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 li...

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 SPH...

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...

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...