UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

Form 10-Q

 

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended June 30, 2022

 

OR

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ________ to ________

 

Commission File Number: 001-40439

 

NeuroOne Medical Technologies Corporation

(Exact name of Registrant as specified in its charter)

 

Delaware   27-0863354
(State or Other Jurisdiction of
Incorporation or Organization)
  (I.R.S. Employer
Identification Number)
     
7599 Anagram Drive
Eden Prairie, MN
  55344
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 952-426-1383

 

Not Applicable
(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchange on Which Registered
Common stock, $0.001 par value   NMTC   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer Non-accelerated filer
Accelerated filer Smaller reporting company
    Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒

 

The number of outstanding shares of the registrant’s common stock as of August 9, 2022 was 16,209,232.

 

 

 

 

 

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

FORM 10-Q

 

INDEX

 

      Page
  PART 1 – FINANCIAL INFORMATION   1
       
Item 1. Financial Statements   1
  Condensed Balance Sheets as of June 30, 2022 (unaudited) and September 30, 2021   1
  Condensed Statements of Operations for the three and nine months ended June 30, 2022 and 2021 (unaudited)   2
  Condensed Statements of Changes in Stockholders’ Equity for the three and nine months ended June 30, 2022 and 2021 (unaudited)   3
  Condensed Statements of Cash Flows for the nine months ended June 30, 2022 and 2021 (unaudited)   4
  Notes to Condensed Financial Statements (unaudited)   5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   24
Item 3. Quantitative and Qualitative Disclosures About Market Risk   36
Item 4. Controls and Procedures   36
       
  PART II – OTHER INFORMATION    
       
Item 1. Legal Proceedings   38
Item 1A. Risk Factors   38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   38
Item 3. Defaults Upon Senior Securities   38
Item 4. Mine Safety Disclosures   38
Item 5. Other Information   38
Item 6. Exhibits   39
       
SIGNATURES   40

 

i

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

NeuroOne Medical Technologies Corporation

Condensed Balance Sheets

 

   As of
June 30,
2022
   As of
September 30,
2021
 
   (unaudited)     
Assets        
Current assets:        
Cash  $10,178,233   $6,901,346 
Accounts receivable   
    48,336 
Inventory   454,285    98,287 
Prepaid and other assets   296,571    244,043 
Total current assets   10,929,089    7,292,012 
Intangible assets, net   117,471    134,207 
Right-of-use assets   208,928    288,948 
Property and equipment, net   315,260    223,329 
Total assets  $11,570,748   $7,938,496 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $325,027   $528,829 
Accrued expenses   487,244    644,249 
Deferred revenue   2,248    8,622 
Total current liabilities   814,519    1,181,700 
Operating lease liabilities   137,959    202,895 
Total liabilities   952,478    1,384,595 
           
Commitments and contingencies (Note 4)   
 
    
 
 
           
Stockholders’ equity:          
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2022 and September 30, 2021; no shares issued or outstanding as of June 30, 2022 and September 30, 2021.   
    
 
Common stock, $0.001 par value; 100,000,000 shares authorized as of June 30, 2022 and September 30, 2021; 16,194,616 and 12,010,019 shares issued and outstanding as of June 30, 2022 and September 30, 2021, respectively.   16,195    12,010 
Additional paid–in capital   60,054,543    47,369,090 
Accumulated deficit   (49,452,468)   (40,827,199)
Total stockholders’ equity   10,618,270    6,553,901 
Total liabilities and stockholders’ equity  $11,570,748   $7,938,496 

 

See accompanying notes to condensed financial statements

 

1

 

 

NeuroOne Medical Technologies Corporation

Condensed Statements of Operations

(unaudited)

 

   For the
Three Months Ended
   For the
Nine Months Ended
 
   June 30,   June 30, 
   2022   2021   2022   2021 
Product revenue  $32,049   $40,096   $102,381   $129,810 
Cost of product revenue   38,462    61,935    158,113    210,429 
Product gross profit (loss)   (6,413)   (21,839)   (55,732)   (80,619)
                     
Collaborations revenue   
    17,451    6,374    59,838 
                     
Operating expenses:                    
Selling, general and administrative   1,529,670    2,129,474    5,090,018    4,636,586 
Research and development   1,225,351    901,134    3,491,193    2,916,721 
Total operating expenses   2,755,021    3,030,608    8,581,211    7,553,307 
Loss from operations   (2,761,434)   (3,034,996)   (8,630,569)   (7,574,088)
Interest expense   
    
    
    (3,053)
Net valuation change of instruments measured at fair value   
    
    
    1,974 
Other income   1,707    83,387    5,300    270,162 
Loss before income taxes   (2,759,727)   (2,951,609)   (8,625,269)   (7,305,005)
Provision for income taxes   
    
    
    
 
Net loss  $(2,759,727)  $(2,951,609)  $(8,625,269)  $(7,305,005)
                     
Net loss per share:                    
Basic and diluted
  $(0.17)  $(0.25)  $(0.54)  $(0.71)
Number of shares used in per share calculations:                    
Basic and diluted
   16,193,442    11,959,101    15,927,734    10,269,216 

 

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, 2020   7,393,637   $7,394   $32,937,809   $(30,879,031)  $2,066,172 
Issuance of common stock upon conversion of convertible notes   292,754    293    1,004,939    
    1,005,232 
Issuance cost settlement in connection with private placement       
    50,400    
    50,400 
Stock-based compensation       
    245,829    
    245,829 
Issuance of common stock upon vesting of restricted stock units   10,450    10    (10)   
    
 
Net loss       
    
    (1,959,480)   (1,959,480)
Balance at December 31, 2020   7,696,841    7,697    34,238,967    (32,838,511)   1,408,153 
Issuance of common stock in connection with private placement   4,166,682    4,167    8,825,069        8,829,236 
Issuance of warrants in connection with private placement           3,670,764        3,670,764 
Issuance costs in connection with private placement       
    (1,198,080)   
    (1,198,080)
Stock-based compensation           326,359        326,359 
Exercise of warrants   39,905    40    212,459        212,499 
Exercise of stock options   758        4,998        4,998 
Issuance of common stock upon vesting of restricted stock units   6,131    6    (6)   
    
 
Net loss           
    (2,393,916)   (2,393,916)
Balance at March 31, 2021   11,910,317    11,910    46,080,530    (35,232,427)   10,860,013 
Stock-based compensation   51,328    51    878,801    
    878,852 
Issuance of common stock upon vesting of restricted stock units   7,814    8    (8)   
    
 
Exercise of stock options   780    1    5,147    
    5,148 
Exercise of stock warrants   11,141    11    62,490    
    62,501 
Net loss               (2,951,609)   (2,951,609)
Balance at June 30, 2021   11,981,380   $11,981   $47,026,960   $(38,184,036)  $8,854,905 
                          
Balance at September 30, 2021   12,010,019   $12,010   $47,369,090   $(40,827,199)  $6,553,901 
Issuance of common stock in connection with public offering   4,172,057    4,172    13,346,410        13,350,582 
Issuance cost in connection with public offering           (1,352,280)       (1,352,280)
Stock-based compensation       
    203,072    
    203,072 
Issuance of common stock upon vesting of restricted stock units   5,646    6    (6)   
    
 
Net loss       
    
    (2,807,475)   (2,807,475)
Balance at December 31, 2021   16,187,722    16,188    59,566,286    (43,634,674)   15,947,800 
Stock-based compensation           232,716        232,716 
Issuance of common stock upon vesting of restricted stock units   3,447    3    (3)        
Net loss               (3,058,067)   (3,058,067)
Balance at March 31, 2022   16,191,169    16,191    59,798,999    (46,692,741)   13,122,449 
Stock-based compensation           255,548    
    255,548 
Issuance of common stock upon vesting of restricted stock units   3,447    4    (4)        
Net loss               (2,759,727)   (2,759,727)
Balance at June 30, 2022   16,194,616   $16,195   $60,054,543   $(49,452,468)  $10,618,270 

 

See accompanying notes to condensed financial statements

 

3

 

 

NeuroOne Medical Technologies Corporation

Condensed Statements of Cash Flows

(unaudited)

 

   For the
Nine Months Ended
June 30,
 
   2022   2021 
Operating activities        
Net loss  $(8,625,269)  $(7,305,005)
Adjustments to reconcile net loss to net cash used in operating activities:          
Amortization and depreciation   85,198    58,385 
Stock-based compensation   691,336    1,451,040 
Issuance costs attributed to financing activities   
    3,053 
Revaluation of convertible notes   
    (1,974)
Non-cash lease expense   80,020    41,056 
Payroll protection program loan forgiveness        (83,333)
Change in assets and liabilities:          
Accounts receivable   48,336    (40,096)
Inventory   (355,998)   (52,182)
Prepaid and other assets   (145,462)   (45,620)
Accounts payable   (87,197)   (466,128)
Accrued expenses, deferred revenue, operating leases and other liabilities   (228,315)   (132,716)
Net cash used in operating activities   (8,537,351)   (6,573,520)
Investing activities          
Purchase of fixed assets   (209,044)   (31,970)
Net cash used in investing activities   (209,044)   (31,970)
Financing activities          
Issuance costs related to convertible notes   
    (3,053)
Proceeds from issuance of common stock in connection with public offering and private placements   13,350,582    8,829,236 
Proceeds from issuance of warrants in connection with private placement   
    3,670,764 
Exercise of warrants   
    275,000 
Exercise of stock options   
    10,146 
Deferred offering costs   
    (24,179)
Issuance costs related to public offering and private placements   (1,327,300)   (1,198,080)
Net cash provided by financing activities   12,023,282    11,559,834 
Net increase in cash   3,276,887    4,954,344 
Cash at beginning of period   6,901,346    4,036,397 
Cash at end of period  $10,178,233   $8,990,741 
           
Supplemental non-cash financing and investing transactions:          
Conversion of convertible notes into equity  $
   $1,005,232 
Unpaid issuance costs and non-cash adjustments attributed to convertible notes and private placements  $
   $50,400 
Reclass of deferred offering costs to additional paid-in capital in connection with public offering  $24,980   $
 

 

See accompanying notes to condensed financial statements

 

4

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

NOTE 1 – Description of Business and Basis of Presentation

 

NeuroOne Medical Technologies Corporation (the “Company” or “NeuroOne”), a Delaware corporation, is an early-stage medical technology company developing comprehensive neuromodulation electroencephalogram (cEEG) and stereoelectrocencephalography (sEEG) recording, monitoring, ablation, and brain stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.

 

The Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for its Evo cortical technology in November 2019, and in September 2021 received 510(k) clearance from the FDA for its Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. To date, the Company has had limited commercial sales.

 

The Company is based in Eden Prairie, Minnesota.

 

Global Economic Conditions

 

The COVID-19 pandemic that began around December 2019 introduced significant volatility to the global economy, disrupted supply chains and had a widespread adverse effect on the financial markets. The development of the Company’s technology was delayed in the first quarter due to interruptions in global manufacturing and shipping as a result of the COVID-19 pandemic. Additionally, the Company’s own staff has been impacted by infections and mandatory quarantines. Testing and clinical trials, manufacturing, component supply, shipping and research and development operations may be further impacted by the continuing effects of COVID-19.

 

The lingering impacts of COVID-19 throughout 2021 and into 2022 have impeded global supply chains and resulted in inflationary cost increases. These broad-based inflationary impacts have increased the manufacturing costs of our products and product candidates. We expect these inflationary impacts to continue for the foreseeable future,

 

In addition to the direct and indirect impacts of COVID-19, the United States and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. In February 2022, Russia launched a full-scale military invasion of Ukraine. As a result of the conflict, the United States, United Kingdom, European Union and other countries have levied economic sanctions and bans on Russia and Russia has responded with its own retaliatory measures. These measures have contributed to significant volatility and negative pressure in financial markets, and could have a lasting impact on regional and global economies, and may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity for the duration of fiscal year 2022 and beyond.

 

Basis of presentation

 

The accompanying unaudited condensed financial statements have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The condensed financial statements may not include all disclosures required by 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, 2021 included in the Annual Report on Form 10-K. The condensed balance sheet at September 30, 2021 was derived from the audited financial statements of the Company.

 

5

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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.

 

Reverse Stock Split

 

On March 11, 2021, the Company’s Board of Directors (the “Board”) approved a one-for-three reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.001 (“common stock”) effective end-of-day March 31, 2021 (the “Reverse Stock Split”).

 

All issued and outstanding common stock and per share amounts contained in the financial statements have been retroactively adjusted to reflect this Reverse Stock Split for all periods presented. In addition, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise and/or vesting of all outstanding stock options, restricted stock units and warrants to purchase shares of common stock. A proportionate adjustment was also made to the number of shares reserved for issuance pursuant to the Company’s equity incentive compensation plans to reflect the Reverse Stock Split. Any fraction of a share of common stock that was created as a result of the Reverse Stock Split was rounded up to the next whole share. The common stock par value and additional paid-in-capital line items contained in the financial statements were adjusted to account for the Reverse Stock Split for all periods presented. Lastly, the authorized shares and par value per share of the common stock and preferred stock were not adjusted as a result of the Reverse Stock Split.

 

NOTE 2 – Going Concern

 

The accompanying condensed financial statements have been prepared on the basis that the Company will continue as a going concern. The Company has incurred losses since inception, negative cash flows from operations, and had an accumulated deficit of $49.5 million as of June 30, 2022. The Company has not established a source of revenues to cover its full operating costs, and as such, has been dependent on funding operations through the issuance of debt and sale of equity securities. The Company does not have adequate liquidity to fund its operations without raising additional funds and such actions are not solely within the control of the Company. These factors raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this condition. If the Company is unable to raise additional funds, or the Company’s anticipated operating results are not achieved, management believes planned expenditures may need to be reduced in order to extend the time period that existing resources can fund the Company’s operations. The Company intends to fund ongoing activities by utilizing its current cash on hand, from product and collaborations revenue and by raising additional capital through equity or debt financings. If management is unable to obtain the necessary capital, it may have a material adverse effect on the operations of the Company and the development of its technology, or the Company may have to cease operations altogether. 

 

NOTE 3 – Summary of Significant Accounting Policies

 

Management’s Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, primarily in connection with the convertible promissory notes when outstanding, 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.

 

Revenue Recognition

 

The Company entered into a development and distribution agreement which has current and future revenue recognition implications. See “Note 7 – Zimmer Development Agreement”.

 

6

 

 

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 contract, performance obligations are identified and the total transaction price is allocated to the performance obligations. The Company commenced commercial sales of cEEG strip/grid and electrode cable assembly products beginning in the first quarter of fiscal year 2021. The Company sold, on a limited application basis for design verification, sEEG depth electrode products for non-human use beginning in late fiscal year 2021.

 

Cost of Product Revenue

 

Cost of product revenue consists of the manufacturing and materials costs incurred by the Company’s third-party contract manufacturer in connection with cEEG strip/grid and sEEG depth electrode products, and outside supplier materials costs in connection with the electrode cable assembly products. In addition, cost of product revenue includes royalty fees incurred in connection with the Company’s license agreements.

 

Collaborations 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 ASC Topic 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.

 

As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation.

 

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

 

Milestone payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. When the Company’s assessment of probability of achievement changes and variable consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in license, collaboration, and other revenues based upon when the customer obtains control of each element.

 

7

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

 

Fair Value of Financial Instruments

 

The Company’s accounting for fair value measurements of assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring or nonrecurring basis adheres to the Financial Accounting Standards Board (“FASB”) fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:

 

  Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the Company at the measurement date.

 

  Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.

 

  Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date.

 

As of June 30, 2022 and September 30, 2021, the fair values of cash, accounts receivable, inventory, prepaid expenses, other assets, accounts payable and accrued expenses approximated their carrying values because of the short-term nature of these assets or liabilities. The fair value of the convertible notes while outstanding were based on both the fair value of our common stock, discount associated with the embedded redemption features, and cash flow models discounted at current implied market rates evidenced in recent arms-length transactions representing expected returns by market participants for similar instruments and are based on Level 3 inputs.

 

There were no transfers between fair value hierarchy levels during the three and nine months ended June 30, 2022 and 2021.

 

The following table provides a roll-forward of the convertible notes at fair value on a recurring basis using unobservable level 3 inputs for the nine months ended June 30, 2021. There were no convertible notes outstanding during the nine months ended June 30, 2022.

   

   2021 
Convertible notes    
Balance as of beginning of period – September 30, 2020  $1,007,206 
Change in fair value including accrued interest   (1,974)
Conversion of convertible promissory notes to common stock   (1,005,232)
Balance as of end of period – June 30, 2021  $
 

 

8

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Intellectual Property

 

The Company has entered into two licensing agreements with major research institutions, which allow for access to certain patented technology and know-how. Payments under those agreements are capitalized and amortized to general and administrative expenses over the expected useful life of the acquired technology.

 

Property and Equipment

 

Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for equipment and furniture ranges from three to seven years and three years for software. Tangible assets acquired for research and development activities and that have alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and, when appropriate, changes are made prospectively. Software purchased for internal use consists primarily of amounts paid for perpetual licenses to third-party software providers and installation costs. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.

 

Allowances for Doubtful Accounts

 

The Company records a provision for doubtful accounts, when appropriate, based on historical experience and a detailed assessment of the collectability of its accounts receivable. In estimating the allowance for doubtful accounts, the Company considers, among other factors, the aging of the accounts receivable, its historical write-offs, the credit worthiness of each customer, and general economic conditions. Account balances are charged off against the allowance when the Company believes that it is probable that the receivable will not be recovered. Actual write-offs may be in excess of the Company’s estimated allowance.

 

Inventories

 

Inventories are stated at the lower of cost (using the first-in, first-out “FIFO” method) or net realizable value. The Company calculates inventory valuation adjustments for excess and obsolete inventory, when appropriate, based on current inventory levels, movement, expected useful lives, and estimated future demand of the products and spare parts. The Company’s inventory is currently comprised of cEEG strip/grid, sEEG depth electrode and electrode cable assembly finished good products and related component parts. The strip/ grid and depth electrode products are produced by a third-party contract manufacturer and the electrode cable assembly products are obtained from outside suppliers.

 

Impairment of Long-Lived Assets

 

The Company evaluates its long-lived assets, which consist of licensed intellectual property and property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset.

 

Research and Development Costs

 

Research and development costs are charged to expense as incurred. Research and development expenses may include costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with Accounting Standards Codification (ASC) 730, Research and Development.

 

9

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 fees relating to corporate matters, intellectual property costs, professional fees for consultants assisting with regulatory, clinical, product development, financial matters and sales and marketing in connection with the commercial sale of cEEG strip/grid, sEEG depth electrode and electrode cable assembly products.

 

Income Taxes

 

For the Company, income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.

 

Net Loss Per Share

 

For the Company, basic loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period.

 

Diluted earnings or loss per share of common stock is computed similarly to basic earnings or loss per share except the weighted average shares outstanding are increased to include additional shares from the assumed exercise of any common stock equivalents, if dilutive. The Company’s warrants, stock options, and restricted stock units while outstanding are considered common stock equivalents for this purpose. Diluted earnings is computed utilizing the treasury method for the warrants, stock options and restricted stock units. No incremental common stock equivalents were included in calculating diluted loss per share because such inclusion would be anti-dilutive given the net loss reported for the three and nine months ended June 30, 2022 and 2021.

 

The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive for the three and nine months ended June 30, 2022 and 2021:

 

   2022   2021 
Warrants   6,753,444    7,503,808 
Stock options   1,245,582    1,162,838 
Restricted stock units   443,670    18,176 

 

Recent Accounting Pronouncements

 

In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, “Financial Instruments – Credit Losses”. The ASU sets forth a “current expected credit loss” (“CECL”) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted. Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023. The Company is currently assessing the impact of the adoption of this ASU on its financial statements.

 

10

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to improve the consistent application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance. The ASU is effective for fiscal years beginning after December 15, 2020. The Company adopted the new guidance on October 1, 2021 and the adoption of this new guidance did not have a material impact on the Company’s financial statements.

 

In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements.

 

In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) - Disclosures by Business Entities about Government Assistance, to increase the transparency of government assistance including the disclosure of the types of assistance, an entity’s accounting for the assistance, and the effect of the assistance on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company does not expect that this guidance will have a material impact to our financial statements.

 

NOTE 4 - Commitments and Contingencies

 

WARF License Agreement

 

The Company has entered into an exclusive start-up company license agreement with the Wisconsin Alumni Research Foundation (“WARF”) for WARF’s neural probe array and thin film micro electrode technology (the “WARF Agreement”). 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. We have agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect. If we or any of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty rate will be tripled for the remaining term of the WARF License.

 

WARF may terminate the WARF License on 30 days’ written notice if we default on the payments of amounts due to WARF or fail to timely submit development reports, actively pursue our development plan or breach any other covenant in the WARF License and fail to remedy such default in 90 days or in the event of certain bankruptcy events involving us. WARF may also terminate the WARF License (i) on 90 days’ notice if we had failed to have commercial sales of one or more FDA-approved products under the WARF License by June 30, 2021 or (ii) if, after royalties earned on sales begin to be paid, such earned royalties cease for more than four calendar quarters. The first commercial sale occurred on December 7, 2020, prior to the June 30, 2021 deadline. The WARF License otherwise expires by its terms on the date that no valid claims on the patents licensed thereunder remain. We expect the latest expiration of a licensed patent to occur in 2030. During the three months ended June 30, 2022 and 2021, $37,500 and $25,000 in royalty fees were incurred related to the WARF License, respectively. During each of the nine month periods ended June 30, 2022 and 2021, $100,000 in royalty fees were incurred related to the WARF License. The royalty fees were reflected as a component of cost of product revenue.

 

11

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Mayo Agreement

 

The Company has an exclusive license and development agreement with the Mayo Foundation for Medical Education and Research (“Mayo”) related to certain intellectual property and development services for thin film micro electrode technology (“Mayo Agreement”). If the Company is successful in obtaining regulatory approval, the Company is to pay royalties to Mayo based on a percentage of net sales of products of the licensed technology through the term of the Mayo Agreement, set to expire May 25, 2037. During the three months ended June 30, 2022 and 2021, $962 and $1,203 in royalty fees were incurred related to the Mayo Agreement, respectively. During the nine months ended June 30, 2022 and 2021, $2,798 and $3,894 in royalty fees were incurred related to the Mayo Agreement, respectively. The royalty fees were reflected as a component of cost of product revenue.

 

Legal 

 

PMT Litigation

 

From time to time, the Company is subject to litigation and claims in the ordinary course of business.

 

On March 29, 2018, the Company was served with a complaint filed by PMT Corporation (“PMT”), the former employer of Mark Christianson, a current Company employee, and Wade Fredrickson, a now former Company employee. The complaint added the Company, NeuroOne, Inc. and Mr. Christianson to its existing lawsuit against Mr. Fredrickson in the Fourth Judicial District Court of the State of Minnesota. In the lawsuit, PMT claims that Mr. Fredrickson and Mr. Christianson, by virtue of their work for the Company and their prior work during employment with PMT, breached their non-competition, non-solicitation and non-disclosure obligations, breached their fiduciary duty obligations, were unjustly enriched, engaged in unfair competition, engaged in a civil conspiracy, tortiously interfered with PMT’s contracts and prospective economic advantage, and breached a covenant of good faith and fair dealing. The complaint purported to attach Mr. Fredrickson’s noncompete agreement as Exhibit A. Against Mr. Fredrickson, PMT also alleged that he intentionally or negligently spoliated evidence, made negligent or fraudulent misrepresentations, misappropriated trade secrets in violation of Minnesota law, and committed the tort of conversion and statutory civil theft. Against the Company and NeuroOne, Inc., PMT alleged that the Company and NeuroOne, Inc. were unjustly enriched and engaged in unfair competition. PMT asked the Court to impose a constructive trust over the shares held by Mr. Fredrickson and Mr. Christianson and to award compensatory damages, equitable relief, punitive damages, attorneys’ fees, costs and interest.

  

On April 18, 2018, Mr. Christianson, the Company and NeuroOne, Inc. filed a motion for dismissal, which was heard by the Court on October 11, 2018. The motion for dismissal stated that: the contract claims against Mr. Christianson fail because his agreement was not supported by consideration; the Minnesota Uniform Trade Secrets Act preempts plaintiff’s claims for unfair competition, civil conspiracy and unjust enrichment; plaintiff fails to state a claim regarding alleged breach of the duties of loyalty and good faith/fair dealing; plaintiff cannot legally obtain a constructive trust; plaintiff has insufficiently pled its tortious interference claims; and Plaintiff has not stated a claim for unfair competition. On January 7, 2019, the judge granted the motion for dismissal with respect to PMT’s claim for breach of the duty of good faith and fair dealing and denied the motion for dismissal with respect to the other claims presented.

 

In April 2019, PMT served the Company, NeuroOne, Inc. and Christianson with a proposed Second Amended Complaint, which included new claims against the Company and NeuroOne, Inc for tortious interference with contract and tortious interference with prospective business advantage and punitive damages against the Company, NeuroOne Inc. and Christianson. On June 28, 2019, the Company presented evidence indicating that PMT had participated in a fraud on the Court and sought an Order that PMT had waived the attorney client privilege.

 

12

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

On July 16, 2019, the defendants served PMT with a joint notice of motion for sanctions seeking a variety of sanctions for litigation misconduct including, but not limited to, dismissal of the case and an award of attorneys’ fees. The Company, NeuroOne Inc and Mr. Christianson further moved for summary judgment on all remaining claims asserted against them as well as for leave to assert counterclaims against PMT for abuse of process. Following hearings on the dispositive motions and defendants’ sanctions motion, the district court granted the Company’s motion for sanctions on April 29, 2020. Additionally, the district court granted the Company’s motion for summary judgment in part with respect to the counts for Christianson’s breach of non-confidentiality agreement and denied the Company’s motion for summary judgment on all other counts.

   

On August 24, 2020, defendants moved the Court to amend their counterclaims for abuse of process against PMT to add a claim for punitive damages with respect to its conduct pertaining to the Fredrickson noncompete. On October 12, 2020 the Court awarded NeuroOne, Inc. $185,000 in Rule 11 sanctions and Fredrickson $145,000 in Rule 11 sanctions with respect to PMT’s misconduct relating to the Fredrickson noncompete. PMT and its former litigation counsel, Barnes & Thornburg, were jointly and severally liable for these awards, which were paid on December 11, 2020 and have been recognized in other income in the statements of operations. The Court granted NeuroOne, Inc.’s motion to amend to permit its assertion of the right to assert a punitive damages claim against PMT associated with fighting the allegations relating to the Fredrickson noncompete.

 

On May 27, 2021 PMT, moved for summary judgment on defendants’ claims for abuse of process and punitive damages, and on August 5, 2021, the district court granted PMT’s motion to dismiss the Company’s abuse of process and punitive damage claims.

 

On April 29, 2022, the district court issued an order ruling on several motions brought by the parties to exclude evidence from the trial, granting many of the Company’s requests to exclude certain evidence, and denying PMT’s exclusion requests.

 

On July 26, 2022, the Special Master appointed by the district court issued an order striking PMT’s attempt to supplement its trade secret claim by adding thirteen new trade secret claims which it never disclosed during discovery. The Special Master found that the attempt by PMT’s fourth set of lawyers to add claims on the eve of trial was both untimely and unfairly prejudicial to the Company. In addition, the Special Master found the alleged trade secrets were too vague and indefinite to constitute actionable trade secrets.

 

Trial was postponed from December 2021 to August 22, 2022. The Company intends to continue to defend itself vigorously. The outcome of any claim against the Company by PMT was not able to be estimated as of the issuance of these financial statements.

 

Facility Leases

 

Headquarters Lease

 

On October 7, 2019, the Company entered into a non-cancellable lease agreement (the “Minnesota Lease”) with Biynah Cleveland, LLC, BIP Cleveland, LLC, and Edenvale Investors (together, the “Landlord”) pursuant to which the Company has agreed to lease office space located at 7599 Anagram Drive, Eden Prairie, Minnesota (the “Premises”). The Company took possession of the Premises on November 1, 2019, with the term of the Minnesota Lease ending 65 months after such date, unless terminated earlier (the “Term”). The initial base rent for the Premises is $6,410 per month for the first 17 months, increasing to $7,076 per month by the end of the Term. In addition, as long as the Company is not in default under the Minnesota Lease, the Company shall be entitled to an abatement of its base rent for the first 5 months. The Company will also pay its pro rata share of the Landlord’s annual operating expenses associated with the premises, calculated as set forth in the Minnesota Lease of which the Company is entitled to an abatement of these operating expense for the first 3 months.

 

13

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Los Gatos Lease

 

On July 1, 2021, the Company entered into a non-cancellable facility lease (the “Los Gatos Lease”), pursuant to which the Company agreed to rent office space for its research and development operations located at 718 University Avenue, Suite #111, Los Gatos, California. The term of the Los Gatos Lease is eighteen months. The facility space under the Los Gatos Lease is approximately 1,162 square feet. The Company took possession of the office space on July 2, 2021. The initial monthly rent under the Los Gatos Lease is approximately $4,241.

 

San Jose Lease:

 

On December 30, 2020, the Company entered into a non-cancellable lease agreement for short term office space in San Jose, California (the “San Jose Lease”) for a three month initial term. After March 31, 2021, the San Jose Lease was cancellable upon a 30-day notice to the landlord. The Company took possession of the office space on January 1, 2021 and the San Jose Lease was terminated upon the commencement of the Los Gatos Lease discussed above. The base rent under the San Jose Lease was $504 per month.

 

During the three and nine months ended June 30, 2022, rent expense associated with the facility leases amounted to $42,185 and $128,315, respectively. During the three and nine months ended June 30, 2021, rent expense associated with the facility leases amounted to $31,485 and $92,746, respectively.

 

Supplemental cash flow information related to the operating leases was as follows:   

 

   For the
Nine Months Ended
June 30,
 
   2022   2021 
Cash paid for amounts included in the measurement of lease liability:        
Operating cash flows from operating leases  $97,799   $58,173 
Right-of-use assets obtained in exchange for lease obligations:          
Operating leases  $
   $
 

 

Supplemental balance sheet information related to the operating leases was as follows: 

 

   As of
June 30,
2022
   As of
September 30,
2021
 
         
Right-of-use assets  $208,928   $288,948 
           
Lease liabilities  $232,011   $315,673 
           
Weighted average remaining lease term (years)   2.5    3.1 
Weighted average discount rate   6.8%   6.7%

 

Maturity of the lease liabilities was as follows:

 

Calendar Year  As of
June 30,
2022
 
2022  $65,856 
2023   82,333 
2024   84,391 
2025   21,227 
Total lease payments   253,807 
Less imputed interest   (21,796)
Total   232,011 
Short-term portion   (94,052)
Long-term portion  $137,959 

 

14

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

NOTE 5 – Supplemental Balance Sheet Information

 

Prepaid and Other Assets

 

Prepaid and other assets consisted of the following:

 

  

As of

June 30,
2022

  

As of

September 30, 2021

 
Prepaid expenses  $296,572   $151,109 
Deferred offering costs   
    92,934 
Total  $296,572   $244,043 

 

Intangibles

 

Intangible assets rollforward is as follows:

 

   Useful Life     
Net Intangibles, September 30, 2021   12-13 years   $134,207 
Less: amortization        (16,736)
Net Intangibles, June 30, 2022       $117,471 

 

Amortization expense was $5,578 and $16,736 for the three and nine months ended June 30, 2022, respectively, and $5,579 and $16,737 for the three and nine months ended June 30, 2021, respectively.

 

Property and Equipment, Net

 

Property and equipment held for use by category are presented in the following table:

 

   As of
June 30,
2022
   As of
September 30,
2021
 
Equipment and furniture  $471,879   $311,486 
Software   1,895    1,895 
Total property and equipment   473,774    313,381 
Less accumulated depreciation   (158,514)   (90,052)
Property and equipment, net  $315,260   $223,329 

 

Depreciation expense was $25,928 and $68,462 for the three months and nine months ended June 30, 2022, respectively, and $14,776 and $41,648 for the three and nine months ended June 30, 2021, respectively.

 

NOTE 6 - Accrued Expenses and Other Liabilities

 

Accrued expenses and other liabilities consisted of the following at June 30, 2022 and September 30, 2021:

 

   As of
June 30,
2022
   As of
September 30,
2021
 
Accrued payroll  $287,962   $376,236 
Operating lease liability, short term   94,052    112,778 
Royalty Payments   75,230    72,083 
Other   30,000    83,152 
Total  $487,244   $644,249 

 

15

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

NOTE 7 – Zimmer Development Agreement

 

On July 20, 2020, the Company entered into an exclusive development and distribution agreement (as amended from time to time, the “Zimmer Development Agreement”) with Zimmer, Inc. (“Zimmer”), pursuant to which the Company granted Zimmer exclusive global rights to distribute the Strip/Grid Products and electrode cable assembly products (the “Electrode Cable Assembly Products”). Additionally, the Company granted Zimmer the exclusive right and license to distribute certain depth electrodes developed by the Company (“SEEG Products”, and together with the Strip/Grid Products and Electrode Cable Assembly Products, the “Products”). The parties have agreed to collaborate with respect to development activities under the Zimmer Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company.

 

Under the terms of the Zimmer Development Agreement, the Company is responsible for all costs and expenses related to developing the Products, and Zimmer is responsible for all costs and expenses related to the commercialization of the Products. In addition to the Zimmer Development Agreement, Zimmer and the Company have entered into a Manufacturing and Supply Agreement (the “MS Agreement”) and a supplier quality agreement (the “Quality Agreement”) with respect to the manufacturing and supply of the Products.

 

Except as otherwise provided in the Zimmer Development Agreement, the Company is responsible for performing all development activities, including non-clinical and clinical studies directed at obtaining regulatory approval of each Product. Zimmer has agreed to use commercially reasonable efforts to promote, market and sell each Product following the “Product Availability Date” (as defined in the Zimmer Development Agreement) for such Product.

 

Pursuant to the Zimmer Development Agreement, Zimmer made an upfront initial exclusivity fee payment of $2.0 million (the “Initial Exclusivity Fee”) to the Company.

 

Except where Zimmer timely delivers a Design Modification Notice pursuant to Section 1.2, if one or more of the events set forth below occurs on or before the deadline indicated for such event and the Product Availability Date (as defined in the Zimmer Development Agreement) for the SEEG Products occurs on or before June 30, 2021, then the Company shall receive the additional amount indicated for such event as part of the SEEG Exclusivity Maintenance Fee:

 

Design freeze for the SEEG Products by December 15, 2020 - $500,000

 

Acceptance of all Deliverables for SEEG Products under the Development Plan (as defined in the Zimmer Development Agreement) by April 30, 2021 - $500,000

 

If Zimmer timely delivers a Design Modification Notice to the Company under the Zimmer Development Agreement, and one or more of the events set forth below occurs on or before the deadline indicated for such event and the Product Availability Date for the SEEG Products occurs on or before June 30, 2021, then the Company shall receive the additional amount indicated for such event as part of the SEEG Exclusivity Maintenance Fee:

 

Acceptance of all Deliverables for SEEG Products under the Development Plan other than the Modified Connector by April 30, 2021 - $500,000

 

Acceptance of all Deliverables for SEEG Products under the Development Plan, including the Modified Connector by September 30, 2021 - $500,000

 

For purposes of the Zimmer Development Agreement, each of the foregoing events shall have occurred only if the Company has demonstrated the achievement of the event to Zimmer’s reasonable satisfaction. Notwithstanding the foregoing, the events in Sections 6.1(c)(ii), (iii) and (iv) of the Zimmer Development Agreement shall not be deemed to be met if FDA Approval for the SEEG Products is not received prior to the applicable deadline.

 

16

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

  

In order to maintain the exclusivity of the SEEG Distribution License, Zimmer must pay the SEEG Exclusivity Maintenance Fee to the Company, on or prior to the SEEG Exclusivity Confirmation Date, in immediately available funds as follows:

 

  if the Product Availability Date for the SEEG Products occurs on or before June 30, 2021, then $3,000,000, plus the amount of any Interim Fee Bonuses earned pursuant to Section 6.1(c), including any such Interim Fee Bonus earned after June 30, 2021 pursuant to Section 6.1(c)(iv) following the delivery of a Design Modification Notice;

 

  if the Product Availability Date for the SEEG Products occurs after June 30, 2021, but on or before September 30, 2021, then $3,000,000, plus if Zimmer timely issues a Design A-9 Modification Notice, any Interim Fee Bonus earned pursuant to Section 6.1(c)(iv);

 

  if the Product Availability Date for the SEEG Products occurs after September 30, 2021, but on or before December 31, 2021, then $2,500,000; and

 

  if the Product Availability Date for the SEEG Products occurs after December 31, 2021, then $1,500,000.

 

The Product Availability Date for the SEEG Products has not yet occurred. Notwithstanding any other provision of the Zimmer Development Agreement, if the Product Availability Date for the SEEG Products has not occurred on or before June 30, 2022, Zimmer shall have the right to terminate the SEEG Distribution License by delivering written notice to the Company to that effect and, upon delivery of such notice, Zimmer shall be relieved of all of its obligations hereunder with respect to SEEG Products, including any obligation to pay the SEEG Exclusivity Maintenance Fee or to purchase, market, distribute or sell any SEEG Products. The Initial Exclusivity Fee and the SEEG Exclusivity Maintenance Fee (including any Interim Fee Bonus(es)), once paid, are non-refundable.

 

The Zimmer Development Agreement will expire on the tenth anniversary of the date of the first commercial sale of the last of the Products to achieve a first commercial sale, unless terminated earlier pursuant to its terms. Either party may terminate the Zimmer Development Agreement (x) with written notice for the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings. In addition, Zimmer may terminate the Development Agreement for any reason with 90 days’ written notice, and the Company may terminate the Zimmer Development Agreement if Zimmer acquires or directly or indirectly owns a controlling interest in certain competitors of the Company.

 

At inception of the Zimmer Development Agreement through June 30, 2022, the Company had identified three performance obligations under the Zimmer Development Agreement and consisted of the following: (1) the Company obligation to grant Zimmer access to its intellectual property; (2) complete SEEG Product development; and (3) complete Strip/Grid Product development. Accordingly, the Company recognized revenue in the amount of zero and $17,451 during the three month periods ended June 30, 2022 and 2021, respectively, and $6,374 and $59,838 during the nine month periods ended June 30, 2022 and 2021, respectively, in connection with the Initial Exclusivity Fee payment. The Zimmer Development Agreement was accounted for under the provisions of ASC 606, Revenue from Contracts with Customers.

 

A reconciliation of the closing balance of deferred revenue related to the Zimmer Development Agreement is as follows during the nine months ended as of June 30, 2022 and 2021:

 

   2022   2021 
Deferred Revenue        
Balance as of beginning of period – September 30  $8,622   $73,434 
Revenue recognized   (6,374)   (59,838)
Balance as of end of period – June 30  $2,248   $13,596 

 

17

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

The remaining performance obligations reflected in deferred revenue as of June 30, 2022 are expected to be completed in the last quarter of fiscal year 2022.

 

On August 2, 2022, the Company and Zimmer entered into the Third Amendment to the Zimmer Development Agreement. See “Note 14 – Subsequent Events”.

 

Product Revenue

 

Product revenue related to its Strip/Grid Products, SEEG Products and Electrode Cable Assembly Products. Product revenue recognized during the three and nine month periods ended June 30, 2022 was $32,049 and $102,381, respectively. Product revenue recognized during the three and nine month periods ended June 30, 2021 was $40,096 and $129,810, respectively.

 

 Advertising Expense

 

Advertising expense is charged to selling, general and administrative expenses during the period that it is incurred. Total advertising expense amounted to $43,479 and $218,011 for the three and nine month periods ended June 30, 2022, respectively. Total advertising expense amounted to $79,261 and $221,408 for the three and nine month periods ended June 30, 2021, respectively.

 

NOTE 8 - Convertible Promissory Notes and Warrant Agreements

 

2019 Paulson Convertible Note Offering

 

On November 1, 2019, the Company entered into a subscription agreement with certain accredited investors, pursuant to which the Company, in a private placement (the “2019 Paulson Private Placement”), agreed to issue and sell to the investors 13% convertible promissory notes (each, a “2019 Paulson Note” and collectively, the “2019 Paulson Notes”) and warrants (each, a “2019 Paulson Warrant” and collectively, the “2019 Paulson Warrants”) to purchase shares of the Company’s common stock.

 

The initial closing of the 2019 Paulson Private Placement was consummated on November 1, 2019, and, on that date and through December 3, 2019, the Company issued the 2019 Paulson Notes in an aggregate principal amount of $3,234,800 to the subscribers for gross proceeds equalling the principal amount. The 2019 Paulson Private Placement terminated on December 3, 2019.

 

On April 24, 2020, the Company and holders of a majority in aggregate principal amount of the 2019 Paulson Notes entered into an amendment to the 2019 Paulson Notes (the “Second 2019 Paulson Notes Amendment”) to, among other things:

 

  i. Extended the Maturity DateThe Second 2019 Paulson Notes Amendment extended the maturity date of the 2019 Paulson Notes from May 1, 2020 to November 1, 2020 (in either case, unless a change of control transaction happens prior to such date);

 

  ii. Revised Optional Conversion TermsThe Second 2019 Paulson Notes Amendment provided that the amount of shares to be received upon the a subscriber’s optional conversion of the 2019 Paulson Notes prior to a 2019 Qualified Financing (as defined in the 2019 Paulson Notes) would have equalled: (1) the Outstanding Balance as defined below of such subscriber’s 2019 Paulson Note elected by the subscriber to be converted divided by (2) an amount equal to 0.6 multiplied by the volume weighted average price of the common stock for the ten (10) trading days immediately preceding the date of conversion; and

 

  iii. Revise the Registration Date – The Second 2019 Paulson Notes Amendment provided that promptly following the earlier of (1) May 1, 2020, if the applicable subscriber converted all or a majority of the Outstanding Balance of such subscriber’s 2019 Paulson Note prior to such date; (2) the final closing a 2019 Qualified Financing; and (3) the maturity date, the Company will enter into a registration rights agreement with the applicable subscriber containing customary and usual terms pursuant to which the Company shall agree to prepare and file with the SEC a registration statement on or prior to the 90th calendar day following the registration date, covering the resale of any common stock received on conversion of such 2019 Paulson Notes, and shares of common stock underlying the Warrants.

 

18

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

The 2019 Paulson Notes had a fixed interest rate of 13% per annum and required the Company to repay the principal and accrued and unpaid interest thereon on November 1, 2020 (the “Maturity Date”). Interest on principal amounted to $5,701 during the nine month period ended June 30, 2021 and was recorded under the net valuation change of instruments measured at fair value in the condensed statements of operations. The 2019 Paulson Notes were not outstanding during the nine month period ended June 30, 2022.

 

The Company elected to account for the 2019 Paulson Notes on a fair value basis under ASC 825 to comprehensively value and streamline the accounting for the embedded conversion options. Subsequent to issuance, the fair value change of the Paulson Notes amounted to a benefit of $(1,974) during the nine months ended June 30, 2021 and was recorded under the net valuation change of instruments measured at fair value in the condensed statements of operations.

 

Each 2019 Paulson Warrant grants the holder the option to purchase the number of shares of common stock equal to (i) 0.5 multiplied by (ii) the principal amount of such subscriber’s 2019 Paulson Notes divided by 5.61, with an exercise price per share equal to $5.61. As of the final closing on December 3, 2019, the Company issued 2019 Paulson Warrants exercisable for 288,305 shares of common stock in connection with all closings of the 2019 Paulson Private Placement. The 2019 Paulson Warrants are immediately exercisable and expire on November 1, 2022. The exercise price is subject to adjustment in the event of any stock dividends or splits, reverse stock split, recapitalization, reorganization or similar transaction, as described therein. The 2019 Paulson warrants were deemed to be a free-standing instrument and were accounted for as equity. Given that the fair value of the 2019 Paulson Notes exceeded the proceeds received at issuance, there was no value attributed to the 2019 Paulson Warrants in the condensed financial statements.

 

Issuance costs during the nine month period ended June 30, 2021 in connection with the 2019 Paulson Private Placement were $3,053 and related to legal costs. The issuance costs were recorded as a component of interest in the accompanying condensed statements of operations.

 

During the first quarter of fiscal year 2021, the remaining holders of the 2019 Paulson Notes elected to convert the remaining outstanding principal and accrued and unpaid interest in the amount of $615,159 into 292,754 shares of common stock.

 

NOTE 9 – Stock-Based Compensation

 

During the three and nine month periods ended June 30, 2022 and 2021, stock-based compensation expense related to stock-based awards was included in selling, general and administrative expenses and research and development costs as follows in the accompanying condensed statements of operations.

 

   Three Months Ended   Nine Months Ended 
   June 30,   June 30, 
   2022   2021   2022   2021 
Selling, general and administrative  $211,472   $816,033   $569,347   $1,251,412 
Research and development   44,076    62,819    121,989    199,628 
Total stock-based compensation expense  $255,548   $878,852   $691,336   $1,451,040 

 

Stock Options

 

During the three month periods ended June 30, 2022 and 2021, under the 2017 Equity Incentive Plan (the “2017 Plan”), the Company granted 88,690 and 81,446 stock options, respectively, to its officers and employees. During the nine month periods ended June 30, 2022 and 2021, the Company granted 150,690 and 703,117, respectively, to its officers, employees and consultants. Vesting generally occurs over an immediate to 48 month period based on a time of service condition although vesting acceleration is provided under one grant in the event that a certain milestone is met. The grant date fair value of the grants issued during the three month periods ended June 30, 2022 and 2021 was $0.57 and $3.65 per share, respectively. The grant date fair value of the grants issued during the nine month periods ended June 30, 2022 and 2021 was $0.76 and $3.01 per share, respectively.

 

19

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

The total expense for the three months ended June 30, 2022 and 2021 related to stock options was $137,109 and $500,149, respectively. The total expense for the nine months ended June 30, 2022 and 2021 related to stock options was $444,891 and $817,761, respectively. The total number of stock options outstanding as of June 30, 2022 and September 30, 2021 was 1,245,582 and 1,122,560, respectively.

 

The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and nine month period ended June 30, 2022 and 2021:

 

   Three Months Ended   Nine Months Ended 
   June 30,   June 30, 
   2022   2021   2022   2021 
Expected stock price volatility   53.5%   56.0%   53.5%   55.9%
Expected life of options (years)   5.3    5.9    5.6    6.0 
Expected dividend yield   0%   0%   0%   0%
Risk free interest rate   2.8%   1.0%   2.3%   0.6%

 

During the three month periods ended June 30, 2022 and 2021, 64,841 and 162,266 stock options vested, respectively, and 5,167 and 21,437 stock options were forfeited during these periods, respectively. During the nine month periods ended June 30, 2022 and 2021, 265,901 and 268,793 stock options vested, respectively and 27,668 and 31,583 stock options were forfeited during these periods, respectively. During the three and nine months ended June 30, 2021, 780 and 1,538 stock options were exercised, respectively, with an intrinsic value of $1,693 and $2,648, respectively. No options were exercised during the three and nine months ended June 30, 2022.

 

Restricted Stock Units

 

During the three and nine months ended June 30, 2022, the Company granted an aggregate of 87,720 and 443,670 restricted stock units (“RSUs”) to certain directors, officers and employees under the 2017 Plan. The weighted average grant date fair value of the RSUs granted during the three and nine months ended June 30, 2022 was $1.14 and $1.91 per unit, respectively. The RSUs vest over a one to three year period with some of the RSUs vesting ratably on a monthly and others vesting at 50 percent on the first anniversary of the grant date with the remaining RSUs vesting in equal monthly installments on the last day of each month over 24 months, subject to the recipient’s continued service on such dates.  During the three and nine month periods ended June 30, 2021, 13,776 RSUs were granted to directors at a weighted average grant date fair value of $7.26.

 

During the three months ended June 30, 2022 and 2021, 9,606 and 7,077 RSUs vested, respectively, and no RSUs were forfeited during these periods. During the nine months ended June 30, 2022 and 2021, 18,694 and 23,453 RSUs vested, respectively, and no RSUs were forfeited during these periods. The total expense for the three months ended June 30, 2022 and 2021 related to these RSUs was $118,439 and $39,702, respectively. The total expense for the nine months ended June 30, 2022 and 2021 related to these RSUs was $246,445 and $123,278, respectively.

 

Other Stock-Based Awards

 

In April 2021, two consulting agreements were executed whereby a total of 62,659 shares of common stock were subject to issuance of which 51,330 shares of common stock were issued as of June 30, 2021. Compensation expense related to the stock awards granted under these consulting agreements amounted to $339,001 for the three and nine months ended June 30, 2021 and were included in the total stock-based compensation expense.

 

20

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

In August 2020, an additional consulting agreement was executed whereby 40,000 shares of common stock were issued, subject to Company repurchase. The stock award under the agreement vests over a six-month period. As of June 30, 2021, 40,000 shares were vested under this agreement of which 33,334 shares vested during the nine months ended June 30, 2021. Compensation expense related to the stock award granted under this consulting agreement amounted to $171,000 for the nine months ended June 30, 2021 and was included in the total stock-based compensation expense.

 

No other stock-based awards were issued during the three and nine month periods ended June 30, 2022 and no expense associated with stock awards was recorded during the three and nine months ended June 30, 2022.

 

Inducement Plan

 

On October 4, 2021, the Company adopted the NeuroOne Medical Technologies Corporation 2021 Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 420,350 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors without stockholder approval in accordance with such rule.

 

2017 Plan Evergreen Provision

 

Under the 2017 Plan, the shares reserved automatically increase on January 1st of each year, for a period of not more than ten years from the date the 2017 Plan is approved by the stockholders of the Company, commencing on January 1, 2019 and ending on (and including) January 1, 2027, to an amount equal to 13% of the fully-diluted shares outstanding as of December 31st of the preceding calendar year. Notwithstanding the foregoing, the Board may act prior to January 1st of a given year to provide that there will be no January 1st increase in the share reserve for such year or that the increase in the share reserve for such year will be a lesser number of shares of common stock than would otherwise occur pursuant to the preceding sentence. “Fully Diluted Shares” as of a date means an amount equal to the number of shares of common stock (i) outstanding and (ii) issuable upon exercise, conversion or settlement of outstanding awards under the 2017 Plan and any other outstanding options, warrants or other securities of the Company that are (directly or indirectly) convertible or exchangeable into or exercisable for shares of common stock, in each case as of the close of business of the Company on December 31 of the preceding calendar year. Effective January 1, 2022, 1,614,538 shares were added to the 2017 Plan as a result of the evergreen provision.

 

General

 

As of June 30, 2022, 1,709,534 shares were available in the aggregate for future issuance under the 2017 Plan and Inducement Plan. No shares were available for future issuance under the 2016 Equity Incentive Plan. Unrecognized stock-based compensation was $1,927,956 as of June 30, 2022. The unrecognized share-based expense is expected to be recognized over a weighted average period of 2.2 years.

 

NOTE 10 – Concentrations

 

Credit Risk

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company’s cash is held by a network of financial institutions in the United States. Amounts on deposit may at times exceed federally insured limits. The Company has not experienced any losses on its deposits since inception, and management believes that minimal credit risk exists with respect to these financial institutions. As of June 30, 2022, the Company had no deposits in excess of federally insured amounts.

 

21

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Revenue

 

One customer accounts for all of the Company’s product and collaborations revenue.

 

Supplier concentration

 

One contract manufacturer produces all of the Company’s Strip/Grid Products and SEEG Products.

 

NOTE 11 – Income Taxes

 

The effective tax rate for the three and nine months ended June 30, 2022 and 2021 was zero percent. As a result of the analysis of all available evidence as of June 30, 2022 and September 30, 2021, the Company recorded a full valuation allowance on its net deferred tax assets. Consequently, the Company reported no income tax benefit during the three and nine months ended June 30, 2022 and 2021. 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 – Stockholders’ Equity

 

2021 Public Offering

 

On October 13, 2021, the Company, entered into an Underwriting Agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC, as underwriter (the “Underwriter”), relating to the issuance and sale of 3,750,000 shares of the Company’s common stock at a price to the public of $3.20 per share. In addition, under the terms of the Underwriting Agreement, the Company granted the Underwriter an option, exercisable for 30 days, to purchase up to an additional 562,500 shares of common stock on the same terms. The base offering closed on October 15, 2021, and the sale of 422,057 shares of common stock subject to the Underwriter’s overallotment option closed on November 15, 2021.

 

The gross proceeds to the Company from this offering were approximately $13.4 million prior to deducting underwriting discounts and other offering expenses payable by the Company in the amount of approximately $1.4 million in the aggregate.

 

2021 Private Placement

 

On January 12, 2021, the Company entered into a Common Stock and Warrant Purchase Agreement with certain accredited investors (the “Purchasers”), pursuant to which the Company agreed to issue and sell an aggregate of 4,166,682 shares common stock, and warrants to purchase an aggregate of 4,166,682 shares of Common Stock (the “2021 Warrants”) at an aggregate purchase price of $3.00 per share of Common Stock and corresponding warrant, resulting in total gross proceeds of $12.5 million before deducting placement agent fees and estimated offering expenses. The 2021 Warrants have an initial exercise price of $5.25 per share. The 2021 Warrants are exercisable beginning on the date of issuance and will expire on the fifth anniversary of such date. This private placement closed on January 14, 2021.

 

22

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Warrant Activity and Summary

 

The following table summarizes warrant activity during the nine month period ended June 30, 2022:

 

       Exercise   Weighted Average   Weighted Average 
   Warrants   Price Per Warrant   Exercise
Price
   Term
(years)
 
Outstanding and exercisable at September 30, 2021   7,503,808   $5.25- $9.00   $6.06    3.23 
Issued   
   $   $
    
 
Exercised   
   $   $
    
 
Forfeited/Expired   (750,364)  $5.40   $5.40    
 
Outstanding and exercisable at June 30, 2022   6,753,444    $5.25-$9.00   $6.14    2.82 

 

NOTE 13 – Deferred Contribution Plan

 

The Company has a 401(k) defined contribution plan (the “401K Plan”) for all employees over age 21. Employees can defer up to 100% of their compensation through payroll withholdings into the 401K Plan subject to federal law limits. The Company may match 100% of deferrals up to 3% of one’s contributions. The Company’s matching contributions to employee deferrals are discretionary. The Company may also make discretionary profit sharing contributions under the 401K Plan in the future, but it has not done so through June 30, 2022.

 

Employee contributions and any employer matching contributions made to satisfy certain non-discrimination tests required by the Internal Revenue Code are 100% vested upon contribution. Discretionary employer matches to employee deferrals vest over a nine year period beginning on the second anniversary of an employee’s date of hire. Discretionary profit sharing contributions vest over a five year period beginning on the first anniversary of an employee’s date of hire. The amount of matching contributions to the 401K Plan to satisfy certain non-discrimination tests was $30,697 and $14,803 during the three and nine month periods ended June 30, 2022 and 2021, respectively.

 

NOTE 14 – Subsequent Events

 

Third Amendment to Exclusive Development and Distribution Agreement with Zimmer, Inc.

 

On August 2, 2022, the Company entered into a Third Amendment to Exclusive Development and Distribution Agreement (the “Zimmer Amendment”) with Zimmer. Pursuant to the terms and conditions of the Zimmer Amendment, Zimmer agreed to make a $3,500,000 payment to the Company within 10 business days of the execution of the Zimmer Amendment.

 

 

On August 2, 2022, in connection with the Zimmer Amendment, the Company issued Zimmer a Warrant to Purchase Common Stock (the “2022 Zimmer Warrant”).

 

The 2022 Zimmer Warrant will be exercisable for up to an aggregate of 350,000 shares of the Company’s common stock. The 2022 Zimmer Warrant will have an exercise price of $3.00 per share, will be exercisable commencing six months from the issuance date, and will expire on August 2, 2027 . Subject to limited exceptions, Zimmer will not have the right to exercise any portion of the 2022 Zimmer Warrant if Zimmer, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise provided, however, that upon prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided further that in no event shall the Beneficial Ownership Limitation exceed 19.99% and any increase in the beneficial ownership limitation will not be effective until 61 days following notice to the Company.

 

23

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and notes included in Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended September 30, 2021.

 

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:

 

  the timing of and our ability to obtain and maintain regulatory clearance of our cortical strip, grid and depth electrode technology, including our ability to obtain 510(k) clearance for use of its Evo sEEG electrode technology for less than 30 days;

 

  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 results of our development and distribution relationship with Zimmer, Inc. (“Zimmer”);

 

  the availability of additional capital on acceptable terms or at all as or when needed;

 

  the clinical utility of our cortical strip, grid and depth electrode including technology under development;

 

  our ability to develop additional applications of our cortical strip, grid and depth electrode technology with the benefits we hope to offer as compared to existing technology, or at all;

  

  the performance, productivity, reliability and regulatory compliance of our third party manufacturers of our cortical strip, grid electrode and depth electrode technology;

 

  our ability to develop future generations of our cortical strip, grid and depth electrode technology;

 

  our future development priorities;

 

  the impact of the COVID-19 pandemic and macroeconomic conditions, including supply chain disruptions, labor shortages and inflationary pressures, on our business;

 

  our ability to obtain reimbursement coverage for our cortical strip, grid and depth electrode technology;

 

  our expectations about the willingness of healthcare providers to recommend our cortical strip, grid and depth electrode technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders;

 

24

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

  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;

 

  the outcome of legal proceedings with PMT Corporation (“PMT”);

  

  our expectations regarding international opportunities for commercializing our cortical strip, grid and depth electrode technology under including technology under development;

 

  our estimates regarding the size of, and future growth in, the market for our technology, including technology under development; and

 

  our estimates regarding our future expenses and needs for additional financing.

 

Forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. You should refer to the “Risk Factors” section of our Annual Report on Form 10-K for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

 

These forward-looking statements speak only as of the date of this Report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. You should, however, review the factors and risks and other information we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”) after the date of this Report.

 

Overview

 

We are a medical technology company focused on the development and commercialization of thin film electrode technology for cEEG and sEEG recording, spinal cord stimulation, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders. Additionally, we are investigating the potential applications of our technology associated with artificial intelligence.

 

We are developing our cortical, sheet and depth electrode technology to provide solutions for diagnosis through cEEG recording and sEEG recording and treatment through brain stimulation and ablation, all in one product. A cEEG is a continuous recording of the electrical activity of the brain that identifies the location of irregular brain activity, which information is required for proper treatment. cEEG recording involves an invasive surgical procedure, referred to as a craniotomy. sEEG involves a less invasive procedure whereby doctors place electrodes in targeted brain areas by drilling small holes through the skull. Both methods of seizure diagnosis are used to identify areas of the brain where epileptic seizures originate in order to precisely locate the seizure source for therapeutic treatment if possible.

 

Deep brain stimulation, or DBS, therapies involve activating or inhibiting the brain with electricity that can be given directly by electrodes on the surface or implanted deeper in the brain via depth electrodes. Introduced in 1987, this procedure involves implanting a power source referred to as a neurostimulator, which sends electrical impulses through implanted depth electrodes, to specific targets in the brain for the treatment of disorders such as Parkinson’s disease, essential tremors, dystonia, and chronic pain. The effects of DBS as a potential treatment for Alzheimer’s is also being evaluated by researchers. Unlike ablative technologies, the effects of DBS are reversible.

 

25

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

RF ablation is a procedure that uses radiofrequency under the electrode contacts which is directed to the site of the brain tissue that is targeted for removal. The process involves delivering energy to the contacts, thereby heating them and destroying the brain tissue. The ablation does not remove the tissue. Rather, it is left in place and typically scar tissue forms in the place where the ablation occurs. This procedure is also known as brain lesioning as it causes irreversible lesions.

 

We received 510(k) FDA clearance for our Evo cortical technology in November 2019, and in September 2021 we received FDA clearance to market our Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

 

In November 2021, the Company submitted a request to the FDA seeking a 510(k) clearance for use of its Evo sEEG electrode technology for less than 30 days. On March 11, 2022, the Company received a letter via email from the FDA that the FDA had denied the Company’s 510(k) application based on a finding of non-substantial equivalence based on their analysis of the methodology used for exhaustive extraction testing. The FDA letter stated the Company has not demonstrated that the sEEG Electrode for less than 30-day use is substantially equivalent to the predicate device (sEEG Electrode for less than 24 hours K211367). The FDA also stated that the Company may re-submit a new 510(k) if it has biocompatibility data it believes can show its device to be substantially equivalent.

 

The Company filed an appeal of this decision to a higher level within the FDA, which placed the submission on hold until a decision was made. In a letter to the Company dated May 13, 2022, the FDA stated that they were upholding their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.

 

The FDA also stated that the Company may submit a new 510(k) with new evidence, specifically as it relates to the subacute toxicity endpoint, to support a finding of substantial equivalence. The Company is in the process of collecting such data and intends to submit a Special 510(k) which according to FDA guidance is processed within 30 days of receipt, rather than the 90 days for a traditional 510(k). The Company expects to resubmit the application to the FDA in August 2022.

 

The Company has stated previously that it expected to be commercial ready with the Evo sEEG electrode in the first calendar quarter of 2022 pending FDA clearance. The Company now expects that additional time will be required and will continue to work with the FDA in pursuit of 510(k) clearance.

 

The Company commenced commercial sales of cEEG strip/grid and electrode cable assembly products beginning in the first quarter of fiscal year 2021. The Company sold, on a limited application basis for design verification, sEEG depth electrode products for non-human use beginning in late fiscal year 2021. Our other products are still under development.

 

Prior to FDA approval or clearance of certain of our products, our primary activities were limited to, and our limited resources were dedicated to, performing business and financial planning, raising capital, recruiting personnel, negotiating with business partners and the licensors of our intellectual property and conducting research and development activities.

 

We have incurred losses since inception. As of June 30, 2022, we had an accumulated deficit of $49.5 million, primarily as a result of expenses incurred in connection with our research and development, selling, general and administrative expenses associated with our operations and interest expense, fair value adjustments and loss on extinguishments related to our debt, offset in part by collaborations and product revenues.

 

Prior to FDA approval of certain of our products, our main source of cash was proceeds from the issuances of notes, common stock, warrants and unsecured loans. See “—Liquidity and Capital Resources—Capital Resources” below. While we have begun to generate revenue from the sale of products based on our cEEG and sEEG technology and through milestone payments from our current collaboration with Zimmer, we expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate a higher level of revenue from commercial sales, and we will need to obtain substantial additional funding in connection with our continuing operations through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources. 

 

26

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

We may be unable to raise additional funds when needed on favorable terms or at all. Our failure to raise such capital as and when needed would have a negative impact on our financial condition and our ability to develop and commercialize our cortical strip, grid electrode and depth electrode technology and future products and our ability to pursue our business strategy. See “—Liquidity and Capital Resources—Liquidity Outlook” below

 

Recent Developments and Upcoming Milestones

 

Corporate Updates

 

In November 2021, we submitted a request to the FDA seeking a 510(k) clearance for use of our Evo sEEG electrode technology for less than 30 days. On March 11, 2022, the FDA denied the Company’s 510(k) application based on a finding of non-substantial equivalence based on their analysis of the methodology used for exhaustive extraction testing.

 

We filed an appeal of this decision to a higher level within the FDA, which placed the submission on hold until a decision was made. On May 13, 2022, the FDA stated that they were upholding their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing. We intend to submit a Special 510(k) which according to FDA guidance is processed within 30 days of receipt, rather than the 90 days for a traditional 510(k). We expect to resubmit the application to the FDA in August 2022.

 

We had stated previously that we expected to be commercial ready with the Evo sEEG electrode in the first calendar quarter of 2022 pending FDA clearance. We now expect that additional time will be required and will continue to work with the FDA in pursuit of 510(k) clearance.

 

We completed feasibility bench top testing with a new design of our diagnostic and ablation depth electrode in the first calendar quarter of 2021, and signed a contract with RBC Medical Innovations to develop and manufacture hardware (a radio frequency generator) for the system in the third calendar quarter of 2021. We are targeting the third calendar quarter of 2022 for completion of a prototype of hardware, with the submission of an application for FDA clearance in early calendar 2023. We also completed an animal feasibility study at Emory University in September 2021 and additional animal studies are planned. During the fiscal quarter, we also announced that we have surpassed five years of accelerated aging testing for our recording electrodes.

 

We continue to develop our Chronic Use electrodes and remain focused on developing a system for the treatment of chronic back pain due to failed back surgeries that provides the capabilities of recording and stimulation in a thin film electrode technology. We recently established a physician advisory board comprised of leading anesthesiologists and neurosurgeons that have extensive experience with implanting these systems. In our fiscal fourth quarter, we will convene the group to begin to develop the framework of a desired feature set customized to the advantages of our electrode technology.

 

Global Economic Conditions

 

The COVID-19 pandemic that began around December 2019 introduced significant volatility to the global economy, disrupted supply chains and had a widespread adverse effect on the financial markets. The development of our technology was delayed in the first quarter due to interruptions in global manufacturing and shipping as a result of the COVID-19 pandemic. Additionally, our own staff has been impacted by infections and mandatory quarantines. Testing and clinical trials, manufacturing, component supply, shipping and research and development operations may be further impacted by the continuing effects of COVID-19.

 

The lingering impacts of COVID-19 throughout 2021 and into 2022 have impeded global supply chains and resulted in inflationary cost increases. These broad-based inflationary impacts have increased the manufacturing costs of our products and product candidates. We expect these inflationary impacts to continue for the foreseeable future,

 

In addition to the direct and indirect impacts of COVID-19, the United States and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. In February 2022, Russia launched a full-scale military invasion of Ukraine. As a result of the conflict, the United States, United Kingdom, European Union and other countries have levied economic sanctions and bans on Russia and Russia has responded with its own retaliatory measures. These measures have contributed to significant volatility and negative pressure in financial markets, and could have a lasting impact on regional and global economies, and may have a material adverse effect on our results of future operations, financial position, and liquidity for the duration of fiscal year 2022 and beyond.

 

27

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

  

Financial Overview

 

Product Revenue

 

Our product revenue was derived from the sale of strip/grid, depth electrode and electrode cable assembly products based on Evo cortical and sEEG technology. For the foreseeable future, we anticipate that we will generate additional revenue from the sale of products based on Evo cortical and sEEG technology.

  

We have received FDA 510(k) clearance for our cortical strip electrode, but we do not expect to generate any significant revenue from the sale of our other products until we develop and obtain all required regulatory approvals or clearances for and commercialize depth electrode technology for human use. If we fail to complete the development of the depth electrode technology, or any other product candidate we may pursue in the future, in a timely manner, or fail to obtain regulatory approval, we may never be able to generate revenue from product sales sufficient to sustain operations.

 

Product Gross Profit (Loss)

 

Product gross profit (loss) represents our product revenue less our cost of product revenue. Our cost of product revenue consists of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our strip/grid and depth electrode products and outside supplier materials costs in connection with the electrode cable assembly products. In addition, cost of product revenue includes royalty fees incurred in connection with our license agreements.

 

Collaborations Revenue

 

Collaborations revenue was derived from the upfront initial exclusivity fee payment under the Zimmer Development Agreement. We anticipate that we may earn additional revenues stemming from additional milestone and royalty payments from Zimmer, however, the achievement and timing of future milestones or level of sales required to earn royalty payments from Zimmer is uncertain. For a discussion of milestones and royalty payments under the Zimmer Development Agreement, see “—Liquidity and Capital Resources—Liquidity Outlook” below and see “Note 7 — Zimmer Development Agreement” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.

 

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 fees relating to corporate matters, intellectual property costs, professional fees for consultants assisting with financial and administrative matters, and sales and marketing in connection with the commercial sale of cEEG strip/grid, sEEG depth electrode and electrode cable assembly products. We anticipate that our selling, general and administrative expenses will significantly increase in the future to support our continued research and development activities, further commercialization of our cortical strip technology, potential further commercialization of our grid electrode and depth electrode technology, if approved, and the increased costs of operating as a public company. These increases will include increased costs related to the hiring of additional personnel and fees for legal and professional services, as well as other public-company related costs.

 

Research and Development

 

Research and development expenses consist of expenses incurred in performing research and development activities in developing our cortical strip, grid electrode and depth electrode technology. Research and development expenses include compensation and benefits for research and development employees including stock-based compensation, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to consultants and other outside expenses. Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed. Lastly, de minimis income from the sale of prototype products and related materials are offset against research and development expenses.

 

28

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

We expect our research and development expenses to significantly increase over the next several years as we develop our cortical strip, grid electrode and depth electrode technology and conduct preclinical testing and clinical trials and will depend on the duration, costs and timing to complete our preclinical programs and clinical trials.

 

Interest Expense

 

Interest expense consists of interest costs related to our convertible notes issued in 2019 (the “2019 Paulson Notes”) outstanding during the first quarter of fiscal year 2021.

 

Net valuation change of instruments measured at fair value

 

The net valuation change of instruments measured at fair value included the change in fair value of the 2019 Paulson Notes while they were outstanding.

 

Other Income

 

Other income primarily consists of interest income related to our cash deposits and proceeds outside of normal operating activity relating to legal settlements and sales of non-commercial supplies.

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2022 and 2021

 

The following table sets forth the results of operations for the three months ended June 30, 2022 and 2021, respectively.

 

   For the Three Months Ended
June 30, (unaudited)
 
   2022   2021   Period to
Period
Change
 
Product revenue  $32,049   $40,096   $(8,047)
Cost of product revenue   38,462    61,935    (23,473)
Product gross profit (loss)   (6,413)   (21,839)   15,426 
                
Collaborations revenue       17,451    (17,451)
                
Operating expenses:               
Selling, general and administrative   1,529,670    2,129,474    (599,804)
Research and development   1,225,351    901,134    324,217 
Total operating expenses   2,755,021    3,030,608    (275,587)
Loss from operations   (2,761,434)   (3,034,996)   273,562 
Other income   1,707    83,387    (81,680)
Loss before income taxes   (2,759,727)   (2,951,609)   191,882 
Provision for income taxes            
Net loss  $(2,759,727)  $(2,951,609)  $191,882 

 

29

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

  

Product Revenue and Product Gross Profit (Loss)

 

Product revenue and product gross profit (loss) was $32,000 and $(6,000), respectively, during the three months ended June 30, 2022. Product revenue and product gross profit (loss) was $40,000 and $(22,000), respectively, during the three months ended June 30, 2021. The product revenue during the second quarter of 2022 related to the sale of our Strip/Grid Products and Electrode Cable Assembly Products. Cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products and outside supplier materials costs in connection with the Electrode Cable Assembly Products. In addition, cost of product revenue included royalty fees incurred in connection with our license agreements.

 

Collaborations Revenue

 

Collaborations revenue was $17,000 for the three months ended June 30, 2021. Revenue during the prior year period was derived from the Zimmer Development Agreement and represented the portion of the upfront initial development fee payment eligible for revenue recognition during the second quarter of fiscal year 2021. The amount of revenue recognized related to the upfront fee was based on development completed in connection with SEEG Products, and to a lesser extent, the Strip/Grid Products. There was no collaborations revenue recognized during the three months ended June 30, 2022.

 

Selling, general and administrative expenses

 

Selling, general and administrative expenses were $1.5 million for the three months ended June 30, 2022, compared to $2.1 million for the three months ended June 30, 2021. The $0.6 million decrease was primarily due to a decrease in stock-based compensation expense of $0.6 million and sales and marketing expenses of $0.1 million, offset in part by an increase in legal and public company costs of $0.1 million.

  

Research and development expenses

 

Research and development expenses were $1.2 million for the three months ended June 30, 2022, compared to $0.9 million during for the three months ended June 30, 2021. The $0.3 million increase period over period was attributed to supporting development activities, which primarily included salary-related expenses and costs related to consulting services, materials and supplies associated with the development of SEEG Products.  

 

Other Income

 

Other income during the three months ended June 30, 2022 related to interest income on our cash deposits in the amount of $2,000. Other income during the three months ended June 30, 2021 was attributed to the forgiveness of the U.S. Small Business Administration Paycheck Protection Program loan in the amount of $0.1 million.

 

30

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Comparison of the Nine Months Ended June 30, 2022 and 2021

 

The following table sets forth the results of operations for the nine months ended June 30, 2022 and 2021, respectively.

 

 

   For the Nine Months Ended
June 30, (unaudited)
 
   2022   2021   Period to
Period
Change
 
Product revenue  $102,381   $129,810   $(27,429)
Cost of product revenue   158,113    210,429    (52,316)
Product gross profit (loss)   (55,732)   (80,619)   24,887 
                
Collaborations revenue   6,374    59,838    (53,464)
                
Operating expenses:               
Selling, general and administrative   5,090,018    4,636,586    453,432 
Research and development   3,491,193    2,916,721    574,472 
Total operating expenses   8,581,211    7,553,307    1,027,904 
Loss from operations   (8,630,569)   (7,574,088)   (1,056,481)
Interest expense       (3,053)   3,053 
Net valuation change of instruments measured at fair value       1,974    (1,974)
Other income   5,300    270,162    (264,862)
Loss before income taxes   (8,625,269)   (7,305,005)   (1,320,264)
Provision for income taxes            
Net loss  $(8,625,269)  $(7,305,005)  $(1,320,264)

 

Product Revenue and Product Gross Profit (Loss)

 

Product revenue and product gross profit (loss) was $102,000 and $(56,000) during the nine months ended June 30, 2022, respectively. Product revenue and product gross profit (loss) was $130,000 and $(81,000) during the nine months ended June 30, 2021, respectively. The product revenue consisted of Strip/Grid Products and Electrode Cable Assembly Products sales. Cost of product revenue consisted of the manufacturing and materials costs incurred by our third-party contract manufacturer in connection with our Strip/Grid Products and outside supplier materials costs in connection with the Electrode Cable Assembly Products. In addition, cost of product revenue included royalty fees incurred in connection with our license agreements.

 

Collaborations Revenue

 

Collaborations revenue was $6,000 and $60,000 for the nine months ended June 30, 2022 and 2021, respectively. Revenue during the period was derived from the Zimmer Development Agreement and represented the portion of the upfront initial development fee payment eligible for revenue recognition during these nine month periods. The amount of revenue recognized related to the upfront fee was based on development completed in connection with SEEG Products, and to a lesser extent, the Strip/Grid Products. 

 

31

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Selling, general and administrative expenses

 

Selling, general and administrative expenses were $5.1 million for the nine months ended June 30, 2022, compared to $4.6 million for the nine months ended June 30, 2021. The $0.5 million increase was primarily due to higher investor relations costs of $0.4 million, litigation support and other legal costs $0.5 million, sales and marketing expenses of $0.1 million and insurance and other operating expenses and fees of $0.2 million, offset in part by stock-based compensation of $0.7 million.

 

Research and development expenses

 

Research and development expenses were $3.5 million for the nine months ended June 30, 2022, compared to $2.9 million for the nine months ended June 30, 2021. The $0.6 million increase period over period was attributed to supporting development activities, which primarily included salary-related expenses and costs related to consulting services, materials and supplies associated with the development of SEEG Products.

 

Interest expense

 

Interest expense for the nine months ended June 30, 2021 was $3,000 and consisted of issuance costs in connection the 2019 Paulson Notes. We did not incur interest expense during the current nine month period ended June 30, 2022. 

 

Net valuation change of instruments measured at fair value:

 

The net valuation change of instruments measured at fair value for the nine months ended June 30, 2021 was a benefit of $2,000 related to the 2019 Paulson Notes that were measured at fair value. The change was due to accrued interest on these convertible notes and due to fluctuations in our common stock fair value and the number of potential shares of common stock issuable upon conversion of these notes while outstanding. There was no net valuation change of instruments measured at fair value during the nine month period ended June 30, 2022 as there were no instruments measured at fair value during the current year period.

 

Other Income

 

Other income during the nine months ended June 30, 2022 consisted of $5,000 related primarily to interest income attributed to our cash deposits.

 

Other income during the nine months ended June 30, 2021 consisted principally of proceeds received in connection with the PMT Corporation litigation in the amount of $0.2 million and the forgiveness of the U.S. Small Business Administration Paycheck Protection Program loan in the amount of $0.1 million. 

 

Liquidity and Capital Resources

 

Overview

 

As of June 30, 2022, our principal source of liquidity consisted of cash deposits of $10.2 million. While we began to generate revenue in fiscal year 2021 from commercial sales and through milestone payments under our collaboration with Zimmer, we expect to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate an adequate level of revenue from commercial sales to cover expenses. Our most significant cash requirements relate to the funding of our ongoing product development and commercialization operations and our royalty obligations under our intellectual property licenses with the Wisconsin Alumni Research Foundation (“WARF”) and the Mayo Foundation for Medical Education and Research (“Mayo”).  Our additional material cash needs include commitments under operating leases and other administrative services. See “—Funding Requirements” below for more information. We anticipate that our expenses will increase substantially as we develop and commercialize our cortical strip, grid electrode and depth electrode technology and pursue pre-clinical and clinical trials, seek regulatory approvals, manufacture products, establish our own sales, marketing and distribution infrastructure to commercialize our ablation electrode technology, hire additional staff, add operational, financial and management systems and continue to operate as a public company.

 

32

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Capital Resources

 

Our sources of cash to date have been limited collaboration and product revenues and proceeds from the issuances of notes with warrants, common stock with and without warrants and unsecured loans, with the terms of our most recent financings described below.

 

October 2021 Underwritten Public Offering

 

On October 13, 2021, we entered into an underwriting agreement relating to the issuance and sale of 3,750,000 shares of our common stock at a price to the public of $3.20 per share (the “October 2021 Underwritten Public Offering”). In addition, under the terms of the underwriting agreement, we granted the underwriter an option, exercisable for 30 days, to purchase up to an additional 562,500 shares of common stock on the same terms. The base offering closed on October 15, 2021, and the sale of 422,057 shares of common stock subject to the underwriter’s overallotment option closed on November 15, 2021. The gross proceeds from this offering were approximately $13.4 million prior to deducting underwriting discounts and other offering expenses payable by us.

 

2021 Private Placement

 

On January 12, 2021, we entered into a purchase agreement with certain accredited investors, pursuant to which the Company, in a private placement (the “2021 Private Placement”), agreed to issue and sell an aggregate of 4,166,682 shares of the common stock of the Company, and warrants to purchase an aggregate of 4,166,682 shares of common stock (the “2021 Warrants”) at an aggregate purchase price of $3.00 per share of common stock and corresponding warrant, resulting in total gross proceeds of $12.5 million before deducting placement agent fees and estimated offering expenses. The 2021 Warrants have an initial exercise price of $5.25 per share. The 2021 Warrants became immediately exercisable beginning on the date of issuance and will expire on the fifth anniversary of such date. Prior to expiration, subject to the terms and conditions set forth in the 2021 Warrants, the holders of such 2021 Warrants may exercise the 2021 Warrants for shares of common stock by providing notice to the Company and paying the exercise price per share for each share so exercised or by utilizing the “cashless exercise” feature contained in each 2021 Warrant. The 2021 Private Placement closed on January 14, 2021. 

 

In connection with the 2021 Private Placement, the Company agreed to file a registration statement with the SEC covering the resale of the Shares, the 2021 Warrants and the shares of common stock issuable upon exercise of the 2021 Warrants. The Company agreed to file such registration statement within 30 days of the execution of the 2021 Purchase Agreement on January 12, 2021 and filed such registration statement on February 10, 2021.

 

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 the Wisconsin Alumni Research Foundation (“WARF”) and the Mayo Foundation for Medical Education and Research (“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, 2021 for a discussion of design, development, pre-clinical and clinical activities that we may conduct in the future, including expected cash expenditures required for some of those activities, to the extent we are able to estimate such costs.

  

On January 22, 2020, we entered into an Amended and Restated License Agreement (the “WARF License”) with WARF, which amended and restated in full our prior license agreement with WARF, dated October 1, 2014 (the “Original WARF License”). Under the WARF License, we have agreed to pay WARF a royalty equal to a single-digit percentage of our product sales pursuant to the WARF License, with a minimum annual royalty payment of $50,000 for 2020, $100,000 for 2021 and $150,000 for 2022 and each calendar year thereafter that the WARF License is in effect. If we or any of our sublicensees contest the validity of any licensed patent, the royalty rate will be doubled during the pendency of such contest and, if the contested patent is found to be valid and would be infringed by us if not for the WARF License, the royalty rate will be tripled for the remaining term of the WARF License.

 

33

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Under the Amended and Restated License and Development Agreement with Mayo (the “Mayo Development Agreement”), we have agreed to pay Mayo a royalty equal to a single-digit percentage of our product sales pursuant to the Mayo Development Agreement. See “Note 4 – Commitments and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for more information about the WARF License and the Mayo Development Agreement.

 

Our other cash requirements within the next twelve months include accounts payable, accrued expenses, purchase commitments and other current liabilities. Our other cash requirements greater than twelve months from various contractual obligations and commitments include operating leases and contracted services. Refer to “Note 4 – Commitments and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for further detail of our lease obligations and the timing of expected future payments. Contracted services include agreements with third-party service providers for clinical research, product development, manufacturing, supplies, payroll services, equipment maintenance services, and audits for periods up to fiscal 2023.

 

We expect to satisfy our short-term and long-term obligations through cash on hand and, until we generate an adequate level of revenue from commercial sales to cover expenses, if ever, from future equity and debt financings.

 

Liquidity Outlook

 

For a discussion of potential fee payments under the Zimmer Development Agreement, see “Note 7 — Zimmer Development Agreement” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report. The Company does not intend to deliver saleable product to Zimmer unless and until it receives regulatory clearance to expand the use of its Evo sEEG Electrode technology for up to 30 days, at which point the Company and Zimmer intend to commence negotiations regarding payments of applicable milestone payments described therein, notwithstanding the deadlines for the Product Availability Date and the Acceptance of all Deliverables for SEEG Products. 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. Further, our inability to agree with Zimmer on dates of completion for product development, regulatory clearance and commercialization milestones on which various fee payments to the Company are based under the Zimmer Development Agreement could have a material adverse impact on our financial and operating results.

 

At June 30, 2022, we had approximately $10.2 million in cash deposits. Management has noted the existence of substantial doubt about our ability to continue as a going concern. Additionally, our independent registered public accounting firm and our former independent registered public accounting firm included explanatory paragraphs in the reports on our financial statements as of and for the years ended September 30, 2021 and 2020, respectively, noting the existence of substantial doubt about our ability to continue as a going concern. Our existing cash may not be sufficient to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need to secure additional funding through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital when needed could compromise our ability to execute on our business plan. If we are unable to raise additional funds, or if our anticipated operating results are not achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing resources can fund our operations. If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and the development of our technology, or we may have to cease operations altogether.

 

The development and commercialization of our cortical strip, grid electrode and depth electrode technology is subject to numerous uncertainties, and we could use our cash 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.

 

34

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Cash Flows

 

The following is a summary of cash flows for each of the periods set forth below.

 

   For the
Nine Months Ended
 
   June 30, 
   2022   2021 
Net cash used in operating activities  $(8,537,351)  $(6,573,520)
Net cash used in investing activities   (209,044)   (31,970)
Net cash provided by financing activities   12,023,282    11,559,834 
Net increase in cash  $3,276,887   $4,954,344 

 

Net cash used in operating activities

 

Net cash used in operating activities was $8.5 million for the nine months ended June 30, 2022, which consisted of a net loss of $8.6 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $0.9 million in the aggregate. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $0.8 million. The change in operating assets and liabilities was primarily attributable to a net decrease in accounts payable and accrued expenses and to an increase in inventory and prepaid expenses attributed to both the timing of payments and the timing of product sales. 

 

Net cash used in operating activities was $6.6 million for the nine months ended June 30, 2021, which consisted of a net loss of $7.3 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, revaluation of convertible notes, operating lease expense and the forgiveness of the U.S. Small Business Administration Paycheck Protection Program loan, totaling approximately $1.5 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 $0.7 million. The change in operating assets and liabilities was primarily attributable to a decrease in accounts payable and accrued expenses attributed to the timing of payments coupled to a lesser extent with an increase in accounts receivable, inventory and prepaid and other assets.

 

Net cash used in investing activities

 

Net cash used in investing activities was $0.2 million and $32,000 during the nine months ended June 30, 2022 and 2021, respectively, and consisted of outlays for purchases of property and equipment.

 

Net cash provided by financing activities

 

Net cash provided by financing activities was $12.0 million for the nine months ended June 30, 2022, which consisted of net proceeds from the October 2021 Underwritten Public Offering.

 

Net cash provided by financing activities was $11.6 million for the nine months ended June 30, 2021, which consisted primarily of net proceeds received from the 2021 Private Placement in the amount of $11.3 million. There were also exercises of stock options and warrants during the nine months ended June 30, 2021 resulting in additional cash proceeds of $0.3 million, offset in part by deferred offering costs of $24,000.

 

Critical Accounting Estimates

 

Our financial statements are prepared in accordance with U.S. generally accepted accounting principles. These accounting principles require us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented. We believe that the estimates and judgments upon which we rely are reasonably based upon information available to us at the time that we make these estimates and judgments. To the extent that there are material differences between these estimates and actual results, our financial results will be affected. The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described in Note 3 — “Summary of Significant Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.

 

35

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Of these policies, the following are considered critical to an understanding of our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report as they require the application of the most subjective and the most complex judgments:  

 

Revenues:

 

For discussion about the determination of collaborations revenue, product revenue and cost of product revenue, see “Note 7 — Zimmer Development Agreement” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report. To date, we have not had, nor expect to have in the future, significant variable consideration adjustments related to product revenue, such as chargebacks, sales allowances and sales returns.

 

Stock-based Compensation

 

For discussions about the application of grant date fair value associated with our stock-based compensation, see “Note 9 — Stock-Based Compensation” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.

 

Income Tax Assets and Liabilities

 

Income tax assets and liabilities include income tax valuation allowances. For additional information, see “Note 11 — Income Taxes” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report and “Note 11 – Income Taxes” in Part II, Item 8 “Financial Statements” of our Annual Report on Form 10-K for the year ended September 30, 2021.

 

Contingencies

 

We are subject to numerous contingencies arising in the ordinary course of business, including legal contingencies. For additional information, see “Note 4 — Commitments and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.

 

Recent Accounting Pronouncements

 

Refer to Note 3 — “Summary of Significant Accounting Policies” to our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for a discussion of recently issued accounting pronouncements.

  

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable for smaller reporting companies.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information we are required to disclose in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

 

36

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

We designed and evaluate our disclosure controls and procedures recognizing that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance and not absolute assurance of achieving the desired control objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based, in part, upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

Under the supervision of and with the participation of our management, including our principal executive officer and principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15(d- 15(e) promulgated under the Exchange Act as of June 30, 2022. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of June 30, 2022.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

37

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

The material legal proceedings in which we are involved are discussed in Note 4, “Commitments and Contingencies – Legal” of the Notes to the Condensed Financial Statements in this Quarterly Report on Form 10-Q, and are hereby incorporated by reference.

 

Item 1A. Risk Factors

 

In addition to the other information set forth elsewhere in this Report, you should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2021 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. Those factors, if they were to occur, could cause our actual results to differ materially from those expressed in our forward-looking statements in this report, and materially adversely affect our financial condition or future results. Although we are not aware of any other factors that we currently anticipate will cause our forward-looking statements to differ materially from our future actual results, or materially affect the Company’s financial condition or future results, additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial conditions and/or operating results.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable to our Company.

 

Item 5. Other Information

 

None.

 

38

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

Item 6. Exhibits

 

3.1   Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.4 on the Registrant’s Current Report on Form 8 filed on June 29, 2017).
     
3.2   Certificate of Amendment to Amended and Restated Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.1 on the Registrant’s Current Report on Form 8-K filed on March 31, 2021).
     
3.3   Bylaws of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.5 on the Registrant’s Current Report on Form 8-K filed on June 29, 2017).
     
4.1   Warrant to Purchase Common Stock dated as of August 2, 2022 issued to Zimmer, Inc.
     
10.1   Amendment No. 2 to Exclusive Development and Distribution Agreement dated as of July 1, 2022 by and between the Company and Zimmer, Inc.
     
10.2   Amendment No. 3 to Exclusive Development and Distribution Agreement dated as of  August 2, 2022 by and between the Company and Zimmer, Inc.
     
31.1   Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2   Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2*   Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101.INS   Inline XBRL Instance Document.
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

*Documents are furnished, not filed.

 

39

 

 

NeuroOne Medical Technologies Corporation

Form 10-Q

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Dated: August 11, 2022

 

NeuroOne Medical Technologies Corporation

 

By: /s/ David Rosa  
  David Rosa  
  Chief Executive Officer  
  (Principal Executive Officer)  
     
By: /s/ Ronald McClurg  
  Ronald McClurg  
  Chief Financial Officer  
  (Principal Financial Officer)  

 

 

40

 

952 426-1383 0.17 0.25 0.54 0.71 10269216 11959101 15927734 16193442 false --09-30 Q3 0001500198 0001500198 2021-10-01 2022-06-30 0001500198 2022-08-09 0001500198 2022-06-30 0001500198 2021-09-30 0001500198 2022-04-01 2022-06-30 0001500198 2021-04-01 2021-06-30 0001500198 2020-10-01 2021-06-30 0001500198 us-gaap:CommonStockMember 2020-09-30 0001500198 us-gaap:AdditionalPaidInCapitalMember 2020-09-30 0001500198 us-gaap:RetainedEarningsMember 2020-09-30 0001500198 2020-09-30 0001500198 us-gaap:CommonStockMember 2020-10-01 2020-12-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2020-10-01 2020-12-31 0001500198 us-gaap:RetainedEarningsMember 2020-10-01 2020-12-31 0001500198 2020-10-01 2020-12-31 0001500198 us-gaap:CommonStockMember 2020-12-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001500198 us-gaap:RetainedEarningsMember 2020-12-31 0001500198 2020-12-31 0001500198 us-gaap:CommonStockMember 2021-01-01 2021-03-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-03-31 0001500198 2021-01-01 2021-03-31 0001500198 us-gaap:RetainedEarningsMember 2021-01-01 2021-03-31 0001500198 us-gaap:CommonStockMember 2021-03-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001500198 us-gaap:RetainedEarningsMember 2021-03-31 0001500198 2021-03-31 0001500198 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0001500198 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0001500198 us-gaap:CommonStockMember 2021-06-30 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-06-30 0001500198 us-gaap:RetainedEarningsMember 2021-06-30 0001500198 2021-06-30 0001500198 us-gaap:CommonStockMember 2021-09-30 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-09-30 0001500198 us-gaap:RetainedEarningsMember 2021-09-30 0001500198 us-gaap:CommonStockMember 2021-10-01 2021-12-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-10-01 2021-12-31 0001500198 2021-10-01 2021-12-31 0001500198 us-gaap:RetainedEarningsMember 2021-10-01 2021-12-31 0001500198 us-gaap:CommonStockMember 2021-12-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2021-12-31 0001500198 us-gaap:RetainedEarningsMember 2021-12-31 0001500198 2021-12-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2022-01-01 2022-03-31 0001500198 2022-01-01 2022-03-31 0001500198 us-gaap:CommonStockMember 2022-01-01 2022-03-31 0001500198 us-gaap:RetainedEarningsMember 2022-01-01 2022-03-31 0001500198 us-gaap:CommonStockMember 2022-03-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2022-03-31 0001500198 us-gaap:RetainedEarningsMember 2022-03-31 0001500198 2022-03-31 0001500198 us-gaap:AdditionalPaidInCapitalMember 2022-04-01 2022-06-30 0001500198 us-gaap:RetainedEarningsMember 2022-04-01 2022-06-30 0001500198 us-gaap:CommonStockMember 2022-04-01 2022-06-30 0001500198 us-gaap:CommonStockMember 2022-06-30 0001500198 us-gaap:AdditionalPaidInCapitalMember 2022-06-30 0001500198 us-gaap:RetainedEarningsMember 2022-06-30 0001500198 2021-03-11 0001500198 pf0:MinimumMember us-gaap:EquipmentMember 2021-10-01 2022-06-30 0001500198 pf0:MaximumMember us-gaap:EquipmentMember 2021-10-01 2022-06-30 0001500198 us-gaap:SoftwareDevelopmentMember 2021-10-01 2022-06-30 0001500198 2020-06-30 0001500198 nmtc:MayoAgreementMember 2022-04-01 2022-06-30 0001500198 nmtc:MayoAgreementMember 2021-04-01 2021-06-30 0001500198 nmtc:MayoAgreementMember 2021-10-01 2022-06-30 0001500198 nmtc:MayoAgreementMember 2020-10-01 2021-06-30 0001500198 2020-10-01 2020-10-12 0001500198 nmtc:WadeFredricksonMember 2020-10-01 2020-10-12 0001500198 2021-07-01 0001500198 2021-06-28 2021-07-01 0001500198 2020-12-01 2020-12-30 0001500198 pf0:MinimumMember 2021-10-01 2022-06-30 0001500198 pf0:MaximumMember 2021-10-01 2022-06-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:December152020Member 2020-12-01 2020-12-15 0001500198 nmtc:DevelopmentAgreementMember nmtc:ScenarioOneMember nmtc:April302021Member 2021-04-01 2021-04-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:ScenarioTwoMember nmtc:ModifiedConnectorbyApril302021Member 2021-04-01 2021-04-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:ScenarioTwoMember nmtc:ModifiedConnectorbySeptember302021Member 2021-09-01 2021-09-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:ScenarioOneMember nmtc:OnOrBeforeJune302021Member 2021-06-01 2021-06-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:ScenarioTwoMember nmtc:AfterJune302021ButOnOrBeforeSeptember302021Member 2021-07-02 2021-09-30 0001500198 nmtc:DevelopmentAgreementMember nmtc:AfterSeptember302021ButOnOrBeforeDecember312021Member 2021-10-01 2021-12-31 0001500198 nmtc:DevelopmentAgreementMember nmtc:AfterDecember312021Member 2021-10-01 2021-12-31 0001500198 nmtc:DevelopmentAgreementMember 2022-04-01 2022-06-30 0001500198 nmtc:DevelopmentAgreementMember 2021-04-01 2021-06-30 0001500198 nmtc:DevelopmentAgreementMember 2021-10-01 2022-06-30 0001500198 nmtc:DevelopmentAgreementMember 2020-10-01 2021-06-30 0001500198 us-gaap:ProductMember 2022-04-01 2022-06-30 0001500198 us-gaap:ProductMember 2021-10-01 2022-06-30 0001500198 us-gaap:ProductMember 2021-04-01 2021-06-30 0001500198 us-gaap:ProductMember 2020-10-01 2021-06-30 0001500198 nmtc:PaulsonPrivatePlacementTwoThousandNineteenMember 2019-11-01 0001500198 2019-12-03 0001500198 2020-11-01 0001500198 2019-11-25 2019-12-03 0001500198 us-gaap:StockOptionMember 2022-04-01 2022-06-30 0001500198 us-gaap:StockOptionMember 2021-04-01 2021-06-30 0001500198 pf0:BoardOfDirectorsChairmanMember 2022-04-01 2022-06-30 0001500198 pf0:BoardOfDirectorsChairmanMember 2021-04-01 2021-06-30 0001500198 us-gaap:EmployeeStockOptionMember 2021-04-01 2021-06-30 0001500198 us-gaap:EmployeeStockOptionMember 2020-10-01 2021-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2022-04-01 2022-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2021-10-01 2022-06-30 0001500198 pf0:MinimumMember us-gaap:RestrictedStockUnitsRSUMember 2021-10-01 2022-06-30 0001500198 pf0:MaximumMember us-gaap:RestrictedStockUnitsRSUMember 2021-10-01 2022-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2021-04-01 2021-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2022-01-01 2022-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-06-30 0001500198 us-gaap:RestrictedStockUnitsRSUMember 2020-10-01 2021-06-30 0001500198 2021-04-01 2021-04-30 0001500198 nmtc:TwentyTwentyActivityMember 2020-08-01 2020-08-31 0001500198 2021-10-01 2021-10-04 0001500198 nmtc:TwoZeroOneSevenPlanEvergreenProvisionMember 2021-10-01 2022-06-30 0001500198 nmtc:TwoThousandAndSeventeenthEquityIncentivePlanAndInducementPlanMember 2022-06-30 0001500198 us-gaap:GeneralAndAdministrativeExpenseMember 2022-04-01 2022-06-30 0001500198 us-gaap:GeneralAndAdministrativeExpenseMember 2021-04-01 2021-06-30 0001500198 us-gaap:GeneralAndAdministrativeExpenseMember 2021-10-01 2022-06-30 0001500198 us-gaap:GeneralAndAdministrativeExpenseMember 2020-10-01 2021-06-30 0001500198 us-gaap:ResearchAndDevelopmentExpenseMember 2022-04-01 2022-06-30 0001500198 us-gaap:ResearchAndDevelopmentExpenseMember 2021-04-01 2021-06-30 0001500198 us-gaap:ResearchAndDevelopmentExpenseMember 2021-10-01 2022-06-30 0001500198 us-gaap:ResearchAndDevelopmentExpenseMember 2020-10-01 2021-06-30 0001500198 nmtc:StockbasedCompensationExpenseMember 2022-04-01 2022-06-30 0001500198 nmtc:StockbasedCompensationExpenseMember 2021-04-01 2021-06-30 0001500198 nmtc:StockbasedCompensationExpenseMember 2021-10-01 2022-06-30 0001500198 nmtc:StockbasedCompensationExpenseMember 2020-10-01 2021-06-30 0001500198 nmtc:PublicOfferingMember 2021-10-01 2021-10-13 0001500198 nmtc:PublicOfferingMember 2021-10-13 0001500198 nmtc:PublicOfferingMember 2021-10-15 0001500198 nmtc:PurchaseAgreementMember 2021-01-02 2021-01-12 0001500198 nmtc:PurchaseAgreementMember 2021-01-12 0001500198 pf0:MinimumMember 2021-09-30 0001500198 pf0:MaximumMember 2021-09-30 0001500198 pf0:MinimumMember 2022-06-30 0001500198 pf0:MaximumMember 2022-06-30 0001500198 us-gaap:SubsequentEventMember 2022-08-02 xbrli:shares iso4217:USD iso4217:USD xbrli:shares xbrli:pure utr:sqft

Exhibit 4.1

 

NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER ANY STATE SECURITIES OR BLUE SKY LAWS. THE SECURITIES ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AND RESALE AND MAY NOT BE OFFERED, SOLD, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED EXCEPT AS PERMITTED UNDER THE SECURITIES ACT AND APPLICABLE STATE SECURITIES OR BLUE SKY LAWS, PURSUANT TO REGISTRATION OR QUALIFICATION OR EXEMPTION THEREFROM. INVESTORS SHOULD BE AWARE THAT THEY MAY BE REQUIRED TO BEAR THE FINANCIAL RISKS OF THIS INVESTMENT FOR AN INDEFINITE PERIOD OF TIME. THE COMPANY MAY REQUIRE AN OPINION OF COUNSEL IN FORM AND SUBSTANCE REASONABLY SATISFACTORY TO THE COMPANY TO THE EFFECT THAT ANY PROPOSED TRANSFER IS IN COMPLIANCE WITH THE SECURITIES ACT AND ANY APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THIS SECURITY IS SUBJECT TO THE TRANSFER RESTRICTIONS SET FORTH HEREIN AS AMENDED FROM TIME TO TIME, COPIES OF WHICH ARE AVAILABLE WITH THE SECRETARY OF THE COMPANY.

 

NeuroOne Medical Technologies Corporation

 

Warrant to Purchase Common Stock

 

Number of Shares: 350,000 (subject to adjustment)

 

Warrant No. 2022 COM-1 Original Issue Date: August 2, 2022

 

NeuroOne Medical Technologies Corporation, a Delaware corporation (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [Zimmer, Inc., a Delaware corporation] or its registered assigns (the “Holder”), is entitled, subject to the terms set forth below, to purchase from the Company up to a total of 350,000 shares of the Common Stock, $0.001 par value per share (the “Common Stock”), of the Company (each such share, a “Warrant Share” and all such shares, the “Warrant Shares”) at an exercise price per share equal to $3.00 per share (as adjusted from time to time as provided in Section 9 herein, the “Exercise Price”) upon surrender of this Warrant to Purchase Common Stock (including any Warrants to Purchase Common Stock issued in exchange, transfer or replacement hereof, this “Warrant”) at any time and from time to time on or after the six (6) month anniversary of the Original Issue Date (the “Initial Exercise Date”) and through and including the earlier of 5:30 P.M., New York City time, on July [●], 2027 or the expiration or termination of this Warrant as set forth herein (the “Expiration Date”), subject to the following terms and conditions:

 

1. Definitions. For purposes of this Warrant, the following terms shall have the following meanings:

 

(a) Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

 

1

 

 

(b) “Closing Sale Price” means, for any security as of any date, the last trade price for such security on the Principal Trading Market for such security, as reported by Bloomberg L.P., or, if such Principal Trading Market begins to operate on an extended hours basis and does not designate the last trade price, then the last trade price of such security prior to 4:00 P.M., New York City time, as reported by Bloomberg L.P., or if the security is not listed for trading on a Trading Market on the relevant date, the last quoted bid price for the security in the over-the-counter market on the relevant date as reported by OTC Markets Group Inc. (or a similar organization or agency succeeding to its functions of reporting prices). If the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market value as mutually determined by the Company and the Holder. If the Company and the Holder are unable to agree upon the fair market value of such security, then the fair market value shall be determined by an independent qualified appraiser selected mutually by the Company and the Holder and paid for by the Company. The independent qualified appraiser’s determination shall be binding upon all parties absent demonstrable error. All such determinations shall be appropriately adjusted for any stock dividend, stock split, stock combination or other similar transaction during the applicable calculation period.

 

(c) “Commission” and/or “SEC” means the United States Securities and Exchange Commission.

 

(d) “Marketable Securities” means securities meeting all of the following requirements: (i) the issuer thereof is then subject to the reporting requirements of Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is then current in its filing of all required reports and other information under the Securities Act and the Exchange Act; (ii) the class and series of shares or other security of the issuer that would be received by Holder in connection with the Fundamental Transaction (as defined below) were Holder to exercise this Warrant on or prior to the closing thereof is then traded or quoted on a nationally recognized securities exchange, inter-dealer quotation system or over-the-counter market, and (iii) following the closing of such Fundamental Transaction, the Holder would not be restricted from publicly re-selling all of the issuer’s shares and/or other securities that would be received by the Holder in such Fundamental Transaction were the Holder to exercise or convert this Warrant in full on or prior to the closing of such Fundamental Transaction, except to the extent that any such restriction (x) arises solely under applicable securities laws, rules or regulations, and (y) does not extend beyond six (6) months from the closing of such Fundamental Transaction.

 

(e) “Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

(f) “Principal Trading Market” means the Trading Market, if any, on which the Common Stock is primarily listed on and quoted for trading.

 

(g) “Trading Day” means a day on which the Principal Trading Market is open for trading. If the Common Stock is not listed or admitted for trading, “Trading Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in New York City are authorized or required by law or other governmental action to close.

 

2

 

 

(h) “Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York Stock Exchange (or any successors to any of the foregoing).

 

(i) “Transfer Agent” means Action Stock Transfer Corporation, the Company’s transfer agent and registrar for the Common Stock, and any successor appointed in such capacity.

 

2. Warrant Register. The Company shall register ownership of this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder (which shall include the initial Holder or, as the case may be, any assignee to which this Warrant is assigned hereunder) from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

 

3. Registration of Transfers. Subject to compliance with all applicable securities laws, the conditions herein and such reasonable requirements as the Company may require, the Company shall, or will cause the Transfer Agent to, register the transfer of all or any portion of this Warrant in the Warrant Register, upon surrender of this Warrant, and payment for all applicable transfer taxes (if any). Upon any such registration or transfer, a new warrant to purchase Common Stock in substantially the form of this Warrant (any such new warrant, a “New Warrant”) evidencing the portion of this Warrant so transferred shall be issued to the transferee, and a New Warrant evidencing the remaining portion of this Warrant not so transferred, if any, shall be issued to the transferring Holder. The acceptance of the New Warrant by the transferee thereof shall be deemed the acceptance by such transferee of all of the rights and obligations in respect of the New Warrant that the Holder has in respect of this Warrant. The Company shall, or will cause the Transfer Agent to, prepare, issue and deliver at the Company’s own expense any New Warrant under this Section 3. Until due presentment for registration of transfer, the Company may treat the registered Holder hereof as the owner and holder for all purposes, and the Company shall not be affected by any notice to the contrary. This Warrant and the Warrant Shares are and may continue to be subject to resale restrictions and hold periods, and the Holder (and any transferee) should consult its legal advisor in respect of the same. If, at the time of the surrender of this Warrant in connection with any transfer of this Warrant, the transfer of this Warrant shall not be either (i) registered pursuant to an effective registration statement under the Securities Act and under applicable state securities or blue sky laws or (ii) eligible for resale without volume or manner-of-sale restrictions or current public information requirements pursuant to Rule 144, the Company may require, as a condition of allowing such transfer, that the Holder or transferee of this Warrant, as the case may be, provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred portion of this Warrant under the Securities Act. The Holder, by the acceptance hereof, represents and warrants that it is acquiring this Warrant and, upon any exercise hereof, will acquire the Warrant Shares issuable upon such exercise, for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in violation of the Securities Act or any applicable state securities law, except pursuant to sales registered or exempted under the Securities Act.

 

3

 

 

4. Exercise and Duration of Warrant.

 

(a) All or any part of this Warrant shall be exercisable by the registered Holder in any manner permitted by this Warrant at any time and from time to time on or after the Initial Exercise Date and through and including the Expiration Date.

 

(b) The Holder may exercise this Warrant by delivering to the Company an exercise notice, in the form attached as Schedule 1 attached hereto (the “Exercise Notice”), completed and duly signed. Within one (1) Trading Day following the date of delivery of the Exercise Notice, the Holder shall make payment of the Exercise Price for the number of Warrant Shares as to which this Warrant is being exercised (which may take the form of a “cashless exercise” if so indicated in the Exercise Notice pursuant to Section 10 below). The date on which such Exercise Notice is delivered to the Company (as determined in accordance with the notice provisions hereof) is an “Exercise Date”; provided, that if the Exercise Price is not delivered on or before one (1) Trading Day following the date of delivery of the Exercise Notice, the Exercise Date shall be deemed to be one (1) Trading Day following the date of that the Exercise Price is delivered to the Company. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise be required. The Holder shall not be required to deliver the original Warrant in order to effect an exercise hereunder. Execution and delivery of the Exercise Notice shall have the same effect as cancellation of the original Warrant and issuance of a New Warrant evidencing the right to purchase the remaining number of Warrant Shares, if any. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

 

5. Delivery of Warrant Shares. Upon exercise of this Warrant, the Company shall promptly (but in no event later than two (2) Trading Days after the Exercise Date) credit such aggregate number of shares of the Common Stock to which the Holder is entitled pursuant to such exercise in book entry form with the Transfer Agent.

 

6. Charges, Taxes and Expenses. Issuance and delivery of certificates for shares of the Common Stock upon exercise of this Warrant shall be made without charge to the Holder for any issue or transfer tax, fees of the Transfer Agent or other incidental tax or expense (excluding any applicable stamp duties) in respect of the issuance of such certificates, all of which taxes and expenses shall be paid by the Company; provided, however, that the Company shall not be required to pay any tax that may be payable in respect of any transfer involved in the registration of any certificates for Warrant Shares or this Warrant in a name other than that of the Holder or an Affiliate thereof. The Holder shall be responsible for all other tax liability that may arise as a result of holding or transferring this Warrant or receiving Warrant Shares upon exercise hereof.

 

4

 

 

7. Replacement of Warrant. If this Warrant is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation hereof, or in lieu of and substitution for this Warrant, a New Warrant, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction (in such case) and, in each case, a customary and reasonable indemnity and surety bond, if requested by the Company which shall not be required if the Holder provides an affidavit of loss and self-indemnity. Applicants for a New Warrant under such circumstances shall also comply with such other reasonable regulations and procedures and pay such other reasonable third-party costs as the Company may prescribe (for the avoidance of doubt, the Holder shall not be required to pay any costs related to legal counsel for the Company). If a New Warrant is requested as a result of a mutilation of this Warrant, then the Holder shall deliver such mutilated Warrant to the Company as a condition precedent to the Company’s obligation to issue the New Warrant.

 

8. Reservation of Warrant Shares. The Company covenants that it will, at all times while this Warrant is outstanding, reserve and keep available out of the aggregate of its authorized but unissued and otherwise unreserved Common Stock, solely for the purpose of enabling it to issue Warrant Shares upon exercise of this Warrant as herein provided, the number of Warrant Shares that are then issuable and deliverable upon the exercise of this entire Warrant, free from preemptive rights or any other contingent purchase rights of persons other than the Holder (taking into account the adjustments and restrictions of Section 9). The Company covenants that all of the Warrant Shares so issuable and deliverable shall, upon issuance and the payment of the applicable Exercise Price in accordance with the terms hereof, be duly and validly authorized, issued and fully paid and non-assessable. The Company will take all such action as may be reasonably necessary to assure that such shares of the Common Stock may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of any securities exchange or automated quotation system upon which the Common Stock may be listed. The Company further covenants that it will not, without the prior written consent of the Holder, take any actions to increase the par value of the Common Stock at any time while this Warrant is outstanding.

 

9. Certain Adjustments. The Exercise Price and number of Warrant Shares issuable upon exercise of this Warrant are subject to adjustment from time to time as set forth in this Section 9.

 

(a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding, (i) pays a stock dividend on shares of the Common Stock or otherwise makes a distribution on any class of capital stock issued and outstanding on the Original Issue Date and in accordance with the terms of such stock on the Original Issue Date that is payable in shares of the Common Stock, (ii) subdivides its outstanding shares of the Common Stock into a larger number of shares of the Common Stock, (iii) combines its outstanding shares of the Common Stock into a smaller number of shares of the Common Stock or (iv) issues by reclassification of shares of capital stock any additional shares of the Common Stock of the Company, then in each such case the Exercise Price shall be multiplied by a fraction, the numerator of which shall be the number of shares of the Common Stock outstanding immediately before such event and the denominator of which shall be the number of shares of the Common Stock outstanding immediately after such event. Any adjustment made pursuant to clause (i) of this paragraph shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution, provided, however, that if such record date shall have been fixed and such dividend is not fully paid on the date fixed therefor, the Exercise Price shall be recomputed accordingly as of the close of business on such record date and thereafter the Exercise Price shall be adjusted pursuant to this paragraph as of the time of actual payment of such dividends. Any adjustment pursuant to clause (ii) or (iii) of this paragraph shall become effective immediately after the effective date of such subdivision or combination.

 

5

 

 

(b) Pro Rata Distributions. If the Company, at any time while this Warrant is outstanding, distributes to all holders of shares of the Common Stock for no consideration (i) evidences of its indebtedness, (ii) any security (other than a distribution of shares of the Common Stock covered by the preceding paragraph), (iii) rights or warrants to subscribe for or purchase any security, or (iv) cash or any other asset (in each case, a “Distribution”), other than a reclassification as to which Section 9(c) applies, then in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of the Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the ownership limitation set forth in Section 11(a) hereof) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of the Common Stock are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the ownership limitation set forth in Section 11(a) hereof, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any shares of the Common Stock as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until the earlier of (i) such time, if ever, as the delivery to such Holder of such portion would not result in the Holder exceeding the ownership limitation set forth in Section 11(a) hereof and (ii) such time as the Holder has exercised this Warrant.

 

(c) Fundamental Transactions. If, at any time while this Warrant is outstanding (i) the Company effects any merger or consolidation of the Company with or into another Person, in which the Company is not the surviving entity and in which the stockholders of the Company immediately prior to such merger or consolidation do not own, directly or indirectly, at least 50% of the voting power of the surviving entity immediately after such merger or consolidation, (ii) the Company effects any sale to another Person of all or substantially all of its assets in one transaction or a series of related transactions, (iii) pursuant to any tender offer or exchange offer (whether by the Company or another Person), holders of capital stock tender shares representing more than 50% of the voting power of the capital stock of the Company and the Company or such other Person, as applicable, accepts such tender for payment, (iv) the Company consummates a stock purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person whereby such other Person acquires more than the 50% of the voting power of the capital stock of the Company (not including any shares of the Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination and excluding shares acquired upon conversion of any currently outstanding convertible securities in accordance with the terms thereof as in effect on the date hereof) or (v) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than as a result of a subdivision or combination of shares of the Common Stock covered by Section 9(a) above) (in any such case, a “Fundamental Transaction”), then following such Fundamental Transaction the Holder shall have the right to receive, upon exercise of this Warrant, the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of the number of Warrant Shares then issuable upon exercise in full of this Warrant without regard to any limitations on exercise contained herein (the “Alternate Consideration”). The Company shall not effect any Fundamental Transaction in which the Company is not the surviving entity or the Alternate Consideration includes securities of another Person unless (i) the Alternate Consideration is solely cash and the Company provides for the simultaneous “cashless exercise” of this Warrant pursuant to Section 10 below or (ii) prior to or simultaneously with the consummation thereof, any successor to the Company, surviving entity or other Person (including any purchaser of assets of the Company) shall assume the obligation to deliver to the Holder such Alternate Consideration as, in accordance with the foregoing provisions, the Holder may be entitled to receive, and the other obligations under this Warrant. The provisions of this paragraph (c) shall similarly apply to subsequent transactions analogous of a Fundamental Transaction type. Notwithstanding the foregoing, in the event of a Fundamental Transaction where the consideration payable to holders of the Common Stock consists solely of cash, solely of Marketable Securities or a combination of cash and Marketable Securities, then this Warrant shall automatically be deemed to be exercised in full in a “cashless exercise” pursuant to Section 10 below effective immediately prior to and contingent upon the consummation of such Fundamental Transaction.

 

6

 

 

(d) Number of Warrant Shares. Simultaneously with any adjustment to the Exercise Price pursuant to Section 9 (including any adjustment to the Exercise Price that would have been effected but for the final sentence in this paragraph (d)), the number of Warrant Shares that may be purchased upon exercise of this Warrant shall be increased or decreased proportionately, so that after such adjustment the aggregate Exercise Price payable hereunder for the increased or decreased number of Warrant Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment. Notwithstanding the foregoing, in no event may the Exercise Price be adjusted below the par value of the Common Stock then in effect.

 

(e) Calculations. All calculations under this Section 9 shall be made to the nearest one-tenth of one cent or the nearest share, as applicable.

 

(f) Notice of Adjustments. Upon the occurrence of each adjustment pursuant to this Section 9, the Company at its expense will, at the written request of the Holder, promptly compute such adjustment, in good faith, in accordance with the terms of this Warrant and prepare a certificate setting forth such adjustment, including a statement of the adjusted Exercise Price and adjusted number or type of Warrant Shares or other securities issuable upon exercise of this Warrant (as applicable), describing the transactions giving rise to such adjustments and showing in detail the facts upon which such adjustment is based. Upon written request, the Company will promptly deliver a copy of each such certificate to the Holder and to the Transfer Agent.

 

(g) Notice of Corporate Events. If, while this Warrant is outstanding, the Company (i) declares a dividend or any other distribution of cash, securities or other property in respect of its Common Stock, including, without limitation, any granting of rights or warrants to subscribe for or purchase any capital stock of the Company or any subsidiary, (ii) authorizes or approves, enters into any agreement contemplating or solicits stockholder approval for any Fundamental Transaction or (iii) authorizes the voluntary dissolution, liquidation or winding up of the affairs of the Company, then, except if such notice and the contents thereof shall be deemed to constitute material non-public information, the Company shall deliver to the Holder a notice of such transaction at least ten (10) days prior to the applicable record or effective date on which a Person would need to hold Common Stock in order to participate in or vote with respect to such transaction; provided, however, that the failure to deliver such notice or any defect therein shall not affect the validity of the corporate action required to be described in such notice. In addition, if while this Warrant is outstanding, the Company authorizes or approves, enters into any agreement contemplating or solicits stockholder approval for any Fundamental Transaction contemplated by Section 9(c), other than a Fundamental Transaction under clause (iii) of Section 9(c), then the Company shall deliver to the Holder a notice of such Fundamental Transaction at least ten (10) days prior to the date such Fundamental Transaction is consummated. Holder agrees to maintain any information disclosed pursuant to this Section 9(g) in confidence until such information is publicly available, and shall comply with applicable law with respect to trading in the Company’s securities following receipt any such information.

 

10. Payment of Exercise Price. This Warrant shall be exercised for cash; provided, however, that if at the time of exercise hereof there is no effective registration statement registering, or the prospectus contained therein is not available for, the issuance of the Warrant Shares, and there is also no effective registration statement registering the resale by the Holder of the Warrant Shares, then the Holder may, in its sole discretion, satisfy its obligation to pay the Exercise Price through a “cashless exercise”, in which event the Company shall issue to the Holder the number of the Warrant Shares in an exchange of securities effected pursuant to Section 3(a)(9) of the Securities Act, as determined as follows:

 

X = Y [(A-B)/A]

 

where:

 

“X” equals the number of the Warrant Shares to be issued to the Holder;

 

“Y” equals the total number of the Warrant Shares with respect to which this Warrant is then being exercised;

 

“A” equals the Closing Sale Price per share of the Common Stock as of the Trading Day immediately preceding the Exercise Date if the Exercise Notice is delivered prior to market close on the Exercise Date; and

 

“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.

 

7

 

 

For purposes of Rule 144 promulgated under the Securities Act, it is intended, understood and acknowledged that the Warrant Shares issued in a “cashless exercise” transaction shall be deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date this Warrant was originally issued (provided that the Commission continues to take the position that such treatment is proper at the time of such exercise). Except as set forth in Section 12 (payment of cash in lieu of fractional shares), in no event will the exercise of this Warrant be settled in cash.

 

11. Limitations on Exercise.

 

(a) Notwithstanding anything to the contrary contained herein, the Company shall not effect any exercise of this Warrant, and the Holder shall not be entitled to exercise this Warrant for a number of the Warrant Shares in excess of that number of the Warrant Shares which, upon giving effect or immediately prior to such exercise, would cause (i) the aggregate number of shares of the Common Stock beneficially owned by the Holder, its Affiliates and any other Persons whose beneficial ownership of the Common Stock would be aggregated with the Holder’s for purposes of Section 13(d) of the Exchange Act to exceed 4.99% (the “Maximum Percentage”) of the total number of issued and outstanding shares of the Common Stock of the Company following such exercise, or (ii) the combined voting power of the securities of the Company beneficially owned by the Holder and its Affiliates and any other Persons whose beneficial ownership of the Common Stock would be aggregated with the Holder’s for purposes of Section 13(d) of the Exchange Act to exceed 4.99% of the combined voting power of all of the securities of the Company then outstanding following such exercise. For purposes of this Warrant, in determining the number of outstanding shares of the Common Stock, the Holder may rely on the number of outstanding shares of the Common Stock as reflected in (x) the Company’s most recent Form 10-Q or Form 10-K, as the case may be, filed with the Commission prior to the date hereof, (y) a more recent public announcement by the Company or (z) any other notice by the Company or the Transfer Agent setting forth the number of shares of the Common Stock outstanding. Upon the written request of the Holder, the Company shall within three (3) Trading Days confirm in writing or by electronic mail to the Holder the number of shares of the Common Stock then outstanding. In any case, the number of outstanding shares of the Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder since the date as of which such number of outstanding shares of the Common Stock was reported. By written notice to the Company, the Holder may from time to time increase or decrease the Maximum Percentage to any other percentage specified not in excess of 19.99% specified in such notice; provided that any such increase will not be effective until the sixty-first (61st) day after such notice is delivered to the Company. For purposes of this Section 11(a), the aggregate number of shares of the Common Stock or voting securities beneficially owned by the Holder and its Affiliates and any other Persons whose beneficial ownership of the Common Stock would be aggregated with the Holder’s for purposes of Section 13(d) of the Exchange Act shall include the shares of the Common Stock issuable upon the exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of the Common Stock which would be issuable upon (x) exercise of the remaining unexercised and non-cancelled portion of this Warrant by the Holder and (y) exercise or conversion of the unexercised, non-converted or non-cancelled portion of any other securities of the Company that do not have voting power (including without limitation any securities of the Company which would entitle the holder thereof to acquire at any time shares of the Common Stock, including without limitation any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, shares of the Common Stock), is subject to a limitation on conversion or exercise analogous to the limitation contained herein and is beneficially owned by the Holder or any of its Affiliates and other Persons whose beneficial ownership of the Common Stock would be aggregated with the Holder’s for purposes of Section 13(d) of the Exchange Act.

 

8

 

 

(b) This Section 11 shall not restrict the number of shares of the Common Stock which a Holder may receive or beneficially own in order to determine the amount of securities or other consideration that such Holder may receive in the event of a Fundamental Transaction as contemplated in Section 9(c) of this Warrant.

 

12. No Fractional Shares. No fractional Warrant Shares will be issued in connection with any exercise of this Warrant. In lieu of any fractional shares that would otherwise be issuable, the number of Warrant Shares to be issued shall be rounded down to the next whole number and the Company shall pay the Holder in cash the fair market value (based on the Closing Sale Price) for any such fractional shares.

 

13. Notices. Any and all notices or other communications or deliveries hereunder (including, without limitation, any Exercise Notice) shall be in writing and shall be deemed given and effective, whether or not received by the recipient party, on the earliest of (i) the time of transmission, if such notice or communication is delivered via confirmed e-mail prior to 5:30 P.M., New York City time, on a Trading Day, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via confirmed e-mail on a day that is not a Trading Day or later than 5:30 P.M., New York City time, on any Trading Day, (iii) the Trading Day following the date of mailing, if sent by nationally recognized overnight courier service specifying next business day delivery, or (iv) upon actual receipt by the Person to whom such notice is required to be given, if by hand delivery. The addresses and e-mail addresses for such communications shall be:

 

If to the Company:

NeuroOne Medical Technologies Corporation

Attention: CEO

7559 Anagram Drive

Eden Prairie, Minnesota 55344

Email: [*]

 

If to the Holder, notice shall be given to:

 

Zimmer, Inc.

c/o General Manager

Zimmer Biomet CMF and Thoracic LLC

1520 Tradeport Drive

Jacksonville, Florida 32218

Email: [*]

 

9

 

 

Or, in each of the above instances, notice shall be given to such other address or e-mail address as the recipient party has specified by written notice given to each other party.

 

14. Warrant Agent. The Company shall initially serve as warrant agent under this Warrant. Upon ten (10) days’ notice to the Holder, the Company may appoint a new warrant agent. Any corporation into which the Company or any new warrant agent may be merged or any corporation resulting from any consolidation to which the Company or any new warrant agent shall be a party or any corporation to which the Company or any new warrant agent transfers substantially all of its corporate trust or shareholders services business shall be a successor warrant agent under this Warrant without any further act. Any such successor warrant agent shall promptly cause notice of its succession as warrant agent to be mailed (by first class mail, postage prepaid) to the Holder at the Holder’s last address as shown on the Warrant Register.

 

15. Miscellaneous.

 

(a) No Rights as a Stockholder. The Holder, solely in such Person’s capacity as a holder of this Warrant, shall not be entitled to vote or receive dividends or be deemed the holder of share capital of the Company for any purpose, nor shall anything contained in this Warrant be construed to confer upon the Holder, solely in such Person’s capacity as the Holder of this Warrant, any of the rights of a stockholder of the Company or any right to vote, give or withhold consent to any corporate action (whether any reorganization, issue of stock, reclassification of stock, consolidation, merger, amalgamation, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or otherwise, prior to the issuance to the Holder of the Warrant Shares which such Person is then entitled to receive upon the due exercise of this Warrant. In addition, nothing contained in this Warrant shall be construed as imposing any liabilities on the Holder to purchase any securities (upon exercise of this Warrant or otherwise) or as a stockholder of the Company, whether such liabilities are asserted by the Company or by creditors of the Company.

 

(b) Authorized Shares. Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate or articles of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and non-assessable Warrant Shares upon the exercise of this Warrant, and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof as may be necessary to enable the Company to perform its obligations under this Warrant.

 

10

 

 

(c) Successors and Assigns. Subject to compliance with applicable securities laws, this Warrant may be assigned by the Holder. This Warrant may not be assigned by the Company without the written consent of the Holder, except to a successor in the event of a Fundamental Transaction. This Warrant shall be binding on and inure to the benefit of the Company and the Holder and their respective successors and assigns. Subject to the preceding sentence, nothing in this Warrant shall be construed to give to any Person other than the Company and the Holder any legal or equitable right, remedy or cause of action under this Warrant. This Warrant may be amended only in writing signed by the Company and the Holder, or their successors and assigns.

 

(d) Amendment and Waiver. Except as otherwise provided herein, the provisions of the Warrant may be amended and the Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the Company has obtained the written consent of the Holder.

 

(e) Acceptance. Receipt of this Warrant by the Holder shall constitute acceptance of and agreement to all of the terms and conditions contained herein.

 

(f) Governing Law; Jurisdiction. ALL QUESTIONS CONCERNING THE CONSTRUCTION, VALIDITY, ENFORCEMENT AND INTERPRETATION OF THIS WARRANT SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES OF CONFLICTS OF LAW THEREOF. EACH OF THE COMPANY AND THE HOLDER HEREBY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING IN THE CITY OF NEW YORK, BOROUGH OF MANHATTAN, FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR WITH ANY TRANSACTION CONTEMPLATED HEREBY OR DISCUSSED HEREIN (INCLUDING WITH RESPECT TO THE ENFORCEMENT OF ANY OF THE TRANSACTION DOCUMENTS), AND HEREBY IRREVOCABLY WAIVES, AND AGREES NOT TO ASSERT IN ANY SUIT, ACTION OR PROCEEDING, ANY CLAIM THAT IT IS NOT PERSONALLY SUBJECT TO THE JURISDICTION OF ANY SUCH COURT. EACH OF THE COMPANY AND THE HOLDER HEREBY IRREVOCABLY WAIVES PERSONAL SERVICE OF PROCESS AND CONSENTS TO PROCESS BEING SERVED IN ANY SUCH SUIT, ACTION OR PROCEEDING BY MAILING A COPY THEREOF VIA REGISTERED OR CERTIFIED MAIL OR OVERNIGHT DELIVERY (WITH EVIDENCE OF DELIVERY) TO SUCH PERSON AT THE ADDRESS IN EFFECT FOR NOTICES TO IT AND AGREES THAT SUCH SERVICE SHALL CONSTITUTE GOOD AND SUFFICIENT SERVICE OF PROCESS AND NOTICE THEREOF. NOTHING CONTAINED HEREIN SHALL BE DEEMED TO LIMIT IN ANY WAY ANY RIGHT TO SERVE PROCESS IN ANY MANNER PERMITTED BY LAW. EACH OF THE COMPANY AND THE HOLDER HEREBY WAIVES ALL RIGHTS TO A TRIAL BY JURY.

 

(g) Headings. The headings herein are for convenience only, do not constitute a part of this Warrant and shall not be deemed to limit or affect any of the provisions hereof.

 

(h) Severability. In case any one or more of the provisions of this Warrant shall be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Warrant shall not in any way be affected or impaired thereby, and the Company and the Holder will attempt in good faith to agree upon a valid and enforceable provision which shall be a commercially reasonable substitute therefor, and upon so agreeing, shall incorporate such substitute provision in this Warrant.

 

Signatures on the Following Page

 

11

 

 

In Witness Whereof, the Company has caused this Warrant to be duly executed by its authorized officer as of the date first indicated above.

 

  NeuroOne Medical Technologies Corporation
     
  By:                           
  Name:  Dave Rosa
  Title: Chief Executive Officer and President

 

 

 

SCHEDULE 1
FORM OF EXERCISE NOTICE

 

[To be executed by the Holder to purchase shares of the Common Stock under the Warrant]

 

Ladies and Gentlemen:

 

(1) The undersigned is the Holder of Warrant No. ___ (the “Warrant”) issued by NeuroOne Medical Technologies Corporation, a Delaware corporation (the “Company”). Capitalized terms used herein and not otherwise defined herein have the respective meanings set forth in the Warrant.

 

(2) The undersigned hereby exercises its right to purchase ______________ Warrant Shares pursuant to the Warrant.

 

(3) The Holder intends that payment of the Exercise Price shall be made as (check one):

 

Cash Exercise

“Cashless Exercise” under Section 10 of the Warrant

 

(4) If the Holder has elected a Cash Exercise, the Holder shall pay the sum of $ in immediately available funds to the Company in accordance with the terms of the Warrant.

 

(5) Pursuant to this Exercise Notice, the Company shall deliver to the Holder Warrant Shares determined in accordance with the terms of the Warrant. The Warrant Shares shall be delivered in book entry form.

 

(6) By its delivery of this Exercise Notice, the undersigned represents and warrants to the Company that in giving effect to the exercise evidenced hereby the Holder will not beneficially own in excess of the number of shares of the Common Stock (as determined in accordance with Section 13(d) of the Securities Exchange Act of 1934, as amended) permitted to be owned under Section 11(a) of the Warrant to which this notice relates.

 

  Dated:  
  Name of Holder:   
  By:  
  Name:  
  Title:  
  Address:  
     
     
  SSN/EIN:   

 

(Signature must conform in all respects to name of Holder as specified on the face of the Warrant)

 

 

 

 

Exhibit 10.1

 

SECOND AMENDMENT TO

EXCLUSIVE DEVELOPMENT AND DISTRIBUTION AGREEMENT

 

THIS SECOND AMENDMENT TO EXCLUSIVE DEVELOPMENT AND DISTRIBUTION AGREEMENT (this “Amendment”) is made as of this 28th day of June, 2022, with an effective date of July 1, 2022 (“Effective Date”), between Zimmer, Inc., a Delaware corporation (“Zimmer”), and NeuroOne Medical Technologies Corporation, a Delaware corporation (the “Company”). Zimmer and the Company are referred to individually as a “Party” and together as the “Parties”.

 

WHEREAS, on or about July 20, 2020, the Parties entered into a written Exclusive Development and Distribution Agreement (the “Agreement”); and

 

WHEREAS, the Parties have agreed to amend the Agreement consistent with the terms herein.

 

In consideration of the mutual covenants and agreements contained in the Agreement and this Amendment, the Parties hereby agree as follows:

 

1.As of the Effective Date of this Amendment, the Parties agree that the transfer price for each Product as set forth in Section 6.2 shall be amended to the pricing set forth in Exhibit F attached hereto and Exhibit F attached to the Agreement is hereby deleted in its entirety and replaced with Exhibit F attached hereto.

 

Unless otherwise defined herein, capitalized terms shall have the meanings set forth in the Agreement. The terms of this Amendment amend and modify the Agreement as if fully set forth in the Agreement. If there is any conflict between the terms, conditions and obligations of this Amendment and the Agreement, this Amendment’s terms, conditions and obligations shall control. All other provisions of the Agreement not specifically modified by this Amendment are preserved. This Amendment may be executed in counterparts (including via facsimile or .pdf), each of which shall be deemed an original, and all of which together shall constitute one and the same document.

 

1

 

 

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment as of the Effective Date.

 

Neuroone Medical Technologies Corporation   Zimmer, Inc.
     
By: /s/ Dave Rosa   By: /s/ Brian Hatcher
Name: Dave Rosa   Name:  Brian Hatcher
Title: CEO   Title: President, CMFT, Trauma, FNA

 

2

 

 

EXHIBIT F

AVERAGE SELLING PRICES/TRANSFER PRICES

 

 

Exhibit F-1 

 

 

Exhibit 10.2

 

THIRD AMENDMENT TO

EXCLUSIVE DEVELOPMENT AND DISTRIBUTION AGREEMENT

 

THIS THIRD AMENDMENT TO EXCLUSIVE DEVELOPMENT AND DISTRIBUTION AGREEMENT (this “Amendment”) is entered into as of August 2, 2022 (the “Effective Date”), by and between Zimmer, Inc., a Delaware corporation (“Zimmer”), and NeuroOne Medical Technologies Corporation, a Delaware corporation (the “Company”). Zimmer and the Company are referred to individually as a “Party” and together as the “Parties.”

 

WHEREAS, on or about July 20, 2020, the Parties entered into a written Exclusive Development and Distribution Agreement, as subsequently amended (collectively the “Agreement”); and

 

WHEREAS, the Parties have agreed to amend the Agreement consistent with the terms herein.

 

In consideration of the mutual covenants and agreements contained in the Agreement and this Amendment, the Parties hereby agree as follows:

 

1.Zimmer shall pay Company the amount of three million, five hundred thousand dollars ($3,500,000) within ten (10) business days of the execution of this Amendment (the “Payment”).   The Payment is comprised of the following:

 

a)One million, five hundred thousand dollars ($1,500,000) for the SEEG Exclusivity Maintenance Fee; and

 

b)Two million dollars ($2,000,000) for satisfaction of each of the Events set forth in Sections 6.1(c)(i)-(iv) even though the satisfaction was after the deadlines identified in the tables set forth in Section 6.1(c).

 

Upon receipt by the Company of the Payment, the Company acknowledges and agrees that: (a) Zimmer has satisfied its payment obligations associated with exclusivity right pursuant to the Agreement and that the Company shall not be entitled to any additional payments from Zimmer for exclusivity, including pursuant to Section 6.1 of the Agreement or any other related provision(s); and (b) Zimmer’s distribution rights as set forth in the terms and conditions of the Agreement shall be exclusive pursuant to the terms and conditions of Section 6.1(b) of the Agreement in exchange for the Payment. Zimmer acknowledges and agrees that pursuant to Section 6.1(e) of the Agreement, the Payment is non-refundable.

 

2.In consideration of the above, Paragraph 10.2 of the Agreement shall be superseded and replaced with the following:

 

10.2 Term of Exclusivity.

 

The license rights granted to Zimmer under the Strip/Grid Distribution License and SEEG Distribution License shall be exclusive from the Effective Date until the end of the Term.

 

Unless otherwise defined herein, capitalized terms shall have the meanings set forth in the Agreement. The terms of this Amendment amend and modify the Agreement as if fully set forth in the Agreement. If there is any conflict between the terms, conditions and obligations of this Amendment and the Agreement, this Amendment’s terms, conditions and obligations shall control. All other provisions of the Agreement not specifically modified by this Amendment are preserved. This Amendment may be executed in counterparts (including via facsimile or .pdf), each of which shall be deemed an original, and all of which together shall constitute one and the same document.

 

 

 

 

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment as of the Effective Date.

 

Neuroone Medical Technologies Corporation   Zimmer, Inc.
     
By: /s/ Dave Rosa                    By: /s/ Chad F. Phipps
Name: David Rosa   Name:  Chad F. Phipps
Title: CEO   Title: SVP, General Counsel & Secretary

  

 

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO EXCHANGE ACT RULE 13a-14(a) OR 15d-14(a), AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

 

I, David Rosa, certify that:

 

1.I have reviewed this Quarterly Report on Form 10-Q of NeuroOne Medical Technologies Corporation for the period ended June 30, 2022;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):

 

(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 11, 2022 /s/ David Rosa
  Name:  David Rosa
  Title: Chief Executive Officer
    (Principal Executive Officer)  

 

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO EXCHANGE ACT RULE 13a-14(a) OR 15d-14(a), AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

 

I, Ronald McClurg, certify that:

 

1.I have reviewed this Quarterly Report on Form 10-Q of NeuroOne Medical Technologies Corporation for the period ended June 30, 2022;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):

 

(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 11, 2022 /s/ Ronald McClurg
  Name:  Ronald McClurg
  Title: Chief Financial Officer
    (Principal Financial Officer)  

 

Exhibit 32.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER,

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002*

 

Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code, David Rosa, Chief Executive Officer of NeuroOne Medical Technologies Corporation (the “Company”) hereby certifies that, to the best of his knowledge:

 

1.The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2022, to which this Certification is attached as Exhibit 32.1 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

 

2.The information contained in the Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Report and results of operations of the Company for the period covered by the Report.

 

Dated: August 11, 2022 /s/ David Rosa
  David Rosa
  Chief Executive Officer
  (Principal Executive Officer)

 

 

*This certification accompanies the report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of NeuroOne Medical Technologies Corporation under the Securities Act of 1933, as amended, or the Exchange Act made before or after the date of the report, irrespective of any general incorporation language contained in such filing.

  

Exhibit 32.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER,

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002*

 

Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code, Ronald McClurg, Chief Financial Officer of NeuroOne Medical Technologies Corporation (the “Company”) hereby certifies that, to the best of his knowledge:

 

1.The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2022, to which this Certification is attached as Exhibit 32.2 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

 

2.The information contained in the Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Report and results of operations of the Company for the period covered by the Report.

 

Dated: August 11, 2022 /s/ Ronald McClurg
  Ronald McClurg
  Chief Financial Officer
  (Principal Financial Officer)

 

 

*This certification accompanies the report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of NeuroOne Medical Technologies Corporation under the Securities Act of 1933, as amended, or the Exchange Act made before or after the date of the report, irrespective of any general incorporation language contained in such filing.