Item 1. Financial Statements
Item 1. Financial Statements
NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
As of
June 30,
As of
September 30,
2024
2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 1,619,977
$ 5,322,493
Accounts receivable
410,551
—
Inventory
1,793,432
1,726,686
Prepaid expenses
261,477
263,746
Total current assets
4,085,437
7,312,925
Intangible assets, net
72,841
89,577
Right-of-use assets
281,833
169,059
Property and equipment, net
472,486
525,753
Total assets
$ 4,912,597
$ 8,097,314
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 759,260
$ 685,104
Accrued expenses and other liabilities
931,700
1,107,522
Total current liabilities
1,690,960
1,792,626
Operating lease liability, long term
209,910
55,284
Total liabilities
1,900,870
1,847,910
Commitments and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding.
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 27,846,722 and 23,928,945 shares issued and outstanding as of June 30, 2024 and September 30, 2023, respectively.
27,847
23,929
Additional paid–in capital
74,637,698
68,911,778
Accumulated deficit
( 71,653,818 )
( 62,686,303 )
Total stockholders’ equity
3,011,727
6,249,404
Total liabilities and stockholders’ equity
$ 4,912,597
$ 8,097,314
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,
2024
2023
2024
2023
Product revenue
$ 825,776
$ 629,906
$ 3,180,719
$ 1,210,661
Cost of product revenue
543,904
386,240
2,242,114
947,799
Product gross profit
281,872
243,666
938,605
262,862
Collaborations revenue
—
—
—
1,455,188
Operating expenses:
Selling, general and administrative
1,881,099
1,862,389
6,057,520
5,347,234
Research and development
1,194,674
1,891,512
3,951,559
5,161,322
Total operating expenses
3,075,773
3,753,901
10,009,079
10,508,556
Loss from operations
( 2,793,901 )
( 3,510,235 )
( 9,070,474 )
( 8,790,506 )
Other income, net
26,376
41,462
102,959
66,136
Loss before income taxes
( 2,767,525 )
( 3,468,773 )
( 8,967,515 )
( 8,724,370 )
Provision for income taxes
—
—
—
—
Net loss
$ ( 2,767,525 )
$ ( 3,468,773 )
$ ( 8,967,515 )
$ ( 8,724,370 )
Net loss per share:
Basic and diluted
$ ( 0.10 )
$ ( 0.20 )
$ ( 0.35 )
$ ( 0.52 )
Number of shares used in per share calculations:
Basic and diluted
27,352,660
17,578,871
25,746,503
16,740,546
See accompanying notes to condensed financial
statements
2
NeuroOne Medical Technologies Corporation
Condensed Statements of Changes in Stockholders’
Equity
(unaudited)
Common Stock
Additional
Paid-In
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
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 attributed to the at-the-market offering
516,484
516
927,741
—
928,257
Issuance costs in connection with the at-the-market offering
—
—
( 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 attributed to the at-the-market offering
923,193
923
1,623,476
—
1,624,399
Issuance costs in connection with the at-the-market offering
—
—
( 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
Balance
at September 30, 2023
23,928,945
$
23,929
$
68,911,778
$
( 62,686,303
)
$
6,249,404
Issuance
of common stock attributed to the at-the-market offering
868,243
868
1,255,403
—
1,256,271
Issuance
costs in connection with the at-the market offering
—
—
( 37,698
)
—
( 37,698
)
Stock-based
compensation
—
—
308,638
—
308,638
Issuance
of common stock upon vesting of restricted stock units
45,078
45
( 45
)
—
—
Share
repurchases for the payment of employee taxes
( 11,176
)
( 11
)
( 13,548
)
—
( 13,559
)
Net loss
—
—
—
( 3,344,900
)
( 3,344,900
)
Balance
at December 31, 2023
24,831,090
24,831
70,424,528
( 66,031,203
)
4,418,156
Issuance
of common stock attributed to the at-the-market offering
1,461,353
1,461
2,092,735
—
2,094,196
Issuance
costs related to the at-the market-offering
—
—
( 148,382
)
—
( 148,382
)
Stock-based
compensation
—
—
356,858
—
356,858
Issuance
of common stock upon vesting of restricted stock units
37,689
38
( 38
)
—
—
Share
repurchases for the payment of employee taxes
( 8,382
)
( 8
)
( 11,287
)
—
( 11,295
)
Net loss
—
—
—
( 2,855,090
)
( 2,855,090
)
Balance
at March 31, 2024
26,321,750
26,322
72,714,414
( 68,886,293
)
3,854,443
Issuance
of common stock attributed to the at-the-market offering
1,419,317
1,419
1,682,020
—
1,683,439
Issuance
costs related to the at-the-market offering
—
—
( 50,519
)
—
( 50,519
)
Stock-based
compensation
—
—
338,609
—
338,609
Issuance
of common stock upon vesting of restricted stock units
146,740
147
( 147
)
—
—
Share
repurchases for the payment of employee taxes
( 41,085
)
( 41
)
( 46,679
)
—
( 46,720
)
Net loss
—
—
—
( 2,767,525
)
( 2,767,525
)
Balance
at June 30, 2024
27,846,722
$
27,847
$
74,637,698
$
( 71,653,818
)
$
3,011,727
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,
2024
2023
Operating activities
Net loss
$
( 8,967,515
)
$
( 8,724,370
)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation
182,664
136,757
Stock-based compensation
1,004,105
834,211
Amortization of discounts and premiums on short-term investments
—
( 45,571
)
Non-cash lease expense
86,611
81,567
Change in assets and liabilities:
Accounts receivable
( 410,551
)
33,237
Inventory
( 66,746
)
( 811,989
)
Prepaids and other assets
2,269
85,022
Accounts payable
44,787
( 62,808
)
Accrued expenses, deferred revenue, operating leases and other liabilities
( 220,581
)
( 1,510,104
)
Net cash used in operating activities
( 8,344,957
)
( 9,984,048
)
Investing activities
Purchases of short-term investments
—
( 1,473,419
)
Maturities of short-term investments
—
4,500,000
Payments for purchase of property and equipment
( 83,292
)
( 326,497
)
Net cash (used in) provided by investing activities
( 83,292
)
2,700,084
Financing activities
Proceeds from issuance of common stock attributed to the at-the-market offering
5,033,906
2,552,656
Issuance costs related to the at-the-market offering
( 236,599
)
( 234,725
)
Share repurchases for the payment of employee taxes
( 71,574
)
( 110,838
)
Net cash provided by financing activities
4,725,733
2,207,093
Net decrease in cash and cash equivalents
( 3,702,516
)
( 5,076,871
)
Cash and cash equivalents at beginning of period
5,322,493
8,160,329
Cash and cash equivalents at end of period
$
1,619,977
$
3,083,458
Supplemental non-cash financing and investing transactions:
Modification of right-of-use asset and associated lease liability
$
199,385
$
97,536
Unpaid deferred issuance costs (offset in prepaids and other assets)
$
—
$
67,159
Purchased property and equipment in accounts payable
$
34,000
$
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 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. The Company is also developing the capability to use its sEEG electrode technology to deliver
drugs or gene therapy while being able to record brain activity before, during, and after delivery. Additionally, the Company is investigating
the potential applications of its technology associated with artificial intelligence.
NeuroOne has received 510(k) clearance for three
of its devices from the FDA, including: (i) its Evo cortical electrode technology for recording, monitoring, and stimulating brain tissue
for up to 30 days, (ii) 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, and (iii) its OneRF
ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures. The Company’s
other products are still under development.
The Company commenced commercial sales of cEEG
strip/grid and electrode cable assembly products beginning in the first quarter of fiscal year 2021. The Company sold, on a limited application
basis for design verification, sEEG depth electrode products for non-human use beginning in late fiscal year 2021, and commenced commercial
sales of its sEEG depth electrode products in late calendar 2022. Lastly, the Company initiated a limited commercial launch of its OneRF
ablation system in March 2024.
The Company is based in Eden Prairie, Minnesota.
Global Economic Condition
Generally, worldwide economic conditions remain
uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East, disruptions in the banking system and
financial markets, 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 Company’s operating results could be
materially impacted by changes in the overall macroeconomic environment and other economic factors. Changes in economic conditions, supply
chain constraints, logistics challenges, labor shortages, the conflicts in Ukraine and the Middle East, disruptions in the banking system
and financial markets, and steps taken by governments and central banks, 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 U.S. 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 (“U.S. 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, 2023 included in the Company’s Annual
Report on Form 10-K. The condensed balance sheet at September 30, 2023 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 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 $ 71.7 million as of June 30, 2024. To date, the Company’s revenues have not
been sufficient to cover its full operating costs, and as such, it has been dependent on funding operations through the issuance of debt
and sale of equity securities. The Company has adequate liquidity, including the net proceeds from the August 2024 private placement
and August 2024 term loan facility, to fund its operations through July 2025. 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. As discussed further in Note 12, on August 2, 2024, the Company closed a private placement and received
net proceeds of approximately $ 2.5 million, and entered into a delayed draw term loan facility in an aggregate principal amount not to
exceed $ 3.0 million. 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.
Segment Information
Operating segments are components of an enterprise
for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker
in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive
Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment,
which is the business of development and commercialization of products related to comprehensive neuromodulation cEEG and sEEG recording,
monitoring, ablation, and brain stimulation solutions. Accordingly, the Company has a single reporting segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments
with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash
equivalents on the condensed 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.
6
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Short-Term Investments
The Company has periodically invested its excess
cash in U.S. Treasury securities and highly rated corporate securities. The Company has held these investments to maturity. Securities
with original maturity dates of more than three months were reported as held-to-maturity investments and were recorded at amortized cost,
which approximated fair value due to the negligible risk of changes in value due to interest rates. There were no short-term investments
outstanding as of June 30, 2024 and September 30, 2023.
Revenue Recognition
The Company entered into a development and distribution
agreement which has current and future revenue recognition implications. In addition, the Company has product revenue in connection with
its OneRF product offerings (“OneRF Products”) which is not covered by a distribution agreement. See “Note 7 –
Zimmer Development Agreement and Other Product Revenue .
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 Accounting 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. When the Company has consigned
inventory at a customer, revenue is recognized at the point in time when the customer issues a purchase order to the Company and when control of the promised goods or services is transferred to the Company's customers. 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), OneRF 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.
7
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Licenses of intellectual property : If
the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified
in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred
to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company
utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation
is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing
revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts
the measure of performance and related revenue recognition.
Milestone payments : At the inception of
each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved
and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant
revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction
price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable
of being achieved until those approvals are received. When the Company’s assessment of probability of achievement changes and variable
consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated
relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in 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, 2024 and September 30, 2023, the
fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, 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 and nine months ended June 30, 2024 and 2023.
8
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Intellectual Property
The Company has entered into two licensing
agreements with major research institutions, which allow for access to certain patented technology and know-how. Payments under those
agreements are capitalized and amortized to selling, general and administrative expense over the expected useful life of the acquired
technology.
Property and Equipment
Property and equipment is recorded at cost and
reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line
method. The estimated useful life for equipment and furniture ranges from three to seven years. 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. 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.
Accounts Receivable and Allowances for Credit Losses
The Company records a provision for credit losses,
when appropriate, based on historical experience, current conditions and reasonable supportable forecasts. In estimating the allowance
for credit losses, the Company considers, among other factors, the estimate of credit losses over the remaining expected life of the
asset, primarily using historical experience and current economic conditions that could affect the collectability of the balances in
the future. 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. The Company has not incurred
any bad debt expense to date and no allowance for credit losses has been recorded during the periods presented.
Inventory
Inventory is stated at the lower of cost (using
the first-in, first-out “FIFO” method) or net realizable value. The Company calculates inventory valuation adjustments for
excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future
demand of the products and spare parts. The Company’s inventory is currently comprised of Strip/Grid Products, sEEG Products, OneRF
Products and Electrode Cable Assembly Products component, work-in-process and finished good product. The Strip/Grid Products, sEEG Products
and OneRF Products are produced by a third-party contract manufacturer and the Electrode Cable Assembly Products are obtained from outside
suppliers. No inventory valuation allowance was required during the periods presented.
Research and Development Costs
Research and development costs are charged to
expense as incurred. Research and development expenses comprise of costs incurred in performing research and development activities,
including 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. 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 .
9
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Advertising Expense
Advertising expense is charged to selling, general
and administrative expenses during the period that it is incurred. Total advertising expense amounted to $ 45,000 and $ 110,053 for the
three and nine months ended June 30, 2024, respectively. Total advertising expense amounted to $ 49,492 and $ 156,131 for the three and
nine months ended June 30, 2023, respectively.
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 sales of the Company’s products.
Stock-Based Compensation
The Company accounts for stock-based compensation
in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation
costs related to equity instruments granted are recognized at the grant-date fair value over the requisite service period. The Company
records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the
applicable provisions of ASC 718.
Income Taxes
Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss
and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income
in the years in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation
allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Net Loss Per Share
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, 2024 and 2023.
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, 2024 and 2023:
2024
2023
Warrants
4,863,566
6,407,495
Stock options
2,814,096
1,708,906
Restricted stock units
1,167,572
431,049
10
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Recent Accounting Pronouncements
In November 2023, the FASB issued Accounting
Standards Update (“ASU”) 2023-07 - Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ,
which enhances reportable segment disclosure requirements, primarily through disclosures of significant segment expenses. This ASU is
effective for fiscal years beginning after December 15, 2023, including interim periods within fiscal years beginning after December
15, 2024, with early adoption permitted. The guidance must be applied retrospectively to all prior periods presented. The Company is
currently evaluating the impact of adoption of this guidance on its financial statements.
In December 2023, the FASB issued ASU 2023-09
Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which enhances income tax disclosures primarily related to the
rate reconciliation and income taxes paid information. This guidance also includes certain other amendments to improve the effectiveness
of income tax disclosures. This ASU is effective for fiscal years beginning after December 15, 2024, including interim periods within
those fiscal years and should be applied on a prospective basis, with retrospective application permitted. The Company is currently evaluating
the impact of adoption of this guidance on its financial statements.
In June 2016, the FASB issued Accounting Standards
Update 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.
The Company adopted the guidance on October 1, 2023. The adoption of this ASU did not have a material impact on the Company’s financial
statements.
NOTE 4 – Commitments and Contingencies
WARF License Agreement
The Company has entered into an exclusive start-up
company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and
thin film micro electrode technology. The Company entered into an Amended and Restated Exclusive Start-up Company License Agreement (the
“WARF License”) with WARF on January 21, 2020, which amended and restated in full the prior license agreement between WARF
and NeuroOne, LLC, a predecessor of the Company, dated October 1, 2014, as amended on February 22, 2017, March 30, 2019 and September
18, 2019.
The WARF License grants to the Company an exclusive
license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array
or thin-film micro electrode array and method. The Company agreed to pay WARF a royalty equal to a single-digit percentage of our product
sales pursuant to the WARF License, with a minimum annual royalty payment of $ 50,000 for 2020, $ 100,000 for 2021 and $ 150,000 for
2022 and each calendar year thereafter that the WARF License is in effect. If the Company or any of its sublicensees contest the validity
of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to
be valid and would be infringed by the Company if not for the WARF License, the royalty rate will be tripled for the remaining term of
the WARF License.
WARF may terminate the WARF License on 30 days’
written notice if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our
development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or in the event of certain
bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial
sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after royalties earned on sales begin
to be paid, such earned royalties cease for more than four calendar quarters. The first commercial sale occurred on December 7, 2020,
prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date that no valid claims on the patents
licensed thereunder remain. The Company expects the latest expiration of a licensed patent to occur in 2030.
11
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
During the three months ended June 30, 2024 and
2023, $ 37,500 in royalty fees were incurred related to the WARF License during each of these periods. During the nine months ended June
30, 2024 and 2023, $ 112,500 in royalty fees were incurred related to the WARF License during each of these periods. 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, 2024 and 2023, zero and
$ 5,727 in royalty fees were incurred related to the Mayo Agreement, respectively. During the nine months ended June 30, 2024 and
2023, $ 4,415 and $ 6,417 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 May 20, 2024, the Company amended its non-cancellable
headquarters lease (the “Lease”) with certain landlords (together, the “Landlord”) pursuant to which the Company
leases 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 June 30, 2028, as amended, unless terminated earlier (the “Lease
Term”). The base rent for the Premises ranges from $ 6,410 per month to $ 7,107 per month by the end of the Lease Term as amended.
In addition, as long as the Company is not in default under the Lease, the Company will be entitled to an abatement of its base rent for
the first two months of the amended Lease Term beginning in April 2025 and for the last month of the amended Lease Term (June 2028). In
addition, the Company pays its pro rata share of the Landlord’s annual operating expenses associated with the Premises.
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 $ 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,
2024, rent expense associated with the facility leases amounted to $ 43,455 and $ 129,560 , respectively. 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.
12
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Supplemental cash flow information related to
the operating leases was as follows:
For the
Nine Months
Ended
June 30,
2024
2023
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$ 103,795
$ 100,562
Modification of right-of-use asset and associated lease liability:
Operating leases
$ 199,385
$ 97,536
Supplemental balance sheet information related
to the operating leases was as follows:
As of
June 30,
2024 As of
September 30,
2023
Right-of-use assets $ 281,833 $ 169,059
Lease liabilities $ 290,090 $ 184,400
Weighted average remaining lease term (years) 3.7 1.4
Weighted average discount rate 7.4 % 7.8 %
Maturity of the lease liabilities was as follows:
Calendar Year
As of
June 30,
2024
2024
$ 70,243
2025
66,097
2026
78,945
2027
81,708
2028
34,816
Total lease payments
331,809
Less imputed interest
( 41,719 )
Total
290,090
Short-term portion in accrued expenses and other liabilities
( 80,180 )
Long-term portion
$ 209,910
Other Contingencies
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.
13
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 5 – Supplemental Balance Sheet Information
Inventory
Inventory consisted of the following:
As of
June 30,
2024
As of
September 30,
2023
Component inventory
$ 835,492
$ 1,202,778
Work-in-process
254,638
343,597
Finished goods
703,302
180,311
Total
$ 1,793,432
$ 1,726,686
Intangibles
Intangible assets rollforward is as follows:
Useful Life
Net Intangibles, September 30, 2023
12 - 13 years
$ 89,577
Less: amortization
( 16,736 )
Net Intangibles, June 30, 2024
$ 72,841
Amortization expense was $ 5,578 during each of
the three months ended June 30, 2024 and 2023 and $ 16,736 during each of the nine months ended June 30, 2024 and 2023, respectively.
Property and Equipment, Net
Property and equipment held for use by category
are presented in the following table:
As of
June 30,
2024
As of
September 30,
2023
Equipment and furniture
$ 973,398
$ 860,737
Total property and equipment
973,398
860,737
Less accumulated depreciation
( 500,912 )
( 334,984 )
Property and equipment, net
$ 472,486
$ 525,753
Depreciation expense was $ 57,529 and $ 165,928
for the three months and nine months ended June 30, 2024, respectively, and $ 51,380 and $ 120,021 for the three months and nine months
ended June 30, 2023, respectively.
14
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 6 – Accrued Expenses and Other
Liabilities
Accrued expenses consisted of the following at
June 30, 2024 and September 30, 2023:
As of
June 30,
2024
As of
September 30,
2023
Accrued payroll
$ 779,284
$ 874,382
Operating lease liability, short term
80,180
129,116
Royalty payments
72,236
104,024
Total
$ 931,700
$ 1,107,522
NOTE 7 – Zimmer Development Agreement
and Other Product Revenue
On July 20, 2020, the Company entered into an
exclusive development and distribution agreement (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 the Electrode Cable Assembly
Products. Additionally, the Company granted Zimmer the exclusive right and license to distribute certain sEEG Products developed by the
Company 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 and a Supplier 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.
On August 2, 2022, the Company entered into a
Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer Amendment”) with Zimmer. Pursuant to
the terms and conditions of the Zimmer 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 Zimmer 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, is 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.
15
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 “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 Strip/Grid Distribution License and sEEG Distribution License as defined
in the Zimmer Development Agreement shall be exclusive from the effective date of the Zimmer Amendment until the end of the term of the
Zimmer Amendment.
The Zimmer Development Agreement and Zimmer Amendment
were accounted for under the provisions of ASC 606. In accordance with the provisions under ASC 606, the Company identified five performance
obligations under the Zimmer Development Agreement and Zimmer 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 Zimmer Amendment, outside of the sEEG exclusivity maintenance obligation, were met by September
30, 2022. The remaining performance obligation in deferred revenue as of September 30, 2022 attributed to sEEG exclusivity maintenance
was completed in first quarter of fiscal year 2023.
The aggregate transaction price associated with
the Zimmer Development Agreement and Zimmer Amendment was $ 5.4 million comprising the Initial Exclusivity Fee of $ 2.0 million and the
$ 3.5 million payment under the Zimmer Amendment, less the fair value 2022 Zimmer Warrant of $ 0.1 million. The transaction price was allocated
between performance obligations based on their relative standalone selling prices. The Company used a market based valuation approach
and an expected cost plus margin approach with regard to estimating the standalone selling price for the performance obligations. The
Company recognized collaborations revenue in the amount of $ 1,455,188 during the nine months ended June 30, 2023 in connection with
the Zimmer Development Agreement and Zimmer Amendment. Given the achievement of the milestones under the Zimmer Development Agreement
and Zimmer Amendment by December 31, 2022, no collaborations revenue was recognized during the nine months ended June 30, 2024.
A reconciliation of the closing balance of deferred
revenue related to the Zimmer Development Agreement and Zimmer Amendment is as follows during the nine months ended as of June 30, 2024
and 2023:
2024
2023
Deferred Revenue
Balance as of beginning of period – September 30
$ —
$ 1,455,188
Revenue recognized
—
( 1,455,188 )
Balance as of end of period – June 30
$ —
$ —
Product Revenue
Product revenue related to the Company’s
Strip/Grid Products, sEEG Products, OneRF Products and Electrode Cable Assembly Products. Product revenue recognized during the three
and nine months ended June 30, 2024 was $ 825,776 and $ 3,180,719 , respectively, inclusive of OneRF Product revenue that amounted to $ 163,549
during the three and nine months ended June 30, 2024. There was no OneRF Product revenue recognized during the prior year periods presented.
The OneRF Products are not covered by the Zimmer Development Agreement. Product revenue recognized during the three and nine months ended
June 30, 2023 was $ 629,906 and $ 1,210,661 , respectively.
16
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 8 – Stock-Based Compensation
During the three and nine months ended June 30,
2024 and 2023, 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,
2024
2023
2024
2023
Selling, general and administrative
$ 270,552
$ 237,007
$ 794,266
$ 691,939
Research and development
68,057
59,395
209,839
142,272
Total stock-based compensation expense
$ 338,609
$ 296,402
$ 1,004,105
$ 834,211
Inducement Plan
In addition to the Company’s 2017 Equity
Incentive Plan (the “2017 Plan”), the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the
“Inducement Plan”) on October 4, 2021, pursuant to which the Company reserved 420,350 shares of its common stock to be used
exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material
to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The
Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance with such rule. On November
9, 2023, the Company’s Board of Directors adopted the First Amendment to the Company’s Inducement Plan, increasing the aggregate
number of shares of common stock that may be issued pursuant to equity incentive awards under the Inducement Plan by 150,000 shares for
a total of 570,350 shares of common stock that may be issued.
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, 2024, 1,051,556 shares were added to the 2017 Plan as a result of the evergreen provision.
Stock Options
During the three months ended June 30, 2024 and
2023, under the 2017 Plan, the Company granted zero and 339,000 stock options, respectively, to its officers, employees and consultants.
During the nine months ended June 30, 2024 and 2023, the Company granted 1,225,669 and 469,512 , respectively, to its board of directors,
officers, employees and consultants. Vesting generally occurs over an immediate to 48 month period based on a time of service condition.
The grant date fair value of the grants issued during the three months ended June 30, 2023 was $ 0.92 per share. The grant date fair value
of the grants issued during the nine months ended June 30, 2024 and 2023 was $ 1.08 and $ 0.88 per share, respectively.
17
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
The total expense for the three months ended June
30, 2024 and 2023 related to stock options was $ 202,338 and $ 158,528 , respectively. The total expense for the nine months ended June 30,
2024 and 2023 related to stock options was $ 603,957 and $ 482,276 , respectively. The total number of stock options outstanding as of June
30, 2024 and September 30, 2023 was 2,814,096 and 1,708,427 , respectively.
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, 2024 and 2023:
Three Months Ended Nine Months Ended
June 30, June 30,
2024 2023 2024 2023
Expected stock price volatility — % 58.1 % 111.9 % 57.4 %
Expected life of options (years) — 6.1 6.1 5.8
Expected dividend yield — % 0 % 0 % 0 %
Risk free interest rate — % 3.6 % 4.6 % 3.7 %
During the three months ended June 30, 2024 and
2023, 127,583 and 69,947 stock options vested, respectively, and 65,000 and 521 stock options were forfeited during these periods, respectively.
During the nine months ended June 30, 2024 and 2023, 232,494 and 282,172 stock options vested, respectively, and 120,000 and 521 stock
options were forfeited during these periods, respectively. During the three and nine months ended June 30, 2024 and 2023, no options were
exercised.
Restricted Stock Units
During the three and nine months ended June 30,
2024, the Company granted an aggregate of zero and 1,006,725 restricted stock units (“RSUs”) to its officers, employees and
consultants under the 2017 Plan, respectively. The weighted average grant date fair value of the RSUs granted during the nine months ended
June 30, 2024 was $ 1.03 per unit. The RSUs granted vest over a four-year period in equal annual installments on the anniversary
date of the grant, subject to the recipient’s continued service on such dates.
During the three and nine months ended June 30,
2023, the Company granted an aggregate of 249,000 and 310,728 RSUs to its board of directors, officers, employees and consultants 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 basis and others vesting at 50 percent on the first anniversary of the grant date with the remaining RSUs vesting in equal
quarterly installments on the last day of each quarter over 24 months, subject to the recipient’s continued service on such dates.
During the three months ended June 30, 2024 and
2023, 162,309 and 52,299 RSUs vested, respectively, and no RSUs were forfeited during these periods. During the nine months ended June
30, 2024 and 2023, 232,523 and 294,109 RSUs vested, respectively, and no RSUs were forfeited during these periods. The total expense for
the three months ended June 30, 2024 and 2023 related to these RSUs was $ 136,271 and $ 137,874 , respectively. The total expense for the
nine months ended June 30, 2024 and 2023 related to these RSUs was $ 400,148 and $ 351,935 , respectively.
General
As of June 30, 2024, 289,215 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 $ 2,713,998 as of June 30, 2024. The unrecognized share-based expense
is expected to be recognized over a weighted average period of 2.5 years.
18
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 9 – Concentrations
Revenue
Through March 31, 2024, one customer accounted for all of the Company’s
product and collaborations revenue. During the three months ended June 30, 2024, the Company initiated a limited commercial launch of
our OneRF ablation system and sold to two additional customers, who accounted for approximately 20 % of the Company’s product revenue
for the period. The OneRF Products are not covered by a distribution agreement.
Supplier concentration
One contract manufacturer produces all of the
Company’s Strip/Grid Products and sEEG Products and another supplier was responsible for the development of the Company’s
OneRF Ablation system.
NOTE 10 – Income Taxes
The effective tax rate for the three and nine
months ended June 30, 2024 and 2023 was zero percent. As a result of the analysis of all available evidence as of June 30, 2024 and September
30, 2023, 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, 2024 and 2023. 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 (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“JonesTrading”)
that created an at-the-market offering program (“ATM”) under which the Company may offer and sell common stock having an aggregate
offering price of up to $ 14.5 million. JonesTrading is entitled to a commission at a fixed commission rate of up to 3 % of the gross
proceeds. On July 24, 2023, the Company decreased the amount of common stock that can be sold pursuant to the Sales Agreement, such that
the Company was offering up to an aggregate of $ 2.6 million of its common stock for sale under the Sales Agreement, including the shares
of common stock previously sold. Subsequently on December 1, 2023, however, the Company increased the amount of common stock that can
be sold pursuant to the Sales Agreement, such that the Company was offering up to an aggregate of $ 4.8 million of its common stock for
sale under the Sales Agreement, including the shares of common stock previously sold. On January 5, 2024, the Company further increased
the amount of common stock that can be sold pursuant to the Sales Agreement, such that the Company is offering up to an aggregate of $ 9.3
million of its common stock for sale under the Sales Agreement, including the shares of common stock previously sold.
During the three and nine months ended June 30,
2024, 1,419,317 and 3,748,913 shares of common stock were issued, respectively, under the ATM for an aggregate offering price of $ 1,683,439
and $ 5,033,906 , respectively. Issuance costs incurred under the ATM during the three and nine months ended June 30, 2024 were $ 50,519
and $ 236,599 , respectively.
During the three and nine months ended June 30,
2023, 923,193 and 1,439,677 shares of common stock were issued, respectively, under the ATM for an aggregate offering price of $ 1,624,399
and $ 2,552,656 during these periods, respectively. Issuance costs incurred during the three and nine months ended June 30, 2023 was $ 51,366
and 234,725 , respectively.
19
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
The total aggregate offering price and common
stock issued since inception of the ATM though June 30, 2024 was $ 7,586,562 and 5,188,590 shares, respectively. Cumulative issuance costs
incurred under the ATM through June 30, 2024 were $ 471,323 .
Warrant Activity and Summary
There were no warrant exercises and 1,338,860
warrants expired during the nine months ended June 30, 2024, respectively. The following table summarizes information about warrants outstanding
at June 30, 2024:
Warrants Exercise
Price Per Warrant Weighted Average Exercise Price Weighted Average Term (Years)
Outstanding and exercisable at September 30, 2023 6,202,426 $ 3.00 - 9.00 $ 5.92 2.00
Issued —
$ —
$ —
—
Exercised —
$ —
$ —
—
Expired ( 1,338,860 ) $ 7.50 - 9.00 $ 8.69 —
Outstanding and exercisable at June 30, 2024 4,863,566 $ 3.00 - 9.00 $ 5.16 1.73
The following table summarizes information about
warrants outstanding at June 30, 2024:
Exercise Price Number Outstanding Weighted Average
Remaining Contractual
life (Years) Number Exercisable
$ 3.00 350,000 3.09 350,000
$ 5.25 4,166,682 1.54 4,166,682
$ 5.61 220,855 4.00 220,855
$ 6.00 45,171 0.00 * 45,171
$ 8.25 62,906 0.00 * 62,906
$ 9.00 17,952 0.00 * 17,952
Total 4,863,566 4,863,566
* Under
0.001
NOTE 12 – Subsequent Events
Private Placement
On August 2, 2024, the Company closed on a private
placement of an aggregate of 2,944,446 shares of common stock and warrants to purchase an aggregate of 2,208,338 shares of common stock
at a purchase price of $ 0.90 per unit, consisting of one share and a warrant to purchase 0.75 shares of common stock, resulting in gross
proceeds of approximately $ 2.65 million, excluding the proceeds, if any, that the Company may receive in the future from the exercise
of the warrants. The warrants have an initial exercise price of $ 1.19 per share and are exercisable for a period of three years from the
date of issuance. A director of the Company participated in the private placement on the same terms and conditions as all other purchasers,
except that the exercise price of such director’s warrant cannot be adjusted below the “Minimum Price” as defined under
Nasdaq rules and regulations.
New Debt Facility Agreement
On August 2, 2024, the Company entered into a loan
and security agreement (the “Debt Facility Agreement”) with Growth Opportunity Funding, LLC, as the lender (the “Lender”),
which provides for a delayed draw term loan facility in an aggregate principal amount not to exceed $ 3.0 million (the “Debt Facility”).
The Company is permitted to borrow loans under the Debt Facility from time to time (collectively, the “Loans”), for general
corporate purposes and subject to certain specified conditions, until the earliest of: (i) November 30, 2024, (ii) the occurrence of any
monetization or change in control, or (iii) at the Lender’s option, upon the occurrence and during the continuance of an event of
default under the Debt Facility Agreement. The Loan(s), upon issuance, will be secured by substantially all of the Company’s assets, subject to certain exceptions set forth in the Debt Facility Agreement,
and will be subject to covenants.
The Debt Facility matures on February 2, 2026 . The outstanding principal
amount of any outstanding Loans will bear interest at a rate of 10 % per annum, payable monthly in arrears and at the maturity date. As
of the closing date of the Debt Facility Agreement, no amounts were drawn by the Company thereunder.
On August 2, 2024, the Company paid a one-time standby facility fee of
$ 150,000 and issued 100,000 warrants to Lender to purchase shares of the Company’s common stock at exercise price of $ 0.66 per share.
The warrants are immediately exercisable and expire on August 2, 2029. Lastly, a cash draw-fee of $ 50,000 is payable and a warrant draw-fee
consisting of the issuance of an additional 50,000 warrants to the Lender is required upon each future funding date under the Debt Facility.
The warrants issuable upon each future funding date will have an exercise price of $ 0.66 per share and will have a five year term.
20
NeuroOne Medical Technologies Corporation
Form 10-Q
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.