NV-387 Advancing to Phase II Clinical Trial for the Treatment of RSV Infection
SHELTON, CT / ACCESSWIRE / May 15, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that it has filed its Quarterly Report on Form 10-Q for the fiscal second quarter ending March 31, 2024 with the Securities and Exchange Commission (SEC) on Tuesday, May 14, 2024. The report can be accessed at the SEC website by searching for the Company's filings.
Financial Status
We reported that, as of March 31, 2024, we had cash and cash equivalent current assets balance of approximately $3.51 Million. Additional agreements have resulted in a further approximately $2.5 Million available cash, that would be equivalent to a total of approximately $6 Million cash available to the Company with no further costs.
In addition, we reported approximately $7.92 Million in Property and Equipment (P&E) and Intangible assets, net of depreciation and amortization from $14.7 Million in P&E assets before depreciation. The strong P&E assets are comprised of our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.81 Million. In comparison, as of June 30, 2023, we had cash and cash equivalent current assets balance of approximately $8.15 Million, and additional approximately $8.1 Million in Property and Equipment (P&E) assets, net of depreciation and amortization, while the total current liabilities were approximately $0.41 Million. The net cash utilized in the nine months from July 1, 2023 was approximately $4.84 Million.
We anticipate certain additional costs from the Phase 1 clinical trial in India, which was completed recently, from the continuing work on statistical evaluations, and generation and submission of the Phase 1 final report.
Management believes that the Company's existing resources, including availability under its $2 million line of credit will not be sufficient to fund the Company's planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company's ability to continue as a going concern.
Management plans to continue controlling its overall expenses and identifying and securing additional financing, as it has done in the past.
We are seeking to mortgage our headquarters facility, estimated to be worth over $12-15 million, with a replacement cost exceeding $25 Million, in order to free up liquidity. There is currently no mortgage on this facility and it is fully owned by NanoViricides, Inc. To date, we have raised funds in the equity markets for the development of our assets.
Additionally, we now have a clinical asset in NV-387 that is available for partnering. If partnered successfully, we can anticipate substantial initial payment, and milestone and royalty payments.
NV-387, A Unique Drug Candidate with Broad-Spectrum Antiviral Activity Poised to Transform the Treatment of Viral Infections Reminiscent of the Broad-Spectrum Antibacterial Activity of Penicillin that Transformed Treatment of Bacterial Infections
While NV-387 was developed in the context of the COVID-19 pandemic as a broad-spectrum pan-Coronavirus drug, we have found that it has strong antiviral activity against diverse types and families of viruses that include Coronaviruses, RSV, Influenza A, as well as Smallpox/Mpox in relevant animal models of these infections.
Thus NV-387 could be the single drug that can combat all of the "tripledemic" viruses - Coronaviruses, RSV, and Influenza, an unmet medical need.
We have found that the antiviral activity of NV-387 against RSV is strong enough to enable lethally infected animals to survive completely and not succumb to the infection. NV-387 thus could possibly be able to cure RSV infection.
Therefore, having completed the Phase I successfully, we plan on advancing NV-387 towards Phase II clinical trial for the treatment of RSV infection under the US FDA. Our goal is to obtain regulatory approval for the use of NV-387 for the treatment of RSV infection in infants and children, where there is a critical unmet need. There is no drug approved for RSV treatment, except the last resort toxic drug ribavirin.
Additionally, we plan on advancing NV-387 into Phase II studies for antiviral indications in India as well. We are in discussions with subject matter experts to determine how to harness the extremely broad-spectrum antiviral activity of NV-387 for rapid approval for the treatment of severe acute respiratory infections caused by viruses.
Update on Further Development of NV-387 (NV-CoV-2) for COVID Indication
The Phase 1 clinical trial for our lead drug candidate NV-CoV-2 (API NV-387) has completed successfully with no adverse events reported and clinical sites were closed in India. The COVID patient treatment part of the clinical trial could not be completed due to lack of patients eligible for recruitment as there were no COVID patients when our licensee and collaborator, Karveer Meditech Pvt Ltd and the CRO, PristynCR opened a second site in Salem, TamilNadu where a mini-COVID wave happened during February, 2024. However, by the time the second site was fully authorized with all regulatory approvals, the COVID wave had already passed and no COVID patients were found in a whole week of testing. Therefore, the CRO, the drug sponsor KMPL, in consultation with Principal Investigator, took the decision to close the clinical trial, having completed the Phase 1 clinical trial for the evaluation of safety and tolerability of NV-387 in healthy subjects in Single Ascending Dose and Multiple Ascending Dose studies, with no adverse events reported.
The work on this clinical trial will continue and a final Phase 1 Clinical Trial Report will be generated and submitted.
The weakening of the pandemic has worsened the difficulties in conducting clinical trials for COVID indication. We will continue to find non-dilutive funding for both COVID and Long COVID treatment, because we believe NV-387 has substantial chances of providing patient benefits in these cases. We plan on focusing our meager resources towards further development of NV-387 for the treatment of RSV, which is an endemic infection.
NanoViricides Drug Pipeline Addresses Several Billion Dollars in Market Sizes for Many Unmet Medical Needs
The market size for COVID drugs is expected to continue to be in the billions of dollars range while drug development for this indication has become challenging.
The market size of an RSV therapeutic is estimated to be several billions of dollars.
Although smallpox therapeutics are limited to government stockpiling, the market size for an effective smallpox therapeutic is estimated to be in the order of several hundred million dollars per year.
In addition the Company has previously developed the drug candidate NV-HHV-1 through IND-enabling safety/toxicology studies. NV-HHV-1 skin cream formulation is designed for the treatment of Shingles Rash, and is also effective against HSV-1 "cold sores" and HSV-2 "genital ulcers". Additionally the Company has a deep and wide pipeline of drug candidates with successful pre-clinical antiviral activity found against a large number of viruses including HIV, Influenza, and others.
Escape of Viruses from NanoViricides Platform Drugs is Unlikely
NanoViricides Platform Technology has an important advantage in that no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug because it is designed to mimic the very host-side features that the virus uses to bind to and enter cells. These specific molecular signature features on the cellular side do not change even as the virus mutates, and nanoviricides are designed to mimic these features. In contrast, viruses readily escape antibodies as drugs, as well as vaccine-induced immunity as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.
Specifically, NV-387 is designed to mimic the host-side feature of Sulfated-Proteoglycans (S-PG) that is used by over 90% of human pathogenic viruses. This, we believe, is the key to its unprecedented, ultra-broad-spectrum antiviral activity crossing virus family and type boundaries.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
Additional information regarding the NanoViricides Platform Technology, and the NanoViricides Drug Pipeline can be found in our Annual Report filed with the SEC filed with the SEC on October 13, 2023.
About NanoViricides
NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". 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 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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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". API means active pharmaceutical ingredient.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn, TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
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