NEUROONE MEDICAL TECHNOLOGIES Corp
For the period ended Sep 30, 2025. Filed Dec 17, 2025.
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FY2025 · Filed Dec 17, 2025
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Notes to Financial Statements
NOTE 1 - Organization and Nature of Operations
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 and brain stimulation solutions to diagnose and treat patients with epilepsy, trigeminal neuralgia, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological disorders. The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while being able to record activity before, during, and after delivery.
The Company has received 510(k) clearance from the United States (“U.S.”) Food and Drug Administration (“FDA”) for four of its devices: (i) its Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days (“Evo Cortical”), (ii) 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 (“Evo sEEG”); (iii) its OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures (the “OneRF Ablation System”) and (iv) our OneRF TN ablation system for use in procedures to create radiofrequency (RF) lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures (“OneRF TN Ablation System”, together with the Evo Cortical, Evo sEEG, and OneRF Ablation System, the “Commercialized Products”). The Company has a distribution agreement with Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and OneRF Ablation System in the brain. The Company initiated a limited market release of its OneRF TN Ablation System in December 2025. The Company’s other products and indications are still under development.
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 has experienced minor price increases from our suppliers related to tariffs on imported goods, and may experience additional price increases.
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 financial statements have been prepared in accordance with accounting standards generally accepted in the United States of America (“U.S. GAAP”).
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 since inception, and an accumulated deficit of $78.6 million as of September 30, 2025. 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 which previously resulted in substantial doubt regarding the Company’s ability to continue as a going concern. As of September 30, 2025, the Company had $6.6 million in cash and cash equivalents. The Company believes its current available cash and cash equivalents coupled with the anticipated increase in product revenues from minimum purchases and improved gross margins under the Zimmer Amendment and forecasted operating expense reductions, will be sufficient to fund the Company’s operations through September 2026. 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 financing. 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.
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 (“CODM”) in deciding how to allocate resources and assessing performance. The Company’s CODM is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business inone operating segment. See “Note 14 – Segment Reporting”.
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 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.
Revenue Recognition
The Company entered into a development and distribution agreement which has current and future revenue recognition implications. See “Note 7 – Zimmer Distribution Agreement and Other Product Revenue.”
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 manufacturers in connection with OneRF Ablation System (the “OneRF Products”), 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 as well as valuation adjustments for excess or obsolete inventory.
License 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: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. When the Company’s assessment of probability of achievement changes and variable consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in license revenues based upon when the customer obtains control of each element.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Warrant Liability
The Company issued warrants in connection with its 2024 Private Placement. See “Note 9– Stockholders’ Equity”. The Company accounts for these warrants as a liability at fair value when warrant pricing protection provisions are not available to other common stockholders. Additionally, issuance costs associated with the warrant liability are expensed as incurred and reflected as a financing cost in the accompanying statements of operations. The Company adjusts the liability for changes in fair value until the earlier of the exercise or expiration of the warrants for any period when pricing protections remain in place. Any future change in the fair value of the warrant liability is recognized in the statements of operations under the fair value change in the warrant liability line item.
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 September 30, 2025 and 2024, the fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, deferred offering costs, accounts payable and accrued expenses and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the warrant liability was based on Level 3 inputs as well as the Company’s underlying stock price and associated volatility, expected term of the warrants and market interest rates. There were no transfers between fair value hierarchy levels during the years ended September 30, 2025 and 2024.
The fair value of financial instruments measured on a recurring basis is as follows:
| Description | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Liabilities: | ||||
| Warrant liability | $1,266,894 | $— | $— | $1,266,894 |
| Total liabilities at fair value | $1,266,894 | $— | $— | $1,266,894 |
| Description | Total | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Liabilities: | ||||
| Warrant liability | $2,140,315 | $— | $— | $2,140,315 |
| Total liabilities at fair value | $2,140,315 | $— | $— | $2,140,315 |
The following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level 3 inputs for the years ended September 30, 2025 and 2024.
| 2025 | 2024 | |
|---|---|---|
| Warrant liability | ||
| Balance as of beginning of year | $2,140,315 | $— |
| Value assigned to warrants in connection with 2024 Private Placement | — | 1,813,223 |
| Change in fair value of warrant liability | (784,670) | 327,092 |
| Exercise | (88,751) | — |
| Balance as of end of year | $1,266,894 | $2,140,315 |
There were no financial instruments measured on a non-recurring basis during the periods presented.
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 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 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 our Commercialized Product components, work-in-process and finished goods. The Commercialized Products are produced by a third-party contract manufacturer and our electrode cable assembly components are obtained from outside suppliers.
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 $165,000 and $108,993 for the years ended September 30, 2025 and 2024, 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 financial and administrative 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(“ASC 718”). Accordingly, compensation costs related to equity instruments granted are recognized at the grant-date fair value over the requisite service period. The Company records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718.
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 years ended September 30, 2025 and 2024.
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 years ended September 30:
| 2025 | 2024 | |
|---|---|---|
| Warrants | 6,895,875 | 7,045,875 |
| Stock options | 6,083,167 | 2,814,096 |
| Restricted stock units | 812,696 | 1,129,762 |
Recent Accounting Pronouncements
In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07*- Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures*, which enhances reportable segment disclosure requirements, primarily through disclosures of significant segment expenses. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The guidance must be applied retrospectively to all prior periods presented. The Company adopted this guidance on October 1, 2024. The adoption of this ASU did not have a material impact on the Company’s financial statements.
In December 2023, the FASB issued ASU 2023-09Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This guidance also includes certain other amendments to improve the effectiveness of income tax disclosures. This ASU is effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years and should be applied on a prospective basis, with retrospective application permitted. The Company is currently evaluating the impact of the adoption of this guidance on its financial statements.
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 each of the years ended September 30, 2025 and 2024, $150,000 in royalty fees were incurred related to the WARF License and 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 year ended September 30, 2024, $6,861 in royalty fees were incurred and were reflected as a component of cost of product revenue. There were no royalty fees in connection with the Mayo Agreement during the year ended September 30, 2025.
Facility Leases
Headquarters Lease
On May 20, 2024, the Company amended its non-cancellable headquarters lease (the “Lease”) with certain landlords (together, the “Landlord”) pursuant to which the Company leases office space located at 7599 Anagram Drive, Eden Prairie, Minnesota (the “Premises”). The Company took possession of the Premises on November 1, 2019, with the term of the Lease ending June 30, 2028, as amended, unless terminated earlier (the “Lease Term”). The base rent for the Premises ranges from $6,410 per month to $7,107 per month by the end of the Lease Term as amended. In addition, as long as the Company is not in default under the Lease, the Company will be entitled to an abatement of its base rent for the first two months of the amended Lease Term beginning in April 2025 and for the last month of the amended Lease Term (June 2028). In addition, the Company pays its pro rata share of the Landlord’s annual operating expenses associated with the Premises.
Los Gatos Lease
On July 1, 2021, the Company entered into a non-cancellable facility lease (the “Los Gatos Lease”), pursuant to which the Company agreed to rent office space for its research and development operations located at 718 University Avenue, Suite #111, Los Gatos, California. The facility space under the Los Gatos Lease is approximately 1,162 square feet. The Company took possession of the office space on July 2, 2021. The initial monthly rent under the Los Gatos Lease was $4,241. On November 4, 2022, the Los Gatos Lease was extended for an additionaltwo years to December 31, 2024. The rent under the extended Los Gatos Lease ranged from $4,453 to $4,632 per month beginning on January 1, 2023. On December 17, 2024, the Los Gatos Lease was extended again for an additionaltwo years to December 31, 2026. The rent under the newly extended Los Gatos Lease ranges from $4,939 to $5,087 per month beginning on January 1, 2025.
During the years ended September 30, 2025 and 2024, rent expense associated with the facility leases amounted to $279,261 and$173,090, respectively.
Supplemental cash flow information related to the operating lease was as follows:
| For the Years Ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liability: | ||
| Operating cash flows from operating leases | $126,435 | $138,917 |
| Modification of right-of-use asset and associated lease liability: | ||
| Operating leases | $111,898 | $199,385 |
Supplemental balance sheet information related to theoperating lease was as follows:
| As of September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Right-of-use assets | $255,195 | $254,910 |
| Lease liability | $266,806 | $260,160 |
| Weighted average remaining lease term (years) | 2.3 | 3.6 |
| Weighted average discount rate | 7.2% | 7.4% |
Maturity of the lease liabilities was as follows:** **
| Calendar Year | As of September 30, 2025 |
|---|---|
| 2025 | $34,045 |
| 2026 | 139,985 |
| 2027 | 81,708 |
| 2028 | 34,815 |
| Total lease payments | 290,553 |
| Less imputed interest | (23,747) |
| Total | 266,806 |
| Short-term portion (included in other liabilities) | (123,658) |
| Long-term portion | $143,148 |
Other Contingencies
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.
NOTE 5 – Supplemental Balance Sheet Information
Inventory
Inventory consisted of the following:
| As of September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Component inventory | $871,492 | $877,065 |
| Work-in-process | 130,100 | 192,360 |
| Finished goods | 1,225,213 | 1,565,728 |
| Total | $2,226,805 | $2,635,153 |
The Company had finished goods on consignment in the amount ofzero and $102,318 as of September 30, 2025 and 2024, respectively. Excess and obsolete valuation reserve adjustments reflected as a reduction of work-in-process inventory as of September 30, 2025 and 2024 were $10,000 andzero, respectively.
Intangibles
Intangible assets roll forward is as follows:
| Useful Life | ||
|---|---|---|
| Net intangibles, September 30, 2023 | 12-13 years | $89,577 |
| Less: amortization | (22,315) | |
| Net intangibles, September 30, 2024 | 67,262 | |
| Less: amortization | (22,316) | |
| Net intangibles, September 30, 2025 | $44,946 | |
The Company anticipates amortization expense of approximately $22,000 per year for fiscal years 2026 through 2027 based upon the two current license agreements.
Property and Equipment
Property and equipment, net held for use by category are presented in the following table:
| As of September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Equipment and furniture | $1,058,045 | $976,303 |
| Total property and equipment | 1,058,045 | 976,303 |
| Less accumulated depreciation | (798,823) | (559,460) |
| Property and equipment, net | $259,222 | $416,843 |
Depreciation expense was $239,363 and $224,476 for the years ended September 30, 2025 and 2024, respectively.
NOTE 6 - Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following
| As of September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Accrued payroll | $1,055,121 | $950,260 |
| Operating lease liability, short term | 123,658 | 65,768 |
| Royalty fees | 112,500 | 108,036 |
| Other | 1,435 | 59,950 |
| Total | $1,292,714 | $1,184,014 |
NOTE 7 – Zimmer Distribution Agreement and Other Product Revenue
On October 25, 2024, the Company entered into the Zimmer Amended and Restated Distribution Agreement (the “Amendment”) with Zimmer pursuant to which the Company granted Zimmer the exclusive right and license to distribute its OneRF Ablation System for an upfront payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified net sales milestones.
The Company and Zimmer previously entered into an Exclusive Development and Distribution Agreement dated July 20, 2020, related to the sEEG and Strip/Grid Product Systems, which was subsequently amended pursuant to the terms and conditions of a letter agreement dated January 6, 2021, a Second Amendment to Exclusive Development and Distribution Agreement dated June 28, 2022, and a Third Amendment to Exclusive Development and Distribution Agreement dated August 2, 2022 (collectively, the “EDDA”). The EDDAs executed prior to the Amendment 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”. In addition, under the prior EDDAs, the Company and Zimmer agreed to collaborate with respect to development activities through a joint development committee composed of an equal number of representatives of Zimmer and the Company.
Under the Amendment, Zimmer paid the Company $3.0 million for an exclusive RF Distribution License (the “RF Distribution License” and “License”) for commercialization of its OneRF™ product. In addition, the Company is eligible to receive a future milestone payment of $1.0 million upon reaching a one-time sales volume threshold, but does not anticipate achieving this milestone.
The revised term under the Amendment (the “Term”) began on the effective date of the Amendment and will remain in effect until October 31, 2034. Upon the expiration of the Term, it may be renewed upon the mutual written consent of the parties. The Amended and Restated Exclusive Development and Distribution Agreement may be terminated before the expiration of the Term in accordance with certain terms under the Amendment. In addition, the license rights granted to Zimmer under this Amendment shall be exclusive (i) until September 30, 2032 for the sEEG Products and Strip/Grid Products; and (ii) until October 31, 2034 for the OneRF™ Product System.
License Revenue
The Amendment was accounted for under the provisions of ASC 606 as a separate contract from the prior EDDAs. In accordance with the provisions under ASC 606, the Company identified the transfer of the RF Distribution License as the sole performance obligation of the RF Distribution License. The distribution rights granted to Zimmer, inclusive of the access to the underlying intellectual property for future production of the OneRF Products if required, was found to have significant standalone functionality as no additional substantive input was required by the Company on a go forward basis. Lastly, ancillary support related to the Amendment was concluded to be a perfunctory obligation and de minimis in terms of required resources.
The transaction price associated with the Amendment was $3.0 million, which was comprised solely of the OneRF Exclusivity Fee, as defined in the Amendment, and was allocated totally to the RF Distribution License performance obligation.
Sales Volume Milestone and Payment
The sales volume milestone associated with the Amendment was determined by sales or usage-based thresholds. The sales volume milestone was accounted for under the sales milestone recognition constraint and will be accounted for as constrained variable consideration. The Company has applied the sales volume constraint to the milestone payment and will not recognize revenue until the sales volume threshold occurs.
Recognition of License Revenue
The Company determined that the RF Distribution License represented functional intellectual property given Zimmer’s access to the underlying intellectual property associated with the OneRF Products. As such, the revenue related to the licenses was recognized at the point in time in which the license/know-how was delivered to Zimmer which occurred in October 2024. Revenue recognized under the Amendment during the year ended September 30, 2025 was $3.0 million.
Product Revenue
Product revenue recognized during the year ended September 30, 2025 was $9.1 million and was comprised primarily of OneRF Ablation System revenue. The OneRF Ablation System was subject to the Amendment upon its execution in October 2024.
During the year ended September 30, 2024, product revenue related to the Company’s Evo Cortical, Evo sEEG, and OneRF Ablation Systems and amounted to $3.5 million of which $0.3 million was comprised of OneRF Products revenue. The OneRF Ablation System was not covered by the Zimmer Distribution Agreement during the year ended September 30, 2024.
NOTE 8 - Stock-Based Compensation
During the years ended September 30, 2025 and 2024, stock-based compensation expense related to the stock options and restricted stock units was included in selling, general and administrative and research and development costs as follows in the accompanying statements of operations:
| 2025 | 2024 | |
|---|---|---|
| Selling, general and administrative | $990,586 | $1,064,819 |
| Research and development | 274,022 | 279,657 |
| Total stock-based compensation expense | $1,264,608 | $1,344,476 |
2025 Equity Incentive Plan
On January 10, 2025, the Board of Directors of the Company adopted the NeuroOne Medical Technologies Corporation 2025 Equity Incentive Plan (the “2025 Plan”). On February 14, 2025, at the 2025 annual meeting of stockholders, the stockholders of the Company approved the 2025 Plan.
The 2025 Plan is the successor to and continuation of the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) and to the Company’s 2016 Equity Incentive Plan (together, the “Prior Plans”). As of the Effective Date, (i) no additional awards may be granted under the Prior Plans; (ii) any Returning Shares will become available for issuance pursuant to Awards granted under the 2025 Plan; and (iii) all outstanding awards granted under the Prior Plans will remain subject to the terms of the Prior Plans (except to the extent such outstanding awards result in returning shares that become available for issuance pursuant to awards granted under the 2025 Plan).
Initially, the maximum number of shares of the Company’s common stock, that may be issued under the 2025 Plan may not exceed (1)3,000,000 and (2) any shares subject to outstanding stock awards under the 2017 Plan that are forfeited or otherwise returned to the share reserve.
Inducement Plan
In October 2021, the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”), 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 a 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, and on May 20, 2025, the Board adopted the Second 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 an additional 575,000 shares.
2017 Plan and Evergreen Provision
On January 1, 2025,1,124,446 shares were added to the 2017 Plan as a result of the evergreen provision within the 2017 Plan. However, upon the adoption of the 2025 Plan, there will be no further issuance of grants under the 2017 Plan and any forfeitures of grants issued under the 2017 Plan will be added to the amount available for future issuance under the 2025 Plan. Grants issued under the 2017 Plan will continue to be governed under the terms of the 2017 Plan.
Stock Options
During the years ended September 30, 2025 and 2024,3,336,571 and 1,225,669 stock options were granted to employees, directors and consultants, respectively, with a weighted average grant date fair value of $0.50 and $1.08 per share, respectively. The options granted have vesting periods ranging fromone year tofour years. All options expireten years from the date of grant. The total expense for the years ended September 30, 2025 and 2024 related to the stock options was $779,428 and $808,057, respectively. The following table summarizes the Company’s stock option plan activity for the years ended September 30, 2025 and 2024:
| Number of Options | Weighted Average Exercise Price | Weighted- Average Remaining Contractual Term (years) | Aggregate Intrinsic Value(1) | |
|---|---|---|---|---|
| Outstanding at September 30, 2023 | 1,708,427 | $4.34 | 7.7 | $20,064 |
| Granted | 1,225,669 | $1.26 | — | — |
| Exercised | — | $— | — | — |
| Forfeited/Cancelled | (120,000) | $1.33 | — | — |
| Outstanding at September 30, 2024 | 2,814,096 | $3.13 | 7.7 | $22,685 |
| Granted | 3,336,571 | $0.60 | — | — |
| Exercised | — | $— | — | — |
| Forfeited/Cancelled | (67,500) | $1.82 | — | — |
| Outstanding at September 30, 2025 | 6,083,167 | $1.76 | 8.3 | 999,882 |
| Vested and expected to vest at September 30, 2025 | 6,083,167 | $1.76 | 8.3 | $999,882 |
| Vested and exercisable at September 30, 2025 | 2,172,035 | $3.62 | 6.4 | $44,288 |
| (1) | The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of our common stock as of September 30, 2025 and 2024 of $0.89 and $0.99 per share, respectively. As of September 30, 2025 and 2024, 2,772,156 and 2,780,581 outstanding options, respectively, had no intrinsic value. |
The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the years ended September 30:
| 2025 | 2024 | |
|---|---|---|
| Expected stock price volatility | 110.0% | 111.9% |
| Expected life of options (years) | 6.0 | 6.1 |
| Expected dividend yield | 0% | 0% |
| Risk free interest rate | 4.0% | 4.6% |
During the years ended September 30, 2025 and 2024,810,476 and 289,072 stock options vested, respectively. During the years ended September 30, 2025 and 2024,67,500 and 120,000 stock options were forfeited, respectively. No options were exercised during the years ended September 30, 2025 and 2024.
Restricted Stock Units
A summary of restricted stock unit (“RSU”) activity is as follows for the years ended September 30, 2025 and 2024:
| Number of | |
|---|---|
| Shares | |
| Non-vested at September 30, 2023 | 393,370 |
| Granted | 1,006,725 |
| Vested | (270,333) |
| Non-vested at September 30, 2024 | 1,129,762 |
| Granted | 83,334 |
| Forfeitures | (2,500) |
| Vested | (397,900) |
| Non-vested at September 30, 2025 | 812,696 |
During the years ended September 30, 2025 and 2024,83,334 and 1,006,725 RSUs were granted to members of the Company’s Board of Directors and employees with a grant date fair value of $1.20 and $1.03 per unit, respectively. The RSUs granted in fiscal year 2025 vest over a one-year period in equal annual installments on a monthly basis, subject to the recipient’s continued service on such dates. The RSUs granted to employees in fiscal year 2024 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 years ended September 30, 2025 and 2024,397,900 and 270,333 RSUs vested, respectively. The total expense for the years ended September 30, 2025 and 2024 related to the RSU’s was $485,180 and $536,419, respectively. There were 2,500 andzero RSU forfeitures during the years ended September 30, 2025 and 2024, respectively.
General
As of September 30, 2025,1,761,970 shares were available for future issuance on a combined basis under the 2025 Plan and the Inducement Plan. Unrecognized stock-based compensation was $2,869,224 as of September 30, 2025. The unrecognized share-based expense is expected to be recognized over a weighted average period of 3.2 years.
NOTE 9 – Stockholders’ Equity
April 2025 Financing
On April 4, 2025, the Company entered into an underwriting agreement with Ladenburg Thalmann & Co. Inc. as underwriter ( “Ladenburg”), relating to the issuance and sale of 16,000,000 shares of the Company’s common stock at a price to the public of $0.50 per share (the “April 2025 Financing”). In addition, under the terms of the underwriting agreement, the Company granted Ladenburg an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common stock on the same terms as the offering, which overallotment was exercised in full. Issuance costs in connection with the April 2025 Financing amounted to $960,717 which included a 7% commission to Ladenburg and legal and other expenses in the amount of $316,717. Net proceeds to the Company were $8,239,283.
At-The-Market Offering
On December 21, 2022, the Company entered into a Capital on Demand TM Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”) that created an at-the-market offering program (“ATM Program”) under which the Company could offer and sell common stock having an aggregate offering price of up to $14.5 million. JonesTrading is entitled to a commission at a fixed commission rate of up to 3% of the gross proceeds. On July 24, 2023, the Company decreased the amount of common stock that could be sold pursuant to the Sales Agreement, such that the Company was offering up to an aggregate of $2.6 million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold. Subsequently on December 1, 2023, however, the Company increased the amount of common stock that could be sold pursuant to the Sales Agreement, such that the Company was offering up to an aggregate of $4.8 million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold. On January 5, 2024, the Company further increased the amount of common stock that can be sold pursuant to the Sales Agreement, such that the Company was offering up to an aggregate of $9.3 million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold. On August 16, 2024, the Company increased the amount of common stock that can be sold pursuant to the Sales Agreement by $3.0 million. On April 3, 2025, the Company decreased the amount of common stock that could be sold pursuant to the Sales Agreement tozero. On August 15, 2025, the Company increased the amount of common stock that can be sold pursuant to the Sales Agreement to $6,750,000.
During the years ended September 30, 2025 and 2024,355,899 and 3,748,913 shares of common stock were issued, respectively, under the ATM Program for an aggregate offering price of $414,037 and $5,033,906, respectively. Issuance costs incurred under the ATM Program during the years ended September 30, 2025 and 2024 were $95,929 and $277,903, respectively. Lastly, during the year ended September 30, 2025, the Company incurred legal costs of $9,325 that were expensed as financing costs.
The total aggregate offering price and common stock issued since inception of the ATM Program through September 30, 2025 was $8,000,600 and 5,544,489 shares, respectively. Cumulative issuance costs incurred under the ATM Program through September 30, 2025 was $608,558.
August 2024 Private Placement
On August 1, 2024, the Company entered into a securities purchase agreement with certain accredited investors, pursuant to which the Company, in a private placement (the “2024 Private Placement”), agreed to issue and sell an aggregate of (i)2,944,446 shares of the Company’s common stock and (ii) warrants to purchase an aggregate of 2,208,338 shares of common stock (the “PIPE Warrants”) at a purchase price of $0.90 per unit, consisting of one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately $2.65 million before deducting expenses. Issuance costs attributed to the 2024 Private Placement amounted to approximately $0.2 million. The 2024 Private Placement closed on August 2, 2024.
The PIPE Warrants are exercisable beginning on the date of issuance and had an initial exercise price of $1.19 per share, subject to adjustment. In April 2025, the exercise price was reset to $0.465 upon the close of the April 2025 Financing for all of the PIPE Warrants, except for the PIPE Warrants to purchase 20,834 shares of common stock issued to a director on the Company’s Board of Directors for which the exercise price was reset to $0.876 per share. The PIPE Warrants will expire on the third anniversary of the date of issuance.
The PIPE Warrants were accounted for and classified as liabilities on the accompanying balance sheets given certain price reset provisions not used for a fair valuation under a fixed for fixed settlement scenario as required for equity balance sheet classification. A Monte Carlo simulation model was used to estimate the aggregate fair value of the PIPE Warrants. Input assumptions used were as follows on September 30, 2025 and 2024: risk-free interest rate 3.55% and 3.53%, respectively; expected volatility of 94.5% and 115.7%; respectively; expected life of 1.84 years and 2.84 years, respectively; and expected dividend yield zero percent for both dates. The underlying stock price used was the market price as quoted on Nasdaq as of September 30, 2025 and 2024, respectively. The aggregate fair value of the PIPE Warrants of $1,813,223 upon issuance was recorded as a long term liability on the accompanying balance sheets. The Company recorded the fair value change of the PIPE Warrants in the amount of a $784,670 benefit and an expense of $327,092 to the fair value change in warrant liability line item on the accompanying statements of operations for the years ended September 30, 2025 and 2024, respectively.
Warrant Activity and Summary
The following table summarizes warrant activity during the years ended September 30, 2025 and 2024:
| Warrants | Exercise Price Per Warrant | Weighted Average Exercise Price | Weighted Average Term (years) | |
|---|---|---|---|---|
| Outstanding and exercisable at September 30, 2023 | 6,202,426 | $3.00-9.00 | $5.92 | 2.00 |
| Issued | 2,308,338 | $0.66-1.19 | $1.17 | 3.09 |
| Exercised | — | $— | $— | — |
| Expired | (1,464,889) | $6.00-9.00 | $8.59 | — |
| Outstanding at September 30, 2024 | 7,045,875 | $ 0.66-5.61 | $3.81 | 1.98 |
| Issued | — | $— | $— | — |
| Exercised | (150,000) | $0.465 | $0.465 | — |
| Expired | — | $— | $— | — |
| Outstanding at September 30, 2025 | 6,895,875 | $0.465-5.61 | $3.65 | 0.96 |
| Outstanding and exercisable at September 30, 2025 | 6,895,875 | $0.465-5.61 | $3.65 | 0.96 |
The following table summarizes information about warrants outstanding at September 30, 2025:
| Exercise Price | Number Outstanding | Weighted Average Remaining Contractual life (Years) | Number Exercisable at September 30, 2025 |
|---|---|---|---|
| $0.465 | 2,037,504 | 1.84 | 2,037,504 |
| $0.66 | 100,000 | 3.84 | 100,000 |
| $0.876 | 20,834 | 1.84 | 20,834 |
| $3.00 | 350,000 | 1.84 | 350,000 |
| $5.25 | 4,166,682 | 0.29 | 4,166,682 |
| $5.61 | 220,855 | 2.75 | 220,855 |
| Total | 6,895,875 | 6,895,875 |
As provided in the PIPE Warrants agreement, the exercise price of the PIPE Warrants was adjusted downward from $1.19 per share as of September 30, 2024 ultimately to $0.465 per share for most of the PIPE Warrants in April 2025 attributed to the April 2025 Financing. The exercise price of the PIPE Warrants issued to a director of the Company’s Board of Directors; however, was reset to $0.876 per given a higher floor price provision for that individual.
NOTE 10 - Debt Financing
Debt Facility Financing
On August 2, 2024, the Company entered into a loan and security agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding, LLC, as the lender (the “Lender”), which provided for a delayed draw term loan facility in an aggregate principal amount not to exceed $3.0 million (the “Debt Facility”). The Company was permitted to borrow loans under the Debt Facility from time to time, for general corporate purposes and subject to certain specified conditions, until the earliest of: (i) November 30, 2024, (ii) the occurrence of any Monetization Event or Change of Control (as each defined in the Debt Facility Agreement), or (iii) at the Lender’s option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement. On November 7, 2024, the Company terminated the Debt Facility Agreement, and no amounts were drawn under the Debt Facility Agreement. The Company paid a termination fee of $125,000 to the Lender and incurred additional legal fees of $7,091 related to the termination. The Company also incurred non-termination Debt Facility costs of $192,647 and $202,656 during the year ended September 30, 2025 and 2024, respectively.
At closing of the Debt Facility, the Company issued to the Lender a warrant exercisable forfive years for 100,000 shares of common stock at an exercise price of $0.66 per share, subject to adjustment (the “Closing Date Debt Facility Warrant”). The Closing Date Debt Facility Warrant was accounted for and classified as equity on the accompanying balance sheets.
NOTE 11 - Concentrations
Revenue
For the year ended September 30, 2025, one customer accounted for 97% of the Company’s product revenue and 4 customers accounted for the remaining 3% of product revenue. For the year ended September 30, 2024, one customer accounted for 90% of the Company’s product revenue andthree customers accounted for the remaining 10% of product 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 and manufacture of the Company’s OneRF Ablation system.
NOTE 12 - Income Taxes
The effective tax rate for the Company for the years ended September 30, 2025 and 2024 waszero percent. A reconciliation of income tax computed at the statutory federal income tax rate to the provision (benefit) for income taxes included in the accompanying statements of operations for the years ended September 30 is as follows:
| 2025 | 2024 | |
|---|---|---|
| Income tax benefit at federal statutory rate | (21.0)% | (21.0)% |
| State income tax, net of federal benefit | (7.7) | (7.7) |
| Research credits | (7.8) | (2.4) |
| Stock-based compensation and other | (3.6) | 1.9 |
| Valuation allowance | 40.1 | 29.2 |
| Effective tax rate | —% | —% |
Significant components of the Company’s deferred tax assets and liabilities are summarized in the tables below as of September 30:
| 2025 | 2024 | |
|---|---|---|
| Deferred tax assets: | ||
| Federal and state operating loss carryforwards | $14,159,229 | $13,789,594 |
| Acquired intangibles | 32,164 | 30,258 |
| Accruals and other | 84,211 | 97,803 |
| Research and development capitalization | 3,236,926 | 2,650,371 |
| Research and development credit carryforwards | 1,889,174 | 1,609,718 |
| Stock-based compensation | 1,165,693 | 986,952 |
| Total deferred tax assets | 20,567,397 | 19,164,696 |
| Deferred tax liabilities: | ||
| Fixed assets and other | (92,060) | (136,659) |
| Total deferred tax liabilities | (92,060) | (136,659) |
| Valuation allowance | (20,475,337) | (19,028,037) |
| Net deferred tax assets | $— | $— |
As of September 30, 2025 and 2024, the Company had gross deferred tax assets of approximately $20,567,000 and $19,165,000, respectively. Realization of the deferred assets is primarily dependent upon future taxable income, if any, the amount and timing of which are uncertain. The Company has had significant pre-tax losses since its inception. The Company has not yet generated revenues from sales to the level of becoming profitable. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance of approximately $20,475,000 and $19,028,000 as of September 30, 2025 and 2024, respectively. Net deferred tax assets will continue to require a valuation allowance until the Company can demonstrate their realizability through sustained profitability or another source of income.
As of September 30, 2025 and 2024, the Company’s federal net operating loss carryforwards were approximately $49,207,000 and $47,958,000, respectively. The Company had federal research credit carryforwards as of September 30, 2025 and 2024 of approximately $1,523,000 and $1,304,000, respectively. The federal net operating loss incurred prior to January 1, 2018 and tax credit carryforwards will begin to expire in 2036 if not utilized. Federal net operating losses incurred after December 31, 2017 will not expire. As of September 30, 2025 and 2024, the Company had state net operating loss carryforwards of approximately $49,415,000 and $48,030,000, respectively. The Company had state research credit carryforwards of approximately $886,000 and $747,000 as of September 30, 2025 and 2024, respectively. The state net operating loss carryforwards will begin to expire in 2031, if not utilized, and the state research credit carryforwards will begin to expire in 2032 if not utilized.
Utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. Generally, in addition to certain entity reorganizations, the limitation applies when one or more “5-percent shareholders” increase their ownership, in the aggregate, by more than 50 percentage points over a 36-month testing period or beginning the day after the most recent ownership change, if shorter. The annual limitation may result in the expiration of net operating losses and credits before utilization.
In accordance with ASC 740, Income Taxes (“ASC 740”), specifically related to uncertain tax positions, a Company is required to use a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. A reconciliation of the beginning and ending amounts of unrecognized tax positions for the years ended September 30 is as follows:
| 2025 | 2024 | |
|---|---|---|
| Unrecognized tax positions, beginning of year | $284,068 | $231,968 |
| Gross increase, current year tax positions | 49,314 | 52,100 |
| Unrecognized tax positions, end of year | $333,382 | $284,068 |
If recognized, none of the unrecognized tax positions would impact the Company’s income tax benefit or effective tax rate as long as the Company’s net deferred tax assets remain subject to a full valuation allowance. The Company does not expect any significant increases or decreases to the Company’s unrecognized tax positions within the next 12 months.
In accordance with ASC Topic 740,Income Taxes guidance, the Company has adopted a policy under which, if required to be recognized in the future, interest related to the underpayment of income taxes will be classified as a component of interest expense and any related penalties will be classified in operating expenses in the accompanying statements of operations.
The Company has tax filing obligations in the following jurisdictions: U.S. federal, Minnesota and California. The income tax returns since 2022 are subject to examination by the federal and state taxing authorities.
NOTE 13 - Defined Contribution Plan
The Company has a 401(k) defined contribution plan (the “401K Plan”) for all employees age 21 and older. Employees can defer up to 100% of their compensation through payroll withholdings into the 401K Plan subject to federal law limits. The Company may match 100% of deferrals up to 3% of one’s contributions. The Company’s matching contributions to employee deferrals are discretionary. The Company may also make discretionary profit sharing contributions under the 401K Plan in the future, but it has not done so through September 30, 2025.
Employee contributions and any employer matching contributions made to satisfy certain non-discrimination tests required by the Internal Revenue Code are 100% vested upon contribution. Discretionary employer matches to employee deferrals vest over a six year period beginning on the second anniversary of an employee’s date of hire. Discretionary profit sharing contributions vest over a five year period beginning on the first anniversary of an employee’s date of hire. The Company made contributions in the amount of $31,105 andzero to the 401K Plan during the years ended September 30, 2025 and 2024, respectively.
NOTE 14 – Segment Reporting
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the CODM in deciding how to allocate resources in assessing performance. The Company has one reportable segment, which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording, monitoring, ablation, and stimulation solutions(“Neuromodulation Products”). NeuroOne is a medical technology company focused on developing and commercializing Neuromodulation Products. The Company recognizes the Neuromodulation Productsasone reporting segment.
The accounting policies of the Neuromodulation Products segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the Neuromodulation Products segment based on net loss, which is reported on the statement of operations as net loss. The measure of segment assets is reported on the balance sheet as total assets. The Company does not have any intra-entity sales or transfers.
The CODM uses cash forecast models in deciding how to invest into the Neuromodulation Products segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment and in establishing management’s compensation.
The statements of operations below are inclusive of the significant expense categories regularly reviewed by the CODM for the years ended September 30, 2025 and 2024:
| Years ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Product revenue | $9,097,692 | $3,453,003 |
| Cost of product revenue | 3,956,286 | 2,373,336 |
| Product gross profit | 5,141,406 | 1,079,667 |
| Collaborations revenue | 3,000,000 | — |
| Operating expenses: | ||
| General and administrative | 5,848,303 | 6,498,394 |
| Sales | 703.570 | 619,276 |
| Marketing | 832,644 | 784,025 |
| Development | 4,349,834 | 4,483,385 |
| Quality assurance | 633,528 | 581,796 |
| Total operating expenses | 12,367,879 | 12,966,876 |
| Loss from operations | (4,226,473) | (11,887,209) |
| Fair value change in warrant liability | 784,670 | (327,092) |
| Financing costs | (334,063) | (228,988) |
| Other income, net | 170,492 | 125,179 |
| Loss before income taxes | (3,605,374) | (12,318,110) |
| Provision for income taxes | — | — |
| Net loss | $(3,605,374) | $(12,318,110) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.