NanoViricides Annual Shareholders Meeting to be Held at 10 am on Saturday, November 5th at on Saturday, November 8, 2025, at the Hampton Inn & Suites Stamford, CT
NanoViricides (NYSE:NNVC) will hold its Annual Shareholders Meeting on November 8, 2025 at 10:00 am at Hampton Inn & Suites Stamford, CT. Management will review progress toward clinical development, including completion of the Clinical Trial Application and plans to initiate a Phase II trial of NV-387 for MPox in the Democratic Republic of Congo. NV-387 completed a Phase I trial with a described safety and tolerability profile and showed efficacy in animal orthopoxvirus models versus tecovirimat.
The release also summarises MPox risks (recent US Clade I cases, case fatality ranges) and contrasts NV-387 with existing countermeasures and their limitations.
NanoViricides (NYSE:NNVC) terrà la sua Assemblea Annuale degli azionisti l'8 novembre 2025 alle 10:00 presso Hampton Inn & Suites Stamford, CT. La direzione analizzerà i progressi nello sviluppo clinico, inclusa la finalizzazione della Clinical Trial Application e i piani per avviare uno studio di Fase II di NV-387 per MPox nella Repubblica Democratica del Congo. NV-387 ha completato uno studio di Fase I con un profilo di sicurezza e tollerabilità descritto e ha mostrato efficacia nei modelli animali di ortopoxvirus rispetto a tecovirimat.
Il comunicato riepiloga inoltre i rischi legati a MPox (recenti casi US Clade I, intervalli di mortalità) e mette a confronto NV-387 con le contromisure esistenti e le loro limitazioni.
NanoViricides (NYSE:NNVC) celebrará su Reunión Anual de accionistas el 8 de noviembre de 2025 a las 10:00 a. m. en Hampton Inn & Suites Stamford, CT. La dirección revisará los avances hacia el desarrollo clínico, incluida la finalización de la Clinical Trial Application y los planes para iniciar un ensayo de fase II de NV-387 para MPox en la República Democrática del Congo. NV-387 completó un ensayo de fase I con un perfil de seguridad y tolerabilidad descrito y mostró eficacia en modelos animales de ortopoxvirus frente a tecovirimat.
El comunicado también resume los riesgos de MPox (casos recientes de US Clade I, rangos de letalidad) y contrasta NV-387 con las contramedidas existentes y sus limitaciones.
NanoViricides (NYSE:NNVC)은 주주 연례 회의를 2025년 11월 8일 오전 10시에 코네티컷 주 스탬퍼 Hampton Inn & Suites에서 개최합니다. 경영진은 임상 개발 진행 상황을 검토하고 임상시험 신청의 완료와 MPox를 위한 NV-387의 제2상 임상 시작 계획을 포함합니다. NV-387은 1상 시험을 완료했고 안전성 및 내약성 프로필이 서술되었으며 테코비리마트에 비해 동물 직립포복 바이러스 모델에서 효과를 보였습니다.
보도자료는 MPox 위험(최근 미국 Clade I 사례, 사례 치명률 범위)을 요약하고 NV-387을 기존 대책과 한계와 대조합니다.
NanoViricides (NYSE:NNVC) tiendra son Assemblée générale annuelle des actionnaires le 8 novembre 2025 à 10h00 au Hampton Inn & Suites Stamford, CT. La direction examinera les progrès du développement clinique, y compris l'achèvement de la Clinical Trial Application et les plans pour lancer un essai de phase II de NV-387 pour le MPox en République démocratique du Congo. NV-387 a terminé un essai de phase I avec un profil de sécurité et de tolérabilité décrit et a montré une efficacité dans des modèles orthopoxvirus animaux par rapport au tecovirimat.
Le communiqué résume également les risques liés au MPox (cas récents US Clade I, plages de létalité) et oppose NV-387 aux contre-mesures existantes et leurs limites.
NanoViricides (NYSE:NNVC) wird am 8. November 2025 um 10:00 Uhr seine jährliche Hauptversammlung in der Hampton Inn & Suites Stamford, CT abhalten. Das Management wird den Fortschritt bei der klinischen Entwicklung prüfen, einschließlich des Abschlusses des Clinical Trial Application und Plänen, eine Phase-II-Studie von NV-387 für MPox in der Demokratischen Republik Kongo zu initiieren. NV-387 hat eine Phase-I-Studie mit einem beschriebenen Sicherheits- und Verträglichkeitsprofil abgeschlossen und zeigte Wirksamkeit in tierischen Orthopoxvirus-Modellen gegenüber Tecovirimat.
Die Mitteilung fasst außerdem MPox-Risiken zusammen (jüngste US Clade I-Fälle, Bandbreiten der Fallsterblichkeit) und vergleicht NV-387 mit bestehenden Gegenmaßnahmen und deren Einschränkungen.
NanoViricides (NYSE:NNVC) ستعقد اجتماع المساهمين السنوي في 8 نوفمبر 2025 الساعة 10:00 صباحاً في فندق Hampton Inn & Suites Stamford، CT. ستراجع الإدارة التقدم نحو التطوير السريري، بما في ذلك إكمال طلب التجربة Clinical Trial Application وخطط لبدء اختبار المرحلة الثانية لـ NV-387 لـ MPox في جمهورية الكونغو الديمقراطية. أكمل NV-387 تجربة المرحلة I بملف السلامة والتحمّل المعلن وأظهر فاعلية في نماذج Orthopoxvirus الحيوانية مقارنة بتكوڤيريمات.
يلخص البيان أيضاً مخاطر MPox (حالات Clade I الأمريكية الأخيرة، نطاقات وفيات الحالات) ويقارن NV-387 مع التدابير المضادة القائمة وقيودها.
- Annual shareholders meeting scheduled for Nov 8, 2025
- Planned Phase II trial of NV-387 for MPox in the Democratic Republic of Congo
- NV-387 completed a Phase I healthy-subject trial reporting safety and tolerability
- No approved specific treatment for MPox exists currently
- Company cannot project exact IND/filing dates due to external dependencies
- Competitor drug TEMBEXA carries a black box warning and notable safety concerns
Insights
NanoViricides announces CTA work and a planned Phase II for NV-387; this advances clinical risk but outcome and regulatory path remain uncertain.
The Company plans a shareholders meeting on
Key dependencies and risks are explicit: the Phase I safety profile and animal-model comparisons are stated facts, but regulatory acceptance of the CTA, successful trial start and conduct in the DRC, and demonstrable clinical efficacy remain unproven. Public-health context is noted with case fatality rates of
Watch for three monitorable items and timing: completion and clearance of the CTA, initiation of the Phase II trial in the DRC, and any interim or top-line efficacy/safety readouts from that trial. Each of these milestones will materially alter the program’s risk profile; expect updates tied to those discrete events over the next 6–24 months.
NV-387 Could be the Answer to the MPox Clade I Rising in the USA, Says Dr. Diwan
SHELTON, CONNECTICUT / ACCESS Newswire / November 5, 2025 / NanoViricides, Inc. (NYSE American:NNVC ) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that the Company will be holding its Annual Shareholders Meeting at 10 am on Saturday, November 8th, 2025, at the Hampton Inn & Suites Stamford, CT.
Event Information:
Event | NanoViricides Annual Shareholders Meeting | ||
Date | Saturday, November 8, 2025 | Time | 10:00 am |
Location | Hampton Inn & Suites Stamford, 26 Mill River Street, Stamford CT 06902. | ||
Requirements | Only current shareholders are eligible to attend. No recording using any devices will be permitted. Any reporters, journalists, or writers must identify themselves with their affiliation at the registration desk. Company retains the right to inspect the attendee's valid US identification. | ||
Anil R. Diwan, PhD, President and Executive Chairman of the Company will review the Company's progress towards clinical trials, and the near future planned clinical trials.
Currently, the Company is fully engaged in completing the Clinical Trial Application (CTA) and initiating a Phase II clinical trial for the evaluation of NV-387 as a treatment for MPox. This clinical trial will be conducted in the Democratic Republic of Congo (DRC). The more severe strains of MPox Clade Ia and Clade Ib are prevalent in DRC. In contrast, the less severe Clade IIa and IIb strains have become endemic in certain Western countries including the USA, but only in specific populations such as men having sex with men (MSM), and HIV-infected immunocompromised patients. MPox Clade II is prevalent in Western African countries.
Recently, three new MPox Clade I cases have occurred in California. All three cases required hospitalization, but are recovering. These cases were not related to travel to the African countries, and authorities suspect that community spread with asymptomatic transmission may be occurring (https://thehill.com/policy/healthcare/5572528-california-mpox-concerns/). This raises the possibility of MPox Clade I spreading further either as small outbreaks, as we have witnessed for Measles recently, or as local epidemics. The potential for a widespread pandemic is low because transmission of the virus requires close dermal contact with infected skin lesions. However, preparedness is warranted.
The case fatality rate (CFR) of MPox Clade I has ranged from about
There is no approved treatment for MPox. For prevention, a smallpox vaccine called Jynneos® is said to have a vaccine effectiveness rate of
"We believe NV-387 could be the answer to the challenges posed by rising MPox Clade I cases, and also the on-going MPox Clade II cases, in the USA," declared Anil R. Diwan, PhD, President of the Company, asserting, "The current countermeasures in the US Government Strategic National Stockpile are clearly deficient and inadequate for an effective public health response to a MPox epidemic should the virus spread further."
A drug approved for smallpox under the FDA "Animal Rule", namely TPOXX ® (tecovirimat) was mobilized during the 2022 MPox Clade II epidemic. Clinical trials of this drug failed to prove effectiveness in treating MPox Clade I or Clade II infections. The utility of tecovirimat as a treatment is questionable because a single point mutation in a viral protein enables the virus to escape the drug.
Another drug, TEMBEXA® (brincidofovir) was also approved for smallpox under the FDA "Animal Rule". Its clinical trial (called "MOSA") for treating MPox in Africa started with fanfare in January, 2025, and top-line results were promised by end of first quarter of 2025. The current status of this clinical trial is unknown. The utility of TEMBEXA for treating MPox in an epidemic scenario is highly questionable because the drug carries a "black box warning", requires medical monitoring after dosing, produces gastrointestinal adverse events, produces hepatic adverse events, has caused discontinuations in
TPOXX and TEMBEXA, as potential treatments, and Jynneos as a preventative vaccine, have been stockpiled by the US Government as preparedness measures for potential smallpox bioterrorism event, and have been mobilized in response to MPox cases.
In contrast to these drugs, NV-387 has demonstrated a strong safety and tolerability profile in Phase I healthy subjects clinical trial, and in non-clinical animal model studies. NV-387 has also demonstrated strong effectiveness in animal models of orthopoxvirus infections when directly compared with tecovirimat. The virus is highly unlikely to escape the attack by NV-387 because the drug NV-387 is created by mimicking the host-side "landing sites" of the virus in the human body, which do not change even as the virus mutates.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a 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.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
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
SOURCE: NanoViricides, Inc.
View the original press release on ACCESS Newswire
FAQ
When and where is the NanoViricides (NNVC) Annual Shareholders Meeting in 2025?
What is NanoViricides announcing about NV-387 and MPox (NNVC) in November 2025?
What safety data does NV-387 (NNVC) have before Phase II?
How does NanoViricides (NNVC) describe existing MPox countermeasures?
Will all shareholders be allowed to attend the NNVC meeting on November 8, 2025?
