Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 28, 2022 | Mar. 31, 2022 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001537561 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --09-30 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Sep. 30, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 000-54986 | ||
Entity Registrant Name | ARCH THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | NV | ||
Entity Tax Identification Number | 46-0524102 | ||
Entity Address, Address Line One | 235 Walnut Street, Suite 6 | ||
Entity Address, City or Town | Framingham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 01702 | ||
City Area Code | 617 | ||
Local Phone Number | 431-2313 | ||
Title of 12(g) Security | Common Stock, par value $0.001 per share | ||
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 | $ 22,000,000 | ||
Entity Common Stock, Shares Outstanding | 249,936,370 | ||
Auditor Firm ID | 23 | ||
Auditor Name | Baker Tilly US, LLP | ||
Auditor Location | Tewksbury, Massachusetts |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Current assets: | ||
Cash | $ 746,940 | $ 2,266,639 |
Inventory | 1,414,848 | 1,093,765 |
Prepaid expenses and other current assets | 436,407 | 307,341 |
Total current assets | 2,598,195 | 3,667,745 |
Long-term assets: | ||
Property and equipment, net | 2,044 | 5,240 |
Other assets | 3,500 | 3,500 |
Total long-term assets | 5,544 | 8,740 |
Total assets | 2,603,739 | 3,676,485 |
Current liabilities: | ||
Accounts payable | 1,328,000 | 408,083 |
Accrued expenses and other liabilities | 318,505 | 319,464 |
Current portion of Series 1 convertible notes | 550,000 | 0 |
Current portion of accrued interest | 127,781 | 0 |
Current portion of derivative liability | 748,275 | 1,000,000 |
Total current liabilities | 3,320,494 | 1,727,547 |
Senior secured convertible notes, net of discount and issuance costs | 0 | |
Accrued interest | 204,575 | 167,137 |
Derivative liability | 459,200 | 1,207,475 |
Total long-term liabilities | 3,476,048 | 2,974,612 |
Total liabilities | 6,796,542 | 4,702,159 |
Commitments and contingencies | ||
Stockholders’ equity (deficit): | ||
Common stock, $0.001 par value, 800,000,000 shares authorized as of September 30, 2022 and 2021, 249,886,370 and 237,169,770 shares issued as of September 30, 2022 and 2021, and 249,936,370 and 236,719,770 outstanding as of September 30, 2022 and 2021 | 249,886 | 236,720 |
Additional paid-in capital | 50,630,084 | 48,534,525 |
Accumulated deficit | (55,072,773) | (49,796,919) |
Total stockholders’ deficit | (4,192,803) | (1,025,674) |
Total liabilities and stockholders’ deficit | 2,603,739 | 3,676,485 |
Insurance Premium Financing [Member] | ||
Current liabilities: | ||
Insurance premium financing | 247,933 | 0 |
Convertible Notes Payable Series One [Member] | ||
Current liabilities: | ||
Series 1 convertible notes | 0 | 550,000 |
Convertible Notes Payable Series Two [Member] | ||
Current liabilities: | ||
Series 1 convertible notes | 450,000 | $ 1,050,000 |
Senior Secured Convertible Notes [Member] | ||
Current liabilities: | ||
Senior secured convertible notes, net of discount and issuance costs | $ 2,362,273 |
Consolidated Balance Sheets-par
Consolidated Balance Sheets-parentheticals (Parentheticals) - $ / shares | Sep. 30, 2022 | Sep. 30, 2021 |
Common Stock, Par Value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized (in shares) | 800,000,000 | 800,000,000 |
Common stock, shares issued (in shares) | 249,886,370 | 237,169,770 |
Common stock, shares issued (in shares) | 249,886,370 | 237,169,770 |
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 249,936,370 | 236,719,770 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue | $ 15,652 | $ 11,565 |
Operating expenses: | ||
Cost of revenues | 51,489 | 26,282 |
Selling, general and administrative expenses | 4,519,636 | 5,009,323 |
Research and development expenses | 1,153,333 | 1,353,084 |
Total costs and expenses | 5,724,458 | 6,388,689 |
Loss from operations | (5,708,806) | (6,377,124) |
Other (expense) income: | ||
Interest expense | (567,048) | (150,531) |
Gain on forgiveness of loan | 0 | 178,229 |
Decrease to fair value of derivative | 1,000,000 | 108,944 |
Total other income | 432,952 | 136,642 |
Net loss | $ (5,275,854) | $ (6,240,482) |
Loss per share - basic and diluted | ||
Net loss per common share - basic and diluted (in dollars per share) | $ (0.02) | $ (0.03) |
Weighted common shares - basic and diluted (in shares) | 239,914,846 | 220,001,412 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at September 30, 2021 (in shares) at Sep. 30, 2020 | 193,044,766 | |||
Balance at September 30, 2021 at Sep. 30, 2020 | $ 193,045 | $ 41,862,901 | $ (43,556,437) | $ (1,500,491) |
Net loss | $ 0 | 0 | (6,240,482) | (6,240,482) |
Issuance of common stock and warrants, net of financing costs (in shares) | 43,125,004 | |||
Issuance of common stock and warrants, net of financing costs | $ 43,125 | 6,176,108 | 0 | 6,219,233 |
Vesting of restricted stock issued (in shares) | 550,000 | |||
Vesting of restricted stock issued | $ 550 | (550) | 0 | |
Stock-based compensation expense | 496,066 | 0 | 496,066 | |
Balance at September 30, 2022 (in shares) at Sep. 30, 2021 | 236,719,770 | |||
Balance at September 30, 2022 at Sep. 30, 2021 | $ 236,720 | 48,534,525 | (49,796,919) | (1,025,674) |
Net loss | $ 0 | 0 | (5,275,854) | (5,275,854) |
Issuance of common stock and warrants, net of financing costs (in shares) | 12,766,600 | |||
Issuance of common stock and warrants, net of financing costs | $ 12,766 | 1,596,375 | 0 | 1,609,141 |
Vesting of restricted stock issued (in shares) | 400,000 | |||
Vesting of restricted stock issued | $ 400 | (400) | 0 | 0 |
Stock-based compensation expense | 499,584 | 0 | 499,584 | |
Balance at September 30, 2022 (in shares) at Sep. 30, 2022 | 249,886,370 | |||
Balance at September 30, 2022 at Sep. 30, 2022 | $ 249,886 | $ 50,630,084 | $ (55,072,773) | $ (4,192,803) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (5,275,854) | $ (6,240,482) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation | 3,196 | 2,587 |
Stock-based compensation | 499,583 | 496,066 |
Decrease to fair value of derivative | (1,000,000) | (108,944) |
Inventory obsolescence charge | 248,073 | 181,988 |
Accretion of discount and debt issuance costs on 2022 Notes | 302,049 | 0 |
Gain on forgiveness of loan | 0 | (178,229) |
Changes in operating assets and liabilities: | ||
Inventory | (569,156) | (307,760) |
Prepaid expenses and other current assets | 225,124 | (91,668) |
Accounts payable | 846,869 | 66,033 |
Accrued interest | 265,000 | 151,285 |
Accrued expenses and other liabilities | (959) | 70,496 |
Net cash used in operating activities | (4,456,075) | (5,958,628) |
Cash flows from investing activities: | ||
Purchases of property and equipment | 0 | (3,275) |
Net cash used in investing activities | 0 | (3,275) |
Cash flows from financing activities: | ||
Repayment of insurance premium financing | (106,257) | 0 |
Proceeds received from convertible notes | 0 | 1,050,000 |
Proceeds received from senior secured convertible notes | 3,525,000 | 0 |
Proceeds from issued common stock and warrants, net of financing costs | 0 | 6,219,233 |
Payment of 2022 Financing debt issuance costs | (482,367) | 0 |
Net cash provided by financing activities | 2,936,376 | 7,269,233 |
Net (decrease) increase in cash | (1,519,699) | 1,307,330 |
Cash, beginning of year | 2,266,639 | 959,309 |
Cash, end of year | 746,940 | 2,266,639 |
Non-cash financing activities: | ||
Financing of insurance premium | 354,190 | 0 |
Issuance of restricted stock | 8,959 | 0 |
Exchange of Series 2 Convertible Notes into Senior Secured Notes (See Note 10) | 699,781 | 0 |
Issuance of restricted stock in consideration for services performed | 30,840 | 103,750 |
Unpaid issuance costs in accounts Payable | 73,048 | $ 0 |
Inducement Shares 2022 [Member] | ||
Non-cash financing activities: | ||
Fair value of 2022 Inducement Shares issued (see Note 10) | 314,523 | |
Warrant 2022 [Member] | ||
Non-cash financing activities: | ||
Fair value of 2022 Warrants issued (see Note 10) | 1,470,133 | |
Placement Agent Warrants [Member] | ||
Non-cash financing activities: | ||
Fair value of 2022 Warrants issued (see Note 10) | $ 219,894 |
Note 1 - Description of Busines
Note 1 - Description of Business | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | 1. DESCRIPTION OF BUSINESS Arch Therapeutics, Inc. (together with its subsidiary, the “ Company Arch Merger ABS Merger Sub ABS was incorporated under the laws of the Commonwealth of Massachusetts on March 6, 2006, as Clear Nano Solutions, Inc. On April 7, 2008, ABS changed its name from Clear Nano Solutions, Inc. to Arch Therapeutics, Inc. Effective upon the closing of the Merger, ABS changed its name from Arch Therapeutics, Inc. to Arch Biosurgery, Inc. In the first quarter of 2021, the Company commenced commercial sales of our first product, AC5® Advanced Wound System, and has devoted substantially all of the Company’s operational effort to the research, development and regulatory programs necessary to turn the Company’s core technology into commercial products. To date, the Company has principally raised capital through the issuance of convertible debt, and the issuance of units consisting of its common stock, $0.001 par value per share (“ Common Stock warrants The Company expects to incur substantial expenses for the foreseeable future relating to research, development and commercialization of its potential future products. However, there can be no assurance that the Company will be successful in securing additional resources when needed, on terms acceptable to the Company, if at all. Therefore, there exists substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability of assets that might be necessary despite this uncertainty. |
Note 2 - Summary Of Significant
Note 2 - Summary Of Significant Accounting Policies | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accompanying consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“ US GAAP Basis of Presentation The consolidated financial statements include the accounts of Arch Therapeutics, Inc. and its wholly owned subsidiary, Arch Biosurgery, Inc., a biotechnology company. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. Recently Issued and Adopted Accounting Guidance In August 2020, the FASB issued ASU 2020-06, “ Debt with Conversion and other Derivatives and Hedging-Contracts in Entity s Own Equity (Subtopic 815-40) ASU 2020-06 . GAAP Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. The Company had no cash equivalents as of September 30, 2022 and 2021. Inventories Inventories are stated at the lower of cost or net realizable value. The cost of inventories comprises expenditures incurred in acquiring the inventories, the cost of conversion and other costs incurred in bringing them to their existing location and condition. The cost of raw materials, goods-in-process and finished goods are determined on a First in First out (FiFo) basis. When determining net realizable value, appropriate consideration is given to obsolescence, excessive levels, deterioration, and other factors. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash. The Company maintains its cash in bank deposits accounts, which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of the related asset. Upon sale or retirement, the cost and accumulated depreciation are eliminated from their respective accounts, and the resulting gain or loss is included in income or loss for the period. Repair and maintenance expenditures are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment when circumstances indicate the carrying value of an asset may not be recoverable in accordance with FASB ASC Topic 360, Property, Plant and Equipment Leases The Company determines if an arrangement is a lease at its inception. Operating lease right-of-use (“ ROU Income Taxes In accordance with FASB ASC Topic 740, Income Taxes ASC 740 The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions when management determines that it is more likely than not that a loss will be incurred related to these matters and the amount of the loss is reasonably determinable. Revenue In accordance with FASB ASC Topic 606, Revenue Recognition The Company’s source of revenue is product sales. Contracts with customers contain a single performance obligation and the Company recognizes revenue from product sales when the Company has satisfied our performance obligation by transferring control of the product to the customers. Control of the product transfers to the customer upon shipment from the Company’s third-party warehouse. The Company launched a reimbursement support program in September 2022. Under the terms of the program, the invoice amount may be adjusted through full or partial write-offs based on actual reimbursement amounts paid by for Medicare and Medicaid Services (“CMS”) for AC5 units applied and billed by doctors. As such, revenue, if any, for the units shipped in connection with the Company’s reimbursement support program will be booked in future periods when all conditions have been satisfied. Cost of Revenues Cost of revenues includes product costs, warehousing, overhead allocation and royalty expenses. Research and Development The Company expenses internal and external research and development costs, including costs of funded research and development arrangements, in the period incurred. Accounting for Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation ASC 718 The determination of the fair value of share-based payment awards utilizing the Black-Scholes model is affected by the fair value of the common stock and a number of other assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends. The expected life for awards uses the simplified method for all “plain vanilla” options, as defined in ASC 718-10-S99, and the contractual term for all other employee and non-employee awards. The risk-free interest rate assumption is based on observed interest rates appropriate for the terms of our awards. The dividend yield assumption is based on history and the expectation of paying no dividends. Stock-based compensation expense, when recognized in the consolidated financial statements, is based on awards that are ultimately expected to vest. Fair Value Measurements The Company measures both financial and nonfinancial assets and liabilities in accordance with FASB ASC Topic 820, Fair Value Measurements and Disclosures At September 30, 2022 and 2021, the carrying amounts of cash, accounts payables and accrued expenses and other liabilities approximate fair value because of their short-term nature. The carrying amounts for the Convertible Notes (See Notes 11 and 12) approximate fair value because borrowing rates and the terms are similar to comparable market participants. The carrying amounts of the Derivative Liabilities (See Note 7) are valued using Level 3 inputs and are recognized in the consolidated financial statements at fair value. Derivative Liabilities The Company accounts for its warrants and other derivative financial instruments as either equity or liabilities based upon the characteristics and provisions of each instrument, in accordance with FASB ASC Topic 815, Derivatives and Hedging ASC 815 . Complex Financial Instruments The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates its financial instruments, including warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. The Company values its derivatives using the Black-Scholes option-pricing model or other acceptable valuation models, including Monte-Carlo simulations. Derivative instruments are valued at inception, upon events such as an exercise of the underlying financial instrument, and at subsequent reporting periods. The classification of derivative instruments, including whether such instruments should be recorded as liabilities, is re-assessed at the end of each reporting period. The Company reviews the terms of debt instruments, equity instruments, and other financing arrangements to determine whether there are embedded derivative features, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument. Additionally, in connection with the issuance of financing instruments, the Company may issue freestanding options and warrants, including options or warrants to non-employees in exchange for consulting or other services performed. The Company accounts for its common stock warrants in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging Financial Statement Reclassification Certain balances in the prior year consolidated financial statements have been reclassified for comparison purposes to conform to the presentation in the current year consolidated financial statements. These reclassifications had no effect on the reported results of operations or financial position. Subsequent Events The Company evaluated all events or transactions through December 28, 2022, the date which these consolidated financial statements were issued. Please note the following matters deemed to be subsequent events. CMS HCPCS Code Status On December 5, 2022, the Company announced that the Centers for Medicare and Medicaid Services (“CMS”) made a preliminary recommendation to establish a dedicated Healthcare Common Procedure Coding System (“HCPCS”) Level II billing code specific to AC5® Advanced Wound System (“AC5”). The preliminary recommendation was discussed at CMS’ First Biannual 2022 HCPCS Public Meeting, which was held on November 30, 2022. The HCPCS code would better enable providers to bill third party payors for AC5® Advanced Wound System that is used in doctors’ offices. Although the establishment of a dedicated HCPCS code does not guarantee coverage or reimbursement, a HCPCS code specific to AC5® Advanced Wound System would also enhance the Company’s ability to work directly with payors and expand access in outpatient settings. Going Concern Basis of Accounting As reflected in the consolidated financial statements, the Company has an accumulated deficit as of September 30, 2022, has suffered significant net losses and negative cash flows from operations, only recently commenced generating limited operating revenues, and has limited working capital. The continuation of the Company’s business as a going concern is dependent upon raising additional capital, the ability to successfully market and sell its product and eventually attaining and maintaining profitable operations. In particular, as of September 30, 2022, the Company will be required to raise additional capital, obtain alternative means of financial support, or both, in order to continue to fund operations, and therefore there is substantial doubt about the Company’s ability to continue as a going concern. The Company expects to incur substantial expenses into the foreseeable future for the research, development and commercialization of its current and potential products. In addition, the Company will require additional financing in order to seek to license or acquire new assets, research and develop any potential patents and the related compounds, and obtain any further intellectual property that the Company may seek to acquire. Finally, some of our product candidates or the materials contained therein (such as the Active Pharmaceutical Ingredients for our AC5® product line), are manufactured from facilities in areas impacted by the outbreak of the COVID-19, which could result in shortages due to ongoing efforts to address the outbreak. Historically, the Company has principally funded operations through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of common stock and warrants. Provisions in the Securities Purchase Agreements that the Company entered into on June 28, 2018 (“ 2018 SPA 2022 SPA The 2021 SPA contains certain restrictions on our ability to conduct subsequent sales of our equity securities (See Note 9). The continued spread of COVID-19 and uncertain market conditions may also limit the Company’s ability to access capital. If the Company is unable to obtain adequate capital, the Company may be required to reduce the scope, delay, or eliminate some or all of its planned activities. These conditions, in the aggregate, raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not include any adjustments that might result from this uncertainty. |
Note 3 - Property and Equipment
Note 3 - Property and Equipment | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 3. PROPERTY AND EQUIPMENT At September 30, 2022 and 2021, property and equipment consisted of: Estimated Useful Life (in years) September 30, 2022 September 30, 2021 Furniture and fixtures 5 $ 9,357 $ 9,357 Leasehold improvements Life of Lease 8,983 8,983 Computer equipment 3 14,416 14,416 Lab equipment 5 1,000 1,000 33,756 33,756 Less – accumulated depreciation 31,712 28,516 Property and equipment, net $ 2,044 $ 5,240 For the years ended September 30, 2022 and 2021 depreciation expense recorded was $3,196 and $2,587, respectively. |
Note 4 - Inventories
Note 4 - Inventories | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 4 INVENTORIES Inventories consist of the following: September 30, September 30, 2022 2021 Finished Goods $ 9,063 $ 249,571 Goods-in-process 1,405,785 844,194 Total $ 1,414,848 $ 1,093,765 The Company capitalizes inventory that has been produced for commercial sale and has been determined to have a probable future economic benefit. The determination of whether or not the inventory has a future economic benefit requires estimates by management, to the extent that inventory is expected to expire prior to being sold or used for research and development or used for samples, the Company will write down the value of inventory. In evaluating the net realizable value of the inventory, appropriate consideration is given to obsolescence, excessive levels, deterioration, and other factors. |
Note 5 - Insurance Premium Fina
Note 5 - Insurance Premium Financing | 12 Months Ended |
Sep. 30, 2022 | |
Insurance Premium Financing [Member] | |
Notes to Financial Statements | |
Short-Term Debt [Text Block] | 5. INSURANCE PREMIUM FINANCING In July 2022, the Company entered into a finance agreement with First Insurance Funding in order to fund a portion of its insurance policies. The amount financed is approximately $354,000 and incurs interest at a rate of 2.99%. The Company is required to make monthly payments of approximately $35,000 through April 2023. The outstanding balance as of September 30, 2022 was approximately $ 248,000 |
Note 6 - Registered Direct Offe
Note 6 - Registered Direct Offerings | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note, Direct Offerings [Text Block] | 6. REGISTERED DIRECT OFFERINGS On September 30, 2016, the Company filed a registration statement with the SEC utilizing a “shelf” registration process, which was subsequently declared effective by the SEC on October 20, 2016 (such registration statement, the “ Shelf Registration Statement On February 20, 2017, the Company entered into a Securities Purchase Agreement (the “ 2017 2017 Investors 2017 Financing Series F Warrant 2017 Warrants 2017 Warrant Shares On June 28, 2018, the Company entered into a Securities Purchase Agreement (“ 2018 SPA eight 2018 Investors 2018 Financing Series G Warrant 2018 Warrants 2018 Warrant Shares On May 12, 2019, the Company entered into a Securities Purchase Agreement (“ 2019 SPA five 2019 Investors 2019 Financing Series H Warrant 2019 Warrants 2019 2019 Warrant Shares During the years ended September 30, 2022 and 2021, no Series F, Series G or Series H Warrants had been exercised. As of September 30, 2022, up to 6,802,500 and 8,615,384 shares may be acquired upon the exercise of the Series G and Series H Warrants, respectively. During the year ended September 30, 2022 , |
Note 7 - Derivative Liabilities
Note 7 - Derivative Liabilities | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Derivatives and Fair Value [Text Block] | 7. Derivative Liabilities The Company accounted for the Series F Warrants, Series G Warrants and the Series H Warrants in accordance with ASC 815 - . Minimum On the respective closing dates, the derivative liabilities related to the Series G Warrants and Series H Warrants were recorded at an aggregate fair value of $1,628,113. Given that the fair value of the derivative liabilities was less than the net proceeds, the remaining proceeds were allocated to Common Stock and additional-paid-in-capital. For the fiscal year ended September 30, 2021, the Company recorded income of $108,944 in connection with the decrease in the fair value of the derivative liability. Fair Value Measurements Using Significant Unobservable Inputs - Year Ended September 30, 2022 (Level 3) Series F Series G Series H Beginning balance at September 30, 2021 $ 1,000,000 $ 748,275 $ 459,200 Issuances — — — Adjustments for the expiration of warrant (1,000,000 ) — — Ending balance at September 30, 2022 $ — $ 748,275 $ 459,200 Fair Value Measurements Using Significant Unobservable Inputs Year Ended September 30, 2021 (Level 3) Series F Series G Series H Beginning balance at September 30, 2020 $ 1,000,000 $ 748,275 $ 568,144 Issuances — — — Adjustments to estimated fair value — — (108,944 ) Ending balance at September 30, 2021 $ 1,000,000 $ 748,275 $ 459,200 The derivative liabilities are recorded as liabilities at September 30, 2022 Series G Series H Closing price per share of Common Stock Exercise price per share $ 0.70 $ 0.40 Expected volatility 132.97 % 122.50 % Risk-free interest rate 4.05 % 4.14 % Dividend yield — — Remaining expected term of underlying securities (years) 0.69 1.57 During the year ended September 30, 2022, the Series F Warrants expired. The derivative liabilities are recorded as liabilities at September 30, 2021 Series F Series G Series H Closing price per share of Common Stock $ 0.12 $ 0.12 $ 0.12 Exercise price per share $ 0.75 $ 0.70 $ 0.40 Expected volatility 90.28 % 87.40 % 86.59 % Risk-free interest rate 0.04 % 0.19 % 0.41 % Dividend yield — — — Remaining expected term of underlying securities (years) 0.34 1.70 2.58 |
Note 8 - October 2019 Registere
Note 8 - October 2019 Registered Direct Offering | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Stockholders Equity Note Direct Offering 2019 October [Text Block] | 8. OCTOBER 2019 REGISTERED DIRECT OFFERING On October 16, 2019, the Company entered into a Securities Purchase Agreement (the “ October 2019 SPA October 2019 Investors October 2019 Financing one Series I Warrant October 2019 Warrant Shares Placement Agent Warrants five The gross proceeds to the Company from the October 2019 Financing, which were received as of October 18, 2019, were approximately $2.5 million before deducting financing costs of approximately $333,000 which includes approximately $158,000 of placement fees. The number of shares of the Company’s Common Stock into which each of the Series I Warrants is exercisable and the exercise price therefore are subject to adjustment, as set forth in the Series I Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise). The Company engaged H.C. Wainwright as its exclusive institutional investor placement agent (the “ Placement Agent 2019 Engagement Agreement During the year ended September 30, 2022, no Series I Warrants or Placement Agent Warrants have been exercised. As of September 30, 2022, up to 14,285,714 and 1,071,429 shares may be acquired upon the exercise of the Series I Warrants and Placement Agent Warrants, respectively. Common Stock At October 18, 2019 the Closing Date of the October 2019 Financing, the Company issued 14,285,714 shares of Common Stock. Equity Value of Warrants The Company accounted for the Series I Warrants and the Placement Agent Warrants relating to the aforementioned October 2019 Registered Direct Offering in accordance with ASC 815-40. Because the Series I Warrants and the Placement Agent Warrants are indexed to the Company’s stock, they are classified within stockholders’ equity (deficit) in the accompanying consolidated financial statements. |
Note 9 - 2021 Registered Direct
Note 9 - 2021 Registered Direct Offering | 12 Months Ended |
Sep. 30, 2022 | |
The 2021 Registered Direct Offering [Member] | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 9. 2021 REGISTERED DIRECT OFFERING On February 11, 2021, the Company entered into a Securities Purchase Agreement (the “ 2021 SPA 2021 Investors Series K Warrants Warrant Shares 2021 Financing 2021 Engagement Agreement Placement Agent Warrants The 2021 SPA contained certain restrictions on the Company’s ability to conduct subsequent sales of the Company’s equity securities. In particular, we were prohibited from entering into or effecting a Variable Rate Transaction (as defined in the 2021 SPA) until February 11, 2022; provided, however, the Company may enter into and effect an at-the-market offering facility with the Placement Agent. The number of shares of the Company’s Common Stock into which each of the Series K Warrants is exercisable and the exercise price therefore are subject to adjustment, as set forth in the Series K Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise). During the fiscal year ended September 30, 2022, no Series K Warrants or 2021 Placement Agent Warrants had been exercised. As of September 30, 2022, up to 32,343,754 and 3,234,375 shares may be acquired upon the exercise of the Series K Warrants and Placement Agent Warrants, respectively. Common Stock On February 17, 2021 the Closing Date of the 2021 Financing, the Company issued 43,125,004 shares of Common Stock. Equity Value of Warrants The Company accounted for the Series K Warrants and the Placement Agent 2 Warrants relating to the aforementioned February 2021 Registered Direct Offering in accordance with ASC 815-40, Derivatives and Hedging |
Note 10 - 2022 Convertible Note
Note 10 - 2022 Convertible Note Offering | 12 Months Ended |
Sep. 30, 2022 | |
Notes 2022 [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 10. 2022 CONVERTIBLE NOTE OFFERING On July 7, 2022, the Company announced that it had entered into a Securities Purchase Agreement (the “ 2022 SPA 2022 Investors 2022 Note 2022 Notes 2022 Warrants 2022 Warrant Shares 2022 Inducement Shares 2022 Note Offering 2022 Closing Date The 2022 Notes bear interest on the unpaid principal balance at a rate equal to ten percent (10%) (computed on the basis of the actual number of days elapsed in a 360-day year) per annum accruing from the Closing Date until the 2022 Notes become due and payable at maturity or upon their conversion, acceleration or by prepayment, and may become due and payable upon the occurrence of an event of default under the 2022 Notes. Any amount of principal or interest on the 2022 Notes which is not paid when due shall bear interest at the rate of the lesser of (i) eighteen percent (18%) per annum or (ii) the maximum amount allowed by law from the due date thereof until payment in full. The 2022 Notes are convertible into shares of Common Stock at the option of each holder of the 2022 Notes from the date of issuance at $0.0457 (the “ Conversion Price Maturity Date provided, however Ownership Limitation provided further provided that The 2022 Notes contain customary events of default, which include, among other things, (i) our failure to pay when due any principal or interest payment under the 2022 Notes; (ii) our insolvency; (iii) delisting of our Common Stock; (iv) our breach of any material covenant or other material term or condition under the 2022 Notes; and (v) our breach of any representations or warranties under the 2022 Notes which cannot be cured within five (5) days. Further, events of default under the 2022 Notes also include (i) the unavailability of Rule 144 on or after January 6, 2023; (ii) our failure to deliver the shares of Common Stock to the 2022 Note holder upon exercise by such holder of its conversion rights under the 2022 Note; (iii) our loss of the “bid” price for its Common Stock and/or a market and such loss is not cured during the specified cure periods; and (iv) our failure to complete an uplisting of our Common Stock to any of the Nasdaq Global Market, Nasdaq Capital Market, New York Stock Exchange or NYSE American by February 15, 2023 (an “ Uplist Transaction The 2022 Warrants (i) have an exercise price of $0.0497 per share; (ii) have a term of exercise equal to 5 years after their issuance date; (iii) became exercisable immediately after their issuance; and (iv) have a provision preventing the exercisability of such 2022 Warrant if, as a result of the exercise of the 2022 Warrant, the holder, together with its affiliates and any other persons whose beneficial ownership of our Common Stock would be aggregated with the holder’s, would be deemed to beneficially own more than the Ownership Limitation. The holder, upon notice to us, may increase or decrease the Ownership Limitation; provided that (i) the Ownership Limitation may only be increased to a maximum of 9.99% of our Common Stock; and (ii) any increase in the Ownership Limitation will not become effective until the 61st day after delivery of such waiver notice. The number of shares of Common Stock into which each of the 2022 Warrants is exercisable and the exercise price therefor are subject to adjustment as set forth in the 2022 Warrants, including standard antidilution provisions, and adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise). In the event of a Fundamental Transaction (as defined in the 2022 Warrants) holders of the 2022 Warrants would be entitled to receive alternate consideration in connection with such Fundamental Transaction, but only to the extent that holders of our Common Stock were entitled to receive the same. Moreover, as long as the 2022 Notes and 2022 Warrants remaining outstanding, upon the issuance of any security in connection with any potential future financing activity on terms more favorable than the existing terms, the Company has an obligation to notify the holders of the 2022 Notes and 2022 Warrants of such more favorable terms and to use best efforts to effect such terms in the 2022 Notes and 2022 Warrants. Finally, because of the Company’s net loss position, the shares underlying the 2022 Notes on an as converted basis are excluded from the calculation of basic and fully diluted earnings per share. Similarly, because of the Company’s net loss position, there was no impact on the calculation of basic and fully diluted earnings per share related to the classification of the 2022 Warrants as participating securities. The Company retained a placement agent in connection with the private placement of $2.4 million of the 2022 Notes to the institutional investors. The Company paid the 2022 Placement Agent 10% of the gross proceeds in the 2022 Placement Agent from certain institutional investors, or $240,000 and we also reimbursed the 2022 Placement Agent approximately $58,000 for non-accountable banking fees, legal fees and other expenses. In addition, we issued 2022 Placement Agent Warrants to purchase an aggregate of 6,301,969 shares of Common Stock. An additional $1.1 million was raised in connection with the placement of the private placement notes, which included certain accredited investors some of which were Board members and executive officers of the Company. Board member, Laurence Hicks, and executive officers, Terrence W. Norchi and Michael S. Abrams, invested in the 2022 Senior Secured Convertible Notes. The investment made in the 2022 Senior Secured Convertible Notes made by the Board member and executive officers totaled $80,000. In addition, as a part of the 2022 Convertible Notes Offering, certain holders (the “ Series Holders Series Notes Subordinated Notes Closing Date Further, in connection with the 2022 Note Financing, we are required to complete an Uplist Transaction by February 15, 2023 under the terms of the 2022 Notes. If we are unable to complete an Uplist Transaction, then the 2022 Notes will become immediately due and payable and we will be obligated to pay to each 2022 Note holder an amount equal to 125%, multiplied by the sum of the outstanding principal amount of the 2022 Notes plus any accrued and unpaid interest on the unpaid principal amount of the 2022 Notes to the date of payment, plus any default interest and any other amounts owed to the holder, payable in cash or shares of Common Stock. During the fiscal year ended September 30, 2022, the Company recorded interest expense on the 2022 Notes of approximately $421,000 consisting of accrued interest of approximately $119,000 and accretion of original issue discount debt discount and issuance costs of approximately $302,000. Allocation of Proceeds The Company accounted for the Senior Secured Convertible Notes, the 2022 Warrants, and the 2022 Inducement Shares relating to the aforementioned July 2022 Senior Secured Convertible Promissory Notes in accordance with ASC 470-20-25-2 “Debt” which states that the allocation of the proceeds from the financing shall be based on the relative fair values of the securities issued at the time of the issuance. The 2022 Inducement Shares and the 2022 Warrants, which are indexed to the Company’s stock, are classified within stockholders’ equity (deficit) in the accompanying consolidated financial statements. The allocated value of the 2022 Inducement Shares and the 2022 Warrants are $314,523 and $1,470,133, respectively. The allocated value of the Senior Secured Convertible Notes are $1,740,344 were allocated as long-term liabilities in the accompanying consolidated financial statements. The fair value of the 2022 Placement Agent Warrants of $219,894 are being accounted for as debt issuance costs and are classified within stockholders’ equity (deficit) in the accompanying consolidated financial statements. As of September 30, 2022, the net carrying amount of the Senior Secured Convertible Notes was $2,362,273 with unamortized debt discount and issuance costs of $2,567,507. The 2022 Warrants and the 2022 Placement Agent Warrants were valued as of July 6, 2022 2022 Investor Warrants 2022 Placement Agent Warrants Closing price per share of Common Stock $ 0.0499 $ 0.0499 Exercise price per share $ 0.0497 $ 0.0503 Expected volatility 88.44 % 88.44 % Risk-free interest rate 2.96 % 2.96 % Dividend yield — — Remaining expected term of underlying securities (years) 5.0 5.0 |
Note 11 - Series 1 and Series 2
Note 11 - Series 1 and Series 2 Convertible Notes | 12 Months Ended |
Sep. 30, 2022 | |
Series 1 & 2 Convertible Notes [Member] | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 11. SERIES 1 AND SERIES 2 CONVERTIBLE NOTES On June 4, 2020 and November 6, 2020, the Company issued unsecured 10% Series 1 Convertible Notes (“ Series 1 Notes Convertible Notes Conversion Price Holder VWAP In-Kind Note Repayment Beginning June 22, 2015 and through June 30, 2015, the Company entered into a series of substantially similar subscription agreements with 20 accredited investors providing for the issuance and sale by the Company to the 2015 Investors, in a private placement, of an aggregate of 14,390,754 Units at a purchase price of $0.22 per Unit. Each Unit consisted of a share of Common Stock and a Series D Warrant to purchase a share of Common Stock at an exercise price of $0.25 per share at any time prior to the fifth anniversary of the issuance date of the Series D Warrant and the shares issuable upon exercise of the Series D Warrants. On June 3, 2020, the Company entered into an agreement (the “ Agreement Majority Holders Series D Warrants Series J Warrants On June 22, 2020, the Company entered into a Series J Warrant Issuance Agreement (the “ Keyes Sulat Agreement Trust one-year As described in Note 10, above, as a part of the 2022 Convertible Notes Offering, certain holders of the Series Notes agreed to exchange Notes with principal amounts of $600,000 and accrued interest of approximately $100,000 for promissory notes of the Company on substantially similar terms to those of the 2022 Notes (the “ Exchanged Notes Closing Date During the fiscal years ended September 30, 2022 and 2021, the Company recorded interest expense on the Series 1 and Series 2 Convertible Notes of approximately $146,000 and $150,000, respectively. |
Note 12 - Income Taxes
Note 12 - Income Taxes | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 12. INCOME TAXES The principal components of the Company's net deferred tax assets consisted of the following at September 30: 2022 2021 Net operating loss carryforwards $ 11,485,524 $ 10,022,020 Capitalized expenditures 1,535,736 1,703,849 Research and development credit carryforwards 946,243 946,158 Stock based compensation 1,427,946 2,352,432 Property and Equipment 2,616 2,740 Accrued expenses 162,191 57,812 Inventory allowance 70,805 62,946 Gross deferred tax assets 15,631,061 15,147,957 Deferred tax asset valuation allowance (15,631,061 ) (15,147,957 ) Net deferred tax assets $ - $ - The provision (benefit) for income taxes differs from the tax computed with the statutory federal income tax rate as follows: 2022 2021 Expected income tax (benefit) at federal statutory rate 21.00 % 21.00 % Increase/(Decrease) due to: State income taxes – net of federal benefit 3.65 % 5.80 % Permanent Differences: Key man life insurance --- % (0.01 )% Stock Based Compensation (18.10 )% --- % R&D, taken as a credit (0.23 )% (0.29 )% Adjustment to fair value of derivative 3.98 % 0.37 % PPP Loan Forgiveness --- % 0.60 % Other (1.14 )% (1.41 )% Change in Valuation Allowance (9.16 )% (26.06 )% Total Income Tax Provision / (Benefit) --- % --- % As of September 30, 2022 and 2021, the Company had federal net operating loss carryforwards totaling approximately $42,695,000 and $37,018,000, respectively, which may be available to offset future taxable income. The pre-2018 federal net operating loss carryforwards total approximately $21,750,000, and begin to expire in 2026. Due to the CARES Act, federal net operating losses generated in tax years beginning after December 31, 2017 can be carried forward indefinitely. As of September 30, 2022 and 2021, the Company has federal net operating loss carryforwards with an indefinite life of $20,945,000 and $15,268,000. As of September 30, 2022 and 2021, the Company had federal research and experimentation credit carryforwards of $626,000 and $643,000, respectively, which may be available to offset future income tax liabilities and which would begin to expire in 2028. As of September 30, 2022 and 2021, the Company had state net operating loss carryforwards of approximately $40,367,000 and $36,033,000, respectively, which may be available to offset future taxable income and which would begin to expire in 2030. As of September 30, 2022 and 2021, the Company had state research and development credit carryforwards of $406,000 and $384,000, respectively, which may be able to offset future income tax liabilities and which would begin to expire in 2023. As the Company has not yet achieved profitable operations, management believes the tax benefits as of September 30, 2022 and 2021 did not satisfy the realization criteria set forth in FASB ASC Topic 740, Income Taxes The Company experienced an ownership change as a result of the Merger described in Note 1, causing a limitation on the annual use of the net operating loss carryforwards, which are subject to a substantial annual limitation due to the ownership change limitations set forth in Internal Revenue Code Section 382 and similar state provisions. A formal Section 382 study has not been performed. As of September 30, 2022, the Company is open to examination in the U.S. federal and certain state jurisdictions for tax years ended September 30, 2022, 2021, 2010 and 2019. In addition, any loss years remain open to the extent that losses are available for carryover to future years. Therefore, the tax years ended 2006 through 2022 remain open for examination by the IRS. The Coronavirus Aid, Relief and Economic Security (CARES) Act was enacted on March 27, 2020. The CARES Act affected items such as carryback periods for net operating losses, modifications to the net interest deduction limitations and changes to tax depreciation methods. The company has taken the CARES Act into consideration for the tax year ended September 30, 2022 and continues to evaluate the impact of the CARES act on the business. |
Note 13- Payroll Protection Pro
Note 13- Payroll Protection Program Loan | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Payroll Protection Program Loan [Text Block] | 13. PAYROLL PROTECTION PROGRAM LOAN On April 25, 2020, the Company executed a promissory note (the “ PPP Note PPP Loan PPP SBA Lender The PPP Loan had a two-year The PPP Note contains customary events of default relating to, among other things, payment defaults, providing materially false and misleading representations to the SBA or Lender, or breaching the terms of the PPP Loan documents. The occurrence of an event of default may result in the immediate repayment of all amounts outstanding, collection of all amounts owing from the Company, or filing suit and obtaining judgment. Under the terms of the CARES Act, PPP Loan recipients can apply for and be granted forgiveness for all or a portion of the loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities. However, no assurance is provided that forgiveness for any portion of the PPP Loan will be obtained. During November 2020, the Company applied for forgiveness of the PPP |
Note 14 - Stock-based Compensat
Note 14 - Stock-based Compensation | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 14. STOCK-BASED COMPENSATION 2013 Stock Incentive Plan On June 18, 2013, the Company established the 2013 Stock Incentive Plan (the “ 2013 Plan Board The exercise price of each option is equal to the closing price of a share of our common stock on the date of grant. Share-based awards During the year ended September 30, 2022, the Company granted 475,000 options to employees and directors and 850,000 options to consultants to purchase shares of common stock under the 2013 Plan . Share-based compensation expense for awards granted during the year ended September 30, 2022 was based on the grant date fair value estimated using the Black-Scholes Option Pricing Model. The following assumptions were used to calculate the fair value of share-based compensation for the year ended September 30, 2022; expected volatility, 79.44% - 119.44%, risk-free interest rate, 0.13% - 2.85%, expected dividend yield, 0%, expected term, 5.6 years. Common Stock Options Stock compensation activity under the 2013 Plan for the year ended September 30, 2022 follows: Weighted Weighted Average Option Average Remaining Aggregate Shares Exercise Contractual Intrinsic Outstanding Price Term (years) Value Outstanding at September 30, 2021 24,899,014 $ 0.29 1.83 $ 140,151 Awarded 1,325,000 $ 0.03 Forfeited/Cancelled (6,498,818 ) $ 0.35 Outstanding at September 30, 2022 19,725,196 $ 0.26 1.46 $ 16,900 Vested at September 30, 2022 16,504,312 $ 0.29 1.52 $ — Vested and expected to vest at September 30, 2022 19,725,196 $ 0.26 1.46 $ 16,900 As of September 30, 2022, 8,273,158 shares are available for future grants under the 2013 Plan. Share-based compensation expense recorded in the Company’s Consolidated Statements of Operations for the year ended September 30, 2022 and 2021 resulting from stock options awarded to the Company’s employees, directors and consultants was approximately $459,000 and $391,000, respectively. Of this amount during the years ended September 30, 2022 and 2021, $148,000 and $124,000, respectively, were recorded as research and development expenses, and $311,000 and $267,000, respectively were recorded as general and administrative expenses in the Company’s Consolidated Statements of Operations. During the years ended September 30, 2022 and 2021, no stock options awarded under the 2013 Stock Incentive Plan were exercised for cash. During the years ended September 30, 2022 and 2021, no stock options awarded under the 2013 Stock Incentive Plan were exercised on a cashless basis. As of September 30, 2022, there is approximately $181,000 of unrecognized compensation expense related to unvested stock-based compensation arrangements granted under the 2013 Plan. That cost is expected to be recognized over a weighted average period of 2.47 years. Restricted Stock On October 14, 2020, the Company awarded 50,000 shares of Restricted Stock to a consultant. The shares subject to this grant were awarded under the 2013 Plan and vested 90 days from the date of the award. On January 27, 2021, the Company awarded 500,000 shares of Restricted Stock to a consultant. The shares subject to this grant were awarded under the 2013 Plan and vested immediately. On July 30, 2021, the Company awarded 150,000 shares of Restricted Stock to an employee. The shares subject to this grant were awarded under the 2013 Plan and 50,000 shares vest on each of the following dates: January 12, 2022, July 12, 2022 and January 12, 2023. On September 27, 2021, the Company awarded 300,000 shares of Restricted Stock to a consultant. The shares subject to this grant were awarded under the 2013 Plan and 1/12 Restricted stock activity in shares under the 2013 Plan for the years ended September 30, 2022 and 2021 follows: 2022 2021 Non Vested at September 30, 2021 and 2020 450,000 Awarded — 1,000,000 Vested (400,000 ) (550,000 Forfeited — — Non Vested at September 30, 2022 and 2021 50,000 450,000 The weighted average restricted stock award date fair value information for the years ended September 30, 2022 and 2019 follows: 2022 2021 Non Vested at September 30, 2021 and 2020 $ 0.10 $ — Awarded 0.13 Vested (0.10 ) (0.16 ) Forfeited — Non Vested at September 30, 2022 and 2021 $ 0.09 $ 0.10 For the years ended September 30, 2022 and 2021 compensation expense recorded for the restricted stock awards was approximately $40,000 and $105,000, respectively. As of September 30, 2022, there is approximately $3,000 of unrecognized compensation expense related to unvested stock-based compensation arrangements granted under the 2013 Plan. |
Note 15 - Commitments and Conti
Note 15 - Commitments and Contingencies | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 15. COMMITMENTS AND CONTINGENCIES In the ordinary course of business, the Company enters into various agreements containing standard indemnification provisions. The Company’s indemnification obligations under such provisions are typically in effect from the date of execution of the applicable agreement through the end of the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of September 30, 2022 and 2021, no amounts have been accrued related to such indemnification provisions. From time to time, the Company may be exposed to litigation in connection with its operations. The Company’s policy is to assess the likelihood of any adverse judgments or outcomes related to legal matters, as well as ranges of probable losses. MIT Licensing Agreement In December 2007, the Company entered into a license agreement with MIT pursuant to which the Company acquired an exclusive world-wide license to develop and commercialize technology related to self-assembling peptide compositions, and methods of making and using such compositions in medical and non-medical applications, including claims that cover the Company’s proposed products and methods of use thereof. The license also provides non-exclusive rights to additional intellectual property in the fields that cover the Company’s proposed products and methods of use thereof, in order to provide freedom to operate. The license provides the Company a right to sublicense the exclusively licensed intellectual property. The Company has not sublicensed the exclusively licensed intellectual property to any party for any field. In exchange for the licenses granted in the agreement, the Company has paid MIT license maintenance fees and patent prosecution costs. The Company paid license maintenance fees of $50,000 to MIT in the fiscal years ended September 30, 2022 and 2021. For the years ended September 30, 2022 and 2021, the annual MIT license maintenance fees of $50,000 are included in accrued expenses and other liabilities on the Consolidated Balance Sheets. The license maintenance fees and patent prosecution costs cover the contract year beginning January 1 through December 31. Annual license maintenance obligations extend through the life of the patents. In addition, MIT is entitled to royalties on applicable future product sales, if any. The annual payments may be applied towards royalties payable to MIT for that year for product sales. The Company is obligated to indemnify MIT and related parties from losses arising from claims relating to the exercise of any rights granted to the Company under the license, with certain exceptions. The maximum potential amount of future payments the Company could be required to make under this provision is unlimited. The Company considers there to be a low performance risk as of September 30, 2022. The agreement expires upon the expiration or abandonment of all patents that are issued and licensed to the Company by MIT under such agreement. The Company expects that patents will be issued from presently pending U.S. and foreign patent applications. Any such patent will have a term of 20 years from the filing date of the underlying application. MIT may terminate the agreement immediately, if the Company ceases to carry on its business, if any nonpayment by the Company is not cured or the Company commits a material breach that is not cured. The Company may terminate the agreement for any reason upon six months’ notice to MIT. Leases The Company's corporate offices are located in Framingham, MA. During July 2017, we entered into a three |
Note 16 - Risks and Uncertainti
Note 16 - Risks and Uncertainties - COVID-19 and Geopolitical Conflicts | 12 Months Ended |
Sep. 30, 2022 | |
Notes to Financial Statements | |
COVID-19 Disclsoure [Text Block] | 16. RISKS AND UNCERTAINTIES - COVID-19 AND GEOPOLITICAL CONFLICTS The Company sources its materials and services for its products and product candidates from facilities in areas impacted or which may be impacted by the outbreak of the COVID-19 or geopolitical conflicts. The Company’s ability to obtain future inventory may be impacted, therefore potentially affecting the Company’s future revenue stream. In addition, the Company has historically and principally funded its operations through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of Common Stock and warrants which may also be impacted by economic conditions beyond the Company’s control as well as uncertainties resulting from geopolitical conflicts, including the recent war in Ukraine. The extent to which the COVID-19 and recent events in Ukraine will impact the global economy and the Company is uncertain and cannot be reasonably measured. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued and Adopted Accounting Guidance Debt with Conversion and other Derivatives and Hedging-Contracts in Entity s Own Equity (Subtopic 815-40) ASU 2020-06 . GAAP |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents |
Inventory, Policy [Policy Text Block] | Inventories |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets Property, Plant and Equipment |
Lessee, Leases [Policy Text Block] | Leases ROU |
Income Tax, Policy [Policy Text Block] | Income Taxes Income Taxes ASC 740 |
Revenue from Contract with Customer [Policy Text Block] | Revenue Revenue Recognition |
Cost of Goods and Service [Policy Text Block] | Cost of Revenues |
Research and Development Expense, Policy [Policy Text Block] | Research and Development |
Share-Based Payment Arrangement [Policy Text Block] | Accounting for Stock-Based Compensation Compensation-Stock Compensation ASC 718 |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value Measurements Fair Value Measurements and Disclosures |
Derivatives, Reporting of Derivative Activity [Policy Text Block] | Derivative Liabilities Derivatives and Hedging ASC 815 . |
Complex Equity Instruments [Policy Text Block] | Complex Financial Instruments Derivatives and Hedging |
Financial Statement Reclassification [Policy Text Block] | Financial Statement Reclassification |
Subsequent Events, Policy [Policy Text Block] | Subsequent Events CMS HCPCS Code Status |
Going Concern Basis Of Accounting [Policy Text Block] | Going Concern Basis of Accounting 2018 SPA 2022 SPA |
Note 3 - Property and Equipme_2
Note 3 - Property and Equipment (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | Estimated Useful Life (in years) September 30, 2022 September 30, 2021 Furniture and fixtures 5 $ 9,357 $ 9,357 Leasehold improvements Life of Lease 8,983 8,983 Computer equipment 3 14,416 14,416 Lab equipment 5 1,000 1,000 33,756 33,756 Less – accumulated depreciation 31,712 28,516 Property and equipment, net $ 2,044 $ 5,240 |
Note 4 - Inventories (Tables)
Note 4 - Inventories (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | September 30, September 30, 2022 2021 Finished Goods $ 9,063 $ 249,571 Goods-in-process 1,405,785 844,194 Total $ 1,414,848 $ 1,093,765 |
Note 7 - Derivative Liabiliti_2
Note 7 - Derivative Liabilities (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Derivative Liabilities at Fair Value [Table Text Block] | Series F Series G Series H Beginning balance at September 30, 2021 $ 1,000,000 $ 748,275 $ 459,200 Issuances — — — Adjustments for the expiration of warrant (1,000,000 ) — — Ending balance at September 30, 2022 $ — $ 748,275 $ 459,200 Series F Series G Series H Beginning balance at September 30, 2020 $ 1,000,000 $ 748,275 $ 568,144 Issuances — — — Adjustments to estimated fair value — — (108,944 ) Ending balance at September 30, 2021 $ 1,000,000 $ 748,275 $ 459,200 |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | Series G Series H Closing price per share of Common Stock Exercise price per share $ 0.70 $ 0.40 Expected volatility 132.97 % 122.50 % Risk-free interest rate 4.05 % 4.14 % Dividend yield — — Remaining expected term of underlying securities (years) 0.69 1.57 Series F Series G Series H Closing price per share of Common Stock $ 0.12 $ 0.12 $ 0.12 Exercise price per share $ 0.75 $ 0.70 $ 0.40 Expected volatility 90.28 % 87.40 % 86.59 % Risk-free interest rate 0.04 % 0.19 % 0.41 % Dividend yield — — — Remaining expected term of underlying securities (years) 0.34 1.70 2.58 |
Note 10 - 2022 Convertible No_2
Note 10 - 2022 Convertible Note Offering (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Share-Based Payment Award, Warrants, Valuation Assumptions [Table Text Block] | 2022 Investor Warrants 2022 Placement Agent Warrants Closing price per share of Common Stock $ 0.0499 $ 0.0499 Exercise price per share $ 0.0497 $ 0.0503 Expected volatility 88.44 % 88.44 % Risk-free interest rate 2.96 % 2.96 % Dividend yield — — Remaining expected term of underlying securities (years) 5.0 5.0 |
Note 12 - Income Taxes (Tables)
Note 12 - Income Taxes (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | 2022 2021 Net operating loss carryforwards $ 11,485,524 $ 10,022,020 Capitalized expenditures 1,535,736 1,703,849 Research and development credit carryforwards 946,243 946,158 Stock based compensation 1,427,946 2,352,432 Property and Equipment 2,616 2,740 Accrued expenses 162,191 57,812 Inventory allowance 70,805 62,946 Gross deferred tax assets 15,631,061 15,147,957 Deferred tax asset valuation allowance (15,631,061 ) (15,147,957 ) Net deferred tax assets $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | 2022 2021 Expected income tax (benefit) at federal statutory rate 21.00 % 21.00 % Increase/(Decrease) due to: State income taxes – net of federal benefit 3.65 % 5.80 % Permanent Differences: Key man life insurance --- % (0.01 )% Stock Based Compensation (18.10 )% --- % R&D, taken as a credit (0.23 )% (0.29 )% Adjustment to fair value of derivative 3.98 % 0.37 % PPP Loan Forgiveness --- % 0.60 % Other (1.14 )% (1.41 )% Change in Valuation Allowance (9.16 )% (26.06 )% Total Income Tax Provision / (Benefit) --- % --- % |
Note 14 - Stock-based Compens_2
Note 14 - Stock-based Compensation (Tables) | 12 Months Ended |
Sep. 30, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Weighted Weighted Average Option Average Remaining Aggregate Shares Exercise Contractual Intrinsic Outstanding Price Term (years) Value Outstanding at September 30, 2021 24,899,014 $ 0.29 1.83 $ 140,151 Awarded 1,325,000 $ 0.03 Forfeited/Cancelled (6,498,818 ) $ 0.35 Outstanding at September 30, 2022 19,725,196 $ 0.26 1.46 $ 16,900 Vested at September 30, 2022 16,504,312 $ 0.29 1.52 $ — Vested and expected to vest at September 30, 2022 19,725,196 $ 0.26 1.46 $ 16,900 |
Nonvested Restricted Stock Shares Activity [Table Text Block] | 2022 2021 Non Vested at September 30, 2021 and 2020 450,000 Awarded — 1,000,000 Vested (400,000 ) (550,000 Forfeited — — Non Vested at September 30, 2022 and 2021 50,000 450,000 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value [Table Text Block] | 2022 2021 Non Vested at September 30, 2021 and 2020 $ 0.10 $ — Awarded 0.13 Vested (0.10 ) (0.16 ) Forfeited — Non Vested at September 30, 2022 and 2021 $ 0.09 $ 0.10 |
Note 1 - Description of Busin_2
Note 1 - Description of Business (Details Textual) - $ / shares | Sep. 30, 2022 | Sep. 30, 2021 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Note 3 - Property and Equipme_3
Note 3 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Depreciation, Total | $ 3,196 | $ 2,587 |
Note 3 - Property and Equipme_4
Note 3 - Property and Equipment - Property and Equipment (Details) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Property and equipment, gross, Total | $ 33,756 | $ 33,756 |
Less - accumulated depreciation, Total | 31,712 | 28,516 |
Property and equipment, net, Total | $ 2,044 | 5,240 |
Furniture and Fixtures [Member] | ||
Property, and equipment, Estimated Useful Life (Year) | 5 years | |
Property and equipment, gross, Total | $ 9,357 | 9,357 |
Leasehold Improvements [Member] | ||
Property and equipment, gross, Total | $ 8,983 | 8,983 |
Computer Equipment [Member] | ||
Property, and equipment, Estimated Useful Life (Year) | 3 years | |
Property and equipment, gross, Total | $ 14,416 | 14,416 |
Technology Equipment [Member] | ||
Property, and equipment, Estimated Useful Life (Year) | 5 years | |
Property and equipment, gross, Total | $ 1,000 | $ 1,000 |
Note 5 - Inventories - Inventor
Note 5 - Inventories - Inventories (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Finished Goods | $ 9,063 | $ 249,571 |
Goods-in-process | 1,405,785 | 844,194 |
Total | $ 1,414,848 | $ 1,093,765 |
Note 5 - Insurance Premium Fi_2
Note 5 - Insurance Premium Financing (Details Textual) - Insurance Premium Financing [Member] - USD ($) | Jul. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 |
Debt Instrument, Face Amount | $ 354,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 2.99% | ||
Debt Instrument, Periodic Payment, Total | $ 35,000 | ||
Short-Term Debt, Total | $ 247,933 | $ 0 |
Note 6 - Registered Direct Of_2
Note 6 - Registered Direct Offerings (Details Textual) | 12 Months Ended | |||||
Feb. 17, 2021 shares | May 12, 2019 item $ / shares shares | Jun. 28, 2018 item $ / shares shares | Feb. 20, 2017 $ / shares shares | Sep. 30, 2022 shares | Sep. 30, 2016 USD ($) | |
Shelf Registration Statement, Maximum Amount Authorized | $ | $ 50,000,000 | |||||
Stock Issued During Period, Shares, New Issues | 43,125,004 | |||||
Class Of Series F Warrant [Member] | ||||||
Percentage of Warrants Per Unit | 0.55 | |||||
Class Of Warrant Or Right Acquired Upon Exercise | 6,802,500 | |||||
Series F Warrant [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.75 | |||||
Class of Warrant or Right, Expired During Period (in shares) | 5,591,664 | |||||
Class Of Series G Warrant [Member] | ||||||
Percentage of Warrants Per Unit | 0.75 | |||||
Class Of Warrant Or Right Acquired Upon Exercise | 8,615,384 | |||||
Class Of Series H Warrant [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.40 | |||||
The 2017 SPA [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 10,166,664 | |||||
Shares Issued, Price Per Share | $ / shares | $ 0.60 | |||||
The 2018 SPA [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 9,070,000 | |||||
Shares Issued, Price Per Share | $ / shares | $ 0.50 | |||||
Number Of Accredited Investors | item | 8 | |||||
Registered Direct Offering 2018 [Member] | Class Of Series G Warrant [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.70 | |||||
The 2019 SPA [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 8,615,384 | |||||
Shares Issued, Price Per Share | $ / shares | $ 0.325 | |||||
Number Of Accredited Investors | item | 5 |
Note 7 - Derivative Liabiliti_3
Note 7 - Derivative Liabilities (Details Textual) - USD ($) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Unrealized Gain (Loss) on Derivatives | $ 1,000,000 | $ 108,944 |
Derivative Warrant Liability [Member] | ||
Derivative Liability, Total | $ 1,628,113 | |
Fair Value Adjustment of Derivatives | $ 108,944 | |
Series F Warrant [Member] | ||
Class of Warrants and Rights, Required Cash Purchase Price (in dollars per share) | $ 0.08 | |
Unrealized Gain (Loss) on Derivatives | $ 1,000,000 | |
Series G Warrant [Member] | ||
Class of Warrants and Rights, Required Cash Purchase Price (in dollars per share) | $ 0.11 | |
Series H Warrant [Member] | ||
Class of Warrants and Rights, Required Cash Purchase Price (in dollars per share) | $ 0.0533 |
Note 7 - Derivative Liabiliti_4
Note 7 - Derivative Liabilities - Fair Value of Derivative Liability (Details) - Fair Value, Inputs, Level 3 [Member] - Derivative Financial Instruments, Liabilities [Member] - USD ($) | 12 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Oct. 09, 2021 | Oct. 01, 2020 | |
Series F Warrant Derivative [Member] | ||||
Beginning balance at September 30, 2021 | $ 1,000,000 | |||
Beginning balance at September 30, 2020 | 0 | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 |
Issuances | 0 | 0 | ||
Adjustments to estimated fair value | (1,000,000) | 0 | ||
Ending balance at September 30, 2022 | 0 | 1,000,000 | ||
Series G Warrant Derivative [Member] | ||||
Beginning balance at September 30, 2021 | 748,275 | |||
Beginning balance at September 30, 2020 | 748,275 | 748,275 | 748,275 | 748,275 |
Issuances | 0 | 0 | ||
Adjustments to estimated fair value | 0 | 0 | ||
Ending balance at September 30, 2022 | 748,275 | 748,275 | ||
Series H Warrant Derivative [Member] | ||||
Beginning balance at September 30, 2021 | 459,200 | |||
Beginning balance at September 30, 2020 | 459,200 | 459,200 | $ 459,200 | $ 568,144 |
Issuances | 0 | 0 | ||
Adjustments to estimated fair value | 0 | (108,944) | ||
Ending balance at September 30, 2022 | $ 459,200 | $ 459,200 |
Note 7 - Derivative Liabiliti_5
Note 7 - Derivative Liabilities - Derivative Liability Value Assumptions (Details) - Derivative Financial Instruments, Liabilities [Member] | Sep. 30, 2022 | Sep. 30, 2021 |
Measurement Input, Share Price [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.12 | |
Measurement Input, Share Price [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.12 | |
Measurement Input, Share Price [Member] | Series G Warrant [Member] | ||
Derivative Liability, Measurement Input | 0.70 | |
Measurement Input, Share Price [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.40 | 0.12 |
Measurement Input, Exercise Price [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.75 | |
Measurement Input, Exercise Price [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.70 | |
Measurement Input, Exercise Price [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.40 | |
Measurement Input, Price Volatility [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.9028 | |
Measurement Input, Price Volatility [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 1.3297 | 0.8740 |
Measurement Input, Price Volatility [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 1.2250 | 0.8659 |
Measurement Input, Risk Free Interest Rate [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.0004 | |
Measurement Input, Risk Free Interest Rate [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 4.05 | 0.0019 |
Measurement Input, Risk Free Interest Rate [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 4.14 | 0.0041 |
Measurement Input, Expected Dividend Rate [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0 | |
Measurement Input, Expected Dividend Rate [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0 | |
Measurement Input, Expected Dividend Rate [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0 | |
Measurement Input, Inception Discount Rate [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0 | |
Measurement Input, Inception Discount Rate [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0 | |
Measurement Input, Expected Term [Member] | Series F Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.0034 | |
Measurement Input, Expected Term [Member] | Series G Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 0.69 | 0.0170 |
Measurement Input, Expected Term [Member] | Series H Warrant Derivative [Member] | ||
Derivative Liability, Measurement Input | 1.57 | 0.0258 |
Note 8 - October 2019 Registe_2
Note 8 - October 2019 Registered Direct Offering (Details Textual) | Feb. 17, 2021 shares | Oct. 18, 2019 USD ($) $ / shares shares | Oct. 10, 2019 USD ($) | Sep. 30, 2022 shares |
Stock Issued During Period, Shares, New Issues | 43,125,004 | |||
Series I Warrant [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.22 | |||
October 2019 Placement Agent Warrants [Member] | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.21875 | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,071,429 | |||
Warrants and Rights Outstanding, Term | 5 years | |||
Class of Series I Warrant [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 14,285,714 | |||
Proceeds from Subscribed, Unissued Common Stock and Warrants | $ | $ 2,500,000 | |||
Payments of Stock Issuance Costs | $ | $ 158,000 | |||
Class of Series I Warrant [Member] | Minimum [Member] | ||||
Percentage of Fee on Gross Proceeds of Warrants | 0.060 | |||
Class of Series I Warrant [Member] | Maximum [Member] | ||||
Percentage of Fee on Gross Proceeds of Warrants | 0.082 | |||
Placement Agent Warrants [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,071,429 | |||
October 2019 Registered Direct Offering [Member] | ||||
Stock Issued During Period, Shares, New Issues | 14,285,714 | |||
Shares Issued, Price Per Share | $ / shares | $ 0.175 | |||
Registered Direct Offering October 2019 [Member] | ||||
Stock Issued During Period, Shares, New Issues | 14,285,714 | |||
Proceeds from Subscribed, Unissued Common Stock and Warrants | $ | $ 2,500,000 | |||
Payments of Financing Costs, Total | $ | 333,000 | |||
Payments of Stock Issuance Costs | $ | $ 158,000 |
Note 9 - 2021 Registered Dire_2
Note 9 - 2021 Registered Direct Offering (Details Textual) - USD ($) | Feb. 17, 2021 | Feb. 11, 2021 | Sep. 30, 2022 |
Stock Issued During Period, Shares, New Issues | 43,125,004 | ||
Series K Warrant [Member] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 32,343,754 | 32,343,754 | |
Warrants and Rights Outstanding, Term | 5 years 6 months | ||
Placement Agent 2 Warrants [Member] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,234,375 | 3,234,375 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.20 | ||
Warrants and Rights, Percent of Stock Oustanding Callable | 7.50% | ||
The 2021 Registered Direct Offering [Member] | |||
Stock Issued During Period, Shares, New Issues | 43,125,004 | ||
Shares Issued, Price Per Share | $ 0.16 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.17 | ||
Proceeds from Issuance or Sale of Equity, Total | $ 6,900,000 | ||
Payments of Stock Issuance Costs | 700,000 | ||
The 2021 Registered Direct Offering [Member] | Non-accountable Expense Fee [Member] | |||
Securities Purchase Agreement, Potential Fees | 10,000 | ||
The 2021 Registered Direct Offering [Member] | Fees and Expenses of Legal Counsel and Other Out-of-pocket Expenses [Member] | |||
Securities Purchase Agreement, Potential Fees | 50,000 | ||
The 2021 Registered Direct Offering [Member] | Clearing Expenses [Member] | |||
Securities Purchase Agreement, Potential Fees | $ 10,000 | ||
The 2021 Registered Direct Offering [Member] | Participating Investors [Member] | |||
Securities Purchase Agreement, Cash Placement Fee | 7.50% | ||
The 2021 Registered Direct Offering [Member] | Certain Investors With Pre-existing Relationships [Member] | |||
Securities Purchase Agreement, Cash Placement Fee | 6% |
Note 10 - 2022 Convertible No_3
Note 10 - 2022 Convertible Note Offering (Details Textual) | 12 Months Ended | |||||
Jul. 07, 2022 USD ($) $ / shares shares | Feb. 17, 2021 shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) | Nov. 06, 2020 USD ($) $ / shares | Jun. 04, 2020 USD ($) $ / shares | |
Stock Issued During Period, Shares, New Issues | shares | 43,125,004 | |||||
Percentage of Principal Amount | 15% | |||||
Proceeds from Issuance of Convertible Notes, Common Stock and Warrants, Gross | $ 3,500,000 | |||||
Debt Issuance Costs, Gross | 775,000 | |||||
Placement Agents Fees | $ 555,000 | |||||
Proceeds from Convertible Debt | $ 0 | $ 1,050,000 | ||||
Inducement Shares 2022 [Member] | ||||||
Proceeds from Issuance or Sale of Equity, Total | $ 314,523 | |||||
Securities Purchase Agreement [Member] | ||||||
Stock Issued During Period, Shares, New Issues | shares | 12,766,600 | |||||
Notes 2022 [Member] | ||||||
Proceeds from Issuance of Private Placement | $ 2,400,000 | |||||
Placement Agent 2022 [Member] | ||||||
Percentage of Gross Proceeds from Issuance of Private Placement | 1,000% | |||||
Reimbursement of Non-accountable Banking Fees | $ 58,000 | |||||
Placement Agent 2022 [Member] | Certain Investors [Member] | ||||||
Payments of Stock Issuance Costs | 240,000 | |||||
Private Placement Notes [Member] | ||||||
Proceeds from Issuance of Private Placement | $ 1,100,000 | |||||
Warrant Shares [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 85,110,664 | |||||
Placement Agent Warrant 2022 [Member] | ||||||
Warrants and Rights Outstanding | $ 220,000 | |||||
Warrant 2022 [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.0497 | |||||
Long-Term Debt, Total | $ 1,470,133 | |||||
Warrant 2022 [Member] | Maximum [Member] | ||||||
Ownership Limitation | 9.99% | |||||
Placement Agent 2022 [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 6,301,969 | |||||
Placement Agent Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 1,071,429 | |||||
Warrants and Rights Outstanding | $ 219,894 | |||||
Notes 2022 [Member] | ||||||
Debt Instrument, Face Amount | $ 4,230,000 | |||||
Debt Instrument, Unamortized Discount, Total | $ 705,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 10% | |||||
Debt Instrument, Interest Rate for Amount of Principal or Interest Not Paid When Due | 18% | |||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.0457 | |||||
Debt Instrument, Convertible, Number of Equity Instruments | 15,312,493 | |||||
Interest Payable | 119,000 | |||||
Interest Expense, Debt, Total | 421,000 | |||||
Accretion of Debt Discount | 302,000 | |||||
Long-Term Debt, Total | 2,362,273 | |||||
Debt Instrument, Unamortized Discount (Premium) and Debt Issuance Costs, Net, Total | 2,567,507 | |||||
Notes 2022 [Member] | Minimum [Member] | ||||||
Ownership Limitation | 4.99% | |||||
Notes 2022 [Member] | Maximum [Member] | ||||||
Ownership Limitation | 9.99% | |||||
Senior Secured Convertible Notes [Member] | Board Member and Executive Officer [Member] | ||||||
Proceeds from Convertible Debt | 80,000 | |||||
Series 1 Convertible Notes [Member] | ||||||
Debt Instrument, Face Amount | $ 550,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 10% | 10% | ||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.27 | |||||
Series 1 Convertible Notes [Member] | Maximum [Member] | ||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.32 | |||||
Series 2 Convertible Notes [Member] | ||||||
Debt Instrument, Face Amount | $ 1,050,000 | |||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.25 | |||||
Convertible Debt, Total | $ 600,000 | |||||
Interest Payable | $ 100,000 | |||||
Debt Instrument, Failure to Complete Uplist Transaction Fee, Percentage of Outstanding Principal | 125% | |||||
Senior Secured Convertible Promissory Notes [Member] | ||||||
Long-Term Debt, Total | $ 1,740,344 |
Note 11 - 2022 Convertible Note
Note 11 - 2022 Convertible Note Offering - Summary of Valuation Assumptions for Warrants (Details) | Jul. 06, 2022 $ / shares |
Investor Warrants [Member] | |
Closing price per share of Common Stock (in dollars per share) | $ 0.0499 |
Investor Warrants [Member] | Measurement Input, Exercise Price [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.0497 |
Investor Warrants [Member] | Measurement Input, Price Volatility [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.8844 |
Investor Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.0296 |
Investor Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0 |
Investor Warrants [Member] | Measurement Input, Expected Term [Member] | |
Warrants and Rights Outstanding, Measurement Input | 5 |
Placement Agent Warrants [Member] | |
Closing price per share of Common Stock (in dollars per share) | $ 0.0499 |
Placement Agent Warrants [Member] | Measurement Input, Exercise Price [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.0503 |
Placement Agent Warrants [Member] | Measurement Input, Price Volatility [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.8844 |
Placement Agent Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0.0296 |
Placement Agent Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |
Warrants and Rights Outstanding, Measurement Input | 0 |
Placement Agent Warrants [Member] | Measurement Input, Expected Term [Member] | |
Warrants and Rights Outstanding, Measurement Input | 5 |
Note 11 - Series 1 and Series_2
Note 11 - Series 1 and Series 2 Convertible Notes (Details Textual) | 12 Months Ended | |||||||||
Jul. 06, 2022 USD ($) | Jun. 22, 2020 USD ($) shares | Jun. 03, 2020 USD ($) shares | Jun. 30, 2015 $ / shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) | Jul. 07, 2022 USD ($) | Jun. 22, 2022 $ / shares | Nov. 06, 2020 USD ($) $ / shares shares | Jun. 04, 2020 USD ($) $ / shares | |
Series 2 Notes Converted to Senior Secured Convertible Notes [Member] | ||||||||||
Debt Conversion, Original Debt, Amount | $ 699,780 | |||||||||
Series D Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.25 | |||||||||
Series D Warrants [Member] | ||||||||||
Proceeds from Warrant Exercises | $ 82,000 | $ 850,000 | ||||||||
Class of Warrant or Right, Warrants Exercised | shares | 454,546 | 4,727,273 | ||||||||
Series J Warrants [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.25 | $ 0.25 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 340,910 | 3,545,454 | 3,375,000 | |||||||
Warrants and Rights Outstanding, Term | 1 year | |||||||||
Private Placement [Member] | ||||||||||
Issuance or Sale of Equity, Number of Units | 14,390,754 | |||||||||
Shares Issued, Price Per Share | $ / shares | $ 0.22 | |||||||||
Series 1 Convertible Notes [Member] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 10% | 10% | ||||||||
Debt Instrument, Face Amount | $ 550,000 | |||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.27 | |||||||||
Series 1 Convertible Notes [Member] | Maximum [Member] | ||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.32 | |||||||||
Series 2 Convertible Notes [Member] | ||||||||||
Debt Instrument, Face Amount | $ 1,050,000 | |||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 0.25 | |||||||||
Convertible Debt, Total | $ 600,000 | |||||||||
Interest Payable | $ 100,000 | |||||||||
Series 1 & 2 Convertible Notes [Member] | ||||||||||
Interest Expense, Debt, Total | $ 146,000 | $ 150,000 |
Note 12 - Income Taxes (Details
Note 12 - Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2021 | |
Effective Income Tax Rate Reconciliation at Federal Statutory Income Tax Rate, Amount | $ 42,695,000 | $ 37,018,000 | |
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | 40,367,000 | $ 36,033,000 | 36,033,000 |
Deferred Tax Assets, Tax Credit Carryforwards, Other | 2,616 | 2,740 | 2,740 |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 946,243 | 946,158 | 946,158 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 483,000 | 1,626,000 | |
Expire In 2026 [Member] | |||
Deferred Tax Assets, Operating Loss Carryforwards, State and Local | 21,750,000 | ||
Expire In 2028 [Member] | |||
Deferred Tax Assets, Tax Credit Carryforwards, Other | 20,945,000 | 15,268,000 | 15,268,000 |
Deferred Tax Assets, Tax Credit Carryforwards, Research | 626,000 | 643,000 | 643,000 |
Expire In 2023 [Member] | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 406,000 | $ 384,000 | $ 384,000 |
Note 12 - Income Taxes - Net De
Note 12 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) | Sep. 30, 2022 | Sep. 30, 2021 |
Net operating loss carryforwards | $ 11,485,524 | $ 10,022,020 |
Capitalized expenditures | 1,535,736 | 1,703,849 |
Research and development credit carryforwards | 946,243 | 946,158 |
Stock based compensation | 1,427,946 | 2,352,432 |
Property and Equipment | 2,616 | 2,740 |
Accrued expenses | 162,191 | 57,812 |
Inventory allowance | 70,805 | 62,946 |
Gross deferred tax assets | 15,631,061 | 15,147,957 |
Deferred tax asset valuation allowance | (15,631,061) | (15,147,957) |
Net deferred tax assets | $ 0 | $ 0 |
Note 12 - Income Taxes - Comput
Note 12 - Income Taxes - Computation of Provision (benefits) Income Taxes from Statutory Federal Income Tax Rate (Details) | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Expected income tax (benefit) at federal statutory rate | 21% | 21% |
Increase/(Decrease) due to: | ||
State income taxes – net of federal benefit | 3.65% | 5.80% |
Permanent Differences: | ||
Key man life insurance | 0% | (0.01%) |
Stock Based Compensation | (18.10%) | |
R&D, taken as a credit | (0.23%) | (0.29%) |
Adjustment to fair value of derivative | 3.98% | 0.37% |
PPP Loan Forgiveness | 0.60% | |
Other | (1.14%) | (1.41%) |
Change in Valuation Allowance | (9.16%) | (26.06%) |
Total Income Tax Provision / (Benefit) | 0% | 0% |
Note 13- Payroll Protection P_2
Note 13- Payroll Protection Program Loan (Details Textual) - Paycheck Protection Program Loan [Member] - USD ($) | 12 Months Ended | |
Apr. 25, 2020 | Sep. 30, 2022 | |
Proceeds from Issuance of Debt | $ 176,300 | |
Debt Instrument, Term (Year) | 2 years | |
Debt Instrument, Interest Rate, Stated Percentage | 100% | |
Debt Instrument, Periodic Payment, Total | $ 20,000 | |
Other Nonoperating Income (Loss) Debt Forgiveness Amount | $ 178,000 |
Note 14 - Stock-based Compens_3
Note 14 - Stock-based Compensation (Details Textual) - USD ($) | 12 Months Ended | |||||||
Sep. 27, 2021 | Jul. 30, 2021 | Jan. 27, 2021 | Oct. 14, 2020 | Jun. 18, 2013 | Sep. 30, 2022 | Sep. 30, 2021 | Oct. 01, 2021 | |
Common Stock, Shares Authorized | 800,000,000 | 800,000,000 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Minimum | 79.44% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Maximum | 119.44% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum | 0.13% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum | 2.85% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 5 years 7 months 6 days | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Number of Shares | 16,504,312 | |||||||
Research and Development Expense [Member] | ||||||||
Share-Based Payment Arrangement, Expense | $ 148,000 | $ 124,000 | ||||||
General and Administrative Expense [Member] | ||||||||
Share-Based Payment Arrangement, Expense | 311,000 | 267,000 | ||||||
Employees Directors And Consultants [Member] | ||||||||
Share-Based Payment Arrangement, Expense | 459,000 | 391,000 | ||||||
Non Employee Restricted Shares [Member] | ||||||||
Share-Based Payment Arrangement, Expense | $ 40,000 | $ 105,000 | ||||||
The 2013 Plan [Member] | ||||||||
Common Stock, Shares Authorized | 31,114,256 | 34,114,256 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized | 3,000,000 | |||||||
Increase In Aggregate Number Of Shares | 3,000,000 | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 8,273,158 | |||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 181,000 | |||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 5 months 19 days | |||||||
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount | $ 3,000 | |||||||
The 2013 Plan [Member] | Restricted Stock [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested, Number of Shares | 50,000 | |||||||
The 2013 Plan [Member] | Restricted Stock [Member] | Share-Based Payment Arrangement, Employee [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) | 150,000 | |||||||
The 2013 Plan [Member] | Restricted Stock [Member] | Board Of Directors And Management [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) | 475,000 | |||||||
The 2013 Plan [Member] | Restricted Stock [Member] | Consultants [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) | 300,000 | 500,000 | 50,000 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Other (in shares) | 850,000 | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 90 days | |||||||
The 2013 Plan [Member] | Restricted Stock [Member] | Consultants [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 8.33% |
Note 14 - Stock-based Compens_4
Note 14 - Stock-based Compensation - Stock Compensation Activity (Details) - USD ($) | 12 Months Ended | 24 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | |
Outstanding, shares (in shares) | 24,899,014 | ||
Outstanding, weighted average exercise price (in dollars per share) | $ 0.29 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term (Year) | 1 year 9 months 29 days | 1 year 5 months 15 days | |
Outstanding, aggregate intrinsic value | $ 16,900 | $ 140,151 | $ 16,900 |
Awarded, shares (in shares) | 1,325,000 | ||
Awarded, weighted average exercise price (in dollars per share) | $ 0.03 | ||
Forfeited/Cancelled, shares (in shares) | (6,498,818) | ||
Forfeited/Cancelled, weighted average exercise price (in dollars per share) | $ 0.35 | ||
Outstanding, shares (in shares) | 19,725,196 | 24,899,014 | 19,725,196 |
Outstanding, weighted average exercise price (in dollars per share) | $ 0.26 | $ 0.29 | $ 0.26 |
Vested, shares (in shares) | 16,504,312 | ||
Vested, weighted average exercise price (in dollars per share) | $ 0.29 | ||
Vested, weighted average remaining contractual term (Year) | 1 year 6 months 7 days | ||
Vested, aggregate intrinsic value | $ 0 | ||
Vested and expected to vest, shares (in shares) | 19,725,196 | 19,725,196 | |
Vested and expected to vest weighted average exercise price (in dollars per share) | $ 0.26 | $ 0.26 | |
Vested and expected to vest, weighted average remaining contractual term (Year) | 1 year 5 months 15 days | ||
Vested and expected to vest, aggregate intrinsic value | $ 16,900 | $ 16,900 |
Note 14 - Stock-based Compens_5
Note 14 - Stock-based Compensation - Restricted Stock Activity (Details) - The 2013 Plan [Member] - shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Non Vested at September 30, 2021 and 2020 (in shares) | 450,000 | |
Awarded (in shares) | 0 | 1,000,000 |
Vested (in shares) | (400,000) | (550,000) |
Forfeited (in shares) | 0 | 0 |
Non Vested at September 30, 2022 and 2021 (in shares) | 50,000 | 450,000 |
Note 14 - Stock-based Compens_6
Note 14 - Stock-based Compensation - Restricted Stock Weighted Average Grant Date Fair Value (Details) - $ / shares | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Non Vested at September 30, 2021 and 2020 (in dollars per share) | $ 0.10 | $ 0 |
Awarded (in dollars per share) | 0.10 | 0.13 |
Vested (in dollars per share) | (0.10) | (0.13) |
Vested (in dollars per share) | (0.16) | |
Forfeited (in dollars per share) | 0 | |
Non Vested at September 30, 2022 and 2021 (in dollars per share) | $ 0.09 | $ 0.10 |
Note 15 - Commitments and Con_2
Note 15 - Commitments and Contingencies (Details Textual) - USD ($) | 12 Months Ended | |||||
Sep. 30, 2021 | Sep. 30, 2022 | Apr. 01, 2022 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2018 | |
Lessee, Operating Lease, Term of Contract | 3 years | |||||
Accrued Rent | $ 42,000 | $ 21,000 | $ 42,000 | $ 39,600 | $ 38,400 | |
Operating Lease, Monthly Rent Payment Obligation | $ 3,500 | |||||
Operating Lease, Right-of-Use Asset | 0 | 0 | ||||
Operating Lease, Liability, Total | $ 0 | $ 0 | ||||
Patents [Member] | ||||||
Finite-Lived Intangible Asset, Useful Life | 20 years | |||||
M I T Licensing Agreement [Member] | ||||||
Contractual Obligation, Total | $ 50,000 |