Item 8. Financial Statements and Supplementary Data
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY
DATA
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID 23 ) F-2
Balance Sheets F-3
Statements of Operations F-4
Statements of Changes in Stockholders’ Equity F-5
Statements of Cash Flows F-6
Notes to Financial Statements F-7
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the board of directors of NeuroOne Medical Technologies Corporation:
Opinion on the Financial Statements
We have
audited the accompanying balance sheets of NeuroOne Medical Technologies Corporation (the "Company") as of September 30, 2023 and 2022,
the related statements of operations, changes in stockholders’ equity, and cash flows, for each of the two years in the period ended
September 30, 2023, and the related notes (collectively referred to as the " financial statements"). In our opinion, the financial statements
present fairly, in all material respects, the financial position of the Company as of September 30, 2023 and 2022, and the results of
the Company’s operations and cash flows for each of the two years in the period ended September 30, 2023, in conformity with accounting
principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming
the Company will continue as a going concern. As discussed in Note 2 of the financial statements, the Company had recurring losses from
operations and an accumulated deficit, expects to incur losses for the foreseeable future and requires additional working capital. These
are the reasons that raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans
in regard to these matters are also described in Note 2. The financial statements do not contain any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility
is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with
the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose
of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such
opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used
and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that
our audits provide a reasonable basis for our opinion.
Critical Audit Matter
Critical audit matters are matters arising from the current
period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate
to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex
judgments. We determined that there are no critical audit matters.
/s/ Baker Tilly US, LLP
We have served as the Company's auditor since
2021.
Minneapolis, Minnesota
December 15, 2023
F- 2
NeuroOne Medical Technologies Corporation
Balance Sheets
As of
September 30,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$ 5,322,493
$ 8,160,329
Short-term investments
—
2,981,010
Accounts receivable
—
33,237
Inventory
1,726,686
704,538
Prepaid expenses
263,746
296,649
Total current assets
7,312,925
12,175,763
Intangible assets, net
89,577
111,892
Right-of-use asset
169,059
181,355
Property and equipment, net
525,753
353,599
Total assets
$ 8,097,314
$ 12,822,609
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 685,104
$ 927,662
Accrued expenses and other liabilities
1,107,522
715,839
Deferred revenue
—
1,455,188
Total current liabilities
1,792,626
3,098,689
Operating lease liability, long term
55,284
119,556
Total liabilities
1,847,910
3,218,245
Commitments and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 10,000,000 shares authorized as of September 30, 2023 and 2022; no shares issued or outstanding as of September 30, 2023 and 2022.
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized as of September 30, 2023 and 2022; 23,928,945 and 16,216,540 shares issued and outstanding as of September 30, 2023 and 2022, respectively.
23,929
16,217
Additional paid–in capital
68,911,778
60,414,959
Accumulated deficit
( 62,686,303 )
( 50,826,812 )
Total stockholders’ equity
6,249,404
9,604,364
Total liabilities and stockholders’ equity
$ 8,097,314
$ 12,822,609
See accompanying notes to financial statements
F- 3
NeuroOne Medical Technologies Corporation
Statements of Operations
Years ended
September 30,
2023
2022
Product revenue
$ 1,952,441
$ 171,169
Cost of product revenue
1,495,924
241,963
Product gross profit (loss)
456,517
( 70,794 )
Collaborations revenue
1,455,188
1,948,872
Operating expenses:
Selling, general and administrative
6,926,269
6,979,416
Research and development
6,940,686
4,929,427
Total operating expenses
13,866,955
11,908,843
Loss from operations
( 11,955,250 )
( 10,030,765 )
Other income, net
95,759
31,152
Loss before income taxes
( 11,859,491 )
( 9,999,613 )
Provision for income taxes
—
—
Net loss
$ ( 11,859,491 )
$ ( 9,999,613 )
Net loss per share:
Basic and diluted
$ ( 0.65 )
$ ( 0.63 )
Number of shares used in per share calculations:
Basic and diluted
18,121,108
15,998,567
See accompanying notes to financial statements
F- 4
NeuroOne Medical Technologies Corporation
Statements of Changes in Stockholders’
Equity
Common Stock
Additional
Paid–In
Accumulated
Total Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance at September 30, 2021
12,010,019
$ 12,010
$ 47,369,090
$ ( 40,827,199 )
$ 6,553,901
Issuance of common stock in connection with public offering
4,172,057
4,172
13,346,410
—
13,350,582
Issuance cost in connection with public offering
—
—
( 1,352,280 )
—
( 1,352,280 )
Issuance of warrants in connection with Zimmer development agreement
—
—
104,562
—
104,562
Stock-based compensation
—
—
947,212
—
947,212
Issuance of common stock upon vesting of restricted stock units
34,464
35
( 35 )
—
—
Net loss
—
—
—
( 9,999,613 )
( 9,999,613 )
Balance at September 30, 2022
16,216,540
16,217
60,414,959
( 50,826,812 )
9,604,364
Issuance of common stock in connection with public offering
6,037,500
6,038
6,031,462
—
6,037,500
Issuance of common stock in connection with at-the-market offering program
1,439,677
1,440
2,551,216
—
2,552,656
Issuance cost in connection with common stock issuances
—
—
( 1,071,663 )
—
( 1,071,663 )
Stock-based compensation
—
—
1,105,457
—
1,105,457
Issuance of common stock upon vesting of restricted stock units
314,485
313
( 313 )
—
—
Share repurchases for the payment of employee taxes
( 79,257 )
( 79 )
( 119,340 )
—
( 119,419 )
Net loss
( 11,859,491 )
( 11,859,491 )
Balance at September 30, 2023
23,928,945
$ 23,929
$ 68,911,778
$ ( 62,686,303 )
$ 6,249,404
See accompanying notes to financial statements
F- 5
NeuroOne Medical Technologies Corporation
Statements of Cash Flows
Years ended
September 30,
2023
2022
Operating activities
Net loss
$ ( 11,859,491 )
$ ( 9,999,613 )
Adjustments to reconcile net loss to net cash used in operating
activities:
Amortization and depreciation
199,266
118,620
Stock-based compensation
1,105,457
947,212
Loss on disposal of fixed assets
32,143
—
Amortization of discounts and premiums on short-term investments
( 45,571 )
( 11,471 )
Non-cash lease expense
109,832
107,593
Issuance of warrants in connection with Zimmer contract
amendment
—
104,562
Change in assets and liabilities:
Accounts receivable
33,237
15,099
Inventory
( 1,022,148 )
( 606,251 )
Prepaid expenses and other assets
32,903
( 145,540 )
Accounts payable
( 247,189 )
515,438
Accrued expenses, deferred revenue,
operating lease and other liabilities
( 1,225,313 )
1,434,817
Net cash used in operating activities
( 12,886,874 )
( 7,519,534 )
Investing activities
Purchases of short-term investments
( 1,473,419 )
( 3,469,539 )
Maturities of short-term investments
4,500,000
500,000
Proceeds from the disposal of fixed assets
7,500
—
Purchases of property and equipment
( 384,117 )
( 275,226 )
Net cash provided by (used in) investing
activities
2,649,964
( 3,244,765 )
Financing activities
Proceeds from issuance of common stock in connection with public
offerings and at-the-market offering program
8,590,156
13,350,582
Issuance costs in connection with common stock issuances
( 1,071,663 )
( 1,327,300 )
Share repurchases for the payment of
employee taxes
( 119,419 )
—
Net cash provided by financing activities
7,399,074
12,023,282
Net (decrease) increase in cash and cash equivalents
( 2,837,836 )
1,258,983
Cash and cash equivalents at beginning
of year
8,160,329
6,901,346
Cash and cash equivalents at end of year
$ 5,322,493
$ 8,160,329
Supplemental non-cash financing and investing
transactions:
Unpaid purchases of property and equipment
$ 4,631
$ —
Modification of right-of-use asset and
associated lease liability
$ 97,536
$ —
Reclass of deferred offering costs to
additional paid-in capital in connection with public offering
$ —
$ 24,980
See accompanying notes to financial statements
F- 6
NeuroOne Medical Technologies
Corporation
Notes to Financial Statements
NOTE 1 - Organization and Nature of Operations
NeuroOne Medical Technologies Corporation (the
“Company” or “NeuroOne”), a Delaware corporation, is a medical technology company focused on the development
and commercialization of thin film electrode for continuous electroencephalogram (“cEEG”) and stereoelectrocencephalography
(“sEEG”) recording, monitoring, ablation, drug delivery and brain stimulation solutions to diagnose and treat patients with
epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological
disorders.
The Company received 510(k) clearance from the
United States (“U.S.”) Food and Drug Administration (“FDA”) for its Evo cortical electrode technology in November
2019 and in October 2022, the Company received 510(k) clearance from the FDA for its Evo sEEG electrode technology for temporary (less
than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals
at the subsurface level of the brain.
The Company is based in Eden Prairie, Minnesota.
Global Economic Conditions
Generally, worldwide economic conditions remain
uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and
financial markets, lingering effects of the COVID-19 pandemic and increased inflation. The general economic and capital market conditions
both in the U.S. and worldwide, have been volatile in the past and at times have adversely affected the Company’s access to capital
and increased the cost of capital. The capital and credit markets may not be available to support future capital raising activity on
favorable terms or at all. If economic conditions continue to decline, the Company’s future cost of equity or debt capital and
access to the capital markets could be adversely affected.
The COVID-19 pandemic that began in late 2019
introduced significant volatility to the global economy, disrupted supply chains and had a widespread adverse effect on the financial
markets. Additionally, the Company’s operating results could be materially impacted by changes in the overall macroeconomic environment
and other economic factors. Changes in economic conditions, supply chain constraints, logistics challenges, labor shortages, the conflicts
in Ukraine and the Middle East, disruptions in the banking system and financial markets, and steps taken by governments and central banks,
particularly in response to the COVID-19 pandemic as well as other stimulus and spending programs, have led to higher inflation, which
has led to an increase in costs and has caused changes in fiscal and monetary policy, including increased interest rates.
NOTE 2 - Going Concern
The accompanying financial statements have been
prepared on the basis that the Company will continue as a going concern. The Company has incurred losses since inception, negative cash
flows from operations, and an accumulated deficit of $ 62.7 million as of September 30, 2023. To date, the Company’s revenues have
not been sufficient to cover its full operating costs, and as such, has been dependent on funding operations through the issuance of debt
and sale of equity securities. With the July 2023 public offering, the Company has adequate liquidity to fund its operations through March
31, 2024. The raising of additional funds is not solely within the control of the Company. These factors raise substantial doubt about
the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result
from the outcome of this condition. If the Company is unable to raise additional funds, or the Company’s anticipated operating results
are not achieved, management believes planned expenditures may need to be reduced in order to extend the time period that existing resources
can fund the Company’s operations. The Company intends to fund ongoing activities by utilizing its current cash and cash equivalents
on hand, from product and collaborations revenue and by raising additional capital through equity or debt financings. If management is
unable to obtain the necessary capital, it may have a material adverse effect on the operations of the Company and the development of
its technology, or the Company may have to cease operations altogether.
F- 7
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 3 - Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been
prepared in accordance with accounting standards generally accepted in the United States of America (“U.S. GAAP”).
Management’s Use of Estimates
The preparation of financial statements in conformity
with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
Segment Information
Operating segments are components of an enterprise
for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker
in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive
Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment,
which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording,
monitoring, ablation, and brain stimulation solutions. Accordingly, the Company has a single reporting segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments
with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash
equivalents on the Balance Sheets. Cash equivalents are stated at cost, which approximates fair value. The Company’s cash and cash
equivalents may include demand deposit accounts with large financial institutions, institutional money market funds, U.S. Treasury securities,
and corporate notes and bonds. The Company monitors the creditworthiness of the financial institutions, institutional money market funds,
and corporations in which the Company invests its surplus funds. The Company has experienced no credit losses from its cash and cash
equivalent investments.
Short-Term Investments
The Company has periodically invested its excess
cash in U.S. Treasury securities and highly rated corporate securities. The Company has held these investments to maturity. Securities
with original maturity dates of more than three months were reported as held-to-maturity investments and were recorded at amortized cost,
which approximated fair value due to the negligible risk of changes in value due to interest rates. All investments held as September
30, 2022 had contractual maturities of less than one year. There were no short-term investments outstanding as of September 30, 2023.
The amortized cost and estimated fair values of the Company’s investments as of September 30, 2022 were as follows:
September 30, 2022
Unrealized
Unrealized
Amortized
Cost
Holding
Gains
Holding
Losses
Fair
Value
Short-term:
U.S. treasury and corporate notes
$ 2,981,010
$ —
$ 2,870
$ 2,978,140
Total
$ 2,981,010
$ —
$ 2,870
$ 2,978,140
F- 8
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Revenue Recognition
The Company entered into a development and distribution
agreement which has current and future revenue recognition implications. See “Note 7 – Zimmer Development Agreement.”
In determining the appropriate amount of revenue
to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of
the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations,
including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint
on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices;
and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
A performance obligation is a promise in a contract
to transfer a distinct good or service to the customer and is the unit of account in Account Standards Codification (“ASC”)
Topic 606 (“ASC 606”). Performance obligations may include license rights, development services, and services associated
with regulatory submission and approval processes. Significant management judgment is required to determine the level of effort required
under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If
the Company cannot reasonably estimate when its performance obligations are either completed or become inconsequential, then revenue
recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated
period of performance using the cumulative catch-up method.
Product Revenue
Revenues from product sales are recognized when
control of the promised goods or services is transferred to the Company’s customers, in an amount that reflects the consideration
the Company expects to be entitled to in exchange for those goods or services. At the inception of each customer contract, performance
obligations are identified and the total transaction price is allocated to the performance obligations.
Cost of Product Revenue
Cost of product revenue consists of the manufacturing
and materials costs incurred by the Company’s third-party contract manufacturer in connection with the Company’s strip and
grid cortical electrodes (the “Strip/Grid Products”), depth electrodes (“sEEG Products) and outside supplier materials
costs in connection with the electrode cable assembly products (“Electrode Cable Assembly Products”). In addition, cost of
product revenue includes royalty fees incurred in connection with the Company’s license agreements.
Collaborations Revenue
As part of the accounting for collaboration arrangements,
the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation
identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted
revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory
success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone
selling prices of the promised goods or service underlying each performance obligation.
Licenses of intellectual property : If
the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified
in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred
to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company
utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation
is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing
revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts
the measure of performance and related revenue recognition.
F- 9
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Milestone payments : At the inception of
each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved
and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant
revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction
price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable
of being achieved until those approvals are received. When the Company’s assessment of probability of achievement changes and variable
consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated
relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in collaborations
revenues based upon when the customer obtains control of each element.
Royalties : For arrangements that include
sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item
to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance
obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Fair Value of Financial Instruments
The Company’s accounting for fair value
measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring
basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level
3 measurements). The three levels of the fair value hierarchy are as follows:
● Level
1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities
accessible to the Company at the measurement date.
● Level
2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the
asset or liability, either directly or indirectly, for substantially the full term of the
asset or liability.
● Level
3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the
extent that observable inputs are not available, thereby allowing for situations in which
there is little, if any, market activity for the asset or liability at the measurement date.
As of September 30, 2023 and 2022, the fair values
of cash, cash equivalents, short-term investments, accounts receivable, inventory, prepaids and other assets, accounts payable and accrued
expenses and other liabilities approximated their carrying values because of the short-term nature of these assets or liabilities.
There were no transfers between fair value hierarchy
levels during the years ended September 30, 2023 and 2022.
Intellectual Property
The Company has entered into two licensing
agreements with major research institutions, which allow for access to certain patented technology and know-how. Payments under those
agreements are capitalized and amortized to selling, general and administrative expense over the expected useful life of the acquired
technology.
Property and Equipment
Property and equipment is recorded at cost and
reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line
method. The estimated useful life for equipment and furniture ranges from three to seven years and three years for
software. Tangible assets acquired for research and development activities and that have alternative use are capitalized over the useful
life of the acquired asset. Estimated useful lives are periodically reviewed, and, when appropriate, changes are made prospectively.
Software purchased for internal use consists primarily of amounts paid for perpetual licenses to third-party software providers and installation
costs. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be
performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.
F- 10
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets,
which consist of licensed intellectual property, property and equipment and right-of-use assets for impairment whenever events or changes
in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of
long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future
cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying
value and the fair value of the impaired asset.
Allowances for Doubtful Accounts
The Company records a provision for doubtful
accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable.
In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable,
its historical write-offs, the credit worthiness of each customer, and general economic conditions. Account balances are charged off
against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may
be in excess of the Company’s estimated allowance.
Inventory
Inventory is stated at the lower of cost (using
the first-in, first-out “FIFO” method) or net realizable value. The Company calculates inventory valuation adjustments for
excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future
demand of the products and spare parts. The Company’s inventory is currently comprised of Strip/Grid Products, sEEG and electrode
cable assembly work-in-process and finished good product. The Strip/Grid Products and sEEG Products are produced by a third-party contract
manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers. No inventory valuation allowance was required
during the periods presented.
Research and Development Costs
Research and development costs are charged to
expense as incurred. Research and development expenses may include costs incurred in performing research and development activities,
including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services,
license fees, and other external costs. Non-refundable advance payments for goods and services that will be used in future research and
development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is
made, in accordance with ASC 730, Research and Development .
Selling, General and Administrative
Selling, general and administrative expenses
consist primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with
research and development activities. Other significant costs include legal and litigation costs relating to corporate matters, intellectual
property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales
and marketing in connection with the commercial sales of the Company’s products.
Stock-Based Compensation
The Company accounts for stock-based compensation
in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation
costs related to equity instruments granted are recognized at the grant-date fair value over the requisite service period. The Company
records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable
provisions of ASC 718.
F- 11
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Income Taxes
Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit
carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance
if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Net Loss Per Share
Basic loss per share of common stock is computed
by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings or loss per share of common
stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include
additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options,
and restricted stock units while outstanding are considered common stock equivalents for this purpose. Diluted earnings or loss per share
of common stock is computed utilizing the treasury method for the warrants, stock options and restricted stock units. No incremental
common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the
net loss reported for the years ended September 30, 2023 and 2022.
The following potential common shares were not
considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the years ended September
30:
2023
2022
Warrants
6,202,426
7,103,344
Stock options
1,708,427
1,239,915
Restricted stock units
393,370
414,430
Unissued vested restricted stock units
—
7,316
Recent Accounting Pronouncements
In June 2016, the FASB issued Accounting Standards
Update (“ASU”) 2016-13, “ Financial Instruments – Credit Losses” . The ASU sets forth a “current
expected credit loss” (“CECL”) model which requires the Company to measure all expected credit losses for financial
instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This
replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized
cost and applies to some off-balance sheet credit exposures. This ASU is effective for fiscal years beginning after December 15, 2019,
including interim periods within those fiscal years, with early adoption permitted. The FASB issued the final ASU to delay adoption for
smaller reporting companies to fiscal years beginning after December 15, 2022. The Company adopted the guidance on October 1, 2023. The
Company does not expect that the adoption of this ASU will have a material impact on its financial statements.
In August 2020, the FASB issued ASU 2020-06 ,
Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own
Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which, among other
things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion
and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s
own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how
particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The
amendments in this ASU are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15,
2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after
December 15, 2020. The Company adopted ASU 2020-06 effective October 1, 2022 and the ASU did not have a material impact to its financial
statements.
F- 12
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 4 - Commitments and Contingencies
WARF License Agreement
The Company has entered into an exclusive start-up
company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and
thin film micro electrode technology (the “WARF Agreement”). The Company entered into an Amended and Restated Exclusive Start-up
Company License Agreement (the “WARF License”) with WARF on January 21, 2020, which amended and restated in full the prior
license agreement between WARF and NeuroOne, LLC, a predecessor of the Company, dated October 1, 2014, as amended on February 22, 2017,
March 30, 2019 and September 18, 2019.
The WARF License grants to the Company an exclusive
license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array
or thin-film micro electrode array and method. The Company agreed to pay WARF a royalty equal to a single-digit percentage of our product
sales pursuant to the WARF License, with a minimum annual royalty payment of $ 50,000 for 2020, $ 100,000 for 2021 and $ 150,000 for
2022 and each calendar year thereafter that the WARF License is in effect. If the Company or any of its sublicensees contest the validity
of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to
be valid and would be infringed by the Company if not for the WARF License, the royalty rate will be tripled for the remaining term of
the WARF License.
WARF may terminate the WARF License on 30 days’
written notice if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our
development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or in the event of certain
bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial
sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after royalties earned on sales begin
to be paid, such earned royalties cease for more than four calendar quarters. The first commercial sale occurred on December 7, 2020,
prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date that no valid claims on the patents
licensed thereunder remain. The Company expects the latest expiration of a licensed patent to occur in 2030. During the years ended September
30, 2023 and 2022, $ 150,000 and $ 137,500 in royalty fees were incurred related to the WARF License, respectively, and were reflected
as a component of cost of product revenue.
Mayo Agreement
The Company has an exclusive license and development
agreement with the Mayo Foundation for Medical Education and Research (“Mayo”) related to certain intellectual property and
development services for thin film micro electrode technology (“Mayo Agreement”). If the Company is successful in obtaining
regulatory approval, the Company is to pay royalties to Mayo based on a percentage of net sales of products of the licensed technology
through the term of the Mayo Agreement, set to expire May 25, 2037. During the years ended September 30, 2023 and 2022, $ 7,486 and
$ 4,861 in royalty fees were incurred, respectively, and were reflected as a component of cost of product revenue.
Facility Leases
Headquarters Lease
On October 7, 2019, the Company entered into
a non-cancellable lease agreement (the “Lease”) with certain landlords (together, the “Landlord”) pursuant to
which the Company has agreed to lease office space located at 7599 Anagram Drive, Eden Prairie, Minnesota (the “Premises”).
The Company took possession of the Premises on November 1, 2019, with the term of the Lease ending 65 months after such date, unless
terminated earlier (the “Lease Term”). The initial base rent for the Premises is $ 6,410 per month for the first 17 months,
increasing to $ 7,076 per month by the end of the Lease Term. In addition, as long as the Company is not in default under the Lease, the
Company shall be entitled to an abatement of its base rent for the first 5 months. In addition, the Company will pay its pro rata share
of the Landlord’s annual operating expenses associated with the Premises, calculated as set forth in the Lease of which the Company
is entitled to an abatement of these operating expense for the first 3 months.
F- 13
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Los Gatos Lease
On July 1, 2021, the Company entered into a non-cancellable
facility lease (the “Los Gatos Lease”), pursuant to which the Company agreed to rent office space for its research and development
operations located at 718 University Avenue, Suite #111, Los Gatos, California. The facility space under the Los Gatos Lease is approximately
1,162 square feet. The Company took possession of the office space on July 2, 2021. The initial monthly rent under the Los Gatos Lease
was approximately $ 4,241 . On November 4, 2022, the Los Gatos Lease was extended for an additional two years to December 31, 2024 . The
rent under the extended Los Gatos Lease ranges from $ 4,453 to $ 4,632 per month beginning on January 1, 2023.
During the years ended September 30, 2023 and
2022, rent expense associated with the facility leases amounted to $ 171,633 and $ 170,501 , respectively.
Supplemental cash flow information related to
the operating lease was as follows:
For the Years Ended
September
30,
2023
2022
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from
operating leases
$ 134,632
$ 130,727
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 97,536
$ —
Supplemental balance sheet information related to the operating lease
was as follows:
As of
September 30,
2023
2022
Right-of-use assets
$ 169,059
$ 181,355
Lease liability
$ 184,400
$ 202,895
Weighted average remaining lease term (years)
1.4
2.4
Weighted average discount rate
7.8 %
6.9 %
Maturity of the lease liability was as follows:
Calendar Year
As of
September 30,
2023
2023 (period from October 1, 2023 to December 31, 2023)
$ 34,070
2024
139,969
2025
21,227
Total lease payments
195,266
Less imputed interest
( 10,866 )
Total
184,400
Short-term portion
( 129,116 )
Long-term portion
$ 55,284
F- 14
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 5 - Supplemental Balance Sheet
Information
Inventory
Inventory consisted of the following:
As of
September 30,
2023
2022
Component inventory
$ 1,202,778
$ 400,063
Work-in-process
343,597
230,507
Finished goods
180,311
73,968
Total
$ 1,726,686
$ 704,538
Intangibles
Intangible assets roll forward is as follows:
Useful Life
Net Intangibles, September 30, 2021
12 - 13 years
$ 134,207
Less: amortization
( 22,315 )
Net Intangibles, September 30, 2022
111,892
Less: amortization
( 22,315 )
Net Intangibles, September 30, 2023
$ 89,577
The Company anticipates amortization expense
of approximately $ 22,000 per year for fiscal year 2024 through 2027 based upon the two current license agreements.
Property and Equipment
Property and equipment, net held for use by category
are presented in the following table:
As of
September 30,
2023
2022
Equipment and furniture
$ 860,737
$ 538,061
Software
—
1,895
Total property and equipment
860,737
539,956
Less accumulated depreciation
( 334,984 )
( 186,357 )
Property and equipment, net
$ 525,753
$ 353,599
Depreciation expense was $ 176,951 and $ 96,305
for the years ended September 30, 2023 and 2022, respectively. Equipment with a net book value of $ 39,643 was disposed by the Company
resulting in net proceeds of $ 7,500 .
NOTE 6 - Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted
of the following
As of
September 30,
2023
2022
Accrued payroll
$ 874,382
$ 521,368
Operating lease liability, short term
129,116
83,339
Royalty fees
104,024
111,132
Total
$ 1,107,522
$ 715,839
F- 15
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 7 - Zimmer Development Agreement
On July 20, 2020, the Company entered into an
exclusive development and distribution agreement (the “Development Agreement”) with Zimmer, Inc. (“Zimmer”),
pursuant to which the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and electrode cable assembly
products (the “Electrode Cable Assembly Products”). Additionally, the Company granted Zimmer the exclusive right and license
to distribute certain depth electrodes developed by the Company (“SEEG Products”, and together with the Strip/Grid Products
and Electrode Cable Assembly Products, the “Products”). The parties have agreed to collaborate with respect to development
activities under the Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer
and the Company.
Under the terms of the Development Agreement,
the Company is responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and
expenses related to the commercialization of the Products. In addition to the Development Agreement, Zimmer and the Company have entered
into a Manufacturing and Supply Agreement and a supplier quality agreement with respect to the manufacturing and supply of the Products.
Except as otherwise provided in the Development
Agreement, the Company is responsible for performing all development activities, including non-clinical and clinical studies directed
at obtaining regulatory approval of each Product. Zimmer has agreed to use commercially reasonable efforts to promote, market and sell
each Product following the “Product Availability Date” (as defined in the Development Agreement) for such Product.
Pursuant to the Development Agreement, Zimmer
made an upfront initial exclusivity fee payment of $ 2.0 million (the “Initial Exclusivity Fee”) to the Company in fiscal
year 2020.
On August 2, 2022, the Company entered into a
Third Amendment to Exclusive Development and Distribution Agreement (the “Amendment”) with Zimmer. Pursuant to the terms
and conditions of the Amendment, Zimmer made a $ 3.5 million payment to the Company. In consideration of the mutual covenants and
agreements contained in the Development Agreement, the fee and milestone payment provisions in the Development Agreement were replaced
with the following below:
● $ 1.5 million for the sEEG Exclusivity Maintenance Fee; and
● $ 2.0 million for satisfaction of each of the milestone events related to the design of sEEG products set forth in the Development Agreement even though the satisfaction was after the deadlines originally identified.
In addition, in connection with the Amendment,
the Company issued Zimmer a warrant to purchase common stock (the “2022 Zimmer Warrant”). The 2022 Zimmer Warrant is
exercisable for up to an aggregate of 350,000 shares of the Company’s common stock. The 2022 Zimmer Warrant has an exercise
price of $ 3.00 per share, will be exercisable commencing six months from the issuance date, and will expire on August 2, 2027 . The
fair value of the 2022 Zimmer Warrant of $ 0.1 million was based on the Black-Scholes pricing model. Input assumptions used were as follows:
a risk-free interest rate of 2.9 %; expected volatility of 53.5 %; expected life of 5 years; expected dividend yield of 0 %; and the underlying
fair market of the common stock. The 2022 Zimmer Warrant was classified in stockholders’ equity as the number of shares were
fixed and determinable, no cash settlement was required and no other provisions precluded equity treatment.
The Development Agreement will expire on the
tenth anniversary of the date of the first commercial sale of the last Products to achieve a first commercial sale (the “Term”),
unless terminated earlier pursuant to its terms. Either party may terminate the Development Agreement (x) with written notice for the
other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings.
In addition, Zimmer may terminate the Development Agreement for any reason with 90 days’ written notice, and the Company may terminate
the Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company.
The license rights granted to Zimmer under the Strip/Grid Distribution License and sEEG Distribution License shall be exclusive from
the Effective Date of the Amendment until the end of the Term.
F- 16
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The Development Agreement and Amendment
were accounted for under the provisions of ASC 606. In accordance with the provisions under ASC 606, the Company identified five performance
obligations under the Development Agreement and Amendment: (1) the Company’s obligation to grant Zimmer access to its intellectual
property; (2) completion SEEG Product development; (3) completion of Strip/Grid Product development; (4) the provision of sEEG exclusivity
maintenance; and (5) completion of sEEG design modifications as requested by Zimmer. All performance obligations under the Development
Agreement and Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September 30, 2022. The remaining performance
obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance was completed in first quarter of
fiscal year 2023.
The aggregate transaction price associated with
the Development Agreement and Amendment was $ 5.4 million comprising the Initial Exclusivity Fee of $ 2.0 million and the $ 3.5 million
payment under the Amendment, less the fair value 2022 Zimmer Warrant of $ 0.1 million. The transaction price was allocated between performance
obligations based on their relative standalone selling prices. The Company used a market based valuation approach and an expected cost
plus margin approach with regard to estimating the standalone selling price for the performance obligations. The Company recognized revenue
in the amount of $ 1,455,188 and $ 1,948,872 during the years ended September 30, 2023 and 2022, respectively, in connection
with the Development Agreement and Amendment.
A reconciliation of the closing balance of deferred
revenue related to the Development Agreement and Amendment is as follows as of September 30, 2023 and 2022:
Deferred Revenue
Balance as of September 30, 2021
$ 8,622
Zimmer agreement amendment related to sEEG exclusivity maintenance
3,395,438
Revenue recognized
( 1,948,872 )
Balance as of September 30, 2022
1,455,188
Revenue recognized
( 1,455,188 )
Balance as of September 30, 2023
$ —
Product Revenue
Product revenue is related to its Strip/Grid
Products, sEEG Products and Electrode Cable Assembly Products. Product revenue recognized during the years ended September 30, 2023
and 2022 was $ 1,952,441 and $ 171,169 , respectively.
Advertising Expense
Advertising expense is charged to selling, general
and administrative expenses during the period that it is incurred. Total advertising expense amounted to $ 173,430 and $ 270,612 for the
years ended September 30, 2023 and 2022, respectively.
NOTE 8 - Stock-Based Compensation
During the years ended September 30, 2023 and
2022, stock-based expense related to the stock options, restricted stock units and stock awards was included in selling, general and
administrative and research and development costs as follows in the accompanying statements of operations:
2023
2022
Selling, general and administrative
$ 905,108
$ 780,818
Research and development
200,349
166,394
Total stock-based compensation expense
$ 1,105,457
$ 947,212
F- 17
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The Company’s 2017 Equity Incentive Plan
(“2017 Plan”) provides for the issuance of restricted shares and stock options to employees, directors, and consultants of
the Company. Effective October 1, 2021, no shares were available for issuance under the 2016 Equity Incentive Plan.
Inducement Plan
In addition to the Company’s 2017 Plan,
the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”) on October
4, 2021, pursuant to which the Company reserved 420,350 shares of its common stock to be used exclusively for grants of awards to individuals
who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment
with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan was approved by the Company’s
board of directors without stockholder approval in accordance with such rule. On November 9, 2023, the Company’s board of directors
adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock that may
be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for a total of 570,350 shares of common stock
that may be issued pursuant to equity incentive awards under the Inducement Plan.
Evergreen provision
Under the 2017 Plan, the shares reserved automatically
increase on January 1st of each year, for a period of not more than ten years from the date the 2017 Plan is approved by the stockholders
of the Company, commencing on January 1, 2019 and ending on (and including) January 1, 2027, to an amount equal to 13 % of the fully-diluted
shares outstanding as of December 31st of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors may act prior
to January 1st of a given year to provide that there will be no January 1st increase in the share reserve for such year or that the increase
in the share reserve for such year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding
sentence. “Fully Diluted Shares” as of a date means an amount equal to the number of shares of common stock (i) outstanding
and (ii) issuable upon exercise, conversion or settlement of outstanding awards under the 2017 Plan and any other outstanding options,
warrants or other securities of the Company that are (directly or indirectly) convertible or exchangeable into or exercisable for shares
of common stock, in each case as of the close of business of the Company on December 31 of the preceding calendar year. On January 1,
2023 and 2022, 129,479 and 1,614,538 shares were added to the 2017 Plan, respectively, as a result of the evergreen provision.
Stock Options
During the years ended September 30, 2023 and
2022, 459,512 and 152,690 stock options were granted to employees, directors and consultants, respectively, with a weighted average grant
date fair value of $ 0.88 and $ 0.76 per share, respectively. The options granted have vesting periods ranging from being immediate to
four years. All options expire ten years from the date of grant. The total expense for the years ended September 30, 2023 and 2022 related
to the stock options was $ 632,315 and $ 582,329 , respectively. The following table summarizes the Company’s stock option plan activity
for the years ended September 30, 2023 and 2022 as follows:
Number of
Options
Weighted
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value(1)
Outstanding at September 30,
2021
1,122,560
$ 5.89
8.8
$ 127,339
Granted
152,690
$ 1.50
—
—
Exercised
—
$ —
—
—
Forfeited/Cancelled
( 35,335 )
$ 4.14
—
—
Outstanding at September 30, 2022
1,239,915
$ 5.40
8.0
$ 89,295
Granted
469,512
$ 1.55
—
—
Exercised
—
$ —
—
—
Forfeited/Cancelled
( 1,000 )
$ 3.78
—
—
Outstanding at September 30, 2023
1,708,427
$ 4.34
7.69
$ 20,064
Vested and expected to vest at September
30, 2023
1,708,427
$ 4.34
7.69
$ 20,064
Vested and exercisable at September 30,
2023
1,120,768
$ 5.08
7.12
$ 20,064
(1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of our common stock as of September 30, 2023 and 2022 of $ 0.89 and $ 1.69 per share, respectively. As of September 30, 2023 and 2022, 1,682,912 and 1,125,710 outstanding options, respectively, had no intrinsic value.
F- 18
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The weighted-average assumptions used in the
Black-Scholes option-pricing model are as follows for the stock options granted during the years ended September 30:
2023
2022
Expected stock price volatility
57.4 %
53.5 %
Expected life of options (years)
5.8
5.6
Expected dividend yield
0 %
0 %
Risk free interest rate
3.7 %
2.3 %
During the years ended September 30, 2023 and
2022, 337,753 and 327,615 stock options vested, respectively. No options were exercised during the years ended September 30, 2023 and
2022.
Restricted Stock Units
A summary of restricted stock unit (“RSU”)
activity is as follows for the years ended September 30, 2023 and 2022:
Number of
Shares
Non-vested at September 30, 2021
11,384
Granted
443,670
Vested
( 40,624 )
Non-vested at September 30, 2022
414,430
Granted
310,728
Vested
( 331,788 )
Non-vested at September 30, 2023
393,370
During the years ended September 30, 2023 and
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
ranging from a one year to three year period, with a grant date fair value of $ 1.60 and $ 1.91 per unit, respectively. During the years
ended September 30, 2023 and 2022, 331,788 and 40,624 RSUs vested, respectively. The total expense for the years ended September 30,
2023 and 2022 related to the RSU’s was $ 473,142 and $ 364,883 , respectively. No RSUs were forfeited during the years ended September
30, 2023 and 2022.
General
As of September 30, 2023, 1,137,983 shares were
available for future issuance on a combined basis under the 2017 Plan and the Inducement Plan. Unrecognized stock-based compensation
was $ 1,474,119 as of September 30, 2023. The unrecognized share-based expense is expected to be recognized over a weighted average
period of 1.8 years.
F- 19
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 9 - Stockholders’ Equity
July 2023 Public Offering
On July 24, 2023, the Company entered into an
underwriting agreement with The Benchmark Company, LLC, as underwriter (“Benchmark”), relating to the issuance and sale of
5,250,000 shares of the Company’s common stock, par value $ 0.001 per share, at a price to the public of $ 1.00 per share (the “July
2023 Public Offering”). In addition, under the terms of the July 2023 Public Offering, the Company granted Benchmark an option,
exercisable for 30 days, to purchase up to an additional 787,500 shares of common stock on the same terms (“the Overallotment Option”).
The July 2023 Public Offering closed on July 27, 2023, and the Company completed the sale and issuance of an aggregate of 6,037,500 shares
of its common stock, including the exercise in full of the Overallotment Option.
The net proceeds to the Company from the July
2023 Public Offering were approximately $ 5.2 million after deducting underwriting discounts and other offering expenses payable by the
Company. The Company intends to use the net proceeds from this offering to: (i) support the commercial launch of the EVO sEEG electrode
with Zimmer Biomet, (ii) support the FDA submission for the OneRF ablation system and (iii) complete the design of a novel drug delivery
electrode, among other general corporate purposes.
At-The-Market Offering
On December 21, 2022, the Company entered into
a Capital on Demand TM Sales Agreement (“Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
to create an at-the-market offering program (“ATM”) under which the Company may offer and sell shares having an aggregate
offering price of up to $ 14.5 million. JonesTrading is entitled to a commission at a fixed commission rate equal to up to 3 % of the gross
proceeds. 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
issuance costs in the amount of $ 234,725 have been incurred in connection with the ATM. On July 24, 2023, we decreased the amount of
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
stock for sale under the Sales Agreement, including the shares of common stock previously sold.
2021 Public Offering
On October 13, 2021, the Company, entered
into an underwriting agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC, as underwriter (the “Underwriter”),
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.
In addition, under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 days, to
purchase up to an additional 562,500 shares of common stock on the same terms. The base offering closed on October 15, 2021, and the
sale of 422,057 shares of common stock subject to the Underwriter’s overallotment option closed on November 15, 2021.
The gross proceeds to the Company from this offering
were approximately $ 13.4 million prior to deducting underwriting discounts and other offering expenses payable by the Company in
the amount of approximately $ 1.4 million in the aggregate.
Warrant Activity and Summary
The following table summarizes warrant activity
during the years ended September 30, 2023 and 2022:
Warrants
Exercise
Price Per
Warrant
Weighted
Average Exercise
Price
Weighted
Average Term
(years)
Outstanding and exercisable at September 30, 2021
7,503,808
$ 5.25 - 9.00
$ 6.06
3.23
Issued
350,000
$ 3.00
$ 3.00
4.84
Exercised
—
$ —
$ —
—
Reverse split adjustment correction
( 100 )
$ —
$ —
—
Expired
( 750,364 )
$ 5.40
$ 5.40
—
Outstanding and exercisable at September 30, 2022
7,103,344
$ 3.00 - 9.00
$ 5.98
2.68
Issued
—
$ —
$ —
—
Exercised
—
$ —
$ —
—
Expired
( 900,918 )
$ 5.61 - 9.00
$ 6.38
—
Outstanding at September 30, 2023
6,202,426
$ 3.00 - 9.00
$ 5.92
2.00
Outstanding and exercisable at September
30, 2023
6,202,426
$ 3.00 - 900
$ 5.92
2.00
F- 20
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The following table summarizes information about
warrants outstanding at September 30, 2023:
Exercise Price
Number Outstanding
Weighted Average
Remaining Contractual
life (Years)
Number Exercisable at
September
30,
2023
$ 3.00
350,000
3.84
350,000
$ 5.25
4,166,682
2.29
4,166,682
$ 5.61
220,855
4.75
220,855
$ 6.00
45,171
0.75
45,171
$ 7.50
279,727
0.41
279,727
$ 8.25
62,906
0.75
62,906
$ 9.00
1,077,085
0.25
1,077,085
Total
6,202,426
6,202,426
NOTE 10 - Concentrations
Revenue
One customer accounts for all of the Company’s
product and collaborations revenue.
Supplier concentration
One contract manufacturer produces all of the
Company’s Strip/Grid Products and sEEG Products and another supplier was responsible for the development of the Company’s
OneRF Ablation system.
NOTE 11 - Income Taxes
The effective tax rate for the Company for the
years ended September 30, 2023 and 2022 was zero percent. A reconciliation of income tax computed at the statutory federal income tax
rate to the provision (benefit) for income taxes included in the accompanying statements of operations for the years ended September
30 is as follows:
2023
2022
Income tax benefit at federal statutory rate
( 21.0 )%
( 21.0 )%
State income tax, net of federal benefit
( 7.7 )
( 7.7 )
Research credits
( 1.7 )
( 3.0 )
Stock-based compensation and other
0.8
0.7
Valuation allowance
29.6
31.0
Effective tax rate
—
%
—
%
Significant components of the Company’s
deferred tax assets and liabilities are summarized in the tables below as of September 30:
2023
2022
Deferred tax assets:
Federal and state operating loss carryforwards
$ 11,657,158
$ 10,164,679
Acquired intangibles
28,352
26,447
Accruals and other
63,301
70,399
Research and development capitalization
1,780,649
—
Research and development credit carryforwards
1,314,487
1,107,559
Stock-based compensation
788,790
688,998
Total deferred tax assets
15,632,737
12,058,082
Deferred tax liabilities:
Fixed assets and other
( 204,829 )
( 140,538 )
Total deferred tax liabilities
( 204,829 )
( 140,538 )
Valuation allowance
( 15,427,908 )
( 11,917,544 )
Net deferred tax assets
$ —
$ —
F- 21
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
As of September 30, 2023 and 2022, the Company
had gross deferred tax assets of approximately $ 15,633,000 and $ 12,058,000 , respectively. Realization of the deferred assets is primarily
dependent upon future taxable income, if any, the amount and timing of which are uncertain. The Company has had significant pre-tax losses
since its inception. The Company has not yet generated revenues from sales to the level of becoming profitable. Accordingly, the net deferred
tax assets have been fully offset by a valuation allowance of approximately $ 15,428,000 and $ 11,918,000 as of September 30, 2023 and 2022,
respectively. Net deferred tax assets will continue to require a valuation allowance until the Company can demonstrate their realizability
through sustained profitability or another source of income.
As of September 30, 2023 and 2022, the Company’s
federal net operating loss carryforwards were approximately $ 40,571,000 and $ 35,408,000 , respectively. The Company had federal research
credit carryforwards as of September 30, 2023 and 2022 of approximately $ 1,074,000 and $ 759,000 , respectively. The federal net operating
loss incurred prior to January 1, 2018 and tax credit carryforwards will begin to expire in 2036 if not utilized. Federal net operating
losses incurred after December 31, 2017 will not expire. As of September 30, 2023 and 2022, the Company had state net operating loss
carryforwards of approximately $ 40,522,000 and $ 35,249,000 , respectively. The Company had state research credit carryforwards of approximately
$ 598,000 and $ 441,000 as of September 30, 2023 and 2022, respectively. The state net operating loss carryforwards will begin to expire
in 2031, if not utilized, and the state research credit carryforwards will begin to expire in 2032 if not utilized.
Utilization of the net operating loss carryforwards
and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the
Internal Revenue Code of 1986, as amended, and similar state provisions. Generally, in addition to certain entity reorganizations, the
limitation applies when one or more “5-percent shareholders” increase their ownership, in the aggregate, by more than 50
percentage points over a 36-month testing period or beginning the day after the most recent ownership change, if shorter. The annual
limitation may result in the expiration of net operating losses and credits before utilization.
In accordance with ASC 740, Income Taxes (“ASC
740”), specifically related to uncertain tax positions, a Company is required to use a recognition threshold and a measurement attribute
for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits
to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. A reconciliation
of the beginning and ending amounts of unrecognized tax positions for the years ended September 30 is as follows:
2023
2022
Unrecognized tax positions, beginning of year
$ —
$ —
Gross increase, current period tax positions
231,968
—
Unrecognized tax positions, end of year
$ 231,968
$ —
If recognized, none of the unrecognized tax positions
would impact the Company's income tax benefit or effective tax rate as long as the Company's net deferred tax assets remain subject to
a full valuation allowance. The Company does not expect any significant increases or decreases to the Company's unrecognized tax positions
within the next 12 months.
In accordance with this guidance, the Company
has adopted a policy under which, if required to be recognized in the future, interest related to the underpayment of income taxes will
be classified as a component of interest expense and any related penalties will be classified in operating expenses in the accompanying
statements of operations.
F- 22
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The Company has tax filing obligations in the
following jurisdictions: U.S. federal, Minnesota and California. The income tax returns since inception as a corporation in 2016 are
subject to examination by the federal and state taxing authorities.
NOTE 12 - Defined Contribution Plan
The Company has a 401(k) defined contribution
plan (the “401K Plan”) for all employees over age 21. Employees can defer up to 100 % of their compensation through payroll
withholdings into the 401K Plan subject to federal law limits. The Company may match 100 % of deferrals up to 3 % of one’s contributions.
The Company’s matching contributions to employee deferrals are discretionary. The Company may also make discretionary profit sharing
contributions under the 401K Plan in the future, but it has not done so through September 30, 2023.
Employee contributions and any employer matching
contributions made to satisfy certain non-discrimination tests required by the Internal Revenue Code are 100 % vested upon contribution.
Discretionary employer matches to employee deferrals vest over a six year period beginning on the second anniversary of an employee’s
date of hire. Discretionary profit sharing contributions vest over a five year period beginning on the first anniversary of an employee’s
date of hire. The amount of contributions made by the Company under the 401K Plan during the years ended September 30, 2023 and 2022
was nil and $ 30,697 , respectively.
NOTE 13 - Subsequent Events
First Amendment to 2021 Inducement Plan
On November 9, 2023, the Company’s board
of directors adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate number of shares of common stock
that may be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for a total of 570,350 shares.
At-The-Market Offering
On December 1, 2023, the Company increased the amount of common stock that can be sold pursuant to the Sales Agreement
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
the shares of common stock previously sold.
F- 23
NeuroOne
Medical Technologies Corporation
FORM 10-K
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.