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

SHELTON, CT / ACCESS Newswire / September 29, 2026 / NanoViricides, Inc. (NYSE American: NNVC ) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 with the Securities and Exchange Commission (SEC) on Monday, September 28, 2026. The report can be accessed at the SEC website ( ). Accomplishments in Reported Fiscal Year ending June 30, 2026 In the fiscal year 2026, we have achieved a substantial level of accomplishments. We have focused on regulatory advancement of our broad spectrum antiviral drug NV- 387. We received approval for Phase II clinical trial to evaluate the safety and efficacy of NV-387 Oral Gummies for the treatment of Mpox in September, 2025, from the regulatory agency ACOREP in the Democratic Republic of Congo (DRC). Unfortunately, the MPox Clade I epidemic that led WHO to declare a Public Health Emergency of International Concern (PHEIC) in August, 2024, had substantially abated in the Kinshasa region. We therefore chose a remote site where Mpox cases were still prevalent. We had to upgrade the facilities at this site including patient isolation facilities as well as laboratory facilities significantly to enable conducting the clinical trial there. This Phase II clinical trial began enrollment at the end of September, 2026. Meanwhile, in May 2026, WHO declared a PHEIC for the Ebola Bundibugyo virus disease outbreak that had just begun in the Ituri province. There is no approved treatment nor an approved vaccine for this virus. Moreover, this Bundibugyo virus (BDBV) differs significantly from previous Bundibugyo viruses that caused outbreaks, as well as from other Ebola viruses. Subsequent to the reporting period, in July, 2026, we applied for regulatory approval to conduct a Phase II clinical trial to evaluate he safety and efficacy of NV-387 Oral Gummies for the treatment of Ebola virus disease (any Ebola virus). In August, 2026, we received the approval for this Phase II clinical trial of NV-387 from ACOREP in DRC. This Phase II clinical trial also began enrollment at the end of September, 2026 at an Ebola Treatment Center in Ituri province. The current Ebola outbreak in DRC is rapidly growing. As of September 23, 2026, there have been 7,890 confirmed cases, 3,799 confirmed deaths, and 1,966 confirmed recoveries in DRC, according to the WHO daily report i . In comparison, as of August 14, 2026, there were reported 4,945 confirmed cases and 2,325 confirmed deaths due to this virus. The crude fatality rate (crude CFR) is about 48%, but the probability of an infected person dying is estimated at 67% ii . In addition, we also began our efforts towards US FDA regulatory approvals for NV-387. We applied for an Orphan Drug Designation (ODD) of NV-387 as a Treatment for Measles in February, 2026. Subsequently, we also applied for a Rare Pediatric Disease Drug (RPDD) designation for NV-387 as a pediatric Measles treatment. The US FDA approved the ODD and the RPDD designation for NV-387 as a treatment of Measles in May and June, 2026, respectively. In addition, we have continued process development work for the manufacture of NV-387. We have also worked on improved formulations of the NV-387 oral gummies. Thus, we have made significant achievements towards regulatory approvals for NV-387 in the reported year. NV-387 Would become an Important Medical Countermeasure for Combatting Several Difficult Viral Infections with Outbreak, Epidemic, and Pandemic Occurrences, if Approved MPox Clade I and Clade II There is no approved drug for the treatment of MPox, Clade I or Clade II. Tecovirimat, a drug approved by the US FDA under the "Animal Rule", and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, failed in clinical trials. Another drug, brincidofovir, also approved by the US FDA under the "Animal Rule", and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, is currently in clinical trial for MPox. First fifty randomized MPox patients (our assumption is possibly 25 in the brincidofovir arm and 25 in a control arm) were evaluated for safety and tolerability. No new safety signals (i.e. toxicities) were found according to a press release in January, 2026 iii . The brincidofovir prescribing information carries a black box warning and lists gastrointestinal toxicities and elevation of liver enzymes as major toxicities of the drug iv . MPox Clade II has become endemic in the Western world after the global epidemic that began in Africa in 2022. It has remained primarily in the cohorts of men-having-sex-with-men (MSM) and their sexual contacts. MPox Clade II virus is difficult to transmit and is transmitted via contact with eroded MPox skin lesions and open bruises. There were 999 cases of MPox (Clade I and Clade II together) in 2026, as of September 2, 2026, according to CDC. Cases of MPox Clade I are increasing in the USA, and those cases not related travel have begun to show up in the since August, 2026. If sustained transmission of MPox Clade I occurs, it could lead to an outbreak in the USA, however, the probability is considered small. MPox Clade I is highly pathogenic, and also transmits more easily compared to Clade II. The case fatality rate of MPox Clade I is between 0.5% to 3%, whereas that for Clade II is less than 0.1% (above information compiled from CDC website v ). CDC recommends two doses of JYNNEOS vaccine to protect from MPox. JYNNEOS was developed as a Smallpox vaccine. The effectiveness of this vaccine in MPox Clade II is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II vi . The vaccine effectiveness is likely to be much less against the more severe MPox Clade I. However, without a drug to treat a viral infection, vaccines alone are not sufficient, even if highly effective. Thus a drug to treat MPox is an unmet medical need. NV-387 for treatment of MPox, if successful, has a strong financial potential. Ebola and Marburg Viruses Family (Filoviruses) There is no approved drug for the treatment of all Ebola and Marburg viruses. Two monoclonal antibodies are approved, and two vaccines are approved, but only for the EBOV Zaire version that caused the 2022 West Africa outbreak. A clinical trial called "PARTNERS" is evaluating Infusion of MBP134, a monoclonal antibody cocktail, Infusion of Remdesivir, and Infusion of both, as a treatment for Ebola BDBV infection against standard treatment control group, in DRC. Infusions are very difficult to administer in the BSL4-like isolation setting required for Ebola. Also, infusion even if approved, would not be scalable for administration to large number of patients in a large outbreak as is occurring in DRC at present. NV-387 Oral Gummies, as an oral drug, has the ideal target product pro fighting this Ebola outbreak. Measles There is no approved drug for Measles. NV-387 is the only drug candidate that has shown effectiveness against Measles virus in a lethal infection study in a humanized (hSLAM+knockin,IfnAR-/-) mouse model for the disease, to the best of our knowledge. Measles cases and outbreaks are rising globally. In the USA, in 2026, as of September 24, 2026, there were 3,659 confirmed measles cases, one confirmed Measles infection death and additional three possibly Measles-related deaths were reported, according to the CDC and news reports vii . Our Strategy of NV-387 for Orphan Diseases of Pandemic Potential has Strong Financial Incentives and Potential for Early Revenues Smallpox and MPox are important for the US Government from the perspective of pandemic preparedness and bioterrorism potential. Likewise, Ebola and Marburg family of viruses is important for pandemic preparedness, and these are considered priority pathogens. A drug that can work against all of them would be sought after for acquisition at least by the US Government and potentially by several other governments. If NV-387 is successful against either MPox or Ebola or both, there would be a strong case that USG agencies may provide non-dilutive funding for its regulatory approval, and upon approval, may acquire the drug for the Strategic National Stockpile (SNS) for preparedness. SNS acquisition contracts have been in the range of high hundreds of millions per year. NV-387 for Measles would be eligible, upon approval, for receiving a Priority Review Voucher (PRV) from the US FDA as a benefit of the RPDD designation. A PRV can be sold and recent trades have fetched as much as $200 million viii . The sale of PRV can fetch such revenues even before commercially meaningful revenues from sale of the drug can be developed, offering a strong incentive for our NV-387 for Measles drug development. We believe that NV-387 is on its way to become a revolutionary antiviral therapy that could be prescribed for practically any respiratory viral infection without first testing for the causative virus, just as broad-spectrum antibiotics can be prescribed even before testing for the causative bacteria. This "empiric therapy" approach would enable immediate treatment and thus improve effectiveness; it is well known that antiviral treatments are most effective when given early. NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such empiric therapy of viral ARI/SARI. To this end, we have proposed a novel adaptive, Phase II clinical trial for the evaluation of NV-387 as a treatment for Viral Acute/Severe Acute Respiratory Infections (V-ARI, V-SARI) towards this goal. A preliminary clinical protocol for this complex trial has been developed. We plan on leveraging the MPox studies towards approval of NV-387 as a treatment of Smallpox under the US FDA "Animal Rule". The US agency BARDA has programs to support such development if NV-387 qualifies. Financials We reported that, as of June 30, 2026, we had cash and cash equivalent current assets balance of approximately $2.79 Million. In addition, we reported approximately $6.40 Million in 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, where we manufacture our clinical trial drug substance and drug products, thus producing substantial savings as compared to working with an external manufacturer (CDMO). The total current liabilities were approximately $1.19 Million. In comparison, as of June 30, 2025, we had cash and cash equivalent balance of approximately $1.67 Million, P&E assets of approximately $6.83 Million (after depreciation), and total current liabilities of approximately $1.31 Million. The net cash utilized in the reported period for operating activities was approximately $7.70 million, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, Clinical Trial Application for Phase II Clinical Trial of NV-387 as a Treatment for MPox in DRC, and R&D and preparatory work including cGMP manufacture of the drug substance for the Phase II clinical trial of NV-387 for treatment of MPox. We raised approximately $7.10 million in sale of equity and warrants in registered direct offerings, and $1.91 million from sale of common stock in ATM equity offering, for a total financing of approximately $9.01 million during the reported period. Subsequent to the reporting period, in July 2026, we raised approximately $3.8 million in gross proceeds from a registered direct offering comprising common stock and warrants to a single investor. Further, our founder, Dr. Anil Diwan has provided a line of credit (LOC) of $3 million to the Company. We have not yet drawn on the LOC. As such, we reported that we do not have sufficient funding in hand as of now to continue operations through September 30, 2027, for our planned objectives. As a result substantial doubt exists about the Company's ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the "At-The-Market" (ATM) agreement that became active around July 17, 2026. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so. We Have Several Important Milestones in the Ensuing Year The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for MPox: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of MPox cases. The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for Ebola: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of Ebola cases. Pursuing Orphan Drug Designations for NV-387-for-MPox, NV-387-for-Smallpox, and NV-387-for-Ebola. Filing of a pre-IND with the US FDA towards NV-387 for Smallpox treatment under the "Animal Rule". Filing of an IND with the US FDA towards evaluation of NV-387 as a Smallpox treatment leading to registration. Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for Viral Acute Respiratory Infections (Viral-ARI) in India, its Approval by the regulator, and Commissioning of the clinical trial, and Interim Results. This Phase II clinical trial is expected to yield data on the safety and efficacy of NV-387 for the treatment of Influenza, RSV, Coronaviruses, and hMPV, which are the most important seasonal epidemic/pandemic viruses, in a single clinical trial. As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity-based funding. More About Our Drug Pipeline We believe the Company has a bright future. Our Phase II clinical stage drug NV-387 has completed Phase I clinical trial with the successful results that there were no drop-outs, and there were no reported adverse events, both of which clearly indicate excellent safety and tolerability in humans. NV-387, as mentioned above, is likely to become a revolutionary broad-spectrum antiviral therapeutic, that could change how we treat viral infections forever. In addition, the Company has developed a pan-Herpesvirus drug, NV-HHV-1. Its skin cream formulation for the treatment of Shingles rash, Chickenpox, HSV-1 Cold Sores, and HSV-2 Genital Ulcers, has completed certain IND-enabling non-clinical studies. NV-HHV-1 has demonstrated effectiveness in a human skin model of VZV infection (Varicella-Zoster-Virus, which causes Chickenpox and Shingles). A systemic form of the herpesvirus drug is in development. The Company has also developed an anti-HIV drug, NV-HHV-1, which the HIV viruses would not be able to escape despite rapid virus evolution. NV-HHV-1 has demonstrated strong effectiveness superior to triple-drug combination HAART therapy in a humanized animal model of HIV infection. The Nanoviricides™ Technology and Non-Clinical Animal Studies Results in Brief The Company's technology is based on mimicking the host-side binding sites that the virus uses which remain the same despite several and extensive changes in the virus. We design and make chemical mimics of these sites to create virus-binding ligands that we attach to a base polymer. This makes the drug look like a cell membrane to the virus. The nanoviricide drug is thus designed to fool the virus into entering the nanoviricide drug micelle and uncoating itself by using the virus's own smarts against it. We believe viruses would not be able to escape nanoviricide drugs because of this design. In contrast, viruses readily escape vaccines, antibodies, and most of the small chemical drugs. Oral NV-387 was found to be superior to the three known drugs oseltamivir (Tamiflu ® , Roche), peramivir (injection, Rapivab ® , BioCryst), as well as baloxavir (Xofluza ® , Shionogi/Roche) in a lethal lung infection animal model of Influenza. Oral NV-387 was found to cure lethal lung RSV infection in an animal model. There is no current approved drug for treating RSV infection. Previously, NV-387 given both orally and as I.V. injections was found to be substantially superior to remdesivir (injection, Gilead) in a lethal lung infection animal model for COVID-19. Oral NV-387 was found to be equivalent to or superior than tecovirimat (TPOXX ® , SIGA) in two different lethal animal models of orthopoxvirus diseases. One of these models simulated skin infection which is the primary route of MPox Clade II infections. Another animal model simulated direct lung infection which is the likely route of Smallpox infection in case of bioterrorism. Oral NV-387 was found to be highly effective as a treatment of lethal Measles virus lung infection in humanized (hSLAM+knockin, IfnAR-/-) mice. There is no approved treatment for Measles. 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. 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 i , retrieved on Monday September 28, 2026 at 00:58 EDT. See also, . ii The Crude CFR is calculated simply by dividing the confirmed deaths by the confirmed number of cases on the same reporting date. It ignores the fact that the deaths are actually occurring in patients that were confirmed infected several days earlier; i.e. the time lag of sickness is not accounted for in the crude CFR. If it is accounted for, the actual fatality rate per confirmed infection (Infected Fatality Rate or IFR) would be much higher than the crude CFR. For example, if one assumes an average time lag of 21 days (Aug 14 to Sept 5), then the IFR on September 5 would be (3,175/4,945 = ) 64%. Not all infections are reported or confirmed by lab tests; however, it is likely that most deaths are counted. This produces a large uncertainty in such CFR and IFR estimates. Another way to estimate IFR would be to simply take a ratio of confirmed deaths to that of confirmed deaths plus confirmed recoveries. This metric, probability of death, is more robust and insensitive to the lag times, except it ignores patients that are still in hospital. The p(death) based on this metric is (using Sept. 10 numbers,(3,398)/(3,398 +1,671) = 67%. That said, a number of cases as well as deaths remain unconfirmed or unreported because of the regional issues. iii iv brincidofovir TEMBEXA prescribing information, from US FDA website, . v . vi From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43. vii see also . viii SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire