UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended June 30, 2023
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission File Number : 001-40439
NeuroOne Medical Technologies Corporation
(Exact name of Registrant as specified in its charter)
Delaware 27-0863354
(State or Other Jurisdiction of
Incorporation or Organization) (I.R.S. Employer
Identification Number)
7599 Anagram Drive
Eden Prairie , MN 55344
(Address of Principal Executive Offices) (Zip Code)
Registrant’s Telephone Number, Including
Area Code: 952 - 426-1383
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common stock, $0.001 par value NMTC The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (section 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”,
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐ Non-accelerated filer ☒
Accelerated filer ☐ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of outstanding shares of the registrant’s
common stock as of August 10, 2023 was 23,919,184 .
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
FORM 10-Q
INDEX
Page
PART 1 – FINANCIAL INFORMATION
Item 1.
Financial Statements
1
Condensed Balance Sheets as of June 30, 2023 (unaudited) and September 30, 2022
1
Condensed Statements of Operations for the three and nine months ended June 30, 2023 and 2022 (unaudited)
2
Condensed Statements of Changes in Stockholders’ Equity for the three and nine months ended June 30, 2023 and 2022 (unaudited)
3
Condensed Statements of Cash Flows for the nine months ended June 30, 2023 and 2022 (unaudited)
4
Notes to Condensed Financial Statements (unaudited)
5
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
32
Item 4.
Controls and Procedures
32
PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
33
Item 1A.
Risk Factors
33
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
33
Item 3.
Defaults Upon Senior Securities
33
Item 4.
Mine Safety Disclosures
33
Item 5.
Other Information
33
Item 6.
Exhibits
34
SIGNATURES
35
i
PART I – FINANCIAL INFORMATION
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
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The following discussion of our financial condition
and results of operations should be read in conjunction with the financial statements and notes included in Part I “Financial Information”,
Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the audited financial statements
and related footnotes included in our Annual Report on Form 10-K for the year ended September 30, 2022.
Forward-Looking Statements
This Report contains forward-looking statements
that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,”
“might,” “will,” “could,” “would,” “should,” “expect,” “intend,”
“plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “target,” “seek,” “contemplate,” “continue”
and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future.
These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity,
performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Report, we caution you that these
statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot
be certain. Forward-looking statements include statements about:
●
our ability to maintain regulatory clearance of our cortical strip and grid electrode technology;
●
our ability to obtain and maintain regulatory clearance for our RF ablation system;
●
our ability to successfully commercialize our technology in the United States;
●
our ability to achieve or sustain profitability;
●
our ability to raise additional capital and to fund our operations;
●
the availability of additional capital on acceptable terms or at all as or when needed;
●
the clinical utility of our cortical strip, grid and depth electrode including technology under development;
●
our ability to develop additional applications of our cortical strip, grid and depth electrode technology with the benefits we hope to offer as compared to existing technology, or at all;
●
the results of our development and distribution relationship with Zimmer, Inc. (“Zimmer”);
●
we have been the victim of a cyber-related crime, and our controls may not be successful in avoiding future cyber-related crimes; and
●
the performance, productivity, reliability and regulatory compliance of our third party manufacturers of our cortical strip, grid electrode and depth electrode technology;
●
our ability to develop future generations of our cortical strip, grid and depth electrode technology;
●
our future development priorities;
●
the impact of the COVID-19 pandemic on our business;
●
our ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;
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NeuroOne Medical Technologies
Corporation
Form 10-Q
●
our expectations about the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders;
●
our future commercialization, marketing and manufacturing capabilities and strategy;
●
our ability to comply with applicable regulatory requirements;
●
our ability to maintain our intellectual property position;
●
our expectations regarding international opportunities for commercializing our cortical strip, grid and depth electrode technology under including technology under development;
●
our estimates regarding the size of, and future growth in, the market for our technology, including technology under development; and
●
our estimates regarding our future expenses and needs for additional financing.
Forward-looking statements are based on management’s
current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s
beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and
other factors that are in some cases beyond our control. You should refer to the “Risk Factors” section of our Annual Report
on Form 10-K for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied
by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Report
will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light
of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.
These forward-looking statements speak only as
of the date of this Report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for
any reason, even if new information becomes available in the future. You should, however, review the factors and risks and other information
we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”) after the
date of this Report.
Overview
We are a medical technology
company focused on the development and commercialization of thin film electrode technology for continuous electroencephalogram (“cEEG”)
and stereoelectrocencephalography (“sEEG”), spinal cord stimulation, brain stimulation, drug delivery and ablation solutions
for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries
and other related neurological disorders. We are also developing the capability to use our sEEG electrode technology to deliver drugs
or gene therapy while being able to record brain activity before, during, and after delivery. Additionally, we are investigating the potential
applications of our technology associated with artificial intelligence.
In November 2019, our Evo cortical technology
received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for up to 30 days, and in October 2022,
we received FDA 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.
We completed feasibility bench top testing with
a new design of our diagnostic and ablation depth electrode in the first calendar quarter of 2021 and signed a contract with RBC Medical
Innovations to develop hardware for the system in the third calendar quarter of 2021. We completed design verification of such hardware
early in the second calendar quarter of 2023. We also completed an animal feasibility study at Emory University in September 2021. We
completed additional animal studies early in the second quarter of calendar 2023 and submitted an application for FDA 510(k) clearance
in June 2023. Our other products are still under development.
We commenced commercial
sales of cEEG strip/grid and electrode cable assembly products beginning in the first quarter of fiscal year 2021. We sold, on a limited
application basis for design verification, sEEG depth electrode products for non-human use beginning in late fiscal year 2021, and we
commenced commercial sales of our sEEG depth electrode products in late calendar 2022. Our other products are still under development.
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NeuroOne Medical Technologies
Corporation
Form 10-Q
We have incurred losses since inception. As of June 30, 2023, we had
an accumulated deficit of $59.6 million, primarily as a result of expenses incurred in connection with our research and development, selling,
general and administrative expenses associated with our operations and interest expense, fair value adjustments and loss on extinguishments
related to our debt, offset in part by collaborations and product revenues.
Prior to FDA clearance
of certain of our products, our main sources of cash, cash equivalents and short-term investments were proceeds from the issuances of
notes, common stock, warrants and unsecured loans. See “Liquidity and Capital Resources—Capital Resources” below. While
we have begun to generate revenue from the sale of products based on our cEEG and sEEG technology and through milestone and other
payments from our current collaboration with Zimmer, we expect to continue to incur significant expenses and increasing operating
and net losses for the foreseeable future until and unless we generate a higher level of revenue from commercial sales, and we will
need to obtain substantial additional funding in connection with our continuing operations through public or private equity or debt financings,
through collaborations or partnerships with other companies or other sources.
We may be unable to raise
additional funds when needed on favorable terms or at all. Our failure to raise such capital as and when needed would have a negative
impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode
technology and future products and our ability to pursue our business strategy. See “Liquidity and Capital Resources—Liquidity
Outlook” below.
Recent Developments and Upcoming Milestones
Corporate Updates
sEEG Commercial Launch
In May 2023 we announced the commercial launch
of the Evo® sEEG electrode product line in the United States with exclusive distribution partner Zimmer Biomet. We have fulfilled
eight shipments of sEEG product to Zimmer Biomet in preparation for launch and completed initial training on the sEEG product line to
Zimmer Biomet sales personnel.
The first clinical case using the Evo® sEEG
electrode in robotic neurosurgery was performed by Dr. William Bingaman at the Cleveland Clinic. The procedure was the first to utilize
NeuroOne’s Evo sEEG electrode with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning
and performing complex yet minimally invasive neurosurgical procedures.
OneRF Ablation
During the second fiscal quarter of 2023, we successfully
completed summative usability testing for OneRF with 15 neurosurgeons, and completed execution of internal device verification/validation
protocols for the final OneRF Ablation System. We submitted a 510(k) application to the FDA for the OneRF ablation system in June 2023.
Spinal Cord Stimulation Program
During the second fiscal quarter of 2023, we completed
an initial animal implant of novel thin film paddle leads for spinal cord stimulation (SCS). The devices are intended for the treatment
of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back, and leg pain. A percutaneous (through
a needle) delivery system for paddle leads is also under development and has been successfully bench-tested.
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NeuroOne Medical Technologies
Corporation
Form 10-Q
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 our 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 decline, our 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, our 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.
Financial Overview
Product Revenue
Our product revenue was derived from the sale
of our strip and grid cortical electrodes (“Strip/Grid Products”), depth electrodes (“sEEG Products”) and electrode
cable assembly products (“Electrode Cable Assembly Products”) based on Evo cortical technology. We anticipate that we will
generate additional revenue from the sale of products based on Evo cortical technology.
In November 2019, we received FDA 510(k) clearance
for our cortical strip electrode for temporary (less than 30 days) recording, monitoring, and stimulation on the surface of the brain.
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.
Product Gross Profit (Loss)
Product gross profit (loss) represents our product
revenue less our cost of product revenue. Our cost of product revenue consists of the manufacturing and materials costs incurred by our
third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products and outside supplier materials costs of producing
the Electrode Cable Assembly Products. In addition, cost of product revenue includes royalty fees incurred in connection with our license
agreements.
Collaborations Revenue
On July 20, 2020, we entered into an exclusive
development and distribution agreement (the “Zimmer Development Agreement”) with Zimmer, pursuant to which we granted Zimmer
exclusive global rights to distribute the Strip/Grid Products and electrode cable assembly products (the “Electrode Cable Assembly
Products”). Additionally, we 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,
we are 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.
23
NeuroOne Medical Technologies
Corporation
Form 10-Q
Except as otherwise provided in the Zimmer Development
Agreement, we are 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. In addition, on August 2, 2022, we entered into a Third Amendment to the Zimmer Development Agreement (the “Amendment”)
with Zimmer. Pursuant to the terms and conditions of the Amendment, Zimmer made a $3.5 million payment to us in August 2022. In consideration
of the mutual covenants and agreements contained in the Zimmer Development Agreement, certain 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 Amendment,
we issued to 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 our 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 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 (the “Zimmer
Term”), 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 Zimmer Development Agreement shall be exclusive from
the effective date of the Amendment until the end of the Zimmer Term.
All payments attributed to the Initial Exclusivity Fee, the sEEG exclusivity
maintenance fee and sEEG design milestone payment are non-refundable.
The Zimmer Development Agreement and Amendment
were accounted for under the provisions of Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with
Customers (“ASC 606”). In accordance with the provisions under ASC 606, we identified five performance obligations under
the Zimmer Development Agreement and Amendment: (1) our obligation to grant Zimmer access to our intellectual property; (2) completion
of sEEG Product development; (3) completion of Strip/Grid Product development; (4) the provision of sEEG exclusivity maintenance; and
(5) sEEG design modifications as requested by Zimmer. All performance obligations under the Zimmer Development Agreement and Amendment
were met as of December 31, 2022.
In October 2022, we received 510(k) clearance
from the FDA 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. Accordingly, we recognized
revenue in the amount of $1.5 million during the nine months ended June 30, 2023 related to the completion of the sEEG exclusivity maintenance
milestone. During the nine months ended June 30, 2022, we recognized revenue in the amount of $6,000 related to sEEG Product development.
The achievement of the level of sales required
to earn royalty payments from Zimmer is uncertain.
For further discussion about the determination
of collaborations revenue, product revenue and cost of product revenue, and for a discussion of milestones and royalty payments under
the Zimmer Development Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note
7 — Zimmer Development Agreement” included in our condensed financial statements included in “Part 1, Item 1 –
Financial Statements” in this Report.
24
NeuroOne Medical Technologies
Corporation
Form 10-Q
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 financial and administrative matters, and sales and marketing in connection with
the commercial sale of cEEG strip/grid, sEEG depth electrode and electrode cable assembly products. We anticipate that our selling, general
and administrative expenses will significantly increase in the future to support our continued research and development activities, further
commercialization of our cortical strip and grid technology, and our depth electrode technology, and the increased costs of operating
as a public company. These increases will include increased costs related to the hiring of additional personnel and fees for legal and
professional services, as well as other public company related costs.
Research and Development
Research and development expenses consist of expenses
incurred in performing research and development activities in developing our cortical strip and grid electrode and depth electrode technology.
Research and development expenses include compensation and benefits for research and development employees including stock-based compensation,
overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory
operations, fees paid to consultants and other outside expenses. Research and development costs are expensed as incurred and costs incurred
by third parties are expensed as the contracted work is performed. Lastly, de minimis income from the sale of prototype products and related
materials are offset against research and development expenses.
We expect our research and development expenses
to significantly increase over the next several years as we develop our cortical strip and grid electrode and depth electrode technology
and conduct preclinical testing and clinical trials and will depend on the duration, costs and timing to complete our preclinical programs
and clinical trials.
Other Income, net
Other income, net primarily consists of interest
income related to our cash, cash equivalents, investment income or loss from short-term investments and other income or expense outside
of normal operating activity relating to legal settlements, sales of non-commercial supplies and other items as applicable.
Results of Operations
Comparison of the Three Months Ended June 30,
2023 and 2022
The following table sets forth the results of
operations for the three months ended June 30, 2023 and 2022, respectively.
For the
Three Months Ended
June 30,
(unaudited)
2023
2022
Period to
Period
Change
Product revenue
$ 629,906
$ 32,049
$ 597,857
Cost of product revenue
386,240
38,462
347,778
Product gross profit (loss)
243,666
(6,413 )
250,079
Operating expenses:
Selling, general and administrative
1,862,389
1,529,670
332,719
Research and development
1,891,512
1,225,351
666,161
Total operating expenses
3,753,901
2,755,021
998,880
Loss from operations
(3,510,235 )
(2,761,434 )
(748,801 )
Other income, net
41,462
1,707
39,755
Loss before income taxes
(3,468,773 )
(2,759,727 )
(709,046 )
Provision for income taxes
—
—
—
Net loss
$ (3,468,773 )
$ (2,759,727 )
$ (709,046 )
25
NeuroOne Medical Technologies
Corporation
Form 10-Q
Product Revenue and Product Gross Profit (Loss)
Product revenue and product gross profit was $0.6
million and $0.2 million, respectively, during the three months ended June 30, 2023. Product revenue and product gross loss was $32,000
and $(6,000), respectively, during the three months ended June 30, 2022. The increase in gross profit during the current three month period
was largely due to the higher sales volume that exceeded fixed royalty period costs. The product revenue consists of the sale of our strip/grid,
sEEG and electrode cable assembly products. Cost of product revenue consisted of the manufacturing and materials costs incurred by our
third-party contract manufacturer in connection with our strip/grid and sEEG products, and outside supplier materials costs in connection
with the electrode cable assembly products. In addition, cost of product revenue included royalty fees incurred of approximately $43,000
and $38,000 in connection with our license agreements during the three months ended June 30, 2023 and 2022, respectively.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
$1.9 million and $1.5 million during the three months ended June 30, 2023 and 2022, respectively. The $0.3 million expense increase in
the current three months was attributed to higher administrative payroll costs of approximately $0.1 million and professional services
costs of $0.2 million.
Research and Development Expenses
Research and development expenses were $1.9 million
for the three months ended June 30, 2023, compared to $1.2 million during for the three months ended June 30, 2022. The $0.7 million increase
period over period was attributed to supporting development activities, which primarily included salary-related expenses and costs related
to consulting services, materials and supplies associated with the development of sEEG Products and to a much lesser extent Strip/Grid
Products.
Other Income, net
Other income during the three months ended June
30, 2023 and 2022 related to interest income on our cash and cash equivalents in the amount of $41,000 and $2,000, respectively.
Comparison of the Nine Months Ended June
30, 2023 and 2022
The following table sets forth the results of
operations for the nine months ended June 30, 2023 and 2022, respectively.
For the
Nine Months Ended
June 30,
(unaudited)
2023
2022
Period to
Period
Change
Product revenue
$ 1,210,661
$ 102,381
$ 1,108,280
Cost of product revenue
947,799
158,113
789,686
Product gross profit (loss)
262,862
(55,732 )
318,594
Collaborations revenue
1,455,188
6,374
1,448,814
Operating expenses:
Selling, general and administrative
5,347,234
5,090,018
257,216
Research and development
5,161,322
3,491,193
1,670,129
Total operating expenses
10,508,556
8,581,211
1,927,345
Loss from operations
(8,790,506 )
(8,630,569 )
(159,937 )
Other income, net
66,136
5,300
60,836
Loss before income taxes
(8,724,370 )
(8,625,269 )
(99,101 )
Provision for income taxes
—
—
—
Net loss
$ (8,724,370 )
$ (8,625,269 )
$ (99,101 )
26
NeuroOne Medical Technologies
Corporation
Form 10-Q
Product Revenue and Product Gross Profit (Loss)
Product revenue and product gross profit was $1.2
million and $0.3 million during the nine months ended June 30, 2023, respectively. Product revenue and product gross loss was $102,000
and $(56,000) during the nine months ended June 30, 2022, respectively. The increase in gross profit during the current period was largely
due to the higher sales volume that exceeded fixed royalty period costs. Product revenue consisted of Strip/Grid Products, sEEG Products
and Electrode Cable Assembly Products sales. Cost of product revenue consisted of the manufacturing and materials costs incurred by our
third-party contract manufacturer in connection with our Strip/Grid Products, sEEG Products and outside supplier materials costs in connection
with the Electrode Cable Assembly Products. In addition, cost of product revenue included royalty fees incurred of approximately $119,000
and $103,000 in connection with our license agreements during the nine months ended June 30, 2023 and 2022, respectively.
Collaborations Revenue
Collaborations revenue was $1.5 million and $6,000
for the nine months ended June 30, 2023 and 2022, respectively. Revenue during each period was derived from the Zimmer Development Agreement
and represented the portion of the upfront initial development fee payment eligible for revenue recognition during such period. The amount
of revenue recognized in the current nine months related to the completion of the sEEG maintenance fee obligation as a result of securing
FDA approval. For the comparable prior year period, the upfront fee was based on development completed in connection with depth electrode
products, and to a lesser extent, the Strip/Grid Products.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
$5.3 million for the nine months ended June 30, 2023, compared to $5.1 million for the nine months ended June 30, 2022. The $0.3 million
increase was primarily due to higher administrative payroll costs of $0.2 million and stock-based compensation of $0.1million.
Research and Development Expenses
Research and development expenses were $5.2 million
for the nine months ended June 30, 2023, compared to $3.5 million for the nine months ended June 30, 2022. The $1.7 million increase period
over period was attributed to supporting development activities, which primarily included salary-related expenses and costs related to
consulting services, materials and supplies associated with the development of sEEG Products and to a much lesser extent Strip/Grid Products.
Other Income, net
Other income, net during the nine months ended
June 30, 2023 of $66,000 consisted of $160,000 related primarily to interest income attributed to our cash, cash equivalents and short-term
investments, while outstanding, which was partially offset by an exploit loss of $94,000.
Other income during the nine months ended June
30, 2022 consisted of $5,000 related primarily to interest income attributed to our cash deposits.
27
NeuroOne Medical Technologies
Corporation
Form 10-Q
Liquidity and Capital Resources
Overview
As of June 30, 2023, our principal source of liquidity
consisted of cash and cash equivalents in the aggregate of approximately $3.1 million. While we began to generate revenue in fiscal year
2021 from commercial sales and through milestone and other payments under our collaboration with Zimmer, we expect to continue to incur
significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate an adequate level
of revenue from commercial sales to cover expenses. Our most significant cash requirements relate to the funding of our ongoing product
development and commercialization operations and our royalty obligations under our intellectual property licenses with the Wisconsin Alumni
Research Foundation (“WARF”) and the Mayo Foundation for Medical Education and Research (“Mayo”). Our additional
material cash needs include commitments under operating leases and other administrative services. See “Funding Requirements”
below for more information. We anticipate that our expenses will increase substantially as we develop and commercialize our cortical strip,
grid electrode and depth electrode technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products,
establish our own sales, marketing and distribution infrastructure to commercialize our ablation electrode technology, hire additional
staff, add operational, financial and management systems and continue to operate as a public company.
Capital Resources
Our sources of cash, cash equivalents and short-term
investments to date have been limited to collaboration and product revenues, along with proceeds from the issuances of notes with warrants,
common stock with and without warrants and unsecured loans, with the terms of our most recent financings, as of the third fiscal quarter
of 2023, described below.
At-The-Market Offering
On December 21, 2022, we 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 we 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.
Through June 30, 2023, we have issued 1,439,677 shares of common stock under the ATM for gross proceeds in the amount of $2.6 million.
We incurred issuance costs in connection with the ATM in the amount of $0.2 million through June 30, 2023. 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 $2.6 million
of our common stock for sale under the Sales Agreement, including the shares of common stock previously sold.
October 2021 Underwritten Public Offering
On October 13, 2021, we entered into an underwriting
agreement relating to the issuance and sale of 3,750,000 shares of our common stock at a price to the public of $3.20 per share (the “October
2021 Underwritten Public Offering”). In addition, under the terms of the underwriting agreement, we 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 from this offering were approximately $13.4 million prior to deducting underwriting discounts and other offering
expenses payable by us.
Funding Requirements
As noted above, certain
of our cash requirements relate to the funding of our ongoing product development and commercialization operations and our milestone and
royalty obligations under our intellectual property licenses with WARF and Mayo. See “Item 1—Business—Clinical
Development and Regulatory Pathway—Clinical Experience, Future Development and Clinical Trial Plans” in our Annual Report
on Form 10-K for the year ended September 30, 2022 for a discussion of design, development, pre-clinical and clinical activities that
we may conduct in the future, including expected cash expenditures required for some of those activities, to the extent we are able to
estimate such costs.
28
NeuroOne Medical Technologies
Corporation
Form 10-Q
On January 22, 2020,
we entered into an Amended and Restated License Agreement (the “WARF License”) with WARF, which amended and restated in full
our prior license agreement with WARF, dated October 1, 2014 (the “Original WARF License”). Under the WARF License, we have
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 we or any of our 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 us if not for the WARF License, the royalty
rate will be tripled for the remaining term of the WARF License.
Under the Amended and
Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty
equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement. See “Note 4 – Commitments
and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
in this Report for more information about the WARF License and the Mayo Development Agreement.
Our other cash requirements
within the next twelve months include accounts payable, accrued expenses, purchase commitments and other current liabilities. Our other
cash requirements greater than twelve months from various contractual obligations and commitments include operating leases and contracted
services. Refer to “Note 4 – Commitments and Contingencies” included in our condensed financial statements included
in “Part 1, Item 1 – Financial Statements” in this Report for further detail of our lease obligations and the timing
of expected future payments. Contracted services include agreements with third-party service providers for clinical research, product
development, manufacturing, supplies, payroll services, equipment maintenance services, and audits for periods up to fiscal year 2025.
We expect to satisfy
our short-term and long-term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales
to cover expenses, if ever, from future equity and debt financings.
Liquidity Outlook
For a discussion of potential fee payments under
the Zimmer Development Agreement, see “Note 7 — Zimmer Development Agreement” included in our condensed financial statements
included in “Part 1, Item 1 – Financial Statements” in this Report. Even though we have received regulatory clearance
to expand the use of our Evo sEEG electrode technology for up to 30 days, commercial sales of the sEEG electrodes are expected to take
some time to be a significant source of liquidity. Zimmer has exclusive global rights to distribute our strip and grid cortical electrodes,
depth electrodes and electrode cable assembly products. Zimmer’s failure to timely develop or commercialize these products would
have a material adverse effect on our business and operating results.
At June 30, 2023, we had cash and cash equivalents
in the aggregate of approximately $3.1 million. Management has noted the existence of substantial doubt about our ability to continue
as a going concern. Additionally, our independent registered public accounting firm included an explanatory paragraph in the report on
our financial statements as of and for the years ended September 30, 2022 and 2021, respectively, noting the existence of substantial
doubt about our ability to continue as a going concern. Our existing cash, cash equivalents and short-term investments may not be sufficient
to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need
to secure additional funding through public or private equity or debt financings, through collaborations or partnerships with other companies
or other sources. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital when
needed could compromise our ability to execute on our business plan. If we are unable to raise additional funds, or if our anticipated
operating results are not achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing
resources can fund our operations. If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations
and the development of our technology, or we may have to cease operations altogether.
The development and commercialization of our cortical
strip, grid electrode and depth electrode technology is subject to numerous uncertainties, and we could use our cash and cash equivalent
resources sooner than we expect. Additionally, the process of developing medical devices is costly, and the timing of progress in pre-clinical
tests and clinical trials is uncertain. Our ability to successfully transition to profitability will be dependent upon achieving further
regulatory approvals and achieving a level of product sales adequate to support our cost structure. We cannot assure you that we will
ever be profitable or generate positive cash flow from operating activities.
29
NeuroOne Medical Technologies
Corporation
Form 10-Q
Cash Flows
The following is a summary of cash flows for each
of the periods set forth below.
For the
Nine Months Ended
June 30,
2023
2022
Net cash used in operating activities
$ (9,984,048 )
$ (8,537,351 )
Net cash provided by (used in) investing activities
2,700,084
(209,044 )
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
Net cash used in operating activities
Net cash used in operating activities was $10.0
million for the nine months ended June 30, 2023, which consisted of a net loss of $8.7 million partially offset principally by non-cash
stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $1.0
million in the aggregate. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities
resulted in a cash use of approximately $2.3 million. The net cash use stemming from the change in operating assets and liabilities was
primarily attributable to a decrease in deferred revenue in connection with the completion of the remaining milestone performance obligation
under the Zimmer Development Agreement, and to a lesser extent, to an increase in inventory purchases, coupled with a decrease in the
aggregate of account payable and accrued expenses, attributed to the timing of payments. Partially offsetting the net cash operating use
during the period was a decrease in our accounts receivable and prepaids in the aggregate of $0.1 million resulting from timing of payments
and fluctuations in our operations.
Net cash used in operating activities was $8.5
million for the nine months ended June 30, 2022, which consisted of a net loss of $8.6 million partially offset principally by non-cash
stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $0.9
million in the aggregate. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities
resulted in a cash use of approximately $0.8 million. The change in operating assets and liabilities was primarily attributable to a net
decrease in accounts payable and accrued expenses and to an increase in inventory and prepaid expenses attributed to both the timing of
payments and the timing of product sales.
Net cash provided by (used in) investing activities
Net cash provided by investing activities was
$2.7 million and consisted of maturities of short-term investments in the amount of $4.5 million, offset by purchases of short term investment
of $1.5 million, consisting of treasury and corporate notes. The balance of activity during the period consisted of outlays for purchases
of property and equipment in the amount $0.3 million.
Net cash used in investing activities was
$0.2 million during the nine months ended June 30, 2022 and consisted of outlays for purchases of property and equipment.
Net cash provided by financing activities
Net cash provided by financing activities was
$2.2 million for the nine months ended June 30, 2023, which consisted of net proceeds from the ATM of $2.3 million, offset partially by
repurchases of common stock for the payment of employee taxes in the amount of $0.1 million.
Net cash provided by financing activities was
$12.0 million for the nine months ended June 30, 2022, which consisted of net proceeds from the October 2021 Underwritten Public Offering.
30
NeuroOne Medical Technologies
Corporation
Form 10-Q
Critical Accounting Estimates
Our financial statements are prepared in accordance
with U.S. generally accepted accounting principles. These accounting principles require us to make estimates and judgments that can affect
the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and
expense during the periods presented. We believe that the estimates and judgments upon which we rely are reasonably based upon information
available to us at the time that we make these estimates and judgments. To the extent that there are material differences between these
estimates and actual results, our financial results will be affected. The accounting policies that reflect our more significant estimates
and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are
described in Note 3 — “Summary of Significant Accounting Policies” to our condensed financial statements included in
“Part 1, Item 1 – Financial Statements” in this Report.
Of these policies, the following are considered
critical to an understanding of our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
in this Report as they require the application of the most subjective and the most complex judgments:
Revenues:
For discussion about the determination of collaborations
revenue, product revenue and cost of product revenue, see “Note 7 — Zimmer Development Agreement” included in our condensed
financial statements included in “Part 1, Item 1 – Financial Statements” in this Report. To date, we have not had, nor
expect to have in the future, significant variable consideration adjustments related to product revenue, such as chargebacks, sales allowances
and sales returns.
Stock-Based Compensation
For discussions about the application of grant
date fair value associated with our stock-based compensation, see “Note 8 — Stock-Based Compensation” included in our
condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
Income Tax Assets and Liabilities
Income tax assets and liabilities include income
tax valuation allowances. For additional information, see “Note 10 — Income Taxes” included in our condensed financial
statements included in “Part 1, Item 1 – Financial Statements” in this Report and “Note 11 – Income Taxes”
in Part II, Item 8 “Financial Statements” of our Annual Report on Form 10-K for the year ended September 30, 2022.
Contingencies
We are subject to numerous contingencies arising
in the ordinary course of business, including legal contingencies. For additional information, see “Note 4 — Commitments
and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
in this Report.
Recent Accounting Pronouncements
Refer to “Note 3— Summary of Significant
Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements”
in this Report for a discussion of recently issued accounting pronouncements.
31
NeuroOne Medical Technologies
Corporation
Form 10-Q
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable for smaller reporting companies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, under the direction of the Chief Executive Officer and the Chief Financial
Officer, we have evaluated our disclosure controls and procedures (as defined in Rule 13a-15(e) or 15d-15(e)) as of the end of the period
covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have
concluded that our disclosure controls and procedures were not effective as of the end of the period covered by this report due to the
material weakness in our internal controls over financial reporting related to our verification process concerning wire transfer
payments to vendors as discussed further below. Notwithstanding this material weakness, our management has concluded that the financial
statements included elsewhere in this Quarterly Report present fairly, in all material respects, our financial position, results of operations
and cash flows in conformity with generally accepted accounting principles.
In January 2023, we became aware that we had been
a victim of a criminal fraud that law enforcement authorities refer to as business email compromise fraud, which involved impersonation
of our vendor and fraudulent demands for wire transfers that targeted our finance department. The fraud resulted in a loss of approximately
$0.1 million. The Company’s investigation into this matter continues as further discussed in Item 1A.
Remediation
During the second fiscal quarter of 2023, enhancements
were made to our controls relating to electronic payments, including by wire transfer of funds. These enhancements include additional
verification and documentation procedures to be followed prior to the initiation or approval of electronic payments by or for us. We believe
these enhancements increase the ability of our personnel to identify and block attempts by third parties to fraudulently initiate electronic
payments from us. Our management believes that the foregoing actions will help improve our internal controls over financial reporting.
We are actively working to implement effective internal control over financial reporting, which includes remediation of the material weakness.
However, such compliance is not guaranteed, and we cannot provide any assurance that our internal control over financial reporting will
be effective as a result of these efforts.
Changes in Internal Control over Financial
Reporting
Other than the identification of the material
weakness described above, there has not been any change in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) and 15d-15(f) under
the Exchange Act) during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
32
NeuroOne Medical Technologies
Corporation
Form 10-Q
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in various
claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that,
in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can
have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors
In addition to the other information set forth
below and elsewhere in this Report, you should carefully consider the factors discussed in Part I, Item 1A “Risk Factors”
of the Company’s Annual Report on Form 10-K for the year ended September 30, 2022. Such factors, if they were to occur, could
cause our actual results to differ materially from those expressed in our forward-looking statements in this Report, and materially adversely
affect our financial condition or future results. Although we are not aware of any other factors that we currently anticipate will cause
our forward-looking statements to differ materially from our future actual results, or materially affect the Company’s financial
condition or future results, additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might
materially adversely affect our actual business, financial condition and/or operating results.
We have been the victim of a cyber-related crime and our controls
may not be successful in avoiding further cyber-related crimes in the future.
In January 2023, we were the victim of a business
email compromise fraud which resulted in our incurring a loss of approximately $0.1 million. We are working with law enforcement authorities
and the banks involved in the wire transfer to pursue recovery of the $0.1 million, but at this time we do not know whether we will be
able to recover such funds. Enhancements have been made to our controls relating to electronic payments by or for us that we believe will
reduce our risk of becoming a victim of future frauds related to our payments, including by wire transfers. However, cyber-related criminal
activities continue to evolve and increase in sophistication, frequency and severity. As a result, the control enhancements that have
been made, and any additional enhancements that may be made in the future, to our controls may not be successful in avoiding our becoming
a victim to further cyber-related crimes.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds
Share Repurchases
During the three months ended June 30, 2023, we
repurchased 8,385 common shares surrendered by employees to satisfy income tax withholding obligations of employees in connection with
the administration of employee share-based compensation plans. The following table summarizes the share repurchase activity:
Total number of
Maximum
number
shares purchased
of
shares that may
as part of publicly
yet be purchased
Total number of
Average price
announced plans
under the plans
Purchase period
shares purchased
paid per share
or programs
or programs
April 1 – April 30, 2023
2,795
$ 1.61
-
-
May 1 – May 31, 2023
2,795
$ 1.54
-
-
June 1 – June 30, 2023
2,795
$ 1.21
-
-
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable to our Company.
Item 5. Other Information
None.
33
NeuroOne Medical Technologies
Corporation
Form 10-Q
Item 6. Exhibits
Exhibit No.
Document
3.1
Certificate of Incorporation
of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.4 on the Registrant’s Current Report on
Form 8-K filed on June 29, 2017).
3.2
Certificate of Amendment
to Amended and Restated Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit
3.1 on the Registrant’s Current Report on Form 8-K on March 31, 2021).
3.3
Bylaws of NeuroOne Medical
Technologies Corporation (incorporated by reference to Exhibit 3.5 on the Registrant’s Current Report on Form 8-K filed on
June 29, 2017).
31.1
Certification
of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification
of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification
of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*
Certification
of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline
XBRL Instance Document.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Documents
are furnished not filed.
34
NeuroOne Medical Technologies
Corporation
Form 10-Q
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: August 14, 2023
NeuroOne Medical Technologies Corporation
By:
/s/ David Rosa
David Rosa
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Ronald McClurg
Ronald McClurg
Chief Financial Officer
(Principal Financial Officer)
35
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.