0001493152-23-017409.txt : 20230515 0001493152-23-017409.hdr.sgml : 20230515 20230515162403 ACCESSION NUMBER: 0001493152-23-017409 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 82 CONFORMED PERIOD OF REPORT: 20230331 FILED AS OF DATE: 20230515 DATE AS OF CHANGE: 20230515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAVmed Inc. CENTRAL INDEX KEY: 0001624326 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 471214177 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-37685 FILM NUMBER: 23922921 BUSINESS ADDRESS: STREET 1: 360 MADISON AVENUE STREET 2: 25TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10017 BUSINESS PHONE: (212) 949-4319 MAIL ADDRESS: STREET 1: 360 MADISON AVENUE STREET 2: 25TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10017 FORMER COMPANY: FORMER CONFORMED NAME: PAXmed Inc. DATE OF NAME CHANGE: 20141105 10-Q 1 form10-q.htm
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PAVM:SeriesBConvertiblePreferredStockMember 2023-01-01 2023-03-31 0001624326 PAVM:SeriesBConvertiblePreferredStockMember 2022-01-01 2022-03-31 0001624326 us-gaap:RestrictedStockMember PAVM:TwoThousandFourteenEquityPlanMember 2022-01-01 2022-03-31 0001624326 us-gaap:RestrictedStockMember PAVM:TwoThousandFourteenEquityPlanMember 2023-01-01 2023-03-31 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure PAVM:Segment

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2023

 

OR

 

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: 001-37685

 

PAVMED INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   47-1214177
(State or Other Jurisdiction of   (IRS Employer
Incorporation or Organization)   Identification No.)
     
360 Madison Avenue    
25th Floor    
New York, NY   10017
(Address of Principal Executive Offices)   (Zip Code)

 

(212) 949-4319

(Registrant’s Telephone Number, Including Area Code)

 

Securities registered under Section 12(b) of the Exchange Act:

 

Title of each Class   Trading Symbol(s)   Name of each Exchange on which Registered
Common Stock, $0.001 par value per share   PAVM   The NASDAQ Stock Market LLC
Series Z Warrants, each to purchase one share of Common Stock   PAVMZ   The NASDAQ Stock Market LLC

 

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

 

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

 

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

 

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

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to section 13(c) 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 11, 2023, there were 104,533,129 shares of the registrant’s Common Stock, par value $0.001 per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan as of such date).

 

 

 

 
 

 

TABLE OF CONTENTS

 

    Page
  Part I - Financial Information  
     
Item 1. Financial Statements  
  Condensed Consolidated Balance Sheets (unaudited) as of March 31 2023 and December 31, 2022 1
  Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2023 and 2022 2
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three months ended March 31, 2023 and 2022 3
  Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2023 and 2022 5
  Notes to Unaudited Condensed Consolidated Financial Statements 6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 24
Item 4. Controls and Procedures 32
     
  Part II - Other Information  
     
Item 1. Legal Proceedings 33
Item 5. Other Information 33
Item 6. Exhibits 33
  Signature 34
  Exhibit Index 35

 

i
 

 

Part I - Financial Information

 

Item 1. Financial Statements

 

PAVMED INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands except number of shares and per share data - unaudited)

 

   March 31, 2023   December 31, 2022 
Assets:          
Current assets:          
Cash  $49,280   $39,744 
Accounts receivable   27    17 
Prepaid expenses, deposits, and other current assets   4,534    4,165 
Total current assets   53,841    43,926 
Fixed assets, net   2,255    2,451 
Operating lease right-of-use assets   5,171    3,037 
Intangible assets, net   2,940    3,445 
Other assets   1,079    1,121 
Total assets  $65,286   $53,980 
Liabilities, Preferred Stock and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $1,258   $2,704 
Accrued expenses and other current liabilities   3,724    3,705 
Operating lease liabilities, current portion   1,264    1,141 
Senior Secured Convertible Notes - at fair value   44,300    33,650 
Total current liabilities   50,546    41,200 
Operating lease liabilities, less current portion   3,936    1,846 
Total liabilities   54,482    43,046 
Commitments and contingencies (Note 9)   -      
Stockholders’ Equity:          
Preferred stock, $0.001 par value. Authorized, 20,000,000 shares; Series B Convertible Preferred Stock, par value $0.001, issued and outstanding 1,229,887 at March 31, 2023 and 1,205,759 shares at December 31, 2022   2,767    2,695 
Common stock, $0.001 par value. Authorized, 250,000,000 shares; 100,596,406 and 94,510,537 shares outstanding as of March 31, 2023 and December 31, 2022, respectively   101    95 
Additional paid-in capital   221,247    216,106 
Accumulated deficit   (246,172)   (228,169)
Treasury stock       (408)
Total PAVmed Inc. Stockholders’ Equity   (22,057)   (9,681)
Noncontrolling interests   32,861    20,615 
Total Stockholders’ Equity   10,804    10,934 
Total Liabilities and Stockholders’ Equity  $65,286   $53,980 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

1
 

 

PAVMED INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands except number of shares and per share data - unaudited)

 

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Revenue  $446   $189 
Operating expenses:          
Cost of revenue   1,346    369 
Sales and marketing   4,539    3,925 
General and administrative   10,018    9,475 
Amortization of acquired intangible assets   505    123 
Research and development   4,439    5,932 
Total operating expenses   20,847    19,824 
Operating loss   (20,401)   (19,635)
Other income (expense):          
Interest income   121    2 
Interest expense   (183)    
Change in fair value - Senior Secured Convertible Notes   (1,040)    
Loss on issue and offering costs - Senior Secured Convertible Note   (1,186)    
Debt extinguishments loss - Senior Secured Convertible Notes   (525)    
Gain on sale of intellectual property   1,000     
Other income (expense), net   (1,813)   2 
Loss before provision for income tax   (22,214)   (19,633)
Provision for income taxes        
Net loss before noncontrolling interests   (22,214)   (19,633)
Net loss attributable to the noncontrolling interests   4,283    2,761 
Net loss attributable to PAVmed Inc.   (17,931)   (16,872)
Less: Series B Convertible Preferred Stock dividends earned   (74)   (68)
Net loss attributable to PAVmed Inc. common stockholders  $(18,005)  $(16,940)
Per share information:          
Net loss per share attributable to PAVmed Inc. - basic and diluted  $(0.18)  $(0.20)
Net loss per share attributable to PAVmed Inc. common stockholders – basic and diluted  $(0.19)  $(0.20)
Weighted average common shares outstanding, basic and diluted   97,095,156    86,336,427 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

2
 

 

PAVMED INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)

for the THREE MONTHS ENDED March 31, 2023

(in thousands, except number of shares and per share data - unaudited)

 

   Shares   Amount   Shares   Amount   Capital   Deficit   Stock   Interest   Total 
   PAVmed Inc. Stockholders’ Equity (Deficit)         
   Series B Convertible Preferred Stock   Common Stock   Additional Paid-In   Accumulated   Treasury   Non controlling    
   Shares   Amount   Shares   Amount   Capital   Deficit   Stock   Interest   Total 
                                     
Balance - December 31, 2022   1,205,759   $2,695    94,510,537   $95   $216,106   $(228,169)  $(408)  $20,615   $10,934 
Dividends declared - Series B Convertible Preferred Stock   24,128    72                (72)            
Issue common stock - PAVM ATM Facility           1,081,997    1    556                557 
Vest - restricted stock awards           100,000                         
Conversions - Senior Secured Convertible Note           4,330,643    5    2,022                2,027 
Purchase - Employee Stock Purchase Plan           384,383        122        60        182 
Purchase - majority-owned subsidiary common stock - Employee Stock Purchase Plan                               276    276 
Issuance - majority-owned subsidiary common stock - At-The-Market Facility, net of financing charges                               284    284 
Impact of subsidiary equity transactions                   1,189            (1,189)    
Issuance - majority-owned subsidiary common stock - Settlement APA-RDx - Termination Payment                               713    713 
Issuance - majority-owned subsidiary preferred stock                               13,625    13,625 
Stock-based compensation - PAVmed Inc.                   1,199                1,199 
Stock-based compensation - majority-owned subsidiaries                   401            2,820    3,221 
Treasury stock           188,846        (348)       348         
Net loss                       (17,931)       (4,283)   (22,214)
Balance - March 31, 2023   1,229,887   $2,767    100,596,406   $101   $221,247   $(246,172)  $   $32,861   $10,804 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

3
 

 

PAVMED INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)

for the THREE MONTHS ENDED March 31, 2022

(in thousands, except number of shares and per share data - unaudited)

 

   PAVmed Inc. Stockholders’ Equity (Deficit)         
   Series B Convertible Preferred Stock   Common Stock   Additional Paid-In   Accumulated   Treasury   Non controlling    
   Shares   Amount   Shares   Amount   Capital   Deficit   Stock   Interest   Total 
                                     
                                     
Balance - December 31, 2021   1,113,919   $2,419    86,367,845   $86   $198,071   $(138,910)  $   $17,752   $79,418 
Dividends declared - Series B Convertible Preferred Stock   22,291    67                (67)            
Vest - restricted stock awards           466,666                         
Exercise - Series Z warrants           5                         
Exercise - stock options           237,499    1    241                242 
Exercise - stock options of majority-owned subsidiary                               187    187 
Purchase - Employee Stock Purchase Plan           194,240        217                217 
Impact of subsidiary equity transactions                   (87)           87     
Stock-based compensation - PAVmed Inc.                   1,277                1,277 
Stock-based compensation - majority-owned subsidiaries                               3,537    3,537 
Treasury stock           (354,609)               (512)       (512)
Net Loss                       (16,872)       (2,761)   (19,633)
Balance - March 31, 2022   1,136,210   $2,486    86,911,646   $87   $199,719   $(155,849)  $(512)  $18,802   $64,733 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4
 

 

PAVMED INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands, except number of shares and per share data - unaudited)

 

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Cash flows from operating activities          
Net loss - before noncontrolling interest (“NCI”)  $(22,214)  $(19,633)
           
Adjustments to reconcile net loss - before NCI to net cash used in operating activities          
Depreciation and amortization expense   727    216 
Stock-based compensation   4,419    4,814 
Gain on sale of intellectual property   (1,000)    
APA-RDx: Issue common stock of majority-owned subsidiary - settle termination payment   713     
Change in fair value - Senior Secured Convertible Notes   1,040     
Loss on issue and offering costs - Senior Secured Convertible Note   1,186     
Debt extinguishment loss - Senior Secured Convertible Note   525     
Non-cash lease expense   79    29 
Changes in operating assets and liabilities:          
Accounts receivable   (10)   111 
Prepaid expenses, deposits and current and other assets   (326)   (134)
Accounts payable   (1,444)   3,922 
Accrued expenses and other current liabilities   18    (1,588)
Net cash flows used in operating activities   (16,287)   (12,263)
           
Cash flows from investing activities          
Purchase of equipment   (26)   (574)
Proceeds from sale of intellectual property   1,000     
Net cash flows used in investing activities   974    (574)
           
Cash flows from financing activities          
Proceeds – issue of preferred stock - majority-owned subsidiary   13,625     
Proceeds – issue of Senior Secured Convertible Note, net of offering costs   9,925     
Proceeds – issue of common stock - At-The-Market Facility   557     
Proceeds – majority-owned subsidiary common stock - At-The-Market Facility   284     
Proceeds – exercise of stock options       241 
Proceeds – issue common stock – Employee Stock Purchase Plan   182    217 
Proceeds – majority-owned subsidiary common stock – Employee Stock Purchase Plan   276    187 
Purchase Treasury Stock – payment of employee payroll tax obligation in connection with stock-based compensation       (329)
Net cash flows provided by financing activities   24,849    316 
Net increase (decrease) in cash   9,536    (12,521)
Cash, beginning of period   39,744    77,258 
Cash, end of period  $49,280   $64,737 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

5
 

 

PAVMED INC.

and SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(amounts in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)

 

Note 1 — The Company

 

Description of the Business

 

PAVmed Inc. and Subsidiaries, referred to herein as “PAVmed” or the “Company,” is comprised of PAVmed Inc. and its wholly-owned subsidiary and its majority-owned subsidiaries, inclusive of Lucid Diagnostics Inc. (“Lucid Diagnostics” or “Lucid”) and Veris Health Inc. (“Veris Health” or “Veris”).

 

PAVmed is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, including through its majority-owned subsidiaries Lucid Diagnostics, a commercial-stage cancer prevention diagnostics company, and Veris Health, a private digital health company focused on enhanced personalized cancer care. The Company’s current central focus is on the commercialization of Lucid’s EsoGuard assay and Veris Health’s Veris Cancer Care Platform. As resources permit, we will continue to explore internal and external innovations that fulfill our project selection criteria without limiting ourselves to any target specialty or condition.

 

The Company has financed its operations principally through public and private issuances of its common stock, preferred stock, common stock purchase warrants, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and conducting clinical trials. The Company expects to continue to experience recurring losses from operations and will continue to fund its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and other debt and equity committed sources of financing, the Company expects to be able to fund its operations for one year from the date of the issue of the Company’s consolidated financial statements included herein in the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2023.

 

Note 2 — Summary of Significant Accounting Policies

 

Significant Accounting Policies

 

The Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 14, 2023, except as otherwise noted herein below.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of PAVmed and its subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned and majority-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company holds a majority-ownership interest and has controlling financial interest in each of: Lucid Diagnostics and Veris Health, with the corresponding noncontrolling interest included as a separate component of consolidated stockholders’ equity (deficit), including the recognition in the unaudited condensed consolidated statement of operations of a net loss attributable to the noncontrolling interest based on the respective minority-interest equity ownership of each majority-owned subsidiary. See Note 15, Noncontrolling Interest, for a discussion of each of the majority-owned subsidiaries noted above. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.

 

As permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair presentation of the Company’s unaudited condensed consolidated financial information.

 

6
 

 

Note 2 — Summary of Significant Accounting Policies - continued

 

The consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 14, 2023.

 

All amounts in the accompanying unaudited condensed consolidated financial statements and these notes thereto are presented in thousands of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.

 

Use of Estimates

 

In preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserve, if any, and liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards, intangible assets and common stock purchase warrants. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.

 

Revenue Recognition

 

Revenues are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

The key aspects considered by the Company include the following:

 

Contracts—The Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient. The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations. The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company considers collection of such consideration to be probable to the extent that it is unconstrained.

 

Performance obligations—A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.

 

7
 

 

Note 2 — Summary of Significant Accounting Policies - continued

 

Transaction price—The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.

 

If the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved.

 

When the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization of such fixed consideration deemed probable based upon actual historical experience.

 

Allocate transaction price—The transaction price is allocated entirely to the performance obligation contained within the contract with a customer on the basis of the relative standalone selling prices of each distinct good or service.

 

Practical Expedients—The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less.

 

Fair Value Option (“FVO”) Election

 

Under a Securities Purchase Agreement dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April 2022 Senior Convertible Note”, and a Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September 2022 Senior Convertible Note”, which are accounted under the “fair value option election” as discussed below.

 

Under a Securities Purchase Agreement dated March 13, 2023, Lucid Diagnostics issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “Lucid March 2023 Senior Convertible Note”, which is accounted under the “fair value option election” as discussed below.

 

Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative and Hedging, (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date.

 

Alternatively, FASB ASC Topic 825, Financial Instruments, (“ASC 825”) provides for the “fair value option” (“FVO”) election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note are presented in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note or the Lucid March 2023 Senior Convertible Note).

 

See Note 10, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 11, Debt, for a discussion of the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note.

 

Reclassifications

 

Certain prior-year amounts have been reclassified to conform to the current year presentation, which includes presenting costs of revenue within operating expenses on the statements of operations, in the unaudited condensed consolidated financial statements and accompanying notes to the unaudited condensed consolidated financial statements. The impact of the reclassifications made to prior year amounts is not material and did not affect net loss.

 

Recently Adopted Accounting Pronouncements

 

In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The updated guidance requires companies to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets, including trade receivables. The guidance was adopted by the Company on January 1, 2023. The adoption of the ASU did not have an impact on the Company’s unaudited condensed consolidated financial statements.

 

8
 

 

Note 3 — Revenue from Contracts with Customers

 

EsoGuard Commercialization Agreement

 

The Company, through its majority-owned subsidiary, Lucid Diagnostics, entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its former commercial laboratory service provider, ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement was on a month-to-month basis, and was terminated on February 25, 2022 upon the execution of an asset purchase agreement (“APA”) dated February 25, 2022, between LucidDx Labs Inc. (a wholly-owned subsidiary of Lucid Diagnostics) and RDx, with such agreement further discussed in Note 5, Asset Purchase Agreement and Management Services Agreement.

 

Revenue Recognized

 

In the three months ended March 31, 2023 and March 31, 2022, the Company recognized total revenue of $446 and $189, respectively. In the three months ended March 31, 2023 the Company recognized revenue of $446, resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three months ended March 31, 2022 was $189, which solely reflects the revenue recognized under the EsoGuard Commercialization Agreement, which represented the minimum fixed monthly fee of $100 for the period January 1, 2022 to the February 25, 2022 termination date as discussed above. The monthly fee was deemed to be collectible for such period as RDx has timely paid the applicable respective monthly fee.

 

Cost of Revenue

 

The cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.

 

In the three months ended March 31, 2023, the cost of revenue was $1,346 and was primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three months ended March 31, 2022 was $369, which solely reflects the costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the period January 1, 2022 to February 25, 2022.

 

Note 4 — Related Party Transactions

 

Case Western Reserve University and Physician Inventors - Amended CWRU License Agreement

 

Case Western Reserve University (“CWRU”) and each of the three physician inventors (“Physician Inventors”) of the intellectual property licensed under the amended and restated patent license agreement with CWRU, dated August 23, 2021 (the “Amended CWRU License Agreement”), each hold a minority equity ownership interest in Lucid Diagnostics Inc. The expenses incurred with respect to the Amended CWRU License Agreement and the three Physician Inventors, as classified in the accompanying unaudited condensed consolidated statement of operations for the periods indicated are summarized as follows:

 

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Cost of Revenue          
CWRU – Royalty Fees  $24   $9 
           
General and Administrative Expense          
Stock-based compensation expense – Physician Inventors’ restricted stock awards   180    272 
           
Research and Development Expense          
Amended CWRU – License Agreement - reimbursement of patent legal fees   389     
Fees - Physician Inventors’ consulting agreements   1    8 
Sponsored research agreement       3 
Stock-based compensation expense – Physician Inventors’ stock options   52    46 
Total Related Party Expenses  $646   $338 

 

9
 

 

Note 4 — Related Party Transactions - continued

 

See Note 12, Stock-Based Compensation, for information regarding each of the “PAVmed Inc. 2014 Long-Term Incentive Equity Plan” and the separate “Lucid Diagnostics Inc 2018 Long-Term Incentive Equity Plan”; and Note 15, Noncontrolling Interest, for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.

 

Other Related Party Transactions

 

Effective June 2021, Veris Health entered into a consulting agreement with Andrew Thoreson, M.D. which provides for compensation on a contractual rate per hour for consulting services provided. Dr. Thoreson holds a partial ownership interest in the legal entity which holds a minority interest in Veris Health. Veris Health recognized general and administrative expense of $5 and $25 in the three months ended March 31, 2023 and 2022, respectively, in connection with the consulting agreement.

 

Note 5 — Asset Purchase Agreement and Management Services Agreement

 

Asset Purchase Agreement and Management Services Agreement - ResearchDx Inc.

 

LucidDx Labs, a wholly-owned subsidiary of Lucid Diagnostics, entered into an asset purchase agreement (“APA”) dated February 25, 2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party (“APA-RDx”). Under the APA-RDx, LucidDx Labs acquired certain assets from RDx which were combined with LucidDx Labs purchased and leased property and equipment to establish a Company-owned Commercial Lab Improvements Act (“CLIA”) certified, College of American Pathologists (“CAP”) accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage. Prior to February 25, 2022, RDx provided such laboratory services at its owned CLIA-certified, CAP-accredited clinical laboratory. In connection with the execution and delivery of the APA-RDx, LucidDx Labs and RDx entered into a separate management services agreement (“MSA-RDx”), dated and effective February 25, 2022, pursuant to which RDx provided certain testing and related services for the Laboratory.

 

The total purchase price consideration payable under the APA-RDx is a face value of $3,200 comprised of three contractually specified periodic payments. The APA-RDx is being accounted for as an asset acquisition, with the recognition of an intangible asset of approximately $3,200, which is included in “Intangible assets, net” on the accompanying unaudited condensed consolidated balance sheet, as further discussed in Note 8, Intangible Assets, net.

 

Termination of Management Services Agreement and Modification of Other Payment Obligations - ResearchDx Inc

 

On February 14, 2023, Lucid Diagnostics and LucidDx Labs entered into an agreement (the “MSA Termination Agreement”) with RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause. The termination was effective as February 10, 2023. Until the termination of the management service agreement with RDx, RDx had continued to provide certain testing and related services for the Laboratory in accordance with the terms of the MSA-RDx.

 

The MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx and the MSA-RDx to $713. The payment was satisfied through the issuance of 553,436 shares of Lucid Diagnostics’ common stock in February 2023. Lucid Diagnostics was not required to make any cash payments in connection with the termination.

 

10
 

 

Note 6 — Prepaid Expenses, Deposits, and Other Current Assets

 

Prepaid expenses and other current assets consisted of the following as of:

 

   March 31, 2023   December 31, 2022 
Advanced payments to service providers and suppliers  $582   $599 
Prepaid insurance   233    300 
Deposits   3,530    3,005 
EsoCheck cell collection supplies   27    59 
EsoGuard mailer supplies   35    52 
Veris Box supplies   127    150 
Total prepaid expenses, deposits and other current assets  $4,534   $4,165 

 

Note 7 — Leases

 

During the three months ended March 31, 2023, the Company entered into additional lease agreements that have commenced and are classified as operating leases and short-term leases, including for each of: principal corporate offices and additional Lucid Test Centers.

 

The Company’s future lease payments as of March 31, 2023, which are presented as operating lease liabilities, current portion and operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:

   

      
2023 (remainder of year)  $1,165 
2024   1,762 
2025   773 
2026   724 
2027   594 
Thereafter   1,319 
Total lease payments  $6,337 
Less: imputed interest   (1,137)
Present value of lease liabilities  $5,200 

 

Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:

  

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Cash paid for amounts included in the measurement of lease liabilities          
Operating cash flows from operating leases  $346   $224 
Non-cash investing and financing activities          
Right-of-use assets obtained in exchange for new operating lease liabilities  $2,473   $3,151 
Weighted-average remaining lease term - operating leases (in years)   4.84    3.32 
Weighted-average discount rate - operating leases   7.875%   7.875%

 

As of March 31, 2023 and December 31, 2022, the Company’s right-of-use assets from operating leases were $5,171 and $3,037, respectively, which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of March 31, 2023 and December 31, 2022, the Company had outstanding operating lease obligations of $5,200 and $2,987, respectively, of which $1,264 and $1,141, respectively, are reported in operating lease liabilities, current portion and $3,936 and $1,846, respectively, are reported in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company calculates its incremental borrowing rates for specific lease terms, used to discount future lease payments, as a function of the financing terms the Company would likely receive on the open market.

 

In September 2022, the Company entered into a lease agreement for its principal corporate offices, in New York, New York. The lease agreement term is from the September 15, 2022 execution date to the date which is seven years and eight months from the lease commencement date, with the rent abated for the first eight months of the lease term. The lease commenced on February 1, 2023. The aggregate (undiscounted) rent payments are approximately $3.2 million over the lease term.

 

11
 

 

Note 8 — Intangible Assets, net

 

Intangible assets, less accumulated amortization, consisted of the following as of:

   

   Estimated Useful Life 

March 31,

2023

  

December 31,

2022

 
Defensive asset  60 months  $2,105   $2,105 
Laboratory licenses and certifications and laboratory information management software  24 months   3,200    3,200 
Other  1 year   70    70 
Total Intangible assets      5,375    5,375 
Less Accumulated Amortization      (2,435)   (1,930)
Intangible Assets, net     $2,940   $3,445 

 

The defensive technology intangible asset was recognized upon its acquisition of CapNostics, an unrelated third-party, for total purchase consideration paid on the October 5, 2021 acquisition date of approximately $2.1 million in cash. The CapNostics transaction was accounted for as an asset acquisition, resulting in the recognition of the defensive technology intangible asset. The defensive technology intangible asset is being amortized on a straight-line basis over an expected useful life 60 months commencing on the acquisition date.

 

The intangible assets recognized under the APA-RDx are the laboratory licenses and certifications, inclusive of a CLIA certification, CAP accreditation, and clinical laboratory licenses for five (5) U.S. States transfer to the Company from RDx, and a laboratory information management software perpetual-use royalty-free license granted under the APA-RDx, with such intangible asset having a useful life of twenty-four months commencing on the APA-RDx February 25, 2022 transaction date.

 

Amortization expense of the intangible assets discussed above was $505 and $123 for the periods ended March 31, 2023 and 2022, respectively, and is included in amortization of acquired intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of March 31, 2023, the estimated future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal years is as follows:

 

      
2023 (remainder of year)  $1,516 
2024   688 
2025   421 
2026   315 
Total  $2,940 

 

Note 9 — Commitment and Contingencies

 

Other Matters

 

In the ordinary course of PAVmed business, particularly as it begins commercialization of its products, the Company may be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from time to time. The Company does not believe it is currently a party to any pending legal proceedings. Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.

 

12
 

 

Note 10 — Financial Instruments Fair Value Measurements

 

Recurring Fair Value Measurements

 

The fair value hierarchy table for the periods indicated is as follows:

   

  

Fair Value Measurement on a Recurring Basis at Reporting

Date Using1

 
   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
March 31, 2023                    
Senior Secured Convertible Note - April 2022  $   $   $20,750   $20,750 
Senior Secured Convertible Note - September 2022           11,650    11,650 
Lucid Senior Secured Convertible Note - March 2023           11,900    11,900 
Totals  $   $   $44,300   $44,300 

 

   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
December 31, 2022                    
Senior Secured Convertible Note - April 2022  $   $   $22,000   $22,000 
Senior Secured Convertible Note - September 2022           11,650    11,650 
Totals  $   $   $33,650   $33,650 

 

1 There were no transfers between the respective Levels during the period ended March 31, 2023.

 

As discussed in Note 11, Debt, the Company issued Senior Secured Convertible Notes dated April 4, 2022 and September 8, 2022, with an initial $27.5 million face value principal (“April 2022 Senior Convertible Note”) and an initial $11.25 million face value principal (“September 2022 Senior Convertible Note”), respectively. Both convertible notes are accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.

 

As discussed in Note 11, Debt, Lucid Diagnostics issued a Senior Secured Convertible Note dated March 21, 2023, with an initial $11.1 million face value principal (“Lucid March 2023 Senior Convertible Note”). This convertible note is also accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.

 

The estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs.

 

The estimated fair value of the Lucid March 2023 Senior Convertible Note as of each of March 21, 2023 and March 31, 2023, and the estimated fair value of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note as of March 31, 2023, were computed using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using the following assumptions:

   

   April 2022 Senior Convertible Note:
March 31, 2023
   September 2022 Senior Convertible Note:
March 31, 2023
   Lucid March 2023 Senior Convertible Note:
March 21, 2023
   Lucid March 2023 Senior Convertible Note:
March 31, 2023
 
Fair Value  $20,750   $11,650   $11,900   $11,900 
Face value principal payable  $20,162   $11,250   $11,111   $11,111 
Required rate of return   11.500%   11.000%   11.00%   11.00%
Conversion Price  $5.00   $5.00   $5.00   $5.00 
Value of common stock  $0.37   $0.37   $1.54   $1.40 
Expected term (years)   0.62    1.44    2.00    1.98 
Volatility   180.00%   180.00%   75.00%   75.00%
Risk free rate   4.75%   4.29%   4.09%   3.99%
Dividend yield   %   %   %   %

 

13
 

 

Note 10 — Financial Instruments Fair Value Measurements - continued

 

The estimated fair values reported utilized the Company’s and Lucid’s common stock prices along with certain Level 3 inputs (as discussed in the table above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated fair values are subjective and are affected by changes in inputs to the valuation models and analyses, including the Company’s and Lucid’s common stock prices, the Company’s and Lucid’s dividend yields, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s and Lucid’s common stock prices. Changes in these assumptions can materially affect the estimated fair values.

 

Note 11 — Debt

 

The fair value and face value principal outstanding of the Senior Convertible Notes as of the dates indicated are as follows:

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
April 2022 Senior Convertible Note  April 4, 2024   7.875%  $5.00   $20,162   $20,750 
September 2022 Senior Convertible Note  September 6, 2024   7.875%  $5.00   $11,250   $11,650 
Lucid March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $11,111   $11,900 
Balance as of March 31, 2023               $42,523   $44,300 

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
April 2022 Senior Convertible Note  April 4, 2024   7.875%  $5.00   $21,497   $22,000 
September 2022 Senior Convertible Note  September 6, 2024   7.875%  $5.00   $11,250   $11,650 
Balance as of December 31, 2022               $32,747   $33,650 

 

The changes in the fair value of debt during the three months ended March 31, 2023 is as follows:

 

 Schedule of Changes in Fair Value Of Debt

   April 2022 Senior Convertible Note   September 2022 Senior Convertible Note   Lucid March 2023 Senior Convertible Note   Sum of Balance Sheet Fair Value Components   Other Income (expense) 
Fair Value - December 31, 2022  $22,000   $11,650   $   $33,650   $ 
Face value principal – issue date           11,111    11,111     
Fair value adjustment – issue date           789    789    (789)
Installment repayments – common stock   (1,335)           (1,335)    
Non-installment payments – common stock   (166)           (166)    
Change in fair value   251            251    (251)
Fair Value at March 31, 2023  $20,750   $11,650   $11,900   $44,300    - 
Other Income (Expense) - Change in fair value – three months ended March 31, 2023                      $(1,040)

 

PAVmed - Senior Secured Convertible Notes

 

The Company entered into a Securities Purchase Agreement (“SPA”) dated March 31, 2022, with an accredited institutional investor (“Investor”, “Lender”, and /or “Holder”), wherein, the Company agreed to sell, and the Investor agreed to purchase an aggregate of $50.0 million face value principal of debt - comprised of: an initial issuance of $27.5 million face value principal; and up to an additional $22.5 million of face value principal (upon the satisfaction of certain conditions). The debt was issued in a registered direct offering under the Company’s effective shelf registration statement.

 

Under the SPA, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April 2022 Senior Convertible Note”, with such note having a $27.5 million face value principal, a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of April 4, 2024. The April 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.

 

14
 

 

Note 11 — Debt - continued

 

Under the same SPA, the Company issued an additional Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September 2022 Senior Convertible Note”, with such note having a $11.25 million face value principal, a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of September 6, 2024. The September 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.

 

The Company is subject to financial covenants requiring: (i) a minimum of $8.0 million of available cash at all times; (ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, to not exceed 30% (except that such maximum percentage was 50% for the period from September 8, 2022 through March 5, 2023) (the “Debt to Market Cap Ratio Test”); and (iii) the Company’s market capitalization to at no time be less than $75 million. (the “Market Cap Test” and, together with the Debt to Market Cap Ratio Test, the “Financial Tests”). From time to time from and after September 8, 2022 through March 12, 2023, the Company was not in compliance with the Financial Tests. As of March 12, 2023, the Investor agreed to waive any such non-compliance during such time period and thereafter through May 31, 2023.

 

In the three months ended March 31, 2023, approximately $1,501 of principal repayments along with approximately $15 of interest expense thereon, were settled through the issuance of 4,330,643 shares of common stock of the Company, with such shares having a fair value of approximately $2,027 (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company). The conversions resulted in a debt extinguishment loss of $0.5 million in the three months ended March 31, 2023. Subsequent to March 31, 2023, as of May 11, 2023, approximately $649 of principal repayments along with approximately $13 of interest expense thereon, were settled through the issuance of 2,183,089 shares of common stock of the Company, with such shares having a fair value of approximately $1,081 (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).

 

Lucid Diagnostics - Senior Secured Convertible Notes

 

Lucid Diagnostics entered into a Securities Purchase Agreement (“Lucid SPA”) dated March 13, 2023, with an accredited institutional investor (“Investor”, “Lender”, and /or “Holder”), wherein, Lucid agreed to sell, and the Investor agreed to purchase an aggregate of $11.1 million face value principal of debt. The debt was issued in a registered direct offering under the Lucid’s effective shelf registration statement.

 

Under the SPA dated March 13, 2023, Lucid issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “Lucid March 2023 Senior Convertible Note”, with such note having a $11.1 million face value principal, a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of Lucid’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of March 21, 2025. The Lucid March 2023 Senior Convertible Note may be converted into shares of common stock of Lucid at the Holder’s election.

 

The Lucid March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs. The lender fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the Company’s unaudited condensed consolidated statement of operations.

 

During the period from March 21, 2023 to September 20, 2023, Lucid is required to pay interest expense only (on the $11.1 million face value principal), at 7.875% per annum, computed on a 360 day year. Lucid paid in cash interest expense of $24 for the three months ended March 31, 2023.

 

Commencing September 21, 2023, and then on each of the successive first and tenth trading day of each month thereafter through to and including March 14, 2025 (each referred to as an “Installment Date”); and on the March 21, 2025 maturity date, Lucid will be required to make a principal repayment of $292 together with accrued interest thereon, with such 38 payments referred to herein as the “Installment Amount”, settled in shares of common stock of Lucid, subject to customary equity conditions, including minimum share price and volume thresholds, or at the election of Lucid, in cash, in whole or in part.

 

In addition to the Installment Amount repayments, the Holder may elect to accelerate the conversion of future Installment Amount repayments, and interest thereon, subject to certain restrictions, as defined, utilizing the then current conversion price of the most recent Installment Date conversion price.

 

The payment of all amounts due and payable under this senior convertible note is guaranteed by Lucid’s subsidiaries; and the obligations under this senior convertible note are secured by all of the assets of Lucid and its subsidiaries.

 

Lucid is subject to certain customary affirmative and negative covenants regarding the rank of the note, along with the incurrence of further indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.

 

Lucid is subject to financial covenants requiring: (i) a minimum of $5.0 million of available cash at all times; (ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) Lucid’s average market capitalization over the prior ten trading days, as of the last day of any fiscal quarter commencing with September 30, 2023, to not exceed 30%; and (iii) Lucid’s market capitalization to at no time be less than $30 million.

 

During the three months ended March 31, 2023, the Company recognized debt extinguishment losses of approximately $525, in connection with issuing common stock for principal repayments on convertible debt mentioned above. During the three months ended March 31, 2022, the Company did not recognize debt extinguishment losses.

 

See Note 10, Financial Instruments Fair Value Measurements, for a further discussion of fair value assumptions.

 

Note 12 — Stock-Based Compensation

 

PAVmed Inc. 2014 Long-Term Incentive Equity Plan

 

The PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”) is designed to enable PAVmed to offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of PAVmed. The types of awards that may be granted under the PAVmed 2014 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the PAVmed board of directors.

 

A total of 21,052,807 shares of common stock of PAVmed are reserved for issuance under the PAVmed 2014 Equity Plan, with 751,778 shares available for grant as of March 31, 2023. The share reservation is not diminished by a total of 600,854 PAVmed Inc. stock options and restricted stock awards granted outside the PAVmed 2014 Equity Plan as of March 31, 2023. In January 2023, the number of shares available for grant was increased by 4,700,000 in accordance with the evergreen provisions of the plan.

 

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Note 12 — Stock-Based Compensation - continued

 

PAVmed Stock Options

 

PAVmed stock options granted under the PAVmed 2014 Equity Plan and stock options granted outside such plan are summarized as follows:

  

   Number of Stock Options   Weighted Average Exercise Price   Remaining Contractual Term (Years)   Intrinsic Value(2) 
Outstanding stock options at December 31, 2022   11,568,655   $2.71    7.4   $ 
Granted(1)   7,280,000   $0.48           
Exercised      $           
Forfeited   (767,935)  $1.77           
Outstanding stock options at March 31, 2023(3)   18,080,720   $1.85    8.1   $ 
Vested and exercisable stock options at March 31, 2023   7,768,903   $2.94    6.1   $ 

 

(1)Stock options granted under the PAVmed 2014 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)The intrinsic value is computed as the difference between the quoted price of the PAVmed common stock on each of March 31, 2023 and December 31, 2022 and the exercise price of the underlying PAVmed stock options, to the extent such quoted price is greater than the exercise price.
(3)The outstanding stock options presented in the table above, are inclusive of 500,854 stock options granted outside the PAVmed 2014 Equity Plan, as of March 31, 2023 and December 31, 2022.

 

PAVmed Restricted Stock Awards

 

PAVmed restricted stock awards granted under the PAVmed 2014 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

  

   Number of Restricted Stock Awards   Weighted Average Grant Date Fair Value 
Unvested restricted stock awards as of December 31, 2022(1)   975,000   $3.05 
Granted        
Vested   (100,000)   3.10 
Forfeited        
Unvested restricted stock awards as of March 31, 2023   875,000   $3.04 

 

(1)The unvested restricted stock awards presented in the table above, are inclusive of 100,000 restricted stock awards granted outside the PAVmed 2014 Equity Plan as of December 31, 2022. These 100,000 restricted stock awards were fully vested during the period ended March 31, 2023.

 

Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan

 

The Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart from the PAVmed 2014 Equity Plan discussed above. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics board of directors.

 

A total of 11,644,000 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan, with 3,834,058 shares available for grant as of March 31, 2023. The share reservation is not diminished by a total of 423,300 stock options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of March 31, 2023. In January 2023, the number of shares available for grant was increased by 2,500,000 in accordance with the evergreen provisions of the plan.

 

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Note 12 — Stock-Based Compensation - continued

 

Lucid Diagnostics Stock Options

 

Lucid Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized as follows:

 

   Number of Stock Options   Weighted Average Exercise Price   Remaining Contractual Term (Years)   Intrinsic Value(2) 
Outstanding stock options at December 31, 2022   2,565,377   $3.14    8.3   $428 
Granted(1)   2,697,500   $1.31           
Exercised      $           
Forfeited   (210,419)  $2.46           
Outstanding stock options at March 31, 2023(3)   5,052,458   $2.19    8.9   $676 
Vested and exercisable stock options at March 31, 2023   1,254,494   $2.67    7.0   $444 

 

(1)Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of March 31, 2023 and December 31, 2022 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price.
(3)The outstanding stock options presented in the table above, are inclusive of 423,300 stock options granted outside the Lucid Diagnostics 2018 Equity Plan, as of March 31, 2023 and December 31, 2022.

 

Lucid Diagnostics Restricted Stock Awards

 

Lucid Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

  

   Number of Restricted Stock Awards   Weighted Average Grant Date Fair Value 
Unvested restricted stock awards as of December 31, 2022(1)   2,091,420   $11.44 
Granted        
Vested   (219,320)   11.27 
Forfeited        
Unvested restricted stock awards as of March 31, 2023   1,872,100   $11.46 

 

(1)The unvested restricted stock awards presented in the table above, are inclusive of 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan as of December 31, 2022. These 50,000 restricted stock awards were fully vested during the period ended March 31, 2023.

 

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Note 12 — Stock-Based Compensation - continued

 

Consolidated Stock-Based Compensation Expense

 

The consolidated stock-based compensation expense recognized by each of PAVmed and Lucid Diagnostics for both the PAVmed 2014 Equity Plan and the Lucid Diagnostics 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above, for the periods indicated, was as follows:

 

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Cost of revenue  $23   $ 
Sales and marketing expenses   444    625 
General and administrative expenses   3,588    4,002 
Research and development expenses   364    187 
Total stock-based compensation expense  $4,419   $4,814 

 

Stock-Based Compensation Expense Recognized by Lucid Diagnostics

 

As noted, the consolidated stock-based compensation expense presented above is inclusive of stock-based compensation expense recognized by Lucid Diagnostics, inclusive of each of: stock options granted under the PAVmed 2014 Equity Plan to the three physician inventors of the intellectual property underlying the CWRU License Agreement (“Physician Inventors”) (as discussed above in Note 4, Related Party Transactions); and stock options and restricted stock awards granted to employees of PAVmed and non-employee consultants under the Lucid Diagnostics 2018 Equity Plan. The stock-based compensation expense recognized by Lucid Diagnostics for both the PAVmed 2014 Equity Plan and the Lucid Diagnostics 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above, for the periods indicated, was as follows:

Schedule of Stock-Based Compensation Expense Recognized by Lucid Diagnostics

   2023   2022 
   Three Months Ended March 31, 
   2023   2022 
Lucid Diagnostics 2018 Equity Plan – cost of revenue  $12   $ 
Lucid Diagnostics 2018 Equity Plan – sales and marketing expenses   223    265 
Lucid Diagnostics 2018 Equity Plan – general and administrative expenses   2,512    3,201 
Lucid Diagnostics 2018 Equity Plan – research and development expenses   70    71 
PAVmed 2014 Equity Plan - cost of revenue   7     
PAVmed 2014 Equity Plan - sales and marketing expenses   133    175 
PAVmed 2014 Equity Plan - general and administrative expenses   156    68 
PAVmed 2014 Equity Plan - research and development expenses   95    55 
Total stock-based compensation expense – recognized by Lucid Diagnostics  $3,208   $3,835 

 

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Note 12 — Stock-Based Compensation - continued

 

The consolidated unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock options and restricted stock awards issued under each of the PAVmed 2014 Equity Plan and the Lucid Diagnostics 2018 Equity Plan, as discussed above, is as follows:

 

   Unrecognized Expense   Weighted Average Remaining Service Period (Years) 
PAVmed 2014 Equity Plan          
Stock Options  $7,612    2.4 
Restricted Stock Awards  $541    0.4 
           
Lucid Diagnostics 2018 Equity Plan          
Stock Options  $4,806    2.5 
Restricted Stock Awards  $1,706    1.1 

 

Stock-based compensation expense recognized with respect to stock options granted under the PAVmed 2014 Equity Plan was based on a weighted average estimated fair value of such stock options of $0.35 per share and $1.22 per share during the periods ended March 31, 2023 and 2022, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:

Schedule of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions 

   Three Months Ended March 31, 
   2023   2022 
Expected term of stock options (in years)   5.7    5.8 
Expected stock price volatility   88%   88%
Risk free interest rate   3.7%   1.8%
Expected dividend yield   %   %

 

Stock-based compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted average estimated fair value of such stock options of $0.87 per share and $2.95 per share during the periods ended March 31, 2023 and 2022, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:

Schedule of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions

   Three Months Ended March 31, 
   2023   2022 
Expected term of stock options (in years)   5.6    5.6 
Expected stock price volatility   75%   86%
Risk free interest rate   3.7%   1.7%
Expected dividend yield   %   %

 

PAVmed Inc. Employee Stock Purchase Plan (“PAVmed ESPP”)

 

A total of 573,229 shares and 194,240 shares of common stock of the Company were purchased for proceeds of approximately $182 and $218, on March 31, 2023 and 2022, respectively under the PAVmed ESPP. The March 31, 2023 purchase was partially settled through the redeployment of 188,846 shares of treasury stock. The PAVmed ESPP has a total reserve of 2,000,000 shares of common stock of PAVmed of which 416,914 shares are available for issue as of March 31, 2023. In January 2023, the number of shares available-for-issue was increased by 250,000 in accordance with the evergreen provisions of the plan.

 

Lucid Diagnostics Inc. Employee Stock Purchase Plan (“Lucid ESPP”)

 

A total of 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $276 on March 31, 2023 under the Lucid ESPP. The Lucid ESPP has a total reserve of 1,000,000 shares of common stock of Lucid Diagnostics of which 683,983 shares are available-for-issue as of March 31, 2023. In January 2023, the number of shares available for issue was increased by 500,000 in accordance with the evergreen provisions of the plan.

 

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Note 13 — Preferred Stock

 

As of March 31, 2023 and December 31, 2022, there were 1,229,887 and 1,205,759 shares of PAVmed Series B Convertible Preferred Stock (classified in permanent equity) issued and outstanding, respectively.

 

Series B Convertible Preferred Stock Dividends

 

The PAVmed Series B Convertible Preferred Stock dividends are 8.0% per annum based on the $3.00 per share stated value of the Series B Convertible Preferred Stock, with such dividends compounded quarterly, accumulate, and are payable in arrears upon being declared by the Company’s board of directors. Such dividends may be settled, at the discretion of the board of directors, through any combination of the issue of additional shares of Series B Convertible Preferred Stock, the issue shares of common stock of the Company, and/or cash payment.

 

Series B Convertible Preferred Stock Dividends Earned

 

The Series B Convertible Preferred Stock dividends earned are included in the calculation of basic and diluted net loss attributable to PAVmed common stockholders for each of the respective corresponding periods presented in the accompanying unaudited condensed consolidated statement of operations, inclusive of approximately $74 of dividends earned in the three months ended March 31, 2023; and approximately $68 of dividends earned in the three months ended March 31, 2022.

 

Series B Convertible Preferred Stock Dividends Declared

 

The Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable by the Company’s board of directors. In this regard, in the three months ended March 31, 2023, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends of $72, earned as of December 31, 2022 with such dividends settled by the issue of 24,128 additional shares of Series B Convertible Preferred Stock.

 

In the three months ended March 31, 2022, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends of $67, earned as of December 31, 2021, with such dividends settled by the issue of 22,291 additional shares of Series B Convertible Preferred Stock.

 

Subsequent to March 31, 2023, in May 2023, the Company’s board of directors declared a Series B Convertible Preferred Stock dividend earned as of March 31, 2023 and payable as of April 1, 2023, of approximately $74, to be settled by the issue of 24,610 additional shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of March 31, 2023, as the Company’s board of directors had not declared the dividends payable as of such date).

 

20
 

 

Note 14 — Common Stock and Common Stock Purchase Warrants

 

Common Stock

 

On December 29, 2022, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until June 27, 2023) to regain compliance. In order to regain compliance, the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days. During the special meeting (“Special Meeting”) of shareholders held on March 31, 2023, the shareholders approved a proposal to amend the Company’s Certificate of Incorporation, to effect, at any time prior to the one-year anniversary date of the Special Meeting, (i) a reverse split of the Company’s outstanding shares of common stock at a specific ratio, ranging from 1-for-5 to 1-for-15, to be determined by the board of directors of the Company in its sole discretion, and (ii) an associated reduction in the number of shares of common stock the Company is authorized to issue, from 250,000,000 shares to 50,000,000 shares. If the Company’s board of directors authorizes the Company to consummate the reverse stock split, the Company anticipates it will regain compliance with the Nasdaq requirements for continued listing through such transaction.

 

During the three months ended March 31, 2023 a total of 573,229 shares of common stock of the Company were issued under the PAVmed ESPP. See Note 12, Stock-Based Compensation, for a discussion of each of the PAVmed 2014 Equity Plan and the PAVmed ESPP.

 

In the three months ended March 31, 2023, 4,330,643 shares of the Company’s common stock were issued upon conversion, at the election of the holder, of the April 2022 Senior Convertible Note, for $1,501 face value principal repayments, as discussed in Note 11, Debt.

 

In the three months ended March 31, 2023, the Company sold 1,081,997 shares through their at-the-market equity facility for net proceeds of approximately $557, after payment of 3% commissions. Subsequent to March 31, 2023, through May 11, 2023, the Company sold 878,634 shares through the at-the-market equity facility for net proceeds of approximately $444, after payment of 3% commissions.

 

Common Stock Purchase Warrants

 

As of March 31, 2023 and December 31, 2022, Series Z Warrants outstanding totaled 11,937,450 and 11,937,450, respectively. A Series Z Warrant is exercisable to purchase one share of common stock of the Company at an exercise price of $1.60 per share, and expire April 30, 2024. There were no Series Z Warrants exercised during the three months ended March 31, 2023.

 

21
 

 

Note 15 — Noncontrolling Interest

 

The noncontrolling interest (“NCI”) included as a component of consolidated total stockholders’ equity is summarized for the periods indicated as follows:

 

   March 31, 2023 
NCI – equity – December 31, 2022  $20,615 
Net loss attributable to NCI   (4,283)
Impact of subsidiary equity transactions   (1,189)
Lucid Diagnostics Inc. proceeds from issuance of preferred stock   13,625 
Lucid Diagnostics Inc. proceeds from At-The-Market Facilities, net of deferred financing charges   284