NanoViricides(NNVC) - 2025 Q2 - Quarterly Report

Financial Performance - The company reported a net loss per common share of $629,931 for the three months ended December 31, 2024, compared to $682,253 for the same period in 2023, indicating a decrease in losses [46]. - The Company reported accrued expenses of $65,424 as of December 31, 2024, compared to $262,467 as of June 30, 2024 [65]. - The Company has a line of credit agreement with a maximum amount of $3,000,000, extended to March 31, 2026, with no amounts drawn as of December 31, 2024 [59]. - The Company recognized non-cash compensation expense of $24,916 related to the issuance of Series A preferred stock for the six months ended December 31, 2024 [67]. - The Company sold 2,445,660 shares of common stock at an average price of approximately $1.69 per share, generating net proceeds of approximately $3,964,000 from the ATM offering [66]. Research and Development - Research and development costs related to TheraCour amounted to $1,274,458 for the six months ended December 31, 2024, compared to $1,321,335 for the same period in 2023, showing a slight decrease [53]. - The Company has exclusive licenses for technologies developed by TheraCour for various virus types, including HIV and Influenza, with a royalty payment of 15% on net sales of licensed drugs [53]. - The Phase 1 human clinical trial of NV-CoV-2 began in India on June 17, 2023, under an agreement with KMPL [53]. - The Company is currently evaluating the impact of recently issued accounting standards on its financial statements, with preliminary assessments indicating minimal effects [49][50][51]. - The Company has initiated work for Phase II clinical trials of NV-387 for the MPox epidemic, with trial sites identified in the Central African region [104]. Clinical Trials and Drug Development - NV-387, the Company's most advanced drug candidate, has successfully completed Phase I clinical trials with no reported adverse events, indicating it was well tolerated [98]. - The Phase I clinical trial of NV-387 showed a NOAEL value of 1,200 mg/kg and an MTD value of 1,500 mg/kg, demonstrating a high level of safety [99]. - The Company is preparing for Phase II clinical trials of NV-387 to evaluate its effectiveness against multiple viral infections, including coronaviruses and respiratory syncytial virus [101]. - NV-387 has demonstrated high effectiveness in pre-clinical studies against lethal lung infections, supporting its oral bioavailability and potential for human clinical trials [196]. - NV-387 demonstrated superior antiviral activity compared to remdesivir in pre-clinical studies, although no COVID patient data was obtained from the clinical trial [211]. Market Potential - The global market for an effective MPox/Smallpox drug is estimated to reach billions of dollars due to its recognition as a bioterrorism threat agent [111]. - The market size for a successful ARI/SARI clinical trial of NV-387 could potentially open up tens of billions of dollars worldwide [116]. - The market for Influenza and Bird Flu is estimated at $4.6 billion in 2024, growing to $5.9 billion by 2027 at a rate of 8.5% [129]. - The market size for RSV is estimated at $2.6 billion in 2024, growing to $4.3 billion by 2027 at a rate of 18.9% [133]. - The global Herpes Simplex Virus treatment market size was estimated at $2.47 billion in 2023, expected to grow at a CAGR of 8.1% from 2024 to 2030 [142]. Manufacturing and Production - The company has established a cGMP-compliant manufacturing facility capable of producing multi-Kg scale clinical supplies for drug candidates, ensuring efficient and compliant production processes [169][170]. - The company has successfully transitioned from research-scale production to cGMP-compliant manufacture for multiple drug candidates in a short timeframe, indicating strong operational capabilities [171]. - The company has doubled the batch size of NV-387 in its cGMP-compliant facility in preparation for Phase II clinical trials for MPox and RSV, indicating a robust manufacturing capability [205]. - The company anticipates that its drug manufacturing capacity will be sufficient for initial market entry for its anti-RSV drug upon approval [174]. Strategic Partnerships and Agreements - The Company entered into a license agreement with KMPL for exclusive rights to use and sell two clinical test drug candidates for COVID-19 in India, with KMPL receiving a 30% fee on clinical trial costs and a 70% royalty on commercial sales [79]. - The Company has a Memorandum of Understanding with TheraCour for antiviral drug development, granting a right of first refusal for licensing any antiviral drugs in development [81]. - The Company amended its COVID License Agreement with TheraCour to defer cash milestone payments until sufficient revenues are generated [80]. Future Plans and Funding - The company plans to seek non-dilutive funding for drug candidates aimed at bio-defense and pandemic preparedness, enhancing its financial strategy for drug development [148][149]. - The company aims to seek non-dilutive funding for various drug development programs, including COVID, Long COVID, and RSV [242]. - The company is performing additional pre-clinical experiments to further understand the antiviral spectrum of NV-387, supporting regulatory advancement for multiple indications [206].