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

SHELTON, CT / ACCESS Newswire / May 15, 2026 / NanoViricides, Inc. (NYSE Amer.: NNVC ) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2026 with the Securities and Exchange Commission (SEC) on Thursday, May 14, 2026. The report can be accessed at the SEC website by searching for the Company ( ) . Clinical Stage NV-387, a Single Drug, Meets Many Unmet Medical Needs in Viral Diseases We continue to advance NV-387, a novel broad-spectrum antiviral that defines a new class of antiviral drugs, towards a Phase II clinical trial. We are working on initiating a Phase II human clinical trial for the evaluation of the safety and effectiveness of NV-387 as a treatment of Monkeypox in the Democratic Republic of Congo. The local regulatory agency, ACOREP, has already approved this Phase II clinical trial. We are now working on clinical trial site readiness. We have chosen an "Orphan-first" development strategy for regulatory advancement of NV-387. To this end, we have filed "Orphan Drug Designation" (ODD) applications with the US FDA for three different scenarios, namely: NV-387 for the treatment of Measles, NV-387 for the treatment of MPox, and NV-387 for the treatment of Smallpox. Orphan drug designation, if approved, will provide us with several incentives. These include frequent communication with the FDA, an additional 7 years of market exclusivity, certain R&D tax benefits, and waiver of certain FDA PDUFA fees. These incentives are expected to result in a shorter timeline of the regulatory process as compared to NV-387 development for Influenza or RSV. An ODD was granted for NV-387 for the treatment of Measles by the US FDA on or about April 27, 2026, subsequent to the reporting period. We have also applied for a "Rare Pediatric Disease Drug" (RPDD) designation for NV-387 for the treatment of Measles. If granted, the RRPD will enable us to obtain a Priority Review Voucher (PRV) upon drug approval from the FDA, which is a tradable instrument. Recently, a PRV was sold for $180 million. This would represent a revenue-generation opportunity even prior to commercial market sales of the drug. We plan on advancing NV-387 for the treatment and prophylaxis of Measles in the USA. We intend to obtain non-dilutive funding such as US government grants for this development. At present: There is no approved drug for Measles. There is no approved drug for MPox. The Smallpox approved drugs (under FDA Animal Rule) have significant shortcomings, leaving the US practically unprepared for this bioterrorism scenario despite several billions of dollars in development and acquisitions. NV-387, based on relevant animal model studies, and based on safety and tolerability observed in a Phase I human clinical trial, can fulfill these glaring gaps in pandemic preparedness for current and emerging threats, as well as for potential bioterrorism threats. We have chosen to first develop NV-387 for the treatment of MPox. Its more severe form, MPox Clade I, is endemic in African region, affecting entire population including children. The less severe form, MPox Clade II, has become endemic in the Western World, where it is primarily transmitted in Men-having-sex-with-men population. There is no approved treatment for MPox viruses. Two drugs that were approved under the US FDA "Animal Rule", namely tecovirimat (TPOXX ® , SIGA) and brincidofovir (TEMBEXA ® , EBS) have been tried for MPox. Tecovirimat has failed in clinical trials to demonstrate efficacy over the standard of care. Brincidofovir has a black box warning and has known hepatotoxicity issues. Yet it was advanced into the MOSA clinical trial with first cohort dosed in January, 2025, It appears that further advancement beyond the initial cohort did not take place. A vaccine Jynneos, is FDA-approved for Smallpox and MPox. However, vaccine deployment logistics and costs are a major problem for developing countries such as DRC. Further, the effectiveness of 2-dose JYNNEOS vaccine against disease progression (not infection prevention) after 2-doses is only 66.6% in HIV negative subjects and 44.8% in HIV positive subjects, for MPox Clade II, based on US surveillance data (Lancet Infect Dis 2025; 25: 1106-15; S1473-3099(25)00180- X). It is suggested that its efficacy against the more severe Clade I is likely even less. We believe that the MPox clinical trial, if successful would help us advance NV-387 towards regulatory approval for Smallpox in the USA. Smallpox is considered an important bioterrorism agent. Two drugs have been stockpiled in the US Strategic National Stockpile for Smallpox preparedness, namely TPOXX and TEMBEXA, at the cost of billions of dollars. However, the virus can readily escape TPOXX by a single point mutation. TEMBEXA requires physician care during treatment, making it unsuitable as a bioterrorism response agent. Thus there is a need for a better antiviral agent. Viruses cannot escape NV-387 because no matter how much a virus changes, it continues to bind to the sulfated proteoglycan attachment receptor(s) of the host which the virus needs to cause infection as well as for human-to-human transmission. NV-387 mimics the critical features of the conserved attachment receptors on the host-side that over 90% of viruses are known to use. This escape-resistant drug feature of NV-387 solves the biggest problem in antiviral medical countermeasures: Viruses readily evolve to escape the countermeasures in the field, whether vaccines, antibodies, or traditional small chemical drugs. NV-387 has an extremely broad spectrum of antiviral activity. To date, it has been found to be highly active against every virus that we have tested in animal models: NV-387 treatment was found to be able to cure lethal RSV infection in mice. NV-387 treatment was substantially superior to the existing treatments, namely Tamiflu (oseltamivir) and Xofluza (baloxavir) in a lethal infection with H3N2 Influenza A virus. NV-387 treatment was highly effective in an animal model for MPox using dermal orthopoxvirus infection. NV-387 treatment was highly effective in an animal model for Smallpox using lethal lung infection with orthopoxvirus. In addition, NV-387 treatment was highly effective in a humanized animal model (hSLAM+k.i., InfAR-/- mice) in lethal infection with Measles virus. Thus, NV-387, as a single drug, is responding to several unmet medical needs in viral infectious diseases at once. Company Financials We reported that, as of March 31, 2026, we had cash and cash equivalent current assets balance of approximately $3.38 Million. In addition, we reported approximately $10.20 Million in total Assets including $6.53 Million of Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $1.07 Million. The net cash utilized during the nine months ended March 31, 2026 was approximately $5.58 Million. This included certain non-recurring expenditures including R&D expenditures in preparation for a Phase II clinical trial application. Based on budgeting considerations, we reported that we do not have sufficient funding in hand to continue operations through May 14, 2027, for our planned objectives that include (i) a Phase II clinical trial of NV-387 for MPox infection in Central Africa, (ii) a Phase II clinical trial of NV-387 for Viral Acute and Severe Acute Respiratory Infections (V-ARI and V-SARI), and (iii) Preparation and pre-IND filing for a Phase II clinical trial of NV-387 for RSV indication in the USA. As such, we have focused on the objective (i), the Phase II Mpox clinical trial. We continue to have access to an "At-The-Market" common stock facility under a shelf registration, with D. Boral Capital, LLC, the sales agent. We also note that an additional gross cash financing of $6.25 Million would result into the Company if and when the Series A warrants from the November, 2025 financing are exercised. Additionally, we continue to have access to an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan. No funds have been drawn on this facility as of now. At present, we have sufficient funding to execute and complete the Phase II clinical trial of NV-387 for MPox infection in DRC according to our plans and projections. We believe our regulatory developments for the orphan diseases and for bioterrorism agents response, provide for a rapid regulatory pathway for US FDA licensure of NV-387, with potential for non-dilutive grant and contracts funding, as well as possible direct US Government acquisition contracts worth hundreds of millions of dollars per year if NV-387 is approved for one of the agents that the US Government stockpiles drugs for. We believe that these early stage revenue opportunities would help us fuel the commercial drug development of NV-387 towards the tens of billions of dollars markets in RSV, Influenza, and other viral infections; as well as to further advance our NV-HHV-1 pan-herpesvirus drug candidate, among others. About NanoViricides NanoViricides, Inc. (the "Company") ( ) 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, and even Measles. 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