<p>以色列拉马特甘，2026 年 4 月 30 日（GLOBE NEWSWIRE）——<em>Can-Fite BioPharma Ltd.</em>（纽约证券交易所：CANF）（特拉维夫证券交易所：CANF）是一家临床阶段的生物技术公司，正在开发一系列用于治疗癌症和炎症性疾病的专有小分子药物，今天宣布了其在晚期胰腺癌患者中进行的 2a 期研究中获得的积极临床数据。</p>
<p>来自完全入组研究的数据表明了临床活动的初步证据，包括在重度预处理患者群体中持久的疾病稳定性，以及之前报告的良好安全性特征。</p>
<p>主要发现包括：</p>
<p>· 在可评估患者中观察到稳定疾病的比例超过 30%</p>
<p>· 治疗持续时间延长，包括一名患者的治疗超过 16 个月。</p>
<p>· 35% 的患者仍在接受治疗并进行随访</p>
<p>· 安全性和耐受性特征良好，与之前的报告一致</p>
<p>在几名患者中观察到的延长治疗时间表明在这一难治人群中可能存在持久的临床获益。</p>
<p>“随着我们继续分析数据，我们对本研究中观察到的持久疾病稳定性的新信号感到鼓舞，” Can-Fite 的董事长兼首席科学官 Pnina Fishman 表示。“重要的是，许多患者在治疗中持续较长时间，这支持了 namodenoson 在胰腺癌中的持续临床开发。”</p>
<p>由于相当比例的患者仍在接受治疗，完整的疗效分析，包括无进展生存期和总体生存期的初步结果预计将在未来几个月内公布，并将在即将召开的临床会议上进行展示。</p>
<p><strong>关于 Namodenoson</strong></p>
<p>Namodenoson 是一种高度选择性的 A3 腺苷受体（A3AR）激动剂，已显示出良好的安全性特征，并在临床前胰腺癌模型中表现出抗肿瘤活性。该药物还在临床试验中评估用于晚期肝癌。</p>
<p>Namodenoson 已获得美国食品和药物管理局（FDA）授予的孤儿药资格，用于治疗胰腺癌。</p>
<p><strong>关于胰腺癌 2a 期研究</strong></p>
<p>Namodenoson 的 2a 期研究是一项开放标签试验，针对在至少一线治疗后病情进展或拒绝标准治疗的晚期胰腺腺癌患者。该试验评估了 namodenoson 在该人群中的安全性、临床活性和药代动力学（PK）。所有患者每天口服 25 毫克的 namodenoson，连续 28 天周期服用。患者定期接受安全性评估。研究共招募了 20 名可评估患者。该试验的主要目标是描述 namodenoson 的安全性特征，次要目标是评估临床活性，具体通过使用实体瘤反应评估标准（RECIST 1.1）确定的客观反应率（ORR）、无进展生存期（PFS）、疾病控制率（DCR）、反应持续时间（DoR）和总体生存期（OS）进行评估。该研究达到了其主要终点，即安全性，表明 namodenoson 在这一重度预处理患者群体中耐受性良好。未发现新的安全信号，安全性特征与 namodenoson 在其他肿瘤疾病中的已知临床经验一致。</p>
<p><strong>关于 Can-Fite BioPharma Ltd.</strong></p>
<p>Can-Fite BioPharma Ltd.（纽约证券交易所：CANF）（特拉维夫证券交易所：CANF）是一家先进的临床阶段药物开发公司，拥有旨在解决数十亿美元市场的技术平台，专注于癌症、肝脏和炎症性疾病的治疗。公司的主要药物候选 Piclidenoson 最近在一项针对银屑病的 3 期试验中报告了初步结果，并开始了一项关键的 3 期试验。Can-Fite 的肝脏药物 Namodenoson 正在进行一项针对肝细胞癌（HCC）的 3 期试验、一项针对 MASH 的 2b 期试验，以及一项针对胰腺癌的 2a 期研究。Namodenoson 已在美国和欧洲获得孤儿药资格，并被美国食品和药物管理局授予 HCC 的二线治疗快速通道资格。Namodenoson 还显示出潜在治疗其他癌症（包括结肠癌、前列腺癌和黑色素瘤）的概念验证。公司的第三个药物候选 CF602 在治疗勃起功能障碍方面显示出疗效。这些药物在临床研究中已有超过 1600 名患者的良好安全性记录。有关更多信息，请访问：https://www.canfite.com/。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿可能包含前瞻性声明，涉及 Can-Fite 对其产品开发工作及产生有意义的疗效数据前景的期望、信念或意图。除与历史事实相关的声明外，本通讯中的所有声明均为 “前瞻性声明”。前瞻性声明可以通过使用诸如 “相信”、“期望”、“打算”、“计划”、“可能”、“应该” 或 “预期” 等前瞻性词汇及其否定形式或其他变体，或通过这些声明与历史或当前事务不严格相关的事实来识别。例如，公司在讨论完成发行、满足与发行相关的惯例交割条件以及计划使用其收益时使用了前瞻性声明。前瞻性声明涉及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已知和未知的风险、不确定性及其他因素的影响，这些因素可能导致 Can-Fite 的实际结果、表现或成就与前瞻性声明所表达或暗示的任何未来结果、表现或成就存在重大差异。可能导致实际结果、表现或成就与这些前瞻性声明中预期的结果存在重大差异的重要因素包括但不限于我们的市场及其他条件、历史亏损及为资助运营所需的额外资本需求，以及我们无法以可接受的条款获得额外资本，或根本无法获得；现金流的不确定性及无法满足营运资金需求；我们临床前研究、临床试验及其他产品候选开发工作的启动、时机、进展及结果；我们将产品候选推进至临床试验或成功完成临床前研究或临床试验的能力；我们获得产品候选的监管批准及其他监管申请和批准的时机；我们产品候选的临床开发、商业化及市场接受度；我们建立和维持战略合作伙伴关系及其他企业合作的能力；我们业务及产品候选的商业模式和战略计划的实施；我们能够建立和维持的知识产权保护范围，以及我们在不侵犯他人知识产权的情况下运营业务的能力；竞争公司、技术及我们的行业；与未满足 NYSE American 持续上市要求相关的风险；以及以色列的政治和安全形势对我们业务的影响的声明。有关这些风险、不确定性及其他因素的更多信息，时常包含在 Can-Fite 于 2026 年 3 月 26 日向 SEC 提交的 20-F 表格年度报告的 “风险因素” 部分及其他向 SEC 提交的公开报告中，以及其在特拉维夫证券交易所的定期提交文件中。现有和潜在投资者被提醒不要对这些前瞻性声明过度依赖，这些声明仅在本日期有效。Can-Fite 没有义务公开更新或审查任何前瞻性声明，无论是由于新信息、未来发展或其他原因，除非适用的证券法律要求。</p>
<p><strong>联系方式</strong></p>
<p>Can-Fite BioPharma</p>
<p>Motti Farbstein</p>
<p>info@canfite.com</p>
<p>+972-3-9241114</p>
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CANF

<p>Can-Fite BioPharma Ltd. 宣布了名为 namodenoson 的药物在晚期胰腺癌的 IIa 期临床试验中取得了积极的数据，显示超过 30% 的患者实现了持久的疾病稳定。值得注意的是，35% 的患者仍在接受治疗，其中一名患者的治疗时间超过 16 个月。该研究达到了主要安全性终点，显示出与之前报告一致的良好安全性特征。完整的疗效分析预计很快会公布，这将支持 namodenoson 在这一具有挑战性的疾病中的持续开发</p>

<p><em>Ramat Gan, Israel, April 30, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd.</em> (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer.</p>
<div class="lb-trans"><p>以色列拉马特甘，2026 年 4 月 30 日（GLOBE NEWSWIRE）——<em>Can-Fite BioPharma Ltd.</em>（纽约证券交易所：CANF）（特拉维夫证券交易所：CANF）是一家临床阶段的生物技术公司，正在开发一系列用于治疗癌症和炎症性疾病的专有小分子药物，今天宣布了其在晚期胰腺癌患者中进行的 2a 期研究中获得的积极临床数据。</p>
</div><p>The data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in a heavily pretreated patient population, in addition to the previously reported favorable safety profile.</p>
<div class="lb-trans"><p>来自完全入组研究的数据表明了临床活动的初步证据，包括在重度预处理患者群体中持久的疾病稳定性，以及之前报告的良好安全性特征。</p>
</div><p>Key findings include:</p>
<div class="lb-trans"><p>主要发现包括：</p>
</div><p>· Stable disease observed in &gt;30% of evaluable patients</p>
<div class="lb-trans"><p>· 在可评估患者中观察到稳定疾病的比例超过 30%</p>
</div><p>· Prolonged treatment duration includes one patient extending beyond 16 months.</p>
<div class="lb-trans"><p>· 治疗持续时间延长，包括一名患者的治疗超过 16 个月。</p>
</div><p>· 35% of patients remain on therapy and follow up</p>
<div class="lb-trans"><p>· 35% 的患者仍在接受治疗并进行随访</p>
</div><p>· Favorable safety and tolerability profile consistent with prior reports</p>
<div class="lb-trans"><p>· 安全性和耐受性特征良好，与之前的报告一致</p>
</div><p>The prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat population.</p>
<div class="lb-trans"><p>在几名患者中观察到的延长治疗时间表明在这一难治人群中可能存在持久的临床获益。</p>
</div><p>“As we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study,” said Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Importantly, a meaningful proportion of patients remain on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer.”</p>
<div class="lb-trans"><p>“随着我们继续分析数据，我们对本研究中观察到的持久疾病稳定性的新信号感到鼓舞，” Can-Fite 的董事长兼首席科学官 Pnina Fishman 表示。“重要的是，许多患者在治疗中持续较长时间，这支持了 namodenoson 在胰腺癌中的持续临床开发。”</p>
</div><p>As a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival, top-line results are expected in the coming months and will be presented in a forthcoming clinical conference.</p>
<div class="lb-trans"><p>由于相当比例的患者仍在接受治疗，完整的疗效分析，包括无进展生存期和总体生存期的初步结果预计将在未来几个月内公布，并将在即将召开的临床会议上进行展示。</p>
</div><p><strong>About Namodenoson</strong></p>
<div class="lb-trans"><p><strong>关于 Namodenoson</strong></p>
</div><p>Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.</p>
<div class="lb-trans"><p>Namodenoson 是一种高度选择性的 A3 腺苷受体（A3AR）激动剂，已显示出良好的安全性特征，并在临床前胰腺癌模型中表现出抗肿瘤活性。该药物还在临床试验中评估用于晚期肝癌。</p>
</div><p>Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.</p>
<div class="lb-trans"><p>Namodenoson 已获得美国食品和药物管理局（FDA）授予的孤儿药资格，用于治疗胰腺癌。</p>
</div><p><strong>About Pancreatic Cancer Phase 2a Study</strong></p>
<div class="lb-trans"><p><strong>关于胰腺癌 2a 期研究</strong></p>
</div><p>The Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.</p>
<div class="lb-trans"><p>Namodenoson 的 2a 期研究是一项开放标签试验，针对在至少一线治疗后病情进展或拒绝标准治疗的晚期胰腺腺癌患者。该试验评估了 namodenoson 在该人群中的安全性、临床活性和药代动力学（PK）。所有患者每天口服 25 毫克的 namodenoson，连续 28 天周期服用。患者定期接受安全性评估。研究共招募了 20 名可评估患者。该试验的主要目标是描述 namodenoson 的安全性特征，次要目标是评估临床活性，具体通过使用实体瘤反应评估标准（RECIST 1.1）确定的客观反应率（ORR）、无进展生存期（PFS）、疾病控制率（DCR）、反应持续时间（DoR）和总体生存期（OS）进行评估。该研究达到了其主要终点，即安全性，表明 namodenoson 在这一重度预处理患者群体中耐受性良好。未发现新的安全信号，安全性特征与 namodenoson 在其他肿瘤疾病中的已知临床经验一致。</p>
</div><p><strong>About Can-Fite BioPharma Ltd.</strong></p>
<div class="lb-trans"><p><strong>关于 Can-Fite BioPharma Ltd.</strong></p>
</div><p>Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: https://www.canfite.com/.</p>
<div class="lb-trans"><p>Can-Fite BioPharma Ltd.（纽约证券交易所：CANF）（特拉维夫证券交易所：CANF）是一家先进的临床阶段药物开发公司，拥有旨在解决数十亿美元市场的技术平台，专注于癌症、肝脏和炎症性疾病的治疗。公司的主要药物候选 Piclidenoson 最近在一项针对银屑病的 3 期试验中报告了初步结果，并开始了一项关键的 3 期试验。Can-Fite 的肝脏药物 Namodenoson 正在进行一项针对肝细胞癌（HCC）的 3 期试验、一项针对 MASH 的 2b 期试验，以及一项针对胰腺癌的 2a 期研究。Namodenoson 已在美国和欧洲获得孤儿药资格，并被美国食品和药物管理局授予 HCC 的二线治疗快速通道资格。Namodenoson 还显示出潜在治疗其他癌症（包括结肠癌、前列腺癌和黑色素瘤）的概念验证。公司的第三个药物候选 CF602 在治疗勃起功能障碍方面显示出疗效。这些药物在临床研究中已有超过 1600 名患者的良好安全性记录。有关更多信息，请访问：https://www.canfite.com/。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts and prospects for generating meaningful efficacy data. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. For example, the Company is using forward-looking statements when it discusses the completion of the offerings, the satisfaction of customary closing conditions related to the offerings and the intended use of proceeds therefrom. 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 known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.</p>
<div class="lb-trans"><p>本新闻稿可能包含前瞻性声明，涉及 Can-Fite 对其产品开发工作及产生有意义的疗效数据前景的期望、信念或意图。除与历史事实相关的声明外，本通讯中的所有声明均为 “前瞻性声明”。前瞻性声明可以通过使用诸如 “相信”、“期望”、“打算”、“计划”、“可能”、“应该” 或 “预期” 等前瞻性词汇及其否定形式或其他变体，或通过这些声明与历史或当前事务不严格相关的事实来识别。例如，公司在讨论完成发行、满足与发行相关的惯例交割条件以及计划使用其收益时使用了前瞻性声明。前瞻性声明涉及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已知和未知的风险、不确定性及其他因素的影响，这些因素可能导致 Can-Fite 的实际结果、表现或成就与前瞻性声明所表达或暗示的任何未来结果、表现或成就存在重大差异。可能导致实际结果、表现或成就与这些前瞻性声明中预期的结果存在重大差异的重要因素包括但不限于我们的市场及其他条件、历史亏损及为资助运营所需的额外资本需求，以及我们无法以可接受的条款获得额外资本，或根本无法获得；现金流的不确定性及无法满足营运资金需求；我们临床前研究、临床试验及其他产品候选开发工作的启动、时机、进展及结果；我们将产品候选推进至临床试验或成功完成临床前研究或临床试验的能力；我们获得产品候选的监管批准及其他监管申请和批准的时机；我们产品候选的临床开发、商业化及市场接受度；我们建立和维持战略合作伙伴关系及其他企业合作的能力；我们业务及产品候选的商业模式和战略计划的实施；我们能够建立和维持的知识产权保护范围，以及我们在不侵犯他人知识产权的情况下运营业务的能力；竞争公司、技术及我们的行业；与未满足 NYSE American 持续上市要求相关的风险；以及以色列的政治和安全形势对我们业务的影响的声明。有关这些风险、不确定性及其他因素的更多信息，时常包含在 Can-Fite 于 2026 年 3 月 26 日向 SEC 提交的 20-F 表格年度报告的 “风险因素” 部分及其他向 SEC 提交的公开报告中，以及其在特拉维夫证券交易所的定期提交文件中。现有和潜在投资者被提醒不要对这些前瞻性声明过度依赖，这些声明仅在本日期有效。Can-Fite 没有义务公开更新或审查任何前瞻性声明，无论是由于新信息、未来发展或其他原因，除非适用的证券法律要求。</p>
</div><p><strong>Contact</strong></p>
<div class="lb-trans"><p><strong>联系方式</strong></p>
</div><p>Can-Fite BioPharma</p>
<div class="lb-trans"><p>Can-Fite BioPharma</p>
</div><p>Motti Farbstein</p>
<div class="lb-trans"><p>Motti Farbstein</p>
</div><p>info@canfite.com</p>
<div class="lb-trans"><p>info@canfite.com</p>
</div><p>+972-3-9241114</p>
<div class="lb-trans"><p>+972-3-9241114</p>
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Can-Fite Reports Positive Phase 2a Data with Namodenoson in Pancreatic Cancer; 35% of Patients Remain on Therapy, Including One Beyond 16 Months | CANF Stock News

Can-Fite 报告了 Namodenoson 在胰腺癌治疗中的积极 2a 期数据；35% 的患者仍在接受治疗，其中一名患者治疗时间超过 16 个月 | CANF 股票新闻