UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

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

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

For the quarterly period ended March 31, 2018June 30, 2021

or

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

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

For the transition period from________ to_________.from ________ to ________.

Commission File Number: 001-38389

001-38389

Motus GI Holdings, Inc.

(Exact name of registrant as specified in its charter)

Delaware81-4042793
(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer


Identification Number)

1301 East Broward Boulevard, 3rd Floor


Ft. Lauderdale, FL

33301
(Address of principal executive offices)(Zip code)

(786) 459 1831(954) 541 8000

(Registrant’s telephone number, including area code)

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 filerAccelerated filer
Non-accelerated filer (Do not check if a smaller reporting company)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 ☒

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

Title of Each ClassTrading Symbol(s)Name of Each Exchanged on Which Registered
Common Stock, $0.0001 par value per shareMOTSThe Nasdaq Capital Market

As of May 7, 2018, 15,645,755August 6, 2021, 48,241,188 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.

 

 

MOTUS GI HOLDINGS, INC.

Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2018

TABLE OF CONTENTS

  Page
 PART I 
   
 FINANCIAL INFORMATION 
   
1.Unaudited Condensed Consolidated Financial Statements 
 Condensed Consolidated Balance Sheets as of March 31, 2018 (unaudited) and December 31, 2017F-1
 Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2018 and 2017 (unaudited)F-2
   
 Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2018 and 2017 (unaudited)F-3
 Notes to the Unaudited Interim Condensed Consolidated Financial StatementsF-4
2.Management’s Discussion and Analysis of Financial Condition and Results of Operations3
3.Quantitative and Qualitative Disclosures about Market Risk11
4.Controls and Procedures11
   
 PART II 
   
 OTHER INFORMATION 
   
1.Legal Proceedings12
1A.Risk Factors12
2.Unregistered Sales of Equity Securities and Use of Proceeds12
3.Defaults Upon Senior Securities13
4.Mine Safety Disclosures13
5.Other Information13
6.Exhibits14

2

 

Motus GI Holdings, Inc. and Subsidiaries

TABLE OF CONTENTS

Page
PART I
FINANCIAL INFORMATION
Item 1.Condensed Consolidated Financial Statements (Unaudited)1
Condensed Consolidated Balance Sheets1
Condensed Consolidated Statements of Comprehensive Loss2
Condensed Consolidated Statements of Changes in Shareholders’ Equity3
Condensed Consolidated Statements of Cash Flows4
Notes to the Condensed Consolidated Financial Statements5
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations18
Item 3.Quantitative and Qualitative Disclosures about Market Risk25
Item 4.Controls and Procedures26
PART II
OTHER INFORMATION
Item 1.Legal Proceedings27
Item 1A.Risk Factors27
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds29
Item 3.Defaults Upon Senior Securities29
Item 4.Mine Safety Disclosures29
Item 5.Other Information29
Item 6.Exhibits30
Signatures31

i

PART I — FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.Statements

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Inin thousands, except share and per share amounts)

     
 March 31, December 31, 
 2018 2017 
  (unaudited)  (*) 
       
ASSETS      
       
Current assets      
Cash and cash equivalents$18,629 $6,939 
Accounts receivable 11  5 
Short-term deposits —    76 
Inventory 21  6 
Prepaid expenses and other 938  658 
Deferred financing fees —    602 
Total current assets 19,599  8,286 
       
Fixed assets, net 837  783 
Long-term deposits 94  99 
       
Total assets$20,530 $9,168 
       
LIABILITIES AND SHAREHOLDERS' EQUITY      
       
Current liabilities      
Accounts payable and accrued expenses$1,515 $1,733 
Other current liabilities 80  250 
Total current liabilities 1,595  1,983 
       
Contingent royalty obligation 1,740  1,662 
Other long-term liabilities 25  —   
       
Total liabilities 3,360  3,645 
       
Shareholders' equity      

Common Stock $0.0001 par value; 50,000,000 shares authorized; 15,645,755 and 10,493,233 shares issued and outstanding as of March 31, 2018 and December 31,2017, respectively 

 2  1 

Preferred Series A stock $0.0001 par value; 2,000,000 shares authorized; 0 and 1,581,128 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively 

 —    —   

Preferred stock $0.0001 par value; 8,000,000 shares authorized; zero shares issued and outstanding 

 —    —   
Additional paid-in capital 63,612  44,643 
Accumulated deficit (46,444) (39,121)
Total shareholders' equity 17,170  5,523 
       
Total liabilities and shareholders' equity$20,530 $9,168 

 

(*) Derived from audited consolidated financial statements

  June 30,  December 31, 
  2021  2020 
  (unaudited)  (*) 
Assets      
Current assets:      
Cash and cash equivalents $26,379  $20,819 
Accounts receivable  73   35 
Inventory  706   805 
Prepaid expenses and other current assets  859   448 
Total current assets  28,017   22,107 
         
Fixed assets, net  1,451   1,178 
Right-of-use assets  712   766 
Other non-current assets  13   13 
Total assets $30,193  $24,064 
         
Liabilities and Shareholders’ Equity        
Current liabilities:        
Accounts payable and accrued expenses $2,150  $2,333 
Operating lease liabilities - current  261   238 
Other current liabilities  7   60 
Term debt, net of debt discount of $17 and $21, respectively  7,983   7,979 
Total current liabilities  10,401   10,610 
         
Contingent royalty obligation  1,734   1,617 
Operating lease liabilities - non-current  467   547 
Total liabilities  12,602   12,774 
         
Commitments and contingent liabilities (Note 9)        
         
Shareholders’ equity        
Preferred Stock $0.0001 par value; 10,000,000 shares authorized; zero shares issued and outstanding  -   - 
Common Stock $0.0001 par value; 115,000,000 shares authorized; 48,241,188 and 32,272,309 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  5   3 
Additional paid-in capital  130,698   115,008 
Accumulated deficit  (113,112)  (103,721)
Total shareholders’ equity  17,591   11,290 
Total liabilities and shareholders’ equity $30,193  $24,064 

 

(*)Derived from audited consolidated financial statements

The accompanying notes are an integral part of these condensed consolidated financial statements.


Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Loss

(Inunaudited, in thousands, except share and per share amounts)

(unaudited) 

     
 Three Months Ended March 31, 
 2018 2017 
     
Revenue$12 $—   
Cost of revenue 15  —   
Gross loss (3) —   
       
Operating expenses:      
Research and development 1,203  614 
Marketing 741  445 
General and administrative 2,133  1,648 
Total operating expenses 4,077  2,707 
       
Operating loss (4,080) (2,707)
       
Warrant expense 3,156   
Loss on change in fair market value of contingent royalty obligation 78  65 
Finance expense, net 9  4 
       
Loss before income taxes (7,323) (2,776)
       

Income tax expense 

 —    (5)
       
Net loss$(7,323)$(2,781)
Basic and diluted loss per common share$(0.57)$(0.28)
Weighted average number of common shares outstanding, basic and diluted 12,933,535  9,849,181 

 

  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2021  2020  2021  2020 
Revenue $100  $1  $151  $29 
                 
Operating expenses:                
Cost of revenue - sales  42   10   70   40 
Research and development  1,508   1,264   2,853   3,199 
Sales and marketing  795   582   1,471   2,445 
General and administrative  2,345   2,365   4,789   5,277 
Total costs and expenses  4,690   4,221   9,183   10,961 
                 
Operating loss  (4,590)  (4,220)  (9,032)  (10,932)
                 
Gain (loss) on change in estimated fair value of contingent royalty obligation  (37)  (76)  (117)  245 
Finance expense, net  (117)  (119)  (234)  (231)
Foreign currency gain (loss)  2   5   (8)  (3)
                 
Net loss  (4,742)  (4,410)  (9,391)  (10,921)
Deemed dividends from warrant issuance  -   -   (6,145)  - 
Net loss attributable to common shareholders $(4,742) $(4,410) $(15,536) $(10,921)
                 
Basic and diluted loss per common share:                
Net loss $(0.10) $(0.15) $(0.21) $(0.38)
Net loss attributable to common shareholders $(0.10) $(0.15) $(0.34) $(0.38)
Weighted average number of common shares outstanding, basic and diluted  47,732,674   28,846,881   45,493,776   28,832,296 

The accompanying notes are an integral part of these condensed consolidated financial statements.


Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash FlowsChanges in Shareholders’ Equity

(Inunaudited, in thousands, except share and per share amounts)

(unaudited) 

     
 For the Three Months Ended March 31, 
 2018 2017 
     
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss$(7,323)$(2,781)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization 26  9 
Revaluation of contingent royalty obligation 78  65 
Share based compensation 602  653 
Warrant expense 3,156   
Changes in operating assets and liabilities:      
Accounts receivable (6) (18)
Inventory (15) (171)
Prepaid expenses and other (280) (260)
Short-term deposits 76  —   
Accounts payable and accrued expenses 347  284 
Other current and long-term liabilities (145) —   
Net cash used in operating activities (3,484) (2,219)
       
CASH FLOWS FROM INVESTING ACTIVITIES:      
Purchase of fixed assets (80) (67)
Proceeds (repayment) from long-term deposits 5  (9)
Net cash used in investing activities (75) (76)
       
CASH FLOWS FROM FINANCING ACTIVITIES:      
Proceeds from public offering, net of broker commissions of $1,400 16,100  —   
Payments of public offering costs (1,109) —   
Proceeds from exercise of overallotment options, net of broker commissions of $22 258  —   
Proceeds from issuance of shares, net of financing cost of $851 —    6,474 
       
Net cash provided by financing activities 15,249  6,474 
       
NET INCREASE IN CASH 11,690  4,179 
CASH AT BEGINNING OF PERIOD 6,939  11,651 
CASH AT END OF PERIOD$18,629 $15,830 
       
SUPPLEMENTAL CASH FLOW INFORMATION:      
CASH PAID FOR:      
Interest$—   $—   
Income taxes$—   $—   
       
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:      
Reclassification of deferred financing costs from current assets to common stock$602 $—   
Conversion of preferred shares into common shares$—   $—   

 

  Common Stock  Additional
paid-in
  Accumulated  Total
shareholders’
 
  Shares  Amount  capital  deficit  equity 
Balance at January 1, 2021  32,272,309  $3  $115,008  $(103,721) $11,290 
Issuance of common shares upon vesting of restricted stock units  65,915   -   -   -   - 
Issuance of common shares upon exercise of warrants, net of financing costs of $366  14,267,250   2   11,591   -   11,593 
Issuance of common stock for board of directors’ compensation  173,554   -   272   -   272 
Share based compensation  -   -   919   -   919 
Net loss  -   -   -   (4,649)  (4,649)
Balance at March 31, 2021  46,779,028  $5  $127,790  $(108,370) $19,425 
Issuance of common shares, net of issuance costs of $74  1,340,870   -   1,826   -   1,826 
Issuance of common shares upon vesting of restricted stock units  53,081   -   -   -   - 
Issuance of common stock for board of directors’ compensation  18,209   -   19   -   19 
Issuance of common stock to consultants  50,000   -   53   -   53 
Share based compensation  -   -   1,010   -   1,010 
Net loss  -   -   -   (4,742)  (4,742)
Balance at June 30, 2021  48,241,188  $5  $130,698  $(113,112) $17,591 

  Common Stock  Additional
paid-in
  Accumulated  Total
shareholders’
 
  Shares  Amount  capital  deficit  equity 
Balance at January 1, 2020  28,811,087  $              3  $102,789  $(84,464) $         18,328 
Issuance of common shares upon vesting of restricted stock units  15,070   -   -   -   - 
Share based compensation  -   -   804   -   804 
Net loss  -   -   -   (6,511)  (6,511)
Balance at March 31, 2020  28,826,157  $3  $103,593  $(90,975) $12,621 
Issuance of common shares upon vesting of restricted stock units   30,916   -    -    -    - 
Share based compensation   -    -    678    -    678 
Net loss   -    -   -    (4,410   (4,410
Balance at June 30, 2020   28,857,073  $ 3  $ 104,271  $ (95,385 $8,889  

The accompanying notes are an integral part of these condensed consolidated financial statements.


Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(unaudited, in thousands)

  For the Six months Ended
June 30,
 
  2021  2020 
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss $(9,391) $(10,921)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  200   201 
Amortization of debt issuance costs  4   21 
(Gain) loss on change in estimated fair value of contingent royalty obligation  117   (245)
Share based compensation  1,929   1,457 
Issuance of common stock for board of directors’ compensation  114   - 
Issuance of common stock for consultants  53   - 
Impairment of fixed assets  -   18 
Non-cash operating lease expense  54   105 
Changes in operating assets and liabilities:        
Accounts receivable  (38)  71 
Inventory  43   (311)
Prepaid expenses and other current assets  (366)  (654)
Accounts payable and accrued expenses  (204)  (975)
Operating lease liabilities - current and non-current  (57)  (104)
Other current liabilities  (53)  (10)
Net cash used in operating activities  (7,595)  (11,347)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchase of fixed assets  (269)  (225)
Proceeds from sale of available-for-sale securities  -   8,203 
Net cash provided by (used in) investing activities  (269)  7,978 
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common shares  1,901   - 
Proceeds from exercise and purchase of warrants  11,959   - 
Financing fees  (436)  (34)
Net cash provided by (used in) financing activities  13,424   (34)
         
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS  5,560   (3,403)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  20,819   20,528 
CASH AND CASH EQUIVALENTS AT END OF PERIOD $26,379  $17,125 
         
SUPPLEMENTAL CASH FLOW INFORMATION:        
CASH PAID FOR:        
Interest $222  $209 
         
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:        
Common stock issued to settle accrued expenses for board of directors’ compensation $56  $- 
Common stock issued for prepaid board of directors’ compensation $121  $- 
Reclassification of inventory to fixed assets $56  $170 
Reclassification of prepaid expenses to fixed assets $75  $- 
Purchase of fixed assets in accounts payable and accrued expenses $73  $- 
Financing costs incurred but unpaid at period end $4  $- 
Financing fees extinguished previously included in accounts payable and accrued expenses $-  $200 

The accompanying notes are an integral part of these condensed consolidated financial statements.


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements


(Inunaudited, in thousands, except share and per share amounts)

Note 1 – Description of Business

Motus GI Holdings, Inc. (the “Company”) was incorporated in Delaware, U.S.A. in September 2016. The Company and its subsidiaries, Motus GI Technologies, Ltd. and Motus Inc.GI, LLC., are collectively referred to as “Motus GI” or the “Company”.

The Company has developed the Pure-Vu System, a single-use medical device system, the Pure-Vu system,that has been cleared by the United StatesU.S. Food and Drug Administration which is intended to connect to standard colonoscopes(the “FDA”) to help facilitate intraprocedural cleaningthe cleansing of a poorly prepared colon by irrigating or cleaning the colongastrointestinal tract during colonoscopy and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.to help facilitate upper gastrointestinal (“GI”) endoscopy procedures.  The Pure-Vu systemSystem has been designed to integratereceived a CE Mark in the EU for use in colonoscopy.  The Pure-Vu System integrates with standard and slim colonoscopes, as well as gastroscopes, to enable cleaningimprove visualization during the procedurecolonoscopy and upper GI procedures while preserving standardestablished procedural workflow and techniques.  Through irrigation and evacuation of debris, the Pure-Vu System is designed to provide better-quality exams. The Pure-Vu system and the procedure to cleanse the colon in preparation for colonoscopy are not currently reimbursable through private or governmental third-party payors in any country, but the Company does intend to seek reimbursement through private or governmental third-party payorsbegan commercialization in the future. To date,fourth quarter of 2019, with the first commercial placements of its second generation Pure-Vu System as part of its initial U.S. market launch targeting early adopter hospitals. The Company does not expect to generate significant revenue from product sales until the Company’s limited pilot launch, the CompanyCOVID-19 pandemic has focused on collecting clinical data on the use offully subsided and it expands its commercialization efforts for the Pure-Vu system.System, which is subject to significant uncertainty.

Note 2 – Basis of Presentation and Going Concern

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 20172020 10-K filed with the SEC on March 28, 2018.16, 2021. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions for Form 10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for annual financial statements, but reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of the results that may be expected for any future periods. The December 31, 20172020 balance sheet information was derived from the audited financial statements as of that date. Certain reclassifications have been made to the prior period consolidated financial statements to conform to the current period presentation.

To date, the Company has generated minimal revenues, from its activitiesexperienced negative operating cash flows and has incurred substantial operating losses.losses from its activities. Management expects the Company to continue to generate substantial operating losses and to continue to fund its operations primarily through utilization of its current financial resources, future product sales, and through additional raisesthe issuance of capital.debt or equity. While the full impact of the COVID-19 pandemic continues to evolve, the financial markets have been subject to significant volatility that adversely impacts the Company’s ability to enter into, modify, and negotiate favorable terms and conditions relative to equity and debt financing initiatives. The uncertain financial markets, potential disruptions in supply chains, mobility restraints, and changing priorities could also affect the Company’s ability to enter into key agreements. The outbreak and government measures taken in response to the pandemic have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as certain medical services and supplies, have spiked, while demand for other goods and services have fallen. The future progression of the outbreak and its effects on the Company’s business and operations are uncertain. The Company and its third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to the Company’s research and development activities, including, for example, medical and laboratory supplies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak. These disruptions may negatively impact the Company’s sales, its results of operations, financial condition, and liquidity in 2021.


 

The Company has financed its operations primarily through sales of equity-related securities. As of June 30, 2021, the Company had an accumulated deficit of $113,112, total current assets of $28,017 and total current liabilities of $10,401 resulting in working capital of $17,616. For the six months ended June 30, 2021 the Company incurred a net loss of $9,391. As of June 30, 2021, the Company had cash and cash equivalents of $26,379. As of June 30, 2021, under the terms of the loan agreement with Silicon Valley Bank (“SVB”), the Company was required to maintain unrestricted cash in accounts held at SVB of at least $10,000 (the “Liquidity Covenant”). As described in greater detail below, in connection with entering into the Kreos Loan Agreement, as defined in Note 12- Subsequent Events, we have terminated the SVB Loan Agreement as of July 16, 2021 and are no longer subject to the Liquidity Covenant.

Such conditions, as well as the uncertainty of the impact of the COVID-19 pandemic, raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plan includes revenue generation through the sale of products and raising funds from outside investors. However, there is no assurance that such sale of products will occur or that outside funding will be available to the Company, will be obtained on favorable terms or will provide the Company with sufficient capital to meet its objectives. These condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.

Note 3 – Summary of Significant Accounting Policies

Significant Accounting Policies

A summary of the

The significant accounting policies appliedused in the preparation of the accompanyingthese condensed consolidated financial statements follows:for the six months ended June 30, 2021 are consistent with those discussed in Note 3 to the consolidated financial statements in the Company’s 2020 Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2021.

Basis of presentation and principles of consolidation

Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements represent the consolidation ofhave been prepared in accordance with GAAP and include the accounts of the Company and its wholly owned subsidiaries, Motus Ltd., an Israel corporation, which has operations in conformity with GAAP.Tirat Carmel, Israel, and Motus Inc., a Delaware corporation, which has operations in the U.S. All intercompanyinter-company accounts and transactions have been eliminated in consolidation.


Motus GI Holdings, Inc.Use of estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and Subsidiariesassumptions that affect the reported amounts of assets and liabilities as of 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.

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

Revenue Recognitionrecognition

The FASB issued ASU No. 2014-09,Sales contracts executed for the second generation Pure-Vu System are accounted for in accordance with ASC Topic 606 - Revenue from Contracts with Customers (“ASC 606”) to depict the transfer of control to the Company’s customers in an amount reflecting the consideration to which provides a single comprehensive model for entitiesthe Company expects to use in accounting for revenue arising from contracts with customers. The Company adopted this ASU effective January 1, 2018 on a full retrospective basis. Adoption of this standard did not result in significant changes to accounting policies, business processes, systems or controls, or have a material impact on the financial position, results of operations and cash flows or related disclosures. As such, prior period financial statements were not recast.

be entitled to. The Pure-Vu System The Company manufacturesconsists of a medical device system (a “Workstation”)Workstation and a single use disposable sleeve (a “Disposable”sleeves (“Disposables”) designed. For contracts outside the scope of ASC 606, the Company determines income for proposed supply arrangements under 1) ASC 842 as it pertains to improvean embedded lease of the Workstation within a colonoscopy procedure. These products are shipped directly to healthcare professionals under contract-based terms. Revenueproposed supply arrangement and 2) ASC 606 for the products sold is recognized atsale of the point in time when control transfersDisposables within the proposed supply arrangement. The Company allocates the transaction price to the customer, which is generally whenperformance obligations within the shipment is receivedproposed supply arrangements using the total estimated purchases method for both (i) arrangements that contain minimum purchase commitments and accepted by(ii) those arrangements that do not contain a minimum purchase commitment, but instead offer a volume discount for purchases that exceed a specified tier. During the customer. In certain circumstances, products are available for free of charge for a limited evaluation period. At the end of the limited evaluation period, the customer may purchase the products at which timethree months ended June 30, 2021, the Company will record the correspondingrecognized revenue or the products may be returned. The Company has not had any returns to date. As of March 31, 2018, the Company had no future performance obligations from any customer contracts.

Stock Based Compensation

The Company applies ASC 718-10, “Share-Based Payment,”$100, which requires the measurement and recognitionprimarily consisted of compensation expenses for all share-based payment awards made to employees and directors including employee stock options under the Company’s stock plans based on estimated fair values.

ASC 718-10 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company’s statement of operations. The Company recognizes share-based award forfeitures as they occur rather than estimate by applying a forfeiture rate. 

The Company accounts for stock-based compensation awards to non-employees$72 in accordance with FASB ASC 505-50, “Equity-Based Payments to Non-Employees” (“FASB606 and $28 in accordance with ASC 505-50”). Under FASB ASC 505-50,842. During the three months ended June 30, 2020, the Company determinesrecognized revenue of $1 in accordance with ASC 606. During the fair valuesix months ended June 30, 2021, the Company recognized revenue of $151, which primarily consisted of $108 in accordance with ASC 606 and $43 in accordance with ASC 842. During the warrants or stock-based compensation awards granted as eithersix months ended June 30, 2020, the fair valueCompany recognized revenue of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable.$29 in accordance with ASC 606.


 

All issuances of stock options or other equity instruments to non-employees as consideration for goods or services received

Basic and diluted net loss per share

Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the year. Diluted loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the year, plus the number of common shares that would have been outstanding if all potentially dilutive ordinary shares had been issued, using the treasury stock method, in accordance with ASC 260-10 “Earnings per Share”. Potentially dilutive common shares were excluded from the calculation of diluted loss per share for all periods presented due to their anti-dilutive effect due to losses in each period.

Net loss attributable to common stockholders consists of net income or loss, as adjusted for actual and deemed preferred stock dividends declared, amortized or accumulated. The Company are accounted for based on the fair value of the equity instruments issued. Non-employee equity based payments are recorded as an expense over the service period, as if the Company had paid casha deemed dividend for the services. Atissuance of warrants during the endthree and six months ended June 30, 2021 of each financial reporting period, prior to vesting or prior$0 and $6,145, respectively. The deemed dividend is added to the completion ofnet loss in determining the services, the fair value of the equity based payments will be re-measured and the non-cash expense recognized during the period will be adjusted accordingly. Since the fair value of equity based payments grantednet loss available to non-employees is subject to change in the future, the amount of the future expense will include fair value re-measurements until the equity based payments are fully vested or the service completed.common stockholders.

Income taxes

The Company recognizes compensation expenses for the value of non-employee awards, which have graded vesting, based on the straight-line method over the requisite service period of each award.

The Company estimates the fair value of stock options granted as equity awards using a Black-Scholes options pricing model. The option-pricing model requires a number of assumptions, of which the most significant are share price, expected volatility and the expected option term (the time from the grant date until the options are exercised or expire). Expected volatility is estimated based on volatility of similar companies in the technology sector. The Company has historically not paid dividends and has no foreseeable plans to issue dividends. The risk-free interest rate is based on the yield from governmental zero-coupon bonds with an equivalent term. The expected option term is calculated for options granted to employees and directors using the “simplified” method. Grants to non-employees are based on the contractual term. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations of the Company.

Income Taxes

The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of March 31, 2018,June 30, 2021, and December 31, 2017,2020, the Company had a full valuation allowance against its deferred tax assets.

For the three and six months ended June 30, 2021 and 2020, the Company recorded zero income tax expense. No tax benefit has been recorded in relation to the pre-tax loss for the three and six months ended June 30, 2021 and 2020, due to a full valuation allowance to offset any deferred tax asset related to net operating loss carry forwards attributable to the losses.

Recently Adopted Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements and disclosures.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes”, or ASU 2019-12, which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The Tax Cuts and Jobs Act (the “Tax Act”), enactednew standard was adopted on December 22, 2017, among other things, permanently lowered the statutory federal corporate tax rate from 35% to 21%, effective for tax years including or beginning January 1, 2018. Under the guidance2021. The adoption of ASC 740, “Income Taxes” (“ASC 740”), the Company revalued its net deferred tax assetsASU 2019-12 did not have a material impact on the dateCompany’s financial position or results of enactment basedoperations.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses” to improve information on credit losses for financial assets and net investment in leases that are not accounted for at fair value through net income. ASU 2016-13 replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses. In April 2019 and May 2019, the FASB issued ASU No. 2019-04, “Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments” and ASU No. 2019-05, “Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief” which provided additional implementation guidance on the reduction inpreviously issued ASU. In November 2019, the overall future tax benefit expected to be realized atFASB issued ASU 2019-10, “Financial Instruments - Credit Loss (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842),” which defers the lower tax rate implementedeffective date for public filers that are considered small reporting companies (“SRC”) as defined by the new legislation. Although in the normal course of businessSecurities and Exchange Commission to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Since the Company is requiredan SRC, implementation is not needed until January 1, 2023. The Company will continue to make estimatesevaluate the effect of adopting ASU 2016-13 will have on the Company’s financial statements and assumptions for certain tax items which cannot be fully determineddisclosures.


Note 4 – Fair Value Measurements

Assets and liabilities measured and recorded at period end, the Company did not identify items for which the income tax effectsfair value on a recurring basis consisted of the Tax Act have not been completed as of March 31, 2018 and, therefore, considers its accounting for the tax effects of the Tax Act on its deferred tax assets and liabilities to be complete as of March 31, 2018.

Fair Value Measurements

The Company accounts for financial instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC 820 establishes a 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 unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below:

Level 1 – Unadjusted quoted prices in active markets that are accessiblefollowing at the measurement date for identical, unrestricted assets or liabilities;

Level 2 – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly; and

Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.

In estimating the fair value of the Company’s contingent consideration (see Note 4), the Company used the discounted cash flow method as of March 31, 2018June 30, 2021 and December 31, 2017. Based on the fair value hierarchy, the Company classified contingent consideration within Level 3 because valuation inputs are based on projected revenues discounted to a present value.2020:


  June 30, 2021 
  Level 1  Level 2  Level 3  Fair Value 
Liabilities                
Contingent royalty obligation $-  $-  $1,734  $1,734 

  December 31, 2020 
  Level 1  Level 2  Level 3  Fair Value 
Liabilities               
Contingent royalty obligation $-  $-  $1,617  $1,617 

Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

Financial instruments with carrying values approximating fair value include cash and cash equivalents, accounts receivable, short-term deposits, prepaid expenses and other current assets, accounts payable and accrued expenses, and certain other current liabilities, due to their short-term nature.

The following table sets forth a summary of changesChanges in the estimated fair value of the Company’s Level 3recurring fair value measurements using significant unobservable inputs (Level 3), which solely consisted of a contingent royalty obligation, forduring the threesix months ended March 31, 2018:June 30, 2021 was as follows:

  Fair Value Measurements of Contingent Royalty Obligation (Level 3) 
Balance at January 1, 2018 $1,662 
Change in estimated fair value of contingent royalty obligation  78 
Balance at March 31, 2018 $1,740 
  Fair Value Measurements of Contingent Royalty Obligation (Level 3) 
Balance at December 31, 2020 $1,617 
Change in estimated fair value of contingent royalty obligation  117 
Balance at June 30, 2021 $1,734 

The Contingent Royalty Obligationcontingent royalty obligation is re-measured at each balance sheet date using several assumptions, including the following assumptionsfollowing: 1) estimated sales growth, 2) length of product cycle, 3) patent life, 4) discount rate (21% as of March 31, 2018June 30, 2021 and December 31, 2017: 1) Discount rate of 20%2020), 2)and 5) rate of royalty payment (3% as of 3%June 30, 2021 and December 31, 2020).

In accordance with ASC-820-10-50-2(g), the Company performed a sensitivity analysisanalyses of the liability, which was classified as a levelLevel 3 financial instrument. The contingent royalty obligation estimate may be significantly impacted by changes in assumptions used in these analyses. For example, the Company recalculated the fair value of the liability by applying a +/- 2% change to the input variable in the discounted cash flow model; the discount rate. A 2% decrease in the discount rate would increase the liability by approximately $209$204 and a 2% increase in the discount rate would decrease the liability by approximately $183.$144.


Note 5 – Inventory

Inventory is stated at lower of cost or net realizable value using the weighted average cost method and is evaluated at least annually for impairment. Write-downs for potentially obsolete or excess inventory are made based on management’s analysis of inventory levels, historical obsolescence and future sales forecasts. There were 0 inventory write-down charges for the three and six months ended June 30, 2021 and 2020.

Inventory at June 30, 2021 and December 31, 2020 consisted of the following:

 

  June 30,
2021
  December 31,
2020
 
Raw materials $273  $             333 
Work-in-process  -   211 
Finished goods  682   529 
Inventory reserve  (249)  (268)
Inventory, net $706  $805 

Recently Issued Accounting Standards

Note 6 – Fixed assets, net

Fixed assets, summarized by major category, consist of the following for the years ended:

  June 30,
2021
  December 31,
2020
 
Office equipment $168  $167 
Computers and software  303   299 
Machinery  775   455 
Lab and medical equipment  1,186   1,039 
Leasehold improvements  186   185 
Total  2,618   2,145 
Less: accumulated depreciation and amortization  (1,167)  (967)
Fixed assets, net $1,451  $1,178 

Depreciation and amortization expense for the three and six months ended June 30, 2021 was $102 and $200, respectively. Depreciation and amortization expense for the three and six months ended June 30, 2020 was $125 and $201, respectively. The Company incurred a loss on the impairment of fixed assets in the amount of $9 and $18 for the three and six months ended June 30, 2020, respectively.


Note 7 – Leases

The Company leases an office in Fort Lauderdale, Florida under an operating lease. The term expires November 2024. The annual base rent is subject to annual increases of 2.75%. As described within Note 10, the Company shares this space with a related party pursuant to the Shared Space Agreement, as defined below.

The Company leases an office in Israel under an operating lease. The term expires on December 31, 2022. The annual base rent is subject to increases of 4%.

The Company leases vehicles under operating leases that expire at various dates through 2022.

Many of these leases provide for payment by the Company, as the lessee, of taxes, insurance premiums, costs of maintenance and other costs which are expenses as incurred. Certain operating leases include escalation clauses and some of which may include options to extend the leases for up to 3 years.

The components of lease cost and supplemental balance sheet information for the Company’s lease portfolio were as follows: 

  

  Three Months ended
June 30,
  Six Months ended
June 30,
 
  2021  2020  2021  2020 
Lease Cost            
Operating lease cost, net of related party license fee $32  $50  $64  $105 
Variable lease cost  30   29   60   58 
Total lease cost $62  $79  $124  $163 

In February 2016,

  As of
June 30,
  As of
December 31,
 
  2021  2020 
Assets      
Operating lease, right-of-use- asset $712  $766 
Liabilities        
Current        
Operating lease liabilities $261  $238 
Non-current        
Operating lease liabilities, net of current portion  467   547 
Total lease liabilities $728  $785 
         
Other information:        
Weighted average remaining lease term - operating leases  2.89 years   3.33 years 
Weighted-average discount rate - operating leases  7.65%  7.78%

The Company records operating lease payments to lease expense using the Financial Accounting Standards Board (“FASB”straight-line method. The Company’s lease expense was $62 and $124 for the three and six months ended June 30, 2021, included in general and administrative expenses which is net of the related party license fee of $47 and $94 for the three and six months ended June 30, 2021, respectively (see Note 10). The Company’s lease expense was $79 and $163 for the three and six months ended June 30, 2020, respectively, included in general and administrative expenses, which is net of the related party license fee of $44 and $79 for the three and six months ended June 30, 2020, respectively.


Note 8 – Term Debt

On December 13, 2019 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) issued Accounting Standards Update (“ASU”for $8,000 (the “Term Debt”) 2016-02 “Leases”with Silicon Valley Bank (the “Bank” or “SVB”). On April 10, 2020, the Company entered into a Deferral Agreement (the “Deferral Agreement”) with SVB, effective April 2, 2020, which amends certain provisions of the Loan and Security Agreement, between the Company and SVB.

Pursuant to increase transparency and comparability among organizationsother changes effected by, recognizing leasethe Deferral Agreement, as of April 2, 2020, the originally scheduled period of monthly interest-only payments under the Loan Agreement, and the originally scheduled maturity date of the Loan Agreement, have each been extended by six months. As a result, pursuant to the Deferral Agreement, the Loan Agreement now provides for monthly interest-only payments through June 30, 2022, followed by monthly payments of principal and interest until June 1, 2024.

The Term Debt of $8,000 bears an interest rate equal to the greater of (i) one-half of one percent (0.50%) above the Prime Rate and (ii) five and one-half percent (5.50%). At June 30, 2021, the interest rate was 5.50%. The Term Debt is collateralized by substantially all assets of the Company. Additionally, the Company has pledged 65% of the outstanding capital stock in the Company’s foreign subsidiary, Motus GI Medical Technologies, Ltd., to collateralize the Term Debt.

Interest payments have commenced on January 1, 2020, following each month until the maturity date. Principal payments will commence July 1, 2022 and lease liabilitiescontinuing for 24 consecutive months thereafter. The Company may prepay all, but not less than all, of the outstanding principal balance of the Term Debt subject to prepayment premium of $240, plus all other sums, if any, that shall have become due and payable.

The Company incurred $50 of debt issuance costs related to the Term Debt. For the three and six months ended June 30, 2021, $2 and $4 of debt issuance costs was amortized to interest expense, respectively, using the effective interest method. For the three and six months ended June 30, 2020, $2 and $21 of debt issuance costs was amortized to interest expense, respectively, using the effective interest method. The effective interest rate on the balance sheet and disclosing key information about leasing arrangements. For operating leases,Term Debt for the ASU requires a lessee to recognize a right-of-use asset and a lease liability, initially measuredthree months ended June 30, 2021 was 5.69%. The Company accounts for its bank indebtedness at amortized cost.

Further, under the present valueterms of the lease payments, on its balance sheet.agreement, the Company must maintain unrestricted cash in accounts with the Bank of at least $10,000. The ASU retainscovenant was met by the Company as of June 30, 2021. The Company’s cash forecast indicates that it will need to raise additional funds during 2021, which is part of the current accounting for lessorsoperating plan, in order to meet this liquidity requirement covenant during the coming year.

The Term Debt includes a subjective acceleration clause. The Company has been continuously evaluating the actual and does not make significant changespotential business impacts related to the recognition, measurement, and presentation of expenses and cash flowsCOVID-19 pandemic. In response to the pandemic, certain measures were taken by a lessee. The ASU is effective forauthorities that could result in adverse financial impacts to the Company, in the first quarter of 2019, with early adoption permitted.including requiring Company workers to stay home. The Company continues to evaluateconsidered the effectprobability of a further slow-down of its sales team and the adoption of this ASU and expects the adoption will result in an increase in the assets and liabilities on the consolidated balance sheets for operating leases and will likely have an insignificantrelated impact on the consolidated statementspotential to trigger the Liquidity Covenant, along with the volatility of comprehensive loss.

In June 2016, the FASB issued ASU 2016-13 “Financial Instruments – Credit Losses”capital markets, which could cause SVB to improve information on credit losses for financial assets and net investmentexercise the subjective acceleration clause in leases that are not accounted for at fair value through net income. The ASU replacesdetermining the current incurred loss impairment methodology with a methodology that reflects expected credit losses. The ASU is effective forclassification of the Company’s Term Debt. When considering these factors, the Company indetermined the first quarterlikelihood of 2020, with early adoption permitted. The Company is currently evaluatingacceleration could be probable as the effect the adoption of this ASU will have on its consolidated financial statements.

In November 2016, the FASB issued ASU 2016-18 “Restricted Cash” to provide guidance on the presentation of restricted cash in the statement of cash flows. Currently, the statement of cash flows explained the change in cashpandemic continues, and cash equivalents for the period. The ASU requires that the statement of cash flows explain the change in cash, cash equivalents and restricted cash for the period. The ASU was adopted bytherefore the Company on January 1, 2018, on a retrospective basis. The adoptionhas classified the Term Debt in current liabilities.

Future maturities under the amended terms of the ASU did not have a material effect on the consolidated statements of cash flows.Term Debt are as follows:

Years Ending December 31, Amount 
2021 (remaining six months) $- 
2022  2,000 
2023  4,000 
2024  2,000 
Total  8,000 
Less unamortized debt issuance costs  (17)
Total Term Debt, less debt issuance costs $7,983 

Term Loan Refinancing

 


Motus GI Holdings, Inc. and Subsidiaries

NotesOn July 16, 2021 (the “Effective Date”), the Company entered into a loan facility (the “Kreos Loan Agreement”) with Kreos Capital VI (Expert Fund) LP (the “Lender”). Under the Kreos Loan Agreement, Lender will provide the Company with access to term loans in an aggregate principal amount of up to $12,000 (the “Loan”). Please see Note 12- Subsequent Events for additional information regarding the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)Kreos Loan Agreement.

 

In May 2017,On the “FASB” issued “ASU” No. 2017-09, “Compensation-Stock Compensation (Topic 718): ScopeEffective Date, the Company used a portion of Modification Accounting,” which clarifies whenthe proceeds from the Loan to repay in full all amounts outstanding under, and discharge all obligations in respect of, the Loan Agreement, between the Company and Silicon Valley Bank. The payment amount of approximately $8,200 included a change to terms or conditionsnegotiated prepayment premium of a share-based payment award must be accounted for as a modification. The new guidance requires modification accounting if the vesting condition, fair value or the award classification is not the same both before and after a change to$220 under the terms and conditions of the award. The new guidance was adopted bypayoff arrangement with SVB. As a result, the Company on January 1, 2018, on a prospective basis. The adoptionSVB Loan Agreement, together with all documents and agreements executed in connection therewith, including the Liquidity Covenant, have terminated and all liens associated therewith have been released as of this standard did not have a material impact on the Company’s consolidated financial statements.Effective Date.


Note 49 – Commitments and Contingencies

Royalty on Coated Products

On January 30, 2018, the Company entered into a license and supply agreement with a third party whereby it was granted a worldwide license to sell its products coated with an agent that is the intellectual property of the third party for providing a lubricious surface to the Company’s products (a “Coated Product” or “Coated Products”). The third party is entitled to a royalty in the amount of:

a.2% of the first $25 million in annual net sales of Coated Products; and
b.1.5% once annual net sales exceed $25 million of Coated Products.

The above two tiers reset annually on January 1st of each calendar year.

Minimum royalties shall be paid for each Coated Product sold by the Company as follows:

a.January 1, 2020 to December 31, 2020 - $5 per calendar quarter;
b.January 1, 2021 to December 31, 2021 - $10 per calendar quarter;
c.January 1, 2022 and beyond - $15 per calendar quarter.

Additionally, the Company shall make one-time milestone payments as follows:

a.$12.5 due 6 months after the first commercial sale of a Coated Product.
b.$12.5 due 12 months after the first commercial sale of a Coated Product.
c.$25 due 18 months after the first commercial sale of a Coated Product.

As of and for the three months ended March 31, 2018, the Company has recorded $25 as other current liabilities, $25 as other long-term liabilities, and $50 as general and administrative expense to accrue the one-time milestone payments since they sold their first coated product. The amount of royalty expense for the three months ended March 31, 2018 was deminimus.

Royalties to the IIA

The Company has received, and may receive in the future, grants from the Government of the State of Israel through the IsraelIsraeli National Authority for Technical Innovation Authority of the Ministry of Economy and Industry (the “IIA”) (formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry (the “OCS”)) for the financing of a portion of its research and development expenditures pursuant to the Israeli Law for the Encouragement of Research, Development and Technological Innovation in Industry 5744-1984 (the “Research Law”), and the Industry Law 5744-1984 (formerly knownregulations previously promulgated thereunder, as well as the Encouragement of Industrial ResearchIIA’s rules and Development Law, 5744-1984), referredbenefit tracks which apply to ascompanies receiving IIA funding (collectively, including the Research Law, and related regulations. We have received funding from the IIA, which“IIA Regulations”) The total amount that was received and recorded between the periods ending December 31, 2011 through 2016 inwas $1,332.  No amounts were received during the aggregate amount of $1,330three and havesix months ended June 30, 2021 and 2020. The Company has a contingent obligation to the IIA for the total amount received along with the accumulated LIBOR interest to date in the amount of approximately $1,370, which$1,413 and $1,407 as of June 30, 2021 and December 31, 2020, respectively. This obligation is generally repaid in the form of royalties rangingon revenues generated in any fashion from 3% to 5% of revenues on sales of products and services based on technologyknow-how developed using IIA grants, with a rate that is currently 4% (which may be increased under certain circumstances), up to an aggregate of 100% (which may be increased under certain circumstances) of the U.S. dollar-linked value of the grant,grants received, plus interest at the rate of 12-month LIBOR.

 

Repayment of the grants is contingent upon the successful completion of the Company’s R&D programs and generating sales. The Company has no obligation to repay these grants if the R&D program fails, is unsuccessful, or aborted, or if no sales are generated. The Company has recorded an immaterial expense and liability duringfor the three and six months ended MarchJune 30, 2021 and 2020, and an immaterial liability at June 30, 2021 and December 31, 2018 as sales occur.2020.


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

Royalty Payment Rights on Series A Convertible Preferred StockRoyalty Payment Rights Certificates

The Company filed a Certificate of Designation of Preferences, Rights and Limitations (the “Certificate of Designation”), establishing the rights and preferences of the holders of the Series A Convertible Preferred Stock, (“including certain directors and officers of the RoyaltyCompany (the “Royalty Payment Rights”). As set forth in the in the Certificate of Designation, the Royalty Payment Rights initially entitled the holders in aggregate, to a royalty in an amount of:

3% of net sales subject to a maximum in any calendar year equal to the total dollar amount of Units closed on in the Company’s 2017 private placement (the “2017 Private Placement;Placement”); and

5% of licensing proceeds subject to a maximum in any calendar year equal to the total dollar amount of Units closed on in the 2017 Private Placement.

On February 16, 2018, each share of Series A Convertible Preferred Stock converted into one share of common stock pursuant to a mandatory conversion. As provided for in the Certificate of Designation, if a holder had elected to convert all of their Series A Convertible Preferred Stock into shares of the Company’s common stock prior to the mandatory conversion, the holder would have forfeited any and all rights to future royalty payments, if any. If a holder had elected to convert any portion of their Series A Convertible Preferred Stock to common stock at any time prior to the mandatory conversion, such holder would have forfeited any rights to future royalty payments, if any, with respect to such converted shares. No such conversion elections were received by the Company prior to the mandatory conversion.

In addition, in connection with completion of the 2017 private placement,Private Placement, the Company issued the placement agent royalty payment rights certificates (the “Placement Agent Royalty Payment Rights Certificates”) which grants the placement agent, and its designees, the right to receive, in the aggregate, 10% of the amount of payments paid to the holders of the Series A Convertible Preferred Stock, or the holders of the Royalty Payment Rights Certificates (the “Royalty Payment Rights Certificates”), upon the conversion of the Series A Convertible Preferred Stock into shares of the Company’s common stock. The Placement Agent Royalty Payment Rights Certificates are on substantially similar terms as the Royalty Payment Rights of the Series A Convertible Preferred Stock.

The Royalty Payment Rights Certificate obligation and Placement Agent Royalty Payment Rights Certificate obligation (the “Contingent Royalty Obligation”) was recorded as a liability at fair value as “Contingent royalty obligation” in the condensed consolidated balance sheets at March 31, 2018June 30, 2021 and December 31, 20172020 (see Contingent Royalty Obligation below). The fair value at inception was allocated to the royalty rights and the residual value was allocated to the preferred shares and recorded as equity.

The Company amended its Certificate of Designation to modify the Royalty Payment Rights when the Company consummated its Initial Public Offering (“IPO)IPO”) on February 16, 2018.2018, at which time the Company converted the Series A Convertible Preferred Stock into shares of the Company’s common stock and issued the Royalty Payment Rights Certificates. Pursuant to the amended terms of the Royalty Payment Rights Certificates, if and when the Company generates sales of the current and potential future versions of the Pure-Vu system,System, including disposables, parts, and services, or if the Company receives any proceeds from the licensing of the current and potential future versions of the Pure-Vu system,System, then the Company will pay to the holders of the Royalty Payment Rights Certificates a royalty (the “Royalty Amount”) equal to, in the aggregate, in royalty payments in any calendar year for all products:


 

3% of net sales*Net Sales* for commercialized product directly; and

5% of any licensing proceeds*Licensing Proceeds** for rights to commercialize the product if sublicensed by the Company to a third-party.

*Notwithstanding the foregoing, with respect to Net Sales based Royalty Amounts, (a) no Net Sales based Royalty Amount shall begin to accrue or become payable until the Company has first generated, in the aggregate, since its inception, Net Sales equal to $20,000 (the “Initial Net Sales Milestone”), and royalties shall only be computed on, and due with respect to, Net Sales generated in excess of the Initial Net Sales Milestone, and (b) the total Net Sales based Royalty Amount due and payable in any calendar year shall be subject to a royalty cap amount per calendar year of $30,000. “Net Sales” is defined in the Royalty Payment Rights Certificates. The Company has not reached the Initial Net Sales Milestone as of June 30, 2021.

 

* Notwithstanding the foregoing, with respect to Net Sales based Royalty Amounts, (a) no Net Sales based Royalty Amount shall begin to accrue or become payable until the Company has first generated, in the aggregate, since its inception, Net Sales equal to $20,000 (the “Initial Net Sales Milestone”), and royalties shall only be computed on, and due with respect to, Net Sales generated in excess of the Initial Net Sales Milestone, and (b) the total Net Sales based Royalty Amount due and payable in any calendar year shall be subject to a cap per calendar year of $30,000. Net Sales is defined in the Certificate of Designations.


**Notwithstanding the foregoing, with respect to Licensing Proceeds based Royalty Amounts, (a) no Licensing Proceeds based Royalty Amount shall begin to accrue or become payable until the Company has first generated, in the aggregate, since its inception, Licensing Proceeds equal to $3,500 (the “Initial Licensing Proceeds Milestone”), and royalties shall only be computed on, and due with respect to, Licensing Proceeds in excess of the Initial Licensing Proceeds Milestone and (b) the total Licensing Proceeds based Royalty Amount due and payable in any calendar year shall be subject to a royalty cap amount per calendar year of $30,000. “Licensing” Proceeds is defined in the Royalty Payment Rights Certificate. The Company has not reached the Initial Licensing Proceeds Milestone as of June 30, 2021.

Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

** Notwithstanding the foregoing, with respect to Licensing Proceeds based Royalty Amounts, (a) no Licensing Proceeds based Royalty Amount shall begin to accrue or become payable until the Company has first generated, in the aggregate, since its inception, Licensing Proceeds equal to $3,500 (the “Initial Licensing Proceeds Milestone”), and royalties shall only be computed on, and due with respect to, Licensing Proceeds in excess of the Initial Licensing Proceeds Milestone and (b) the total Licensing Proceeds based Royalty Amount due and payable in any calendar year shall be subject to a cap per calendar year of $30,000. Licensing Proceeds is defined in the Certificate of Designations.

The Royalty Amount will be payable up to the later of (i) the latest expiration date forof the Company’s current patents (which is currently October 2026),issued as of December 22, 2016, or (ii) the latest expiration date of any pending patents as of the date of the Initial ClosingDecember 22, 2016 that have since been issued or may be issued in the future.future (which is currently May 2036). Following the expiration of all such patents, the holders of the Royalty Payment Rights Certificates and the holders of the Placement Agent Royalty Payment Rights Certificates will no longer be entitled to any further royalties for any period following the latest to occur of such patent expiration.

On February 16, 2018, the date of the closing of the IPO, (1) the amendment to the Certificate of Designation became effective, (2) all outstanding shares of Series A Convertible Preferred Stock were converted into shares of the Company’s common stock pursuant to a mandatory conversion, and (3) the Royalty Payment Rights Certificates were issued to the former holders of the Series A Convertible Preferred Stock.

Contingent Royalty Obligation

The Contingent Royalty Obligation was recorded as a non-current liability at fair value as “other-long-term liabilities” in the consolidated balance sheets at March 31, 2018June 30, 2021 and December 31, 20172020 in the amount of $1,740$1,734 and $1,662,$1,617, respectively. The Company records changesA loss on change in the fair value of the Contingent Royalty Obligation in the consolidated statements of comprehensive loss as “financing” income or expense. For$37 and $117 was recorded for the three and six months ending March 31, 2018 and 2017, the Company recorded financing expenseended June 30, 2021, respectively. A loss on change in the amountfair value of $78 and $65 in connection with the Contingent Royalty Obligation.Obligation of $77 and a gain on change in fair value of Contingent Royalty Obligation of $245 was recorded for the three and six months ended June 30, 2020, respectively. 

Lease Agreements

On April 13, 2017, the Company entered into a lease for a facility in Fort Lauderdale, Florida, which the Company began occupying in October 2017. The facility currently consists of 4.6 square feet, which will increase to 6.4 square feet by the second year of the lease. The term runs for seven years and two months from October 2017. Annual base rent is initially $159 per year, subject to annual increases of 2.75%, which is recognized on a straight-line basis.

On January 1, 2015, the Company entered into a five-year lease agreement for its facilities in Israel through December 31, 2019. The facility currently consists of 7.7 square feet. The annual lease fees are $82. The Company has an option to renew the lease agreement for three more years after the initial term period ends. The annual lease fees will increase by 4% beginning on the renewal option date.

Certain vehicles are leased by the Company under agreements that expire at various dates through 2021.

Many of these leases provide for payment by us, as the lessee, of taxes, insurance premiums, costs of maintenance and other costs. At March 31, 2018, the Company had the following future minimum lease commitments:

Twelve Months Ended March 31,  Amount 
2019  $357 
2020   312 
2021   214 
2022   175 
2023   180 
Thereafter   295 
Total  $1,533 


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

Other Commitments and Contingencies

The Company has a severance liabilitycontingency for severance payments to its CEO, COO, and CFO in the aggregate of approximately $600$1,408, in the event that they are terminated without cause or leave due to good cause,reason, as outlined in their employee agreements. Management estimates that the likelihood of payment is remote; therefore, no liability was reflected in these consolidated financial statements.

Any serious disruption with the Company’s operations due to the COVID-19 outbreak could impair the Company’s ability to generate sufficient cash to repay its debt obligations when they become due and payable, either when they mature, or in the event of a default, which will cause the Company to breach its covenants and may negatively impact the Company’s business operations, financial condition, and results of operations. The Company is unable to predict the outcome of these matters and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from an unfavorable outcome.


Note 510 – Related Party Transactions

Shared Space Agreement

Other than transactions and balances related to cash and share-based compensation to officers and directors,

In January 2020, the Company did not haveentered into a license agreement (the “Shared Space Agreement”) with Orchestra BioMed, Inc., formerly a greater than 5% holder of the Company’s common stock and entity in which David Hochman, the Chairman of the Company’s board of directors, serves as the Chairman of the board of directors and Chief Executive Officer, and Darren Sherman, a member of the Company’s board of directors, serves as a director and as President and Chief Operating Officer. During the three and six months ended June 30, 2021, the Company recorded license fee of $47 and $94, respectively, in relation to the Shared Space Agreement. This amount is netted with rent expense in general and administrative expenses. During the three and six months ended June 30, 2020, the Company recorded license fee of $44 and $79, respectively, in relation to the Shared Space Agreement. This amount is netted with rent expense in general and administrative expenses. As of June 30, 2021 and December 31, 2020, the Company recorded a related party receivable of $2 and $0, respectively.

Orchestra BioMed, Inc. will continue to pay a monthly license fee based on the shared space to the Company until the expiration of the Shared Space Agreement in September 2024. Aggregate license fees will range from $162 to $198 in any transactions and balances with related parties and executive officersgiven calendar year during the term of the Shared Space Agreement.

Note 11 – Stock-based compensation

Issuance of Common Stock

On January 13, 2021, the non-employee members of the Board of Directors were granted an aggregate of 52,317 fully vested shares of Common Stock as compensation, in lieu of cash compensation, for service as directors during the fourth quarter of 2020, pursuant to the Company’s non-employee director compensation policy. The Company recorded $56 in accrued expenses as of December 31, 2020 for director services during the three months ending Marchended December 31, 20182020. The number of shares granted to the Company’s directors, in lieu of cash compensation, was determined by the dollar amount of quarterly fees due under the non-employee director compensation policy divided by the fair market value of a share of Common Stock as of the grant date which was $1.08.

On February 17, 2021, the Company’s Compensation Committee approved a modification to the non-employee director compensation policy to permit payment of the fees for service as directors for 2021 in grants of the Company’s common stock, in lieu of cash compensation. Non-employee members of the Board of Directors were granted an aggregate of 121,237 fully vested shares of common stock at a price equal to $1.78 per share of common stock, as compensation, in lieu of $216 of cash compensation, for service as directors for 2021. On June 22, 2021, the Company granted to its newly appointed director an aggregate of 18,209 fully vested shares of common stock at a price equal to $1.04 per share of common stock, as compensation, in lieu of $19 of cash compensation, for service as a director for 2021. As of June 30, 2021, the Company recorded $121 in prepaid board of directors’ compensation. For the three and 2017 except forsix months ended June 30, 2021, the following:Company recorded $60 and $114 of expense, respectively, in relation to the board of directors’ compensation.

 

SalesIn March 2021, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) , or at- the- market offering, with Oppenheimer & Co. Inc. (“Oppenheimer”), under which it may offer and Marketing Services Arrangement with FreeHold Surgical, Inc.sell from time to time common shares having an aggregate offering price of up to $25,000. On April 30, 2021, the Company sold 1,340,870 shares of common stock pursuant to the above-described Equity Distribution Agreement, resulting in net cash proceeds of $1,826, after deducting issuance costs of $74.

 

In August, 2017, the Company began payingOn May 17, 2021, we issued an aggregate of 50,000 fully vested shares of common stock tomonthly fee to FreeHold Surgical, Inc (“FreeHold”), an entityconsultant in which one of our Directors serves as a Director and President. Pursuant to the fee arrangement, the Company pays FreeHold a monthly amount of approximately $25 as all-in compensationconsideration for sales and marketing services that were performed for the Company, on a part time basis, by two Freehold sales representatives. As of March 31, 2018 and December 31, 2017, the Company had $50 recorded as accounts payable to FreeHold. Forduring the three months ended March 31, 2018,June 30, 2021 under a consulting agreement, with fair value of $53, based on a price of $1.06 per share of common stock, which was the closing price of the Company’s stock at the date of issuance. The Company recorded $53 of expense in the six months ended June 30, 2021, in relation to the consulting agreement.

Issuance of Warrants to Purchase Common Stock

On February 6, 2020, the Company entered into a services agreement whereby it agreed to issue warrants to purchase 120,000 shares of common stock of the Company. The warrants will vest over a one-year period on a monthly basis and expire three years from the date of issuance. 60,000 of the granted warrants are exercisable at a price equal to $2.16 per share of common stock and 60,000 of the remaining warrants granted are exercisable at a price equal to $3.50 per share of common stock. The fair value of the warrants were valued on the date of grant at $112 using the Black-Scholes option-pricing model with the following parameters: (1) risk-free interest rate of 1.43%; (2) expected life in years of 3.0; (3) expected stock volatility of 74.82%; and (4) expected dividend yield of 0%. The Company recorded $75$28 and $47 as general and administrative expense relatedin the accompanying condensed consolidated statement of comprehensive loss in relation to this arrangement.the consulting agreement for the three and six months ended June 30, 2020, respectively. The Company recorded $0 and $9 as general and administrative expense in the accompanying condensed consolidated statement of comprehensive loss in relation to the consulting agreement for the three and six months ended June 30, 2021, respectively.

 

Note 6 – Stockholder’s Equity

Initial Public Offering

On February 16, 2018,January 20, 2021, the Company closed its IPOentered into a services agreement with a service provider whereby it agreed to issue warrants to purchase an aggregate 340,020 shares of common stock of the Company with an exercise price equal to $1.75 per share of common stock, which will vest over a one-year period on a monthly basis and will have an exercise period of three years from the date of issuance. The fair value of the warrants were valued on the date of grant at $355 using the Black-Scholes option-pricing model with the following parameters: (1) risk-free interest rate of 0.19%; (2) expected life in years of 3.0; (3) expected stock volatility of 100.99%; and (4) expected dividend yield of 0%. The Company recorded $89 and $148 as general and administrative expense in the accompanying consolidated statement of comprehensive loss in relation to the consulting agreement for the three and six months ended June 30, 2021, respectively.


On August 28, 2020 the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) under which it sold 3,500,000and issued to an institutional investor (the “Holder”), in a registered direct offering, an aggregate of 3,200,000 shares of the Company’s common stock at a public offering price of $5.00par value $0.0001 per share. In connection with the closing of the IPO, (1) the Company received net proceeds of approximately $15,000 after deducting underwriting discountsshare (the “Common Stock”), and commissions of $1,400 and other offering expenses of approximately $1,100, (2) the amendment to the registration rights agreement described below became effective, (3) the amendment to the Certificate of Designation described above in Note 4 became effective, (4) all outstanding shares of Series A Convertible Preferred Stock converted, on a one-to-one basis, into shares of the Company’s common stock, (5) the Company issued the Royalty Payment Rights Certificates as described in Note 4, and (6) the Company issuedpre-funded warrants to certain of the former Series A Convertible Preferred Stock and common stock holders, pursuant to the amendment to the Registration Rights Agreement, the amendment to the Certificate of Designation, and the execution of a lock up agreement, to purchase an aggregate of 1,095,6825,533,625 shares of the Company’s common stockCommon Stock (the “Ten Percent“Pre-Funded Warrants”). The Ten Percent Warrants are exercisable any time on or after the 180-day anniversary of the completion of the IPO, have a five-year term, and provide for cashless exercise. In addition, the Company granted the representative of the several underwriters in the IPO (the “Representative”) a 30-day option (the “Over-Allotment Option”) to purchase up to an aggregate 525,000 additional shares of the Company’s common stock at an exercise price of $5.00$0.001 per share.

The Ten Percent Warrants were valued using the Black-Scholes option pricing model under the following assumptions, (i) expected life of 5 years, (ii) volatility of 67.08%, (iii) risk-free rate of 2.63%, and (iv) dividend rate of zero. The fair value of the Ten Percent Warrants was estimated to be $3,156 which was recorded as warrant expense in the accompanying condensed consolidated statements of comprehensive loss.

On March 12, 2018, the Company closed the sale of an additional 56,000 shares of its common stock at a price of $5.00 per share, pursuant to the Representative’s partial exercise of the Over-Allotment Option. In connection with the closing of the partial exercise of the Over-Allotment Option, the Company received net proceeds of $258 after deducting underwriting discounts and commissions of $22.

Registration Rights

The Company entered into an amended registration rights agreement to waive investors’ rights to receive penalties which became effective upon the closing of the IPO. Accordingly, all penalties or other amounts due to the investors under the registration rights agreement have been forever waived and discharged, and the Company may be required to file a registration statement in accordance with the registration rights agreement, as amended, within 225 days after the IPO date.


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

Issuance of Stock

On March 27, 2018, the Company’s Board of Directors approved the issuance of 15,000 shares of the Company’s common stock to a third party for services to be provided. The stock vests immediately and is subject to a lock-up through February 14, 2019. The Company recorded the fair market value of the stock on the date of issuance as stock-based compensation in the amount of $69.

Exercise of Options

On February 21, 2018, a consultant exercised 896 options on a cashless basis which resulted in the issuance of 394 shares of the Company’s common stock.

Stock Based Compensation

Stock Options

The following table summarizes stock option activity during During the three and six months ended March 31, 2018:

   Shares Underlying Options  Weighed Average Exercise Price  Weighted average Remaining Contractual Life (years)  Aggregate Intrinsic Value 
Outstanding at December 31, 2017   1,803,094  $4.41   9.19  $334 
Granted   94,000   4.58       —  
Exercised   (896)  2.52      2 
Forfeited/canceled   (8,968)  4.30         
Outstanding at March 31, 2018   1,887,230  $4.42   9.04  $330 

At March 31, 2018, unamortized stock compensationJune 30, 2021, the Pre-Funded Warrants for stock options was $2,494, with a weighted-average recognition period of 1.21 years.

At March 31, 2018, outstanding options to purchase 657,3055,533,625 shares of common stock were exercised which resulted in aggregate proceeds of $0 and $6.

Pursuant to the Securities Purchase Agreement, as described above, in a concurrent private placement, the Company also agreed to issue to the purchaser warrants to purchase up to 8,733,625 shares of Common Stock (the “Private Placement Warrants”). These warrants were immediately exercisable at an exercise price of $1.30 per share and expire on the fifth anniversary of the date of issuance. On January 27, 2021, the Company entered into a Warrant Exercise Agreement (the “Exercise Agreement”) with the Holder, at which time 8,000,000 of the Private Placement Warrants remained outstanding, due to the prior exercise of 733,625 of the Private Placement Warrants on January 22, 2021. Pursuant to the Exercise Agreement, the Holder agreed to exercise the remaining outstanding 8,000,000 Private Placement Warrants. In consideration of the exercise, the Company agreed to sell to the Holder, new warrants (the “New Warrants”) to purchase 0.75 shares of Common Stock for each share of Common Stock issued upon such exercise of the remaining 8,000,000 Private Placement Warrants pursuant to the Exercise Agreement, or an aggregate of 6,000,000 New Warrants. In addition, the Holder paid a cash payment of $0.10 for each New Warrant issued to the Holder, for an aggregate of $600,000 to the Company. The Company received aggregate gross proceeds before expenses of approximately $11,000 from the exercise of all of the remaining 8,000,000 outstanding Private Placement Warrants held by the Holder and the payment of the purchase price for the New Warrants. The terms of the New Warrants are substantially similar to those of the Private Placement Warrants, except that the New Warrants will have an exercise price of $2.12, will be immediately exercisable and will expire five years from the date of the Exercise Agreement. The aggregate of 6,000,000 New Warrants were issued in four tranches during the first quarter of 2021 as the 8,000,000 Private Placement Warrants were exercised. The fair values of the 6,000,000 New Warrants were valued on the date of grant of each tranche and totaled in aggregate of $6,745 using the Black-Scholes option-pricing model with the following parameters: (1) risk-free interest rates with a weighted-average exerciserange of 0.41%-0.57%.; (2) expected life in years with a range of 4.95-5.00; (3) expected stock volatilities with a range of 103.00%-103.23%; and (4) expected dividend yields of 0%. The Company recognized the excess fair value of the New Warrants above the aggregate purchase price per shareas a deemed dividend of $4.31.

Stock Based Compensation

The following table sets forth total non-cash stock-based compensation by operating statement classification$6,145 for the three months ended March 31, 20182021. However, as the Company is in an accumulated deficit position as of the issuance dates, the resulting deemed dividend was recorded as a reduction of additional paid-in capital, however the deemed divided was included in net loss attributable to common shareholders in the calculation of loss per share.

In connection with the Exercise Agreement, the Company entered into a financial advisory agreement (the “Letter Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”), pursuant to which A.G.P. acted as exclusive financial advisor to the Company in this transaction and 2017:received a cash fee of $300 upon full cash exercise of the Private Placement Warrants, which was included in financing fees in the consolidated statement of shareholders’ equity, as of June 30, 2021. As additional compensation, A.G.P. will receive a cash fee equal to $200 upon the cash exercise in full of the New Warrants.

Warrants

A summary of the Company’s warrants to purchase common stock activity is as follows:

  Shares
Underlying
Warrants
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Life (years)
  Aggregate
Intrinsic Value
 
Outstanding and exercisable at December 31, 2020  17,058,051  $1.86   5.78  $        - 
Granted  6,340,020   2.10         
Exercised  (14,267,250)  1.24       - 
Outstanding at June 30, 2021  9,130,821  $3.00   3.44  $- 

As of June 30, 2021, 8,932,491 warrants were exercisable.


 

  Three Months ended March 31, 
  2018  2017 
Research and development $68  $6 
Marketing  29    
General and administrative  505   647 
Total $602  $653 

Stock Options

2016 Equity Incentive Plan

The options granted during

In December 2016, the three months ending March 31, 2018 were valued usingCompany adopted the Black-Scholes option pricing model using the following weighted average assumptions: (i) expected life of 5.7 years, (ii) volatility of 67.04%, (iii) risk free interest rate of 2.63% and (iv) dividend yield of zero.


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

2016 Equity Incentive Plan

The Company has one equity incentive plan that was adjusted in 2016. As of March 31, 2018, there are 2,641,250 shares of common stock available for issuance under the 2016 Equity Incentive Plan (the “Equity“2016 Plan”). ThePursuant to the 2016 Plan, the Company’s board of directors may grant options to purchase shares of the Company’s common stock, stock appreciation rights, restricted stock, stock units, performance shares, performance units, incentive bonus awards, other cash-based awards and other stock-based awards to employees, officers, directors, consultants and advisors. Pursuant to the terms of an annual evergreen provision in the 2016 Plan, the number of shares of common stock available for issuance under the Equity2016 Plan shall increase annually by six percent (6%) of the total number of shares of our Common Stockcommon stock outstanding on December 31st of the preceding calendar year; provided, however, that the board of directors may act prior to the first day of any calendar year to provide that there shall be no increase such calendar year, or that the increase shall be a lesser number of shares of our Common Stockthe Company’s common stock than would otherwise occur.

As On January 1, 2021, pursuant to an annual evergreen provision, the number of March 31, 2018, there were 745,788 shares of common stock reserved for future grants was increased by 1,936,669 shares. Under the 2016 Plan, effective as of January 1, 2021, the maximum number of shares of the Company’s common stock authorized for issuance is 7,592,663. As of June 30, 2021, there were 261,863 shares of common stock available for future grant under the Equity2016 Plan.

A summary of the Company’s stock option activity is as follows:

  Shares Underlying Options  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life (years)  Aggregate Intrinsic Value 
Outstanding at December 31, 2020  5,029,119  $3.00   7.96  $      - 
Granted  1,166,500   1.74         
Forfeited  (159,400)  3.53         
Outstanding at June 30, 2021  6,036,219  $2.75   8.02  $- 

The Company estimated the fair value of each stock option award using the Black-Scholes option pricing model based on the following weighted average assumptions:

  Six months Ended
June 30,
 
  2021  2020 
Expected term, in years  5.75   5.8 
Expected volatility  106.76%  79.59%
Risk-free interest rate  0.73%  1.49%
Dividend yield  -   - 
Grant date fair value $1.74  $0.95 

As of June 30, 2021, unamortized share-based compensation for stock options was $2,354, with a weighted-average recognition period of 1.04 years.

As of June 30, 2021, outstanding options to purchase 3,637,864 shares of common stock were exercisable with a weighted-average exercise price per share of $3.43.

For the three and six months ended June 30, 2021, the Company recorded $680 and $1,349, respectively, for share based compensation expense related to stock options.

For the three and six months ended June 30, 2020, the Company recorded $498 and $1,180, respectively, for share based compensation expense related to stock options.

Restricted Stock Units

On February 17, 2021, the Company’s Compensation Committee approved the issuance of 160,000 restricted stock unit awards to non-employee directors which vest on the first anniversary of the date of grant, and 266,000 restricted stock unit awards, to executives which vest over a three-year period on a quarterly basis. The aggregate fair value of the restricted stock unit awards granted was estimated to be $758 using the market price of the stock on the date of the grant which is expensed using the straight-line method over a one to three-year period.

The Company recorded $241 and $423 as general and administrative expense in the accompanying condensed consolidated statements of comprehensive loss for the three and six months ended June 30, 2021, respectively, in relation to the aggregate 927,266 restricted stock units issued to date to the CEO, executives, and directors.


A summary of the Company’s restricted stock unit awards activity is as follows:

  Number of Shares  Weighted Average Grant Date Fair Value 
Nonvested at December 31, 2020  337,927  $3.10 
Granted  426,000    1.78 
Vested  (118,996)  2.74 
Nonvested at June 30, 2021  644,929  $2.30 

As of June 30, 2021, unamortized share compensation for restricted stock units was $1,233, with a weighted-average recognition period of 0.99 years.

Share-based Compensation

The following table sets forth total non-cash share-based compensation for the issuance of options to purchase common stock, warrants to purchase common stock, and restricted stock unit award by operating statement classification for the three and six months ended June 30, 2021 and 2020:

  Three Months ended
June 30,
  Six Months ended
June 30,
 
  2021  2020  2021  2020 
Research and development $169  $114  $303  $337 
Sales and marketing  105   44   222   172 
General and administrative  736   495   1,404   948 
Total $1,010  $653  $1,929  $1,457 

Note 712 – Subsequent Events

Term Loan Refinancing

On July 16, 2021 (the “Effective Date”), the Company entered into a loan facility (the “Kreos Loan Agreement”) with Kreos Capital VI (Expert Fund) LP (the “Lender”). Under the Kreos Loan Agreement, the Lender will provide the Company with access to term loans in an aggregate principal amount of up to $12,000 (the “Loan”) in three tranches as follows: (a) on the Effective Date, a loan in the aggregate principal amount of $4,000 (the “Convertible Bullet Loan”), (b) on the Effective Date, a loan in the aggregate principal amount of $5,000 (“Tranche B”), and (c) available until December 31, 2021, a loan in the aggregate principal amount of $3,000 (“Tranche C”, together with the Convertible Bullet Loan and Tranche B, the “Loan” or “Loans”). The Convertible Bullet Loan and Tranche B were funded on the Effective Date.

The Company has analyzed its operations subsequentConvertible Bullet Loan requires forty-eight monthly interest only payments commencing after the Effective Date and thereafter full payment of the then outstanding principal balance of the Bullet Loan on July 1, 2025. The Tranche B loan requires interest only monthly payments commencing on the Effective Date until September 30, 2022 and, thereafter, thirty-three monthly payments of principal and interest accrued thereon until June 1, 2025. The Tranche C loan, to Marchthe extent drawn on or prior to December 31, 20182021, requires monthly payments of interest only commencing on the date drawn until September 30, 2022 and, notedthereafter, thirty-three monthly payments of principal and interest accrued thereon until June 1, 2025. Notwithstanding the following subsequent events:foregoing, in the event the Borrower completes a capital raise of a minimum of $20,000 prior to September 30, 2022, the repayment terms of the Tranche B and Tranche C loans shall automatically be amended so that the interest only period will be extended to June 30, 2023, and, thereafter, the Borrower shall pay twenty-four monthly payments of principal and interest accrued thereon until June 1, 2025.

Interest on the Convertible Bullet Loan accrues at 7.75% per annum. Interest on the Tranche B and Tranche C loans accrues at 9.5% per annum.

On May 10, 2018,

The Loan Agreement contains customary representations and warranties, indemnification provisions in favor of Lender, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s Boardability to, among other things, incur additional indebtedness, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of Directors approvedassets and enter into certain transactions with affiliates, in each case subject to certain exceptions. There are no liquidity or financial covenants.

In connection with the issuance of 58,000 optionsKreos Loan Agreement, the Company also issued to 4 employees which vest overLender a three-year period on a quarterly basiswarrant (“Warrant”), dated July 16, 2021, to purchase up to 190,949 shares of the Company’s common stock, at $4.36, the closing share price of the Company’s common stock on the Nasdaq Capital Market on May 10, 2018.

On May 10, 2018, the Company’s Board of Directors approved the entry into a Consultant Agreement with a proposed service provider to the Company. Pursuant to the agreement, the board authorized (a) upon execution of the agreement, issuance of a warrant to purchase 10,000 shares of the Company’s common stock, with an exercise price of $5.25$1.0474 per share, (b) uponpayable in cash or on a cashless basis according to the four (4) month anniversary offormula set forth in the execution of the agreement, provided the service provider is still engaged at that time, issuance of a warrant to purchase 10,000 shares of the Company’s common stock, with anWarrant. The exercise price of $6.25 per share,the Warrant and (c)the number of shares issuable upon the eight (8) month anniversaryexercise of the executionWarrant are subject to adjustments for stock splits, combinations, stock dividends or similar events. The Warrant is exercisable until the date that is ten years after the date of issuance.

On the Effective Date, the Company used a portion of the agreement, providedproceeds from the service provider is still engaged at that time, issuance of a warrantLoan to purchase 10,000 sharesrepay in full all amounts outstanding under, and discharge all obligations in respect of, the Company’s common stock,Loan Agreement, between the Company and Silicon Valley Bank. The payment amount of approximately $8,200 included a negotiated prepayment premium of $220 under the terms of the payoff arrangement with an exercise price of $7.25 per share (collectively, such warrants referred to as the “Consultant Warrants”). The Consultant Warrants will each have a five year term and will provide for cashless exercise. Silicon Valley Bank.


 


Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under “Risk Factors.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

our limited operating history;

our history of operating losses in each year since inception and expectation that we will continue to incur operating losses for the foreseeable future;

our current and future capital requirements to support our development and commercialization efforts for the Pure-Vu systemSystem and our ability to satisfy our capital needs;

our dependence on the Pure-Vu system,System, our sole product candidate, which is still in development;product;

our ability to obtain approval from regulatory agents in different jurisdictions for the Pure-Vu system;System;

our Pure-Vu systemSystem and the procedure to cleanse the colon in preparation for colonoscopy are not currently separately reimbursable through private or governmental third-party payors;

our lack of a developed sales and marketing organization and our ability to commercialize the Pure-Vu system;System;

our dependence on third-parties to manufacture the Pure-Vu system;System;

our ability to maintain or protect the validity of our patents and other intellectual property;

our ability to retain key executives and medical and science personnel;

our ability to internally develop new inventions and intellectual property;

interpretations of current laws and the passages of future laws;

acceptance of our business model by investors;


the accuracy of our estimates regarding expenses and capital requirements; andrequirements

our ability to adequately support growth.growth; and

our ability to project in the short term the hospital medical device environment considering the global pandemic and strains on hospital systems

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipateanticipated in our forward-looking statements. Please see “Part II—Item 1A—Risk Factors” for additional risks which could adversely impact our business and financial performance.


All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

Overview

We have developed the Pure-Vu System, a single-use medical device system (the “Pure-Vu system”),that has been cleared by the United StatesU.S. Food and Drug Administration (the “FDA”), that is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaningthe cleansing of a poorly prepared colon by irrigating or cleaning the colongastrointestinal tract during colonoscopy and evacuating the irrigation fluid (water), feces and other bodily fluids and matter.to help facilitate upper gastrointestinal (“GI”) endoscopy procedures.  The Pure-Vu systemSystem has been designed to integratereceived a CE Mark in the EU for use in colonoscopy.  The Pure-Vu System integrates with standard and slim colonoscopes, as well as gastroscopes, to enable cleaningimprove visualization during the procedurecolonoscopy and upper GI procedures while preserving standardestablished procedural workflow and techniques.  OurThrough irrigation and evacuation of debris, the Pure-Vu systemSystem is designed to provide better-quality exams. Challenges exist for inpatient colonoscopy and endoscopy, particularly for patients who are elderly, with comorbidities, or active bleeds, where the procedureability to cleansevisualize, diagnose and treat is often compromised due to debris, including fecal matter, blood, or blood clots.  We believe this is especially true in high acuity patients, like GI bleeding where the existence of blood and blood clots can impair a physician’s view and removing them can be critical in allowing a physician the ability to identify and treat the source of bleeding on a timely basis.  We believe use of the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon and upper GI tract, potentially enabling effective diagnosis and treatment without delay.  In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. We also believe that the technology may be useful in preparationthe future as a tool to help reduce user dependency on conventional pre-procedural bowel prep regimens. Based on our review and analysis of 2019 market data and 2021 projections for the U.S. and Europe, as obtained from iData Research Inc., we estimate that during 2021 approximately 1.5 million inpatient colonoscopy areprocedures will be performed in the U.S. and approximately 4.8 million worldwide.  Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The Pure-Vu System does not currently reimbursable throughhave a unique reimbursement code with any private or governmental third-party payors in any country, but we intend to seek reimbursement through private or governmental third-party payorscountry. We began commercialization in the future. We do not currently promote a particular prep regimen as this is left up tofourth quarter of 2019, with the discretionfirst commercial placements of the physician since our current indication does not reference any preparation protocol. We will look to expand thesecond generation Pure-Vu system indication to allow us to actively promote minimal prep capabilities directly to patients. We plan to initiate a clinical trial in 2018 that should facilitate approval of expanded labeling in 2019. To date,System as part of our limited pilotinitial U.S. market launch we have focused on collecting clinical data on the use of the Pure-Vu system.targeting early adopter hospitals. We do not expect to generate significant revenue from product sales unlessuntil the COVID-19 pandemic has fully subsided and until we expand our commercialization efforts.efforts for the Pure-Vu System, which is subject to significant uncertainty.

Recent Developments

Our business

In March 2021, we presented a request for an ICD-10 code at a Center for Medicare and Medicaid Services (“CMS”) meeting, which is part of our broader strategy to obtain reimbursement for certain inpatient and outpatient procedures where the Pure-Vu System can help facilitate visualization of inadequately prepared colons in high medical need patients.

On August 2, 2021, CMS granted the Pure-Vu System a permanent ICD-10 code which will commence on October 1, 2021.  The Pure-Vu System was spun outnot selected for the fast-track new technology add-on payment for inpatient procedures.  However, the Company does not believe it faces reimbursement headwinds in the hospital inpatient environment.

On April 30, 2021, we announced that we received 510(k) clearance from the New Generation TechnologyFDA for a version of the Pure-Vu System that is compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to remove blood, blood clots and debris in order to provide a clear field-of-view for the endoscopist. The device is designed to integrate with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.


Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. We believe providing continuous irrigation and suction, while not obstructing the working channel of the gastroscope will assist physicians as they identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).

On May 7, 2021, we announced the publication of a sponsored Pure-Vu System Cost Effectiveness Analysis in the Journal of Cost Effectiveness and Resource Allocation, which is titled, “Colonoscopy in poorly prepped colons. A cost effectiveness analysis comparing standard of care to a new cleansing technology.” Sponsorship of analysis and development of the manuscript was provided by us. 

The publication presents new data from a cost effectiveness and resource allocation analysis of the Pure-Vu System on the outcomes of cost, quality of life, and aversion of colorectal cancers, as compared to the current standard of care for outpatient colonoscopy.

On June 3, 2021, we announced the publication of data from our REDUCE (“NGT”Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement”) incubator basedstudy in Nazareth, Israelan article (the “Article”) titled, “A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in 2011hospitalized patients: the REDUCE study” in the peer-reviewed journal BMC Gastroenterology.

We note evaluations of the data from our REDUCE study continue to focus exclusivelysupport our belief that the Pure-Vu System can improve bowel preparation quality in hospitalized subjects undergoing colonoscopy. We believe the Article will assist with educating the market on the potential for the Pure-Vu System to enhance patient care while also lowering costs for hospitals and payers. The Article suggests clarity of last bowel movement may be a useful indicator in predicting poor bowel preparation. However, larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings.

Our clinical research efforts in the U.S. are currently focused on critical patient populations such as acute lower GI bleeds, where time to a successful colonoscopy can be clinically impactful. We are working with a major U.S. hospital system on a study that has recently initiated enrollment that is focused on eliminating the barrier of traditional preparation to facilitate urgent colonoscopies in significant lower GI bleed patients. In this study the patients will ingest minimal to no purgative-based preparation and only receive two tap water enemas prior to the procedure. The Company continues to investigate and develop additional U.S. clinical programs to accelerate its commercial efforts as well as its outpatient reimbursement activities.

On June 16, 2021, we announced the enrollment of the first patients in the European Union (EU) study of the Pure-Vu System, which is evaluating the clinical outcomes in patients with a history of poor bowel preparation using a low volume preparation with limited diet restrictions and the Pure-Vu System.

The EU study will enroll approximately 44 patients who have a history of poor bowel preparation and are scheduled for either screening, diagnostic, or surveillance colonoscopy across two sites, including the Radboud University Medical Center (Netherlands) and the University Medical Center Mainz (Germany). The patients will undergo a low volume bowel preparation, with just 2x150ml picoprep. The patients will also be allowed to eat a low fiber diet for two days prior to the colonoscopy as opposed to the typical clear liquid diet the day before a colonoscopy. The patients will then receive intra-procedural bowel cleansing with the Pure-Vu System. The primary endpoint for the study is improvement of the bowel preparation from baseline to post procedure as assessed by the Boston Bowel Preparation Scale (BBPS), which assesses the cleanliness of each of the three segments of the colon on a zero to three scale and requires a minimum score of two or better per segment to be considered adequately prepped. The study will also look at key clinical endpoints related to the quality of the examination including detection of critical pathology in the colon.

On June 22, 2021, upon the recommendation of the Nominating and Corporate Governance Committee of our Board of Directors (the “Board”), our Board increased its size to eight directors and appointed Sonja Nelson as a director to fill the newly created vacancy. Ms. Nelson was also appointed to serve as a member of, and as Chair of, the Audit Committee of the Board effective as of June 22, 2021. Ms. Nelson was selected as a director due to her management experience with pharmaceutical and consumer health products, and her financial and accounting experience.  In connection with Ms. Nelson’s appointment, Shervin Korangy stepped down as a member of, and as Chair of, the Audit Committee, effective as of June 22, 2021. Mr. Korangy continues to serve as a director of the Company.

The Company is also announcing the development of the Pure-Vu system. We initiated preclinical testing in 2011 and started clinical testingEVS, the third generation of the first prototype versionCompany’s system that will offer continued advancement of the current platform, including upper and lower GI capabilities, a reduced footprint workstation, and faster set-up times. The Company expects to submit the Pure-Vu system in Europe in late 2012. In clinical studies and pilot accounts in Europe, Israel andEVS to the US from 2012 throughFDA for 510K approval by the end of 2021.

We continue to be encouraged by an increase in GI procedural volume in the first quarter of 2018, the Pure-Vu systemU.S., as well as an uptake in hospital access and earlier prototype versions have demonstrated effective cleaningphysician availability in over 300 patients.

Recent Developments

On February 16, 2018, we closed our initial public offering (the “IPO”) in which we sold 3,500,000 shares of our common stock, par value $0.0001 per shares (the “Common Stock”), at a public offering price of $5.00 per share. In connection with the closingcertain parts of the IPO,country where the prevalence of COVID-19 has lessened. We intend to continue to be nimble in our commercial approach and explore all options with respect to how we received net proceedscan best minimize the negative consequences of approximately $15 million after deducting underwriting discountsCOVID-19 on our business. We continue to monitor the effects of COVID-19, and commissions of approximately $1.4 millionat this date we cannot fully predict the potential impact on our financial results and other offering expenses of approximately $1.1 million. On March 12, 2018, we received net proceeds of approximately $258,000 after deducting underwriting discounts and commissions of approximately $22,000 in relation to the sale of an additional 56,000 shares of our Common Stock at a price of $5.00 per share, pursuant to a partial exercise of the underwriters 30-day option to purchase up to an additional 525,000 shares of our Common Stock in connection with the IPO (the “Partial IPO Over-Allotment Exercise”).operations.


 

Financial Operations Overview

We are a development stage company and have not generated any significantlimited revenues to date from the sale of products. We have never been profitable and have incurred significant net losses each year since our accumulated deficit asinception, including a loss of March 31, 2018 was approximately $46.4 million. Our net loss$9.4 million for the threesix months ended March 31, 2018June 30, 2021, and 2017 was approximately $7.3 million and $2.8 million, respectively. Wewe expect to continue to incur significant expenses and increasingnet operating losses for the foreseeable future. As of June 30, 2021, we had $26.4 million in cash and cash equivalents and an accumulated deficit of $113.1 million. We expect our expenses to increase significantly in connection with our ongoing activities to commercialize and market the Pure-Vu system. Furthermore, we expect to incur additional costs associated with operating as a public company.System. Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

Furthermore, the extent of the impact and effects of the recent outbreak of the coronavirus COVID-19 on the operation and financial performance of our business will depend on future developments, including the duration and spread of the outbreak, related travel advisories and restrictions, production delays, or the uncertainty with respect to the accessibility of additional liquidity or capital markets, all of which are highly uncertain and cannot be predicted. If the demand for our Pure-Vu system is impacted by this outbreak for an extended period, our results of operations may be materially adversely affected.


We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

conduct a limited pilotcontinue commercialization which began in the fourth quarter of 2019, with the first commercial placements of our Pure-Vu System as part of our initial U.S. market launch through 2018 to refine how the Pure-Vu system integrates into the workflow oftargeting early adopter hospitals;

scale manufacturing with our contracted partners for both the out-patient and in-patient settings;
contract with third parties to scale up the manufacture of the workstation and disposable portions of the disposable portionPure-Vu System;

develop future generations of the Pure-Vu system;
develop a second generation systemSystem to improve user interface, optimize ease of usehandling and reduce the cost structure;

 raise sufficient funds in the capital market to effectuate our business plan, including commercialization activities and reimbursement efforts related to our Pure-Vu systemSystem and our research and development activities, including clinical and regulatory development, and the continued development and enhancement of our Pure-Vu system;System; and

operate as a public company.

Critical Accounting Policies and Estimates

Our accounting policies are essential to understanding and interpreting the financial results reported on the condensed consolidated financial statements. The significant accounting policies used in the preparation of our condensed consolidated financial statements are summarized in note 2Note 3 to the consolidated financial statements and notes thereto found in our Annual Report on Form 10-K for the year ended December 31, 2017.2020. Certain of those policies are considered to be particularly important to the presentation of our financial results because they require us to make difficult, complex or subjective judgments, often as a result of matters that are inherently uncertain.

During the threesix months ended March 31, 2018,June 30, 2021, there were no material changes to matters discussed under the heading “Critical Accounting PolicesPolicies and Estimates” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 except for the following:2020.

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-09 (ASU 2014-09) “Revenue from Contracts with Customers.” ASU 2014-09 supersedes the revenue recognition requirements in “Revenue Recognition (Topic 605)”,Results of Operations

Comparison of Three Months Ended June 30, 2021 and requires entities to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. 2020

Revenue

As currently issued, ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period.

We adopted Accounting Standards Update 2014-09 effective January 1, 2018 on a full retrospective basis. Adoption of this standard did not result in significant changes to accounting policies, business processes, systems or controls, or have a material impact on the financial position, results of operations and cash flows or related disclosures. As such, prior period financial statements were not recast.

Revenue

To date, as part of our limited launch,June 30, 2021, we have generated limited revenue from the sales of products. We do not expect to generate significant revenue from product sales unless and until we further expand our commercialization efforts for the Pure-Vu system,System, which we expect will take a number of years and is subject to significant uncertainty.

Research and Development

We incurred expenses of approximately $1.2 million and $0.6 million, respectively, duringRevenue totaled $100.0 thousand for the three months ended March 31, 2018June 30, 2021, compared to $1.0 thousand for the three months ended June 30, 2020.

Cost of Revenue

Cost of revenue for the three months ended June 30, 2021 totaled $42.0 thousand, compared to $10.0 thousand for the three months ended June 30, 2020. 


Research and 2017 for researchDevelopment

Research and development activities. These expenses include cash and non-cash expenses relating to the advancement of our development and clinical programs for the Pure-Vu system.System. We have research and development capabilities in electrical and mechanical engineering with laboratories in our facility in Israel for development and prototyping, and electronics design and testing. We also use consultants and third-party design houses to complement our internal capabilities.


Sales

Research and Marketing

We incurreddevelopment expenses of approximately $0.7 million and $0.4 million, respectively, duringfor the three months ended March 31, 2018June 30, 2021 totaled $1.5 million, compared to $1.3 million for the three months ended June 30, 2020. The increase of $0.2 million was primarily attributable to increases of $0.1 million in material costs, $0.1 million in professional services, and 2017 for sales$0.1 in stock compensation and other research and development costs, offset by a decrease of $0.1 million in salaries and other personnel related costs.

Sales and Marketing

Sales and marketing activities. These expenses include cash and non-cash expenses relatingprimarily related to the development of our sales and marketing personnel and infrastructure forsupporting the commercialization of the second generation Pure-Vu system. We have hired limited salesSystem. 

Sales and marketing personnel in the U.S. as part of our pilot launch to develop our policies and procedures, as well as to spearhead the pilot phase of the company’s market penetration.

General and Administrative Expenses

We incurred expenses of approximately $2.1 million and $1.6 million, respectively, duringfor the three months ended March 31, 2018June 30, 2021 totaled $0.8 million, compared to $0.6 million for the three months ended June 30, 2020. The increase of $0.2 million was primarily attributable to increases of $0.1 million in professional and 2017 for generalconsulting fees and administrative activities. $0.1 million of stock compensation and other sales and marketing costs.

General and Administrative

General and administrative expenses consist primarily of payrollcosts associated with our overall operations and being a public company. These costs include personnel, legal and financial professional services. Other general and administrative expenses include accounting and legal services, insurance, investor relations, compliance related fees, and expenses associated with obtaining and maintaining patents. We anticipate that our general

General and administrative expenses will increase significantly during 2018 and infor the future as we increase our headcountthree months ended June 30, 2021 totaled $2.3 million, compared to support our continued development and commercialization activities related to our Pure-Vu system. We also anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, and investor relations and communication costs associated with being a public company. Additionally, commencing in July 2017, we began to compensate our outside directors.

Stock-Based Compensation

Stock options are granted with an exercise price at no less than fair market value at$2.4 million for the date of the grant. The stock options normally expire ten years from the date of grant. Stock option awards vest upon terms determined by our board of directors.three months ended June 30, 2020.

We recognize compensation costs resulting from the issuance of stock-based awards to employees, members of our Board of directors and consultants. The fair value of each option grant was estimated as of the date of grant using the Black-Scholes option-pricing model. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. Due to our limited operating history and limited volume of sales of our common stock, we estimated our volatility in consideration of a number of factors, including the volatility of comparable public companies. The expected term of options granted to employees under our stock plans is based on the simplified method. Under this method, the expected term is equal to the sum of the weighted average vesting term plus the original contractual term, divided by two. We have elected this method as we have concluded that we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term due to the limited period of time our equity shares have been publicly traded. The vesting period is generally 36 months. The expected term of options granted under the 2016 Equity Incentive Plan (the “2016 Equity Incentive Plan”), all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is based on the average of the 5.81 years. For non-employee options, the expected term is the contractual term and stock options granted to non-employee consultants are revalued at the end of each reporting period until vested and changes in their fair value are recorded as adjustments to expense over the related vesting period. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the expected term of the option. We have never paid dividends on our common stock and do not anticipate paying dividends on our common stock in the foreseeable future. Accordingly, we have assumed no dividend yield for purposes of estimating the fair value of our share-based compensation. We recognize share-based award forfeitures as they occur rather than estimate by applying a forfeiture rate.

Emerging Growth Company Status

Under Section 107(b) of the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 


Results of OperationsOther Income and Expenses

 

Other expense, net for the three months ended June 30, 2021 totaled $0.2 million compared to other expense of $0.2 million for the three months ended June 30, 2020.

Comparison of ThreeSix Months Ended March 31, 2018June 30, 2021 and 20172020

To date, as partRevenue

As of our limited launch,June 30, 2021, we have generated limited revenue from the sales of products. We do not expect to generate significant revenue from product sales unless and until we further expand our commercialization efforts for the Pure-Vu system,System, which we expect will take a number of years and is subject to significant uncertainty.

Revenue totaled $151.0 thousand for the six months ended June 30, 2021, compared to $29.0 thousand for the six months ended June 30, 2020.

Cost of Revenue

Cost of revenue for the six months ended June 30, 2021 totaled $70.0 thousand, compared to $40.0 thousand for the six months ended June 30, 2020.


 

Research and Development

Research and development expenses include cash and non-cash expenses relating to the advancement of our development and clinical programs for the Pure-Vu System. We have research and development capabilities in electrical and mechanical engineering with laboratories in our facility in Israel for development and prototyping, and electronics design and testing. We also use consultants and third-party design houses to complement our internal capabilities.

Research and development expenses for the threesix months ended March 31, 2018June 30, 2021 totaled approximately $1.2$2.9 million, an increase of $0.6compared to $3.2 million over the $0.6 million recorded for the threesix months ended March 31, 2017.June 30, 2020. The increasedecrease of $0.3 million was primarily attributable to increasesa decrease of $0.4$0.5 million in salaries and wages, $0.2other personnel related costs, offset by increases of $0.1 million in subcontractormaterial costs $0.06and $0.1 million in stock-based compensation, partially offset by a decrease in other costs of $0.02 million.professional and consulting services.

Sales and Marketing

Sales and marketing expenses include cash and non-cash expenses primarily related to our sales and marketing personnel and infrastructure supporting the commercialization of the second generation Pure-Vu System. 

Sales and marketing expenses for the threesix months ended March 31, 2018June 30, 2021 totaled approximately $0.70$1.5 million, an increase of $0.30compared to $2.4 million over the $0.40 million recorded for the threesix months ended March 31, 2017.June 30, 2020. The increasedecrease of $0.9 million was primarily attributable to increasesdecreases of $0.08$1.0 million in salaries and wages, $0.08other personnel related cost to support our commercialization efforts of the Pure-Vu System and $0.2 million in marketingdemonstration product, offset by increases of $0.1 million professional services and training product units, $0.09$0.2 million in subcontractor costs, $0.01 million inshare-based compensation and other costs,sales and $0.03 million in stock-based compensation.marketing costs. 

General and Administrative

General and administrative expenses consist primarily of costs associated with our overall operations and being a public company. These costs include personnel, legal and financial professional services, insurance, investor relations, compliance related fees, and expenses associated with obtaining and maintaining patents.

General and administrative expenses for the threesix months ended March 31, 2018June 30, 2021 totaled approximately $2.1$4.8 million, an increasecompared to $5.3 million for the six months ended June 30, 2020. The decrease of $0.5 million over the $1.6 million recorded for the year ended March 31, 2017. The increase was primarily attributable to increasesdecreases of $0.7 million in salaries and other personnel related costs, $0.2 million in lease termination fees, and $0.2 million in professional services, offset with a $0.5 million increase in share-based compensation and $0.1 million other general and administrative costs. 

Other Income and Expenses

Other expense, net for the six months ended June 30, 2021 totaled $0.4 million compared to other income of $11.0 thousand for the six months ended June 30, 2020. The increase of $0.4 million in other expense, was primarily attributable to a loss of $0.1 million in 2021 compared to a gain of $0.3 million in legal and professional fees, $0.08 million2020 from the change in salaries and wages, $0.08 million in insurance related expenses, $0.03 million in travel fees, $0.05 in license fees and $0.1 million in other expenses, offset by a decreaseestimated fair value of $0.1 million in stock-based compensationcontingent royalty obligation.

Liquidity and Capital Resources

Since inception,To date, we have generated minimal revenues, experienced negative operating cash flows and have incurred substantial operating losses from operations.our activities. We have financedexpect operating costs will increase significantly as we incur costs associated with commercialization activities related to the Pure-Vu System. We expect to continue to fund our operations primarily through utilization of our current financial resources, future product sales, and through the issuance of equity-related securities. At March 31, 2018, our accumulated deficit since inception was approximately $46.4 million.debt or equity.

In December 2019, we entered into a Loan and Security Agreement, as subsequently amended from time to time (the “SVB Loan Agreement”), for $8.0 million with Silicon Valley Bank (the “Bank” or “SVB”). Under the terms of the SVB Loan Agreement we were required to maintain unrestricted cash in accounts held at SVB of at least $10.0 million (the “Liquidity Covenant”). As described in greater detail below, in connection with entering into the Kreos Loan Agreement (as defined below), we have terminated the SVB Loan Agreement as of July 16, 2021 and are no longer subject to the Liquidity Covenant. 

 

At


On August 28, 2020, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) under which we sold and issued to an institutional investor (the “Holder”), in a registered direct offering, an aggregate of 3,200,000 shares of our common stock par value $0.0001 per share (the “Common Stock”), and pre-funded warrants to purchase an aggregate of 5,533,625 shares of Common Stock (the “Pre-Funded Warrants”). The offering price was $1.145 for each share of Common Stock and $1.144 for each Pre-Funded Warrant. The Pre-Funded Warrants were immediately exercisable at a price of $0.001 per share of Common Stock. Pursuant to the Securities Purchase Agreement, in a concurrent private placement, we also agreed to issue to the Holder warrants to purchase up to 8,733,625 shares of Common Stock (the “Private Placement Warrants”). These warrants were immediately exercisable at an exercise price of $1.30 per share and expire on the fifth anniversary of the date of issuance. In connection with the closing of the offering, we received gross proceeds of $10.0 million before deducting placement agent fees and other offering expenses of $0.8 million from the issuance of the Common Stock, the Pre-Funded Warrants and the Private Placement Warrants.

On January 27, 2021, we entered into a Warrant Exercise Agreement (the “Exercise Agreement”) with the Holder, at which time 8,000,000 of the Private Placement Warrants remained outstanding, due to the prior exercise of 733,625 of the Private Placement Warrants on January 22, 2021. Pursuant to the Exercise Agreement, in order to induce the Holder to exercise all of its remaining outstanding 8,000,000 Private Placement Warrants for cash, we agreed to sell to the Holder, new warrants (the “New Warrants”) to purchase 0.75 shares of Common Stock for each share of Common Stock issued upon such exercise of the remaining 8,000,000 Private Placement Warrants pursuant to the Exercise Agreement, or an aggregate of 6,000,000 New Warrants. The terms of the New Warrants are substantially similar to those of the Private Placement Warrants, except that the New Warrants will have an exercise price of $2.12, will be immediately exercisable and will expire five years from the date of the Exercise Agreement. In addition, the Holder paid a cash payment of $0.10 for each New Warrant issued to the Holder, for an aggregate of $600,000 to the Company. We received aggregate gross proceeds before expenses of approximately $11.0 million from the exercise of all of the remaining 8,000,000 outstanding Private Placement Warrants held by the Holder and the payment of the purchase price for the New Warrants.

In connection with the Exercise Agreement, we entered into a financial advisory agreement (the “Letter Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”), pursuant to which A.G.P. acted as exclusive financial advisor to us in this transaction and received a cash fee of $0.3 million upon full cash exercise of the Private Placement Warrants. As additional compensation, A.G.P. will receive a cash fee equal to $0.2 million upon the cash exercise in full of the New Warrants.

In March 31, 2018,2021, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”), under which it may offer and sell from time to time common shares having an aggregate offering price of up to $25.0 million. During the three and six months ended June 30, 2021, we sold approximately 1.3 million shares of common stock pursuant to the above-described Equity Distribution Agreement, resulting in net cash proceeds of $1.8 million, after deducting issuance costs of $0.1 million.

On July 16, 2021 (the “Effective Date”), we entered into a loan facility (the “Kreos Loan Agreement”) with Kreos Capital VI (Expert Fund) LP (the “Lender”). Under the Kreos Loan Agreement, Lender will provide us with access to term loans in an aggregate principal amount of up to $12.0 million. We drew $9.0 million of term loans pursuant to the Kreos Loan Agreement on the Effective Date, and applied $8.2 million of the proceeds, inclusive of a negotiated prepayment premium of approximately $0.2 million, to repay in full all amounts outstanding under, and discharge all obligations in respect of the SVB Loan Agreement. As a result, the SVB Loan Agreement, together with all documents and agreements executed in connection therewith, including the Liquidity Covenant, have terminated and all liens associated therewith have been released as of the Effective Date. The Company intends to use the remaining proceeds of the Kreos Loan Agreement to enhance the Company’s product development and commercial growth plans, and for general corporate purposes.

We have been continuously evaluating the actual and potential business impacts related to the COVID-19 pandemic. While the full impact of the pandemic continues to evolve, the financial markets have been subject to significant volatility that adversely impacts our ability to enter into, modify, and negotiate favorable terms and conditions relative to equity and debt financing initiatives. The uncertain financial markets, potential disruptions in supply chains, mobility restraints, and changing priorities could also affect our ability to enter into key agreements. The outbreak and government measures taken in response to the pandemic have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, have spiked, while demand for other goods and services have fallen. The future progression of the outbreak and its effects on our business and operations are uncertain. We and our third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak.

As of June 30, 2021, we had total current assets of approximately $19.6$28.1 million and total current liabilities of approximately $1.6$10.4 million resulting in working capital of $18.0$17.7 million. Net cash used in operating activities for the threesix months ended March 31, 2018June 30, 2021 was approximately $3.5$7.6 million, which includes a net loss of approximately $7.3$9.4 million, offset by non-cash expenses of approximately $3.9 million principally related to warrant expense of $3.2 million , stock-basedshare based compensation expense of $0.6$1.9 million, depreciation and amortization of $0.2 million, issuance of common stock for board of directors’ compensation of $0.1 million, and revaluationa loss on the change in estimated fair value of contingent royalty obligation of $0.08$0.1 million, approximately $0.03 million of cash provided from a change in net working capital items principally related to the increase in accounts payable and accrued expenses, and approximately $0.3 million of cash used from a changeoffset by changes in net working capital items principally related to the increase in prepaid expenses and other current assets of $0.4 million, and long-term assets.the increase in accounts payable and accrued expenses of $0.2 million.


 

Cash

Net cash used in investing activities for the threesix months ended March 31, 2018June 30, 2021 totaled approximately $0.08 for$0.3 million related to the purchase of fixed assets.

 

CashNet cash provided by financing activities for the threesix months ended March 31, 2018June 30, 2021 totaled approximately $15 million. On February 16, 2018, we closed our IPO in which we sold 3,500,000$13.4 million related to proceeds from issuance of common shares of our Common Stock at a public offering price$1.9 million, exercise and purchase of $5.00 per share. In connection withwarrants of $12.0 million, offset by financing fees related to the closingexercise of the IPO, we received net proceedswarrants of approximately $15 million after deducting underwriting discounts and commissions of approximately $1.4$0.3 million and other offering expenses of approximately $1.1 million. On March 12, 2018, we received net proceeds of approximately $258,000 in relationfinancing fees related to the saleat the market offering of an additional 56,000 shares of our Common Stock at a price of $5.00 per share, pursuant to the Partial IPO Over-Allotment Exercise completed in March 2018.$0.1 million.

 


At March 31, 2018,As of June 30, 2021, we had cash and cash equivalents of approximately $18.6$26.4 million. Based on our current business plan, we believe our cash and cash equivalents balance as of March 31, 2018 will be sufficient to meet our anticipated cash requirements through approximately the second quarter of 2019. However, there is no assurance that the current business plan will be achievable, and such conditions raise substantial doubts about the Company's ability to continue as a going concern.

We will need to raise significant additional capital to continue to fund operations. We may seek to sell common or preferred equity, convertible debt securities or seek other debt financing. In addition, we may seek to raise cash through collaborative agreements or from government grants. The sale of equity and convertible debt securities may result in dilution to our stockholdersshareholders and certain of those securities may have rights senior to those of our common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights.

The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our product and clinical development programs.programs as well as commercial activities. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate expenses including some or all ofthose associated with our planned product development, clinical trials.

Contractual Obligationstrial and Commitmentscommercial efforts.

Royalty on Coated ProductsShelf Registration Statements

On January 30, 2018, we entered into a license and supply agreement with a third party whereby we were granted a worldwide license to sell our products coated with an agent that is the initial property of the third party for providing a lubricious surface to our products (a “Coated Product” or “Coated Products”). The third party is entitled to a royalty in the amount of:

a.2% of the first $25 million in annual net sales of Coated Products; and
b.1.5% once annual net sales exceed $25 million of Coated Products.

The above two tiers reset annually on January 1st of each calendar year.

Minimum royalties shall be paid for each Coated Product sold by us as follows:

a.

January 1, 2020 to December 31, 2020 - $5,000 per calendar quarter;

b.January 1, 2021 to December 31, 2021 - $10,000 per calendar quarter;
c.January 1, 2022 and beyond - $15,000 per calendar quarter.

Additionally, we shall make one-time milestone payments as follows:

a.$12,500 due 6 months after the first commercial sale of a Coated Product.
b.$12,500 due 12 months after the first commercial sale of a Coated Product.
c.

$25,000 due 18 months after the first commercial sale of a Coated Product.

Royalty Payment Rights on Series A Convertible Preferred Stock

On December 20, 2016,March 26, 2019, we filed a Certificate of Designation of Preferences, Rightsshelf registration statement (File No. 333-230516) with the Securities and LimitationsExchange Commission (the “Certificate of Designation”“2019 Shelf Registration Statement”), establishing the rightswhich was declared effective on April 24, 2019, that allows us to offer, issue and preferences of the holders of the Series A Convertible Preferred Stock (“the Royalty Payment Rights”). As set forth in the in the Certificate of Designation, the Royalty Payment Rights initially entitled the holders in aggregate,sell up to a royaltymaximum aggregate offering price of $75.0 million of any combination of our common stock, preferred stock, warrants, debt securities, subscription rights and/or units from time to time, together or separately, in an amount of:

3% of net sales subject to a maximum in any calendar year equal to the total dollar amount of Units closed on in the 2017 Private Placement; and

one or more offerings. As of June 30, 2021, we have sold approximately $31.8 million of securities under 2019 Shelf Registration Statement.


5% of licensing proceeds subject to a maximum in any calendar year equal to the total dollar amount of Units closed on in the 2017 Private Placement.

On FebruaryMarch 16, 2018, each share2021, we filed a shelf registration statement (File No. 333-254343) with the Securities and Exchange Commission (the “2021 Shelf Registration Statement”), which was declared effective on March 26, 2021, that allows us to offer, issue and sell up to a maximum aggregate offering price of Series A Convertible Preferred Stock converted into$100.0 million of any combination of our common stock, preferred stock, warrants, debt securities, subscription rights and/or units from time to time, together or separately, in one shareor more offerings. As of June 30, 2021, we have not sold any securities under 2021 Shelf Registration Statement, except as described below.

The 2021 Shelf Registration Statement includes a prospectus registering the at-the-market offering program pursuant to the Equity Distribution Agreement with Oppenheimer, under which we may offer and sell from time to time common shares having an aggregate offering price of up to $25.0 million. During the three and six months ended June 30, 2021, we sold approximately 1.3 million shares of common stock pursuant to a mandatory conversion. As provided forthe above-described Equity Distribution Agreement, resulting in net cash proceeds of $1.8 million, after deducting issuance costs of $0.1 million.

Our ability to issue securities is subject to market conditions and other factors including, in the Certificate of Designation, if a holder had elected to convert all of their Series A Convertible Preferred Stock into sharescase of our common stock prior todebt securities, our credit ratings. Each issuance under the mandatory conversion,shelf registration statements will require the holder would have forfeited anyfiling of a prospectus supplement identifying the amount and all rights to future royalty payments, if any. If a holder had elected to convert any portion of their Series A Convertible Preferred Stock to common stock at any time prior to the mandatory conversion, such holder would have forfeited any rights to future royalty payments, if any, with respect to such converted shares. No such conversion elections were received by us prior to the mandatory conversion.

In addition, in connection with completionterms of the 2017 private placement, we issued the placement agent royalty payment rights certificates (the “Placement Agent Royalty Payment Rights Certificates”) which grants the placement agent, and its designees the rightsecurities to receive, in the aggregate, 10% of the amount of payments paid to the holders of the Series A Convertible Preferred Stock, or the holders of the Royalty Payment Rights Certificates (the “Royalty Payment Rights Certificates”), upon the conversion of the Series A Convertible Preferred Stock into shares of our common stock. The Placement Agent Royalty Payment Rights Certificates are on substantially similar terms as the Royalty Payment Rights of the Series A Convertible Preferred Stock.

We amended the Certificate of Designation to modify the Royalty Payment Rights when we consummated our Initial Public Offering (“IPO) on February 16, 2018. Pursuant to the amended terms, if and when we generate sales of the Pure-Vu system, including disposables, parts, and services, or if we receive any proceeds from the licensing of the Pure-Vu system, then we will pay to the holders of the Royalty Payment Rights Certificates a royalty (the “Royalty Amount”) equal to, in the aggregate, in royalty payments in any calendar year for all products:

3% of net sales* for commercialized product directly;
5% of any licensing proceeds** for rights to commercialize the product if sublicensed by the Company to a third-party.

* Notwithstanding the foregoing, with respect to Net Sales based Royalty Amounts, (a) no Net Sales based Royalty Amount shall begin to accrue or become payable until we have first generated, in the aggregate, since our inception, Net Sales equal to $20,000 (the “Initial Net Sales Milestone”), and royalties shall only be computed on, and due with respect to, Net Sales generated in excess of the Initial Net Sales Milestone, and (b) the total Net Sales based Royalty Amount due and payable in any calendar year shall be subject to a cap per calendar year of $30,000. Net Sales is defined in the Certificate of Designations.

** Notwithstanding the foregoing, with respect to Licensing Proceeds based Royalty Amounts, (a) no Licensing Proceeds based Royalty Amount shall begin to accrue or become payable until we have first generated, in the aggregate, since our inception, Licensing Proceeds equal to $3,500 (the “Initial Licensing Proceeds Milestone”), and royalties shall only be computed on, and due with respect to, Licensing Proceeds in excess of the Initial Licensing Proceeds Milestone and (b) the total Licensing Proceeds based Royalty Amount due and payable in any calendar year shall be subject to a cap per calendar year of $30,000. Licensing Proceeds is defined in the Certificate of Designations.

The royalty will be payable up to the later of (i) the latest expiration date for our current patents (which is currently October 2026), or (ii) the latest expiration date of any pending patents as of the date of the Initial Closing that may be issued in the future. Following the expiration of all such patents, the holders of the Royalty Payment Rights will no longer be entitled to any further royalties for any period following the latest to occur of such patent expiration.

On February 16, 2018, the date of the closing of the IPO, (1) the amendment to the Certificate of Designation became effective, (2) all outstanding shares of Series A Convertible Preferred Stock were converted into shares of our common stock pursuant to a mandatory conversion, and (3) the Royalty Payment Rights Certificates were issued to the former holders of the Series A Convertible Preferred Stock.

issued.


Lease Agreements

On January 1, 2015, we entered into a five year lease for a facility with 7,732 square feet of space in Tirat Carmel, Israel. Annual rent is $82 thousand per year.

On April 13, 2017, we entered into a lease for a facility in Fort Lauderdale, Florida, which we began occupying in October 2017. The facility currently consists of 4,554 square feet, which will increase to 6,390 square feet by the second year of the lease. The term will run for seven years and two months from October 2017. Annual base rent is initially $159 thousand per year, subject to annual increases of 2.75%.

Other

We may enter into contracts in the normal course of business with suppliers and other vendors for operating purposes. These contracts generally provide for termination on notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules, such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance sheets.


Item 3.Quantitative and Qualitative Disclosures About Market Risk.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not Applicable.


 

Not Applicable.

Item 4.Controls and Procedures.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Evaluation of Our Disclosure Controls

Our management, with the participation of our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report.June 30, 2021. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of the period covered by this report,June 30, 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Evaluation of Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in RuleRules 13a-15(f) ofand 15d-15(f) under the Exchange Act) that occurred during the period to whichcovered by this report relatesQuarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. From time to time, we make changes to our internal control over financial reporting that are intended to enhance its effectiveness and which do not have a material effect on our overall internal control over financial reporting.

As a newly public company, we continue the process of reviewing and documenting our disclosure controls and procedures, including our internal controls and procedures for financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business. 

 11


 

PART II — OTHER INFORMATION

Item 1.Legal Proceedings.

Item 1. Legal Proceedings.

None.

Item 1A.Risk Factors.

Item 1A. Risk Factors.

There have been no material changes

In addition to the other information set forth in riskthis report, you should carefully consider the factors from what was reporteddiscussed in Part I, “Item 1A. Risk Factors” in our 2017 Annual Report on Form 10-K.10-K for the year ended December 31, 2020, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, for the year ended December 31, 2020 may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.

 

There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 16, 2021, except as noted below

Risks Related to Our Financial Position and Need for Capital

Our indebtedness to Kreos Capital VI (Expert Fund) LP may limit our flexibility in operating our business and adversely affect our financial health and competitive position. Our obligations to Kreos Capital VI (Expert Fund) LP are secured by substantially all of our assets. If we default on these obligations, Kreos Capital VI (Expert Fund) LP could foreclose on our assets, which could have a materially adverse effect on our business.

In July 2021, we entered into an Agreement for the Provision of a Loan Facility with Kreos Capital VI (Expert Fund) LP (the “Loan Agreement”). All obligations under the Loan Agreement are secured by a first priority security interest on substantially all of our personal property assets, including our material intellectual property and equity interests in our subsidiaries. As a result, if we default on any of our obligations under the Loan Agreement, Kreos Capital VI (Expert Fund) LP could foreclose on its security interest and liquidate some or all of the collateral, which would harm our business, financial condition and results of operations and could require us to reduce or cease operations.

In order to service this indebtedness and any additional indebtedness we may incur in the future, we will need to generate cash from our operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business strategy, as well as general economic, financial, competitive, regulatory and other factors beyond our control. If we are unable to generate sufficient cash to repay our debt obligations when they become due and payable, either when they mature, or in the event of a default, we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact our business operations and financial condition.


The Loan Agreement restricts our ability, among other things, in each case subject to certain exceptions, to:

sell, transfer or otherwise dispose of any of our business assets or property;

enter into transactions resulting in significant changes to the voting control of our stock;

consolidate or merge with other entities or acquire other entities;

incur additional indebtedness or create encumbrances on our assets;

pay dividends, or make distributions on and, in certain cases, repurchase our capital stock;

enter into certain transactions with our affiliates;

repay subordinated indebtedness; or

make certain investments.

In addition, we are required under the Loan Agreement to comply with various undertakings. The undertakings and restrictions and obligations in the Loan Agreement, as well as any future financing agreements that we may enter into, may restrict our ability to finance our operations, engage in business activities or expand or fully pursue our business strategies. Our ability to comply with these undertakings may be affected by events beyond our control, and we may not be able to meet those undertakings.

If we breach any of the undertakings or default on any of our obligations under the Loan Agreement all of the outstanding indebtedness under the Loan Agreement could become immediately due and payable, and/or Kreos Capital VI (Expert Fund) LP could foreclose on its security interest and liquidate some or all of the collateral, which would harm our business, financial condition and results of operations and could require us to reduce or cease operations.

If our indebtedness under the Loan Agreement were to be accelerated, there can be no assurance that our assets would be sufficient to repay in full that indebtedness. In addition, upon any distribution of assets pursuant to any liquidation, insolvency, dissolution, reorganization or similar proceeding, Kreos Capital VI (Expert Fund) LP will be entitled to receive payment in full from the proceeds of the collateral which secures our indebtedness before the holders of other indebtedness or holders of our common stock receive any distribution with respect thereto.

Our cash, cash equivalents or short-term investments will only fund our operations for a limited time and we will need to raise additional capital in order to support our development and commercialization efforts.

We are currently operating at a loss and expect our operating costs will increase significantly as we incur costs associated with commercialization activities related to our Pure-Vu System. The independent registered public accounting firm that audited our 2020 financial statements, in their report, included an explanatory paragraph referring to our recurring losses since inception and expressing management’s assessment and conclusion that there is substantial doubt in our ability to continue as a going concern. At June 30, 2021, we had a cash and cash equivalents balance of approximately $26.4 million.

We will need to raise additional capital or generate substantial revenue in order to support our development and commercialization efforts.

If our available cash balances are insufficient to satisfy our liquidity requirements, including due to risks described herein, we may seek to raise additional capital through equity offerings, debt financings, collaborations or licensing arrangements. We will need to raise additional capital, and we may also consider raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities, or for other reasons, including to:

fund development and efforts of any future products;

acquire, license or invest in technologies;

acquire or invest in complementary businesses or assets; and

finance capital expenditures and general and administrative expenses.


Our present and future funding requirements will depend on many factors, including:

our revenue growth rate and ability to generate cash flows from operating activities;

our sales and marketing and research and development activities;

costs of and potential delays in product development;

changes in regulatory oversight applicable to our products; and

costs related to international expansion.

Except for our Loan Agreement with Kreos Capital VI (Expert Fund) LP, we have no arrangements or credit facilities in place as a source of funds, and there can be no assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all, and if we are not successful in raising additional capital, we may not be able to continue as a going concern. We may seek additional capital through a combination of private and public equity offerings, debt financings, which, except for limited circumstances, would require the prior written consent of Kreos Capital VI (Expert Fund) LP pursuant to our Loan Agreement, and strategic collaborations. Debt financing, if obtained, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, that could increase our expenses and require that our assets secure such debt. Equity financing, if obtained, could result in dilution to our then existing stockholders and/or require such stockholders to waive certain rights and preferences. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be materially adversely affected. We can provide no assurances that any additional sources of financing will be available to us on favorable terms, if at all. In addition, if we are unable to secure sufficient capital to fund our operations, we might have to enter into strategic collaborations that could require us to share commercial rights to the Pure-Vu System with third parties in ways that we currently do not intend or on terms that may not be favorable to us. If we choose to pursue additional indications and/or geographies for the Pure-Vu System or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital sooner than expected.

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

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

Unregistered Sales of Equity Securities

During the period covered by this Form 10-Q, or such period as described below, we made sales ofissued the following unregistered securities:

Ten Percent Warrants

Simultaneously with the closing of our IPO,On May 17, 2021, we issued warrants to purchase an aggregate of 1,095,68250,000 shares of our Common Stock (the “Ten Percent Warrants”) to certain of the holders of our formerly outstanding convertible preferredcommon stock par value $0.0001 (the “Series A Convertible Preferred Stock”), pursuant to an amendment to the registration rights agreement entered into with the investors in our 2017 private placement offering and an amendment to the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock. The Ten Percent Warrants are exercisable for our Common Stock at an exercise price of $5.00. The Ten Percent Warrants are exercisable any time on or after the 180 day anniversary of the completion of our IPO, have a five year term, and provide for cashless exercise. No fractional shares will be issued upon the exercise of the Ten Percent Warrants.

Conversion of Series A Convertible Preferred Stock

Simultaneously with the closing of our IPO, all 1,581,128 previously outstanding shares of our Series A Convertible Preferred Stock were converted, on a one-to-one basis, into shares of our Common Stock. At such time we issued (i) 1,581,128 shares of our Common Stock and (ii) Royalty Payment Rights Certificates (the “Royalty Payment Rights Certificates”) to each former holder of our Series A Convertible Preferred Stock, entitling the holders of such Royalty Payment Rights Certificates to the same royalty payment rights as were included in the Series A Convertible Preferred Stock.

Service Provider Stock and Warrants

On March 27, 2018, we issued a service provider 15,000 shares of our Common Stock, subject to a lock-up agreement, as partial paymentconsultant in consideration for services pursuant tounder a consulting agreement, between the service provider and us.valued at $53.0 thousand. 

Stock Options

On February 21, 2018, a consultant exercised 896 options on a cashless basis which resulted in the issuance of 394 shares of our common stock.

 


Securities Act Exemptions

We deemed the offers, sales and issuances of the securities described above to be exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act, including Regulation D and Rule 506 promulgated thereunder, relative to transactions by an issuer not involving a public offering.

All certificates representing the securities issued in the transactions described above included appropriate legends setting forth that the securities had not been offered or sold pursuant to a registration statement and describing the applicable restrictions on transfer of the securities.

Use of Proceeds from Registered Securities

On February 13, 2018, our registration statement on Form S-1 (Registration No. 333-222441) was declared effective by the SEC for our IPO pursuant to which we sold an aggregate of 3,500,000 shares of our Common Stock at a price to the public of $5.00 per share, for an aggregate offering of approximately $17.5 million. Piper Jaffray & Co. acted as the sole book-running manager and Oppenheimer& Co. acted as lead manager for the offering. On February 16, 2018, we closed the sale of 3,500,000 shares, resulting in net proceeds to us of $15 million after deducting underwriting discounts and commissions and other offering expenses. On March 12, 2018 we closed the sale of an additional 56,000 shares pursuant to the Partial IPO Over-Allotment Exercise, resulting in net proceeds to us of approximately $258,000 after deducting underwriting discounts and commissions. No payments were made by us to directors, officers or persons owning ten percent or more of our Common Stock or to their associates, or to our affiliates. There has been no material change in the planned use of proceeds from our IPO as described in our final prospectus filed with the SEC on February 15, 2018 pursuant to Rule 424(b).

Item 3.Defaults Upon Senior Securities.

Item 3. Defaults Upon Senior Securities.

None.

Item 4.Mine Safety Disclosures.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5.Other Information.

Item 5. Other Information.

None.


 

None.


Item 6. Exhibits

Item 6.ExhibitExhibits

Exhibit

No.

DescriptionIncorporated by ReferenceFiled
NumberExhibit DescriptionFormFile No.ExhibitFiling DateHerewith
3.131.1Certificate of Amendment of Certificate of Designations of Series A Convertible Preferred Stock*
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*X
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*X
32.132.1**Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350).**

*Filed herewith.X
101.INSInline  XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).X
101.SCHInline XBRL Taxonomy Extension Schema Document.X
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document.X
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document.X
101.LABInline XBRL Taxonomy Extension Label Linkbase Document.X
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document.X
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101)X

**Furnished, not filed.

 14


 

EXHIBIT INDEX

Exhibit

No.

Description
3.1Certificate of Amendment of Certificate of Designations of Series A Convertible Preferred Stock*
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).*
32.1Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350).**

*Filed herewith.
**Furnished, not filed.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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.

Motus GI Holdings, Inc.
Date: May 14, 2018August 12, 2021By:/s/ Mark PomeranzTimothy P. Moran
Name:Mark PomeranzTimothy P. Moran
Title:President, Chief Executive Officer and Director
(Principal Executive Officer)
Date: May 14, 2018August 12, 2021By:/s/ Andrew Taylor
Name:Andrew Taylor
Title:Chief Financial Officer
(Principal Financial Officer and
Chief Accounting Officer)


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