The Albany Gazette - NanoViricides, Inc. Has Filed its Annual Report

Broad-spectrum Antiviral NV-387 At Phase II Clinical Trial Stage - NV-387 Could Become a Revolutionary Antiviral for Respiratory Viral Infections

SHELTON, CONNECTICUT / ACCESS Newswire / September 30, 2025 / 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, 2025 with the Securities and Exchange Commission (SEC) on Monday, September 29, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000110465925094527/nnvc-20250630x10k.htm).

In the fiscal year 2025, we have achieved a substantial level of accomplishments. We have focused on evaluating the broad spectrum of antiviral activity of NV- 387.

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 "emperic 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 emperic 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.

At present, we are fully engaged in completing the Clinical Trial Application (CTA) for a Phase II clinical trial of NV-387 for the treatment of MPox disease in Africa. MPox continues to spread and surge in African countries and is endemic in the Democratic Republic of Congo (DRC) and neighboring countries. Due to this, African CDC has continued its declaration of Public Health Emergency of Continental Security (PHECS), initiated in August 2024, as of September, 2025. We have already obtained a preliminary approval for our clinical trial protocol for this clinical trial from the regulatory agency in charge, namely ACOREP in DRC.

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.

A potential acquisition of NV-387 for Smallpox under the US Strategic National Stockpile (US-SNS) if approved could be worth of the order of $1 billion over five years. We believe (i) NV-387 for treatment of MPox, (ii) NV-387 for the treatment of Smallpox, and (iii) NV-387 for the treatment of Measles, would be separately eligible for Orphan Drug Designation (ODD) by the US FDA. An ODD carries several benefits. Certain FDA fees would be waived. Up to seven years of market exclusivity would become available. There are also research and development tax benefits. In addition, some of these programs may be eligible for issuance of a tradable "Priority Review Voucher" (PRV) upon drug approval. A PRV if issued to us would in itself be a revenue generator with a value of over $150 million.

Smallpox is a bioterrorism threat. Two drugs, namely, tecovirimat and brincidofovir were approved in the USA for Smallpox under the FDA "Animal Rule" and have been acquired in the US-SNS. Both of these drugs have limitations. Therefore, the US agency BARDA is searching for a new drug. We believe NV-387 matches their requirements.

MPox Clade II is endemic in the USA and some European countries. MPox Clade Ia and Ib are more severe strains than Clade IIa or IIb, and are spreading in Africa. Clade Ia/Ib strains could break out of Africa globally and thereby cause severe pandemics. MPox is a much less severe cousin of Smallpox when compared in terms of the pathogenic effects and case fatality rates of the virus.

There is no drug for treatment of MPox at present. Tecovirimat failed in clinical trials for the treatment of MPox ^[1], ^[2]. Brincidofovir entered clinical trials for MPox in January, 2025, and interim results were anticipated in Q1 2025, according to the press release by Africa CDC ^[3]. The current status of this brincidofovir for MPox clinical trial is not publicly known ^[4] . Brincidofovir carries a black box warning due to increased mortality rates in another indication, causes elevation of liver damage-related markers, is a carcinogen, may cause embryonic or fetal harm, and may irreversibly impair fertility, according to its prescribing information ^[5], limiting its applicability.

Thus we believe NV-387 has a wide opportunity as a treatment of MPox, which can be currently estimated to be a market size approaching $1 Billion in African region alone.

We reported that, as of June 30, 2025, we had cash and cash equivalent current assets balance of approximately $1.67 Million. In addition, we reported approximately $6.83 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 $1.31 Million. In comparison, as of June 30, 2024, we had cash and cash equivalent balance of approximately $4.97 Million, P&E assets of approximately $7.5 Million (after depreciation), and total current liabilities of approximately $1.36 Million.

The net cash utilized in the reported period for operating activities was approximately $8.48 million, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, 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 in Africa.

We raised approximately $5.3 million in net cash from financing activities, which comprised of an "At-the-Market" offering in an ATM Agreement with D. Boral Capital.

Subsequent to the reported period, we have raised approximately $1 million additional under the said ATM. 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, 2026, 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 April 5, 2024. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so.

This year, we have re-calibrated our priorities to seek opportunities with early fruition and lower cost compared to going after the longer horizon opportunities such as pediatric RSV treatment. We note that the Phase II clinical trial evaluating NV-387 for V-ARI/V-SARI will provide us with required information to move further into a Phase III for pediatric RSV approval.

We have several important milestones in the new year:

Completion and submission of the Phase I Clinical Study Report to the Indian regulatory Agency.

Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for MPox to ACOREP in DRC, its Approval by the regulator, Commissioning of the clinical trial, and Interim Results.

Filing of Orphan Drug Designation applications to the US FDA as cited above, and their anticipated approval.

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 Respiratory Infections in India, its Approval by the regulator, and Commissioning of the clinical trial, and Interim Results.

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.

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 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.

About NanoViricides

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.
[email protected]

Public Relations Contact:
[email protected]

View the original press release on ACCESS Newswire

(F.Jackson--TAG)