SHELTON, CT / ACCESSWIRE / September 30, 2024 / 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, 2024 with the Securities and Exchange Commission (SEC) on Friday, September 27, 2024. The report can be accessed at the SEC website (https://www.sec.gov/ix?doc=/Archives/edgar/data/1379006/000141057824001650/nnvc-20240630x10k.htm).
We reported that, as of June 30, 2024, we had cash and cash equivalent current assets balance of approximately $4.97 Million. In addition, we reported approximately $7.5 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 $1.36 Million. In comparison, as of June 30, 2023, we had cash and cash equivalent balance of approximately $8.15 Million, P&E assets of approximately $8.1 Million (after depreciation), and total current liabilities of approximately $0.53 Million.
The net cash utilized in the reported period for operating activities was approximately $6.31 million that included certain expenditures for Phase Ia/Ib clinical trial of NV-387 and drug manufacturing costs for this clinical trial.
We raised approximately $3.12 million net of commission and certain expenses in an At-the-Market offering ("ATM") in the reported period at an average share price of $2.47.
With an additional raise of approximately $1.53 million subsequent to the period under the ATM, and an available line of credit that was increased to $3 million from $2 million provided by our founder and President Dr. Anil Diwan, we have approximately $9.5 million (approximately $8.1 million net of current liabilities) available for cash operational expenses going forward. As such, we reported that we do not have sufficient funding in hand to continue operations through September 30, 2025, for our planned objectives that include a Phase II clinical trial of NV-387 for RSV indication in the USA. 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 perviously adjusted our objectives and development plans on the basis of available resources and we will continue to do so.
NV-387 - A Potentially Revolutionary Antiviral Drug that the Viruses are Unlikely to Escape
We have made significant progress in the regulatory advancement of NV-387. A Phase Ia/Ib clinical trial in healthy subjects was completed with all subjects discharged as of end of December, 2023. There were no adverse events reported. Lab data analysis is currently being conducted. We are awaiting a final report.
Additionally, we have made significant progress in expanding the indications of NV-387, that would result in substantial improvement in the return on investment when regulatory approvals are obtained.
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, and Influenza.
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 the approved drug tecovirimat (TPOXX®, SIGA).
NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for Influenza and for 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.
Advancing NV-387 into Phase II Clinical Trials
In the ensuing year, we plan on advancing NV-387 into Phase II clinical trials. We believe that NV-387 qualifies under the MEURI WHO protocol to enter Phase II clinical trial for the treatment of MPOX disease that is a current epidemic in Central Africa (MEURI = Monitored Emergency Use of Unregistered and Investigational Interventions). This epidemic was declared a Public Health Emergency of International Concern (PHEIC) by the WHO in August, 2024. There is currently no drug available for treatment of MPOX since the clinical trial of tecovirimat did not demonstrate improvement in outcomes as compared to the standard of care, according to a press release by NIH in August, 2024.
We are also planning to advance NV-387 into a Phase II clinical trial for treatment of RSV infection in adults as part of the regulatory process required for registration of the drug for the treatment of pediatric RSV infection.
We plan on advancing the regulatory processes for NV-387 registration for other indications such as 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.
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.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
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