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, 20182023

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_________.

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)

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

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

As of May 7, 2018, 15,645,75501, 2023, 4,778,873 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding.

 

MOTUS

Motus GI HOLDINGS, INC.Holdings, Inc. and Subsidiaries

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
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’ (Deficiency) 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 Operations16
Item 3.Quantitative and Qualitative Disclosures about Market Risk22
Item 4.Controls and Procedures22
PART II
OTHER INFORMATION
Item 1.Legal Proceedings23
Item 1A.Risk Factors23
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds23
Item 3.Defaults Upon Senior Securities23
Item 4.Mine Safety Disclosures23
Item 5.Other Information23
Item 6.Exhibits24
Signatures25

i

2

PART I — FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.Statements (Unaudited)

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Inin thousands, except share and per share amounts)

  March 31,  December 31, 
  2023  2022 
  (unaudited)    
Assets        
Current assets:        
Cash and cash equivalents $8,648  $14,042 
Accounts receivable  52   59 
Inventory, current  464   488 
Prepaid expenses and other current assets  1,093   781 
Total current assets  10,257   15,370 
         
Fixed assets, net  1,237   1,325 
Inventory, non-current  334   511 
Right-of-use assets  390   428 
Other non-current assets  13   13 
Total assets $12,231  $17,647 
         
Liabilities and Shareholders’ (Deficiency) Equity        
Current liabilities:        

Current portion of long-term debt, net of unamortized debt discount of $168 and $182, respectively

 $2,611  $2,532 
Accounts payable and accrued expenses  1,472   1,969 
Operating lease liabilities - current  248   245 
Other current liabilities  47   53 
Total current liabilities  4,378   4,799 
         
Convertible note, net of unamortized debt discount of $94 and $108, respectively  3,906   3,892 
Long-term debt, net of unamortized debt discount of $104 and $135, respectively  3,904   4,589 
Contingent royalty obligation  992   1,212 
Operating lease liabilities - non-current  136   178 
Total liabilities  13,316   14,670 
         
Commitments and contingent liabilities (Note 9)  -   - 
         
Shareholders’ (deficiency) equity        
Common stock $0.0001 par value;115,000,000 shares authorized; 4,778,873 and 4,659,769 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively  -   - 
Additional paid-in capital  144,652   144,328 
Accumulated deficit  (145,737)  (141,351)
Total shareholders’ (deficiency) equity  (1,085)  2,977 
Total liabilities and shareholders’ (deficiency) equity $12,231  $17,647 

     
 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

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


1

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 
  2023  2022 
  Three Months Ended
March 31,
 
  2023  2022 
       
Revenue $56  $20 
         
Operating expenses:        
Cost of revenue - sales  9   15 
Cost of revenue - impairment of inventory  165   159 
Research and development  1,454   1,275 
Sales and marketing  842   983 
General and administrative  1,945   2,114 
Total costs and expenses  4,415   4,546 
Loss from Operations  (4,359)  (4,526)
         
Gain on change in estimated fair value of contingent royalty obligation  220   29 
Finance expense, net  (239)  (332)
Foreign currency (loss) gain  (8)  18 
         
Net loss $(4,386) $(4,811)
Basic and diluted loss per common share: $(0.92) $(1.86)
Weighted average number of common shares outstanding, basic and diluted  4,763,210   2,589,712 

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


2

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash FlowsChanges in Shareholders’ (Deficiency) Equity

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

(unaudited) 

  Shares  Amount  capital  deficit  deficit 
  Common Stock  

Additional

paid-in

  Accumulated  

Total

shareholders’

 
  Shares  Amount  capital  deficit  deficiency 
Balance at January 1, 2023  4,659,769  $-  $144,328  $(141,351) $2,977 
Issuance of common shares pursuant to at-the-market registered offering, net of issuance costs of $19  119,104            -   102   -   102 
Share based compensation  -   -   222   -   222 
Net loss  -   -   -   (4,386)  (4,386)
Balance at March 31, 2023  4,778,873  $-  $144,652  $(145,737) $(1,085)

  Common Stock  

Additional

paid-in

  Accumulated  

Total

shareholders’

 
  Shares  Amount  capital  deficit  equity 
Balance at January 1, 2022  2,416,021  $-  $132,411  $(122,754) $9,657 
Issuance of common shares pursuant to at-the-market registered offering, net of issuance costs of $111  298,761             -   3,005   -   3,005 
Issuance of common shares upon vesting of restricted stock units  13,721   -   -   -   - 
Issuance of common stock for board of directors’ compensation  24,458   -   235   -   235 
Share based compensation  -   -   521   -   521 
Net loss  -   -   -   (4,811)  (4,811)
Balance at March 31, 2022  2,752,961  $-  $136,172  $(127,565) $8,607 

     
 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 $—   
Conversion of preferred shares into common shares$—   $—   

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


3

Motus GI Holdings, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(unaudited, in thousands)

  2023  2022 
  For the Three Months Ended March 31, 
  2023  2022 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss $(4,386) $(4,811)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  117   124 
Amortization of debt issuance costs  62   59 
Gain on change in estimated fair value of contingent royalty obligation  (220)  (29)
Share based compensation  222   521 
Impairment of inventory  165   159 
Issuance of common stock for board of directors’ compensation  -   57 
Amortization on operating lease right-of-use asset  73   79 
Changes in operating assets and liabilities:        
Accounts receivable  7   91 
Inventory  22   (376)
Prepaid expenses and other current assets  (312)  (378)
Accounts payable and accrued expenses  (472)  (658)
Operating lease liabilities - current and non-current  (74)  (82)
Other current and non-current liabilities  (6)  (2)
Net cash used in operating activities  (4,802)  (5,246)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchase of fixed assets  (39)  (1)
Net cash used in investing activities  (39)  (1)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common shares  121   3,116 
Repayment of debt  (655)  - 
Equity financing fees  (19)  (94)
Net cash (used in) provided by financing activities  (553)  3,022 
         
NET DECREASE IN CASH AND CASH EQUIVALENTS  (5,394)  (2,225)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  14,042   22,563 
CASH AND CASH EQUIVALENTS AT END OF PERIOD $8,648  $20,338 
         
SUPPLEMENTAL CASH FLOW INFORMATION:        
CASH PAID FOR:        
Interest $246  $244 
         
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:        
Common stock issued for prepaid board of directors’ compensation $-  $178 
Reclassification of prepaid expenses to fixed assets $-  $4 
Reclassification of inventory to fixed assets $14  $12 
Purchase of fixed assets in accounts payable and accrued expenses $-  $45 
Financing fees included in accounts payable and accrued expenses $-  $17 
Right-of-use asset obtained in exchange for lease obligation $35  $35 
Prepaid expenses resulting from right-of-use asset obtained $-  $3 

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

4

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 Company received 510(k) clearance in February 2022 from the FDA for the Pure-Vu systemEVS 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 thehas commenced commercialization of this product. The Company does intendnot expect to seek reimbursement through private or governmental third-party payors in the future. To date, as part of the Company’s limited pilot launch, the Company has focused on collecting clinical data on the use of the Pure-Vu system.generate significant revenue from product sales until it further expands its commercialization efforts, which is subject to significant uncertainty.

Note 2 – Basis of Presentation and Going Concern Uncertainty

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 20172022 10-K filed with the SEC on March 28, 2018.31, 2023. 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, 20172022 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 theThe Company has generated minimallimited revenues to date from its activitiesthe sale of products. The Company has never been profitable and has incurred substantialsignificant net losses each year since its inception, including a loss of $4.4 million for the three months ended March 31, 2023. The Company expects to continue to incur net operating losses. Management expectslosses for the foreseeable future. Net cash used in operating activities for the three months ended March 31, 2023 was $4.8 million. As of March 31, 2023, the Company had cash and cash equivalents of $8.6 million and an accumulated deficit of $145.7 million.

In January and April 2023, the Company committed to a restructuring initiative designed to position the Company to continueexplore a range of strategic and financing alternatives focused on maximizing stockholder value and accelerating the commercialization of the Pure-Vu System. If a strategic transaction is not completed, or if additional financing is not available, the Company may not be able to generate substantial operating lossesservice our outstanding indebtedness and our payables and may have to continuefile for bankruptcy protection or pursue a dissolution of the Company and liquidation of all of the Company’s remaining assets. In such an event, the amount of cash available for distribution to the Company’s shareholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as the Company continues to fund its operations primarily through utilizationand service the Company’s outstanding indebtedness. The Company cannot provide assurance as to the amount of cash that will be available to distribute to shareholders, if any, after paying its current financial resources, future product sales,debts and through additional raisesother obligations and setting aside funds for reserves, nor as to the timing of capital.

any such distribution, if any. Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plan includes revenue generation

5

The Company has financed its operations primarily through sales of equity-related securities. In March 2021, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Oppenheimer & Co. Inc. (“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 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 tothree months ended March 31, 2023, the Company will be obtained on favorable terms or will provide the Company with sufficient capital to meet its objectives. These financial statements do not include any adjustments relating to the recoverability and classificationsold approximately 119 thousand shares of assets, carrying amounts or the amount and classificationour common stock under this agreement, resulting in net cash proceeds of liabilities that may be required should the Company be unable to continue as a going concern.$102 thousand, after deducting issuance costs of $19 thousand.

Note 3 – Summary of Significant Accounting Policies

A summary of theSignificant Accounting Policies

The significant accounting policies appliedused in preparation of these condensed consolidated financial statements for the three months ended March 31, 2023 are consistent with those discussed in Note 3 to the consolidated financial statements in the preparationCompany’s 2022 Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2023.

 

Reverse Stock Split

On July 25, 2022, the Company effected a reverse stock split of its issued and outstanding common stock, par value $0.0001 per share, at a ratio of 1-for-20. Shares of common stock underlying outstanding stock options and other equity instruments convertible into common stock were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities.

Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements follows:and notes thereto have been retroactively adjusted, where applicable, to reflect the reverse stock split.

Principles

Basis of Consolidationpresentation and 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.

Use of estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions 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.

6

 


Motus GI Holdings, Inc.

Accounting Pronouncements- Adopted

In September 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses” to improve information on credit losses for financial assets and Subsidiaries

Notes tonet investment in leases that are not accounted for at fair value through net income. ASU 2016-13 replaces the Interim Condensed Consolidated Financial Statements

(current incurred loss impairment methodology with a methodology that reflects expected credit losses. In thousands, except shareApril 2019 and per share amounts)

Revenue Recognition

TheMay 2019, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers,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 provides a single comprehensive modelprovided additional implementation guidance on the previously issued ASU. In November 2019, the FASB issued ASU 2019-10, “Financial Instruments - Credit Loss (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842),” which defers the effective date for entitiespublic filers that are considered smaller reporting companies as defined by the Securities and Exchange Commission to use in accounting for revenue arising from contracts with customers.fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted this ASU effectiveon January 1, 2018 on a full retrospective basis. Adoption2023.  The adoption of this standardASU did not result in significant changes to accounting policies, business processes, systems or controls, or have a material impact onto the financial position, results of operations and cash flows or related disclosures. As such, prior periodconsolidated financial statements wereand disclosures.

Accounting Pronouncements- Not Yet Adopted

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This guidance simplifies the accounting for convertible instruments primarily by eliminating the existing cash conversion and beneficial conversion models within Subtopic 470-20, which will result in fewer embedded conversion options being accounted for separately from the debt host. The guidance also amends and simplifies the calculation of earnings per share relating to convertible instruments. This guidance is effective for annual periods beginning after December 15, 2021, including interim periods within that reporting period, excluding smaller reporting companies. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within that reporting period, using either a full or modified retrospective approach. Since the Company is a smaller reporting company (“SRC”), implementation is not recast.

The Pure-Vu System –The Company manufactures a medical device system (a “Workstation”) and a single use disposable sleeve (a “Disposable”) designed to improve a colonoscopy procedure. These productsneeded until after December 15, 2023. We are shipped directly to healthcare professionals under contract-based terms. Revenue forcurrently evaluating the products sold is recognized at the point in time when control transfers to the customer, which is generally when the shipment is received and accepted by the customer. In certain circumstances, products are available for free of charge for a limited evaluation period. At the endimpact of the limited evaluation period,provisions of this guidance on our consolidated financial statements.

7

Note 4 –Fair Value Measurements

Liabilities measured and recorded at fair value on a recurring basis consisted of the customer may purchase the productsfollowing at which time the Company will record the corresponding 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,” which requires the measurement and recognition 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 in accordance with FASB ASC 505-50, “Equity-Based Payments to Non-Employees” (“FASB ASC 505-50”). Under FASB ASC 505-50, the Company determines the fair value of the warrants or stock-based compensation awards granted as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable.

All issuances of stock options or other equity instruments to non-employees as consideration for goods or services received by 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 cash for the services. At the end of each financial reporting period, prior to vesting or prior to the completion of 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 granted 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.

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, 2018,2023 and December 31, 2017, the Company had a full valuation allowance against deferred tax assets.2022:

The Tax Cuts and Jobs Act (the “Tax Act”), enacted 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 guidanceSchedule of ASC 740, “Income Taxes” (“ASC 740”), the Company revalued its net deferred tax assets on the date of enactment based on the reduction in the overall future tax benefit expected to be realized at the lower tax rate implemented by the new legislation. Although in the normal course of business the Company is required to make estimates and assumptions for certain tax items which cannot be fully determined at period end, the Company did not identify items for which the income tax effects 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 Measurementsof Financial Assets and Liabilities

  March 31, 2023 
  Level 1  Level 2  Level 3  Fair Value 
             
Liabilities                
Contingent royalty obligation $      -  $     -  $992  $992 

  December 31, 2022 
  Level 1  Level 2  Level 3  Fair Value 
Liabilities                
Contingent royalty obligation $       -  $        -  $1,212  $1,212 

The Company accounts for financialFinancial instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC 820 establishes acarrying values approximating fair value hierarchy that prioritizes the inputsinclude cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, and certain other current liabilities, due 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:their short-term nature.

Level 1 – Unadjusted quoted prices in active markets that are accessible 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),royalty obligation, the Company used the discounted cash flow method as of March 31, 20182023 and December 31, 2017.2022. Based on the fair value hierarchy, the Company classified contingent considerationroyalty obligation within Level 3 because valuation inputs are based on projected revenues discounted to a present value.


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 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 three months ended March 31, 2018:2023 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 

TheSchedule of Estimated Fair Value of Level 3 Contingent Royalty Obligation

  Fair Value Measurements of Contingent Royalty Obligation (Level 3) 
Balance at December 31, 2022 $1,212 
Change in estimated fair value of contingent royalty obligation               (220)
Balance at March 31, 2023 $992 

The contingent royalty obligation is re-measured at each balance sheet date using several assumptions, including the following assumptions following: 1) estimated sales growth, 2) length of product cycle, 3) patent life, 4) discount rate (28.5% and 23% as of March 31, 20182023 and December 31, 2017: 1) Discount rate of 20%2022, respectively), 2)and 5) rate of royalty payment (3% as of 3%March 31, 2023 and December 31, 2022).

In accordance with ASC-820-10-50-2(g), the Company performed a sensitivity analysis of the liability, which was classified as a levelLevel 3 financial instrument. 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$94 and a 2% increase in the discount rate would decrease the liability by approximately $183.$84. Such amounts are based on highly sensitive estimates and actual results could result in material change in future periods.

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. For the three months ended March 31, 2023 and 2022, an inventory impairment of $165 and $159, respectively, was recorded. Inventories that exceed estimated realization for the next twelve months from balance sheet date based on future sales forecasts are classified as long-term assets.

8

 

Recently Issued Accounting Standards

Inventory at March 31, 2023 and December 31, 2022 consisted of the following:

Schedule of Inventory

  March 31,
2023
  December 31,
2022
 
Raw materials $497  $697 
Work-in-process  164   155 
Finished goods  703   548 
Inventory reserve  (566)  (401)
Inventory, net $798  $999 
Inventory, current $464  $488 
Inventory, non-current $334  $511 

Note 6 – Fixed assets, net

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

Schedule of Fixed Assets Net

  March 31,
2023
  December 31,
2022
 
Office equipment $171  $171 
Computers and software  321   321 
Machinery  1,052   1,049 
Lab and medical equipment  1,503   1,477 
Leasehold improvements  200   200 
Total  3,247   3,218 
Less: accumulated depreciation and amortization  (2,010)  (1,893)
Fixed assets, net $1,237  $1,325 

Depreciation and amortization expense for the three months ended March 31, 2023 and 2022 was $117 and $124, respectively.

Note 7 – Leases

The Company leases offices in Fort Lauderdale, Florida and Israel which expire in November 2024 and December 2023, respectively.

The Company leases vehicles under operating leases that expire at various dates through 2025.

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

Schedule of Lease Cost and Supplemental Balance Sheet Information

  Three Months
Ended
March 31,
  Three Months
Ended
March 31,
 
  2023  2022 
Lease Cost        
Operating lease cost, net of related party license fee $16  $39 
Variable lease cost         25          30 
Total lease cost $41  $69 

9

 

In February 2016,

  As of
March 31,
  As of
December 31,
 
  2023  2022 
Assets        
Operating lease, right-of-use- asset $390  $428 
Liabilities        
Current        
Operating lease liabilities $248  $245 
Non-current        
Operating lease liabilities, net of current portion  136   178 
Total lease liabilities $384  $423 
         
Other information:        
Weighted average remaining lease term - operating leases  1.75 years   1.79 years 
Weighted-average discount rate - operating leases  7.20%  7.36%

The Company’s lease expense is included in general and administrative expenses which is net of the Financial Accounting Standards Boardrelated party license fee of $49 and $47 for the three months ended March 31, 2023 and 2022, respectively (see Note 10).

Note 8 – Convertible Note and Long-Term Debt

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 Note”, or “Tranche A”), (b) on the Effective Date, a loan in the aggregate principal amount of $5,000 (“FASB”Tranche B”) issued Accounting Standards Update, and (c) available until December 31, 2021, a loan in the aggregate principal amount of $3,000 (“ASU”Tranche C”, together with Tranche B, the “Long-term Debt”) 2016-02 “Leases”. The Kreos Loan Agreement contains customary representations and warranties, indemnification provisions in favor of the Lender, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to, increase transparency and comparability among organizations by recognizing leaseother things, incur additional indebtedness, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and lease liabilitiesenter into certain transactions with affiliates, in each case subject to certain exceptions. Outstanding borrowings under the Loan are secured by a first priority security interest on substantially all of the personal property assets of the Company, including the Company’s material intellectual property and equity interests in its subsidiaries. There are no liquidity or financial covenants.

The Convertible Note and Tranche B were funded on the Effective Date. As of December 31, 2021, the Company drew down the full $3,000 aggregate principal amount of Tranche C.

The Convertible Note requires forty-eight monthly interest only payments at 7.75% per annum commencing after the Effective Date and thereafter full payment of the then outstanding principal balance of the Convertible Note on July 1, 2025. The Kreos Loan Agreement contains features that would permit the Lender to convert all or any portion of the outstanding principal balance of the Convertible Note at any time, pursuant to which the converted part of the Convertible Note will be converted into that number of shares of common stock of the Company to be issued to the Lender at a price per share equal to the conversion price, of $28 per share. Following the conversion of any portion of the outstanding principal balance of the Convertible Note, the principal balance of the Convertible Note remaining outstanding shall continue to bear interest at 7.75% per annum. 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 requires interest only monthly payments commencing on the date of the draw down until September 30, 2022 and, thereafter, thirty-two monthly payments of principal and interest accrued thereon until June 1, 2025.

10

In connection with the Kreos Loan Agreement, the Company also issued to the Lender a warrant (“Warrant”), dated July 16, 2021, to purchase up to 9,547 shares of the Company’s common stock, at an exercise price of $20.948 per share, payable in cash or on a cashless basis according to the formula set forth in the Warrant. The exercise price of the Warrant and the number of shares issuable upon exercise of the Warrant 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. The Company concluded that the Warrant is indexed to its own stock and, accordingly is classified as equity. See Note 11 for further discussion of the Warrant.

The Company treated Tranche A, Tranche B and Tranche C, and the Warrant as three separate freestanding financial instruments with the proceeds received in connection with the transaction allocated amongst the instruments based on relative fair value. The proceeds received in connection with the transaction allocated amongst the instruments based on relative fair value resulted in $165 being allocated to the Warrant and a corresponding amount recorded as a debt discount to the Convertible Note and Long-term Debt. The Company recorded an aggregate debt discount of $845 related to the Loan, inclusive of the debt discount of $165 in connection to the Warrant, which will be amortized to interest expense over the term of each respective tranche using the effective interest method. The Company also paid $540 in cash for debt issuance costs. Additionally, per the Kreos Loan Agreement, with respect to the Long-term Debt, there is an advance payment of $274 that is recorded at a debt discount. The advance payment represents the last month’s payment in relation to the Long-term Debt.There is also an end of loan payment of $140 which is included on the balance sheet as a liability within the Long-term Debt and disclosing key information about leasing arrangements. also within the total aggregate debt discount of $845.

For operating leases, the ASU requires a lessee to recognize a right-of-use assetthree months ended March 31, 2023 and a lease liability, initially measured at the present value of the lease payments, on its balance sheet. The ASU retains the current accounting for lessors and does not make significant changes to the recognition, measurement, and presentation of expenses and cash flows by a lessee. The ASU is effective2022, interest expense for the Company inLoan was as follows:

Schedule of Interest Expense for Loan

  

Three Months
Ended
March 31,

 

Three Months
Ended
March 31,

 
  

2023

 2022 
Contractual interest expense $246  $268 
Amortization of debt issuance costs  62   59 
Total interest expense $308  $327 

Future principal payments under the first quarterConvertible Note as of 2019, with early adoption permitted. The Company continues to evaluateMarch 31, 2023 are as follows:

Schedule of Future Principal Payments of Convertible Note

Years Ending December 31, Amount 
2023 $- 
2024  - 
2025  4,000 
Total future principal payments  4,000 
Less unamortized debt issuance costs  (94)
Total balance – Convertible Note $3,906 

Future principal payments under the effectLong-term Debt as of the adoptionMarch 31, 2023 are as follows:

Schedule 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 insignificant impact on the consolidated statementsFuture Principal Payments of comprehensive loss.Long-term Debt

Years Ending December 31, Amount 
2023 $2,059 
2024  2,983 
2025  1,601 
Total future principal payments  6,643 
End of loan payments  140 
Less unamortized debt issuance costs of current portion of long-term debt  (168)
Less unamortized debt issuance costs of non-current portion of long-term debt  (100)
Total balance $6,515 
Less long-term debt, current $(2,611)
Long- term debt, net of current portion $3,904 

11

 

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. The ASU replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses. The ASU is effective for the Company in the first quarter of 2020, with early adoption permitted. The Company is currently evaluating 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 cash 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 by the Company on January 1, 2018, on a retrospective basis. The adoption of the ASU did not have a material effect on the consolidated statements of cash flows.


Motus GI Holdings, Inc. and Subsidiaries

Notes to the Interim Condensed Consolidated Financial Statements

(In thousands, except share and per share amounts)

In May 2017, the “FASB” issued “ASU” No. 2017-09, “Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting,” which clarifies when a change to terms or conditions 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 the terms and conditions of the award. The new guidance was adopted by the Company on January 1, 2018, on a prospective basis. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Note 49Commitments 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 grantsentered into and expects to enter into from time to time in the Government offuture, license agreements, strategic alliance agreements, assignment agreements, research service agreements, and similar agreements related to the State of Israel through the Israel 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 portionadvancement of its research and development expenditures pursuantefforts. Significant agreements are described in detail in the Company’s 2022 Form 10-K. While specific amounts will differ from quarter to quarter, the Company believes its overall activities regarding these agreements are materially consistent with those described in the 2022 Form 10-K. In addition to the Encouragement of Research, Development and Technological Innovationspecific agreements described in the Industry Law 5744-1984 (formerly known as2022 Form 10-K, the Encouragement of Industrial ResearchCompany has entered into, and Development Law, 5744-1984), referred to as the Research Law, and related regulations. We have received funding from the IIA, which was received and recorded between the periods ending December 31, 2011 through 2016,will in the aggregate amountfuture enter into, other research and service provider agreements for the advancement of $1,330its research and have a contingent obligation to the IIA in the amount of approximately $1,370, which is generally repaid in the form of royalties ranging from 3% to 5% of revenues on sales of products and services based on technology developed using IIA grants, up to an aggregate of 100% (which may be increased under certain circumstances) of the U.S. dollar-linked value of the grant, 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.development efforts. The Company has no obligationexpects 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 during the three months ended March 31, 2018 as sales occur.


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 Stock

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 (“the Royalty Payment Rights”). As set forthpay additional amounts 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 2017 Private 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,periods in connection with completion of the 2017 private placement, the Company issued the placement agent royalty payment rights certificates (the “Placement Agent Royalty Payment Rights Certificates”) which grants the placement agent,existing 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.future research and service provider agreements.

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, 2018 and December 31, 2017 (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.

Manufacturing Component Purchase Obligations

The Company amendedutilizes two outsourcing partners to manufacture its Certificate of Designation to modify the Royalty Payment Rights when the Company consummated its Initial Public Offering (“IPO) on February 16, 2018. Pursuant to the amended terms, ifworkstation and when the Company generates salesdisposable portions of the Pure-Vu system, including disposables, parts,System, and services, or ifto perform final assembly and testing of finished products. These outsourcing partners acquire components and build product based on demand information supplied by the Company. As of March 31, 2023, the Company receives any proceeds fromexpects to pay $114 under manufacturing-related supplier arrangements within the licensingnext year, substantially all of the Pure-Vu 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* 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 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.


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 for the Company’s 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 and Placement Agent 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 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 liability at fair value as “other-long-term liabilities” in the consolidated balance sheets at March 31, 2018 and December 31, 2017 in the amount of $1,740 and $1,662, respectively. The Company records changes in the fair value of the Contingent Royalty Obligation in the consolidated statements of comprehensive loss as “financing” income or expense. For the three months ending March 31, 2018 and 2017, the Company recorded financing expense in the amount of $78 and $65 in connection with the Contingent Royalty Obligation.

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.noncancelable.

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 and CFOExecutives in the aggregate of approximately $600$1,428, 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 condensed consolidated financial statements.

12

Note 510Related Party Transactions

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

In January 2020, the Company did not have any transactionsentered into a license agreement (the “Shared Space Agreement”) with Orchestra BioMed, Inc. (OBIO), formerly a greater than 5%holder of the Company’s common stock and balances with related parties and executive officers during the three months ending March 31, 2018 and 2017 except for the following:

Sales and Marketing Services Arrangement with FreeHold Surgical, Inc.

In August, 2017, the Company began paying a monthly fee to FreeHold Surgical, Inc (“FreeHold”), an entity in which oneDavid Hochman, the Chairman of our Directorsthe 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 Directordirector and President.as President and Chief Operating Officer. Pursuant to the fee arrangement,Shared Space Agreement, the Company pays FreeHoldgranted a monthly amount of approximately $25 as all-in compensation for sales and marketing services performedlicense to OBIO for the Company, on a part time basis,use of portions of the office space not being used by two Freehold sales representatives. As of March 31, 2018 and December 31, 2017, the Company had $50 recorded as accounts payablein the Company’s leased facility in Fort Lauderdale, Florida (the “Premises”), and a proportionate share of common areas of such Premises, which previously covered approximately 35% of the Premises and was to FreeHold. Forexpand incrementally to approximately 60 to 70% of the Premises by September 2024. In May 2022, the Company entered into an amendment to the Shared Space Agreement. Pursuant to the amendment, the area covered by the Shared Space Agreement was expanded to 95% of the premises and the aggregate license fees will generally range from approximately $212to approximately $270in any given calendar year during the term of the Shared Space Agreement until the termination of the lease in November 2024. During the three months ended March 31, 2018,2023 and 2022, the Company recorded $75 asa license fee of $49and $47, respectively, in relation to the Shared Space Agreement. This amount is netted with rent expense in general and administrative expense related to this arrangement.expenses.

Note 611Stockholder’s EquityShare-based compensation

Initial Public Offering

On February 16, 2018, the Company closed its IPO in which it sold 3,500,000 shares of the Company’s common stock at a public offering price of $5.00 per share. In connection with the closing of the IPO, (1) the Company received net proceeds of approximately $15,000 after deducting underwriting discounts 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 issued 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 1,095,682 shares of the Company’s common stock (the “Ten Percent 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 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 the three 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 compensation for stock options was $2,494, with a weighted-average recognition period of 1.21 years.

At March 31, 2018, outstanding options to purchase 657,305 shares of common stock were exercisable with a weighted-average exercise price per share of $4.31.

Stock Based Compensation

The following table sets forth total non-cash stock-basedshare-based compensation for the issuance of common stock, options to purchase common stock, warrants to purchase common stock, and restricted stock unit awards by operating statement classification for the three months ended March 31, 20182023 and 2017:2022:

Schedule of Stock-based Compensation

 2023  2022 
 Three Months ended March 31,  

Three Months ended

March 31,

 
 2018 2017  2023  2022 
Research and development $68  $6  $59  $97 
Marketing  29    
Sales and marketing  1   58 
General and administrative  505   647   162   366 
Total $602  $653  $222  $521 

As of March 31, 2023, unamortized share-based compensation for stock options was $572, with a weighted-average recognition period of 0.79 years.

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Stock option and warrant activity

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

Schedule of Stock Option and Warrants

  Options  Warrants 
  

Shares

Underlying

Options

  

Weighted

Average

Exercise Price

  

Shares

Underlying

Warrants

  

Weighted

Average

Exercise Price

 
Outstanding at December 31, 2022  400,137  $42.69   393,261  $50.86 
Expired  (249) $10.40   (54,717) $100.00 
Forfeited  (24,854) $12.70   -  $- 
Outstanding at March 31, 2023  375,034  $44.70   338,544  $42.91 
Exercisable at March 31, 2023  318,094  $50.04   338,544  $42.91 

As of March 31, 2023, there were 16,606 nonvested restricted stock unit awards at a weighted average grant date fair value of $16.17. As of December 31, 2022, there were 20,278 nonvested restricted stock unit awards at a weighted average grant date fair value of $18.62.

As of March 31, 2023, unamortized stock compensation for restricted stock units was $233, with a weighted-average recognition period of 0.76 years.

Issuance of Warrants to Purchase Common Stock

In February 2020, the Company entered into a services agreement whereby it agreed to issue warrants to purchase 6,000 shares of common stock of the Company. The warrants fully vested over a one-year period on a monthly basis and expire three years from the date of issuance and were exercisable at weighted average exercise price equal to $56.60 per share of common stock. In March 2022, the Company granted new warrants as a replacement to the vested warrants held by the service provider, for which all the share-based compensation expense had been recognized in prior fiscal periods. The issuance of new warrants concurrently with the cancellation of the existing warrants was treated as a modification. The Company agreed to issue replacement warrants to purchase 6,000 shares of common stock of the Company exercisable at a price equal to $10 per share of common stock. The replacement warrants immediately vested upon issuance and expire three years from the date of issuance. As a result, the Company recognized $0 and $26 of share-based compensation for the three months ended March 31, 2023 and 2022, related to the incremental fair value which is equal to the excess of the fair value of the new stock options granted over the fair value of the original award on the cancellation date.

Note 12 – Restructuring

In January 2023, the Company commenced a strategic restructuring program aimed at capital preservation. It reduced its quarterly cash expenditures by approximately 35% by eliminating approximately 45% of its workforce during the first quarter of 2023. In addition, the non-management members of the Board agreed to defer their Board fees until a future date. During the three months ended March 31, 2023, the Company recorded charges of $1,250 related to the strategic restructuring program. Of that amount, the Company paid $1,007 during the three months endingended March 31, 2018 were valued using 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

2023. The Company has one equity incentive plan that was adjustedexpects to pay the remaining $244 in 2016.the second quarter of 2023.

In April 2023, the Company approved the implementation of additional cost cutting measures, including an executive reorganization and other cuts in clinical expenses, in connection with its ongoing efforts to reduce operating expenses. The Company expects to incur non-recurring charges related to these cost-cutting measures of approximately $400 in the second quarter of 2023. See Note 13.

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The outstanding restructuring liabilities are included in accounts payable and accrued expenses on the condensed consolidated balance sheet. As of March 31, 2018, there are 2,641,250 shares of common stock available for issuance under2023, the 2016 Equity Incentive Plan (the “Equity Plan”). The number of shares of common stock available for issuance under the Equity Plan shall increase annually by six percent (6%)components of the total numberliabilities were as follows:

Schedule of shares of our Common 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 Stock than would otherwise occur.Restructuring Liabilities included in Accounts Payable and Accrued Expenses

  

Employee Severance and

Other Benefits (1)

 
Balance as of January 1, 2023 $- 
Restructuring expenses- Sales and Marketing  453 
Restructuring expenses- Research and Development  582 
Restructuring expenses- General and Administrative  215 
Restructuring expenses  - 
Cash payments  (1,007)
Liability included in accounts payable and accrued expenses at March 31, 2023 $243 

As of March 31, 2018, there were 745,788 shares reserved for future issuance under the Equity Plan.

(1)Employee severance and other benefits expenses were included in sales and marketing expenses, research and development expenses, and general and administrative expenses in the statements of comprehensive loss.

Note 713Subsequent Events

 

The Company has analyzed its operations subsequentIn addition, in order to March 31, 2018 and notedfurther reduce expenses, Andrew Taylor, our current Chief Financial Officer, intends to step down from his role as Chief Financial Officer before the following subsequent events:

On May 10, 2018, the Company’s Board of Directors approved the issuance of 58,000 options to 4 employees which vest over a three-year period on a quarterly basis to purchase sharesend of the Company’s common stock at $4.36, the closing share pricesecond quarter of the Company’s common stock on the Nasdaq Capital Market on May 10, 2018.2023.  We are actively putting in place an internal transition plan and intend to appoint another officer to replace Mr. Taylor as our Chief Financial Officer.

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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 per share, (b) upon the four (4) month anniversary of 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 an exercise price of $6.25 per share, and (c) upon the eight (8) month anniversary of 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 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. 


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;history and need for additional capital and need for additional capital;

our ability to execute our strategic restructuring program aimed at capital preservation, reduction in cash expenditures and reduction of our workforce;
our ability to enter into and consummate strategic alternatives, including any acquisition, merger, reverse merger, other business combination, sale of assets, licensing and other strategic transactions;
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 ability to remain compliant with the requirements of The Nasdaq Capital Market for continued listing;
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 forcommercialize 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 commercializeobtain approval or certification from regulatory agents or other competent entities in different jurisdictions for 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;

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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; and

our ability to adequately support growth.growth;
our ability to predict the financial impact of inflation on costs such as labor, freight and materials; and
our ability to project in the short term the hospital medical device environment considering the global pandemic and strains on hospital systems

Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations. Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. Similarly, on March 12, 2023, Signature Bank or any other financial institution that is placed into receivership by the FDIC, may be unable to access undrawn amounts thereunder. Although we are not a borrower or party to any such instruments with SVB, Signature or any other financial institution currently in receivership, if we were to borrow money in the future and if any of our lenders or counterparties to any such instruments were to be placed into receivership, we may be unable to access such funds. In addition, if any of our customers, suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay or perform their obligations to us or to enter into new commercial arrangements requiring additional payments to us or additional funding could be adversely affected. In this regard, counterparties to SVB credit agreements and arrangements, and third parties such as beneficiaries of letters of credit (among others), may experience direct impacts from the closure of SVB and uncertainty remains over liquidity concerns in the broader financial services industry, including for example in the case of First Republic Bank and Credit Suisse during March 2023. Similar impacts have occurred in the past, such as during the 2008-2010 financial crisis.

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 system has been designed to integrateSystem is also CE marked in the European Economic Area (EEA) 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 believe that during 2022 approximately 1.5 million inpatient colonoscopy areprocedures were 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 has been assigned an ICD-10 code in the US. The system does not currently reimbursable throughhave unique codes with any private or governmental third-party payors in any other country butor for any other use; however, we intend to seekmay pursue reimbursement through private or governmental third-party payorsactivities in the future.future, particularly in the outpatient colonoscopy market. We do not currently promotereceived 510(k) clearance in February 2022 from the FDA for our Pure-Vu EVS System and have commenced commercialization of this product.

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Recent Developments

In January 2023, we initiated a particular prep regimen as this is left upprocess to the discretionexplore a range of the physician since our current indication does not reference any preparation protocol. We will look to expand the 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, as part of our limited pilot launch, we havestrategic and financing alternatives focused on collecting clinical data onmaximizing stockholder value and accelerating the usecommercialization of the Pure-Vu system.System. We do not expectengaged Lake Street Capital Markets LLC (“Lake Street Capital”) to generate significant revenue from product sales unlessadvise us in this process. Potential strategic alternatives that we may consider are expected to include an acquisition, merger, reverse merger, other business combination, sale of assets, licensing and untilother strategic transactions. To support these objectives, we expandcommenced a strategic restructuring program aimed at capital preservation. We have reduced our commercialization efforts.

Our business was spun out from the New Generation Technology (“NGT”) incubator based in Nazareth, Israel in 2011 to focus exclusively on the developmentquarterly cash expenditures by approximately 35% by eliminating approximately 45% of the Pure-Vu system. We initiated preclinical testing in 2011 and started clinical testing of the first prototype version of the Pure-Vu system in Europe in late 2012. In clinical studies and pilot accounts in Europe, Israel and the US from 2012 through the end ofour workforce during the first quarter of 2018,2023.

In April 2023, we approved the Pure-Vu systemimplementation of additional cost cutting measures, including an executive reorganization and earlier prototype versions have demonstratedother cuts in clinical expenses, in connection with its ongoing efforts to reduce operating expenses. As part of the executive changes, Mark Pomeranz, the Company’s Chief Operating Officer, director and former Chief Executive Officer, has been appointed as the Company’s Chief Executive Officer, effective cleaning 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.immediately. In connection with the closingMr. Pomeranz’s appointment, Timothy Moran has stepped down as Chief Executive Officer of the IPO, we received net proceeds of approximately $15 million after deducting underwriting discounts and commissions of approximately $1.4 million 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 exerciseCompany. Mr. Moran shall succeed David Hochman as Chairman of the underwriters 30-day optionBoard, effective immediately. Mr. Hochman will continue to purchase up toserve as an additional 525,000 sharesindependent director of our Common Stock in connection with the IPO (the “Partial IPO Over-Allotment Exercise”).Company, effective immediately.

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$4.4 million for the three months ended March 31, 20182023, 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. We expect our expensesAs of March 31, 2023, we had $8.6 million in cash and cash equivalents and an accumulated deficit of $145.7 million. In January and April 2023, the Company committed to increase significantly in connection with our ongoing activitiesa restructuring initiative designed to commercializeposition the Company to explore a range of strategic and marketfinancing alternatives focused on maximizing stockholder value and accelerating the commercialization of the Pure-Vu system. Furthermore, we expectSystem. If a strategic transaction is not completed, or if additional financing is not available, the Company may not be able to incur additional costs associatedservice our outstanding indebtedness and our payables and may have to file for bankruptcy protection or pursue a dissolution of the Company and liquidation of all of the Company’s remaining assets. In such an event, the amount of cash available for distribution to the Company’s shareholders, if any, will depend heavily on the timing of such decision, as with operatingthe passage of time the amount of cash available for distribution will be reduced as the Company continues to fund its operations and service the Company’s outstanding indebtedness. The Company cannot provide assurance as to the amount of cash that will be available to distribute to shareholders, if any, after paying its debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution, if any. Such conditions raise substantial doubts about the Company’s ability to continue as a public company. Accordingly, we will need additional financinggoing concern.

We continue 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.parties and evaluating other strategic alternative transactions including an acquisition, merger, reverse merger, other business combination, sale of assets, licensing and other transactions. The sale of equity and convertible debt securities may result in dilution to our shareholders 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 as well as commercial activities. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital or execute a strategic transaction 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. Additionally, the effects of inflation on costs such as labor, freight, and materials as well as the ongoing volatility in the financial markets may negatively affect the financial performance and the liquidity of the business.

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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 pilot launch through 2018 to refine how the Pure-Vu system integrates into the workflow of both the out-patient and in-patient settings;
contract with third parties to scale up the manufacture of the workstation and the disposable portion of Pure-Vu system;
develop a second generation system to improve user interface, optimize ease of use and reduce the cost structure;
raise sufficient funds in the capital market to effectuate our business plan, including commercialization activities related to our Pure-Vu system and our research and development activities, including clinical and regulatory development and the continued development and enhancement of our Pure-Vu 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, 2017.2022. 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 three months ended March 31, 2018,2023, there were no material changes to matters discussed under the heading “Critical Accounting PolicesPolicies and Significant Judgement 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 for2022.

Results of Operations

Comparison of Three Months Ended March 31, 2023 and 2022

Revenue

As of March 31, 2023, our commercial launch of the following:

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)”, 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. 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, we haveFDA-cleared Pure-Vu EVS System has generated limited revenue from the sales of products.revenue. We do not expect to generate significantgreater revenue from product sales unlessif and untilwhen we expand our commercialization efforts for the Pure-Vu system, which we expect will take a number of years andefforts; however, this is subject to significant uncertainty.

ResearchRevenue totaled $56.0 thousand for the three months ended March 31, 2023, compared to $20.0 thousand for the three months ended March 31, 2022. The increase of $36.0 thousand was primarily attributable to the sales of Pure-Vu Gen EVS disposables product.

Cost of Revenue

Cost of revenue for the three months ended March 31, 2023 totaled $174.0 thousand, compared to $174.0 thousand for the three months ended March 31, 2022. Cost of revenue includes the impairment of inventory of $165.0 thousand and Development

We incurred expenses of approximately $1.2 million and $0.6 million, respectively,$159.0 thousand during the three months ended March 31, 20182023 and 20172022, respectively. Impairment of inventory for researchthe three months ended March 31, 2023 is attributed to the implementation of additional cost cutting measures and executive reorganization in April 2023. As certain developments occur in the business and operations, we anticipate further possible impairment to inventory in 2023.

Research and Development

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.


SalesResearch and Marketing

We incurreddevelopment expenses of approximately $0.7totaled $1.5 million and $0.4 million, respectively, duringfor the three months ended March 31, 20182023 compared to $1.3 million for the three months ended March 31, 2022. The $0.2 million increase is primarily attributable to an increase of $0.3 million in salaries and 2017 for salespersonnel related costs relating to our restructuring in Q1 2023, partially offset with a $0.1 million decrease in other research and development 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 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 $2.1totaled $0.8 million and $1.6 million, respectively, duringfor the three months ended March 31, 20182023 compared to $1.0 million for the three months ended March 31, 2022. The decrease of $0.2 million is primarily attributable to a decrease of $0.2 million in marketing sample costs.

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General and 2017 for general and administrative activities. 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 and administrative expenses will increase significantly during 2018 and in the future as we increase our headcount 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 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.

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 Operations

Comparison of Three Months Ended March 31, 2018 and 2017

To date, as part of our limited launch, 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 expand our commercialization efforts for the Pure-Vu system, which we expect will take a number of years and is subject to significant uncertainty.

Research and Development

Research and development expenses for the three months ended March 31, 2018 totaled approximately $1.2 million, an increase of $0.6 million over the $0.6 million recorded for the three months ended March 31, 2017. The increase was primarily attributable to increases of $0.4 million in salaries and wages, $0.2 million in subcontractor costs, $0.06 million in stock-based compensation, partially offset by a decrease in other costs of $0.02 million.

Sales and Marketing

Sales and marketing expenses for the three months ended March 31, 2018 totaled approximately $0.70 million, an increase of $0.30 million over the $0.40 million recorded for the three months ended March 31, 2017. The increase was primarily attributable to increases of $0.08 million in salaries and wages, $0.08 million in marketing and training product units, $0.09 million in subcontractor costs, $0.01 million in other costs, and $0.03 million in stock-based compensation.

General and Administrative

General and administrative expenses for the three months ended March 31, 20182023 totaled approximately$1.9 million, compared to $2.1 million an increase of $0.5 million over the $1.6 million recorded for the year ended March 31, 2017. The increase was primarily attributable to increases of $0.3 million in legal and professional fees, $0.08 million 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 decrease of $0.1 million in stock-based compensation

Liquidity and Capital Resources

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At March 31, 2018, our accumulated deficit since inception was approximately $46.4 million.

At March 31, 2018, we had total current assets of approximately $19.6 million and total current liabilities of approximately $1.6 million resulting in working capital of $18.0 million. Net cash used in operating activities for the three months ended March 31, 20182022. The decrease of $0.2 million was approximately $3.5primarily attributable to decreases of $0.1 million which includes a net loss of approximately $7.3in professional services, $0.2 million in share-based compensation and $0.1 million in other general and administrative costs, partially offset by non-cash expensesincreases in salaries and other personnel related costs of approximately $3.9$0.2 million principally relatedrelating to warrant expense of $3.2 million , stock-based compensation expense of $0.6 millionour restructuring in Q1 2023.

Liquidity and revaluation of contingent royalty obligation of $0.08 million, approximately $0.03 million ofCapital Resources

To date, we have generated minimal revenues, experienced negative operating cash providedflows and have incurred substantial operating losses from a change in net working capital items principallyour activities. We expect operating costs will increase significantly as we incur costs associated with commercialization activities related to the increasePure-Vu System. As described above under “Overview” and “Financial Operations Overview,” we adopted a restructuring program in accounts payableJanuary and accruedApril 2023 intended to reduce our operating costs and other expenses and approximately $0.3 millionhave commenced a process to evaluate strategic alternatives. In connection with the executive reorganization, in April 2023, Mark Pomeranz, our Chief Operating Officer, director and former Chief Executive Officer, was appointed as our Chief Executive Officer, and Timothy Moran stepped down as our Chief Executive Officer. In addition, in order to further reduce expenses, Andrew Taylor, our current Chief Financial Officer, intends to step down from his role as Chief Financial Officer before the end of the second quarter of 2023.  We are actively putting in place an internal transition plan and intend to appoint another officer to replace Mr. Taylor as our Chief Financial Officer. If a strategic transaction is not completed, or if additional financing is not available, we may not be able to service our outstanding indebtedness and our payables and may have to file for bankruptcy protection or pursue a dissolution of the company and liquidation of all of our remaining assets. In such an event, the amount of cash used from a change in net working capital items principally relatedavailable for distribution to our shareholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations and service our outstanding indebtedness. We cannot provide assurance as to the increase in prepaid expenses,amount of cash that will be available to distribute to shareholders, if any, after paying our debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution, if any. We expect to continue to fund our operations primarily through utilization of our current financial resources, future product sales, the issuance of debt or equity, as well as through other strategic alternative transactions. As of March 31, 2023, our accumulated deficit was $145.7 million. Such conditions raise substantial doubt about our ability to continue as a going concern.

In March 2021, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”), under which we may offer and long-term assets.

Cash used in investing activities forsell from time to time common shares having an aggregate offering price of up to $25.0 million. During the three months ended March 31, 2018 totaled2023, the Company sold approximately $0.08 for the purchase of fixed assets.

Cash provided by financing activities for the three months ended March 31, 2018 totaled approximately $15 million. On February 16, 2018, we closed our IPO in which we sold 3,500,000119 thousand shares of our Common Stock at a public offering pricecommon stock under this agreement, resulting in net cash proceeds of $5.00 per share. In connection with the closing$102 thousand, after deducting issuance costs of $19 thousand.

Rising inflation, rising interest rates, and financial market volatility may adversely impact 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, and changing priorities could also affect our ability to enter into key agreements. COVID-19 and government measures taken in response have also had an 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 IPO, we received net proceedsoutbreak and its longer-term effects on our business and operations continue to evolve and are still 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 approximately $15 million after deducting underwriting discounts and commissions of approximately $1.4 million and other offering expenses of approximately $1.1 million. On March 12, 2018, we received net proceeds of approximately $258,000 in relationongoing efforts related to the saleoutbreak in certain parts of an additional 56,000 sharesthe world. These disruptions may negatively impact our future sales, results of operations, financial condition, and liquidity.

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Our ability to continue as a going concern for the next twelve months from the issuance of our Common Stock at a priceQuarterly Report on Form 10-Q, depends on our ability to execute our business plan, increase revenue and reduce expenditures. As of $5.00 per share, pursuant to the Partial IPO Over-Allotment Exercise completed in March 2018.


At March 31, 2018,2023, we had cash and cash equivalents of approximately $18.6$8.6 million and an accumulated deficit of $145.7 million. Based on our current business plan, we believe our cash and cash equivalents balance as of March 31, 20182023 will be sufficient to meet our anticipated cash requirements through approximatelyinto the secondfourth 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.

2023. 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.grants, as well as evaluate other strategic alternative transactions. 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.trial and commercial efforts.

Contractual Obligations and Commitments

Royalty on Coated Products

On January 30, 2018, we entered intoThese factors raise substantial doubt about our ability to continue as a license and supply agreement with a third party whereby we were granted a worldwide licensegoing concern. For more information, refer to sell our products coated with an agent that is the initial property of the third party for providing a lubricious surfaceNote 2 to our products (a “Coated Product” or “Coated Products”). The third party is entitledcondensed consolidated financial statements included elsewhere in this Quarterly Report.

As of March 31, 2023, we had total current assets of $10.3 million and total current liabilities of $4.4 million resulting in working capital of $5.9 million. Net cash used in operating activities for the three months ended March 31, 2023 was $4.8 million, which includes a net loss of $4.4 million, offset by non-cash expenses principally related to a royaltyshare based compensation expense of $0.2 million, depreciation and amortization of $0.1 million, amortization of debt issuance costs of $0.1 million, inventory impairment of $0.2 million, offset by changes in net working capital items principally related to the amount of:increase in prepaid expenses and other current assets of $0.4 million, the increase in accounts payable and accrued expenses of $0.5 million, and operating lease liabilities of $0.1 million.

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 1stNet cash used in investing activities for the three months ended March 31, 2023 related to the purchase of each calendar year.fixed assets of $39.0 thousand.

Minimum royalties shall be paidNet cash provided by financing activities for each Coated Product soldthe three months ended March 31, 2023 totaled $0.5 million related to proceeds from issuance of common shares pursuant to at-the-market issuance registered offering of $0.1 million, offset by us as follows:repayment under loan terms of $0.6 million.

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:Shelf Registration Statement

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 16, 2021, we filed a Certificate of Designation of Preferences, Rightsshelf registration statement (File No. 333-254343) with the Securities and LimitationsExchange Commission (the “Certificate of Designation”“2021 Shelf Registration Statement”), establishing the rightswhich was declared effective on March 26, 2021, 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 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 2017 Private 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 sharemaximum aggregate offering price of Series A Convertible Preferred Stock converted into one share$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 or more offerings. As of March 31, 2023, we have not sold any securities under the 2021 Shelf Registration Statement, except as described below.

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The 2021 Shelf Registration Statement includes a prospectus registering an at-the-market offering program pursuant to a mandatory conversion. As provided foran Equity Distribution Agreement (the “Equity Distribution Agreement”) with Oppenheimer & Co. Inc. (“Oppenheimer”), entered into in the Certificate of Designation, if a holder had electedMarch 2021, under which Oppenheimer may offer and sell from time to convert all of their Series A Convertible Preferred Stock intotime shares of our common stock priorhaving an aggregate offering price of up to $25.0 million, subject to the mandatory conversion,provisions of General Instruction I.B.6 of Form S-3, which provides that we may not sell securities in a public primary offering with a value exceeding one-third of our public float in any twelve-month period (approximately $8.8 million beginning effective as of March 31, 2023, the holder would have forfeited any and all rights to future royalty payments, if any.date of filing of our most recent Annual Report on Form 10-K) unless our public float is at least $75 million. If a holder had elected to convert any portion of their Series A Convertible Preferred Stock to common stockour public float meets or exceeds $75.0 million 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 completion 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 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 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 amendmentsubject to the Certificaterestrictions set forth in General Instruction I.B.6 of Designation became effective, (2) all outstanding sharesForm S-3, at least until the filing of Series A Convertible Preferred Stock were converted intoour next Section 10(a)(3) update as required under the Securities Act.

During the quarter ended March 31, 2023, we sold approximately 119 thousand shares of our common stock pursuant to a mandatory conversion, and (3) the Royalty Payment Rights Certificates were issuedabove-described Equity Distribution Agreement, resulting in net cash proceeds of $102 thousand, after deducting issuance costs of $19 thousand.

Our ability to the former holders of the Series A Convertible Preferred Stock.


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 rentissue securities 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 contractsmarket conditions and other factors including, in the normal coursecase 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.debt securities, our credit ratings.

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.

Item 4.Controls and Procedures.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Evaluation of Our Disclosure Controls

Our management,Management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report.March 31, 2023. 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’sour management, including itsour 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,March 31, 2023, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures, were effective at the reasonable assurance level.as defined above, are effective.

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 three-month period to which this report relatesended March 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Because of its inherent limitations,

Our management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or our internal control over financial reporting maywill prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not preventabsolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or detect misstatements. Also, projectionsmistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any evaluationsystem of effectiveness tocontrols is also based in part upon certain assumptions about the likelihood of future periods are subject to the risksevents, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. From timeBecause of the inherent limitations in a cost-effective control system, misstatements due to time, we make changes to our internal control over financial reporting that are intended to enhance its effectivenesserror or fraud may occur and which do not have a material effect on our overall internal control over financial reporting.be detected.

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

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PART II — OTHER INFORMATION

Item 1.Legal Proceedings.

None.Item 1. Legal Proceedings.

None.

Item 1A.Risk Factors.

There have been no material changesItem 1A. Risk Factors.

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, 2022, 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, 2022 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, 2022 filed with the Securities and Exchange Commission on March 31, 2023.

Item 2.

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

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

Ten Percent Warrants

Simultaneously with the closing of our IPO, we issued warrants to purchase an aggregate of 1,095,682 shares of our Common Stock (the “Ten Percent Warrants”) to certain of the holders of our formerly outstanding convertible preferred 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 payment for services pursuant to a consulting agreement between the service provider and us.

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 SecuritiesProceeds.

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).None

Item 3.Defaults Upon Senior Securities.

None.Item 3. Defaults Upon Senior Securities.

None.

Item 4.Mine Safety Disclosures.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

In order to further reduce expenses, as of the date of this report, Andrew Taylor, our current Chief Financial Officer, intends to step down from his role as Chief Financial Officer before the end of the second quarter of 2023. We are actively putting in place an internal transition plan and intend to appoint another officer to replace Mr. Taylor as our Chief Financial Officer.

On May 9, 2023, we amended the compensation terms for Mark Pomeranz, our Chief Executive Officer and President, to provide for an annual salary of $450,000 per year and an annual bonus percentage of up to 60% based on achieving certain targets established by our Board of Directors.

Item 5.Other Information.23

None.


Item 6.Exhibits

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.

 14

 

EXHIBIT INDEXItem 6. Exhibits.

Exhibit   Incorporated by Reference Filed
Number Exhibit Description Form File No. Exhibit Filing Date Herewith
             
4.1 Form of November 2018 Consultant Warrant 10-Q 001-38389 4.4 11/14/2018  
             
31.1 Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).         X
             
31.2 Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a).         X
             
32.1** Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350).         X
             
101.INS Inline 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.SCH Inline XBRL Taxonomy Extension Schema Document.         X
             
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.         X
             
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document.         X
             
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document.         X
             
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.         X
             
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101).         X

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.


24

SIGNATURES

 

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.

(Registrant)

Date: May 14, 201810, 2023By:/s/ Mark Pomeranz
Name:Mark PomeranzTimothy P. Moran
Title:President, Chief Executive Officer and Director
(Principal Executive Officer)
Date: May 14, 201810, 2023By:/s/ Andrew Taylor
Name:Andrew Taylor
Title:Chief Financial Officer
(Principal Financial Officer and Chief Accounting Officer)

25