NanoViricides Inc 2025年季度报告

FORM10-Q QUARTERLY REPORT UNDER SECTION1320 OR 15(d)OFTHE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period endedDecember 31, 2024 Commission File Number:001-36081 NANOVIRICIDES,INC.(Exact name of Company as specified in its charter) 76-0674577 (IRS Employer Identification No.) 1 Controls DriveShelton,Connecticut06484(Address of principal executive offices and zip code)(203)937-6137(Company’s telephone number, including area code) Indicate by check mark whether the Company (1)has filed all reports required to be filed by Section13 or 15(d)of theExchange Act during the preceding 12months (or for such shorter period that the Company was required to file such reports),and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmittedpursuant to Rule405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12months (or for suchshorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the Company is a larger accelerated filer, an accelerated filer, a non-accelerated filer, smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section13(a)of the ExchangeAct.☐ Indicate by check mark whether the Company is a shell company (as defined in Rule12b-2 of the Exchange Act). Securities registered pursuant to Section 12(b) of the Act: As of February 14, 2025 there were approximately15,641,000 shares of common stock of the registrant issued andoutstanding. NanoViricides,Inc.FORM10-QINDEXPART I FINANCIAL INFORMATION2Item 1. Financial Statements2Condensed Balance Sheets at December 31, 2024 and June 30, 2024 (Unaudited)2Condensed Statements of Operations for the Three and Six Months Ended December 31, 2024 and 2023(Unaudited)3Condensed Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended December31, 2024 and 2023 (Unaudited)4Condensed Statements of Cash Flows for the Six Months Ended December 31, 2024 and 2023(Unaudited)6Notes to the Condensed Financial Statements (Unaudited)7Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations18Item 3. Quantitative and Qualitative Disclosures About Market Risk39Item 4. Controls and Procedures39PART II OTHER INFORMATION40Item 1. Legal Proceedings40Item 2. Unregistered Sales of Equity Securities and Use of Proceeds40Item 3. Defaults Upon Senior Securities41Item 4. Mine Safety Disclosures41Item 5. Other Information41Item 6. Exhibits and Reports on Form 8-K42Signatures43Certifications PART I. FINANCIAL INFORMATION NanoViricides,Inc.Condensed Statements of Operations(Unaudited) NanoViricides,Inc.Condensed Statements of Cash Flows(Unaudited) NANOVIRICIDES,INC.December 31, 2024NOTESTO THE CONDENSED FINANCIAL STATEMENTS(Unaudited) Note1– Organization and Nature of Business NanoViricides, Inc. (the “Company”) is a clinical stage nano-biopharmaceutical company specializing in thediscovery, development, and commercialization of drugs to combat viral infections using its unique and novelnanomedicines technology. NanoViricides possesses its own facility that supports research and development anddrug discovery, drug candidate optimization, cGMP-compliant drug substance manufacturing, cGMP-compliantmanufacturing and packaging of drug products for human clinical trials, and early commercialization. TheCompany has several drugs in various stages of development. NanoViricides, Inc. is domiciled under the laws of the State of Delaware, with its principal operations located inthe State of Connecticut. The Company’s fiscal year begins on July 1stand ends on the next June 30thof thecalendar year. The Company operates inonereportable business segment. The Company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has demonstrated strongactivity in lethal lung infection animal model trials for the treatment of Coronaviruses, RSV, Influenza viruses(including H5N1 Bird Flu) as well as Smallpox and MPox. The Company has initiated work to begin Phase II clinical trials to evaluate safety and effectiveness of NV-387treatment in MPox patients. To this effect, the Company has engaged a CRO to help with conducting the MPoxclinical trial of NV-387 in countries in the central African region. Trial sites have also been identified already. TheCompany is preparing a clinical trial application for the Phase II clinical trial for submission to the appropriateregulatory agency. MPox caused by Clade 1 and 1b variants is currently a pandem