP-positive and will evaluate mucosal healing, a new gold standard in assessing efficacy in Crohn's disease, and MAP eradication utilizing novel and decisive endpoints and imaging, allowing for a study design with a relatively small sample size. RHB-204 builds upon RHB-104's successful Phase 3 study, which successfully met its Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus standard of care. It also showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes. RHB-107 (upamostat) update: On January 30, 2025, we were notified that funding from the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination, requiring the study to cease enrollment on Feb 28, 2025. 93 patients have been enrolled out of a fully enrolled target patient population of 300. Due to the reduced number of patients enrolled in this study, the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial. The U.S. Army-funded Ebola development program remains ongoing, with RHB-107 having demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies. Annual Report: A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at: https://www.redhillbio.com/investors/financial-filings/quarterly-reports/default.aspx. The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at: [email protected]. About RedHill Biopharma RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults7, with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at www.redhillbio.com / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Financials REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) The accompanying notes are an integral part of these consolidated financial statements. REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION The accompanying notes are an integral part of these consolidated financial statements. REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF CASH FLOWS The accompanying notes are an integral part of these consolidated financial statements. [1] Including cash, cash equivalents, short-term bank deposits and restricted cash. [2] All financial highlights are approximate and are rounded to the nearest hundreds of thousands. [3] The Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement"), announced July22, 2024. https://www.redhillbio.com/news/news-details/2024/RedHill-Biopharma-Strengthens-Cash-Balance-Settles-Obligations-and-Removes-Talicia-Lien/default.aspx [4] Opaganib is an investigational new drug, not available for commercial distribution. [5] Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 [6] Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983 https://doi.org/10.2147/DMSO.S514548 [7] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-full-year-2024-financial-results-and-operational-highlights-302425587.html SOURCE RedHill Biopharma Ltd.