Item 1. Financial Statements
Item 1. Financial Statements
NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
June 30,
2023
September 30,
2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 3,083,458
$ 8,160,329
Short-term investments
—
2,981,010
Accounts receivable
—
33,237
Inventory
1,516,527
704,538
Prepaids and other assets
278,786
296,649
Total current assets
4,878,771
12,175,763
Intangible assets, net
95,156
111,892
Right-of-use asset
197,324
181,355
Property and equipment, net
586,873
353,599
Total assets
$ 5,758,124
$ 12,822,609
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 958,811
$ 927,662
Accrued expenses and other liabilities
789,097
715,839
Deferred revenue
—
1,455,188
Total current liabilities
1,747,908
3,098,689
Operating lease liability, long term
88,918
119,556
Total liabilities
1,836,826
3,218,245
Commitments and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 10,000,000 shares authorized as of June 30, 2023 and September 30, 2022; no shares issued or outstanding as of June 30, 2023 and September 30, 2022.
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized as of June 30, 2023 and September 30, 2022; 17,862,162 and 16,216,540 shares issued and outstanding as of June 30, 2023 and September 30, 2022, respectively.
17,862
16,217
Additional paid–in capital
63,454,618
60,414,959
Accumulated deficit
( 59,551,182 )
( 50,826,812 )
Total stockholders’ equity
3,921,298
9,604,364
Total liabilities and stockholders’ equity
$ 5,758,124
$ 12,822,609
See accompanying notes to condensed financial statements
1
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
For the
Three Months Ended
For the
Nine Months Ended
June 30,
June 30,
2023
2022
2023
2022
Product revenue
$ 629,906
$ 32,049
$ 1,210,661
$ 102,381
Cost of product revenue
386,240
38,462
947,799
158,113
Product gross profit (loss)
243,666
( 6,413 )
262,862
( 55,732 )
Collaborations revenue
—
—
1,455,188
6,374
Operating expenses:
Selling, general and administrative
1,862,389
1,529,670
5,347,234
5,090,018
Research and development
1,891,512
1,225,351
5,161,322
3,491,193
Total operating expenses
3,753,901
2,755,021
10,508,556
8,581,211
Loss from operations
( 3,510,235 )
( 2,761,434 )
( 8,790,506 )
( 8,630,569 )
Other income, net
41,462
1,707
66,136
5,300
Loss before income taxes
( 3,468,773 )
( 2,759,727 )
( 8,724,370 )
( 8,625,269 )
Provision for income taxes
—
—
—
—
Net loss
$ ( 3,468,773 )
$ ( 2,759,727 )
$ ( 8,724,370 )
$ ( 8,625,269 )
Net loss per share:
Basic and diluted
$ ( 0.20 )
$ ( 0.17 )
$ ( 0.52 )
$ ( 0.54 )
Number of shares used in per share calculations:
Basic and diluted
17,578,871
16,193,442
16,740,546
15,927,734
See accompanying notes to condensed financial
statements
2
NeuroOne Medical Technologies Corporation
Condensed Statements of Changes in Stockholders’
Equity
(unaudited)
Additional
Total
Common Stock
Paid-In
Accumulated
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 )
Stock-based compensation
—
—
203,072
—
203,072
Issuance of common stock upon vesting of restricted stock units
5,646
6
( 6 )
—
—
Net loss
—
—
—
( 2,807,475 )
( 2,807,475 )
Balance at December 31, 2021
16,187,722
16,188
59,566,286
( 43,634,674 )
15,947,800
Stock-based compensation
—
—
232,716
—
232,716
Issuance of common stock upon vesting of restricted stock units
3,447
3
( 3 )
—
—
Net loss
—
—
—
( 3,058,067 )
( 3,058,067 )
Balance at March 31, 2022
16,191,169
16,191
59,798,999
( 46,692,741 )
13,122,449
Stock-based compensation
—
—
255,548
—
255,548
Issuance of common stock upon vesting of restricted stock units
3,447
4
( 4 )
—
—
Net loss
—
—
—
( 2,759,727 )
( 2,759,727 )
Balance at June 30, 2022
16,194,616
$ 16,195
$ 60,054,543
$ ( 49,452,468 )
$ 10,618,270
Balance at September 30, 2022
16,216,540
$ 16,217
$ 60,414,959
$ ( 50,826,812 )
$ 9,604,364
Stock-based compensation
—
—
300,181
—
300,181
Issuance of common stock upon vesting of restricted stock units
21,924
22
( 22 )
—
—
Net loss
—
—
—
( 1,732,769 )
( 1,732,769 )
Balance at December 31, 2022
16,238,464
16,239
60,715,118
( 52,559,581 )
8,171,776
Issuance of common stock in connection with at-the-market offering program
516,484
516
927,741
—
928,257
Issuance costs in connection with the at-the-market offering program
—
—
( 183,359 )
—
( 183,359 )
Stock-based compensation
—
—
237,628
—
237,628
Share repurchases for the payment of employee taxes
( 67,109 )
( 67 )
( 98,583 )
—
( 98,650 )
Issuance of common stock upon vesting of restricted stock units
199,899
200
( 200 )
—
—
Net loss
—
( 3,522,828 )
( 3,522,828 )
Balance at March 31, 2023
16,887,738
16,888
61,598,345
( 56,082,409 )
5,532,824
Issuance of common stock in connection with at-the-market offering program
923,193
923
1,623,476
—
1,624,399
Issuance costs in connection with the at-the-market offering program
—
—
( 51,366 )
—
( 51,366 )
Stock-based compensation
—
—
296,402
—
296,402
Share repurchases for the payment of employee taxes
( 8,385 )
( 8 )
( 12,180 )
—
( 12,188 )
Issuance of common stock upon vesting of restricted stock units
59,616
59
( 59 )
—
—
Net loss
—
—
—
( 3,468,773 )
( 3,468,773 )
Balance at June 30, 2023
17,862,162
$ 17,862
$ 63,454,618
$ ( 59,551,182 )
$ 3,921,298
See accompanying notes to condensed financial
statements
3
NeuroOne Medical Technologies Corporation
Condensed Statements of Cash Flows
(unaudited)
For the Nine Months Ended
June 30,
2023
2022
Operating activities
Net loss
$ ( 8,724,370 )
$ ( 8,625,269 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation
136,757
85,198
Stock-based compensation
834,211
691,336
Amortization of discounts and premiums on short-term investments
( 45,571 )
—
Non-cash lease expense
81,567
80,020
Change in assets and liabilities:
Accounts receivable
33,237
48,336
Inventory
( 811,989 )
( 355,998 )
Prepaids and other assets
85,022
( 145,462 )
Accounts payable
( 62,808 )
( 87,197 )
Accrued expenses, deferred revenue, operating leases and other liabilities
( 1,510,104 )
( 228,315 )
Net cash used in operating activities
( 9,984,048 )
( 8,537,351 )
Investing activities
Purchases of short-term investments
( 1,473,419 )
—
Maturities of short-term investments
4,500,000
—
Purchase of property and equipment
( 326,497 )
( 209,044 )
Net cash provided by (used in) investing activities
2,700,084
( 209,044 )
Financing activities
Proceeds from issuance of common stock in connection with at-the-market offering program and public offering
2,552,656
13,350,582
Issuance costs related to at-the-market offering program and public offering
( 234,725 )
( 1,327,300 )
Share repurchases for the payment of employee taxes
( 110,838 )
—
Net cash provided by financing activities
2,207,093
12,023,282
Net (decrease) increase in cash and cash equivalents
( 5,076,871 )
3,276,887
Cash and cash equivalents at beginning of period
8,160,329
6,901,346
Cash and cash equivalents at end of period
$ 3,083,458
$ 10,178,233
Supplemental non-cash financing and investing transactions:
Reclass of deferred offering costs to additional paid-in capital in connection with public offering
$ —
$ 24,980
Modification of right-of-use asset and associated lease liability
$ 97,536
$ —
Unpaid deferred issuance costs (offset in prepaids and other assets)
$ 67,159
$ —
Purchased property and equipment in accounts payable
$ 26,798
$ —
See accompanying notes to condensed financial
statements
4
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 1 – Description of Business and
Basis of Presentation
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, 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) from the FDA clearance 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. 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 conflict between Russia and Ukraine, 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 conflict
in Ukraine, 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.
Basis of presentation
The accompanying unaudited condensed financial
statements have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted
accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed financial
statements may not include all disclosures required by U.S. GAAP; however, the Company believes that the disclosures are adequate to make
the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited
financial statements and the notes thereto for the year ended September 30, 2022 included in the Annual Report on Form 10-K. The condensed
balance sheet at September 30, 2022 was derived from the audited financial statements of the Company.
In the opinion of management, all adjustments,
consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and
cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of
the operating results for the full fiscal year or any future periods.
5
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 2 – Going Concern
The accompanying
condensed 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 $ 59.6 million as of June 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 (see Note 13 - Subsequent Events), 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.
NOTE 3 – Summary of Significant Accounting
Policies
Management’s Use of Estimates
The preparation of financial statements in conformity
with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
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 invested its excess cash in U.S.
Treasury securities and highly rated corporate securities in prior periods. 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. The were no short-term investments outstanding as of June 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
6
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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.
7
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 June 30, 2023 and September 30, 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 three or nine months ended June 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 general and administrative expense over the expected useful
life of the acquired technology.
8
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 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.
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.
9
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 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
three and nine months ended June 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 three and nine months
ended June 30, 2023 and 2022:
2023
2022
Warrants
6,407,495
6,753,444
Stock options
1,708,906
1,245,582
Restricted stock units
431,049
443,670
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 fiscal years beginning after December 15, 2022. The Company does not expect that the adoption of this
ASU will have a material impact on its 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 adopted ASU 2020-06 effective October 1, 2022 and the ASU did not have a material impact to its financial statements.
10
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 License”).
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. 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 three months ended June
30, 2023 and 2022, $ 37,500 in royalty fees were incurred related to the WARF License during each of these periods. During the nine months
ended June 30, 2023 and 2022, $ 112,500 and $ 100,000 in royalty fees were incurred related to the WARF License, respectively. The royalty
fees 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 three months ended June 30, 2023 and 2022, $ 5,727
and $ 962 in royalty fees were incurred related to the Mayo Agreement, respectively. During the nine months ended June 30, 2023 and
2022, $ 6,417 and $ 2,798 in royalty fees were incurred related to the Mayo Agreement, respectively. The royalty fees 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 “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.
11
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 three and nine months ended June 30,
2023, rent expense associated with the facility leases amounted to $ 43,053 and $ 128,580 , respectively. During the three and nine months
ended June 30, 2022, rent expense associated with the facility leases amounted to $ 42,185 and $ 128,315 , respectively
Supplemental cash flow information related to
the operating leases was as follows:
For the
Nine Months Ended
June 30,
2023
2022
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$ 100,562
$ 97,799
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 97,536
$ —
Supplemental balance sheet information related
to the operating leases was as follows:
As of
June 30,
2023
As of
September 30,
2022
Right-of-use assets
$ 197,324
$ 181,355
Lease liabilities
$ 214,482
$ 202,895
Weighted average remaining lease term (years)
1.7
2.4
Weighted average discount rate
7.8 %
6.9 %
Maturity of the lease liabilities was as follows:
Calendar Year
As of
June 30,
2023
2023
$ 68,139
2024
139,969
2025
21,227
Total lease payments
229,335
Less imputed interest
( 14,853 )
Total
214,482
Short-term portion in accrued expenses and other liabilities
( 125,564 )
Long-term portion
$ 88,918
12
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
Other
In the ordinary course of business, from time
to time, the Company may be subject to a broad range of claims and legal proceedings that relate to contractual allegations, patent infringement
and other claims. The Company establishes accruals when applicable for matters and commitments which it believes losses are probable and
can be reasonably estimated. To date, no loss contingency for such matters and potential commitments have been recorded. Although it is
not possible to predict with certainty the outcome of these matters or potential commitments, the Company is of the opinion that the ultimate
resolution of these matters and potential commitments will not have a material adverse effect on its results of operations or financial
position.
NOTE 5 – Supplemental Balance Sheet Information
Prepaid and other assets consisted of the following:
As of
June 30,
2023
As of
September 30,
2022
Prepaid expenses
$ 211,627
$ 296,649
Deferred offering costs
67,159
—
Total
$ 278,786
$ 296,649
As of June 30, 2023, the Company incurred deferred
issuance costs in the amount of $ 67,159 related to a pending financing. See Note 13 – Subsequent Events.
Inventory
Inventory consisted of the following:
As of
June 30,
2023
As of
September 30,
2022
Work-in-process
$ 1,323,508
$ 630,570
Finished goods
193,019
73,968
Total
$ 1,516,527
$ 704,538
Intangibles
Intangible assets rollforward is as follows:
Useful Life
Net Intangibles, September 30, 2022
12 - 13 years
$ 111,892
Less: amortization
( 16,736 )
Net Intangibles, June 30, 2023
$ 95,156
Amortization expense was $ 5,578 and $ 16,736 for
the three and nine months ended June 30, 2023, respectively, and $ 5,578 and $ 16,736 for the three and nine months ended June 30, 2022,
respectively.
13
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
Property and Equipment, Net
Property and equipment held for use by category
are presented in the following table:
As of
June 30,
2023
As of
September 30,
2022
Equipment and furniture
$ 891,356
$ 538,061
Software
—
1,895
Total property and equipment
891,356
539,956
Less accumulated depreciation
( 304,483 )
( 186,357 )
Property and equipment, net
$ 586,873
$ 353,599
Depreciation expense was $ 51,380 and $ 120,021
for the three months and nine months ended June 30, 2023, respectively, and $ 25,928 and $ 68,462 for the three months and nine months ended
June 30, 2022, respectively. Software assets were fully depreciated as of September 30, 2022 and were written-off during the third quarter
of 2023.
NOTE 6 - Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted
of the following:
As of
June 30,
2023
As of
September 30,
2022
Accrued payroll
$ 582,806
$ 521,368
Operating lease liability, short term
125,564
83,339
Royalty payments
80,727
111,132
Total
$ 789,097
$ 715,839
NOTE 7 – Zimmer Development Agreement
On July
20, 2020, the Company entered into an exclusive development and distribution agreement (as amended from time to time, the “Zimmer
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 Zimmer Development Agreement through a joint development
committee composed of an equal number of representatives of Zimmer and the Company.
Under the
terms of the Zimmer 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 Zimmer 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 Zimmer 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 Zimmer Development
Agreement) for such Product.
Pursuant
to the Zimmer 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.
14
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
On August
2, 2022, the Company entered into a Third Amendment to the Zimmer Development Agreement (the “Third Amendment”) with Zimmer.
Pursuant to the terms and conditions of the Third Amendment, Zimmer made a $ 3.5 million payment to the Company. In consideration
of the mutual covenants and agreements contained in the Zimmer Development Agreement, the fee and milestone payment provisions in the
Zimmer 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 Zimmer Development Agreement
even though the satisfaction was after the deadlines originally identified.
In addition,
in connection with the Third 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 Zimmer 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, unless terminated earlier pursuant to
its terms. Either party may terminate the Zimmer 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 Zimmer Development Agreement for any reason with 90 days’ written notice, and the Company may terminate the Zimmer 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 Third Amendment until the end of the term.
The Zimmer Development Agreement and Third 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 Third Amendment: (1) the Company’s obligation to grant Zimmer access to its
intellectual property; (2) completion of 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 Zimmer Development Agreement and Third Amendment were met as of December 31, 2022.
The aggregate transaction price associated with
the Zimmer Development Agreement and Third Amendment was $ 5.4 million comprising the Initial Exclusivity Fee of $ 2.0 million and the $ 3.5
million payment under the Third Amendment, less the fair value of the 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.
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. Accordingly, the Company recognized
revenue in the amount of zero and $ 1,455,188 during the three and nine months ended June 30, 2023, respectively, related to the completion
of the sEEG exclusivity maintenance milestone. During the three and nine months ended June 30, 2022, the Company recognized revenue in
the amount of zero and $ 6,374 related to sEEG Product development, respectively.
15
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
A reconciliation of the closing balance of deferred
revenue related to the Zimmer Development Agreement and Third Amendment is as follows during the nine months ended as of June 30, 2023
and 2022:
2023
2022
Deferred Revenue
Balance as of beginning of period
$ 1,455,188
$ 8,622
Revenue recognized
( 1,455,188 )
( 6,374 )
Balance as of end of period
$ —
$ 2,248
Product Revenue
Product revenue related to its Strip/Grid Products,
sEEG Products and Electrode Cable Assembly Products. Product revenue recognized during the three and nine months ended June 30, 2023 was
$ 629,906 and $ 1,210,661 , respectively. Product revenue recognized during the three and nine months ended June 30, 2022 was $ 32,049 and
$ 102,381 , 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 $ 49,492 and $ 156,131 for the
three and nine months ended June 30, 2023, respectively. Total advertising expense amounted to $ 43,479 and $ 218,011 for the three and
nine months ended June 30, 2022, respectively.
NOTE 8 – Stock-Based Compensation
During the three and nine months ended June 30,
2023 and 2022, stock-based compensation expense related to stock-based awards was included in selling, general and administrative and
research and development costs as follows in the accompanying condensed statements of operations.
Three Months Ended
Nine Months Ended
June 30,
June 30,
2023
2022
2023
2022
Selling, general and administrative
$
237,007
$
211,472
$
691,939
$
569,347
Research and development
59,395
44,076
142,272
121,989
Total stock-based compensation expense
$
296,402
$
255,548
$
834,211
$
691,336
Stock Options
During the three months ended June 30, 2023 and
2022, under the 2017 Equity Incentive Plan (the “2017 Plan”), the Company granted 339,000 and 88,890 stock options, respectively,
to its board of directors, officers and employees. During the nine months ended June 30, 2023 and 2022, the Company granted 469,512 and
150,690 , respectively, to its board of directors, officers, employees and consultants. Vesting generally occurs over an immediate to four-year
period based on a time of service condition although vesting acceleration is provided under one grant in the event that a certain milestone
is met. The grant date fair value of the grants issued during the three months ended June 30, 2023 and 2022 was $ 0.92 and $ 0.57 per share,
respectively. The grant date fair value of the grants issued during the nine months ended June 30, 2023 and 2022 was $ 0.88 and $ 0.76 per
share, respectively.
The total expense for the three months ended June
30, 2023 and 2022 related to stock options was $ 158,528 and $ 137,109 , respectively. The total expense for the nine months ended June 30,
2023 and 2022 related to stock options was $ 482,276 and $ 444,891 , respectively. The total number of stock options outstanding as of June
30, 2023 and September 30, 2022 was 1,708,906 and 1,239,915 , respectively.
16
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
The weighted-average assumptions used in the Black-Scholes
option-pricing model are as follows for the stock options granted during the three and nine months ended June 30, 2023 and 2022:
Three Months Ended
Nine Months Ended
June 30,
June 30,
2023
2022
2023
2022
Expected stock price volatility
58.1 %
53.5 %
57.4 %
53.5 %
Expected life of options (years)
6.1
5.3
5.8
5.6
Expected dividend yield
0 %
0 %
0 %
0 %
Risk free interest rate
3.6 %
2.8 %
3.7 %
2.3 %
During the three months ended June 30, 2023 and
2022, 69,947 and 64,841 stock options vested, respectively, and 521 and 5,167 stock options were forfeited during these periods, respectively.
During the nine months ended June 30, 2023 and 2022, 282,172 and 265,901 stock options vested, respectively, and 521 and 27,668 stock
options were forfeited during these periods, respectively. During the three and nine months ended June 30, 2023 and 2022, no options were
exercised.
Restricted Stock Units
During the three and nine months ended June 30,
2023, the Company granted an aggregate of 249,000 and 310,728 restricted stock units (“RSUs”) to its board of directors under
the 2017 Plan, respectively. The weighted average grant date fair value of the RSUs granted during the three and nine months ended June
30, 2023 was $ 1.59 and $ 1.60 per unit, respectively. The RSUs vest over a one to three year period with some of the RSUs vesting ratably
on a monthly and others vesting at 50 percent on the first anniversary of the grant date with the remaining RSUs vesting in equal monthly
installments on the last day of each month over 24 months, subject to the recipient’s continued service on such dates.
During the three and nine months ended June 30,
2022, the Company granted an aggregate of 87,720 and 443,670 RSUs to certain directors, officers and employees under the 2017 Plan. The
weighted average grant date fair value of the RSUs granted during the three and nine months ended June 30, 2022 was $ 1.14 and $ 1.91 per
unit, respectively. The RSUs vest over a one to three year period with some of the RSUs vesting ratably on a monthly and others vesting
at 50 percent on the first anniversary of the grant date with the remaining RSUs vesting in equal monthly installments on the last day
of each month over 24 months, subject to the recipient’s continued service on such dates.
During the three months ended June 30, 2023 and
2022, 52,299 and 9,606 RSUs vested, respectively, and no RSUs were forfeited during these periods. During the nine months ended June 30,
2023 and 2022, 294,109 and 18,694 RSUs vested, respectively, and no RSUs were forfeited during these periods. The total expense for the
three months ended June 30, 2023 and 2022 related to these RSUs was $ 137,874 and $ 118,439 , respectively. The total expense for the nine
months ended June 30, 2023 and 2022 related to these RSUs was $ 351,935 and $ 246,445 , respectively.
Inducement Plan
On October 4, 2021, the Company adopted the NeuroOne
Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 420,350 shares
of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company,
as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the
Nasdaq Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance
with such rule.
2017 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 Company’s 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. Effective
January 1, 2023, 129,479 shares were added to the 2017 Plan as a result of the evergreen provision.
17
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
General
As of June 30, 2023, 1,129,125 shares were available
in the aggregate for future issuance under the 2017 Plan and Inducement Plan. No shares were available for future issuance under the 2016
Equity Incentive Plan. Unrecognized stock-based compensation was $ 1,745,365 as of June 30, 2023. The unrecognized share-based expense
is expected to be recognized over a weighted average period of 2.0 years.
NOTE 9 – 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.
NOTE 10 – Income Taxes
The effective tax rate for the three and nine
months ended June 30, 2023 and 2022 was zero percent. As a result of the analysis of all available evidence as of June 30, 2023 and September
30, 2022, the Company recorded a full valuation allowance on its net deferred tax assets. Consequently, the Company reported no income
tax benefit during the three and nine months ended June 30, 2023 and 2022. If the Company’s assumptions change and the
Company believes that it will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation
allowance on deferred tax assets will be recognized as a reduction of future income tax expense. If the assumptions do not
change, each period the Company could record an additional valuation allowance on any increases in the deferred tax assets.
NOTE 11 – Stockholders’ Equity
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 June 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. See Note 13 – Subsequent Events.
Public Offering
On October 13, 2021, the Company, entered
into an Underwriting Agreement (the “CH Underwriting Agreement”) with Craig-Hallum Capital Group LLC, as underwriter (“Craig-Hallum”),
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 CH Underwriting Agreement, the Company granted Craig-Hallum 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 Craig-Hallum’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.
18
NeuroOne Medical Technologies
Corporation
Notes to Condensed Financial Statements
(unaudited)
Warrant Activity and Summary
There were no warrant exercises during the three
and nine months ended June 30, 2023 and 425,370 and 695,848 warrants expired during the three and nine months ended June 30, 2023, respectively.
The following table summarizes information about
warrants outstanding at June 30, 2023:
Exercise Price
Number Outstanding
Weighted Average
Remaining Contractual
life (Years)
Number Exercisable at
June 30,
2023
$
3.00
350,000
4.09
350,000
$
5.25
4,166,682
2.55
4,166,682
$
5.61
220,855
5.01
220,855
$
6.00
45,171
1.01
45,171
$
7.50
279,727
0.67
279,727
$
8.25
62,906
1.01
62,906
$
9.00
1,282,154
0.43
1,282,154
Total
6,407,495
6,407,495
NOTE 12 – Deferred Contribution Plan
The Company has a 401(k) defined contribution
plan (the “401K Plan”) for all employees aged 21 and over. 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 June 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 nine 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 matching contributions to the 401K Plan to satisfy certain non-discrimination tests was zero and $ 30,697 during
the three and nine months ending June 30, 2023 and 2022, respectively.
NOTE 13 – Subsequent Events
ATM
As of June 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
are 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.
July 2023 Public Offering
On July 24, 2023, the Company entered into an Underwriting Agreement
(the “Benchmark 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. In addition, under the terms of the Benchmark Underwriting Agreement, 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 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 this offering were approximately
$ 5,214,875 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.
19
NeuroOne Medical Technologies
Corporation
Form 10-Q
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.