Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Dec. 31, 2023 | Feb. 14, 2024 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Dec. 31, 2023 | |
Entity File Number | 001-36081 | |
Entity Registrant Name | NANOVIRICIDES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 76-0674577 | |
Entity Address, Address Line One | 1 Controls Drive | |
Entity Address, City or Town | Shelton | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06484 | |
City Area Code | 203 | |
Local Phone Number | 937-6137 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NYSE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 11,779,000 | |
Entity Central Index Key | 0001379006 | |
Current Fiscal Year End Date | --06-30 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Trading Symbol | NNVC | |
Document Transition Report | false | |
Document Quarterly Report | true |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Dec. 31, 2023 | Jun. 30, 2023 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 5,245,374 | $ 8,149,808 |
Prepaid expenses | 72,442 | 295,486 |
Total current assets | 5,317,816 | 8,445,294 |
Property and equipment, net | 7,746,092 | 8,106,647 |
Intangible assets, net | 329,443 | 333,578 |
OTHER ASSETS | ||
Service agreements | 8,859 | 14,361 |
Total assets | 13,402,210 | 16,899,880 |
CURRENT LIABILITIES: | ||
Accrued expenses | 180,372 | 143,760 |
Total current liabilities | 951,074 | 534,250 |
Other non-current liability- related party | 1,500,000 | |
Total liabilities | 951,074 | 2,034,250 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY: | ||
Common stock, $0.00001 par value; 150,000,000 shares authorized, 11,778,643 and 11,698,497 shares issued and outstanding, at December 31, 2023 and June 30, 2023, respectively | 117 | 116 |
Additional paid-in capital | 147,615,441 | 145,946,258 |
Accumulated deficit | (135,164,431) | (131,080,749) |
Total stockholders' equity | 12,451,136 | 14,865,630 |
Total liabilities and stockholders' equity | 13,402,210 | 16,899,880 |
Nonrelated party | ||
CURRENT LIABILITIES: | ||
Accounts payable | 266,663 | 157,056 |
Related party | ||
CURRENT LIABILITIES: | ||
Accounts payable | 504,039 | 233,434 |
Series A convertible preferred stock | ||
STOCKHOLDERS' EQUITY: | ||
Series A convertible preferred stock, $0.00001 par value, 10,000,000 shares designated, 890,511 and 547,674 shares issued and outstanding, at December 31, 2023 and June 30, 2023, respectively | $ 9 | $ 5 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Jun. 30, 2023 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 11,778,643 | 11,698,497 |
Common stock, shares, outstanding | 11,778,643 | 11,698,497 |
Series A convertible preferred stock | ||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 890,511 | 547,674 |
Preferred stock, shares outstanding | 890,511 | 547,674 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
OPERATING EXPENSES | ||||
Research and development | $ 1,573,879 | $ 1,170,710 | $ 3,040,544 | $ 2,283,369 |
General and administrative | 610,877 | 663,284 | 1,175,803 | 1,172,985 |
Total operating expenses | 2,184,756 | 1,833,994 | 4,216,347 | 3,456,354 |
LOSS FROM OPERATIONS | (2,184,756) | (1,833,994) | (4,216,347) | (3,456,354) |
OTHER INCOME (EXPENSE) | ||||
Interest income | 83,134 | 88,954 | 182,472 | 141,516 |
Interest expense | (13,315) | (94) | (49,808) | (938) |
Other income (expense), net | 69,819 | 88,860 | 132,664 | 140,578 |
NET LOSS | $ (2,114,937) | $ (1,745,134) | $ (4,083,683) | $ (3,315,776) |
Net loss/Weighted average common shares | ||||
Net loss per common share- basic | $ (0.18) | $ (0.15) | $ (0.35) | $ (0.29) |
Net loss per common share- diluted | $ (0.18) | $ (0.15) | $ (0.35) | $ (0.29) |
Weighted average common shares outstanding - basic | 11,745,906 | 11,610,303 | 11,732,349 | 11,601,335 |
Weighted average common shares outstanding - diluted | 11,745,906 | 11,610,303 | 11,732,349 | 11,601,335 |
Condensed Statement of Changes
Condensed Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) | Series A Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Jun. 30, 2022 | $ 5 | $ 116 | $ 145,574,080 | $ (122,492,176) | $ 23,082,025 |
Balance (in shares) at Jun. 30, 2022 | 484,582 | 11,592,173 | |||
Series A preferred stock issued for employee stock compensation | 13,864 | 13,864 | |||
Series A preferred stock issued for employee stock compensation (in shares) | 10,591 | ||||
Common stock issued for consulting and legal services rendered | 27,000 | 27,000 | |||
Common stock issued for consulting and legal services rendered (in shares) | 12,710 | ||||
Warrants issued to Scientific Advisory Board | 480 | 480 | |||
Common stock issued for Directors fees | 11,250 | 11,250 | |||
Common stock issued for Directors fees (in shares) | 5,154 | ||||
Net Income (Loss) | $ 0 | $ 0 | 0 | (1,570,642) | (1,570,642) |
Balance at Sep. 30, 2022 | $ 5 | $ 116 | 145,626,674 | (124,062,818) | 21,563,977 |
Balance (in shares) at Sep. 30, 2022 | 495,173 | 11,610,037 | |||
Balance at Jun. 30, 2022 | $ 5 | $ 116 | 145,574,080 | (122,492,176) | 23,082,025 |
Balance (in shares) at Jun. 30, 2022 | 484,582 | 11,592,173 | |||
Forgiveness of interest on related party debt | 0 | ||||
Net Income (Loss) | (3,315,776) | ||||
Balance at Dec. 31, 2022 | $ 5 | $ 116 | 145,678,202 | (125,807,952) | 19,870,371 |
Balance (in shares) at Dec. 31, 2022 | 495,560 | 11,634,576 | |||
Balance at Sep. 30, 2022 | $ 5 | $ 116 | 145,626,674 | (124,062,818) | 21,563,977 |
Balance (in shares) at Sep. 30, 2022 | 495,173 | 11,610,037 | |||
Series A preferred stock issued for employee stock compensation | 13,055 | 13,055 | |||
Series A preferred stock issued for employee stock compensation (in shares) | 387 | ||||
Common stock issued for consulting and legal services rendered | 27,000 | 27,000 | |||
Common stock issued for consulting and legal services rendered (in shares) | 17,366 | ||||
Warrants issued to Scientific Advisory Board | 223 | 223 | |||
Common stock issued for Directors fees | 11,250 | 11,250 | |||
Common stock issued for Directors fees (in shares) | 7,173 | ||||
Net Income (Loss) | (1,745,134) | (1,745,134) | |||
Balance at Dec. 31, 2022 | $ 5 | $ 116 | 145,678,202 | (125,807,952) | 19,870,371 |
Balance (in shares) at Dec. 31, 2022 | 495,560 | 11,634,576 | |||
Balance at Jun. 30, 2023 | $ 5 | $ 116 | 145,946,258 | (131,080,749) | 14,865,630 |
Balance (in shares) at Jun. 30, 2023 | 547,674 | 11,698,497 | |||
Series A preferred stock issued for employee stock compensation | 9,617 | 9,617 | |||
Series A preferred stock issued for employee stock compensation (in shares) | 10,591 | ||||
Common stock issued for consulting and legal services rendered | $ 1 | 50,599 | 50,600 | ||
Common stock issued for consulting and legal services rendered (in shares) | 39,103 | ||||
Warrants issued to Scientific Advisory Board | 159 | 159 | |||
Common stock issued for Directors fees | 11,250 | 11,250 | |||
Common stock issued for Directors fees (in shares) | 7,947 | ||||
Net Income (Loss) | (1,968,746) | (1,968,746) | |||
Balance at Sep. 30, 2023 | $ 5 | $ 117 | 146,017,882 | (133,049,494) | 12,968,510 |
Balance (in shares) at Sep. 30, 2023 | 558,265 | 11,745,547 | |||
Balance at Jun. 30, 2023 | $ 5 | $ 116 | 145,946,258 | (131,080,749) | 14,865,630 |
Balance (in shares) at Jun. 30, 2023 | 547,674 | 11,698,497 | |||
Common stock issued for consulting and legal services rendered (in shares) | 62,482 | ||||
Common stock issued for Directors fees (in shares) | 17,664 | ||||
Forgiveness of interest on related party debt | 49,808 | ||||
Net Income (Loss) | (4,083,683) | ||||
Balance at Dec. 31, 2023 | $ 9 | $ 117 | 147,615,441 | (135,164,431) | 12,451,136 |
Balance (in shares) at Dec. 31, 2023 | 890,511 | 11,778,643 | |||
Balance at Sep. 30, 2023 | $ 5 | $ 117 | 146,017,882 | (133,049,494) | 12,968,510 |
Balance (in shares) at Sep. 30, 2023 | 558,265 | 11,745,547 | |||
Series A preferred stock issued for employee stock compensation | 9,358 | 9,358 | |||
Series A preferred stock issued for employee stock compensation (in shares) | 387 | ||||
Series A preferred stock issued upon conversion of related party promissory note | $ 4 | 1,499,996 | 1,500,000 | ||
Series A preferred stock issued upon conversion of related party promissory note (in shares) | 331,859 | ||||
Common stock issued for consulting and legal services rendered | 27,000 | 27,000 | |||
Common stock issued for consulting and legal services rendered (in shares) | 23,379 | ||||
Warrants issued to Scientific Advisory Board | 147 | 147 | |||
Common stock issued for Directors fees | 11,250 | 11,250 | |||
Common stock issued for Directors fees (in shares) | 9,717 | ||||
Forgiveness of interest on related party debt | 49,808 | 49,808 | |||
Net Income (Loss) | (2,114,937) | (2,114,937) | |||
Balance at Dec. 31, 2023 | $ 9 | $ 117 | $ 147,615,441 | $ (135,164,431) | $ 12,451,136 |
Balance (in shares) at Dec. 31, 2023 | 890,511 | 11,778,643 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,083,683) | $ (3,315,776) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Preferred shares issued as compensation | 18,975 | 26,919 |
Common shares issued as compensation and for services | 100,100 | 76,500 |
Warrants granted to Scientific Advisory Board | 306 | 703 |
Depreciation | 374,320 | 366,190 |
Amortization | 4,135 | 4,135 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | 223,044 | 245,476 |
Other assets | 5,502 | 15,930 |
Accounts payable | 109,607 | (18,669) |
Accounts payable - related party | 270,605 | 159,027 |
Accrued expenses | 86,420 | 6,185 |
NET CASH USED IN OPERATING ACTIVITIES | (2,890,669) | (2,433,380) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (13,765) | (89,845) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of loan payable | 0 | (94,788) |
NET CASH (USED IN) FINANCING ACTIVITIES | 0 | (94,788) |
NET CHANGE IN CASH AND CASH EQUIVALENTS | (2,904,434) | (2,618,013) |
Cash and cash equivalents at beginning of period | 8,149,808 | 14,066,359 |
Cash and cash equivalents at end of period | 5,245,374 | 11,448,346 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||
Interest paid | 0 | 938 |
NON-CASH FINACING ACTIVITIES: | ||
Fair value of Series A Preferred shares issued upon conversion of related party convertible promissory note | 1,500,000 | 0 |
Forgiveness of interest on related party debt | $ 49,808 | $ 0 |
Organization and Nature of Busi
Organization and Nature of Business | 6 Months Ended |
Dec. 31, 2023 | |
Organization and Nature of Business | |
Organization and Nature of Business | 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 for the treatment of COVID, NV-CoV-2, is in Phase1a/1b human clinical trials sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (KMPL). This candidate has shown effectiveness and safety in pre-clinical studies. The healthy subjects part of the Phase 1a/1b clinical trial was successfully completed recently with no adverse events in both single dose escalation studies and multiple dose escalation studies. NV-CoV-2 mechanism of action is orthogonal and complementary to that of the existing therapeutics, enabling combination therapy with the existing drugs in the market. Further, the active pharmaceutical ingredient (API) of NV-CoV-2, namely NV-387, was found to be active against Respiratory Syncytial Virus (RSV) in a lethal pre-clinical lung infection study. Therefore NV-387, a broad-spectrum antiviral, may be eligible for a Phase II clinical trial for RSV as well as Coronavirus infections after completing the current Phase 1 study. In addition, the Company reported on November 14, 2023 that NV-387 was found to be effective in a lethal animal model emulating smallpox disease, namely lethal intradigital footpad infection by ectromelia virus in mice. Smallpox therapeutics are important for biodefense purposes. 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-CoV-2 (NV-387) that are expected to move rapidly from current Phase 1a/1b to Phase 2. 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 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 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, as well as process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour. Milestone payments were made or are specified in certain of the license agreements, details of which have been disclosed at the time the agreements were entered into. The Company negotiates and licenses specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested. The Company’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 has 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, sponsored by KMPL, 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 70% of sales to unaffiliated third parties. |
Liquidity
Liquidity | 6 Months Ended |
Dec. 31, 2023 | |
Liquidity | |
Liquidity | 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 December 31, 2023 of approximately $135.1 $4.0 Since the onset of the COVID-19 pandemic, the Company has focused its efforts primarily on a single lead program to minimize cost outlays, namely, taking the COVID drug candidate against SARS-CoV-2 into human clinical trials. The same drug candidate, with the Active Pharmaceutical Ingredient (API) NV-387, demonstrated effectiveness against RSV, indicating that its broad-spectrum antiviral activity is not limited to coronaviruses. The prior lead program for a shingles drug will follow the regulatory development of the NV-387 drug program. The Company believes that it has several important upcoming milestones, including Phase 1a/1b human clinical trials for the Company’s broad-spectrum, pan-coronavirus drug NV-CoV-2, that is now in progress. Management believes that as it achieves these milestones, the Company’s ability to raise additional funds in the public markets would be enhanced. However, there is no guarantee that the Company will be able to raise funds on terms acceptable to it, or at all. Management believes that the Company’s existing resources, including availability under its $2 million line of credit will 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. However, the Company cannot provide assurance that its 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 condensed financial statements do not include any adjustments that may result from the outcome of these uncertainties. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 3 - Summary of Significant Accounting Policies Basis of Presentation – Interim Financial Information The accompanying unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete condensed financial statements. The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The accompanying condensed financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Form 10-K for the fiscal year ended June 30, 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 Six Months Six Months Ended Ended Ended Ended December 31, 2023 December 31, 2022 December 31, 2023 December 31, 2022 Warrants 7,433 8,820 7,433 8,576 The Company has 890,511 shares of Series A preferred stock outstanding as of December 31, 2023. Only in the event of a “change of control” of the Company is each Series A preferred share is convertible to 3.5 shares of its new common stock. A “change of control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a change of control event, the Series A preferred stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At December 31, 2023, the number of potentially dilutive shares of the Company’s common stock into which these Series A preferred shares can be converted into is 3,116,789, and is not included in diluted earnings per share since the shares are contingently convertible only upon a change of control. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 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. For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Property and Equipment During the reporting period, TheraCour acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company $ 5,474 $ 3,493 $ 13,765 $ 29,369 As of December 31, June 30, 2023 2023 Account Payable – Related Party-TheraCour Pursuant to an Exclusive License Agreement with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. On November 1, 2019, the Company entered into the VZV Licensing Agreement with TheraCour. In consideration for obtaining these exclusive licenses, the Company agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of certain direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) the Company will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on the Company’s behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour and; (4) to pay an advance payment equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses. Accounts payable due TheraCour at December 31, 2023 and June 30, 2023 were $831,227 and $733,434, respectively, which were each offset by a two month advance of $500,000. $ 331,227 $ 233,434 December 31, June 30, 2023 2023 Accounts Payable- Related Party-KMPL 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 has 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. Under the agreement with KMPL, the Company agreed to pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive royalties from KMPL equal to $ 172,812 $ — For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Research and Development Costs Related Party Development fees and other costs charged by to TheraCour pursuant to the license agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at December 31, 2023 and June 30, 2023 $ 682,258 $ 633,247 $ 1,321,335 $ 1,245,958 For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Clinical Trial Costs - Related Party Clinical trial related and other costs charged by KMPL pursuant to the license between KMPL and the Company were approximately $150,000 and $365,000 for the three and six months ended December 31, 2023. As of December 31, 2023 and June 30, 2023 approximately $ 150,000 $ — $ 365,000 $ — License Milestone Fee – Related Party On September 9, 2021, the Company entered into a COVID-19 License Agreement with TheraCour to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. Pursuant to such license agreement, the Board of Directors authorized the issuance of 100,000 fully vested shares of the Company’s Series A preferred stock as a license milestone payment and recorded an expense to research and development of $935,088 for the year ended June 30, 2022. On April 20, 2023, the Company was notified that the Company’s licensee, KMPL was authorized to enter into Phase 1a/1b clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the COVID-19 License Agreement a milestone payment of 50,000 fully vested shares of the Company’s Series A preferred stock was issued as a license milestone payment and recorded as an expense to research and development of approximately $157,000 for the year ended June 30, 2023 representing the fair value of the shares on the date of grant. On June 19, 2023, the Company was notified that the Company’s licensee, KMPL had commenced volunteer recruitments for Phase 1a/1b clinical trials of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. Pursuant to the COVID-19 License Agreement a milestone payment of $1,500,000 became due 5 days thereafter and was recorded as a non-current liability and research and development expense. On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award. The Note accrues simple interest at the rate of 12% per annum and is due and payable on January 19, 2025, the maturity date. The principal of the Note is convertible, at TheraCour’s option, into 331,859 shares of the Company’s Series A preferred stock, par value $0.00001 at the conversion price, specified as the fair value of the Series A shares on July 19, 2023 in the terms and conditions contained within the promissory Note. On October 27, 2023 TheraCour exercised its right to convert the principal of the July 19, 2023 Note into 331,859 shares of the Company’s Series A preferred stock. Furthermore, TheraCour cancelled all of the accrued interest on the Note totaling approximately $50,000 which has been reported as a capital transaction credit to additional paid in capital on the accompanying condensed statements of changes in stockholder’s equity. Total interest incurred under the Note for the three and six months ended December 31, 2023 was $13,000 and $50,000, respectively. 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 $2,000,000. All amounts outstanding under the Line of Credit, including principal, accrued interest and other fees and charges, will be due and payable on December 31, 2025. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit are collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C - 1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. The Company has not drawn against the facility as of December 31, 2023. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Property and Equipment | Note 5 - Property and Equipment Property and equipment, stated at cost, less accumulated depreciation consisted of the following: December 31, June 30, 2023 2023 GMP Facility $ 8,168,045 $ 8,168,045 Land 260,000 260,000 Office Equipment 63,056 60,347 Furniture and Fixtures 5,607 5,607 Lab Equipment 6,326,783 6,315,727 Total Property and Equipment 14,823,491 14,809,726 Less Accumulated Depreciation (7,077,399) (6,703,079) Property and Equipment, Net $ 7,746,092 $ 8,106,647 Depreciation expense for the three months ended December 31, 2023 and 2022 was $187,262 and $184,855, respectively, and for the six months ended December 31, 2023 and 2022 was $374,320 and $366,190, respectively. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Dec. 31, 2023 | |
Intangible Assets | |
Intangible Assets | Note 6 – Intangible Assets Intangible assets, net consists of the following: December 31, 2023 Total June 30, 2023 Total Finite Lived Indefinite Lived December 31, Finite Lived Indefinite Lived June 30, Intangible Assets Intangible Assets 2023 Intangible Assets Intangible Assets 2023 Intangible Assets $ 153,393 $ 305,561 $ 458,954 $ 153,393 $ 305,561 $ 458,954 Less Accumulated Amortization (129,511) — (129,511) (125,376) — (125,376) Intangible Assets, Net $ 23,882 $ 305,561 $ 329,443 $ 28,017 $ 305,561 $ 333,578 Amortization expense amounted to $2,068 and $2,068 for the three months ended December 31, 2023 and 2022, respectively, and for the six months ended December 31, 2023 and 2022 were $4,135 and $4,135, respectively. NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. Intangible assets with finite lives, licenses and patent costs, are amortized using the straight- line method over the estimated economic lives of the assets, which range from seventeen to twenty years. The Company’s intangible assets with finite lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Intangible assets determined to have indefinite useful lives, primarily patent costs, are not amortized but are tested for impairment annually, or more frequently if events or changes in circumstances indicate the asset may be impaired. The Company accounts for patent costs in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 350- 30, General Intangibles Other than Goodwill The Company 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. |
Accrued expenses
Accrued expenses | 6 Months Ended |
Dec. 31, 2023 | |
Accrued expenses | |
Accrued expenses | Note 7 – Accrued Expenses Accrued expenses consisted of the following: December 31, June 30, 2023 2023 Personnel and compensation costs $ 23,872 $ 39,060 Consultant 6,500 4,700 Clinical trial costs due to KMPL 150,000 100,000 $ 180,372 $ 143,760 |
Equity Transactions
Equity Transactions | 6 Months Ended |
Dec. 31, 2023 | |
Equity Transactions | |
Equity Transactions | Note 8 - Equity Transactions On October 6, 2023, the Company and Dr. Anil Diwan executed an extension of his employment agreement for a period of one year from July 1, 2023 through June 30, 2024 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, 2023, December 31, 2023, March 31, 2024 and June 30, 2024 and are subject to forfeiture. The Company recognized non-cash compensation expense related to the issuance of the Series A preferred stock of $8,124 and 16,248, respectively for the three and six months ended December 31, 2023. The balance of $16,250 will be recognized as the remaining 5,102 shares vest and service is rendered for the remaining six months ended June 30, 2024. For the three and six months ended December 31, 2023, the Company’s Board of Directors authorized the issuance of 387 and 774, respectively of fully vested shares of its Series A preferred stock for employee compensation. The Company recorded expense of $1,234 and $2,727, respectively for the three and six months ended December 31, 2023 related to these issuances. There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The conversion of the shares is triggered by a change of control. The fair value of the Series A Convertible preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability. The Scientific Advisory Board was granted in August 2023 fully vested warrants to purchase 286 shares of common stock with an exercise price of $1.63 per share expiring in August 2027 and in November 2023 fully vested warrants to purchase 286 shares of common stock with an exercise price of $1.55 per share expiring in November 2027. The fair value of the warrants was $147 for the three months ended December 31, 2023 and $306 for the six months ended December 31, 2023 and was recorded as consulting expense. The Company estimated the fair value of the warrants granted to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model Expected life (year) 4 Expected volatility 51.93-54.02 % Expected annual rate of quarterly dividends 0.00 % Risk-free rate(s) 4.5-4.6 % For the three and six months ended December 31, 2023, the Company’s Board of Directors authorized the issuance of 23,379 and 62,482, respectively, fully vested shares of its common stock with a restrictive legend for consulting and legal services. The Company recorded expense of $27,000 and $77,600, respectively, for the three and six months ended December 31, 2023, which is reflective of the fair value of the common stock on the dates of issuance. For the three and six months ended December 31, 2023, the Company’s Board of Directors authorized the issuance of 9,717 and 17,664, fully vested shares of its common stock with a restrictive legend for director services, respectively. The Company recorded an expense of $11,250 and $22,500 for the three and six months ended December 31, 2023, which is reflective of the fair value of the common stock on the dates of issuance. |
Common Stock Warrants
Common Stock Warrants | 6 Months Ended |
Dec. 31, 2023 | |
Common Stock Warrants | |
Common Stock Warrants | Note 9 - Common Stock Warrants Weighted Average Weighted Exercise Average Price Remaining Aggregate Number of per share Contractual Term Intrinsic Value Common Stock Warrants Shares ($) (years) ($) Outstanding and exercisable at June 30, 2023 8,004 $ 4.96 1.79 $ — Granted 572 1.59 3.75 — Expired (1,143) 4.26 — — Outstanding and exercisable at December 31, 2023 7,433 $ 4.81 1.71 $ — Of the outstanding warrants at December 31, 2023, 1,143 expire in fiscal year ending June 30, 2024, 2,287 expire in fiscal year ending June 30, 2025, 2,287 warrants expire in the fiscal year ending June 30, 2026, 1,144 warrants expire in the fiscal year ending June 30, 2027 and 572 warrants expire in the fiscal year ending June 30, 2028. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 10 - Commitments and Contingencies Legal Proceedings From time to time, The Company is subject to various legal proceedings arising in the ordinary course of business, including proceedings for which The Company has insurance coverage. There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge no action, suit or proceeding has been threatened against the Company that it believes will have a material adverse effect to its business, financial position, results of operations, or liquidity. Employment Agreements On October 6, 2023, the Company and Dr. Diwan, the Company’s President and Chief Executive Officer, executed an extension of his employment agreement for a period of one year from July 1, 2023 through June 30, 2024 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2024. On August 21, 2023, the Company’s Board of Directors approved the extension of the agreement with Meeta Vyas, Chief Financial Officer of the Company. On October 6, 2023, Company and Meeta Vyas signed an extension of the agreement for a period of one year from July 1, 2023 through June 30, 2024 under the same general terms and conditions as the current agreement, except that she will be additionally compensated for up to 50% of all medical insurance costs, not to exceed $2,500 per month. 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 9, 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 two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will be reimbursed by the Company for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty percent (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales to unaffiliated third parties. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | Note 11 – Subsequent Events On February 12, 2024 the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Extension Agreement which extended the Company’s Line of Credit from December 31, 2024 to December 31, 2025. There were no other amendments to the original Line of Credit. The Company has not drawn against the facility as of December 31, 2023. On February 12, 2024 the Company requested and TheraCour agreed to suspend the existing license requirement to maintain an advance with TheraCour equal to two months of projected Theracour invoices which is recalculated quarterly. The suspension will remain in effect until such time as the Company is able to raise sufficient capital. The existing available advance will be applied towards payment of TheraCour invoices. On February 13, 2024, the Company and TheraCour amended the COVID-19 License Agreement (the “Amendment”). The Amendment provides that the as yet unearned and unremitted cash awards specified in the COVID-19 License Agreement for milestone payments shall not be due and payable until the Company achieves a Revenue Event which shall mean, but not be limited to, the receipt of revenue by the Company generated from, but not limited to, sources such as (1) research and development grants, government contracts, non-profit organizations and other sources to the extent that the amount of Recognized Revenue (as defined in the Amendment) is only considered to be the profit portion of Revenue Event, if any; (2) licensing of third-party development partnerships to the extent Recognized Revenue is considered to include only the profit or retained earnings portion received from such deals (and exclude any at-cost-reimbursements); (3) drug commercialization wherein recognized revenue shall be the amount of gross profit (i.e., net sales less cost of net sales); or (4) other sources of revenue such as gross profits from private contract work. Additionally, the Amendment provides that no more than 50% of the Recognized Revenue shall be applied for remitting such consideration at the time of payment. Further the Amendment clarifies that financing raised by the Company from sale of equity, mortgage or debt transactions, and such other instruments shall not be regarded as Recognized Revenue. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation - Interim Financial Information | Basis of Presentation – Interim Financial Information The accompanying unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete condensed financial statements. The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The accompanying condensed financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with the Company’s audited financial statements and related notes included in the Company’s Form 10-K for the fiscal year ended June 30, 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 | Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants and convertible preferred stock. The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as they were anti-dilutive: Potentially Outstanding Dilutive Common Shares For the For the For the For the Three Months Three Months Six Months Six Months Ended Ended Ended Ended December 31, 2023 December 31, 2022 December 31, 2023 December 31, 2022 Warrants 7,433 8,820 7,433 8,576 The Company has 890,511 shares of Series A preferred stock outstanding as of December 31, 2023. Only in the event of a “change of control” of the Company is each Series A preferred share is convertible to 3.5 shares of its new common stock. A “change of control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a change of control event, the Series A preferred stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At December 31, 2023, the number of potentially dilutive shares of the Company’s common stock into which these Series A preferred shares can be converted into is 3,116,789, and is not included in diluted earnings per share since the shares are contingently convertible only upon a change of control. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Schedule of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation | Potentially Outstanding Dilutive Common Shares For the For the For the For the Three Months Three Months Six Months Six Months Ended Ended Ended Ended December 31, 2023 December 31, 2022 December 31, 2023 December 31, 2022 Warrants 7,433 8,820 7,433 8,576 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions | |
Summary of related party | 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. For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Property and Equipment During the reporting period, TheraCour acquired property and equipment on behalf of the Company from third party vendors and sold such property and equipment, at cost, to the Company $ 5,474 $ 3,493 $ 13,765 $ 29,369 As of December 31, June 30, 2023 2023 Account Payable – Related Party-TheraCour Pursuant to an Exclusive License Agreement with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. On November 1, 2019, the Company entered into the VZV Licensing Agreement with TheraCour. In consideration for obtaining these exclusive licenses, the Company agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of certain direct costs as a development fee and such development fees shall be due and payable in periodic installments as billed, (2) the Company will pay $2,000 or actual costs each month, whichever is higher for other general and administrative expenses incurred by TheraCour on the Company’s behalf, (3) to make royalty payments of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour and; (4) to pay an advance payment equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses. Accounts payable due TheraCour at December 31, 2023 and June 30, 2023 were $831,227 and $733,434, respectively, which were each offset by a two month advance of $500,000. $ 331,227 $ 233,434 December 31, June 30, 2023 2023 Accounts Payable- Related Party-KMPL 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 has 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. Under the agreement with KMPL, the Company agreed to pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive royalties from KMPL equal to $ 172,812 $ — For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Research and Development Costs Related Party Development fees and other costs charged by to TheraCour pursuant to the license agreements between TheraCour and the Company for the development of the Company’s drug pipeline. No royalties are due TheraCour from the Company at December 31, 2023 and June 30, 2023 $ 682,258 $ 633,247 $ 1,321,335 $ 1,245,958 For the three months ended For the six months ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Clinical Trial Costs - Related Party Clinical trial related and other costs charged by KMPL pursuant to the license between KMPL and the Company were approximately $150,000 and $365,000 for the three and six months ended December 31, 2023. As of December 31, 2023 and June 30, 2023 approximately $ 150,000 $ — $ 365,000 $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Schedule of property and equipment | December 31, June 30, 2023 2023 GMP Facility $ 8,168,045 $ 8,168,045 Land 260,000 260,000 Office Equipment 63,056 60,347 Furniture and Fixtures 5,607 5,607 Lab Equipment 6,326,783 6,315,727 Total Property and Equipment 14,823,491 14,809,726 Less Accumulated Depreciation (7,077,399) (6,703,079) Property and Equipment, Net $ 7,746,092 $ 8,106,647 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Intangible Assets | |
Schedule of intangible assets | December 31, 2023 Total June 30, 2023 Total Finite Lived Indefinite Lived December 31, Finite Lived Indefinite Lived June 30, Intangible Assets Intangible Assets 2023 Intangible Assets Intangible Assets 2023 Intangible Assets $ 153,393 $ 305,561 $ 458,954 $ 153,393 $ 305,561 $ 458,954 Less Accumulated Amortization (129,511) — (129,511) (125,376) — (125,376) Intangible Assets, Net $ 23,882 $ 305,561 $ 329,443 $ 28,017 $ 305,561 $ 333,578 |
Accrued expenses (Tables)
Accrued expenses (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Accrued expenses | |
Schedule of accrued expenses | December 31, June 30, 2023 2023 Personnel and compensation costs $ 23,872 $ 39,060 Consultant 6,500 4,700 Clinical trial costs due to KMPL 150,000 100,000 $ 180,372 $ 143,760 |
Equity Transactions (Tables)
Equity Transactions (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Equity Transactions | |
Schedule of estimation of estimated the fair value of the warrants granted | Expected life (year) 4 Expected volatility 51.93-54.02 % Expected annual rate of quarterly dividends 0.00 % Risk-free rate(s) 4.5-4.6 % |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 6 Months Ended |
Dec. 31, 2023 | |
Common Stock Warrants | |
Schedule of common stock warrants activity | 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, 2023 8,004 $ 4.96 1.79 $ — Granted 572 1.59 3.75 — Expired (1,143) 4.26 — — Outstanding and exercisable at December 31, 2023 7,433 $ 4.81 1.71 $ — |
Organization and Nature of Bu_2
Organization and Nature of Business (Details) | 6 Months Ended |
Dec. 31, 2023 | |
Organization and Nature of Business | |
Royalties on sales (in percent) | 70% |
TheraCour Pharma Inc | |
Organization and Nature of Business | |
Percentage of net sales allocated for royalty payments (in percent) | 15% |
Liquidity (Details)
Liquidity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Dec. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2023 | |
Liquidity | |||||||
Accumulated deficit | $ 135,164,431 | $ 135,164,431 | $ 131,080,749 | ||||
Net loss | 2,114,937 | $ 1,968,746 | $ 1,745,134 | $ 1,570,642 | 4,083,683 | $ 3,315,776 | |
Net cash used in operating activities | 2,890,669 | $ 2,433,380 | |||||
Revenue | 0 | ||||||
Cash and cash equivalents | 5,245,374 | 5,245,374 | $ 8,149,808 | ||||
Line of credit | $ 2,000,000 | $ 2,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Anti-dilutive warrants (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Warrants | ||||
Summary of Significant Accounting Policies | ||||
Potentially outstanding dilutive common shares | 7,433 | 8,820 | 7,433 | 8,576 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Details) - Series A convertible preferred stock | 6 Months Ended | |
Dec. 31, 2023 shares | Jun. 30, 2023 shares | |
Summary of Significant Accounting Policies | ||
Preferred stock, shares outstanding | 890,511 | 547,674 |
Reverse stock split | 3.5 | |
Percentage of change of control | 60 | |
Number of potentially dilutive common shares | 3,116,789 |
Related Party Transactions - Su
Related Party Transactions - Summary of related parties (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
TheraCour Pharma Inc | ||||
Related Party Transaction | ||||
Property and Equipment | $ 5,474 | $ 3,493 | $ 13,765 | $ 29,369 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Nov. 13, 2023 | Oct. 27, 2023 | Jul. 19, 2023 | Jan. 27, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 19, 2023 | Sep. 09, 2021 | |
Related Party Transaction | ||||||||||||
Royalties on sales (in percent) | 70% | |||||||||||
Research and Development Costs Related Party | $ 1,573,879 | $ 1,170,710 | $ 3,040,544 | $ 2,283,369 | ||||||||
Interest expense | 13,000 | 50,000 | ||||||||||
Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Account Payable - Related Party | 504,039 | 504,039 | $ 233,434 | |||||||||
COVID 19 License Agreement | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Research and Development Costs Related Party | 157,000 | |||||||||||
Milestone payment amount due | $ 1,500,000 | |||||||||||
Line of credit agreement | Dr. Anil Diwan | ||||||||||||
Related Party Transaction | ||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 2,000,000 | |||||||||||
Fixed rate of interest on the amount drawn under the line of credit facility | 12% | |||||||||||
KMPL | ||||||||||||
Related Party Transaction | ||||||||||||
Account Payable - Related Party | 172,812 | $ 172,812 | ||||||||||
Royalties on sales (in percent) | 70% | |||||||||||
Clinical trial related and other costs | 150,000 | $ 365,000 | ||||||||||
KMPL | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Accrued clinical trial related and other costs | 150,000 | 100,000 | ||||||||||
Clinical trial Costs Accrued - Related Party | 150,000 | 365,000 | ||||||||||
TheraCour Pharma Inc | ||||||||||||
Related Party Transaction | ||||||||||||
Account Payable - Related Party | 331,227 | $ 331,227 | $ 233,434 | |||||||||
Percentage of direct costs | 30% | |||||||||||
Other general and administrative expense | $ 2,000 | |||||||||||
Percentage of net sales allocated for royalty payments (in percent) | 15% | |||||||||||
Accounts payable | 831,227 | $ 831,227 | 733,434 | |||||||||
Accounts payable offset by advance | 500,000 | 500,000 | 500,000 | |||||||||
Accrued royalties | 0 | 0 | $ 0 | |||||||||
Research and Development Costs Related Party | $ 682,258 | $ 633,247 | 1,321,335 | $ 1,245,958 | ||||||||
TheraCour Pharma Inc | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Number of shares upon principle of note convertible | 331,859 | |||||||||||
Gain on extinguishment | $ 50,000 | |||||||||||
TheraCour Pharma Inc | COVID 19 License Agreement | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Research and Development Costs Related Party | $ 935,088 | |||||||||||
Unsecured promissory note | TheraCour Pharma Inc | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Interest rate per annum (as a percent) | 12% | |||||||||||
Series A Preferred stock | COVID 19 License Agreement | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Shares issued for milestone payment | 50,000 | |||||||||||
Series A Preferred stock | TheraCour Pharma Inc | ||||||||||||
Related Party Transaction | ||||||||||||
Number of shares upon principle of note convertible | 331,859 | |||||||||||
Debt instrument, conversion stock, par value | $ 0.00001 | |||||||||||
Series A Preferred stock | TheraCour Pharma Inc | COVID 19 License Agreement | Related party | ||||||||||||
Related Party Transaction | ||||||||||||
Number of shares authorized for license milestone payment | 100,000 |
Property and Equipment - Schedu
Property and Equipment - Schedule of property and equipment (Details) - USD ($) | Dec. 31, 2023 | Jun. 30, 2023 |
Property and Equipment | ||
GMP Facility | $ 8,168,045 | $ 8,168,045 |
Land | 260,000 | 260,000 |
Office Equipment | 63,056 | 60,347 |
Furniture and Fixtures | 5,607 | 5,607 |
Lab Equipment | 6,326,783 | 6,315,727 |
Total Property and Equipment | 14,823,491 | 14,809,726 |
Less Accumulated Depreciation | (7,077,399) | (6,703,079) |
Property and Equipment, Net | $ 7,746,092 | $ 8,106,647 |
Property and Equipment - Additi
Property and Equipment - Additional information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment | ||||
Depreciation expense | $ 187,262 | $ 184,855 | $ 374,320 | $ 366,190 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | Dec. 31, 2023 | Jun. 30, 2023 |
Intangible Assets | ||
Intangible Assets | $ 458,954 | $ 458,954 |
Less Accumulated Amortization | (129,511) | (125,376) |
Intangible Assets, Net | 329,443 | 333,578 |
Finite Lived Intangible Assets | ||
Intangible Assets | ||
Intangible Assets | 153,393 | 153,393 |
Less Accumulated Amortization | (129,511) | (125,376) |
Intangible Assets, Net | 23,882 | 28,017 |
Indefinite Lived Intangible Assets | ||
Intangible Assets | ||
Intangible Assets | 305,561 | 305,561 |
Intangible Assets, Net | $ 305,561 | $ 305,561 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Trademark and patents | ||||
Intangible Assets | ||||
Amortization expense | $ 2,068 | $ 2,068 | $ 4,135 | $ 4,135 |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) | Dec. 31, 2023 | Jun. 30, 2023 |
Accrued expenses | ||
Personnel and compensation costs | $ 23,872 | $ 39,060 |
Consultant | 6,500 | 4,700 |
Clinical trial costs due to KMPL | 150,000 | 100,000 |
Accrued expenses | $ 180,372 | $ 143,760 |
Equity Transactions - Additiona
Equity Transactions - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Oct. 06, 2023 | Nov. 30, 2023 | Aug. 31, 2023 | Dec. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2023 | |
Equity Transactions | ||||||||
Non-cash compensation expense, balance amount to be recognized | $ 16,250 | |||||||
Number of remaining shares to be vested | 5,102 | |||||||
Warrants | ||||||||
Equity Transactions | ||||||||
Number of fully vested warrants granted to purchase shares of common stock | 286 | 286 | ||||||
Exercise price (in dollars per share) | $ 1.55 | $ 1.63 | ||||||
Non-cash compensation expense recognized | $ 147 | $ 306 | ||||||
Director | ||||||||
Equity Transactions | ||||||||
Stock-based compensation expense | 11,250 | 22,500 | ||||||
Consulting services | ||||||||
Equity Transactions | ||||||||
Stock-based compensation expense | $ 27,000 | $ 77,600 | ||||||
Founder, Chairman, President | ||||||||
Equity Transactions | ||||||||
Employment agreement extension term (in years) | 1 year | |||||||
Common Stock | ||||||||
Equity Transactions | ||||||||
Common stock issued for consulting and legal services rendered (in shares) | 23,379 | 39,103 | 17,366 | 12,710 | 62,482 | |||
Common stock issued for Directors fees (in shares) | 9,717 | 7,947 | 7,173 | 5,154 | 17,664 | |||
Scientific Advisory Board Common Stock Warrants | ||||||||
Equity Transactions | ||||||||
Warrants and Rights Outstanding, Valuation Technique | us-gaap:ValuationTechniqueOptionPricingModelMember | us-gaap:ValuationTechniqueOptionPricingModelMember | ||||||
Series A Preferred Stock | Employee compensation | ||||||||
Equity Transactions | ||||||||
Shares granted | 387 | 774 | ||||||
Stock-based compensation expense | $ 1,234 | $ 2,727 | ||||||
Series A Preferred Stock | Founder, Chairman, President | ||||||||
Equity Transactions | ||||||||
Shares granted | 10,204 | |||||||
Number of shares vest on quarterly installments | 2,551 | |||||||
Non-cash compensation expense | $ 8,124 | $ 16,248 |
Equity Transactions - Estimated
Equity Transactions - Estimated the fair value of warrants granted quarterly to the Scientific Advisory Board (Details) - Scientific Advisory Board | 6 Months Ended |
Dec. 31, 2023 | |
Equity Transactions | |
Expected life (year) | 4 years |
Expected volatility, minimum | 51.93% |
Expected volatility, maximum | 54.02% |
Expected annual rate of quarterly dividends | 0% |
Risk-free rate(s), minimum | 4.50% |
Risk-free rate(s), maximum | 4.60% |
Common Stock Warrants- Common S
Common Stock Warrants- Common Stock Warrants (Details) - Common Stock Warrants - USD ($) | 6 Months Ended | 12 Months Ended |
Dec. 31, 2023 | Jun. 30, 2023 | |
Common Stock Warrants | ||
Number of Shares, Outstanding and exercisable (in shares) | 8,004 | |
Number of Shares, Granted (in shares) | 572 | |
Number of Shares, Expired (in shares) | (1,143) | |
Number of Shares, Outstanding and exercisable (in shares) | 7,433 | 8,004 |
Weighted Average Exercise Price per share, Outstanding and exercisable (dollars per share) | $ 4.96 | |
Weighted Average Exercise Price per share, Granted (dollars per share) | 1.59 | |
Weighted Average Exercise Price per share, Expired (dollars per share) | 4.26 | |
Weighted Average Exercise Price per share, Outstanding and exercisable (dollars per share) | $ 4.81 | $ 4.96 |
Weighted Average Remaining Contractual Term (years), Granted | 3 years 9 months | |
Weighted Average Remaining Contractual Term (years), Outstanding and exercisable | 1 year 8 months 15 days | 1 year 9 months 14 days |
Aggregate Intrinsic Value, Outstanding and exercisable (in dollars) | $ 0 | $ 0 |
Aggregate Intrinsic Value, Granted (in dollars) | 0 | |
Aggregate Intrinsic Value, Expired (in dollars) | $ 0 |
Common Stock Warrants - Additio
Common Stock Warrants - Additional Information (Details) | 6 Months Ended |
Dec. 31, 2023 shares | |
June 30 2024 | |
Common Stock Warrants | |
Warrants exercisable | 1,143 |
June 30, 2025 | |
Common Stock Warrants | |
Warrants exercisable | 2,287 |
June 30, 2026 | |
Common Stock Warrants | |
Warrants exercisable | 2,287 |
June 30, 2027 | |
Common Stock Warrants | |
Warrants exercisable | 1,144 |
June 30, 2028 | |
Common Stock Warrants | |
Warrants exercisable | 572 |
Commitments and Contingencies -
Commitments and Contingencies - Employment Agreements (Details) | Oct. 06, 2023 USD ($) shares |
Founder, Chairman and President | |
Commitments and Contingencies | |
Employment agreement extension term (in years) | 1 year |
Founder, Chairman and President | Series A Preferred stock | |
Commitments and Contingencies | |
Shares granted | shares | 10,204 |
Chief Financial Officer | |
Commitments and Contingencies | |
Employment agreement extension term (in years) | 1 year |
Chief Financial Officer | Maximum | |
Commitments and Contingencies | |
Additional compensation, percentage of medical insurance costs to be allocated | 50% |
Additional compensation, medical insurance costs to be allocated per month | $ | $ 2,500 |
Commitments and Contingencies_2
Commitments and Contingencies - License Agreements (Details) - Related party - KMPL | Mar. 27, 2023 |
Commitments and Contingencies | |
Percentage of clinical trials fees | 30% |
Percentage of royalty fee | 70% |
Subsequent Events (Details)
Subsequent Events (Details) | Feb. 12, 2024 USD ($) |
Subsequent event | |
Subsequent Events | |
Line of credit | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Dec. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (2,114,937) | $ (1,968,746) | $ (1,745,134) | $ (1,570,642) | $ (4,083,683) | $ (3,315,776) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |