SHELTON, CONNECTICUT -- Tuesday, May 16, 2023 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal third quarter ending March 31, 2023 with the Securities and Exchange Commission (SEC) on Monday, May 15, 2023. The report can be accessed at the SEC website (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000141057823001235/nnvc-20230331x10q.htm).
Financial Status - Sufficient Funds to Conduct Clinical Trials
We reported that, as of March 31, 2023, we had cash and cash equivalent current assets balance of approximately $9.9 Million. In addition, we reported approximately $8.6 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 comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.35 Million. In comparison, as of December 31, 2022, we had cash and cash equivalent current assets balance of approximately $11.5 Million, and additional approximately $8.4 Million in Property and Equipment (P&E) assets, net of depreciation and amortization from $14.7 Million in P&E assets before depreciation, while the total current liabilities were approximately $0.46 Million. The net cash utilized in the nine months from July 1, 2022 was approximately $4.2 Million. The cash expenditure is expected to increase once clinical trials begin for NV-CoV-2, our lead drug candidate to treat SARS-CoV-2 infection that causes COVID.
On March 27, 2023 the Company entered into a License Agreement with Karveer Meditech, Pvt. Ltd., India, (Karveer) wherein the Company granted to Karveer a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company's two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India.
Our lead drug candidate NV-CoV-2 is a broad-spectrum, pan-coronavirus drug for the treatment of COVID. NV-CoV-2 is about to enter into Phase Ia/Ib human clinical trials sponsored by our licensee and collaborator in India, Karveer Meditech, Pvt. Ltd. We await notification of the start of the clinical trials. Two oral formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies will be evaluated in the clinical trial. On April 12, 2023, we shipped the clinical drug products to Karveer and the products have been received in good condition.
We estimate that we have sufficient funds to complete initial human clinical trials for our lead drug candidate NV-CoV-2 for the treatment of SARS-CoV-2 infection that causes COVID and also "long COVID".
Broad-Spectrum Antivirals to Meet Unmet Medical Need in COVID and Beyond
Both NV-CoV-2 and NV-CoV-2-R have demonstrated pan-coronavirus, broad-spectrum effectiveness in pre-clinical studies. This broad-spectrum effectiveness indicates that SARS-CoV-2 variants that are continuously generated in the field are quite unlikely to escape either of these two drug candidates, a highly sought after characteristic for an antiviral drug.
In contrast, we note that all of the existing antibodies and cocktails with emergency use approvals, including Evusheld, have lost effectiveness and have lost their emergency use authorizations (EUA) against the current SARS-CoV-2 Omicron variants. Paxlovid has limited application as it has been found to be effective only in adults over 65 years of age with co-morbidities, and its composition further limits its usefulness due to side effects and interactions with other drugs commonly taken by persons with co-morbidities. Molnupiravir is a known mutagen and its use is not recommended or severely restricted by international health authorities. Remdesivir is the only FDA approved drug for treating COVID, but it is only approved for hospitalized patients; it requires long, daily infusions, and clinically it has shown only marginal improvements, with reduction in hospital stay of a few days.
We have successfully developed NV-CoV-2 formulations for different severities of the disease, including (i) NV-CoV-2 Oral "Gummies" and (ii) NV-CoV-2 Oral Syrup, to treat mild to moderate disease, and (iii) NV-CoV-2 for Injection, Infusion or Inhalation for hospitalized patients with severe disease including the direct-lung-inhalation for severe lower lung disease, thus covering the entire disease severity spectrum.
Thus NV-CoV-2 is poised to meet the unmet medical need of a highly effective and safe drug to treat COVID, and potentially long COVID with residual virus, that would be useable in all segments of patient populations, from children to otherwise healthy patients to older patients and patients with co-morbidities.
Exploring Additional Applications of NV-387 to Maximize Return on Investments and to Fulfill Unmet Medical Needs
NV-387 has been found to have broad-spectrum activity against all of the tested seasonal coronaviruses and SARS-CoV-2 in pre-clinical studies.
We anticipate that the active pharmaceutical ingredient of NV-CoV-2, namely NV-387, may have significantly broader spectrum of antiviral effectiveness than the coronavirus family alone, based on its design. This because NV-387 was designed to mimic a well-known feature on human cell surfaces, called "sulfated proteoglycans" that a large number of virus families bind to as the first step in infecting a cell (reviewed in (1)).
Antibiotics such as penicillin attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.
Having a safe and effective broad-spectrum antiviral agent such as NV-387 in hand would help combat future viral infection epidemics before they expand. This strategy should form a backbone of pandemic preparedness strategy, rather than reliance on vaccines and antibodies that have now been proven to be of limited durable utility.
Additionally, once NV-387 based drug formulations such as NV-CoV-2 have undergone Phase I Safety/Tolerability study in humans, next antiviral applications or other indications of NV-387 are likely to be eligible for a much faster clinical pathway, possibly entering directly into Phase II/III clinical trials. This would provide substantial reduction in resource requirements and would significantly improve return on investments.
To this end, we are exploring in pre-clinical studies potential antiviral activity of NV-387 against other viruses, beginning with respiratory viruses. We have initiated studies to treat Respiratory Syncytial Virus (RSV) infection. There is no approved safe and effective drug for treatment of RSV in children, except that ribavirin, a highly toxic drug, is approved for use as a last resort.
The markets addressed by our drug programs are extremely large, into several tens of billions of dollars if not more.