SHELTON, CT / ACCESSWIRE / February 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 December 31, 2023 with the Securities and Exchange Commission (SEC) on Wednesday, February 14, 2024. The report can be accessed at the SEC website at https://www.sec.gov/Archives/edgar/data/1379006/000141057824000048/nnvc-20231231x10q.htm.
Financial Status - Sufficient Funds to Conduct Clinical Trial
We reported that, as of December 31, 2023, we had cash and cash equivalent current assets balance of approximately $5.31 Million. Additional agreements have resulted in a further approximately $2.5 Million available cash, that would be equivalent to a total of approximately $7.8 Million cash available to the Company with no further costs.
In addition, we reported approximately $8.07 Million in Intangible Assets and Property and Equipment (P&E) 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 $0.95 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 six months from July 1, 2023 was approximately $2.89 Million.
As our clinical trials for NV-CoV-2, our lead drug candidate, progress further, our cash expenditure rate is expected to increase.
NV-CoV-2 is a unique, ultra-broad-spectrum antiviral nanomedicine in that we believe it may be a single drug that is effective for the treatment of many viral infections. These include, SARS-CoV-2 infection that causes COVID, RSV infections as well as Poxvirus infections (including Smallpox, a bioterrorism threat, Mpox, a recurring epidemic causing virus, and Alaskapox, an emerging zoonotic infection that recently claimed one human life in the USA.)
Several steps were taken to improve our cash flow and potential disbursements for the following one year budgeting period. The Company's Board requested TheraCour Pharma, Inc., our largest shareholder and licensor of our technology ("TheraCour"), to change the milestone payments clause of the COVID Licensing Agreement so that any forthcoming milestones would be acknowledged at achievement, but any cash award corresponding to the same would only be payable from a revenue stream generated from the product or product development operations, excluding capital or debt financings. The Coronavirus License Agreement between TheraCour, the Licensor, and NanoViricides, the Licensee was amended on February 12, 2023 to provide for the same. Additionally, the Company requested, and TheraCour agreed on February 12, 2023, that the required 2-month equivalent advance maintained by the Company, which at present is approximately $500,000, be applied to current bills and that no advance be required until the Company has sufficient funds to support the same. On October 27, 2023, TheraCour, our largest shareholder and licensor of our technology, exercised its right to convert the principal of the July 19, 2023 $1,500,000 convertible promissory note into 331,859 shares of the Company's Series A preferred stock and forgave and cancelled all of the accrued interest of $49,808 on the note. On November 8, 2023, the Company's President and CEO, Dr. Anil R. Diwan, agreed to provide a standby Line of Credit to the Company in the maximum amount of $2,000,000, with interest payable only on amounts drawn. On February 12, 2023, the maturity date of the Line of Credit was extended to December 31, 2025. The Company does not anticipate any borrowings under the Line of Credit during the current fiscal year.
These actions have significantly improved the near-term liquidity outlook.
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. 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. The nanoviricide drug NV-387 in Phase 1a/1b clinical trials itself alone addresses all of these markets.
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, which is also effective against HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company has a deep and wide pipeline of drug candidates with successful pre-clinical effectiveness against a large number of viruses including HIV, Influenza, and others.
Drug Development Status
Strong Safety and Tolerability of NV-CoV-2 Oral Syrup and Oral Gummies Established in Phase 1a/1b Human Clinical Trial
On January 29, 2024, we reported that the Healthy Subjects Part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2 (API NV-387), our broad-spectrum antiviral drug, were completed successfully. All subjects have been successfully discharged. There were no discontinuations. All dosage levels at all dosing instances were well tolerated. There were no adverse events. Thus the drug NV-387 was found to be safe for both single dosing and for repeat dosing even at amounts as high as 40 mg/Kg, including a first "loading" dose at 80mg/Kg. The data are undergoing internal audit. After this, the data will be provided for biostatistical analysis.
The second part of the Phase 1a/1b clinical trial is the treatment of COVID patients suffering from mild to moderate disease. We believe that the recent COVID wave in India is providing an opportunity to conduct this part of treating COVID patients with our drug and we have undertaken efforts towards this goal. This part is designed to evaluate the safety and tolerability of NV-CoV-2 in COVID patients, and to obtain information on the effective dosing level(s) to select for the subsequent Phase II/III clinical trials.
The clinical trial in India is managed by our licensee and collaborator, and Indian drug sponsor company, Karveer Meditech Pvt. Ltd., and is conducted by the clinical research organization (CRO) PristynCR.
The strong safety and tolerability of NV-387 demonstrated in human clinical trial implies that it can be used: (i) across all ages from pediatrics to seniors; (ii) irrespective of co-morbidities such as diabetes, other pre-existing diseases, or immune compromised status of the individual; and (iii) at all levels of disease severity, from mild/moderate to severe to very severe (hospitalized patients)1. This capability of NV-387 is analogous to the highly successful antibiotics against bacteria.
In contrast, currently available antiviral drugs have substantial limitations on the patient populations that they can be used in. For example, of the two remaining approved drugs for treatment of COVID, Paxlovid which is given orally, is not indicated for the treatment of COVID-19 in patients without a risk factor for progression to severe COVID-19, whereas Remdesivir can only be used in hospitalized cases.
Ultra-Broad Antiviral Spectrum of NV-CoV-2 Oral Syrup and Oral Gummies Enables Phase II/III Clinical trials for Multiple Indications
We believe that upon completion of the Phase 1a/1b human clinical trials of NV-CoV-2, the NV-387 oral formulations are expected to be eligible for Phase II/III clinical trials for RSV. There is no therapeutic available for RSV other than the last resort option of toxic drug Ribavirin.
We anticipate that NV-387 formulations would be expected to be eligible for the development of Poxvirus therapeutics under the FDA "Animal Rule," if further studies are successful. We plan to seek non-dilutive government funding for this indication.
NV-387 has such broad-spectrum activity because it is designed to mimic the attachment receptors to which over 90% of viruses bind before infecting a cell. We are currently engaged in expanding the spectrum of activity of NV-387. NV-387 is an example of NanoViricides Platform Modality #1 implementation.
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 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.
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.
Manufacturing Capacity Increase in Preparation of Drug Supply for Phase II Clinical Trials
Importantly, in the reported quarter, we have approximately doubled our production batch size and capacity for NV-387 manufacture. We believe that this capacity will be sufficient for Phase II clinical trials for COVID or Phase II/III clinical trials for RSV. The production program for Phase II clinical supply is expected to be commissioned soon.
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.
[1] Statements regarding safety and effectiveness or NV-CoV-2 and NV-387 have not been evaluated by the US FDA.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) 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. Our lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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-CoV-2 into Phase I/II human clinical trials.
NV-CoV-2 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-CoV-2 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 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.
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".
(1. Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472.)
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
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