NANOVIRICIDES INC
For the period ended Dec 31, 2024. Filed Feb 14, 2025.
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Dec 31, 2024 · Filed Feb 14, 2025
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Notes to the Condensed Financial Statements (Unaudited)
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
Note 1 – Organization and Nature of Business
NanoViricides, Inc. (the “Company”) is a clinical stage nano-biopharmaceutical company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides possesses its own facility that supports research and development and drug discovery, drug candidate optimization, cGMP-compliant drug substance manufacturing, cGMP-compliant manufacturing and packaging of drug products for human clinical trials, and early commercialization. The Company has several drugs in various stages of development.
NanoViricides, Inc. is domiciled under the laws of the State of Delaware, with its principal operations located in the State of Connecticut. The Company’s fiscal year begins on July 1 st and ends on the next June 30 th of the calendar year. The Company operates inone reportable business segment.
The Company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model trials for the treatment of Coronaviruses, RSV, Influenza viruses (including H5N1 Bird Flu) as well as Smallpox and MPox.
The Company has initiated work to begin Phase II clinical trials to evaluate safety and effectiveness of NV-387 treatment in MPox patients. To this effect, the Company has engaged a CRO to help with conducting the MPox clinical trial of NV-387 in countries in the central African region. Trial sites have also been identified already. The Company is preparing a clinical trial application for the Phase II clinical trial for submission to the appropriate regulatory agency.
MPox caused by Clade 1 and 1b variants is currently a pandemic emergency in the African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. A less pathogenic variant, MPox Clade 2, has spread across the globe and caused a widespread epidemic in May 2022 in the Western world that has now become endemic.
We believe the global public health governmental markets would reach into billions of dollars for an MPox/Smallpox drug because of the recognition of smallpox as a bioterrorism threat agent, and the continuing spread of its cousin MPox that threatens a global pandemic that could be fueled by anticipated potential additional mutations in the virus as it simmers in Africa.
The Company is also in discussions with experts regarding a Phase II clinical trial for the evaluation of the effectiveness of NV-387 in the treatment of ARI and SARI of Viral origin (ARI = Acute Respiratory Infection and SARI = Severe Acute Respiratory Infection) For the very first time in the world, such clinical trial has become possible because the design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections.
NV-387 was found to be active against all tested respiratory viral infection (lethal lung infection) in animal model studies, that included RSV, Influenza viruses, Coronaviruses, as well as MPox/Smallpox.
NV-387 is expected to be active against most if not all Highly Pathogenic Influenza viruses (HPAI) including H5N1 “Bird Flu” (or Avian Flu), and the Company plans to obtain non-dilutive funding to advance this drug for the H5N1 indication.
In addition, the Company is planning clinical trials towards the approval of NV-387 for the treatment of RSV infection in pediatric patients in the US. The market size for a pediatric RSV treatment is estimated to be several billion dollars.
NV-387 has completed a Phase I human clinical trial for safety and tolerability in healthy subjects that was sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (“KMPL”). As topline results of this clinical trial, there were no reported adverse events at all doses studied, and there were no drop-outs either, observations that are indicative that NV-387 was well tolerated by the healthy subjects in this clinical trial. These results of the Phase I clinical trial are consistent with the results of safety/tolerability studies in animals conducted in support of the clinical trial application. We are awaiting the final clinical trial study report from this clinical trial.
In addition to NV-387, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans to progress NV-HHV-1 into human clinical trials, and further develop the HerpeCide™ program after the Phase II clinical trial of NV-387 for RSV, MPox, ARI/SARI, and possibly for multiple other indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.
The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), a related party substantially owned by Dr. Anil Diwan, to which the Company has broad, exclusive licenses. The licenses are to entire fields and not limited to specific compounds. In all, the Company has exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated), Varicella Zoster Virus (“VZV”) infections (i.e. Shingles and Chickenpox), and SARS-CoV-2 infections.
Additionally, on September 23, 2024, the Company signed a Memorandum of Understanding (“MoU”) for all antivirals drug development with TheraCour whereby it has obtained a right of first refusal (ROFR) for all antiviral drug developments from TheraCour. This MoU expands the Company’s abilities to opportunistically and rapidly develop novel drugs to treat viral infections of public health importance, even for those viruses that do not exist today and cannot be predicted. The MoU has also formalized the process of development of drugs for unlicensed viral indications leading later to appropriate license agreements. There was no compensation paid to or due to TheraCour as a result of this MoU. The Parties have also agreed in this MoU that any cash milestone payments related to development activities, that are awardable, will become payable only upon the Company having sufficient revenue, thus extending the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements.
In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour. Milestone payments were made or are specified in certain of the license agreements, details of which have been disclosed at the time the agreements were entered into. The Company negotiates and licenses specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested.
The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored the NV-CoV-2 (NV-387) into Phase Ia/Ib human clinical trial, to study the safety and tolerability of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies formulations of the API NV-387 in healthy human subjects, described earlier. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive from KMPL a royalty of 70% calculated as the percentage of final invoiced sales less the cost of sales and goods sold to unaffiliated third parties.
Note 2 – Liquidity and Going Concern
The Company’s condensed financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the condensed financial statements, the Company has an accumulated deficit at December 31, 2024 of approximately $144.5 million and a net loss of approximately $5.2 million and net cash used in operating activities of approximately $4.8 million for the six months then ended. In addition, the Company has not generated any revenues andno revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future.
As of December 31, 2024, the Company had available cash and cash equivalents of approximately $4.0 million. The Company’s liabilities at December 31, 2024 were approximately $1.2 million including accounts payable of approximately $252,000 payable to third parties, accounts payable to related parties of approximately $867,000, and accrued expenses of approximately $65,000. Management believes that the Company’s cash and cash equivalents balance of approximately $4.0 million, additional capital raised of approximately $469,000, net of offering expenses, from ATM sales of our common stock during the period from January 1, 2025 through January 6, 2025, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern.
The Company believes that it has several important milestones, building on the successful Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387 as described elsewhere, with further progress of NV-387 into Phase II clinical trials. We are anticipating the Phase Ia/Ib clinical study report (final report or CSR) to be received by us soon. We plan on submitting the CSR to the regulatory authorities in India, which would be a significant milestone in the regulatory progress of NV-387.
Additional milestones include filing of Clinical Trial Application (CTA) for Phase II clinical trial of NV-387 as treatment for MPox, execution of the Phase II clinical trial and attendant top-line readout, and the anticipated successful completion of the clinical trial. The Company anticipates that its Phase II clinical trial will be successful in demonstrating that NV-387 is effective and safe in the treatment of MPox infection, based on the known safety of NV-387 in both animal studies and the observations in Phase I human clinical trial, and the activity of NV-387 against lethal orthopoxvirus infection in animal models that simulate the dermal transfer of infection as well as direct lung infection. Additional milestones include filing of Clinical Trial Application for Phase II clinical trial of NV-387 as treatment for MPox, execution of the Phase II clinical trial and attendant top-line readout, and the anticipated successful completion of the clinical trial. The Company anticipates that its Phase II clinical trial will be successful in demonstrating that NV-387 is effective and safe in the treatment of MPox infection, based on the known safety of NV-387 in both animal studies and the observations in Phase I human clinical trial, and the activity of NV-387 against lethal orthopoxvirus infection in animal models that simulate the dermal transfer of infection as well as direct lung infection. Additionally, the Company continues toward developing the Pre-IND and IND applications for a Phase IIa clinical trial of NV-387 for the treatment of RSV infection in adults, to be followed by a Phase IIb/III clinical trial of NV-387 for the treatment of RSV infection in hospitalized pediatric patients. To this end, the Company is also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans. The Company executes its plans in a manner consistent with available resources, which can lead to reshuffling of priorities in its programs. Nevertheless, the Company has in the past and will continue to progress towards its goal of revolutionizing antiviral therapeutics.
Management believes that as these various milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present.
Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, as well as debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with D. Boral Capital (Formerly EF Hutton LLC), the Sales Agent.
There can be no assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company will need to raise additional capital to fund its long-term operations and research and development plans including human clinical trials for its various drug candidates until it generates revenue that reaches a level sufficient to provide self-sustaining cash flows. There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. The accompanying financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.
Note 3 - Summary of Significant Accounting Policies
Basis of Presentation – Interim Financial Information
The accompanying unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete condensed financial statements. The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The accompanying condensed financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Form 10-K for the fiscal year ended June 30, 2024 filed with the SEC on September 27, 2024.
The June 30, 2024 year-end balance sheet data in the accompanying interim condensed financial statements was derived from the audited financial statements.
For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2024 filed on September 27, 2024.
Net Loss per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants and convertible preferred stock.
The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:
| · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · Potentially Outstanding Dilutive Common Shares | |||||||
| · · For the · · For the · · For the · · For the | |||||||
| · · Three Months · · Three Months · · Six Months · · Six Months | |||||||
| · · Ended · · Ended · · Ended · · Ended | |||||||
| · December 31, 2024 · December 31, 2023 · December 31, 2024 · December 31, 2023 | |||||||
| Warrants | 6,290 | | 7,433 | | 6,290 | | 7,433 |
The Company has 903,603 shares of Series A preferred stock outstanding as of December 31, 2024. Only in the event of a “change of control” of the Company is each Series A preferred share convertible to 3.5 shares of its new common stock. A “change of control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a change of control event, the Series A preferred stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At December 31, 2024, the number of potentially dilutive shares of the Company’s common stock into which these Series A preferred shares can be converted into is 3,162,611, and is not included in diluted earnings per share since the shares are contingently convertible only upon a change of control.
Recently Issued Accounting Pronouncements
The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements.
ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities (PBEs) to disclose, in interim and annual reporting periods, additional information about certain expenses in the notes to financial statements. The requirements of ASU 2024-03 apply to all public business entities. The ASU requires disaggregated disclosure of income statement expenses for public business entities (PBEs). The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income [or loss] by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024. Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
Note 4 - Related Party Transactions
Related Parties
Related parties with whom the Company had transactions are:
| | | |
|---|---|---|
| Related Parties | Relationship | |
| Dr. Anil Diwan | | Chairman, President, CEO, significant stockholder through TheraCour, and Director |
| | | |
| TheraCour Pharma, Inc. (“TheraCour”) | | An entity owned and controlled by Dr. Anil Diwan |
| | | |
| Karveer Meditech, Pvt., Ltd (“KMPL”) | | An entity of which Dr. Anil Diwan is a passive investor and advisor without operating control. |
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · For the three months ended · · For the six months ended | ||||||||
| · December 31, · December 31, · December 31, · December 31, | ||||||||
| | | 2024 | | 2023 | | 2024 | | 2023 |
| Property and Equipment · · · · · · · · · · · | ||||||||
| · · · · · · · · · · · · | ||||||||
| During the reporting period, TheraCour acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company | | $— | | $5,474 | | $46,765 | | $13,765 |
| · · · · · · | ||||
|---|---|---|---|---|
| · · As of | ||||
| | | December 31, | | June 30, |
| · 2024 · 2024 | ||||
| Account Payable – Related Party-TheraCour · · · · · · | ||||
| · · · · · · | ||||
| Pursuant to an Exclusive License Agreement with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. On November 1, 2019, the Company entered into the VZV Licensing Agreement with TheraCour. In consideration for obtaining these exclusive licenses, the Company agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of certain direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) the Company will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on the Company’s behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour and; (4) to pay an advance payment equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses. On February 12, 2024, TheraCour and the Company agreed to suspend the license requirement for a two month advance until the Company raises sufficient capital, therefore there was no advance offset of the accounts payable due TheraCour as of December 31, 2024 and at June 30, 2024. | | $629,416 | | $720,039 |
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, · June 30, | ||||
| | 2024 | 2024 | ||
| Accounts Payable- Related Party-KMPL | | | | |
| · · · · · · | ||||
| KMPL has retained a local clinical research organization (CRO) to conduct the clinical trials. The Phase1 human clinical trial of NV-CoV-2 began in India on June 17, 2023. Under the agreement with KMPL, the Company agreed to pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. In prior periods the amount due KMPL had been accrued and recorded in accrued expenses. At June 30, 2024, the aforesaid clinical trial related costs, of $227,435 were recorded as accrued expense in the accompanying June 30, 2024 balance sheet. The aforesaid clinical trial related costs of $237,367 have since been invoiced and recorded in accounts payable-related parties. Accounts payable to KMPL at December 31, 2024 and June 30, 2024 were: | | $237,367 | | $— |
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| | | For the three months ended | | For the six months ended | ||||
| | | December 31, | | December 31, | | December 31, | | December 31, |
| · 2024 · 2023 · 2024 · 2023 | ||||||||
| Research and Development Costs Related Party · · · · · · · · · · · · | ||||||||
| · · · · · · · · · · · · | ||||||||
| Development fees and other costs charged by TheraCour pursuant to the license agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at December 31, 2024 and June 30, 2024 | | $629,931 | | $682,253 | | $1,274,458 | | $1,321,335 |
| · · · · · · | ||||
|---|---|---|---|---|
| | As of | |||
| · · December 31, · June 30, | ||||
| · 2024 · 2024 | ||||
| Clinical Trial Costs Accrued - Related Party · · · · · · | ||||
| · · · · · · | ||||
| Clinical trial related and other costs were accrued by Company pursuant to the license agreement between the Company and KMPL for the clinical trial related costs that have been incurred but not yet invoiced to the Company for Phase 1a/1b clinical trials in India as of June 30, 2024. The amount has been recorded within accrued expenses in the accompanying balance sheet as of June 30, 2024. The aforesaid clinical trial related costs of $237,367 have since been invoiced and recorded in accounts payable-related party at December 31, 2024. | | $— | | $227,435 |
License Milestone Fee – Related Party
On September 7, 2021, the Company entered into a COVID-19 License Agreement (the “ TheraCour–Nanoviricides COVID License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. Pursuant to such license agreement, the Board of Directors authorized the issuance of 100,000 fully vested shares of the Company’s Series A preferred stock as a license milestone payment and recorded an expense to research and development of $935,088 for the year ended June 30, 2022. On April 20, 2023, the Company was notified that the Company’s licensee, KMPL was authorized to enter into Phase 1a/1b clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the TheraCour–Nanoviricides COVID License Agreement a milestone payment of 50,000 fully vested shares of the Company’s Series A preferred stock was issued as a license milestone payment and recorded as an expense to research and development of approximately $157,000 for the year ended June 30, 2023 representing the fair value of the shares on the date of grant. On June 19, 2023, the Company was notified that the Company’s licensee, KMPL had commenced volunteer recruitments for Phase 1a/1b clinical trials of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. Pursuant to the TheraCour–Nanoviricides COVID License Agreement a milestone payment of $1,500,000 became due 5 days thereafter and was recorded as a non-current liability and research and development expense.
On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award. The Note accrued simple interest at the rate of 12% per annum and was due and payable on January 19, 2025, the maturity date. The principal of the Note was convertible, at TheraCour’s option, into 331,859 shares of the Company’s Series A preferred stock, par value $0.00001 at the conversion price, specified as the fair value of the Series A shares on July 19, 2023 in the terms and conditions contained within the promissory Note. Interest of $49,808 was accrued under the Note for the period June 19, 2023 to October 27, 2023. On October 27, 2023 TheraCour exercised its right to convert the principal of the July 19, 2023 convertible promissory note into 331,859 shares of the Company’s Series A preferred stock. TheraCour cancelled all of the accrued interest on the Note totaling $49,808 which has been reported as a capital transaction credit to additional paid in capital for the year ended June 30, 2024.
On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
Line of Credit - Related Party
On November 13, 2023, the Company’s President and CEO, Dr. Anil Diwan, entered into a Line of Credit Agreement whereby Dr. Diwan agreed to provide a standby Line of Credit to the Company in the maximum amount of $2,000,000. All amounts outstanding under the Line of Credit, including principal, accrued interest and other fees and charges, was due and payable on December 31, 2024. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit will be collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C - 1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. On February 12, 2024 the Company, signed an Extension Agreement which extended the maturity of the Company’s Line of Credit from December 31, 2024 to December 31, 2025.
On September 23, 2024 and becoming effective as of September 20, 2024, the Company, signed an Amendment Agreement which increased the available line of credit from $2,000,000 to $3,000,000, and extended the maturity of the Company’s Line of Credit from December 31, 2025 to March 31, 2026. There wereno other amendments to the original Line of Credit. The Company has not drawn against the Line of Credit facility as of December 31, 2024.
Note 5 - Property and Equipment
Property and equipment, stated at cost, less accumulated depreciation consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · June 30, | ||||||
| · · 2024 · · 2024 | ||||||
| GMP Facility | | $8,168,045 | | $8,168,045 | ||
| | | | | | | |
| Land | | 260,000 | | | 260,000 | |
| | | | | | | |
| Office Equipment | | 77,425 | | | 63,056 | |
| | | | | | | |
| Furniture and Fixtures | | 5,607 | | | 5,607 | |
| | | | | | | |
| Lab Equipment | | 6,501,973 | | | 6,469,578 | |
| | | | | | | |
| Total Property and Equipment | | 15,013,050 | | | 14,966,286 | |
| | | | | | | |
| Less Accumulated Depreciation | | (7,841,185) | | | (7,453,823) | |
| Property and Equipment, Net | | $7,171,865 | | $7,512,463 | ||
Depreciation expense for the three months ended December 31, 2024 and 2023 was $193,816 and $187,262, respectively, and for the six months ended December 31, 2024 and 2023 was $387,362 and $374,320, respectively.
Note 6 – Intangible Assets
Intangible assets, net consists of the following:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · December 31, 2024 · Total · June 30, 2024 · Total | ||||||||||||||||||
| · · Finite Lived · · Indefinite Lived · · December 31, · · Finite Lived · · Indefinite Lived · · June 30, | ||||||||||||||||||
| · · Intangible Assets · Intangible Assets · · 2024 · · Intangible Assets · Intangible Assets · · 2024 | ||||||||||||||||||
| Intangible Assets | | $153,393 | | $305,561 | | $458,954 | | $153,393 | | $305,561 | | $458,954 | ||||||
| Less Accumulated Amortization | | | (137,780) | | | — | | | (137,780) | | | (133,646) | | | — | | | (133,646) |
| Intangible Assets, Net | | $15,613 | | $305,561 | | $321,174 | | $19,747 | | $305,561 | | $325,308 | ||||||
Amortization expense amounted to $2,067 and $2,068 for the three months ended December 31, 2024 and 2023, respectively, and for the six months ended December 31, 2024 and 2023 were $4,134 and $4,135, respectively.
NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. Intangible assets with finite lives, licenses and patent costs, are amortized using the straight- line method over the estimated economic lives of the assets, which range from seventeen totwenty years. The Company’s intangible assets with finite lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.
Intangible assets determined to have indefinite useful lives, primarily patent costs, are not amortized but are tested for impairment annually, or more frequently if events or changes in circumstances indicate the asset may be impaired. The Company accounts for patent costs in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 350-30,General Intangibles Other than Goodwill. The Company will begin amortizing the patent costs when they are brought to the market or otherwise commercialized.
The Company does assess the recoverability of intangible assets with indefinite lives annually in the fourth quarter of each fiscal year, or more often if indicators warrant, by determining whether the fair value of each of the intangible assets, as a unit, supports its carrying value. In accordance with ASC 350, each year the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of each license is less than its carrying amount as a basis for determining whether it is necessary to complete quantitative impairment assessments.
Note 7 – Accrued Expenses
Accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · June 30, | ||||||
| · · 2024 · · 2024 | ||||||
| Personnel and compensation costs | | $26,301 | | $23,532 | ||
| Consultant and other | | | 10,285 | | | 11,500 |
| Clinical trial costs due to KPML | | | — | | | 227,435 |
| Costs related to the sale of securities | | | 28,838 | | | — |
| | | $65,424 | | $262,467 | ||
Note 8 - Equity Transactions
On April 15, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities (now D. Boral Capital), the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agent, shares of common stock having an aggregate offering price of up to $50 million. From July 1, 2024 through December 31, 2024 the Company sold 2,445,660 shares of common stock at an average price of approximately $1.69 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706, which became effective on May 22, 2023). The net proceeds to the Company from the offering was approximately $3,964,000 after placement agent fees and other estimated offering expenses.
The Company accounted for the proceeds of the ATM Offering, approximately, as follows:
| | | | |
|---|---|---|---|
| Gross proceeds | $4,123,300 | ||
| Less: offering costs and expenses | | | 159,300 |
| Net proceeds from issuance of common stock | | $3,964,000 | |
As of July 1, 2024 the Company and Dr. Anil Diwan entered into an extension of his employment agreement for a period ofone year from July 1, 2024 through June 30, 2025 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares shall be vested in quarterly installments of 2,551 shares on September 30, 2024, December 31, 2024, March 31, 2025 and June 30, 2025 and are subject to forfeiture. The Company recognized non-cash compensation expense related to the issuance of the Series A preferred stock of $24,916 for the six months ended December 31, 2024. The balance of $24,916 will be recognized as the remaining 5,102 shares vest and service is rendered for the remaining six months ended June 30, 2025.
For the three and six months ended December 31, 2024, the Company’s Board of Directors authorized the issuance of 387 and 774, respectively of fully vested shares of its Series A preferred stock for employee compensation. The Company recorded expense of $1,547 and $3,497, respectively for the three and six months ended December 31, 2024 related to these issuances.
There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The conversion of the shares is triggered by a change of control. The fair value of the Series A Convertible preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability.
The Scientific Advisory Board was granted in August 2024 fully vested warrants to purchase 286 shares of common stock with an exercise price of $2.35 per share expiring in August 2028 and in November 2024 fully vested warrants to purchase 286 shares of common stock with an exercise price of $1.58 per share expiring in November 2028. The fair value of the warrants was $154 for the three months ended December 31, 2024 and $383 for the six months ended December 31, 2024 and was recorded as consulting expense.
The Company estimated the fair value of the warrants granted to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following ranges:
| | | | |
|---|---|---|---|
| Expected life (year) | 4 | ||
| | | | |
| Expected volatility | | 52.55% - 54.18% | |
| | | | |
| Expected annual rate of quarterly dividends | | 0.00% | |
| | | | |
| Risk-free rate(s) | | 3.845% - 4.285% |
For the three and six months ended December 31, 2024, the Company’s Board of Directors authorized the issuance of 18,470 and 38,183, respectively, fully vested shares of its common stock with a restrictive legend for consulting and legal services. The Company recorded expense of $27,000 and $61,500, respectively, for the three and six months ended December 31, 2024, which is reflective of the fair value of the common stock on the dates of issuance.
For the three and six months ended December 31, 2024, the Company’s Board of Directors authorized the issuance of 7,674 and 13,713, fully vested shares of its common stock with a restrictive legend for director services, respectively. The Company recorded an expense of $11,250 and $22,500 for the three and six months ended December 31, 2024, which is reflective of the fair value of the common stock on the dates of issuance.
Note 9 - Common Stock Warrants
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Weighted · · · · · | ||||||||||
| · · · · Average · · Weighted · · · | ||||||||||
| · · · · Exercise · · Average · · · | ||||||||||
| · · · · Price · · Remaining · · Aggregate | ||||||||||
| · · Number of · · per share · · Contractual Term · · Intrinsic Value | ||||||||||
| Common Stock Warrants · Shares · ($) · (years) · ($) | ||||||||||
| Outstanding and exercisable at June 30, 2024 | | 6,862 | | $3.64 | | 1.67 | | $399 | ||
| | | | | | | | | | | |
| Granted | | 572 | | | 1.97 | | 3.75 | | | — |
| | | | | | | | | | | |
| Expired | | (1,144) | | | 5.53 | | — | | | — |
| Outstanding and exercisable at December 31, 2024 | | 6,290 | | $3.14 | | 1.66 | | $62 | ||
Of the outstanding warrants at December 31, 2024,1,143 expire in fiscal year ending June 30, 2025,2,287 expire in fiscal year ending June 30, 2026,1,144 warrants expire in the fiscal year ending June 30, 2027,1,144 warrants expire in the fiscal year ending June 30, 2028 and 572 warrants expire in the fiscal year ending June 30, 2029.
Note 10 - Commitments and Contingencies
Legal Proceedings
From time to time, The Company is subject to various legal proceedings arising in the ordinary course of business, including proceedings for which The Company has insurance coverage. There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge no action, suit or proceeding has been threatened against the Company that it believes will have a material adverse effect to its business, financial position, results of operations, or liquidity.
Employment Agreements
As discussed in Note 8, as of July 1, 2024, the Company and Dr. Diwan, the Company’s President and Chief Executive Officer, executed an extension of his employment agreement for a period ofone year from July 1, 2024 through June 30, 2025 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2025.
As of July 1, 2024, the Company’s Board of Directors approved the extension of the agreement with Meeta Vyas, Chief Financial Officer of the Company. The Company and Meeta Vyas signed an extension of the agreement for a period ofone year from July 1, 2024 through June 30, 2025 under the same general terms and conditions as the current agreement.
License Agreements
The Company is dependent upon its license agreements with TheraCour (See Notes 1 and 4). If the Company lost the right to utilize any of the proprietary information that is the subject of the TheraCour license agreement on which it depends, the Company will incur substantial delays and costs in development of its drug candidates. On November 1, 2019, the Company entered into a VZV License Agreement with TheraCour for an exclusive license for the Company to use, promote, offer for sale, import, export, sell and distribute products for the treatment of VZV derived indications. Process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed.
On September 7, 2021, the Company entered into a COVID-19 License Agreement to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed.
On March 27, 2023 the Company entered into a license agreement with KMPL wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’stwo clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will receive a customary clinical trials manager fee of thirty percent (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales to unaffiliated third parties.
On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
On September 23, 2024 and effective as of September 20, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the MoU) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive Right of First Refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MoU also clarified the roles and responsibilities of the Parties and essentially codified the process that the parties have adopted since inception. The MoU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID-19 License Agreement.
Note 11 – Subsequent Events
As discussed at Note 8 to the financial statements, on April 15, 2024, the Company entered into a sales agreement with. D. Boral Capital (formerly EF Hutton, LLC), the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock At-the-Market or ATM Offering. From January 1, 2025 through January 6, 2025 the Company sold 310,264 shares of common stock at an average price of approximately $1.56 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended File No. 333-271706, which became effective on May 22, 2023. The net proceeds to the Company from the offering from January 1, 2025 through January 6, 2025 was approximately $469,000 after placement agent fees and other estimated offering expenses.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.