UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT UNDER SECTION 1320 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934.
For the quarterly period ended
Commission File Number:
(Exact name of Company as specified in its charter)
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(State or other jurisdiction) |
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of incorporation or organization) |
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(Address of principal executive offices and zip code)
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(Company’s telephone number, including area code)
Indicate by check mark whether the Company (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the Company is a larger accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ |
| Accelerated filer | ☐ |
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| Smaller reporting company | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Company is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: |
| Trading Symbol(s) |
| Name of each exchange on which registered: |
As of May 14, 2024 there were approximately
NanoViricides, Inc.
FORM 10-Q
INDEX
1
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NanoViricides, Inc.
Condensed Balance Sheets
| March 31, |
| June 30, | |||
2024 |
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(Unaudited) | ||||||
ASSETS | ||||||
CURRENT ASSETS: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses | | | ||||
Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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OTHER ASSETS |
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Total assets | $ | | $ | | ||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable | $ | | $ | | ||
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Accrued expenses |
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Total current liabilities |
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Other non-current liability – related party | — | | ||||
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COMMITMENTS AND CONTINGENCIES |
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STOCKHOLDERS’ EQUITY: |
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Series A convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes to the condensed financial statements
2
NanoViricides, Inc.
Condensed Statements of Operations
(Unaudited)
For the Three Months Ended | For the Nine Months Ended | |||||||||||
March 31, | March 31, | |||||||||||
| 2024 |
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OPERATING EXPENSES |
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Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
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Total operating expenses |
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LOSS FROM OPERATIONS |
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OTHER INCOME (EXPENSE) |
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Interest income |
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Interest expense | — | — | ( | ( | ||||||||
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Other income (expense), net |
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NET LOSS | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Net loss per common share- basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Weighted average common shares outstanding- basic and diluted |
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See accompanying notes to the condensed financial statements
3
NanoViricides, Inc.
Condensed Statement of Changes in Stockholders’ Equity
For the nine months ended March 31, 2024
(Unaudited)
Series A Preferred | Common Stock: | ||||||||||||||||||
Stock: Par $0.001 | Par $0.001 | ||||||||||||||||||
Number | Number | Additional | Total | ||||||||||||||||
of | of | Paid-in | Accumulated | Stockholders’ | |||||||||||||||
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| Capital |
| Deficit |
| Equity | ||||||
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 stock issued for Directors fees | — | — | | — | | — | | ||||||||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||
Balance, September 30, 2023 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
Series A preferred stock issued for employee stock compensation |
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Series A preferred stock issued upon conversion of related party promissory note | | | — | — | | — | | ||||||||||||
Common stock issued for consulting and legal services rendered |
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Warrants issued to Scientific Advisory Board |
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Common stock issued for Directors fees |
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Forgiveness of interest on related party debt | — | — | — | — | | — | | ||||||||||||
Net loss |
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Balance, December 31, 2023 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
Series A preferred stock issued for employee stock compensation | | — | — | — | | — | | ||||||||||||
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Common stock issued for employee compensation | — | — | | — | | — | | ||||||||||||
Common stock issued for consulting and legal services rendered | — | — | | | | — | | ||||||||||||
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Warrants issued to Scientific Advisory Board | — | — | — | — | | — | | ||||||||||||
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Common stock issued for Directors fees | — | — | | — | | — | | ||||||||||||
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Net loss | — | — | — | — | — | ( | ( | ||||||||||||
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Balance, March 31, 2024 |
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4
NanoViricides, Inc.
Condensed Statement of Changes in Stockholders’ Equity
For the nine months ended March 31, 2023
(Unaudited)
Series A Preferred | Common Stock: | ||||||||||||||||||
Stock: Par $0.001 | Par $0.001 | ||||||||||||||||||
Number | Number | Additional | Total | ||||||||||||||||
of | of | Paid-in | Accumulated | Stockholders’ | |||||||||||||||
| Shares |
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| Shares |
| Amount |
| Capital |
| Deficit |
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Balance, June 30, 2022 |
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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 stock issued for Directors fees | — | — | | — | | — | | ||||||||||||
Net loss | | | | | | ( | ( | ||||||||||||
Balance, September 30, 2022 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
Series A preferred stock issued for employee stock compensation | | — | — | — | | — | | ||||||||||||
Common stock issued for consulting and legal services rendered | — | — | | — | | — | | ||||||||||||
Warrants issued to Scientific Advisory Board |
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Common stock issued for Directors fees |
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Net loss |
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Balance, December 31, 2022 | | $ | | | $ | | $ | | $ | ( | $ | | |||||||
Series A preferred stock issued for employee stock compensation | | — | — | — | | — | | ||||||||||||
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Common stock issued for employee compensation | — | — | | — | | — | | ||||||||||||
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Common stock issued for consulting and legal services rendered | — | — | | — | | — | | ||||||||||||
Warrants issued to Scientific Advisory Board | — | — | — | — | | — | | ||||||||||||
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Common stock issued for Directors fees | — | — | | — | | — | | ||||||||||||
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Net loss | — | — | — | — | — | ( | ( | ||||||||||||
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Balance, March 31, 2023 |
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See accompanying notes to the condensed financial statements
5
NanoViricides, Inc.
Condensed Statements of Cash Flows
(Unaudited)
For the Nine Months Ended | ||||||
| March 31, |
| March 31, | |||
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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Common shares issued as compensation and for services |
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Warrants granted to Scientific Advisory Board |
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Depreciation |
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Amortization | | | ||||
Changes in operating assets and liabilities: |
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Prepaid expenses |
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Service Agreement |
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Accounts payable |
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Accounts payable - related party |
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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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Payment of Loan Payable | | ( | ||||
NET CASH (USED IN) INVESTING 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 | $ | | $ | | ||
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||||||
Interest paid | $ | | $ | | ||
NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||
Fair value of Series A Preferred shares issued upon conversion of related party convertible promissory note | $ | | $ | | ||
Forgiveness of interest on related party debt | $ | | $ | |
See accompanying notes to the condensed financial statements
6
NANOVIRICIDES, INC.
March 31, 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 state of the art 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. The Company’s lead drug candidate NV-387, formulated as the drug product NV-CoV-2, has recently completed Phase 1a/1b clinical trial for the assessment of human safety and tolerability upon increasing single and multiple dosings. This Phase 1a/1b clinical trial is sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (KMPL). NV-CoV-2 contains the nanoviricide active pharmaceutical ingredient (API) called NV-387.
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 clinical trials of NV-387. 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 drugs in development against all Influenzas including Bird Flu H5N1 in its FluCide™ program, as well as drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.
The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc., a related party substantially owned by Dr. Anil Diwan, (“TheraCour”), to which the Company has broad, exclusive licenses. The licenses are to entire fields and not 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. In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, and 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. Upon commercialization, NanoViricides will pay
The Company’s business plan is based on developing the drug candidates into regulatory approvals, and partnering and sub-licensing for commercialization of the drugs whenever possible.
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 sponsored NV-CoV-2 for human clinical trials and obtained regulatory approvals in India. KMPL retained a local clinical research organization (CRO) to conduct the clinical trials. The Phase1a/1b human clinical trial of NV-CoV-2 began in India on June 17, 2023. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus, and then shipped to and received by KMPL. 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
7
Note 2 - Liquidity
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 March 31, 2024 of approximately $
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 the Company will be achieving several important milestones, including release of the Phase I clinical trial report, a pre-IND application for use of NV-387 in RSV infections as an antiviral, and clinical trial applications (including US FDA IND) for use of NV-387 to treat RSV and other important respiratory diseases, in the ensuing year. Management believes that as it achieves these milestones, the Company would likely experience improvement in the liquidity of the Company’s stock, and would improve the Company’s ability to raise funds on the public markets at terms that may be more favorable to the terms presently offered to the Company. 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 in April 2024. Management believes that the Company’s stock is currently substantially undervalued in contrast to its asset value, based on the potential of NV-387 alone. Management believes that as the Company’s investor outreach program expands and bears fruit, this deviation should be lessened, enabling the Company to access public markets for equity funding at reasonable valuations. In addition, Management has already begun soliciting 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. However, there is no guarantee that the Company will be able to raise funds on terms acceptable to it, 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 likely result in an initial payment at signing, milestone payments as the program advances, and royalty payments from future sales. The Company does not currently have a licensed partner other than KMPL and there is no guarantee that the Company can enter into such licensing agreement that provides substantial cash value to the Company.
There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. Similarly, there can be no assurance that the Company can enter into licensing agreement(s) that provide(s) substantial cash value to the Company. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of these 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 or Plan of Operation” should be read in conjunction with the
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Company’s audited financial statements and related notes included in the Company’s Form 10-K for the fiscal year ended June 30, 2023 filed with the SEC on October 13, 2023.
The June 30, 2023 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, 2023 filed on October 13, 2023.
Net Loss per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants and convertible preferred stock.
The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive:
Potentially Outstanding Dilutive Common Shares | ||||||||
For the | For the | For the | For the | |||||
Three Months | Three Months | Nine Months | Nine Months | |||||
Ended | Ended | Ended | Ended | |||||
| March 31, 2024 |
| March 31, 2023 | March 31, 2024 |
| March 31, 2023 | ||
Warrants |
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The Company has
Note 4 - Related Party Transactions
Related Parties
Related parties with whom the Company had transactions are:
Related Parties |
| Relationship |
Dr. Anil R. Diwan |
| Chairman, President, CEO, significant stockholder through TheraCour, and Director |
TheraCour Pharma, Inc. (“TheraCour”) |
| An entity owned and controlled by Dr. Anil R. Diwan |
Karveer Meditech, Pvt., Ltd (“KMPL”) |
| An entity of which Dr. Anil R. Diwan is a passive investor and advisor without operating control. |
9
For the three months ended | For the nine months ended | |||||||||||
| March 31, |
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2024 | 2023 | 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 | $ | | $ | — | $ | | $ | |
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