Financial Performance - For the year ended June 30, 2023, the company reported a net loss of approximately $8,589,000, compared to a net loss of approximately $8,107,000 for the year ended June 30, 2022, reflecting an increase of $482,000 attributed to higher license milestone expenses [507]. - The company has an accumulated deficit of approximately $131,081,000 as of June 30, 2023, with no revenues generated and no revenues anticipated in the foreseeable future [515]. - The company has not generated any revenues since its inception in May 2005 and does not expect to generate revenues in the near future [500]. - Interest income increased to approximately $356,000 for the year ended June 30, 2023, compared to approximately $12,000 for the year ended June 30, 2022, due to higher interest rates [504]. - The company has approximately $2,034,000 in liabilities as of June 30, 2023, compared to approximately $413,000 as of June 30, 2022 [514]. Cash and Funding - As of June 30, 2023, the company had approximately $8,150,000 in cash and cash equivalents, down from approximately $14,066,000 as of June 30, 2022 [514]. - The Company has approximately $8,150,000 in cash and cash equivalents, expected to fund operations through October 2024 [516]. - The Company has filed a registration statement allowing for the sale of up to $150 million in various securities, with the entire amount still available for sale [518]. - The Company anticipates needing additional funding for later stages of human clinical trials unless a partnership with a larger pharmaceutical company is formed [521]. - The Company intends to seek non-dilutive financing, grants, and pharmaceutical partnerships as its drug candidates progress [532]. Research and Development - Research and development expenses increased to approximately $6,392,000 for the year ended June 30, 2023, up from approximately $5,785,000 for the year ended June 30, 2022, primarily due to increased license fees [503]. - The Company plans to file an IND for its Shingles Skin Cream after advancing its pan-coronavirus and RSV program drugs into clinical trials [511]. - The Company plans to file an IND for the Shingles Skin Cream after advancing its pan-coronavirus and RSV programs into clinical trials [517]. - The estimated costs for Phase I clinical trials are approximately $1.5 million, $5 million for Phase II, and $10 million for Phase III, assuming successful prior phases [522]. - The planned recruitment for Phase 1a/1b clinical trials includes 36 healthy volunteers and 36 COVID patients [524]. - The Company has limited experience in pharmaceutical drug development, leading to potential inaccuracies in budget estimates [526]. - The Company is classified as a clinical drug development stage company and will continue until regulatory approvals are obtained [533]. Strategic Partnerships - The company has signed several cooperative research and development agreements with TheraCour and expects to enter into additional agreements with other entities [509]. - The company plans to actively pursue co-development and licensing agreements with other pharmaceutical companies to enhance revenue opportunities [497]. - The Company believes its market capitalization will improve as its coronavirus program matures through human clinical trials [523].

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for the period ended March 31, 2023, including balance sheets, statements of operations, and cash flows, reporting a net loss of $1.7 million for the quarter and $5.0 million for the nine months [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) | Balance Sheet Highlights | March 31, 2023 (Unaudited) | June 30, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,650,958 | $14,066,359 | | Total current assets | $9,931,075 | $14,416,380 | | Total assets | $18,576,799 | $23,494,862 | | Total current liabilities | $348,744 | $412,837 | | Total stockholders' equity | $18,228,055 | $23,082,025 | - Cash and cash equivalents decreased by approximately **$4.4 million**, reflecting cash used in operations[9](index=9&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) | Operating Results (Unaudited) | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | Nine Months Ended Mar 31, 2023 | Nine Months Ended Mar 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,196,094 | $1,255,074 | $3,479,463 | $4,613,302 | | General and administrative | $614,647 | $532,801 | $1,787,632 | $1,707,514 | | **Loss from operations** | **($1,810,741)** | **($1,787,875)** | **($5,267,095)** | **($6,320,816)** | | **Net loss** | **($1,702,804)** | **($1,792,664)** | **($5,018,580)** | **($6,326,866)** | | Net loss per share | ($0.15) | ($0.16) | ($0.43) | ($0.55) | - Net loss for the nine months ended March 31, 2023, decreased due to lower research and development expenses[11](index=11&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) | Cash Flow Summary (Unaudited) | Nine Months Ended March 31, 2023 | Nine Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,171,467) | ($4,493,550) | | Net cash used in investing activities | ($149,146) | ($248,986) | | Net cash used in financing activities | ($94,788) | ($202,007) | | **Net change in cash** | **($4,415,401)** | **($4,944,543)** | | Cash at end of period | $9,650,958 | $15,572,134 | [Notes to the Condensed Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) These notes provide crucial context to the financial statements, detailing the company's clinical-stage status, lead drug candidate NV-CoV-2 entering Phase 1 trials, liquidity position, and significant related-party transactions - The company is a clinical-stage biopharmaceutical firm with its lead candidate, **NV-CoV-2 for COVID-19**, entering Phase 1a/1b human clinical trials in India[20](index=20&type=chunk)[21](index=21&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of approximately **$127.5 million** and no revenue, but management believes **$9.7 million** in cash is sufficient for at least 12 months of operations[27](index=27&type=chunk)[30](index=30&type=chunk) - The company holds exclusive worldwide licenses from **TheraCour Pharma, Inc.**, a related party, for its core technology, with a **15% royalty** on net sales upon commercialization[24](index=24&type=chunk) - The company licensed its COVID-19 drug candidates to **Karveer Meditech** for clinical development and commercialization in India, with NanoViricides reimbursing trial costs plus a **30% fee** and receiving a **70% royalty** on net sales[40](index=40&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business, drug pipeline, and financial performance, focusing on advancing **NV-CoV-2** into human clinical trials and expanding **NV-387**'s use against other viruses, with a net loss of **$5.0 million** for the nine months [Drug Pipeline and Strategy](index=17&type=section&id=Drug%20Pipeline%20and%20Strategy) - The lead clinical-stage drug, **NV-CoV-2** for COVID-19, is poised to enter Phase 1a/1b trials in India[66](index=66&type=chunk)[75](index=75&type=chunk) - The company is exploring additional applications for **NV-387**, the active ingredient in NV-CoV-2, against other viruses like RSV and mpox[68](index=68&type=chunk)[85](index=85&type=chunk)[92](index=92&type=chunk) - The company's platform technology develops drugs resistant to viral mutation by mimicking human cellular receptors[108](index=108&type=chunk)[109](index=109&type=chunk) - NanoViricides possesses its own **cGM-compliant manufacturing facility**, providing a competitive advantage for rapid and cost-effective production of clinical trial materials[103](index=103&type=chunk)[104](index=104&type=chunk) [Recent Developments and Financial Status](index=30&type=section&id=Recent%20Developments%20and%20Financial%20Status) - During the quarter, the company completed **cGM-compliant manufacturing** of **NV-387** and **NV-CoV-2 Oral Syrup and Gummies** for clinical trials in India[124](index=124&type=chunk) - Subsequent to the quarter, drug products were shipped to partner **Karveer** in India on April 12, 2023, with clinical trials expected to commence shortly[125](index=125&type=chunk) - As of March 31, 2023, the company held **$9.7 million** in cash and cash equivalents, deemed sufficient to fund operations for over twelve months and initial human clinical trials for **NV-CoV-2**[128](index=128&type=chunk)[129](index=129&type=chunk) [Results of Operations Analysis](index=41&type=section&id=Results%20of%20Operations%20Analysis) | Expense Category | Nine Months Ended Mar 31, 2023 | Nine Months Ended Mar 31, 2022 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $3,479,463 | $4,613,302 | ($1,133,839) | Decrease in external lab expenses and a prior-year milestone payment | | General & Administrative | $1,787,632 | $1,707,514 | $80,118 | Increase in professional fees | - The net loss for the nine months ended March 31, 2023, was **$5.02 million** (or **$0.43 per share**), a decrease from **$6.33 million** (or **$0.55 per share**) in the prior year period[182](index=182&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is primarily limited to non-material interest rate fluctuations on cash equivalents, with no foreign currency or derivative instrument exposure - The company's market risk exposure is primarily limited to **non-material interest rate risk** on its cash equivalents[188](index=188&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2023, due to a material weakness in internal control over financial reporting, with a remediation plan in place - Disclosure controls and procedures were deemed **ineffective** as of March 31, 2023, due to a **material weakness** in internal control over financial reporting[190](index=190&type=chunk) - The material weakness arises from insufficient timely review of the period-end closing process and inadequate personnel and resources[190](index=190&type=chunk) - A remediation plan, including a **financial reporting controls committee**, is in place to enhance oversight and ensure financial reporting reliability[192](index=192&type=chunk) [PART II OTHER INFORMATION](index=46&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending or threatened legal proceedings expected to materially adversely affect its business, financial condition, or results of operations - As of the filing date, there are **no legal proceedings** against the company, nor is the company aware of any threatened actions[197](index=197&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the issuance of unregistered equity securities, including Series A preferred stock, common stock, and warrants, as compensation to various parties under Section 4(a)(2) exemptions - Issued **Series A preferred stock** and **common stock** for employee, director, and consulting services[198](index=198&type=chunk)[199](index=199&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk) - Granted fully vested warrants to the **Scientific Advisory Board** to purchase common stock shares[200](index=200&type=chunk) - All securities were issued without registration under the Securities Act, relying on **Section 4(a)(2) exemptions**, and are considered restricted[203](index=203&type=chunk) [Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - The company reported **no defaults** upon senior securities[204](index=204&type=chunk) [Mine Safety Disclosures](index=48&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This disclosure item is **not applicable**[205](index=205&type=chunk) [Other Information](index=48&type=section&id=Item%205.%20Other%20Information) No other material information was reported - The company reported **no other information**[206](index=206&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits%20and%20Reports%20on%20Form%208-K) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include **Rule 13(a)-14(a)/15(d)-14(a)** and **Section 1350 certifications** for the CEO and CFO, along with Inline XBRL files[208](index=208&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT UNDER SECTION 1320 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended December 31, 2022 Commission File Number: 001-36081 (Exact name of Company as specified in its charter) of incorporation or organization) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) 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 $1.6 million for Q3 2022, with total assets decreasing to $22.1 million and cash at $12.9 million [Balance Sheets](index=3&type=section&id=Balance%20Sheets) Total assets decreased to $22.1 million by September 30, 2022, primarily due to reduced cash, while equity declined to $21.6 million Balance Sheet Summary (in thousands) | Balance Sheet Items | Sep 30, 2022 (Unaudited) | June 30, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,918 | $14,066 | | Total current assets | $13,150 | $14,416 | | Property and equipment, net | $8,557 | $8,694 | | Total assets | $22,082 | $23,495 | | **Liabilities & Equity** | | | | Total current liabilities | $518 | $413 | | Total stockholders' equity | $21,564 | $23,082 | | Total liabilities and stockholders' equity | $22,082 | $23,495 | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Net loss for Q3 2022 improved to $1.57 million ($0.14 per share) from $2.61 million in Q3 2021, driven by lower R&D expenses Statement of Operations Summary (in thousands) | Metric | Q3 2022 (3 months ended Sep 30) | Q3 2021 (3 months ended Sep 30) | | :--- | :--- | :--- | | Research and development | $1,112.7 | $2,096.9 | | General and administrative | $509.7 | $515.4 | | Total operating expenses | $1,622.4 | $2,612.4 | | Loss from operations | $(1,622.4) | $(2,612.4) | | Net loss | $(1,570.6) | $(2,613.1) | | Net loss per share | $(0.14) | $(0.23) | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $1.03 million, resulting in a $1.15 million net decrease in cash, ending at $12.9 million Cash Flow Summary (in thousands) | Cash Flow Activity | Q3 2022 (3 months ended Sep 30) | Q3 2021 (3 months ended Sep 30) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,032.9) | $(724.2) | | Net cash used in investing activities | $(44.5) | $(24.3) | | Net cash used in financing activities | $(71.0) | $(71.3) | | Net change in cash | $(1,148.3) | $(819.9) | | Cash at end of period | $12,918.0 | $19,696.8 | [Notes to the Financial Statements](index=8&type=section&id=Notes%20to%20the%20Financial%20Statements) The notes detail the company's antiviral R&D, accumulated deficit of $124 million, going concern status, and related-party transactions - The company's lead drug program is NV-CoV-2 for COVID-19, for which IND-enabling studies are complete. The company is preparing for Phase I/II human clinical trials[21](index=21&type=chunk) - New limited drug development programs have been initiated for Monkeypox virus (MPXV) and Enterovirus D68 (EV68) in response to recent outbreaks[22](index=22&type=chunk)[23](index=23&type=chunk) - As of September 30, 2022, the company had an accumulated deficit of approximately **$124 million** and has not generated any revenue. Management believes existing cash of **$12.9 million** is sufficient to fund operations for at least the next 12 months[29](index=29&type=chunk)[35](index=35&type=chunk) - The company has an At The Market (ATM) sales agreement for up to **$50 million**, under which it previously sold **$6.1 million** worth of common stock in March 2021[31](index=31&type=chunk)[32](index=32&type=chunk) - The company has exclusive license agreements with TheraCour Pharma, Inc., an entity controlled by the company's CEO, for its core technology. In Q3 2021, a milestone payment of **100,000 Series A preferred shares** (valued at **$935,088**) was made to TheraCour under the COVID-19 license agreement[26](index=26&type=chunk)[27](index=27&type=chunk)[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the development-stage biopharma's lead COVID-19 drug candidates, manufacturing capabilities, reduced net loss, and future capital needs [Organization and Nature of Business](index=20&type=section&id=Organization%20and%20Nature%20of%20Business) NanoViricides is a development-stage antiviral drug company with lead COVID-19 candidates, in-house cGMP manufacturing, and broad-spectrum technology - The company's most advanced drug candidates, NV-CoV-2 and NV-CoV-2-R, are for COVID-19. The company is working towards filing an IND for NV-CoV-2 to begin human clinical trials[65](index=65&type=chunk) - NanoViricides possesses its own cGMP-compliant manufacturing facility, enabling it to produce clinical supplies of its drug candidates, which simplifies and expedites manufacturing operations[76](index=76&type=chunk) - The company has developed multiple formulations for NV-CoV-2, including oral gummies, oral syrup, and a solution for injection, infusion, or inhalation, to treat different patient populations and disease severities[82](index=82&type=chunk)[94](index=94&type=chunk) - The company's technology platform is based on biomimetic engineering, creating drugs that viruses are unlikely to escape through mutation. This is a key differentiator from vaccines and antibody therapies that have lost effectiveness against new variants[77](index=77&type=chunk)[80](index=80&type=chunk) [Financial Status and Drug Programs](index=31&type=section&id=Financial%20Status%20and%20Drug%20Programs) The company holds $12.9 million in cash, sufficient for initial trials, with a pipeline focused on COVID-19, HerpeCide™, Monkeypox, and Enterovirus - As of September 30, 2022, the company had approximately **$12.9 million** in cash and cash equivalents, which is considered sufficient for more than twelve months of operations at the current expenditure rate[117](index=117&type=chunk)[118](index=118&type=chunk) - The company's drug pipeline priority is: 1) COVID-19 (NV-CoV-2), 2) HerpeCide™ program (NV-HHV-1 for shingles, followed by HSV-1/HSV-2), and 3) newly initiated programs for Monkeypox and Enterovirus[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The market for anti-viral drugs was estimated at **$40 billion** in 2018 and projected to be **$65.5 billion** in 2023, excluding the COVID-19 market, indicating a large potential market for the company's pipeline[124](index=124&type=chunk) - The company has demonstrated cGMP manufacturing capabilities for complex nanomedicine drugs at its own facility, a significant milestone that saves time and money compared to using external contract manufacturers[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Net loss decreased to $1.6 million due to a $0.98 million reduction in R&D expenses, primarily from a prior-year non-cash milestone payment Comparison of Operating Results (in thousands) | Expense Category | Q3 2022 (3 months ended Sep 30) | Q3 2021 (3 months ended Sep 30) | Change | | :--- | :--- | :--- | :--- | | Research and Development | $1,112.7 | $2,096.9 | $(984.2) | | General and Administration | $509.7 | $515.4 | $(5.7) | | Net Loss | $(1,570.6) | $(2,613.1) | $1,042.5 | - The decrease in R&D expenses was mainly due to a one-time milestone payment in Q3 2021, where **100,000 shares of Series A preferred stock** (fair value ~**$935,000**) were issued to TheraCour for the COVID-19 license[230](index=230&type=chunk) [Liquidity and Capital Reserves](index=54&type=section&id=Liquidity%20and%20Capital%20Reserves) With $12.9 million in cash, the company has sufficient liquidity for 12 months but requires additional capital for long-term R&D and trials, with an ATM agreement in place - The company has an accumulated deficit of **$124.1 million** as of September 30, 2022, and expects losses to continue[236](index=236&type=chunk) - An At The Market (ATM) Sales Agreement for up to **$50 million** is in place, providing a mechanism to raise capital. To date, approximately **$6.4 million** has been raised under this agreement[236](index=236&type=chunk) - Management believes existing resources are sufficient for the next twelve months, but long-term plans, including later-stage clinical trials, will require additional capital[237](index=237&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces minimal market risk, primarily non-material interest rate risk on cash equivalents, with no foreign currency exposure - The company's primary market risk is interest rate risk associated with short-term cash equivalents, which is deemed non-material[242](index=242&type=chunk) - The company has no foreign operations and is not exposed to foreign currency fluctuations[242](index=242&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective due to a material weakness in financial reporting, with a remediation plan including a new controls committee - Management concluded that disclosure controls and procedures were not effective as of September 30, 2022[244](index=244&type=chunk) - The ineffectiveness is due to an unremediated material weakness in internal control over financial reporting, stemming from inadequate resources and review of the period-end closing process[244](index=244&type=chunk) - A remediation plan has been initiated, which includes a new financial reporting controls committee to provide oversight and ensure reliability and accuracy[246](index=246&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) There are no pending or threatened legal proceedings against the company as of the filing date - There are no pending or threatened legal proceedings against the Company as of the filing date[250](index=250&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued unregistered equity securities, including preferred and common stock, and warrants, for compensation and services during the quarter - Issued **10,204 shares of Series A preferred stock** to CEO Dr. Anil Diwan as part of a one-year employment agreement extension[251](index=251&type=chunk) - Issued a total of **17,864 shares of common stock** for consulting and director services, and warrants to purchase **286 shares of common stock** to the Scientific Advisory Board[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk) - All securities were issued without registration under the Securities Act, in reliance on exemptions provided by Section 4(a)(2) and Rule 506(b) of Regulation D[256](index=256&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits%20and%20Reports%20on%20Form%208-K) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL data files - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents (101 series)[262](index=262&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED JUNE 30, 2022 Commission File Number 001-36081 NANOVIRICIDES, INC. (Name of Business Issuer in Its Charter) (State or other jurisdiction of incorporation or NEVADA 76-0674577 (I.R.S. Employer Identification No.) organization) 1 CONTROLS DRIVE, SHELTON, CONNECTICUT, 06484 (Address of principal execu ...

Table of Contents 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, 2022 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 princ ...

Table of Contents 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. Commission File Number: 001-36081 NANOVIRICIDES, INC. (Exact name of Company as specified in its charter) of incorporation or organization) NEVADA 76-0674577 (State or other jurisdiction) (IRS Employer Identification No.) 1 Controls Drive Shelton, Connecticut 06484 (Address of principal executive offices and zip code) (203) 937 ...

Table of Contents 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, 2021 Indicate by check mark whether the Company (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been subject to such f ...

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, 2021 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 ...

PART I FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements for the period ended March 31, 2021, show a significant increase in cash and total assets compared to June 30, 2020, primarily due to equity financing activities, with the company continuing to operate at a net loss and an accumulated deficit of approximately $112.3 million, while operating expenses, particularly Research and Development, have increased year-over-year, reflecting intensified drug development efforts [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of March 31, 2021, the company's total assets were $32.8 million, a significant increase from $23.9 million at June 30, 2020, driven by a rise in cash and cash equivalents from $13.7 million to $22.9 million, while total liabilities decreased from $2.2 million to $0.9 million, primarily due to mortgage note repayment, consequently increasing total stockholders' equity from $21.8 million to $31.9 million Balance Sheet Summary (Unaudited) | Balance Sheet Items | March 31, 2021 ($) | June 30, 2020 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 22,899,518 | 13,708,594 | | Total current assets | 23,231,069 | 13,985,657 | | Property and equipment, net | 9,174,355 | 9,544,431 | | Total assets | 32,761,125 | 23,914,339 | | **Liabilities & Equity** | | | | Total current liabilities | 871,344 | 2,156,377 | | Total stockholders' equity | 31,889,781 | 21,757,962 | | Total liabilities and stockholders' equity | 32,761,125 | 23,914,339 | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) For the nine months ended March 31, 2021, the company reported a net loss of $6.7 million, a significant improvement from the $11.6 million net loss in the same period of 2020, primarily due to the absence of a large non-cash expense related to the change in fair value of derivative liability present in the prior year, while operating expenses increased from $6.2 million to $6.7 million, driven by higher research and development costs Statements of Operations Summary (Unaudited) | Metric | Nine Months Ended Mar 31, 2021 ($) | Nine Months Ended Mar 31, 2020 ($) | | :--- | :--- | :--- | | Research and development | 4,530,448 | 3,628,622 | | General and administrative | 2,139,392 | 2,536,050 | | **Loss from operations** | **(6,669,840)** | **(6,164,672)** | | Change in fair value of derivative liability | - | (5,845,313) | | **Net loss** | **(6,749,317)** | **(11,571,963)** | | Net loss per common share | (0.63) | (2.45) | [Statements of Changes in Stockholders' Equity](index=5&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity increased from $21.8 million at June 30, 2020, to $31.9 million at March 31, 2021, primarily driven by net proceeds of approximately $16.6 million from common stock issuance through equity financing, partially offset by a net loss of $6.7 million for the nine-month period - Net proceeds from the issuance of common stock in connection with equity financing totaled approximately **$16.6 million** for the nine months ended March 31, 2021[13](index=13&type=chunk) - The accumulated deficit grew from **$105.6 million** at June 30, 2020, to **$112.3 million** at March 31, 2021, due to continued net losses[13](index=13&type=chunk) [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) For the nine months ended March 31, 2021, net cash used in operating activities was approximately $6.0 million, while net cash provided by financing activities was $15.3 million, primarily from common stock issuance, resulting in a net increase in cash and cash equivalents of $9.2 million, bringing the ending balance to $22.9 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Nine Months Ended Mar 31, 2021 ($) | Nine Months Ended Mar 31, 2020 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (5,986,138) | (4,957,235) | | Net cash used in investing activities | (154,122) | (4,139) | | Net cash provided by financing activities | 15,331,184 | 8,511,697 | | **Net change in cash and cash equivalents** | **9,190,924** | **3,550,323** | | Cash and cash equivalents at end of period | 22,899,518 | 6,105,530 | [Notes to the Financial Statements](index=9&type=section&id=Notes%20to%20the%20Financial%20Statements) The notes detail the company's business, liquidity status, accounting policies, and specific financial items, highlighting its focus on the COVID-19 drug program, reliance on licensed technology from TheraCour Pharma, Inc., and its financial condition as a development-stage company with no revenue, having raised significant capital through equity offerings to ensure sufficient funds for operations for at least the next twelve months, with additional details on related-party transactions, equity issuances, and employment agreements - The company is a nano-biopharmaceutical R&D firm focused on developing drugs for viral infections, with its lead program currently targeting COVID-19[20](index=20&type=chunk)[21](index=21&type=chunk) - The company has an accumulated deficit of approximately **$112.3 million** as of March 31, 2021, and has not yet generated any revenue; management believes existing cash of **$22.9 million** is sufficient to fund operations for at least the next twelve months[27](index=27&type=chunk)[35](index=35&type=chunk) - The company relies on exclusive licenses from TheraCour Pharma, Inc., a related party, for its core technology; a Memorandum of Understanding for a license in the field of coronaviruses was executed in June 2020 and extended to June 2021[23](index=23&type=chunk)[24](index=24&type=chunk)[70](index=70&type=chunk) - In July 2020 and March 2021, the company raised net proceeds of approximately **$10.4 million** and **$6.1 million**, respectively, through common stock offerings[29](index=29&type=chunk)[31](index=31&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion focuses on the company's status as a development-stage biopharmaceutical firm with no revenue, highlighting its strategic pivot to prioritize the COVID-19 drug development program, detailing the progress of its lead candidates, NV-CoV-2 and NV-CoV-2-R, including promising pre-clinical safety and efficacy data, while the HerpeCide™ program, particularly NV-HHV-101 for shingles, remains a key asset, with development to resume after the COVID-19 program's clinical trials begin; the company has successfully raised capital, securing approximately $22.9 million in cash, deemed sufficient for operations for the next year, including initial clinical trials, and the analysis of operations shows an increased R&D spend and a decreased net loss compared to the prior year, primarily due to non-recurring derivative liability charges in 2020 [Business Overview and Strategy](index=23&type=section&id=Business%20Overview%20and%20Strategy) NanoViricides is a development-stage company focused on creating anti-viral drugs using its proprietary nanomedicine platform technology, licensed from TheraCour Pharma, Inc., with a strategy to develop drugs that directly attack virus particles using a "bind-encapsulate-destroy" mechanism designed to be effective against viral mutations, and a current primary focus on advancing its COVID-19 drug candidates into human clinical trials, followed by its HerpeCide™ program for shingles - The company is a development-stage entity with no customers or revenue to date, focusing on pre-clinical drug development[77](index=77&type=chunk) - The core technology is based on an exclusive license from TheraCour Pharma, Inc., a related party controlled by the company's CEO, Dr. Anil Diwan[78](index=78&type=chunk) - The nanoviricide® platform technology is designed to create biomimetic drugs that directly attack multiple points on a virus particle, making it difficult for viruses to develop resistance through mutation[92](index=92&type=chunk)[93](index=93&type=chunk) - The company operates its own cGMP-compliant manufacturing facility, enabling production of drugs for clinical trials, which is a significant strategic advantage[81](index=81&type=chunk) [COVID-19 Drug Development Program](index=24&type=section&id=COVID-19%20Drug%20Development%20Program) The company has prioritized its COVID-19 program, developing two broad-spectrum, pan-coronavirus drug candidates: NV-CoV-2 and NV-CoV-2-R (which encapsulates remdesivir), with pre-clinical studies showing both candidates to be well-tolerated in safety pharmacology studies and highly effective in animal models, outperforming remdesivir in extending survival, and the company has completed required safety studies, is preparing a pre-IND application for the FDA, and has initiated cGMP-compliant manufacturing of the drug substance for clinical trials at its own facility - The lead drug candidates are **NV-CoV-2** and **NV-CoV-2-R**; NV-CoV-2-R encapsulates remdesivir and is designed to attack both extracellular virus and intracellular viral replication[88](index=88&type=chunk)[89](index=89&type=chunk) - Safety pharmacology studies in rats and non-human primates found **NV-CoV-2** to be well-tolerated, with no adverse effects on respiratory or cardiovascular functions at tested doses[102](index=102&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - In a lethal coronavirus infection animal model, **NV-CoV-2** and **NV-CoV-2-R** significantly extended survival to **14 and 16 days**, respectively, compared to **7.5 days** for remdesivir[112](index=112&type=chunk) - The company is preparing a pre-IND application for submission to the US FDA and is manufacturing the drug for clinical trials in its own cGMP-capable facility[91](index=91&type=chunk)[129](index=129&type=chunk) [HerpeCide™ Program and Other Pipeline](index=34&type=section&id=HerpeCide%E2%84%A2%20Program%20and%20Other%20Pipeline) The HerpeCide™ program is the company's other major focus, with the lead candidate being NV-HHV-101, a topical skin cream for treating shingles rash (VZV), which has shown strong effectiveness in human skin models, outperforming acyclovir, and the company has completed IND-enabling studies for NV-HHV-101 and plans to file an IND after its COVID-19 drug candidate enters clinical trials, while the HerpeCide pipeline also includes candidates for HSV-1 (cold sores) and HSV-2 (genital ulcers), and other programs like FluCide™ and HIVCide™ are at a lower priority due to resource constraints - The lead candidate, **NV-HHV-101**, is a skin cream for shingles that has completed IND-enabling studies and has shown strong effectiveness, being up to **five times more effective** than acyclovir in cell culture studies[162](index=162&type=chunk)[80](index=80&type=chunk) - The company has successfully scaled up cGMP-like manufacturing of the **NV-HHV-101 API** and the final cream product at its own facility, saving significant time and cost[169](index=169&type=chunk) - The HerpeCide™ pipeline targets a multi-billion dollar market and includes treatments for **VZV (shingles)**, **HSV-1 (cold sores)**, **HSV-2 (genital ulcers)**, herpes keratitis, and viral Acute Retinal Necrosis (v-ARN)[144](index=144&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) - Other programs, including **FluCide™** and **HIVCide™**, have demonstrated high effectiveness in animal models but are currently at a lower development priority due to limited resources[225](index=225&type=chunk)[228](index=228&type=chunk) [Intellectual Property](index=44&type=section&id=Intellectual%20Property) The company's intellectual property is founded on a worldwide, exclusive, perpetual license from TheraCour for its nanomedicine technology across a range of specified viruses, including Coronaviruses (via a recent MOU), Herpes viruses, Influenza, and HIV, covering patents, know-how, and trade secrets, with the core technology protected by over 61 issued patents globally, having nominal expiry dates ranging from 2027 to 2029, and the company plans to file additional patents for its specific drug candidates as they advance toward clinical trials - Holds a worldwide exclusive license from TheraCour for its technology to treat numerous viruses, including a recent MOU for human coronaviruses[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk) - The license agreements include milestone payments upon achieving regulatory and clinical milestones, such as **$1.5 million** in cash upon completion of Phase I trials for the VZV drug[249](index=249&type=chunk) - The fundamental platform technology is covered by over **61 issued patents** globally, with nominal expiry dates between **2027 and 2029**[255](index=255&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) For the nine months ended March 31, 2021, the company reported a net loss of $6.7 million, compared to a net loss of $11.6 million for the same period in 2020, with the decrease in net loss primarily attributable to a non-cash charge of $5.8 million for the change in fair value of derivative liabilities in the prior year, which did not recur, while research and development expenses increased by $0.9 million due to intensified lab activities, and general and administrative expenses decreased by $0.4 million Operating Expenses Comparison (Nine Months Ended March 31) | Expense Category | 2021 ($) | 2020 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and Development | 4,530,448 | 3,628,622 | +901,826 | | General and Administrative | 2,139,392 | 2,536,050 | -396,658 | Net Loss Comparison (Nine Months Ended March 31) | Metric | 2021 ($) | 2020 ($) | | :--- | :--- | :--- | | Net Loss | $(6,749,317) | $(11,571,963) | | Net Loss per Share | $(0.63) | $(2.45) | - The significant decrease in net loss for the nine months ended March 31, 2021, was mainly due to the absence of a **$5.8 million** non-cash expense from the change in fair value of derivative liabilities that was recorded in the prior-year period[289](index=289&type=chunk)[291](index=291&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company had cash and cash equivalents of $22.9 million and an accumulated deficit of $112.3 million, having raised approximately $6.1 million in net proceeds from an "At-the-Market" offering on March 2, 2021, and management believes existing cash resources are sufficient to fund planned operations and expenditures, including initial human clinical trials for its COVID-19 drug candidate, for at least the next twelve months, though additional capital will be required to fund long-term operations and further clinical trials - The company had cash and cash equivalents of **$22,899,518** as of March 31, 2021[292](index=292&type=chunk) - On March 2, 2021, the company sold **814,242 shares** of common stock in an "At-the-Market" offering, raising net proceeds of approximately **$6.1 million**[292](index=292&type=chunk) - Management believes existing resources are sufficient to fund operations for at least the next twelve months, but long-term plans will require additional capital[293](index=293&type=chunk)[296](index=296&type=chunk) - The COVID-19 pandemic has not had a direct adverse financial impact but required a reorganization of priorities, shifting focus from the shingles program to the COVID-19 program[295](index=295&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its primary market risk exposure is non-material interest rate risk associated with its short-term cash equivalent investments, having no foreign operations, no exposure to foreign currency fluctuations, and not using derivative financial instruments for speculative purposes - The company's primary market risk is interest rate risk on its cash equivalents, which is considered non-material[301](index=301&type=chunk) - The company has no foreign operations and therefore no exposure to foreign currency exchange rate risk[301](index=301&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that as of March 31, 2021, the company's disclosure controls and procedures were not effective due to a previously disclosed and unremediated material weakness in internal control over financial reporting, and the company has established a financial reporting controls committee to oversee remediation efforts - As of March 31, 2021, the company's disclosure controls and procedures were concluded to be not effective[303](index=303&type=chunk) - The ineffectiveness is due to a material weakness in internal control over financial reporting that was previously identified and remains unremediated[303](index=303&type=chunk) - A remediation plan is in place, involving a financial reporting controls committee to provide oversight and ensure the reliability and accuracy of financial reporting[305](index=305&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=52&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 - As of the filing date, there are no legal proceedings against the company, and none are known to be threatened[309](index=309&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the nine months ended March 31, 2021, the company issued unregistered securities for compensation and services, including 2,501 shares of Series A preferred stock for employee compensation, warrants to purchase common stock for its Scientific Advisory Board, 18,677 shares of common stock for consulting services, 9,446 shares for Director services, and 3,572 shares for employee compensation, all issued in reliance on exemptions from registration under the Securities Act - For the nine months ended March 31, 2021, the company issued **2,501 shares** of Series A preferred stock and **3,572 shares** of common stock for employee compensation[310](index=310&type=chunk)[314](index=314&type=chunk) - Warrants to purchase common stock were granted to the Scientific Advisory Board[311](index=311&type=chunk) - A total of **18,677 common shares** were issued for consulting services and **9,446 common shares** for Director services during the nine-month period[312](index=312&type=chunk)[313](index=313&type=chunk) [Defaults Upon Senior Securities](index=52&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[316](index=316&type=chunk) [Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[317](index=317&type=chunk) [Other Information](index=53&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[318](index=318&type=chunk) [Exhibits](index=53&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include CEO and CFO certifications as required by the Sarbanes-Oxley Act (Rules 13a-14(a) and Section 1350) and XBRL data files - The exhibits filed include certifications from the Chief Executive Officer and Chief Financial Officer[319](index=319&type=chunk) - XBRL Instance Documents and related taxonomy files were also submitted as exhibits[319](index=319&type=chunk)