NanoViricides(US:NNVC)2024-05-15 00:25Financial Performance - The company reported a net loss per common share for the three months ended March 31, 2024, with basic and diluted losses reflecting the weighted average number of shares outstanding during the period[33]. - As of March 31, 2024, accounts payable to TheraCour amounted to $213,148, a decrease from $233,434 as of June 30, 2023[38]. - The company has suspended the existing license requirement to maintain an advance with TheraCour until sufficient capital is raised, applying the existing advance of $500,000 towards current invoices[38]. - Total interest incurred under the unsecured convertible promissory note for the nine months ended March 31, 2024, was $49,808[42]. - As of March 31, 2024, the total property and equipment net value is $7,602,835, a decrease from $8,106,647 as of June 30, 2023, reflecting accumulated depreciation of $7,265,288[45]. - The Company’s intangible assets, net, amount to $327,376 as of March 31, 2024, down from $333,578 as of June 30, 2023, with amortization expense of $2,067 for the three months ended March 31, 2024[46]. - Accrued expenses totaled $258,795 as of March 31, 2024, compared to $143,760 as of June 30, 2023, with significant increases in clinical trial costs due to KMPL-related party[50]. - The company reported stockholders' equity of $10,651,570 as of March 31, 2024, compared to $8,149,808 as of June 30, 2023[226]. - Operating activities used approximately $4.8 million in cash during the nine months ended March 31, 2024, compared to $4.2 million in the same period of 2023[227]. Research and Development - Research and development costs charged by TheraCour for the three months ended March 31, 2024, were $588,763, compared to $622,016 for the same period in 2023[40]. - Clinical trial costs charged by KMPL for the three months ended March 31, 2024, were $77,435, while for the nine months ended March 31, 2024, these costs totaled $442,845[40]. - The company recorded a non-current liability and research and development expense of $1,500,000 related to a milestone payment due under the COVID-19 License Agreement[41]. - Research and development costs are aggregated across all projects, with a focus on COVID program drug candidates in the reported quarter[229]. Drug Development and Clinical Trials - NanoViricides, Inc. has completed Phase 1a/1b human clinical trials for its first drug candidate NV-CoV-2, with no reported adverse events and good tolerability at high dosing levels[75]. - The company plans to develop NV-387 as an ultra-broad-spectrum antiviral to treat various viral infections, including coronaviruses, RSV, and influenza, potentially covering all "tripledemic" viruses[76]. - NV-387 has shown superior efficacy in animal studies compared to existing therapeutics, significantly increasing lifespan in models infected with coronaviruses, RSV, smallpox, and influenza[86][87][88][89]. - NV-387 has shown positive results in Phase 1a/1b clinical trials, being well tolerated at the highest dose levels with no reported adverse events[100]. - The successful completion of Phase I trials for NV-387 positions the drug for advancement into Phase II efficacy trials, indicating a high probability of success[124]. - The company plans to initiate a Phase II clinical trial for NV-387 in India shortly after the Phase I report, with RSV and Influenza as potential indications[104]. - NV-387 has shown strong antiviral activity in pre-clinical studies, significantly outperforming Remdesivir in treating COVID-19[156]. - The company plans to advance NV-387 into clinical trials for RSV infection in pediatric patients, addressing an unmet medical need[160]. - A pre-IND application for NV-387 in RSV infection is being prepared, with plans to support it with non-clinical and Phase I clinical trial data[168]. - The company has successfully completed Phase 1 human clinical trials for the antiviral drug candidate NV-387 with no adverse events reported, indicating a high level of safety[200]. Market Potential and Strategy - The global RSV therapeutics market is projected to grow from $1.8 billion in 2022 to $8.73 billion by 2031, with a CAGR of 18.9%[96]. - The influenza market size is expected to increase from approximately $3.6 billion in 2021, with a CAGR of 8.5% from 2019 to 2032[97]. - The company is exploring partnerships for regulatory development and commercialization of its drug candidates, which may involve initial license fees and milestone payments[82]. - The company plans to develop NV-387 for additional indications, such as pediatric applications, to expand market penetration and improve return on investment[215]. - The company aims to secure non-dilutive funding for drug candidates that align with bio-defense and pandemic preparedness objectives[83]. Manufacturing and Production - The in-house cGMP-compliant manufacturing facility allows the company to produce clinical supplies efficiently, resulting in significant cost savings[120]. - The company has doubled its manufacturing capacity for NV-387 in preparation for Phase II/III clinical trials for RSV, ensuring sufficient supply[147]. - The company has established a cGMP-capable manufacturing facility designed to support the production of multi-kilogram-scale quantities of its nanoviricides drugs, including various formulations[205]. Intellectual Property and Regulatory - The company has filed two international PCT patent applications related to the TheraCour polymeric micelle technology for Coronavirus antiviral drugs, with expected patent expiry extending into 2043[223]. - The company is developing NV-HHV-1 for shingles treatment, with sufficient drug product manufactured for Phase I and II trials[193]. - The company is also developing a systemic drug for herpesvirus infections, expected to be superior to current acyclovir-related drugs[196]. - The company plans to seek non-dilutive funding for the development of NV-387 as a therapeutic for poxviruses under the FDA "Animal Rule"[189]. Financial Position and Funding - The company has limited experience with pharmaceutical drug development, which may affect budget estimates and timelines for drug development[211]. - The company intends to keep capital expenditures minimal to conserve cash for drug development purposes[210]. - As of March 31, 2024, the company had cash and cash equivalents of $3,257,240, an increase from $8,149,808 as of June 30, 2023[226].