Darolutamide

一、集团战略全球人口的持续增长和日益老龄化‌,以及自然生态系统压力与日俱增，‌是当前人类面临的主要挑战。作为健康与营养领域的全球领导者，我们的使命是"全民健康，消除饥饿（Health for all, Hunger for none）"。在这一使命的指导下，我们做出了通过产品和服务持续改善人类生活质量的承诺。我们将致力于提升营养与医疗服务的可及性‌，同时减少农业全产业链及企业自身的生态足迹‌。我们不仅强调产品与解决方案的开发与创新，还将持续推动业务流程的数字化‌。我们将继续在监管严格且利润丰厚的创新驱动型行业深耕，并以“超行业增速”为发展目标‌。此外，我们将持续优化资源配置与成本结构‌，以实现业务成长、盈利与可持续性的协同发展‌。我们的业务运营可为联合国可持续发展目标（SDGs）的达成做出贡献‌，同时在全价值链推行基于科学的气候行动方案‌。‌2023年，我们开始深化战略与公司使命的契合度‌。作为公司战略的核心元素，我们引入了“动态共享责任制（Dynamic Shared Ownership）”的运营模式‌。该模式以员工自主管理团队为基础‌，以充分释放创造力与专业能力‌。我们的目标是加速创新，为农民、患者和消费者提供更好的支持与帮助。‌我们将动态回顾战略‌，以确保公司能够灵活应对经济与政策环境的变化‌，并在全集团范围内推行新型运营模式‌。通过这些改革，我们致力于实现三大目标：1）提升员工的生产力与满意度；2）‌加速全球领先创新产品上市；3）持续提升财务表现。所有业务活动均基于其对公司使命的贡献度进行优先级排序‌，并以90天为周期评估进展‌。此举旨在让公司变得更灵活‌，减少跨部门协调成本及管理层级冗余‌。各业务单元的具体战略将遵循上述框架展开‌。二、业务层战略1. 作物科学业务在全球气候变化和人口持续增长的双重压力下，农业迎来了转型关键期。农业生产主体亟需探索资源集约型发展道路，以可持续方式保障粮食安全、能源供给及纺织纤维需求。这些挑战‌加速了行业的颠覆性变革‌，不仅‌重构了价值链的竞争格局‌，还‌催生出新型参与者‌和新市场机会。在这充满变革的产业环境中，创新的速度与规模、可为客户带来可持续发展的成果交付能力是制胜的关键。我们的目标是在未来十年内推出10款年销售额超5亿欧元的重磅产品‌，以创新技术赋能全球农户。依托覆盖种子&性状（Seeds & Traits）、作物保护及数字农业（Digital Farming）的创新管线，深度融合的数字化生态体系，遍布全球的业务网络与合作关系，我们正着力打造紧贴客户需求的敏捷型组织架构，聚焦培育具有抗风险能力的商业模式。另外，在系统化解决方案创新方面，我们已形成突破性成果矩阵：‌Preceon™智能玉米系统‌、新一代耐除草剂大豆品种、30年来首个苗后广谱除草剂新作用机理，以及颠覆性的技术储备，包括小麦杂交种、水稻直播技术（DSR）、亚非玉米生物技术性状、生物源植保产品及碳汇农业系统。在人工智能领域，我们正通过‌植保化学创新标杆技术CropKey‌，实现新植保产品研发在精准性、安全性及可持续性方面的革命性突破。通过将产品组合与数字洞察相融合，能够倍增农户收益‌。例如我们开发的Climate FieldView™数字农业平台就是这种实践的典范‌。在B2B领域，我们依托AgPowered Services等数字化平台创造价值‌。数字化战略的深化实施显著加速了创新的进程，推动了全链条流程自动化升级，改善了研发成功率。我们的愿景是通过规模化推广再生农业系统，构建更高产、更稳定的粮食生产体系‌。为了实现这一愿景，我们构建了“Produce 50% More（增产50%以上）”、“Restore Nature（自然修复）”、“Scale Regenerative Agriculture（规模化再生农业）”三大战略支柱‌‌。我们将在2030年以前实现的一大重要目标是，“通过提升中低收入国家小农户对‌农产品、服务及合作伙伴关系‌的获取渠道，累计支持‌1亿户小农户‌‌”。2. 制药业务随着人口老龄化的不断加剧和‌慢病发病率的持续上升‌，越来越多患者因多种病症叠加而生活质量受损‌。而细胞与基因疗法、精准医学等领域的科学突破，有望治愈需求最迫切的患者，甚至实现疾病预防‌，这为制药市场提供了巨大的机遇。与此同时，全球医疗系统成本上升也对药品定价及新药成本效益评估模式形成了压力‌。为此，我们制定了明确的战略优先级：1）最大化上市产品的价值，2）通过成功发布新品扩大收入，3）推进晚期阶段的研发管线。在‌充分发掘现有产品组合潜力‌的同时‌，着力开发‌新增长引擎‌，包括四款具有显著销售潜力的新药（Nubeqa、Kerendia、elinzanetant‌、acoramidis‌），以及正在开发二级中风预防适应症的‌asundexian‌ 。我们正集中‌营销与研发资源‌推动这些战略性产品的成功商业化，另外，鉴于美国市场的高增长潜力，公司将持续地投资。为保障长期增长‌，我们将持续投资研发以构建创新的、差异化且可持续的研发管线‌。业务聚焦于抗肿瘤、心血管、神经系统、罕见病、免疫系统等具有高临床价值与市场潜力的治疗领域‌。为了持续提升研发效率与效能，我们将构建以在研产品为核心的组织架构、实施动态资源配置、深化数据科学与人工智能技术应用。除了强化内部研发能力，我们还将持续投资平台性公司。BlueRock Therap与Asklepios BioPharma正稳步推进突破性细胞与基因疗法开发，Vividion Therap有助于强化我们的新药发现能力，尤其是在抗肿瘤与免疫领域。此外，我们通过研发合作与授权引进加速获取外部创新，以持续把握生物制剂与新兴技术带来的发展机遇‌。除了提升药品可及性，我们的另一核心要务是改善女性健康状况并强化其社会角色。依托在妇女保健领域的市场领导地位‌，我们的目标是到2030年，每年为中低收入国家1亿女性提供现代避孕药具获取渠道‌。此外，我们还将持续推进抗击热带病及非传染性疾病的行动‌。3. 消费者保健业务消费者健康意识的持续提升‌、总人口的不断增长与人口结构的不断变化，以及医疗成本的逐步攀升，推动着消费保健市场长期向好的发展态势。消费者对自我护理、疾病预防及整体健康的关注度显著增强‌，预计将持续驱动所有核心消费者保健品类的增长‌。我们同时预判消费渠道将持续向电商平台转移。我们将继续为消费者提供有助于改善日常健康的产品、服务及信息，并拓展业务版图以覆盖全球更多人口。战略聚焦于品类的培育与延伸，以及将处方药转化为OTC。为了推动业务强势而可持续的增长，我们将采用“以科学为本且值得信赖的品牌”和“持续推出创新型新产品”为抓手。在业务运营中，我们采用‌敏捷的资源配置机制‌‌，优先聚焦‌前瞻性增长机会，旨在通过品牌影响力赢得消费者信任。与此同时，我们还强调“为零售伙伴创造价值及‌深化与专业医疗机构的合作关系”，将致力于提升‌全价值链的生产力、柔性与韧性‌‌，以强化‌成本与资金效能‌‌，并同步降低对环境的影响。另外，我们还将通过内部创新与外部合作‌，以持续地发展现有品牌树和交付创新，通过并购与合作‌，以获取“可为市场带来‌个性化诊疗解决方案”的新商业模式及新能力。我们的目标是到2030年，每年为经济或医疗资源薄弱地区的1亿人口提升自我护理服务的可及性‌‌。为实现这一目标，我们将可持续性‌全面融入了运营体系‌‌，以开发‌精准匹配消费者需求‌的解决方案，尤其关注‌以自我护理为核心健康管理方式‌‌的群体。参考阅读 案例之一：罗氏的战略（2024年）药事纵横投稿须知：稿费已上调，欢迎投稿

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 and posted on the Company's investor relations website at: . 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 / 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. [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. [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 [7] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED