NanoViricides(NNVC)

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NanoViricides president backs FDA's targeted COVID booster policy shift
Proactiveinvestors NAยท 2025-05-22 13:24
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 across 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]
NanoViricides advances NV-387 antiviral program, eyes Phase II trials for Mpox
Proactiveinvestors NAยท 2025-05-16 13:10
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 key finance and investing hubs, including London, New York, Toronto, Vancouver, Sydney, and Perth [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 delivered by the team includes insights across various 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 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 published content is edited and authored by humans [5]
NanoViricides(NNVC) - 2025 Q3 - Quarterly Report
2025-05-15 20:31
PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements for March 31, 2025, show a **$7.4 million** net loss, **$146.7 million** accumulated deficit, and **$2.5 million** cash, raising substantial doubt about going concern [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$10.03 million** from **$12.82 million**, driven by reduced cash, while liabilities and equity also saw slight declines Condensed Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 ($) | June 30, 2024 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $2,542,590 | $4,797,778 | | Total current assets | $2,727,306 | $4,970,520 | | Total assets | $10,031,960 | $12,822,853 | | Total current liabilities | $1,198,911 | $1,358,776 | | Total stockholders' equity | $8,833,049 | $11,464,077 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the nine months ended March 31, 2025, net loss increased to **$7.37 million** from **$5.94 million**, primarily due to higher operating expenses Operating Results Comparison (Unaudited) | Metric | Nine Months Ended Mar 31, 2025 ($) | Nine Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | Research and development | $4,371,693 | $4,255,205 | | General and administrative | $3,104,349 | $1,869,545 | | Total operating expenses | $7,476,042 | $6,124,750 | | Loss from operations | $(7,476,042) | $(6,124,750) | | Net loss | $(7,371,085) | $(5,938,159) | | Net loss per share | $(0.50) | $(0.51) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended March 31, 2025, net cash used in operations was **$6.78 million**, offset by **$4.57 million** from financing, resulting in a **$2.26 million** net decrease in cash Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Mar 31, 2025 ($) | Nine Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(6,776,773) | $(4,834,171) | | Net Cash Used in Investing Activities | $(46,764) | $(58,397) | | Net Cash Provided by Financing Activities | $4,568,349 | $0 | | Net Change in Cash | $(2,255,188) | $(4,892,568) | | Cash at End of Period | $2,542,590 | $3,257,240 | [Notes to the Condensed Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) Notes highlight the company's clinical-stage status, **going concern** doubt due to insufficient cash, related-party reliance, **$4.57 million** ATM proceeds, and recent MPox Phase II trial approval - The company has an accumulated deficit of approximately **$146.7 million** and a net loss of **$7.4 million** for the nine months ended March 31, 2025[23](index=23&type=chunk)[24](index=24&type=chunk) - Management states that current cash of **$2.5 million** is insufficient to fund planned operations for at least 12 months, raising substantial doubt about its ability to continue as a going concern[24](index=24&type=chunk) - The company is highly dependent on related-party TheraCour Pharma, Inc., controlled by CEO Dr. Anil Diwan, for technology licenses and R&D services[38](index=38&type=chunk)[40](index=40&type=chunk) - As of March 31, 2025, accounts payable to TheraCour were **$576,110**[40](index=40&type=chunk) - CEO Dr. Anil Diwan provided a standby Line of Credit to the company, which was increased from **$2 million** to **$3 million** and extended to March 31, 2026[45](index=45&type=chunk)[46](index=46&type=chunk) - The company has not drawn against this facility as of March 31, 2025[46](index=46&type=chunk) - From July 1, 2024, to March 31, 2025, the company sold 2,844,240 shares of common stock through its ATM agreement, generating net proceeds of approximately **$4,568,000**[54](index=54&type=chunk) - Subsequent to the quarter end, on May 5, 2025, the company received approval from the National Ethics Committee for Health in the Democratic Republic of Congo (DRC) for its proposed Phase II clinical trial of NV-387 for the treatment of MPox[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage nanoviricide platform, lead drug NV-387's broad-spectrum potential and Phase I completion, in-house cGMP manufacturing, and significant liquidity challenges with going concern doubts [Business Overview and Strategy](index=19&type=section&id=Business%20Overview%20and%20Strategy) The company's strategy centers on its clinical-stage nanoviricide platform and lead drug NV-387, a broad-spectrum antiviral, leveraging in-house cGMP manufacturing, non-dilutive funding, and partnerships for multiple indications - The company's core technology is a nanoviricide platform that creates host-mimetic drugs, which are designed to be difficult for viruses to escape through mutation[78](index=78&type=chunk)[79](index=79&type=chunk) - Lead drug candidate NV-387 is a broad-spectrum antiviral with demonstrated activity in animal models against Coronaviruses, RSV, Influenza, and Smallpox/MPox[84](index=84&type=chunk)[89](index=89&type=chunk)[95](index=95&type=chunk) - It has completed a Phase I human clinical trial with no reported adverse events[95](index=95&type=chunk) - The company possesses its own cGMP-compliant manufacturing facility, enabling production of drug substances and products for clinical trials and initial commercialization, which is a significant capability and cost-saving measure[178](index=178&type=chunk)[184](index=184&type=chunk) - The business strategy focuses on advancing NV-387 for multiple indications to maximize ROI, seeking non-dilutive funding (grants/contracts), and pursuing partnerships for late-stage development and commercialization[99](index=99&type=chunk)[156](index=156&type=chunk)[158](index=158&type=chunk) [Clinical Pipeline Developments](index=25&type=section&id=Clinical%20Pipeline%20Developments) The company prioritizes NV-387's clinical development, preparing for MPox Phase II in DRC, planning pediatric RSV Phase II in the U.S., initiating Measles evaluation, and deprioritizing the COVID program - The company is actively preparing for a Phase II clinical trial of NV-387 for MPox in the Democratic Republic of Congo (DRC), having recently received regional ethics committee approval[107](index=107&type=chunk)[108](index=108&type=chunk)[210](index=210&type=chunk) - A program has been initiated to evaluate NV-387 as a treatment for Measles virus infection, with an animal model study commissioned[214](index=214&type=chunk)[215](index=215&type=chunk) - The company plans to develop NV-387 for pediatric RSV infections, citing it as a major unmet medical need, and is preparing a Pre-IND application for the US FDA[143](index=143&type=chunk)[144](index=144&type=chunk) - The COVID-19 clinical program has been challenging due to a lack of patient enrollment[221](index=221&type=chunk) - Further development for COVID and Long COVID will depend on securing partnerships or non-dilutive funding[224](index=224&type=chunk) [Results of Operations](index=60&type=section&id=Results%20of%20Operations) For the three and nine months ended March 31, 2025, the company reported no revenue, with net loss increasing to **$2.2 million** and **$7.4 million** respectively, driven by higher G&A and R&D expenses Comparison of Operating Expenses and Net Loss (Unaudited) | Expense/Loss | Three Months Ended Mar 31, 2025 ($) | Three Months Ended Mar 31, 2024 ($) | Nine Months Ended Mar 31, 2025 ($) | Nine Months Ended Mar 31, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $1,282,251 | $1,214,661 | $4,371,693 | $4,255,205 | | G&A Expenses | $966,905 | $693,742 | $3,104,349 | $1,869,545 | | Net Loss | $(2,216,783) | $(1,854,476) | $(7,371,085) | $(5,938,159) | - The increase in G&A expenses for the three and nine-month periods was due to higher professional fees associated with investor outreach[271](index=271&type=chunk) - The increase in R&D expenses was attributed to a rise in outside lab fees and clinical trial costs[270](index=270&type=chunk) [Liquidity and Capital Resources](index=61&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$2.5 million** cash, deemed insufficient for 12 months of operations, raising substantial going concern doubt, with plans to secure additional funding via ATM, grants, and partnerships - The company has an accumulated deficit of **$146.7 million** and cash of **$2.5 million** as of March 31, 2025[276](index=276&type=chunk) - Management believes existing resources are insufficient to fund operations for at least 12 months, resulting in substantial doubt about the company's ability to continue as a going concern[276](index=276&type=chunk) - The company plans to secure additional funding through its 'At-The-Market' (ATM) agreement, non-dilutive grants, partnerships, and potentially mortgaging its fully owned campus facilities[277](index=277&type=chunk)[279](index=279&type=chunk)[281](index=281&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=63&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing disclosures regarding market risk - As a smaller reporting company, NanoViricides is exempt from providing disclosures about market risk[286](index=286&type=chunk) [Item 4. Controls and Procedures](index=63&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2025, management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective, with no material changes during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[290](index=290&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of March 31, 2025[291](index=291&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=66&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending or threatened legal proceedings expected to materially affect its business or financial condition - As of the filing date, there are no legal proceedings against the Company, and none have been threatened[296](index=296&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company sold **2,844,240** common shares via ATM, raising **$4.57 million** net, and issued unregistered Series A preferred and common stock for services ATM Offering Proceeds (July 1, 2024 - March 31, 2025) | Description | Amount ($) | | :--- | :--- | | Gross proceeds | $4,746,300 | | Less: offering costs and expenses | $178,300 | | Net proceeds | $4,568,000 | - The company issued Series A preferred stock and common stock as compensation to its CEO, employees, directors, and consultants[299](index=299&type=chunk)[300](index=300&type=chunk)[304](index=304&type=chunk) - These securities were issued without registration under the Securities Act, relying on exemptions[299](index=299&type=chunk)[305](index=305&type=chunk) [Item 3. Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults on its senior securities - None[306](index=306&type=chunk) [Item 4. Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[307](index=307&type=chunk) [Item 5. Other Information](index=68&type=section&id=Item%205.%20Other%20Information) The company reports no other material information, confirming no changes to director nomination procedures and no Rule 10b5-1 trading plan adoptions or terminations - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the reporting period[311](index=311&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files
NanoViricides progresses antiviral portfolio as measles and MPox threats rise
Proactiveinvestors NAยท 2025-05-14 13:09
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]
NanoViricides wins ethics approval for Phase II Mpox drug trial in DRC
Proactiveinvestors NAยท 2025-05-08 12:58
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's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
NanoViricides, Inc. Announces Participation in the D. Boral Capital Inaugural Global Conference, May 14th, NYC
Newsfileยท 2025-05-05 10:30
Company Overview - NanoViricides, Inc. is a clinical stage company focused on developing broad-spectrum antivirals using host-mimetic nanomedicine technology that viruses cannot escape [2][4] - The company has developed NV-387, a novel antiviral drug that has completed Phase I human clinical trials and is preparing for a Phase II trial for treating MPox in Africa [4] - Additional clinical trials for NV-387 are planned for RSV, Influenza, COVID, and other respiratory infections, with expectations for efficacy against Measles virus as well [4] - The company also developed NV-HHV-1 for herpesvirus infections and NV-HIV-1 for HIV/AIDS treatment [4] - The overall market size for NV-387, NV-HHV-1, and NV-HIV-1 is estimated to be between $20 to $30 billion [4] Event Participation - NanoViricides will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, at The Plaza Hotel in New York City [2] - Anil R. Diwan, President & Executive Chairman, will host one-on-one meetings during the conference from 9:00 A.M. to 3:00 P.M. (ET) [3]
NanoViricides advances measles drug development amid rising US cases
Proactiveinvestors NAยท 2025-04-29 13:23
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's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
NanoViricides evaluating antiviral drug NV-387 for measles treatment
Proactiveinvestors NAยท 2025-04-14 12:59
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 ...
NanoViricides unaffected by US tariff turmoil, says CFO
Proactiveinvestors NAยท 2025-04-05 16:56
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]
NanoViricides eyes role in US bird flu fight as USDA unveils $100M initiative
Proactiveinvestors NAยท 2025-03-28 13:17
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]