NanoViricides(NNVC) - 2025 Q4 - Annual Report

Drug Development and Clinical Trials - NanoViricides is a clinical stage company with its first drug candidate, NV-387, ready to enter Phase II human clinical efficacy trials after successfully completing Phase Ia/Ib trials with no reported adverse events[30][35]. - The Phase Ia/Ib clinical trial for NV-387 began in June 2023, with the treatment and observation phase completed by December 2023[51]. - The company is initiating a Phase II clinical trial for NV-387 targeting MPox in the Democratic Republic of Congo, with preliminary approval from the Ethics Committee[63]. - An additional Phase II clinical trial is planned to evaluate NV-387 as an empirical antiviral therapeutic for acute and severe-acute viral respiratory infections[64]. - NV-387 is expected to provide definitive data against Influenza, RSV, and Coronaviruses in a "basket-type" clinical trial, potentially saving costs and enabling further Phase III trials[68]. - The company plans to expand the indications for NV-387 following the completion of Phase I clinical trials, enabling direct entry into Phase II/III trials for new indications[158]. - The company is preparing for two Phase II clinical trials for NV-387 targeting MPox Virus Infection and Viral Acute and Severe-Acute Respiratory Infections[183]. - A novel adaptive "basket-type" Phase II clinical trial is being planned to evaluate NV-387 against multiple respiratory viruses, including Influenza and RSV[217]. Drug Efficacy and Safety - NV-387 has demonstrated strong antiviral activity against multiple viruses, including Coronavirus, RSV, Influenza, and Smallpox, and is designed to mimic heparan sulfate proteoglycans to prevent viral infection[36][37]. - NV-387 is expected to provide significant safety and tolerability benefits as a direct-acting antiviral, potentially revolutionizing the treatment of viral infections[39][41]. - NV-387 demonstrated a broad antiviral spectrum in animal models, showing substantial increases in survival against RSV, Influenza, MPox, Smallpox, and Measles[59][60][61]. - NV-387 has shown complete cure rates in lethal lung infection models for RSV, indicating potential for successful regulatory approval[87]. - NV-387 demonstrated a No-Observed-Adverse-Effect-Level (NOAEL) of 1,200 mg/Kg/dose and a Maximum Tolerated Dose (MTD) of 1,500 mg/Kg/dose in animal studies, indicating high safety levels[126]. - In a Phase Ia/Ib clinical trial, NV-387 showed no discontinuations or adverse events reported, even at the highest dosage levels[129]. - NV-387 was found to be non-immunogenic, non-allergenic, non-mutagenic, and non-genotoxic, eliminating the need for carcinogenicity studies[128]. - NV-387 treatment demonstrated a significant increase in survival in a lethal Influenza A/H3N2 mouse model, surpassing three well-known approved anti-influenza drugs[160]. - NV-387 showed antiviral activity in animal models relevant to Smallpox/Mpox infections, with the WHO declaring MPOX a "public health emergency of international concern" due to its pathogenic strain[161]. Drug Formulation and Accessibility - The company has developed NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies for COVID treatment, with a royalty agreement of 70% of net sales from commercialization in India[51]. - NV-387's formulation includes oral gummies and injectable options, enhancing accessibility for patients with difficulty swallowing tablets[69][70]. - The injectable formulation of NV-387 can be delivered directly into the lungs, providing 100% bioavailability for hospitalized patients[133]. - The unique versatility of the Nanoviricide Platform allows NV-387 to be used across all segments of the population and various disease severities[135]. Financial and Market Potential - The company anticipates significant revenue potential from NV-387 upon approval for biodefense stockpiling and treatment of MPox, with estimates in the hundreds of millions[78][79]. - The market for Influenza treatments is multi-billion dollars, with NV-387 showing superior efficacy in animal models compared to existing antiviral drugs[86]. - NV-387's broad application minimizes regulatory workload and costs, potentially leading to robust commercial footing and improved returns on investment[89]. - The company plans to seek partnerships for further regulatory development and commercialization of its drug candidates, potentially involving initial license fees and milestone payments[104]. - NV-387 is expected to be effective against various viruses, including Henipaviruses and filoviruses, with plans for collaborations and non-dilutive funding for further development[187]. Company Operations and Infrastructure - NanoViricides owns integrated facilities that support the entire drug development process, enabling rapid development of NV-CoV-2 from concept to clinical trials within one year[48][49]. - The company has established a cGMP-capable manufacturing facility that can produce sufficient drugs for approximately 1,000 patients in a single batch, supporting upcoming clinical trials[202]. - NanoViricides has built a Biological Safety Level-2 (BSL2) Virology Laboratory for early evaluation of drug candidates against various viruses[207]. - The company has financed its drug development programs through equity-based financing from private and public offerings[109]. - NanoViricides is one of the few small pharmaceutical companies with a fully integrated operation from drug discovery to product manufacturing, reducing risks and costs in drug development[212]. Pipeline and Future Developments - The company has a robust drug pipeline, including NV-HHV-1 for shingles, which has completed safety-pharmacology studies for a US FDA IND filing[100]. - The company is also developing additional drug candidates for other viral infections, including Dengue and Ebola viruses, at various preclinical stages[47]. - Future plans include developing NV-387 for pediatric RSV treatment and as a biodefense application for Smallpox[185][186]. - The company has a broad pipeline with over ten drug candidates across nearly forty antiviral drug development programs, anticipating exponential growth upon the approval of its first drug candidate[181]. - The production scale of NV-387 has approximately doubled, resulting in a batch size of about 6kg of the purified drug substance, with a 10kg scale feasible[218]. Regulatory and Licensing Agreements - The company has exclusive worldwide licenses for treating several viral diseases, including HIV, Hepatitis B and C, and Influenza, with a 15% royalty on net sales to TheraCour Pharma[54]. - A Memorandum of Understanding with TheraCour allows NanoViricides a right of first refusal for all antiviral drug developments, ensuring collaboration on future drug candidates[55]. - NV-387 is being developed under a FDA rare disease pathway, making it economically viable despite the small number of global cases[98].