Smallpox and Monkeypox Vaccine, Live, Nonreplicating(Bavarian Nordic A/S)

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American: NNVC ) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD). If approved, orphan drug designation will qualify NanoViricides for incentives including: Tax credits for qualified clinical trials; Exemption from certain user fees; Potential seven years of market exclusivity after approval; according to the US FDA ( ). "NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat." WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus. MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern. There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections 1 . Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study" 2 . In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial 3 . The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles 4 . MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived 5 . The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox. In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases 6 . Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation. NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors. NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles. Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective. Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system. These factors make NV-387 unique in the field of antiviral drugs and vaccines. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( ) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments. The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: ir@nanoviricides.com 1 The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439. 2 Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network . 3 . 4 Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir. 5 Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • • Vol. 31, No. 2, February 2025. DOI: . 6 . SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire

在疫苗行业从被动应对向主动防御转变的过程中，Bavarian Nordic展示了一条不依赖单一爆款产品的独特路径。其价值基石是一个经过临床验证的专有技术平台——MVA-BN®。该平台建立在可追溯的免疫机制与适用于广泛人群的安全性数据之上，不仅支撑了现有疫苗的有效性，也为其在利基市场的深耕与风险分散的商业布局提供了可能。本报告将拆解其技术内核、串联临床证据、分析商业模式并评估潜在风险，为投资者提供一个基于事实的评估框架。 MVA-BN®平台： 以安全性为基石的免疫引擎 Bavarian Nordic的核心竞争力根植于其改良安卡拉牛痘病毒平台。该平台的核心价值在于其非复制特性带来的极致安全边界，以及作为病毒载体诱导广泛T细胞免疫的能力。这两个特性构成了公司所有研发与商业活动的科学起点，但其适用性也存在明确边界。 MVA-BN®平台的安全性由其非复制特性根本性决定。该病毒株经过超过500次连续传代，其基因组缺失了约15%，特别是在人类细胞中复制所必需的基因。基于此类生物学机制，病毒在接种后无法在人体内产生新的感染性颗粒，不会引起典型的全身性感染或皮肤病灶。这使MVA-BN®被监管机构定义为第三代非复制型疫苗。此类特性使其能够覆盖免疫缺陷人群、湿疹患者及老年人，解决了传统复制型天花疫苗的临床使用禁忌。 然而，平台的灵活性并不意味着其成功可自动传导至所有抗原目标。MVA-BN®拥有较大的基因组容量，利于开发多价疫苗，但每个候选疫苗都需要独立的抗原优化与临床试验验证。公司目前不具备mRNA平台应对突发大流行病的快速研发能力。此外，虽然针对MVA载体的预存免疫问题不如腺病毒载体显著，但多次接种后可能产生的抗载体免疫反应，仍是设计某些治疗性疫苗方案时需要考虑的科学因素。 临床证据链： 从真实世界效力到关键人群保护 Bavarian Nordic的已上市资产提供了从临床前到真实世界的证据链，其在特定人群中的优势数据需要与失败案例并置审视，以完整评估平台能力。 天花/猴痘疫苗JYNNEOS的保护效力得到了动物模型与真实世界证据的双重验证。由于伦理限制无法进行人体攻毒试验，其批准基于在非人灵长类动物模型中的保护效力，以及人体中诱导的中和抗体水平。2022年全球猴痘大流行期间的真实世界数据进一步提供了支持： 接种两剂JYNNEOS的保护效力估值在66%至90%之间。 疫苗接种能显著降低突破性感染后的临床严重程度和住院风险。 在2-11岁儿童中的研究显示，接种后的免疫反应不劣于成人，平均中和抗体滴度甚至是成年人的2.5倍，且未出现新的安全性信号。 商业模式： 公共准备与旅行健康的双轮驱动 通过战略收购整合成熟产品线与依赖政府公共准备订单，Bavarian Nordic构建了一个旨在平衡现金流与分散风险的双轮驱动模式。 公司的产品组合与收入来源清晰地划分为公共准备与旅行健康两大板块。公共准备板块的核心是自研的MVA-BN®平台疫苗，主要客户为各国政府储备机构。旅行健康板块则由收购所得的传统疫苗构成，包括狂犬病、森林脑炎、伤寒和霍乱疫苗，面向私人市场。此类结构旨在平衡政府合同的长期稳定性与私人市场的增长潜力。 战略收购是快速构建旅行健康板块并实现现金流互补的关键手段。公司于2019年从GSK收购了狂犬病和森林脑炎疫苗，于2023年从Emergent BioSolutions收购了伤寒和霍乱疫苗。此类收购带来了已上市、具有稳定现金流的成熟产品以及即时的销售渠道。公司目前正将此类产品的生产向内转移，以提升利润空间。 长期政府合同为公共准备业务提供了明确的收入可见性，但也带来了客户集中度风险。公司是美国生物医学高级研究与发展管理局的长期合作伙伴。2025年5月，美国政府行使了价值1.436亿美元的合同期权，购买冻干版JYNNEOS。在欧洲，公司与欧盟卫生应急准备和响应管理局签订了为期4年的框架协议。2025年，预计约50%的收入将来自此类政府机构。 公司通过灵活的资产货币化与市场准入策略来补充现金流并拓展市场。Vimkunya®获批后，公司获得了美国FDA颁发的一张“热带疾病优先审评券”，并于2025年6月以1.6亿美元的价格出售。此类操作直接补充了营运现金流。在市场准入上，公司采用混合模式： 在高收入市场采用直接销售。 在新兴市场采用授权合作模式，例如与印度血清研究所就猴痘疫苗的合作，以及与Eurofarma就基孔肯雅热疫苗在巴西的合作。 核心风险： 平台局限性与运营转型的挑战 尽管战略清晰，但Bavarian Nordic面临来自科学平台内在局限性、生产转型执行风险以及外部竞争格局变化的持续挑战。 RSV疫苗的失败已明确警示平台存在“抗原构象陷阱”风险。该III期临床试验的失败直接证明，MVA-BN®载体并不能保证所有插入抗原都能诱导出具有临床保护效力的免疫反应。对于某些复杂病原体，其抗原在载体内的表达与展示方式可能无法有效模拟天然构象。这意味着公司后续管线（如EBV疫苗、莱姆病疫苗）的成功仍高度依赖于抗原设计本身，平台无法提供确定性保证。 正在进行中的生产回流是短期内最关键的运营风险。公司将狂犬病和森林脑炎疫苗的生产从GSK转移至自身设施的过程复杂。此类生物工艺转移对生产环境的细微差异极为敏感，任何偏差都可能导致监管机构发出整改通知，从而延误产品上市和预期利润释放。管理层预计完成转移后相关产品的毛利率将提升15-20个百分点，但此目标取决于转移过程能否顺利通过监管审查。 现有鸡蛋生产工艺和开发中的新工艺均存在供应链风险。目前MVA-BN®疫苗的生产依赖无特定病原体鸡蛋，供应链易受禽流感疫情威胁。为突破瓶颈，公司正在开发基于专有鹌鹑细胞系的生产工艺，相关IIb期免疫原性比较研究预计2026年完成。在新工艺获得批准并完全取代旧工艺之前，供应链风险依然存在。 外部竞争，特别是mRNA技术的演进，可能压缩公司的技术差异化窗口期。在莱姆病和爱泼斯坦-巴尔病毒疫苗等新兴领域，Moderna等公司正在快速推进mRNA候选疫苗。mRNA平台在研发速度和初始抗体滴度上具有优势。如果mRNA平台未来在免疫持久性、热稳定性和成本控制上取得进一步突破，可能会侵蚀Bavarian Nordic基于MVA平台在T细胞免疫和长期记忆方面所建立的理论优势。公司需要在其管线资产的早期临床数据中，明确展示相对于mRNA平台的差异化价值。 以上是久谦的生物医药研究团队本次针对Bavarian Nordic的主要内容。之后我们还会继续推出一系列海外生科公司前沿生物医药研究文章。获取更多深度解析，敬请关注我们的公众号。我们将为您带来更多独家的海外创新药数据解读、管线与机制拆解、真实世界研究与交易案例分析与前沿趋势研判，助您保持领先认知，掌握全球生物医药信息差。 我们自 2023 年起 开始 持续、系统性地追踪 海外生物医药领域的 创新药研发演进，重点覆盖 创新药物作用机制（MOA）、平台型技术路径 及其 临床与商业化验证进展，涵盖 上百家欧美及其他海外市场的主流 / 前沿生物科技公司。 我们已逐步构建起一套 以机制可重复性与商业可扩展性为核心 的研究分析框架，完善了针对不同 技术平台、适应症与研发阶段 的 多维度评估 指标，并基于 大量横向机制对比 与 临床、BD 及商业化场景的交叉验证，沉淀出对 技术成熟度、应用边界 与 长期价值创造潜力 的 专业洞见。 关于我们： 我们是久谦旗下的生物医药研究团队，专注于创新药研发、生命科学工具、医疗技术平台及生物医药产业链等领域的研究，提供包含但不限于商业尽职调查、管线与机制评估、竞争格局分析、行业与赛道研究等服务类型。我们致力于 对早期技术路径与行业演进过程进行系统性研究与持续跟踪，助力投资人与企业在关键技术周期中形成认知优势与高质量决策支持。我们相信，唯有基于一线研究与数据与事实驱动的真实洞察，才能为客户提供真正可落地、可验证的研究结论。 若您有意向与我们进一步交流或合作，请扫描下方二维码联系我们： 您最看好哪个疫苗研发公司？您对疫苗研发公司的未来方向有何见解？欢迎在评论区与我们交流！