About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Company Overview - NanoViricides is focused on developing broad-spectrum antiviral therapeutics, with its lead candidate NV-387 targeting over 90% of pathogenic viruses, including influenza, RSV, Covid, and smallpox [2][6] - The company conducts all research and development in-house in Shelton, Connecticut, making it immune to international tariff changes [4][5] Technology and Product Development - NV-387 is not a vaccine but a therapeutic drug that mimics receptor sites used by pathogenic viruses, allowing it to remain effective despite viral mutations [5][6] - The drug is based on heparan sulfate, which is utilized by more than 90% of pathogenic viruses, providing a broad-spectrum treatment option [6] Market Position and Strategy - The current U.S. administration is adopting a balanced approach towards pandemic preparedness, recognizing the importance of therapeutics alongside vaccines [7] - The U.S. Department of Agriculture's investment of approximately $100 million to combat avian influenza aligns with the company's interests, as NV-387 can address H5N1 [8][9] Clinical Trials and Future Outlook - The company is conducting Phase 2 trials for NV-387 against smallpox, following a successful Phase 1 trial with no adverse effects [10] - The company emphasizes the importance of looking towards the future and the potential of its groundbreaking technology to combat 90% of viral infections [11]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive has a strong emphasis on technology adoption, utilizing various tools to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive employs technology to enhance workflows and has a forward-looking approach to technology adoption [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive has a strong emphasis on technology adoption, utilizing various tools to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive has a strong emphasis on technology adoption, utilizing various tools to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - Bird flu, specifically H5N1, is reported to be widespread among birds in Massachusetts, with new cases emerging in both wild and domestic birds [1][2] - The outbreak in Massachusetts follows similar incidents in at least ten other states, with a total of 67 confirmed human cases since April 2024, including a fatality in Louisiana [2] Group 1: Human Cases and Transmission - Most human cases linked to dairy cows have been mild, while those from birds have been severe and sometimes fatal [3] - There is no confirmed human-to-human transmission of H5N1, but scientists warn that minor changes in the virus could enable rapid transmission [3] Group 2: Antiviral Preparedness - Concerns are raised regarding the inadequacy of current antiviral strategies to address potential pandemic risks from H5N1 due to rapid viral changes [4] - Dr. Anil Diwan emphasizes the need for novel antiviral drugs like NV-387 to be advanced quickly to prepare for a potential H5N1 pandemic [5] Group 3: Limitations of Current Treatments - Current vaccines and antibodies may offer limited protection against a potential pandemic strain of H5N1, as viruses can quickly develop resistance [5][6] - Existing antiviral drugs are known to have resistant strains, and such resistance can be transferred to H5N1 strains [6] - NV-387 is designed to mimic a key host feature required for infection, making it difficult for the virus to develop resistance, and has shown superior efficacy in preclinical trials compared to existing treatments [6]