UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended December 31, 2020 Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) of incorporation or organization) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive ...

PART I FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of $2.31 million for the three months ended September 30, 2020, an increase from the $1.56 million loss in the same period of 2019. Total assets grew to $31.85 million from $23.91 million at June 30, 2020, primarily due to a significant increase in cash and cash equivalents to $21.79 million, bolstered by a $10.4 million net proceed from an equity offering. The company remains in the development stage with no revenue [Balance Sheets](index=3&type=section&id=Balance%20Sheets) Balance Sheet Summary (Unaudited) | Account | September 30, 2020 | June 30, 2020 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $21,791,822 | $13,708,594 | | Total current assets | $22,024,628 | $13,985,657 | | **Total Assets** | **$31,848,180** | **$23,914,339** | | **Current Liabilities** | | | | Mortgage note payable – related party | $1,091,812 | $1,081,987 | | Total current liabilities | $1,865,901 | $2,156,377 | | **Total Stockholders' Equity** | **$29,982,279** | **$21,757,962** | - Total assets increased by approximately **$7.9 million** from June 30, 2020, to September 30, 2020, primarily driven by an increase in cash and cash equivalents resulting from financing activities[9](index=9&type=chunk) [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Statements of Operations Summary (Unaudited) | Account | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Research and development | $1,573,071 | $1,482,405 | | General and administrative | $697,312 | $505,472 | | **Total operating expenses** | **$2,270,383** | **$1,987,877** | | **Loss from operations** | **($2,270,383)** | **($1,987,877)** | | **Net Loss** | **($2,311,233)** | **($1,561,133)** | | Net loss per common share | ($0.22) | ($0.41) | - The net loss for the quarter increased year-over-year, driven by higher operating expenses in both R&D and G&A, and the absence of a gain from the change in fair value of derivative liability that was present in the prior year's quarter[11](index=11&type=chunk) [Statements of Changes in Stockholders' Equity](index=5&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity) - Stockholders' equity increased from **$21.76 million** at June 30, 2020, to **$29.98 million** at September 30, 2020. This was primarily due to net proceeds of approximately **$10.44 million** from the issuance of common stock, offset by a net loss of **$2.31 million** for the quarter[13](index=13&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Cash Flow Summary (Unaudited) | Activity | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,235,945) | ($1,434,010) | | Net cash used in investing activities | ($34,985) | ($4,139) | | Net cash provided by (used in) financing activities | $10,354,158 | ($242,105) | | **Net change in cash** | **$8,083,228** | **($1,680,254)** | | **Cash at end of period** | **$21,791,822** | **$874,953** | - The company's cash position significantly improved due to **$10.35 million** in net cash from financing activities, primarily from an issuance of common stock and warrants, which more than offset the **$2.24 million** cash used in operations[17](index=17&type=chunk) [Notes to the Financial Statements](index=8&type=section&id=Notes%20to%20the%20Financial%20Statements) - The company is a development-stage biopharmaceutical firm with no revenue and an accumulated deficit of approximately **$107.9 million** as of September 30, 2020. Management believes existing cash of **$21.8 million** is sufficient to fund operations through November 2021[23](index=23&type=chunk)[30](index=30&type=chunk) - In July 2020, the company raised approximately **$10.4 million** in net proceeds from an underwritten public offering of common stock. It also entered into an At-The-Market (ATM) offering agreement to sell up to **$50 million** in common stock[25](index=25&type=chunk)[26](index=26&type=chunk) - The company has exclusive, worldwide licenses from TheraCour Pharma, Inc. for its nanomedicine technology to combat various viral diseases, including a recent MOU for human coronavirus infections. Milestone payments and royalties are due to TheraCour upon commercialization and development progress[22](index=22&type=chunk)[64](index=64&type=chunk) [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 its position as a development-stage company with no revenue, focusing on its antiviral drug pipeline. Key developments include nominating a clinical candidate for COVID-19 and advancing it towards an IND filing, with safety pharmacology studies underway. The lead HerpeCide™ program candidate, NV-HHV-101 for shingles, has completed pre-clinical studies. The company's financial condition was strengthened by an **$11.5 million** gross proceeds offering in July 2020, providing sufficient cash for over two years of operations at the current burn rate. R&D and G&A expenses increased year-over-year, leading to a higher net loss for the quarter [Business Overview and Drug Programs](index=19&type=section&id=Business%20Overview%20and%20Drug%20Programs) - The company is a development-stage biopharma firm with no products or revenue, focusing on pre-clinical drug candidates for various viral infections including influenza, HIV, herpes viruses, and dengue[71](index=71&type=chunk)[72](index=72&type=chunk) - The core technology is a 'bind-encapsulate-destroy' platform that creates biomimetic nanoviricides designed to attack viruses at multiple points, making it difficult for viruses to develop resistance through mutation[77](index=77&type=chunk)[78](index=78&type=chunk) - The company possesses its own cGMP-compliant manufacturing facility, enabling rapid production of drug candidates for clinical trials, which is a significant strategic advantage[75](index=75&type=chunk)[91](index=91&type=chunk) [COVID-19 Program Developments](index=21&type=section&id=COVID-19%20Program%20Developments) - A clinical drug candidate for COVID-19 was nominated on September 15, 2020, and is moving rapidly towards an IND filing to enable human clinical trials[83](index=83&type=chunk)[86](index=86&type=chunk) - The drug candidates have shown broad-spectrum anti-coronavirus activity in cell culture and strong effectiveness in animal models against h-CoV-NL63, a coronavirus that uses the same ACE2 receptor as SARS-CoV-2[83](index=83&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - The company is developing a potential cure by encapsulating remdesivir within its nanoviricide, aiming to simultaneously block viral reinfection and intracellular replication while protecting remdesivir from rapid metabolism[124](index=124&type=chunk)[125](index=125&type=chunk) [HerpeCide™ Program (NV-HHV-101 for Shingles)](index=26&type=section&id=HerpeCide%E2%84%A2%20Program%20(NV-HHV-101%20for%20Shingles)) - The lead candidate, NV-HHV-101, is a skin cream for shingles rash that has completed IND-enabling pre-clinical studies and has shown strong effectiveness in human skin models, being up to **five times** more effective than acyclovir in cell culture studies[73](index=73&type=chunk)[128](index=128&type=chunk) - The company manufactured the API and the formulated drug product at its own facility at a **~1kg** scale, saving significant time and money compared to using a contract manufacturer[135](index=135&type=chunk) - The market for an effective shingles therapy is estimated to be several **billion dollars**, particularly if it can reduce the incidence of post-herpetic-neuralgia (PHN)[129](index=129&type=chunk)[134](index=134&type=chunk) [Results of Operations Analysis](index=40&type=section&id=Results%20of%20Operations%20Analysis) Comparison of Operating Expenses | Expense Category | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Research and Development | $1,573,071 | $1,482,405 | | General and Administration | $697,312 | $505,472 | - R&D expenses increased by **$90,666** due to higher costs for laboratory supplies, materials, and maintenance[248](index=248&type=chunk) - G&A expenses increased by **$191,840** primarily due to a rise in professional fees and general operating costs[249](index=249&type=chunk) - The net loss increased to **$2.31 million** from **$1.56 million** in the prior-year period, mainly due to higher operating expenses and a **$421,527** decrease in income from the change in fair value of derivative liabilities[254](index=254&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2020, the company had cash and cash equivalents of **$21.79 million**[255](index=255&type=chunk) - Management believes existing resources are sufficient to fund planned operations for at least the next twelve months, including initial human clinical trials for its SARS-CoV-2 drug candidate[239](index=239&type=chunk)[255](index=255&type=chunk) - The company will need to raise additional capital to fund long-term operations and further clinical trials for its drug pipeline[239](index=239&type=chunk)[257](index=257&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its primary market risk is non-material interest rate risk associated with its short-term cash equivalent investments. It has no foreign operations, is not exposed to foreign currency fluctuations, and does not use derivative financial instruments for speculative purposes - The company's primary market risk exposure is interest rate risk on its cash equivalents, which is considered non-material[262](index=262&type=chunk) - The company has no foreign operations and therefore no exposure to foreign currency exchange rate fluctuations[262](index=262&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were not effective as of September 30, 2020. This was due to a previously disclosed material weakness in internal control over financial reporting, which remains unremediated. A remediation plan is in place, involving a financial reporting controls committee to provide oversight and address the weakness - Management concluded that disclosure controls and procedures were not effective as of September 30, 2020[264](index=264&type=chunk) - The ineffectiveness is due to a material weakness in internal control over financial reporting identified in the Form 10-K for the fiscal year ended June 30, 2020, which has not yet been remediated[264](index=264&type=chunk) - A remediation plan has been established, including a financial reporting controls committee with members from senior management and the Audit Committee to provide oversight[266](index=266&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that there are no pending legal proceedings against it, and to its knowledge, no action, suit, or proceeding has been threatened - There are no pending or threatened legal proceedings against the Company as of the reporting date[270](index=270&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued unregistered securities for services and compensation. This included **387** shares of Series A preferred stock for employee compensation, warrants to purchase **572** shares of common stock for the Scientific Advisory Board, **5,135** shares of common stock for consulting services, and **2,040** shares of common stock for Director services. The company relied on the exemption from registration under Section 4(a)(2) of the Securities Act - Issued **387** shares of Series A preferred stock for employee compensation[271](index=271&type=chunk) - Granted warrants to purchase **572** shares of common stock to the Scientific Advisory Board[273](index=273&type=chunk) - Issued **5,135** shares of common stock for consulting services and **2,040** shares for Director services[273](index=273&type=chunk)[274](index=274&type=chunk) [Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - None[277](index=277&type=chunk) [Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[278](index=278&type=chunk) [Other Information](index=46&type=section&id=Item%205.%20Other%20Information) None - None[279](index=279&type=chunk) [Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the report, including CEO and CFO certifications (Rule 13(a)-14(a)/15(d)-14(a) and Section 1350) and XBRL data files - Lists required certifications from the CEO and CFO, as well as XBRL instance and taxonomy documents[280](index=280&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED JUNE 30, 2020 NANOVIRICIDES, INC. (Name of Business Issuer in Its Charter) (State or other jurisdiction of incorporation or organization) NEVADA 76-0674577 (I.R.S. Employer Identification No.) 1 CONTROLS DRIVE, SHELTON, CONNECTICUT, 06484 (Address of principal executive offices) 203-937-6137 (Issuer's telephone numb ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended March 31, 2020 Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) of incorporation or organization) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive off ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended December 31, 2019 Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) of incorporation or organization) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended September 30, 2019 Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) of incorporation or organization) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive ...

| --- | --- | --- | |---------------|------------------------------------------------------------------------------------------|-------------------| | | "Bind-Encapsulate-Destroy" | | | | | | | | | NNVC (NYSE Amer.) | | | | | | | NanoViricides' Highly Effective and Safe | | | | Topical Drug Candidate Against Shingles (VZV) Preparing for Regulatory Trials; | | | | An Array of Indications in Herpecide™ Program Alone | | | | | | | | | | | | Corporate Presentation | | | | September 9, 2019 | | | Presented by: | ...

PART I [Business Overview](index=4&type=section&id=ITEM%201%3A%20BUSINESS) NanoViricides, Inc. is a development-stage nanobiopharmaceutical company focused on antiviral drug development, primarily advancing NV-HHV-101 for shingles into pre-IND safety/toxicology studies. - Company is a development-stage company with no customers, products, or revenue, and may not achieve revenue or profitability in the future[20](index=20&type=chunk) - Company primarily focuses on advancing **NV-HHV-101**, a topical shingles treatment, into human clinical trials, considered its most advanced candidate[21](index=21&type=chunk)[53](index=53&type=chunk) - Company possesses unique Nanoviricide® platform technology designed to directly attack enveloped virus particles via a "bind-encapsulate-destroy" strategy, also disrupting intracellular viral replication for broad-spectrum antiviral effects[23](index=23&type=chunk)[28](index=28&type=chunk)[32](index=32&type=chunk) - Company has secured multiple exclusive licenses from TheraCour Pharma, Inc. for HIV, influenza, HSV-1/2, hepatitis, rabies, dengue, Ebola/Marburg, and is negotiating a license for VZV (shingles, chickenpox virus)[24](index=24&type=chunk)[608](index=608&type=chunk) - Company owns a BSL-2 certified virology lab and cGMP manufacturing facility, enabling in-house cell culture screening and kilogram-scale drug production, accelerating development and reducing costs[46](index=46&type=chunk)[51](index=51&type=chunk)[155](index=155&type=chunk) - In FY2019, the company focused on the HerpeCide™ program, achieving milestones including announcing clinical candidate NV-HHV-101, developing kilogram-scale manufacturing, completing non-GLP safety/toxicology studies, submitting a pre-IND application, and receiving positive FDA feedback[53](index=53&type=chunk)[63](index=63&type=chunk) - The market size for shingles treatment is estimated at over **$1 billion**, while the total market for the HerpeCide™ program is estimated to exceed **$5 billion**, with the overall market for the company's potential drugs estimated between **$40 billion** and **$65 billion**[21](index=21&type=chunk)[137](index=137&type=chunk)[216](index=216&type=chunk) [Organization and Nature of Business](index=4&type=section&id=Organization%20and%20Nature%20of%20Business) This section details the company's corporate structure and its core business activities as a nanobiopharmaceutical developer. [The Nanoviricide® Platform Technology](index=5&type=section&id=The%20Nanoviricide%C2%AE%20Platform%20Technology) This section describes the proprietary Nanoviricide® platform technology, its mechanism of action, and broad antiviral potential. [cGMP Manufacturing Facility](index=9&type=section&id=cGMP%20Manufacturing%20Facility) This section outlines the company's in-house cGMP manufacturing capabilities and their role in drug development. [State of the Company – Drug Development Programs – Focus on HerpeCide™ Program](index=9&type=section&id=State%20of%20the%20Company%20%E2%80%93%20Drug%20Development%20Programs%20%E2%80%93%20Focus%20on%20HerpeCide%E2%84%A2%20Program) This section provides an overview of the company's current drug development status, with a primary focus on the HerpeCide™ program. [HerpeCide Program Collaborations and Program Update](index=14&type=section&id=HerpeCide%20Program%20Collaborations%20and%20Program%20Update) This section details collaborations and recent updates regarding the HerpeCide™ drug development program. [Shingles and Associated Pain, Postherpetic Neuralgia (PHN)](index=15&type=section&id=Shingles%20and%20Associated%20Pain%2C%20Postherpetic%20Neuralgia%20%28PHN%29) This section discusses the medical conditions of shingles and postherpetic neuralgia, highlighting the market need for effective treatments. [HSV-1, HSV-2, Ocular Herpes Keratitis](index=16&type=section&id=HSV-1%2C%20HSV-2%2C%20Ocular%20Herpes%20Keratitis) This section covers the company's focus on developing treatments for HSV-1, HSV-2, and ocular herpes keratitis. [Viral Acute Retinal Necrosis (v-ARN)](index=16&type=section&id=Viral%20Acute%20Retinal%20Necrosis%20%28v-ARN%29) This section addresses the company's efforts in developing therapies for viral acute retinal necrosis. [cGMP Manufacture](index=17&type=section&id=cGMP%20Manufacture) This section describes the company's capabilities and processes for cGMP manufacturing. [The FluCide™ Program](index=17&type=section&id=The%20FluCide%E2%84%A2%20Program) This section outlines the development efforts and status of the FluCide™ program for influenza. [DengueCide™](index=17&type=section&id=DengueCide%E2%84%A2) This section details the company's DengueCide™ program aimed at combating dengue virus. [HIVCide™](index=17&type=section&id=HIVCide%E2%84%A2) This section provides information on the HIVCide™ program for HIV treatment. [EKC](index=17&type=section&id=EKC) This section discusses the company's program targeting Epidemic Keratoconjunctivitis (EKC). [Other Drug Programs: Ebola, Rabies and others](index=18&type=section&id=Other%20Drug%20Programs%3A%20Ebola%2C%20Rabies%20and%20others) This section briefly mentions other drug development programs, including those for Ebola and Rabies. [Safety and Toxicology Studies](index=18&type=section&id=Safety%20and%20Toxicology%20Studies) This section describes the safety and toxicology studies conducted for the company's drug candidates. [Clinical and Regulatory Strategy](index=18&type=section&id=Clinical%20and%20Regulatory%20Strategy) This section outlines the company's approach to clinical trials and regulatory approvals for its drug pipeline. [Large Market Sizes – The Company Targets an Overall Anti-Viral Drug Market Size that Exceeds $40B](index=19&type=section&id=Large%20Market%20Sizes%20%E2%80%93%20The%20Company%20Targets%20an%20Overall%20Anti-Viral%20Drug%20Market%20Size%20that%20Exceeds%20%2440B) This section highlights the significant market potential for the company's antiviral drug candidates, exceeding **$40 billion**. [Our Campus in Shelton, CT](index=20&type=section&id=Our%20Campus%20in%20Shelton%2C%20CT) This section describes the company's facilities located in Shelton, Connecticut. [Process Scale-Up Production Capability](index=20&type=section&id=Process%20Scale-Up%20Production%20Capability) This section details the company's capabilities for scaling up drug production processes. [cGMP Production Capability](index=20&type=section&id=cGMP%20Production%20Capability) This section outlines the company's capacity for cGMP-compliant drug production. [Resource Considerations](index=20&type=section&id=Resource%20Considerations) This section discusses the resources required for the company's operations and drug development. [Our BSL-2 Certified Virology Lab](index=21&type=section&id=Our%20BSL-2%20Certified%20Virology%20Lab) This section describes the company's BSL-2 certified virology laboratory and its functions. [Manufacturing Requirements of Some of Our Drug Candidates](index=21&type=section&id=Manufacturing%20Requirements%20of%20Some%20of%20Our%20Drug%20Candidates) This section details the specific manufacturing requirements for certain drug candidates in the company's pipeline. [Patents, Trademarks, Proprietary Rights: Intellectual Property](index=22&type=section&id=Patents%2C%20Trademarks%2C%20Proprietary%20Rights%3A%20Intellectual%20Property) This section covers the company's intellectual property portfolio, including patents, trademarks, and proprietary rights. [Trademarks](index=26&type=section&id=Trademarks) This section specifically lists and describes the company's trademarks. [Presentations and Conferences](index=26&type=section&id=Presentations%20and%20Conferences) This section provides information on the company's participation in presentations and conferences. [Glossary of Terms](index=27&type=section&id=Glossary%20of%20Terms) This section offers a glossary of key terms used throughout the report. [The Company's Drug Pipeline](index=28&type=section&id=The%20Company%27s%20Drug%20Pipeline) This section presents an overview of the company's current drug development pipeline. [Drug Development Plan](index=32&type=section&id=Drug%20Development%20Plan) This section outlines the strategic plan for the company's drug development initiatives. [Manufacturing](index=32&type=section&id=Manufacturing) This section details the company's manufacturing processes and capabilities. [Competition](index=33&type=section&id=Competition) This section analyzes the competitive landscape within the biotechnology and biopharmaceutical industries. [Government Regulation](index=34&type=section&id=Government%20Regulation) This section discusses the impact of government regulations on the company's drug development and commercialization efforts. [A Note on US FDA Priority Review Vouchers](index=38&type=section&id=A%20Note%20on%20US%20FDA%20Priority%20Review%20Vouchers) This section provides information regarding the potential benefits of US FDA Priority Review Vouchers. [Time Schedules, Milestones and Development Costs](index=39&type=section&id=Time%20Schedules%2C%20Milestones%20and%20Development%20Costs) This section outlines the projected timelines, key milestones, and associated development costs for the company's programs. [Our Collaborations and Service Contract Agreements](index=41&type=section&id=Our%20Collaborations%20and%20Service%20Contract%20Agreements) This section details the company's collaborations and service contract agreements with external parties. [Significant Alliances and Related Parties](index=45&type=section&id=Significant%20Alliances%20and%20Related%20Parties) This section identifies significant alliances and related party relationships impacting the company. [Employees](index=46&type=section&id=Employees) This section provides information regarding the company's employee base. [Reports to Security Holders](index=46&type=section&id=Reports%20to%20Security%20Holders) This section describes the company's reporting practices to its security holders. [Website](index=46&type=section&id=Website) This section provides information about the company's official website. [Our Contact Information](index=46&type=section&id=Our%20Contact%20Information) This section lists the company's contact details. [Description of Property](index=46&type=section&id=Description%20of%20Property) This section describes the company's owned or leased properties. [Risk Factors](index=47&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces multiple risks, including its development-stage status, funding needs, clinical trial uncertainties, reliance on licensed technology, and competitive pressures. - Company is a development-stage entity with no approved commercial products, has never generated revenue, and may not achieve profitability in the future[322](index=322&type=chunk) - Company has incurred substantial operating losses, with an accumulated deficit of **$92,116,586** as of June 30, 2019, and expects to continue incurring losses[325](index=325&type=chunk) - Company needs to raise substantial additional capital to fund operations, with no assurance of obtaining financing on acceptable terms when needed[326](index=326&type=chunk) - Company has limited drug development experience, has not conducted any clinical trials, and must outsource all clinical trials to third parties, increasing risks of delays or failures[329](index=329&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) - Company has not yet licensed the shingles drug (its primary candidate) from TheraCour, and despite a signed MOU, there is no guarantee of a definitive agreement on favorable terms[349](index=349&type=chunk) - Company relies on TheraCour's licensed patents to protect its technology, but patent protection may be inadequate, and some licensed patents expire between **2020** and **2028**[365](index=365&type=chunk)[375](index=375&type=chunk) - The biotechnology and biopharmaceutical industries are characterized by rapid technological change and intense competition, and the company may not be able to compete with better-resourced competitors[409](index=409&type=chunk)[413](index=413&type=chunk) - The company's stock price may be highly volatile and could be considered a "penny stock," potentially limiting investor trading ability and increasing transaction costs[422](index=422&type=chunk)[424](index=424&type=chunk) [Unresolved Staff Comments](index=69&type=section&id=ITEM%201B%3A%20UNRESOLVED%20STAFF%20COMMENTS.) There are no unresolved staff comments in this report. - There are no unresolved staff comments in this report[437](index=437&type=chunk) [Properties](index=69&type=section&id=ITEM%202%3A%20PROPERTIES) The company's main administrative office in Shelton, CT, includes 18,000 square feet of wholly-owned office, lab, and cGMP manufacturing space. - Company's main administrative office is located at 1 Controls Drive, Shelton, CT, comprising approximately **18,000 square feet** of office, laboratory, and cGMP-compliant drug manufacturing space[316](index=316&type=chunk)[438](index=438&type=chunk) - These facilities are wholly owned by the company, with no mortgages[316](index=316&type=chunk)[438](index=438&type=chunk) - Company subcontracts laboratory research and development to TheraCour Pharma, Inc., and believes its existing space is sufficient to monitor subcontractor development progress[317](index=317&type=chunk)[439](index=439&type=chunk) [Legal Proceedings](index=69&type=section&id=ITEM%203%3A%20LEGAL%20PROCEEDINGS.) The company is not currently involved in any legal proceedings that could materially impact its financial condition or operating results. - The company is not currently involved in any legal proceedings that could have a material adverse effect on its financial condition or operating results[319](index=319&type=chunk)[440](index=440&type=chunk)[743](index=743&type=chunk) [Mine Safety Disclosures](index=70&type=section&id=ITEM%204%3A%20MINE%20SAFETY%20DISCLOSURES.) This item is not applicable. - This item is not applicable[441](index=441&type=chunk) PART II [Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=70&type=section&id=ITEM%205%3A%20MARKET%20FOR%20THE%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES.) The company's common stock trades on NYSE American, and it has not paid cash dividends, instead reinvesting earnings into business development. - Company's common stock has traded on NYSE MKT (now NYSE American) under the ticker symbol **“NNVC”** since **September 25, 2013**[443](index=443&type=chunk) Common Stock High and Low Prices (USD/share) | Quarter End | Low Price | High Price | | :--- | :--- | :--- | | June 30, 2019 | 0.22 | 0.31 | | March 31, 2019 | 0.20 | 0.68 | | December 31, 2018 | 0.20 | 0.40 | | September 30, 2018 | 0.25 | 0.50 | | June 30, 2018 | 0.36 | 0.86 | | March 31, 2018 | 0.80 | 1.08 | | December 31, 2017 | 0.87 | 1.23 | | September 30, 2017 | 0.94 | 1.64 | - As of June 30, 2019, the company had **76,898,295** shares of common stock issued and **154** record holders, with approximately **7,963,000** unexercised warrants[445](index=445&type=chunk) - Company has not paid any cash dividends since inception and plans to reinvest future earnings into business[446](index=446&type=chunk) - In fiscal year 2019, the company raised **$2,500,000** by issuing **6,944,446** shares of common stock at **$0.36 per share** through a registered direct offering, with a concurrent private placement of **6,944,446** warrants[476](index=476&type=chunk)[478](index=478&type=chunk) - Net proceeds from this offering were primarily used for research and development and working capital[485](index=485&type=chunk) [Selected Financial Data](index=75&type=section&id=ITEM%206%3A%20SELECTED%20FINANCIAL%20DATA) The company provides a five-year summary of financial data, reflecting continuous operating losses and increasing accumulated deficits as a development-stage entity. Summary of Operating Data (as of June 30) | Metric | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | Research and Development Expenses | $5,921,720 | $5,913,720 | $6,565,966 | $5,028,970 | $3,660,322 | | General and Administrative Expenses | $2,737,962 | $3,411,449 | $3,034,758 | $3,830,531 | $3,402,778 | | Total Operating Expenses | $8,659,682 | $9,325,169 | $9,600,724 | $8,859,501 | $7,063,100 | | Operating Loss | $(8,659,682) | $(9,325,169) | $(9,600,724) | $(8,859,501) | $(7,063,100) | | Net Loss | $(8,424,440) | $(8,563,455) | $(10,304,490) | $(10,724,629) | $(2,198,172) | | Net Loss Per Share (Basic) | $(0.12) | $(0.13) | $(0.17) | $(0.19) | $(0.04) | Summary of Balance Sheet Data (as of June 30) | Metric | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $2,555,207 | $7,081,771 | $15,099,461 | $24,162,185 | $31,467,748 | | Working Capital | $(22,732) | $6,440,080 | $10,624,109 | $17,637,629 | $31,081,278 | | Total Assets | $13,448,513 | $18,546,212 | $27,002,814 | $36,633,418 | $44,187,089 | | Long-Term Liabilities | $0 | $0 | $2,015,354 | $6,841,190 | $11,800,327 | | Accumulated Deficit | $(92,116,586) | $(83,692,146) | $(75,128,691) | $(64,824,201) | $(54,099,572) | | Stockholders' Equity | $10,600,360 | $17,664,264 | $20,321,942 | $23,048,214 | $31,785,867 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=76&type=section&id=ITEM%207%3A%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's financial challenges as a development-stage entity, including ongoing losses and the need for additional financing, while prioritizing the HerpeCide™ program. - Company has been engaged in R&D activities since inception, focusing on developing targeted antiviral drugs, has not commenced any product commercialization, and has not generated revenue[502](index=502&type=chunk)[609](index=609&type=chunk) - As of June 30, 2019, the company's cash and cash equivalents were **$2,555,207**, which is insufficient to support current budgeted operations for one year, raising substantial doubt about its ability to continue as a going concern[506](index=506&type=chunk)[609](index=609&type=chunk) - Company has focused all efforts on the HerpeCide™ program, specifically advancing its first clinical candidate, **NV-HHV-101**, into human clinical trials, in response to limited financial resources[215](index=215&type=chunk)[525](index=525&type=chunk) R&D Expense Allocation (as of June 30) | Program | 2019 | 2018 | 2017 | | :--- | :--- | :--- | :--- | | HerpeCide™ Program | $5,601,720 | $5,723,720 | $4,976,266 | | FluCide™ | $150,000 | $150,000 | $150,000 | | HIV-Cide™ | $20,000 | $20,000 | $100,000 | | EKC-Cide™, Other Ocular Viral Infections | $0 | $0 | $540,000 | | Dengue | $0 | $0 | $50,000 | | Other (Ebola, etc.) | $0 | $0 | $50,000 | | Unallocated Stock-Based Compensation | $150,000 | $200,000 | $789,700 | | **Total** | **$5,921,720** | **$5,913,720** | **$6,565,966** | - Company anticipates a total cash expenditure budget of approximately **$7 million** for the next **12 months**, with approximately **$5 million** allocated to R&D and **$2 million** to general and administrative expenses[538](index=538&type=chunk) - Company anticipates additional expenses of approximately **$21 million** for human clinical development of the shingles skin cream over the two years starting September 1, 2020[539](index=539&type=chunk) [Management's Plan of Operation](index=77&type=section&id=Management%27s%20Plan%20of%20Operation) This section outlines management's strategic operational plans for the company's drug development and business activities. [Current Financial Status](index=78&type=section&id=Current%20Financial%20Status) This section provides an overview of the company's present financial condition, including cash position and liabilities. [Results of Operations](index=78&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, focusing on revenue, expenses, and net loss. [Liquidity and Capital Reserves](index=81&type=section&id=Liquidity%20and%20Capital%20Reserves) This section discusses the company's cash position, ability to meet short-term obligations, and capital-raising efforts. [Research and Development Costs](index=82&type=section&id=Research%20and%20Development%20Costs) This section details the expenses incurred for the company's research and development activities. [Anticipated Budgets and Expenditures in the Near Future](index=83&type=section&id=Anticipated%20Budgets%20and%20Expenditures%20in%20the%20Near%20Future) This section outlines the company's projected budgets and expected expenditures for upcoming periods. [Off-Balance Sheet Arrangements](index=85&type=section&id=Of%20Balance%20Sheet%20Arrangements) This section discloses any off-balance sheet arrangements that could impact the company's financial position. [Critical Accounting Policies and Estimates](index=85&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) This section describes the key accounting policies and estimates that are crucial to the company's financial reporting. [Recent Accounting Pronouncements](index=86&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) This section discusses recent accounting standards and their potential impact on the company's financial statements. [Quantitative and Qualitative Disclosures About Market Risk](index=86&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company currently does not face market risks related to foreign currency interest rates. - Company does not face market risks related to foreign currency interest rates[560](index=560&type=chunk) [Financial Statements and Supplementary Data](index=86&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) The financial statements and supplementary data required for this report are provided after the signature page. - The financial statements and supplementary data required for this report are provided after the signature page[561](index=561&type=chunk) [Changes In and Disagreements With Accountants on Accounting and Financial Disclosure](index=86&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) There have been no changes or disagreements with accountants regarding accounting and financial disclosures. - There have been no changes or disagreements with accountants regarding accounting and financial disclosures[562](index=562&type=chunk) [Controls and Procedures](index=87&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES.) Management assessed disclosure controls and internal financial reporting controls as ineffective due to review deficiencies and resource limitations, with remediation plans underway. - As of June 30, 2019, company management assessed its disclosure controls and procedures and internal control over financial reporting as ineffective[565](index=565&type=chunk)[566](index=566&type=chunk) - Key deficiencies include a lack of timely and effective review of 10-K reports, third-party valuation reports, and income taxes, along with insufficient personnel and resources[567](index=567&type=chunk) - Company has developed remediation plans, including strengthening financial transaction reviews, engaging external experts for income tax preparation assistance, and forming a financial reporting control committee to oversee internal control improvements[568](index=568&type=chunk)[569](index=569&type=chunk)[570](index=570&type=chunk) [Other Information](index=88&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) There is no other information in this report. - There is no other information in this report[573](index=573&type=chunk) PART III [Directors, Executive Officers, Promoters and Corporate Governance](index=88&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%2C%20PROMOTERS%20AND%20CORPORATE%20GOVERNANCE) Information for this item will be disclosed by reference to the 2019 Annual Meeting proxy statement or Form 10-K/A, with the company having adopted a formal code of conduct. - Information required for this item will be disclosed by reference to the company's 2019 Annual Meeting of Stockholders' definitive proxy statement or in an amendment to Form 10-K/A[574](index=574&type=chunk) - Company has adopted a formal code of business conduct and ethics applicable to all board members, officers, and employees[575](index=575&type=chunk) [Executive Compensation](index=88&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information for this item will be disclosed by reference to the 2019 Annual Meeting proxy statement or Form 10-K/A. - Information required for this item will be disclosed by reference to the company's 2019 Annual Meeting of Stockholders' definitive proxy statement or in an amendment to Form 10-K/A[576](index=576&type=chunk) [Security Ownership of Certain Beneficial Owners, Management, and Related Stockholders Matters](index=88&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%2C%20MANAGEMENT%2C%20AND%20RELATED%20STOCKHOLDERS%20MATTERS.) Information for this item will be disclosed by reference to the 2019 Annual Meeting proxy statement or Form 10-K/A. - Information required for this item will be disclosed by reference to the company's 2019 Annual Meeting of Stockholders' definitive proxy statement or in an amendment to Form 10-K/A[577](index=577&type=chunk) [Certain Relationships and Related Transactions and Director Independence](index=89&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%20AND%20DIRECTOR%20INDEPENDENCE) Information for this item will be disclosed by reference to the 2019 Annual Meeting proxy statement or Form 10-K/A. - Information required for this item will be disclosed by reference to the company's 2019 Annual Meeting of Stockholders' definitive proxy statement or in an amendment to Form 10-K/A[578](index=578&type=chunk) [Principal Accountant Fees and Services](index=89&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Information for this item will be disclosed by reference to the 2019 Annual Meeting proxy statement or Form 10-K/A. - Information required for this item will be disclosed by reference to the company's 2019 Annual Meeting of Stockholders' definitive proxy statement or in an amendment to Form 10-K/A[579](index=579&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=89&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all exhibits and financial statement schedules included in the company's Form 10-K report, such as corporate documents, agreements, and XBRL files. - This section lists all exhibits and financial statement schedules included in the company's Form 10-K report, including articles of incorporation, warrants, license agreements, employment agreements, securities purchase agreements, and XBRL files[580](index=580&type=chunk)[582](index=582&type=chunk) [Form 10-K Summary](index=90&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) There is no Form 10-K summary in this report. - There is no Form 10-K summary in this report[581](index=581&type=chunk) [Signatures](index=91&type=section&id=SIGNATURES) This report has been signed by authorized representatives of NanoViricides, Inc., including Dr. Anil R. Diwan and Meeta Vyas. - This report has been signed by authorized representatives of NanoViricides, Inc., including President and Executive Chairman Dr. Anil R. Diwan and Chief Financial Officer Meeta Vyas[584](index=584&type=chunk)[585](index=585&type=chunk) [Index to the Financial Statements](index=92&type=section&id=Index%20to%20the%20Financial%20Statements) [Report of Independent Registered Public Accounting Firm](index=93&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) EISNERAMPER LLP audited the financial statements, affirming fair presentation under U.S. GAAP, while noting substantial doubt about the company's going concern ability due to continuous losses. - EISNERAMPER LLP issued an audit opinion on the company's financial statements, deeming them fairly presented in all material respects in accordance with U.S. GAAP[590](index=590&type=chunk) - The company's continuous operating losses and negative operating cash flows raise substantial doubt about its ability to continue as a going concern[591](index=591&type=chunk) [Balance Sheets](index=94&type=section&id=Balance%20Sheets) As of June 30, 2019, the company reported **$2.55 million** in cash, **$13.45 million** in total assets, **$2.85 million** in total liabilities, and **$10.60 million** in stockholders' equity, showing decreases in cash and equity from 2018. Summary of Balance Sheets | Metric | June 30, 2019 | June 30, 2018 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $2,555,207 | $7,081,771 | | Prepaid Expenses | $270,214 | $240,257 | | Property and Equipment, Net | $10,227,247 | $10,841,093 | | Trademarks and Patents, Net | $366,658 | $374,929 | | Other Assets | $29,187 | $8,162 | | **Total Assets** | **$13,448,513** | **$18,546,212** | | Accounts Payable | $309,893 | $223,339 | | Amounts Due to Related Parties | $823,783 | $107,468 | | Derivative Liabilities – Warrants | $1,645,606 | $298,092 | | Accrued Expenses | $68,871 | $253,049 | | **Total Liabilities** | **$2,848,153** | **$881,948** | | Accumulated Deficit | $(92,116,586) | $(83,692,146) | | **Total Stockholders' Equity** | **$10,600,360** | **$17,664,264** | [Statements of Operations](index=95&type=section&id=Statements%20of%20Operations) The company reported no revenue and continuous net losses in fiscal years 2019, 2018, and 2017, with R&D and G&A as primary expenses. Summary of Statements of Operations | Metric | Year Ended June 30, 2019 | Year Ended June 30, 2018 | Year Ended June 30, 2017 | | :--- | :--- | :--- | :--- | | Research and Development Expenses | $5,921,720 | $5,913,720 | $6,565,966 | | General and Administrative Expenses | $2,737,962 | $3,411,449 | $3,034,758 | | Total Operating Expenses | $8,659,682 | $9,325,169 | $9,600,724 | | Operating Loss | $(8,659,682) | $(9,325,169) | $(9,600,724) | | Interest Income | $55,497 | $100,429 | $60,955 | | Convertible Debenture Interest Expense | $0 | $(185,274) | $(780,767) | | Loss on Extinguishment of Debt | $0 | $(1,348,247) | $(332,524) | | Convertible Debenture Discount | $0 | $(359,214) | $(1,347,748) | | Change in Fair Value of Derivatives | $179,745 | $2,554,020 | $1,696,318 | | Other Income (Expense), Net | $235,242 | $761,714 | $(703,766) | | Net Loss | $(8,424,440) | $(8,563,455) | $(10,304,490) | | Net Loss Per Share (Basic and Diluted) | $(0.12) | $(0.13) | $(0.17) | [Statement of Changes in Stockholders' Equity](index=96&type=section&id=Statement%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased to **$10.60 million** by June 30, 2019, primarily due to ongoing net losses, despite some equity issuances for compensation and debt. Summary of Changes in Stockholders' Equity | Metric | Balance June 30, 2016 | Balance June 30, 2017 | Balance June 30, 2018 | Balance June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Series A Preferred Stock (Shares) | 4,091,094 | 4,348,744 | 4,531,394 | 5,114,044 | | Common Stock (Shares) | 58,179,699 | 63,306,774 | 69,171,740 | 76,898,295 | | Additional Paid-in Capital | $87,810,143 | $95,382,977 | $101,282,707 | $102,634,934 | | Accumulated Deficit | $(64,824,201) | $(75,128,691) | $(83,692,146) | $(92,116,586) | | **Total Stockholders' Equity** | **$23,048,214** | **$20,321,942** | **$17,664,264** | **$10,600,360** | [Statements of Cash Flows](index=97&type=section&id=Statements%20of%20Cash%20Flows) In FY2019, the company experienced net cash outflows from operating and investing activities, partially offset by financing inflows, resulting in a reduced cash balance of **$2.55 million**. Summary of Statements of Cash Flows | Cash Flow Activity | Year Ended June 30, 2019 | Year Ended June 30, 2018 | Year Ended June 30, 2017 | | :--- | :--- | :--- | :--- | | Net Cash Outflow from Operating Activities | $(6,802,770) | $(7,775,868) | $(7,897,746) | | Net Cash Outflow from Investing Activities | $(73,794) | $(241,822) | $(164,978) | | Net Cash Inflow (Outflow) from Financing Activities | $2,350,000 | $0 | $(1,000,000) | | Ending Cash and Cash Equivalents Balance | $2,555,207 | $7,081,771 | $15,099,461 | [Notes to the Financial Statements](index=98&type=section&id=Notes%20to%20the%20Financial%20Statements) These notes provide detailed information on the company's organization, going concern, accounting policies, related party transactions, and financial items, highlighting ongoing financial challenges and the need for additional funding. - Company is a nanobiopharmaceutical R&D company focused on developing antiviral nanomedicines, possessing its own design, synthesis, analytical, and cGMP manufacturing facilities[606](index=606&type=chunk) - As of June 30, 2019, the company's accumulated deficit was approximately **$92.1 million**, net loss approximately **$8.4 million**, and net cash outflow from operating activities approximately **$6.8 million**, raising substantial doubt about its ability to continue as a going concern[609](index=609&type=chunk) - Company has secured extensive exclusive licenses from TheraCour Pharma, Inc., covering various virus types, and is negotiating a license for VZV (shingles, chickenpox virus)[608](index=608&type=chunk) R&D Costs Paid to Related Party TheraCour Pharma, Inc. | Year | Amount | | :--- | :--- | | Year Ended June 30, 2019 | $3,119,863 | | Year Ended June 30, 2018 | $3,176,977 | | Year Ended June 30, 2017 | $3,368,919 | - As of June 30, 2019, amounts payable to related party TheraCour Pharma, Inc. totaled **$823,783**, with **$300,000** deferred until after IND submission[504](index=504&type=chunk)[641](index=641&type=chunk) - Company in fiscal year 2019 raised **$2,500,000** through a registered direct offering and issued warrants, which were classified as derivative liabilities with a fair value of **$1,527,259**[703](index=703&type=chunk)[705](index=705&type=chunk)[706](index=706&type=chunk)[708](index=708&type=chunk) - As of June 30, 2019, the company recorded a full valuation allowance to offset its deferred tax assets of **$34,157,707**, as management determined these assets are unlikely to be realized[739](index=739&type=chunk) [Note 1 – Organization and Nature of Business](index=98&type=section&id=Note%201%20%E2%80%93%20Organization%20and%20Nature%20of%20Business) This note describes the company's corporate structure and its primary business as a nanobiopharmaceutical research and development entity. [Note 2 – Liquidity and Going Concern](index=98&type=section&id=Note%202%20%E2%80%93%20Liquidity%20and%20Going%20Concern) This note addresses the company's liquidity position and the significant doubt regarding its ability to continue as a going concern. [Note 3 – Summary of Significant Accounting Policies](index=99&type=section&id=Note%203%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods applied in the preparation of the financial statements. [Note 4 – Related Party Transactions](index=105&type=section&id=Note%204%20%E2%80%93%20Related%20Party%20Transactions) This note details transactions and relationships between the company and its related parties. [Note 5 – Property and Equipment](index=108&type=section&id=Note%205%20%E2%80%93%20Property%20and%20Equipment) This note provides a breakdown of the company's property and equipment, including their net book values. [Note 6 – Trademark and Patents](index=109&type=section&id=Note%206%20%E2%80%93%20Trademark%20and%20Patents) This note describes the company's intellectual property assets, specifically trademarks and patents. [Note 7 – Convertible Debentures and Derivatives](index=110&type=section&id=Note%207%20%E2%80%93%20Convertible%20Debentures%20and%20Derivatives) This note provides information on the company's convertible debentures and derivative financial instruments. [Note 8 – Accrued expenses](index=114&type=section&id=Note%208%20%E2%80%93%20Accrued%20expenses) This note details the company's accrued expenses as of the balance sheet date. [Note 9 – Equity Transactions](index=114&type=section&id=Note%209%20%E2%80%93%20Equity%20Transactions) This note describes the various equity-related transactions undertaken by the company. [Note 10 – Stock Options and Warrants](index=123&type=section&id=Note%2010%20%E2%80%93%20Stock%20Options%20and%20Warrants) This note provides information on the company's outstanding stock options and warrants. [Note 11 – Fair Value Measurement](index=124&type=section&id=Note%2011%20%E2%80%93%20Fair%20Value%20Measurement) This note explains the methodologies used for fair value measurements of financial instruments. [Note 12 – Income Tax Provision](index=127&type=section&id=Note%2012%20%E2%80%93%20Income%20Tax%20Provision) This note details the company's income tax provisions, including deferred tax assets and valuation allowances. [Note 13 – Commitments and Contingencies](index=128&type=section&id=Note%2013%20%E2%80%93%20Commitments%20and%20Contingencies) This note discloses the company's commitments and potential contingent liabilities. [Note 14 - Subsequent Events](index=130&type=section&id=Note%2014%20-%20Subsequent%20Events) This note reports significant events that occurred after the balance sheet date but before the financial statements were issued.

FORM 10-Q QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended March 31, 2019 Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) of incorporation or organization) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive off ...

PART I FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements for the period ended December 31, 2018, show a net loss of approximately $4.1 million for the six months, a decrease in cash and cash equivalents to $3.9 million, and an accumulated deficit of $87.8 million. The company has not generated any revenue and notes raise substantial doubt about its ability to continue as a going concern [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of December 31, 2018, total assets decreased to $15.0 million from $18.5 million at June 30, 2018, primarily due to a reduction in cash and cash equivalents from $7.1 million to $3.9 million. Total liabilities increased to $1.2 million from $0.9 million, driven by a significant rise in accounts payable to a related party. Consequently, total stockholders' equity declined from $17.7 million to $13.8 million Balance Sheet Summary (Unaudited) | Balance Sheet Items | Dec 31, 2018 | June 30, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,903,672 | $7,081,771 | | Total current assets | $4,072,620 | $7,322,028 | | Property and equipment, net | $10,555,494 | $10,841,093 | | Total assets | $15,004,219 | $18,546,212 | | **Liabilities & Equity** | | | | Total current liabilities | $1,163,660 | $881,948 | | Total stockholders' equity | $13,840,559 | $17,664,264 | | Total liabilities and stockholders' equity | $15,004,219 | $18,546,212 | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) For the six months ended December 31, 2018, the company reported a net loss of $4.1 million, or ($0.06) per share, compared to a net loss of $4.8 million, or ($0.08) per share, for the same period in 2017. The reduced loss was primarily due to the absence of interest expense, loss on extinguishment of debt, and discount on convertible debenture related to a debenture redeemed in November 2017, partially offset by a smaller gain from the change in fair value of derivatives Statement of Operations Highlights (Unaudited) | Metric | Six Months Ended Dec 31, 2018 | Six Months Ended Dec 31, 2017 | | :--- | :--- | :--- | | Research and development | $3,024,779 | $3,091,549 | | General and administrative | $1,383,517 | $1,532,678 | | Loss from operations | ($4,408,296) | ($4,624,227) | | Net loss | ($4,072,455) | ($4,802,449) | | Net loss per share | ($0.06) | ($0.08) | [Statements of Changes in Stockholders' Equity](index=5&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased from $17.7 million at June 30, 2018, to $13.8 million at December 31, 2018. The decline was primarily driven by a net loss of $4.1 million for the six-month period, partially offset by non-cash compensation through the issuance of preferred and common stock for employee, consulting, and director services - The primary driver for the decrease in stockholders' equity was the net loss of **$4,072,455** for the six months ended December 31, 2018[10](index=10&type=chunk)[12](index=12&type=chunk) - The company issued Series A Preferred Stock and common stock for employee compensation, consulting services, and director fees, which increased additional paid-in capital[12](index=12&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) For the six months ended December 31, 2018, net cash used in operating activities was $3.1 million, a slight increase from $3.0 million in the prior-year period. The company's cash and cash equivalents decreased by $3.2 million during the period, ending at $3.9 million, compared to $12.0 million at the end of the same period in 2017 Cash Flow Summary (Unaudited) | Metric | Six Months Ended Dec 31, 2018 | Six Months Ended Dec 31, 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,120,563) | ($2,960,521) | | Net change in cash and cash equivalents | ($3,178,099) | ($3,053,061) | | Cash and cash equivalents at end of period | $3,903,672 | $12,046,400 | [Notes to the Financial Statements](index=8&type=section&id=Notes%20to%20the%20Financial%20Statements) The notes detail the company's business as a pre-revenue nano-biopharmaceutical firm focused on antiviral drugs, primarily through licenses from TheraCour Pharma, Inc. Key disclosures include a going concern warning due to an accumulated deficit of $87.8 million and recurring losses, significant related-party transactions, and details on equity compensation. A subsequent event notes the resignation of the CEO in January 2019 - The company is a nano-biopharmaceutical R&D company specializing in antiviral drugs, with its lead program being HerpeCide™ for herpes viruses. It operates under exclusive licenses from TheraCour Pharma, Inc[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern due to an accumulated deficit of approximately **$87.8 million**, a net loss of **$4.1 million** for the six months ended Dec 31, 2018, and no revenue generation[30](index=30&type=chunk) - The company has significant related-party transactions with TheraCour Pharma, Inc., an entity controlled by a significant stockholder, for license and development fees, totaling **$1.75 million** for the six months ended Dec 31, 2018[37](index=37&type=chunk)[39](index=39&type=chunk) - Subsequent to the reporting period, on January 24, 2019, CEO Irach Taraporewala resigned for personal reasons and transitioned to a consulting role[81](index=81&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic focus on the HerpeCide™ program, particularly the shingles drug candidate (NV-HHV-101), which has commenced IND-enabling studies. The report details the nanoviricide® platform technology, the extensive product pipeline, and the company's in-house manufacturing capabilities. Financially, the company remains a pre-revenue entity with a net loss of $4.1 million for the six months ended December 31, 2018, and highlights the critical need to raise additional capital to fund operations and clinical trials [Recent Developments](index=23&type=section&id=Recent%20Developments) The company has formally commenced IND-Enabling Safety/Toxicology studies for its first drug candidate, NV-HHV-101, in the HerpeCide™ program for shingles rash. Key personnel changes include the resignation of CEO Dr. Irach Taraporewala (subsequent to the period) and the appointment of Mr. James Sapirstein to the Board of Directors, which restored compliance with NYSE-American listing requirements. The company has also increased investor outreach efforts - A major milestone was achieved with the formal commencement of IND-Enabling Safety/Toxicology studies for the first drug candidate, NV-HHV-101, for shingles rash[88](index=88&type=chunk)[89](index=89&type=chunk) - Mr. James Sapirstein joined the Board of Directors, bringing over **35 years** of pharmaceutical industry experience and helping the company regain full compliance with NYSE-American listing requirements[92](index=92&type=chunk)[98](index=98&type=chunk) - Subsequent to the reporting period, CEO Irach Taraporewala resigned for personal reasons and was retained as a consultant[91](index=91&type=chunk) [Our Product Pipeline](index=26&type=section&id=Our%20Product%20Pipeline) The company's primary focus is the HerpeCide™ program, which includes candidates for shingles (VZV), cold sores (HSV-1), genital herpes (HSV-2), herpes keratitis (HK), and viral Acute Retinal Necrosis (v-ARN). The shingles candidate is the most advanced, moving towards clinical trials. Pre-clinical studies have shown strong effectiveness and a good safety profile for these candidates. Other programs like FluCide™, DengueCide™, and HIVCide™ are at a lower priority due to budget constraints. The total market size for all development programs is estimated at around $100 billion - The company has at least **9 drug development programs**, with the HerpeCide™ program being the highest priority, targeting five indications: Shingles (VZV), cold sores (HSV-1), genital herpes (HSV-2), ocular herpes keratitis (HK), and viral Acute Retinal Necrosis (v-ARN)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) - The anti-shingles drug candidate could reach peak annual sales of up to **$2 billion** if it proves effective in reducing post-herpetic neuralgia (PHN)[126](index=126&type=chunk) - Pre-clinical studies in a human skin model showed that nanoviricide drug candidates markedly inhibited VZV (shingles virus) infection, replication, and spread, with effectiveness equivalent to a **1%** cidofovir topical formulation[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - The total market size for the company's drug development programs, including herpes, influenza, and HIV, is estimated at around **$100 billion**[184](index=184&type=chunk) [Analysis of Financial Condition, and Result of Operations](index=44&type=section&id=Analysis%20of%20Financial%20Condition%2C%20and%20Result%20of%20Operations) For the six months ended December 31, 2018, the company had no revenue and a net loss of $4.1 million, down from $4.8 million in the prior-year period. The decrease in net loss is mainly due to the absence of expenses related to a convertible debenture redeemed in 2017. Research and development expenses were stable at $3.0 million, while general and administrative expenses decreased to $1.4 million from $1.5 million due to lower officer compensation. Cash and cash equivalents stood at $3.9 million as of December 31, 2018 Comparison of Operating Results (Six Months Ended Dec 31) | Metric | 2018 | 2017 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $3,024,779 | $3,091,549 | ($66,770) | | General & Administrative | $1,383,517 | $1,532,678 | ($149,161) | | Net Loss | ($4,072,455) | ($4,802,449) | $730,000 | - The decrease in net loss for the six-month period was primarily attributable to the redemption of the Series C Debenture in November 2017, which eliminated interest expense, amortization of debt discount, and the loss on extinguishment of debt recorded in the prior year[256](index=256&type=chunk)[257](index=257&type=chunk)[260](index=260&type=chunk) - As of December 31, 2018, the company had cash and cash equivalents of **$3.9 million**, down from **$7.1 million** at June 30, 2018[242](index=242&type=chunk)[243](index=243&type=chunk) [Liquidity and Capital Reserves](index=47&type=section&id=Liquidity%20and%20Capital%20Reserves) The company's liquidity is a significant concern, with cash and cash equivalents of $3.9 million as of December 31, 2018, and an accumulated deficit of approximately $87.8 million. Management states that current funds are insufficient for projected work leading to an IND filing and clinical trials. The company is actively exploring debt or equity financing but provides no assurance of success, noting that failure to raise additional funds will significantly delay its business plan - The company had cash and cash equivalents of **$3.9 million** and an accumulated deficit of approximately **$87.8 million** as of December 31, 2018[262](index=262&type=chunk) - Management believes current funds are insufficient for the projected work required for an IND filing and is actively seeking additional funding through debt or equity financing[263](index=263&type=chunk) - There is no assurance the company will be successful in obtaining sufficient financing on acceptable terms. Failure to do so will cause significant delays to the business plan[263](index=263&type=chunk)[265](index=265&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate risk associated with its short-term cash equivalent investments, which is considered non-material. The company has no foreign operations, no exposure to foreign currency fluctuations, and does not use derivative financial instruments for speculative purposes - The company's market risk is limited to interest rate risk on its cash equivalents, which is deemed non-material[270](index=270&type=chunk) [Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that as of December 31, 2018, the company's disclosure controls and procedures were not effective. This was due to unremediated material weaknesses in internal control over financial reporting previously identified in the Form 10-K for the fiscal year ended June 30, 2018. A remediation plan is underway, including enhanced review of financial transactions and additional training for finance staff - Management concluded that disclosure controls and procedures were not effective as of December 31, 2018[273](index=273&type=chunk) - The ineffectiveness is due to material weaknesses in internal control that remained unremediated from the fiscal year ended June 30, 2018[273](index=273&type=chunk) - A remediation plan is in place, involving enhanced review processes and additional training for accounting and finance staff[275](index=275&type=chunk)[277](index=277&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, there are no pending legal proceedings against the company, and to the company's knowledge, no action, suit, or proceeding has been threatened - There are no pending or threatened legal proceedings against the Company[281](index=281&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the six months ended December 31, 2018, the company issued unregistered equity securities as compensation. This included 525,000 shares of Series A preferred stock to the President, 15,432 shares of Series A preferred stock for employee compensation, warrants to purchase common stock to the Scientific Advisory Board, and common stock for consulting and director services - Issued **525,000 shares** of Series A preferred stock to the Company's President, Dr. Anil Diwan, as part of an employment agreement extension[283](index=283&type=chunk) - Issued a total of **275,453 shares** of common stock for consulting services and **54,161 shares** for Director services during the six-month period[286](index=286&type=chunk)[287](index=287&type=chunk) [Other Information](index=51&type=section&id=Item%205.%20Other%20Information) The company disclosed a significant subsequent event: on January 24, 2019, CEO Irach Taraporewala resigned for personal reasons. He has since entered into a two-year consulting agreement with the company - On January 24, 2019, after the reporting period, CEO Irach Taraporewala resigned for personal reasons and transitioned to a consultant for the company for a **two-year period**[290](index=290&type=chunk)