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 March 31, 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 May 11, 2022 was 16,193,467.

 

 

 

 

 

 

NEUROONE MEDICAL TECHNOLOGIES CORPORATION

FORM 10-Q

 

INDEX

 

      Page
  PART 1 – FINANCIAL INFORMATION   1
       
Item 1. Financial Statements   1
  Condensed Balance Sheets as of March 31, 2022 (unaudited) and September 30, 2021   1
  Condensed Statements of Operations for the three and six months ended March 31, 2022 and 2021 (unaudited)   2
  Condensed Statements of Changes in Stockholders’ Equity for the three and six months ended March 31, 2022 and 2021 (unaudited)   3
  Condensed Statements of Cash Flows for the six months ended March 31, 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   23
Item 3. Quantitative and Qualitative Disclosures About Market Risk   36
Item 4. Controls and Procedures   36
       
  PART II – OTHER INFORMATION    
       
Item 1. Legal Proceedings   37
Item 1A. Risk Factors   37
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   37
Item 3. Defaults Upon Senior Securities   37
Item 4. Mine Safety Disclosures   37
Item 5. Other Information   37
Item 6. Exhibits   38
       
SIGNATURES   39

 

i

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

NeuroOne Medical Technologies Corporation

Condensed Balance Sheets

 

    As of March 31,
2022
    As of September 30,
2021
 
    (unaudited)        
Assets            
Current assets:            
Cash   $ 12,869,091     $ 6,901,346  
Accounts receivable     36,584       48,336  
Inventory     221,903       98,287  
Prepaid and other assets     315,099       244,043  
Total current assets     13,442,677       7,292,012  
Intangible assets, net     123,049       134,207  
Right-of-use assets     236,043       288,948  
Property and equipment, net     286,954       223,329  
Total assets   $ 14,088,723     $ 7,938,496  
                 
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable   $ 446,024     $ 528,829  
Accrued expenses     361,959       644,249  
Deferred revenue     2,248       8,622  
Total current liabilities     810,231       1,181,700  
Operating lease liabilities     156,043       202,895  
Total liabilities     966,274       1,384,595  
                 
Commitments and contingencies (Note 4)    
 
     
 
 
                 
Stockholders’ equity:                
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2022 and September 30, 2021; no shares issued or outstanding as of March 31, 2022 and September 30, 2021.    
     
 
Common stock, $0.001 par value; 100,000,000 shares authorized as of March 31, 2022 and September 30, 2021; 16,191,169 and 12,010,019 shares issued and outstanding as of March 31, 2022 and September 30, 2021, respectively.     40,015       35,834  
Additional paid–in capital     59,775,175       47,345,266  
Accumulated deficit     (46,692,741 )     (40,827,199 )
Total stockholders’ equity     13,122,449       6,553,901  
Total liabilities and stockholders’ equity   $ 14,088,723     $ 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
Six Months Ended
 
    March 31,     March 31,  
    2022     2021     2022     2021  
Product revenue   $ 36,584     $ 18,240     $ 70,332     $ 89,714  
Cost of product revenue     72,807       39,363       119,651       148,494  
Product gross profit (loss)     (36,223 )     (21,123 )     (49,319 )     (58,780 )
                                 
Collaborations revenue    
      20,113       6,374       42,387  
                                 
Operating expenses:                                
Selling, general and administrative     1,818,207       1,313,252       3,560,348       2,507,112  
Research and development     1,205,380       1,081,429       2,265,842       2,015,587  
Total operating expenses     3,023,587       2,394,681       5,826,190       4,522,699  
Loss from operations     (3,059,810 )     (2,395,691 )     (5,869,135 )     (4,539,092 )
Interest expense    
     
     
      (3,053 )
Net valuation change of instruments measured at fair value    
     
     
      1,974  
Other income     1,743       1,775       3,593       186,775  
Loss before income taxes     (3,058,067 )     (2,393,916 )     (5,865,542 )     (4,353,396 )
Provision for income taxes    
     
     
     
 
Net loss   $ (3,058,067 )   $ (2,393,916 )   $ (5,865,542 )   $ (4,353,396 )
                                 
Net loss per share:                                
Basic and diluted   $ (0.19 )   $ (0.21 )   $ (0.37 )   $ (0.46 )
Number of shares used in per share calculations:                                
Basic and diluted     16,189,867       11,238,084       15,794,880       9,419,599  

 

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     $ 22,181     $ 32,923,022     $ (30,879,031 )   $ 2,066,172  
Issuance of common stock upon conversion of convertible notes     292,754       878       1,004,354      
      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       31       (31 )    
       
Net loss          
     
      (1,959,480 )     (1,959,480 )
Balance at December 31, 2020     7,696,841       23,090       34,223,574       (32,838,511 )     1,408,153  
                                         
Issuance of common stock in connection with private placement     4,166,682       12,500       8,816,736             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       120       212,379             212,499  
Exercise of stock options     758       2       4,996             4,998  
Issuance of common stock upon vesting of restricted stock units     6,131       18       (18 )            
Net loss                       (2,393,916 )     (2,393,916 )
Balance at March 31, 2021     11,910,317     $ 35,730     $ 46,056,710     $ (35,232,427 )   $ 10,860,013  
                                         
Balance at September 30, 2021     12,010,019     $ 35,834     $ 47,345,266     $ (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     $ 40,012     $ 59,542,462     $ (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     $ 40,015     $ 59,775,175     $ (46,692,741 )   $ 13,122,449  

 

See accompanying notes to condensed financial statements

 

3

 

 

NeuroOne Medical Technologies Corporation

Condensed Statements of Cash Flows

(unaudited)

 

    For the
six months ended
March 31,
 
    2022     2021  
Operating activities            
Net loss   $ (5,865,542 )   $ (4,353,396 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Amortization and depreciation     53,692       38,030  
Stock-based compensation     435,788       572,188  
Issuance costs attributed to financing activities    
      3,053  
Revaluation of convertible notes    
      (1,974 )
Non-cash lease expense     52,905       26,802  
Change in assets and liabilities:                
Accounts receivable     11,752      
 
Inventory     (123,616 )    
 
Prepaid and other assets     (163,990 )     37,585  
Accounts payable     33,800       (444,197 )
Accrued expenses, deferred revenue, operating leases and other liabilities     (335,516 )     (162,193 )
Net cash used in operating activities     (5,900,727 )     (4,284,102 )
Investing activities                
Purchase of fixed assets     (154,810 )     (2,059 )
Net cash used in investing activities     (154,810 )     (2,059 )
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    
      212,499  
Exercise of stock options    
      4,998  
Issuance costs related to public offering and private placements     (1,327,300 )     (1,190,495 )
Net cash provided by financing activities     12,023,282       11,523,949  
Net increase in cash     5,967,745       7,237,788  
Cash at beginning of period     6,901,346       4,036,397  
Cash at end of period   $ 12,869,091     $ 11,274,185  
                 
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   $
    $ 57,985  
Reclass of deferred offering costs to additional paid-in capital in connection with public offering   $ 24,980     $
 
Purchased fixed assets in accounts payable and accrued expenses   $
    $ 19,869  

 

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.

 

COVID-19

 

On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) as a global pandemic. As a result of the COVID-19 pandemic, the Company has experienced, and will likely continue to experience, delays and disruptions in its pre-clinical and clinical trials, as well as interruptions in its manufacturing, supply chain, shipping, and research and development operations. 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 extent to which the COVID-19 pandemic and macroeconomic conditions may further impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as global supply chain disruptions, the duration of the pandemic and the impact of variants, travel restrictions and social distancing in the U.S. and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S. and other countries to contain and treat the disease.

 

Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, the continuing impact of the pandemic 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.

 

In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.

 

5

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Reverse Stock Split

 

On 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 (the “Reverse Stock Split”) effective end-of-day March 31, 2021.

 

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 authorized shares and par value 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 $46.7 million as of March 31, 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”.

 

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.

 

6

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 March 31, 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 six months ended March 31, 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 six months ended March 31, 2021. There were no convertible notes outstanding during the six months ended March 31, 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 – March 31, 2021   $
 

 

Intellectual Property

 

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

 

8

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

Property and Equipment

 

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

 

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.

 

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.

 

9

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 six months ended March 31, 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 six months ended March 31, 2022 and 2021:

 

    2022     2021  
Warrants     6,753,444       7,514,949  
Stock options     1,162,059       1,103,609  
Restricted stock units     359,394       10,326  

 

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.

 

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.

 

10

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 March 31, 2022 and 2021, $37,500 and $25,000 in royalty fees were incurred related to the WARF License, respectively. During the six months ended March 31, 2022 and 2021, $62,500 and $75,000 in royalty fees were incurred related to the WARF License, respectively. The royalty fees were reflected as a component of cost of product revenue.

 

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 March 31, 2022 and 2021, $1,097 and $547 in royalty fees were incurred related to the Mayo Agreement, respectively. During the six months ended March 31, 2022 and 2021, $1,836 and $2,691 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.

 

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.

   

12

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 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.

 

Trial has been postponed from December 2021 to August of 2022. The Company intends to continue to defend itself vigorously and to continue to aggressively prosecute its affirmative counterclaim against PMT. The outcome of any claim against the Company by PMT was not estimable 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.

 

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 six months ended March 31, 2022, rent expense associated with the facility leases amounted to $43,085 and $86,130, respectively. During the three and six months ended March 31, 2021, rent expense associated with the facility leases amounted to $31,800 and $61,261, respectively.

 

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

   

    For the
six months ended
March 31,
 
    2022     2021  
Cash paid for amounts included in the measurement of lease liability:            
Operating cash flows from operating leases   $ 64,871     $ 38,462  
Right-of-use assets obtained in exchange for lease obligations:                
Operating leases   $
    $
 

 

13

 

  

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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

 

    As of
March 31,
2022
    As of
September 30,
2021
 
             
Right-of-use assets   $ 236,043     $ 288,948  
                 
Lease liabilities   $ 260,669     $ 315,673  
                 
Weighted average remaining lease term (years)     2.7       3.1  
Weighted average discount rate     6.8 %     6.7 %

 

Maturity of the lease liabilities was as follows:

 

Calendar Year   As of
March 31,
2022
 
2022   $ 98,785  
2023     82,333  
2024     84,391  
2025     21,227  
Total lease payments     286,736  
Less imputed interest     (26,067 )
Total     260,669  
Short-term portion     (104,626 )
Long-term portion   $ 156,043  

 

NOTE 5 – Supplemental Balance Sheet Information

 

Prepaid and Other Assets

 

Prepaid and other assets consisted of the following:

 

   

As of

March 31, 2022

   

As of

September 30, 2021

 
Prepaid expenses   $ 315,099     $ 151,109  
Deferred offering costs    
      92,934  
Total   $ 315,099     $ 244,043  

 

Intangibles

 

Intangible assets rollforward is as follows:

 

    Useful Life      
Net Intangibles, September 30, 2021   12-13 years   $ 134,207  
Less: amortization         (11,158 )
Net Intangibles, March 31, 2022       123,049  

 

Amortization expense was $5,579 and $11,158 for the three and six months ended March 31, 2022, respectively, and $5,579 and $11,158 for the three and six months ended March 31, 2021, respectively.

 

14

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Property and Equipment, Net

 

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

 

    As of
March 31, 2022
    As of
September 30,
2021
 
Equipment and furniture   $ 417,645     $ 311,486  
Software     1,895       1,895  
Total property and equipment     419,540       313,381  
Less accumulated depreciation     (132,586 )     (90,052 )
Property and equipment, net   $ 286,954     $ 223,329  

 

Depreciation expense was $22,952 and $42,534 for the three months and six months ended March 31, 2022, respectively, and $13,715 and $26,872 for the three and six months ended March 31, 2021, respectively.

 

NOTE 6 - Accrued Expenses and Other Liabilities

 

Accrued expenses consisted of the following at March 31, 2022 and September 30, 2021:

 

    As of
March  31,
2022
    As of
September 30,
2021
 
Accrued payroll   $ 188,735     $ 376,236  
Operating lease liability, short term     104,626       112,778  
Royalty Payments     38,598       72,083  
Other     30,000       83,152  
Total   $ 361,959     $ 644,249  

  

NOTE 7 – Zimmer Development Agreement

 

On July 20, 2020, the Company entered into an exclusive development and distribution agreement (the “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 Development Agreement through a joint development committee composed of an equal number of representatives of Zimmer and the Company.

 

Under the terms of the 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 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 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 Development Agreement) for such Product.

 

15

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Pursuant to the 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 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 Development Agreement) by April 30, 2021 - $500,000

 

If Zimmer timely delivers a Design Modification Notice to the Company under the 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 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 Development Agreement shall not be deemed to be met if FDA Approval for the SEEG Products is not received prior to the applicable deadline.

  

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 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.

 

16

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

The 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 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 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 March 31, 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 $20,113 during the three month periods ended March 31, 2022 and 2021, respectively, and $6,374 and $42,387 during the six month periods ending March 31, 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 six months ended as of March 31, 2022 and 2021:

 

    2022     2021  
Deferred Revenue            
Balance as of beginning of period – September 30   $ 8,622     $ 73,434  
Revenue recognized     (6,374 )     (42,387 )
Balance as of end of period – March 31   $ 2,248     $ 31,047  

 

The remaining performance obligations reflected in deferred revenue as of March 31, 2022 are expected to be completed in the second half of fiscal year 2022.

 

Product Revenue

 

Product revenue related to its Strip/Grid Products, SEEG Products and Electrode Cable Assembly Products. Product revenue recognized during the three and six month periods ended March 31, 2022 was $36,584 and $70,332, respectively. Product revenue recognized during the three and six month periods ended March 31, 2021 was $18,240 and $89,714, 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 $113,197 and $174,532 for the three and six month periods ended March 31, 2022, respectively. Total advertising expense amounted to $113,140 and $142,147 for the three and six month periods ended March 31, 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.

 

17

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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 Date The 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 Terms The 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.

 

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 six month period ended March 31, 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 six month period ended March 31, 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 six months ended March 31, 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.

 

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NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Issuance costs during the six month period ended March 31, 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 six month periods ended March 31, 2022 and 2021, stock-based compensation expense related to stock-based awards was included in general and administrative and research and development costs as follows in the accompanying condensed statements of operations.

 

    Three Months Ended     Six Months Ended  
    March 31,     March 31,  
    2022     2021     2022     2021  
General and administrative   $ 194,874     $ 253,586     $ 357,875     $ 435,379  
Research and development     37,842       72,773       77,913       136,809  
Total stock-based compensation expense   $ 232,716     $ 326,359     $ 435,788     $ 572,188  

 

Stock Options

 

During the three month periods ended March 31, 2022 and 2021, under the 2017 Equity Incentive Plan (the “2017 Plan”), the Company granted 60,000 and 580,002 stock options, respectively, to its officers and employees. During the six month periods ended March 31, 2022 and 2021, the Company granted 62,000 and 621,671, 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 March 31, 2022 and 2021 was $1.00 and $3.02 per share, respectively. The grant date fair value of the grants issued during the six month periods ended March 31, 2022 and 2021 was $1.03 and $2.92 per share, respectively.

 

The total expense for the three months ended March 31, 2022 and 2021 related to stock options was $145,421 and $217,466, respectively. The total expense for the six months ended March 31, 2022 and 2021 related to stock options was $307,782 and $317,612, respectively. The total number of stock options outstanding as of March 31, 2022 and September 30, 2021 was 1,162,059 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 six month period ended March 31, 2022 and 2021:

 

    Three Months Ended     Six Months Ended  
    March 31,     March 31,  
    2022     2021     2022     2021  
Expected stock price volatility   53.5 %   56.0 %   53.5 %   55.9 %
Expected life of options (years)     6.1       6.1       6.1       6.0  
Expected dividend yield     0 %     0 %     0 %     0 %
Risk free interest rate     1.6 %     0.6 %     1.6 %     0.6 %

 

During the three month periods ended March 31, 2022 and 2021, 182,217 and 34,752 stock options vested, respectively, and 9,167 and 10,146 stock options were forfeited during these periods, respectively. During the six month periods ended March 31, 2022 and 2021, 201,060 and 106,527 stock options vested, respectively and 22,501 and 10,146 stock options were forfeited during these periods, respectively. During the three and six months ended March 31, 2021, 758 stock options were exercised with an intrinsic value of $955. No options were exercised during the three and six months ended March 31, 2022.

 

19

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

Restricted Stock Units

 

During the three and six months ended March 31, 2022, the Company granted an aggregate of 355,950 restricted stock units (“RSUs”) to certain officers and employees under the 2017 Plan. The weighted average grant date fair value of the RSU granted during the three and six months ended March 31, 2022 was $2.10 per unit. The RSUs vest over a three year period with 50 percent vesting on the first anniversary of the grant date and 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.  No RSUs were granted during the three and six month periods ended March 31, 2021.

 

During the three months ended March 31, 2022 and 2021, 3,444 and 7,992 RSUs vested, respectively, and no RSUs were forfeited during these periods. During the six months ended March 31, 2022 and 2021, 9,088 and 16,376 RSUs vested, respectively, and no RSUs were forfeited during these periods. The total expense for the three months ended March 31, 2022 and 2021 related to these RSUs was $87,295 and $40,493, respectively. The total expense for the six months ended March 31, 2022 and 2021 related to these RSUs was $128,006 and $83,576, respectively.

 

Other Stock-Based Awards

 

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 vested over a six-month period. As of March 31, 2021, 40,000 shares were vested under this agreement of which 13,334 and 33,334 shares vested during the three and six month periods ended March 31, 2021, respectively. Compensation expense related to the stock award granted under this consulting agreement amounted to $68,400 and $171,000 for the three and six months ended March 31, 2021, respectively, and was included in the total stock-based compensation expense.

 

No other stock-based awards were issued during the three and six month periods ended March 31, 2022 and no expense associated with stock awards was recorded during the three and six months ended March 31, 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.

 

20

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

General

 

As of March 31, 2022, 1,880,777 shares were available in the aggregate for future issuance under the 2017 Plan and Inducement Plan. No shares were available for future issuance under the 2016 Equity Incentive Plan. Unrecognized stock-based compensation was $2,035,046 as of March 31, 2022. The unrecognized share-based expense is expected to be recognized over a weighted average period of 2.6 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 March 31, 2022, the Company had no deposits in excess of federally insured amounts.

 

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 six months ended March 31, 2022 and 2021 was zero percent. As a result of the analysis of all available evidence as of March 31, 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 six months ended March 31, 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

 

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.

 

21

 

 

NeuroOne Medical Technologies Corporation

Notes to Condensed Financial Statements

(unaudited)

 

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. The 2021 Private Placement closed on January 14, 2021.

 

Warrant Activity and Summary

 

The following table summarizes warrant activity during the six month period ended March 31, 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 March 31, 2022     6,753,444     $ 5.25-$9.00     $ 6.14       3.07  

 

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 March 31, 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 six year period beginning on the second anniversary of an employee’s date of hire. Discretionary profit sharing contributions vest over a five year period beginning on the first anniversary of an employee’s date of hire. The amount of matching contributions to the 401K Plan to satisfy certain non-discrimination tests was $30,697 and $14,803 during the three and six month periods ending March 31, 2022 and 2021, respectively.

 

NOTE 14 – Subsequent Events

 

TBD 

 

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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 resulting 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;

 

23

 

 

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

 

our future commercialization, marketing and manufacturing capabilities and strategy;

 

our ability to comply with applicable regulatory requirements;

 

our ability to maintain our intellectual property position;

 

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.

 

24

 

 

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.

 

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 places the submission on hold until a decision is made. This process may take up to 60 days from date of the appeal before an FDA decision is reached.

 

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 March 31, 2022, we had an accumulated deficit of $46.7 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. 

 

25

 

 

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, 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 places the submission on hold until a decision is made. This process may take up to 60 days from date of the appeal before an FDA decision is reached.

 

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.

 

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. Subsequent to the end of the fiscal quarter, we also announced that we have surpassed five years of accelerated aging testing for our recording electrodes.

 

COVID-19

 

On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a global pandemic. COVID-19 and its variants continue to impact the United States and the world. As a result of the COVID-19 pandemic, the Company has experienced delays and disruptions in our pre-clinical and clinical trials, as well as interruptions in our manufacturing, supply chain, and research and development operations. For example:

 

  development of our technology has been and may continue to be delayed further into fiscal 2022 due to interruptions in global manufacturing and shipping as a result of the COVID-19 pandemic and macroeconomic conditions, including as one of our key manufacturing partners and one of the Company’s suppliers had staffing issues leading to delays in the Company’s development builds and delays in shipping product;

 

  the Company’s own staff has been impacted by infections and mandatory quarantines;

 

  the Company is currently experiencing and may continue to experience product shortages of its primary component, polyimide film, due to supply chain shortages attributed to COVID related issues;

 

  the Company is experiencing and may continue to experience delays in timelines for product availability and delivery from vendors, including related to staffing shortages, both generally and due to employee illness, and due to increases in demand from other larger or more longstanding customers of our suppliers placing large orders due to concerns with supply chain disruption and the impact of COVID-19.

 

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The Company’s plans for further testing or clinical trials and costs to obtain components may be further impacted by the continuing effects of COVID-19, supply chain challenges and inflationary pressures.

 

The global outbreak of COVID-19 continues to rapidly evolve as new variants emerge. The extent to which the COVID-19 pandemic may impact our business and pre-clinical and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the effect of the pandemic on our suppliers and distributors and the global supply chain, the impact of inflation, the ultimate geographic spread of the disease and its variants, the duration of the outbreak, travel restrictions and social distancing in the U.S. and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S. and other countries to contain and treat the disease.

 

The COVID-19 pandemic may also impact our ability to secure additional financing. Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity in the remainder of fiscal year 2022 and beyond.

  

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.

 

27

 

 

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.

 

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.

 

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Results of Operations

 

Comparison of the Three Months Ended March 31, 2022 and 2021

 

The following table sets forth the results of operations for the three-months ended March 31, 2022 and 2021, respectively.

 

    For the
three months ended
March 31,
(unaudited)
 
    2022     2021     Period to
Period
Change
 
Product revenue   $ 36,584     $ 18,240     $ 18,344  
Cost of product revenue     72,807       39,363       33,444  
Product gross profit (loss)     (36,223 )     (21,123 )     (15,100 )
                         
Collaborations revenue           20,113       (20,113 )
                         
Operating expenses:                        
Selling, general and administrative     1,818,207       1,313,252       504,955  
Research and development     1,205,380       1,081,429       123,951  
Total operating expenses     3,023,587       2,394,681       628,906  
Loss from operations     (3,059,810 )     (2,395,691 )     (664,119 )
Other income     1,743       1,775       (32 )
Loss before income taxes     (3,058,067 )     (2,393,916 )     (664,151 )
Provision for income taxes                  
Net loss   $ (3,058,067 )   $ (2,393,916 )   $ (664,151 )

  

Product Revenue and Product Gross Profit (Loss)

 

Product revenue and product gross profit (loss) was $37,000 and $(36,000), respectively, during the three months ended March 31, 2022. Product revenue and product gross profit (loss) was $18,000 and $(21,000), respectively, during the three months ended March 31, 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 $20,000 for the three months ended March 31, 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 March 31, 2022.

 

Selling, general and administrative expenses

 

Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2022, compared to $1.3 million for the three months ended March 31, 2021. The $0.5 million increase was primarily due to investor relations costs of $0.3 million, litigation support and other legal costs of $0.2 million and sales and marketing expenses of $0.1 million, offset in part by a decrease in administrative personnel expenses of $0.1 million.

  

Research and development expenses

 

Research and development expenses were $1.2 million for the three months ended March 31, 2022, compared to $1.1 million during for the three months ended March 31, 2021. The $0.1 million increase period over period was attributed to supporting development activities, which primarily included salary-related expenses and costs related to consulting services, materials and supplies associated with the development of SEEG Products and to a lesser extent Strip/Grid Products.

 

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Other Income

 

Other income during the three months ended March 31, 2022 related to interest income on our cash deposits in the amount of $2,000. Other income during the three months ended March 31, 2021 consisted of proceeds from the sale of certain supplies in the amount of $2,000.

 

Comparison of the Six Months Ended March 31, 2022 and 2021

 

The following table sets forth the results of operations for the six months ended March 31, 2022 and 2021, respectively.

 

    For the
six months ended
March 31,
(unaudited)
 
    2022     2021     Period to
Period
Change
 
Product revenue   $ 70,332     $ 89,714     $ (19,382 )
Cost of product revenue     119,651       148,494       (28,843 )
Product gross profit (loss)     (49,319 )     (58,780 )     9,461  
                         
Collaborations revenue     6,374       42,387       (36,013 )
                         
Operating expenses:                        
Selling, general and administrative     3,560,348       2,507,112       1,053,236  
Research and development     2,265,842       2,015,587       250,255  
Total operating expenses     5,826,190       4,522,699       1,303,491  
Loss from operations     (5,869,135 )     (4,539,092 )     (1,330,043 )
Interest expense           (3,053 )     3,053  
Net valuation change of instruments measured at fair value           1,974       (1,974 )
Other income     3,593       186,775       (183,182 )
Loss before income taxes     (5,865,542 )     (4,353,396 )     (1,512,146 )
Provision for income taxes                  
Net loss   $ (5,865,542 )   $ (4,353,396 )   $ (1,512,146 )

 

Product Revenue and Product Gross Profit (Loss)

 

Product revenue and product gross profit (loss) was $70,000 and $(49,000) during the six months ended March 31, 2022, respectively. Product revenue and product gross profit (loss) was $90,000 and $(59,000) during the six months ended March 31, 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.

 

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Collaborations Revenue

 

Collaborations revenue was $6,000 and $42,000 for the six months ended March 31, 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 six 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.

 

Selling, general and administrative expenses

 

Selling, general and administrative expenses were $3.6 million for the six months ended March 31, 2022, compared to $2.5 million for the six months ended March 31, 2021. The $1.1 million increase was primarily due to higher investor relations costs of $0.3 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.

 

Research and development expenses

 

Research and development expenses were $2.3 million for the six months ended March 31, 2022, compared to $2.0 million for the six months ended March 31, 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 and to a lesser extent Strip/Grid Products.

 

Interest expense

 

Interest expense for the six months ended March 31, 2021 was $3,000 and consisted of issuance costs in connection the 2019 Paulson Notes. We did not incur interest expense during the current six month period.

 

Net valuation change of instruments measured at fair value:

 

The net valuation change of instruments measured at fair value for the six months ended March 31, 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 six month period ended March 31, 2022 as there were no instruments measured at fair value during the current year period.

 

Other Income

 

Other income during the six months ended March 31, 2022 consisted of $4,000 related primarily to interest income attributed to our cash deposits.

 

Other income during the six months ended March 31, 2021 consisted principally of proceeds received in connection with the PMT Corporation litigation in the amount of $0.2 million and proceeds received from the sale of certain supplies in the amount of $2,000.

  

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Liquidity and Capital Resources

 

Overview

 

As of March 31, 2022, our principal source of liquidity consisted of cash deposits of $12.9 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.

 

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.

 

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

 

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

 

Our other cash requirements within the next twelve months include accounts payable, accrued expenses, purchase commitments and other current liabilities. Our other cash requirements greater than twelve months from various contractual obligations and commitments include operating leases and contracted services. Refer to “Note 4 – Commitments and Contingencies” included in our condensed financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for further detail of our lease obligations and the timing of expected future payments. Contracted services include agreements with third-party service providers for clinical research, product development, manufacturing, supplies, payroll services, equipment maintenance services, and audits for periods up to fiscal 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 March 31, 2022, we had approximately $12.9 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.

 

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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.

 

Cash Flows

 

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

 

    For the
six Months Ended
 
    March 31,  
    2022     2021  
Net cash used in operating activities   $ (5,900,727 )   $ (4,284,102 )
Net cash used by investing activities     (154,810 )     (2,059 )
Net cash provided by financing activities     12,023,282       11,523,949  
Net increase in cash   $ 5,967,745     $ 7,237,788  

 

Net cash used in operating activities

 

Net cash used in operating activities was $5.9 million for the six months ended March 31, 2022, which consisted of a net loss of $5.9 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, operating lease expense, totaling approximately $0.5 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 approximately $0.6 million. The change in operating assets and liabilities was primarily attributable to a net decrease in 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 $4.3 million for the six months ended March 31, 2021, which consisted of a net loss of $4.4 million partially offset principally by non-cash stock-based compensation, depreciation, amortization related to intangible assets, revaluation of convertible notes and operating lease expense, totaling approximately $0.6 million in the aggregate. The net change in our net operating assets and liabilities associated with fluctuations in our operating activities resulted in a cash use of approximately $0.6 million. The change in operating assets and liabilities was primarily attributable to a net decrease in accounts payable and accrued expenses attributed to the timing of payments.

 

Net cash used by investing activities

 

Net cash used by investing activities was $0.2 million and $2,000 during the six months ended March 31, 2022 and 2021, respectively, and consisted of outlays for purchases of equipment in the current period six month period vs. the purchase of furniture during the prior six month period.

 

Net cash provided by financing activities

 

Net cash provided by financing activities was $12.0 million for the six months ended March 31, 2022, which consisted of net proceeds from the October 2021 Underwritten Public Offering.

 

34

 

 

Net cash provided by financing activities was $11.5 million for the six months ended March 31, 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 six months ended March 31, 2021 resulting in additional cash proceeds of $0.2 million.

 

Critical Accounting Estimates

 

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

 

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

 

Revenues:

 

For discussion about the determination of 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.

 

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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.

 

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 March 31, 2022. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of March 31, 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 March 31, 2022, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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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 set forth blow and discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2021. 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.

 

Our common stock is listed on the Nasdaq Capital Market, or Nasdaq. We can provide no assurance that we will be able to comply with the continued listing requirements over time and that our common stock will continue to be listed on Nasdaq.

 

In May 2021, we successfully listed our common stock on Nasdaq. However, we can give no assurance that we will be able to satisfy the continued listing requirements of Nasdaq in the future, including maintaining a minimum closing bid price of $1.00 per share. Since April 25, 2022, the closing price of our common stock has been below $1.00. If the closing bid price of our common stock is below $1.00 per share for 30 consecutive business days, we will receive a deficiency notice from Nasdaq advising us that we have a certain period of time, typically 180 days, to regain compliance by maintaining a minimum closing bid price of at least $1.00 for at least ten consecutive business days, although Nasdaq could require a longer period. If we fail to maintain compliance with the minimum closing bid price requirement, or any other of the continued listing requirements of Nasdaq, the exchange may take steps to de-list our common stock. If such delisting should occur, it would likely have a negative effect on the price of our common stock and would impair an investor’s ability to sell or purchase our common stock when desired. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements.

 

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.

 

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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-K filed on June, 29, 2017).
     
3.2   Certificate of Amendment to Amended and Restated Certificate of Incorporation of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.1 on the Registrant’s Current Report on Form 8-K filed on March 31, 2021).
     
3.3   Bylaws of NeuroOne Medical Technologies Corporation (incorporated by reference to Exhibit 3.5 on the Registrant’s Current Report on Form 8-K filed on June 29, 2017).
     
31.1   Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2   Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
32.2*   Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101.INS   Inline XBRL Instance Document.
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

* Documents are furnished, not filed.

 

38

 

 

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: May 12, 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)  

 

 

39

 

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