Financial Statements
−Removed: Medical Technologies Corporation
−Removed: Balance Sheets
+Added: NeuroOne Medical Technologies Corporation
+Added: Condensed Balance Sheets
September 30,
2 unchanged sentences
Accounts receivable
−Removed: Prepaid expenses and other assets
+Added: Prepaid expenses
Total current assets
16 unchanged sentences
100,000,000 shares authorized;
−Removed: 24,831,090 and 23,928,945 shares issued and outstanding as of December 31, 2023 and September 30, 2023, respectively.
+Added: 26,321,750 and 23,928,945 shares issued and outstanding as of March 31, 2024 and September 30, 2023, respectively.
Additional paid–in capital
4 unchanged sentences
Total liabilities and stockholders’ equity
−Removed: accompanying notes to condensed financial statements
−Removed: Medical Technologies Corporation
−Removed: Statements of Operations
−Removed: For the three months ended
−Removed: of product revenue
−Removed: gross profit (loss)
−Removed: Collaborations
−Removed: general and administrative
−Removed: and development
+Added: See accompanying notes to condensed financial statements
+Added: NeuroOne Medical Technologies Corporation
+Added: Condensed Statements of Operations
+Added: Three Months Ended
+Added: Six Months Ended
+Added: Product revenue
+Added: Cost of product revenue
+Added: Product gross profit
+Added: Collaborations revenue
Operating expenses:
−Removed: from operations
+Added: Selling, general and administrative
+Added: Research and development
+Added: Total operating expenses
+Added: Loss from operations
( 2,886,098 )
( 3,495,919 )
−Removed: before income taxes
( 6,276,573 )
( 5,280,271 )
−Removed: for income taxes
+Added: Other income (expense), net
+Added: Loss before income taxes
( 2,855,090 )
( 3,522,828 )
+Added: ( 6,199,990 )
+Added: ( 5,255,597 )
+Added: Provision for income taxes
+Added: $ ( 2,855,090 )
+Added: $ ( 3,522,828 )
+Added: $ ( 6,199,990 )
+Added: $ ( 5,255,597 )
Net loss per share:
2 unchanged sentences
Basic and diluted
−Removed: accompanying notes to condensed financial statements
−Removed: Medical Technologies Corporation
−Removed: Statements of Changes in Stockholders’ Equity
+Added: See accompanying notes to condensed financial
+Added: NeuroOne Medical Technologies
+Added: Condensed Statements of Changes in Stockholders’
Stockholders’
−Removed: at September 30, 2022
+Added: Balance at September 30, 2022
$ ( 50,826,812 )
−Removed: of common stock upon vesting of restricted stock units
+Added: Stock-based compensation
+Added: Issuance of common stock upon vesting of restricted stock units
( 1,732,769 )
( 1,732,769 )
−Removed: at December 31, 2022
+Added: Balance at December 31, 2022
( 52,559,581 )
+Added: Issuance of common stock in connection with at-the-market offering program
+Added: Issuance costs in connection with the at-the-market offering program
+Added: Stock-based compensation
+Added: Share repurchases for the payment of employee taxes
+Added: Issuance of common stock upon vesting of restricted stock units
+Added: ( 3,522,828 )
+Added: ( 3,522,828 )
+Added: Balance at March 31, 2023
+Added: $ ( 56,082,409 )
Balance at September 30, 2023
$ ( 62,686,303 )
−Removed: of common stock attributed to equity financings
−Removed: costs related to equity financings
−Removed: of common stock upon vesting of restricted stock units
−Removed: repurchases for the payment of employee taxes
+Added: Issuance of common stock attributed to equity financings
+Added: Issuance costs related to equity financings
+Added: Stock-based compensation
+Added: Issuance of common stock upon vesting of restricted stock units
+Added: Share repurchases for the payment of employee taxes
( 3,344,900 )
( 3,344,900 )
−Removed: at December 31, 2023
+Added: Balance at December 31, 2023
( 66,031,203 )
−Removed: accompanying notes to condensed financial statements
−Removed: Medical Technologies Corporation
−Removed: Statements of Cash Flows
−Removed: For the three months ended
+Added: Issuance of common stock attributed to equity financings
+Added: Issuance costs related to equity financings
+Added: Stock-based compensation
+Added: Issuance of common stock upon vesting of restricted stock units
+Added: Share repurchases for the payment of employee taxes
( 2,855,090 )
( 2,855,090 )
−Removed: to reconcile net loss to net cash used in operating activities:
−Removed: and depreciation
−Removed: of discounts and premiums on short-term investments
−Removed: lease expense
−Removed: in assets and liabilities:
−Removed: and other assets
+Added: Balance at March 31, 2024
$ ( 68,886,293 )
−Removed: expenses, operating leases and other liabilities
−Removed: cash used in operating activities
+Added: See accompanying notes to condensed financial
+Added: NeuroOne Medical Technologies Corporation
+Added: Condensed Statements of Cash Flows
+Added: Six Months Ended
+Added: Operating activities
$ ( 6,199,990 )
$ ( 5,255,597 )
−Removed: of short-term investments
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Amortization and depreciation
+Added: Stock-based compensation
+Added: Amortization of discounts and premiums on short-term investments
+Added: Non-cash lease expense
+Added: Change in assets and liabilities:
+Added: Accounts receivable
+Added: Prepaid expenses
+Added: Accounts payable
+Added: Accrued expenses, deferred revenue, operating leases and other liabilities
( 1,669,283 )
−Removed: of short-term investments
−Removed: of property and equipment
−Removed: cash (used in) provided by investing activities
−Removed: from issuance of common stock attributed to equity financings
−Removed: costs related to equity financings
−Removed: repurchases for the payment of employee taxes
−Removed: cash provided by (used in) financing activities
−Removed: decrease in cash
+Added: Net cash used in operating activities
( 5,984,554 )
( 7,043,789 )
−Removed: at beginning of period
−Removed: at end of period
−Removed: non-cash financing and investing transactions:
−Removed: deferred offering and issuance costs attributed to the at-the-market offering program and public offering
−Removed: of right-of-use asset and associated lease liability
−Removed: accompanying notes to condensed financial statements
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: – Description of Business and Basis of Presentation
−Removed: Medical Technologies Corporation (the “Company” or “NeuroOne”), a Delaware corporation, is a medical technology
−Removed: company focused on the development and commercialization of thin film electrode for continuous electroencephalogram (“cEEG”)
−Removed: and stereoelectrocencephalography (“sEEG”) recording, monitoring, ablation, drug delivery and brain stimulation solutions
−Removed: to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back
−Removed: surgeries and other related neurological disorders.
−Removed: Company received 510(k) clearance from the United States (“U.S.”) Food and Drug Administration (“FDA”) for its
−Removed: Evo cortical electrode technology in November 2019 and in October 2022, the Company received 510(k) clearance from the FDA for its Evo®
−Removed: sEEG electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording,
−Removed: monitoring, and stimulation of electrical signals at the subsurface level of the brain.
−Removed: In December 2023, we received 510(k) clearance for our OneRF ablation system for creation of radiofrequency lesions
−Removed: in nervous tissue for functional neurosurgical procedures.
−Removed: Company is based in Eden Prairie, Minnesota.
−Removed: Economic Conditions
−Removed: worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East,
−Removed: disruptions in the banking system and financial markets, and increased inflation.
−Removed: The general economic and capital market conditions
−Removed: both in the U.S.
−Removed: and worldwide, have been volatile in the past and at times have adversely affected the Company’s access to capital
−Removed: and increased the cost of capital.
−Removed: The capital and credit markets may not be available to support future capital raising activity on
−Removed: favorable terms or at all.
−Removed: If economic conditions continue to decline, the Company’s future cost of equity or debt capital and
−Removed: access to the capital markets could be adversely affected.
−Removed: Company’s operating results could be materially impacted by changes in the overall macroeconomic environment and other economic
−Removed: Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflicts in Ukraine and
−Removed: the Middle East, disruptions in the banking system and financial markets, and steps taken by governments and central banks, have led
−Removed: to higher inflation, which has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased
−Removed: interest rates.
−Removed: of presentation
−Removed: The accompanying unaudited condensed financial statements have been
−Removed: prepared by the Company, pursuant to the rules and regulations of the U.S.
−Removed: Securities and Exchange Commission (the “SEC”).
−Removed: Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.
−Removed: generally accepted
−Removed: accounting principles (U.S.
+Added: Investing activities
+Added: Purchases of short-term investments
+Added: ( 1,473,419 )
+Added: Maturities of short-term investments
+Added: Purchase of property and equipment
+Added: Net cash (used in) provided by investing activities
+Added: Financing activities
+Added: Proceeds from issuance of common stock attributed to equity financings
+Added: Issuance costs related equity financings
+Added: Share repurchases for the payment of employee taxes
+Added: Net cash provided by financing activities
+Added: Net decrease in cash and cash equivalents
+Added: ( 2,887,838 )
+Added: ( 4,558,166 )
+Added: Cash and cash equivalents at beginning of period
+Added: Cash and cash equivalents at end of period
+Added: Supplemental non-cash financing and investing transactions:
+Added: Unpaid issuance costs in accounts payable and accrued expenses
+Added: Modification of right-of-use asset and associated lease liability
+Added: Purchased property and equipment in accounts payable
+Added: See accompanying notes to condensed financial
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 1 – Description of Business and
+Added: Basis of Presentation
+Added: NeuroOne Medical Technologies Corporation (the
+Added: “Company” or “NeuroOne”), a Delaware corporation, is a medical technology company focused on the development and
+Added: commercialization of thin film electrode for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography (“sEEG”)
+Added: recording, monitoring, ablation, drug delivery and brain stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s
+Added: disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.
+Added: The Company received 510(k) clearance from the
+Added: United States (“U.S.”) Food and Drug Administration (“FDA”) for its Evo cortical electrode technology in November
+Added: 2019 and in October 2022, the Company received 510(k) clearance from the FDA for its Evo® sEEG electrode technology for temporary
+Added: (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical
+Added: signals at the subsurface level of the brain.
+Added: In December 2023, we received 510(k) clearance for our OneRF ablation system for creation
+Added: of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
+Added: The Company is based in Eden Prairie, Minnesota.
+Added: Global Economic Conditions
+Added: Generally, worldwide economic conditions remain
+Added: uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and
+Added: financial markets, and increased inflation.
+Added: The general economic and capital market conditions both in the U.S.
+Added: and worldwide, have been
+Added: volatile in the past and at times have adversely affected the Company’s access to capital and increased the cost of capital.
+Added: capital and credit markets may not be available to support future capital raising activity on favorable terms or at all.
+Added: If economic conditions
+Added: continue to decline, the Company’s future cost of equity or debt capital and access to the capital markets could be adversely affected.
+Added: The Company’s operating results could be
+Added: materially impacted by changes in the overall macroeconomic environment and other economic factors.
+Added: Changes in economic conditions, supply
+Added: chain constraints, logistics challenges, labor shortages, the conflicts in Ukraine and the Middle East, disruptions in the banking system
+Added: and financial markets, and steps taken by governments and central banks, have led to higher inflation, which has led to an increase in
+Added: costs and has caused changes in fiscal and monetary policy, including increased interest rates.
+Added: Basis of presentation
+Added: The accompanying unaudited condensed financial
+Added: statements have been prepared by the Company, pursuant to the rules and regulations of the U.S.
+Added: Securities and Exchange Commission (the
+Added: Certain information and footnote disclosures normally included in financial statements prepared in accordance with
+Added: generally accepted accounting principles (“U.S.
GAAP”) have been condensed or omitted pursuant to such rules and regulations.
−Removed: The condensed financial statements
−Removed: may not include all disclosures required by U.S.
−Removed: however, the Company believes that the disclosures are adequate to make the information
−Removed: presented not misleading.
−Removed: These unaudited condensed financial statements should be read in conjunction with the audited financial statements
−Removed: and the notes thereto for the year ended September 30, 2023 included in the Company’s Annual Report on Form 10-K.
−Removed: The condensed
−Removed: balance sheet at September 30, 2023 was derived from the audited financial statements of the Company.
−Removed: the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the
−Removed: financial position, results of operations, and cash flows for the interim periods, have been made.
−Removed: The results of operations for the
−Removed: interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: 2 - Going Concern
−Removed: The accompanying financial statements have been prepared on the basis
−Removed: that the Company will continue as a going concern.
−Removed: The Company has incurred losses since inception, negative cash flows from operations,
−Removed: and an accumulated deficit of $ 66.0 million as of December 31, 2023.
−Removed: To date, the Company’s revenues have not been sufficient to
−Removed: cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt and sale of equity
−Removed: The Company has adequate liquidity to fund its operations through mid-2024.
−Removed: The raising of additional funds is not solely
−Removed: within the control of the Company.
−Removed: These factors raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: The condensed financial statements may not include all disclosures required by U.S.
+Added: however, the Company believes that the disclosures
+Added: are adequate to make the information presented not misleading.
+Added: These unaudited condensed financial statements should be read in conjunction
+Added: with the audited financial statements and the notes thereto for the year ended September 30, 2023 included in the Company’s Annual
+Added: Report on Form 10-K.
+Added: The condensed balance sheet at September 30, 2023 was derived from the audited financial statements of the Company.
+Added: In the opinion of management, all adjustments,
+Added: consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and
+Added: cash flows for the interim periods, have been made.
+Added: The results of operations for the interim periods are not necessarily indicative of
+Added: the operating results for the full fiscal year or any future periods.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 2 – Going Concern
+Added: The accompanying financial statements have been
+Added: prepared on the basis that the Company will continue as a going concern.
+Added: The Company has incurred losses since inception, negative cash
+Added: flows from operations, and an accumulated deficit of $ 68.9 million as of March 31, 2024.
+Added: To date, the Company’s revenues have not
+Added: been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt
+Added: and sale of equity securities.
+Added: The Company has adequate liquidity to fund its operations through July 2024.
+Added: The raising of additional
+Added: funds is not solely within the control of the Company.
+Added: These factors raise substantial doubt about the Company’s ability to continue
+Added: as a going concern.
The financial statements do not include any adjustments that might result from the outcome of this condition.
−Removed: If the Company is unable
−Removed: to raise additional funds, or the Company’s anticipated operating results are not achieved, management believes planned expenditures
−Removed: may need to be reduced in order to extend the time period that existing resources can fund the Company’s operations.
−Removed: intends to fund ongoing activities by utilizing its current cash and cash equivalents on hand, from product and collaborations revenue
−Removed: and by raising additional capital through equity or debt financings.
−Removed: If management is unable to obtain the necessary capital, it may have
−Removed: a material adverse effect on the operations of the Company and the development of its technology, or the Company may have to cease operations
−Removed: 3 – Summary of Significant Accounting Policies
−Removed: Use of Estimates
−Removed: preparation of financial statements in conformity with U.S.
−Removed: GAAP requires management to make estimates and assumptions that affect the
−Removed: reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
−Removed: and the reported amounts of revenues and expenses during the reporting period.
+Added: Company is unable to raise additional funds, or the Company’s anticipated operating results are not achieved, management believes
+Added: planned expenditures may need to be reduced in order to extend the time period that existing resources can fund the Company’s operations.
+Added: The Company intends to fund ongoing activities by utilizing its current cash and cash equivalents on hand, from product and collaborations
+Added: revenue and by raising additional capital through equity or debt financings.
+Added: If management is unable to obtain the necessary capital,
+Added: it may have a material adverse effect on the operations of the Company and the development of its technology, or the Company may have
+Added: to cease operations altogether.
+Added: NOTE 3 – Summary of Significant Accounting
+Added: Management’s Use of Estimates
+Added: The preparation of financial statements in conformity
+Added: GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
+Added: of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
+Added: the reporting period.
Actual results could differ from those estimates.
−Removed: segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company’s
−Removed: chief operating decision maker in deciding how to allocate resources and assessing performance.
−Removed: The Company’s chief operating decision
−Removed: maker is its Chief Executive Officer.
−Removed: The Company’s Chief Executive Officer views the Company’s operations and manages its
−Removed: business in one operating segment, which is the business of development and commercialization of products related to comprehensive neuromodulation
−Removed: cEEG and sEEG recording, monitoring, ablation, and brain stimulation solutions.
+Added: Segment Information
+Added: Operating segments are components of an enterprise
+Added: for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker
+Added: in deciding how to allocate resources and assessing performance.
+Added: The Company’s chief operating decision maker is its Chief Executive
+Added: The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment,
+Added: which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording,
+Added: monitoring, ablation, and brain stimulation solutions.
Accordingly, the Company has a single reporting segment.
−Removed: and Cash Equivalents
−Removed: Company considers all highly liquid investments with an original contractual maturity on date of purchase of less than or equal to three
−Removed: months to be classified and presented as cash equivalents on the condensed balance sheets.
−Removed: Cash equivalents are stated at cost, which
−Removed: approximates fair value.
−Removed: The Company’s cash and cash equivalents may include demand deposit accounts with large financial institutions,
−Removed: institutional money market funds, U.S.
−Removed: Treasury securities, and corporate notes and bonds.
−Removed: The Company monitors the creditworthiness
−Removed: of the financial institutions, institutional money market funds, and corporations in which the Company invests its surplus funds.
−Removed: Company has experienced no credit losses from its cash and cash equivalent investments.
−Removed: Company has periodically invested its excess cash in U.S.
+Added: Cash and Cash Equivalents
+Added: The Company considers all highly liquid investments
+Added: with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash
+Added: equivalents on the condensed balance sheets.
+Added: Cash equivalents are stated at cost, which approximates fair value.
+Added: The Company’s cash
+Added: and cash equivalents may include demand deposit accounts with large financial institutions, institutional money market funds, U.S.
+Added: securities, and corporate notes and bonds.
+Added: The Company monitors the creditworthiness of the financial institutions, institutional money
+Added: market funds, and corporations in which the Company invests its surplus funds.
+Added: The Company has experienced no credit losses from its cash
+Added: and cash equivalent investments.
+Added: Short-Term Investments
+Added: The Company has periodically invested its excess
Treasury securities and highly rated corporate securities.
−Removed: The Company has
−Removed: held these investments to maturity.
−Removed: Securities with original maturity dates of more than three months were reported as held-to-maturity
−Removed: investments and were recorded at amortized cost, which approximated fair value due to the negligible risk of changes in value due to
−Removed: interest rates.
−Removed: There were no short-term investments outstanding as of December 31, 2023 and September 30, 2023.
−Removed: Company entered into a development and distribution agreement which has current and future revenue recognition implications.
−Removed: 7 – Zimmer Development Agreement.”
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs
−Removed: the following steps:
−Removed: (i) identification of the promised goods or services in the contract;
−Removed: (ii) determination of whether the promised
−Removed: goods or services are performance obligations, including whether they are distinct in the context of the contract;
−Removed: (iii) measurement
−Removed: of the transaction price, including the constraint on variable consideration;
−Removed: (iv) allocation of the transaction price to the performance
−Removed: obligations based on estimated selling prices;
+Added: The Company has held these investments to maturity.
+Added: with original maturity dates of more than three months were reported as held-to-maturity investments and were recorded at amortized cost,
+Added: which approximated fair value due to the negligible risk of changes in value due to interest rates.
+Added: There were no short-term investments
+Added: outstanding as of March 31, 2024 and September 30, 2023.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: Revenue Recognition
+Added: The Company entered into a development and distribution
+Added: agreement which has current and future revenue recognition implications.
+Added: See “Note 7 – Zimmer Development Agreement.”
+Added: In determining the appropriate amount of revenue
+Added: to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps:
+Added: (i) identification of
+Added: the promised goods or services in the contract;
+Added: (ii) determination of whether the promised goods or services are performance obligations,
+Added: including whether they are distinct in the context of the contract;
+Added: (iii) measurement of the transaction price, including the constraint
+Added: on variable consideration;
+Added: (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.
−Removed: A performance obligation is a promise in a contract to transfer a distinct
−Removed: good or service to the customer and is the unit of account in Accounting Standards Codification (“ASC”) Topic 606 (“ASC
−Removed: Performance obligations may include license rights, development services, and services associated with regulatory submission
−Removed: and approval processes.
−Removed: Significant management judgment is required to determine the level of effort required under an arrangement and
−Removed: the period over which the Company expects to complete its performance obligations under the arrangement.
−Removed: If the Company cannot reasonably
−Removed: estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is deferred until the
−Removed: Company can reasonably make such estimates.
−Removed: Revenue is then recognized over the remaining estimated period of performance using the cumulative
−Removed: catch-up method.
−Removed: from product sales are recognized when control of the promised goods or services is transferred to the Company’s customers, in
−Removed: an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services.
−Removed: At the inception
−Removed: of each customer contract, performance obligations are identified and the total transaction price is allocated to the performance obligations.
−Removed: of Product Revenue
−Removed: of product revenue consists of the manufacturing and materials costs incurred by the Company’s third-party contract manufacturer
−Removed: in connection with the Company’s strip and grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG
−Removed: Products) and outside supplier materials costs in connection with the electrode cable assembly products (“Electrode Cable Assembly
−Removed: In addition, cost of product revenue includes royalty fees incurred in connection with the Company’s license
−Removed: Collaborations
−Removed: part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone
−Removed: selling price of each performance obligation identified in the contract.
−Removed: The Company uses key assumptions to determine the stand-alone
−Removed: selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates
−Removed: and probabilities of technical and regulatory success.
−Removed: The Company allocates the total transaction price to each performance obligation
−Removed: based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation.
−Removed: of intellectual property :
−Removed: If the license to the Company’s intellectual property is determined to be distinct from the other
−Removed: performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to
−Removed: the license when the license is transferred to the customer, and the customer can use and benefit from the license.
−Removed: For licenses that
−Removed: are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine
−Removed: whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of
−Removed: measuring progress for purposes of recognizing revenue from non-refundable, up-front fees.
−Removed: The Company evaluates the measure of progress
−Removed: each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
−Removed: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are
−Removed: considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method.
−Removed: If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission)
−Removed: is included in the transaction price.
−Removed: Milestone payments that are not within the control of the Company, such as approvals from regulators,
−Removed: are not considered probable of being achieved until those approvals are received.
−Removed: When the Company’s assessment of probability
−Removed: of achievement changes and variable consideration becomes probable, any additional estimated consideration is allocated to each performance
−Removed: obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation
−Removed: and recorded in collaborations revenues based upon when the customer obtains control of each element.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed
−Removed: to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur,
−Removed: or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: Value of Financial Instruments
−Removed: Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the
−Removed: financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair
−Removed: value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
−Removed: The hierarchy gives the highest priority
−Removed: to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements
−Removed: involving significant unobservable inputs (Level 3 measurements).
+Added: A performance obligation is a promise in a contract
+Added: to transfer a distinct good or service to the customer and is the unit of account in Accounting Standards Codification (“ASC”)
+Added: Topic 606 (“ASC 606”).
+Added: Performance obligations may include license rights, development services, and services associated with
+Added: regulatory submission and approval processes.
+Added: Significant management judgment is required to determine the level of effort required under
+Added: an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement.
+Added: If the Company
+Added: cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue recognition is
+Added: deferred until the Company can reasonably make such estimates.
+Added: Revenue is then recognized over the remaining estimated period of performance
+Added: using the cumulative catch-up method.
+Added: Product Revenue
+Added: Revenues from product sales are recognized when
+Added: control of the promised goods or services is transferred to the Company’s customers, in an amount that reflects the consideration
+Added: the Company expects to be entitled to in exchange for those goods or services.
+Added: At the inception of each customer contract, performance
+Added: obligations are identified and the total transaction price is allocated to the performance obligations.
+Added: Cost of Product Revenue
+Added: Cost of product revenue consists of the manufacturing
+Added: and materials costs incurred by the Company’s third-party contract manufacturer in connection with the Company’s strip and
+Added: grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products) and outside supplier materials
+Added: costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”).
+Added: In addition, cost of
+Added: product revenue includes royalty fees incurred in connection with the Company’s license agreements.
+Added: Collaborations Revenue
+Added: As part of the accounting for collaboration arrangements,
+Added: the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified
+Added: in the contract.
+Added: The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development
+Added: timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
+Added: allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the
+Added: promised goods or service underlying each performance obligation.
+Added: Licenses of intellectual property :
+Added: license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in
+Added: the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred
+Added: to the customer, and the customer can use and benefit from the license.
+Added: For licenses that are bundled with other promises, the Company
+Added: utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation
+Added: is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing
+Added: revenue from non-refundable, up-front fees.
+Added: The Company evaluates the measure of progress each reporting period and, if necessary, adjusts
+Added: the measure of performance and related revenue recognition.
+Added: Milestone payments :
+Added: At the inception of
+Added: each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved
+Added: and estimates the amount to be included in the transaction price using the most likely amount method.
+Added: If it is probable that a significant
+Added: revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction
+Added: Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable
+Added: of being achieved until those approvals are received.
+Added: When the Company’s assessment of probability of achievement changes and variable
+Added: consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated
+Added: relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in collaborations
+Added: revenues based upon when the customer obtains control of each element.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: For arrangements that include sales-based royalties,
+Added: including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties
+Added: relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which
+Added: some or all of the royalty has been allocated has been satisfied (or partially satisfied).
+Added: Fair Value of Financial Instruments
+Added: The Company’s accounting for fair value
+Added: measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring
+Added: basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation
+Added: techniques used to measure fair value.
+Added: The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
+Added: assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level
+Added: 3 measurements).
The three levels of the fair value hierarchy are as follows:
−Removed: Level 1 Inputs:
−Removed: quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date.
−Removed: Level 2 Inputs:
−Removed: quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially
−Removed: the full term of the asset or liability.
−Removed: Level 3 Inputs:
−Removed: inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing
−Removed: for situations in which there is little, if any, market activity for the asset or liability at the measurement date.
−Removed: of December 31, 2023 and September 30, 2023, the fair values of cash, cash equivalents, accounts receivable, inventory, prepaids and
−Removed: other assets, accounts payable and accrued expenses and other liabilities approximated their carrying values because of the short-term
−Removed: nature of these assets or liabilities.
−Removed: were no transfers between fair value hierarchy levels during the three months ended December 31, 2023 and 2022.
−Removed: Company has entered into two licensing agreements with major research institutions, which allow for access to certain patented
−Removed: technology and know-how.
−Removed: Payments under those agreements are capitalized and amortized to selling, general and administrative expense
−Removed: over the expected useful life of the acquired technology.
−Removed: and Equipment
−Removed: and equipment is recorded at cost and reduced by accumulated depreciation.
−Removed: Depreciation expense is recognized over the estimated useful
−Removed: lives of the assets using the straight-line method.
−Removed: The estimated useful life for equipment and furniture ranges from three to seven
−Removed: Tangible assets acquired for research and development activities and that have alternative use are capitalized over the useful
−Removed: life of the acquired asset.
−Removed: Estimated useful lives are periodically reviewed, and, when appropriate, changes are made prospectively.
−Removed: Software purchased for internal use consists primarily of amounts paid for perpetual licenses to third-party software providers and installation
−Removed: When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be
−Removed: performed on the recoverability of the carrying amounts.
−Removed: Maintenance and repairs are charged directly to expense as incurred.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: of Long-Lived Assets
−Removed: Company evaluates its long-lived assets, which consist of licensed intellectual property, property and equipment and right-of-use assets
−Removed: for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable.
−Removed: Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered
−Removed: through undiscounted expected future cash flows.
−Removed: If the asset is considered to be impaired, the amount of any impairment is measured
−Removed: as the difference between the carrying value and the fair value of the impaired asset.
−Removed: Receivable and Allowances for Doubtful Accounts
−Removed: Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the
−Removed: collectability of its accounts receivable.
−Removed: In estimating the allowance for doubtful accounts, the Company considers, among other factors,
−Removed: the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and economic conditions that
−Removed: could affect the collectability of the balances in the future.
−Removed: Account balances are charged off against the allowance when the Company
−Removed: believes that it is probable that the receivable will not be recovered.
−Removed: Actual write-offs may be in excess of the Company’s estimated
−Removed: The Company has not incurred any bad debt expense to date and no allowance for doubtful accounts has been recorded during
−Removed: the periods presented.
−Removed: is stated at the lower of cost (using the first-in, first-out “FIFO” method) or net realizable value.
−Removed: The Company calculates
−Removed: inventory valuation adjustments for excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected
−Removed: useful lives, and estimated future demand of the products and spare parts.
−Removed: The Company’s inventory is currently comprised of Strip/Grid
−Removed: Products, sEEG and electrode cable assembly work-in-process and finished good product.
−Removed: The Strip/Grid Products and sEEG Products are
−Removed: produced by a third-party contract manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers.
−Removed: valuation allowance was required during the periods presented.
−Removed: and Development Costs
−Removed: and development costs are charged to expense as incurred.
−Removed: Research and development expenses comprise of costs incurred in performing
−Removed: research and development activities , including compensation and benefits for research and development employees (including stock-based
−Removed: compensation), overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related
−Removed: to regulatory operations, fees paid to consultants and other outside expenses.
+Added: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement
+Added: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly,
+Added: for substantially the full term of the asset or liability.
+Added: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available,
+Added: thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date.
+Added: As of March 31, 2024 and September 30, 2023, the
+Added: fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, accounts payable and accrued expenses and other
+Added: liabilities approximated their carrying values because of the short-term nature of these assets or liabilities.
+Added: There were no transfers between fair value hierarchy
+Added: levels during the three and six months ended March 31, 2024 and 2023.
+Added: Intellectual Property
+Added: The Company has entered into two licensing
+Added: agreements with major research institutions, which allow for access to certain patented technology and know-how.
+Added: Payments under those
+Added: agreements are capitalized and amortized to selling, general and administrative expense over the expected useful life of the acquired
+Added: Property and Equipment
+Added: Property and equipment is recorded at cost and
+Added: reduced by accumulated depreciation.
+Added: Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line
+Added: The estimated useful life for equipment and furniture ranges from three to seven years.
+Added: Tangible assets acquired for research
+Added: and development activities and that have alternative use are capitalized over the useful life of the acquired asset.
+Added: Estimated useful
+Added: lives are periodically reviewed, and, when appropriate, changes are made prospectively.
+Added: When certain events or changes in operating conditions
+Added: occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts.
+Added: and repairs are charged directly to expense as incurred.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: Impairment of Long-Lived Assets
+Added: The Company evaluates its long-lived assets, which
+Added: consist of licensed intellectual property, property and equipment and right-of-use assets for impairment whenever events or changes in
+Added: circumstances indicate that the carrying value of these assets may not be recoverable.
+Added: The Company assesses the recoverability of long-lived
+Added: assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows.
+Added: If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the
+Added: fair value of the impaired asset.
+Added: Accounts Receivable and
+Added: Allowances for Credit Losses
+Added: records a provision for credit losses, when appropriate, based on historical experience, current conditions and reasonable supportable
+Added: In estimating the allowance for credit losses, the Company considers, among other factors, the estimate of credit losses over
+Added: the remaining expected life of the asset, primarily using historical experience and current economic conditions that could affect the
+Added: collectability of the balances in the future.
+Added: Account balances are charged off against the allowance when the Company believes that it
+Added: is probable that the receivable will not be recovered.
+Added: Actual write-offs may be in excess of the Company’s estimated allowance.
+Added: Company has not incurred any bad debt expense to date and no allowance for credit losses has been recorded during the periods
+Added: Inventory is stated at the lower of cost (using
+Added: the first-in, first-out “FIFO” method) or net realizable value.
+Added: The Company calculates inventory valuation adjustments for
+Added: excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future
+Added: demand of the products and spare parts.
+Added: The Company’s inventory is currently comprised of Strip/Grid Products, sEEG and electrode
+Added: cable assembly component, work-in-process and finished good product.
+Added: The Strip/Grid Products and sEEG Products are produced by a third-party
+Added: contract manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers.
+Added: No inventory valuation allowance
+Added: was required during the periods presented.
+Added: Research and Development Costs
+Added: Research and development costs are charged
+Added: to expense as incurred.
+Added: Research and development expenses comprise of costs incurred in performing research and development
+Added: activities, including compensation and benefits for research and development employees (including stock-based compensation),
+Added: overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to
+Added: regulatory operations, fees paid to consultants and other outside expenses.
Non-refundable advance payments for goods and services
−Removed: that will be used in future research and development activities are expensed when the activity is performed or when the goods have been
−Removed: received, rather than when payment is made, in accordance with ASC 730, Research and Development .
−Removed: General and Administrative
−Removed: general and administrative expenses consist primarily of personnel-related costs including stock-based compensation for personnel in
−Removed: functions not directly associated with research and development activities.
−Removed: Other significant costs include legal and litigation costs
−Removed: relating to corporate matters, intellectual property costs, professional fees for consultants assisting with regulatory, clinical, product
−Removed: development, financial matters and sales and marketing in connection with the commercial sales of the Company’s products.
−Removed: Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation
−Removed: Accordingly, compensation costs related to equity instruments granted are recognized at the grant-date fair
−Removed: value over the requisite service period.
−Removed: The Company records forfeitures when they occur.
−Removed: Stock-based compensation arrangements to non-employees
−Removed: are accounted for in accordance with the applicable provisions of ASC 718.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: taxes are accounted for under the asset and liability method.
−Removed: Deferred tax assets and liabilities are recognized for the future tax consequences
−Removed: attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
−Removed: tax base and operating loss and tax credit carryforwards.
−Removed: Deferred tax assets and liabilities are measured using enacted tax rates expected
−Removed: to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
−Removed: Deferred tax assets
−Removed: 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.
−Removed: Loss Per Share
−Removed: loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding
−Removed: during the period.
−Removed: earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares
−Removed: outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive.
−Removed: The Company’s
−Removed: warrants, stock options, and restricted stock units while outstanding are considered common stock equivalents for this purpose.
−Removed: earnings or loss per share of common stock is computed utilizing the treasury method for the warrants, stock options and restricted stock
−Removed: No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive
−Removed: given the net loss reported for the three months ended December 31:
+Added: that will be used in future research and development activities are expensed when the activity is performed or when the goods have
+Added: been received, rather than when payment is made, in accordance with ASC 730, Research and Development .
+Added: Advertising Expense
+Added: Advertising expense is charged to selling, general
+Added: and administrative expenses during the period that it is incurred.
+Added: Total advertising expense amounted to $ 15,781 and $ 65,053 for the three
+Added: and six months ended March 31, 2024, respectively.
+Added: Total advertising expense amounted to $ 53,613 and $ 106,639 for the three and six months
+Added: ended March 31, 2023, respectively.
+Added: Selling, General and Administrative
+Added: Selling, general and administrative expenses consist
+Added: primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with research
+Added: and development activities.
+Added: Other significant costs include legal and litigation costs relating to corporate matters, intellectual property
+Added: costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales and marketing
+Added: in connection with the commercial sales of the Company’s products.
+Added: Stock-Based Compensation
+Added: The Company accounts for stock-based compensation
+Added: in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”).
+Added: Accordingly, compensation
+Added: costs related to equity instruments granted are recognized at the grant-date fair value over the requisite service period.
+Added: records forfeitures when they occur.
+Added: Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable
+Added: provisions of ASC 718.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: Income taxes are accounted for under the asset
+Added: and liability method.
+Added: Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
+Added: the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit
+Added: carryforwards.
+Added: Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
+Added: in which those temporary differences are expected to be recovered or settled.
+Added: Deferred tax assets are reduced by a valuation allowance
+Added: if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
+Added: Net Loss Per Share
+Added: For the Company, basic loss per share of common
+Added: stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
+Added: Diluted earnings or loss per share of common stock
+Added: is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional
+Added: shares from the assumed exercise of any common stock equivalents, if dilutive.
+Added: The Company’s warrants, stock options, and restricted
+Added: stock units while outstanding are considered common stock equivalents for this purpose.
+Added: Diluted earnings or loss per share of common stock
+Added: is computed utilizing the treasury method for the warrants, stock options and restricted stock units.
+Added: No incremental common stock equivalents
+Added: were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the
+Added: three and six months ended March 31, 2024 and 2023.
+Added: The following potential common shares were not
+Added: considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and six months
+Added: ended March 31, 2024 and 2023:
Stock options
Restricted stock units
−Removed: Unissued vested restricted stock units
−Removed: Accounting Pronouncements
−Removed: November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07 - Segment Reporting (Topic 280):
−Removed: to Reportable Segment Disclosures , which enhances reportable segment disclosure requirements, primarily through disclosures of significant
−Removed: segment expenses.
−Removed: This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal
−Removed: years, with early adoption permitted.
+Added: Recent Accounting Pronouncements
+Added: In November 2023, the FASB issued Accounting Standards
+Added: Update (“ASU”) 2023-07 - Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures , which enhances
+Added: reportable segment disclosure requirements, primarily through disclosures of significant segment expenses.
+Added: This ASU is effective for fiscal
+Added: years beginning after December 15, 2023, including interim periods within fiscal years beginning after December 15, 2024, with early adoption
The guidance must be applied retrospectively to all prior periods presented.
−Removed: The Company is currently
−Removed: evaluating the impact of adoption of this guidance on its financial statements.
−Removed: December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures , which enhances income
−Removed: tax disclosures primarily related to the rate reconciliation and income taxes paid information.
−Removed: This guidance also includes certain other
−Removed: amendments to improve the effectiveness of income tax disclosures.
−Removed: This ASU is effective for fiscal years beginning after December 15,
−Removed: 2024, including interim periods within those fiscal years and should be applied on a prospective basis, with retrospective application
−Removed: The Company is currently evaluating the impact of adoption of this guidance on its financial statements.
−Removed: June 2016, the FASB issued Accounting Standards Update 2016-13, “ Financial Instruments – Credit Losses” .
−Removed: ASU sets forth a “current expected credit loss” (“CECL”) model which requires the Company to measure all expected
−Removed: credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable
−Removed: supportable forecasts.
−Removed: This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial
−Removed: assets measured at amortized cost and applies to some off-balance sheet credit exposures.
−Removed: This ASU is effective for fiscal years beginning
−Removed: after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted.
−Removed: The FASB issued the final
−Removed: ASU to delay adoption for smaller reporting companies to fiscal years beginning after December 15, 2022.
−Removed: The Company adopted the guidance
−Removed: on October 1, 2023.
−Removed: The adoption of this ASU did not have a material impact on the Company’s financial statements.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: 4 – Commitments and Contingencies
+Added: The Company is currently evaluating the impact
+Added: of adoption of this guidance on its financial statements.
+Added: In December 2023, the FASB issued ASU 2023-09
+Added: Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures , which enhances income tax disclosures primarily related to the
+Added: rate reconciliation and income taxes paid information.
+Added: This guidance also includes certain other amendments to improve the effectiveness
+Added: of income tax disclosures.
+Added: This ASU is effective for fiscal years beginning after December 15, 2024, including interim periods within
+Added: those fiscal years and should be applied on a prospective basis, with retrospective application permitted.
+Added: The Company is currently evaluating
+Added: the impact of adoption of this guidance on its financial statements.
+Added: In June 2016, the FASB issued Accounting Standards
+Added: Update 2016-13, Financial Instruments – Credit Losses .
+Added: The ASU sets forth a “current expected credit loss” (“CECL”)
+Added: model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical
+Added: experience, current conditions, and reasonable supportable forecasts.
+Added: This replaces the existing incurred loss model and is applicable
+Added: to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures.
+Added: The FASB issued the final ASU to delay adoption for smaller reporting companies to fiscal years beginning after December 15, 2022.
+Added: Company adopted the guidance on October 1, 2023.
+Added: The adoption of this ASU did not have a material impact on the Company’s financial
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 4 – Commitments and Contingencies
License Agreement
−Removed: Company has entered into an exclusive start-up company license agreement with the Wisconsin Alumni Research Foundation (“WARF”)
−Removed: for WARF’s neural probe array and thin film micro electrode technology.
−Removed: The Company entered into an Amended and Restated Exclusive
−Removed: Start-up Company License Agreement (the “WARF License”) with WARF on January 21, 2020, which amended and restated in full
−Removed: the prior license agreement between WARF and NeuroOne, LLC, a predecessor of the Company, dated October 1, 2014, as amended on February
−Removed: 22, 2017, March 30, 2019 and September 18, 2019.
−Removed: WARF License grants to the Company an exclusive license to make, use and sell, in the United States only, products that employ certain
−Removed: licensed patents for a neural probe array or thin-film micro electrode array and method.
−Removed: The Company agreed to pay WARF a royalty equal
−Removed: to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $ 50,000 for
−Removed: 2020, $ 100,000 for 2021 and $ 150,000 for 2022 and each calendar year thereafter that the WARF License is in effect.
−Removed: Company or any of its sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency
−Removed: 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,
−Removed: the royalty rate will be tripled for the remaining term of the WARF License.
−Removed: 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
−Removed: submit development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy
−Removed: such default in 90 days or in the event of certain bankruptcy events involving us.
−Removed: WARF may also terminate the WARF License (i) on 90
−Removed: days’ notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30,
−Removed: 2021 or (ii) if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters.
−Removed: The first commercial sale occurred on December 7, 2020, prior to the June 30, 2021 deadline.
−Removed: The WARF License otherwise expires
−Removed: by its terms on the date that no valid claims on the patents licensed thereunder remain.
−Removed: The Company expects the latest expiration of
−Removed: a licensed patent to occur in 2030.
−Removed: During the three months ended December 31, 2023 and 2022, $ 37,500 in royalty fees were incurred related
−Removed: to the WARF License during each of these periods and were reflected as a component of cost of product
−Removed: Company has an exclusive license and development agreement with the Mayo Foundation for Medical Education and Research (“Mayo”)
−Removed: related to certain intellectual property and development services for thin film micro electrode technology (“Mayo Agreement”).
−Removed: If the Company is successful in obtaining regulatory approval, the Company is to pay royalties to Mayo based on a percentage of net sales
−Removed: of products of the licensed technology through the term of the Mayo Agreement, set to expire May 25, 2037.
−Removed: the three months ended December 31, 2023 and 2022, $ 269 and $ 690 in royalty fees were incurred related to the Mayo Agreement, respectively,
−Removed: and were reflected as a component of cost of product revenue.
−Removed: October 7, 2019, the Company entered into a non-cancellable lease agreement (the “Lease”) with certain landlords (together,
−Removed: the “Landlord”) pursuant to which the Company has agreed to lease office space located at 7599 Anagram Drive, Eden Prairie,
−Removed: Minnesota (the “Premises”).
−Removed: The Company took possession of the Premises on November 1, 2019, with the term of the Lease ending
−Removed: 65 months after such date, unless terminated earlier (the “Lease Term”).
−Removed: The initial base rent for the Premises is $ 6,410
−Removed: per month for the first 17 months, increasing to $ 7,076 per month by the end of the Lease Term.
−Removed: In addition, as long as the Company is
−Removed: not in default under the Lease, the Company shall be entitled to an abatement of its base rent for the first 5 months.
−Removed: In addition, the
−Removed: Company will pay its pro rata share of the Landlord’s annual operating expenses associated with the Premises, calculated as set
−Removed: forth in the Lease of which the Company is entitled to an abatement of these operating expense for the first 3 months.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: July 1, 2021, the Company entered into a non-cancellable facility lease (the “Los Gatos Lease”), pursuant to which the Company
−Removed: agreed to rent office space for its research and development operations located at 718 University Avenue, Suite #111, Los Gatos, California.
−Removed: The facility space under the Los Gatos Lease is approximately 1,162 square feet.
−Removed: The Company took possession of the office space on July
−Removed: The initial monthly rent under the Los Gatos Lease was approximately $ 4,241 .
−Removed: On November 4, 2022, the Los Gatos Lease was extended
−Removed: for an additional two years to December 31, 2024 .
−Removed: The rent under the extended Los Gatos Lease ranges from $ 4,453 to $ 4,632 per month
−Removed: beginning on January 1, 2023.
−Removed: the three months ended December 31, 2023 and 2022, rent expense associated with the facility leases amounted to $ 43,053 and $ 42,474 ,
−Removed: respectively.
−Removed: cash flow information related to the operating leases was as follows:
−Removed: For the three months ended
+Added: The Company has entered into an exclusive start-up
+Added: company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and thin
+Added: film micro electrode technology.
+Added: The Company entered into an Amended and Restated Exclusive Start-up Company License Agreement (the “WARF
+Added: License”) with WARF on January 21, 2020, which amended and restated in full the prior license agreement between WARF and NeuroOne,
+Added: LLC, a predecessor of the Company, dated October 1, 2014, as amended on February 22, 2017, March 30, 2019 and September 18, 2019.
+Added: The WARF License grants to the Company an exclusive
+Added: license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array
+Added: or thin-film micro electrode array and method.
+Added: The Company agreed to pay WARF a royalty equal to a single-digit percentage of our product
+Added: 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
+Added: 2022 and each calendar year thereafter that the WARF License is in effect.
+Added: If the Company or any of its sublicensees contest the validity
+Added: of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to
+Added: 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
+Added: the WARF License.
+Added: WARF may terminate the WARF License on 30 days’
+Added: written notice if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our
+Added: 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
+Added: bankruptcy events involving us.
+Added: WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial
+Added: 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
+Added: be paid, such earned royalties cease for more than four calendar quarters.
+Added: The first commercial sale occurred on December 7, 2020, prior
+Added: to the June 30, 2021 deadline.
+Added: The WARF License otherwise expires by its terms on the date that no valid claims on the patents licensed
+Added: thereunder remain.
+Added: The Company expects the latest expiration of a licensed patent to occur in 2030.
+Added: During the three months ended March 31, 2024 and
+Added: 2023, $ 37,500 in royalty fees were incurred related to the WARF License during each of these periods.
+Added: During the six months ended March
+Added: 31, 2024 and 2023, $ 75,000 in royalty fees were incurred during each of these periods related to the WARF License, respectively.
+Added: fees were reflected as a component of cost of product revenue.
+Added: The Company has an exclusive license and development
+Added: agreement with the Mayo Foundation for Medical Education and Research (“Mayo”) related to certain intellectual property and
+Added: development services for thin film micro electrode technology (“Mayo Agreement”).
+Added: If the Company is successful in obtaining
+Added: regulatory approval, the Company is to pay royalties to Mayo based on a percentage of net sales of products of the licensed technology
+Added: through the term of the Mayo Agreement, set to expire May 25, 2037.
+Added: During the three months ended March 31, 2024 and 2023,
+Added: $ 4,146 and zero in royalty fees were incurred related to the Mayo Agreement, respectively.
+Added: During the six months ended March 31,
+Added: 2024 and 2023, $ 4,415 and $ 690 in royalty fees were incurred related to the Mayo Agreement, respectively.
+Added: The royalty fees were
+Added: reflected as a component of cost of product revenue.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: Facility Leases
+Added: During the three and six months ended March 31,
+Added: 2024, rent expense associated with the facility leases amounted to $ 43,052 and $ 86,105 , respectively.
+Added: During the three and six months
+Added: ended March 31, 2023, rent expense associated with the facility leases amounted to $ 43,053 and $ 85,527 , respectively.
+Added: Supplemental cash flow information related to
+Added: the operating leases was as follows:
+Added: Six Months Ended
Cash paid for amounts included in the measurement of lease liability:
−Removed: cash flows from operating leases
−Removed: Right-of -use assets obtained in exchange for
−Removed: lease obligations:
−Removed: of right-of-use asset and associated lease liability
−Removed: balance sheet information related to the operating leases was as follows:
+Added: Operating cash flows from operating leases
+Added: Right-of-use assets obtained in exchange for lease obligations:
+Added: Operating leases
+Added: Supplemental balance sheet information related
+Added: to the operating leases was as follows:
September 30,
+Added: Right-of-use assets
Lease liabilities
−Removed: Weighted average remaining
−Removed: lease term (years)
−Removed: Weighted average discount
−Removed: of the lease liabilities was as follows:
+Added: Weighted average remaining lease term (years)
+Added: Weighted average discount rate
+Added: Maturity of the lease liabilities was as follows:
+Added: Calendar Year
Total lease payments
1 unchanged sentence
Short-term portion (included in other liabilities)
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: the ordinary course of business, from time to time, the Company may be subject to a broad range of claims and legal proceedings that
−Removed: relate to contractual allegations, patent infringement and other claims.
−Removed: The Company establishes accruals when applicable for matters
−Removed: and commitments which it believes losses are probable and can be reasonably estimated.
−Removed: To date, no loss contingency for such matters
−Removed: and potential commitments have been recorded.
−Removed: Although it is not possible to predict with certainty the outcome of these matters or potential
−Removed: commitments, the Company is of the opinion that the ultimate resolution of these matters and potential commitments will not have a material
−Removed: adverse effect on its results of operations or financial position.
−Removed: 5 – Supplemental Balance Sheet Information
−Removed: and other assets
−Removed: and other assets consisted of the following:
−Removed: September 30,
−Removed: consisted of the following:
+Added: Long-term portion
+Added: In the ordinary course of business, from time
+Added: to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual allegations, patent infringement
+Added: and other claims.
+Added: The Company establishes accruals when applicable for matters and commitments which it believes losses are probable and
+Added: can be reasonably estimated.
+Added: To date, no loss contingency for such matters and potential commitments have been recorded.
+Added: Although it is
+Added: not possible to predict with certainty the outcome of these matters or potential commitments, the Company is of the opinion that the ultimate
+Added: resolution of these matters and potential commitments will not have a material adverse effect on its results of operations or financial
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 5 – Supplemental Balance Sheet Information
+Added: Inventory consisted of the following:
September 30,
2 unchanged sentences
Finished goods
−Removed: assets rollforward is as follows:
+Added: Intangible assets rollforward is as follows:
Net Intangibles, September 30, 2023
12 - 13 years
−Removed: Net Intangibles, December 31, 2023
−Removed: Amortization expense was $ 5,579 for each of the three months ended
−Removed: December 31, 2023 and 2022.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: and Equipment
−Removed: and equipment held for use by category are presented in the following table:
+Added: Net Intangibles, March 31, 2024
+Added: Amortization expense was $ 5,579 and $ 11,158 for
+Added: 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,
+Added: respectively.
+Added: Property and Equipment, Net
+Added: Property and equipment held for use by category
+Added: are presented in the following table:
September 30,
−Removed: and furniture
+Added: Equipment and furniture
Total property and equipment
Less accumulated depreciation
−Removed: Property and equipment,
−Removed: expense was $ 53,078 and $ 30,310 for the three months ended December 31, 2023 and 2022, respectively.
−Removed: 6 - Accrued Expenses and Other Liabilities
−Removed: expenses and other liabilities consisted of the following:
+Added: Property and equipment, net
+Added: Depreciation expense was $ 55,321 and $ 108,399
+Added: 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
+Added: 31, 2023, respectively.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 6 – Accrued Expenses and Other Liabilities
+Added: Accrued expenses consisted of the following at
+Added: March 31, 2024 and September 30, 2023:
September 30,
2 unchanged sentences
Royalty payments
−Removed: 7 – Zimmer Development Agreement
−Removed: On July 20, 2020, the Company entered into an exclusive development
−Removed: and distribution agreement (the “Zimmer Development Agreement”) with Zimmer, Inc.
−Removed: (“Zimmer”), pursuant to which
−Removed: the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and the Electrode Cable Assembly Products.
−Removed: Additionally,
−Removed: the Company granted Zimmer the exclusive right and license to distribute certain sEEG Products developed by the Company and together with
−Removed: the Strip/Grid Products and Electrode Cable Assembly Products, the “Products”.
−Removed: The parties have agreed to collaborate with
−Removed: respect to development activities under the Zimmer Development Agreement through a joint development committee composed of an equal number
−Removed: of representatives of Zimmer and the Company.
−Removed: the terms of the Zimmer Development Agreement, the Company is responsible for all costs and expenses related to developing the Products,
−Removed: and Zimmer is responsible for all costs and expenses related to the commercialization of the Products.
−Removed: In addition to the Zimmer Development
−Removed: Agreement, Zimmer and the Company have entered into a Manufacturing and Supply Agreement and a Supplier Quality Agreement with respect
−Removed: to the manufacturing and supply of the Products.
−Removed: as otherwise provided in the Zimmer Development Agreement, the Company is responsible for performing all development activities, including
−Removed: non-clinical and clinical studies directed at obtaining regulatory approval of each Product.
−Removed: Zimmer has agreed to use commercially reasonable
−Removed: efforts to promote, market and sell each Product following the “Product Availability Date” (as defined in the Zimmer Development
−Removed: Agreement) for such Product.
−Removed: to the Zimmer Development Agreement, Zimmer made an upfront initial exclusivity fee payment of $ 2.0 million (the “Initial
−Removed: Exclusivity Fee”) to the Company in fiscal year 2020.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: August 2, 2022, the Company entered into a Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer
−Removed: Amendment”) with Zimmer.
−Removed: Pursuant to the terms and conditions of the Zimmer Amendment, Zimmer made a $ 3.5 million payment
−Removed: to the Company.
−Removed: In consideration of the mutual covenants and agreements contained in the Zimmer Development Agreement, the fee and milestone
−Removed: payment provisions in the Zimmer Development Agreement were replaced with the following below:
+Added: NOTE 7 – Zimmer Development Agreement
+Added: On July 20, 2020, the Company entered into an
+Added: exclusive development and distribution agreement (the “Zimmer Development Agreement”) with Zimmer, Inc.
+Added: pursuant to which the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and the Electrode Cable Assembly
+Added: Additionally, the Company granted Zimmer the exclusive right and license to distribute certain sEEG Products developed by the
+Added: Company and together with the Strip/Grid Products and Electrode Cable Assembly Products, the “Products”.
+Added: The parties have
+Added: agreed to collaborate with respect to development activities under the Zimmer Development Agreement through a joint development committee
+Added: composed of an equal number of representatives of Zimmer and the Company.
+Added: Under the terms of the Zimmer Development Agreement,
+Added: the Company is responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and
+Added: expenses related to the commercialization of the Products.
+Added: In addition to the Zimmer Development Agreement, Zimmer and the Company have
+Added: entered into a Manufacturing and Supply Agreement and a Supplier Quality Agreement with respect to the manufacturing and supply of the
+Added: Except as otherwise provided in the Zimmer Development
+Added: Agreement, the Company is responsible for performing all development activities, including non-clinical and clinical studies directed
+Added: at obtaining regulatory approval of each Product.
+Added: Zimmer has agreed to use commercially reasonable efforts to promote, market and sell
+Added: each Product following the “Product Availability Date” (as defined in the Zimmer Development Agreement) for such Product.
+Added: Pursuant to the Zimmer Development Agreement,
+Added: Zimmer made an upfront initial exclusivity fee payment of $ 2.0 million (the “Initial Exclusivity Fee”) to the Company
+Added: in fiscal year 2020.
+Added: On August 2, 2022, the Company entered into
+Added: a Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer Amendment”) with Zimmer.
+Added: to the terms and conditions of the Zimmer Amendment, Zimmer made a $ 3.5 million payment to the Company.
+Added: In consideration of the mutual
+Added: covenants and agreements contained in the Zimmer Development Agreement, the fee and milestone payment provisions in the Zimmer Development
+Added: Agreement were replaced with the following below:
million for the sEEG Exclusivity Maintenance Fee;
−Removed: ● $ 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.
−Removed: addition, in connection with the Zimmer Amendment, the Company issued Zimmer a warrant to purchase common stock (the “2022
−Removed: Zimmer Warrant”).
−Removed: The 2022 Zimmer Warrant is exercisable for up to an aggregate of 350,000 shares of the Company’s
−Removed: common stock.
−Removed: The 2022 Zimmer Warrant has an exercise price of $ 3.00 per share, is exercisable commencing six months from the issuance
−Removed: date, and will expire on August 2, 2027.
−Removed: The fair value of the 2022 Zimmer Warrant of $ 0.1 million was based on the Black-Scholes pricing
+Added: million for satisfaction of each of the milestone events related to the design of sEEG Products set forth in the Zimmer Development Agreement
+Added: even though the satisfaction was after the deadlines originally identified.
+Added: In addition, in connection with the Zimmer Amendment,
+Added: the Company issued Zimmer a warrant to purchase common stock (the “2022 Zimmer Warrant”).
+Added: The 2022 Zimmer Warrant is
+Added: exercisable for up to an aggregate of 350,000 shares of the Company’s common stock.
+Added: The 2022 Zimmer Warrant has an exercise
+Added: price of $ 3.00 per share, is exercisable commencing six months from the issuance date, and will expire on August 2, 2027.
+Added: value of the 2022 Zimmer Warrant of $ 0.1 million was based on the Black-Scholes pricing model.
Input assumptions used were as follows:
3 unchanged sentences
expected dividend yield of 0 %;
−Removed: and the underlying fair market of the common stock.
−Removed: The 2022 Zimmer Warrant was classified in stockholders’
−Removed: equity as the number of shares were fixed and determinable, no cash settlement was required and no other provisions precluded equity
−Removed: Zimmer Development Agreement will expire on the tenth anniversary of the date of the first commercial sale of the last Products to achieve
−Removed: a first commercial sale (the “Term”), unless terminated earlier pursuant to its terms.
−Removed: Either party may terminate the Zimmer
−Removed: Development Agreement (x) with written notice for the other party’s material breach following a cure period or (y) if the other
−Removed: party becomes subject to certain insolvency proceedings.
−Removed: In addition, Zimmer may terminate the Zimmer Development Agreement for any reason
−Removed: with 90 days’ written notice, and the Company may terminate the Zimmer Development Agreement if Zimmer acquires or directly or
−Removed: indirectly owns a controlling interest in certain competitors of the Company.
−Removed: The license rights granted to Zimmer under the Strip/Grid
−Removed: Distribution License and sEEG Distribution License as defined in the Zimmer Development Agreement shall be exclusive from the effective
−Removed: date of the Zimmer Amendment until the end of the term of the Zimmer Amendment.
−Removed: Zimmer Development Agreement and Zimmer Amendment were accounted for under the provisions of ASC 606.
−Removed: In accordance with the provisions
−Removed: under ASC 606, the Company identified five performance obligations under the Zimmer Development Agreement and Zimmer Amendment:
−Removed: Company’s obligation to grant Zimmer access to its intellectual property;
−Removed: (2) completion sEEG Product development;
−Removed: (3) completion
−Removed: of Strip/Grid Product development;
−Removed: (4) the provision of sEEG exclusivity maintenance;
−Removed: and (5) completion of sEEG design modifications
−Removed: as requested by Zimmer.
−Removed: All performance obligations under the Zimmer Development Agreement and Zimmer Amendment, outside of the sEEG
−Removed: exclusivity maintenance obligation, were met by September 30, 2022.
−Removed: The remaining performance obligation in deferred revenue as of September
−Removed: 30, 2022 attributed to sEEG exclusivity maintenance was completed in first quarter of fiscal year 2023.
−Removed: aggregate transaction price associated with the Zimmer Development Agreement and Zimmer Amendment was $ 5.4 million comprising the Initial
−Removed: 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
−Removed: The transaction price was allocated between performance obligations based on their relative standalone selling prices.
−Removed: used a market based valuation approach and an expected cost plus margin approach with regard to estimating the standalone selling price
−Removed: for the performance obligations.
−Removed: The Company recognized collaborations revenue in the amount of $ 1,455,188 during the three months
−Removed: ended December 31, 2022 in connection with the Zimmer Development Agreement and Zimmer Amendment.
−Removed: Given the achievement of the milestones
−Removed: under the Zimmer Development Agreement and Zimmer Amendment by December 31, 2022, no collaborations revenue was recognized during the
−Removed: three months ended December 31, 2023.
−Removed: reconciliation of the closing balance of deferred revenue related to the Zimmer Development Agreement and Zimmer Amendment is as follows
−Removed: during the three months ended as of December 31, 2023 and 2022:
+Added: and the underlying
+Added: fair market of the common stock.
+Added: The 2022 Zimmer Warrant was classified in stockholders’ equity as the number of shares were
+Added: fixed and determinable, no cash settlement was required and no other provisions precluded equity treatment.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: The Zimmer Development Agreement will expire on
+Added: the tenth anniversary of the date of the first commercial sale of the last Products to achieve a first commercial sale (the “Term”),
+Added: unless terminated earlier pursuant to its terms.
+Added: Either party may terminate the Zimmer Development Agreement (x) with written notice for
+Added: the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.
+Added: In addition, Zimmer may terminate the Zimmer Development Agreement for any reason with 90 days’ written notice, and the Company
+Added: may terminate the Zimmer Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors
+Added: of the Company.
+Added: The license rights granted to Zimmer under the Strip/Grid Distribution License and sEEG Distribution License as defined
+Added: in the Zimmer Development Agreement shall be exclusive from the effective date of the Zimmer Amendment until the end of the term of the
+Added: Zimmer Amendment.
+Added: The Zimmer Development Agreement and Zimmer Amendment
+Added: were accounted for under the provisions of ASC 606.
+Added: In accordance with the provisions under ASC 606, the Company identified five performance
+Added: obligations under the Zimmer Development Agreement and Zimmer Amendment:
+Added: (1) the Company’s obligation to grant Zimmer access to
+Added: its intellectual property;
+Added: (2) completion of sEEG Product development;
+Added: (3) completion of Strip/Grid Product development;
+Added: (4) the provision
+Added: of sEEG exclusivity maintenance;
+Added: and (5) completion of sEEG design modifications as requested by Zimmer.
+Added: All performance obligations under
+Added: the Zimmer Development Agreement and Zimmer Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September 30,
+Added: The remaining performance obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance was
+Added: completed in first quarter of fiscal year 2023.
+Added: The aggregate transaction price associated with
+Added: the Zimmer Development Agreement and Zimmer Amendment was $ 5.4 million comprising the Initial Exclusivity Fee of $ 2.0 million and the
+Added: $ 3.5 million payment under the Zimmer Amendment, less the fair value 2022 Zimmer Warrant of $ 0.1 million.
+Added: The transaction price was allocated
+Added: between performance obligations based on their relative standalone selling prices.
+Added: The Company used a market based valuation approach
+Added: and an expected cost plus margin approach with regard to estimating the standalone selling price for the performance obligations.
+Added: Company recognized collaborations revenue in the amount of $ 1,455,188 during the six months ended March 31, 2023 in connection with
+Added: the Zimmer Development Agreement and Zimmer Amendment.
+Added: Given the achievement of the milestones under the Zimmer Development Agreement
+Added: and Zimmer Amendment by December 31, 2022, no collaborations revenue was recognized during the six months ended March 31, 2024.
+Added: A reconciliation of the closing balance of deferred
+Added: revenue related to the Zimmer Development Agreement and Zimmer Amendment is as follows during the six months ended as of March 31, 2024
Deferred Revenue
2 unchanged sentences
( 1,455,188 )
−Removed: Balance as of end of period – December
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: revenue recognized during the three months ended December 31, 2023 and 2022 was $ 977,649 and $ 114,579 , respectively, related to the Company’s
+Added: Balance as of end of period – March 31
+Added: Product Revenue
+Added: Product revenue related to the Company’s
Strip/Grid Products, sEEG Products and Electrode Cable Assembly Products.
−Removed: expense is charged to selling, general and administrative expenses during the period that it is incurred.
−Removed: Total advertising expense amounted
−Removed: to $ 49,272 and $ 53,026 for the three months ended December 31, 2023 and 2022, respectively.
−Removed: 8 – Stock-Based Compensation
−Removed: During the three-month periods ended December 31, 2023 and 2022, stock-based
−Removed: compensation expense was included in selling, general and administrative and research and development costs as follows in the accompanying
−Removed: condensed statements of operations.
+Added: Product revenue recognized during the three and six months ended
+Added: March 31, 2024 was $ 1,377,294 and $ 2,354,943 , respectively.
+Added: Product revenue recognized during the three and six months ended March 31,
+Added: 2023 was $ 466,176 and $ 580,755 , respectively.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 8 – Stock-Based Compensation
+Added: During the three and six months ended March 31,
+Added: 2024 and 2023, stock-based compensation expense related to stock-based awards was included in selling, general and administrative and
+Added: research and development costs as follows in the accompanying condensed statements of operations.
+Added: Three Months Ended
+Added: Six Months Ended
Selling, general and administrative
Research and development
−Removed: Total stock-based compensation
−Removed: The Company’s 2017 Equity Incentive Plan (“2017 Plan”)
−Removed: provides for the issuance of restricted shares and stock options to employees, directors, and consultants of the Company.
−Removed: In addition to the Company’s 2017 Plan, the Company adopted the
−Removed: NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”) on October 4, 2021, pursuant to which
−Removed: the Company reserved 420,350 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously
−Removed: employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within
−Removed: the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
−Removed: The Inducement Plan was approved by the Company’s Board of Directors
−Removed: without stockholder approval in accordance with such rule.
−Removed: On November 9, 2023, the Company’s Board of Directors adopted the First
−Removed: Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock that may be issued pursuant
−Removed: 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
−Removed: pursuant to equity incentive awards under the Inducement Plan.
−Removed: Under the 2017 Plan, the shares reserved automatically increase on
−Removed: 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,
−Removed: 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
−Removed: as of December 31st of the preceding calendar year.
−Removed: Notwithstanding the foregoing, the Company’s Board of Directors may act prior
−Removed: 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
−Removed: 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
−Removed: “Fully Diluted Shares” as of a date means an amount equal to the number of shares of common stock (i) outstanding
−Removed: and (ii) issuable upon exercise, conversion or settlement of outstanding awards under the 2017 Plan and any other outstanding options,
−Removed: warrants or other securities of the Company that are (directly or indirectly) convertible or exchangeable into or exercisable for shares
−Removed: of common stock, in each case as of the close of business of the Company on December 31 of the preceding calendar year.
−Removed: On January 1,
−Removed: 2024, 1,051,556 shares were added to the 2017 Plan as a result of the evergreen provision.
−Removed: See Note 12 – Subsequent Events.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: the three months ended December 31, 2023 and 2022, under the 2017 Plan and the Inducement Plan, the Company granted 1,160,669 and 73,731
−Removed: stock options, respectively, to its employees and consultants.
+Added: Total stock-based compensation expense
+Added: Inducement Plan
+Added: In addition to the Company’s 2017 Equity
+Added: Incentive Plan (the “2017 Plan”), the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the
+Added: “Inducement Plan”) on October 4, 2021, pursuant to which the Company reserved 420,350 shares of its common stock to be used
+Added: exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material
+Added: to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
+Added: Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance with such rule.
+Added: 9, 2023, the Company’s Board of Directors adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate
+Added: number of shares of common stock that may be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for
+Added: a total of 570,350 shares of common stock that may be issued.
+Added: Evergreen provision
+Added: Under the 2017 Plan, the shares reserved automatically
+Added: 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
+Added: 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
+Added: shares outstanding as of December 31st of the preceding calendar year.
+Added: Notwithstanding the foregoing, the Company’s Board of Directors
+Added: 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
+Added: 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
+Added: to the preceding sentence.
+Added: “Fully Diluted Shares” as of a date means an amount equal to the number of shares of common stock
+Added: (i) outstanding and (ii) issuable upon exercise, conversion or settlement of outstanding awards under the 2017 Plan and any other outstanding
+Added: options, warrants or other securities of the Company that are (directly or indirectly) convertible or exchangeable into or exercisable
+Added: 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.
+Added: January 1, 2024, 1,051,556 shares were added to the 2017 Plan as a result of the evergreen provision.
+Added: Stock Options
+Added: During the three months ended March 31, 2024 and
+Added: 2023, under the 2017 Plan, the Company granted 65,000 and 56,781 stock options, respectively, to its board of directors, officers and
+Added: During the six months ended March 31, 2024 and 2023, the Company granted 1,225,669 and 130,512 stock options, respectively,
+Added: 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.
−Removed: The weighted-average grant date fair value of the grants issued during the three months ended December 31,
−Removed: 2023 and 2022 was $ 1.08 and $ 0.66 per share, respectively.
−Removed: The total expense for the three months ended December 31, 2023 and 2022 related
−Removed: to stock options was $ 187,431 and $ 181,744 , respectively.
−Removed: The total number of stock options outstanding as of December 31, 2023 and September
−Removed: 30, 2023 was 2,814,096 and 1,708,427 , respectively.
−Removed: weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three-month
−Removed: periods ended December 31, 2023 and 2022:
+Added: The grant date fair value of the grants issued during the three months ended March 31, 2024 and 2023 was
+Added: $ 0.91 and $ 0.88 per share, respectively.
+Added: The grant date fair value of the grants issued during the six months ended March 31, 2024 and
+Added: 2023 was $ 1.08 and $ 0.75 per share, respectively.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: The total expense for the three months ended March
+Added: 31, 2024 and 2023 related to stock options was $ 214,188 and $ 142,003 , respectively.
+Added: The total expense for the six months ended March 31,
+Added: 2024 and 2023 related to stock options was $ 401,619 and $ 323,747 , respectively.
+Added: The total number of stock options outstanding as of March
+Added: 31, 2024 and September 30, 2023 was 2,879,096 and 1,708,427 , respectively.
+Added: The weighted-average assumptions used in the Black-Scholes
+Added: option-pricing model are as follows for the stock options granted during the three and six months ended March 31, 2024 and 2023:
+Added: Three Months Ended
+Added: Six Months Ended
Expected stock price volatility
2 unchanged sentences
Risk free interest rate
−Removed: During the three months ended December 31, 2023 and 2022, 56,616 and
−Removed: 127,446 stock options vested, and 55,000 and zero stock options were forfeited during these periods, respectively.
−Removed: were no restricted stock units (“RSUs”) granted during the three months ended December 31, 2023 and 2022.
−Removed: 37,679 and 21,930
−Removed: previously granted RSUs vested during these periods, respectively.
−Removed: The total expense for the three months ended December 31, 2023 and
+Added: During the three months ended March 31, 2024 and
+Added: 2023, 48,295 and 84,778 stock options vested, respectively, and zero stock options were forfeited.
+Added: During the six months ended March 31,
+Added: 2024 and 2023, 104,911 and 212,224 stock options vested, respectively, and 55,000 and zero stock options were forfeited during these periods,
+Added: respectively.
+Added: During the three and six months ended March 31, 2024 and 2023, no options were exercised.
+Added: Restricted Stock Units
+Added: During the three and six months ended March 31,
+Added: 2024, the Company granted an aggregate of 1,006,725 restricted stock units (“RSUs”) to its employees and consultants under
+Added: the 2017 Plan.
+Added: The weighted average grant date fair value of the RSUs granted during the three and six months ended March 31, 2024 was
+Added: $ 1.03 per unit.
+Added: The RSUs granted vest over a four-year period in equal annual installments on the anniversary date of the grant, subject
+Added: to the recipient’s continued service on such dates.
+Added: During the three and six months ended March 31,
+Added: 2023, the Company granted an aggregate of 61,728 RSUs to its board of directors under the 2017 Plan.
+Added: The weighted average grant date fair
+Added: value of the RSUs granted during the three and six months ended March 31, 2023 was $ 1.62 per unit.
+Added: The RSUs vest over a one-year period
+Added: in equal monthly installments on the last day of each month, subject to the recipient’s continued service on such dates.
+Added: During the three months ended March 31, 2024 and
+Added: 2023, 32,535 and 219,880 RSUs vested, respectively, and no RSUs were forfeited.
+Added: During the six months ended March 31, 2024 and 2023, 70,214
+Added: and 241,810 RSUs vested, respectively, and no RSUs were forfeited.
+Added: The total expense for the three months ended March 31, 2024 and 2023
related to these RSUs was $ 142,670 and $ 95,625 , respectively.
−Removed: No RSUs were forfeited during the three months ended December 31,
−Removed: 2023 and 2022.
−Removed: of December 31, 2023, 182,314 shares were available in the aggregate for future issuance under the 2017 Equity Incentive Plan and Inducement
−Removed: Unrecognized stock-based compensation was $ 2,372,540 as of December 31, 2023.
−Removed: The unrecognized share-based expense is expected
−Removed: to be recognized over a weighted average period of 2.5 years.
−Removed: 9 – Concentrations
−Removed: customer accounts for all of the Company’s product and collaborations revenue.
−Removed: concentration
−Removed: contract manufacturer produces all of the Company’s Strip/Grid Products and sEEG Products and another supplier was responsible
−Removed: for the development of the Company’s OneRF Ablation system.
−Removed: 10 – Income Taxes
−Removed: effective tax rate for the three months ended December 31, 2023 and 2022 was zero percent.
−Removed: As a result of the analysis of all available
−Removed: evidence as of December 31, 2023 and September 30, 2023, the Company recorded a full valuation allowance on its net deferred
−Removed: Consequently, the Company reported no income tax benefit during the three months ended December 31, 2023
−Removed: If the Company’s assumptions change and the Company believes that it will be able to realize these deferred tax assets,
−Removed: the tax benefits relating to any reversal of the valuation allowance on deferred tax assets will be recognized as a reduction of future
−Removed: income tax expense.
−Removed: If the assumptions do not change, each period the Company could record an additional valuation allowance
−Removed: on any increases in the deferred tax assets.
−Removed: Medical Technologies Corporation
−Removed: to Condensed Financial Statements
−Removed: 11 – Stockholders’ Equity
−Removed: At-The-Market
−Removed: December 21, 2022, the Company entered into a Capital on Demand TM Sales Agreement (the “Sales Agreement”) with
−Removed: JonesTrading Institutional Services LLC (“JonesTrading”) that created an at-the-market offering program (“ATM”)
−Removed: under which the Company may offer and sell common stock having an aggregate offering price of up to $ 14.5 million.
−Removed: is entitled to a commission at a fixed commission rate of up to 3 % of the gross proceeds.
−Removed: On July 24, 2023, the Company decreased the
−Removed: amount of common stock that can be sold pursuant to the Sales Agreement, such that the Company was offering up to an aggregate of $ 2.6
−Removed: million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold.
−Removed: Subsequently on
−Removed: December 1, 2023, however, the Company increased the amount of common stock that can be sold pursuant to the Sales Agreement, such that
+Added: The total expense for the six months ended March 31, 2024 and 2023 related
+Added: to these RSUs was $ 263,877 and $ 214,062 , respectively.
+Added: As of March 31, 2024, 183,130 shares were available
+Added: in the aggregate for future issuance under the 2017 Plan and Inducement Plan.
+Added: Unrecognized stock-based compensation was $ 3.1 million as
+Added: of March 31, 2024.
+Added: The unrecognized share-based expense is expected to be recognized over a weighted average period of 2.7 years.
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: NOTE 9 – Concentrations
+Added: One customer accounts for all of the Company’s product and collaborations
+Added: Supplier concentration
+Added: One contract manufacturer produces all of the
+Added: Company’s Strip/Grid Products and sEEG Products and another supplier was responsible for the development of the Company’s
+Added: OneRF Ablation system.
+Added: NOTE 10 – Income Taxes
+Added: The effective tax rate for the three and six months
+Added: ended March 31, 2024 and 2023 was zero percent.
+Added: As a result of the analysis of all available evidence as of March 31, 2024 and September
+Added: 30, 2023, the Company recorded a full valuation allowance on its net deferred tax assets.
+Added: Consequently, the Company reported no income
+Added: tax benefit during the three and six months ended March 31, 2024 and 2023.
+Added: If the Company’s assumptions change and the
+Added: Company believes that it will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation
+Added: allowance on deferred tax assets will be recognized as a reduction of future income tax expense.
+Added: If the assumptions do not
+Added: change, each period the Company could record an additional valuation allowance on any increases in the deferred tax assets.
+Added: NOTE 11 – Stockholders’ Equity
+Added: At-The-Market Offering
+Added: On December 21, 2022, the Company entered into
+Added: a Capital on Demand TM Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
+Added: that created an at-the-market offering program (“ATM”) under which the Company may offer and sell common stock having an aggregate
+Added: offering price of up to $ 14.5 million.
+Added: JonesTrading is entitled to a commission at a fixed commission rate of up to 3 % of the gross
+Added: On July 24, 2023, the Company decreased 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 $ 2.6 million of its common stock for sale under the Sales Agreement, including the shares
of common stock previously sold.
−Removed: January 5, 2024, the Company further increased the amount of common stock that can be sold pursuant to the Sales Agreement, such that
−Removed: the Company is offering up to an aggregate of $ 9.3 million of its common stock for sale under the Sales Agreement, including the shares
−Removed: of common stock previously sold.
+Added: Subsequently on December 1, 2023, however, the Company increased the amount of common stock that can
+Added: 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
+Added: sale under the Sales Agreement, including the shares of common stock previously sold.
+Added: On January 5, 2024, the Company further increased
+Added: the amount of common stock that can be sold pursuant to the Sales Agreement, such that the Company is offering up to an aggregate of $ 9.3
+Added: million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold.
+Added: During the three and six months ended March 31,
+Added: 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
+Added: and $ 3,350,467 , respectively.
+Added: The total aggregate offering price and common stock issued since inception of the ATM though March 31, 2024
+Added: was $ 5,903,123 and 3,769,273 shares, respectively.
+Added: Issuance costs incurred under the ATM during the three and six months ended March 31,
+Added: 2024 were $ 148,382 and $ 186,080 , respectively.
+Added: During the three and six months ended March 31,
+Added: 2023, 516,484 shares of common stock were issued under the ATM for an aggregate offering price of $ 928,257 .
+Added: Issuance costs incurred during
+Added: the three and six months ended March 31, 2023 was $ 183,359 .
See “Note 12 – Subsequent Events”.
−Removed: the three months ended December 31, 2023, 868,243 shares of common stock were issued under the ATM for an aggregate offering price of
−Removed: $ 1,256,271 .
−Removed: The total aggregate offering price and common stock issued since inception of the ATM though December 31, 2023 was $ 3,808,927
−Removed: and 2,307,920 shares, respectively.
−Removed: Issuance costs incurred under the ATM during the three months ended December 31, 2023 were $ 37,698 .
−Removed: the three months ended December 31, 2022, deferred issuance costs in the amount of $ 103,787 were incurred in connection with the ATM,
−Removed: but no shares of common stock were issued under the ATM during that period.
−Removed: Activity and Summary
+Added: NeuroOne Medical Technologies
+Added: Notes to Condensed Financial Statements
+Added: Warrant Activity and Summary
+Added: There were no warrant exercises during the three
+Added: 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,
+Added: respectively.
+Added: The following table summarizes information about
+Added: warrants outstanding at March 31, 2024:
Average Exercise
−Removed: Outstanding and exercisable at
−Removed: September 30, 2023
+Added: Outstanding and exercisable at September 30, 2023
$ 3.00 - 9.00
−Removed: Outstanding and exercisable
−Removed: at December 31, 2023
( 1,338,860 )
−Removed: following table summarizes information about warrants outstanding at December 31, 2023:
+Added: $ 7.50 - 9.00
+Added: Outstanding and exercisable at March 31, 2024
+Added: $ 3.00 - 9.00
+Added: The following table summarizes information about
+Added: warrants outstanding at March 31, 2024:
+Added: Exercise Price
+Added: Number Outstanding
+Added: Weighted Average
Remaining Contractual
−Removed: 12 – Subsequent Events
−Removed: Plan Evergreen Provision
−Removed: January 1, 2024, 1,051,556 shares were added to the 2017 Plan as a result of the evergreen provision.
−Removed: See Note 8 – Stock-Based
−Removed: Compensation.
−Removed: At-The-Market
−Removed: On January 5, 2024, the Company increased the amount of common stock
−Removed: that can be sold pursuant to the Sales Agreement with JonesTrading, such that we are offering up to an aggregate of $ 9.3 million of common
−Removed: stock for sale under the Sales Agreement, including the shares of common stock previously sold.
−Removed: As a of result of the higher issuance
−Removed: threshold under the Sales Agreement, the Company sold an additional 1,080,314 shares of common stock for net proceeds in the amount of
−Removed: $ 1.5 million during January 2024.
−Removed: Medical Technologies Corporation
+Added: Number Exercisable
+Added: NOTE 12 – Subsequent Events
+Added: Between April 1 and May 10, 2024, we issued an
+Added: additional 1,093,135 shares of common stock for net proceeds in the amount of $ 1,286,844 in connection with the Sales Agreement.
+Added: NeuroOne Medical Technologies
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.