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-4
Statements of Operations F-5
Statements of Changes in Stockholders’ Equity F-6
Statements of Cash Flows F-7
Notes to Financial Statements F-8
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, 2022 and 2021, the related statements of operations,
changes in stockholders’ equity, and cash flows, for each of the two years in the period ended September 30, 2022, 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, 2022 and 2021, and the results of its operations and
its cash flows for each of the two years in the period ended September 30, 2022, 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 has recurring
losses from operations, 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 their 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.
F- 2
Critical Audit Matters
The critical audit matters communicated below
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. The communication of critical audit matters does not alter in any way our opinion
on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions
on the critical audit matters or on the accounts or disclosures to which they relate.
Revenue Recognition – Milestone Payments
Critical Audit Matter Description
As described in Notes 3 and 7 to the
financial statements, the Company recognizes revenue for milestone payments received based on when the related performance obligations
have been fulfilled. The determination of the allocation of the standalone selling price to the identified performance obligations requires
management to make significant estimates and assumptions related to the fair value of the allocation. As disclosed by management, changes
in these assumptions could have a significant impact on allocating the fair value of the standalone selling price to the identified performance
obligations.
We identified milestone payment revenue
recognition as a critical audit matter. The related audit effort in evaluating management’s judgments in determining the allocation
of the standalone selling price between the identified performance obligations was extensive and required a high degree of auditor judgment.
How We Addressed the Matter in Our
Audit
The primary procedures we performed
to address this critical audit matter included:
● We obtained an understanding of the design and implementation of internal controls relating to the evaluation
of the assumptions and inputs used in determining the allocation of the stand along selling price to the identified performance obligations
● We evaluated management’s significant accounting policies related to milestone payments for reasonableness
● We evaluated the reasonableness of management’s estimate of allocating the standalone selling price
between the identified performance obligations
● We tested the allocation of the standalone selling price and performed the following procedures:
● Tested a sample of the underlying costs
● Tested management’s assumptions in determining how to allocate costs
● Assessed the terms in the customer agreement and evaluated the appropriateness of management’s application
of their accounting policies, along with their use of estimates, in the determination of revenue recognition conclusions
● We tested the mathematical accuracy of management’s calculations of revenue and the associated timing
of revenue recognized in the financial statements.
/s/ Baker Tilly US, LLP
We have served as the Company’s auditor since
2021.
Minneapolis, Minnesota
December 21, 2022
F- 3
NeuroOne Medical Technologies Corporation
Balance Sheets
As of
September 30,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$ 8,160,329
$ 6,901,346
Short-term investments
2,981,010
—
Accounts receivable
33,237
48,336
Inventory
704,538
98,287
Prepaid and other assets
296,649
244,043
Total current assets
12,175,763
7,292,012
Intangible assets, net
111,892
134,207
Right-of-use asset
181,355
288,948
Property and equipment, net
353,599
223,329
Total assets
$ 12,822,609
$ 7,938,496
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 927,662
$ 528,829
Accrued expenses
715,839
644,249
Deferred revenue
1,455,188
8,622
Total current liabilities
3,098,689
1,181,700
Operating lease liability, long term
119,556
202,895
Total liabilities
3,218,245
1,384,595
Commitments and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and 2021; no shares issued or outstanding as of September 30, 2022 and 2021.
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized as of September 30, 2022 and 2021; 16,216,540 and 12,010,019 shares issued and outstanding as of September 30, 2022 and 2021, respectively.
16,217
12,010
Additional paid–in capital
60,414,959
47,369,090
Accumulated deficit
( 50,826,812 )
( 40,827,199 )
Total stockholders’ equity
9,604,364
6,553,901
Total liabilities and stockholders’ equity
$ 12,822,609
$ 7,938,496
See accompanying notes to financial statements
F- 4
NeuroOne Medical Technologies Corporation
Statements of Operations
Years ended
September 30,
2022
2021
Product revenue
$ 171,169
$ 178,146
Cost of product revenue
241,963
275,895
Product gross loss
( 70,794 )
( 97,749 )
Collaborations revenue
1,948,872
64,812
Operating expenses:
Selling, general and administrative
6,979,416
6,260,266
Research and development
4,929,427
3,925,008
Total operating expenses
11,908,843
10,185,274
Loss from operations
( 10,030,765 )
( 10,218,211 )
Interest expense
—
( 3,053 )
Net valuation change of instruments measured at fair value
—
1,974
Other income
31,152
271,122
Net loss
$ ( 9,999,613 )
$ ( 9,948,168 )
Net loss per share:
Basic and diluted
$ ( 0.63 )
$ ( 0.93 )
Number of shares used in per share calculations:
Basic and diluted
15,998,567
10,696,799
See accompanying notes to financial statements
F- 5
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, 2020
7,393,637
$ 7,394
$ 32,937,809
$ ( 30,879,031 )
$ 2,066,172
Issuance of common stock and warrants under securities purchase agreement
4,166,682
4,167
12,495,833
—
12,500,000
Conversion of convertible notes into common stock
292,754
293
1,004,939
—
1,005,232
Issuance costs in connection with securities issuances
—
—
( 1,198,080 )
—
( 1,198,080 )
Issuance cost adjustment related to private placement
—
—
50,400
—
50,400
Stock-based compensation
—
—
1,793,199
—
1,793,199
Issuance of common stock for consulting services
74,327
74
( 74 )
—
—
Issuance of common stock upon vesting of restricted stock units
30,021
30
( 30 )
—
—
Exercise of stock options
1,552
1
10,145
—
10,146
Exercise of warrants
51,046
51
274,949
—
275,000
Net loss
—
—
—
( 9,948,168 )
( 9,948,168 )
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
See accompanying notes to financial statements
F- 6
NeuroOne Medical Technologies Corporation
Statements of Cash Flows
Years ended
September 30,
2022
2021
Operating activities
Net loss
$ ( 9,999,613 )
$ ( 9,948,168 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation
118,620
80,748
Stock-based compensation
947,212
1,793,199
Payroll protection program loan forgiveness
—
( 83,333 )
Fair value change of convertible promissory notes
—
( 1,974 )
Issuance costs attributed to financing activities
—
3,053
Amortization of discounts and premiums on short-term investments
( 11,471 )
Non-cash lease expense
107,593
66,382
Issuance of warrants in connection with Zimmer contract amendment
104,562
—
Change in assets and liabilities:
Accounts receivable
15,099
( 48,336 )
Inventory
( 606,251 )
( 98,287 )
Prepaid and other assets
( 145,540 )
( 8,320 )
Accounts payable
515,438
( 350,313 )
Accrued expenses, deferred revenue, operating lease and other liabilities
1,434,817
( 7,477 )
Net cash used in operating activities
( 7,519,534 )
( 8,602,826 )
Investing activities
Purchases of short-term investments
( 3,469,539 )
—
Maturities of short-term investments
500,000
—
Purchase of property and equipment
( 275,226 )
( 67,079 )
Net cash used in investing activities
( 3,244,765 )
( 67,079 )
Financing activities
Proceeds from issuance of common stock in connection with public offering and private placements
13,350,582
8,829,236
Proceeds from issuance of warrants in connection with private placements
—
3,670,764
Issuance costs in connection with convertible promissory notes
—
( 3,053 )
Issuance costs in connection with public offering and private placements
( 1,327,300 )
( 1,198,080 )
Exercise of warrants
—
275,000
Exercise of stock-options
—
10,146
Deferred offering costs
—
( 49,159 )
Net cash provided by financing activities
12,023,282
11,534,854
Net increase in cash and cash equivalents
1,258,983
2,864,949
Cash and cash equivalents at beginning of year
6,901,346
4,036,397
Cash and cash equivalents at end of year
$ 8,160,329
$ 6,901,346
Supplemental non-cash financing and investing transactions:
Conversion of convertible promissory notes to equity
$ —
$ 1,005,232
Unpaid issuance costs and non-cash adjustments attributed to convertible notes and private placement
$ —
$ 50,400
Operating lease right of use asset obtained in exchange for operating lease
$ —
$ 73,118
Payroll protection program loan forgiveness
$ —
$ 83,333
Unpaid deferred offering costs
$ —
$ 67,954
Unpaid purchases of property and equipment
$ —
$ 48,651
Reclass of deferred offering costs to additional paid-in capital in connection with public offering
$ 24,980
$ —
See accompanying notes to financial statements
F- 7
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 an early-stage medical technology company developing comprehensive
neuromodulation electroencephalogram (cEEG) and stereoelectrocencephalography (sEEG) recording, monitoring, ablation, 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
U.S. Food and Drug Administration (“FDA”) for its Evo cortical technology in November 2019 and in October 2022, we received
FDA 510(k) clearance for our 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. To date, the Company has had limited commercial sales.
The Company is based in Eden Prairie, Minnesota.
Global Economic Conditions
Generally, worldwide economic conditions remain
uncertain, particularly due to the 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. If economic conditions 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 conflict
in Ukraine, 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 $ 50.8 million as of September 30, 2022. 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. The Company does not have adequate liquidity to fund its operations without
raising additional funds and such actions are not solely within the control of the Company. These factors raise substantial doubt about
its 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, cash equivalents and short-term
investments 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- 8
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.
Segment Information
Operating segments are components of an enterprise
for which separate financial information is available and is 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.
Reverse
Stock Split
On March 11, 2021, the Company’s Board of
Directors (the “Board”) approved a one-for-three reverse stock split of the Company’s issued and outstanding shares
of common stock, par value $ 0.001 (“common stock”) effective end-of-day March 31, 2021 (the “Reverse Stock Split”).
All issued and outstanding common stock and per
share amounts contained in the financial statements have been retroactively adjusted to reflect this Reverse Stock Split for all periods
presented. In addition, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the
exercise and/or vesting of all outstanding stock options, restricted stock units and warrants to purchase shares of common stock. A proportionate
adjustment was also made to the number of shares reserved for issuance pursuant to the Company’s equity incentive compensation plans
to reflect the Reverse Stock Split. Any fraction of a share of common stock that was created as a result of the Reverse Stock Split was
rounded up to the next whole share. The common stock par value and additional paid-in-capital line items contained in the financial statements
were adjusted to account for the Reverse Stock Split for all periods presented. Lastly, the authorized shares and par value per share
of the common stock and preferred stock were not adjusted as a result of the Reverse Stock Split.
Management’s Use of Estimates
The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, primarily in connection with the convertible promissory notes when outstanding,
and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during
the reporting period. Actual results could differ from those estimates.
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.
F- 9
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Short Term Investment
The Company invests its excess cash in United
States (U.S.) Treasury securities and highly rated corporate securities. The Company intends and has the ability to hold these investments
to maturity. Securities with original maturity dates of more than three months are reported as held-to-maturity investments and are recorded
at amortized cost, which approximates fair value due to the negligible risk of changes in value due to interest rates. All investments
held on September 30, 2022 had contractual maturities of less than one year . The amortized cost and estimated fair values of the Company’s
investments as of September 30, 2022 are as follows:
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
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.
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.
The Company commenced commercial sales of cEEG strip/grid and electrode cable assembly products in the first quarter of fiscal year 2021.
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”) 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
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.
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.
F- 10
NeuroOne Medical Technologies
Corporation
Notes to Financial Statements
Licenses
of intellectual property : If the license to the Company’s intellectual property is determined to be distinct from the other
performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to
the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that
are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine
whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of
measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress
each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone
payments : At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are
considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method.
If it is probable that a significant revenue reversal 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 license, collaboration, and other 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, 2022 and 2021, the fair values
of cash, cash equivalents, short-term investments, accounts receivable, inventory, prepaid, other assets, accounts payable and accrued
expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the convertible
notes while outstanding were based on both the fair value of our common stock, discount associated with the embedded redemption features,
and cash flow models discounted at current implied market rates evidenced in recent arms-length transactions representing expected returns
by market participants for similar instruments and are based on Level 3 inputs.
F- 11
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
There were no transfers between fair value hierarchy
levels during the years ended September 30, 2022 and 2021.
There were no financial instruments measured on
a recurring basis outstanding as of September 30, 2022.
The following table provides a roll-forward of
the convertible notes measured at fair value on a recurring basis using unobservable level 3 inputs for the year ended September 30, 2021
as follows:
2021
Convertible notes
Balance as of beginning of period – September 30, 2020
$ 1,007,206
Conversion of convertible promissory notes to common stock
( 1,005,232 )
Change in fair value including accrued interest
( 1,974 )
Balance as of end of period – September 30, 2021
$ —
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 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.
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.
Inventories
Inventories
are 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 cEEG
strip/grid and electrode cable assembly work-in-process and finished good product. The Strip/Grid Products are produced by a third-party
contract manufacturer and the Electrode Cable Assembly Products are obtained from outside suppliers.
F- 12
NeuroOne Medical Technologies
Corporation
Notes to Financial Statements
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 beginning in the first quarter of fiscal year 2021, sales and marketing in connection with the commercial sale
of cEEG strip/grid and electrode cable assembly 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. The Company records forfeitures when they occur.
Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718.
Income
Taxes
For the
Company, income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or
settled. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred
tax asset will not be realized.
Net Loss Per Share
For the Company, basic loss per share of common
stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.
Diluted earnings or loss per share of common stock
is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional
shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s convertible notes, warrants, stock
options and restricted stock units, while outstanding, are considered common stock equivalents for this purpose. Diluted earnings is computed
utilizing the treasury method for the warrants, stock options and restricted stock units. Diluted earnings with respect to the convertible
notes utilize the if-converted method. 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 both the years ended September 30, 2022 and 2021.
F- 13
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
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:
2022
2021
Warrants
7,103,344
7,503,808
Stock options
1,239,915
1,122,560
Restricted stock units
414,430
11,384
Unissued vested restricted stock units
7,316
1,148
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. Recently, the FASB issued the final ASU to delay adoption
for smaller reporting companies to calendar year 2023. The Company is currently assessing the impact of the adoption of this ASU on its
financial statements.
In December 2019, the FASB issued ASU No. 2019-12,
Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to
simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to
improve the consistent application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance.
The ASU is effective for fiscal years beginning after December 15, 2020. The Company adopted the new guidance on October 1, 2021 and the
adoption of this new guidance did not have a material impact on the Company’s financial statements.
In August 2020, 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 is currently evaluating the impact of ASU 2020-06 on its financial statements.
In November 2021, the FASB issued ASU 2021-10,
Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency
of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the
effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their
scope for financial statements issued for annual periods beginning after December 15, 2021. This guidance will not have a material impact
to the Company’s financial statements.
F- 14
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,
2022 and 2021, $ 137,500 and $ 125,000 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, 2022 and 2021, $ 4,861 and $ 3,894 in royalty fees were incurred, respectively, and were reflected as a component of cost
of product revenue.
Legal
PMT
Litigation
On March 29, 2018, the Company was served with
a complaint filed by PMT Corporation (“PMT”), the former employer of Mark Christianson, a current Company employee, and Wade
Fredrickson, a former Company employee. The complaint added the Company, NeuroOne, Inc. and Mr. Christianson to its existing lawsuit against
Mr. Fredrickson in the Fourth Judicial District Court of the State of Minnesota. In the lawsuit, PMT claimed that Mr. Fredrickson and
Mr. Christianson, by virtue of their work for the Company and their prior work during employment with PMT, breached their non-competition,
non-solicitation and non-disclosure obligations, breached their fiduciary duty obligations, were unjustly enriched, engaged in unfair
competition, engaged in a civil conspiracy, tortiously interfered with PMT’s contracts and prospective economic advantage, and breached
a covenant of good faith and fair dealing. The litigation was settled on September 29, 2022.
The associated legal costs associated with all
of the Company’s litigation activities amounted to $ 663,629 and $ 80,356 during the years ended September 30, 2022 and 2021, respectively,
and were recorded in selling, general and administrative expenses in the accompanying statements of operations.
F- 15
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Facility Leases
Headquarters Lease
On October 7, 2019, the Company entered into a
non-cancellable lease agreement (the “Lease”) with Biynah Cleveland, LLC, BIP Cleveland, LLC, and Edenvale Investors (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 “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 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.
Los Gatos Lease
In 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 term of the New Lease is eighteen months. 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 is approximately $ 4,241 . On November 4, 2022, the Los Gatos Lease was extended for an additional
two year term. See “Note 13 – Subsequent Events”.
San Jose Lease :
On December 30, 2020, the Company entered into
a non-cancellable lease agreement for short term office space in San Jose, California (the “San Jose Lease”) for a three month
initial term. After March 31, 2021, the San Jose Lease was cancellable upon a 30-day notice to the landlord. The Company took possession
of the office space on January 1, 2021 and the San Jose Lease was terminated upon the commencement of the Los Gatos Lease discussed above.
The base rent under the San Jose Lease was $ 504 per month.
During the years ended September 30, 2022 and
2021, rent expense associated with the facility leases amounted to $ 170,501 and $ 136,826 , respectively.
Supplemental cash flow information related to
the operating lease was as follows:
For the Years Ended
September
30,
2022
2021
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$ 130,727
$ 70,897
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ —
$ 73,118
F- 16
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Supplemental balance sheet information related
to the operating lease was as follows:
As of
September 30,
2022
2021
Right-of-use assets
$ 181,355
$ 288,948
Lease liability
$ 202,895
$ 315,673
Weighted average remaining lease term (years)
2.4
3.1
Weighted average discount rate
6.9 %
6.7 %
Maturity of the lease liability was as follows:
Calendar Year
As of
September 30,
2022
2022 (period from October 1, 2022 to December 31, 2022)
$ 32,928
2023
82,333
2024
84,391
2025
21,227
Total lease payments
220,879
Less imputed interest
( 17,984 )
Total
202,895
Short-term portion
( 83,339 )
Long-term portion
$ 119,556
NOTE 5 – Supplemental Balance Sheet Information
Inventory
Inventory consisted of the following:
As of
September 30,
2022
2021
Work-in-process
$ 630,570
$ 98,287
Finished goods
73,968
—
Total
$ 704,538
$ 98,287
Prepaid and Other Assets
Prepaid and other assets consisted of the following:
As of
September 30,
2022
2021
Prepaid expenses
$ 296,649
$ 151,109
Deferred offering costs
—
92,934
Total
$ 296,649
$ 244,043
F- 17
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Intangibles
Intangible assets roll forward is as follows:
Useful Life
Net Intangibles, September 30, 2020
12 - 13 years
$ 156,523
Less: amortization
( 22,316 )
Net Intangibles, September 30, 2021
134,207
Less: amortization
( 22,315 )
Net Intangibles, September 30, 2022
$ 111,892
The Company anticipates amortization expense of
approximately $ 22,000 per year for fiscal year 2023 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,
2022
2021
Equipment and furniture
$ 538,061
$ 311,486
Software
1,895
1,895
Total property and equipment
539,956
313,381
Less accumulated depreciation
( 186,357 )
( 90,052 )
Property and equipment, net
$ 353,599
$ 223,329
Depreciation expense was $ 96,305 and $ 58,432 for
the years ended September 30, 2022 and 2021, respectively.
NOTE 6 - Accrued Expenses
Accrued expenses consisted of the following:
As of
September 30,
2022
2021
Accrued payroll
$ 521,368
$ 376,236
Operating lease liability, short term
83,339
112,778
Royalty Fees
111,132
72,083
Other
—
83,152
Total
$ 715,839
$ 644,249
The “other” category is primarily
comprised of board fees.
Paycheck Protection Program
The CARES Act, signed into law in March 2020,
established the Paycheck Protection Program (“PPP”). The PPP authorizes over $600 billion in forgivable loans to small
businesses. Loan amounts may be forgiven to the extent proceeds are used to cover documented payroll, mortgage interest, rent, and utility
costs over a 24-week measurement period following loan funding. Loans have a maturity of 2 years and an interest rate of 1%. Prepayments
may be made without penalty. In April 2020, the Company received loan funding of $83,333 under the PPP and was recorded as a long-term
liability. The PPP loan was forgiven on June 9, 2021 by the U.S. Small Business Administration and was reflected as other income in the
accompanying statements of operations. Interest was nominal during the year ended September 30, 2021.
F- 18
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 (the “MS Agreement”) and a supplier quality
agreement (the “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- 19
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
The Zimmer
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 Zimmer 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 as of September
30, 2022.
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 $ 1,948,872 and $ 64,812 during the years ended September 30, 2022 and 2021, respectively,
in connection with the Development Agreement and Amendment.
A reconciliation of the closing balance of deferred
revenue related to the Zimmer Development Agreement and Amendment is as follows as of September 30, 2022 and 2021:
Deferred Revenue
Balance as of September 30, 2020
$ 73,434
Revenue recognized
( 64,812 )
Balance as of September 30, 2021
8,622
Zimmer agreement amendment related to SEEG exclusivity maintenance
1,455,188
Revenue recognized
( 8,622 )
Balance as of September 30, 2022
$ 1,455,188
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 achievement
of the level of sales required to earn royalty payments under the Development Agreement from Zimmer is uncertain and was considered constrained
for revenue recognition purposes as of September 30, 2022.
Product Revenue
In December 2020, the Company commenced commercial
sales of its Strip/Grid Products and Electrode Cable Assembly Products in connection with the Development Agreement. Product revenue recognized
during the years ended September 30, 2022 and 2021 was $ 171,169 and $ 178,146 , 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 $ 270,612 and $ 338,837 for the
years ended September 30, 2022 and 2021, respectively.
F- 20
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 8 - Convertible Promissory Notes and Warrant
Agreements
2019 Paulson Convertible Note Offering
On November 1, 2019, the Company entered into
a subscription agreement with certain accredited investors, pursuant to which the Company, in a private placement (the “2019 Paulson
Private Placement”), agreed to issue and sell to the investors 13 % convertible promissory notes (each, a “2019 Paulson Note”
and collectively, the “2019 Paulson Notes”) and warrants (each, a “2019 Paulson Warrant” and collectively, the
“2019 Paulson Warrants”) to purchase shares of the Company’s common stock.
The initial closing of the 2019 Paulson Private
Placement was consummated on November 1, 2019, and, on that date and through December 3, 2019, the Company issued the 2019 Paulson Notes
in an aggregate principal amount of $ 3,234,800 to the subscribers for gross proceeds equaling the principal amount. The 2019 Paulson Private
Placement terminated on December 3, 2019.
On April 24, 2020, the Company and holders of
a majority in aggregate principal amount of the 2019 Paulson Notes entered into an amendment to the 2019 Paulson Notes (the “Second
2019 Paulson Notes Amendment”) to, among other things:
i. Extended the Maturity Date – The Second 2019 Paulson Notes Amendment extended the maturity date of the 2019 Paulson Notes from May 1, 2020 to November 1, 2020 (in either case, unless a change of control transaction happens prior to such date);
ii. Revised Optional Conversion Terms – The Second 2019 Paulson Notes Amendment provided that the amount of shares to be received upon the a subscriber’s optional conversion of the 2019 Paulson Notes prior to a 2019 Qualified Financing (as defined in the 2019 Paulson Notes) would have equalled: (1) the Outstanding Balance as defined below of such subscriber’s 2019 Paulson Note elected by the subscriber to be converted divided by (2) an amount equal to 0.6 multiplied by the volume weighted average price of the common stock for the ten (10) trading days immediately preceding the date of conversion; and
iii. Revise the Registration Date – The Second 2019 Paulson Notes Amendment provided that promptly following the earlier of (1) May 1, 2020, if the applicable subscriber converted all or a majority of the Outstanding Balance of such subscriber’s 2019 Paulson Note prior to such date; (2) the final closing a 2019 Qualified Financing; and (3) the maturity date.
The 2019 Paulson Notes had a fixed interest rate
of 13 % per annum and required the Company to repay the principal and accrued and unpaid interest thereon on November 1, 2020 (the “Maturity
Date”). Interest on principal amounted to $ 5,701 during the year ended September 30, 2021 and was recorded under the net valuation
change of instruments measured at fair value in the accompanying statements of operations. The 2019 Paulson Notes were not outstanding
during the year ended September 30, 2022.
The Company elected to account for the 2019 Paulson
Notes on a fair value basis under ASC 825 to comprehensively value and streamline the accounting for the embedded conversion options.
Subsequent to issuance, the fair value change of the Paulson Notes amounted to a benefit of $( 1,974 ) during the year ended September 30,
2021 and was recorded under the net valuation change of instruments measured at fair value in the accompanying statements of operations.
Each 2019 Paulson Warrant grants the holder the
option to purchase the number of shares of common stock equal to (i) 0.5 multiplied by (ii) the principal amount of such subscriber’s
2019 Paulson Notes divided by 5.61, with an exercise price per share equal to $5.61. As of the final closing on December 3, 2019, the
Company issued 2019 Paulson Warrants exercisable for 288,305 shares of common stock in connection with all closings of the 2019 Paulson
Private Placement. The 2019 Paulson Warrants are immediately exercisable and expire on November 1, 2022 . The exercise price is subject
to adjustment in the event of any stock dividends or splits, reverse stock split, recapitalization, reorganization or similar transaction,
as described therein. The 2019 Paulson warrants were deemed to be a free-standing instrument and were accounted for as equity. Given that
the fair value of the 2019 Paulson Notes exceeded the proceeds received at issuance, there was no value attributed to the 2019 Paulson
Warrants in the financial statements.
F- 21
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Issuance costs during the year ended September
30, 2021 in connection with the 2019 Paulson Private Placement were $ 3,053 and related to legal costs. The issuance costs were recorded
as a component of interest in the accompanying statements of operations.
During the first quarter of fiscal year 2021,
the remaining holders of the 2019 Paulson Notes elected to convert the remaining outstanding principal and accrued and unpaid interest
in the amount of $ 615,159 into 292,754 shares of common stock.
NOTE 9 - Stock-Based Compensation
During the years ended September 30, 2022 and
2021, 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:
2022
2021
Selling, general and administrative
$ 780,818
$ 1,550,841
Research and development
166,394
242,358
Total stock-based compensation expense
$ 947,212
$ 1,793,199
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.
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 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, 2022 and 2021,
1,614,538 and 484,622 shares were added to the 2017 Plan, respectively, as a result of the evergreen provision.
F- 22
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Stock Options
During the years ended September 30, 2022 and
2021, 152,690 and 703,117 stock options were granted to employees, directors and consultants, respectively, with a weighted average grant
date fair value of $ 0.76 and $ 3.01 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, 2022 and 2021 related
to the stock options was $ 582,329 and $ 983,301 , respectively.
The following table summarizes the Company’s
stock option plan activity for the years ended September 30, 2022 and 2021 as follows:
Number of
Options
Weighted
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value(1)
Outstanding at September 30, 2020
492,842
$ 6.13
8.8
$ 96,088
Granted
703,117
$ 5.83
—
—
Exercised
( 1,538 )
$ 6.60
—
—
Forfeited/Cancelled
( 71,861 )
$ 6.85
—
—
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
Vested and expected to vest at September 30, 2022
1,239,915
$ 5.40
8.0
$ 89,295
Vested and exercisable at September 30, 2022
783,494
$ 5.76
7.7
$ 56,542
(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, 2022 and 2021 of $ 1.69
and $ 3.95 per share, respectively. As of September 30, 2022 and 2021, 1,125,710 and 1,055,376 outstanding options, respectively, had
no intrinsic value.
The weighted-average assumptions used in the Black-Scholes
option-pricing model are as follows for the stock options granted during the years ended September 30:
2022
2021
Expected stock price volatility
53.5 %
55.9 %
Expected life of options (years)
5.6
6.0
Expected dividend yield
0 %
0 %
Risk free interest rate
2.3 %
0.6 %
During the years ended September 30, 2022 and
2021, 327,615 and 280,557 stock options vested, respectively. 1,538 stock options were exercised
during the year ended September 30, 2021 with an intrinsic value of $ 2,648 . No options were exercised during the year ended September
30, 2022.
F- 23
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
Restricted Stock Units
A summary of restricted stock unit (“RSU”)
activity is as follows for the years ended September 30, 2022 and 2021:
Number of
Shares
Non-vested at September 30, 2020
26,698
Granted
13,776
Vested
( 29,090 )
Non-vested at September 30, 2021
11,384
Granted
443,670
Vested
( 40,624 )
Non-vested at September 30, 2022
414,430
During the years ended September 30, 2022 and
2021, 443,670 and 13,776 RSUs were granted to members of the Company’s board of directors and employees that vest over a period
ranging from an immediate to a two year period, with a grant date fair value of $ 1.91 and $ 7.26 per unit, respectively. During the years
ended September 30, 2022 and 2021, 40,624 and 29,090 RSUs vested, respectively. The total expense for the years ended September 30, 2022
and 2021 related to the RSU’s was $ 364,883 and $ 163,988 , respectively. No RSUs were forfeited during the years ended September 30,
2022 and 2021.
Other Stock-Based Awards
2022 Activity
The Company did not issue any other stock-based
awards, outside of stock options and RSUs, during the year ended September 30, 2022.
2021 Activity
In April 2021, two consulting agreements were
executed whereby a total of 62,659 shares of common stock were issued and vested as of September 30, 2022.
In July 2021, two consulting agreements were executed
whereby a total of 11,668 shares of common stock were issued and vested as of September 30, 2022.
Activity Prior to 2021
In August 2020, an additional consulting agreement
was executed whereby 40,000 shares of common stock were issued, subject to Company repurchase. The stock award under the agreement vested
over a six-month period. As of September 30, 2021 all of the shares vested under this agreement.
Compensation
expense related to the stock awards granted under the consulting agreements referenced above amounted to zero and $ 645,910 for the years
ended September 30, 2022 and 2021, respectively, and was included in stock-based compensation expense. The expense recognition related
to the grants was based on the fair value of the underlying common stock at the point of vesting which ranged from $ 5.22 to $ 6.62 per
share.
General
As of September 30, 2022, 1,703,872 shares were
available for future issuance on a combined basis under the 2017 Plan and the Inducement Plan. Unrecognized stock-based compensation was
$ 1.7 million as of September 30, 2022. The unrecognized share-based expense is expected to be recognized over a weighted average period
of 2.0 years.
F- 24
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 10 - Stockholders’ Equity
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.
2021 Private Placement
On January 12, 2021, the Company entered into
a Common Stock and Warrant Purchase Agreement with certain accredited investors (the “Purchasers”), pursuant to which the
Company agreed to issue and sell an aggregate of 4,166,682 shares common stock, and warrants to purchase an aggregate of 4,166,682 shares
of Common Stock (the “2021 Warrants”) at an aggregate purchase price of $ 3.00 per share of Common Stock and corresponding
warrant, resulting in total gross proceeds of $ 12.5 million before deducting placement agent fees and estimated offering expenses. The
2021 Warrants have an initial exercise price of $ 5.25 per share. The 2021 Warrants are exercisable beginning on the date of issuance and
will expire on the fifth anniversary of such date. This private placement closed on January 14, 2021.
Warrant Activity and Summary
The following table summarizes warrant activity
during the years ended September 30, 2022 and 2021:
Warrants
Exercise
Price Per
Warrant
Weighted
Average Exercise
Price
Weighted
Average Term
(years)
Outstanding and exercisable at September 30, 2020
3,390,320
$
5.40 - 9.00
$
7.05
2.89
Issued
4,166,682
$
5.25
$
4.29
—
Exercised
( 53,194
)
$
5.61 - 8.25
$
5.61
—
Forfeited
—
$
—
$
—
—
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
)
$
—
$
—
—
Forfeited
( 750,364
)
$
5.40
$
5.40
—
Outstanding at September 30, 2022
7,103,344
$
3.00 - 9.00
$
5.98
2.68
Outstanding and exercisable at September 30, 2022
6,753,344
$
5.25 - 9.00
$
6.14
2.57
The following table summarizes information about
warrants outstanding at September 30, 2022:
Exercise Price
Number Outstanding
Weighted Average
Remaining Contractual
life (Years)
Number Exercisable at
September 30,
2022
$
3.00
350,000
4.84
—
$
5.25
4,166,682
3.29
4,166,682
$
5.61
916,704
1.68
916,704
$
6.00
45,171
1.75
45,171
$
7.50
279,727
1.41
279,727
$
8.25
62,906
1.75
62,906
$
9.00
1,282,154
1.18
1,282,154
Total
7,103,344
6,753,344
F- 25
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
NOTE 11 - Income Taxes
The effective tax rate for the Company for the
years ended September 30, 2022 and 2021 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:
2022
2021
Income tax benefit at federal statutory rate
( 21.0 )%
( 21.0 )%
State income tax, net of federal benefit
( 7.7 )
( 7.7 )
Research credits
( 3.0 )
( 3.7 )
Stock-based compensation and other
0.7
1.0
Valuation allowance
31.0
31.4
Effective tax rate
—
%
—
%
Significant components of the Company’s
deferred tax assets and liabilities are summarized in the tables below as of September 30:
2022
2021
Deferred tax assets:
Federal and state operating loss carryforwards
$ 10,164,679
$ 7,575,069
Acquired intangibles
26,447
24,541
Accruals and other
70,399
8,370
Research and development credit carryforwards
1,107,559
812,781
Stock-based compensation
688,998
451,757
Total deferred tax assets
12,058,082
8,872,518
Deferred tax liabilities:
Fixed assets and other
( 140,538 )
( 64,189 )
Total deferred tax liabilities
( 140,538 )
( 64,189 )
Valuation allowance
( 11,917,544 )
( 8,808,329 )
Net deferred tax assets
$ —
$ —
As of September 30, 2022 and 2021, the Company
had gross deferred tax assets of approximately $ 12,058,000 and $ 8,873,000 , 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 and faces significant challenges to becoming profitable. Accordingly,
the net deferred tax assets have been fully offset by a valuation allowance of approximately $ 11,918,000 and $ 8,808,000 as of September
30, 2022 and 2021, respectively. The U.S. 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, 2022 and 2021, the Company’s
federal net operating loss carryforwards were approximately $ 35,408,000 and $ 26,355,000 , respectively. The Company had federal research
credit carryforwards as of September 30, 2022 and 2021 of approximately $ 759,000 and $ 506,000 , 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, 2022 and 2021, the Company had state net operating loss carryforwards
of approximately $ 35,249,000 and $ 26,355,000 , respectively. The Company had state research credit carryforwards of approximately $ 441,000
and $ 307,000 as of September 30, 2022 and 2021, 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. The Company believes
its income tax filing positions and deductions will be sustained upon examination, and accordingly, no reserves or related accruals for
interest and penalties have been recorded at September 30, 2022 and 2021.
F- 26
NeuroOne Medical Technologies Corporation
Notes to Financial Statements
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.
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, 2022.
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, 2022 and 2021 was
$ 30,697 and 14,803 , respectively.
NOTE 13 - Subsequent Events
Los Gatos Lease
On November
4, 2022, the term of the Los Gatos Lease was extended by two years to December 31, 2024. The rent under the Los Gatos Lease will range
from $ 4,453 to $ 4,632 per month.
At-The-Market
Offering
On December
21, 2022, we entered into a Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC (JonesTrading)
to create an at-the-market offering program under which we may offer and sell shares having an aggregate offering price of up to $ 9.0
million. JonesTrading is entitled to a commission at a fixed commission rate equal to up to 3 % of the gross proceeds.
F- 27
NeuroOne Medical Technologies Corporation
Form 10-K
ITEM 9. CHANGES IN AND
DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.