Cover
Cover - USD ($) | 12 Months Ended | ||
Mar. 31, 2023 | Jun. 26, 2023 | Sep. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Mar. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --03-31 | ||
Entity File Number | 001-37487 | ||
Entity Registrant Name | Aethlon Medical, Inc. | ||
Entity Central Index Key | 0000882291 | ||
Entity Tax Identification Number | 13-3632859 | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Address, Address Line One | 11555 Sorrento Valley Road | ||
Entity Address, Address Line Two | Suite 203 | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | (619) | ||
Local Phone Number | 941-0360 | ||
Title of 12(b) Security | COMMON STOCK, $0.001 PAR VALUE | ||
Trading Symbol | AEMD | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 13,200,000 | ||
Entity Common Stock, Shares Outstanding | 24,771,367 | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 23 | ||
Auditor Name | Baker Tilly US, LLP | ||
Auditor Location | San Diego, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 14,532,943 | $ 17,072,419 |
Accounts receivable | 0 | 127,965 |
Prepaid expenses and other current assets | 557,623 | 956,623 |
TOTAL CURRENT ASSETS | 15,090,566 | 18,157,007 |
Property and equipment, net | 1,144,004 | 441,238 |
Right-of-use lease asset | 1,151,909 | 696,698 |
Patents, net | 1,650 | 2,200 |
Restricted cash | 87,506 | 87,506 |
Deposits | 33,305 | 33,305 |
TOTAL ASSETS | 17,508,940 | 19,417,954 |
CURRENT LIABILITIES | ||
Accounts payable | 432,890 | 499,962 |
Due to related parties | 214,221 | 155,742 |
Deferred revenue | 0 | 344,547 |
Lease liability, current portion | 269,386 | 126,905 |
Other current liabilities | 588,592 | 696,893 |
TOTAL CURRENT LIABILITIES | 1,505,089 | 1,824,049 |
Lease liability, less current portion | 939,642 | 602,505 |
TOTAL LIABILITIES | 2,444,731 | 2,426,554 |
COMMITMENTS AND CONTINGENCIES (Note 9) | ||
STOCKHOLDERS’ EQUITY | ||
Common stock, $0.001 par value, 60,000,000 and 30,000,000 shares authorized at March 31, 2023 and 2022, respectively; 22,992,466 and 15,419,163 shares issued and outstanding at March 31, 2023 and 2022, respectively | 22,994 | 15,421 |
Additional paid-in capital | 157,405,911 | 147,446,868 |
Accumulated other comprehensive loss | (6,141) | 0 |
Accumulated deficit | (142,358,555) | (130,329,181) |
TOTAL AETHLON MEDICAL, INC. STOCKHOLDERS’ EQUITY BEFORE NONCONTROLLING INTERESTS | 15,064,209 | 17,133,108 |
NONCONTROLLING INTERESTS | 0 | (141,708) |
TOTAL STOCKHOLDERS’ EQUITY | 15,064,209 | 16,991,400 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 17,508,940 | $ 19,417,954 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Mar. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock par value | $ 0.001 | $ 0.001 |
Common stock shares authorized | 60,000,000 | 30,000,000 |
Common stock issued | 22,992,466 | 15,419,163 |
Common stock outstanding | 22,992,466 | 15,419,163 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
REVENUES: | ||
Government contract and grant revenue | $ 574,245 | $ 294,165 |
Total revenues | 574,245 | 294,165 |
OPERATING COSTS AND EXPENSES | ||
Professional fees | 3,548,028 | 2,634,026 |
Payroll and related expenses | 4,443,552 | 4,625,802 |
General and administrative | 4,481,303 | 3,455,222 |
Total operating expenses | 12,472,883 | 10,715,050 |
OPERATING LOSS | (11,898,638) | (10,420,885) |
OTHER EXPENSE (INCOME) | ||
Loss on dissolution of subsidiary | 142,121 | 0 |
Interest income | (10,973) | 0 |
Other expense (income) | 131,148 | 0 |
NET LOSS BEFORE NONCONTROLLING INTERESTS | (12,029,786) | (10,420,885) |
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS | 0 | (4,794) |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | (12,029,786) | (10,416,091) |
OTHER COMPREHENSIVE LOSS | (6,141) | 0 |
COMPREHENSIVE LOSS | $ (12,035,927) | $ (10,416,091) |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - $ / shares | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Earnings Per Share, Basic | $ (0.59) | $ (0.71) |
Earnings Per Share, Diluted | $ (0.59) | $ (0.71) |
Weighted Average Number of Shares Outstanding, Basic | 20,537,434 | 14,756,967 |
Weighted Average Number of Shares Outstanding, Diluted | 20,537,434 | 14,756,967 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Common Stock [Member] | ||
Statement [Line Items] | ||
BALANCE - MARCH 31, 2022 | $ 15,421 | $ 12,152 |
Beginning balance, shares | 15,419,163 | 12,150,597 |
Issuances of common stock for cash under at the market program | $ 7,481 | $ 626 |
Issuances of common stock for cash under at the market program, shares | 7,480,836 | 626,000 |
Issuance of common shares upon vesting of restricted stock units | $ 92 | |
Issuance of common stock upon vesting of restricted stock units, shares | 92,467 | |
Loss on dissolution of subsidiary | ||
Issuances of common stock for cash in registered direct financing | $ 1,381 | |
Issuances of common stock for cash in registered direct financing, shares | 1,380,555 | |
Issuances of common stock for cash under warrant exercises | $ 531 | |
Issuances of common stock for cash under warrant exercises, shares | 531,167 | |
Issuances of common stock for cash under stock option exercises | $ 11 | |
Issuances of common stock for cash under stock option exercises, shares | 11,562 | |
Issuances of common stock under cashless warrant exercises | $ 676 | |
Issuances of common stock under cashless warrant exercises, shares | 675,554 | |
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | $ 44 | |
Issuance of common shares upon vesting of restricted stock units and net stock option exercise, shares | 43,728 | |
Stock-based compensation expense | ||
Net loss | ||
Other comprehensive loss | ||
BALANCE - MARCH 31, 2023 | $ 22,994 | $ 15,421 |
Ending balance, shares | 22,992,466 | 15,419,163 |
Additional Paid-in Capital [Member] | ||
Statement [Line Items] | ||
BALANCE - MARCH 31, 2022 | $ 147,446,868 | $ 129,331,542 |
Issuances of common stock for cash under at the market program | 8,919,730 | 4,947,159 |
Issuance of common shares upon vesting of restricted stock units | (12,585) | |
Loss on dissolution of subsidiary | ||
Issuances of common stock for cash in registered direct financing | 11,657,663 | |
Issuances of common stock for cash under warrant exercises | 820,407 | |
Issuances of common stock for cash under stock option exercises | 28,314 | |
Issuances of common stock under cashless warrant exercises | (676) | |
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | (88,162) | |
Stock-based compensation expense | 1,051,898 | 750,621 |
Net loss | ||
Other comprehensive loss | ||
BALANCE - MARCH 31, 2023 | 157,405,911 | 147,446,868 |
Retained Earnings [Member] | ||
Statement [Line Items] | ||
BALANCE - MARCH 31, 2022 | (130,329,181) | (119,913,090) |
Issuances of common stock for cash under at the market program | ||
Issuance of common shares upon vesting of restricted stock units | ||
Loss on dissolution of subsidiary | ||
Issuances of common stock for cash in registered direct financing | ||
Issuances of common stock for cash under warrant exercises | ||
Issuances of common stock for cash under stock option exercises | ||
Issuances of common stock under cashless warrant exercises | ||
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | ||
Stock-based compensation expense | ||
Net loss | (12,029,373) | (10,416,091) |
Other comprehensive loss | ||
BALANCE - MARCH 31, 2023 | (142,358,554) | (130,329,181) |
AOCI Attributable to Parent [Member] | ||
Statement [Line Items] | ||
BALANCE - MARCH 31, 2022 | 0 | 0 |
Issuances of common stock for cash under at the market program | ||
Issuance of common shares upon vesting of restricted stock units | ||
Loss on dissolution of subsidiary | ||
Issuances of common stock for cash in registered direct financing | ||
Issuances of common stock for cash under warrant exercises | ||
Issuances of common stock for cash under stock option exercises | ||
Issuances of common stock under cashless warrant exercises | ||
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | ||
Stock-based compensation expense | ||
Net loss | ||
Other comprehensive loss | (6,141) | |
BALANCE - MARCH 31, 2023 | (6,141) | 0 |
Noncontrolling Interest [Member] | ||
Statement [Line Items] | ||
BALANCE - MARCH 31, 2022 | (141,708) | (136,914) |
Issuances of common stock for cash under at the market program | ||
Issuance of common shares upon vesting of restricted stock units | ||
Loss on dissolution of subsidiary | 142,121 | |
Issuances of common stock for cash in registered direct financing | ||
Issuances of common stock for cash under warrant exercises | ||
Issuances of common stock for cash under stock option exercises | ||
Issuances of common stock under cashless warrant exercises | ||
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | ||
Stock-based compensation expense | ||
Net loss | (413) | (4,794) |
Other comprehensive loss | ||
BALANCE - MARCH 31, 2023 | 0 | (141,708) |
BALANCE - MARCH 31, 2022 | 16,991,400 | 9,293,690 |
Issuances of common stock for cash under at the market program | 8,927,211 | 4,947,785 |
Issuance of common shares upon vesting of restricted stock units | (12,493) | |
Loss on dissolution of subsidiary | 142,121 | |
Issuances of common stock for cash in registered direct financing | 11,659,044 | |
Issuances of common stock for cash under warrant exercises | 820,938 | |
Issuances of common stock for cash under stock option exercises | 28,325 | |
Issuances of common stock under cashless warrant exercises | ||
Issuance of common shares upon vesting of restricted stock units and net stock option exercise | (88,118) | |
Stock-based compensation expense | 1,051,898 | 750,621 |
Net loss | (12,029,786) | (10,420,885) |
Other comprehensive loss | (6,141) | |
BALANCE - MARCH 31, 2023 | $ 15,064,209 | $ 16,991,400 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (12,029,786) | $ (10,420,885) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 240,892 | 123,685 |
Stock based compensation | 1,051,898 | 750,621 |
Loss of dissolution of subsidiary | 142,121 | 0 |
Accretion of right-of-use lease asset | 24,408 | 30,532 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 127,965 | 21,117 |
Prepaid expenses and other current assets | 398,169 | (636,688) |
Accounts payable and other current liabilities | (174,727) | 97,541 |
Deferred revenue | (344,547) | 229,698 |
Due to related parties | 58,479 | 37,222 |
Net cash used in operating activities | (10,505,128) | (9,767,157) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (943,109) | (349,193) |
Net cash used in investing activities | (943,109) | (349,193) |
Cash flows from financing activities: | ||
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units | (12,493) | (88,118) |
Net proceeds from the issuance of common stock and exercise of warrants | 8,927,211 | 17,456,092 |
Net cash provided by financing activities | 8,914,718 | 17,367,974 |
Effect of Exchange Rate on Changes on Cash | (5,957) | 0 |
Net (decrease) increase in cash and restricted cash | (2,533,519) | 7,251,624 |
Cash and restricted cash at beginning of year | 17,159,925 | 9,908,301 |
Cash and restricted cash | 14,620,449 | 17,159,925 |
Supplemental information of non-cash investing and financing activities: | ||
Issuances of common stock under cashless warrant exercises | 0 | 676 |
Initial recognition of right-of-use lease asset and lease liability | 625,471 | 744,430 |
Issuance of shares under vested restricted stock units, net stock option exercises and unvested share issuance for services | 92 | 44 |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | ||
Cash and cash equivalents | 14,532,943 | 17,072,419 |
Restricted cash | $ 87,506 | $ 87,506 |
ORGANIZATION, LIQUIDITY AND SUM
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES ORGANIZATION Aethlon Medical, Inc., or Aethlon, the Company, we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for two independent indications: · · We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. On October 4, 2019, the FDA approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. This clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two patients. Due to lack of further patient enrollment, we and UPMC terminated this trial. In January 2023, we entered into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to oversee our clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We anticipate that the initial clinical trials will begin in Australia. We also believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola. Additionally, in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes. On June 17, 2020, the FDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States. Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022. Under Single Patient Emergency Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above. We currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change. In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary will initially focus on oncology trials in Australia. There were only insignificant expenses in that subsidiary in the three months ended December 31, 2022. We also obtained Ethics Review Board, or ERB, approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. One patient has completed participation in the Indian COVID-19 study. The relevant authorities in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier. In May 2023, we also received ERB approval from the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MMAC is affiliated with the University of Delhi and is operated by the Delhi government. We also recently announced that we also have begun investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from harvested organs. We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier. This process potentially may reduce complications following transplantation of the harvested organ, which can include viral infection, delayed graft function and rejection. We believe this new approach could be additive to existing technologies that currently are in place to increase the number of viable organs for transplant. Previously, we were the majority owner of Exosome Sciences, Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases, and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI were limited to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and we, as the majority stockholder of ESI, approved the dissolution of ESI. Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology. In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war in Ukraine on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the war in Ukraine will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain. Our executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360. Our website address is www.aethlonmedical.com. Our common stock is listed on the Nasdaq Capital Market under the symbol “AEMD.” LIQUIDITY AND GOING CONCERN Management expects existing cash as of March 31, 2023 and funds raised subsequent to that date to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these consolidated financial statements. PRINCIPLES OF CONSOLIDATION The accompanying consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd, as well as its previously majority-owned subsidiary, ESI, which dissolved in September 2022. All significant inter-company transactions and balances have been eliminated in consolidation. The consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the consolidated financial statements as of and for the fiscal years ended March 31, 2023 and 2022, and the consolidated statement of cash flows for the fiscal years ended March 31, 2023 and 2022. Estimates were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial and research and development expenses. RISKS AND UNCERTAINTIES We operate in an industry that is subject to intense competition, government regulation and rapid technological change. Our operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and including the potential risk of business failure. USE OF ESTIMATES We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, which requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect the reported amounts of expenses during the reporting period. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future conditions. We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting estimates relate to revenue recognition, stock purchase warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance, and contingencies. CASH AND CASH EQUIVALENTS Accounting standards define “cash and cash equivalents” as any short-term, highly liquid investment that is both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. For the purpose of financial statement presentation, we consider all highly liquid investment instruments with original maturities of three months or less when purchased, or any investment redeemable without penalty or loss of interest to be cash equivalents. Cash is carried at cost, which approximates fair value, and cash equivalents are carried at fair value. As of March 31, 2023, our cash and cash equivalents were comprised of the following instruments: Schedule of cash and cash equivalents Cash in US bank checking account $ 575,766 Cash equivalents held in US Treasury bills 13,910,973 Cash in Australian bank checking account 46,204 Total cash and cash equivalents $ 14,532,943 As of March 31, 2022, we had no CONCENTRATIONS OF CREDIT RISKS Cash is maintained at one US financial institution in a checking account. Accounts at this institution are secured by the Federal Deposit Insurance Corporation up to $250,000. Our March 31, 2023 cash balances were approximately $ 574,572 We do not believe that the Company is exposed to any significant risk with respect to its cash in that checking account. At March 31, 2023, we maintained cash equivalents of approximately $ 13.9 Cash is maintained at one Australian financial institution in checking accounts. Accounts at this institution are secured by the Financial Claims Scheme for up to Australian $ 250,000 All of our revenue in the fiscal years ended March 31, 2023 and 2022 related to our government contracts. We did not have any accounts receivable at March 31, 2023. RESTRICTED CASH To comply with the terms of our laboratory, office, and manufacturing space leases, we caused our bank to issue two standby letters of credit, or the L/Cs, in the amount of $ 87,506 PROPERTY AND EQUIPMENT Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the related assets, which range from two to five years. Repairs and maintenance are charged to expense as incurred while improvements are capitalized. Upon the sale or retirement of property and equipment, the accounts are relieved of the cost and the related accumulated depreciation with any gain or loss included in the consolidated statements of operations. INCOME TAXES Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the difference between the consolidated financial statements and their respective tax basis. Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax credit carryforwards. We record a valuation allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in the foreseeable future, it is more likely than not that some portion of the deferred tax assets may not be realized. LONG-LIVED ASSETS Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. If the cost basis of a long-lived asset is greater than the projected future undiscounted net cash flows from such asset, an impairment loss is recognized. We believe no LOSS PER SHARE Basic loss per share is computed by dividing net income available to common stockholders by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded as their effect would be antidilutive. As of March 31, 2023 and 2022, a total of 2,045,006 2,243,838 DEFERRED FINANCING COSTS Costs related to the issuance of debt are capitalized as a deduction to our convertible notes based on the accounting standard on imputation of interest, and amortized to interest expense over the life of the related debt using the effective interest method. There was no REVENUE RECOGNITION Our revenues consist entirely of amounts earned under contracts and grants with the National Institutes of Health, or NIH. During the fiscal years ended March 31, 2023 and 2022, we recognized revenues totaling $ 574,245 294,165 We identify the deliverables included within these agreements and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. A milestone is an event having all of the following characteristics: (1) There is substantive uncertainty at the date the arrangement is entered into that the event will be achieved. A vendor’s assessment that it expects to achieve a milestone does not necessarily mean that there is not substantive uncertainty associated with achieving the milestone. (2) The event can only be achieved based in whole or in part on either: (a) the vendor’s performance; or (b) a specific outcome resulting from the vendor’s performance. (3) If achieved, the event would result in additional payments being due to the vendor. A milestone does not include events for which the occurrence is either: (a) contingent solely upon the passage of time; or (b) the result of a counterparty’s performance. The policy for recognizing deliverable consideration contingent upon achievement of a milestone must be applied consistently to similar deliverables. The assessment of whether a milestone is substantive is performed at the inception of the arrangement. The consideration earned from the achievement of a milestone must meet all of the following for the milestone to be considered substantive: (1) The consideration is commensurate with either: (a) the vendor’s performance to achieve the milestone; or (b) the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone; (2) The consideration relates solely to past performance; and (3) The consideration is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. A milestone is not considered substantive if any portion of the associated milestone consideration relates to the remaining deliverables in the unit of accounting (i.e., it does not relate solely to past performance). To recognize the milestone consideration in its entirety as revenue in the period in which the milestone is achieved, the milestone must be substantive in its entirety. Milestone consideration cannot be bifurcated into substantive and nonsubstantive components. In addition, if a portion of the consideration earned from achieving a milestone may be refunded or adjusted based on future performance, the related milestone is not considered substantive. We have recognized revenue under the following contracts/grants: Phase 2 Melanoma Cancer Contract On September 12, 2019, the National Cancer Institute, or NCI, part of the NIH, awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract. The Award Contract amount was $ 1,860,561 The work performed pursuant to this Award Contract was focused on melanoma exosomes. This work followed from our completion of a Phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program involved the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform. The Award Contract ended on September 15, 2022 and we presented the required final report to the NCI. As the NCI completed its close out review of the contract, we recognized as revenue the $ 574,245 Subaward with University of Pittsburgh In December 2020, we entered into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $ 256,750 no 64,467 In October 2022, we agreed with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement requiring repayment of cash received for work completed through November 10, 2022. STOCK-BASED COMPENSATION Employee stock options and rights to purchase shares under stock participation plans are accounted for under the fair value method. Accordingly, share-based compensation is measured when all granting activities have been completed, generally the grant date, based on the fair value of the award. The exercise price of options is generally equal to the market price of the Company’s common stock (defined as the closing price as quoted on the Nasdaq Capital Market or OTCBB on the date of grant). Compensation cost recognized by the Company includes (a) compensation cost for all equity incentive awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair value estimated in accordance with the original provisions of the then current accounting standards, and (b) compensation cost for all equity incentive awards granted subsequent to March 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of subsequent accounting standards. We use a Binomial Lattice option pricing model for estimating fair value of options granted (see Note 4). The following table summarizes share-based compensation expenses relating to shares and options granted and the effect on loss per common share during the years ended March 31, 2023 and 2022: Schedule of share-based compensation expenses Fiscal Years Ended March 31, 2023 March 31, 2022 Vesting of Stock Options and Restricted Stock Units $ 1,051,898 $ 750,621 Total Stock-Based Compensation Expense $ 1,051,898 $ 750,621 Weighted average number of common shares outstanding – basic and diluted 20,537,434 14,756,967 Basic and diluted loss per common share $ (0.59 ) $ (0.71 ) We record share-based compensation expenses for awards of stock options and RSUs under ASC 718, Share-based compensation, or ASC 718. For awards to non-employees for periods prior to the adoption of ASU 2018-07, Compensation-Stock Compensation: Improvements to Non-employee Share-Based Payment Accounting, on April 1, 2019, the Company had applied ASC 505-50, Equity – Equity-based payments to non-employees, or ASC 505-50. ASC 718 establishes guidance for the recognition of expenses arising from the issuance of share-based compensation awards at their fair value at the grant date. We recognize share-based compensation expense related to stock options and stock appreciation rights granted to employees, directors and consultants based on the estimated fair value of the awards on the date of grant. We estimate the grant date fair value, and the resulting share-based compensation expense, for stock options that only have service vesting requirements or performance-based vesting requirements without market conditions using the binomial lattice option-pricing model. The grant date fair value of the share-based awards with service vesting requirements is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Determining the appropriate amount to expense for performance-based awards based on the achievement of stated goals requires judgment. The estimate of expense is revised periodically based on the probability of achieving the required performance targets and adjustments are made as appropriate. The cumulative impact of any revisions is reflected in the period of change. If any applicable financial performance goals are not met, no compensation cost is recognized and any previously recognized compensation cost is reversed. For performance-based awards with market conditions, we determine the fair value of awards as of the grant date using a Monte Carlo simulation model. We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The effect of adjusting the forfeiture rate for all expense amortization after March 31, 2007 is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the fiscal year ended March 31, 2023 was insignificant. PATENTS Patents include both foreign and domestic patents. We capitalize the cost of patents, some of which were acquired, and amortize such costs over the shorter of the remaining legal life or their estimated economic life, upon issuance of the patent. The unamortized costs of patents are subject to our review for impairment under our long-lived asset policy above. STOCK PURCHASE WARRANTS In the past we issued warrants for the purchase of shares of our common stock in connection with the issuance of common stock for cash. Warrants issued in connection with common stock for cash, if classified as equity, are considered issued in connection with equity transactions and the warrant fair value is recorded to additional paid-in-capital. RESEARCH AND DEVELOPMENT EXPENSES Our research and development costs are expensed as incurred. We incurred approximately $ 2,745,000 2,341,000 OFF-BALANCE SHEET ARRANGEMENTS We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial statements. SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, or ASU No. 2018-07. ASU No. 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU No. 2018-07 is effective for interim and annual reporting periods beginning after December 15, 2018. Entities must apply the guidance retrospectively with a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption. The adoption of ASU No. 2018-07 on April 1, 2019 did not have a material impact on the Company's consolidated financial position, results of operations and related disclosures. On April 1, 2019, the Company adopted ASC Topic 842, “Leases,” utilizing the alternative transition method allowed for under this guidance. As a result, the Company recorded lease liabilities and right-of-use lease assets on its balance sheet. Topic 842 also allows lessees and lessors to elect certain practical expedients. The Company elected the following practical expedients: · Transitional practical expedients, which must be elected as a package and applied consistently to all of the Company’s leases: ° The Company need not reassess whether any expired or existing contracts are or contain leases. ° The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases). ° The Company need not reassess initial direct costs for any existing leases. · Hindsight practical expedient. The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 2. PROPERTY AND EQUIPMENT, NET Property and equipment, net, consist of the following: Schedule of property and equipment March 31, 2023 March 31, 2022 Furniture and office equipment, at cost $ 989,987 $ 813,412 Leasehold improvements 888,224 121,690 Accumulated depreciation (734,207 ) (493,864 ) Furniture and office equipment, net $ 1,144,004 $ 441,238 Depreciation expense for the fiscal years ended March 31, 2023 and 2022 was $ 240,342 68,931 |
PATENTS, NET
PATENTS, NET | 12 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
PATENTS, NET | 3. PATENTS, NET Patents, net consist of the following: Schedule of patents March 31, 2023 March 31, 2022 Issued patents $ 157,442 $ 157,442 Accumulated amortization (155,792 ) (155,242 ) Issued patents, net of accumulated amortization 1,650 2,200 Patents pending – – Patents, net $ 1,650 $ 2,200 Amortization expense for our capitalized issued patents for each of the fiscal years ended March 31, 2023 and 2022 was $ 550 54,754 3 |
EQUITY TRANSACTIONS
EQUITY TRANSACTIONS | 12 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
EQUITY TRANSACTIONS | 4. EQUITY TRANSACTIONS ISSUANCES OF COMMON STOCK AND WARRANTS Equity Transactions in the Fiscal Year Ended March 31, 2023. 2022 At The Market Offering Agreement with H.C. Wainwright & Co., LLC On March 24, 2022, we entered into an At The Market Offering Agreement, or the 2022 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, which established an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the 2022 ATM Agreement. The offering was registered under the Securities Act of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-259909), as previously filed with the Securities and Exchange Commission, or SEC, and declared effective on October 21, 2021. We filed a prospectus supplement, dated March 24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to $15,000,000, or the 2022 ATM Shares. Under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the 2022 ATM Shares. In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions with our consent and in block transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if the sales cannot be effected at or above the price designated by us from time to time. We are not obligated to make any sales of the 2022 ATM Shares under the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein. The 2022 ATM Agreement contains customary representations, warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement. In the fiscal year ended March 31, 2023, we raised net proceeds of $ 8,927,211 229,610 27,153 7,480,836 RSU Grants to Non-Employee Directors The Compensation Committee of the Board of Directors of the Company, or Compensation Committee, approved, effective as of April 1, 2022, pursuant to the terms of the Company’s Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual RSUs to each of the two non-employee directors of the Company then serving on the Board of Directors of the Company, or Board, and the grant of an RSU for the then newly appointed director. The RSU grants were made subject to stockholder approval of an increase of 1,800,000 34,247 51,370 Equity Transactions in the Fiscal Year Ended March 31, 2022. 2021 At The Market Offering Agreement with H.C. Wainwright & Co., LLC On March 22, 2021, we entered into an At the Market Offering Agreement, or the 2021 ATM Agreement, with Wainwright, as sales agent, pursuant to which we could offer and sell shares of our common stock, from time to time as set forth in the 2021 ATM Agreement. The offering was registered under the Securities Act pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-237269), as previously filed with the SEC and declared effective on March 30, 2020. We filed a prospectus supplement with the SEC, dated March 22, 2021, in connection with the offer and sale of the shares of common stock, pursuant to which we could offer and sell shares of common stock having an aggregate offering price of up to $5,080,000 from time to time. Subject to the terms and conditions set forth in the 2021 ATM Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the shares under the 2021 ATM Agreement from time to time, based upon our instructions. We provided Wainwright with customary indemnification rights under the 2021 ATM Agreement, and Wainwright was entitled to a commission at a fixed rate equal to up to three percent of the gross proceeds per share sold. In addition, we agreed to reimburse Wainwright for certain specified expenses in connection with entering into the 2021 ATM Agreement. The 2021 ATM Agreement provided that it would terminate upon the written termination by either party as permitted thereunder. Sales of the shares, under the 2021 ATM Agreement are made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as otherwise agreed with Wainwright. The 2021 ATM Agreement provided that we have no obligation under the 2021 ATM Agreement to sell any of the shares, and, at any time, we could suspend offers under the 2021 ATM Agreement or terminate the agreement. In the fiscal year ended March 31, 2022, we raised aggregate net proceeds under the 2021 ATM Agreement described above of $ 4,947,785 126,922 2,154 626,000 7.90 Registered Direct Financing In the fiscal year ended March 31, 2022, we sold an aggregate of 1,380,555 11,659,044 Warrant Exercises In the fiscal year ended March 31, 2022, pursuant to the exercise of outstanding warrants to purchase 531,167 820,938 Also in the fiscal year ended March 31, 2022, pursuant to the exercise of 874,664 675,554 199,110 Stock Option Exercises In the fiscal year ended March 31, 2022, former employees paid us an aggregate of $ 28,325 11,562 RSU Grants to Non-Employee Directors The Company maintains the Director Compensation Policy which provides for cash and equity compensation for persons serving as non-employee directors of the Company. Under this policy, each new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock options or of RSUs at the beginning of each fiscal year. The (i) stock options are subject to vesting and (ii) RSUs are subject to vesting and represent the right to be issued on a future date shares of our common stock upon vesting. On April 1, 2021, pursuant to the Director Compensation Policy, the Compensation Committee granted RSUs under the 2020 Plan to each non-employee director of the Company. The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year, with the RSUs priced at the average for the closing prices for the five days preceding and including the date of grant, or $2.06 per share as of April 1, 2021. Each eligible director was granted an RSU in the amount of 24,295 In June 2021, 18,221 7,289 35,786 In September 2021, 18,221 7,289 28,134 In December 2021, 18,221 7,289 13,557 In March 2022, 18,221 7,289 10,641 There were no vested RSUs outstanding as of March 31, 2022. WARRANTS: We did not issue any warrants during the fiscal years ended March 31, 2023 and 2022. A summary of the aggregate warrant activity for the years ended March 31, 2023 and 2022 is presented below: Summary of warrant activity Fiscal Year Ended March 31, 2023 2022 Warrants Weighted Warrants Weighted Outstanding, beginning of year 576,738 $ 11.21 1,991,973 $ 5.23 Granted – $ N/A – $ N/A Exercised – $ N/A (1,206,721 ) $ 2.21 Cancelled/Forfeited (249,985 ) $ 23.24 (208,514 ) $ 6.11 Outstanding, end of year 326,753 $ 2.01 576,738 $ 11.21 Exercisable, end of year 326,753 $ 2.01 576,738 $ 11.21 Weighted average estimated fair value of warrants granted $ N/A $ N/A The detail of the warrants outstanding and exercisable as of March 31, 2023 is as follows: Summary of warrant activity exercisable and outstanding Warrants Outstanding Warrants Exercisable Range of Number Weighted Weighted Number Weighted $1.88 or Below 202,167 1.75 $ 1.57 202,167 $ 1.57 $2.50 - $2.75 124,586 1.83 $ 2.73 124,586 $ 2.73 326,753 326,753 STOCK-BASED COMPENSATION: 2020 EQUITY INCENTIVE PLAN In September 2020, our stockholders approved the adoption of the 2020 Plan, to provide incentives to attract, retain and motivate employees, directors and consultants, whose present and potential contributions are important to our success, by offering them an opportunity to participate in our future performance through awards of options, the right to purchase common stock, stock bonuses and stock appreciation rights and other awards. We initially authorized a total of 1,842,556 common shares for issuance under the 2020 Plan pursuant to stock option grants, RSUs or other forms of stock-based compensation. In September 2022, our stockholders approved an increase in the number of shares of common stock authorized for issuance under the 2020 Plan by 1,800,000 1,667,479 NON-EMPLOYEE DIRECTOR COMPENSATION POLICY The Company maintains the Director Compensation Policy which provides cash and equity compensation for persons serving as non-employee directors of the Company. Under this policy, each new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock options or RSUs at the beginning of each fiscal year. The (i) stock options are subject to vesting and (ii) RSUs are subject to vesting and represent the right to be issued on a future date shares of our common stock upon vesting. Please see above under the heading "Equity Transactions in the Fiscal Year Ended March 31, 2023—RSU Grants to Non-Employee Directors" for disclosure regarding equity awards under the Director Compensation Policy during the fiscal year ended March 31, 2023. STOCK OPTION ACTIVITY During the fiscal year ended March 31, 2023, we issued stock option grants to two executives for the purchase of an aggregate of 266,888 0.95 Options outstanding that were vested as of March 31, 2023 and options that are expected to vest subsequent to March 31, 2023 are as follows: Options outstanding that have vested and are expected to vest Number of Weighted Weighted Vested 755,531 $ 2.45 7.74 Expected to vest 962,722 $ 2.07 8.45 Total 1,718,253 The following is a summary of the stock options outstanding at March 31, 2023 and 2022 and the changes during the years then ended: Schedule of stock option activity Fiscal Year Ended March 31, 2023 2022 Options Weighted Options Weighted Outstanding, beginning of year 1,665,948 $ 2.31 844,089 $ 3.07 Granted 122,220 $ .95 941,188 $ 2.48 Exercised – $ – (11,562 ) $ 2.45 Cancelled/Forfeited (69,915 ) $ 1.77 (107,767 ) $ 9.66 Outstanding, end of year 1,718,253 $ 2.24 1,665,948 $ 2.31 Exercisable, end of year 755,531 $ 2.45 267,221 $ 2.51 Weighted average estimated fair value of options granted $ .92 $ 2.41 The detail of the options outstanding and exercisable as of March 31, 2023 is as follows: Detail of options outstanding and exercisable by exercise price Options Outstanding Options Exercisable Exercise Prices Number Weighted Weighted Number Weighted $0.69 - $1.68 1,207,034 8.28 $ 1.35 505,246 $ 1.36 $2.45 - $5.17 508,654 8.05 $ 3.91 247,720 $ 3.77 $57.00 - $142.50 2,565 .85 $ 91.09 2,565 $ 91.09 1,718,253 755,531 We recorded stock-based compensation expense related to RSU issuances and to options granted totaling $ 1,051,898 750,621 Our total stock-based compensation for fiscal years ended March 31, 2023 and 2022 included the following: Schedule of stock-based compensation Fiscal Year Ended March 31, 2023 March 31, 2022 Vesting of restricted stock units $ 175,000 $ 150,000 Vesting of restricted shares issued for services – 16,500 Vesting of stock options 876,898 584,121 Total Stock-Based Compensation $ 1,051,898 $ 750,621 We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the fiscal year ended March 31, 2023 was insignificant. On March 31, 2023, our outstanding stock options had no intrinsic value since the closing price on that date of $ 0.38 At March 31, 2023, there was approximately $ 1,877,000 2.3 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 5. RELATED PARTY TRANSACTIONS DUE TO RELATED PARTIES Historically, certain of our officers and other related parties have advanced us funds, agreed to defer compensation and/or paid expenses on our behalf to cover working capital deficiencies. There were no such related party transactions during the fiscal year ended March 31, 2023, except that we had accrued unpaid Board fees of $ 57,000 Due to related parties were comprised of the following items: Due to related parties March 31, 2023 March 31, 2022 Accrued Board fees $ 57,000 $ 55,750 Accrued vacation 157,221 99,992 Total due to related parties $ 214,221 $ 155,742 |
OTHER CURRENT LIABILITIES
OTHER CURRENT LIABILITIES | 12 Months Ended |
Mar. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
OTHER CURRENT LIABILITIES | 6. OTHER CURRENT LIABILITIES Other current liabilities were comprised of the following items: Other Current Liabilities March 31, 2023 March 31, 2022 Accrued professional fees $ 588,592 $ 696,893 Total other current liabilities $ 588,592 $ 696,893 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 7. INCOME TAXES For the years ended March 31, 2023 and 2022, we had no income tax expense due to our net operating losses and 100% deferred tax asset valuation allowance. At March 31, 2023 and 2022, we had net deferred tax assets as detailed below. These deferred tax assets are primarily composed of capitalized research and development costs and tax net operating loss carryforwards. Due to uncertainties surrounding our ability to generate future taxable income to realize these assets, a 100% valuation allowance has been established to offset the net deferred tax assets. Significant components of our net deferred tax assets at March 31, 2023 and 2022 are shown below: Schedule of deferred tax assets YEAR ENDED MARCH 31, 2023 2022 Deferred tax assets: Research and development credit carryforwards $ 3,442,000 $ 3,442,000 Capitalized research and development costs 519,000 – Net operating loss carryforwards (1) 24,158,000 22,039,000 Stock compensation 1,903,000 1,609,000 Total deferred tax assets 30,022,000 27,090,000 Total deferred tax liabilities – – Net deferred tax assets 30,022,000 27,090,000 Valuation allowance for deferred tax assets (30,022,000 ) (27,090,000 ) Net deferred tax assets $ – $ – ______________ (1) Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited. At March 31, 2023, we had tax net operating loss carryforwards for federal and state purposes approximating $ 88 80 The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended March 31, 2023 and 2022 due to the following: Provision for income taxes 2023 2022 Income taxes (benefit) at federal statutory rate of 21.00% $ (2,526,000 ) $ (2,188,000 ) Tax effect on non-deductible expenses and credits 2,000 1,000 True up items 57,000 (5,000 ) Expiration of net operating loss carryforwards (1) 353,000 593,000 Change in valuation allowance 2,114,000 1,599,000 Income Tax Expense (Benefit) $ – $ – ______________ (1) Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited. ASC 740, “Income Taxes”, clarifies the accounting for uncertainty in income taxes recognized in an entity's financial statements, and prescribes recognition thresholds and measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under ASC 740, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, ASC 740 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. Our practice is to recognize interest and/or penalties related to income tax matters in income tax expense. During the years ended March 31, 2023 and 2022, we did not recognize any interest or penalties relating to tax matters. At and for the years ended March 31, 2023 and 2022, management does not believe the Company has any uncertain tax positions. Accordingly, there are no Our tax returns remain open for examination by the applicable authorities, generally 3 years for federal and 4 years for state. We are currently not under examination by any taxing authorities. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES CONTRACTUAL OBLIGATIONS AND COMMITMENTS We have had the following material changes to our contractual obligations and commitments outside the ordinary course of business during the fiscal year ended March 31, 2023: LEASE COMMITMENTS Office, Lab and Manufacturing Space Leases In December 2020, we entered into an agreement to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121 and 11575 Sorrento Valley Road, Suite 200, San Diego, California 92121, respectively. The agreement carries a term of 63 months and we took possession of the office space effective October 1, 2021. We took possession of the laboratory space effective January 1, 2022. In October 2021, we entered into another lease for approximately 2,655 square feet of space to house our manufacturing operations located at 11588 Sorrento Valley Road, San Diego, California 92121. The term is for 55 13,772 12,080 During the fiscal year ended March 31, 2023, we recorded a $ 625,471 55 4.25 The office, lab and manufacturing leases are coterminous with a remaining term of 48 4.25 As of our March 31, 2023 balance sheet, we have a right-of-use lease asset of $ 1,151,909 The following table presents a maturity analysis of expected undiscounted cash flows for operating leases on an annual basis for the next four fiscal years. All of our leases conterminously expire during the fiscal year ending March 31, 2027. Schedule of lease maturities Fiscal Years Ended March 31, 2024 $ 314,493 2025 323,812 2026 333,462 2027 343,351 Total minimum lease payments 1,315,118 Less amount representing imputed interest (106,090 ) Present value of minimum lease payments $ 1,209,028 Mobile Clean Room In addition, we rented a mobile clean room on a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed. The mobile clean room was located on leased land near our office and lab and we paid $ 2,000 168,171 Overall, our rent expense, which is included in general and administrative expenses, approximated $ 519,000 401,000 LEGAL MATTERS From time to time, claims are made against us in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more products or engaging in other activities. The occurrence of an unfavorable outcome in any specific period could have a material adverse effect on our results of operations for that period or future periods. We are not presently a party to any pending or threatened legal proceedings. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 9. SUBSEQUENT EVENTS Management has evaluated events subsequent to March 31, 2023 through the date that the accompanying consolidated financial statements were filed with the Securities and Exchange Commission for transactions and other events which may require adjustment of and/or disclosure in such financial statements. Sales Under 2022 ATM Agreement Subsequent to March 31, 2023, we raised net proceeds of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of 1,778,901 shares of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement. RSU GRANTS In April 2023, the Compensation Committee approved, pursuant to the terms of the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board. The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current directors then serving on the Board, and for a grant of stock options or $75,000 worth of RSUs for a newly elected director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $0.43 per share for the April 2023 RSU grants. As a result, in April 2023 the three eligible directors each was granted an RSU in the amount of 116,279 shares under the 2020 Plan. The RSUs are subject to vesting in four equal installments, with 25% of the restricted stock units vesting on each of June 30, 2023, September 30, 2023, December 31, 2023, and March 31, 2024, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date. |
ORGANIZATION, LIQUIDITY AND S_2
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
ORGANIZATION | ORGANIZATION Aethlon Medical, Inc., or Aethlon, the Company, we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for two independent indications: · · We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. On October 4, 2019, the FDA approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. This clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two patients. Due to lack of further patient enrollment, we and UPMC terminated this trial. In January 2023, we entered into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to oversee our clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We anticipate that the initial clinical trials will begin in Australia. We also believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola. Additionally, in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes. On June 17, 2020, the FDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States. Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022. Under Single Patient Emergency Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above. We currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change. In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary will initially focus on oncology trials in Australia. There were only insignificant expenses in that subsidiary in the three months ended December 31, 2022. We also obtained Ethics Review Board, or ERB, approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. One patient has completed participation in the Indian COVID-19 study. The relevant authorities in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier. In May 2023, we also received ERB approval from the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MMAC is affiliated with the University of Delhi and is operated by the Delhi government. We also recently announced that we also have begun investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from harvested organs. We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier. This process potentially may reduce complications following transplantation of the harvested organ, which can include viral infection, delayed graft function and rejection. We believe this new approach could be additive to existing technologies that currently are in place to increase the number of viable organs for transplant. Previously, we were the majority owner of Exosome Sciences, Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases, and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI were limited to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and we, as the majority stockholder of ESI, approved the dissolution of ESI. Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology. In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war in Ukraine on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the war in Ukraine will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain. Our executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360. Our website address is www.aethlonmedical.com. Our common stock is listed on the Nasdaq Capital Market under the symbol “AEMD.” |
LIQUIDITY AND GOING CONCERN | LIQUIDITY AND GOING CONCERN Management expects existing cash as of March 31, 2023 and funds raised subsequent to that date to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these consolidated financial statements. |
PRINCIPLES OF CONSOLIDATION | PRINCIPLES OF CONSOLIDATION The accompanying consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd, as well as its previously majority-owned subsidiary, ESI, which dissolved in September 2022. All significant inter-company transactions and balances have been eliminated in consolidation. The consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the consolidated financial statements as of and for the fiscal years ended March 31, 2023 and 2022, and the consolidated statement of cash flows for the fiscal years ended March 31, 2023 and 2022. Estimates were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial and research and development expenses. |
RISKS AND UNCERTAINTIES | RISKS AND UNCERTAINTIES We operate in an industry that is subject to intense competition, government regulation and rapid technological change. Our operations are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and including the potential risk of business failure. |
USE OF ESTIMATES | USE OF ESTIMATES We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, which requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect the reported amounts of expenses during the reporting period. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future conditions. We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting estimates relate to revenue recognition, stock purchase warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance, and contingencies. |
CASH AND CASH EQUIVALENTS | CASH AND CASH EQUIVALENTS Accounting standards define “cash and cash equivalents” as any short-term, highly liquid investment that is both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. For the purpose of financial statement presentation, we consider all highly liquid investment instruments with original maturities of three months or less when purchased, or any investment redeemable without penalty or loss of interest to be cash equivalents. Cash is carried at cost, which approximates fair value, and cash equivalents are carried at fair value. As of March 31, 2023, our cash and cash equivalents were comprised of the following instruments: Schedule of cash and cash equivalents Cash in US bank checking account $ 575,766 Cash equivalents held in US Treasury bills 13,910,973 Cash in Australian bank checking account 46,204 Total cash and cash equivalents $ 14,532,943 As of March 31, 2022, we had no |
CONCENTRATIONS OF CREDIT RISKS | CONCENTRATIONS OF CREDIT RISKS Cash is maintained at one US financial institution in a checking account. Accounts at this institution are secured by the Federal Deposit Insurance Corporation up to $250,000. Our March 31, 2023 cash balances were approximately $ 574,572 We do not believe that the Company is exposed to any significant risk with respect to its cash in that checking account. At March 31, 2023, we maintained cash equivalents of approximately $ 13.9 Cash is maintained at one Australian financial institution in checking accounts. Accounts at this institution are secured by the Financial Claims Scheme for up to Australian $ 250,000 All of our revenue in the fiscal years ended March 31, 2023 and 2022 related to our government contracts. We did not have any accounts receivable at March 31, 2023. |
RESTRICTED CASH | RESTRICTED CASH To comply with the terms of our laboratory, office, and manufacturing space leases, we caused our bank to issue two standby letters of credit, or the L/Cs, in the amount of $ 87,506 |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the related assets, which range from two to five years. Repairs and maintenance are charged to expense as incurred while improvements are capitalized. Upon the sale or retirement of property and equipment, the accounts are relieved of the cost and the related accumulated depreciation with any gain or loss included in the consolidated statements of operations. |
INCOME TAXES | INCOME TAXES Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the difference between the consolidated financial statements and their respective tax basis. Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax credit carryforwards. We record a valuation allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in the foreseeable future, it is more likely than not that some portion of the deferred tax assets may not be realized. |
LONG-LIVED ASSETS | LONG-LIVED ASSETS Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. If the cost basis of a long-lived asset is greater than the projected future undiscounted net cash flows from such asset, an impairment loss is recognized. We believe no |
LOSS PER SHARE | LOSS PER SHARE Basic loss per share is computed by dividing net income available to common stockholders by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded as their effect would be antidilutive. As of March 31, 2023 and 2022, a total of 2,045,006 2,243,838 |
DEFERRED FINANCING COSTS | DEFERRED FINANCING COSTS Costs related to the issuance of debt are capitalized as a deduction to our convertible notes based on the accounting standard on imputation of interest, and amortized to interest expense over the life of the related debt using the effective interest method. There was no |
REVENUE RECOGNITION | REVENUE RECOGNITION Our revenues consist entirely of amounts earned under contracts and grants with the National Institutes of Health, or NIH. During the fiscal years ended March 31, 2023 and 2022, we recognized revenues totaling $ 574,245 294,165 We identify the deliverables included within these agreements and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. A milestone is an event having all of the following characteristics: (1) There is substantive uncertainty at the date the arrangement is entered into that the event will be achieved. A vendor’s assessment that it expects to achieve a milestone does not necessarily mean that there is not substantive uncertainty associated with achieving the milestone. (2) The event can only be achieved based in whole or in part on either: (a) the vendor’s performance; or (b) a specific outcome resulting from the vendor’s performance. (3) If achieved, the event would result in additional payments being due to the vendor. A milestone does not include events for which the occurrence is either: (a) contingent solely upon the passage of time; or (b) the result of a counterparty’s performance. The policy for recognizing deliverable consideration contingent upon achievement of a milestone must be applied consistently to similar deliverables. The assessment of whether a milestone is substantive is performed at the inception of the arrangement. The consideration earned from the achievement of a milestone must meet all of the following for the milestone to be considered substantive: (1) The consideration is commensurate with either: (a) the vendor’s performance to achieve the milestone; or (b) the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone; (2) The consideration relates solely to past performance; and (3) The consideration is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. A milestone is not considered substantive if any portion of the associated milestone consideration relates to the remaining deliverables in the unit of accounting (i.e., it does not relate solely to past performance). To recognize the milestone consideration in its entirety as revenue in the period in which the milestone is achieved, the milestone must be substantive in its entirety. Milestone consideration cannot be bifurcated into substantive and nonsubstantive components. In addition, if a portion of the consideration earned from achieving a milestone may be refunded or adjusted based on future performance, the related milestone is not considered substantive. We have recognized revenue under the following contracts/grants: Phase 2 Melanoma Cancer Contract On September 12, 2019, the National Cancer Institute, or NCI, part of the NIH, awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract. The Award Contract amount was $ 1,860,561 The work performed pursuant to this Award Contract was focused on melanoma exosomes. This work followed from our completion of a Phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program involved the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform. The Award Contract ended on September 15, 2022 and we presented the required final report to the NCI. As the NCI completed its close out review of the contract, we recognized as revenue the $ 574,245 Subaward with University of Pittsburgh In December 2020, we entered into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $ 256,750 no 64,467 In October 2022, we agreed with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement requiring repayment of cash received for work completed through November 10, 2022. |
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION Employee stock options and rights to purchase shares under stock participation plans are accounted for under the fair value method. Accordingly, share-based compensation is measured when all granting activities have been completed, generally the grant date, based on the fair value of the award. The exercise price of options is generally equal to the market price of the Company’s common stock (defined as the closing price as quoted on the Nasdaq Capital Market or OTCBB on the date of grant). Compensation cost recognized by the Company includes (a) compensation cost for all equity incentive awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair value estimated in accordance with the original provisions of the then current accounting standards, and (b) compensation cost for all equity incentive awards granted subsequent to March 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of subsequent accounting standards. We use a Binomial Lattice option pricing model for estimating fair value of options granted (see Note 4). The following table summarizes share-based compensation expenses relating to shares and options granted and the effect on loss per common share during the years ended March 31, 2023 and 2022: Schedule of share-based compensation expenses Fiscal Years Ended March 31, 2023 March 31, 2022 Vesting of Stock Options and Restricted Stock Units $ 1,051,898 $ 750,621 Total Stock-Based Compensation Expense $ 1,051,898 $ 750,621 Weighted average number of common shares outstanding – basic and diluted 20,537,434 14,756,967 Basic and diluted loss per common share $ (0.59 ) $ (0.71 ) We record share-based compensation expenses for awards of stock options and RSUs under ASC 718, Share-based compensation, or ASC 718. For awards to non-employees for periods prior to the adoption of ASU 2018-07, Compensation-Stock Compensation: Improvements to Non-employee Share-Based Payment Accounting, on April 1, 2019, the Company had applied ASC 505-50, Equity – Equity-based payments to non-employees, or ASC 505-50. ASC 718 establishes guidance for the recognition of expenses arising from the issuance of share-based compensation awards at their fair value at the grant date. We recognize share-based compensation expense related to stock options and stock appreciation rights granted to employees, directors and consultants based on the estimated fair value of the awards on the date of grant. We estimate the grant date fair value, and the resulting share-based compensation expense, for stock options that only have service vesting requirements or performance-based vesting requirements without market conditions using the binomial lattice option-pricing model. The grant date fair value of the share-based awards with service vesting requirements is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Determining the appropriate amount to expense for performance-based awards based on the achievement of stated goals requires judgment. The estimate of expense is revised periodically based on the probability of achieving the required performance targets and adjustments are made as appropriate. The cumulative impact of any revisions is reflected in the period of change. If any applicable financial performance goals are not met, no compensation cost is recognized and any previously recognized compensation cost is reversed. For performance-based awards with market conditions, we determine the fair value of awards as of the grant date using a Monte Carlo simulation model. We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The effect of adjusting the forfeiture rate for all expense amortization after March 31, 2007 is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the fiscal year ended March 31, 2023 was insignificant. |
PATENTS | PATENTS Patents include both foreign and domestic patents. We capitalize the cost of patents, some of which were acquired, and amortize such costs over the shorter of the remaining legal life or their estimated economic life, upon issuance of the patent. The unamortized costs of patents are subject to our review for impairment under our long-lived asset policy above. |
STOCK PURCHASE WARRANTS | STOCK PURCHASE WARRANTS In the past we issued warrants for the purchase of shares of our common stock in connection with the issuance of common stock for cash. Warrants issued in connection with common stock for cash, if classified as equity, are considered issued in connection with equity transactions and the warrant fair value is recorded to additional paid-in-capital. |
RESEARCH AND DEVELOPMENT EXPENSES | RESEARCH AND DEVELOPMENT EXPENSES Our research and development costs are expensed as incurred. We incurred approximately $ 2,745,000 2,341,000 |
OFF-BALANCE SHEET ARRANGEMENTS | OFF-BALANCE SHEET ARRANGEMENTS We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial statements. |
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS | SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, or ASU No. 2018-07. ASU No. 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU No. 2018-07 is effective for interim and annual reporting periods beginning after December 15, 2018. Entities must apply the guidance retrospectively with a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption. The adoption of ASU No. 2018-07 on April 1, 2019 did not have a material impact on the Company's consolidated financial position, results of operations and related disclosures. On April 1, 2019, the Company adopted ASC Topic 842, “Leases,” utilizing the alternative transition method allowed for under this guidance. As a result, the Company recorded lease liabilities and right-of-use lease assets on its balance sheet. Topic 842 also allows lessees and lessors to elect certain practical expedients. The Company elected the following practical expedients: · Transitional practical expedients, which must be elected as a package and applied consistently to all of the Company’s leases: ° The Company need not reassess whether any expired or existing contracts are or contain leases. ° The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases). ° The Company need not reassess initial direct costs for any existing leases. · Hindsight practical expedient. The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets. |
ORGANIZATION, LIQUIDITY AND S_3
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of cash and cash equivalents | Schedule of cash and cash equivalents Cash in US bank checking account $ 575,766 Cash equivalents held in US Treasury bills 13,910,973 Cash in Australian bank checking account 46,204 Total cash and cash equivalents $ 14,532,943 |
Schedule of share-based compensation expenses | Schedule of share-based compensation expenses Fiscal Years Ended March 31, 2023 March 31, 2022 Vesting of Stock Options and Restricted Stock Units $ 1,051,898 $ 750,621 Total Stock-Based Compensation Expense $ 1,051,898 $ 750,621 Weighted average number of common shares outstanding – basic and diluted 20,537,434 14,756,967 Basic and diluted loss per common share $ (0.59 ) $ (0.71 ) |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Schedule of property and equipment March 31, 2023 March 31, 2022 Furniture and office equipment, at cost $ 989,987 $ 813,412 Leasehold improvements 888,224 121,690 Accumulated depreciation (734,207 ) (493,864 ) Furniture and office equipment, net $ 1,144,004 $ 441,238 |
PATENTS, NET (Tables)
PATENTS, NET (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of patents | Schedule of patents March 31, 2023 March 31, 2022 Issued patents $ 157,442 $ 157,442 Accumulated amortization (155,792 ) (155,242 ) Issued patents, net of accumulated amortization 1,650 2,200 Patents pending – – Patents, net $ 1,650 $ 2,200 |
EQUITY TRANSACTIONS (Tables)
EQUITY TRANSACTIONS (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of warrant activity | Summary of warrant activity Fiscal Year Ended March 31, 2023 2022 Warrants Weighted Warrants Weighted Outstanding, beginning of year 576,738 $ 11.21 1,991,973 $ 5.23 Granted – $ N/A – $ N/A Exercised – $ N/A (1,206,721 ) $ 2.21 Cancelled/Forfeited (249,985 ) $ 23.24 (208,514 ) $ 6.11 Outstanding, end of year 326,753 $ 2.01 576,738 $ 11.21 Exercisable, end of year 326,753 $ 2.01 576,738 $ 11.21 Weighted average estimated fair value of warrants granted $ N/A $ N/A |
Summary of warrant activity exercisable and outstanding | Summary of warrant activity exercisable and outstanding Warrants Outstanding Warrants Exercisable Range of Number Weighted Weighted Number Weighted $1.88 or Below 202,167 1.75 $ 1.57 202,167 $ 1.57 $2.50 - $2.75 124,586 1.83 $ 2.73 124,586 $ 2.73 326,753 326,753 |
Options outstanding that have vested and are expected to vest | Options outstanding that have vested and are expected to vest Number of Weighted Weighted Vested 755,531 $ 2.45 7.74 Expected to vest 962,722 $ 2.07 8.45 Total 1,718,253 |
Schedule of stock option activity | Schedule of stock option activity Fiscal Year Ended March 31, 2023 2022 Options Weighted Options Weighted Outstanding, beginning of year 1,665,948 $ 2.31 844,089 $ 3.07 Granted 122,220 $ .95 941,188 $ 2.48 Exercised – $ – (11,562 ) $ 2.45 Cancelled/Forfeited (69,915 ) $ 1.77 (107,767 ) $ 9.66 Outstanding, end of year 1,718,253 $ 2.24 1,665,948 $ 2.31 Exercisable, end of year 755,531 $ 2.45 267,221 $ 2.51 Weighted average estimated fair value of options granted $ .92 $ 2.41 |
Detail of options outstanding and exercisable by exercise price | Detail of options outstanding and exercisable by exercise price Options Outstanding Options Exercisable Exercise Prices Number Weighted Weighted Number Weighted $0.69 - $1.68 1,207,034 8.28 $ 1.35 505,246 $ 1.36 $2.45 - $5.17 508,654 8.05 $ 3.91 247,720 $ 3.77 $57.00 - $142.50 2,565 .85 $ 91.09 2,565 $ 91.09 1,718,253 755,531 |
Schedule of stock-based compensation | Schedule of stock-based compensation Fiscal Year Ended March 31, 2023 March 31, 2022 Vesting of restricted stock units $ 175,000 $ 150,000 Vesting of restricted shares issued for services – 16,500 Vesting of stock options 876,898 584,121 Total Stock-Based Compensation $ 1,051,898 $ 750,621 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Due to related parties | Due to related parties March 31, 2023 March 31, 2022 Accrued Board fees $ 57,000 $ 55,750 Accrued vacation 157,221 99,992 Total due to related parties $ 214,221 $ 155,742 |
OTHER CURRENT LIABILITIES (Tabl
OTHER CURRENT LIABILITIES (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Current Liabilities | Other Current Liabilities March 31, 2023 March 31, 2022 Accrued professional fees $ 588,592 $ 696,893 Total other current liabilities $ 588,592 $ 696,893 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred tax assets | Schedule of deferred tax assets YEAR ENDED MARCH 31, 2023 2022 Deferred tax assets: Research and development credit carryforwards $ 3,442,000 $ 3,442,000 Capitalized research and development costs 519,000 – Net operating loss carryforwards (1) 24,158,000 22,039,000 Stock compensation 1,903,000 1,609,000 Total deferred tax assets 30,022,000 27,090,000 Total deferred tax liabilities – – Net deferred tax assets 30,022,000 27,090,000 Valuation allowance for deferred tax assets (30,022,000 ) (27,090,000 ) Net deferred tax assets $ – $ – |
Provision for income taxes | Provision for income taxes 2023 2022 Income taxes (benefit) at federal statutory rate of 21.00% $ (2,526,000 ) $ (2,188,000 ) Tax effect on non-deductible expenses and credits 2,000 1,000 True up items 57,000 (5,000 ) Expiration of net operating loss carryforwards (1) 353,000 593,000 Change in valuation allowance 2,114,000 1,599,000 Income Tax Expense (Benefit) $ – $ – ______________ (1) Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited. |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of lease maturities | Schedule of lease maturities Fiscal Years Ended March 31, 2024 $ 314,493 2025 323,812 2026 333,462 2027 343,351 Total minimum lease payments 1,315,118 Less amount representing imputed interest (106,090 ) Present value of minimum lease payments $ 1,209,028 |
ORGANIZATION, LIQUIDITY AND S_4
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | $ 14,532,943 | $ 17,072,419 |
Cash In U S Bank [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 575,766 | |
Cash Equivalents In U S Treasury Bills [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 13,910,973 | |
Cash In Australian Bank [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Cash and cash equivalents | $ 46,204 |
ORGANIZATION, LIQUIDITY AND S_5
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Accounting Policies [Abstract] | ||
Vesting of Stock Options and Restricted Stock Units | $ 1,051,898 | $ 750,621 |
Total Stock-Based Compensation Expense | $ 1,051,898 | $ 750,621 |
Weighted Average Number of Shares Outstanding, Basic | 20,537,434 | 14,756,967 |
Weighted Average Number of Shares Outstanding, Diluted | 20,537,434 | 14,756,967 |
Earnings Per Share, Basic | $ (0.59) | $ (0.71) |
Earnings Per Share, Diluted | $ (0.59) | $ (0.71) |
ORGANIZATION, LIQUIDITY AND S_6
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | 36 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Sep. 15, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Cash equivalents | $ 0 | |||
Cash balances over insured amount | $ 574,572 | |||
Cash equivalents of US treasury bills | 13,900,000 | |||
Cash equivalents | 250,000 | |||
Restricted Cash | 87,506 | 87,506 | ||
Asset impairment charges | $ 0 | $ 0 | ||
Antidilutive shares | 2,045,006 | 2,243,838 | ||
Amortization of deferred financing costs | $ 0 | $ 0 | ||
Contract revenue | 574,245 | 294,165 | ||
Deferred revenue | $ 574,245 | |||
Revenue | 574,245 | 294,165 | ||
Research and development expenses | 2,745,000 | 2,341,000 | ||
Subaward With University Of Pittsburgh [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue | 0 | $ 64,467 | ||
Melanoma Cancer Contract Phase 2 [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Award Contract amount | $ 1,860,561 | |||
Subaward With University Of Pittsburgh [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Award Contract amount | $ 256,750 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Property, Plant and Equipment [Abstract] | ||
Furniture and office equipment, at cost | $ 989,987 | $ 813,412 |
Leasehold improvements | 888,224 | 121,690 |
Accumulated depreciation | (734,207) | (493,864) |
Furniture and office equipment, net | $ 1,144,004 | $ 441,238 |
PROPERTY AND EQUIPMENT, NET (_2
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 240,342 | $ 68,931 |
PATENTS, NET (Details)
PATENTS, NET (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Issued patents | $ 157,442 | $ 157,442 |
Accumulated amortization | (155,792) | (155,242) |
Issued patents, net of accumulated amortization | 1,650 | 2,200 |
Patents pending | 0 | 0 |
Patents, net | $ 1,650 | $ 2,200 |
PATENTS, NET (Details Narrative
PATENTS, NET (Details Narrative) - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of patents | $ 550 | $ 54,754 |
Weighted average remaining life of patents | 3 years |
EQUITY TRANSACTIONS (Details -
EQUITY TRANSACTIONS (Details - Warrant activity) - Warrant [Member] - $ / shares | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Warrants outstanding, beginning balance | 576,738 | 1,991,973 |
Outstanding, Weighted Average Exercise Price | $ 11.21 | $ 5.23 |
Warrants granted | 0 | 0 |
Warrants exercised | 0 | (1,206,721) |
Exercised, Weighted Average Exercise Price | $ 2.21 | |
Warrants cancelled/forfeited | (249,985) | (208,514) |
Cancelled/Forfeited, Weighted Average Exercise Price | $ 23.24 | $ 6.11 |
Warrants outstanding, ending balance | 326,753 | 576,738 |
Outstanding Weighted Average Exercise Price | $ 2.01 | $ 11.21 |
Warrants exercisable | 326,753 | 576,738 |
Exercisable, Weighted Average Exercise Price | $ 2.01 | $ 11.21 |
EQUITY TRANSACTIONS (Details _2
EQUITY TRANSACTIONS (Details - Warrants outstanding and exercisable) - Warrant [Member] - $ / shares | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Warrants outstanding | 326,753 | 576,738 | 1,991,973 |
Weighted Average Exercise Price, outstanding | $ 2.01 | $ 11.21 | $ 5.23 |
Warrants exercisable | 326,753 | ||
Price 1 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Warrants outstanding | 202,167 | ||
Weighted Average Remaining Life (Years) | 1 year 9 months | ||
Weighted Average Exercise Price, outstanding | $ 1.57 | ||
Warrants exercisable | 202,167 | ||
Weighted Average Exercise Price, exercisable | $ 1.57 | ||
Price 2 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Warrants outstanding | 124,586 | ||
Weighted Average Remaining Life (Years) | 1 year 9 months 29 days | ||
Weighted Average Exercise Price, outstanding | $ 2.73 | ||
Warrants exercisable | 124,586 | ||
Weighted Average Exercise Price, exercisable | $ 2.73 |
EQUITY TRANSACTIONS (Details _3
EQUITY TRANSACTIONS (Details - Option Outstanding) - Equity Option [Member] | 12 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options vested | 755,531 |
Weighted average exercise price options vested | $ / shares | $ 2.45 |
Weighted average remaining contractual term options vested | 7 years 8 months 26 days |
Options expected to vest | 962,722 |
Weighted average exercise price options expected to vest | $ / shares | $ 2.07 |
Weighted average remaining contractual term options expected to vest | 8 years 5 months 12 days |
Total options outstanding | 1,718,253 |
EQUITY TRANSACTIONS (Details _4
EQUITY TRANSACTIONS (Details - Option activity) - Options Held [Member] - $ / shares | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock options Outstanding, beginning balance | 1,665,948 | 844,089 |
Outstanding, Weighted Average Exercise Price, beginning price | $ 2.31 | $ 3.07 |
Stock options granted | 122,220 | 941,188 |
Granted, Weighted Average Exercise Price | $ 0.95 | $ 2.48 |
Stock options exercised | 0 | (11,562) |
Exercised, Weighted Average Exercise Price | $ 0 | $ 2.45 |
Stock options cancelled/forfeited | (69,915) | (107,767) |
Cancelled/Forfeited, Weighted Average Exercise Price | $ 1.77 | $ 9.66 |
Stock options outstanding, ending balance | 1,718,253 | 1,665,948 |
Outstanding Weighted Average Exercise Price, ending price | $ 2.24 | $ 2.31 |
Stock options exercisable | 755,531 | 267,221 |
Exercisable, Weighted Average Exercise Price | $ 2.45 | $ 2.51 |
Stock options Weighted average estimated fair value of warrants granted | $ 0.92 | $ 2.41 |
EQUITY TRANSACTIONS (Details _5
EQUITY TRANSACTIONS (Details - Options exercisable) - Options Held [Member] - $ / shares | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options outstanding | 1,718,253 | 1,665,948 | 844,089 |
Outstanding Weighted Average Exercise Price | $ 2.24 | $ 2.31 | $ 3.07 |
Stock options exercisable | 755,531 | 267,221 | |
Stock options exercisable Weighted Average Exercise Price | $ 2.45 | $ 2.51 | |
$1.28 - $1.68 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options outstanding | 1,207,034 | ||
Weighted Average Remaining Life (Years) | 8 years 3 months 10 days | ||
Outstanding Weighted Average Exercise Price | $ 1.35 | ||
Stock options exercisable | 505,246 | ||
Stock options exercisable Weighted Average Exercise Price | $ 1.36 | ||
$2.45 - $5.17 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options outstanding | 508,654 | ||
Weighted Average Remaining Life (Years) | 8 years 18 days | ||
Outstanding Weighted Average Exercise Price | $ 3.91 | ||
Stock options exercisable | 247,720 | ||
Stock options exercisable Weighted Average Exercise Price | $ 3.77 | ||
$57.00 - $142.50 [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Stock options outstanding | 2,565 | ||
Weighted Average Remaining Life (Years) | 10 months 6 days | ||
Outstanding Weighted Average Exercise Price | $ 91.09 | ||
Stock options exercisable | 2,565 | ||
Stock options exercisable Weighted Average Exercise Price | $ 91.09 |
EQUITY TRANSACTIONS (Details _6
EQUITY TRANSACTIONS (Details - Stockbased Compensation) - USD ($) | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock based compensation | $ 1,051,898 | $ 750,621 |
Restricted Stock Units (RSUs) [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock based compensation | 175,000 | 150,000 |
Restricted Shares Issued For Services [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock based compensation | 0 | 16,500 |
Options Held [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock based compensation | $ 876,898 | $ 584,121 |
EQUITY TRANSACTIONS (Details Na
EQUITY TRANSACTIONS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Apr. 02, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from issuance of common stock | $ 8,927,211 | $ 17,456,092 | |||||
Number of shares increase and authorized | 1,800,000 | ||||||
Warrants Cancelled | 199,110 | ||||||
Payments to satify tax withholding | $ 12,493 | 88,118 | |||||
Shares available for grant | 1,667,479 | ||||||
Stock based compensation expense | $ 1,051,898 | 750,621 | |||||
Intrinsic value per share | $ 0.38 | ||||||
Unrecognized compensation cost to share based | $ 1,877,000 | ||||||
Weighted average period | 2 years 3 months 18 days | ||||||
Equity 2020 Plan [Member] | CEO [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Options granted | 266,888 | ||||||
Share price | $ 0.95 | ||||||
Warrants [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Warrants exercised, common shares issued | 531,167 | ||||||
Proceeds from warrant exercises | $ 820,938 | ||||||
Warrants Cashless Basis [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Warrants exercised cashless basis | 874,664 | ||||||
Stock issued from exercise of warrants cashless basis | 675,554 | ||||||
Offering Agreement [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from issuance of common stock | $ 4,947,785 | ||||||
Stock issued new, shares issued | 626,000 | ||||||
Stock sale - average price per share | $ 7.90 | ||||||
Restricted Stock Units (RSUs) [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of shares increase and authorized | 1,800,000 | ||||||
Conversion of Stock, Shares Converted | 18,221 | 18,221 | 18,221 | 18,221 | |||
Stock based compensation expense | $ 175,000 | $ 150,000 | |||||
Restricted Stock Units (RSUs) [Member] | Non Employee Directors [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Stock cancelled in exchange for withholding tax, shares | 7,289 | 7,289 | 7,289 | 7,289 | |||
Payments to satify tax withholding | $ 10,641 | $ 13,557 | $ 28,134 | $ 35,786 | |||
Restricted Stock Units (RSUs) [Member] | Plan 2020 [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Restricted stock grant | 24,295 | ||||||
Equity Option [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from options exercised | $ 28,325 | ||||||
Stock issued for exercise of options | 11,562 | ||||||
Hc Wainwright [Member] | Offering Agreement [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Payment of commissions | $ 126,922 | ||||||
Eligible Directors Each [Member] | Restricted Stock Units (RSUs) [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Restricted stock grant | 34,247 | ||||||
Newly Appointed Director [Member] | Restricted Stock Units (RSUs) [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Restricted stock grant | 51,370 | ||||||
Other Offering Expense [Member] | Offering Agreement [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Payment of stock issuance costs | $ 2,154 | ||||||
Maxim Group L L C [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from issuance of common stock | $ 11,659,044 | ||||||
Stock issued new, shares issued | 1,380,555 | ||||||
Offering Agreement [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Proceeds from issuance of common stock | $ 8,927,211 | ||||||
Stock issued new, shares issued | 7,480,836 | ||||||
Offering Agreement [Member] | Other Offering Expense [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Payment of stock issuance costs | $ 27,153 | ||||||
Offering Agreement [Member] | Hc Wainwright [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Payment of commissions | $ 229,610 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Related Party Transaction [Line Items] | ||
Due to related parties | $ 214,221 | $ 155,742 |
Accrued Board Fees [Member] | ||
Related Party Transaction [Line Items] | ||
Due to related parties | 57,000 | 55,750 |
Accrued Vacation [Member] | ||
Related Party Transaction [Line Items] | ||
Due to related parties | $ 157,221 | $ 99,992 |
RELATED PARTY TRANSACTIONS (D_2
RELATED PARTY TRANSACTIONS (Details Narrative) | Mar. 31, 2023 USD ($) |
Related Party Transactions [Abstract] | |
Accrued director fees | $ 57,000 |
OTHER CURRENT LIABILITIES (Deta
OTHER CURRENT LIABILITIES (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Accrued professional fees | $ 588,592 | $ 696,893 |
Total other current liabilities | $ 588,592 | $ 696,893 |
INCOME TAXES (Details - Deferre
INCOME TAXES (Details - Deferred tax assets) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 | |
Deferred tax assets: | |||
Research and development credit carryforwards | $ 3,442,000 | $ 3,442,000 | |
Capitalized research and development costs | 519,000 | 0 | |
Net operating loss carryforwards | [1] | 24,158,000 | 22,039,000 |
Stock compensation | 1,903,000 | 1,609,000 | |
Total deferred tax assets | 30,022,000 | 27,090,000 | |
Total deferred tax liabilities | 0 | 0 | |
Net deferred tax assets | 30,022,000 | 27,090,000 | |
Valuation allowance for deferred tax assets | (30,022,000) | (27,090,000) | |
Net deferred tax assets | $ 0 | $ 0 | |
[1]Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited. |
INCOME TAXES (Details - Provisi
INCOME TAXES (Details - Provision for income taxes) - USD ($) | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Income Tax Disclosure [Abstract] | |||
Income taxes (benefit) at federal statutory rate of 21.00% | $ (2,526,000) | $ (2,188,000) | |
Tax effect on non-deductible expenses and credits | 2,000 | 1,000 | |
True up items | 57,000 | (5,000) | |
Expiration of state net operating loss carryforwards | [1] | 353,000 | 593,000 |
Change in valuation allowance | 2,114,000 | 1,599,000 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 | |
[1]Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited. |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Operating Loss Carryforwards [Line Items] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforward | 88,000,000 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforward | $ 80,000,000 |
LEASE COMMITMENTS (Details)
LEASE COMMITMENTS (Details) | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Lessee, Operating Lease, Liability, to be Paid, Year One | $ 314,493 |
Lessee, Operating Lease, Liability, to be Paid, Year Two | 323,812 |
Lessee, Operating Lease, Liability, to be Paid, Year Three | 333,462 |
Lessee, Operating Lease, Liability, to be Paid, Year Four | 343,351 |
Lessee, Operating Lease, Liability, to be Paid | 1,315,118 |
Lessee, Operating Lease, Liability, Undiscounted Excess Amount | (106,090) |
Operating Lease, Liability | $ 1,209,028 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Aug. 31, 2022 | |
Statement [Line Items] | |||
Lease term | 55 months | ||
Payments for rent | $ 12,080 | ||
Right of use lease asset | 1,151,909 | $ 696,698 | |
Right of use lease asset | 1,209,028 | ||
Payment for rent per month | 2,000 | ||
Operating Lease, Expense | 519,000 | $ 401,000 | |
Office And Laboratory [Member] | |||
Statement [Line Items] | |||
Payments for rent | $ 13,772 | ||
Manufacturing Space [Member] | |||
Statement [Line Items] | |||
Lease term | 55 months | ||
Right of use lease asset | $ 625,471 | ||
Right of use lease asset | $ 625,471 | ||
Borrowing rate | 4.25% | ||
Office Lab And Manufacturing Leases [Member] | |||
Statement [Line Items] | |||
Lease term | 48 months | ||
Weighted average discount rate | 4.25% | ||
Mobile Clean Room [Member] | |||
Statement [Line Items] | |||
Payments for rent | $ 168,171 |