NanoViricides, Inc. Has Filed its Quarterly Report: Broad-Spectrum Antiviral NV-387 To Combat MPox Pandemic in Africa - Phase II Clinical Trial Update, Also Readying to Combat Measles Outbreaks, and to Tackle Bird Flu

Miami Herald

16-05-2025

SHELTON, CT / ACCESS Newswire / May 16, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending March 31, 2025 with the Securities and Exchange Commission (SEC) on Thursday, May 15, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057825001336/nnvc-20250331x10q.htm) .
NV-387 - Phase II Clinical Trial to Treat MPox Infection - Unmet Medical Need
We reported that we submitted requisite due diligence information to the National Ethics Committee of the Democratic Republic of Congo (DRC) including a draft report from the Phase I clinical trial for the safety and tolerability of oral formulations of NV-387, the summary information from our studies for treatment of lethal MPox infections in animal models, as well as summary information on the manufacturing.
The National Ethics Committee found that the provided information was sufficient to justify a Phase II clinical trial, and has cleared us to file a Phase II Clinical Trial Application for the Use of Oral NV-387 for the Treatment of MPox Disease Caused by the hMPXV virus, subsequent to the reporting period.
We also reported that we have commissioned manufacture of clinical trial quantities of NV-387 drug substance and the corresponding NV-387 oral gummies formulations drug products at our own cGMP compliant facility in Shelton, CT.
We are now preparing the Phase II Clinical Trial Application for NV-387 to combat MPOX for submission to the DRC regulatory agency.
There is no drug available for the treatment of MPox disease. The MPox Clade 1a/1b viruses have a substantially greater fatality rate than COVID, at 3-4%, and Clade 1b has been disproportionately affecting pediatric populations.
The MPox Disease which is caused by hMPXV Clade 1a/1b virus infection was initially declared a Public Health Emergency of International Concern (PHEIC) by the WHO in August 2024, a designation that has been continued to stay in effect in April 2025, due to the severity of the pandemic in WHO African Region.
Spillover cases of MPox Clade 1a/1b have occurred in several Eastern and Western countries already, raising the probability that the epidemic may spread more widely, although the current MPox virus is not as communicable as Coronaviruses or Measles virus.
MPox Clade 2 spilled over from Africa into the Western World in a small pandemic during 2022, and has become endemic with several cases occurring every year in many countries, driven primarily by sexual contact. MPox Clade 2 causes much less severe disease than the Clade 1a and 1b viruses.
MPox/Smallpox drug represents a billion dollar market globally, should an effective drug be developed, because of potential biosecurity implications.
NV-387 as Treatment for Measles Virus Infection - Unmet Medical Need
Upon finding significant rationale that NV-387 would be potentially highly effective against the Measles virus, we have initiated a program to evaluate NV-387 in a humanized animal model of Measles lethal infection.
The Measles outbreaks in the USA have continued to grow since January, 2025, and have crossed 1,000 confirmed cases as well as 3 deaths. Measles cases have been increasing year over year in the USA, especially after the COVID pandemic substantially resolved with the SARS-CoV-2 becoming an endemic virus. In Europe, over 35,000 cases of Measles have been reported in 2024 according to the European CDC.
A 95% vaccination coverage is required to eliminate Measles virus. This has become a practically impossible goal because of several factors, among them: (i) Vaccine Hesitancy as a rebound public response because of compulsion of COVID vaccine shots multiple times; (ii) Religious Vaccine Prohibitions in certain communities, including certain Jewish religious communities, Mennonites, and other conservative religious communities; (iii) Increasing immune function disability in the general population due to chronic diseases such as Diabetes, Obesity, Cardiac Issues, Autoimmune Diseases, Allergies, etc. wherein the person upon vaccination would not develop strong enough immunity and would become a carrier if infected; (iv) Vaccine Failure caused primarily by a variety of immune function disabilities.
The Measles vaccination rates across the world, and particularly in European countries and the USA have dipped well below 95% on average, and much lower in specific areas, and vaccine breakout cases i.e. Measles disease in vaccinated persons, have also increased substantially, as seen from the ECDC statistics [1] , [2] .
It is therefore essential to develop a drug to treat Measles in order to combat these outbreaks and achieve full control over the public health situation. There is no drug available for treatment of Measles.
We strongly expect that NV-387 would be effective against Measles. This is because NV-387 cured lethal RSV infection in an animal model. RSV and Measles both are paramyxoviruses, and both use HSPG as the Attachment Receptor, and then transfer to their respective Cognate Receptor that is needed for cell fusion. NV-387 was designed to present to the virus like a cell that displays HSPG-mimetic small chemical ligands on its surface, thereby providing the attachment-receptor-mimetic landing sites for the virus, capturing, engulfing, and destroying it. (HSPG = Heparan Sulfated Proteoglycans).
NV-387 as Treatment for Bird Flu, H5N1, H7N9 - Unmet Medical Need
We have previously found that NV-387 was substantially more effective than the existing stockpiled influenza virus treatments including Tamiflu (oseltamivir) and Xofluza (baloxavir) in lethal animal models of Influenza virus lung infection.
Given the extremely broad antiviral activity spectrum of NV-387, and knowing that the Highly Pathogenic Avian Influenza (HPAI) viruses such as H5N1 and H7N9 have polybasic sequences in their H-protein that bind to HSPG, we believe NV-387 would be effective against Bird Flu viruses.
Influenza viruses mutate rapidly, and also exchange their full genomic RNA segments with other co-infecting viruses ("Re-assortment"), or copy portions of a different genomic sequence into their own RNA ("Re-combination"). Thereby an Influenza virus can acquire new traits such as (i) rapid communicability from person-to-person, and (ii) readily escaping vaccines, antibodies, and the small chemical drugs such as oseltamivir and baloxavir.
NV-387, we believe, fulfills the unmet medical need for a pan-Influenza drug that the Influenza virus would not be able to escape, because the virus does not lose its ability bind to HSPG as Attachment Receptor and then to Sialic Acid Receptors leading to cell fusion and infection.
A severe version of H5N1 is widely circulating in the wild birds, and has caused sporadic losses of entire poultry farm houses. This, and a mild version of H5N1 have infected thousands of dairy herds in the USA. The H5N1 virus is only a few mutations away from becoming highly communicable from person to person, and if that comes to bear, we would be facing a pandemic possibly worse than COVID-19.
It is well established now that vaccines, antibodies, and small chemical drugs do not provide the ability to stall an outbreak let alone a pandemic caused by a highly variable virus such as a Coronavirus or an Influenza virus.
We believe NV-387 will be ready to fight any human outbreaks of H5N1 under emergency use protocols for investigational drugs.
Company Financials
We reported that, as of March 31, 2025, we had cash and cash equivalent current assets balance of approximately $2.73 Million. In addition, we reported approximately $6.98 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. The total current liabilities were approximately $1.20 Million.
The net cash utilized during the nine months ended March 31, 2025 was approximately $6.78 million. This included certain non-recurring expenditures including R&D expenditures in preparation for a Phase II clinical trial application. We raised approximately $4.57 million net of commission and certain expenses in an At-the-Market offering ("ATM") during the nine months ended March 31, 2025.
We have approximately $5.7 million (approximately $4.5 million net of current liabilities) available for cash operational expenses going forward including an available line of credit of $3 million provided by our founder and President Dr. Anil Diwan. As such, we reported that we do not have sufficient funding in hand to continue operations through February 14, 2026, for our planned objectives that include (i) a Phase II clinical trial of NV-387 for MPOX 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. We have access to the aforementioned ATM Equity Offering, and we believe we will have access to the equity markets to raise the funds necessary for our current objectives. We continue to re-prioritize our programs in line with available resources.
NV-387 - Phase I Clinical Trial Completed Successfully with No Reported Adverse Events
NV-387 has successfully completed a Phase Ia/Ib clinical trial in healthy subjects with all subjects discharged as of end of December, 2023. There were no adverse events reported. We are now awaiting a final report of this Phase I clinical trial.
NV-387 A Potentially Revolutionary Antiviral Drug that the Viruses are Unlikely to Escape
Our host-mimetic, direct-acting, broad-spectrum, antiviral agent. NV-387 was found to have activity that surpassed the activity of known agents in lethal virus infection animal model trials for COVID, RSV, Influenza, and Mpox/Smallpox.
In fact, we found that NV-387 treatment possibly completely cured the lethal RSV infection in mice, based on indefinite survival of the animals with no lung pathology. There is currently no treatment for RSV infection. In particular, pediatric RSV infection treatment is an unmet medical need that we believe is of critical importance. Pediatric RSV treatment itself is expected to be a multi-billion-dollar market in the USA alone.
NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs, namely, oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, Biocryst), and baloxavir (Xofluza®, Shionogi/Roche).
Additionally, NV-387 also demonstrated activity against lethal poxvirus infection animal models that was on par with or superior to the approved drug tecovirimat (TPOXX®, SIGA).
NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for COVID, Influenza and Poxviruses.
This demonstrated broad-spectrum activity of NV-387 against widely varying viruses is because NV-387 is designed to attack the virus particle by mimicking sulfated proteoglycan (S-PG) feature, and all of these viruses are known to utilize heparan sulfate proteoglycans for gaining cell entry.
Further, for all of these tested viruses, even as the virus genome changes in the field, NV-387 is expected to continue to be effective, and the virus would be highly unlikely to escape NV-387. This is because despite all of the genomic changes, the virus continues to use HSPG, as is well known. Thus NV-387 solves the greatest problem in antiviral countermeasures; the problem of virus escape. Viruses are known to escape all of the current antiviral tools that include vaccines, antibodies, and small chemical drugs.
Thus we anticipate that NV-387 would revolutionize the treatment of viral infections reminiscent of how penicillin revolutionized the treatment of bacterial infections.
NV-387 Regulatory Strategy
In the ensuing year, we plan on advancing NV-387 into Phase II clinical trials. In addition to the Phase II clinical trial to assess effectiveness of NV-387 in treating MPox infections, we are also planning to advance NV-387 into a Phase II clinical trial for treatment of Viral Acute Respiratory Infections (V-ARI), and Viral Severe Acute Respiratory Infections (V-SARI). This clinical trial is expected to provide information on NV-387 effectiveness in treating Influenza viruses, Coronaviruses (including SARS-CoV-2/COVID) as well as RSV.
Thereafter we are planning a regulatory program for advancing NV-387 as the treatment of pediatric RSV infection.
We plan on advancing the regulatory processes for NV-387 registration for other indications including Influenza and COVID via partnerships and non-dilutive funding.
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.
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.
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.
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