美國證券交易委員會
華盛頓特區 20549
表格
根據1934年《證券交易所法》第1320條或15(d)的季度報告。
根據1934年《證券交易所法》。
截至2024年6月30日季度結束
委員會檔案編號：
（按照章程指定的正式公司名称）
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（註冊地區或其他司法管轄區） |
| (國稅局雇主身份識別號碼) |
成立或組織證明文件) |
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(主要營運地之地址及郵遞區號)
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(Company’s telephone number, including area code)
請在核准符號旁註明：（1）公司在過去12個月（或公司應當提交此類報告的較短期間內）已按照紐交所法案第13或15(d)條的規定提交所有必須提交的報告，並且（2）公司過去90天一直受到此類報告提交要求的約束。
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以檢查標記指示公司是否為較大的加速報表人、加速報表人、非加速報表人、較小的報告公司或新興成長公司。請參見《交易所法》第120億2條對「大型加速報表人」、「加速報表人」、「較小的報告公司」和「新興成長公司」的定義。
大型加速歸檔人 | ☐ |
| 加速歸檔人 | ☐ |
☒ |
| 小型報告公司 | ||
| 新興成長型企業 |
如果一家新興成長型企業，請勾選“是”表示註冊人選擇不使用根據證券交易所法第13(a)條所提供的任何新的或修改後的財務會計準則的延長過渡期來遵守。 ☐
請以勾選符號表示公司是否為貝殼公司（如《紐交所法》第120億2條所定義）。
是的
根據法案第12(b)條規定註冊的證券：
每個類別的標題： |
| 交易標的（s） |
| 在哪些交易所上市： |
截至2023年11月14日，發行並流通的普通股約有
第一部分. 財務資訊
項目1. 財務報表
NanoViricides, Inc.
簡明資產負債表
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2024 |
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資產 | ||||||
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總資產 | $ | | $ | | ||
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負債及股東權益 |
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流動負債： |
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應付賬款-相關方 |
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流動負債總額 |
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承諾事項與可能負擔之事項 |
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股东权益： |
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A系列可轉換優先股， $ |
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普通股, $ |
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資本公積額額外增資 |
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累積虧損 |
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負債和股東權益總額 | $ | | $ | | ||
請參閱附帶的簡明基本報表註釋
2
NanoViricides, Inc.
營運報表
(未經審計)
截至三個月 | ||||||
九月三十日， | ||||||
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營業費用 |
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研發 | $ | | $ | | ||
一般及行政費用 |
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利息收入 |
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利息支出 | — | ( | ||||
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其他費用，淨額 |
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淨虧損 | $ | ( | $ | ( | ||
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每普通股淨損 - 基本及攤薄 | $ | ( | $ | ( | ||
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加權平均已發行普通股-基本及攤薄 |
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請參閱相關的基本報表附註
3
NanoViricides, Inc.
Statement of Changes in Stockholders’ Equity
For the three months ended September 30, 2024
(Unaudited)
Series A Preferred | Common Stock: | ||||||||||||||||||
Stock: Par $0.00001 | Par $0.00001 | ||||||||||||||||||
Number | Number | Additional | Total | ||||||||||||||||
of | of | Paid-in | Accumulated | Stockholders’ | |||||||||||||||
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Balance, June 30, 2024 |
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Proceeds from sale of common stock in connection with equity financings net of issuance costs of $ | — | — | | | | — | | ||||||||||||
Series A preferred stock issued for employee stock compensation |
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Common stock issued for consulting and legal services rendered | — | — | | — | | — | | ||||||||||||
Warrants issued to Scientific Advisory Board | — | — | — | — | | — | | ||||||||||||
Common shares issued for Directors fees | — | — | | — | | — | | ||||||||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Balance, September 30, 2024 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
See accompanying notes to the financial statements
4
NanoViricides, Inc.
Statement of Changes in Stockholders’ Equity
For the three months ended September 30, 2023
(Unaudited)
Series A Preferred | Common Stock: | ||||||||||||||||||
Stock: Par $0.00001 | Par $0.00001 | ||||||||||||||||||
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of | of | Paid-in | Accumulated | Stockholders’ | |||||||||||||||
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Balance, June 30, 2023 |
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Series A preferred stock issued for employee stock compensation |
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Common stock issued for consulting and legal services rendered | — | — | | | | — | | ||||||||||||
Warrants issued to Scientific Advisory Board | — | — | — | — | | — | | ||||||||||||
Common shares issued for Directors fees | — | — | | — | | — | | ||||||||||||
Net loss | | | | | | ( | ( | ||||||||||||
Balance, September 30, 2023 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
See accompanying notes to the financial statements
5
NanoViricides, Inc.
Statements of Cash Flows
For the Three Months Ended | ||||||
| September 30, | |||||
2024 |
| 2023 | ||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||
Net loss | $ | ( | $ | ( | ||
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Adjustments to reconcile net loss to net cash used in operating activities |
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Preferred shares issued as compensation |
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Warrants granted to Scientific Advisory Board | | | ||||
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Changes in operating assets and liabilities: |
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Other assets |
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Accounts payable - related parties |
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Accrued expenses |
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NET CASH USED IN OPERATING ACTIVITIES |
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CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||
Purchase of property and equipment | ( | ( | ||||
NET CASH USED IN INVESTING ACTIVITIES | ( | ( | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
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Net proceeds from sale of common stock | | | ||||
NET CASH PROVIDED BY FINANCING ACTIVITIES | | | ||||
NET CHANGE IN CASH AND CASH EQUIVALENTS |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period | $ | | $ | | ||
NON CASH FINANCING AND INVESTING ACTIVITIES: | ||||||
Related party non-current liability converted to note payable | $ | | $ | | ||
Forgiveness of interest in related party debt | $ | | $ | | ||
See accompanying notes to the financial statements
6
NANOVIRICIDES, INC.
September 30, 2024
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(Unaudited)
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 1st and ends on the next June 30th of the calendar year. The Company operates in
The Company devotes substantially all its activity to advancing research and development, including efforts in connection with clinical trials. The Company’s lead drug candidate is the active pharmaceutical ingredient (API) NV-387. NV-387 is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies and is being developed to treat Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox. The Company plans on developing NV-387 first as a treatment of RSV infection in pediatric patients.
At present, NV-387 is in a Phase Ia/Ib human clinical trial for safety and tolerability in healthy subjects for the treatment of COVID-19, sponsored by our licensee and collaborator in India, Karveer Meditech Privale Limited (“KMPL”). All subjects have been discharged and follow-up visits have been completed as of approximately the end of December 2023. 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 of tolerability of the API NV-387. These results are consistent with the results of safety/tolerability studies in animals conducted in support of the clinical trial application. The Company is awaiting the final study report from this clinical trial for further regulatory advancement of NV-387 into a Phase II clinical trial.
The Company is now working on developing the necessary datasets, documentation, and clinical trial pathway and trial designs, for a Phase II clinical trial application for the use of NV-387 for the treatment of RSV infection, as the Phase Ia/Ib study progresses into the data analysis phase.
On August 14, 2024, the WHO declared a Public Health Emergency of International Concern (PHEIC) regarding the expanding epidemic of MPox infections in Central Africa. There is no drug currently available for the treatment of MPox. NV-387 has been found to possess activity against orthopoxvirus infection in animal model studies, making it a viable candidate for clinical trial as a treatment for MPox infection under the MEURI (“Monitored Emergency Use of Unregistered and Investigational Interventions”) WHO protocol. The Company is now in the process of defining a clinical protocol for such a Phase II clinical trial with its collaborators in preparation for a clinical trial application to the appropriate regulatory agency.
Subsequent to the MPOx and RSV Phase II clinical trials that are at high priority, the Company plans on expanding the indications of NV-387 to other respiratory viral infections including Influenzas, Coronaviruses, and others.
Additionally, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans on taking 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, 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.
7
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 don’t 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
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 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 royalties from KMPL equal to
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 September 30, 2024 of approximately $
As of September 30, 2024, the Company had available cash and cash equivalents of approximately $
8
The Company believes that it has several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387. This Phase Ia/Ib human clinical trial is for evaluating the safety and tolerability of two oral formulations of NV-387, namely (i) NV-CoV-2 Oral Gummies, and (ii) NV-387 Oral Syrup, as described elsewhere, with COVID as the indication. The safety and tolerability data from this clinical trial is expected to be applicable as Phase Ia/Ib data for other indications of NV-387 as well, including RSV, MPOX, Influenza and others. Additional milestones include Pre-IND and IND filing to the US FDA for RSV and clinical trial application for Phase II clinical trial of NV-387 for the treatment of RSV infection in adults with the goal towards further regulatory advancement and approval of NV-387 for the treatment of pediatric RSV infection. Additionally, the Company believes that NV-387 qualifies for a Phase II clinical trial for the treatment of MPOX infection in Central African nations under the MEURI protocol of WHO because there is no other treatment available for this epidemic that is declared by the WHO as a public health emergency of international concern (MEURI = Monitored Emergency Use of Unregistered and Investigational Interventions.). We plan on initiating the Phase II study for MPOX as soon as feasible if the Company receives the appropriate regulatory clearances. 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.
Management believes that as these 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, 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 EF Hutton, 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 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 of Financial Condition and Results of Operations” 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.
9
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 | |||
Three Months | Three Months | |||
Ended | Ended | |||
| September 30, 2024 |
| September 30, 2023 | |
Warrants |
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The Company has
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
10
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 his ownership of TheraCour, and Director |
TheraCour Pharma, Inc. (“TheraCour”) |
| An entity owned and controlled by Dr. Anil Diwan |
Karveer Meditech Private Limited (“KMPL”) |
| An entity where Dr. Anil Diwan is a passive investor and advisor without operating control |
11
For the three months ended | ||||||
| September 30, |
| September 30, | |||
2024 | 2023 | |||||
Property and Equipment |
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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 | $ | | $ | | ||
As of | ||||||
September 30, | June 30, | |||||
| 2024 |
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Accounts Payable – Related Party | ||||||
Pursuant to an Exclusive License Agreement entered into 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 it was agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than | $ | | $ | | ||
For the three months ended | ||||||
September 30, | September 30, | |||||
| 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. | $ | | $ | | ||
| As of | |||||
September 30, |
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| 2024 |
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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. The amount has been recorded within accrued expenses in the accompanying balance sheet | $ | | $ | | ||
12
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
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 accrues simple interest at the rate of
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 R. 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 $
On September 23, 2024 and becoming effective as of September 20, 2024, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Amendment Agreement which increased the available line of credit from $
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Note 5 - Property and Equipment
Property and equipment, stated at cost, less accumulated depreciation consisted of the following:
| September 30, |
| June 30, | |||
2024 | 2024 | |||||
GMP Facility | $ | | $ | | ||
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Land |
| |
| | ||
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Office Equipment |
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Furniture and Fixtures |
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Lab Equipment |
| |
| | ||
Total Property and Equipment |
| |
| | ||
|
| |||||
Less Accumulated Depreciation |
| ( |
| ( | ||
Property and Equipment, Net | $ | | $ | | ||
Depreciation expense for the three months ended September 30, 2024 and 2023 was $
Note 6 – Intangible Assets
Intangible assets, net consists of the following:
| September 30, 2024 |
| September 30, 2024 |
| Total |
| June 30, 2024 |
| June 30, 2024 |
| Total | |||||||
Finite Lived | Indefinite Lived | September 30, | Finite Lived | Indefinite Lived | June 30, | |||||||||||||
Intangible Assets | Intangible Assets | 2024 | Intangible Assets | Intangible Assets | 2024 | |||||||||||||
Intangible Assets | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Less Accumulated Amortization |
| ( |
| — |
| ( |
| ( |
| — |
| ( | ||||||
Intangible Assets, Net | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Amortization expense amounted to $
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 to
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.
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Note 7 – Accrued expenses
Accrued expenses consisted of the following:
| September 30, |
| June 30, | |||
2024 | 2024 | |||||
Personnel and compensation costs | $ | | $ | | ||
Consultant |
| |
| | ||
Clinical trial costs due to KMPL |
| |
| | ||
$ | | $ | | |||
Note 8 - Equity Transactions
On April 15, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities, 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 $
The Company accounted for the proceeds of the ATM Offering, approximately, as follows:
Gross proceeds |
| $ | |
Less: offering costs and expenses | | ||
Net proceeds from issuance of common stock | $ | |
As of July 1, 2024 the Company and Dr. Anil Diwan entered into an extension of his employment agreement for a period of
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of
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
15
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 assumptions:
Expected life (year) |
|
| |
| |||
Expected volatility |
| | % |
| |||
Expected annual rate of quarterly dividends |
| | % |
| |||
Risk-free rate(s) |
| | % |
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of
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 |
| | $ | |
| $ | | |||
|
| |||||||||
Granted |
| |
| |
|
| | |||
Expired |
| ( |
| |
| — |
| | ||
Outstanding and exercisable at September 30, 2024 |
| | $ | |
| $ | | |||
Of the outstanding warrants at September 30, 2024,
Note 10 - Commitments and Contingencies
Legal Proceedings
From time to time, we are subject to various legal proceedings arising in the ordinary course of business, including proceedings for which we have 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 we believe will have a material adverse effect to our 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 of
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 of
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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’s
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. E.F. Hutton Securities (now 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 October 1, 2024 through November 7, 2024 the Company sold
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the information contained in the condensed financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in the Company’s Annual Report on Form 10-K for the year ended June 30, 2024. Readers should carefully review the risk factors disclosed in the Company’s Form 10-K and other documents filed by the Company with the SEC.
As used in this report “Safety”, “Efficacy”, “Effectiveness” and related terms refer to the results of the Company’s research studies and these statements have not been evaluated by regulatory bodies including the US FDA that have the authority for the purpose of commercial use of the drugs.
As used in this report, the terms “Company”, “we”, “our”, “us” and “NNVC” refer to NanoViricides, Inc., a Delaware corporation.
PRELIMINARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact made in this report are forward looking. In particular, the statements herein regarding industry prospects and future results of operations or financial position are forward-looking statements. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “Company believes,” “management believes” and similar language. These forward-looking statements can be identified by the use of words such as “believes,” “estimates,” “could,” “possibly,” “probably,” “anticipates,” “projects,” “expects,” “may,” “will,” or “should,” or other variations or similar words. No assurances can be given that the future results anticipated by the forward-looking statements will be achieved. Forward-looking statements reflect management’s current expectations and are inherently uncertain. The forward-looking statements are based on the current expectations of NanoViricides, Inc. and are inherently subject to certain risks, uncertainties and assumptions, including those set forth in the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. Actual results may differ materially from results anticipated in these forward-looking statements. We base the forward-looking statements on information currently available to us, and we assume no obligation to update them.
Investors are also advised to refer to the information in our previous filings with the Securities and Exchange Commission (SEC), especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more detail various important factors that could cause actual results to differ from expected or historic results. It is not possible to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive statement of all risks and uncertainties or potentially inaccurate assumptions.
Organization and Nature of Business
NanoViricides, Inc. (the “Company”, “NanoViricides”, “we,” or “us”) was incorporated in Nevada on April 1, 2005, and redomiciled to Delaware effective May 30, 2023. Our corporate offices are located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137. Our Website is located at http://www.nanoviricides.com. We do not incorporate by reference into this Quarterly Report the information on or accessible through our website, and you should not consider it part of this Quarterly Report.
On September 25, 2013, the Company’s common stock began trading on the New York Stock Exchange American under the symbol, “NNVC”.
We are a clinical stage company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling the virus without assistance from the human immune system. As a host-mimetic, viruses cannot escape a nanoviricide drug by generating mutants and variants in the field, because all variants still require the same signature host features that our drugs mimic. In contrast, vaccines, antibodies and small chemical drugs are readily escaped by viruses as mutations occur, rendering these medical countermeasures ineffective. This was repeatedly observed in the recent COVID pandemic. As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response.
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These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine design. After decades of development, this novel nanoviricide technology has now successfully reached clinical stage.
Broad and Long Pipeline for Sustained Commercial Success and Cures of Viral Infections
NV-387, our most advanced drug candidate, administered orally, has successfully completed Phase I human clinical trial for the evaluation of safety and tolerability in healthy subjects. There were no reported adverse events, and the drugs were well tolerated even at the highest level of dosing given multiple times in this trial.
We are now preparing for Phase II human clinical trials to assess effectiveness of NV-387 treatment in a number of different viral diseases in humans. We plan to further develop NV-387, as an ultra-broad-spectrum antiviral medication to treat a number of viral infections including Coronaviruses (SARS-CoV-2, MERS-CoV, Seasonal Coronaviruses, hCoV-NL63), Respiratory Syncytial Virus (RSV), Influenza Viruses, and possibly other respiratory viral infections, thus covering all of the “tripledemic” viruses and more with this single drug.
We plan on Phase II clinical trial of NV-387 for the treatment of RSV infection, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV. RSV is an important disease particularly for infants and children under 6 years of age, as well as for older persons and immunocompromised patients. The market size for RSV is estimated at $2.6 Billion in 2024, growing to $4.3 Billion in three years, at a rate of 18.9% as reported by GrowthPlusReports (https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519). There are two protective antibodies and two protective vaccines, approved in the U.S. but no drug for the treatment of RSV infection, other than the last resort toxic drug ribavirin.
We believe NV-387 can meet the challenge of becoming an effective treatment for MPox infection that is currently ravaging in multiple nations in Central Africa. WHO declared a Public Health Emergency of International Concern for MPox on August 14, 2024. The current strain of the virus, MPXV Clade 1 and 1b, is thought to be more severe than the Clade 2 strain that resulted in a global PHEIC in July 2022, which was declared over in May, 2023. Clade 1b is more transmissible than Clade 1 and Clade 2, and is also causing more pediatric infections. (https://www.who.int/news/item/14-08-2024-who-director-general-declares-MPox-outbreak-a-public-health-emergency-of-international-concern).
There is no drug for the treatment of MPox infection in this public health emergency. Tecovirimat (TPOXX®, SIGA), a drug approved for smallpox under the US FDA “Animal Rule” protocol, was found to be safe and well tolerated but not superior to standard of care in a clinical trial assessing its effectiveness to treat MPox viral infection caused by Clade 1/1b that was co-sponsored by NIAID/NIH (https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo).
We believe that NV-387 would be eligible for a Phase II clinical trial to assess its effectiveness against MPox infection under the MEURI protocol of WHO (MEURI = “Monitored Emergency Use of Unregistered and Investigational Interventions”, https://en.wikipedia.org/wiki/Monitored_Emergency_Use_of_Unregistered_and_Investigational_Interventions”, especially given the failure of tecovirimat in the clinical trial. We believe that if successful in a Phase II clinical trial, NV-387 would also be approvable for the treatment of smallpox.
SIGA Technologies, Inc. has received procurement orders for tecovirimat from US Government alone for over $250 million in 2023-2024, illustrative of the market size of an effective drug against poxviruses (www.siga.com, various press releases). Smallpox is an important disease from biodefense perspective, and the US BARDA (Biomedical Advanced Research and Development Authority) has new drug development for smallpox as an important objective.
In addition, we plan on pursuing NV-387 as a treatment for Influenza virus infections. NV-387 was found to be superior in activity against Influenza A/H3N2 lethal lung infection in comparison to the three approved drugs oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, BioCryst), and baloxavir (Xofluza®, Shionogi/Roche) in an animal model.
We believe NV-387 would be effective against H5N1 bird flu as well. Also we believe NV-387 would be effective against influenza viruses resistant to available drugs.
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The market size for Influenza and Bird Flu is estimated at $4.6 Billion in 2024, growing to an estimated $5.9 Billion in three years, at a rate of 8.5% as reported by DelveInSight (https://www.delveinsight.com/report-store/influenza-a-infections-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr). In case a pandemic occurs, reality may outrun such projections by magnitudes, as was seen with the COVID pandemic.
We developed NV-387 to mimic the host-side features of sulfated proteoglycans (“S-PG”) such as heparan sulfate proteoglycan (HSPG). Over 90% of human pathoneic viruses are known to use HSPG as the first attachment site to cause infection into human cells. Thus, NV-387 is designed to have an extremely broad range of viruses against which it could be potentially clinically active.
Indeed, NV-387 has been found to have strong activity in lethal animal models of several viral diseases. Its activity was evident from NV-387-treated animals demonstrating significant increase in survival lifetime, as well as protection of lungs and reduction of clinical pathologies caused by the different viruses we have tested to date.
This extremely broad antiviral spectrum of NV-387 is reminiscent of the broad antibacterial spectrum of antibiotics such as penicillin and we believe NV-387 could revolutionize the treatment of viral infections the same way that penicillin revolutionized the treatment of bacterial infections.
Antibiotics such as penicillin directly attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to directly attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed, ultra-broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.
A safe and effective antiviral drug, when approved, with an extensive broad-spectrum activity across multiple, distinct, virus families as observed for NV-387, is an unmet medical need. Currently available broad-spectrum antivirals such as Remdesivir, Ribavirin, Cidofovir, etc. suffer from extensive and varied dose-limiting toxicities, and thereby present limitations on eligible patient populations as well as on clinical effectiveness.
In addition to NV-387, we have developed NV-HHV-1, a drug for the treatment of HSV-1 (“cold sores”), HSV-2 (“genital ulcers”), and VZV (“Shingles”, “chickenpox”) that mimics the host-side feature of the HVEM host protein that is required by all of these viruses for cell entry and infection. NV-HHV-1 formulated as skin cream has substantially completed IND-enabling studies for the treatment of Shingles rash. We plan to pursue clinical trials and regulatory approval of NV-HHV-1 after NV-387 undergoes a Phase II clinical trial.
We are also developing an oral drug for the systemic treatment of most of the herpesvirus family related infections, including HSV-1 cold sores, HSV-2 and VZV that is based on the same active ingredient as NV-HHV-1. Further, we have drug candidates in HIVCide™ program that have shown substantial antiviral activities in animal studies warranting further clinical development. We have previously worked on Ebola virus drug development, as well as Dengue virus drug development, which are at an early stage.
The global Herpes Simplex Virus treatment market size was estimated at $2.47 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 8.1% from 2024 to 2030, according to Grand View Research (https://www.grandviewresearch.com/industry-analysis/herpes-simplex-virus-treatment-market-report).
In addition, with the goal of curing virus infections, we have developed novel platform technologies. Under these technologies, we have developed several other drug candidates that are at different preclinical drug development stages in our pipeline.
Thus, we have developed a strong pipeline of drug candidates that, we anticipate, will yield new drug candidates over a very long timeframe into the future, and, we expect, will enable cures of many currently non-curable viral diseases.
The drug development process is long and expensive. We do not have any approved drugs on the market as of now. We have no customers, products or revenues to date, and may never achieve revenues or profitable operations. We continue to add to our existing portfolio of products through our robust internal discovery and clinical development programs.
We believe we have developed several assets worthy of partnering for further regulatory development and commercialization. We seek to partner and out-license our drug candidates for these purposes. Such partnering may potentially involve initial license fees, milestone payments, and royalty payments to us that could result in an early revenue stream prior to commercial product sales.
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We plan on seeking non-dilutive grant and contracts funding for our drug candidates that are responsive to bio-defense and pandemic-preparedness objectives.
There is no guarantee that we will be successful in partnering our drug candidates or obtaining non-dilutive funding for furtherance of our drug development programs. To date, we have financed our drug development programs using equity-based financing from the sale of our shares in private and public transactions including registered direct offerings as well as “At the Market” (ATM) offerings.
NV-387, a First-of-a-Kind, Novel, Ultra-Broad-Spectrum Antiviral Nanomedicine
NV-387 was designed to be and has been found to be an ultra-broad-spectrum antiviral, reminiscent of antibiotics. So far it has been evaluated for antiviral activity in animal models of Coronavirus, RSV, Smallpox, and Influenza infections. In all cases the studies demonstrated extremely positive results for NV-387 treatment that matched or exceeded corresponding available therapeutics or positive controls.
1. Coronaviruses: NV-387 was found to effectively reduce the cytopathic effects caused by coronaviruses in cell culture studies without cellular toxicity. It was also found to suppress infection of cells by SARS-CoV-2 pseudovirion as much as a control antibody. NV-387 was found to significantly increase the lifespan of rats infected lethally into the lungs with the coronavirus hCoV-NL63, a model virus stand-in for SARS-CoV-2. Further, the increase in lifespan upon NV-387 Intravenous (“IV”) administration was substantially greater than that obtained with remdesivir IV administration. Additionally, NV-387 given orally also increased the lifespan by more than that seen with remdesivir IV administration.
2. RSV: Oral dosing with NV-387 led to full survival of mice lethally infected with RSV/A2 to cause severe lung disease, whereas the only available drug against RSV, namely ribavirin, showed a limited increase in lifespan. The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all time points during the study, whereas animals in the ribavirin-treated group showed progressive pathology, eventually leading to death. Ribavirin is a highly toxic drug and is given only as a last resort. Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer). Abrysvo was recently approved for use in pregnant women for protection of infants. A new antibody, nirsevimab (Beyfortus®) was approved for protection of newborn children at risk of RSV disease, but not for treatment. There is no approved drug for the treatment of RSV infection, other than the last resort drug, ribavirin that has limited effectiveness.
Survival Lifespan of Lethally Infected Mice - Lung Infection with RSV A2 | |||||
|---|---|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, | ||
NV-387, Oral | 22+ (Complete) | > | 14 | > | 175% |
Ribavirin, Oral | 14 | 6 | 75% | ||
Vehicle | 8 | 0 | 0% | ||
3. Smallpox/MPox: Oral dosing with NV-387 led to an increase in lifespan of mice lethally infected with ectromelia virus (a cousin and model stand-in for smallpox/MPox viruses) into lungs that was comparable to treatment with tecovirimat (TPOXX®, SIGA). In addition, we also found that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment. This model is relevant to the skin-abrasion mode of MPox transmission that was found to be dominant in the recent MPox pandemic, and is also found to be operative in the current Congo MPox epidemic. Tecovirimat, approved for Smallpox treatment under the FDA “Animal Rule”, is currently stockpiled under the US Strategic National Stockpile.
4. Influenza: Oral dosing with NV-387 led to a substantially increased lifespan of mice lethally infected with Influenza A/H3N2 compared to the increase in lifespan afforded by treatment with Oseltamivir (Tamiflu®, Roche), Peramivir (Biocryst), or Baloxavir (Xofluza®, Shionogi, Roche), approved drugs against influenza viruses.
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Survival Lifespan of Lethally Infected Mice - Lung Infection with Ectromelia Virus | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, |
NV-387, Oral | 15 | 7 | 88% |
Tecovirimat, Oral | 16 | 8 | 100% |
NV-387 + Tecovirimat, Oral | 19 | 11 | 138% |
Vehicle | 8 | 0 | 0% |
NV-387 treated animals showed significant reduction in immune infiltration into lungs. Killer immune cells that migrate in response to infection can kill lung epithelial cells leading to lung damage. Lung mucus index was also significantly reduced upon NV-387 treatment. These effects indicate that NV-387 is beneficial in reducing lung disease pathology.
NV-387 Treatment Significantly Protected Lungs of Balb-c Mice | ||
|---|---|---|
Treatment | Lung Mucus Index | % Immune Cell Infiltration |
NV-387, Intravenous | 32 | 22% |
NV-387, Oral | 53 | 31% |
Untreated Infected Control | 138 | 68% |
Knowing the broad-spectrum nature of NV-387, we anticipate that NV-387 would possess clinically relevant antiviral activity against the HPAI (Highly Pathogenic Avian Influenza) viruses including H5N1 “Bird Flu”.
We note that all three approved influenza drugs oseltamivir, peramivir and baloxavir are known to be prone to viral escape by mutations. In contrast, NV-387 as a host-mimetic is highly unlikely to be escaped by the susceptible viruses.
Oseltamivir-resistant mutants are known and have spread across the world. Resistance to oseltamivir also generates resistance to Peramivir because the two drugs share the same mechanism of action. Baloxavir clinical trial demonstrated generation of resistant influenza viruses in 2.2% of treated patients. Thus, an escape-resistant drug that we believe NV-387 is, is sorely needed in the face of potential prospects of a resistant bird flu or influenza epidemic.
Given that, in each of these studies, we have compared the results of treatment with NV-387 with those of approved drugs, and found NV-387 treatment to be superior. We believe that NV-387 has strong prospects for regulatory approval in each of these indications.
Novel Orthogonal Nanoviricide Mechanism Has Many Benefits
Additionally, the NV-387 putative mechanism of action is orthogonal and complementary to that of the existing therapeutics, enabling combination therapy with the existing drugs in the market. NV-387 acts on the free virus outside cells blocking infection of new cells by destroying the virus. Existing antiviral therapeutics (except antibodies and entry inhibitors) act on the replication cycle of the virus (ex.: remdesivir, acyclovir, ribavirin, cidofovir, brincidofovir) inside cells, or exiting of the virus (ex.: oseltamivir, peramivir, tecovirimat) from inside cells. Thus combining the action outside the cells of NV-387 with the action inside the cells (or at exit) of these existing agents is expected to lead to complete blockage of any virus thus resulting in a rapid and complete cure. Combining multiple drugs also leads to reduction in emergence of viral resistance, as has been scientifically proven already.
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Nanoviricides Can Encapsulate Small Chemicals as Guests, Enabling Improved Pharmacokinetics and thus Activity of the Guest
Further, NV-387 also acts as a unique and novel drug delivery vehicle, similar in action to exosomes. Thus, encapsulation of remdesivir in NV-387 enabled oral delivery of NV-387 and the activity of the resulting drug, NV-387-g-Rp, given orally in lethally infected animals, was found to be superior to that of each of NV-387 and remedesivir (Veklury®, Gilead).
We have also developed our own, patent-pending replication inhibitor antiviral agents that can be encapsulated in NV-387 for improved antiviral activity in animal models, with the objective of curing long-term (long COVID) and lifelong (HSV-1, HSV-2, VZV, others) viral infections.
Clinical Development Program: NV-387 Phase I Clinical Trial
In the Phase I human clinical trial, even at the highest dose level, dosed multiple times, NV-387 was found to be well tolerated, and there were no reported adverse events of the drug that was given orally.
This clinical trial finding is consistent with the findings that the evaluation of safety of NV-387 in pre-clinical studies demonstrated a No-Observed-Adverse-Effects-Level (NOAEL) at 1,200 mg/Kg, and the Maximum Tolerable Dose level (MTD) at 1,500 mg/Kg in rats, which are very high numbers (high is good).
Further, NV-387 was found to be non-mutagenic, non-immunogenic, non-allergenic, and non-genotoxic in IND-enabling studies.
We therefore anticipate that NV-387 can be given to patients across all patient population, in age from infants to seniors, including immunocompromised persons, patients with co-morbidities, and others, when approved. This is in contrast to available antiviral therapeutics that, limited by their toxicity and metabolic effects, cannot be given to many pools of patients.
Further Clinical Development of NV-387 Towards Drug Approvals: Multiple Indications for NV-387 Against Different Viral Infections Enable Maximizing Return on Investments While Fulfilling Unmet Medical Needs
We intend to initiate a Phase II clinical trial in India shortly after the Phase I final report becomes available. We are in discussions with subject matter experts in India regarding the best indication to go with in Phase II; RSV and Influenza being some of the choices.
We also plan on initiating a Phase IIa clinical trial of NV-387 for the treatment of RSV infection under the US FDA (see further below). We are in the process of developing a Pre-IND application to the US FDA for this purpose. Our overall objective of the program is to evaluate NV-387 for commercialization as a treatment of infants to young children. We believe that our Phase IIa clinical trial design will enable us to proceed to a Phase II/III registration clinical trials in infants and young children with RSV infection. This is an unmet medical need.
Each year in the United States, RSV leads to approximately 2.1 million outpatient (non-hospitalization) visits among children younger than 5 years old, resulting in 58,000-80,000 hospitalizations among children younger than 5 years old, and 100–300 deaths in children younger than 5 years old, according to the CDC (https://www.cdc.gov/rsv/research/index.html).
In light of the WHO public health emergency declaration regarding the MPox epidemic in Central Africa, we have begun efforts to progress NV-387 for Phase II evaluation of efficacy in the treatment of MPox virus infection. This is an unmet medical need since there is no drug available for the treatment of MPox infection given the failure of tecovirimat in clinical trial.
Additionally, we anticipate that NV-387 would be expected to be eligible for the development of Poxvirus therapeutics under the FDA “Animal Rule”. The Animal Rule program requires well-controlled GLP studies in specific animal poxvirus infection models as replacement of the Phase II/III human clinical trials, and expanded Phase I human clinical trials to elucidate safety of the drug in human use. We plan to seek non-dilutive government funding for this indication.
Multiple indications of NV-387 enable us to maximize return on investments. The Phase I safety and tolerability clinical trial would be generally applicable across all indications. All of IND-enabling non-clinical studies would also be reused, with the addition of animal model antiviral activity studies for the specific indication. The Chemistry, Manufacture, and Controls for the drug substance would remain substantially the same and potentially the drug product sections also could be reused.
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Multiple Formulations Enable Treatment of All Segments of Patient Population with Varying Disease Severity, from Mild to Moderate to Severe and Hospitalized
We have successfully developed NV-387 formulations for different severities of viral diseases, and with different patient populations in mind. These include:
(i) | Oral “Gummies” for adults and older children. Oral gummies have an advantage over tablets in that the drug dissolves slowly in the mouth and does not require swallowing. Older adults as well as children with certain respiratory infections are known to have difficulty swallowing. |
(ii) | Oral Syrup. In infants and younger children, the drug must be “titrated” on the basis of body weight or a similar parameter. A syrup form is best suited for this purpose. |
(iii) | Solution for Injection, Infusion or Inhalation. For hospitalized patients with severe disease, injections and infusions are better suited to provide immediate antiviral action. A simple inhalation of the same solution using a standard available nebulizer enables direct delivery to lower respiratory system where the virus is causing lung damage that can lead to lung failure and potentially death. |
Unique, Novel Design Leading to Broad-Spectrum Activity of NV-387
NV-387 has such broad-spectrum activity because it is designed to mimic the attachment receptors to which viruses bind before infecting a cell. The family of attachment receptors mimicked by NV-387 is called Sulfated Proteoglycans (S-PG). This family includes glycosaminoglycans (“GAG”s), and proteoglycans containing heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (CSPG), among others.
Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Chickengunya Virus, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, and Poxviruses, among others (Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472). Thus, a large number of virus families use these S-PG family attachment receptors to concentrate next to cells and thereby efficiently infect cells, with different virus families having preferences to one or more of such attachment factors.
We believe our unique and successful mimicking of S-PG is responsible for the observed broad-spectrum activity of NV-387. NV-387 is an example of NanoViricides Platform Modality #1 implementation discussed in our Annual report filed with the SEC on September 27, 2024
Virus Escaping a Nanoviricide Drug is Unlikely
The NanoViricides Platform Technology has an important advantage in that no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug, because the nanoviricide drug is designed to mimic the very features that the virus uses to bind to and enter cells. These specific molecular signature features on the cellular side do not change even as the virus mutates, and nanoviricides are designed to mimic these host-side features. In contrast viruses readily escape antibodies as drugs, as well as vaccine-induced immunity as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.
A safe and effective antiviral drug that the virus would not escape by mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
Further details of the NanoViricides Platform Technology, the various Modalities of its implementation, and the extensive drug candidate developments that we have undertaken, have been discussed in our Annual Report filed with the SEC on September 27, 2024.
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cGMP-Compliant Manufacture of Nanoviricide Drug Candidates in Our Own Facility
NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. We have designed and developed a cGMP-capable drug substance and drug product manufacturing facility at our headquarters in Shelton, CT. The manufacturing facility comprises a Scale-Up Suite, Clean Room Suites (Class 1000 and Class 100) for Manufacture of the Drug Substances, and Formulation and Packaging Suites for our Drug Products.
We believe our capabilities in manufacturing clinical drug products are now well established. We have manufactured multi-Kg scale clinical supply of drug substances as well as the oral drug products for NV-CoV-2 at our own facility, from synthesis all the way to fill-finish-labeling and packaging, simplifying and expediting the cGMP-compliant manufacturing operations.
Our team has successfully and rapidly translated from the research scale production of several grams drug substance to Kg-scale cGMP-compliant manufacture for two different drug candidates, namely NV-HHV-1 and NV-CoV-2, in three different formulations, namely skin cream, oral syrup, and oral gummies, in a very short time span. This includes manufacture of the active ingredients (drug substances), the formulated drug products, and packaged drug products for clinical trials usage.
Manufacturing nanomedicines, especially under cGMP conditions, has been identified as a major risk, and has led to failure of several nanomedicines programs. NanoViricides co-founder Dr. Anil Diwan and our team have employed considerations for cGMP manufacture of our nanomedicines right from the design, development and optimization of the drug candidates, the polymers and ligands that go into them, as well as the processes employed right from the small research scale to the initial process verification batches.
We have thus demonstrated that we have unique expertise in the industry of performing cGMP-compliant manufacture of multiple complex nanomedicine drugs, including cGMP manufacture of (a) drug substance from simple chemical starting materials, (b) the formulated drug product, and (c) the final packaged drug. This is a very significant milestone on the way of NanoViricides becoming a fully integrated pharma company.
We continue to improve the production processes and production scale. Our production capacity is anticipated to be more than sufficient for Phase I, Phase II and Phase III human clinical trials for all of our drugs in development.
We believe that our drug manufacturing capacity is sufficient for initial market entry for our anti-RSV drug when approved.
Our in-house cGMP production capability has resulted in and is expected to continue to result in significant cost savings across all our drug development programs.
NanoViricides is Fully Equipped for Rapid Antiviral Drug Development from Discovery to cGMP Drug Product Delivery for Clinical Trials; Which Makes NanoViricides a “FIPCO”
In addition to the manufacturing facility, we have on site specialized nanomedicines characterization facility with advanced instrumentation including Wyatt Dynamic Light Scattering instruments, Mass Spectrometry Equipment with “Multiple Reaction Monitoring (MRM)” capability, and others.
We also have on site full-fledged chemistry laboratories to enable drug design, discovery, small scale synthesis, testing, and scale-up of drug candidates worthy of further development.
We also have our own BSL2 Virology Lab for initial evaluation of our drug candidates in cell culture and other in vitro studies.
Thus we are a “Fully-Integrated-Pharmaceutical Company” (FIPCO) unlike most biopharma companies that do not possess the full suite of drug discovery, synthesis, testing, characterization, scale-up, as well as drug substance and drug product manufacture capabilities in house.
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High Probability of Success in Clinical Trials for Drugs Based on NanoViricides Platform Technology
We are now a clinical stage innovative drug development company, advancing from the research and development (“R&D”) stage into regulatory development of our drug candidates towards commercialization. We have been executing rapidly and efficiently, as well as in a cost-effective and productive manner, resulting in successful completion of the Phase I Safety and Tolerability clinical trial of our drug candidate, NV-CoV-2 (API NV-387). We believe that this successful completion with no reported adverse events, which is the most desirable outcome from Phase I clinical trial to establish safety and tolerability of the drug candidate NV-387 is a very important milestone enabling NV-387 to advance for multiple antiviral indications into Phase II efficacy clinical trials. Additionally, this Phase I bodes well for our entire platform technology as being capable of producing drug candidates that are capable of successfully completing Phase I safety and tolerability studies.
In addition, our pre-clinical lethal virus infection animal model studies provide us the confidence that the drug candidates we advance into Phase II efficacy clinical trials would have a high probability of success. This is because in these animal studies, the animal model plays the role of a “test tube” where the virus can proliferate, and our drugs are designed to directly attack the virus without interfering with functions of the host animal. Additionally, we design the studies to provide clear readout in terms of survival lifespan that can be used for ranking the activity of each tested drug, including already approved drugs where available.
Our non-clinical programs are designed to minimize the risk of failure of our drug candidates in clinical trials. Specifically, we perform evaluation of antiviral activity in lethal studies in direct comparison with known approved drugs if available, and choose drug candidates that show at least comparable or superior activity to the approved ones. We employ lethal infection studies so that the survival time is a clear indicator of the antiviral activity, and can be used to rank relative activity of drug candidates. We believe our success rate of drug approval would be substantially better than industry averages because of the features of our nanoviricides platform technology and the de-risking strategies we employ in drug development.
The NanoViricides Platform Technology: (i) Solving the Problem of Drug Escape by Virus Variants
We believe that our platform technology enables development of drugs that viruses would not escape from. In fact, during the pre-clinical development in the COVID program, we have successfully screened our drug candidates to be able to protect cells against infection by distinctly different coronaviruses. This broad-spectrum, pan-coronavirus drug development approach was adopted to ensure that our drug candidates should remain effective even as variants of SARS-CoV-2 continue to evolve in the field, just as we had already anticipated at the very beginning of the pandemic.
Our nanoviricides™ platform technology is based on biomimetic engineering that copies the features of the human cellular receptor of the virus. No matter how much the virus mutates, all virus variants bind to the same receptor in the same fashion. Thus our platform technology is inherently designed to combat the issue of viruses escaping drugs by generation of variants.
We mimic the feature on the cellular protein at which the virus binds, and, using molecular modeling, design small molecules that act as “ligands” to bind to the virus surface glycoproteins as though the virus was binding to that cellular protein itself. This host-side chemical signature that the virus uses for infecting cells does not change even as the virus mutates, evolves and generates variants. We chemically synthesize the optimal ligands, and separately attach them to the polymeric micelle scaffold to generate a number of initial “nanoviricide” drug candidates to screen against the virus. Thus the nanoviricide is designed to “look like” the cell membrane with copious amounts of sites for the virus to bind to. When initial interaction of a few ligands with the virus particle takes place, the “metstable” nanoviricide micelle is anticipated to shift its shape, inverting itself onto the virus particle promoted by the “lipid-lipid mixing effect” driven by the lipid chains normally on the interior of a nanoviricide micelle and the lipid membrane that is on the virus surface. Such an attack on the virus particle is expected to de-stabilize the virus particle and uproot the surface glycoproteins it uses for fusing with a cell. Thus the virus would no longer be capable of infecting a cell. This process would result in complete blockage of the “Re-Infection Cycle” of the virus if successful. We call this mechanism “Re-Infection Inhibition”. This mechanism goes beyond the simple neutralization of the virus by antibodies, which requires the human immune system to further take care of the resulting virus-antibody complex. This mechanism also goes beyond the simple blocking of virus entry by small chemical entry inhibitors, which would require extremely high concentrations of the inhibitor to effect complete blockage of each virus particle based on mass-action considerations.
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The nanoviricide polymeric micelle is expected to be able to completely coat the virus particle. This is unlike the antiviral antibodies as well as small molecule entry inhibitors that can only partially block the virus particle whereby the virus would still remain capable of infecting a cell. Additionally, antibodies only tag the virus for recognition by the patient’s immune system for clearance. In contrast, a nanoviricide is designed to complete the task of dismantling the machinery of the virus that enables it to infect cells.
Mimicking the attachment receptor families may lead to extremely broad-spectrum drug candidates. We call this implementation NanoViricides Platform Technology Modality #1. NV-387 is an example of this Modality #1, namely, Broad-Spectrum Antiviral Re-infection Inhibitors. NV-387 is designed to mimic key features required by viruses of the host-side sulfated proteoglycans that viruses use as attachment receptors.
Mimicking the cognate receptor would lead to a narrower range but can be anticipated to have greater efficacy compared to mimicking the attachment receptor families. We call mimicking the cognate receptor the NanoViricides Platform Technology Modality #2, or Specific Antiviral Re-Infection Inhibitors.
The NanoViricides Platform Technology: (ii) Promising Potential Cures for Infections by Non-latency Viruses
Additionally, we are the only company that, to the best of our knowledge, is developing antiviral treatments that are designed to (a) directly attack the virus and disable it from infecting human cells (i.e. block the “Re-Infection Cycle”), and (b) simultaneously block the reproduction of the virus that has already gone inside a cell (i.e. block the “Replication Cycle”). Together, this strategy of a two-pronged attack against the virus, both inside the cell and outside the cell, and thus blocking the complete lifecycle of the virus, can be expected to result in a cure for coronaviruses and other viruses that do not become latent. We call this implementation, namely encapsulation of other active ingredients within the polymeric micelle of the virus-targeted nanoviricide (which can be based on either Modality #1 or Modality #2), the NanoViricides Platform Technology Modality #3.
As an example of the Modality #3, we have developed NV-387-g-R, which comprises NV-387 that encapsulates Remdesivir, a known broad-spectrum antiviral drug that is already approved for COVID treatment of hospitalized patients. Although approved, the clinical effectiveness of Remdesivir is limited by its bodily metabolism. It is well known that this drug is highly active in cell culture studies, but the clinical results do not match the expectations corresponding to its cell culture effectiveness. We developed NV-387-g-R to overcome this issue and we have demonstrated that encapsulation within NV-387 successfully improves the PK/PD (pharmacokinetics and pharmacodynamics) profile of Remdesivir. The increased circulating lifetime and also concentration of intact Remdesivir should improve its effectiveness. Additionally, NV-387-g-R affords the synergistic effects of attacking the virus lifecycle by two orthogonal mechanisms, going well beyond the effects of Remdesivir alone. In NV-387-g-R, one component, NV-387, is designed to block the “Re-Infection Cycle”, and the encapsulated guest component, Remdesivir is known to block the “Replication Cycle”. Thus NV-387-g-R is designed to block the entire lifecycle of many viruses, not just coronaviruses.
This total attack on the complete lifecycle of the virus is expected to result in the most effective drug candidates. It is now well accepted that multiple antivirals together produce better effectiveness than single ones individually. Our strategy goes beyond simply a mix of multiple antivirals. Our unique, shape-shifting nanomedicine technology leads to substantial improvement in the pharmacokinetic properties of the guest antiviral drug. We have demonstrated this capability in the case of NV-387-g-R, as discussed above, wherein encapsulation of Remdesivir within the polymeric micelles of NV-387 protects the former drug from bodily metabolism in animal studies. This allows higher concentrations of the guest drug to be reached and simultaneously extends the effectiveness time period in comparison to the standard Veklury® (Gilead) formulation. The resulting drug, NV-387-g-R has not only significantly improved characteristics for its Remdesivir component, but additionally provides the novel re-infection blocking mechanism of NV-387; together enabling complete block of the viral lifecycle, which would potentially result in a cure. (Chakraborty A, Diwan A, Chiniga V, Arora V, Holkar P, Thakur Y, et al. (2022) Dual effects of NV-CoV-2 biomimetic polymer: An antiviral regimen against COVID-19. PLoS One 17(12): e0278963. https://doi.org/10.1371/journal. pone.0278963.)
The NanoViricides Platform Technology: (iii) Routes of Administration Include Oral Route
It is generally believed that nanomedicines as a class would not have good bio-availability if taken orally. We believe that this biased opinion has unnecessarily resulted in curbing potential innovation to overcome the issue of oral bioavailability.
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In fact, we have found in pre-clinical animal studies that NV-387 was highly effective when given orally in combating a lethal lung infections that models the severe SARS-CoV-2 disease as seen with the delta variant. In comparing the effect on combating the infection by oral treatment versus injectable treatment, we believe that the bioavailability of the oral dosage forms is substantially good, and in the range of many approved oral drugs. In addition, the API NV-387 was found to be highly effective when given orally in the case of lethal lung RSV infection animal model, a lethal smallpox-emulating ectromelia footpad infection mouse model, a lethal smallpox-emulating ectromelia lung infection mouse model, as well as a lethal Influenza A/H3N2 lung infection mouse model, further substantiating the oral bio-availability of NV-387.
These findings have enabled us to develop oral formulations of NV-387 for human clinical trials. We have successfully developed orally active formulations of our NV-387 in an oral syrup form, as well as an oral gummies (“Chewable Soft Solids”) form. We believe that for mild to moderate viral infection disease, for pediatric, and for geriatric patients, the oral syrup and gummies forms would be highly advantageous over tablets, capsules, injections, infusions, or lung inhalations.
The injectable formulation of NV-387 is expected to be valuable in the treatment of severe cases. Out-patient single dose injection treatment may be feasible if the effectiveness of NV-387 in human clinical trials matches that observed in pre-clinical animal studies. Further, this injectable formulation is designed to be deliverable also as an aerosol by a simple hand-held nebulizer device directly into lungs. Such inhalation, as an aerosol, is expected to provide greater benefits to more severe patients by providing high concentration of the drug locally in the lungs where the RSV, SARS-CoV-2, and Influenza viruses cause the most damage in severe cases. The Solution for Injection, Infusion and Inhalation of NV-387 would also be very important in pediatric as well as hospitalized cases.
We believe that the extremely strong antiviral activity we have observed in cell culture studies and in lethal virus infection animal studies, in comparison to approved drugs is a strong positive indication of clinical success and potential regulatory approval of NV-387 for the different viral infection indications we are seeking.
We believe we have demonstrated that we can rapidly develop different types of formulations for different routes of administration, such as injectable, skin cream, lotion, gel, and even oral, because of the inherent strength of the flexible and tailorable Nanoviricide Platform technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.
A Note on Nomenclature of NanoViricides Candidates:
“g” denotes that the next component is encapsulated as a guest within the preceding nanoviricide. Thus NV-387-g-R refers to Remdesivir encapsulated as a guest within NV-387. Similarly NV-387-g-Rp refers to a pro-drug of Remdesivir (denoted Rp) is encapsulated as a guest within NV-387.
“m” denotes that the next component is mixed in with the preceding nanoviricide. Thus NV-387-m-T refers to NV-387 and Tecovirimat mixed together in a formulation method.
Developments During the Reported Period
During the three months ended September 30, 2024, we have focused on preparing regulatory documentation that will be necessary for primarily (i) a Phase II MPox clinical trial of NV-387, and (ii) a Phase II RSV clinical trial of NV-387. We are in the process of designing a Phase II clinical trial protocol for the treatment of MPox infection with NV-387 under the MEURI guidelines. We have also started working on a Phase II clinical trial protocol for the treatment of RSV infection.
In addition, we have continued to further scale-up the manufacture of NV-387 in our cGMP-compliant facility, effectively doubling the prior batch size, in preparation for supplying the drug products for the Phase II clinical trials. We believe this scale will be sufficient for a Phase II clinical trial for MPox or for a Phase II clinical trial for RSV. We will commission additional batches as we engage into additional clinical trials.
We have initiated the production program for Phase II clinical supply of NV-387 drug products.
We are also performing additional pre-clinical experiments to further understand the spectrum of antiviral activity of NV-387 towards obtaining information for regulatory advancement against different antiviral indications.
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In the non-clinical studies leading to the Phase I clinical trial, NV-387 was found to be non-immunogenic, non-allergenic, non-mutagenic, as well as non-genotoxic. No adverse effects were reported in GLP Safety-Toxicology studies in multiple animal models including non-human primates (NHP, Cynomolgus monkeys). The NOAEL (No-Observed-Adverse-Events-Level) was 1,200 mg/Kg and MTD (Maximum Tolerable Dose) was 1,500 mg/Kg in rats, which are very high numbers (high is good).
A Phase I clinical trial of (i) NV-387 Oral Syrup and (ii) NV-387 Oral Gummies formulations to evaluate Safety and Tolerability in healthy human subjects was completed with the discharge and final visit of the last subject at the end of December, 2023. There were no reported adverse events, and there were no drop-outs in this clinical trial of 72 subjects. Thus, the drug NV-387, in both of the oral formulations studied, namely oral syrup and oral gummies (a soft solid form that dissolves in the mouth), is deemed to be safe and well tolerated and can be further advanced into Phase II clinical trials, as per communications with the Data Safety and Monitoring Board (DSMB) for this clinical trial. We are awaiting a final report of the clinical trial. This statement regarding safety and tolerability will be evaluated, after we submit the final Phase I report, by the regulatory agency.
The results of the Phase I clinical trial are consistent with our non-clinical findings.
Thus NV-387 can now be advanced into Phase II human clinical trials against the different antiviral indications within its antiviral activity spectrum.
Update on Our COVID Program
The original plan for the Phase 1a/1b clinical trial was to include COVID patients in Phase 1b-COVID cohorts to obtain initial indications of efficacy and dosage requirement. The healthy injected portion of the clinical trial, which is the traditional Phase I clinical trial involving the evaluation of single-ascending-dose and multiple-ascending dose of the investigational medical product in healthy subjects was completed in December, 2023. Thereafter, efforts to find COVID patients were continued, and an additional clinical site was added during February 2024. In spite of this, the lack of obtaining PCR-positive COVID patients eligible for enrollment into the clinical trial became the obstacle. Our diligent efforts to identify COVID-19 participants for the clinical trial have been met with a notable absence of positive cases at the designated clinical trial site(s). Therefore, the Phase 1a/1b clinical trial was closed in April 2024, concluding the study as a traditional Phase I study.
We note that we do not have any information regarding the activity of NV-387 (drug product NV-CoV-2) in COVID from this clinical trial because no COVID patients could be found for enrolment in the study. We believe that NV-387 has strong, clinically relevant, activity in treatment of COVID based on our pre-clinical studies that directly evaluated the activity of NV-387 in comparison with remdesivir, an approved drug for the treatment of COVID, and found that the activity of NV-387 was substantially superior to that of remdesivir.
We have been in discussion with subject matter experts in the U.S. as well regarding potential clinical trials towards approval of NV-387 for COVID indication. While COVID still continues to be important globally, the prospect of conducting meaningful clinical trials in COVID patients has become substantially difficult. Long COVID remains an important disease in the U.S.. However, it is multi-factorial, and conducting meaningful clinical trials is even more difficult than with COVID patients, and could result in lengthy and expensive clinical trial designs, not within the capabilities of small companies like us.
Therefore, while we fully believe that (i) NV-387 has demonstrated strong pan-coronavirus antiviral activity in pre-clinical studies and therefore (ii) NV-387 is a viable clinical drug candidate for COVID treatment; (iii) NV-387 could be substantially superior to available drugs such as remdesivir and Paxlovid®; and (iv) NV-387 would be available to the entire patient population while the available drugs have severe limitations, regrettably, we have determined that we cannot take NV-387 forward for COVID indication with our limited resources.
If resources become available for clinical trial of NV-387 for a subset of Long COVID patients with residual virus found in sensitive assays, then we would very much like to advance clinical trials to develop NV-387 for the Long COVID indication. This continues to be an unmet medical need.
We are seeking to advance NV-387 for COVID and Long COVID indications via partnerships.
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NV-387 Has Multiple Antiviral Indications Beyond COVID towards Regulatory Approvals
Knowing that NV-387 is designed to be broad-spectrum, over the previous three months we have continued to work towards understanding the extremely broad spectrum of antiviral activity of the API NV-387.
Of the potential indications, we have decided to focus our resources on advancing NV-387 into clinical trials towards approval for RSV infection in pediatric patients, an unmet medical need.
The results of the NV-387 Phase 1a/1b clinical trial indicate that NV-387 can be used: (i) across all ages from pediatrics to seniors; (ii) irrespective of co-morbidities such as diabetes, other pre-existing diseases, or immune compromised status of the individual; and (iii) at all levels of disease severity, from mild/moderate to severe to very severe (hospitalized patients).
This capability of NV-387 is analogous to the highly successful antibiotics against bacteria.
In contrast, currently available antiviral drugs have substantial limitations on the patient populations that they can be used in. For example, of the two remaining approved drugs for treatment of COVID, Paxlovid which is given orally, is not indicated for the treatment of COVID in patients without a risk factor for progression to severe COVID-19, whereas Remdesivir can only be used in hospitalized cases. Similarly ribavirin, indicated for RSV infection and other viral infections, is only indicated as a last resort because of severe toxicities. Other antivirals such as Cidofovir, Brincidofovir, etc. also have limitations due to toxicities.
RSV causes severe infections primarily in infants and young children, persons over age of 60 and immune-compromised persons. Each year in the United States, an estimated 58,000–80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood acute lower respiratory infection (ALRI, which includes pneumonia) and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3.2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.
However, there are no safe and effective therapeutics for RSV to date. Ribavirin, a highly toxic drug, is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), and recently approved Beyfortus (nirsevimab) are antibodies approved only for prophylactic use in children and infants at high risk of severe RSV infection, but neither is approved for treatment of RSV infection, which remains an unmet medical need.
Our press release regarding NV-387 activity against a lethal lung infection animal model of smallpox/MPox in comparison to the approved drug tecovirimat was published on May 8, 2024 via AccessWire.
Our press release regarding NV-387 activity leading to complete survival of animals in a lethal lung infection animal model of RSV in comparison to the toxic drug ribavirin was published on May 14, 2024 via AccessWire.
Our Other Drug Development Programs
NV-HHV-1, Our Drug Candidate for Treatment of Shingles Rash
Previously, we have developed a clinical drug candidate NV-HHV-1 and formulated it as a skin cream for the treatment of Shingles. We plan on undertaking clinical trials of NV-HHV-1 after NV-387 RSV Phase II clinical trials. We have performed cGMP-like manufacture of both the active pharmaceutical ingredient (the API in NV-HHV-1 i.e. NV-360), and the fully formulated skin cream (the drug product candidate), at our own facilities at ~1Kg scale (API basis) with attendant significant time, project management, and cost savings as opposed to going to an external contract manufacturer. Approximately 10Kg of fully formulated drug product was manufactured. We believe this scale is sufficient for the requirements of Phase I and Phase II human clinical trials of NV-HHV-1.
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Previously, NV-HHV-1 was found to have antiviral activity against HSV-1 as well as HSV-2 in animal models. The antiviral ligand in NV-HHV-1 is designed to mimic the host protein HVEM (HerpesVirus Entry Mediator) that almost all herpesvirus family viruses use for cell entry as a cognate receptor. We plan on pursuing indications of NV-HHV-1 skin cream formulation for the treatment of (i) Shingles rash (VZV), (ii) Chickenpox rash (VZV), (iii) HSV-1 “cold sores”, and (iv) HSV-2 “genital ulcers”.
In addition, we are also developing a systemic drug for the treatment of herpesvirus family infections, based on the same API NV-360 that we believe will be superior to acyclovir related drugs, the current workhorse drugs for HSV-1 and HSV-2. While acyclovir and related drugs are also given for severe shingles, they do not work very well. This is because these drugs require first phosphorylation by the viral Thymidinylate Kinase (v-TK) enzyme, which is not very active in VZV.
Other Pre-clinical Drug Programs
We also have drug candidates against HIV that have shown antiviral activity in cell culture studies as well as in SCID-hu-Thy-Liv mouse model studies. We plan on undertaking further development of the HIV drug in partnership because of the expensive nature of the development.
Additionally, we have developed drug candidates in the past against several other viral infections including Influenza viruses, H5N1 bird flu virus (successful cell culture studies using two different H5N1 strains in Vietnam), Adenoviral epidemic kerato-conjunctivitis (EKC) (successful animal study in rabbits). We also have drug development programs to treat Dengue viruses and Ebola/Marburg viruses.
All of our drug programs are established to target what we believe are unmet medical needs.
Both the safety and effectiveness of any new drug has to be determined experimentally. The safety of a nanoviricide drug is expected to depend upon the safety of the nanomicelle portion as well as the safety of the antiviral ligand. We have observed excellent indications in the evaluation of safety of our broad-spectrum antiviral drug candidate NV-387 as well as that of NV-360, our herpesvirus family specific antiviral drug candidate to date in non-clinical studies including IND-enabling safety pharmacology studies. Further, NV-387 has successfully completed Phase 1 human clinical trial with no adverse events, indicating an excellent level of safety. The final determination of safety and efficacy of a drug rests with the regional drug regulatory authority such as the US FDA, EU EMEA, India CDSCO/DCGI, UK MHRA and others.
Our timelines depend upon several assumptions, many of which are outside the control of the Company, and thus are subject to delays.
We are currently focused on the development of NV-387 with the goal of the treatment of pediatric RSV infection with urgency. Further, we continue to perform pre-clinical investigations to expand the usage of NV-387 as an antiviral drug against other viruses to improve return on investment, ROI. Additionally, we are also performing topical drug development against several indications related to infections by herpes family viruses.
Our Campus in Shelton, CT
Our campus at Shelton, CT, is fully operative. With our R&D discovery labs, analytical labs, the bio labs for virology R&D, the process scale-up production facility, and the cGMP-capable manufacturing facility established at our Shelton campus, we are in a strong position to move our drug development programs into the clinic rapidly.
Process Scale-Up Production Capability
The process scale-up area is operational at kilogram to multi-kg scales for different chemical synthesis and processing steps. It comprises reactors and process vessels on chassis or skids, ranging from 250mL to 100L capacities, as needed. Many of the reactors and vessels have been designed by us for specific tasks related to our unique manufacturing processes.
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cGMP Production Capability
Our versatile, customizable cGMP-capable manufacturing facility is designed to support the production of multi-kilogram-scale quantities of any of our nanoviricides drugs. In addition, it is designed to support the production of the drug in any formulation such as injectable, oral, skin cream, eye drops, lotions, etc. The production scale is designed so that clinical batches for Phase I, Phase II, and Phase III can be made in this facility. The clean room suite contains areas suitable for the production of sterile injectable drug formulations, which require special considerations.
We also have a manufacturing suite for cGMP-compliant Oral Drug Product Formulation, Fill, and Packaging. We manufactured and delivered the clinical NV-387 oral syrup and oral gummies (semi-solids) drug products in this suite using equipment that we had custom-designed and fabricated in the U.S.
We plan to produce multiple batches of a drug product in our facility. At the appropriate time as required we plan to register the facility as a cGMP manufacturing facility with the FDA.
Our BSL-2 Certified Virology Lab
We have significantly enhanced our internal anti-viral cell culture testing capabilities at our Shelton campus. Our Virology Research Lab suite has a BSL-2 (Biological Safety Level 2) certification from the State of Connecticut. This suite comprises three individual virology workrooms, enabling us to work on several different viruses and strains at the same time. This facility is designed only for cell culture studies on viruses, and no animal studies can be conducted at any of our own facilities.
We have established several different types of assays for screening of drug candidates against Coronaviruses, SARS-CoV-2 Pseudovirions, VZV, HSV-1, HSV-2, Influenza viruses, RSV, Ectromelia virus (a stand-in for MPox and Smallpox viruses), among others in this lab. Our BSL-2 Virological capability has been instrumental in our rapid development of potential drug candidates for further investigation towards human clinical trials. We believe that having developed the internal capabilities for cell culture testing of our ligands and nanoviricides against a variety of viruses has substantially strengthened and accelerated our drug development programs.
NanoViricides Business Strategy in Brief
We intend to perform the regulatory filings and own all the regulatory licenses for the drugs we are currently developing. We will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials. We plan to market these drugs either on our own or in conjunction with marketing partners. We also plan to actively pursue co-development, as well as other licensing agreements with pharmaceutical companies. Such agreements may entail up-front payments, milestone payments, royalties, and/or cost sharing, profit sharing and many other instruments that may bring early revenues. Such licensing and/or co-development agreements may shape the manufacturing and development options that we may pursue. There can be no assurance that we will be able to enter into co-development or other licensing agreements.
We have kept our capital expenditures to a minimum in the past, and we intend to continue to do the same, in order to conserve our cash for drug development purposes, and in order to minimize additional capital requirements.
As a risk factor, we have limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development.
We plan to take NV-387 into Phase II/III clinical trials for treatment of RSV infections. We plan on obtaining non-dilutive funding for the poxvirus drug development program. We plan on seeking partnerships for our COVID program as well as our RSV, Poxvirus, and other programs, as these programs mature further.
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We have previously substantially completed IND-enabling studies for a drug candidate for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). We plan on taking the shingles drug candidate into human clinical trials after phase II clinical trials of our NV-387 drug candidate for RSV.
As a risk factor, we recognize that the FDA may require additional studies to be done before approving the IND for any of our programs. Assuming that the FDA allows us to conduct human clinical studies as we intend to propose, we believe that this coming year’s work plan will lead us to obtain certain information about the safety and efficacy NV-387 in human clinical studies for the treatment of RSV and/or MPox infection. If our studies are not successful, we will have to develop additional drug candidates and perform further studies. If our studies are successful, then we expect to be able to undertake further additional studies as necessary towards drug approval or licensure from regulatory agencies.
As a strategy, we plan to develop the same drug, once initial clinical trials towards a first approval of the drug are completed, for commercial approval for additional indications, such as pediatric applications, special case applications for certain classes of immuno-compromised patients, among others, provided that appropriate levels of funding is available. We believe that adding further indications would significantly expand market penetration and improve return on investment for our drugs.
Collaborations, Agreements and Contracts
On March 27, 2023, we entered into a License Agreement (the “Agreement”) with Karveer Meditech Private Limited, India (“KMPL”), whereby we granted to KMPL a limited, non-transferable, exclusive license for the development and commercialization and further use, sale, or offer of sale of the Licensed Product(s) NV-CoV-2 and NV-CoV-2-R (the “Two Clinical Test Drug Candidates”) in the Territory of India, and as part of the drug evaluation and development, KMPL agreed to sponsor the clinical test drug candidates for Phase I and Phase II clinical trials and act as clinical trials manager. The Company shall have rights to the data generated by KMPL in the clinical trials for use in other jurisdictions, and KMPL shall provide the Company with applicable reports and data. The license conveyed pursuant to the Agreement shall have no set term, and will continue for the period during which KMPL uses the Company’s proprietary technologies. In return, the Company will reimburse KMPL for all direct and indirect costs incurred for the clinical trials, as well as a customary fee of 30% of such costs. Further pursuant to the Agreement, KMPL shall pay the Company 70% of any invoiced commercial net sales of either or both of the Two Clinical Test Drug Candidates to unaffiliated third parties; there will be no minimum royalties, nor any license maintenance fees. KMPL is a related party in that Dr. Anil Diwan, our President, co-founder, and Executive Chairman, is also a co-founder and passive investor in KMPL.
KMPL has successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 that contains the active ingredient NV-387, as a COVID treatment in India, on or about January 30, 2023. Previously, on September 15, 2021, we signed a Master Services Agreement with KMPL in which KMPL declared its intent to license NV-COV-2 and NV-CoV-2-R (both of which contain the active ingredient NV-387; NV-CoV-2-R being remdesivir encapsulated within NV-387) for commercialization in India, and undertook the responsibility to obtain necessary licenses and regulatory approvals as would be needed for the clinical evaluation and commercialization of the drugs in India. No binding licensing activity took place under that earlier agreement. Subsequently KMPL proceeded to develop and file the required regulatory documents including a clinical trials application with the regulatory authority in India. KMPL has retained a local clinical research organization (CRO) for the purpose of developing such documents and planning and executing the clinical trials. We helped KMPL with assembling the necessary datasets and information. Around June, 2023, began the Phase 1a/1b clinical trial of NV-CoV-2. The healthy subjects part of the single ascending dose (“SAD”) and the multiple ascending dose(“MAD”) clinical trial cohorts were completed at the end of December, 2023. KMPL and we spent the next several months in an attempt to initiate the COVID-patient part of the proposed Phase 1a/1b. However, by the time we were able to obtain the required approvals for engaging a different clinical site where COVID patients existed when we initiated our efforts, the COVID wave was gone and it did not become possible to recruit COVID patients. The clinical trial was therefore completed as safety and tolerability study of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies in healthy subjects only.
We have not engaged any other new collaborators during the reported quarter.
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Patents, Proprietary Rights: Intellectual Property – Recent events
NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. We intend to obtain a license for poxviruses, enteroviruses, RSV and other viruses that we engage into research for, if the initial research is successful. TheraCour has not denied any licenses requested by us to date. Our business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at the Company’s foundation in 2005.
In September 2021, we entered into a world-wide, exclusive, sub-licensable, license, 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. These licenses are not limited to underlying patents, but also include the know-how, trade secrets, and other important knowledge base that is utilized for developing the drugs and making them successful. In addition, these extremely broad licenses are not limited to some specific chemical structures, but comprise all possible structures that we could deploy against the particular virus, based on these technologies. Further, the licenses are held by NanoViricides for worldwide use. These are described in our most current Annual Report.
COVID Related Drugs: Patent Coverage and Lifetime
Two International PCT patent applications have been filed relating to the application of the TheraCour polymeric micelle technology to drug development for Coronavirus antiviral drugs including ones for the treatment of COVID. PCT/US21/39050 was filed on June 25, 2021. Additionally, PCT/US22/35210 was filed on June 28, 2022, with a request for the same priority date as that of the prior PCT/US21/39050 application. These broad patents cover new compositions of matter, methods of making them (processes), drug formulations, and uses of the articles of manufacture. The patents resulting from these are expected to have expiry dates extending at least into the year 2043, with additional specific extensions possible in various countries based on regulatory extensions for pharmaceutical products. All ensuing patents will be automatically exclusively licensed to NanoViricides for anti-coronavirus drugs pursuant to the COVID-19 License Agreement.
We have licenses to key patents, patent applications and rights to proprietary and patent-pending technologies related to our compounds, products and technologies, but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.
Table 1: Update on recent Intellectual Property, Patents, and Pending Patents Licensed by the Company
PCT/US21/39050 - SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTI-COVID-19 AGENTS | Applied: June 25, 2021 | Ca. 2043 (estimated) | PCT Application filed. | TheraCour Pharma, Inc. [Exclusive License]. |
PCT/US22/35210 – SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTI-COVID-19 AGENTS (**) | Applied: June 28, 2022 | Ca. 2043 (estimated) | PCT Application filed, | TheraCour Pharma, Inc. [Exclusive License]. |
**: The PCT application PCT/US22/35210 was filed with request for priority of PCT/US21/39050. | ||||
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Analysis of Financial Condition, and Result of Operations
As of September 30, 2024, we had cash and cash equivalents of $3,866,289, prepaid expenses of $175,133 and net property and equipment of $7,365,681. Accounts payable and accrued expenses were $1,632,706, inclusive of accounts payables to a related party of $636,550. Stockholders’ equity was $10,107,791 at September 30, 2024. In comparison, as of June 30, 2024, we had $4,797,778 in cash and cash equivalents, prepaid expenses of $172,742 and $7,512,463 of net property and equipment. Our liabilities at June 30, 2024 were $1,358,776 including accounts payable of $376,270 payable to third parties and accounts payable to TheraCour of $720,039, and accrued expenses of $262,467.
During the three month period ended September 30, 2024, we used approximately $2.6 million in cash toward operating activities. This was substantial greater than the prior one year ago period primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II.
During the three month period ended September 30, 2023, we used approximately $1.2 million in cash toward operating activities.
Research and Development Costs
We do not maintain separate accounting line items for each project in development. We maintain aggregate expense records for all research and development conducted. Because at this time all of our projects share a common core material, we allocate expenses across all projects at each period-end for purposes of providing accounting basis for each project. Project costs are allocated based upon labor hours performed for each project. Far fewer man-hours are spent on the projects at low priority than the projects at high priority. In the reported quarter, we have focused exclusively on our NV-387 drug development program. We have continued to work on development of documents for initiating a Phase II clinical trial for using NV-387 as a treatment for MPox infections in Central Africa, and on developing a Phase II clinical trial application for the development of NV-387 for the treatment of pediatric RSV infections in the U.S..
Results of Operations
Revenues The Company is a biopharmaceutical company and did not have any revenue for the three month periods ended September 30, 2024 and 2023.
Research and Development Expenses – Research and development expenses for the three months ended September 30, 2024 increased $466,426 to $1,933,091 from $1,466,665 for the three months ended September 30, 2023. The increase in research and development expenses for the three months ended September 30, 2024 is due to an increase in laboratory fees.
General and Administration Expenses – General and administrative expenses for the three months ended September 30, 2024 increased $699,817 to $1,234,743 from $534,926 for the three months ended September 30, 2023. The increase in general and administrative expenses for the three months ended September 30, 2024 is due to an increase in professional fees associated with investor outreach.
Interest Income – Interest income for the three months ended September 30, 2024 decreased $58,315 to $41,023, from $99,338 for the three months ended September 30, 2023. The decrease in interest income for the three months ended September 30, 2024 is due to a decrease in cash balances during the three month period ended September 30, 2024.
Interest Expense – Interest expense for the three months ended September 30, 2024 decreased $36,493 to $0.00 from $36,493 for the three months ended September 30, 2023. The decrease in interest expense for the three months ended September 30, 2024 is a result of the interest accrued on the $1,500,000 convertible promissory note issued in lieu of a cash milestone payment. On October 27, 2023, TheraCour cancelled all of the accrued interest on the Note and converted the principal of the Note to Series A preferred shares.
Income Taxes – There is no provision for income taxes due to ongoing operating losses.
Net Loss – For the three months ended September 30, 2024, the Company had a net loss of $3,126,811 or $0.23 per share compared to a net loss of $1,968,746 or $0.17 per share for the three months ended September 30, 2023. The increase in the net loss for the periods presented is attributable to the factors discussed above.
Liquidity and Capital Resources
As of September 30, 2024 we had $3,866,289 in cash and cash equivalents.
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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 September 30, 2024 of approximately $142.5 million and a net loss of approximately $3.13 million and net cash used in operating activities of approximately $2.6 million for the three months then ended. In addition, the Company has not generated any revenues and no 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 September 30, 2024, the Company had available cash and cash equivalents of approximately $3.9 million. The Company’s liabilities at September 30, 2024 were approximately $1.6 million including accounts payable of approximately $713,000 payable to third parties, accounts payable to TheraCour of approximately $637,000, and accrued expenses of approximately $283,000. The Company raised additional capital of approximately $631,000, net of offering expenses, by ATM sales of our common stock from October 1, 2024 through November 7, 2024. Management believes that 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 ability of the Company to continue as a going concern is dependent upon controlling its overall expenses and identifying and securing additional financing. Management has considered several options for financing the net working capital deficit as well as to obtain additional funds that will be needed for future human clinical trials. Management believes that we will be achieving several important milestones, including release of the Phase I clinical trial final report, a pre-IND application for use of NV-387 in RSV infections as an antiviral, and a clinical trial applications (including US FDA IND) for use of NV-387 to treat RSV and/or MPox, and other important respiratory diseases, in the ensuing year. Management believes that as it achieves these milestones, there would be improvement in the liquidity of the Company’s stock, and that would improve our ability to raise funds on the public markets at terms that may be more favorable to the terms we are offered at present. Management believes that it has on-going access to the capital markets under an “At-The-Market” (ATM) agreement with EF Hutton that became active around April 5, 2024. Management believes that the Company’s stock is currently undervalued in contrast to its asset value, based on the potential of NV-387 alone. Management believes that as our investor outreach program expands and bears fruit, this deviation should be lessened, enabling access to public markets for equity funding at reasonable valuations. In addition, Management plans to solicit funds by mortgaging its existing fully owned campus and cGMP manufacturing facilities in Shelton, CT, in order to free up a portion of the fixed capital for use as liquid working capital. These facilities were recently valued at $12 to $15 Million by industry experts. However, there is no guarantee that we will be able to raise funds on reasonable terms acceptable to us, or at all.
In addition, Management continues to adjust its planned expenditures, activities, and programs, in accordance with budgetary constraints and in accordance with its expectations of obtaining additional financing. Management is also taking steps for seeking to license NV-387 to potential partners. Such licenses, if effected, would result in an initial payment at signing, milestone payments as the program advances, and royalty payments from future sales. We do not currently have a licensed partner other than KMPL and there is no guarantee that we can enter into such licensing agreement that provides substantial cash value to us. KMPL has enabled clinical trials of NV-387, our lead drug candidate, in India.
Management is actively exploring additional required funding through 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. To cover the shortfall, we intend to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies in addition to equity-based financing. There can be no assurance that we will be able to obtain such additional capital resources or that such financing will be on terms that are favorable to us. We cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of the capital resources more rapidly than we currently anticipate. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.
We do not anticipate any major capital costs going forward in the near future. We intend to seek collaborations to develop NV-387 drug further towards approvals by FDA as well as international regulatory authorities. We believe that we have several important milestones that we will be achieving in the current year. Management believes that as it achieves these milestones, our ability to raise additional funds in the public markets would be enhanced. There can be no assurance that we will be able to raise the necessary capital or that it will be on acceptable terms.
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We do not have direct experience in taking a drug through human clinical trials at present. In addition, we depend upon external collaborators, service providers and consultants for much of our drug development work. Our estimates for external costs are based on various preliminary discussions and “soft” quotes from contract research organizations that provide pre-clinical and clinical studies support. The estimates are also based on certain time estimates for achievement of various objectives. If we miss these time estimates or if the actual costs of the development are greater than the early estimates we have at present, our drug development cost estimates may be substantially greater than anticipated now. In that case, we may have to re-prioritize our programs and/or seek additional funding.
Off Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements during the three months ended September 30, 2024.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a smaller reporting company as defined by 17.C.F.R. and are not required to provide information under this item.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission (the “SEC”). Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act is accumulated and communicated to our management, including our chief executive officer and our chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Due to the inherent limitations of control systems, not all misstatements may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.
As of September 30, 2024, an evaluation was carried out under the supervision and with the participation of our management, including our President and our Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(f) under the Securities Exchange Act of 1934). Based on this evaluation, our President and our Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective as of September 30, 2024.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness, as of September 30, 2024, of our internal control over financial reporting based on the framework in 2013 Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under this framework, our management concluded that our internal control over financial reporting was effective as of September 30, 2024.
Changes in Internal Control Over Financial Reporting
There were no material changes in our system of internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934) during the three months ended September 30, 2024 that has materially affected, or is likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, the Company may be a party to legal proceedings in the ordinary course of our business in addition to those described below. The Company does not, however, expect such other legal proceedings to have a material adverse effect on our business, financial condition or results of operations.
There are no 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.
ITEM 1A. RISK FACTORS
We are a smaller reporting company as defined by 17 C.F.R. and are not required to provide information under this item.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
On April 15, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities, 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 September 30 2024 the Company sold 893,006 shares of common stock at an average price of approximately $1.98 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 $1,710,000 after placement agent fees and other estimated offering expenses.
The Company accounted for the proceeds of the ATM Offering, approximately, as follows:
Gross proceeds |
| $ | 1,764,000 |
Less: offering costs and expenses |
| 54,000 | |
Net proceeds from issuance of common stock | $ | 1,710,000 |
As of July 1, 2024 the Company and Dr. Anil Diwan entered into an extension of his employment agreement for a period of one 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 $12,458 for the three months ended September 30, 2024. The balance of $37,375 will be recognized as the remaining 7,653 shares vest and service is rendered for the remaining nine months ended June 30, 2025.
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of 387 of fully vested shares of its Series A preferred stock for employee compensation. The Company recorded expense of $1,950 for the three months ended September 30, 2024 related to this issuance.
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. The fair value of the warrants was $229 for the three months ended September 30, 2024 and was recorded as consulting expense.
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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 assumptions:
Expected life (year) |
| 4 | |
Expected volatility |
| 54.18 | % |
Expected annual rate of quarterly dividends |
| 0.00 | % |
Risk-free rate(s) |
| 3.85 | % |
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of 19,713 fully vested shares of the Company’s common stock with a restrictive legend for consulting services. The Company recorded an expense of $34,500 for the three months ended September 30, 2024, which is reflective of the fair value of the common stock on the dates of issuance.
For the three months ended September 30, 2024, the Company’s Board of Directors authorized the issuance of 6,039 fully vested shares of its common stock with a restrictive legend for director services. The Company recorded an expense of $11,250 for the three months ended September 30, 2024, which is reflective of the fair value of the common stock on the dates of issuance.
All of the securities referred to above were issued without registration under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506(b) of Regulation D promulgated thereunder. None of the foregoing securities as well as common stock issuable upon conversion or exercise of such securities, have been registered under the Securities Act or any other applicable laws and are deemed restricted securities, and unless so registered may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
(a) None.
(b) Corporate Governance
During the period covered by this Quarterly Report on Form 10-Q, there were no changes to the procedures by which security holders may recommend nominees to the Company’s Board of Directors.
(c) Insider Trading Arrangements and Policies
During the period covered by this Quarterly Report on Form 10-Q, no director or officer of the Company “
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ITEM 6. EXHIBITS
Exhibit No. |
| Description |
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31.1 |
| Rule 13(a)-14(a)/15(d)-14(a) Certification of Chief Executive Officer |
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31.2 |
| Rule 13(a)-14(a)/15(d)-14(a) Certification of Chief Financial Officer |
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32.1 |
| |
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32.2 |
| |
|
|
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101.INS |
| Inline XBRL Instance Document |
|
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101.SCH |
| Inline XBRL Taxonomy Extension Schema Document |
|
|
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101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
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101.LAB |
| Inline XBRL Taxonomy Extension Label Linkbase Document |
|
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101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 | Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit) |
39
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NANOVIRICIDES, INC. | |
|
| |
| /s/ Anil R. Diwan | |
Dated: November 14, 2024 | Name: | Anil R. Diwan |
| Title: | President, Chairman of the Board |
| (Principal Executive Officer) | |
|
| |
| /s/ Meeta Vyas | |
Dated: November 14, 2024 | Name: | Meeta Vyas |
| Title: | Chief Financial Officer |
| (Principal Financial Officer) | |
40