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, 2025
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE 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 12, 2025 was 49,999,519 .
NEUROONE
MEDICAL TECHNOLOGIES CORPORATION
FORM
10-Q
INDEX
Page
PART 1 – FINANCIAL INFORMATION
1
Item
1.
Financial Statements
1
Condensed Balance Sheets as of June 30, 2025 (unaudited) and September 30, 2024
1
Condensed Statements of Operations for the three and nine months ended June 30, 2025 and 2024 (unaudited)
2
Condensed Statements of Changes in Stockholders’ Equity for the three and nine months ended June 30, 2025 and 2024 (unaudited)
3
Condensed Statements of Cash Flows for the nine months ended June 30, 2025 and 2024 (unaudited)
4
Notes to Condensed Financial Statements (unaudited)
5
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
22
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
34
Item
4.
Controls and Procedures
34
PART II – OTHER INFORMATION
35
Item
1.
Legal Proceedings
35
Item
1A.
Risk Factors
35
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
35
Item
3.
Defaults Upon Senior Securities
35
Item
4.
Mine Safety Disclosures
35
Item
5.
Other Information
35
Item
6.
Exhibits
36
SIGNATURES
37
i
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
NeuroOne
Medical Technologies Corporation
Condensed
Balance Sheets
As of
June 30,
September 30,
2025
2024
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 8,039,683
$ 1,460,042
Accounts receivable
—
176,636
Inventory
1,897,701
2,635,153
Deferred offering costs
—
142,633
Prepaid expenses
233,363
216,461
Total current assets
10,170,747
4,630,925
Intangible assets, net
50,525
67,262
Right-of-use asset
283,621
254,910
Property and equipment, net
314,588
416,843
Total assets
$ 10,819,481
$ 5,369,940
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 467,734
$ 1,029,206
Accrued expenses and other liabilities
958,056
1,184,014
Total current liabilities
1,425,790
2,213,220
Warrant liability
1,040,894
2,140,315
Operating lease liability, long term
175,344
194,392
Total liabilities
2,642,028
4,547,927
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; 49,824,780 and 30,816,499 shares issued and outstanding as of June 30, 2025 and September 30, 2024, respectively.
49,825
30,816
Additional paid–in capital
85,118,194
75,795,610
Accumulated deficit
( 76,990,566 )
( 75,004,413 )
Total stockholders’ equity
8,177,453
822,013
Total liabilities and stockholders’ equity
$ 10,819,481
$ 5,369,940
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,
2025
2024
2025
2024
Product revenue
$ 1,696,050
$ 825,776
$ 6,356,767
$ 3,180,719
Cost of product revenue
781,215
543,904
2,743,982
2,242,114
Product gross profit
914,835
281,872
3,612,785
938,605
License revenue
—
—
3,000,000
—
Operating expenses:
Selling, general and administrative
1,618,950
1,881,099
5,602,818
6,057,520
Research and development
1,182,485
1,194,674
3,865,376
3,951,559
Total operating expenses
2,801,435
3,075,773
9,468,194
10,009,079
Loss from operations
( 1,886,600 )
( 2,793,901 )
( 2,855,409 )
( 9,070,474 )
Fair value change in warrant liability
319,625
—
1,099,421
—
Financing costs
( 9,325 )
—
( 334,063 )
—
Other income
75,432
26,376
103,898
102,959
Loss before income taxes
( 1,500,868 )
( 2,767,525 )
( 1,986,153 )
( 8,967,515 )
Provision for income taxes
—
—
—
—
Net loss
$ ( 1,500,868 )
$ ( 2,767,525 )
$ ( 1,986,153 )
$ ( 8,967,515 )
Net loss per share:
Basic and diluted
$ ( 0.03 )
$ ( 0.10 )
$ ( 0.05 )
$ ( 0.35 )
Number of shares used in per share calculations:
Basic and diluted
48,604,996
27,352,660
36,850,431
25,746,503
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, 2023
23,928,945
$ 23,929
$ 68,911,778
$ ( 62,686,303 )
$ 6,249,404
Issuance of common stock attributed to equity financings
868,243
868
1,255,403
—
1,256,271
Issuance costs related to equity financings
—
—
( 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 equity financings
1,461,353
1,461
2,092,735
—
2,094,196
Issuance costs related to equity financings
—
—
( 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
Common Stock
Additional
Paid–In
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance at September 30, 2024
30,816,499
$ 30,816
$ 75,795,610
$ ( 75,004,413 )
$ 822,013
Stock-based compensation
—
—
339,224
—
339,224
Issuance of common stock upon vesting of restricted stock units
37,798
37
( 37 )
—
—
Share repurchases for the payment of employee taxes
( 12,467 )
( 12 )
( 11,255 )
( 11,267 )
Net income
—
—
—
1,785,322
1,785,322
Balance at December 31, 2024
30,841,830
30,841
76,123,542
( 73,219,091 )
2,935,292
Issuance of common stock attributed to equity financings
355,899
356
413,681
—
414,037
Issuance costs related to equity financings
—
—
( 95,929 )
—
( 95,929 )
Stock-based compensation
—
—
250,170
—
250,170
Issuance of common stock upon vesting of restricted stock units
282,128
282
( 282 )
—
—
Share repurchases for the payment of employee taxes
( 94,331 )
( 94 )
( 107,011 )
—
( 107,105 )
Net loss
—
—
—
( 2,270,607 )
( 2,270,607 )
Balance at March 31, 2025
31,385,526
31,385
76,584,171
( 75,489,698 )
1,125,858
Issuance of common stock attributed to equity financing
18,400,000
18,400
9,181,600
—
9,200,000
Issuance costs related to equity financing
—
—
( 960,717 )
—
( 960,717 )
Stock-based compensation
—
—
316,654
—
316,654
Issuance of common stock upon vesting of restricted stock units
43,339
44
( 44 )
—
—
Share repurchases for the payment of employee taxes
( 4.085 )
( 4 )
( 3,470 )
—
( 3,474 )
Net loss
—
—
—
( 1,500,868 )
( 1,500,868 )
Balance at June 30, 2025
49,824,780
$ 49,825
$ 85,118,194
$ ( 76,990,566 )
$ 8,177,453
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,
2025
2024
Operating activities
Net loss
$ ( 1,986,153 )
$ ( 8,967,515 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation
197,355
182,664
Valuation adjustments for excess or obsolete inventory
7,500
—
Stock-based compensation
906,048
1,004,105
Amortization of deferred offering costs
192,647
—
Non-cash lease expense
83,187
86,611
Fair value change in warrant liability
( 1,099,421 )
—
Debt and equity facility termination costs reclassed to financing activities
141,416
—
Change in assets and liabilities:
Accounts receivable
176,636
( 410,551 )
Inventory
729,952
( 66,746 )
Prepaid expenses
( 16,902 )
2,269
Accounts payable
( 286,960 )
44,787
Accrued expenses, operating leases and other liabilities
( 356,905 )
( 220,581 )
Net cash used in operating activities
( 1,311,600 )
( 8,344,957 )
Investing activities
Purchase of property and equipment
( 71,135 )
( 83,292 )
Net cash used in investing activities
( 71,135 )
( 83,292 )
Financing activities
Proceeds from issuance of common stock attributed to equity financings
9,614,037
5,033,906
Issuance costs related equity financings
( 1,231,873 )
( 236,599 )
Financing costs in connection with debt facility
( 297,942 )
—
Share repurchases for the payment of employee taxes
( 121,846 )
( 71,574 )
Net cash provided by financing activities
7,962,376
4,725,733
Net increase (decrease) in cash and cash equivalents
6,579,641
( 3,702,516 )
Cash and cash equivalents at beginning of period
1,460,042
5,322,493
Cash and cash equivalents at end of period
$ 8,039,683
$ 1,619,977
Supplemental non-cash financing and investing transactions:
Modification of right-of-use asset and associated lease liability
$ 111,898
$ 199,385
Purchased property and equipment in accounts payable
$ 7,228
$ 34,000
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 for continuous electroencephalogram (“cEEG”)
and stereoelectrocencephalography (“sEEG”) recording, monitoring, ablation, drug delivery and brain stimulation solutions
to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back
surgeries and other related neurological disorders.
The
Company has received 510(k) clearance from the United States (“U.S.”) Food and Drug Administration (“FDA”) for
three of its devices: (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 has a distribution
agreement with Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute these three products
in the brain. The Company’s other products and indications are still under development.
The
Company is based in Eden Prairie, Minnesota.
Global
Economic Conditions
Generally,
worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East,
disruptions in the banking system and financial markets, 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 does not currently anticipate any significant impact from current
or proposed tariffs on imported goods.
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, 2024 included in the Company’s Annual Report on Form 10-K. The condensed balance sheet at September 30, 2024 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 – Liquidity
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 since inception, and an accumulated deficit of $ 77.0 million
as of June 30, 2025. 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 which previously resulted in substantial
doubt regarding the Company's ability to continue as a going concern. As of June 30, 2025, the Company had $ 8.0 million in cash and cash
equivalents. The Company believes its current available cash and cash equivalents coupled with the anticipated increase in product revenues
from minimum purchases and improved gross margins under the Zimmer Amendment and forecasted operating expense reductions, will be sufficient
to fund the Company’s planned expenditures and meet its obligations for at least twelve months from the date of issuance of these
financial statements.
In
the future, the Company may need to raise additional funds until it is able to generate sufficient revenues to fund its development activities.
The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional
liquidity in the future; however, these actions are not solely within the control of the Company and the Company is unable to predict
the outcome of these actions to generate the liquidity ultimately required.
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)
Revenue
Recognition
The
Company entered into a development and distribution agreement which has current and future revenue recognition implications. See “Note
7 – Zimmer Distribution 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. 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 manufacturers
in connection with OneRF Ablation system (the “OneRF Products”), 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 as well as valuation adjustments for excess or obsolete inventory.
License
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 will not occur, the value of the associated milestone (such as a regulatory submission)
is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators,
are not considered probable of being achieved until those approvals are received. When the Company’s assessment of probability
of achievement changes and variable consideration becomes probable, any additional estimated consideration is allocated to each performance
obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation
and recorded in license 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).
Warrant
Liability
The
Company issued warrants in connection with its 2024 Private Placement. See “Note 12– Stockholders’ Equity”. The
Company accounts for these warrants as a liability at fair value when warrant pricing protection provisions are not available to other
common stockholders. Additionally, issuance costs associated with the warrant liability are expensed as incurred and reflected as a financing
cost in the accompanying condensed statements of operations. The Company adjusts the liability for changes in fair value until the earlier
of the exercise or expiration of the warrants for any period when pricing protections remain in place. Any future change in the fair
value of the warrant liability is recognized in the condensed statements of operations under the fair value change in the warrant liability
line item.
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, 2025 and September 30, 2024, the fair values of cash, cash equivalents, accounts receivable, inventory, prepaids and deferred
offering costs, accounts payable and accrued expenses and other liabilities approximated their carrying values because of the short-term
nature of these assets or liabilities. The fair value of the warrant liability was based on Level 3 inputs as well as the Company’s
underlying stock price and associated volatility, expected term of the warrants and market interest rates. There were no transfers
between fair value hierarchy levels during the three and nine months ended June 30, 2025 and 2024.
8
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
The
fair value of financial instruments measured on a recurring basis is as follows:
As of June 30, 2025
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
$ 1,040,894
$ —
$ —
$ 1,040,894
Total liabilities at fair value
$ 1,040,894
$ —
$ —
$ 1,040,894
As of September 30, 2024
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
$ 2,140,315
$ —
$ —
$ 2,140,315
Total liabilities at fair value
$ 2,140,315
$ —
$ —
$ 2,140,315
The
following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis using unobservable level 3
inputs for the nine months ended June 30, 2025.
2025
Warrant liability
Balance as of beginning of period
$ 2,140,315
Change in fair value of warrant liability
( 1,099,421 )
Balance as of end of period
$ 1,040,894
There
were no financial instruments measured on a non-recurring basis during the periods presented.
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 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 impairment is measured as the difference
between the carrying value and the fair value of the impaired asset.
9
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
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.
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 .
Advertising
Expense
Advertising
expense is charged to selling, general and administrative expenses during the period that it is incurred. Total advertising expense amounted
to $ 45,120 and $ 128,663 for the three and nine months ended June 30, 2025, respectively. Total advertising expense amounted to $ 45,000
and $ 110,053 for the three and nine months ended June 30, 2024, 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.
10
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
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, 2025 and 2024.
The
following potential common shares were not considered in the computation of basic net loss per share as their effect would have been
anti-dilutive for the three and nine months ended June 30, 2025 and 2024:
2025
2024
Warrants
7,045,875
4,863,566
Stock options
6,131,448
2,814,096
Restricted stock units
848,468
1,167,572
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 adopted this guidance on October 1, 2024. The adoption of this ASU did not have a material impact on the Company’s
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 the adoption of this guidance on its 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.
11
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
The
WARF License grants to the Company an exclusive license to make, use and sell, in the United States only, products that employ certain
licensed patents for a neural probe array or thin-film micro electrode array and method. The Company agreed to pay WARF a royalty equal
to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $ 50,000 for
2020, $ 100,000 for 2021 and $ 150,000 for 2022 and each calendar year thereafter that the WARF License is in effect. If the
Company or any of its sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency
of such contest and, if the contested patent is found to be valid and would be infringed by the Company if not for the WARF License,
the royalty rate will be tripled for the remaining term of the WARF License.
WARF
may terminate the WARF License on 30 days’ written notice if we default on the payments of amounts due to WARF or fail to timely
submit development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy
such default in 90 days or in the event of certain bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90
days’ notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30,
2021 or (ii) if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters.
The first commercial sale occurred on December 7, 2020, prior to the June 30, 2021 deadline. The WARF License otherwise expires
by its terms on the date that no valid claims on the patents licensed thereunder remain. The Company expects the latest expiration of
a licensed patent to occur in 2030.
During
the three months ended June 30, 2025 and 2024, $ 37,500 in royalty fees were incurred related to the WARF License during each of these
periods. During the nine months ended June 30, 2025 and 2024, $ 112,500 in royalty fees were incurred during each of these periods related
to the WARF License. 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, 2025 and 2024, no royalty fees were incurred related to the Mayo Agreement, respectively. During the nine months
ended June 30, 2025 and 2024, zero and $ 4,415 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.
12
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 $ 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 ranged from $ 4,453 to $ 4,632 per month beginning
on January 1, 2023. On December 17, 2024, the Los Gatos Lease was extended again for an additional two years to December 31, 2026. The
rent under the newly extended Los Gatos Lease ranges from $ 4,939 to $ 5,087 per month beginning on January 1, 2025.
During
the three and nine months ended June 30, 2025, rent expense associated with the facility leases amounted to $ 70,121 and $ 209,364 , respectively.
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.
Supplemental
cash flow information related to the operating leases was as follows:
For the Nine Months Ended
June
30,
2025
2024
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$ 92,390
$ 103,795
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 111,898
$ 199,385
Supplemental
balance sheet information related to the operating leases was as follows:
As of
June 30,
2025 As of
September 30,
2024
Right-of-use assets $ 283,621 $ 254,910
Lease liabilities $ 295,717 $ 260,160
Weighted average remaining lease term (years) 2.6 3.6
Weighted average discount rate 7.2 % 7.4 %
Maturity
of the lease liabilities was as follows:
Calendar Year
As of
June 30,
2025
2025
$ 68,091
2026
139,985
2027
81,708
2028
34,815
Total lease payments
324,599
Less imputed interest
( 28,882 )
Total
295,717
Short-term portion (included in other liabilities)
( 120,373 )
Long-term portion
$ 175,344
13
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
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.
NOTE
5 – Supplemental Balance Sheet Information
Inventory
Inventory
consisted of the following:
As of
June 30,
2025
As of
September 30,
2024
Component inventory
$ 793,383
$ 877,065
Work-in-process
328,368
192,360
Finished goods
775,950
1,565,728
Total
$ 1,897,701
$ 2,635,153
Excess
and obsolete valuation reserve adjustments reflected as a reduction of work-in-process inventory at June 30, 2025 and September 30, 2024
were $ 7,500 and zero , respectively.
Intangibles
Intangible
assets rollforward is as follows:
Useful Life
Net Intangibles, September 30, 2024
12 - 13 years
$ 67,262
Less: amortization
( 16,737 )
Net Intangibles, June 30, 2025
$ 50,525
Amortization
expense was $ 5,579 and $ 16,737 for the three and nine months ended June 30, 2025, respectively, and $ 5,578 and $ 16,736 for the three
and nine months ended June 30, 2024, respectively.
Property
and Equipment, Net
Property
and equipment held for use by category are presented in the following table:
As of
June 30,
2025
As of
September 30,
2024
Equipment and furniture
$ 1,054,666
$ 976,303
Total property and equipment
1,054,666
976,303
Less accumulated depreciation
( 740,078 )
( 559,460 )
Property and equipment, net
$ 314,588
$ 416,843
14
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
Depreciation
expense was $ 61,015 and $ 180,618 for the three months and nine months ended June 30, 2025, respectively, and $ 57,529 and $ 165,928 for
the three and nine months ended June 30, 2024, respectively.
NOTE
6 – Accrued Expenses and Other Liabilities
Accrued
expenses consisted of the following at June 30, 2025 and September 30, 2024:
As of
June 30,
2025
As of
September 30,
2024
Accrued payroll
$ 759,263
$ 950,260
Operating lease liability, short term
120,373
65,768
Royalty payments
75,000
108,036
Other
3,420
59,950
Total
$ 958,056
$ 1,184,014
NOTE
7 – Zimmer Distribution Agreement and Other Product Revenue
On
October 25, 2024, the Company entered into the Zimmer Amended and Restated Distribution Agreement (the “Amendment”) with
Zimmer pursuant to which the Company granted Zimmer the exclusive right and license to distribute its OneRF Ablation System for an upfront
payment of $ 3.0 million, with eligibility for an additional $ 1.0 million payment from Zimmer upon achievement of certain specified net
sales milestones.
The
Company and Zimmer previously entered into an Exclusive Development and Distribution Agreement dated July 20, 2020, related to the sEEG
and Strip/Grid Product Systems, which was subsequently amended pursuant to the terms and conditions of a letter agreement dated January
6, 2021, a Second Amendment to Exclusive Development and Distribution Agreement dated June 28, 2022, and a Third Amendment to Exclusive
Development and Distribution Agreement dated August 2, 2022 (collectively, the “EDDA”).The EDDAs executed prior to the Amendment
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”. In addition, under the prior EDDAs, the
Company and Zimmer agreed to collaborate with respect to development activities through a joint development committee composed of an
equal number of representatives of Zimmer and the Company.
Under
the Amendment, Zimmer paid the Company $ 3.0 million for an exclusive RF Distribution License (the “RF Distribution License”
and “License”) for commercialization of its OneRF™ product. In addition, the Company is eligible to receive a future
milestone payment of $ 1.0 million upon reaching a one-time sales volume threshold.
The
revised term under the Amendment (the “Term”) began on the effective date of the Amendment and will remain in effect until
October 31, 2034. Upon the expiration of the Term, it may be renewed upon the mutual written of the parties. The Amended and Restated
Exclusive Development and Distribution Agreement may be terminated before the expiration of the Term in accordance with certain terms
under the Amendment. In addition, the license rights granted to Zimmer under this Amendment shall be exclusive (i) until September 30,
2032 for the sEEG Products and Strip/Grid Products; and (ii) until October 31, 2034 for the OneRF™ Product System.
License
Revenue
The
Amendment was accounted for under the provisions of ASC 606 as a separate contract from the prior EDDAs. In accordance with the provisions
under ASC 606, the Company identified the transfer of the RF Distribution License as the sole performance obligation of the RF Distribution
License. The distribution rights granted to Zimmer, inclusive of the access to the underlying intellectual property for future production
of the OneRF Product if required, was found to have significant standalone functionality as no additional substantive input was required
by the Company on a go forward basis. Lastly, ancillary support related to the Amendment was concluded to be a perfunctory obligation
and de minimis in terms of required resources.
The
transaction price associated with the Amendment was $ 3.0 million, which was comprised solely of the OneRF Exclusivity Fee and was
allocated totally to RF Distribution License performance obligation.
15
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
Sales
Volume Milestone and Payment
The
sales volume milestone associated with the Amendment was determined by sales or usage-based thresholds. The sales volume milestone was
accounted for under the sales milestone recognition constraint and will be accounted for as constrained variable consideration. The
Company has applied the sales volume constraint to the milestone payment and will not recognize revenue until the sales volume threshold
occurs.
Recognition
of License Revenue
The
Company determined that the RF Distribution License represented functional intellectual property given Zimmer’s access to
the underlying intellectual property associated with the OneRF Product. As such, the revenue related to the licenses was recognized at
the point in time in which the license/know-how was delivered to Zimmer which occurred in October 2024. Revenue recognized under
the Amendment during the nine months ended June 30, 2025 was $ 3.0 million.
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, 2025 was $ 1,696,050 and $ 6,356,767 , respectively and was comprised
solely of OneRF Product revenue. OneRF Products were subject to the Amendment upon its execution in October 2024.
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.
NOTE
8 – Stock-Based Compensation
During
the three and nine months ended June 30, 2025 and 2024, 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,
2025
2024
2025
2024
Selling, general and administrative
$ 246,709
$ 270,552
$ 711,896
$ 794,266
Research and development
69,945
68,057
194,152
209,839
Total stock-based compensation expense
$ 316,654
$ 338,609
$ 906,048
$ 1,004,105
2025
Equity Incentive Plan
On
January 10, 2025, the Board of Directors of the Company adopted the NeuroOne Medical Technologies Corporation 2025 Equity Incentive Plan
(the “2025 Plan”). On February 14, 2025, at the 2025 annual meeting of stockholders, the stockholders of the Company approved
the 2025 Plan.
16
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
The 2025 Plan is the
successor to and continuation of the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) and to the Company’s
2016 Equity Incentive Plan (the “Prior Plans”). As of the Effective Date, (i) no additional awards may be granted under the
Prior Plans; (ii) any Returning Shares will become available for issuance pursuant to Awards granted under the 2025 Plan; and (iii) all
outstanding awards granted under the Prior Plans will remain subject to the terms of the Prior Plans (except to the extent such outstanding
awards result in returning shares that become available for issuance pursuant to awards granted under the 2025 Plan.
Initially,
the maximum number of shares of the Company’s Common Stock (the “Common Stock”), that may be issued under the 2025
Plan may not exceed (1) 3,000,000 and (2) any shares subject to outstanding stock awards under the NeuroOne Medical Technologies 2017
Equity Incentive Plan that are forfeited or otherwise returned to the share reserve.
Inducement
Plan
In
October 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 a 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, and on May 20, 2025, the Board adopted
the Second 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 an additional 575,000 shares.
2017
Plan and Evergreen Provision
On
January 1, 2025, 1,124,446 shares were added to the 2017 Plan as a result of the evergreen provision within the 2017 Plan. However,
upon the adoption of the 2025 Plan, there will be no further issuance of grants under the 2017 Plan and any forfeitures of grants issued
under the 2017 Plan will be added to the amount available for future issuance under the 2025 Plan. Grants issued under the 2017 Plan
will continue to be governed under the terms of the 2017 Plan.
Stock
Options
During the three months ended June 30, 2025 and
2024, the Company granted 3,285,496 and zero stock options, respectively, to its board of directors, officers, employees and consultants.
During the nine months ended June 30, 2025 and 2024, the Company granted 3,336,571 and 1,225,669 stock options, respectively, to its board
of directors, officers, employees and consultants. Vesting generally occurs over a 12 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, 2025 was $ 0.50 per share. The grant date fair value
of the grants issued during the nine months ended June 30, 2025 and 2024 was $ 0.50 and $ 1.08 per share, respectively.
The
total expense for the three months ended June 30, 2025 and 2024 related to stock options was $ 203,095 and $ 202,338 , respectively. The
total expense for the nine months ended June 30, 2025 and 2024 related to stock options was $ 534,426 and $ 603,957 , respectively. The
total number of stock options outstanding as of June 30, 2025 and September 30, 2024 was 6,131,448 and 2,814,096 , respectively.
17
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, 2025 and 2024:
Three Months Ended Nine Months Ended
June 30, June 30,
2025 2024 2025 2024
Expected stock price volatility 109.9 % —
% 110.0 % 111.9 %
Expected life of options (years) 6.0 —
6.0 6.1
Expected dividend yield —
% —
% —
% 0 %
Risk free interest rate 4.0 % —
% 4.0 % 4.6 %
During
the three months ended June 30, 2025 and 2024, 136,589 and 127,583 stock options vested, respectively, and 19,219 and 65,000 stock options
were forfeited, respectively. During the nine months ended June 30, 2025 and 2024, 640,573 and 232,494 stock options vested, respectively,
and 19,219 and 120,000 stock options were forfeited during these periods, respectively. During the three and nine months ended June 30,
2025 and 2024, no options were exercised.
Restricted
Stock Units
During
the three and nine months ended June 30, 2025, the Company granted an aggregate of zero and 83,334 restricted stock units (“RSUs”)
to non-employee directors under the 2025 Plan. The weighted average grant date fair value of the RSUs granted during the nine months
ended June 30, 2025 was $ 1.20 per RSU. The RSUs granted vest over a one-year period in equal monthly installments, subject to the recipient’s
continued service on such dates.
During the nine months ended June 30, 2024, the
Company granted an aggregate of 1,006,725 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 months ended June 30, 2025 and 2024, 35,771 and 162,309 RSUs vested, respectively, and 2,500 and zero RSUs were forfeited during
these periods, respectively. During the nine months ended June 30, 2025 and 2024, 362,129 and 232,523 RSUs vested, respectively, and
2,500 and zero RSUs were forfeited these periods, respectively. The total expense for the three months ended June 30, 2025 and 2024 related
to these RSUs was $ 113,559 and $ 136,271 , respectively. The total expense for the nine months ended June 30, 2025 and 2024 related to
these RSUs was $ 371,622 and $ 400,148 , respectively. The total number of RSUs outstanding as of June 30, 2025 and September 30, 2024 was
848,468 and 1,129,762 , respectively.
General
As
of June 30, 2025, 1,709,604 shares were available in the aggregate for future issuance under the 2025 Plan and Inducement Plan. Unrecognized
stock-based compensation was $ 3,227,785 as of June 30, 2025. The unrecognized share-based expense is expected to be recognized over a
weighted average period of 3.7 years.
NOTE
9 – Concentrations
Revenue
For
the three months and nine months ended June 30, 2025, one customer accounted for 100 % and 96 % of the Company’s product revenue,
respectively. For the three months and nine months ended June 30, 2024, one customer accounted for 80 % and 95 % of the Company’s
product revenue, respectively.
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 generator and manufactures it.
18
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
NOTE
10 – Income Taxes
The effective tax rate for the three and nine
months ended June 30, 2025 and 2024 was zero percent. As a result of the analysis of all available evidence as of June 30, 2025 and September
30, 2024, 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, 2025 and 2024. 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. The One Big Beautiful
Bill Act (OBBBA) was enacted on July 4, 2025 and the Company continues to evaluate the impact on its financial position. The OBBBA is
not currently expected to materially impact the Company’s effective tax rate or cash flows in the current fiscal year.
NOTE
11 - Debt Financing
Debt
Facility Financing
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 provided for a delayed draw term loan facility in an aggregate principal
amount not to exceed $ 3.0 million (the “Debt Facility”). The Company was 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 Event (as defined in the Debt Facility Agreement)
or Change of Control (as defined in the Debt Facility Agreement), or (iii) at the Lender’s option, upon the occurrence and during
the continuance of an event of default under the Debt Facility Agreement. On November 7, 2024, the Company terminated the Debt Facility
Agreement, and no amounts were drawn under the Debt Facility Agreement. The Company paid a termination fee of $ 125,000 to the Lender
and incurred additional legal fees of $ 7,091 related to the termination. The Company also incurred non-termination Debt Facility costs
of $ 192,647 during the nine months ended June 30, 2025.
At
closing of the Debt Facility, the Company issued to the Lender a warrant exercisable for five years for 100,000 shares of common stock
at an exercise price of $ 0.66 per share, subject to adjustment (the “Closing Date Debt Facility Warrant”). The Closing Date
Debt Facility Warrant was accounted for and classified as equity on the accompanying condensed balance sheets.
NOTE
12 – Stockholders’ Equity
April
2025 Financing
On April
4, 2025, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.
Inc. as underwriter (the “Underwriter”), relating to the issuance and sale of 16,000,000 shares of the Company’s common
stock at a price to the public of $ 0.50 per share (the “April 2025 Financing”). In addition, under the terms of the Underwriting
Agreement, the Company granted the Underwriter an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of
common stock on the same terms as the offering, which overallotment was exercised in full. Issuance costs in connection with the April
2025 Financing amounted to $ 960,717 which included a 7 % commission to the Underwriter and legal and other expenses in the amount of $ 316,717 .
Net proceeds to the Company were $ 8,239,283 .
August
2024 Private Placement
On August 1, 2024, the Company entered into a Securities
Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Purchasers”), pursuant
to which the Company, in a private placement (the “2024 Private Placement”), agreed to issue and sell an aggregate of (i)
2,944,446 shares of the Company’s common stock and (ii) warrants to purchase an aggregate of 2,208,338 shares of common stock (the
“PIPE Warrants”) at a purchase price of $ 0.90 per unit, consisting of one share and a PIPE Warrant to purchase 0.75 shares
of common stock, resulting in total gross proceeds of approximately $ 2.65 million before deducting expenses. Issuance costs attributed
to 2024 Private Placement amounted to approximately $ 0.2 million. The 2024 Private Placement closed on August 2, 2024.
19
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
The PIPE Warrants are exercisable beginning on
the date of issuance and had an initial exercise price of $ 1.19 per share, subject to adjustment. In April 2025, the exercise price was
reset to $ 0.465 upon the close of the April 2025 Financing for all of the PIPE Warrants, except for the PIPE Warrants to purchase 20,834
shares of common stock issued to a director on the Company’s Board of Directors for which the exercise price was reset to $ 0.876
per share. The PIPE Warrants will expire on the third anniversary of the date of issuance.
The
PIPE Warrants were accounted for and classified as liabilities on the accompanying condensed balance sheets given certain price reset
provisions not used for a fair valuation under a fixed for fixed settlement scenario as required for equity balance sheet classification. A
Monte Carlo simulation model was used to estimate the aggregate fair value of the PIPE Warrants. Input assumptions used were as follows
on June 30, 2025 and September 30, 2024: risk-free interest rate 3.65 % and 3.53 %, respectively; expected volatility of 97.9 % and 115.7 %;
respectively; expected life of 2.1 years and 2.84 years, respectively; and expected dividend yield zero percent for both dates. The underlying
stock price used was the market price as quoted on Nasdaq as of June 30, 2025 and September 30, 2024. The Company recorded the fair value
change of the PIPE Warrants in the amount of $ 319,625 and $ 1,099,421 , respectively, to the fair value change in warrant liability line
item on the accompanying condensed statements of operations for the three and nine months ended June 30, 2025.
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 was 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. On August 16, 2024, the Company increased the amount of common
stock that can be sold pursuant to the Sales Agreement by $ 3.0 million. On April 3, 2025, the Company decreased the amount of common
stock that can be sold pursuant to the Sales Agreement to zero .
During
the nine months ended June 30, 2025, 355,899 shares of common stock were issued under the ATM for an aggregate offering price of $ 414,037 .
Issuance costs incurred under the ATM during the three and nine months ended June 30, 2025 were $ 9,325 and $ 105,254 , respectively.
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.
The
total aggregate offering price and common stock issued since inception of the ATM though June 30, 2025 was $ 8,000,600 and 5,544,489 shares,
respectively.
Warrant
Activity and Summary
There
were no warrant exercises or expirations during the three and nine months ended June 30, 2025.
20
NeuroOne
Medical Technologies Corporation
Notes
to Condensed Financial Statements
(unaudited)
The
following table summarizes information about warrants outstanding at June 30, 2025:
Warrant
Activity and Summary
Warrants Exercise
Price Per
Warrant Weighted
Average Exercise
Price Weighted
Average Term
(Years)
Outstanding and exercisable at September 30, 2024 7,045,875 $ 0.66 - 5.61 $ 3.81 1.98
Issued — $ — $ — —
Exercised — $ — $ — —
Expired — $ — $ — —
Outstanding and exercisable at June 30, 2025 7,045,875 $ 0.465 - 5.61 $ 3.59 1.23
The
following table summarizes information about warrants outstanding at June 30, 2024:
Exercise Price Number Outstanding Weighted Average
Remaining Contractual
life (Years) Number Exercisable at
June 30,
2025
$ 0.465 2,187,504 2.09 2,187,504
$ 0.66 100,000 4.09 100,000
$ 0.876 20,834 2.09 20,834
$ 3.00 350,000 2.09 350,000
$ 5.25 4,166,682 0.54 4,166,682
$ 5.61 220,855 3.00 220,855
Total 7,045,875 7,045,875
As provided in the PIPE Warrant agreement, the
exercise price of the PIPE Warrants was adjusted downward from $ 1.08 per share as of March 31, 2025 to $ 0.465 per share for most of the
PIPE Warrants as of June 30, 2025 attributed to the April 2025 Financing. The exercise price of the PIPE Warrants issued to a director
of the Company’s Board of Directors, however, was reset to $ 0.876 per share given a higher floor price provision for that individual.
21
NeuroOne Medical Technologies Corporation
Form 10-Q
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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, and our OneRF 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, RF ablation system, and 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;
●
the
performance, productivity, reliability and regulatory compliance of our third-party manufacturers of our cortical strip, grid electrode
and depth electrode and RF ablation technology;
●
our
ability to develop future generations of our cortical strip, grid and depth electrode technology;
●
our
future development priorities;
●
our
ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;
●
our
expectations about the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode and RF ablation
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;
22
NeuroOne Medical Technologies Corporation
Form 10-Q
●
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.
We
have received 510(k) clearance for three of our devices from the FDA, including: (i) our Evo cortical electrode technology for recording,
monitoring, and stimulating brain tissue for up to 30 days, (ii) 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, and (iii) our OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional
neurosurgical procedures. Our other products are still under development. We distribute each of these three devices with Zimmer Biomet.
We
have incurred mostly losses since inception. As of June 30, 2025, we had an accumulated deficit of $77.0 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 license 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 OneRF System,
and through milestone and other payments from our current collaboration and distribution arrangement with Zimmer, we expect to continue
to incur significant expenses and may incur increasing operating and net losses for the foreseeable future until we generate a higher
level of revenue from commercial sales.
23
NeuroOne Medical Technologies Corporation
Form 10-Q
Recent
Developments
Corporate
Updates
510(k)
Submission for Trigeminal Facial Pain
On
April 22, 2025, we filed a 510(k) submission to the FDA for our OneRF® Trigeminal Nerve Ablation System to treat facial pain.
April
2025 Financing
On
April 4, 2025, we entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.
Inc. as underwriter (the “Underwriter”), relating to the issuance and sale of 16,000,000 shares of the Company’s common
stock, at a price to the public of $0.50 per share (the “April 2025 Financing”). In addition, under the terms of the Underwriting
Agreement, we granted the Underwriter an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common
stock on the same terms as the offering, which was exercised in full. Net proceeds to the Company were approximately $8.2 million.
Zimmer
Amended and Restated Distribution Agreement
On
October 25, 2024, we entered into the Zimmer Amended and Restated Distribution Agreement (the “Amendment”) with Zimmer, Inc.
(“Zimmer”) pursuant to which we granted Zimmer the exclusive right and license to distribute our OneRF Ablation System for
an upfront payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified
net sales milestones.
We
previously entered into an Exclusive Development and Distribution Agreement dated July 20, 2020 with Zimmer, related to the sEEG and
Strip/Grid Product Systems, which was subsequently amended pursuant to the terms and conditions of a letter agreement dated January 6,
2021, a Second Amendment to Exclusive Development and Distribution Agreement dated June 28, 2022, and a Third Amendment to Exclusive
Development and Distribution Agreement dated August 2, 2022 (collectively, the “EDDA”).The EDDAs executed prior to the Amendment
granted Zimmer exclusive global rights to distribute the Strip/Grid Products and the Electrode Cable Assembly Products. Additionally,
we 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”. In addition, under the prior EDDAs, we agreed
to collaborate with respect to development activities through a joint development committee composed of an equal number of representatives
of Zimmer and the Company.
Under
the Amendment, Zimmer paid us $3.0 million for an exclusive RF Distribution License (the “RF Distribution License” and “License”)
for commercialization of its OneRF™ product. In addition, we are eligible to receive a future milestone payment of $1.0 million
upon reaching a one-time sales volume threshold.
The
revised term under the Amendment (the “Term”) began on the Effective Date and will remain in effect until October 31, 2034.
Upon the expiration of the Term, it may be renewed upon the mutual written of the Parties. The Amended and Restated Exclusive Development
and Distribution Agreement may be terminated before the expiration of the Term only by the Parties in accordance with certain terms under
the Amendment. In addition, the license rights granted to Zimmer under this Amendment shall be exclusive (i) from the Original Effective
Date until September 30, 2032 for the sEEG Products and Strip/Grid Products (the “sEEG and Strip/Grid Product Term”); and
(ii) from the Effective Date until October 31, 2034 for the OneRF™ Product System (the “RF Term”).
Global
Economic Conditions
Generally,
worldwide economic conditions remain uncertain, particularly due to the conflicts between Russia and Ukraine and in the Middle East,
disruptions in the banking system and financial markets, 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 continue to decline, our future cost of equity or debt capital and access to the capital markets could
be adversely affected. We do not currently anticipate any meaningful impact from current or proposed tariffs on imported goods.
24
NeuroOne Medical Technologies Corporation
Form 10-Q
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, increased inflation, 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.
Financial
Overview
Product
Revenue
Our
product revenue was derived from the sale of our Strip/Grid Products, the sEEG Products and the Electrode Cable Assembly Products based
on Evo cortical electrode technology and the OneRF Products, which are products based on our OneRF Ablation System. We anticipate that
we will generate additional revenue from the sale of products based on Evo cortical electrode technology and our OneRF Ablation System.
We
have received FDA 510(k) clearance for our cortical electrode for temporary (less than 30 days) recording, monitoring, and stimulation
on the surface of the brain, 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, and
our OneRF Ablation System for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedure.
Product
Gross Profit
Product
gross profit 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 manufacturers in connection with our Strip/Grid Products, sEEG Products, OneRF
Products and outside supplier materials costs of producing the Electrode Cable Assembly Products. In addition, the cost of product revenue
includes royalty fees incurred in connection with our license agreements as well as valuation adjustments for excess or obsolete inventory.
License
Revenue
The
Company determined that the RF Distribution License granted under the Zimmer Amended and Restated Distribution Agreement represented
functional intellectual property given Zimmer’s access to the underlying intellectual property associated with the OneRF Product.
As such, the revenue related to the license was recognized at the point in time in which the license/know-how was delivered to Zimmer
which occurred in October 2024. Revenue recognized under the Amendment during the nine months ending June 30, 2025 was $3.0 million.
For further discussion about the determination of license revenue, product revenue and cost of product revenue, and for a discussion
of milestones and royalty payments under the Amended and Restated Zimmer Distribution Agreement, see “—Liquidity and Capital
Resources—Liquidity Outlook” below and see “Note 7 — Zimmer Distribution Agreement and Other Product Revenue”
included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
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, OneRF ablation system
and electrode cable assembly products. We anticipate that our selling, general and administrative expenses will increase in the future
to support our continued research and development activities, further commercialization of our cortical strip and grid technology, ablation
system 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.
25
NeuroOne Medical Technologies Corporation
Form 10-Q
Research
and Development
Research
and development expenses consist of expenses incurred in performing research and development activities in developing our technology.
Research and development expenses include compensation and benefits for research and development employees including stock-based compensation,
overhead expenses, 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.
Fair
Value Change in Warrant Liability
The
net change in the fair value line item is attributed to the warrant liability while outstanding.
Financing
Costs
Financing
costs consists of the amortization of the deferred issuance costs and other lending and issuance costs in connection with the debt facility
and at-the market offering facility (both described below).
Other
Income
Other
income primarily consists of interest income related to our cash and cash equivalents,
Results
of Operations
Comparison
of the Three Months Ended June 30, 2025 and 2024
The
following table sets forth the results of operations for the three months ended June 30, 2025 and 2024, respectively.
For the
Three Months Ended
June 30,
(unaudited)
2025
2024
Period to
Period
Change
Product revenue
$ 1,696,050
$ 825,776
$ 870,274
Cost of product revenue
781,215
543,904
237,311
Product gross profit
914,835
281,872
632,963
Operating expenses:
Selling, general and administrative
1,618,950
1,881,099
(262,149 )
Research and development
1,182,485
1,194,674
(12,189 )
Total operating expenses
2,801,435
3,075,773
(274,338 )
Loss from operations
(1,886,600 )
(2,793,901 )
907,301
Fair value change in warrant liability
319,625
—
319,625
Financing costs
(9,325 )
—
(9,325 )
Other income
75,432
26,376
49,056
Loss before income taxes
(1,500,868 )
(2,767,525 )
1,266,657
Provision for income taxes
—
—
—
Net loss
$ (1,500,868 )
$ (2,767,525 )
$ 1,266,657
26
NeuroOne Medical Technologies Corporation
Form 10-Q
Product
Revenue and Product Gross Profit
Product
revenue was $1.7 million during the three months ended June 30, 2025 with a gross profit and gross profit percentage of $0.9 million
and 53.9%, respectively. Product revenue was $0.8 million during the three months ended June 30, 2024 with a gross margin and gross profit
percentage of $0.3 million and 34.1%, respectively. The increase in gross profit percentage during the current period was largely due
to the higher margin OneRF Products being sold in the current period under the Amendment with Zimmer. Product revenue consisted largely
of OneRF Products during the three months ended June 30, 2025 while revenue consisted of Strip/Grid Products, sEEG Products, Electrode
Cable Assembly Products, and OneRF Product sales during the comparable prior year period. The cost of product revenue consisted of the
manufacturing and materials costs incurred by our third-party contract manufacturers in connection with our Strip/Grid Products, sEEG
Products and OneRF Products, and outside supplier materials costs in connection with the Electrode Cable Assembly. In addition, cost
of product revenue included royalty fees incurred of approximately $38,000 in connection with our license agreements during each of the
three months ended June 30, 2025 and 2024.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were $1.6 million and $1.9 million during the three months ended June 30, 2025 and 2024, respectively.
The $0.3 million expense decrease in the current quarter over the comparable prior year quarter was largely attributed to lower legal
costs of $0.1 million and lower investor relations and other public company costs of $0.2 million. Selling, general and administrative
expenses included $0.2 million and $0.3 million of stock-based compensation during the three months ended June 30, 2025 and 2024, respectively.
Research
and Development Expenses
Research
and development expenses were $1.2 million for each of the three months ended June 30, 2025 and 2024. There was a negligible decease
in the current period over the prior year period which was attributed largely to the timing of product development activities in the
current quarter when compared to the comparable prior year quarter. Research and development expenses 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. Research and development expenses included $70,000 and $68,000 of stock-based compensation during
the three months ended June 30, 2025 and 2024, respectively.
Fair
Value Change in Warrant Liability
The
net change in fair value of the warrant liability during the three months ended June 30, 2025 was $0.3 million benefit. The change was
due primarily to fluctuations in our common stock fair value. There were no warrants outstanding during the three months ended June 30,
2024 that were measured on a fair value basis.
Financing
Costs
Financing
costs during the three months ended June 30, 2025 consisted of the costs associated with the at-the market offering facility (described
further below) in the amount of $9,000. We did not incur any financing costs during the three months ended June 30, 2024.
Other
Income
Other
income during the three months ended June 30, 2025 and 2024 related to interest income on our cash and cash equivalents in the amount
of $75,000 and $26,000, respectively.
27
NeuroOne Medical Technologies Corporation
Form 10-Q
Comparison
of the Nine Months Ended June 30, 2025 and 2024
The
following table sets forth the results of operations for the nine months ended June 30, 2025 and 2024, respectively.
For the
Nine Months Ended
June 30,
(unaudited)
2025
2024
Period to
Period
Change
Product revenue
$ 6,356,767
$ 3,180,719
$ 3,176,048
Cost of product revenue
2,743,982
2,242,114
501,868
Product gross profit
3,612,785
938,605
2,674,180
License revenue
3,000,000
—
3,000,000
Operating expenses:
Selling, general and administrative
5,602,818
6,057,520
(454,702 )
Research and development
3,865,376
3,951,559
(86,183 )
Total operating expenses
9,468,194
10,009,079
(540,885 )
Loss from operations
(2,855,409 )
(9,070,474 )
6,215,065
Fair value change in warrant liability
1,099,421
—
1,099,421
Financing costs
(334,063 )
—
(334,063 )
Other income
103,898
102,959
939
Loss before income taxes
(1,986,153 )
(8,967,515 )
6,981,362
Provision for income taxes
—
—
—
Net loss
$ (1,986,153 )
$ (8,967,515 )
$ 6,981,362
Product
Revenue and Product Gross Profit
Product
revenue was $6.4 million during the nine months ended June 30, 2025 with a gross profit and gross profit percentage of $3.6 million and
56.8%, respectively. Product revenue was $3.2 million during the nine months ended June 30, 2024 with a gross profit and gross profit
percentage of $0.9 million and 29.5%, respectively. The increase in gross profit percentage during the current period was largely due
to higher margin OneRF Products being sold in the current period under the Amendment with Zimmer. Product revenue consisted largely of
OneRF Products during the nine months ended June 30, 2025 while revenue consisted of Strip/Grid Products, sEEG Products, Electrode Cable
Assembly Products, and OneRF Product sales during the comparable prior year period. The cost of product revenue consisted of the manufacturing
and materials costs incurred by our third-party contract manufacturers in connection with our Strip/Grid Products, sEEG Products and
OneRF 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 $113,000 and $117,000 in connection with our license agreements during the nine
months ended June 30, 2025 and 2024, respectively.
License
Revenue
License
revenue was $3.0 million for the nine months ended June 30, 2025. License revenue during the current period related to the distribution
license granted to Zimmer for the OneRF Product in October 2024. No license revenue was generated from the Amended and Restated Zimmer
Development Agreement during the nine months ended June 30, 2024.
28
NeuroOne Medical Technologies Corporation
Form 10-Q
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were $5.6 million for the nine months ended June 30, 2025, compared to $6.1 million for the nine
months ended June 30, 2024. The $0.5 million decrease in the current nine months ended June 30, 2025 compared to the comparable prior
year period was primarily due to lower legal costs of $0.3 million, lower investor relations and other public company costs of $0.5 million,
offset by higher professional fees of $0.3 million on a net basis. Selling, general and administrative expenses included $0.7 million
and $0.8 million of stock-based compensation during the nine months ended June 30, 2025 and 2024, respectively.
Research
and Development Expenses
Research
and development expenses were $3.9 million for the nine months ended June 30, 2025, compared to $4.0 million for the nine months ended
June 30, 2024. The $0.1 million decrease period over period was attributed to the timing and an overall reduction in OneRF Product development
activities during the current nine months ended June 30, 2025 when compared to the comparable prior year period. Research and development
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. Research and development expenses included $0.2 million of stock-based
compensation during each of the nine months ended June 30, 2025 and 2024.
Fair
Value Change in Warrant Liability
The
net change in fair value of the warrant liability during the nine months ended June 30, 2025 was $1.1 million. The change was due primarily
to fluctuations in our common stock fair value. There were no warrants outstanding during the nine months ended June 30, 2024 that were
measured on a fair value basis.
Financing
Costs
Financing
costs during the nine months ended June 30, 2025 consisted of the amortization of the deferred issuance costs associated with the debt
facility (described further below) in the amount of $0.2 million and additional legal and loan facility termination costs of $0.1 million
upon the termination of the Debt Facility in November 2024. In addition, $9,000 in legal fees were incurred in connection with the at-the
market offering facility (described further below). We did not incur any financing costs during the nine months ended June 30, 2024.
Other
Income
Other
income during the nine months ended June 30, 2025 and 2024 consisted of $104,000 and $103,000 related to interest income attributed to
our cash and cash equivalents, respectively.
Liquidity
and Capital Resources
Overview
As
of June 30, 2025, our principal source of liquidity consisted of cash and cash equivalents in the aggregate of approximately $8.0 million.
Capital
Resources
Our
sources of cash and cash equivalents to date have been limited to license, 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 more recent financings
described below.
29
NeuroOne Medical Technologies Corporation
Form 10-Q
April
2025 Financing
On
April 4, 2025, we entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.
Inc. as underwriter (the “Underwriter”), relating to the issuance and sale of 16,000,000 shares of our common stock, at a
price to the public of $0.50 (the “April 2025 Financing”). In addition, under the terms of the Underwriting Agreement, we
granted the Underwriter an option, exercisable for 45 days, to purchase up to an additional 2,400,000 shares of common stock on the same
terms as the offering, which was exercised in full. Issuance costs in connection with the April 2025 Financing amounted to approximately
$1.0 million which included a 7.0% commission to the Underwriter and legal and other expenses in the amount of $0.3 million. The Company
received approximately $8.2 million in net proceeds.
August
2024 Private Placement
On August 1, 2024, we entered into a Securities
Purchase Agreement with certain Purchasers, pursuant to which we, in a private placement, agreed to issue and sell an aggregate of
(i) 2,944,446 shares of our Company’s common stock (the “Shares”), par value $0.001 per share and (ii) warrants to purchase
an aggregate of 2,208,338 shares of common stock (the “PIPE Warrants”) at a purchase price of $0.90 per unit, consisting of
one share and a PIPE Warrant to purchase 0.75 shares of common stock, resulting in total gross proceeds of approximately $2.65 million
before deducting estimated expenses. The 2024 Private Placement closed on August 2, 2024. Issuance costs attributed to the 2024 Private
Placement amounted to $0.2 million.
The PIPE Warrants are exercisable beginning on
the date of issuance and had an initial exercise price of $1.19 per share, subject to adjustment. In April 2025, the exercise price was
reset to $0.465 upon the close of the April 2025 Financing for all of the PIPE Warrants, except for the PIPE Warrants to purchase 20,834
shares of common stock issued to a director on our Board of Directors for which the exercise price was reset to $0.876 per share. The
PIPE Warrants will expire on the third anniversary of the date of issuance.
In
connection with the 2024 Private Placement, we agreed to file a registration statement with the SEC covering the resale of the Shares
and the shares of common stock issuable upon exercise of the PIPE Warrants which became effective on September 13, 2024.
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 of up to 3% of the gross proceeds. On July 24, 2023, we decreased the amount of common stock that can be sold pursuant
to the Sales Agreement, such that we were offering up to an aggregate of $2.6 million of our common stock for sale under the Sales Agreement,
including the shares of our common stock previously sold. Subsequently, on December 1, 2023, however, we increased the amount of common
stock that can be sold pursuant to the Sales Agreement, such that we were offering up to an aggregate of $4.8 million of our common stock
for sale under the Sales Agreement, including the shares of our common stock previously sold. On January 5, 2024, we further increased
the amount of common stock that can be sold pursuant to the Sales Agreement, such that we are offering up to an aggregate of $9.3 million
of our common stock for sale under the Sales Agreement, including the shares of common stock previously sold. Through June 30, 2025,
we have issued 5,544,489 shares of common stock under the ATM for gross proceeds in the amount of $8.0 million. We incurred issuance
costs in connection with the ATM in the amount of $0.6 million through June 30, 2025. On August 16, 2024, we increased the amount of
common stock that can be sold pursuant to the Sales Agreement by $3.0 million. On April 3, 2025, we decreased the amount of common stock
that can be sold pursuant to the Sales Agreement to zero.
Debt
Facility Financing
On
August 2, 2024, we entered into the Debt Facility Agreement with Growth Opportunity Funding, LLC, as the Lender, which provided for a
delayed draw term loan facility in an aggregate principal amount not to exceed $3.0 million. We were permitted to borrow loans under
the Debt Facility Agreement from time to time, for general corporate purposes and subject to certain specified conditions, until the
earliest of: (i) November 30, 2024, (ii) the occurrence of any Monetization Event as defined in the Debt Facility Agreement or a change
of 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. On November 7, 2024, the Company terminated the Debt Facility Agreement, and no amounts were drawn under the Debt
Facility Agreement. Total costs incurred under the debt facility financing was $0.4 million.
30
NeuroOne Medical Technologies Corporation
Form 10-Q
Funding
Requirements
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 “Part 1, 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, 2024 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.
On
January 21, 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. 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
2027.
We
expect to satisfy our short-term and long-term obligations through cash on hand and revenue from commercial sales to cover expenses.
Liquidity
Outlook
For
a discussion of potential fee payments under the Amended and Restated Zimmer Development Agreement, see “Note 7 — Zimmer
Distribution Agreement and Other Product Revenue” 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 and OneRF Products 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. On October 2024, we entered into an Amended and Restated Distribution
Agreement with Zimmer to provide Zimmer with the exclusive right and license to distribute also our OneRF Ablation System for an upfront
payment of $3.0 million, with eligibility for an additional $1.0 million payment from Zimmer upon achievement of certain specified net
sales milestones.
31
NeuroOne Medical Technologies Corporation
Form 10-Q
At
June 30, 2025, we had cash and cash equivalents in the aggregate of approximately $8.0 million. 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, 2024 and
2023, respectively, noting the existence of substantial doubt about our ability to continue as a going concern. We believe our current
available cash and cash equivalents coupled with the anticipated increase in product revenues from minimum purchases and improved gross
margins under the Zimmer Amendment and forecasted operating expense reductions, will be sufficient to fund our planned expenditures and
meet our obligations for at least twelve months from the date of issuance of these financial statements.
In
the future, however, in the absence of an adequate level of commercial sales to cover expenses, we may 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 in the future from operating results or future financing, 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, depth electrode, ablation system technology and future products
and 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.
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,
2025
2024
Net cash used in operating activities
$ (1,311,600 )
$ (8,344,957 )
Net cash used in investing activities
(71,135 )
(83,292 )
Net cash provided by financing activities
7,962,376
4,725,733
Net increase (decrease) in cash and cash equivalents
$ 6,579,641
$ (3,702,516 )
Net
cash used in operating activities
Net
cash used in operating activities was $1.3 million for the nine months ended June 30, 2025, which consisted of a net loss of $2.0 million
partially offset by non-cash stock-based compensation, depreciation, amortization related to intangible assets, a fair value change in
warrant liability and operating lease expense, totaling approximately $0.3 million in the aggregate. Our net loss was further adjusted
to account for the reclassification of debt and equity facility termination costs to financing activities in the amount of $0.1 million.
The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash
source of approximately $0.3 million. The net cash source stemming from the change in operating assets and liabilities was primarily
attributable to both a decrease in accounts receivable and inventory, partially offset by a net decrease in our aggregate accrued expense
and accounts payable as well as by a slight increase in our prepaid expenses associated with the timing of payments.
Net
cash used in operating activities was $8.3 million for the nine months ended June 30, 2024, which consisted of a net loss of $9.0 million
partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, operating
lease expense, totaling approximately $1.3 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 $0.6 million. The net cash use stemming from the
change in operating assets and liabilities was primarily attributable to both an increase in our accounts receivable and inventory purchases.
32
NeuroOne Medical Technologies Corporation
Form 10-Q
Net
cash used in investing activities
Net
cash used in investing activities was $0.1 million for the nine months ended June 30, 2025 and consisted of outlays for purchases of
property and equipment.
Net
cash used in investing activities was $0.1 million for the nine months ended June 30, 2024 and consisted of outlays for purchases of
property and equipment.
Net
cash provided by financing activities
Net
cash provided by financing activities was $8.0 million for the nine months ended June 30, 2025, which consisted of net proceeds from
the April 2025 Financing of $8.2 million and from the ATM in the amount of $0.3 million, offset by debt facility issuance costs of $0.3
million, issuance costs paid in connection with a prior year private placement of approximately $0.1 million and repurchases of common
stock for the payment of employee taxes in the amount of $0.1 million.
Net
cash provided by financing activities was $4.7 million for the nine months ended June 30, 2024, which consisted of net proceeds from
the ATM of $4.8 million, offset partially by repurchases of common stock for the payment of employee taxes in the amount of $0.1 million.
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 license revenue and product revenue, see “Note 7 — Zimmer Distribution Agreement and
Other Product Revenue” 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.
Fair
Value of Warrant liability
We
issued warrants in connection with our August 2024 Private Placement. The warrants were classified as a liability on our balance sheet
and were recorded at fair value as certain provisions precluded equity accounting treatment for these instruments. We will continue to
adjust the liabilities for changes in fair value until the earlier of the exercise, expiration, or until such time that cash settlement
or indexation provisions are no longer in effect for the warrants. For discussions about the application of fair value associated
with the warrants, see “Note 12 – Stockholders’ Equity” included in “Part 1, Item 1 – Financial Statements”
in this Report.
33
NeuroOne Medical Technologies Corporation
Form 10-Q
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 12 – Income Taxes” in “Part II, Item 8 - Financial Statements” of our Annual Report
on Form 10-K for the year ended September 30, 2024.
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.
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 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 are effective as of the end of the period covered by this report.
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.
Changes
in Internal Control over Financial Reporting
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.
34
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 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, 2024. 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.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable to our Company.
Item
5. Other Information
Rule
10b5-1 Trading Plans - Directors and Section 16 Officers
During
the three months ended March 31, 2025, none of the Company’s directors or Section 16 officers adopted or terminated any contract,
instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions
of Rule 10b5-1(c) of the Exchange Act or any “non-Rule 10b5-1 trading arrangement”.
Inducement
Plan Amendment
On
May 20, 2025, the Company's board of directors adopted the Second Amendment (the “Second 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 575,000 shares of common stock that may be issued pursuant to equity incentive awards under
the Inducement Plan. The Company believes that the increase in the shares reserved under the Inducement Plan is necessary to allow it
to attract qualified employees.
The
foregoing description of the terms of the Second Amendment is qualified in its entirety by reference to the actual terms of the Second
Amendment, which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
35
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 filed on March 31, 2021) .
3.3
Amended and Restated Bylaws of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.1 on the Registrant’s Current Report on Form 8-K filed on June 21, 2024 ) .
10.1*
Second Amendment to NeuroOne Medical Technologies Corporation 2021 Incentive Plan
10.2
Underwriting Agreement, dated April 4, 2025, between NeuroOne Medical Technologies Corporation and Ladenburg Thalmann & Co. Inc. (incorporated by reference to Exhibit 1.1 on the Registrant’s Current Report on Form 8-K filed on April 7, 2025).
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)
*
Filed
herewith.
**
Documents
are furnished and not filed.
36
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, 2025
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 and
Principal Accounting Officer)
37
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.