UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) (State or other jurisdiction of incorporation or organiza ...

业绩总结 - Inovio Pharmaceuticals, Inc. 在过去12个月里成功降低了50%的OpEx支出[4] - 公司将在今年下半年提交3107的BLA[7] - Inovio公司将在今年下半年提交BLA，IN0-3107将是公司首个上市产品[57] 产品研发 - 3107的Phase 1/2研究显示80%的参与者手术次数减少，28%的患者在治疗后没有手术[22] - 3112是公司的另一个重要项目，与Coherus合作，针对HPV阳性喉癌[36] - 公司还有其他后续项目，包括5401、VGX-3100等，将在未来一年内实现重要里程碑[38] 市场扩张和合作 - Inovio公司已与中国合作伙伴Apollo在中国进行VGX-3100宫颈病变的第三阶段研究，该研究进展顺利[69] 其他信息 - Inovio公司已决定内部终止4800项目，将其提供给世卫组织用于“团结”研究，世卫组织将就该研究的进展进行公告[71]

Precancerous Anal Dysplasia: Phase 2 open-label trial n=24 3 or 4 dose regimen at Months 0, 1, 3 and Week 36 (optional) Final findings (6 months after start of treatment) Clearance of HPV 16/18+ lesions: 50% of patients The Spontaneous Rate is estimated to be less than 27% • VGX-3100: composed of plasmids encoding for HPV-16 and HPV-18 subtypes; E6 and E7 oncogenes • Open-label trial of VGX-3100 in 24 HIV-negative participants with HPV-16 and/or -18-positive anal HSIL • 50% (11/22 evaluable) of participants ...

财务数据和关键指标变化 - 第三季度运营费用下降20%至3590万美元,剔除一次性商誉减值费用后下降43% [58][59] - 前9个月运营费用下降近一半至1.173亿美元 [59] - 第三季度研发费用下降53%至1550万美元,主要由于INO-4800和其他COVID-19研究的药品制造、临床试验费用以及员工和顾问薪酬等下降 [59][60] - 第三季度收入为38.8万美元,去年同期为920万美元,主要由于之前与美国国防部的采购合同已终止 [61] - 第三季度净亏损3390万美元,每股0.13美元,剔除商誉减值费用后每股亏损0.09美元 [61] - 截至9月30日,现金、现金等价物和短期投资为1.675亿美元,预计可支持运营至2025年第二季度 [62] 各条业务线数据和关键指标变化 - 无具体披露各业务线的数据和指标变化 各个市场数据和关键指标变化 - 无具体披露各市场的数据和指标变化 公司战略和发展方向及行业竞争 - 公司正专注于优化INO-3107作为治疗复发性呼吸道乳头状瘤(RRP)的机会,并推进8个其他临床阶段候选药物 [51] - 公司正在开发下一代DNA药物技术,包括针对COVID-19的DNA编码单克隆抗体和针对传染病和癌症的DNA启动纳米颗粒 [51] - 公司正在与合作伙伴就INO-5401在新诊断的胶质母细胞瘤和BRCA1/2基因突变乳腺癌患者中的进一步开发进行讨论 [52][53] - 公司正在与合作伙伴就INO-4201作为埃博拉疫苗增强剂的下一步行动进行讨论 [55] 管理层对经营环境和未来前景的评论 - 公司有信心INO-3107可以为RRP患者带来生活改变的非手术治疗选择 [88][89] - 公司有多元化的管线,专注于具有科学和临床前景、可行的上市路径和强大商业潜力的候选药物 [90] - 公司拥有专有的DNA药物平台和技术,以及加速进展和创新的强大合作伙伴关系 [90] - 公司专注于财务纪律、运营卓越,并以患者为中心 [90] 问答环节重要的提问和回答 问题1 **Roger Song 提问** 关于INO-3107的BLA申报和III期确证性试验设计,还有哪些待解决的事项?BLA申报和潜在批准的时间指引如何? [66] **Jacque Shea 和 Michael Sumner 回答** - 公司正在与FDA就BLA提交所需的内容和确证性试验设计进行讨论和对齐 [67][68] - 公司计划在今年四季度与FDA进行突破性疗法会议,以确定关键里程碑的时间表 [28][30] - 公司将利用突破性疗法地位的优势,包括滚动提交和优先审评,以加快开发进程 [30] 问题2 **Yi Chen 提问** 对于INO-3107,患者是否有灵活选择重复给药的频率?还是可能受到支付方的限制? [79] **Michael Sumner 和 Mark Twyman 回答** - DNA疫苗平台的优势之一是可以重复给药,不会产生抗载体反应 [81] - 目前尚未对I/II期试验患者进行重复给药,未来会评估如何进一步提高临床疗效 [81] - 重复给药目前属于off-label使用,需由医生决定 [82] - 公司正在与支付方就INO-3107的价值主张进行沟通,希望获得支持,满足医生和患者的需求 [83][84]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 INOVIO PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) Delaware 33-0969592 (State or other jurisdiction ...

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) H.C. Wainwright 25th Annual Global Investment Conference Call September 12, 2023 4:30 PM ET Company Participants Jacqueline Shea - President and Chief Executive Officer Conference Call Participants Li Chen - H.C. Wainwright Li Chen Good afternoon, everyone, and welcome to H.C. Wainwright 25th Annual Global Investment Conference. My name is Li Chen, and I'm H.C. Wainwright Equity Research Associate. I'd like now to welcome our next speaker, Dr. Jacqueline Shea, Presi ...

As we've shared previously, in our recent Phase 1/2 trial, which included patients who had two or more surgeries in the prior year, 81% saw a reduction in surgical interventions as compared to the year prior to treatment. Patients and advocates have expressed time and again that a reduction in even one surgery would have a profound impact. Moving on to VGX-3100. As announced in our press release, Inovio will cease further development of VGX3100 as a potential treatment for cervical HSIL in the U.S. This dec ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NO. 001-14888 660 W. Germantown Pike, Suite 110 Plymouth Meeting, Pennsylvania 19462 (Address of principal executive offices) (Zip Code) (I.R.S. Employ ...

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) 2023 RBC Capital Markets Global Healthcare Conference May 16, 2023 4:05 PM ET Company Participants Greg Renza - Biotechnology Equity Research Analyst, RBC Conference Call Participants Jacqueline Shea - President & CEO Greg Renza Great. So welcome back to the 2023 RBC Global Healthcare Conference. My name is Greg Renza, I'm one of the biotechnology equity research analyst here at RBC and we're pleased now to be joined by Inovio Pharmaceuticals and representing the co ...

Next, I'd like to share some highlights on the cellular and immune response we saw in this trial. Treatment induced cellular responses against both HPV-6 and HPV-11, inducing both activated CD4 and activated lytic CD8 T-cells. We believe this type of cytotoxic CD8 T-cell response may be important in clearing HPV infected cells. T-cell responses were also observed at week-52, which was 43 weeks after final treatment with INO-3107 indicating a persistent cellular memory response. Additional analyses are also ...