<p>题为 &#34; <strong>靶向</strong> <strong>SCD1 增强标准治疗药物瑞戈非尼在肝细胞癌中的活性：阿拉姆醇与瑞戈非尼联合使用的 1/2 期研究的转化依据</strong> &#34; 的最新摘要将于 12 月 9 日下午 3 点（HST）以海报形式展示。</p>
<p>, /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD)（&#34;Galmed&#34;或&#34;公司&#34;），一家专注于肝脏、心代谢疾病和胃肠道肿瘤治疗的临床阶段生物制药公司，宣布将在 HEP-DART 2025 会议上展示其主要药物候选者阿拉姆醇的最新摘要。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg"/></p>
<p>此前，Galmed 宣布阿拉姆醇显著增强拜耳的瑞戈非尼在胃肠道癌症模型中杀死胃肠道肿瘤细胞的效果。SCD1 抑制通过 ATM-AMPK-自噬信号通路增强瑞戈非尼（Stivarga®）的活性。这些发现为启动阿拉姆醇与标准治疗药物瑞戈非尼联合使用的 1/2 期临床试验提供了科学和转化依据，适用于肝细胞癌和其他胃肠道癌症。一旦找到推荐的 2 期剂量，Galmed 计划增加一个剂量扩展队列，包括二甲双胍，并评估这三种药物的联合疗效。</p>
<p>&#34;我们最新摘要被 HEP-DART 这一享有盛誉的科学会议接受，突显了我们数据的重要性。所展示的研究工作直接影响了 VCU Massey 综合癌症中心启动阿拉姆醇与瑞戈非尼在晚期胃肠道癌症（包括肝细胞癌）中的研究者发起的 1/2 期临床试验的决定，计划于 2026 年开始招募。积极的研究结果不仅将为阿拉姆醇在三种关键胃肠道癌症中的后续加速临床开发奠定基础，还可能扩展 Galmed 的肿瘤学管线，为投资者和利益相关者创造价值，&#34; Galmed Pharmaceuticals 首席执行官 Allen Baharaff 表示。</p>
<p><strong>关于 HEP-DART</strong></p>
<p>HEP-DART 于 1995 年首次召开，作为&#34;国际病毒性肝炎治疗会议&#34;。自 1995 年成立以来，HEP-DART 为解决病毒性肝炎和慢性肝病药物开发中的挑战提供了前沿平台。HEP-DART 2025 的目标是汇集临床医生、研究人员和医师，共同推进我们对病毒性肝炎、纤维化、代谢功能障碍相关脂肪肝炎（MASH）和肝细胞癌（HCC）治疗中正在进行的药物开发过程的认识，并为科学界提供对肝脏感染、疾病和癌症治疗中当前和未来挑战的更深入理解。</p>
<p><strong>关于 Galmed Pharmaceuticals Ltd.：</strong></p>
<p>我们是一家专注于阿拉姆醇开发的生物制药公司。我们几乎完全专注于阿拉姆醇在肝脏疾病治疗中的开发，并继续积极推进阿拉姆醇在 NASH 联合治疗中的应用。我们还寻求在 NASH 和纤维化以外的某些肿瘤指征中开发阿拉姆醇。此外，作为我们的增长战略的一部分，我们正在积极寻求扩展和多样化我们的产品管线的机会，特别是针对心代谢指征和其他与我们药物开发核心专长相一致的创新产品候选者。</p>
<p><strong>前瞻性声明：</strong></p>
<p>前瞻性声明涉及到截至声明发布之日预期或预计的事件、活动、趋势或结果。由于前瞻性声明涉及尚未发生的事项，因此这些声明本质上受到风险和不确定性的影响，这可能导致我们的实际结果与前瞻性声明所表达或暗示的未来结果存在重大差异。前瞻性声明可能包括但不限于与 Aramchol、Stivarga®和 Metformin 作为新固定剂量组合治疗的潜在协同效应相关的声明、临床试验的预期时间、未来的临床开发以及为投资者和利益相关者创造价值的预期。许多因素可能导致我们的实际活动或结果与前瞻性声明中预期的活动和结果存在重大差异，包括但不限于 Aramchol 或我们开发的任何其他产品候选药物在非酒精性脂肪性肝炎（NASH）或代谢功能障碍相关脂肪性肝炎（MASH）及纤维化或联合治疗方面的开发和批准；Aramchol 或我们开发的任何其他产品候选药物的任何临床前或临床试验的时间和成本；任何临床前或临床试验的完成及获得良好结果；美国食品药品监督管理局（FDA）或欧洲药品管理局（EMA）对 Aramchol 或任何其他产品候选药物的监管行动，包括但不限于对市场授权申请的接受、对该申请的审查和批准，以及如果获得批准，批准的适应症和标签的范围；Aramchol 及任何未来产品候选药物的商业推出和未来销售；我们在寻求市场产品的国家中遵守所有适用的市场后监管要求的能力；我们为 Aramchol 或任何其他产品候选药物实现有利定价的能力；第三方支付方对 Aramchol 或任何其他产品候选药物的报销；我们对预期资本需求和额外融资需求的估计；医生和患者对 Aramchol 或任何其他产品候选药物的市场接受度；Aramchol 或任何其他产品候选药物的商业推出的时间、成本或其他方面；我们获得和维护知识产权的充分保护的能力；我们可能面临第三方知识产权侵权索赔的可能性；我们以商业数量、足够质量或可接受成本制造产品候选药物的能力；我们建立足够的销售、市场和分销渠道的能力；我们行业内的激烈竞争，竞争对手在财务、技术、研发、监管和临床、制造、市场营销和销售、分销及人力资源方面拥有远超我们的资源；我们对许可、收购和战略运营的预期；当前或未来不利的经济和市场条件以及与金融机构相关的流动性风险的不利发展；我们在纳斯达克资本市场维持普通股上市的能力；中东地区的安全、政治和经济不稳定可能对我们的业务造成损害，包括由于以色列当前的安全形势、与我们的数字资产管理策略相关的风险，包括加密货币和其他数字资产价格的高度波动性、我们的股价可能与我们持有的加密货币和其他数字资产的价格高度相关的风险、我们所处行业竞争加剧的风险、与加密货币和其他数字资产普遍存在的重大法律、商业、监管和技术不确定性相关的风险、与加密资产在美国和外国税务处理相关的风险，以及在 2025 年 8 月 25 日向证券交易委员会（&#34;SEC&#34;）提交的外国私人发行人报告的附录 99.2 中识别的那些风险和不确定性。我们认为这些前瞻性声明是合理的；然而，这些声明仅是当前的预测，并受到已知和未知的风险、不确定性及其他因素的影响，这可能导致我们或我们行业的实际结果、活动水平、表现或成就与前瞻性声明所预期的存在重大差异。我们在 2025 年 4 月 2 日向 SEC 提交的截至 2024 年 12 月 31 日的年度报告（表格 20-F）中更详细地讨论了许多这些风险，标题为 “风险因素”。鉴于这些不确定性，您不应将前瞻性声明视为未来事件的预测。所有归因于我们或代表我们行事的人员的前瞻性声明仅在此日期有效，并且完全受到本报告中包含的警示性声明的明确限定。我们没有义务更新或修订前瞻性声明，以反映声明发布后发生的事件或情况，或反映意外事件的发生。在评估前瞻性声明时，您应考虑这些风险和不确定性。</p>
<p>Logo - https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg</p>
<p>来源：Galmed Pharmaceuticals Ltd.</p>

Galmed制药

<p>Galmed 制药宣布其主要药物候选者 Aramchol 的晚期摘要在 HEP-DART 2025 会议上获得接受。该摘要强调了在与 Aramchol 联合使用时，瑞戈非尼在肝细胞癌中的增强活性。这一接受突显了他们数据的重要性，并通知了 1/2 期临床试验的启动。积极的研究结果可能会扩展 Galmed 的肿瘤学产品线，并为投资者创造价值</p>

<p>Late Breaking Abstract titled &#34; <strong>Targeting</strong> <strong>SCD1 enhances activity of standard of care regorafenib in hepatocellular carcinoma: translational rationale for a phase 1/2 study of the combination of Aramchol and regorafenib&#34;</strong> to be presented with a poster on December 9 at 3pm (HST).</p>
<div class="lb-trans"><p>题为 &#34; <strong>靶向</strong> <strong>SCD1 增强标准治疗药物瑞戈非尼在肝细胞癌中的活性：阿拉姆醇与瑞戈非尼联合使用的 1/2 期研究的转化依据</strong> &#34; 的最新摘要将于 12 月 9 日下午 3 点（HST）以海报形式展示。</p>
</div><p>, /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (&#34;Galmed&#34; or the &#34;Company&#34;), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced the presentation of a late breaking abstract for its lead drug candidate, Aramchol at HEP-DART 2025 Meeting.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD)（&#34;Galmed&#34;或&#34;公司&#34;），一家专注于肝脏、心代谢疾病和胃肠道肿瘤治疗的临床阶段生物制药公司，宣布将在 HEP-DART 2025 会议上展示其主要药物候选者阿拉姆醇的最新摘要。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg"/></p>
<p>Previously, Galmed announced that Aramchol significantly enhances Bayer's regorafenib effect in GI cancer models to kill GI tumor cells. SCD1 inhibition augments regorafenib (Stivarga®) activity through ATM-AMPK-autophagy signaling. These findings provide the scientific and translational rationale for the initiation of a Phase 1/2 clinical trial of the combination of standard of care regorafenib with the SCD1 inhibitor Aramchol in HCC and other GI cancers. Once a recommended Phase 2 dose is found, Galmed plans to add a dose expansion cohort that will include Metformin and will evaluate the 3-drugs' combination efficacy.</p>
<div class="lb-trans"><p>此前，Galmed 宣布阿拉姆醇显著增强拜耳的瑞戈非尼在胃肠道癌症模型中杀死胃肠道肿瘤细胞的效果。SCD1 抑制通过 ATM-AMPK-自噬信号通路增强瑞戈非尼（Stivarga®）的活性。这些发现为启动阿拉姆醇与标准治疗药物瑞戈非尼联合使用的 1/2 期临床试验提供了科学和转化依据，适用于肝细胞癌和其他胃肠道癌症。一旦找到推荐的 2 期剂量，Galmed 计划增加一个剂量扩展队列，包括二甲双胍，并评估这三种药物的联合疗效。</p>
</div><p>&#34;The acceptance of our late-breaking abstract to the HEP-DART prestigious scientific meeting underscores the significance of our data. The research work presented has directly informed VCU Massey Comprehensive Cancer's decision to initiate an investigator-initiated Phase 1/2 clinical trial of Aramchol and regorafenib in advanced GI cancers, including HCC, with planned enrollment starting in 2026. Positive findings would not only lay the groundwork for subsequent accelerated clinical development of Aramchol in key three GI cancers, but could potentially expand Galmed's oncology pipeline and create value for investors and stakeholders&#34; said Allen Baharaff, CEO of Galmed Pharmaceuticals.</p>
<div class="lb-trans"><p>&#34;我们最新摘要被 HEP-DART 这一享有盛誉的科学会议接受，突显了我们数据的重要性。所展示的研究工作直接影响了 VCU Massey 综合癌症中心启动阿拉姆醇与瑞戈非尼在晚期胃肠道癌症（包括肝细胞癌）中的研究者发起的 1/2 期临床试验的决定，计划于 2026 年开始招募。积极的研究结果不仅将为阿拉姆醇在三种关键胃肠道癌症中的后续加速临床开发奠定基础，还可能扩展 Galmed 的肿瘤学管线，为投资者和利益相关者创造价值，&#34; Galmed Pharmaceuticals 首席执行官 Allen Baharaff 表示。</p>
</div><p><strong>About HEP-DART</strong></p>
<div class="lb-trans"><p><strong>关于 HEP-DART</strong></p>
</div><p>HEP-DART started in 1995 as the &#34;FIRST International Conference on Therapies for Viral Hepatitis.&#34; Since its inception in 1995, HEP-DART has provided a cutting-edge platform for tackling challenges in drug development for viral hepatitis and chronic liver disease. The aim of HEP-DART 2025 is to assemble clinicians, researchers, and physician together to advance our knowledge of the ongoing drug development processes in the treatment of viral hepatitis, fibrosis, Metabolic Dysfunction-Associated Steatohepatitis MASH), and hepatocellular carcinoma (HCC) and to provide the scientific community with an increased understanding of the current and future challenges in therapeutics for liver infection, disease and cancer.</p>
<div class="lb-trans"><p>HEP-DART 于 1995 年首次召开，作为&#34;国际病毒性肝炎治疗会议&#34;。自 1995 年成立以来，HEP-DART 为解决病毒性肝炎和慢性肝病药物开发中的挑战提供了前沿平台。HEP-DART 2025 的目标是汇集临床医生、研究人员和医师，共同推进我们对病毒性肝炎、纤维化、代谢功能障碍相关脂肪肝炎（MASH）和肝细胞癌（HCC）治疗中正在进行的药物开发过程的认识，并为科学界提供对肝脏感染、疾病和癌症治疗中当前和未来挑战的更深入理解。</p>
</div><p><strong>About Galmed Pharmaceuticals Ltd.:</strong></p>
<div class="lb-trans"><p><strong>关于 Galmed Pharmaceuticals Ltd.：</strong></p>
</div><p>We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.</p>
<div class="lb-trans"><p>我们是一家专注于阿拉姆醇开发的生物制药公司。我们几乎完全专注于阿拉姆醇在肝脏疾病治疗中的开发，并继续积极推进阿拉姆醇在 NASH 联合治疗中的应用。我们还寻求在 NASH 和纤维化以外的某些肿瘤指征中开发阿拉姆醇。此外，作为我们的增长战略的一部分，我们正在积极寻求扩展和多样化我们的产品管线的机会，特别是针对心代谢指征和其他与我们药物开发核心专长相一致的创新产品候选者。</p>
</div><p><strong>Forward-Looking Statements:</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明：</strong></p>
</div><p>Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga® and Metformin as a new fixed-dose combination treatment, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel, risks relating to our digital asset management strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign tax purposes and those risks and uncertainties identified in Exhibit 99.2 to our Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission (&#34;SEC&#34;) on August 25, 2025. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 2, 2025 in greater detail under the heading &#34;Risk Factors.&#34; Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.</p>
<div class="lb-trans"><p>前瞻性声明涉及到截至声明发布之日预期或预计的事件、活动、趋势或结果。由于前瞻性声明涉及尚未发生的事项，因此这些声明本质上受到风险和不确定性的影响，这可能导致我们的实际结果与前瞻性声明所表达或暗示的未来结果存在重大差异。前瞻性声明可能包括但不限于与 Aramchol、Stivarga®和 Metformin 作为新固定剂量组合治疗的潜在协同效应相关的声明、临床试验的预期时间、未来的临床开发以及为投资者和利益相关者创造价值的预期。许多因素可能导致我们的实际活动或结果与前瞻性声明中预期的活动和结果存在重大差异，包括但不限于 Aramchol 或我们开发的任何其他产品候选药物在非酒精性脂肪性肝炎（NASH）或代谢功能障碍相关脂肪性肝炎（MASH）及纤维化或联合治疗方面的开发和批准；Aramchol 或我们开发的任何其他产品候选药物的任何临床前或临床试验的时间和成本；任何临床前或临床试验的完成及获得良好结果；美国食品药品监督管理局（FDA）或欧洲药品管理局（EMA）对 Aramchol 或任何其他产品候选药物的监管行动，包括但不限于对市场授权申请的接受、对该申请的审查和批准，以及如果获得批准，批准的适应症和标签的范围；Aramchol 及任何未来产品候选药物的商业推出和未来销售；我们在寻求市场产品的国家中遵守所有适用的市场后监管要求的能力；我们为 Aramchol 或任何其他产品候选药物实现有利定价的能力；第三方支付方对 Aramchol 或任何其他产品候选药物的报销；我们对预期资本需求和额外融资需求的估计；医生和患者对 Aramchol 或任何其他产品候选药物的市场接受度；Aramchol 或任何其他产品候选药物的商业推出的时间、成本或其他方面；我们获得和维护知识产权的充分保护的能力；我们可能面临第三方知识产权侵权索赔的可能性；我们以商业数量、足够质量或可接受成本制造产品候选药物的能力；我们建立足够的销售、市场和分销渠道的能力；我们行业内的激烈竞争，竞争对手在财务、技术、研发、监管和临床、制造、市场营销和销售、分销及人力资源方面拥有远超我们的资源；我们对许可、收购和战略运营的预期；当前或未来不利的经济和市场条件以及与金融机构相关的流动性风险的不利发展；我们在纳斯达克资本市场维持普通股上市的能力；中东地区的安全、政治和经济不稳定可能对我们的业务造成损害，包括由于以色列当前的安全形势、与我们的数字资产管理策略相关的风险，包括加密货币和其他数字资产价格的高度波动性、我们的股价可能与我们持有的加密货币和其他数字资产的价格高度相关的风险、我们所处行业竞争加剧的风险、与加密货币和其他数字资产普遍存在的重大法律、商业、监管和技术不确定性相关的风险、与加密资产在美国和外国税务处理相关的风险，以及在 2025 年 8 月 25 日向证券交易委员会（&#34;SEC&#34;）提交的外国私人发行人报告的附录 99.2 中识别的那些风险和不确定性。我们认为这些前瞻性声明是合理的；然而，这些声明仅是当前的预测，并受到已知和未知的风险、不确定性及其他因素的影响，这可能导致我们或我们行业的实际结果、活动水平、表现或成就与前瞻性声明所预期的存在重大差异。我们在 2025 年 4 月 2 日向 SEC 提交的截至 2024 年 12 月 31 日的年度报告（表格 20-F）中更详细地讨论了许多这些风险，标题为 “风险因素”。鉴于这些不确定性，您不应将前瞻性声明视为未来事件的预测。所有归因于我们或代表我们行事的人员的前瞻性声明仅在此日期有效，并且完全受到本报告中包含的警示性声明的明确限定。我们没有义务更新或修订前瞻性声明，以反映声明发布后发生的事件或情况，或反映意外事件的发生。在评估前瞻性声明时，您应考虑这些风险和不确定性。</p>
</div><p>Logo - https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg</p>
<div class="lb-trans"><p>Logo - https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg</p>
</div><p>SOURCE Galmed Pharmaceuticals Ltd.</p>
<div class="lb-trans"><p>来源：Galmed Pharmaceuticals Ltd.</p>
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Galmed 宣布其一项最新的摘要已被接受，并将在 HEP-DART 2025 会议上进行展示 | GLMD 股票新闻