Durvalumab

– First patients dosed in the VIRAGE2 Phase 2a clinical study evaluating more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) the goal of which is to improve treatment outcomes in metastatic pancreatic ductal adenocarcinoma (PDAC) patients – – Cash and cash equivalents of $11.3 million as of June 30, 2026; cash runway into Q1 2027 – ROCKVILLE, Md., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. “We have successfully converted last quarter’s regulatory achievements into clinical progress in the VCN-01 program,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Dosing of the first patients in the VIRAGE2 trial brings us closer to refining a VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy. A repeated VCN-01 dosing regimen may also improve outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments. If more frequent repeated administration of VCN-01 is feasible and well-tolerated, use of this dosing regimen may further derisk future Phase 3 clinical trials.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Recent Highlights and Anticipated Milestones VCN-01 Metastatic PDAC: As recently announced , the first patients have been dosed in the VIRAGE2 Phase 2a clinical trial entitled “A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00; NCT07701486 ). The VIRAGE2 study design incorporates feedback from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) recognizing improved survival outcomes in the VIRAGE Phase 2b trial in metastatic PDAC patients treated with 2 doses of VCN-01 (in combination with standard-of-care chemotherapy), highlighting the possibility that more frequent repeated dosing of VCN-01 may provide additional clinical benefit. The VIRAGE2 trial will evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients. Results from the VIRAGE2 study will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial. VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Retinoblastoma: Undertook extensive discussions with key opinion leaders and completed the design of a proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy. Proposed clinical trial protocol builds on compelling Phase 1 clinical data in this ultra rare population for which there is no current treatment. Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026. VCN-01 has Orphan Drug Designation from both the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher. Head & Neck Squamous Cell Carcinoma: Clinical and translational results from the Phase 1 clinical trial of VCN-01 in refractory or metastatic head & neck squamous cell carcinoma (HNSCC) patients (whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors) were published in the journal Clinical Cancer Research in an online first article titled “Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy”. In the Phase 1 trial, prolonged overall survival (OS) was observed in these heavily pre-treated refractory HNSCC patients administered intravenous VCN-01 prior to the immune checkpoint inhibitor durvalumab (sequential delivery). Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action, resensitizing refractory tumors to durvalumab. These findings support further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC and potentially other cancer indications. Second Quarter Ended June 30, 2026 Financial Results General and Administrative Expenses General and administrative expenses decreased to $2.0 million for the three months ended June 30, 2026, from $11.2 million for the three months ended June 30, 2025. This decrease of 82% is primarily comprised of the prior year increase in fair value of the contingent consideration adjustment of $9.2 million due to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints, offset set by current year increase in legal fees. The charge related to stock-based compensation expense was $110,000 for the three months ended June 30, 2026, compared to $97,000 for the three months ended June 30, 2025. Research and Development Expenses Research and development expenses decreased to $1.3 million for the three months ended June 30, 2026, from $2.0 million for the three months ended June 30, 2025. This decrease of 35% is primarily the result of lower indirect cost related to compensation expense and lower direct clinical trial expenses related to the Company’s Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower expenses related to SYN-020, offset by higher direct expenses related to VCN-01 manufacturing activities and expenses associated with the planning for the Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period. Other Income/Expense Other income was $78,000 for the three months ended June 30, 2026, compared to other income of $74,000 for the three months ended June 30, 2025. Other income for the three months ended June 30, 2026 is comprised of interest income of $79,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2025 is comprised of interest income of $54,000 and an exchange gain of $20,000. Cash and Cash Equivalents Cash and cash equivalents totaled $11.3 million as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended June 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $5.3 million for the year ended December 31, 2025 and the six months ended June 30, 2026, respectively. About Theriva™ Biologics, Inc. Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial remains open with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Enrollment is paused and completion of this trial is pending receipt of grant funding or funding through a partnership or other collaboration. For more information, please visit Theriva™ Biologics’ website at . Forward-Looking Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the results from the VIRAGE2 trial informing the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy; a repeated VCN-01 dosing regimen improving outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments; more frequent repeated administration of VCN-01 further derisking future Phase 3 clinical trials; more frequent repeated dosing of VCN-01 providing additional clinical benefit; completing enrollment into the VIRAGE2 trial in H2 2026 with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027; administering at least 3 doses of VCN-01 in the VIRAGE2 trial given approximately 2 months apart in combination with standard-of-care chemotherapy; the trial enrolling 6 patients; discussing the proposed clinical trial protocol with the FDA in Q3 2026; the findings in the Phase 1 clinical trial of VCN-01 in HNSCC supporting further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC.. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize protocols for future clinical trials evaluating VCN-01; results of future trials supporting further clinical development of VCN-01 and supporting the benefits of more frequent repeated dosing of VCN-01; the Company’s ability to obtain development funding and/or partnerships; the Company’s commencement of planned clinical trials, which remains subject to sufficient financing; the Company’s ability to raise capital and/or enter into one or more strategic alternatives, that may include a business combination, merger or reverse merger; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in cancer patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat cancer patients; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For further information, please contact: Investor Relations Kevin Gardner LifeSci Advisors, LLC kgardner@lifesciadvisors.com Theriva Biologics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands except share and par value amounts) June 30, 2026 (unaudited) December 31, 2025 Assets Current Assets Cash and cash equivalents $ 11,337 $ 13,056 Tax credit receivable 1,681 3,351 Prepaid expenses and other current assets 653 1,060 Total Current Assets 13,671 17,467 Non-Current Assets Property and equipment, net 173 222 Restricted cash 44 46 Right of use asset 1,825 803 In-process research and development 19,064 19,619 Deposits and other assets 80 82 Total Assets $ 34,857 $ 38,239 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable $ 984 $ 1,014 Accrued expenses 6,418 6,276 Contingent consideration, current portion 2,650 — Accrued employee benefits 290 443 Deferred research and development tax credit-current portion 1,210 1,675 Loans payable-current 34 57 Operating lease liability-current portion 525 549 Total Current Liabilities 12,111 10,014 Non-current Liabilities Non-current contingent consideration 7,169 10,004 Loan Payable - non-current 1,620 1,671 Non-current deferred research and development tax credit 396 815 Non-current operating lease liability 1,374 352 Total Liabilities 22,670 22,856 Commitments and Contingencies (Note 14) — — Stockholders’ Equity: Common stock, $0.001 par value; 350,000,000 shares authorized, 45,921,478 issued and 45,892,668 outstanding at June 30, 2026, and 35,717,159 issued and 35,688,350 outstanding at December 31, 2025 45 34 Additional paid-in capital 376,154 373,592 Treasury stock at cost, 28,810 shares at June 30, 2026 and at December 31, 2025 (288 ) (288 ) Accumulated other comprehensive loss 247 755 Accumulated deficit (363,971 ) (358,710 ) Total Stockholders’ Equity 12,187 15,383 Total Liabilities and Stockholders’ Equity $ 34,857 $ 38,239 Theriva Biologics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) For the three months ended June 30, For the six months ended June 30, 2026 2025 2026 2025 License Revenue $ — $ — $ 300 $ — Operating Costs and Expenses: General and administrative 2,027 11,179 4,099 12,628 Research and development 1,268 1,953 1,623 4,921 Total Operating Costs and Expenses 3,295 13,132 5,722 17,549 Loss from Operations (3,295 ) (13,132 ) (5,422 ) (17,549 ) Other Income/Expense: Foreign currency exchange (loss) gain (1 ) 20 — 17 Interest income 79 54 161 150 Total Other Income 78 74 161 167 Net Loss before income taxes (3,217 ) (13,058 ) (5,261 ) (17,382 ) Income tax benefit — — — — Net Loss Attributable to Common Stockholders $ (3,217 ) $ (13,058 ) $ (5,261 ) $ (17,382 ) Net Loss Per Share - Basic and Dilutive $ (0.07 ) $ (1.93 ) $ (0.12 ) $ (3.64 ) Weighted average number of shares outstanding during the period - Basic and Dilutive 45,892,668 6,752,953 43,496,012 4,778,669 Net Loss (3,217 ) (13,058 ) (5,261 ) (17,382 ) (Loss) gain on foreign currency translation (130 ) 1,317 (508 ) 1,971 Total comprehensive loss $ (3,347 ) $ (11,741 ) $ (5,769 ) $ (15,411 )

再鼎医药26年中期业绩会开了一场英文场和一场中文场， 英文场再鼎研发大佬Rafael Amado（全球研发总裁）亲自出马，中文场rafael则没有出席。Rafael是美国医药行业顶级大咖，在临床研究方面可以和辉瑞、安进的顶级专家媲美，所以英文场内容更丰富。我们将英文场的译文版分享给大家： 2026 年 8 月 6 日 美国东部时间下午 4:34 再鼎医药（ZLAB）股票 16.16 万关注者 | 评论区2026 年Q2 业绩摘要 每股亏损 0.46 美元，较市场预期优 0.20 美元 营收 1.0631 亿美元，同比下滑 3.33%，超出市场预期 245 万美元 再鼎医药 2026 年第二季度财报电话会议，美国东部时间 8 月 6 日上午 8 点。 公司参会管理层： Christine Chiou—— 投资者关系高级副总裁、负责人 杜莹（Ying Du）—— 创始人、董事长兼首席执行官 Rafael Amado—— 全球研发总裁 陈娅静（Yajing Chen）—— 首席财务官 王轶喆（Yizhe Wang）—— 运营合伙人 投行参会分析师 Anupam Rama—— 摩根大通 杨开悦（Kaiyue Yang）—— 瑞银 王丽・沃特塞克（Li Wang Watsek）——Cantor Fitzgerald 戴娜・格雷博施（Daina Graybosch）——Leerink Partners 赵林海（Linhai Zhao）—— 高盛会议正文开场 各位女士、先生，大家好。感谢各位等候，欢迎参加再鼎医药 2026 年第二季度财务业绩电话会议。【会议操作提示】温馨提示：本次会议全程录音。 接下来，有请投资者关系高级副总裁Christine Chiou女士主持会议。Christine Chiou（投资者关系高级副总裁） 感谢主持人。各位好，欢迎大家。本次业绩会议由再鼎医药创始人、董事长兼首席执行官杜莹博士主讲；一同参会的还有全球研发总裁 Rafael Amado 博士、首席财务官陈娅静博士。首席商务官何珊博士、运营合伙人王轶喆博士也将在问答环节参与答疑。 温馨提示：本次会议中我们将基于当前预期发表部分前瞻性陈述。该类陈述存在大量风险与不确定性，受多重因素影响，公司实际经营结果可能与预期存在重大差异，相关风险详见公司提交至美国证监会的备案文件。会议中我们还会提及调整后经营性亏损这一非公认会计准则财务指标，如需了解该指标详细说明，请查阅公司 8 月 6 日同步向美国证监会报送的业绩公告。 下面，有请杜莹博士发言。 杜莹（创始人、董事长兼首席执行官） 感谢晓雯。各位早上好、晚上好，感谢大家拨冗参会。再鼎医药正处在发展的关键拐点：从区域性药企转型为全球化生物制药企业。公司创立之初，我们专注为中国患者引进同类首创或同类最优药物；如今，我们自主研发创新药，面向全球患者，首款计划申报美国监管的产品预计明年递交申请。本次转型，依托的是我们多年搭建的完整研发体系。目前，我们正在开展多项全球多中心肿瘤注册临床；同步推进肿瘤、免疫领域多条临床管线，多款临床前资产计划在今年递交临床试验申请（IND）。公司核心产品 Zoci（靶向 DLL3 的抗体药物偶联物 ADC）充分印证了再鼎的研发实力：从递交 IND 到启动全球关键 III 期试验仅用时不到 2 年，彰显了我们一体化研发平台的高效推进能力。 截至今年年底，我们将拥有 3 项针对小细胞肺癌、神经内分泌癌的注册临床项目。同时，我们还与安进、勃林格殷格翰开展合作，探索 Zoci 联合 T 细胞衔接器（TCE）的联合疗法。公司第二大全球化核心管线为 ZL-1503—— 一款潜在同类首创长效 IL-13/IL-31 双特异性抗体，用于特应性皮炎。该产品有望集多重优势于一体：皮损清除效果优异、快速且持续缓解瘙痒、给药间隔更长。今年下半年，我们将公布该产品首个人体临床数据。 与此同时，商业化板块持续夯实。本季度我们聚焦核心重磅产品，净产品收入环比增长 11%，商业化业务持续盈利。我们已打下坚实基础，预计 2027 年营收恢复显著同比增长，2028 年有望迎来首款产品在美国上市。 再鼎向全球生物药企的转型进程稳步推进，管线储备多款差异化全球创新药，商业化板块实现盈利。我们对未来发展路径充满信心，有能力为患者与股东创造长期价值。接下来，交由 Rafael 博士详细解读管线进展。谢谢大家。 Rafael Amado（全球研发总裁） 感谢杜博士。接下来我为大家梳理管线及今年关键里程碑，首先从核心产品 Zoci（DLL3 ADC）说起。 小细胞肺癌是肿瘤领域难治性病种，Zoci 目前展现出潜在同类最优 ADC 疗效。针对多线治疗失败的晚期患者，本品缓解率亮眼，还能有效控制脑转移；疗效明确且安全性可控，可作为多线联合治疗的基础用药，项目推进节奏持续领跑。针对二线及以上小细胞肺癌的全球注册 III 期临床，预计 2027 年上半年完成患者入组，同年晚些时候递交美国加速上市申请，预计 2028 年获批。今年 10 月欧洲肿瘤内科学会年会（ESMO），我们将公布 Zoci 联合 PD-L1、± 化疗用于一线小细胞肺癌 / 维持治疗的联合临床数据。 当前一线标准方案为免疫治疗联合化疗，客观缓解率 60%-70%，中位无进展生存期约 5 个月，3 级及以上治疗相关不良反应发生率近 60%；NCCN 指南推荐 4 周期铂类化疗。无化疗联合方案耐受性更佳、可延长治疗周期，同时更好控制脑转移，这也是我们与监管机构沟通后确定 III 期联合免疫疗法的核心逻辑，相关临床试验将于近几个月启动。 针对二线及以上肺外神经内分泌癌，目前行业无标准治疗方案，现有疗法客观缓解率仅约 18%，而 Zoci 单药确认客观缓解率达 38.2%，优势显著。我们正与监管机构沟通，依托当前二线单臂扩展临床数据申请上市，后续再拓展一线适应症；因此截至今年年末，公司将落地 3 项注册临床项目。 我们同步与安进、勃林格殷格翰推进 Zoci 联合 T 细胞衔接器的合作临床：与安进合作的全球 Ib 期试验已启动入组，其中一个队列探索初治小细胞肺癌三联方案（Zoci + 安进 IMDELLTRA + 度伐利尤单抗）；与勃林格殷格翰合作、针对神经内分泌癌的全球 Ib/II 期试验预计近几个月启动。 讲完 Zoci，下一批全球化核心管线推进速度同样可观。ZL-1503 是长效人源化 IgG1 双抗，靶向 IL-13 与 IL-31 受体 α；Fc 段引入 YTE 氨基酸修饰，延长药物血清半衰期，实现更长给药间隔。通过同时阻断两条炎症通路，ZL-1503 有望打破 “瘙痒 - 抓挠 - 炎症” 恶性循环，为中重度特应性皮炎带来快速、持久疗效，且给药频次更低。 ZL-1503 现已进入临床阶段，健康受试者首个人体数据将于今年下半年公布，数据包含单次给药药代动力学、药效标志物（pSTAT6、TARC、CCL26 等 2 型炎症标志物），同时评估安全性、免疫原性及抗药抗体水平。目前我们正在开展多剂量递增患者入组，相关临床数据将于明年大型医学会议披露。 特应性皮炎是全球规模最大的免疫疾病市场之一，ZL-1503 差异化优势显著，可满足大量未被满足的临床需求；除核心适应症外，本品还具备拓展至其他 IL-13/IL-31 介导炎症疾病的潜力，长期开发空间广阔，后续我们将持续更新项目进展。 另外再介绍两款重点管线：ZL-6201 为公司自主研发的 LRRC15 靶向 ADC，全球 I 期试验正在快速入组，剂量爬坡阶段预计明年上半年完成并披露初步临床数据；年末我们计划递交 ZL-1311 的 IND 申请，这是一款新一代靶向 MUC17 的 T 细胞衔接器，针对胃肠道肿瘤，靶点前景广阔。 总结来看，我们具备完善平台与产能，可同步、高效、跨区域推进多条不同阶段的全球管线，同时落地国内区域管线。今年多款核心产品将陆续公布关键临床数据，期待未来数月持续与大家同步进展。 接下来交给首席财务官陈娅静博士。 陈娅静（首席财务官） 感谢 Rafael 博士。正如杜博士与 Rafael 博士介绍，再鼎医药迈入全新发展阶段。从财务角度，我们的核心目标清晰：在维持商业化盈利的基础上，审慎投入创新管线，支撑公司下一阶段增长。 第二季度，公司净产品收入环比增长 11%，达 1.058 亿美元，商业化业务持续保持盈利状态。 则乐（ZEJULA）销售额保持稳定；卫利全（VYVGART）销量环比双位数增长；XACDURO 需求旺盛，仅受供应限制；KarXT 精神分裂症新药上市开局表现亮眼。下半年，公司将进一步稳定产品销售，为 2027 年营收恢复大幅增长铺路。KarXT 将是核心增长驱动：这是数十年来精神分裂症领域全新作用机制药物，可同时改善阳性、阴性症状，无黑框安全警示，已纳入国内诊疗指南，临床未满足需求巨大。目前医生认可度、患者反馈积极，2027 年有望纳入国家医保目录（NRDL），增长势能充足。 针对卫利全系列，我们计划推动皮下剂型卫利全 Hytrulo 纳入医保，同步推进静脉剂型向皮下剂型的切换。受医保谈判节奏影响，下半年账面营收或无法完全反映终端真实需求。放眼 2027 年，依托新品放量、多款产品医保落地、核心产品需求持续提升，我们有信心实现营收显著增长。2027 年后，公司自主研发管线将逐步贡献收入，持续优化毛利率水平。 费用端我们保持严格管控：优先投入高价值管线，同时通过组织精简、全职能（临床、注册、商业化、后台）引入人工智能工具提升运营效率，全年剩余时间运营费用整体保持平稳。 本季度末公司现金储备 7.175 亿美元，财务弹性充足，可持续布局优质创新项目。 综上，公司商业化板块稳定盈利、资本分配审慎，全球化创新管线将持续驱动长期增长，为患者与股东创造可观价值。接下来进入问答环节。问答环节 问题 1：摩根大通 Anupam Rama 想了解 ESMO 大会上将公布的一线小细胞肺癌 Zoci 联合免疫 ± 化疗临床数据：样本规模、数据覆盖范围如何？公司如何定义该试验的临床成功标准？ Rafael Amado 答复 由我来解答。ESMO 将披露约 60 例患者数据，包含双药、三药联合队列，绝大多数患者采用 1.6mg/kg 最高剂量 ADC 联合免疫检查点抑制剂。截至大会披露节点，数据成熟度较高，中位随访时长 8-9 个月，具备充分参考价值。 对比现有免疫联合化疗标准方案：客观缓解率 60%-70%，中位无进展生存期仅约 5 个月，仍有巨大提升空间。我们的临床预期目标为：客观缓解率提升至 80% 左右，中位无进展生存期延长 50%，达到该标准即具备明确临床价值。 目前我们一边整理本次 ESMO 数据，一边推进无化疗联合 III 期试验布局。选择无化疗方案并非因为三药联用存在剂量限制性毒性（DLT），而是出于给药便捷性考量，同时可给到患者更高 Zoci 给药剂量强度。 问题 2：瑞银 杨开悦（代 Michael Yee 提问） 两个问题： 1.公司此前指引 2025 年底实现整体盈利，目前该目标如何看待？投资者何时可重新评估盈利兑现节奏？ 2.特应性皮炎赛道竞争加剧，近期还有同业 IPO 企业布局 IL-13/IL-31 靶点，ZL-1503 相比竞品差异化优势是什么？ 陈娅静（盈利问题答复） 盈利判断核心围绕资本分配逻辑展开：目前公司商业化板块本身已实现盈利；XACDURO、KarXT 国内本地化生产落地后，将进一步提升商业化盈利水平。 但与此同时，多条具备巨大长期价值的全球化管线需要持续投入，现阶段我们会严格设立投资回报门槛，择优布局。 随着 2028 年首款全球产品在美国获批上市，公司毛利率将持续改善，叠加全组织运营效率提升，多重利好叠加将自然推动整体盈利水平逐年提升。 Rafael Amado（ZL-1503 差异化答复） ZL-1503 同时具备三大核心优势： 1.皮损清除效果优异：双重阻断 2 型炎症通路，从根源打破瘙痒 - 炎症循环；靶向 IL-31 受体可快速缓解瘙痒，瘙痒是特应性皮炎患者最主要的痛苦来源； 2.YTE 修饰长效设计：给药间隔显著优于当前主流产品，度普利尤单抗每两周给药一次，竞品多数每月一次，我们目标实现更长给药周期； 3.靶点设计差异化：行业内部分竞品靶向配体，本品同时靶向 IL-13 配体与 IL-31 受体，双重抑制炎症通路，长效改造进一步优化瘙痒、皮损两大核心指标。 赛道内同时兼具三大优势的产品较少，部分竞品仍处于临床前阶段。特应性皮炎市场空间广阔，不存在单一产品垄断格局，只要能改善患者生活质量、延长给药间隔、优化炎症控制，均具备稳定市场空间。 ZL-1503 临床推进速度领先多数竞品：今年公布健康受试者数据，明年披露特应性皮炎患者多剂量递增临床数据。 问题 3：Cantor Fitzgerald 王丽・沃特塞克 管线、商业化各一个问题： 1.ZL-1503 预期给药方案是怎样的？今年下半年将公布的单次给药（SAD）人体数据，会从哪些维度验证产品特性？多剂量递增（MAD）队列目前是否观察到早期抗药抗体（ADA）信号？ 2.商业化层面，未来几个季度国内业务整体发展规划是什么？管理层最核心跟踪哪些经营指标？ Rafael Amado（管线问题答复） 健康受试者单次给药采用静脉注射，设置 6 个分组、4 个给药剂量，给药后长期随访，核心用于评估药物耐受性、药代动力学（含半衰期）、炎症药效标志物，同步监测抗药抗体免疫原性。 多剂量递增试验同样为静脉给药，设 2 个剂量队列、样本量更大。最终最优给药剂量仍需更多试验验证：我们后续将开展静脉 / 皮下给药生物等效性研究，并进一步优化皮下给药剂量梯度。 初步规划为短期诱导给药 + 长期维持给药，但确切给药频次现阶段无法预判。抗药抗体指标我们会持续跟踪，相关结果会随临床数据同步披露，试验仍在稳步推进。王轶喆（商业化问题答复） 短期核心重心仍是中国区域商业化，但放眼三年周期，Zoci 等全球化产品有望 2028 年在美国上市，长期业务不止局限国内。 国内商业化管线结构多元，包含合作授权销售产品、自有团队推广产品；现阶段我们聚焦三大核心品牌：推动则乐重回增长、持续放量卫利全、保障 KarXT 上市落地。运营层面回归基础精细化管理。核心跟踪指标以终端真实需求为核心：各产品新增用药患者数量是重中之重。存量下滑品种推动恢复增长，高增长品种持续提速，相关需求信号已初步显现。依托以上动作，未来几个季度营收将持续企稳，为 2027 年大幅增长奠定基础。 同时我们将推进多款产品医保谈判，力争以合理价格成功纳入国家医保目录。补充：二季度营收环比增长 11%，我们有信心下一季度持续巩固该增长势头。 问题 4：花旗 Caroline（代 Yigal 提问） 靶向 MUC17 的新一代 T 细胞衔接器即将进入临床，临床前数据中哪些特性，有望解决实体瘤 T 细胞衔接器传统痛点？ Rafael Amado 答复 MUC17 靶点在胃肠道肿瘤高表达，集中于胃癌、胰腺癌等消化道肿瘤。本品采用双表位设计，结合亲和力更强；CD3 结合区域平衡了分子结合 / 解离速率，临床前数据显示可大幅降低细胞因子释放综合征（CRS）风险 —— 这也是实体瘤 T 细胞衔接器最大短板，现有产品因 CRS 必须住院给药。 行业管线研发核心方向就是提升疗效、降低 CRS 毒性，最终实现门诊给药。对比同靶点竞品，本品临床前各项指标表现突出，我们十分看好；目标在今年年末递交该产品 IND 申请。 问题 5：Leerink Partners 戴娜・格雷博施 能否从机制层面解释：Zoci（DLL3 ADC）联合 DLL3 靶向 T 细胞衔接器，对比 DLL3 TCE 联合 B7-H3 ADC，具备哪些独特临床价值与差异化优势？ Rafael Amado 答复 核心逻辑是两种药物作用机制互补、协同增效：ADC 强效杀伤肿瘤、缩减瘤体负荷，释放肿瘤新生抗原；T 细胞衔接器激活免疫细胞清除残留病灶、建立长期免疫监视，若同步联合 PD-1 抑制剂，抗肿瘤效果进一步放大。 以 Zoci 联合安进 IMDELLTRA 为例：两款药物结合 DLL3 蛋白不同表位，可同时结合同一肿瘤细胞；ADC、TCE 对靶点受体密度要求不同，ADC 存在旁观者杀伤效应，对低 DLL3 表达肿瘤细胞同样起效。 二者不良反应无明显重叠，仅骨髓抑制存在潜在叠加风险，整体耐受性可控。安进同步开展 B7-H3 ADC 联合 IMDELLTRA 试验，但该项目目前处于暂停状态。 从靶点安全性对比：B7-H3 并非肿瘤特异性靶点，正常肺上皮细胞也会表达，联用后存在肺部毒性风险；而 DLL3 在小细胞肺癌高度特异表达，肺间质疾病（ILD）风险更低，安全性优势显著。相关联合临床数据预计明年公布。 问题 6：高盛 赵林海 跟进 Zoci 联合 DLL3 T 细胞衔接器临床问题：安进、勃林格殷格翰两项 I/II 期试验均设置后线、初治患者队列；一线三联方案的推荐 II 期剂量（RP2D）是否维持 1.6mg/kg，还是会下调剂量梯度？两项 I/II 期试验预计何时披露临床数据？ Rafael Amado（剂量问题答复） 联用的 PD-L1、T 细胞衔接器均采用各自标准给药剂量，给药周期适配 Zoci 三周一次的给药节奏，可小幅调整给药时间窗口。 Zoci 仅探索 1.2mg/kg、1.6mg/kg 两个剂量梯度；目前无安全性信号显示 1.6mg/kg 无法耐受，我们希望最终扩展试验采用 1.6mg/kg 目标剂量。安进牵头的试验入组进度良好，初治患者队列最具临床潜力。单独 T 细胞衔接器客观缓解率仅 30%-40%，ADC 单药缓解率更高，二者联用可兼顾高缓解率、长期疗效；此前二线 TCE III 期临床证实，联用可延长患者生存期 6 个月，机制协同逻辑充分。我们希望 Zoci 全开发阶段核心剂量固定为 1.6mg/kg，无需下调。 赵林海追问：试验数据何时披露？ Rafael Amado 答复 试验由安进主导推进，数据披露时间将由双方共同商议，安进拥有主导权。初步判断数据将于明年公布，大概率集中在明年下半年。会议收尾 主持人 目前无剩余提问，会议交回杜莹博士做总结发言。 杜莹（收尾致辞） 感谢主持人，也感谢各位参会分析师。感谢大家长期以来对再鼎医药的关注与支持，我们将在 2026 年第三季度财报会议上同步最新进展。主持人，可以结束本次会议。 主持人 感谢各位参与，本次业绩电话会议到此结束，各位可挂断连线。 我们在知识星球里更早更全面做了相关分析，并有关注公司的业绩会、调研、研报等相关资料等分享。有兴趣加入星球的朋友可以点击以下链接： 港股价值投资 还可以识别或扫描下面的二维码加入：