NanoViricides(NNVC) - 2025 Q3 - Quarterly Report

PART I FINANCIAL INFORMATION Item 1. Financial Statements 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 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 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 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 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][24] - 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] - 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][40] - As of March 31, 2025, accounts payable to TheraCour were $576,110[40] - 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][46] - The company has not drawn against this facility as of March 31, 2025[46] - 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] - 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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][79] - Lead drug candidate NV-387 is a broad-spectrum antiviral with demonstrated activity in animal models against Coronaviruses, RSV, Influenza, and Smallpox/MPox[84][89][95] - It has completed a Phase I human clinical trial with no reported adverse events[95] - 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][184] - 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][156][158] Clinical Pipeline Developments 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][108][210] - A program has been initiated to evaluate NV-387 as a treatment for Measles virus infection, with an animal model study commissioned[214][215] - 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][144] - The COVID-19 clinical program has been challenging due to a lack of patient enrollment[221] - Further development for COVID and Long COVID will depend on securing partnerships or non-dilutive funding[224] Results of Operations 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] - The increase in R&D expenses was attributed to a rise in outside lab fees and clinical trial costs[270] Liquidity and Capital Resources 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] - 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] - 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][279][281] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] Item 4. Controls and Procedures 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] - Management concluded that the company's internal control over financial reporting was effective as of March 31, 2025[291] PART II OTHER INFORMATION Item 1. Legal Proceedings 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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][300][304] - These securities were issued without registration under the Securities Act, relying on exemptions[299][305] Item 3. Defaults Upon Senior Securities The company reports no defaults on its senior securities - None[306] Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - Not applicable[307] Item 5. Other Information 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] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files