PH-762

INTASYL siRNA - Redefining the Treatment Paradigm for Cutaneous Squamous Cell Carcinoma; Potential to Decrease Morbidities and Surgical Fatigue King of Prussia, Pennsylvania--(News - November 9, 2026) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® gene silencing technology to eliminate cancer. Phio announced today that clinical data from its Phase 1b trial were presented at the 2026 Annual Meeting of the American Society for Dermatologic Surgery (ASDS), held in San Diego, California, from November 5-8, 2026. "The growing body of clinical evidence supporting PH-762 continues to demonstrate its potential to address an important unmet need in the treatment of cutaneous carcinomas," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "We believe these findings highlight PH-762's potential to become a differentiated, tissue-sparing neoadjuvant therapy that may shrink tumors before surgery, reduce the extent of resection, and ultimately improve patient outcomes." Phio's e-presentation " Intasyl siRNA Compound PH-762 ", was presented by John Strasswimmer, M.D., Ph.D. , of Florida Atlantic University and Integrity Research at Dermatology Associates of the Palm Beaches, Inc. , Delray Beach, Florida. Dr. Strasswimmer served as the lead investigator of the Phase 1b clinical trial. Highlights of the presentation included final results of the first Phase 1b study assessing the safety and efficacy of INTASYL PH-762 as a neoadjuvant intratumoral injection for cutaneous carcinomas. Study findings suggested PH-762 is well-tolerated and may represent a tissue-sparing neoadjuvant to the current cSCC treatment standard of MMS and/or standard excision. Additional studies are needed to further evaluate the safety and efficacy of PH-762 and a Phase 2b study is planned for the first half of 2027. About Phio Pharmaceuticals Corp. Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical development program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. These statements, which include statements, among other things, regarding the possibility that our INTASYL ® siRNA gene silencing technology will make the body's immune cells more effective in killing cancer cells, the potential for PH-762 to offer patients and physicians a meaningful new treatment option capable of shrinking tumors prior to surgery while maintaining an attractive safety profile, the potential for PH-762 to become a differentiated, tissue-sparing neoadjuvant treatment that may reduce the burden of surgery while preserving favorable clinical outcomes, and our expectation that a Phase 2b study will occur in the first half of 2027, are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact of future FDA interactions on the development of our product candidates; the impact to our business and operations by inflationary pressures; recession fears; the development of our product candidates, results from our nonclinical, preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those risks identified in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the U.S. Securities and Exchange Commission. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law. Contact: Phio Pharmaceuticals Corp. Jennifer Phillips: jphillips@phiopharma.com Corporate Affairs To view the source version of this press release, please visit

part 01 本周重点 中美瑞康｜RAG-01：针对非肌层浸润性膀胱癌的多中心Ⅱ期研究启动，涉及 11 家中心。 金赛药业｜GenSci117：靶向 MMP7 的吸入 siRNA 临床试验申请获受理，拟用于特发性肺纤维化。 ADC Therapeutics｜ZYNLONTA：LOTIS-7 Ⅰb 期摘要中，97 例可评价患者的客观缓解率为 88.7%，完全缓解率为 75.3%。 中国生物制药｜ADC 及 T 细胞衔接器项目：与勃林格殷格翰就 6 个临床前项目达成选择权及许可协议。 part 02 Part A｜核酸药（含 mRNA） 二、临床 / 注册进展 中美瑞康｜RAG-01｜启动非肌层浸润性膀胱癌多中心Ⅱ期研究 中美瑞康启动 RAG-01 中国多中心Ⅱ期研究 RAG010201，研究由复旦大学附属肿瘤医院叶定伟教授牵头，11 家医疗机构参与。RAG-01 是靶向上调 p21 的小激活 RNA，采用 LiCO 递送系统经膀胱灌注给药。研究评估中危或高危患者接受 RAG-01 单药及联合丝裂霉素 C 的方案：高危队列在安全导入后比较单药与联合方案，主要终点为 24 个月无事件生存率；中危队列为单臂设计，主要终点为 24 个月无复发生存率。 来源：中美瑞康 金赛药业｜GenSci117｜吸入 siRNA 临床试验申请获受理 长春高新公告，子公司金赛药业的 GenSci117 吸入用粉末境内生产药品注册临床试验申请获得受理，受理号为 CXHL2601358，拟用于治疗特发性肺纤维化。GenSci117 是靶向基质金属蛋白酶 7（MMP7）的双链 siRNA，基于 GPODS 肝外递送平台，通过小分子配体递送至靶细胞，采用吸入给药。公告所列规格为 60 mg / 瓶，预期给药周期为每两个月一次。 当前节点为申请受理。 来源：长春高新公告 Phio Pharmaceuticals｜PH-762｜提交Ⅰb期研究报告并推进Ⅱb期准备 Phio 向 FDA 提交 PH-762 Ⅰb 期临床研究最终报告、会议申请及拟开展的Ⅱb期研究资料。PH-762 是靶向 PD-1 的 siRNA 候选药物；已完成的Ⅰb期研究采用瘤内给药，共纳入 22 人，其中 20 人患皮肤鳞状细胞癌。公司计划于 2027 年第一季度启动皮肤鳞癌新辅助治疗Ⅱb期研究，并已完成首批商业规模 cGMP 原料药的放行及向制剂生产商的发运。 来源：Phio Pharmaceuticals 三、BD / 合作 / 融资 Penn–BioNTech 基金｜Emvena 胎盘靶向 mRNA｜宣布首笔投资 Penn–BioNTech Innovative Therapeutics Seed Fund 宣布投资 Emvena Therapeutics，这是该基金启动并资助的首家企业。Emvena 正开发针对母体及胎儿疾病的胎盘靶向 mRNA 药物，首个项目聚焦子痫前期。公司技术源自宾夕法尼亚大学 Michael J. Mitchell 实验室：其既往研究开发了偏向胎盘递送 mRNA 的脂质纳米颗粒，并在子痫前期小鼠模型中评估了编码 VEGF 的 mRNA。投资金额未披露。 来源：Business Wire 新闻稿 part 03 Part B｜XDC（ADC / PDC / RDC） 四、临床 / 注册进展 ADC Therapeutics｜ZYNLONTA｜公布 LOTIS-7 等研究摘要数据 ADC Therapeutics 公布 ZYNLONTA（loncastuximab tesirine）临床项目的 ASH 会议摘要数据。在Ⅰb期 LOTIS-7 研究中，截至 2026 年 6 月 15 日，ZYNLONTA 联合 glofitamab 治疗复发或难治性大 B 细胞淋巴瘤的 97 例可评价患者中，客观缓解率为 88.7%，完全缓解率为 75.3%；中位随访 10.35 个月。 细胞因子释放综合征发生率为 32%，以 1–2 级为主，报告 3 例 5 级治疗期间发生的不良事件。 来源：ADC Therapeutics 默沙东｜MK-2870｜前列腺癌Ⅰ/Ⅱ期研究登记 默沙东的 ADC sacituzumab tirumotecan（MK-2870）Ⅰ/Ⅱ期研究拟评估单药或联合其他治疗用于转移性去势抵抗性前列腺癌。研究计划入组 290 人，目前尚未开始招募。 来源：NCT07908524 默沙东｜MK-2870｜膀胱灌注研究完成 MK-2870 的Ⅰ/Ⅱ期研究评估膀胱灌注给药在中危非肌层浸润性膀胱癌中的安全性和疗效，实际入组 35 人，登记状态为已完成。 来源：NCT06637423 RayzeBio｜²²⁵Ac-RYZ401｜放射性治疗Ⅰ期研究 RayzeBio 的 ²²⁵Ac 标记放射性治疗药物 RYZ401 正在Ⅰ期剂量递增和扩展研究中，用于生长抑素受体表达的神经内分泌肿瘤及其他实体瘤；研究处于招募状态。 来源：NCT07165132 ABX｜¹⁸F-PSMA-1007｜前列腺癌 PET 影像Ⅲ期研究 ABX 的Ⅲ期多中心研究评估 ¹⁸F-PSMA-1007 PET/CT 对新诊断高危或极高危前列腺癌的诊断表现，计划入组 434 人，正在招募。 来源：NCT06122584 NIDDK｜¹⁷⁷Lu-DOTA-EB-TATE｜甲状腺癌放射性治疗Ⅰ/Ⅱ期研究 美国国家糖尿病、消化和肾脏疾病研究所开展的Ⅰ/Ⅱ期研究拟评估 ¹⁷⁷Lu-DOTA-EB-TATE 治疗放射性碘无应答的转移性嗜酸性细胞甲状腺癌，计划入组 18 人，尚未招募。 来源：NCT06991738 五、BD / 合作 / 融资 中国生物制药｜ADC 及 T 细胞衔接器项目｜与勃林格殷格翰达成选择权及许可协议 中国生物制药与勃林格殷格翰达成战略选择权及许可协议，涵盖 6 个临床前 ADC 和 T 细胞衔接器项目，其中 5 个来自礼新医药，1 个来自北京泰德。中国生物制药负责项目早期开发至全球Ⅰ期临床完成；达到约定里程碑后，勃林格殷格翰可行使选择权，取得其中 4 个项目的中国大陆、香港及澳门以外地区权益，以及另 2 个项目的全球权益。中国生物制药可获 3.58 亿美元首付款及近期付款，另有最高 70 亿美元选择权行使及里程碑付款，以及分级销售提成。 来源：中国生物制药公告 part 04 Part C｜技术 / CMC / 制造 六、技术新闻 Belter 等｜miRarchitect｜机器学习辅助人工 miRNA 设计研究发表 波兰科学院生物有机化学研究所的 Agnieszka Belter、Jaroslaw Synak 等在Molecular Therapy Nucleic Acids发表人工 miRNA 设计研究。研究提出将 siRNA 插入序列与经过精确加工的内源性 pri-miRNA 骨架匹配，并开发使用机器学习辅助定制设计的网页平台 miRarchitect。研究团队针对 TMPRSS2 和 ACE-2 的实验验证显示，所设计的人工 miRNA 实现靶点敲低及精确加工；研究还报告对另外 6 个治疗靶点的有效沉默。 来源：Molecular Therapy Nucleic Acids00343-4)