Cover
Cover - shares | 6 Months Ended | |
Mar. 31, 2024 | May 10, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Information [Line Items] | ||
Entity Registrant Name | NeuroOne Medical Technologies Corporation | |
Entity Central Index Key | 0001500198 | |
Entity File Number | 001-40439 | |
Entity Tax Identification Number | 27-0863354 | |
Entity Incorporation, State or Country Code | DE | |
Current Fiscal Year End Date | --09-30 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Contact Personnel [Line Items] | ||
Entity Address, Address Line One | 7599 Anagram Drive | |
Entity Address, City or Town | Eden Prairie | |
Entity Address, State or Province | MN | |
Entity Address, Postal Zip Code | 55344 | |
Entity Phone Fax Numbers [Line Items] | ||
City Area Code | 952 | |
Local Phone Number | 426-1383 | |
Entity Listings [Line Items] | ||
Title of 12(b) Security | Common stock, $0.001 par value | |
Trading Symbol | NMTC | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 27,515,921 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 2,434,655 | $ 5,322,493 |
Accounts receivable | 555,639 | |
Inventory | 1,311,673 | 1,726,686 |
Prepaid expenses | 407,777 | 263,746 |
Total current assets | 4,709,744 | 7,312,925 |
Intangible assets, net | 78,419 | 89,577 |
Right-of-use assets | 110,724 | 169,059 |
Property and equipment, net | 496,015 | 525,753 |
Total assets | 5,394,902 | 8,097,314 |
Current liabilities: | ||
Accounts payable | 780,839 | 685,104 |
Accrued expenses and other liabilities | 759,620 | 1,107,522 |
Total current liabilities | 1,540,459 | 1,792,626 |
Operating lease liability, long term | 55,284 | |
Total liabilities | 1,540,459 | 1,847,910 |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding. | ||
Common stock, $0.001 par value; 100,000,000 shares authorized; 26,321,750 and 23,928,945 shares issued and outstanding as of March 31, 2024 and September 30, 2023, respectively. | 26,322 | 23,929 |
Additional paid–in capital | 72,714,414 | 68,911,778 |
Accumulated deficit | (68,886,293) | (62,686,303) |
Total stockholders’ equity | 3,854,443 | 6,249,404 |
Total liabilities and stockholders’ equity | $ 5,394,902 | $ 8,097,314 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2024 | Sep. 30, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 26,321,750 | 23,928,945 |
Common stock, shares outstanding | 26,321,750 | 23,928,945 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||||
Product revenue | $ 1,377,294 | $ 466,176 | $ 2,354,943 | $ 580,755 |
Cost of product revenue | 986,875 | 434,673 | 1,698,210 | 561,559 |
Product gross profit | 390,419 | 31,503 | 656,733 | 19,196 |
Collaborations revenue | 1,455,188 | |||
Operating expenses: | ||||
Selling, general and administrative | 2,002,949 | 1,821,108 | 4,176,421 | 3,484,845 |
Research and development | 1,273,568 | 1,706,314 | 2,756,885 | 3,269,810 |
Total operating expenses | 3,276,517 | 3,527,422 | 6,933,306 | 6,754,655 |
Loss from operations | (2,886,098) | (3,495,919) | (6,276,573) | (5,280,271) |
Other income (expense), net | 31,008 | (26,909) | 76,583 | 24,674 |
Loss before income taxes | (2,855,090) | (3,522,828) | (6,199,990) | (5,255,597) |
Provision for income taxes | ||||
Net loss | $ (2,855,090) | $ (3,522,828) | $ (6,199,990) | $ (5,255,597) |
Net loss per share: | ||||
Basic (in Dollars per share) | $ (0.11) | $ (0.21) | $ (0.25) | $ (0.32) |
Number of shares used in per share calculations: | ||||
Basic (in Shares) | 25,910,478 | 16,414,795 | 24,947,813 | 16,321,891 |
Condensed Statements of Opera_2
Condensed Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||||
Diluted | $ (0.11) | $ (0.21) | $ (0.25) | $ (0.32) |
Diluted | 25,910,478 | 16,414,795 | 24,947,813 | 16,321,891 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2022 | $ 16,217 | $ 60,414,959 | $ (50,826,812) | $ 9,604,364 |
Balance (in Shares) at Sep. 30, 2022 | 16,216,540 | |||
Stock-based compensation | 300,181 | 300,181 | ||
Issuance of common stock upon vesting of restricted stock units | $ 22 | (22) | ||
Issuance of common stock upon vesting of restricted stock units (in Shares) | 21,924 | |||
Net loss | (1,732,769) | (1,732,769) | ||
Balance at Dec. 31, 2022 | $ 16,239 | 60,715,118 | (52,559,581) | 8,171,776 |
Balance (in Shares) at Dec. 31, 2022 | 16,238,464 | |||
Balance at Sep. 30, 2022 | $ 16,217 | 60,414,959 | (50,826,812) | 9,604,364 |
Balance (in Shares) at Sep. 30, 2022 | 16,216,540 | |||
Net loss | (5,255,597) | |||
Balance at Mar. 31, 2023 | $ 16,888 | 61,598,345 | (56,082,409) | 5,532,824 |
Balance (in Shares) at Mar. 31, 2023 | 16,887,738 | |||
Balance at Dec. 31, 2022 | $ 16,239 | 60,715,118 | (52,559,581) | 8,171,776 |
Balance (in Shares) at Dec. 31, 2022 | 16,238,464 | |||
Issuance of common stock in connection with at-the-market offering program | $ 516 | 927,741 | 928,257 | |
Issuance of common stock in connection with at-the-market offering program (in Shares) | 516,484 | |||
Issuance costs in connection with the at-the-market offering program | (183,359) | (183,359) | ||
Stock-based compensation | 237,628 | 237,628 | ||
Share repurchases for the payment of employee taxes | $ (67) | (98,583) | (98,650) | |
Share repurchases for the payment of employee taxes (in Shares) | (67,109) | |||
Issuance of common stock upon vesting of restricted stock units | $ 200 | (200) | ||
Issuance of common stock upon vesting of restricted stock units (in Shares) | 199,899 | |||
Net loss | (3,522,828) | (3,522,828) | ||
Balance at Mar. 31, 2023 | $ 16,888 | 61,598,345 | (56,082,409) | 5,532,824 |
Balance (in Shares) at Mar. 31, 2023 | 16,887,738 | |||
Balance at Sep. 30, 2023 | $ 23,929 | 68,911,778 | (62,686,303) | 6,249,404 |
Balance (in Shares) at Sep. 30, 2023 | 23,928,945 | |||
Issuance of common stock attributed to equity financings | $ 868 | 1,255,403 | 1,256,271 | |
Issuance of common stock attributed to equity financings (in Shares) | 868,243 | |||
Issuance costs related to equity financings | (37,698) | (37,698) | ||
Stock-based compensation | 308,638 | 308,638 | ||
Share repurchases for the payment of employee taxes | $ (11) | (13,548) | (13,559) | |
Share repurchases for the payment of employee taxes (in Shares) | (11,176) | |||
Issuance of common stock upon vesting of restricted stock units | $ 45 | (45) | ||
Issuance of common stock upon vesting of restricted stock units (in Shares) | 45,078 | |||
Net loss | (3,344,900) | (3,344,900) | ||
Balance at Dec. 31, 2023 | $ 24,831 | 70,424,528 | (66,031,203) | 4,418,156 |
Balance (in Shares) at Dec. 31, 2023 | 24,831,090 | |||
Balance at Sep. 30, 2023 | $ 23,929 | 68,911,778 | (62,686,303) | $ 6,249,404 |
Balance (in Shares) at Sep. 30, 2023 | 23,928,945 | |||
Issuance of common stock attributed to equity financings (in Shares) | 1,461,353 | |||
Net loss | $ (6,199,990) | |||
Balance at Mar. 31, 2024 | $ 26,322 | 72,714,414 | (68,886,293) | 3,854,443 |
Balance (in Shares) at Mar. 31, 2024 | 26,321,750 | |||
Balance at Dec. 31, 2023 | $ 24,831 | 70,424,528 | (66,031,203) | 4,418,156 |
Balance (in Shares) at Dec. 31, 2023 | 24,831,090 | |||
Issuance of common stock attributed to equity financings | $ 1,461 | 2,092,735 | $ 2,094,196 | |
Issuance of common stock attributed to equity financings (in Shares) | 1,461,353 | 2,329,596 | ||
Issuance costs related to equity financings | (148,382) | $ (148,382) | ||
Stock-based compensation | 356,858 | 356,858 | ||
Share repurchases for the payment of employee taxes | $ (8) | (11,287) | (11,295) | |
Share repurchases for the payment of employee taxes (in Shares) | (8,382) | |||
Issuance of common stock upon vesting of restricted stock units | $ 38 | (38) | ||
Issuance of common stock upon vesting of restricted stock units (in Shares) | 37,689 | |||
Net loss | (2,855,090) | (2,855,090) | ||
Balance at Mar. 31, 2024 | $ 26,322 | $ 72,714,414 | $ (68,886,293) | $ 3,854,443 |
Balance (in Shares) at Mar. 31, 2024 | 26,321,750 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (6,199,990) | $ (5,255,597) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization and depreciation | 119,557 | 79,799 |
Stock-based compensation | 665,496 | 537,809 |
Amortization of discounts and premiums on short-term investments | (41,003) | |
Non-cash lease expense | 58,335 | 53,886 |
Change in assets and liabilities: | ||
Accounts receivable | (555,639) | (180,715) |
Inventory | 415,013 | (469,769) |
Prepaid expenses | (144,031) | (74,054) |
Accounts payable | 76,899 | (24,862) |
Accrued expenses, deferred revenue, operating leases and other liabilities | (420,194) | (1,669,283) |
Net cash used in operating activities | (5,984,554) | (7,043,789) |
Investing activities | ||
Purchases of short-term investments | (1,473,419) | |
Maturities of short-term investments | 3,500,000 | |
Purchase of property and equipment | (68,491) | (187,206) |
Net cash (used in) provided by investing activities | (68,491) | 1,839,375 |
Financing activities | ||
Proceeds from issuance of common stock attributed to equity financings | 3,350,467 | 928,257 |
Issuance costs related equity financings | (160,406) | (183,359) |
Share repurchases for the payment of employee taxes | (24,854) | (98,650) |
Net cash provided by financing activities | 3,165,207 | 646,248 |
Net decrease in cash and cash equivalents | (2,887,838) | (4,558,166) |
Cash and cash equivalents at beginning of period | 5,322,493 | 8,160,329 |
Cash and cash equivalents at end of period | 2,434,655 | 3,602,163 |
Supplemental non-cash financing and investing transactions: | ||
Unpaid issuance costs in accounts payable and accrued expenses | 25,674 | |
Modification of right-of-use asset and associated lease liability | 97,536 | |
Purchased property and equipment in accounts payable | $ 14,800 | $ 50,646 |
Description of Business and Bas
Description of Business and Basis of Presentation | 6 Months Ended |
Mar. 31, 2024 | |
Description of Business and Basis of Presentation [Abstract] | |
Description of Business and Basis of Presentation | NOTE 1 – Description of Business and Basis of Presentation NeuroOne Medical Technologies Corporation (the “Company” or “NeuroOne”), a Delaware corporation, is a medical technology company focused on the development and commercialization of thin film electrode for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography (“sEEG”) recording, monitoring, ablation, drug delivery and brain stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders. The Company received 510(k) clearance from the United States (“U.S.”) Food and Drug Administration (“FDA”) for its Evo cortical electrode technology in November 2019 and in October 2022, the Company received 510(k) clearance from the FDA for its Evo® sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. In December 2023, we received 510(k) clearance for our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures. The Company is based in Eden Prairie, Minnesota. Global Economic Conditions Generally, worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and financial markets, and increased inflation. The general economic and capital market conditions both in the U.S. and worldwide, have been volatile in the past and at times have adversely affected the Company’s access to capital and increased the cost of capital. The capital and credit markets may not be available to support future capital raising activity on favorable terms or at all. If economic conditions continue to decline, the Company’s future cost of equity or debt capital and access to the capital markets could be adversely affected. The Company’s operating results could be materially impacted by changes in the overall macroeconomic environment and other economic factors. Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflicts in Ukraine and the Middle East, disruptions in the banking system and financial markets, and steps taken by governments and central banks, have led to higher inflation, which has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased interest rates. Basis of presentation The accompanying unaudited condensed financial statements have been prepared by the Company, pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed financial statements may not include all disclosures required by U.S. GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended September 30, 2023 included in the Company’s Annual Report on Form 10-K. The condensed balance sheet at September 30, 2023 was derived from the audited financial statements of the Company. In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods. |
Going Concern
Going Concern | 6 Months Ended |
Mar. 31, 2024 | |
Going Concern [Abstract] | |
Going Concern | NOTE 2 – Going Concern The accompanying financial statements have been prepared on the basis that the Company will continue as a going concern. The Company has incurred losses since inception, negative cash flows from operations, and an accumulated deficit of $68.9 million as of March 31, 2024. To date, the Company’s revenues have not been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt and sale of equity securities. The Company has adequate liquidity to fund its operations through July 2024. The raising of additional funds is not solely within the control of the Company. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this condition. If the Company is unable to raise additional funds, or the Company’s anticipated operating results are not achieved, management believes planned expenditures may need to be reduced in order to extend the time period that existing resources can fund the Company’s operations. The Company intends to fund ongoing activities by utilizing its current cash and cash equivalents on hand, from product and collaborations revenue and by raising additional capital through equity or debt financings. If management is unable to obtain the necessary capital, it may have a material adverse effect on the operations of the Company and the development of its technology, or the Company may have to cease operations altogether. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 3 – Summary of Significant Accounting Policies Management’s Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Segment Information Operating segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording, monitoring, ablation, and brain stimulation solutions. Accordingly, the Company has a single reporting segment. Cash and Cash Equivalents The Company considers all highly liquid investments with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash equivalents on the condensed balance sheets. Cash equivalents are stated at cost, which approximates fair value. The Company’s cash and cash equivalents may include demand deposit accounts with large financial institutions, institutional money market funds, U.S. Treasury securities, and corporate notes and bonds. The Company monitors the creditworthiness of the financial institutions, institutional money market funds, and corporations in which the Company invests its surplus funds. The Company has experienced no credit losses from its cash and cash equivalent investments. Short-Term Investments The Company has periodically invested its excess cash in U.S. Treasury securities and highly rated corporate securities. The Company has held these investments to maturity. Securities with original maturity dates of more than three months were reported as held-to-maturity investments and were recorded at amortized cost, which approximated fair value due to the negligible risk of changes in value due to interest rates. There were no short-term investments outstanding as of March 31, 2024 and September 30, 2023. Revenue Recognition The Company entered into a development and distribution agreement which has current and future revenue recognition implications. See “Note 7 – Zimmer Development Agreement.” In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”). Performance obligations may include license rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Product Revenue Revenues from product sales are recognized when control of the promised goods or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. At the inception of each customer contract, performance obligations are identified and the total transaction price is allocated to the performance obligations. Cost of Product Revenue Cost of product revenue consists of the manufacturing and materials costs incurred by the Company’s third-party contract manufacturer in connection with the Company’s strip and grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products) and outside supplier materials costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”). In addition, cost of product revenue includes royalty fees incurred in connection with the Company’s license agreements. Collaborations Revenue As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. Licenses of intellectual property Milestone payments Royalties Fair Value of Financial Instruments The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows: ● Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date. ● Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. ● Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. As of March 31, 2024 and September 30, 2023, the fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, accounts payable and accrued expenses and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities. There were no transfers between fair value hierarchy levels during the three and six months ended March 31, 2024 and 2023. Intellectual Property The Company has entered into two licensing agreements with major research institutions, which allow for access to certain patented technology and know-how. Payments under those agreements are capitalized and amortized to selling, general and administrative expense over the expected useful life of the acquired technology. Property and Equipment Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for equipment and furniture ranges from three to seven years. Tangible assets acquired for research and development activities and that have alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and, when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred. Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist of licensed intellectual property, property and equipment and right-of-use assets for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. In estimating the allowance for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the asset, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented. Inventory Inventory is stated at the lower of cost (using the first-in, first-out “FIFO” method) or net realizable value. The Company calculates inventory valuation adjustments for excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future demand of the products and spare parts. The Company’s inventory is currently comprised of Strip/Grid Products, sEEG and electrode cable assembly component, work-in-process and finished good product. The Strip/Grid Products and sEEG Products are produced by a third-party contract manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers. No inventory valuation allowance was required during the periods presented. Research and Development Costs Research and development costs are charged to expense as incurred. Research and development expenses comprise of costs incurred in performing research and development activities, including compensation and benefits for research and development employees (including stock-based compensation), overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with ASC 730, Research and Development Advertising Expense Advertising expense is charged to selling, general and administrative expenses during the period that it is incurred. Total advertising expense amounted to $15,781 and $65,053 for the three and six months ended March 31, 2024, respectively. Total advertising expense amounted to $53,613 and $106,639 for the three and six months ended March 31, 2023, respectively. Selling, General and Administrative Selling, general and administrative expenses consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with research and development activities. Other significant costs include legal and litigation costs relating to corporate matters, intellectual property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales and marketing in connection with the commercial sales of the Company’s products. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. Net Loss Per Share For the Company, basic loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options, and restricted stock units while outstanding are considered common stock equivalents for this purpose. Diluted earnings or loss per share of common stock is computed utilizing the treasury method for the warrants, stock options and restricted stock units. No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the three and six months ended March 31, 2024 and 2023. The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and six months ended March 31, 2024 and 2023: 2024 2023 Warrants 4,863,566 6,832,865 Stock options 2,879,096 1,370,427 Restricted stock units 1,329,881 234,348 Recent Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures In June 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments – Credit Losses |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | NOTE 4 – Commitments and Contingencies WARF License Agreement The Company has entered into an exclusive start-up company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and thin film micro electrode technology. The Company entered into an Amended and Restated Exclusive Start-up Company License Agreement (the “WARF License”) with WARF on January 21, 2020, which amended and restated in full the prior license agreement between WARF and NeuroOne, LLC, a predecessor of the Company, dated October 1, 2014, as amended on February 22, 2017, March 30, 2019 and September 18, 2019. The WARF License grants to the Company an exclusive license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array or thin-film micro electrode array and method. The Company agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect. If the Company or any of its sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to be valid and would be infringed by the Company if not for the WARF License, the royalty rate will be tripled for the remaining term of the WARF License. WARF may terminate the WARF License on 30 days’ written notice if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or in the event of certain bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters. The first commercial sale occurred on December 7, 2020, prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date that no valid claims on the patents licensed thereunder remain. The Company expects the latest expiration of a licensed patent to occur in 2030. During the three months ended March 31, 2024 and 2023, $37,500 in royalty fees were incurred related to the WARF License during each of these periods. During the six months ended March 31, 2024 and 2023, $75,000 in royalty fees were incurred during each of these periods related to the WARF License, respectively. The royalty fees were reflected as a component of cost of product revenue. Mayo Agreement The Company has an exclusive license and development agreement with the Mayo Foundation for Medical Education and Research (“Mayo”) related to certain intellectual property and development services for thin film micro electrode technology (“Mayo Agreement”). If the Company is successful in obtaining regulatory approval, the Company is to pay royalties to Mayo based on a percentage of net sales of products of the licensed technology through the term of the Mayo Agreement, set to expire May 25, 2037. During the three months ended March 31, 2024 and 2023, $4,146 and zero in royalty fees were incurred related to the Mayo Agreement, respectively. During the six months ended March 31, 2024 and 2023, $4,415 and $690 in royalty fees were incurred related to the Mayo Agreement, respectively. The royalty fees were reflected as a component of cost of product revenue. Facility Leases During the three and six months ended March 31, 2024, rent expense associated with the facility leases amounted to $43,052 and $86,105, respectively. During the three and six months ended March 31, 2023, rent expense associated with the facility leases amounted to $43,053 and $85,527, respectively. Supplemental cash flow information related to the operating leases was as follows: For the 2024 2023 Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating leases $ 68,673 $ 66,493 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 97,536 Supplemental balance sheet information related to the operating leases was as follows: As of As of Right-of-use assets $ 110,724 $ 169,059 Lease liabilities $ 121,896 $ 184,400 Weighted average remaining lease term (years) 0.9 1.4 Weighted average discount rate 7.7 % 7.8 % Maturity of the lease liabilities was as follows: Calendar Year As of 2024 $ 105,365 2025 21,227 Total lease payments 126,592 Less imputed interest (4,696 ) Total 121,896 Short-term portion (included in other liabilities) (121,896 ) Long-term portion $ — Other In the ordinary course of business, from time to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual allegations, patent infringement and other claims. The Company establishes accruals when applicable for matters and commitments which it believes losses are probable and can be reasonably estimated. To date, no loss contingency for such matters and potential commitments have been recorded. Although it is not possible to predict with certainty the outcome of these matters or potential commitments, the Company is of the opinion that the ultimate resolution of these matters and potential commitments will not have a material adverse effect on its results of operations or financial position. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 6 Months Ended |
Mar. 31, 2024 | |
Supplemental Balance Sheet Information [Abstract] | |
Supplemental Balance Sheet Information | NOTE 5 – Supplemental Balance Sheet Information Inventory Inventory consisted of the following: As of As of Component inventory $ 850,271 $ 1,202,778 Work-in-process 461,402 343,597 Finished goods — 180,311 Total $ 1,311,673 $ 1,726,686 Intangibles Intangible assets rollforward is as follows: Useful Life Net Intangibles, September 30, 2023 12-13 years $ 89,577 Less: amortization (11,158 ) Net Intangibles, March 31, 2024 $ 78,419 Amortization expense was $5,579 and $11,158 for the three and six months ended March 31, 2024, respectively, and $5,579 and $11,158 for the three and six months ended March 31, 2023, respectively. Property and Equipment, Net Property and equipment held for use by category are presented in the following table: As of As of Equipment and furniture $ 939,398 $ 860,737 Total property and equipment 939,398 860,737 Less accumulated depreciation (443,383 ) (334,984 ) Property and equipment, net $ 496,015 $ 525,753 Depreciation expense was $55,321 and $108,399 for the three months and six months ended March 31, 2024, respectively, and $38,331 and $68,641 for the three and six months ended March 31, 2023, respectively. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 6 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses and Other Liabilities [Abstract] | |
Accrued Expenses and Other Liabilities | NOTE 6 – Accrued Expenses and Other Liabilities Accrued expenses consisted of the following at March 31, 2024 and September 30, 2023: As of As of Accrued payroll $ 579,071 $ 874,382 Operating lease liability, short term 121,896 129,116 Royalty payments 41,646 104,024 Other 17,007 — Total $ 759,620 $ 1,107,522 |
Zimmer Development Agreement
Zimmer Development Agreement | 6 Months Ended |
Mar. 31, 2024 | |
Zimmer Development Agreement [Abstract] | |
Zimmer Development Agreement | NOTE 7 – Zimmer Development Agreement On July 20, 2020, the Company entered into an exclusive development and distribution agreement (the “Zimmer Development Agreement”) with Zimmer, Inc. (“Zimmer”), pursuant to which the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and the Electrode Cable Assembly Products. Additionally, the Company granted Zimmer the exclusive right and license to distribute certain sEEG Products developed by the Company and together with the Strip/Grid Products and Electrode Cable Assembly Products, the “Products”. The parties have agreed to collaborate with respect to development activities under the Zimmer Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company. Under the terms of the Zimmer Development Agreement, the Company is responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and expenses related to the commercialization of the Products. In addition to the Zimmer Development Agreement, Zimmer and the Company have entered into a Manufacturing and Supply Agreement and a Supplier Quality Agreement with respect to the manufacturing and supply of the Products. Except as otherwise provided in the Zimmer Development Agreement, the Company is responsible for performing all development activities, including non-clinical and clinical studies directed at obtaining regulatory approval of each Product. Zimmer has agreed to use commercially reasonable efforts to promote, market and sell each Product following the “Product Availability Date” (as defined in the Zimmer Development Agreement) for such Product. Pursuant to the Zimmer Development Agreement, Zimmer made an upfront initial exclusivity fee payment of $2.0 million (the “Initial Exclusivity Fee”) to the Company in fiscal year 2020. On August 2, 2022, the Company entered into a Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer Amendment”) with Zimmer. Pursuant to the terms and conditions of the Zimmer Amendment, Zimmer made a $3.5 million payment to the Company. In consideration of the mutual covenants and agreements contained in the Zimmer Development Agreement, the fee and milestone payment provisions in the Zimmer Development Agreement were replaced with the following below: ● $1.5 million for the sEEG Exclusivity Maintenance Fee; and ● $2.0 million for satisfaction of each of the milestone events related to the design of sEEG Products set forth in the Zimmer Development Agreement even though the satisfaction was after the deadlines originally identified. In addition, in connection with the Zimmer Amendment, the Company issued Zimmer a warrant to purchase common stock (the “2022 Zimmer Warrant”). The 2022 Zimmer Warrant is exercisable for up to an aggregate of 350,000 shares of the Company’s common stock. The 2022 Zimmer Warrant has an exercise price of $3.00 per share, is exercisable commencing six months from the issuance date, and will expire on August 2, 2027. The fair value of the 2022 Zimmer Warrant of $0.1 million was based on the Black-Scholes pricing model. Input assumptions used were as follows: a risk-free interest rate of 2.9%; expected volatility of 53.5%; expected life of 5 years; expected dividend yield of 0%; and the underlying fair market of the common stock. The 2022 Zimmer Warrant was classified in stockholders’ equity as the number of shares were fixed and determinable, no cash settlement was required and no other provisions precluded equity treatment. The Zimmer Development Agreement will expire on the tenth anniversary of the date of the first commercial sale of the last Products to achieve a first commercial sale (the “Term”), unless terminated earlier pursuant to its terms. Either party may terminate the Zimmer Development Agreement (x) with written notice for the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings. In addition, Zimmer may terminate the Zimmer Development Agreement for any reason with 90 days’ written notice, and the Company may terminate the Zimmer Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company. The license rights granted to Zimmer under the Strip/Grid Distribution License and sEEG Distribution License as defined in the Zimmer Development Agreement shall be exclusive from the effective date of the Zimmer Amendment until the end of the term of the Zimmer Amendment. The Zimmer Development Agreement and Zimmer Amendment were accounted for under the provisions of ASC 606. In accordance with the provisions under ASC 606, the Company identified five performance obligations under the Zimmer Development Agreement and Zimmer Amendment: (1) the Company’s obligation to grant Zimmer access to its intellectual property; (2) completion of sEEG Product development; (3) completion of Strip/Grid Product development; (4) the provision of sEEG exclusivity maintenance; and (5) completion of sEEG design modifications as requested by Zimmer. All performance obligations under the Zimmer Development Agreement and Zimmer Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September 30, 2022. The remaining performance obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance was completed in first quarter of fiscal year 2023. The aggregate transaction price associated with the Zimmer Development Agreement and Zimmer Amendment was $5.4 million comprising the Initial Exclusivity Fee of $2.0 million and the $3.5 million payment under the Zimmer Amendment, less the fair value 2022 Zimmer Warrant of $0.1 million. The transaction price was allocated between performance obligations based on their relative standalone selling prices. The Company used a market based valuation approach and an expected cost plus margin approach with regard to estimating the standalone selling price for the performance obligations. The Company recognized collaborations revenue in the amount of $1,455,188 during the six months ended March 31, 2023 in connection with the Zimmer Development Agreement and Zimmer Amendment. Given the achievement of the milestones under the Zimmer Development Agreement and Zimmer Amendment by December 31, 2022, no A reconciliation of the closing balance of deferred revenue related to the Zimmer Development Agreement and Zimmer Amendment is as follows during the six months ended as of March 31, 2024 and 2023: 2024 2023 Deferred Revenue Balance as of beginning of period – September 30 $ — $ 1,455,188 Revenue recognized — (1,455,188 ) Balance as of end of period – March 31 $ — $ — Product Revenue Product revenue related to the Company’s Strip/Grid Products, sEEG Products and Electrode Cable Assembly Products. Product revenue recognized during the three and six months ended March 31, 2024 was $1,377,294 and $2,354,943, respectively. Product revenue recognized during the three and six months ended March 31, 2023 was $466,176 and $580,755, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | NOTE 8 – Stock-Based Compensation During the three and six months ended March 31, 2024 and 2023, stock-based compensation expense related to stock-based awards was included in selling, general and administrative and research and development costs as follows in the accompanying condensed statements of operations. Three Months Ended Six Months Ended March 31, March 31, 2024 2023 2024 2023 Selling, general and administrative $ 280,516 $ 199,467 $ 523,714 $ 454,932 Research and development 76,342 38,161 141,782 82,877 Total stock-based compensation expense $ 356,858 $ 237,628 $ 665,496 $ 537,809 Inducement Plan In addition to the Company’s 2017 Equity Incentive Plan (the “2017 Plan”), the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”) on October 4, 2021, pursuant to which the Company reserved 420,350 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance with such rule. On November 9, 2023, the Company’s Board of Directors adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock that may be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for a total of 570,350 shares of common stock that may be issued. Evergreen provision Under the 2017 Plan, the shares reserved automatically increase on January 1st of each year, for a period of not more than ten years from the date the 2017 Plan is approved by the stockholders of the Company, commencing on January 1, 2019 and ending on (and including) January 1, 2027, to an amount equal to 13% of the fully-diluted shares outstanding as of December 31st of the preceding calendar year. Notwithstanding the foregoing, the Company’s Board of Directors may act prior to January 1st of a given year to provide that there will be no January 1st increase in the share reserve for such year or that the increase in the share reserve for such year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. “Fully Diluted Shares” as of a date means an amount equal to the number of shares of common stock (i) outstanding and (ii) issuable upon exercise, conversion or settlement of outstanding awards under the 2017 Plan and any other outstanding options, warrants or other securities of the Company that are (directly or indirectly) convertible or exchangeable into or exercisable for shares of common stock, in each case as of the close of business of the Company on December 31 of the preceding calendar year. Effective January 1, 2024, 1,051,556 shares were added to the 2017 Plan as a result of the evergreen provision. Stock Options During the three months ended March 31, 2024 and 2023, under the 2017 Plan, the Company granted 65,000 and 56,781 stock options, respectively, to its board of directors, officers and employees. During the six months ended March 31, 2024 and 2023, the Company granted 1,225,669 and 130,512 stock options, respectively, to its board of directors, officers, employees and consultants. Vesting generally occurs over an immediate to 48 month period based on a time of service condition. The grant date fair value of the grants issued during the three months ended March 31, 2024 and 2023 was $0.91 and $0.88 per share, respectively. The grant date fair value of the grants issued during the six months ended March 31, 2024 and 2023 was $1.08 and $0.75 per share, respectively. The total expense for the three months ended March 31, 2024 and 2023 related to stock options was $214,188 and $142,003, respectively. The total expense for the six months ended March 31, 2024 and 2023 related to stock options was $401,619 and $323,747, respectively. The total number of stock options outstanding as of March 31, 2024 and September 30, 2023 was 2,879,096 and 1,708,427, respectively. The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months ended March 31, 2024 and 2023: Three Months Ended Six Months Ended March 31, March 31, 2024 2023 2024 2023 Expected stock price volatility 111.7 % 58.1 % 111.9 % 55.5 % Expected life of options (years) 6.0 5.3 6.1 5.2 Expected dividend yield 0 % 0 % 0 % 0 % Risk free interest rate 4.3 % 3.7 % 4.6 % 3.9 % During the three months ended March 31, 2024 and 2023, 48,295 and 84,778 stock options vested, respectively, and zero stock options were forfeited. During the six months ended March 31, 2024 and 2023, 104,911 and 212,224 stock options vested, respectively, and 55,000 and zero stock options were forfeited during these periods, respectively. During the three and six months ended March 31, 2024 and 2023, no Restricted Stock Units During the three and six months ended March 31, 2024, the Company granted an aggregate of 1,006,725 restricted stock units (“RSUs”) to its employees and consultants under the 2017 Plan. The weighted average grant date fair value of the RSUs granted during the three and six months ended March 31, 2024 was $1.03 per unit. The RSUs granted vest over a four-year period in equal annual installments on the anniversary date of the grant, subject to the recipient’s continued service on such dates. During the three and six months ended March 31, 2023, the Company granted an aggregate of 61,728 RSUs to its board of directors under the 2017 Plan. The weighted average grant date fair value of the RSUs granted during the three and six months ended March 31, 2023 was $1.62 per unit. The RSUs vest over a one-year period in equal monthly installments on the last day of each month, subject to the recipient’s continued service on such dates. During the three months ended March 31, 2024 and 2023, 32,535 and 219,880 RSUs vested, respectively, and no no General As of March 31, 2024, 183,130 shares were available in the aggregate for future issuance under the 2017 Plan and Inducement Plan. Unrecognized stock-based compensation was $3.1 million as of March 31, 2024. The unrecognized share-based expense is expected to be recognized over a weighted average period of 2.7 years. |
Concentrations
Concentrations | 6 Months Ended |
Mar. 31, 2024 | |
Concentrations [Abstract] | |
Concentrations | NOTE 9 – Concentrations Revenue One customer accounts for all of the Company’s product and collaborations revenue. Supplier concentration One contract manufacturer produces all of the Company’s Strip/Grid Products and sEEG Products and another supplier was responsible for the development of the Company’s OneRF Ablation system. |
Income Taxes
Income Taxes | 6 Months Ended |
Mar. 31, 2024 | |
Income Taxes [Abstract] | |
Income Taxes | NOTE 10 – Income Taxes The effective tax rate for the three and six months ended March 31, 2024 and 2023 was zero percent. As a result of the analysis of all available evidence as of March 31, 2024 and September 30, 2023, the Company recorded a full valuation allowance on its net deferred tax assets. Consequently, the Company reported no |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Mar. 31, 2024 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | NOTE 11 – Stockholders’ Equity At-The-Market Offering On December 21, 2022, the Company entered into a Capital on Demand TM During the three and six months ended March 31, 2024, 1,461,353 and 2,329,596 shares of common stock were issued, respectively, under the ATM for an aggregate offering price of $2,094,196 and $3,350,467, respectively. The total aggregate offering price and common stock issued since inception of the ATM though March 31, 2024 was $5,903,123 and 3,769,273 shares, respectively. Issuance costs incurred under the ATM during the three and six months ended March 31, 2024 were $148,382 and $186,080, respectively. During the three and six months ended March 31, 2023, 516,484 shares of common stock were issued under the ATM for an aggregate offering price of $928,257. Issuance costs incurred during the three and six months ended March 31, 2023 was $183,359. See “Note 12 – Subsequent Events”. Warrant Activity and Summary There were no warrant exercises during the three and six months ended March 31, 2024, and 279,727 and 1,338,860 warrants expired during the three and six months ended March 31, 2024, respectively. The following table summarizes information about warrants outstanding at March 31, 2024: Warrants Exercise Weighted Weighted Outstanding and exercisable at September 30, 2023 6,202,426 $ 3.00-9.00 $ 5.92 2.00 Issued — $ — $ — — Exercised — $ — $ — — Expired (1,338,860 ) $ 7.50-9.00 $ 8.69 — Outstanding and exercisable at March 31, 2024 4,863,566 $3.00-9.00 $ 5.16 1.97 The following table summarizes information about warrants outstanding at March 31, 2024: Exercise Price Number Outstanding Weighted Average Number Exercisable $ 3.00 350,000 3.34 350,000 $ 5.25 4,166,682 1.79 4,166,682 $ 5.61 220,855 4.25 220,855 $ 6.00 45,171 0.25 45,171 $ 8.25 62,906 0.25 62,906 $ 9.00 17,952 0.25 17,952 Total 4,863,566 4,863,566 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | NOTE 12 – Subsequent Events Between April 1 and May 10, 2024, we issued an additional 1,093,135 shares of common stock for net proceeds in the amount of $1,286,844 in connection with the Sales Agreement. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (2,855,090) | $ (3,344,900) | $ (3,522,828) | $ (1,732,769) | $ (6,199,990) | $ (5,255,597) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Management’s Use of Estimates | Management’s Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording, monitoring, ablation, and brain stimulation solutions. Accordingly, the Company has a single reporting segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash equivalents on the condensed balance sheets. Cash equivalents are stated at cost, which approximates fair value. The Company’s cash and cash equivalents may include demand deposit accounts with large financial institutions, institutional money market funds, U.S. Treasury securities, and corporate notes and bonds. The Company monitors the creditworthiness of the financial institutions, institutional money market funds, and corporations in which the Company invests its surplus funds. The Company has experienced no credit losses from its cash and cash equivalent investments. |
Short-Term Investments | Short-Term Investments The Company has periodically invested its excess cash in U.S. Treasury securities and highly rated corporate securities. The Company has held these investments to maturity. Securities with original maturity dates of more than three months were reported as held-to-maturity investments and were recorded at amortized cost, which approximated fair value due to the negligible risk of changes in value due to interest rates. There were no short-term investments outstanding as of March 31, 2024 and September 30, 2023. |
Revenue Recognition | Revenue Recognition The Company entered into a development and distribution agreement which has current and future revenue recognition implications. See “Note 7 – Zimmer Development Agreement.” In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in Accounting Standards Codification (“ASC”) Topic 606 (“ASC 606”). Performance obligations may include license rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Product Revenue Revenues from product sales are recognized when control of the promised goods or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. At the inception of each customer contract, performance obligations are identified and the total transaction price is allocated to the performance obligations. Cost of Product Revenue Cost of product revenue consists of the manufacturing and materials costs incurred by the Company’s third-party contract manufacturer in connection with the Company’s strip and grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products) and outside supplier materials costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”). In addition, cost of product revenue includes royalty fees incurred in connection with the Company’s license agreements. Collaborations Revenue As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. Licenses of intellectual property Milestone payments Royalties |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows: ● Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date. ● Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. ● Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. As of March 31, 2024 and September 30, 2023, the fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, accounts payable and accrued expenses and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities. There were no transfers between fair value hierarchy levels during the three and six months ended March 31, 2024 and 2023. |
Intellectual Property | Intellectual Property The Company has entered into two licensing agreements with major research institutions, which allow for access to certain patented technology and know-how. Payments under those agreements are capitalized and amortized to selling, general and administrative expense over the expected useful life of the acquired technology. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for equipment and furniture ranges from three to seven years. Tangible assets acquired for research and development activities and that have alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and, when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist of licensed intellectual property, property and equipment and right-of-use assets for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. |
Accounts Receivable and Allowances for Credit Losses | Accounts Receivable and Allowances for Credit Losses The Company records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. In estimating the allowance for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the asset, primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance. The Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented. |
Inventories | Inventory Inventory is stated at the lower of cost (using the first-in, first-out “FIFO” method) or net realizable value. The Company calculates inventory valuation adjustments for excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future demand of the products and spare parts. The Company’s inventory is currently comprised of Strip/Grid Products, sEEG and electrode cable assembly component, work-in-process and finished good product. The Strip/Grid Products and sEEG Products are produced by a third-party contract manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers. No inventory valuation allowance was required during the periods presented. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred. Research and development expenses comprise of costs incurred in performing research and development activities, including compensation and benefits for research and development employees (including stock-based compensation), overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with ASC 730, Research and Development |
Advertising Expense | Advertising Expense Advertising expense is charged to selling, general and administrative expenses during the period that it is incurred. Total advertising expense amounted to $15,781 and $65,053 for the three and six months ended March 31, 2024, respectively. Total advertising expense amounted to $53,613 and $106,639 for the three and six months ended March 31, 2023, respectively. |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative expenses consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with research and development activities. Other significant costs include legal and litigation costs relating to corporate matters, intellectual property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales and marketing in connection with the commercial sales of the Company’s products. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. |
Net Loss Per Share | Net Loss Per Share For the Company, basic loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options, and restricted stock units while outstanding are considered common stock equivalents for this purpose. Diluted earnings or loss per share of common stock is computed utilizing the treasury method for the warrants, stock options and restricted stock units. No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the three and six months ended March 31, 2024 and 2023. The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and six months ended March 31, 2024 and 2023: 2024 2023 Warrants 4,863,566 6,832,865 Stock options 2,879,096 1,370,427 Restricted stock units 1,329,881 234,348 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures In June 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments – Credit Losses |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Schedule of Calculating Diluted Loss Per Share | The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and six months ended March 31, 2024 and 2023: 2024 2023 Warrants 4,863,566 6,832,865 Stock options 2,879,096 1,370,427 Restricted stock units 1,329,881 234,348 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Schedule of Supplemental Cash Flow Information Related to the Operating Leases | Supplemental cash flow information related to the operating leases was as follows: For the 2024 2023 Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating leases $ 68,673 $ 66,493 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ — $ 97,536 |
Schedule of Supplemental Balance Sheet Information Related to the Operating Lease | Supplemental balance sheet information related to the operating leases was as follows: As of As of Right-of-use assets $ 110,724 $ 169,059 Lease liabilities $ 121,896 $ 184,400 Weighted average remaining lease term (years) 0.9 1.4 Weighted average discount rate 7.7 % 7.8 % |
Schedule of Maturity of the Lease Liabilities | Maturity of the lease liabilities was as follows: Calendar Year As of 2024 $ 105,365 2025 21,227 Total lease payments 126,592 Less imputed interest (4,696 ) Total 121,896 Short-term portion (included in other liabilities) (121,896 ) Long-term portion $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Supplemental Balance Sheet Information [Abstract] | |
Schedule of Inventory Consisted | Inventory consisted of the following: As of As of Component inventory $ 850,271 $ 1,202,778 Work-in-process 461,402 343,597 Finished goods — 180,311 Total $ 1,311,673 $ 1,726,686 |
Schedule of Intangible Assets | Intangible assets rollforward is as follows: Useful Life Net Intangibles, September 30, 2023 12-13 years $ 89,577 Less: amortization (11,158 ) Net Intangibles, March 31, 2024 $ 78,419 |
Schedule of Property and Equipment | Property and equipment held for use by category are presented in the following table: As of As of Equipment and furniture $ 939,398 $ 860,737 Total property and equipment 939,398 860,737 Less accumulated depreciation (443,383 ) (334,984 ) Property and equipment, net $ 496,015 $ 525,753 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Accrued Expenses and Other Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses consisted of the following at March 31, 2024 and September 30, 2023: As of As of Accrued payroll $ 579,071 $ 874,382 Operating lease liability, short term 121,896 129,116 Royalty payments 41,646 104,024 Other 17,007 — Total $ 759,620 $ 1,107,522 |
Zimmer Development Agreement (T
Zimmer Development Agreement (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Zimmer Development Agreement [Abstract] | |
Schedule of Deferred Revenue | A reconciliation of the closing balance of deferred revenue related to the Zimmer Development Agreement and Zimmer Amendment is as follows during the six months ended as of March 31, 2024 and 2023: 2024 2023 Deferred Revenue Balance as of beginning of period – September 30 $ — $ 1,455,188 Revenue recognized — (1,455,188 ) Balance as of end of period – March 31 $ — $ — |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Schedule of Stock-Based Compensation Expense | During the three and six months ended March 31, 2024 and 2023, stock-based compensation expense related to stock-based awards was included in selling, general and administrative and research and development costs as follows in the accompanying condensed statements of operations. Three Months Ended Six Months Ended March 31, March 31, 2024 2023 2024 2023 Selling, general and administrative $ 280,516 $ 199,467 $ 523,714 $ 454,932 Research and development 76,342 38,161 141,782 82,877 Total stock-based compensation expense $ 356,858 $ 237,628 $ 665,496 $ 537,809 |
Schedule of Weighted-Average Assumptions Used in the Black-Scholes Option-Pricing Model | The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months ended March 31, 2024 and 2023: Three Months Ended Six Months Ended March 31, March 31, 2024 2023 2024 2023 Expected stock price volatility 111.7 % 58.1 % 111.9 % 55.5 % Expected life of options (years) 6.0 5.3 6.1 5.2 Expected dividend yield 0 % 0 % 0 % 0 % Risk free interest rate 4.3 % 3.7 % 4.6 % 3.9 % |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Mar. 31, 2024 | |
Stockholders’ Equity [Abstract] | |
Schedule of Warrant Activity and Summary | The following table summarizes information about warrants outstanding at March 31, 2024: Warrants Exercise Weighted Weighted Outstanding and exercisable at September 30, 2023 6,202,426 $ 3.00-9.00 $ 5.92 2.00 Issued — $ — $ — — Exercised — $ — $ — — Expired (1,338,860 ) $ 7.50-9.00 $ 8.69 — Outstanding and exercisable at March 31, 2024 4,863,566 $3.00-9.00 $ 5.16 1.97 |
Schedule of Warrants Outstanding | The following table summarizes information about warrants outstanding at March 31, 2024: Exercise Price Number Outstanding Weighted Average Number Exercisable $ 3.00 350,000 3.34 350,000 $ 5.25 4,166,682 1.79 4,166,682 $ 5.61 220,855 4.25 220,855 $ 6.00 45,171 0.25 45,171 $ 8.25 62,906 0.25 62,906 $ 9.00 17,952 0.25 17,952 Total 4,863,566 4,863,566 |
Going Concern (Details)
Going Concern (Details) - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Going Concern [Line Items] | ||
Accumulated deficit | $ (68,886,293) | $ (62,686,303) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | ||||
Advertising expense | $ 15,781 | $ 53,613 | $ 65,053 | $ 106,639 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of Calculating Diluted Loss Per Share - shares | 6 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock Options [Member] | ||
Schedule of Calculating Diluted Loss Per Share [Line Items] | ||
Anti-dilutive net loss | 2,879,096 | 1,370,427 |
Restricted Stock Units [Member] | ||
Schedule of Calculating Diluted Loss Per Share [Line Items] | ||
Anti-dilutive net loss | 1,329,881 | 234,348 |
Warrant [Member] | ||
Schedule of Calculating Diluted Loss Per Share [Line Items] | ||
Anti-dilutive net loss | 4,863,566 | 6,832,865 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies [Line Items] | |||||||
Annual royalty payment | $ 37,500 | $ 37,500 | $ 75,000 | $ 75,000 | |||
Number of days to remedy default | 90 days | ||||||
Leases rent expense | 43,053 | $ 86,105 | 85,527 | ||||
Mayo Agreement [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Annual royalty payment | 4,146 | $ 0 | $ 4,415 | $ 690 | |||
WARF License Agreement [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Annual royalty payment | $ 150,000 | $ 100,000 | $ 50,000 | ||||
Written license notice period | 30 days | ||||||
Los Gatos Lease [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Leases rent expense | $ 43,052 |
Commitments and Contingencies_3
Commitments and Contingencies (Details) - Schedule of Supplemental Cash Flow Information Related to the Operating Leases - USD ($) | 6 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule of Supplemental Cash Flow Information Related to the Operating Leases [Abstract] | ||
Operating cash flows from operating leases | $ 68,673 | $ 66,493 |
Operating leases | $ 97,536 |
Commitments and Contingencies_4
Commitments and Contingencies (Details) - Schedule of Supplemental Balance Sheet Information Related to the Operating Lease - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Schedule of Supplemental Balance Sheet Information Related to the Operating Lease [Abstract] | ||
Right-of-use assets | $ 110,724 | $ 169,059 |
Lease liabilities | $ 121,896 | $ 184,400 |
Weighted average remaining lease term (years) | 10 months 24 days | 1 year 4 months 24 days |
Weighted average discount rate | 7.70% | 7.80% |
Commitments and Contingencies_5
Commitments and Contingencies (Details) - Schedule of Maturity of the Lease Liabilities - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Schedule of Maturity of the Lease Liabilities [Abstract] | ||
2024 | $ 105,365 | |
2025 | 21,227 | |
Total lease payments | 126,592 | |
Less imputed interest | (4,696) | |
Total | 121,896 | $ 184,400 |
Short-term portion (included in other liabilities) | (121,896) | |
Long-term portion | $ 55,284 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Supplemental Balance Sheet Information [Line Items] | ||||
Amortization expense, intangible | $ 5,579 | $ 5,579 | $ 11,158 | $ 11,158 |
Depreciation expense | $ 55,321 | $ 38,331 | $ 108,399 | $ 68,641 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information (Details) - Schedule of Inventory Consisted - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Schedule of Inventory Consisted [Abstract] | ||
Component inventory | $ 850,271 | $ 1,202,778 |
Work-in-process | 461,402 | 343,597 |
Finished goods | 180,311 | |
Total | $ 1,311,673 | $ 1,726,686 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information (Details) - Schedule of Intangible Assets - USD ($) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Oct. 01, 2023 | |
Schedule of Intangible Assets [Line Items] | |||||
Net Intangibles, beginning | $ 89,577 | ||||
Less: amortization | $ (5,579) | $ (5,579) | (11,158) | $ (11,158) | |
Net Intangibles, ending | $ 78,419 | $ 78,419 | |||
Minimum [Member] | |||||
Schedule of Intangible Assets [Line Items] | |||||
Net Intangibles useful life | 12 years | ||||
Maximum [Member] | |||||
Schedule of Intangible Assets [Line Items] | |||||
Net Intangibles useful life | 13 years |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information (Details) - Schedule of Property and Equipment - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Schedule of Property and Equipment [Abstract] | ||
Equipment and furniture | $ 939,398 | $ 860,737 |
Total property and equipment | 939,398 | 860,737 |
Less accumulated depreciation | (443,383) | (334,984) |
Property and equipment, net | $ 496,015 | $ 525,753 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - Schedule of Accrued Expenses and Other Liabilities - USD ($) | Mar. 31, 2024 | Sep. 30, 2023 |
Schedule of Accrued Expenses [Line Items] | ||
Accrued payroll | $ 579,071 | $ 874,382 |
Operating lease liability, short term | 121,896 | 129,116 |
Royalty payments | 41,646 | 104,024 |
Other | 17,007 | |
Total | $ 759,620 | $ 1,107,522 |
Zimmer Development Agreement (D
Zimmer Development Agreement (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Aug. 02, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | |
Zimmer Development Agreement [Line Items] | |||||||
Fee payment | $ 2,000,000 | ||||||
Payment to the Company | $ 3,500,000 | ||||||
Warrant exercise price (in Dollars per share) | $ 3 | ||||||
Fair value of warrant | $ 100,000 | ||||||
Risk-free interest rate | 4.30% | 3.70% | 4.60% | 3.90% | |||
Expected term | 6 years | 5 years 3 months 18 days | 6 years 1 month 6 days | 5 years 2 months 12 days | |||
Expected dividend yield | 0% | 0% | 0% | 0% | |||
Aggregate transaction price | $ 5,400,000 | ||||||
Collaborations revenue | $ 1,455,188 | ||||||
Product revenue | 1,377,294 | $ 466,176 | 2,354,943 | $ 580,755 | |||
Development Agreement [Member] | |||||||
Zimmer Development Agreement [Line Items] | |||||||
Maintenance Fee | 1,500,000 | ||||||
Milestone payments paid | $ 2,000,000 | ||||||
Fair value of warrant | $ 100,000 | ||||||
Zimmer Development Agreement [Member] | |||||||
Zimmer Development Agreement [Line Items] | |||||||
Risk-free interest rate | 2.90% | ||||||
Expected volatility percentage | 53.50% | ||||||
Expected term | 5 years | ||||||
Expected dividend yield | 0% | ||||||
Collaborations revenue | $ 1,455,188 | $ 1,455,188 | |||||
Minimum [Member] | |||||||
Zimmer Development Agreement [Line Items] | |||||||
Fee payment | 2,000,000 | ||||||
Maximum [Member] | |||||||
Zimmer Development Agreement [Line Items] | |||||||
Fee payment | $ 3,500,000 | ||||||
Common Stock [Member] | Zimmer Development Agreement [Member] | Warrant [Member] | |||||||
Zimmer Development Agreement [Line Items] | |||||||
Aggregate shares (in Shares) | 350,000 | 350,000 |
Zimmer Development Agreement _2
Zimmer Development Agreement (Details) - Schedule of Deferred Revenue - USD ($) | 6 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule of Deferred Revenue [Abstract] | ||
Balance as of beginning of period – September 30 | $ 1,455,188 | |
Revenue recognized | (1,455,188) | |
Balance as of end of period – December 31 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Jan. 01, 2024 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Nov. 09, 2023 | Sep. 30, 2023 | Oct. 04, 2021 | |
Stock-Based Compensation [Line Items] | ||||||||
Shares outstanding percentage | 13% | |||||||
Option plan shares | 1,051,556 | |||||||
Granted shares | 65,000 | 56,781 | 1,225,669 | 130,512 | ||||
Weighted-average grant date fair value (in Dollars per share) | $ 0.91 | $ 0.88 | $ 1.08 | $ 0.75 | ||||
Total share based expenses (in Dollars) | $ 356,858 | $ 237,628 | $ 665,496 | $ 537,809 | ||||
Total number of stock options outstanding | 2,879,096 | 2,879,096 | 1,708,427 | |||||
Stock option vested | 48,295 | 84,778 | 104,911 | 212,224 | ||||
Stock options, forfeited | 0 | 0 | 55,000 | 0 | ||||
Options were exercised (in Dollars) | ||||||||
Future issuance | 183,130 | 183,130 | ||||||
Unrecognized stock-based compensation (in Dollars) | $ 3,100,000 | $ 3,100,000 | ||||||
Weighted average period | 2 years 8 months 12 days | |||||||
Restricted Stock Units (RSUs) [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Granted shares | 1,006,725 | 61,728 | 1,006,725 | 61,728 | ||||
Total share based expenses (in Dollars) | $ 142,670 | $ 95,625 | $ 263,877 | $ 214,062 | ||||
Weighted-average grant date fair value (in Dollars per share) | $ 1.03 | $ 1.62 | $ 1.03 | $ 1.62 | ||||
Restricted stock units (in Dollars per share) | $ 32,535 | $ 219,880 | $ 70,214 | $ 241,810 | ||||
Restricted stock units forfeited | ||||||||
Stock Options [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Total share based expenses (in Dollars) | $ 214,188 | $ 142,003 | ||||||
Equity Option [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Total share based expenses (in Dollars) | $ 401,619 | $ 323,747 | ||||||
NeuroOne Medical Technologies Corporation [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Future issuance shares | 420,350 | |||||||
Inducement Plan [Member] | Minimum [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Equity incentive awards under inducement plan | 150,000 | |||||||
Inducement Plan [Member] | Maximum [Member] | ||||||||
Stock-Based Compensation [Line Items] | ||||||||
Equity incentive awards under inducement plan | 570,350 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details) - Schedule of Stock-Based Compensation Expense - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule of Stock-Based Compensation Expense [Line Items] | ||||
Selling, general and administrative | $ 280,516 | $ 199,467 | $ 523,714 | $ 454,932 |
Research and development | 76,342 | 38,161 | 141,782 | 82,877 |
Total stock-based compensation expense | $ 356,858 | $ 237,628 | $ 665,496 | $ 537,809 |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details) - Schedule of Weighted-Average Assumptions Used in the Black-Scholes Option-Pricing Model | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Schedule of Weighted-Average Assumptions Used in the Black-Scholes Option-Pricing Model [Abstract] | ||||
Expected stock price volatility | 111.70% | 58.10% | 111.90% | 55.50% |
Expected life of options (years) | 6 years | 5 years 3 months 18 days | 6 years 1 month 6 days | 5 years 2 months 12 days |
Expected dividend yield | 0% | 0% | 0% | 0% |
Risk free interest rate | 4.30% | 3.70% | 4.60% | 3.90% |
Concentrations (Details)
Concentrations (Details) | 6 Months Ended |
Mar. 31, 2024 | |
Concentrations [Abstract] | |
Number of customer | One |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Income Taxes [Abstract] | ||||
Effective tax rate | 0% | 0% | 0% | 0% |
Income tax benefit |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||||
Dec. 21, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | Jan. 05, 2024 | Dec. 31, 2023 | Dec. 01, 2023 | Jul. 24, 2023 | |
Stockholders’ Equity [Line Items] | |||||||||
Maximum aggregate common stock offering price | $ 14,500,000 | $ 9,300,000 | $ 4,800,000 | $ 2,600,000 | |||||
Fixed commission rate | 3% | ||||||||
Share issued (in Shares) | 2,329,596 | 1,461,353 | |||||||
Aggregate offering price | $ 2,094,196 | $ 516,484 | $ 3,350,467 | $ 928,257 | |||||
Common stock shares issued (in Shares) | 5,903,123 | ||||||||
Issuance cost | $ 183,359 | 160,406 | $ 183,359 | ||||||
Warrant exercises | $ 0 | $ 0 | |||||||
Warrant expired (in Shares) | 1,338,860 | 279,727 | |||||||
At The Market Offering [Member] | |||||||||
Stockholders’ Equity [Line Items] | |||||||||
Issuance cost | $ 148,382 | $ 186,080 | |||||||
Common Stock [Member] | |||||||||
Stockholders’ Equity [Line Items] | |||||||||
Common stock shares issued (in Shares) | 3,769,273 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of Warrant Activity and Summary - Warrant [Member] | 6 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Class of Warrant or Right [Line Items] | |
Warrants, Outstanding and exercisable, beginning (in Shares) | shares | 6,202,426 |
Weighted Average Exercise Price, Outstanding and exercisable, beginning | $ 5.92 |
Weighted Average Term (Years), Outstanding and exercisable, beginning | 2 years |
Warrants, Issued (in Shares) | shares | |
Exercise Price Per Warrant, Issued | |
Weighted Average Exercise Price, Issued | |
Weighted Average Term (Years), Issued | |
Warrants, Exercised (in Shares) | shares | |
Exercise Price Per Warrant, Exercised | |
Weighted Average Exercise Price, Exercised | |
Weighted Average Term (Years), Exercised | |
Warrants, Expired (in Shares) | shares | (1,338,860) |
Weighted Average Exercise Price, Expired | $ 8.69 |
Weighted Average Term (years), Expired | |
Warrants, Outstanding and exercisable, Ending (in Shares) | shares | 4,863,566 |
Weighted Average Exercise Price, Outstanding and exercisable, Ending | $ 5.16 |
Weighted Average Term (Years), Outstanding and exercisable, Ending | 1 year 11 months 19 days |
Minimum [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price Per Warrant, Outstanding and exercisable, beginning | $ 3 |
Exercise Price Per Warrant, Expired | 7.5 |
Exercise Price Per Warrant, Outstanding and exercisable, Ending | 3 |
Maximum [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise Price Per Warrant, Outstanding and exercisable, beginning | 9 |
Exercise Price Per Warrant, Expired | 9 |
Exercise Price Per Warrant, Outstanding and exercisable, Ending | $ 9 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of Warrants Outstanding - Warrant [Member] - $ / shares | 6 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Schedule of Warrants Outstanding [Line Items] | ||
Number Outstanding, Total | 4,863,566 | |
Weighted Average Remaining Contractual life (Years), Total | 1 year 11 months 19 days | |
Number Exercisable , Total | 4,863,566 | |
3.00 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | $ 3 | |
Number Outstanding, Total | 350,000 | |
Weighted Average Remaining Contractual life (Years), Total | 3 years 4 months 2 days | |
Number Exercisable , Total | 350,000 | |
5.25 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | 5.25 | |
Number Outstanding, Total | 4,166,682 | |
Weighted Average Remaining Contractual life (Years), Total | 1 year 9 months 14 days | |
Number Exercisable , Total | 4,166,682 | |
5.61 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | 5.61 | |
Number Outstanding, Total | 220,855 | |
Weighted Average Remaining Contractual life (Years), Total | 4 years 3 months | |
Number Exercisable , Total | 220,855 | |
6.00 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | 6 | |
Number Outstanding, Total | 45,171 | |
Weighted Average Remaining Contractual life (Years), Total | 3 months | |
Number Exercisable , Total | 45,171 | |
8.25 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | 8.25 | |
Number Outstanding, Total | 62,906 | |
Weighted Average Remaining Contractual life (Years), Total | 3 months | |
Number Exercisable , Total | 62,906 | |
9.00 [Member] | ||
Schedule of Warrants Outstanding [Line Items] | ||
Exercise Price, Total (in Dollars per share) | $ 9 | |
Number Outstanding, Total | 17,952 | |
Weighted Average Remaining Contractual life (Years), Total | 3 months | |
Number Exercisable , Total | 17,952 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] - USD ($) $ in Millions | May 10, 2024 | Apr. 01, 2024 |
Subsequent Events [Line Items] | ||
Share sold | 1,093,135 | 1,093,135 |
Net Proceeds (in Dollars) | $ 1,286,844 |