−Removed: FINANCIAL STATEMENTS AND SUPPLEMENTARY
+Added: FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
5 unchanged sentences
Notes to Financial Statements F-8
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: To the stockholders and the board of directors of NeuroOne Medical Technologies Corporation:
+Added: NeuroOne Medical Technologies Corporation
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: To the stockholders and the board of directors
+Added: of NeuroOne Medical Technologies Corporation:
Opinion on the Financial Statements
−Removed: audited the accompanying balance sheets of NeuroOne Medical Technologies Corporation (the "Company") as of September 30, 2023 and 2022,
−Removed: the related statements of operations, changes in stockholders’ equity, and cash flows, for each of the two years in the period ended
+Added: We have audited the accompanying balance
+Added: sheets of NeuroOne Medical Technologies Corporation (the “Company”) as of September 30, 2024 and 2023, the related
+Added: statements of operations, changes in stockholders’ equity, and cash flows, for each of the two years in the period ended
September 30, 2024, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements
−Removed: present fairly, in all material respects, the financial position of the Company as of September 30, 2023 and 2022, and the results of
−Removed: the Company’s operations and cash flows for each of the two years in the period ended September 30, 2023, in conformity with accounting
−Removed: principles generally accepted in the United States of America.
+Added: In our opinion, the
+Added: financial statements present fairly, in all material respects, the financial position of the Company as of September 30, 2024 and
+Added: 2023, and the results of the Company’s operations and cash flows for each of the two years in the period ended September 30,
+Added: 2024, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
−Removed: The accompanying financial statements have been prepared assuming
−Removed: the Company will continue as a going concern.
−Removed: As discussed in Note 2 of the financial statements, the Company had recurring losses from
−Removed: operations and an accumulated deficit, expects to incur losses for the foreseeable future and requires additional working capital.
−Removed: are the reasons that raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: Management’s plans
−Removed: in regard to these matters are also described in Note 2.
−Removed: The financial statements do not contain any adjustments that might result from
−Removed: the outcome of this uncertainty.
+Added: The accompanying financial statements have been
+Added: prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 2 of the financial statements, the Company had recurring
+Added: losses from operations and an accumulated deficit, expects to incur losses for the foreseeable future and requires additional working
+Added: These are the reasons that raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: plans in regard to these matters are also described in Note 2.
+Added: The financial statements do not contain any adjustments that might result
+Added: from the outcome of this uncertainty.
Basis for Opinion
−Removed: These financial statements are the responsibility of the Company's management.
−Removed: Our responsibility
−Removed: is to express an opinion on the Company’s financial statements based on our audits.
−Removed: We are a public accounting firm registered with
−Removed: the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company
−Removed: in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
−Removed: and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform
−Removed: the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose
−Removed: of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
−Removed: Accordingly, we express no such
−Removed: Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due
−Removed: to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used
−Removed: and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that
−Removed: our audits provide a reasonable basis for our opinion.
+Added: These financial statements are the responsibility
+Added: of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and
+Added: are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules
+Added: and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
+Added: statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged
+Added: to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
+Added: control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
+Added: to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
+Added: the overall presentation of the financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: NeuroOne Medical Technologies Corporation
Critical Audit Matter
−Removed: Critical audit matters are matters arising from the current
−Removed: period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex
−Removed: We determined that there are no critical audit matters.
+Added: The critical audit matter communicated below
+Added: is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to
+Added: the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our
+Added: especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter in any way our opinion
+Added: on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions
+Added: on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Valuation of warrants
+Added: Critical Audit Matter Description
+Added: As described in Note 9 to the financial statements, the Company
+Added: completed a private placement offering during the year which included the issuance of warrants.
+Added: Management determined the proper classification
+Added: of the warrants by reviewing the terms and conditions of the issued warrants and applying the applicable accounting guidance, including
+Added: Accounting Standards Codification (ASC) 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and Hedging.
+Added: Management concluded
+Added: the warrants met the criteria for the classification as a liability.
+Added: The Company determined the fair value of warrants at the date of
+Added: issuance and year-end using a Monte Carlo simulation model.
+Added: We identified the assessment of the measurement of fair value
+Added: of the common stock warrants as a critical audit matter.
+Added: Specifically, there was a high degree of subjective auditor judgment, including
+Added: the involvement of professionals with specialized skills and knowledge, due to the complex valuation methodology that incorporates several
+Added: How We Addressed the Matter in
+Added: The primary procedures we performed
+Added: to address this critical audit matter included:
+Added: ◾ With the assistance of firm personnel having specialized
+Added: skills and knowledge, we tested the model and methodology used to calculate the fair value of the common stock warrants including an
+Added: independent re-calculation.
+Added: ◾ Performed audit procedures surrounding management’s
+Added: assumptions utilized in the valuation model.
/s/ Baker Tilly US, LLP
7 unchanged sentences
Cash and cash equivalents
−Removed: Short-term investments
Accounts receivable
+Added: Deferred offering costs
Prepaid expenses
7 unchanged sentences
Accrued expenses and other liabilities
−Removed: Deferred revenue
Total current liabilities
+Added: Warrant liability
Operating lease liability, long term
3 unchanged sentences
Preferred stock, $ 0.001 par value;
−Removed: 10,000,000 shares authorized as of September 30, 2023 and 2022;
−Removed: no shares issued or outstanding as of September 30, 2023 and 2022.
+Added: 10,000,000 shares authorized;
+Added: no shares issued or outstanding.
Common stock, $ 0.001 par value;
−Removed: 100,000,000 shares authorized as of September 30, 2023 and 2022;
+Added: 100,000,000 shares authorized;
30,816,499 and 23,928,945 shares issued and outstanding as of September 30, 2024 and 2023, respectively.
11 unchanged sentences
Cost of product revenue
−Removed: Product gross profit (loss)
+Added: Product gross profit
Collaborations revenue
6 unchanged sentences
( 11,955,250 )
+Added: Fair value change in warrant liability
+Added: Financing costs
Other income, net
16 unchanged sentences
Issuance of common stock in connection with public offering
−Removed: Issuance cost in connection with public offering
+Added: Issuance of common stock in connection with at-the-market offering program
+Added: Issuance costs in connection with common stock issuances
( 1,071,663 )
( 1,071,663 )
−Removed: Issuance of warrants in connection with Zimmer development agreement
Stock-based compensation
Issuance of common stock upon vesting of restricted stock units
+Added: Share repurchases for the payment of employee taxes
( 11,859,491 )
2 unchanged sentences
( 62,686,303 )
−Removed: Issuance of common stock in connection with public offering
+Added: Issuance of common stock in connection with 2024 Private Placement
Issuance of common stock in connection with at-the-market offering program
−Removed: Issuance cost in connection with common stock issuances
−Removed: ( 1,071,663 )
−Removed: ( 1,071,663 )
+Added: Issuance costs in connection with common stock issuances
Stock-based compensation
1 unchanged sentence
Share repurchases for the payment of employee taxes
+Added: Issuance of warrants in connection with debt facility
( 12,318,110 )
7 unchanged sentences
Operating activities
−Removed: $ ( 11,859,491 )
−Removed: $ ( 9,999,613 )
−Removed: Adjustments to reconcile net loss to net cash used in operating
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation
+Added: Amortization of deferred issuance costs
Stock-based compensation
+Added: Fair value change in warrant liability
+Added: Private placement warrant issuance costs reclassed to financing activities
Loss on disposal of fixed assets
1 unchanged sentence
Non-cash lease expense
−Removed: Issuance of warrants in connection with Zimmer contract
Change in assets and liabilities:
Accounts receivable
−Removed: ( 1,022,148 )
−Removed: Prepaid expenses and other assets
+Added: Prepaid expenses
Accounts payable
−Removed: Accrued expenses, deferred revenue,
−Removed: operating lease and other liabilities
−Removed: ( 1,225,313 )
+Added: Accrued expenses, deferred revenue, operating lease and other liabilities
Net cash used in operating activities
−Removed: ( 12,886,874 )
−Removed: ( 7,519,534 )
Investing activities
Purchases of short-term investments
−Removed: ( 1,473,419 )
−Removed: ( 3,469,539 )
Maturities of short-term investments
1 unchanged sentence
Purchases of property and equipment
−Removed: Net cash provided by (used in) investing
−Removed: ( 3,244,765 )
+Added: Net cash (used in) provided by investing activities
Financing activities
−Removed: Proceeds from issuance of common stock in connection with public
−Removed: offerings and at-the-market offering program
−Removed: Issuance costs in connection with common stock issuances
−Removed: ( 1,071,663 )
−Removed: ( 1,327,300 )
−Removed: Share repurchases for the payment of
−Removed: employee taxes
+Added: Proceeds from issuance of common stock in connection with private placement
+Added: Proceeds from issuance of warrants in connection with private placement
+Added: Proceeds from issuance of common stock in connection with at-the-market offering program
+Added: Issuance costs attributed to common stock and warrants issued in private placement
+Added: Issuance costs in connection with at-the-market offering program
+Added: Deferred issuance costs in connection with at-the-market offering program
+Added: Deferred issuance costs in connection with debt facility
+Added: Share repurchases for the payment of employee taxes
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
−Removed: ( 2,837,836 )
−Removed: Cash and cash equivalents at beginning
+Added: Net decrease in cash and cash equivalents
+Added: Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
−Removed: Supplemental non-cash financing and investing
−Removed: transactions:
+Added: Supplemental non-cash financing and investing transactions:
Unpaid purchases of property and equipment
−Removed: Modification of right-of-use asset and
−Removed: associated lease liability
−Removed: Reclass of deferred offering costs to
−Removed: additional paid-in capital in connection with public offering
+Added: Modification of right-of-use asset and associated lease liability
+Added: Non-cash warrants issued in connection with debt facility
+Added: Unpaid issuance costs in connection with private placement
+Added: Unpaid deferred issuance costs
See accompanying notes to financial statements
−Removed: NeuroOne Medical Technologies
+Added: NeuroOne Medical Technologies Corporation
Notes to Financial Statements
1 unchanged sentence
NeuroOne Medical Technologies Corporation (the
−Removed: “Company” or “NeuroOne”), a Delaware corporation, is a medical technology company focused on the development
−Removed: and commercialization of thin film electrode for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography
−Removed: (“sEEG”) recording, monitoring, ablation, drug delivery and brain stimulation solutions to diagnose and treat patients with
−Removed: epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological
+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.
The Company received 510(k) clearance from the
United States (“U.S.”) Food and Drug Administration (“FDA”) for its Evo cortical electrode technology in November
−Removed: 2019 and in October 2022, the Company received 510(k) clearance from the FDA for its Evo sEEG electrode technology for temporary (less
−Removed: than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals
−Removed: at the subsurface level of the brain.
+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.
The Company is based in Eden Prairie, Minnesota.
2 unchanged sentences
uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and
−Removed: financial markets, lingering effects of the COVID-19 pandemic 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: The COVID-19 pandemic that began in late 2019
−Removed: introduced significant volatility to the global economy, disrupted supply chains and had a widespread adverse effect on the financial
−Removed: Additionally, the Company’s operating results could be materially impacted by changes in the overall macroeconomic environment
−Removed: and other economic factors.
−Removed: Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflicts
−Removed: in Ukraine and the Middle East, disruptions in the banking system and financial markets, and steps taken by governments and central banks,
−Removed: particularly in response to the COVID-19 pandemic as well as other stimulus and spending programs, have led to higher inflation, which
−Removed: has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased interest rates.
+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.
NOTE 2 - Going Concern
4 unchanged sentences
To date, the Company’s revenues have
−Removed: not been sufficient to cover its full operating costs, and as such, has been dependent on funding operations through the issuance of debt
−Removed: and sale of equity securities.
−Removed: With the July 2023 public offering, the Company has adequate liquidity to fund its operations through March
+Added: not been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of
+Added: debt and sale of equity securities.
+Added: The Company has adequate liquidity, including the net proceeds from the 2024 Private Placement (See
+Added: Note 9 – Stockholders’ Equity) and the 2024 Debt Facility (See Note 10 - Debt Financing), to fund its operations through April
The raising of additional funds is not solely within the control of the Company.
−Removed: These factors raise substantial doubt about
−Removed: the Company’s ability to continue as a going concern.
−Removed: The financial statements do not include any adjustments that might result
−Removed: from the outcome of this condition.
+Added: These factors raise substantial doubt about the
+Added: Company’s ability to continue as a going concern.
+Added: The financial statements do not include any adjustments that might result from
+Added: the outcome of this condition.
If the Company is unable to raise additional funds, or the Company’s anticipated operating results
1 unchanged sentence
can fund the Company’s operations.
−Removed: The Company intends to fund ongoing activities by utilizing its current cash and cash equivalents
−Removed: on hand, from product and collaborations revenue and by raising additional capital through equity or debt financings.
−Removed: If management is
−Removed: unable to obtain the necessary capital, it may have a material adverse effect on the operations of the Company and the development of
−Removed: its technology, or the Company may have to cease operations altogether.
+Added: The Company intends to fund ongoing activities
+Added: by utilizing its current cash and cash equivalents on hand, from product and collaborations revenue and by raising additional capital
+Added: through equity or debt financings.
+Added: If management is unable to obtain the necessary capital, it may have a material adverse effect on the
+Added: operations of the Company and the development of its technology, or the Company may have to cease operations altogether.
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
−Removed: NOTE 3 - Summary of Significant Accounting Policies
+Added: NOTE 3 - Summary of Significant Accounting
Basis of Presentation
1 unchanged sentence
prepared in accordance with accounting standards generally accepted in the United States of America (“U.S.
+Added: Reclassifications
+Added: Certain amounts presented in the prior year period
+Added: have been reclassified to conform to current period financial statement presentation.
+Added: The financing proceeds and issuance costs attributed
+Added: to the at-the-market offering program and private placement reflected in the statements of cash flows during the comparable prior year
+Added: period were reclassified into two separate line item categories.
Management’s Use of Estimates
24 unchanged sentences
and corporations in which the Company invests its surplus funds.
−Removed: The Company has experienced no credit losses from its cash and cash
−Removed: equivalent investments.
+Added: The Company has experienced no credit losses from its cash and cash equivalent
Short-Term Investments
4 unchanged sentences
which approximated fair value due to the negligible risk of changes in value due to interest rates.
−Removed: All investments held as September
−Removed: 30, 2022 had contractual maturities of less than one year.
−Removed: There were no short-term investments outstanding as of September 30, 2023.
−Removed: The amortized cost and estimated fair values of the Company’s investments as of September 30, 2022 were as follows:
−Removed: September 30, 2022
−Removed: treasury and corporate notes
+Added: There were no short-term investments
+Added: outstanding as of September 30, 2024 and 2023.
NeuroOne Medical Technologies Corporation
3 unchanged sentences
agreement which has current and future revenue recognition implications.
−Removed: See “Note 7 – Zimmer Development Agreement.”
+Added: In addition, the Company has product revenue in connection with
+Added: its OneRF product offerings (“OneRF Products”) which is not covered by a distribution agreement.
+Added: See “Note 7 –
+Added: Zimmer Amended and Restated Distribution Agreement and Other Product Revenue.
In determining the appropriate amount of revenue
9 unchanged sentences
A performance obligation is a promise in a contract
−Removed: to transfer a distinct good or service to the customer and is the unit of account in Account Standards Codification (“ASC”)
+Added: to transfer a distinct good or service to the customer and is the unit of account in Accounting Standards Codification (“ASC”)
Topic 606 (“ASC 606”).
−Removed: Performance obligations may include license rights, development services, and services associated
−Removed: with regulatory submission and approval processes.
−Removed: Significant management judgment is required to determine the level of effort required
−Removed: under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement.
−Removed: the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue
−Removed: recognition is deferred until the Company can reasonably make such estimates.
−Removed: Revenue is then recognized over the remaining estimated
−Removed: period of performance using the cumulative catch-up method.
+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.
Product Revenue
2 unchanged sentences
the Company expects to be entitled to in exchange for those goods or services.
−Removed: At the inception of each customer contract, performance
−Removed: obligations are identified and the total transaction price is allocated to the performance obligations.
+Added: When the Company has consigned inventory at a customer,
+Added: revenue is recognized at the point in time when the customer issues a purchase order to the Company and when control of the promised goods
+Added: or services is transferred to the Company’s customers.
+Added: At the inception of each customer contract, performance obligations are identified
+Added: and the total transaction price is allocated to the performance obligations.
Cost of Product Revenue
1 unchanged sentence
and materials costs incurred by the Company’s third-party contract manufacturer in connection with the Company’s strip and
−Removed: grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products) and outside supplier materials
−Removed: costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”).
−Removed: In addition, cost of
−Removed: product revenue includes royalty fees incurred in connection with the Company’s license agreements.
+Added: grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products), OneRF Products and outside
+Added: supplier materials costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”).
+Added: addition, cost of product revenue includes royalty fees incurred in connection with the Company’s license agreements.
Collaborations Revenue
As part of the accounting for collaboration arrangements,
−Removed: the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation
−Removed: identified in the contract.
−Removed: The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted
−Removed: revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory
−Removed: The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone
−Removed: selling prices of the promised goods or service underlying each performance obligation.
+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.
Licenses of intellectual property :
−Removed: the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified
−Removed: in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred
+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
to the customer, and the customer can use and benefit from the license.
5 unchanged sentences
the measure of performance and related revenue recognition.
−Removed: NeuroOne Medical Technologies Corporation
+Added: NeuroOne Medical Technologies
Notes to Financial Statements
15 unchanged sentences
obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
+Added: Warrant Liability
+Added: The Company issued warrants in connection with
+Added: its 2024 Private Placement (See Note 9– Stockholders’ Equity).
+Added: The Company accounts for these warrants as a liability at fair
+Added: value when warrant pricing protection provisions are not available to other common stockholders.
+Added: Additionally, issuance costs associated
+Added: with the warrant liability are expensed as incurred and reflected as a financing cost in the accompanying statements of operations.
+Added: Company adjusts the liability for changes in fair value until the earlier of the exercise or expiration of the warrants for any period
+Added: when pricing protections remain in place.
+Added: Any future change in fair value of the warrant liability, when outstanding, is recognized in
+Added: the statements of operations under the fair value change in warrant liability line item.
Fair Value of Financial Instruments
7 unchanged sentences
The three levels of the fair value hierarchy are as follows:
−Removed: Unadjusted quoted prices in active markets for identical assets or liabilities
−Removed: accessible to the Company at the measurement date.
−Removed: Other than quoted prices included in Level 1 inputs that are observable for the
−Removed: asset or liability, either directly or indirectly, for substantially the full term of the
−Removed: asset or liability.
−Removed: Unobservable inputs for the asset or liability used to measure fair value to the
−Removed: extent that observable inputs are not available, thereby allowing for situations in which
−Removed: there is little, if any, market activity for the asset or liability at the measurement date.
+Added: ● Level 1 Inputs:
+Added: Unadjusted quoted prices in active markets
+Added: for identical assets or liabilities accessible to the Company at the measurement date.
+Added: ● Level 2 Inputs:
+Added: Other than quoted prices included in Level
+Added: 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset
+Added: or liability.
+Added: ● Level 3 Inputs:
+Added: Unobservable inputs for the asset or liability
+Added: used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is
+Added: little, if any, market activity for the asset or liability at the measurement date.
As of September 30, 2024 and 2023, the fair values
−Removed: of cash, cash equivalents, short-term investments, accounts receivable, inventory, prepaids and other assets, accounts payable and accrued
−Removed: expenses and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities.
−Removed: There were no transfers between fair value hierarchy
−Removed: levels during the years ended September 30, 2023 and 2022.
+Added: of cash, cash equivalents, accounts receivable, inventory, prepaids and deferred offering costs, accounts payable and accrued expenses
+Added: and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities.
+Added: The fair value
+Added: of the warrant liability was based on Level 3 inputs as well the Company’s underlying stock price and associated volatility, expected
+Added: term of the warrants and market interest rates.
+Added: There were no transfers between fair value hierarchy levels during the years ended
+Added: September 30, 2024 and 2023.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+Added: The fair value of financial instruments measured
+Added: on a recurring basis is as follows:
+Added: As of September 30, 2024
+Added: Warrant liability
+Added: Total liabilities at fair value
+Added: There was not a warrant liability as of September
+Added: The following table provides a roll-forward of
+Added: the warrant liability measured at fair value on a recurring basis using unobservable level 3 inputs for the year ended September
+Added: Warrant liability
+Added: Balance as of beginning of year
+Added: Value assigned to warrants in connection with 2024 Private Placement
+Added: Change in fair value of warrant liability
+Added: Balance as of end of year
Intellectual Property
7 unchanged sentences
Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line
−Removed: The estimated useful life for equipment and furniture ranges from three to seven years and three years for
−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: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
+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.
Impairment of Long-Lived Assets
−Removed: The Company evaluates its long-lived assets,
−Removed: which consist of licensed intellectual property, property and equipment and right-of-use assets for impairment whenever events or changes
−Removed: in circumstances indicate that the carrying value of these assets may not be recoverable.
−Removed: The Company assesses the recoverability of
−Removed: long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future
−Removed: If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying
−Removed: value and the fair value of the impaired asset.
−Removed: Allowances for Doubtful Accounts
−Removed: The Company records a provision for doubtful
−Removed: accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable.
−Removed: In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable,
−Removed: its historical write-offs, the credit worthiness of each customer, and general economic conditions.
−Removed: Account balances are charged off
−Removed: against the allowance when the Company believes that it is probable that the receivable will not be recovered.
−Removed: Actual write-offs may
−Removed: be in excess of the Company’s estimated allowance.
+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 Allowances for Credit
+Added: The Company records a provision for credit losses,
+Added: when appropriate, based on historical experience, current conditions and reasonable supportable forecasts.
+Added: In estimating the allowance
+Added: for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the asset,
+Added: primarily using historical experience and current economic conditions that could affect the collectability of the balances in the future.
+Added: Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered.
+Added: Actual write-offs may be in excess of the Company’s estimated allowance.
+Added: The Company has not incurred any bad debt expense
+Added: to date and no allowance for credit losses has been recorded during the periods presented.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
Inventory is stated at the lower of cost (using
3 unchanged sentences
demand of the products and spare parts.
−Removed: The Company’s inventory is currently comprised of Strip/Grid Products, sEEG and electrode
−Removed: cable assembly work-in-process and finished good product.
−Removed: The Strip/Grid Products and sEEG Products are produced by a third-party contract
−Removed: manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers.
−Removed: No inventory valuation allowance was required
−Removed: during the periods presented.
+Added: The Company’s inventory is currently comprised of Strip/Grid Products, sEEG Products, OneRF
+Added: Products and Electrode Cable Assembly Products component, work-in-process and finished good product.
+Added: The Strip/Grid Products, sEEG Products
+Added: and OneRF Products are produced by a third-party contract manufacturer and the Electrode Cable Assembly Products are obtained from outside
+Added: No inventory valuation allowance was required during the periods presented.
Research and Development Costs
1 unchanged sentence
expense as incurred.
−Removed: Research and development expenses may include costs incurred in performing research and development activities,
−Removed: including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services,
−Removed: license fees, and other external costs.
−Removed: Non-refundable advance payments for goods and services that will be used in future research and
−Removed: development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is
−Removed: made, in accordance with ASC 730, Research and Development .
+Added: Research and development expenses comprise of costs incurred in performing research and development activities, including
+Added: compensation and benefits for research and development employees (including stock-based compensation), overhead expenses, cost of laboratory
+Added: supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants
+Added: and other outside expenses.
+Added: Non-refundable advance payments for goods and services that will be used in future research and development
+Added: activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance
+Added: 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 $ 108,993 and $ 173,430 for the
+Added: years ended September 30, 2024 and 2023, respectively.
Selling, General and Administrative
−Removed: Selling, general and administrative expenses
−Removed: consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with
−Removed: research and development activities.
−Removed: Other significant costs include legal and litigation costs relating to corporate matters, intellectual
−Removed: property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales
−Removed: and marketing in connection with the commercial sales of the Company’s products.
+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 financial and administrative matters, and sales and marketing in connection with
+Added: the commercial sales of the Company’s products.
Stock-Based Compensation
6 unchanged sentences
provisions of ASC 718.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
Income taxes are accounted for under the asset
7 unchanged sentences
if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
Net Loss Per Share
1 unchanged sentence
by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
−Removed: Diluted earnings or loss per share of common
−Removed: stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include
−Removed: additional shares from the assumed exercise of any common stock equivalents, if dilutive.
−Removed: The Company’s warrants, stock options,
−Removed: and restricted stock units while outstanding are considered common stock equivalents for this purpose.
−Removed: Diluted earnings or loss per share
−Removed: of common stock is computed utilizing the treasury method for the warrants, stock options and restricted stock units.
−Removed: No incremental
−Removed: common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the
−Removed: net loss reported for the years ended September 30, 2023 and 2022.
+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: years ended September 30, 2024 and 2023.
The following potential common shares were not
2 unchanged sentences
Restricted stock units
−Removed: Unissued vested restricted stock units
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
+Added: The guidance must be applied retrospectively to all prior periods presented.
+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.
In June 2016, the FASB issued Accounting Standards
−Removed: Update (“ASU”) 2016-13, “ Financial Instruments – Credit Losses” .
−Removed: The ASU sets forth a “current
−Removed: expected credit loss” (“CECL”) model which requires the Company to measure all expected credit losses for financial
−Removed: instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
−Removed: replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized
−Removed: cost and applies to some off-balance sheet credit exposures.
−Removed: This ASU is effective for fiscal years beginning after December 15, 2019,
−Removed: including interim periods within those fiscal years, with early adoption permitted.
−Removed: The FASB issued the final ASU to delay adoption for
−Removed: smaller reporting companies to fiscal years beginning after December 15, 2022.
+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.
The Company adopted the guidance on October 1, 2023.
−Removed: Company does not expect that the adoption of this ASU will have a material impact on its financial statements.
−Removed: In August 2020, the FASB issued ASU 2020-06 ,
−Removed: Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own
−Removed: Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which, among other
−Removed: things, provides guidance on how to account for contracts on an entity’s own equity.
−Removed: This ASU eliminates the beneficial conversion
−Removed: and cash conversion accounting models for convertible instruments.
−Removed: It also amends the accounting for certain contracts in an entity’s
−Removed: own equity that are currently accounted for as derivatives because of specific settlement provisions.
−Removed: In addition, this ASU modifies how
−Removed: particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation.
−Removed: amendments in this ASU are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15,
−Removed: 2023, including interim periods within those fiscal years.
−Removed: Early adoption is permitted, but no earlier than fiscal years beginning after
−Removed: December 15, 2020.
−Removed: The Company adopted ASU 2020-06 effective October 1, 2022 and the ASU did not have a material impact to its financial
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
+Added: The adoption of this ASU did not have a material impact on the Company’s financial
NOTE 4 - Commitments and Contingencies
1 unchanged sentence
The Company has entered into an exclusive start-up
−Removed: company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and
−Removed: thin film micro electrode technology (the “WARF Agreement”).
+Added: company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and thin
+Added: film micro electrode technology (the “WARF Agreement”).
The Company entered into an Amended and Restated Exclusive Start-up
12 unchanged sentences
the WARF License.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
WARF may terminate the WARF License on 30 days’
3 unchanged sentences
WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial
−Removed: 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
−Removed: to be paid, such earned royalties cease for more than four calendar quarters.
−Removed: The first commercial sale occurred on December 7, 2020,
−Removed: prior to the June 30, 2021 deadline.
−Removed: The WARF License otherwise expires by its terms on the date that no valid claims on the patents
−Removed: licensed thereunder remain.
+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.
The Company expects the latest expiration of a licensed patent to occur in 2030.
−Removed: During the years ended September
−Removed: 30, 2023 and 2022, $ 150,000 and $ 137,500 in royalty fees were incurred related to the WARF License, respectively, and were reflected
−Removed: as a component of cost of product revenue.
+Added: During each of the years ended September
+Added: 30, 2024 and 2023, $ 150,000 in royalty fees were incurred related to the WARF License and were reflected as a component of cost of product
Mayo Agreement
9 unchanged sentences
Headquarters Lease
−Removed: On October 7, 2019, the Company entered into
−Removed: a non-cancellable lease agreement (the “Lease”) with certain landlords (together, the “Landlord”) pursuant to
−Removed: which the Company has agreed to lease office space located at 7599 Anagram Drive, Eden Prairie, Minnesota (the “Premises”).
−Removed: The Company took possession of the Premises on November 1, 2019, with the term of the Lease ending 65 months after such date, unless
−Removed: terminated earlier (the “Lease Term”).
−Removed: The initial base rent for the Premises is $ 6,410 per month for the first 17 months,
−Removed: increasing to $ 7,076 per month by the end of the Lease Term.
−Removed: In addition, as long as the Company is not in default under the Lease, the
−Removed: Company shall be entitled to an abatement of its base rent for the first 5 months.
−Removed: In addition, the Company will pay its pro rata share
−Removed: of the Landlord’s annual operating expenses associated with the Premises, calculated as set forth in the Lease of which the Company
−Removed: is entitled to an abatement of these operating expense for the first 3 months.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
+Added: On May 20, 2024, the Company amended its non-cancellable
+Added: headquarters lease (the “Lease”) with certain landlords (together, the “Landlord”) pursuant to which the Company
+Added: leases office space located at 7599 Anagram Drive, Eden Prairie, Minnesota (the “Premises”).
+Added: The Company took possession of
+Added: the Premises on November 1, 2019, with the term of the Lease ending June 30, 2028, as amended, unless terminated earlier (the “Lease
+Added: The base rent for the Premises ranges from $ 6,410 per month to $ 7,107 per month by the end of the Lease Term as amended.
+Added: In addition, as long as the Company is not in default under the Lease, the Company will be entitled to an abatement of its base rent for
+Added: the first two months of the amended Lease Term beginning in April 2025 and for the last month of the amended Lease Term (June 2028).
+Added: addition, the Company pays its pro rata share of the Landlord’s annual operating expenses associated with the Premises.
Los Gatos Lease
6 unchanged sentences
The initial monthly rent under the Los Gatos Lease
−Removed: was approximately $ 4,241 .
+Added: was $ 4,241 .
On November 4, 2022, the Los Gatos Lease was extended for an additional two years to December 31, 2024.
−Removed: rent under the extended Los Gatos Lease ranges from $ 4,453 to $ 4,632 per month beginning on January 1, 2023.
+Added: The rent under the
+Added: extended Los Gatos Lease ranges from $ 4,453 to $ 4,632 per month beginning on January 1, 2023.
During the years ended September 30, 2024 and
3 unchanged sentences
For the Years Ended
+Added: September 30,
Cash paid for amounts included in the measurement of lease liability:
−Removed: Operating cash flows from
−Removed: operating leases
−Removed: Right-of-use assets obtained in exchange for lease obligations:
+Added: Operating cash flows from operating leases
+Added: Modification of right-of-use asset and associated lease liability:
Operating leases
−Removed: Supplemental balance sheet information related to the operating lease
−Removed: was as follows:
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+Added: Supplemental balance sheet information related
+Added: to the operating lease was as follows:
September 30,
6 unchanged sentences
September 30,
−Removed: 2023 (period from October 1, 2023 to December 31, 2023)
Total lease payments
Less imputed interest
−Removed: Short-term portion
+Added: Short term portion in accrued expenses and other liabilities
Long term portion
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
−Removed: NOTE 5 - Supplemental Balance Sheet
+Added: NOTE 5 - Supplemental Balance Sheet Information
Inventory consisted of the following:
3 unchanged sentences
Finished goods
+Added: The Company had finished goods on consignment
+Added: in the amount of $ 102,318 as of September 30, 2024.
+Added: There was no consigned inventory as of September 30, 2023.
Intangible assets roll forward is as follows:
3 unchanged sentences
Net intangibles, September 30, 2024
−Removed: The Company anticipates amortization expense
−Removed: of approximately $ 22,000 per year for fiscal year 2024 through 2027 based upon the two current license agreements.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+Added: The Company anticipates amortization expense of
+Added: approximately $ 22,000 per year for fiscal year 2025 through 2027 based upon the two current license agreements.
Property and Equipment
9 unchanged sentences
Equipment with a net book value of $ 39,643 was disposed by the Company
−Removed: resulting in net proceeds of $ 7,500 .
+Added: resulting in net proceeds of $ 7,500 during the year ended September 30, 2023.
NOTE 6 - Accrued Expenses and Other Liabilities
4 unchanged sentences
Operating lease liability, short term
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
−Removed: NOTE 7 - Zimmer Development Agreement
−Removed: On July 20, 2020, the Company entered into an
−Removed: exclusive development and distribution agreement (the “Development Agreement”) with Zimmer, Inc.
−Removed: pursuant to which the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and electrode cable assembly
−Removed: products (the “Electrode Cable Assembly Products”).
−Removed: Additionally, the Company granted Zimmer the exclusive right and license
−Removed: to distribute certain depth electrodes developed by the Company (“SEEG Products”, and together with the Strip/Grid Products
−Removed: and Electrode Cable Assembly Products, the “Products”).
−Removed: The parties have agreed to collaborate with respect to development
−Removed: activities under the Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer
−Removed: and the Company.
−Removed: Under the terms of the Development Agreement,
+Added: NOTE 7 - Zimmer Distribution Agreement and
+Added: Other Product Revenue
+Added: On July 20, 2020, the Company entered into
+Added: an exclusive development and distribution agreement (the “Zimmer Distribution 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 Distribution 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 Distribution Agreement,
the Company is responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and
expenses related to the commercialization of the Products.
−Removed: In addition to the Development Agreement, Zimmer and the Company have entered
−Removed: into a Manufacturing and Supply Agreement and a supplier quality agreement with respect to the manufacturing and supply of the Products.
−Removed: Except as otherwise provided in the Development
+Added: In addition to the Zimmer Distribution 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 Distribution
Agreement, the Company is responsible for performing all development activities, including non-clinical and clinical studies directed
1 unchanged sentence
Zimmer has agreed to use commercially reasonable efforts to promote, market and sell
−Removed: each Product following the “Product Availability Date” (as defined in the Development Agreement) for such Product.
−Removed: Pursuant to the Development Agreement, Zimmer
−Removed: made an upfront initial exclusivity fee payment of $ 2.0 million (the “Initial Exclusivity Fee”) to the Company in fiscal
+Added: each Product following the “Product Availability Date” (as defined in the Zimmer Distribution Agreement) for such Product.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+Added: Pursuant to the Zimmer Distribution 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.
On August 2, 2022, the Company entered into a
−Removed: Third Amendment to Exclusive Development and Distribution Agreement (the “Amendment”) with Zimmer.
−Removed: Pursuant to the terms
−Removed: and conditions of the Amendment, Zimmer made a $ 3.5 million payment to the Company.
−Removed: In consideration of the mutual covenants and
−Removed: agreements contained in the Development Agreement, the fee and milestone payment provisions in the Development Agreement were replaced
−Removed: with the following below:
+Added: Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer Amendment”) with Zimmer.
+Added: 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 Distribution Agreement, the fee and milestone payment provisions in the Zimmer Distribution
+Added: Agreement were replaced with the following below:
● $ 1.5 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 Development Agreement even though the satisfaction was after the deadlines originally identified.
−Removed: In addition, in connection with the Amendment,
+Added: ● $ 2.0 million for satisfaction of each of the milestone events
+Added: related to the design of sEEG Products set forth in the Zimmer Distribution Agreement even though the satisfaction was after the deadlines
+Added: originally identified.
+Added: In addition, in connection with the Zimmer Amendment,
the Company issued Zimmer a warrant to purchase common stock (the “2022 Zimmer Warrant”).
2 unchanged sentences
The 2022 Zimmer Warrant has an exercise
−Removed: price of $ 3.00 per share, will be exercisable commencing six months from the issuance date, and will expire on August 2, 2027 .
−Removed: fair value of the 2022 Zimmer Warrant of $ 0.1 million was based on the Black-Scholes pricing model.
+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:
7 unchanged sentences
fixed and determinable, no cash settlement was required and no other provisions precluded equity treatment.
−Removed: The Development Agreement will expire on the
−Removed: tenth anniversary of the date of the first commercial sale of the last Products to achieve a first commercial sale (the “Term”),
−Removed: unless terminated earlier pursuant to its terms.
−Removed: Either party may terminate the Development Agreement (x) with written notice for the
−Removed: other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.
−Removed: In addition, Zimmer may terminate the Development Agreement for any reason with 90 days’ written notice, and the Company may terminate
−Removed: the Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company.
−Removed: The license rights granted to Zimmer under the Strip/Grid Distribution License and sEEG Distribution License shall be exclusive from
−Removed: the Effective Date of the Amendment until the end of the Term.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
−Removed: The Development Agreement and Amendment
+Added: The Zimmer Distribution Agreement will expire
+Added: on the tenth anniversary of the date of the first commercial sale of the last Products to achieve a first commercial sale, unless terminated
+Added: earlier pursuant to its terms.
+Added: Either party may terminate the Zimmer Distribution Agreement (x) with written notice for the other party’s
+Added: material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.
+Added: In addition, Zimmer
+Added: may terminate the Zimmer Distribution Agreement for any reason with 90 days’ written notice, and the Company may terminate the Zimmer
+Added: Distribution Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company.
+Added: The license rights granted to Zimmer under the Strip/Grid Distribution License and sEEG Distribution License as defined in the Zimmer
+Added: Distribution Agreement shall be exclusive from the effective date of the Zimmer Amendment until the end of the term of the Zimmer Amendment.
+Added: The Zimmer Distribution Agreement and Zimmer Amendment
were accounted for under the provisions of ASC 606.
In accordance with the provisions under ASC 606, the Company identified five performance
−Removed: obligations under the Development Agreement and Amendment:
−Removed: (1) the Company’s obligation to grant Zimmer access to its intellectual
−Removed: (2) completion SEEG Product development;
+Added: obligations under the Zimmer Distribution 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;
(3) completion of Strip/Grid Product development;
−Removed: (4) the provision of sEEG exclusivity
+Added: (4) the provision
+Added: of sEEG exclusivity maintenance;
and (5) completion of sEEG design modifications as requested by Zimmer.
−Removed: All performance obligations under the Development
−Removed: Agreement and Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September 30, 2022.
−Removed: The remaining performance
−Removed: obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance was completed in first quarter of
−Removed: fiscal year 2023.
+Added: All performance obligations under
+Added: the Zimmer Distribution Agreement and Zimmer Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September
+Added: The remaining performance obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance
+Added: was completed in first quarter of fiscal year 2023.
The aggregate transaction price associated with
−Removed: the Development Agreement and Amendment was $ 5.4 million comprising the Initial Exclusivity Fee of $ 2.0 million and the $ 3.5 million
−Removed: payment under the Amendment, less the fair value 2022 Zimmer Warrant of $ 0.1 million.
−Removed: The transaction price was allocated between performance
−Removed: obligations based on their relative standalone selling prices.
−Removed: The Company used a market based valuation approach and an expected cost
−Removed: plus margin approach with regard to estimating the standalone selling price for the performance obligations.
−Removed: The Company recognized revenue
−Removed: in the amount of $ 1,455,188 and $ 1,948,872 during the years ended September 30, 2023 and 2022, respectively, in connection
−Removed: with the Development Agreement and Amendment.
+Added: the Zimmer Distribution 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 year ended September 30, 2023 in connection with
+Added: the Zimmer Distribution Agreement and Zimmer Amendment.
+Added: Given the achievement of the milestones under the Zimmer Distribution Agreement
+Added: and Zimmer Amendment by December 31, 2022, no collaborations revenue was recognized during the year ended September 30, 2024.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
A reconciliation of the closing balance of deferred
−Removed: revenue related to the Development Agreement and Amendment is as follows as of September 30, 2023 and 2022:
+Added: revenue related to the Zimmer Distribution Agreement and the Zimmer Amendment is as follows as of September 30, 2024 and 2023:
Deferred Revenue
Balance as of September 30, 2022
−Removed: Zimmer agreement amendment related to sEEG exclusivity maintenance
Revenue recognized
2 unchanged sentences
Revenue recognized
−Removed: ( 1,455,188 )
Balance as of September 30, 2024
Product Revenue
−Removed: Product revenue is related to its Strip/Grid
−Removed: Products, sEEG Products and Electrode Cable Assembly Products.
−Removed: Product revenue recognized during the years ended September 30, 2023
−Removed: and 2022 was $ 1,952,441 and $ 171,169 , respectively.
−Removed: Advertising Expense
−Removed: Advertising expense is charged to selling, general
−Removed: and administrative expenses during the period that it is incurred.
−Removed: Total advertising expense amounted to $ 173,430 and $ 270,612 for the
−Removed: years ended September 30, 2023 and 2022, respectively.
+Added: Product revenue related to the Company’s
+Added: Strip/Grid Products, sEEG Products, OneRF Products and Electrode Cable Assembly Products.
+Added: Product revenue recognized during the years
+Added: ended September 30, 2024 and 2023 was $ 3,453,003 and $ 1,952,441 , respectively, inclusive of OneRF Product revenue that amounted to $ 340,185
+Added: during the year ended September 30, 2024.
+Added: There was no OneRF Product revenue recognized during the prior year period presented.
+Added: Products were not covered by the Zimmer Distribution Agreement during the year ended September 30, 2024.
NOTE 8 - Stock-Based Compensation
During the years ended September 30, 2024 and
−Removed: 2022, stock-based expense related to the stock options, restricted stock units and stock awards was included in selling, general and
−Removed: administrative and research and development costs as follows in the accompanying statements of operations:
+Added: 2023, stock-based expense related to the stock options and restricted stock units was included in selling, general and administrative
+Added: and research and development costs as follows in the accompanying statements of operations:
Selling, general and administrative
1 unchanged sentence
Total stock-based compensation expense
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
The Company’s 2017 Equity Incentive Plan
2 unchanged sentences
Inducement Plan
−Removed: In addition to the Company’s 2017 Plan,
−Removed: the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”) on October
−Removed: 4, 2021, pursuant to which the Company reserved 420,350 shares of its common stock to be used exclusively for grants of awards to individuals
−Removed: who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment
−Removed: with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules.
−Removed: The Inducement Plan was approved by the Company’s
−Removed: board of directors without stockholder approval in accordance with such rule.
−Removed: On November 9, 2023, the Company’s board of directors
−Removed: adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock that may
−Removed: be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for a total of 570,350 shares of common stock
−Removed: that may be issued pursuant to equity incentive awards under the 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.
Evergreen provision
12 unchanged sentences
2024 and 2023, 1,051,556 and 129,479 shares were added to the 2017 Plan, respectively, as a result of the evergreen provision.
−Removed: Stock Options
+Added: Medical Technologies Corporation
+Added: to Financial Statements
During the years ended September 30, 2024 and
−Removed: 2022, 459,512 and 152,690 stock options were granted to employees, directors and consultants, respectively, with a weighted average grant
−Removed: date fair value of $ 0.88 and $ 0.76 per share, respectively.
−Removed: The options granted have vesting periods ranging from being immediate to
+Added: 2023, 1,225,669 and 459,512 stock options were granted to employees, directors and consultants, respectively, with a weighted average
+Added: grant date fair value of $ 1.08 and $ 0.88 per share, respectively.
+Added: The options granted have vesting periods ranging from being immediate
+Added: to four years .
All options expire ten years from the date of grant.
−Removed: The total expense for the years ended September 30, 2023 and 2022 related
−Removed: to the stock options was $ 632,315 and $ 582,329 , respectively.
−Removed: The following table summarizes the Company’s stock option plan activity
−Removed: for the years ended September 30, 2023 and 2022 as follows:
+Added: The total expense for the years ended September 30, 2024 and 2023
+Added: related to the stock options was $ 808,057 and $ 632,315 , respectively.
+Added: The following table summarizes the Company’s stock option
+Added: plan activity for the years ended September 30, 2024 and 2023 as follows:
+Added: Options Weighted
+Added: Price Weighted-
+Added: Term (years) Aggregate
Outstanding at September 30, 2022 1,239,915 $ 5.40 8.0 $ 89,295
+Added: Granted 469,512 $ 1.55 — —
Forfeited/Cancelled ( 1,000 ) $ 3.78 — —
Outstanding at September 30, 2023 1,708,427 $ 4.34 7.7 $ 20,064
+Added: Granted 1,225,669 $ 1.26 — —
Forfeited/Cancelled ( 120,000 ) $ 1.33 — —
4 unchanged sentences
As of September 30, 2024 and 2023, 2,780,581 and 1,682,912 outstanding options, respectively, had no intrinsic value.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
−Removed: The weighted-average assumptions used in the
−Removed: Black-Scholes option-pricing model are as follows for the stock options granted during the years ended September 30:
+Added: The weighted-average assumptions used in the Black-Scholes
+Added: option-pricing model are as follows for the stock options granted during the years ended September 30:
Expected stock price volatility 111.9 % 57.4 %
4 unchanged sentences
2023, 289,072 and 337,753 stock options vested, respectively.
+Added: During the years ended September 30, 2024 and 2023, 120,000 and 1,000 stock
+Added: options were forfeited, respectively.
No options were exercised during the years ended September 30, 2024 and 2023.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
Restricted Stock Units
5 unchanged sentences
During the years ended September 30, 2024 and
−Removed: 2022, 310,728 and 443,670 RSUs were granted to members of the Company’s board of directors and employees that vest over a period
−Removed: ranging from a one year to three year period, with a grant date fair value of $ 1.60 and $ 1.91 per unit, respectively.
−Removed: During the years
−Removed: ended September 30, 2023 and 2022, 331,788 and 40,624 RSUs vested, respectively.
−Removed: The total expense for the years ended September 30,
−Removed: 2023 and 2022 related to the RSU’s was $ 473,142 and $ 364,883 , respectively.
+Added: 2023, 1,006,725 and 310,728 RSUs were granted to members of the Company’s board of directors and employees with a grant date fair
+Added: value of $ 1.03 and $ 1.60 per unit, respectively.
+Added: The RSUs granted in fiscal year 2024 vest over a four -year period in equal annual installments
+Added: on the anniversary date of the grant, subject to the recipient’s continued service on such dates.
+Added: The RSUs granted in fiscal 2023
+Added: vest over a one to three year period with some of the RSUs vesting ratably on a monthly basis and others vesting
+Added: at 50 percent on the first anniversary of the grant date with the remaining RSUs vesting in equal quarterly installments on
+Added: the last day of each quarter over 24 months, subject to the recipient’s continued service on such dates.
+Added: During the years ended
+Added: September 30, 2024 and 2023, 270,333 and 331,788 RSUs vested, respectively.
+Added: The total expense for the years ended September 30, 2024 and
+Added: 2023 related to the RSU’s was $ 536,419 and $ 473,142 , respectively.
No RSUs were forfeited during the years ended September 30, 2024
−Removed: 30, 2023 and 2022.
As of September 30, 2024, 297,461 shares were
available for future issuance on a combined basis under the 2017 Plan and the Inducement Plan.
−Removed: Unrecognized stock-based compensation
−Removed: was $ 1,474,119 as of September 30, 2023.
−Removed: The unrecognized share-based expense is expected to be recognized over a weighted average
−Removed: period of 1.8 years.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
+Added: Unrecognized stock-based compensation was
+Added: $ 2,373,628 as of September 30, 2024.
+Added: The unrecognized share-based expense is expected to be recognized over a weighted average period
+Added: of 2.3 years.
NOTE 9 - Stockholders’ Equity
+Added: August 2024 Private Placement
+Added: On August 1, 2024, the
+Added: Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors
+Added: (the “Purchasers”), pursuant to which the Company, in a private placement (the “2024 Private Placement”), agreed
+Added: to issue and sell an aggregate of (i) 2,944,446 shares of the Company’s common stock, par value $ 0.001 per share and (ii) warrants
+Added: to purchase an aggregate of 2,208,333 shares of common stock (the “PIPE Warrants”) at a purchase price of $ 0.90 per unit,
+Added: consisting of one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately
+Added: $ 2.65 million before deducting expenses.
+Added: Issuance costs attributed to the 2024 Private Placement amounted to approximately $ 0.2 million.
+Added: The 2024 Private Placement closed on August 2, 2024.
+Added: The PIPE Warrants are
+Added: exercisable beginning on the date of issuance, have an exercise price of $ 1.19 per share, subject to adjustment, and will expire on the
+Added: third anniversary of the date of issuance.
+Added: One of the Purchasers in the 2024 Private Placement included Paul Buckman, a director on the
+Added: Company’s Board of Directors.
+Added: The PIPE Warrants were
+Added: accounted for and classified as liabilities on the accompanying balance sheets given certain price reset provisions not used for a fair
+Added: valuation under a fixed for fixed settlement scenario as required for equity balance sheet classification.
+Added: A Monte Carlo simulation
+Added: model was used to estimate the aggregate fair value of the PIPE Warrants.
+Added: Input assumptions used were as follows on August 2, 2024 and
+Added: September 30, 2024:
+Added: risk-free interest rate 3.63 % and 3.53 %, respectively;
+Added: expected volatility of 116.1 % and 115.7 %;
+Added: respectively;
+Added: life of 3 years and 2.84 years, respectively;
+Added: and expected dividend yield zero percent for both dates.
+Added: The underlying stock price used
+Added: was the market price as quoted on Nasdaq as of August 2, 2024 and September 30, 2024.
+Added: The aggregate fair value of the PIPE Warrants of
+Added: $ 1,813,223 upon issuance was recorded as a long term liability on the accompanying balance sheets.
+Added: The Company recorded the fair
+Added: value change of the PIPE Warrants in the amount of $ 327,092 to the fair value change in warrant liability line item on the accompanying
+Added: statements of operations for the year ended September 30, 2024.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+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
+Added: 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
+Added: 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 was offering up to an aggregate of
+Added: $ 9.3 million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold.
+Added: On August 16,
+Added: 2024, we increased the amount of common stock that can be sold pursuant to the Sales Agreement by $ 3.0 million.
+Added: During the years ended September 30, 2024 and
+Added: 2023, 3,748,913 and 1,439,677 shares of common stock were issued, respectively, under the ATM for an aggregate offering price of $ 5,033,906
+Added: and $ 2,552,656 , respectively.
+Added: Issuance costs incurred under the ATM during the years ended
+Added: September 30, 2024 and 2023 were $ 277,903 and $ 234,725 , respectively.
+Added: The total aggregate offering price and common
+Added: stock issued since inception of the ATM though September 30, 2024 was $ 7,586,562 and 5,188,590 shares, respectively.
+Added: Cumulative issuance
+Added: costs incurred under the ATM through September 30, 2024 was $ 512,628 of which $ 41,305 was included as a deferred cost on the balance sheet
+Added: as of September 30, 2024.
July 2023 Public Offering
9 unchanged sentences
2023 Public Offering were approximately $ 5.2 million after deducting underwriting discounts and other offering expenses payable by the
−Removed: The Company intends to use the net proceeds from this offering to:
−Removed: (i) support the commercial launch of the EVO sEEG electrode
−Removed: with Zimmer Biomet, (ii) support the FDA submission for the OneRF ablation system and (iii) complete the design of a novel drug delivery
−Removed: electrode, among other general corporate purposes.
−Removed: At-The-Market Offering
−Removed: On December 21, 2022, the Company entered into
−Removed: a Capital on Demand TM Sales Agreement (“Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
−Removed: to create an at-the-market offering program (“ATM”) under which the Company may offer and sell shares having an aggregate
−Removed: offering price of up to $ 14.5 million.
−Removed: JonesTrading is entitled to a commission at a fixed commission rate equal to up to 3 % of the gross
−Removed: As of September 30, 2023, 1,439,677 shares of common stock were issued for gross proceeds of $ 2,552,656 under the ATM, and
−Removed: issuance costs in the amount of $ 234,725 have been incurred in connection with the ATM.
−Removed: On July 24, 2023, we decreased the amount of
−Removed: common stock that can be sold pursuant to the Sales Agreement, such that we were offering up to an aggregate of $ 2,560,000 of our common
−Removed: stock for sale under the Sales Agreement, including the shares of common stock previously sold.
−Removed: 2021 Public Offering
−Removed: On October 13, 2021, the Company, entered
−Removed: into an underwriting agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC, as underwriter (the “Underwriter”),
−Removed: relating to the issuance and sale of 3,750,000 shares of the Company’s common stock at a price to the public of $ 3.20 per share.
−Removed: In addition, under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 days, to
−Removed: purchase up to an additional 562,500 shares of common stock on the same terms.
−Removed: The base offering closed on October 15, 2021, and the
−Removed: sale of 422,057 shares of common stock subject to the Underwriter’s overallotment option closed on November 15, 2021.
−Removed: The gross proceeds to the Company from this offering
−Removed: were approximately $ 13.4 million prior to deducting underwriting discounts and other offering expenses payable by the Company in
−Removed: the amount of approximately $ 1.4 million in the aggregate.
+Added: The Company used the net proceeds from this offering to:
+Added: (i) support the commercial launch of the EVO sEEG electrode with Zimmer
+Added: Biomet, (ii) support the FDA submission for the OneRF ablation system and (iii) complete the design of a novel drug delivery electrode,
+Added: among other general corporate purposes.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
Warrant Activity and Summary
1 unchanged sentence
during the years ended September 30, 2024 and 2023:
+Added: Warrants Exercise
+Added: Warrant Weighted
Average Exercise
+Added: Price Weighted
Outstanding and exercisable at September 30, 2022 7,103,344 $ 3.00 - 9.00 $ 5.98 2.68
−Removed: $ 5.25 - 9.00
−Removed: Reverse split adjustment correction
+Added: Expired ( 900,918 ) $ 5.61 - 9.00 $ 6.38 —
Outstanding and exercisable at September 30, 2023 6,202,426 $ 3.00 - 9.00 $ 5.92 2.00
−Removed: $ 3.00 - 9.00
−Removed: $ 5.61 - 9.00
+Added: Issued 2,308,338 $ 0.66 - 1.19 $ 1.17 3.09
+Added: Expired ( 1,464,889 ) $ 6.00 - 9.00 $ 8.59 —
Outstanding at September 30, 2024 7,045,875 $ 0.66 - 5.61 $ 3.81 1.98
−Removed: $ 3.00 - 9.00
Outstanding and exercisable at September 30, 2024 7,045,875 $ 0.66 - 5.61 $ 3.81 1.98
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
The following table summarizes information about
warrants outstanding at September 30, 2024:
−Removed: Exercise Price
−Removed: Number Outstanding
−Removed: Weighted Average
+Added: Exercise Price Number Outstanding Weighted Average
Remaining Contractual
−Removed: Number Exercisable at
+Added: life (Years) Number Exercisable at
+Added: September 30,
+Added: $ 0.66 100,000 4.84 100,000
+Added: $ 1.19 2,208,338 2.84 2,208,338
+Added: $ 3.00 350,000 2.84 350,000
+Added: $ 5.25 4,166,682 1.29 4,166,682
+Added: $ 5.61 220,855 3.75 220,855
+Added: Total 7,045,875 7,045,875
+Added: NOTE 10 - Debt Financing
+Added: Debt Facility Financing
+Added: On August 2, 2024, the Company entered into a loan
+Added: and security agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding, LLC, as the lender (the “Lender”),
+Added: which provides for a delayed draw term loan facility in an aggregate principal amount not to exceed $ 3.0 million (the “Debt Facility”).
+Added: The Company was permitted to borrow loans under the Debt Facility from time to time (collectively, the “Loans”), for general
+Added: corporate purposes and subject to certain specified conditions, until the earliest of:
+Added: (i) November 30, 2024, (ii) the occurrence of any
+Added: Monetization Event (as defined below) or Change of Control (as defined in the Debt Facility Agreement), or (iii) at the Lender’s
+Added: option, upon the occurrence and during the continuance of an event of default under the Debt Facility Agreement.
+Added: On November 7, 2024,
+Added: the Company terminated the Debt Facility Agreement (See Note 14 – Subsequent Events).
+Added: The Loans would have
+Added: matured on February 2, 2026, if issued.
+Added: Interest on any outstanding principal amount would have been at a rate of 10 % per annum, payable
+Added: monthly in arrears and at the maturity date.
+Added: As of September 30, 2024, no amounts were drawn under the Debt Facility Agreement by the
+Added: At closing of the Debt
+Added: Facility, the Company issued to the Lender a warrant exercisable for five years for 100,000 shares of common stock at an exercise price
+Added: of $ 0.66 per share, subject to adjustment (the “Closing Date Debt Facility Warrant”).
+Added: The Closing Date Debt Facility Warrant
+Added: was accounted for and classified as equity on the accompanying balance sheets.
+Added: At the time of any borrowing
+Added: of Loans, the Company would have issued to the Lender additional warrants exercisable for five years for 50,000 shares of common stock
+Added: (for each $ 500,000 of Loans borrowed) at the same per share exercise price as the Closing Date Debt Facility Warrant ( the “Additional
+Added: Debt Facility Warrants”, and together with the Closing Date Debt Facility Warrant, the “Debt Facility Warrants”).
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
+Added: The Company was permitted
+Added: to voluntarily prepay the outstanding Loans at any time, without premium or penalty, upon five business days’ prior written notice
+Added: to the Lender.
+Added: The Company was required to prepay outstanding Loans upon the occurrence of (i) any Change of Control or (ii) certain other
+Added: events as more fully described in the Debt Facility Agreement, but in any event including any capital raise or other transaction pursuant
+Added: to which the Company received cumulative cash proceeds in excess of $ 5.0 million in the aggregate (each such event in this prong (ii),
+Added: a “ Monetization Event ”).
+Added: The obligations of the Company under the Debt Facility were secured by a first-priority security
+Added: interest in substantially all assets of the Company, subject to certain exceptions set forth in the Debt Facility Agreement.
+Added: The Debt Facility Agreement
+Added: included other customary representations and warranties, conditions, affirmative and negative covenants, and events of default.
+Added: Issuance costs incurred
+Added: through September 30, 2024 in connection with the Debt Facility amounted to $ 202,656 which included legal fees of $ 74,532 , warrant fair
+Added: of the warrant issuance in the amount of $ 53,124 and a transaction fee to the lender in the amount of $ 75,000 and were initially recorded
+Added: as a deferred cost on the accompanying balance sheets.
+Added: The deferred costs were being amortized over the term of the Debt Facility.
+Added: the year ended September 30, 2024, $ 101,329 of the deferred costs were amortized and were included in the financing costs line item in
+Added: the accompanying statements of operations.
NOTE 11 - Concentrations
−Removed: One customer accounts for all of the Company’s
−Removed: product and collaborations revenue.
+Added: For the year ended September 30, 2024, one customer
+Added: accounted for 90 % of the Company’s product revenue and three customers accounted for the remaining 10 % of product revenue.
+Added: year ended September 30, 2023, one customer accounted for all of the Company’s product and collaborations revenue.
Supplier concentration
31 unchanged sentences
Net deferred tax assets
−Removed: NeuroOne Medical Technologies Corporation
+Added: NeuroOne Medical Technologies
Notes to Financial Statements
19 unchanged sentences
losses incurred after December 31, 2017 will not expire.
−Removed: As of September 30, 2023 and 2022, the Company had state net operating loss
−Removed: carryforwards of approximately $ 40,522,000 and $ 35,249,000 , respectively.
+Added: As of September 30, 2024 and 2023, the Company had state net operating loss carryforwards
+Added: of approximately $ 48,030,000 and $ 40,522,000 , respectively.
The Company had state research credit carryforwards of approximately $ 747,000
and $ 598,000 as of September 30, 2024 and 2023, respectively.
−Removed: The state net operating loss carryforwards will begin to expire
−Removed: in 2031, if not utilized, and the state research credit carryforwards will begin to expire in 2032 if not utilized.
+Added: The state net operating loss carryforwards will begin to expire in 2031,
+Added: if not utilized, and the state research credit carryforwards will begin to expire in 2032 if not utilized.
Utilization of the net operating loss carryforwards
−Removed: and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the
−Removed: Internal Revenue Code of 1986, as amended, and similar state provisions.
−Removed: Generally, in addition to certain entity reorganizations, the
−Removed: limitation applies when one or more “5-percent shareholders” increase their ownership, in the aggregate, by more than 50
−Removed: percentage points over a 36-month testing period or beginning the day after the most recent ownership change, if shorter.
−Removed: limitation may result in the expiration of net operating losses and credits before utilization.
+Added: and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal
+Added: Revenue Code of 1986, as amended, and similar state provisions.
+Added: Generally, in addition to certain entity reorganizations, the limitation
+Added: applies when one or more “ 5 -percent shareholders” increase their ownership, in the aggregate, by more than 50 percentage points
+Added: over a 36-month testing period or beginning the day after the most recent ownership change, if shorter.
+Added: The annual limitation may result
+Added: in the expiration of net operating losses and credits before utilization.
In accordance with ASC 740, Income Taxes (“ASC
17 unchanged sentences
statements of operations.
−Removed: NeuroOne Medical Technologies Corporation
−Removed: Notes to Financial Statements
The Company has tax filing obligations in the
1 unchanged sentence
federal, Minnesota and California.
−Removed: The income tax returns since inception as a corporation in 2016 are
−Removed: subject to examination by the federal and state taxing authorities.
+Added: The income tax returns since 2021 are subject to examination by the federal
+Added: and state taxing authorities.
+Added: NeuroOne Medical Technologies
+Added: Notes to Financial Statements
NOTE 13 - Defined Contribution Plan
13 unchanged sentences
date of hire.
−Removed: The amount of contributions made by the Company under the 401K Plan during the years ended September 30, 2023 and 2022
−Removed: was nil and $ 30,697 , respectively.
+Added: The Company did not make any contributions to the 401K Plan during the years ended September 30, 2024 and 2023.
NOTE 14 - Subsequent Events
−Removed: First Amendment to 2021 Inducement Plan
−Removed: On November 9, 2023, the Company’s board
−Removed: of directors adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock
−Removed: that may be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for a total of 570,350 shares.
−Removed: At-The-Market Offering
−Removed: On December 1, 2023, the Company increased the amount of common stock that can be sold pursuant to the Sales Agreement
−Removed: with JonesTrading, such that we are offering up to an aggregate of $ 4.8 million of common stock for sale under the Sales Agreement, including
−Removed: the shares of common stock previously sold.
+Added: On October 25, 2024, we entered into the Zimmer
+Added: Amended and Restated Distribution Agreement with Zimmer pursuant to which we granted Zimmer the exclusive right and license to distribute
+Added: our OneRF Ablation System for an upfront payment of $ 3.0 million, with eligibility for an additional $ 1.0 million payment from Zimmer
+Added: upon achievement of certain specified net sales milestones.
+Added: On November 7, 2024, the Company terminated the
+Added: Debt Facility Agreement and no amounts were drawn under the Debt Facility Agreement, The Company and paid the standby fee of $ 125,000
+Added: to the Lender.
Medical Technologies Corporation
−Removed: CHANGES IN AND DISAGREEMENTS WITH
−Removed: ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
+Added: CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
+Added: AND FINANCIAL DISCLOSURE
Not applicable.
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.