Item 1. Financial Statements
Item 1. Financial Statements
NeuroOne Medical Technologies Corporation
Condensed Balance Sheets
As of
March 31,
2026
(As
Restated)
September 30,
2025
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 2,804,011
$ 6,570,382
Accounts receivable
1,897,383
1,264,805
Inventory, net
2,099,415
2,226,805
Deferred offering costs
22,920
22,920
Prepaid expenses
283,716
141,372
Total current assets
7,107,445
10,226,284
Intangible assets, net
33,789
44,946
Right-of-use asset
196,775
255,195
Property and equipment, net
230,596
259,222
Total assets
$ 7,568,605
$ 10,785,647
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 934,196
$ 1,010,369
Accrued expenses and other liabilities
755,258
1,292,714
Total current liabilities
1,689,454
2,303,083
Warrant liability
709,507
1,266,894
Operating lease liability, long term
92,361
143,148
Total liabilities
2,491,322
3,713,125
Commitments and contingencies (Note 5)
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; 8,615,532 and 8,334,336 shares issued and outstanding as of March 31, 2026 and September 30, 2025, respectively.
8,616
8,334
Additional paid-in capital
87,498,366
85,673,975
Accumulated deficit
( 82,429,699 )
( 78,609,787 )
Total stockholders’ equity
5,077,283
7,072,522
Total liabilities and stockholders’ equity
$ 7,568,605
$ 10,785,647
See accompanying notes to condensed financial statements
1
NeuroOne Medical Technologies Corporation
Condensed Statements of Operations
(unaudited)
For the
Three Months Ended
For the
Six Months Ended
March 31,
March 31,
2026
(As
Restated)
2025
2026
(As Restated)
2025
Product revenue
$ 1,862,050
$ 1,386,550
$ 4,754,685
$ 4,660,717
Cost of product revenue
871,786
615,489
2,196,593
1,962,767
Product gross profit
990,264
771,061
2,558,092
2,697,950
License revenue
-
-
-
3,000,000
Operating expenses:
Selling, general and administrative
1,919,371
1,940,414
3,804,826
3,983,868
Research and development
1,468,090
1,510,663
2,857,770
2,682,891
Total operating expenses
3,387,461
3,451,077
6,662,596
6,666,759
Loss from operations
( 2,397,197 )
( 2,680,016 )
( 4,104,504 )
( 968,809 )
Fair value change in warrant liability
( 8,271 )
390,351
214,469
779,796
Financing costs
-
-
-
( 324,738 )
Other income
23,446
19,058
70,123
28,466
Loss before income taxes
( 2,382,022 )
( 2,270,607 )
( 3,819,912 )
( 485,285 )
Provision for income taxes
-
-
-
-
Net loss
$ ( 2,382,022 )
$ ( 2,270,607 )
$ ( 3,819,912 )
$ ( 485,285 )
Net loss per share (Note 1):
Basic
$ ( 0.28 )
$ ( 0.44 )
$ ( 0.45 )
$ ( 0.09 )
Diluted
$ ( 0.28 )
$ ( 0.44 )
$ ( 0.47 )
$ ( 0.09 )
Number of shares used in per share calculations (Note 1):
Basic
8,484,926
5,185,075
8,436,158
5,161,971
Diluted
8,484,926
5,185,075
8,554,213
5,161,971
See accompanying notes to condensed financial statements
2
NeuroOne Medical Technologies Corporation
Condensed Statements of Changes in Stockholders’
Equity
(unaudited)
Common Stock
Additional
Paid-In
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance at September 30, 2024
5,135,861
$ 5,136
$ 75,821,290
$ ( 75,004,413 )
$ 822,013
Stock-based compensation
-
-
339,224
-
339,224
Issuance of common stock upon vesting of restricted
stock units
6,295
6
( 6 )
-
-
Share repurchases for the payment of employee taxes
( 2,075 )
( 2 )
( 11,265 )
-
( 11,267 )
Net income
-
-
-
1,785,322
1,785,322
Balance at December 31, 2024
5,140,081
5,140
76,149,243
( 73,219,091 )
2,935,292
Issuance of common stock attributed to equity financings
59,314
59
413,978
-
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
47,017
47
( 47 )
-
-
Share repurchases for the payment of employee taxes
( 15,719 )
( 15 )
( 107,090 )
-
( 107,105 )
Net loss
-
-
-
( 2,270,607 )
( 2,270,607 )
Balance at March 31, 2025
5,230,693
$ 5,231
$ 76,610,325
$ ( 75,489,698 )
$ 1,125,858
Common Stock
Additional
Paid-In
Accumulated
Deficit
Total
Stockholders’
Equity
Shares
Amount
Capital
(As Restated)
(As Restated)
Balance at September 30, 2025
8,334,336
$ 8,334
$ 85,673,975
$ ( 78,609,787 )
$ 7,072,522
Stock-based compensation
-
-
359,255
-
359,255
Exercise of warrants
62,500
63
411,607
-
411,670
Issuance of common stock upon vesting of restricted
stock units
5,959
6
( 6 )
-
-
Share repurchases for the payment of employee taxes
( 680 )
( 1 )
( 3,631 )
-
( 3,632 )
Net loss
-
-
-
( 1,437,890 )
( 1,437,890 )
Balance at December 31, 2025
8,402,115
8,402
86,441,200
( 80,047,677 )
6,401,925
Issuance of common stock attributed to equity financings
166,666
167
670,233
-
670,400
Stock-based compensation
-
-
342,135
-
342,135
Exercise of warrants
14,470
15
105,607
-
105,622
Issuance of common stock upon vesting of restricted
stock units
47,069
47
( 47 )
-
-
Share repurchases for the payment of employee taxes
( 14,788 )
( 15 )
( 60,762 )
-
( 60,777 )
Net loss (as restated)
-
-
-
( 2,382,022 )
( 2,382,022 )
Balance at March 31, 2026 (as restated)
8,615,532
$ 8,616
$ 87,498,366
$ ( 82,429,699 )
$ 5,077,283
See accompanying notes to condensed financial
statements
3
NeuroOne Medical Technologies Corporation
Condensed Statements of Cash Flows
(unaudited)
For the
Six Months Ended
March 31,
2026
(As Restated)
2025
Operating activities
Net loss
$ ( 3,819,912 )
$ ( 485,285 )
Adjustments to reconcile net loss to net cash (used in) provided by operating
activities:
Amortization and depreciation
125,552
130,761
Stock-based compensation
701,390
589,394
Amortization of deferred offering costs
-
192,647
Non-cash lease expense
58,420
55,156
Fair value change in warrant liability
( 214,469 )
( 779,796 )
Debt termination costs reclassed to financing activities
-
132,091
Change in assets and liabilities:
Accounts receivable
( 632,578 )
( 142,144 )
Inventory
127,390
800,546
Prepaid expenses
( 142,344 )
8,394
Accounts payable
( 59,752 )
80,885
Accrued expenses, operating leases and other liabilities
( 588,243 )
( 430,744 )
Net cash (used in) provided by operating activities
( 4,444,546 )
151,905
Investing activities
Purchase of property and equipment
( 79,270 )
( 27,587 )
Net cash used in investing activities
( 79,270 )
( 27,587 )
Financing activities
Proceeds from issuance of common stock attributed to equity financings
670,400
414,037
Issuance costs related to equity financings
-
( 261,832 )
Financing costs in connection with debt facility
-
( 297,942 )
Deferred issuance costs in connection with at-the-market offering program
( 22,920 )
-
Exercise of warrants
174,374
-
Share repurchases for the payment of employee taxes
( 64,409 )
( 118,372 )
Net cash provided by (used in) financing
activities
757,445
( 264,109 )
Net decrease in cash and cash equivalents
( 3,766,371 )
( 139,791 )
Cash and cash equivalents at beginning of period
6,570,382
1,460,042
Cash and cash equivalents at end of period
$ 2,804,011
$ 1,320,251
Supplemental non-cash financing and investing transactions:
Change in unpaid issuance costs
$ 22,920
$ 72,377
Modification of right-of-use asset and associated lease liability
$ -
$ 111,898
Purchased property and equipment in accounts payable
$ 6,499
$ 10,026
Cashless exercise of warrants
$ 87,188
$ -
Reclass of warrant liability to equity upon exercise
$ 342,918
$ -
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 and stimulation solutions to diagnose and treat patients with epilepsy, trigeminal neuralgia, Parkinson’s
disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other pain-related neurological disorders. The Company
is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while being able to record activity
before, during, and after delivery.
The Company has received 510(k) clearance from
the United States (“U.S.”) Food and Drug Administration (“FDA”) for four of its devices: (i) its Evo cortical
electrode technology for recording, monitoring, and stimulating brain tissue for up to 30 days (“Evo Cortical”), (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 (“Evo sEEG”); (iii) its
OneRF ablation system for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures (the “OneRF
Ablation System”) and (iv) our OneRF TN ablation system for use in procedures to create radiofrequency (RF) lesions for the treatment
of pain, or for lesioning nerve tissue for functional neurosurgical procedures (“OneRF TN Ablation System”, together with
the Evo Cortical, Evo sEEG, and OneRF Ablation System, the “Commercialized Products”). The Company has a distribution agreement
with Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and
OneRF Ablation System in the brain. The Company initiated a limited market release of its OneRF TN Ablation System in December 2025 and
completed the limited market release in March 2026. 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 has experienced minor price increases from our suppliers related to tariffs on imported goods and may experience additional
price increases.
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. The Company expects to submit a request
for a tariff refund for minor tariffs paid by the Company to the U.S. government under the International Emergency Economic Powers Act,
but the timing and amount of cash receipt pursuant to such future submission remains uncertain. We will continue to monitor guidance issued
regarding the refund process.
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, 2025 included in the Company’s Annual Report
on Form 10-K. The condensed balance sheet at September 30, 2025 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)
Reverse Stock Split
On April 14, 2026, the
Company filed an amendment to its Amended and Restated Certificate of Incorporation, as amended and/or restated from time to time, to
effectuate a reverse stock split of the Company’s issued and outstanding shares of common stock, par value $ 0.001 per share (the
“Reverse Stock Split”). Trading of the common stock on The Nasdaq Capital Market commenced on a split-adjusted basis at market
open on April 16, 2026. All amounts in the condensed financial statements have been retroactively adjusted to reflect the Reverse Stock
Split.
As a result of the Reverse
Stock Split, every 6 shares of the Company’s common stock issued or outstanding was automatically reclassified into one validly
issued, fully-paid and non-assessable new share of common stock, subject to the treatment of fractional shares as described below, without
any action on the part of the holders. Proportional adjustments were made to the number of shares of common stock awarded and available
for issuance under the Company’s equity incentive plans, as well as the exercise price and the number of shares issuable upon the
exercise or conversion of the Company’s outstanding stock options and other equity securities under the Company’s equity incentive
plans. All outstanding warrants were also adjusted in accordance with their terms. The shares of common stock outstanding following the
Reverse Stock Split will remain fully paid and non-assessable. The Reverse Stock Split did not affect the number of authorized shares
of common stock or the par value per share of the common stock.
No fractional shares
were issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive fractional shares as a
result of the Reverse Stock Split were automatically entitled to receive a cash payment equal to the market value of the fractional share.
The Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s relative interest in the Company’s
equity securities, except for any adjustments for fractional shares.
NOTE 2 - Restatement of Previously Issued Unaudited Condensed
Financial Statements
The unaudited condensed financial statements
as of March 31, 2026 and for the three and six months ended March 31, 2026 have been restated to reflect the correction of misstatements.
The Company also restated all amounts impacted within the notes to the financial statements. A description of the adjustments and their
impact on the previously issued unaudited condensed financial statements are included below. The error was identified after a customer
questioned the validity of certain invoices related to product shipments made on March 31, 2026. Management’s subsequent review
of the related purchase orders, order modifications, packing slips, and invoices determined that revenue and cost of product revenue
had been recognized for certain invoices that should have been cancelled under the modified customer order arrangement.
Nature of the Errors
The errors resulted in an overstatement of
product revenue of $ 0.5 million and a corresponding overstatement of accounts receivable of $ 0.5 million as well as an overstatement of
cost of product revenue of $ 0.2 million and a corresponding understatement of inventory of $ 0.2 million in the periods presented. The
net overstatement was $ 0.3 million for the three and six months ended March 31, 2026. These errors did not affect the Company’s
cash or cash flows from operations, and did not involve any intentional misconduct by the Company, its management, or its employees.
In accordance with Accounting Standards Codification
(ASC) 250, Accounting Changes and Error Corrections , the Company is restating the previously issued unaudited condensed balance
sheet, statement of operations, stockholders’ equity, and cash flows to reflect the effects of the misstatements.
Impact of the Restatement
The following tables summarize the impact
of the restatement on the Company’s previously issued unaudited condensed financial statements:
Condensed Balance Sheet as of March
31, 2026 (Excerpt)
As Previously
Reported
Adjustment
As Restated
Accounts receivable
$ 2,426,518
$ ( 529,135 )
$ 1,897,383
Inventory, net
$ 1,866,633
$ 232,782
$ 2,099,415
Total current assets
$ 7,403,798
$ ( 296,353 )
$ 7,107,445
Total assets
$ 7,864,958
$ ( 296,353 )
$ 7,568,605
Accumulated deficit
$ ( 82,133,346 )
$ ( 296,353 )
$ ( 82,429,699 )
Total stockholders’ equity
$ 5,373,636
$ ( 296,353 )
$ 5,077,283
Total liabilities and stockholders’ equity
$ 7,864,958
$ ( 296,353 )
$ 7,568,605
Condensed Statement of Operations -
Three Months Ended March 31, 2026 (Excerpt)
As Previously
Reported
Adjustment
As Restated
Product revenue
$ 2,391,185
$ ( 529,135 )
$ 1,862,050
Cost of product revenue
$ 1,104,568
$ ( 232,782 )
$ 871,786
Product gross profit
$ 1,286,617
$ ( 296,353 )
$ 990,264
Loss from operations
$ ( 2,100,844 )
$ ( 296,353 )
$ ( 2,397,197 )
Loss before income taxes
$ ( 2,085,669 )
$ ( 296,353 )
$ ( 2,382,022 )
Net loss
$ ( 2,085,669 )
$ ( 296,353 )
$ ( 2,382,022 )
Net loss per share, basic and diluted
$ ( 0.25 )
$ ( 0.03 )
$ ( 0.28 )
6
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Condensed Statement of Stockholders’
Equity - Three Months Ended March 31, 2026 (Excerpt)
As Previously
Reported
Adjustment
As Restated
Net loss
$ ( 2,085,669 )
$ ( 296,353 )
$ ( 2,382,022 )
Accumulated deficit
$ ( 82,133,346 )
$ ( 296,353 )
$ ( 82,429,699 )
Total stockholders’ equity
$ 5,373,636
$ ( 296,353 )
$ 5,077,283
Condensed Statement of Operations -
Six Months Ended March 31, 2026 (Excerpt)
As Previously
Reported
Adjustment
As Restated
Product revenue
$ 5,283,820
$ ( 529,135 )
$ 4,754,685
Cost of product revenue
$ 2,429,375
$ ( 232,782 )
$ 2,196,593
Product gross profit
$ 2,854,445
$ ( 296,353 )
$ 2,558,092
Loss from operations
$ ( 3,808,151 )
$ ( 296,353 )
$ ( 4,104,504 )
Loss before income taxes
$ ( 3,523,559 )
$ ( 296,353 )
$ ( 3,819,912 )
Net loss
$ ( 3,523,559 )
$ ( 296,353 )
$ ( 3,819,912 )
Net loss per share, basic
$ ( 0.42 )
$ ( 0.03 )
$ ( 0.45 )
Net loss per share, diluted
$ ( 0.44 )
$ ( 0.03 )
$ ( 0.47 )
Condensed Statement of Cash Flows -
Six Months Ended March 31, 2026 (Excerpt)
As Previously
Reported
Adjustment
As Restated
Net loss
$ ( 3,523,559 )
$ ( 296,353 )
$ ( 3,819,912 )
Accounts receivable
$ ( 1,161,713 )
$ 529,135
$ ( 632,578 )
Inventory
$ 360,172
$ ( 232,782 )
$ 127,390
Net cash used in operating activities
$ ( 4,444,546 )
$ -
$ ( 4,444,546 )
NOTE 3 - Going Concern (As Restated)
The accompanying condensed financial statements
have been prepared on the basis that the Company will continue as a going concern. The Company has incurred losses since inception, negative
cash flows from operations, and an accumulated deficit of $ 82.4 million as of March 31, 2026. 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 March 31, 2026, the Company had $ 2.8 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 distribution agreement with Zimmer (See “Note 8 - Zimmer Distribution Agreement and Other Product Revenue”)
and forecasted operating expense reductions, will be sufficient to fund the Company’s operations through September 2026. The raising
of additional funds is not solely within the control of the Company. These factors raise substantial doubt about the Company’s
ability to continue as a going concern. The condensed financial statements do not include any adjustments that might result from the
outcome of this condition. If the Company is unable to raise additional funds, or the Company’s anticipated operating results are
not achieved, management believes planned expenditures may need to be reduced in order to extend the time period that existing resources
can fund the Company’s operations.
The Company intends to fund ongoing activities
by utilizing its current cash and cash equivalents on hand, from product and collaborations revenue and by raising additional capital
through equity or debt financing. If management is unable to obtain the necessary capital, it may have a material adverse effect on the
operations of the Company and the development of its technology, or the Company may have to cease operations altogether.
7
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 4 - Summary of Significant Accounting
Policies (As Restated)
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
(“CODM”) in deciding how to allocate resources and assessing performance. The Company’s CODM is its Chief Executive
Officer . The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating
segment. See “Note 15 - Segment Reporting”.
Cash and Cash Equivalents
The Company considers all highly liquid investments
with an original contractual maturity on date of purchase of less than or equal to three months to be classified and presented as cash
equivalents on the balance sheets. Cash equivalents are stated at cost, which approximates fair value. The Company’s cash and cash
equivalents may include demand deposit accounts with large financial institutions, institutional money market funds, U.S. Treasury securities,
and corporate notes and bonds. The Company monitors the creditworthiness of the financial institutions, institutional money market funds,
and corporations in which the Company invests its surplus funds. The Company has experienced no credit losses from its cash and cash equivalent
investments.
Revenue Recognition
The Company entered into a development and
distribution agreement which has current and future revenue recognition implications. See “Note 8 - 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, Revenue from Contracts with Customers (“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.
8
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 Brain Ablation System
and the OneRF® Trigeminal Nerve 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”) when sold. 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 stand-alone 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.
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 stand-alone 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 13- 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 warrant liability line item.
9
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 March 31, 2026 and September 30, 2025, the
fair values of cash, cash equivalents, accounts receivable, inventory, prepaid expenses, 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 six months ended March 31, 2026 and 2025.
The fair value of financial instruments measured
on a recurring basis is as follows:
As of March 31, 2026
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
$ 709,507
$ -
$ -
$ 709,507
Total liabilities at fair value
$ 709,507
$ -
$ -
$ 709,507
As of September 30, 2025
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Warrant liability
$ 1,266,894
$ -
$ -
$ 1,266,894
Total liabilities at fair value
$ 1,266,894
$ -
$ -
$ 1,266,894
10
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 six months ended March
31, 2026 and 2025, respectively.
2026
2025
Warrant liability
Balance as of beginning of Period
$ 1,266,894
$ 2,140,315
Change in fair value of warrant liability
( 214,469 )
( 779,796 )
Exercise
( 342,918 )
-
Balance as of end of period
$ 709,507
$ 1,360,519
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 five 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.
Accounts Receivable and Allowances for Credit
Losses
The Company records a provision for credit
losses, when appropriate, based on historical experience, current conditions and reasonably 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 its commercialized product components,
work-in-process and finished goods. The commercialized products are produced by a third-party contract manufacturer and electrode cable
assembly components are obtained from outside suppliers.
11
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 $ 58,848 and $ 119,399 for
the three and six months ended March 31, 2026, respectively. Total advertising expense amounted to $ 45,000 and $ 83,543 for the
three and six months ended March 31, 2025, respectively.
Selling, General and Administrative
Selling, general and administrative expenses consist
primarily of personnel-related costs including stock-based compensation for personnel in functions not directly associated with research
and development activities. Other significant costs include legal and litigation costs relating to corporate matters, intellectual property
costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with
the commercial sales of the Company’s products.
Stock-Based Compensation
The Company accounts for stock-based compensation
in accordance with the provisions of ASC 718, Compensation - Stock Compensation (“ASC 718”). Accordingly, compensation
costs related to equity instruments granted are recognized at the grant-date fair value over the requisite service period. The Company
records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable
provisions of ASC 718.
Income Taxes
Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit
carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance
if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Net Loss Per Share (As Restated)
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.
12
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
The table below presents the computation of basic
and diluted loss per share:
Three Months Ended
Six Months Ended
March 31,
March 31,
2026
(As Restated)
2025
2026
(As Restated)
2025
Basic:
Net loss available to common stockholders
- basic
$ ( 2,382,022 )
$ ( 2,270,607 )
$ ( 3,819,912 )
$ ( 485,285 )
Weighted average common shares outstanding - basic
8,484,926
5,185,075
8,436,158
5,161,971
Loss per share - basic
$ ( 0.28 )
$ ( 0.44 )
$ ( 0.45 )
$ ( 0.09 )
Diluted (1):
Net loss available to common stockholders - diluted
$ ( 2,382,022 )
$ ( 2,270,607 )
$ ( 4,031,518 )
$ ( 485,285 )
Weighted average common shares outstanding - diluted
8,484,926
5,185,075
8,554,213
5,161,971
Loss per share - diluted
$ ( 0.28 )
$ ( 0.44 )
$ ( 0.47 )
$ ( 0.09 )
(1) For the three and six months ended March 31, 2025, no adjustment was made to the numerator and no incremental shares were added to the denominator for the PIPE Warrants being accounted for as a derivative liability as the PIPE Warrants were out-of-the-money during these periods. See “Note 13 - Stockholders’ Equity”.
The following table presents the computation of
weighted average common shares considered in the computation of diluted net loss per share during the three and six months ended March
31,
Three Months Ended
Six Months Ended
March 31,
March 31,
2026
2025
2026
2025
Denominator (weighted average shares)
Basic common shares outstanding
8,484,926
5,185,075
8,436,158
5,161,971
Dilutive stock options
-
-
-
-
Dilutive restricted stock units
-
-
-
-
Dilutive warrants
-
-
118,055
-
Diluted common shares outstanding
8,484,926
5,185,075
8,554,213
5,161,971
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 six months ended
March 31, 2026 and 2025:
Three Months Ended
Six Months Ended
March 31,
March 31,
2026
2025
2026
2025
Warrants
361,111
1,174,322
243,056
1,174,322
Stock options
1,098,038
477,561
1,098,038
477,561
Restricted stock units
84,750
147,780
84,750
147,780
Recent Accounting Pronouncements
In December 2023, the FASB issued Accounting
Standards Update (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 adopted this guidance on October 1, 2025 and the newly adopted guidance will result
in additional income tax disclosures in its financial statements.
13
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
In November
2024, the FASB issued ASU 2024-03 Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic
220-40): Disaggregation of Income Statement Expenses. This ASU is intended to improve the disclosures related to expenses and provide
investors more detailed information about certain types of expenses. This ASU is effective for annual periods beginning after December
15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating
the potential impact that this new standard will have on its financial statements and related disclosures.
NOTE 5 - Commitments and Contingencies
WARF
License Agreement
The Company has entered into an exclusive start-up
company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and thin
film micro electrode technology. The Company entered into an Amended and Restated Exclusive Start-up Company License Agreement (the “WARF
License”) with WARF on January 21, 2020, which amended and restated in full the prior license agreement between WARF and NeuroOne,
LLC, a predecessor of the Company, dated October 1, 2014, as amended on February 22, 2017, March 30, 2019 and September 18, 2019.
The WARF License grants to the Company an exclusive
license to make, use and sell, in the United States only, products that employ certain licensed patents for a neural probe array
or thin-film micro electrode array and method. The Company agreed to pay WARF a royalty equal to a single-digit percentage of our product
sales pursuant to the WARF License, with a minimum annual royalty payment of $ 150,000 while 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 if, after royalties earned on sales begin to be paid, such earned
royalties cease for more than four calendar quarters. 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 March 31, 2026 and 2025, $ 37,500 in royalty fees were incurred related to the WARF License during each of these periods.
During the six months ended March 31, 2026 and 2025, $ 75,000 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
and six months ended March 31, 2026 and 2025, no royalty fees were incurred related to the Mayo Agreement.
14
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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. In addition,
as long as the Company is not in default under the Lease, the Company will be entitled to an abatement of its base rent for the first
two months of the amended Lease Term beginning in April 2025 and for the last month of the amended Lease Term (June 2028). In addition,
the Company pays its pro rata share of the Landlord’s annual operating expenses associated with the Premises.
Los Gatos Lease
In 2021, the Company entered into and commenced
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. In 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 six months ended March 31,
2026, rent expense associated with the facility leases amounted to $ 69,785 and $ 140,186 , respectively. During the three and six months
ended March 31, 2025, rent expense associated with the facility leases amounted to $ 70,065 and $ 139,243 , respectively.
Supplemental cash flow information related to the operating leases
was as follows:
For the six months ended
March 31,
2026
2025
Cash paid for amounts included in the measurement of lease liability:
Operating cash flows from operating leases
$ 68,535
$ 71,164
Right-of-use assets obtained in exchange for lease obligations:
Modification of right-of-use asset and associated lease liability
$ -
$ 111,898
Supplemental balance sheet information related
to the operating leases was as follows:
As of
March 31,
2026 As of
September 30,
2025
Right-of-use assets $ 196,775 $ 255,195
Lease liabilities $ 206,973 $ 266,806
Weighted average remaining lease term (years) 1.9 2.3
Weighted average discount rate 7.2 % 7.2 %
15
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Maturity of the lease liabilities was as follows:
Calendar Year
As of
March 31,
2026
2026
$ 105,495
2027
81,708
2028
34,815
Total lease payments
222,018
Less imputed interest
( 15,045 )
Total
206,973
Short-term portion (included in accrued expenses and other liabilities)
( 114,612 )
Long-term portion
$ 92,361
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 6 - Supplemental Balance Sheet Information
(As Restated)
Inventory (As Restated)
Inventory consisted of the following as of:
March 31, 2026
(As Restated)
September 30, 2025
Component inventory
$ 1,085,758
$ 871,492
Work-in-process
292,314
130,100
Finished goods
721,343
1,225,213
Total
$ 2,099,415
$ 2,226,805
Excess and obsolete valuation
reserve adjustments reflected as a reduction of component inventory as of both March 31, 2026 and September 30, 2025 was $ 10,000 .
Intangibles
Intangible assets rollforward is as follows:
Useful Life
Net Intangibles, September 30, 2025
12 - 13 years
$ 44,946
Less: amortization
( 11,157 )
Net Intangibles, March 31, 2026
$ 33,789
Amortization expense was $ 5,579 and $ 11,157 for
the three and six months ended March 31, 2026, respectively, and $ 5,579 and $ 11,158 for the three and six months ended March 31, 2025,
respectively.
16
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
Property and Equipment
Property and equipment held for use by category
are presented in the following table:
As of
March 31,
2026
As of
September 30,
2025
Equipment and furniture
$ 1,143,814
$ 1,058,045
Total property and equipment
1,143,814
1,058,045
Less accumulated depreciation
( 913,218 )
( 798,823 )
Property and equipment, net
$ 230,596
$ 259,222
Depreciation expense was $ 54,450 and $ 114,395
for the three months and six months ended March 31, 2026, respectively, and $ 60,055 and $ 119,603 for the three months and six months ended
March 31, 2025, respectively.
NOTE 7 - Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted
of the following:
As of
March 31,
2026
As of
September 30,
2025
Accrued payroll
$ 603,146
$ 1,055,121
Operating lease liability, short term
114,612
123,658
Royalty payments
37,500
112,500
Other
-
1,435
Total
$ 755,258
$ 1,292,714
NOTE 8 - Zimmer Distribution Agreement
and Other Product Revenue (As Restated)
On October 25, 2024, the Company entered into
the Zimmer Amended and Restated Distribution Agreement (the “Amendment” or “Zimmer Distribution Agreement”) 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 related to the sEEG and Strip/Grid Product Systems, which was subsequently amended
a couple of times through August 2, 2022 (the “EDDA”). The EDDA 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 Ablation System in the brain. Distribution and commercialization of the OneRF® Trigeminal Nerve Ablation System is not
covered by the License. In addition, the Company is eligible to receive a future milestone payment of $ 1.0 million upon reaching a one-time
sales volume threshold, but does not anticipate achieving this milestone.
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 consent 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 Ablation System in the brain.
17
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 One RF Exclusivity Fee and was allocated totally to RF Distribution License performance
obligation.
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.
Product Revenue (As Restated)
Product revenue recognized during the three
and six months ended March 31, 2026 was $ 1,862,050 and $ 4,754,685 , respectively, and was comprised of sales of OneRF Products.
Product revenue recognized during the three and
six months ended March 31, 2025 was $ 1,386,550 and $ 4,660,717 , respectively, and was comprised solely of OneRF Product revenue
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 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 six months ended March 31, 2025 was $ 3.0 million.
No license revenue was recognized during the three and six months ended March 31, 2026.
NOTE 9 - Stock-Based Compensation
During the three and six months ended March 31,
2026 and 2025, 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
Six Months Ended
March 31,
March 31,
2026
2025
2026
2025
Selling, general and administrative
$ 262,474
$ 195,559
$ 541,859
$ 465,189
Research and development
79,661
54,611
159,531
124,205
Total stock-based compensation expense
$ 342,135
$ 250,170
$ 701,390
$ 589,394
18
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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.
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
(together, 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 that may be issued under the 2025 Plan may not exceed (1) 500,000 and (2) any shares subject
to outstanding stock awards under the 2017 Plan that are forfeited or otherwise returned to the share reserve. See “Note 16 - Subsequent
Events”.
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 70,058 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 25,000 shares. Additionally, on May 20, 2025, the Board of Directors 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 95,833 shares. Lastly, on February 25, 2026, the Board of Directors
adopted the Third 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 83,333 shares for an aggregate total
of 274,224 shares.
Stock Options
During the three months ended March 31, 2026
and 2025, the Company granted 83,334 and 8,514 stock options, respectively, to its board of directors and officers. During the six months
ended March 31, 2026 and 2025, the Company granted 84,135 and 8,514 stock options, respectively, to its board of directors and officers.
Vesting generally occurs over a 12 to 46 month period based on a time of service condition. The grant date fair value of the grants issued
during the three months ended March 31, 2026 and 2025 was $ 3.35 and $ 5.87 per share, respectively. The grant date fair value of the grants
issued during the six months ended March 31, 2026 and 2025 was $ 3.35 and $ 5.87 per share, respectively.
The total expense for the three months ended
March 31, 2026 and 2025 related to stock options was $ 243,854 and $ 128,378 , respectively. The total expense for the six months ended
March 31, 2026 and 2025 related to stock options was $ 489,088 and $ 331,332 , respectively. The total number of stock options outstanding
as of March 31, 2026 and September 30, 2025 was 1,098,038 and 1,013,903 , respectively.
19
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 six months ended March 31, 2026
and 2025:
Three Months Ended Six Months Ended
March 31, March 31,
2026 2025 2026 2025
Expected stock price volatility 107.1 % 110.2 % 107.1 % 110.2 %
Expected life of options (years) 6.0 5.25 6.0 5.25
Expected dividend yield 0 % 0 % 0 % 0 %
Risk free interest rate 3.6 % 4.3 % 3.6 % 4.3 %
During the three months ended March 31, 2026
and 2025, 27,059 and 18,282 stock options vested, respectively, and zero stock options were forfeited during these periods. During the
six months ended March 31, 2026 and 2025, 55,443 and 84,024 stock options vested, respectively, and zero stock options were forfeited
during these periods, respectively. During the three and six months ended March 31, 2026 and 2025, no options were exercised.
Restricted Stock Units
During the six months ended March 31, 2026, the
Company granted an aggregate of 1,293 restricted stock units (“RSUs”) to a non-employee director under the 2025 Plan. The
weighted average grant date fair value of the RSUs granted during the six months ended March 31, 2026 was $ 4.30 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 three and six months ended March 31,
2025, the Company granted an aggregate of 13,887 RSUs to non-employee directors under the 2025 Plan. The weighted average grant date
fair value of the RSUs granted during the three and six months ended March 31, 2025 was $ 7.20 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 three months ended March 31, 2026
and 2025, 45,915 and 48,088 RSUs vested, respectively, and no RSUs were forfeited during these periods. During the six months ended March
31, 2026 and 2025, 51,983 and 54,390 RSUs vested, respectively, and no RSUs were forfeited during these periods. The total expense for
the three months ended March 31, 2026 and 2025 related to these RSUs was $ 98,281 and $ 121,792 , respectively. The total expense for the
six months ended March 31, 2026 and 2025 related to these RSUs was $ 212,302 and $ 258,062 , respectively. The total RSUs outstanding as
of March 31, 2026 and September 30, 2025 was 84,750 and 135,439 , respectively.
General
As of March 31, 2026, 307,010 shares were available
in the aggregate for future issuance under the 2025 Plan, 2017 Plan and Inducement Plan. Unrecognized stock-based compensation was $ 2,454,928
as of March 31, 2026. The unrecognized share-based expense is expected to be recognized over a weighted average period of 2.5 years.
NOTE 10 - Concentrations
Revenue
For the three months and six months ended March
31, 2026, one customer accounted for 99.4 % and 99.7 % of the Company’s product revenue, respectively.
For the three months and six months ended March
31, 2025, one customer accounted for 100.0 % and 93.9 % 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 System generator.
20
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
NOTE 11 - Income Taxes
The effective tax rate for the three and six
months ended March 31, 2026 and 2025 was zero percent. As a result of the analysis of all available evidence as of March 31, 2026 and September
30, 2025, 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 six months ended March 31, 2026 and 2025. If the Company’s assumptions change and the
Company believes that it will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation
allowance on deferred tax assets will be recognized as a reduction of future income tax expense. If the assumptions do not change,
each period the Company could record an additional valuation allowance on any increases in the deferred tax assets.
NOTE 12 - Debt 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 or Change of Control (as each 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 six months ended March 31, 2025.
At closing of the Debt
Facility, the Company issued to the Lender a warrant exercisable for five years for 16,666 shares of common stock at an exercise price
of $ 3.96 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 13 - Stockholders’ Equity
March 2026 Private Placement
On March 1, 2026, the
Company entered into a securities purchase agreement (the “March 2026 Private Placement”) with a newly appointed officer
of the Company, David Wambeke, to issue and sell 166,666 shares of the Company’s common stock at a price per share equal to $ 4.02242 .
The March 2026 Private Placement closed on March 2, 2026 upon which the Company received gross proceeds in the amount of $ 670,400 . Issuance
costs in connection with the March 2026 Private Placement were nil .
August 2024 Private
Placement
On August 1, 2024, the
Company entered into a Securities 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)
490,741 shares of the Company’s common stock and (ii) warrants to purchase an aggregate of 368,052 shares of common stock (the
“PIPE Warrants”) at a purchase price of $ 5.40 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.
The PIPE Warrants are
exercisable beginning on the date of issuance, have an initial exercise price of $ 7.14 per share, subject to adjustment, and will expire
on the third anniversary of the date of issuance. One of the Purchasers in the 2024 Private Placement included Paul Buckman, a director
on the Company’s Board of Directors. In April 2025, the exercise price was reset to $ 2.79 upon the close of the April 2025 Financing
for all of the PIPE Warrants, except for the PIPE Warrants to purchase 3,472 shares of common stock issued to a director on our Board
of Directors for which the exercise price was reset to $ 5.26 per share.
21
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
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 March 31, 2026 and September
30, 2025: risk-free interest rate 3.65 % and 3.55 %, respectively; expected volatility of 94.2 % and 94.5 %; respectively; expected life
of 1.34 years and 1.84 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 March 31, 2026 and September 30, 2025. The Company recorded the fair value change of the
PIPE Warrants in the amount of $ 8,271 and a benefit of $( 214,469 ) to the fair value change in warrant liability line item on the accompanying
condensed statements of operations for the three and six months ended March 31, 2026, respectively. The Company recorded the fair value
change of the PIPE Warrants in the amount of a $( 390,351 ) benefit and a $( 779,796 ) benefit to the fair value change in warrant liability
line item on the accompanying condensed statements of operations for the three and six months ended March 31, 2025, respectively.
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.
In
2023, the Company changed the amount of common stock that can be sold pursuant to the Sales Agreement to $ 4.8 million (including shares
previously sold). On April 3, 2025, we decreased the amount of
common stock available under the ATM to zero , and August 15, 2025, we increased the amount of common stock that can be sold pursuant
to the Sales Agreement to $ 6,750,000 .
During the three and six months ended March 31,
2025, 59,314 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 six months ended March 31, 2025 were $ 95,929 . There were no shares issued out of the ATM during the three
and six months ended March 31, 2026.
The total aggregate offering price and common
stock issued since inception of the ATM Program through March 31, 2026 was $ 8,000,600 and 924,081 shares, respectively. Cumulative
issuance costs incurred under the ATM Program through March 31, 2026 was $ 617,882 , inclusive of deferred offering costs.
Warrant Activity and Summary
Warrants Exercise
Price Per
Warrant Weighted Average Exercise
Price Weighted Average Term (years)
Outstanding at September 30, 2025 1,149,323 $ 2.79 - 33.66 $ 21.92 0.96
Issued -
$ -
$ -
-
Exercised (1) ( 93,750 ) $ 2.79 $ 2.79 -
Expired ( 694,462 ) $ 31.50 $ 31.50 -
Outstanding at March 31, 2026 361,111 $ 2.79 - 33.66 $ 8.47 1.52
Outstanding and exercisable at March 31, 2026 361,111 $ 2.79 - 33.66 $ 8.47 1.52
(1) 16,780 of the shares exercised were withheld in connection with a cashless exercise.
22
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
The following table summarizes information about
warrants outstanding as of March 31, 2026:
Exercise Price Number Outstanding Weighted Average
Remaining Contractual
life (Years) Number Exercisable as of
March 31, 2026
$ 2.79 245,830 1.34 245,830
$ 3.96 16,666 3.34 16,666
$ 5.26 3,472 1.34 3,472
$ 18.00 58,333 1.34 58,333
$ 33.66 36,810 1.25 36,810
Total 361,111 361,111
NOTE 14 - Defined Contribution Plan
The Company has a 401(k) defined contribution
plan (the “401K Plan”) for all employees age 21 and older. Employees can defer up to 100 % of their compensation through
payroll withholdings into the 401K Plan subject to federal law limits. The Company may match 100 % of deferrals up to 3 % of
one’s contributions. The Company’s matching contributions to employee deferrals are discretionary. The Company may also make
discretionary profit sharing contributions under the 401K Plan in the future, but it has not done so through March 31, 2026.
Employee contributions and any employer matching
contributions made to satisfy certain non-discrimination tests required by the Internal Revenue Code are 100 % vested upon contribution.
Discretionary employer matches to employee deferrals vest over a six year period beginning on the second anniversary of an employee’s
date of hire. Discretionary profit sharing contributions vest over a five year period beginning on the first anniversary of an employee’s
date of hire. The Company did not make any contributions to the 401K Plan during the three and six months ended March 31, 2026 and 2025.
NOTE 15 - Segment Reporting (As Restated)
Operating segments are defined as components
of an enterprise about which separate discrete information is available for evaluation by the CODM in deciding how to allocate resources
in assessing performance. The Company has one reportable segment, which is the business of development and commercialization
of products related to comprehensive neuromodulation cEEG and sEEG recording, monitoring, ablation, and stimulation solutions (“Neuromodulation
Products”). NeuroOne is a medical technology company focused on developing and commercializing Neuromodulation Products. The Company
recognizes the Neuromodulation Products as one reporting segment.
The accounting policies of the Neuromodulation
Products segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for
the Neuromodulation Products segment based on net loss income, which is reported on the statements of operations as net loss. The measure
of segment assets is reported on the balance sheet as total assets. The Company does not have any intra-entity sales or transfers.
The CODM uses cash forecast models in deciding
how to invest into the Neuromodulation Products segment. Such cash forecast models are reviewed to assess the entity-wide operating results
and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing
performance of the segment and in establishing management’s compensation.
23
NeuroOne Medical Technologies Corporation
Notes to Condensed Financial Statements
(unaudited)
The statements of operations below are inclusive
of the significant expense categories regularly reviewed by the CODM for the three and six months ended March 31, 2026 and 2025:
Three months ended
March
31,
Six months ended
March 31,
2026
(As Restated)
2025
2026
(As Restated)
2025
Product revenue
$ 1,862,050
$ 1,386,550
$ 4,754,685
$ 4,660,717
Cost of product revenue
871,786
615,489
2,196,593
1,962,767
Product gross profit
990,264
771,061
2,558,092
2,697,950
License revenue
-
-
-
3,000,000
Operating expenses:
General and administrative
1,503,576
1,581,895
2,957,792
3,236,261
Sales
199,136
157,436
373,293
362,352
Marketing
216,659
201,083
473,741
385,255
Development
1,310,388
1,337,781
2,554,705
2,339,967
Quality assurance
157,702
172,882
303,065
342,924
Total operating expenses
3,387,461
3,451,077
6,662,596
6,666,759
Loss from operations
( 2,397,197 )
( 2,680,016 )
( 4,104,504 )
( 968,809 )
Fair value change in warrant liability
( 8,271 )
390,351
214,469
779,796
Financing costs
-
-
-
( 324,738 )
Other income
23,446
19,058
70,123
28,466
Loss before income taxes
( 2,382,022 )
( 2,270,607 )
( 3,819,912 )
( 485,285 )
Provision for income taxes
-
-
-
-
Net loss
$ ( 2,382,022 )
$ ( 2,270,607 )
$ ( 3,819,912 )
$ ( 485,285 )
NOTE 16 - Subsequent Events
2025 Plan
On April 3, 2026, at the 2026 annual meeting
of stockholders, the stockholders of the Company approved the increase in share authorization under the 2025 Plan by 250,000 shares.
In addition, an evergreen provision was approved whereby the number of shares available under the 2025 Plan will be increased
automatically on January 1 each year between January 1, 2027 and January 1, 2031. The aggregate number of shares of common stock
that may be issued pursuant to awards (as defined in the 2025 Plan) by an amount equal to 5 % of the fully diluted shares (as defined
in the 2025 Plan) as of the last day of the preceding calendar year, provided, however that the Board of Directors may act prior to
the effective date of any such annual increase to provide that the increase for such year will be a lesser number of shares of
common stock.
24
NeuroOne Medical Technologies Corporation
Form 10-Q
I tem 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations (As Restated)
The following discussion
of our financial condition and results of operations should be read in conjunction with the financial statements and notes included in
Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”)
and the audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended September 30,
2025.
Forward-Looking Statements
This Report contains
forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements
by the words “may,” “might,” “will,” “could,” “would,” “should,”
“expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,”
“estimate,” “predict,” “project,” “potential,” “target,” “seek,”
“contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology
intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that
may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed
or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement
contained in this Report, we caution you that these statements are based on a combination of facts and factors currently known by us
and our expectations of the future, about which we cannot be certain. Forward-looking statements include statements about:
●
our ability to maintain
regulatory clearance of our cortical strip and grid electrode technology, 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 restatement
of our financial statements;
● The material
weaknesses in our internal controls over financial reporting and the potential insufficiency
of our disclosure controls and procedures to detect errors or acts of fraud;
●
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;
25
NeuroOne Medical Technologies Corporation
Form 10-Q
●
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 back pain and other related neurological disorders;
●
our future commercialization,
marketing and manufacturing capabilities and strategy;
●
our ability to comply with
applicable regulatory requirements;
●
our ability to maintain
our intellectual property position;
●
our expectations regarding
international opportunities for commercializing our cortical strip, grid and depth electrode technology under including technology
under development;
●
our estimates regarding
the size of, and future growth in, the market for our technology, including technology under development; and
●
our estimates regarding
our future expenses and needs for additional financing.
Forward-looking statements
are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which
we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known
and unknown risks, uncertainties and other factors that are in some cases beyond our control. You should refer to the “Risk Factors”
section of our Annual Report on Form 10-K for a discussion of important factors that may cause our actual results to differ materially
from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking
statements in this Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy
may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements
as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame,
or at all.
These forward-looking
statements speak only as of the date of this Report. Except as required by law, we assume no obligation to update or revise these forward-looking
statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks
and other information we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”)
after the date of this Report.
Restatement of Previously Issued Financial
Statements
This “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” has been amended and restated to give effect to the restatement of our unaudited condensed
financial statements, as more fully described in Note 2 “Restatement of Previously Issued Unaudited Condensed Financial Statements.”
Overview
We are a medical technology
company focused on (i) diagnostic, ablation and deep brain stimulation technology for brain related conditions such as epilepsy and Parkinson’s
disease; (ii) ablation and stimulation for pain management throughout the body; and (iii) drug delivery including diagnostic and stimulation
capabilities.
We are developing and
commercializing 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,
trigeminal neuralgia, Parkinson’s disease, dystonia, essential tremors, chronic back pain and other pain-related neurological disorders.
The Company is also developing the capability to use its sEEG electrode technology to deliver drugs or gene therapy while being able
to record activity before, during, and after delivery.
We have received 510(k)
clearance for four of our devices from the Food and Drug Administration (“FDA”), including: (i) our Evo cortical electrode
technology for recording, monitoring, and stimulating brain tissue for up to 30 days (“Evo Cortical”), (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 (“Evo sEEG”), (iii) our OneRF ablation system
for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures (“OneRF Ablation System”),
(iv) our OneRF TN ablation system for use in procedures to create radiofrequency (RF) lesions for the treatment of pain, or for lesioning
nerve tissue for functional neurosurgical procedures (“OneRF TN Ablation System”). We have a distribution agreement with
Zimmer, Inc. (“Zimmer”) providing Zimmer with a license to commercialize and distribute the Evo Cortical, Evo sEEG, and OneRF
Ablation System in the brain. We initiated a limited market release of the OneRF TN Ablation System in December 2025 and completed the
limited market release in March 2026. The Company’s other products and indications are still under development.
26
NeuroOne Medical Technologies Corporation
Form 10-Q
We have largely
incurred losses since inception. As of March 31, 2026, we had an accumulated deficit of $82.4 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 our Evo Cortical, Evo sEEG, OneRF Ablation System, and OneRF TN Ablation 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.
We may be unable to
raise additional funds when needed on favorable terms or at all. Our failure to raise such capital as and when needed would have a negative
impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode
technology and future products and our ability to pursue our business strategy. See “Liquidity and Capital Resources-Liquidity
Outlook” below.
Recent Developments
Corporate Updates
Reverse Stock Split
On April 14, 2026, we
filed an amendment to our Amended and Restated Certificate of Incorporation, as amended and/or restated from time to time, to effectuate
a reverse stock split of our issued and outstanding shares of common stock, par value $0.001 per share, which became effective on April
15, 2026 at 5:00 p.m. Eastern Time (the “Reverse Stock Split”). Trading of the common stock on The Nasdaq Capital Market
commenced on a split-adjusted basis at market open on April 16, 2026. All amounts in the condensed financial statements have been retroactively
adjusted to reflect the Reverse Stock Split.
As a result of the Reverse
Stock Split, every 6 shares of our common stock issued or outstanding was automatically reclassified into one validly issued, fully-paid
and non-assessable new share of common stock, subject to the treatment of fractional shares as described below, without any action on
the part of the holders. Proportional adjustments were made to the number of shares of common stock awarded and available for issuance
under our equity incentive plans, as well as the exercise price and the number of shares issuable upon the exercise or conversion of
our outstanding stock options and other equity securities under our equity incentive plans. All outstanding warrants were also adjusted
in accordance with their terms. The shares of common stock outstanding following the Reverse Stock Split remain fully paid and non-assessable.
The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value per share of the common stock.
No fractional shares
were issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive fractional shares as
a result of the Reverse Stock Split were automatically entitled to receive a cash payment equal to the market value of the fractional
share. The Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s relative interest in our
equity securities, except for any adjustments for fractional shares.
27
NeuroOne Medical Technologies Corporation
Form 10-Q
2025 Equity Incentive Plan
On April 3, 2026, at the 2026
annual meeting of stockholders, our stockholders approved the increase in share authorization under the 2025 Equity Incentive Plan (the
“2025 Plan”) by 250,000 shares. In addition, an evergreen provision was approved whereby the number of shares available under
the 2025 Plan will be increased automatically on January 1 each year between January 1, 2027 and January 1, 2031. The aggregate number
of shares of common stock that may be issued pursuant to awards (as defined in the 2025 Plan) by an amount equal to 5% of the fully diluted
shares (as defined in the 2025 Plan) as of the last day of the preceding calendar year, provided, however that our Board of Directors
may act prior to the effective date of any such annual increase to provide that the increase for such year will be a lesser number of
shares of common stock.
March 2026 Private Placement
On March 1, 2026, we
entered into a securities purchase agreement (the “March 2026 Private Placement”) with a newly appointed officer of the Company,
David Wambeke, to issue and sell 166,666 shares of our common stock at a price per share equal to $4.02242. The March 2026 Private Placement
closed on March 2, 2026 upon which we received gross proceeds in the amount of $670,400.
Trigeminal Limited
Market Release
We initiated a limited
market release of the OneRF TN Ablation System in December 2025 and completed the limited market release in March 2026. The Company is
currently evaluating the distribution options for the OneRF TN Ablation System.
Nasdaq Minimum Bid
Price Notification
On May 6, 2025, we
received a letter from the Listing Qualifications Department of Nasdaq Stock Market (“Nasdaq”) notifying us that because
the closing bid price of our common stock was below $1.00 per share for the prior 30 consecutive business days, we are not in compliance
with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2)
(the “Minimum Bid Price Requirement”). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), we had a period of 180 calendar
days, or until November 3, 2025, to regain compliance with the Minimum Bid Price Requirement.
On November 4, 2025,
we received a letter from Nasdaq notifying us that we have been granted a 180-day extension, until May 4, 2026, to regain compliance
with the Minimum Bid Price Requirement.
On April 30, 2026, we
received a letter from Nasdaq notifying us that we have regained compliance with the Minimum Bid Price Requirement as a result of the
closing bid price of the Company’s common stock being at $1.00 per share or greater for the prior 10 consecutive business days.
Accordingly, the letter indicated we are in compliance with the Minimum Bid Price Requirement and the matter is closed.
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 have experienced
minor price increases from our suppliers related to tariffs on imported goods, and may experience additional price increases. We expect
to submit a request for a tariff refund for minor tariffs paid by the Company to the U.S. government under the International Emergency
Economic Powers Act, but the timing and amount of cash receipt pursuant to such future submission remains uncertain. We will continue
to monitor guidance issued regarding the refund process.
28
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 Evo Cortical, Evo sEEG, and OneRF Ablation Systems when they occur, which have each received FDA 510(k)
clearance.
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 Evo Cortical, Evo sEEG, and OneRF Ablation Systems, and
outside supplier costs of producing our 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 Ablation System in the brain.
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 three months ended December 31, 2024
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 Zimmer Amended and Restated Distribution Agreement, see “-Liquidity
and Capital Resources-Liquidity Outlook” below and see “Note 8 - Zimmer Distribution Agreement and Other Product Revenue”
to our condensed financial statements included in “Part 1, Item 1 - Financial Statements” of 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 our Evo Cortical, Evo sEEG, and OneRF Ablation Systems. 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 technology, and the increased costs of operating as a public company.
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.
29
NeuroOne Medical Technologies Corporation
Form 10-Q
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 described
further below.
Other Income
Other income primarily
consists of interest income related to our cash and cash equivalents,
Results of Operations (As Restated)
Comparison of the Three Months Ended March
31, 2026 and 2025
The following table sets forth the results of
operations for the three months ended March 31, 2026 and 2025, respectively.
For the
Three Months Ended
March 31,
(unaudited)
2026
(As Restated)
2025
Period to
Period
Change
(As Restated)
Product revenue
$ 1,862,050
$ 1,386,550
$ 475,500
Cost of product revenue
871,786
615,489
256,297
Product gross profit
990,264
771,061
219,203
Operating expenses:
Selling, general and administrative
1,919,371
1,940,414
(21,043 )
Research and development
1,468,090
1,510,663
(42,573 )
Total operating expenses
3,387,461
3,451,077
(63,616 )
Loss from operations
(2,397,197 )
(2,680,016 )
282,819
Fair value change in warrant liability
(8,271 )
390,351
(398,622 )
Other income
23,446
19,058
4,388
Loss before income taxes
(2,382,022 )
(2,270,607 )
(111,415 )
Provision for income taxes
-
-
-
Net loss
$ (2,382,022 )
$ (2,270,607 )
$ (111,415 )
Product Revenue and Product Gross Profit
Product revenue was $1.9 million during the
three months ended March 31, 2026 with a gross profit and gross profit percentage of $1.0 million and 53.2%, respectively. Product revenue
was $1.4 million during the three months ended March 31, 2025 with a gross profit and gross profit percentage of $0.8 million and 55.6%,
respectively. The decrease in gross profit percentage during the current period was largely due to higher component costs in the current
period coupled with a slightly lower average selling price attributed to a change in sales mix. Product revenue consisted of OneRF Products
related sales during the periods presented. The cost of product revenue consisted of the manufacturing and materials costs incurred by
our third-party contract manufacturers in connection with our OneRF Products and outside supplier materials costs. 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 March 31, 2026 and 2025.
30
NeuroOne Medical Technologies Corporation
Form 10-Q
Selling, General and Administrative Expenses
Selling, general and administrative expenses
were $1.9 million during each of the three months ended March 31, 2026 and 2025. The slight decrease of $21,000 in the current quarter
over the comparable prior year quarter was largely attributed to lower legal costs of $0.1 million and lower professional fees of $0.1
million, offset by higher administrative payroll and stock-based compensation of $0.1 million and by sales and marketing costs of $0.1
million. Selling, general and administrative expenses included $0.3 million and $0.2 million of stock-based compensation during the three
months ended March 31, 2026 and 2025, respectively.
Research and Development Expenses
Research and development expenses were $1.5
million during each of the three months ended March 31, 2026 and 2025. The slight decrease of $43,000 in the current period over the
prior year period 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 additional applications of our thin-film electrode technology, including
the delivery of drugs or gene therapy to the brain, and basivertebral nerve ablation (BVNA) and spinal cord stimulation for treatment
of chronic lower back pain. Research and development expenses included $0.1 million of stock-based compensation during each of the three
months ended March 31, 2026 and 2025.
Fair Value Change in Warrant Liability
The net change in fair
value of the warrant liability during the three months ended March 31, 2026 was $8,000 compared to a $(0.4) million benefit during the
three months ended March 31, 2025. The change was due primarily to fluctuations in our common stock fair value.
Other Income
Other income during the three months ended March
31, 2026 and 2025 related to interest income on our cash, cash equivalents and short-term investments in the amount of $23,000 and $19,000,
respectively.
Comparison of the Six Months Ended March 31,
2026 and 2025
The following table sets forth the results of
operations for the six months ended March 31, 2026 and 2025, respectively.
For the
Six Months Ended
March 31,
(unaudited) (As Restated)
2026
(As Restated)
2025
Period to
Period
Change
(As Restated)
Product revenue
$ 4,754,685
$ 4,660,717
$ 93,968
Cost of product revenue
2,196,593
1,962,767
233,826
Product gross profit
2,558,092
2,697,950
(139,858 )
License revenue
-
3,000,000
(3,000,000 )
Operating expenses:
Selling, general and administrative
3,804,826
3,983,868
(179,042 )
Research and development
2,857,770
2,682,891
174,879
Total operating expenses
6,662,596
6,666,759
(4,163 )
Loss from operations
(4,104,504 )
(968,809 )
(3,135,695 )
Fair value change in warrant liability
214,469
779,796
(565,327 )
Financing costs
-
(324,738 )
324,738
Other income
70,123
28,466
41,657
Loss before income taxes
(3,819,912 )
(485,285 )
(3,334,627 )
Provision for income taxes
-
-
-
Net loss
$ (3,819,912 )
$ (485,285 )
$ (3,334,627 )
31
NeuroOne Medical Technologies Corporation
Form 10-Q
Product Revenue and Product Gross Profit
Product revenue was $4.8 million during the
six months ended March 31, 2026 with a gross profit and gross profit percentage of $2.6 million and 53.8%, respectively. Product revenue
was $4.7 million during the six months ended March 31, 2025 with a gross profit and gross profit percentage of $2.7 million and 57.9%,
respectively. The decrease in gross profit percentage during the current period was largely due to higher product costs coupled with
a slightly lower average selling price associated with the sales mix. Product revenue consisted of OneRF Products during the period presented.
The cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract manufacturers in
connection with our OneRF Products and outside supplier materials costs. In addition, cost of product revenue included royalty fees incurred
of approximately $75,000 in connection with our license agreements during each of the six months ended March 31, 2026 and 2025.
License Revenue
License revenue was $3.0 million for the six
months ended March 31, 2025 related to the distribution license granted to Zimmer for the OneRF Product in the brain in October 2024.
No license revenue was generated from the Amended and Restated Zimmer Development Agreement during the six months ended March 31, 2026.
Selling, General and Administrative Expenses
Selling, general and administrative expenses
were $3.8 million for the six months ended March 31, 2026, compared to $4.0 million for the six months ended March 31, 2025. The $0.2
million decrease in the current six-month period compared to the comparable prior year period was primarily due to lower legal costs
of $0.3 million and lower professional fees of $0.2 million, offset by higher administrative payroll of $0.2 million and marketing and
sales costs of $0.1 million. Selling, general and administrative expenses included $0.5 million of stock-based compensation during each
of the six months ended March 31, 2026 and 2025.
Research and Development Expenses
Research and development expenses were $2.9
million for the six months ended March 31, 2026, compared to $2.7 million for the six months ended March 31, 2025. The $0.2 million increase
period over period was attributed to the timing of development activities during the current six-month period 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 additional applications of our thin-film electrode technology, including the delivery
of drugs or gene therapy to the brain, and basivertebral nerve ablation (BVNA) and spinal cord stimulation for treatment of chronic lower
back pain.. Research and development expenses included $0.2 million and $0.1 million of stock-based compensation during the six months
ended March 31, 2026 and 2025, respectively.
32
NeuroOne Medical Technologies Corporation
Form 10-Q
Fair Value Change
in Warrant Liability
The net change in fair
value of the warrant liability during the six months ended March 31, 2026 was $(0.2) million benefit compared to a $(0.8) million benefit
for the six months ended March 31, 2025. The change was due primarily to fluctuations in our common stock fair value.
Financing Costs
Financing costs during
the six months ended March 31, 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. We did not incur any financing costs during the six months ended March 31, 2026.
Other Income
Other income during the six months ended March
31, 2026 and 2025 consisted of $70,000 and $28,000 related to interest income attributed to our cash and cash equivalents, respectively.
Liquidity and
Capital Resources (As Restated)
Overview
As of March 31, 2026,
our principal source of liquidity consisted of cash and cash equivalents in the aggregate of approximately $2.8 million. While we began
to generate revenue in fiscal year 2021 from commercial sales and through milestone and other payments under our agreement with Zimmer,
we expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless
we generate an adequate level of revenue from commercial sales to cover expenses. Our most significant cash requirements relate to the
funding of our ongoing product development and commercialization operations. Our additional material cash needs include commitments under
operating leases, royalty obligations under our intellectual property licenses with the Wisconsin Alumni Research Foundation and the
Mayo Foundation for Medical Education and Research as well as other administrative services. See “Funding Requirements” below
for more information. We anticipate that our expenses will increase substantially as we continue to develop and commercialize our electrode
technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products, market and distribute our OneRF
Products, hire additional staff, add operational, financial and management systems and continue to operate as a public company.
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.
March 2026 Private Placement
On March 1, 2026, we
entered into the March 2026 Private Placement with a newly appointed officer of the Company, David Wambeke, to issue and sell 166,666
shares of our common stock at a price per share equal to $4.02242. The March 2026 Private Placement closed on March 2, 2026 upon which
we received gross proceeds in the amount of $670,400. Issuance costs in connection with the March 2026 Private Placement were nil.
33
NeuroOne Medical Technologies Corporation
Form 10-Q
April 2025 Financing
On April 4, 2025, we
entered into an underwriting agreement with Ladenburg, relating to the issuance and sale of 2,666,666 shares of our common stock, at
a price to the public of $3.00. In addition, under the terms of the underwriting agreement, we granted Ladenburg an option, exercisable
for 45 days, to purchase up to an additional 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) 490,741 shares of our Company’s common stock (the “Shares”), and (ii) warrants
to purchase an aggregate of 368,052 shares of common stock (the “PIPE Warrants”) at a purchase price of $5.40 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. 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 $7.14 per share, subject to adjustment. In April 2025,
the exercise price was reset to $2.79 upon the close of the April 2025 Financing for all of the PIPE Warrants, except for the PIPE Warrants
to purchase 3,472 shares of common stock issued to a director on our Board of Directors for which the exercise price was reset to $5.26
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 Program”) 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 April 3, 2025, we decreased the amount of common stock that can be sold pursuant
to the Sales Agreement to zero, and on August 15, 2025, we increased the amount of common stock that can be sold pursuant to the Sales
Agreement to $6,750,000. Through March 31, 2026, we have issued 924,081 shares of common stock under the ATM Program for gross proceeds
in the amount of $8.0 million. We incurred issuance costs in connection with the ATM Program in the amount of $0.6 million through March
31, 2026.
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 or a Change of Control, as each 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. Total
costs incurred under the debt facility financing was $0.4 million.
34
NeuroOne Medical
Technologies Corporation
Form 10-Q
Funding Requirements
As noted above, certain
of our cash requirements relate to the funding of our ongoing product development and commercialization operations and our milestone
and royalty obligations under our intellectual property licenses with WARF and Mayo. See “Item 1-Business-Clinical
Development and Regulatory Pathway-Clinical Experience, Future Development and Clinical Trial Plans” in our Annual Report
on Form 10-K for the year ended September 30, 2025 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.
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 certain of our product sales pursuant to the Mayo Development Agreement. See “Note
5 - Commitments and Contingencies” to our condensed financial statements included in “Part 1, Item 1 - Financial
Statements” of 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 5 - Commitments and Contingencies” to our condensed financial statements included
in “Part 1, Item 1 - Financial Statements” of 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 2028.
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 8 - Zimmer Distribution Agreement
and Other Product Revenue” to our condensed financial statements included in “Part 1, Item 1 - Financial Statements”
of 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 Ablation System 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. In October 2024, we entered into an Amended and Restated Distribution Agreement with Zimmer (“Zimmer
Distribution Agreement”) to provide Zimmer with the exclusive right and license to distribute our OneRF Ablation System in the
brain 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.
As of March 31, 2026,
we had cash and cash equivalents in the aggregate of approximately $2.8 million. Management has noted the existence of substantial doubt
about our ability to continue as a going concern. Additionally, our independent registered public accounting firm included an explanatory
paragraph in the report on our financial statements as of and for the years ended September 30, 2025 and 2024, respectively, noting the
existence of substantial doubt about our ability to continue as a going concern. Our existing cash and cash equivalents may not be sufficient
to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need
to secure additional funding through public or private equity or debt financing, through collaborations or partnerships with other companies,
or other sources.
35
NeuroOne Medical Technologies Corporation
Form 10-Q
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.
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.
We expect to satisfy
our short term and long term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales
to cover expenses, if ever, from future equity and debt financings.
Cash Flows
The following is a summary of cash flows for
each of the periods set forth below.
For the
Six Months Ended
March 31,
2026
2025
Net cash (used in) provided by operating activities
$ (4,444,546 )
$ 151,905
Net cash used in investing activities
(79,270 )
(27,587 )
Net cash provided by (used in) financing activities
757,445
(264,109 )
Net decrease in cash and cash equivalents
$ (3,766,371 )
$ (139,791 )
Net cash (used in) provided by operating activities
Net cash used in operating activities was
$4.4 million for the six months ended March 31, 2026, which consisted of a net loss of $3.8 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 $0.7 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 $1.3 million. The change in operating assets and liabilities consisted
of an increase in our accounts receivable and prepaid expenses as well as of a decrease in our accounts payable and accrued expenses
attributed to the timing of payments, partially offset by decrease in our inventory.
Net cash provided by operating activities was
$152,000 for the six months ended March 31, 2025, which consisted of a net loss of $0.5 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 $0.2 million in the aggregate. Our net loss was further adjusted to account for the reclassification of debt 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 inventory and prepaid expenses, partially
offset by a net decrease in our aggregate accrued expenses, other liabilities and accounts payable as well as by an increase in our accounts
receivable attributed to the timing of payments.
36
NeuroOne Medical Technologies Corporation
Form 10-Q
Net cash used in investing activities
Net cash used in investing activities was $79,000
for the six months ended March 31, 2026 and consisted of outlays for purchases of property and equipment.
Net cash used in investing activities was $28,000
for the six months ended March 31, 2025 and consisted of outlays for purchases of property and equipment.
Net cash provided by (used in) financing activities
Net cash provided by financing activities was
$0.8 million for the six months ended March 31, 2026, which consisted of proceeds from a private placement in the amount of $0.7 million
and from the exercise of warrants in the amount of $0.2 million. The proceeds were offset in part by issuance costs and by repurchases
of common stock for the payment of employee taxes in the amount of $0.1 million in the aggregate.
Net cash used in financing activities was $0.3
million for the six months ended March 31, 2025, which consisted of issuance costs and repurchases of common stock for the payment of
employee taxes in the amount of $0.7 million in the aggregate, offset partially by proceeds from the ATM of $0.4 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 4 - “Summary of Significant Accounting Policies” to our condensed
financial statements in “Part 1, Item 1 - Financial Statements” of 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” of 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 8 - Zimmer Distribution Agreement and Other Product Revenue”
to our condensed financial statements included in “Part 1, Item 1 - Financial Statements” of 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.
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 13 - Stockholders’ Equity” to our condensed financial statements included in “Part 1, Item 1 - Financial
Statements” of this Report.
Recent Accounting
Pronouncements
Refer to
“Note 4 - Summary of Significant Accounting Policies” to our condensed financial statements included in “Part 1,
Item 1 - Financial Statements” of this Report for a discussion of recently issued accounting pronouncements.
37
NeuroOne Medical Technologies Corporation
Form 10-Q
Item 3. Quantitative and Qualitative Disclosures
About Market Risk
Not applicable for smaller
reporting companies.
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.