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,September 30, 2022

 

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: 001-40901

 

LUCID DIAGNOSTICS INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware 82-5488042
(State or Other Jurisdiction of (IRS Employer
Incorporation or Organization) Identification No.)

One Grand Central Place  
60 E. 42nd Street  
Suite 4600  
New York, NY 10165 10165
(Address of Principal Executive OfficesOffices) (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 LUCD The NASDAQ Stock Market LLC

 

Securities registered under Section 12(g) of the Exchange Act: None

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 filerAccelerated filed
Non-accelerated filerSmaller 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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 12,November 10, 2022 there were 38,138,03639,108,245 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 Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan as of such date).

 

 

 

 

TABLE OF CONTENTS

 

Page
 Page
Part I - Financial Information
   
Item 1.Financial Statements 
 Condensed Consolidated Balance Sheets (unaudited) as of March 31,September 30, 2022 and December 31, 20211
 Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended March 31,September 30, 2022 and 20212
 Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and nine months ended March 31,September 30, 2022 and 20213
 Condensed Consolidated Statements of Cash Flows (unaudited) for the threenine months ended March 31,September 30, 2022 and 202145
 Notes to Unaudited Condensed Consolidated Financial Statements56
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2118
Item 4.Controls and Procedures3226
   
 Part II - Other Information 
   
Item 1.Legal Proceedings3326
Item 5.Other Information3326
Item 6.Exhibits33
 Signature3426
 Signature27
Exhibit Index3528

 

i

Part I. Financial Information

 

Item 1. Financial Statements

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARYSUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

 March 31, 2022 December 31, 2021  September 30, 2022  December 31, 2021 
Assets:                
Current assets:                
Cash $47,919  $53,656  $26,934  $53,656 
Accounts receivable  89   200   31   200 
Prepaid expenses, deposits, and other current assets  4,324   3,447   2,882   3,447 
Total current assets  52,332   57,303   29,847   57,303 
Fixed assets, net  1,095   971   1,499   971 
Operating lease right-of-use assets  2,224      2,002    
Intangible assets, net  5,714      3,950    
Other assets  695   725   1,078   725 
Total assets $62,060  $58,999  $38,376  $58,999 
Liabilities, Preferred Stock and Stockholders’ Equity                
Current liabilities:                
Accounts payable $4,462  $1,490  $1,102  $1,490 
Accrued expenses and other current liabilities  2,226   1,113   1,128   1,113 
Operating lease liabilities, current portion  769      860    
Contingent purchase consideration payable  4,887    
Due To: PAVmed Inc. - MSA Fee and operating expenses  1,770   1,657   6,610   1,657 
Total current liabilities  14,114   4,260   9,700   4,260 
Long-term liabilities        
Operating lease liabilities, less current portion  1,455      1,143    
Total long-term liabilities  1,455    
Total liabilities  15,569   4,260   10,843   4,260 
Commitments and contingencies                
Stockholders’ Equity:                
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021      
Common stock, $0.001 par value, 100,000,000 shares authorized; 35,171,796 and 34,917,907 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively  35   35 
Preferred stock, $0.001 par value, 20,000,000 shares authorized; no shares issued and outstanding as of September 30, 2022 and December 31, 2021      
Common stock, $0.001 par value, 100,000,000 shares authorized; 37,016,225 and 34,917,907 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively  37   35 
Additional paid-in capital  100,630   96,608   110,643   96,608 
Accumulated deficit  (54,174)  (41,904)  (83,147)  (41,904)
Total Stockholders’ Equity  46,491   54,739   27,533   54,739 
Total Liabilities and Stockholders’ Equity $62,060  $58,999  $38,376  $58,999 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

1

LUCID DIAGNOSTICS INC.

and SUBSIDIARYSUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

 2022 2021  2022 2021 2022 2021 
 Three Months Ended March 31,  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
 2022 2021  2022 2021 2022 2021 
Revenue $189  $  $76  $200  $265  $200 
Operating expenses:                
Cost of revenue  369      

1,626

   

144

   

1,996

   

144

 
Gross profit (loss)  (180)   
Operating expenses:        
Sales and marketing  3,318   689   3,930   918   11,121   2,627 
General and administrative  5,718   1,212   5,660   3,458   18,223   7,793 
Amortization of acquired intangible assets  505   

   

1,144

   

 
Research and development  2,881   1,752   2,704   2,190   9,024   5,814 
Total operating expenses  11,917   3,653   14,425   6,710   41,508   16,378 
Loss from operations  (12,097)  (3,653)
Net loss from operations  (14,349)  (6,510)  (41,243)  (16,178)
Other income (expense):                        
Change in fair value - contingent consideration payable  (173)   
Interest expense - Senior Unsecured Promissory Note     (447)     (594)
Other income (expense), net  (173)        (447)     (594)
Loss before provision for income tax  (12,270)  (3,653)  (14,349)  (6,957)  (41,243)  (16,772)
Provision for income taxes   ��              
Net loss $(12,270) $(3,653) $(14,349) $(6,957) $(41,243) $(16,772)
Net loss per share - basic and diluted $

(0.35

) $(0.26) $(0.39) $(0.49) $(1.15) $(1.19)
Weighted average common shares outstanding, basic and diluted  

35,123,039

   14,114,437   36,405,945   14,114,707   35,767,857   14,114,707 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

2

LUCID DIAGNOSTICS INC.

and SUBSIDIARYSUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

for the THREE AND NINE MONTHS ENDED September 30, 2022

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

  Shares  Amount  Capital  Deficit  Total 
  Common Stock  

Additional

Paid-In

  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of June 30, 2022  35,994,667  $36  $105,003  $(68,798) $36,241 
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan  5,327      6      6 
Stock-based compensation - Lucid Diagnostics Inc.        3,280      3,280 
Stock-based compensation - PAVmed Inc.        291      291 
Vest - restricted stock awards  169,320             
APA-RDx - Installment Payment  82,618      188      188 
Issuance - Committed Equity Facility, net of deferred financing charges  680,263   1   1,766      1,767 
Purchase - Employee Stock Purchase Plan  84,030      109      109 
Net loss           (14,349)  (14,349)
Balance as of September 30, 2022  37,016,225  $37  $110,643  $(83,147) $27,533 

  Common Stock  

Additional

Paid-In

  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of December 31, 2021  34,917,907  $35  $96,608  $(41,904) $54,739 
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan  964,716   1   693      694 
Stock-based compensation - Lucid Diagnostics Inc.        10,371      10,371 
Stock-based compensation - PAVmed Inc.        880      880 
Vest - restricted stock awards  169,320             
CapNostics, LLC transfer        (211)     (211)
APA-RDx - Installment Payment  199,989      427      427 
Issuance - Committed Equity Facility, net of deferred financing charges  680,263   1   1,766      1,767 
Purchase - Employee Stock Purchase Plan  84,030      109      109 
Net loss           (41,243)  (41,243)
Balance as of September 30, 2022  37,016,225  $37  $110,643  $(83,147) $27,533 

See accompanying notes to the unaudited condensed consolidated financial statements.

3

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

for the THREE AND NINE MONTHS ENDED March 31, 2022 andSeptember 30, 2021

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

 

  Shares  Amount  Capital  Deficit  Total 
  Common Stock  Additional Paid-In  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of December 31, 2021  34,917,907  $35  $96,608  $(41,904) $54,739 
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan  253,889      187      187 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan        3,537      3,537 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan        298      298 
Net Loss           (12,270)  (12,270)
Balance as of March 31, 2022  35,171,796  $35  $100,630  $(54,174) $46,491 
  Common Stock  

Additional

Paid-In

  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of June 30, 2021  14,114,707  $14  $3,677  $(23,641) $(19,950)
Stock-based compensation - Lucid Diagnostics Inc.        2,717      2,717 
Stock-based compensation - PAVmed Inc.        56      56 
Net loss           (6,957)  (6,957)
Balance as of September 30, 2021  14,114,707  $14  $6,450  $(30,598) $(24,134)

 

  Shares  Amount  Capital  Deficit  Total 
  Common Stock  Additional Paid-In  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of December 31, 2020  14,114,707  $10  $298  $(13,826) $(13,518)
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan        802      802 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan        3      3 
Net loss           (3,653)  (3,653)
Balance as of March 31, 2021  14,114,707  $10  $1,103  $(17,479) $(16,366)
  Common Stock  

Additional

Paid-In

  Accumulated    
  Shares  Amount  Capital  Deficit  Total 
Balance as of December 31, 2020  14,114,707  $14  $294  $(13,826) $(13,518)
Stock-based compensation - Lucid Diagnostics Inc.        6,045      6,045 
Stock-based compensation - PAVmed Inc.        111      111 
Net loss           (16,772)  (16,772)
Balance as of September 30, 2021  14,114,707  $14  $6,450  $(30,598) $(24,134)

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

34

LUCID DIAGNOSTICS INC.

and SUBSIDIARYSUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

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

 

 2022 2021  2022 2021 
 Three Months Ended March 31,  Nine Months Ended September 30, 
 2022 2021  2022 2021 
Cash flows from operating activities                
Net loss $(12,270) $(3,653) $(41,243) $(16,772)
                
Adjustments to reconcile net loss to net cash used in operating activities                
Depreciation expense  24   3 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan  3,537   802 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan  298   3 
Fair value adjustment to contingent consideration payable  173    
Depreciation and amortization expense  1,321   3 
Stock-based compensation - Lucid Diagnostics Inc.  10,371   6,045 
Stock-based compensation - PAVmed Inc.  880   111 
APA-RDx: Issue common stock - settle installment payment  427    
Changes in operating assets and liabilities:                
Accounts receivable  111      169   (200)
Prepaid expenses and other current assets  168   104   171   (954)
Accounts payable  1,958   (1,269)  (388)  781 
Accrued expenses and other current liabilities  112   (108)  16   136 
Due To: PAVmed Inc. - operating expenses paid on-behalf-of Lucid Diagnostics Inc.  (510)  33 
Due To: PAVmed Inc. - Management Services Agreement Fee     770 
Due To: PAVmed Inc. - Employee Related Costs  623    
Accrued CWRU License Agreement Fee     (223)
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee  2,849   2,688 
Due To: PAVmed Inc. - Interest Expense - Senior Unsecured Promissory Note     594 
Net cash flows used in operating activities  (5,776)  (3,315)  (25,427)  (7,791)
                
Cash flows from investing activities                
Purchase of equipment  (148)  (9)  (705)  (38)
Payments - Acquisition  (3,200)   
Net cash flows used in investing activities  (148)  (9)  (3,905)  (38)
                
Cash flows from financing activities                
Proceeds – issue of common stock – Committed Equity Facility  1,807    
Proceeds – exercise of stock options  187      694    
Proceeds – issue common stock – Employee Stock Purchase Plan  109    
Proceeds – Due To: PAVmed Inc. - working capital cash advances     3,300      7,739 
Net cash flows provided by financing activities  187   3,300   2,610   7,739 
                
Net increase (decrease) in cash  (5,737)  (24)  (26,722)  (90)
Cash, beginning of period  53,656   111   53,656   111 
Cash, end of period $47,919  $87  $26,934  $21 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

45

LUCID DIAGNOSTICS INC.

and SUBSIDIARYSUBSIDIARIES

(a majority-owned subsidiary of PAVmed Inc.)

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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

 

Note 1 — Summary Description of the Company

 

The accompanying unaudited condensed consolidated financial statements are thoseLucid Diagnostics Inc. and Subsidiaries, referred to herein as “Lucid Diagnostics” or the “Company” is comprised of Lucid Diagnostics Inc. (“Lucid Diagnostics” or “the Company”), which was incorporated in the Stateand its wholly-owned subsidiaries, inclusive of Delaware on May 8, 2018.LucidDx Labs, Inc. and CapNostics LLC. Lucid Diagnostics Inc. is a majority-owned subsidiary of PAVmed Inc., as discussed below.

 

The Company operates in one segment as a commercial-stage medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease - “GERD” - which is also known variously as chronic heartburn, acid reflux or simply reflux - who are at risk for developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (EAC)(“EAC”).

 

Lucid Diagnostics Inc. entered into a patent license agreement with Case Western Reserve University (“CWRU”), captioned the Amended and Restated License Agreement, dated August 23, 2021 (“Amended CWRU License Agreement”). The Amended CWRU License Agreement is a successor to and replaced in its entirety the previous CWRU License Agreement, dated May 12, 2018. The Amended CWRU License Agreement terminates upon the expiration of certain related patents, or on May 12, 2038 in countries where no such patents exist, or upon expiration of any exclusive marketing rights granted by the FDA or other U.S. government agency, whichever comes later.

 

The Amended CWRU License Agreement (as did the predecessor CWRU License Agreement) provides for the exclusive worldwide license of the intellectual property rights for the proprietary technologies of two distinct technology components - the “EsoCheck Cell Collection Device” referred to as “EsoCheck®”; and a panel of proprietary methylated DNA biomarkers, a laboratory developed test (“LDT”), referred to as “EsoGuard®”; and together are collectively referred to as the “EsoGuard Technology”. See the Company’s consolidated financial statements for the year ended December 31, 2021, Note 3, Patent License Agreement - Case Western Reserve University, as included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on April 6, 2022, for a further discussion of the Amended CWRU License Agreement.

On February 25, 2022, LucidDx Labs, Inc. entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx, LucidDx Labs Inc. acquired certain assets from RDx to be combined with LucidDx Labs Inc. 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. See Note 6, Asset Purchase Agreement and Management Services Agreement, for a further discussion of the APA-RDx.

 

Since its inception, the Company has advanced the proprietary technologies underlying EsoGuard and EsoCheck from the academic research laboratory to commercial diagnosticsdiagnostic tests and devices with scalable manufacturing capacity. The Company is presently focused on expanding commercialization across multiple sales channels, including: the communication and education of medical practitioners and clinicians of the EsoGuard LDT;EsoGuard; and establishing “Lucid Diagnostics Test Centers” for the collection of cell samples using EsoCheck. Recently, the American Gastroenterological Association (“AGA”) and the American College of Gastroenterology (“ACG”) updated its clinical practice guidelines to now support Lucid’s EsoCheck UpCell Collection Device and until February 25, 2022, delivery ofEsoGuard Esophageal DNA Test as an acceptable alternative to endoscopy.Both guidelines expand the collected cell samples were sentaddressable market opportunity for these products to ResearchDX Inc. (“RDx”), a CLIA certified commercial laboratory service provider,now affirmatively include screening women. The AGA updated guideline further expands the target population for the performance offirst time to include asymptomatic patients who otherwise present with the EsoGuard LDT. See LucidDx Labs, Inc. and Asset Purchase Agreement-February 2022 below.certain risk factors. Additionally, the Company is conducting two concurrent clinical trials, including each of: the “EsoGuard screening study” (“ESOGUARD-BE-1”); and the “EsoGuard case control study” (“ESOGUARD-BE-2”), to support a United States Food and Drug Administration (“FDA”) pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro diagnostic medical device (“IVD”). Further, the Company is developing expanded clinical evidence to support recommendationinsurance reimbursement adoption by government and private insurers. Further, the Company is also pursuing development of ourother products in professional society guidelines.

5

Note 1 — Summary Descriptionand services, including EsoCure™, an esophageal ablation device. The ability of the Company - continued

Since its inception and through the date ofto generate revenue depends upon the Company’s IPO on October 14, 2021,ability to successfully advance the commercialization of EsoGuard, while also completing its clinical studies to accelerate the adoption of insurance reimbursement. There are no assurances, however, the Company will be able to obtain an adequate level of financial resources required for the long-term commercialization and development of its products and services.

Prior to its initial public offering (“IPO”) of its common stock, the operations of Lucid Diagnostics Inc. have beenthe Company were funded by PAVmed Inc., inclusive of providing working capital cash advances and the payment by PAVmed Inc. of certain operating expenses on-behalf-of Lucid Diagnostics Inc.the Company. Additionally, the dailycertain operations of Lucid Diagnostics Inc. continue to be managed by personnel employed byof PAVmed Inc., for which Lucid Diagnostics Inc. incurs expense according to the provisions of a Management Services Agreement between Lucid Diagnostics Inc. and PAVmed Inc. See Note 5,4, Related Party Transactions, for information with respect to the Management Services Agreement; and Note 6,5, Due To PAVmed Inc., for further information with respect to amounts owed to PAVmed Inc. by Lucid Diagnostics Inc.

The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic and medical device 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 andcommitted equity committed sources of capital with Lucid and its parent company, PAVmed,financing, the Company expects to be able to fund its future operations and meet its financial obligations as they become due for the one year period from the date of the issue of the Company’s unaudited condensed consolidated financial statements, as included herein in this Quarterly Report on Form 10-Q for the period ended March 31,September 30, 2022.

Lucid Diagnostics Inc. Initial Public Offering - October 14, 2021

 

On October 14, 2021, Lucid Diagnostics Inc. completed an initial public offering (“IPO”) of its common stock under an effective registration statement on Form S-1 (SEC File No. 333-259721), wherein a total of 5.0 million IPO shares of common stock were issued, with such total IPO shares inclusive of 571,428 IPO shares issued to PAVmed Inc., at an IPO price of $14.00 per share, resulting gross proceeds of $70.0 million, before underwriting fees of $4.9 million, and approximately $0.7 million of offering costs incurred by the Company.

LucidDx Labs Inc.

In December 2021, Lucid Diagnostics, Inc. formed a new wholly owned subsidiary, LucidDx Labs Inc., principally to construct and operate a Company-owned Commercial Lab Improvements Act (“CLIA”) certified, College of American Pathologists (“CAP”) accredited commercial clinical laboratory.

On February 25, 2022, LucidDx Labs, Inc., entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”), an unrelated third-party - “RDx APA”. Under the RDx APA, LucidDx Labs Inc. acquired certain assets from RDx to be combined with LucidDx Labs Inc. purchased and leased property and equipment to establish a Company-owned CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage. See Note 7, Acquisitions - Asset Purchase Agreement - Research Dx Inc., for a further discussion of the RDx APA.

6

Note 2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates

 

Significant Accounting Policies

 

The Company’s significant accounting policies are as disclosed in the Company’s annual reportAnnual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted herein below.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of Lucid Diagnostics Inc. and 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 subsidiary, LucidDx Labs Inc.subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. Lucid Diagnostics Inc. (“the Company”) is a majority-owned consolidated subsidiary of PAVmed Inc., which has a majority equity ownership interest and has financial control of Lucid Diagnostics Inc. 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, 2021 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.

The consolidated results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2022 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 Lucid Diagnostics Inc. and Subsidiaries audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K as filed with the SEC on April 6, 2022.

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.

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.

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 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 stock-based equity awards and contingent consideration.intangible assets. 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.

 

Contingent ConsiderationLeases

 

Contingent Consideration relatesThe Company adopted FASB ASC Topic 842, Leases, (“ASC 842”) effective December 31, 2021.

All significant lease agreements and contractual agreements with embedded lease agreements are accounted for under the provisions of ASC 842, wherein, if the contractual arrangement: involves the use of a distinct identified asset; provides for the right to substantially all the potential payment for an acquisition that is contingent uponeconomic benefits from the achievementuse of the acquired business meeting certain milestones. The Company records contingent consideration at fair value atasset throughout the datecontractual period; and, provides for the right to direct the use of acquisition based on the consideration expectedasset. A lease agreement is accounted for as either a finance lease (generally with respect real estate) or an operating lease (generally with respect to be transferred. For potential payments related to milestone achievements,equipment). Under both a finance lease and an operating lease, the Company estimated the fair value based on the probability of achievement of such milestones. The assumptions utilized in the calculationrecognizes as of the acquisitionlease commencement date fair value include probability of successa lease right-of-use (“ROU”) asset and the discount rates. Contingent consideration involves certain assumptions requiring significant judgment and actual results may differ from assumed and estimated amounts. Contingent consideration is remeasured each reporting period, and subsequent changes in fair value, including accretion for the passage of time, are recognized within other income (expense), net in the Company’s unaudited condensed consolidated statements of operations.a corresponding lease payment liability.

 

7

Note 2 — Summary of Significant Accounting Policies- continued

A lease ROU asset represents the Company’s right to use an underlying asset for the lease term, and the lease liability represents its contractual obligation to make lease payments. The lease ROU asset is measured at the lease commencement date as the present value of the future lease payments plus initial direct costs incurred. The Company recognizes lease expense of the amortization of the lease ROU asset for an operating lease on a straight-line basis over the lease term; and for financing leases on a straight-line basis unless another basis is more representative of the pattern of economic benefit. The operating ROU asset also includes any lease incentives received for improvements to leased property, when the improvements are lessee owned. For improvements to leased property that are lessor owned, the Company includes amounts the Company incurred for the improvements as ROU assets which are amortized on a straight-line basis over the life of the lease.

The lease liability is measured at the lease commencement date with the discount rate generally based on the Company’s incremental borrowing rate (to the extent the lease implicit rate is not known nor determinable), with interest expense recognized using the interest method for financing leases.

Certain leases may include options to extend or terminate the agreement. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to be reasonably certain at lease commencement. As well, an option to terminate is considered unless it is reasonably certain the Company will not exercise the option. The Company elected the practical expedient to not recognize a lease ROU asset and lease payment liability for leases with a term of twelve months or less (“short-term leases”), resulting in the aggregate lease payments being recognized on a straight line basis over the lease term. The Company’s leases with a commencement date prior to January 1, 2022 were short-term leases and therefore did not require recording a ROU asset or lease liability at December 31, 2021. Additionally, the Company elected the practical expedient to not separate lease and non-lease components.

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.

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.

8

Note 2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued

 

Recent Accounting Standards Updates AdoptedWhen 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

 

Effective December 31, 2021,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 adopted FASB ASC Topic 842, Leases, (“ASC 842”). ASC 842 established a right-of-use (“ROU”) model requiring a lesseeexpects the collection cycle to recognize a ROU asset and a lease liability for all leases with terms greater-than 12 months. Leases are classified as either financebe one year or operating, with classification affecting the pattern of expense recognition in the income statement. The Company’s adoption of ASC 842 did not have an effect on the Company’s consolidated financial statements. See Note 9, Leases.less.

 

Note 3 — Patent License Agreement - Case Western Reserve University

The Company has a patent license agreement with CWRU which provides for each of patent fees reimbursement payments, milestone payments and royalty payments - each as discussed below. For further details of this agreement, see Note 3 of the Company’s Consolidated Financial Statements in the Company’s Form 10-K for the year ended December 31, 2021.

Lucid Diagnostics Inc. is responsible for reimbursement of certain CWRU billed patent fees. See Note 5, Related Party Transactions, for patent fee reimbursement payments paid to CWRU in the periods ended March 31, 2022 and 2021.

The CWRU License Agreement contained milestones for which a $75 research and development expense was recognized and paid with respect to the achievement of the regulatory milestone related to FDA clearance of EsoCheck. The CWRU License Agreement was amended effective February 12, 2021 such that a regulatory milestone related to FDA PMA submission of a licensed product (“PMA Milestone”) is included in the Amended CWRU License Agreement, and is the sole remaining unachieved milestone, for which a $200 milestone payment would be payable to CWRU upon its achievement.

8

Note 3 — Patent License Agreement - Case Western Reserve University - continued

Under the Amended CWRU License Agreement, the Company is required to pay a royalty fee to CWRU with respect to the “Licensed Products” (as defined in the CWRU License Agreement) of a percentage of “Net Sales”, as defined in the Amended CWRU License Agreement, as follows: 5.0% of Net Sales up to $100.0 million per year; and 8.0% of Net Sales of $100.0 million or greater per year, with such amounts subject-to a minimum annual royalty fee. The Company recorded a royalty expense of $10 for the three months ended March 31, 2022

Note 4 — Revenue from Contracts with Customers

Revenue is recognized when the satisfaction of the performance obligation occurs, which is when the delivery of product and /or the provision of service is rendered, and is measured as the amount of estimated consideration expected to be realized. In the period ended March 31, 2022, the Company recognized revenue under the EsoGuard Commercialization Agreement, dated August 1, 2021, as discussed below.

 

EsoGuard Commercialization Agreement

 

The Company entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its CLIA certifiedformer commercial laboratory service provider, ResearchDXResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement initial term was on a month-to-month basis and was terminated on February 25, 2022 upon the execution of thean asset purchase agreement (“APA”) dated February 25, 2022, between LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc., and RDx, APA. Seewith such agreement further discussed in Note 7,6, Acquisitions - Asset Purchase Agreement - Research Dx Inc.and Management Services Agreement, for a further discussion of the RDx APA..

Revenue Recognized

 

In the three months and nine months ended March 31,September 30, 2022, the Company recognized total revenue of $76 and $265, respectively. For the three month period ended September 30, 2022, the Company recognized revenue 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 as the Company did not estimate expected variable consideration given the lack of historical experience and objective reliable actual reimbursement data. In addition to the revenue recognized during the three month period ended September 30, 2022, the Company’s revenue for the nine month period ended September 30, 2022 includes $189 of revenue recognized under the EsoGuard Commercialization Agreement,, which representsrepresented the minimum fixed monthly fee of $100for 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. In the three and nine months ended September 30, 2021, the Company recognized total revenue of $200 and $200, respectively, under the EsoGuard Commercialization Agreement.

 

Cost of Revenue

The cost of revenue recognized with respectrevenues 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 September 30, 2022, the cost of revenue recognizedwas $1,626 and was primarily related to costs for our laboratory operations and EsoCheck device supplies. For the nine months ended September 30, 2022, the cost of revenue was $1,996, including $369 reflecting costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the period January 1, 2022 to February 25, 2022 totaled2022. In the three and nine months ended September 30, 2021, the cost of revenue was $369144 and $144, inclusive of employeerespectively, which solely related costs of employees engaged into the delivery of the administration to patients of the EsoCheck cell sample collection procedure, EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed to medical practitioners’ locations and the Lucid Test Centers; Lucid Test Centers operating expenses, including rent expense and supplies; and royalty fees incurred under the Amended CWRU LicenseCommercialization Agreement.

 

9

Note 54Related 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 (“Physician Inventors”Agreement”), each hold a minority equity ownership minority interestsinterest 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 consolidated statement of operations for the periods indicated are summarized as follows:

Schedule of Incurred Expenses of Minority Shareholders

  2022  2021 
  Three Months Ended March 31, 
  2022  2021 
Cost of Revenue        
CWRU – Royalty Fee $9  $ 
Cost of Revenue  369   - 
         
General and Administrative Expense        
Stock-based compensation expense – Physician Inventors’ restricted stock awards  272   91 
General and Administrative Expense  5,718   1,212 
         
Research and Development Expense        
CWRU License Agreement - reimbursement of patent legal fees      
Fees - Physician Inventors’ consulting agreements  8   13 
Sponsored research agreement  3    
Stock-based compensation expense – Physician Inventors’ stock options  46   6 
Research and Development Expense  2,881   1,752 
Total Related Party Expenses $338  $110 

Lucid Diagnostics Inc. entered into consulting agreements with each of the three Physician Inventors, with each such consulting agreement providing for compensation on a contractual rate per hour for consulting services provided, and an expiration date of May 12, 2024, upon the agreements’ renewal effective May 12, 2021. Additionally, as discussed below, each of the Physician Inventors have been granted stock options under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan, and stock options and restricted stock awards under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan.

Under each of their respective (initial) consulting agreements with Lucid Diagnostics Inc., the three Physician Inventors were each granted 25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12, 2018, an exercise price of $1.59 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018 and ending March 31, 2021, and a contractual period of ten years from the date of grant. As of March 31, 2021, such stock options were fully vested and exercisable. Subsequent to March 31, 2021, each of the Physician Inventors were granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of June 21, 2021, an exercise price of $6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2021 and ending March 31, 2024, and a contractual period of ten years from the date of grant.

On March 1, 2021, restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan to each of the three Physician Inventors, with such restricted stock awards having a single vesting date of March 1, 2023, with the fair value of such restricted stock awards recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.

10

Note 5 — Related Party Transactions - continued

  2022  2021  2022  2021 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  2022  2021  2022  2021 
Cost of Revenue                
CWRU – Royalty Fee $4  $10  $13  $10 
General and Administrative Expense                
CWRU – License Agreement - Amendment Fee - Milestone III     10      10 
Stock-based compensation expense – Physician Inventors’ restricted stock awards  275   273   819   637 
                 
Research and Development Expense                
CWRU License Agreement - reimbursement of patent legal fees     82   209   195 
Fees - Physician Inventors’ consulting agreements  15   8   32   22 
Sponsored research agreement  4      6    
Stock-based compensation expense – Physician Inventors’ stock options  52   56   151   114 
Total Related Party Expenses $350  $439  $1,230  $988 

 

PAVmed Inc. - Management Services Agreement

 

The Company’s daily operations of Lucid Diagnostics Inc. are managed by personnel employed by PAVmed Inc., for which Lucid Diagnostics Inc. incurs a service fee, referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed Inc. The MSA does not have a termination date, but may be terminated by the Lucid Diagnostics Inc. board of directors. The MSA Fee is charged on a quarterlymonthly basis and is subject-to periodic adjustment corresponding with changes in the number ofservices provided by PAVmed Inc. employees providing servicespersonnel to Lucid Diagnostics Inc.,the Company, with theany such change in the MSA Fee approved bybeing subject to approval of the boards of directors of each of the Lucid Diagnostics Inc. and PAVmed Inc. boardOn August 11, 2022, the respective Company’s boards of directors.directors approved a sixth amendment to the MSA to increase the MSA Fee to $550 per month from $390 per month, with such increase effective on a prospective basis that commenced July 1, 2022. Pursuant to the sixth amendment, the parties agreed PAVmed Inc. may elect to receive payment of the monthly MSA Fee in cash or in shares of common stock of the Company, with such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of the applicable month (subject to a floor price of $0.70 per share). However, in no event will PAVmed Inc. be entitled to receive under the MSA, as amended, more than 7,709,836 shares of common stock the Company (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the sixth amendment). The shares that may be issued under the MSA, as amended, are being offered and sold in transactions exempt from registration under the Securities Act of 1933, as amended, in reliance on the exemption afforded under Section 4(a)(2) thereof.

 

Lucid Diagnostics Inc. recognized MSA Fee expense of $1,170 and $770 in the periods ended March 31, 2022 and 2021, respectively. The MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:

Schedule of MSA Fee Expense Classification in Unaudited Condensed Statement of Operations

 2022 2021  2022  2021  2022  2021 
 Three Months Ended March 31,  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
 2022 2021  2022  2021  2022  2021 
Cost of Revenues $  $  $  $40  $  $40 
Sales & Marketing  

183

   323   330   352   713   971 
General & Administrative  

640

   270   891   254   2,175   872 
Research & Development  

347

   177   429   224   1,102   627 
Total MSA Fee $

1,170

  $770  $1,650  $870  $3,990  $2,510 

10

Note 4 — Related Party Transactions - continued

 

The classification of the MSA Fee as presented above is based on the PAVmed Inc. classification of employee salary expense. In this regard, PAVmed Inc. classifies employee salary expense as cost-of-revenue for employees engaged in service delivery under the EsoGuard Commercialization Agreement, and sales and marketing expenses for employees performing sales, marketing, and reimbursement activities and functions, general and administrative, and research and development except for those employees who are engaged in product and services engineering development and design and /or clinical trials activities, for which such employee salary is classified as research and development expense.

Other Related Party Transactions

 

Lucid Diagnostics Inc. previously entered into a consulting agreement with Stanley N. Lapidus, effective June 2020 with such consulting agreement providing for compensation on a contractual rate per hour for consulting services provided. In July 2021, Mr. Lapidus was appointed as Vice Chairman of the Board of Directors of Lucid Diagnostics Inc. Lucid Diagnostics Inc. recognized general and administrative expense of $68 and $21in the periodthree and nine months ended March 31,September 30, 2021 in connection with the consulting agreement.

 

11

Note 65Due To PAVmed Inc.Inc.

 

The aggregate Due To: PAVmed Inc., inclusive of the Senior Unsecured Promissory Note, for the periods indicated is summarized as follows:

Schedule of Senior Unsecured Promissory Note

 Working Capital Cash Advances PAVmed Inc. OBO Payments Employee-Related Costs MSA Fees Total  CapNostics, LLC Transfer PAVmed Inc. OBO Payments Employee-Related Costs MSA Fees Total 
Balance - December 31, 2021 $  $620  $1,037  $  $1,657  $  $620  $1,037  $  $1,657 
MSA fees           

1,170

   1,170            3,990   3,990 
On Behalf Of (OBO) activities     153         

153

      1,114         1,114 
ERC - Payroll & Benefits        2,122      

2,122

         7,178      7,178 
CapNostics, LLC transfer  2,105            2,105 
Cash payments to PAVmed Inc.     (662)  (1,500)  (1,170)  (3,332)     (1,598)  (5,496)  (2,340)  (9,434)
Balance - March 31, 2022 $  $111  $1,659 $ $1,770
Balance - September 30, 2022 $2,105  $136  $2,719  $1,650  $6,610 

Prior to the Company’s initial public offering (IPO), it principally financed its operations through working capital cash advances from PAVmed Inc. and the periodic payment of certain operating expenses by PAVmed Inc. on-behalf-of Lucid Diagnostics Inc. (the “PAVmed Inc. OBO Payments”). Additionally, the daily operations of Lucid Diagnostics Inc. are managed by personnel employed by PAVmed Inc., for which the Company incurs expense according to the provisions of a Management Services Agreement (the “MSA”) between the Company and PAVmed Inc (the “MSA Fee”). See Note 5, Related Party TransactionsCapNostics, LLC, for further information regarding the MSA.

 

On October 5, 2021, PAVmed Subsidiary Corp, a wholly-owned subsidiary of PAVmed Inc., acquired 100% of the outstanding membership interest of CapNostics, LLC (“CapNostics”), an unrelated third-party, for total (gross) purchase consideration of approximately $2.1 million in cash, paid at the closing of the transaction. Subsequently, effective April 1, 2022, PAVmed Subsidiary Corp and the Company entered into an agreement pursuant to which PAVmed Subsidiary Corp assigned to Lucid Diagnostics Inc. 100% of the membership interest in CapNostics, LLC, resulting in the recognition by the Company principally of an acquired defensive technology intangible asset, and a $2.1 million payment obligation Due To: PAVmed Inc. Additionally, Lucid Diagnostics Inc. was also assigned on a prospective basis effective April 1, 2022, the consulting agreement with the previous principal owner of CapNostics, LLC. The transfer was accounted for as entities under common control. See Note 9 - Intangible Assets, net, with respect to the transferred intangible asset.

EsoCure License Agreement with PAVmed Inc.

EsoCure has been in development as an esophageal ablation device by PAVmed Inc., with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. In April 2022, following the approval from both the Company’s and PAVmed Inc.’s boards of directors, the companies entered into an intercompany license agreement (“EsoCure License Agreement”), pursuant to which the Company was granted the rights to commercialize EsoCure, a technology under development intended for the treatment of dysplastic Barrett’s Esophagus. The EsoCure License Agreement, includes a royalty arrangement whereby the Company will pay PAVmed Inc. a 5% royalty on all EsoCure sales up to $100 million per calendar year, and an 8.0% royalty on annual sales in excess of $100 million per calendar year. The Company is obligated to reimburse PAVmed Inc. for any ongoing development costs and cumulative patent expenses associated with the licensed technology.

1211

Note 76AcquisitionsAsset Purchase Agreement and Management Services Agreement

Asset Purchase Agreement - ResearchDx Inc.

 

On February 25, 2022,Through its wholly-owned subsidiary, LucidDx Labs Inc., the Company entered into an asset purchase agreement (“APA”) dated February 25, 2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “RDx APA”“APA-RDx”. Under the RDx APA,APA-RDx, LucidDx Labs Inc. acquired certain assets from RDx to bewhich were combined with LucidDx Labs Inc. purchased and leased property and equipment to establish a Company-owned CLIA certified, 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 consummation of the RDx APA,February 25, 2022, RDx provided such laboratory services at its owned CLIA-certified, CAP-accredited clinical laboratory.

 

As of March 31, 2022,The total purchase price consideration payable under the Company’s preliminary analysis is the RDx APA transactionAPA-RDx is a business combination, resulting inface 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 and measurement of a preliminary purchase considerationan intangible asset of approximately $3,200, which is included in accordance with“Intangible assets, net” on the valuation methodology describedaccompanying unaudited condensed consolidated balance sheet, as further discussed in Note 2,9, SummaryIntangible Assets, net. In the three and nine months ended September 30, 2022, a total of Significant Accounting Policies$1,000 and Recent Accounting Standards Updates.$3,200, respectively, of cash was paid with respect to the periodic payments.

 

UnderAdditionally, the terms ofAPA-RDx requires the RDx APA, LucidDx Labs Inc. willCompany to pay RDx an aggregate purchase price of up to $6.2 million for the acquired assets. Thea total of $6.2 3,000million is comprised to be paid as twelve (12) equal installment payments commencing May 25, 2022 and then on each three month anniversary thereof, inclusive of non-contingent purchase considerationa final installment payment on February 25, 2025, with such installment payments recognized as current period expense as incurred. In the three and nine months ended September 30, 2022, as provided for in the APA-RDx, installment payments were settled with the issuances of 82,618 and 199,989 shares of common stock of Lucid Diagnostics Inc., with such shares having fair values of $1.0 188 and $427million (included, respectively, (with the fair value measured as the quoted closing price on the dates the shares were issued), which was recognized as a current period expense included in “Accruedgeneral and administrative expenses and other liabilities” in the accompanying unaudited condensed consolidated balance sheets, asstatement of March 31, 2022),operations.

The APA-RDx provides for each of an acceleration and contingent purchase consideration of a total of $5.2 million face value, with such contingent purchase consideration having a preliminary $4,714 initial estimated fair value ascancellation of the transaction date. The preliminary $5,714 purchase consideration (inclusive of both the non-contingent and contingent purchase consideration discussed above) is unallocatedremaining unpaid installment payments, summarized as of March 31, 2022, and as such is included in intangible assets in the accompanying unaudited consolidated balance sheet. The preliminary estimated fair value of the contingent purchase price consideration and the identification and estimated fair value of acquired assets are subject-to further revision.follows:

The payment of the remaining unpaid installment payments will be accelerated as immediately due and payable as of the date the “MSA-RDx” (as such agreement is discussed below) is either terminated by LucidDx Labs Inc. without cause or if it is terminated by mutual agreement between the Company and RDx.
The payment of the remaining unpaid installment payments will be cancelled if the MSA-RDx is terminated by LucidDx Labs Inc. for cause, defined as the occurrence of any one of: (i) a material breach by RDx which is not cured within thirty days of LucidDx Labs Inc. written notice; (ii) RDx becomes insolvent and /or bankrupt; or (ii) RDx fails to comply with applicable statutes, is barred from participating in federal health care programs, or by action of changes in law or regulation, or by action of judicial interpretation of law, or by judicial civil proceedings decisions.

Concurrent with the RDx APA, Management Services Agreement - Research Dx Inc

LucidDx Labs Inc. and RDx also entered into a separate management services agreement (“RDx MSA”MSA-RDx”), dated and effective February 25, 2022, with such agreement having a term of three years, commencing on the agreement’s effective date, and a totalan initial fee of approximately $1.8 150million payable in equal quarterly payments.

per quarter. The MSA-RDx provides for the cancellation of the remaining unpaid installment payments upon termination of the MSA-RDx for any reason or no reason by either party thereto.

Pro Forma Information.

The RDx APA transaction impact for purposes of pro forma financial statement disclosures would have primarily impacted the Company’s EsoGuard Commercialization Agreement with RDx, summarized as follows:

Schedule of Business Acquisition Pro Forma Information

  Three Months Ended March 31, 
  2022  2021 
Revenue        
As reported $189  $ 
Pro forma $  $ 
Net Loss        
As reported $(12,270) $(3,653)
Pro forma $(12,459) $(3,653)
Basic and diluted net loss per share        
As reported $(0.35) $(0.26)
Pro forma $(0.35) $(0.26)

13

 

Note 87Prepaid Expenses, Deposits, and Other Current Assets

 

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

Schedule of Prepaid Expenses and Other Current Assets

 March 31, 2022 December 31, 2021  September 30, 2022  December 31, 2021 
Advanced payments to service providers and suppliers $259  $260  $363  $260 
Prepaid insurance  1,052   1,578   26   1,578 
Deposits  1,668   1,116   2,389   1,116 
Deferred financing charges  1,014    
EsoCheck cell collection supplies  266   434   55   434 
EsoGuard mailer supplies  65   59   49   59 
Total prepaid expenses, deposits and other current assets $4,324  $3,447  $2,882  $3,447 

12

 

Note 98Leases

During the nine months ended September 30, 2022, the Company entered into additional lease agreements that have commenced and are classified as operating leases and short-term leases, including for each of: a commercial clinical laboratory and additional Lucid Test Centers.

The Company’s future lease payments as of September 30, 2022, 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:

Schedule Of Future Lease Payments Of Operating Lease Liabilities

     
2022 (remainder of year) $246 
2023  980 
2024  928 
2025  24 
Total lease payments $2,178 
Less: imputed interest  (175)
Present value of lease liabilities $2,003 

 

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

Schedule ofOf Cash Flow Supplemental Information

 2022 2021 
 Three Months Ended March 31,  Nine Months Ended September 30, 
 2022 2021  2022  2021 
Cash paid for amounts included in the measurement of lease liabilities                
Operating cash flows from operating leases $224  $  $689  $ 
Non-cash investing and financing activities                
Right-of-use assets obtained in exchange for new operating lease liabilities $2,404  $  $2,567  $ 
Weighted-average remaining lease term - operating leases (in years)  2.72      2.24    
Weighted-average discount rate - operating leases  7.875%  %  7.875%  %

 

As of March 31,September 30, 2022, the Company’s right-of-use assets from operating leases are $2,2242,002, which are reporting in right-of-use assets - operating leases in the unaudited condensed consolidated balance sheets. As of March 31,September 30, 2022, the Company has outstanding operating lease obligations of $2,2242,003, of which $769860 is reported in operating lease liabilities, current portion and $1,455 1,143is reporting in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company did not have operating leases as of December 31, 2021. 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.

1413

Note 109 — Intangible Assets, net

 

Financial Instruments Fair Value MeasurementsIntangible assets, less accumulated amortization, consisted of the following as of:

Schedule of Intangible Assets Accumulated Amortization

  Estimated Useful Life September 30, 2022 
Defensive technology 60 months $2,105 
Laboratory licenses and certifications and laboratory information management software 24 months  3,200 
Total Intangible assets    5,305 
Less Accumulated Amortization    (1,355)
Intangible Assets, net   $3,950 

The defensive technology intangible asset of $2.1 million (and approximately $0.2 million of accumulated amortization) was recognized by the Company as of the April 1, 2022 effective date of the intercompany transfer of CapNostics, LLC to the Company from PAVmed Subsidiary Corp (a wholly-owned subsidiary of PAVmed Inc.). The transfer was accounted for as entities under common control. The defensive technology intangible asset was recognized by PAVmed Subsidiary Corp upon its acquisition of CapNostics, LLC, 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 LLC 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. See Note 5, Due To PAVmed Inc., with respect to the transfer of the corresponding $2.1 million payment obligation Due To: PAVmed Inc.

 

As noted in Note 6, Recurring Fair Value MeasurementsAsset Purchase Agreement and Management Services Agreement, the asset purchase agreement between the Company and ResearchDx Inc. (“APA-RDx”), is being accounted for as an asset acquisition. 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.

 

The fair value hierarchy tableAmortization expense of the intangible assets discussed above was $505 and $0 for the reporting dates notedthree month periods ended September 30, 2022 and 2021, respectively, and $1,144 and $0 for the nine month periods ended September 30, 2022 and 2021, respectively, and is included in general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations. As of September 30, 2022, 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:

 

Schedule of Fair value Measurement on Recurring BasisFuture Amortization Expense

  Level-1 Inputs  Level-2 Inputs  Level-3 Inputs  Total 
  Fair Value Measurement on a Recurring Basis at Reporting
Date Using(1)
 
  Level-1 Inputs  Level-2 Inputs  Level-3 Inputs  Total 
March 31, 2022                
Contingent consideration payable (1) $  $  $4,887  $4,887 
Totals (1) $  $  $4,887  $4,887 

(1)As noted above, as presented in the fair value hierarchy table, Level-1 represents quoted prices in active markets for identical items, Level-2 represents significant other observable inputs, and Level-3 represents significant unobservable inputs. There were no transfers between the respective Levels during the period ended March 31, 2022.

Fair value measurements of contingent consideration

The Company recorded $4.9 million, which is the fair value, of contingent consideration related to the RDx acquisition. The Company is required to make contingent consideration payments of up to $5.2 million related to the RDx APA agreement. The contingent agreement is based on achieving milestones to obtain certain certifications and licensing rights. The Company estimated the fair value on a probability based model that assessed achievement of such milestones. The model used present value factors, that applied probability ranges of 94-99%, a discount rate of 7.875% and achievement times ranging from one month to six months to achieve the respective milestones.

The final settlement of contingent consideration liabilities for the acquisition could vary from current estimates based on the actual results of the financial measures described above. This liability is considered to be a Level 3 financial liability that is re-measured each reporting period. The change in fair value of contingent consideration for these acquisitions is included in other income (expense), net.

The following table presents a reconciliation of the liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3):

Schedule of Reconciliation of Liability Measured at Fair Value Recurring Basis Using Unobservable Inputs

  March 31, 2022 
Fair value of contingent consideration at the date of acquisition $4,714 
Payments   
Change in fair value of contingent consideration  173 
Contingent consideration payable $4,887 

As of December 31, 2021 there were no fair value measurements.

15

     
2022 (remainder of year) $504 
2023  2,021 
2024  688 
2025  421 
2026  316 
Total $3,950 

 

Note 1110Stock-Based Compensation

 

Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan

 

The Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”) is separate and apart from the PAVmed Inc. 2014 Equity Plan discussed below. The Lucid Diagnostics Inc. 2018 Equity Plan is designed to enable Lucid Diagnostics Inc. to offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of Lucid Diagnostics Inc. The types of awards that may be granted under the Lucid Diagnostics Inc. 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 Inc. board of directors.

 

A total of 5,644,0009,144,000 shares of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc. 2018 Equity Plan, with 733,5413,754,051 shares available for grant as of March 31,September 30, 2022. The share reservation is not diminished by a total of 473,300 423,300Lucid Diagnostics Inc. stock options and50,000 restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan, as of March 31,September 30, 2022.

14

Note 10 — Stock-Based Compensation - continued

 

Lucid Diagnostics Inc. 2018 Equity Plan - Stock Options

 

StockLucid Diagnostics Inc. stock options issued and outstandinggranted under the Lucid Diagnostics Inc. 2018 Equity Plan and including Lucid Diagnostics stock options granted outside thesuch plan isare summarized as follows:

Schedule of Stock Options Issued and Outstanding Activities

 Number of Stock Options Weighted Average Exercise Price Remaining Contractual Term (Years)  Number of Stock Options Weighted Average Exercise Price Remaining Contractual Term (Years) Intrinsic Value(2) 
Outstanding stock options at December 31, 2021  1,419,242  $0.73   7.0   1,419,242  $0.73   7.0  $6,665 
Granted(1)  1,760,000  $4.16       2,320,000  $3.71         
Exercised  (253,889) $0.74       (964,717) $0.72         
Forfeited  (60,926) $4.61       (141,436) $4.33         
Outstanding stock options at March 31, 2022  2,864,427  $2.75   6.9 
Vested and exercisable stock options at March 31, 2022  1,277,026  $0.99   3.3 
Outstanding stock options at September 30, 2022(3)  2,633,089  $3.17   8.6  $499 
Vested and exercisable stock options at September 30, 2022  960,364  $2.33   7.2  $499 

(1)Stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan and those granted outside such plan generally vest ratably over twelve quarters, with the vesting commencing with the grant date quarter,quarter-end, 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 Inc. common stock on each of September 30, 2022 and December 31, 2021 and the exercise price of the underlying Lucid Diagnostics Inc. 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 Inc. 2018 Equity Plan, as of September 30, 2022 and December 31, 2021.

 

See Note 5,4, Related Party Transactions, for a summary of the stock-based compensation expense recognized with respect to the stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan to the Physician Inventors.

16

Note 11 — Stock-Based Compensation - continued

Lucid Diagnostics Inc. 2018 Equity Plan – Restricted Stock Awards

 

A summary ofLucid Diagnostics Inc. restricted stock award activity isawards granted under the Lucid Diagnostics Inc. 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

 

Schedule of Restricted Stock Award Activity

 Number of Restricted Stock Awards Weighted Average Grant Date Fair Value  

Number of Restricted

Stock Awards

 

Weighted Average Grant

Date Fair Value

 
Unvested restricted stock awards as of December 31, 2021  1,890,740  $12.94   1,940,740  $12.76 
Granted  320,000   4.53   320,000   4.53 
Vested        (169,320)  13.48 
Forfeited           
Unvested restricted stock awards as of March 31, 2022  2,210,740  $11.07 
Unvested restricted stock awards as of September 30, 2022(1)  2,091,420  $11.44 

(1)The unvested restricted stock awards presented in the table above, are inclusive of 50,000 restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan as of September 30, 2022 and December 31, 2021.

 

On January 7, 2022, 320,000restricted stock awards were granted under the Lucid Diagnostics Inc 2018 Equity Plan, with such restricted stock awards having a single vesting date on January 7, 2025, and an aggregate grant date fair value of approximately $1.4million, measured as the grant date closing price of Lucid Diagnostics Inc. common stock, with such aggregate estimated fair value recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.

 

PAVmed Inc. 2014 Equity Plan

 

The PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed Inc. 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics Inc. 2018 Equity Plan (as such equity plan is discussed above).

 

15

The three Physician Inventors were each granted 25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12, 2018, an exercise price of $1.59 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018 and ending March 31, 2021, and a contractual period of ten years from the date of grant. Additionally, the three Physician Inventors were each granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of June 21, 2021, an exercise price of $6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2021 and ending March 31, 2024, and a contractual period of ten years from the date of grant. See Note 5, Related Party Transactions, for a summary of the stock-based compensation expense recognized with respect to the stock options granted under the PAVmed Inc. 2014 Equity Plan to the Physician Inventors.

Note 10 — Stock-Based Compensation - continued

Stock-Based Compensation Expense

 

The stock-based compensation expense recognized by the Company for both the Lucid Diagnostics Inc. 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan, for the periods indicated, was as follows:

Schedule of Stock-Based Compensation Expense

  2022   2021  2022  2021  2022  2021 
 Three Months Ended March 31,  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
  2022   2021  2022  2021  2022  2021 
Lucid Diagnostics Inc 2018 Equity Plan – cost of revenue $9  $  $9  $ 
Lucid Diagnostics Inc 2018 Equity Plan – sales and marketing expenses $265  $   253      733    
Lucid Diagnostics Inc 2018 Equity Plan - general and administrative expense  3,201   789 
Lucid Diagnostics Inc 2018 Equity Plan - general and administrative expenses  2,990   2,695   9,504   5,988 
Lucid Diagnostics Inc 2018 Equity Plan - research and development expenses  71   13   28   21   125   57 
PAVmed Inc 2014 Equity Plan - sales and marketing expenses  175      161      497    
PAVmed Inc 2014 Equity Plan - general and administrative expenses  68      78      224    
PAVmed Inc 2014 Equity Plan - research and development expenses  55   3   52   56   159   111 
Total stock-based compensation expense $3,835  $805  $3,571  $2,772  $11,251  $6,156 

 

The stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan to employees of PAVmed Inc., the Physician Inventors (as discussed above), and members of the board of directors of Lucid Diagnostics Inc., as well as the stock options granted under the PAVmed Inc. 2014 Equity Plan to the Physician Inventors (as discussed above).

17

Note 11 — Stock-Based Compensation - continuedInventors.

 

As of March 31,September 30, 2022, 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 Lucid Diagnostics Inc. 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan, as discussed above, is as follows:

Schedule of Unrecognized Compensation Expense and Weighted Average Remaining Service Period

 Unrecognized
Expense
 Weighted Average Remaining Service Period (Years)  

Unrecognized

Expense

 

Weighted Average

Remaining Service

Period (Years)

 
Lucid Diagnostics Inc. 2018 Equity Plan                
Stock Options $4,660   2.7  $3,791   2.4 
Restricted Stock Awards $14,080   1.3  $7,165   0.8 
PAVmed Inc. 2014 Equity Plan                
Stock Options $2,317   2.1  $1,618   1.7 
Restricted Stock Awards $264   1.7  $187   1.2 

 

Stock-based compensation expense recognized with respect to stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan was based on a weighted average estimated fair value of such stock options of $2.951.61 per share during the year ended March 31, 2022. There were 0 stock-based awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan during the period ended March 31, 2021.September 30, 2022. The stock-based compensation was calculated using the following weighted average Black-Scholes valuation model assumptions:

 

Schedule of Stock-based Compensation Valuation Assumptions

2022

Nine Months Ended

September 30,

Three Months Ended March 31,2022
2022
Expected term of stock options (in years)5.65.8
Expected stock price volatility8672%
Risk free interest rate1.73.2%
Expected dividend yield%

16
 %

Note 10 — Stock-Based Compensation - continued

 

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

 

The Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid Diagnostics Inc ESPP”), initial six-month stock purchase period iswas April 1, 2022 to September 30, 2022. A total of 84,030 shares of common stock of Lucid Diagnostics Inc were purchased for proceeds of approximately $109 on September 30, 2022 under the Lucid Diagnostics Inc. ESPP. The Lucid Diagnostics Inc. ESPP has a total reservation of 500,000shares of common stock forof which all415,970 shares are available-for-issue as of March 31,September 30, 2022.

18

 

Note 1211Stockholders’ Equity

Lucid Diagnostics Inc. Common Stock

 

ThereAs of September 30, 2022 and December 31, 2021 there were 35,171,79637,016,225 and 34,917,907 shares of common stock issued and outstanding, as of March 31, 2022 and December 31, 2021, respectively. As of March 31,September 30, 2022, PAVmed Inc. holds 27,927,190 shares, representing a majority-interest equity ownership and PAVmed Inc. has a controlling financial interest in Lucid Diagnostics Inc.

 

Committed Equity Facility - March 28, 2022

 

On March 28, 2022, Lucid Diagnostics, Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the committed equity facility, Cantor has committed to purchase up to $50million of Lucid Diagnostics Inc. common stock from time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market price. As of September 30, 2022, under the committed equity facility, a total of 680,263 shares of common stock of the Company were issued for proceeds of approximately $1,807.

 

In connection with the execution of the agreement for the committed equity facility, the Company agreed to paypaid Cantor $1.0 million as consideration for its irrevocable commitment to purchase the shares upon the terms and subject to the satisfaction of the conditions set forth in such agreement. In addition, pursuant to the agreement, we agreed to reimburse Cantor for certain of its expenses. theThe Company also entered into a registration rights agreement with Cantor. theThe Company has the right to terminate the agreement at any time after initial satisfaction of the conditions to Cantor’s obligation to purchase shares under the facility, at no cost or penalty, upon three trading days’ prior written notice.

 

19

Note 1312Net Loss Per Share

 

The “Net loss per share basic and diluted” for the respective periods indicated - is as follows:

Schedule of Basic and Fully Diluted Net Loss Per Share

 2022 2021  2022  2021  2022  2021 
 Three Months Ended March 31,  

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 
 2022 2021  2022  2021  2022  2021 
Numerator                     
Net loss $(12,270) $(3,653) $(14,349) $(6,957) $(41,243) $(16,772)
                        
Denominator                        
Weighted average common shares outstanding, basic and diluted  

35,123,039

   14,114,437   36,405,945   14,114,707   35,767,857   14,114,707 
                        
Loss per share        
Net loss per share                
Net loss per share - basic and diluted $

(0.35

) $(0.26) $(0.39) $(0.49) $(1.15) $(1.19)

 

Basic weighted-average number of shares of common stock outstanding for the periods ended March 31,September 30, 2022 and 2021 include the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded from the computation of diluted weighted average shares outstanding are as follows:

Schedule of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share

 Three Months Ended March 31,  September 30, 
 2022 2021  2022  2021 
Lucid Diagnostics Inc. 2018 Equity Plan:     
     
Stock options  3,287,727   1,145,353   2,633,089   1,399,242 
Unvested restricted stock awards  2,260,740   1,467,440   2,091,420   1,806,080 
        
Total  5,548,467   2,612,793   4,724,509   3,205,322 

The total of stock options and unvested restricted stock awards presented in the table above, are inclusive of 423,300 stock options as of March 31, 2022 and 2021, and 50,000 restricted stock awards as of March 31, 2022, granted outside the Lucid Diagnostics Inc. 2018 Equity Plan. 

Note 14 — Subsequent Events

CapNostics, LLC

On October 5, 2021, PAVmed Subsidiary Corporation, a wholly-owned subsidiary of PAVmed Inc., acquired all of the outstanding common stock of CapNostics, LLC (“CapNostics”) for total (gross) purchase consideration of approximately $2.1 million of cash, paid at the closing of the transaction. In April 2022, following the approval from both the PAVmed and Lucid board of directors, the respective companies entered into an agreement to transfer the CapNostics, LLC assets from PAVmed to Lucid as well as transferring the consulting agreement with the previous principal owner of CapNostics, LLC. The transfer price is $2.1 million for the assets.

EsoCure

EsoCure has been in development as an Esophageal Ablation Device by PAVmed, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. In April 2022, following the approval from both the PAVmed and Lucid board of directors have the Companies entered into an intercompany license between PAVmed and Lucid such that Lucid will be granted the rights to commercialize EsoCure for the treating dysplastic Barrett’s Esophagus, including a royalty arrangement whereby Lucid will pay PAVmed a 5% royalty on all EsoCure sales up to $100 million per calendar year, and 8% above that threshold. Lucid will obligated to fund ongoing development costs and cumulative patent expenses. EsoCure will become part of an integrated suite of Lucid products addressing BE-EAC.

 

2017

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

 

The following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read together with our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”), as filed with the Securities and Exchange Commission (the “SEC”). We are a majority-owned consolidated subsidiary of PAVmed Inc. (“PAVmed”).

 

Unless the context otherwise requires, references herein to “we”, “us”, and “our”, and to the “Company” or “Lucid Diagnostics” are to Lucid Diagnostics Inc and its subsidiarysubsidiaries LucidDx Labs Inc. (“LucidDx Labs”) and CapNostics, LLC (“CapNostics”).

 

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”

 

Important factors that may affect our actual results include:

 

our limited operating history;
our financial performance, including our ability to generate revenue;
our ability to obtain regulatory approval for the commercialization of our products;
ourthe ability of our products to achieve market acceptance;
our success in retaining or recruiting, or changes required in, our officers, key employees or directors;
our potential ability to obtain additional financing when and if needed;
our ability to protect our intellectual property;
our ability to complete strategic acquisitions;
our ability to manage growth and integrate acquired operations;
the potential liquidity and trading of our securities;
our regulatory and operational risks;
cybersecurity risks;
risks related to SARS-CoV-2 /COVID-19the COVID-19 pandemic;
the impact of the material weakness identified byrisks related to our management;relationship with PAVmed; and
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

 

In addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions, joint ventures or investments we may make.

 

We may not actually achieve the plans, intentions, and /orand/or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. You should read this Form 10-Q and the Form 10-K, and the documents we have filed as exhibits to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

2118

Overview

 

We are a commercial-stage, cancer prevention, medical diagnostics technology company focused on the millions of patients with long-standing gastroesophageal reflux disease (“GERD”) who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”), which is expected to lead to approximately 16,000 U.S. deaths in 2021.per year.

 

We believe that our lead products, the EsoGuard Esophageal DNA Test performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent EAC deaths, through early detection of esophageal precancer in at-risk GERD patients.

 

EsoGuard is a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been shown to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of the esophagus and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheckspectrum. (Moinova, et al. Sci Transl Med. 2018 Jan 17;10(424): eaao5848).
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasivea swallowable balloon capsule catheter capable of sampling surface esophageal cells in a less than five-minuteless-than -five-minute, noninvasive office procedure. We believe its proprietaryEsoCheck’s Collect+Protect™ technology makes it the only noninvasive esophageal cell collection device capable of anatomically targeted and protected sampling to prevent dilution and contamination during device withdrawal.

We are party to an amended and restated patent license agreement with CWRU, dated August 23, 2021 (the “Amended CWRU License Agreement”), which provides for the exclusive worldwide license of the intellectual property rights for the proprietary technologies underlying EsoCheck and EsoGuard.

 

EsoGuard is commercialized in the U.S. as a laboratory developed test (“LDT”). It was previously performed by our unrelated third-party commercial clinical laboratory service partner ResearchDx Inc. (with a d/b/a “Pacific Dx”) (“RDx”), at their Clinical Laboratory Improvement Amendments (“CLIA”) certified commercial clinical laboratory, located in Irvine, CA. Beginning in March 2022, the EsoGuard LDT has been performed at our own CLIA-certified commercial clinical laboratory, located in Lake Forest, CA. Additionally, RDx also currently manufactures our EsoGuard Specimen Kits.specimen kits. EsoCheck is commercialized in the U.S. as a 510(k) cleared esophageal cell collection device currently manufactured for us by our contract manufacturing partner, Sage Product Development Inc., located in Foxborough, MA. WeAs discussed below, we are in the process of transferring EsoCheck manufacturing to Coastline International Inc., a high-volume manufacturer headquartered in San Diego, CA with plants in Mexico. Both EsoGuard andCA. EsoCheck havehas completed the CE Mark certification process. While EsoGuard, used with EsoCheck, was granted Food and EsoCheck mayDrug Administration (“FDA”) Breakthrough Device designation and requires the completion of an international multicenter pre-market approval (“PMA”) clinical trial to be marketed separately, they are not presently approvedable to submit EsoGuard to the FDA for marketing togetherapproval as an in vitro diagnostic device (“IVD”). EsoGuard, used with EsoCheck as an IVD, was granted FDA Breakthrough Device designation and is the subject of two large, actively enrolling, international multicenter PMA clinical trials.

 

The EsoGuard PLA code 0114U secured a final Medicare payment determination of $1,938.01, effective January 1, 2021. The CLIA certified laboratory where the EsoGuard assay is performed has begun to submit claims and receive out-of-network private insurance payments. We are awaiting a Medicare local coverage determination.determination (“LCD”), as discussed in more detail below. We are also aggressively pursuing EsoGuard U.S. private payor payment and coverage, as well as payment in Europe.

 

We are working to expand EsoGuard commercialization across multiple channels by building a direct sales and marketing team targeting primary care physicians, specialists, institutions and consumers. To assure sufficient testing capacity and geographic coverage, as part of this expansion, we are building our own network of Lucid Test Centers, staffed by Lucid-employed clinical personnel, where patients can undergo the EsoCheck procedure and have the sample sent for EsoGuard testing, starting with three test centers launched in the Phoenix metropolitan area andtesting. We have recently expanded our test centers into Utah, Nevada, Colorado, Washington, Oregon and Idaho. We’ve also established an EsoGuard Telemedicine Program, in partnership with UpScript, LLC, an independent third-party telemedicine provider, that can accommodate EsoGuard self-referrals from direct-to-consumer marketing.

 

We are a majority owned subsidiary of PAVmed. We are party to an amendedUpdated Clinical Guidelines and restated patent license agreement with CWRU, dated August 23, 2021 (“Amended CWRU License Agreement”), which provides for the exclusive worldwide license of the intellectual property rights for the proprietary technologies underlying EsoCheck and EsoGuard.

22

Recent Developments

Guidance 

Business

Clinical Guideline Update - ACG

 

In April 2022, the American College of Gastroenterology (“ACG”) updated its clinical guideline to support esophageal precancer (“Barrett’s Esophagus”, “BE”)(including BE) screening to prevent highly lethal esophageal cancer (“EAC”)EAC utilizing our EsoGuard® DNA TestEsoGuard on samples collected with our EsoCheck® Cell Collection Device.EsoCheck. The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening in at-risk patients with gastroesophageal reflux disease (“GERD”),GERD, commonly known as chronic heartburn, acid reflux or simply reflux. In its Recommendation 5, the ACG suggests a single screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age >50 yr,greater than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative. Furthermore, and importantly for the first time, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative to costly and invasive endoscopy by stating in its Recommendation 6 that the ACG suggests that a swallowable, nonendoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy for screening for BE. The clinical guideline specifically mentions EsoCheck, along with Lucid’s EsophaCap®our EsophaCap device, as such swallowable, nonendoscopic esophageal cell collection devices, as well asdevices. The clinical guideline also mentions methylated DNA biomarkersmarkers (like those detected by the EsoGuard test) as such as EsoGuard.a biomarker. The summary of evidence for this recommendation citesincludes a reference to the seminal NIH-funded multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

 

19

Overview - continued

In July 2022, the American Gastroenterology Association (“AGA”) published updated clinical guidance that mirrors the same furnished by the ACG as described above, endorsing the use of non-invasive screening tools like EsoCheck, which is cited in its guideline, as an acceptable alternative to endoscopy to directly address the need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of BE. The clinical practice update by the AGA also significantly expands the target population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of reflux. The AGA does so by adding a history of chronic GERD as merely an additional, seventh risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended for screening. As a result, chronic symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three of the other six risk factors (e.g., male sex, age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE) are now considered at-risk patients recommended for screening.

Local Coverage Determination Update - CMS

In April 2022, a proposed Local Coverage Determination (“LCD”)LCD DL39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” was published on the Center for Medicare and Medicaid Services (“CMS”) website by MACthe Medicare Administrative Contractor (“MAC”) Palmetto GBA. The proposed LCD is a further step in Lucid’sour efforts to secure Medicare coverage and payment for EsoGuard.

 

The proposed LCD, which the CMS website explicitly characterizes as a “work in progress” for “public review,” outlines criteria that MolDXMAC Palmetto GBA’s Molecular Diagnostic Services Program (“MolDX”) expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet. These criteria include active GERD with at least two risk factors, as well as evidence of analytic validity, clinical validity, and clinical utility. Although it found that no currently existing test has fulfilled all these criteria, it indicated that it will “monitor the evidence and will provide coverage based on the pertinent literature and society recommendations.” Notably, the proposed LCD pre-dated, and therefore does not include consideration of, the most recent ACG clinical guideline update endorsing swallowable, nonendoscopic capsule devices combined with a biomarker, such as EsoCheck and EsoGuard. The publication of the proposed LCD included a written comment period that extended through May 14, 2022. MolDX held an open meeting on May 10, 2022, during which stakeholders and other interested parties had the opportunity to address the proposed LCD.

 

We have used the written comment process and the open meeting to bring to MolDX essential information that was not incorporated into the proposed LCD. These include: the updated ACG clinical guideline; the fact that EsoGuard’s published performance is at or above accepted performance criteria for detection of lower gastrointestinal cancers in approved and currently effective Medicare coverage determinations; and data from ongoing clinical utility studies Lucid and clinical investigators are performing. A final LCD will not be issued until the MAC has had the opportunity to assess and consider the comments and input from the written comment period and the open meeting.

 

Following the MAC Palmetto GBA release of a proposed LCD, the MAC Noridian Healthcare Solutions published a proposed LCD entitled Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262. The proposed LCD mirrors the MAC Palmetto GBA proposed LCD. We have used the MAC Noridian Healthcare Solutions open meeting held on May 26, 2022, and the written comment period that ended on June 11, 2022 to bring the same essential information that we provided to the MAC Palmetto GBA to maintain consistency in our approach and advocate appropriately.

MediNcrease Health PlansStatus of Clinical Trials

 

In May 2022 LucidDx Labs, Inc. entered into2021, we began conducting two concurrent clinical trials, the “EsoGuard screening study” (“BE-1”) and the “EsoGuard case-control study” (“BE-2”), to expand the clinical evidence for the technologies and to support FDA pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro diagnostic medical device (“IVD”). However, in light of the MAC Palmetto GBA’s recently published proposed LCD DL39256, the recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to prevent highly lethal EAC utilizing a participating provider agreementbiomarker test like EsoGuard on samples collected with MediNcrease Health Plans, LLC (“MediNcrease”). A national directly-contracted, multi-specialty PPO provider networka swallowable, nonendoscopic capsule device like EsoCheck, we have determined to prioritize our clinical trial efforts and resources towards supporting studies that will help secure insurance reimbursement adoption for EsoGuard by government and private insurers. Consequently, we have decided to delay for the time being the BE-1 trial while continuing to enroll GERD patients with over 8 million lives covered through its clients and payers, which include regional and national health plans, insurance companies, third party administrators, self-insured employer groups, municipalities, unions and other entities involveda previous diagnosis of nondysplastic BE, low grade dysplasia, high grade dysplasia, or EAC in the management of medical claims. Pursuant to the agreement, persons covered by MediNcrease clients and payers will have in-network access to Lucid’s EsoGuard® DNA test, the first and only commercially available test capable of serving as a widespread tool to prevent esophageal cancer deathsBE-2 case-control study through the early detection of esophageal precancer in at-risk chronic heartburn patients. The agreement provides rates of reimbursement as a percent of charges for services rendered to such covered persons by LucidDx Labs, including the performance of the EsoGuard test.Q2 2023.

23

Recent Developments - continued

 

Business - continuedEsoCure Esophageal Ablation Device

CLIA Lab Acquisition

 

In February 2022, Lucid Diagnostics, Inc. through its wholly owned subsidiary LucidDx Labs, Inc. entered into an asset purchase agreement (“APA”)connection with ResearchDx, Inc. (“RDx”) Underour efforts to expand our presence in the APA, LucidDx Labs acquired certain licenses and other related assets necessary to operatediagnostic market, we are also developing a CLIA-certified, CAP-accredited clinical laboratory. The acquired assets, together with certain additional assets necessary to commence laboratory operations that were separately purchased by LucidDx Labs, will be used by Lucid to performthird product, the EsoGuard®EsoCure Esophageal DNA assay.

EsoCure Intercompany License

In April 2022, we entered into an intercompany license between PAVmed and Lucid such that Lucid has been granted the rights to commercialize EsoCure for treating dysplastic Barrett’s Esophagus, including a royalty arrangement whereby Lucid will pay PAVmed will be obligated to fund ongoing development costs and cumulative patent expenses. EsoCure will become part of an integrated suite of Lucid products addressing BE-EAC. EsoCure is in development as an “Esophageal Ablation Device”Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. We have successfully completedAs described in Note 5, Due To PAVmed Inc., we entered into a license agreement with our parent company, PAVmed, pursuant to which we were granted the rights to commercialize EsoCure. A successful pre-clinical feasibility animal study of EsoCure has been completed, demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. An acute and survival animal study of EsoCure has also been completed, demonstrating successful direct thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. We plan to conduct additional development work and animal testing of EsoCure to support a plannedfuture FDA 510(k) submission in the second half of 2022.submission. 

 

20

Recent Developments

EsophaCap Intercompany AssignmentBusiness

 

Reimbursement – Private Payer

As part of the transition to our own CLIA-certified commercial clinical laboratory, we contracted with a revenue cycle management (“RCM”) service provider to submit third-party reimbursement claims on our behalf. The RCM service provider has joint oversight of payer claims, appeals processes, patient billing, online payment collection, and claims tracking. On August 1, 2022, our new RCM company began submitting claims to third-party payers. At the point when submission by the RCM began, more than 2,000 claims had accumulated since the commencement of our laboratory operations on February 25, 2022. These claims and other claims that were subsequently generated are now being processed, including 1,088 tests in the three months ended September 30, 2022.

Refer to Note 3 of our Condensed Consolidated Financial Statements for more information on Revenue from Contracts with Customers.

EsoCheck Cell Collection Device Update

In AprilOctober 2022, following the approval from bothFDA announced they completed their review of the PAVmedEsoCheck 510(k) (#K222366) premarket notification of intent to market the device and Lucid boardgranted the use of directors, the respective companies entered into an agreement to transfer the CapNostics, LLC assets from PAVmed to Lucid as well as transferring the consulting agreement with the previous principal owner of CapNostics, LLC. The transfer price is $2.1 millionEsoCheck Cell Collection Device for the assets. collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older. This action by the FDA now expands the targeted US patient population to include adolescents not previously covered by the Company’s initial EsoCheck 510(k) clearance.

EsoCheck Manufacturing Update

On October 5, 2021, PAVmed Subsidiary Corporation,4, 2022, we completed our first full day of manufacturing of EsoCheck at Coastline International Inc., a wholly-owned subsidiary of PAVmedhigh-volume medical device manufacturer. By mid-2023, we expect to transition from our current manufacturer, Sage Product Development Inc., acquired all ofto Coastline International Inc., as the outstanding common stock of CapNostics, LLC (“CapNostics”) for a total (gross) purchase consideration of approximately $2.1 million of cash, paid at the closing of the transaction.manufacturing process is further optimized.

 

Financing

In March 2022, Lucid Diagnostics, Inc.we entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc.our common stock from time to time at the request of Lucid Diagnostics Inc.upon our request. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics Inc.us to raise primary capital on a periodic basis at prices based on the existing market price.

24

Impact of SARS-CoV-2 - COVID-19 Pandemic

Previously, in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United Nations World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2” - or “SARS-CoV-2”. The SARS-CoV-2 spread on a global basis to other countries, including the United States. On March 11, 2020, the WHO declared a pandemic resulting from SARS-CoV-2, with such pandemic commonly referred to by its resulting illness of coronavirus disease 2019, or “COVID-19”. The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19 pandemic on the United States national economy, the global economy, and our business.

The COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those Through September 30, 2022, 680,263 shares of our contractors, and increase our expenses, including as a resultcommon stock were issued under this facility for total proceeds of impacts associated with preventive and precautionary measures being taken, restrictions on travel, quarantine polices, and social distancing. Such adverse impact may include, for example, the inability of our employees and /or those of our contractors to perform their work or curtail their services provided to us.

We expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and consolidated operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or to contain the SARS-CoV-2 and the impact of such efforts.

In addition, the spread of the SARS-CoV-2 has disrupted the United States’ healthcare and healthcare regulatory systems which could divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with respect to our products.

Furthermore, our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions imposed by governments, and the inability to access clinical test sites for initiation and monitoring.

The COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the USA, resulting in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.

Although we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic (or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition, consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.$1.8 million.

 

2521

Results of Operations

 

Overview

 

Revenue

 

RevenueThe Company recognized revenue resulting from the delivery of patient EsoGuard test results for which cash collections have occurred or payment was reasonably assured. Additionally, revenue was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned subsidiary, Lucid Diagnostics Inc.,Company and ResearchDX Inc. (“RDx”),RDx, a CLIA certified commercial laboratory service provider. On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset Purchase Agreement between LucidDx Labs Inc., athe Company’s wholly-owned subsidiary of Lucid DiagnosticsLucidDx Labs Inc. and RDx.

 

Cost of revenue

Cost of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due to costs being incurred in one period that relate to revenues recognized in a later period.

We expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies, patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.

 

The cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty fee incurred under the Amended CWRU License Agreement; the MSA Fee (as defined and discussed herein below) allocated to cost of revenue, which is principally employee related costs of PAVmed employees engaged in the administration to patients of the EsoCheck cell sample collection procedure (principally at the LUCIDLucid Test Centers); the EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed to medical practitioners locations and the LUCIDLucid Test Centers; and LUCIDLucid Test Centers operating expenses, including rent expense and supplies.

 

Sales and marketing expenses

 

Sales and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well as the portion of the MSA Fee allocated to sales and marketing expenses, which are principally employee related costs of PAVmed employees, as well as advertising and promotion expenses.employees. We anticipate our sales and marketing expenses will increase in the future, as we anticipate an increase in payroll and related expenses related to the roll-out of our commercial sales and marketing operations as we execute on our business strategy.

 

General and administrative expenses

 

General and administrative expenses consist primarily of professional fees, accounting and legal services, consultants and expenses associated with obtaining and maintaining patents within our intellectual property portfolio, along with the portion of the MSA Fee allocated to general and administrative expenses.

 

We anticipate our general and administrative expenses will increase in the future as we anticipate an increase in the MSA Fee allocated to general and administrative expense, related to continued expansion of our overall business operations. We also anticipate expenses related to being a public company, including professional services fees for legal, accounting, tax, audit, employees involved in third-party payor reimbursement contract negotiations and regulatory services associated with maintaining compliance as a public company, along with insurance premiums, investor relations, and other corporate expenses.

 

26

Results of Operations - continued

Overview - continued

Research and Development Expensesdevelopment expenses

 

Research and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred for the development of our technologies and conducting clinical trials, including:

 

consulting costs charged to us by various external contract research organizations we contract with to conduct clinical and preclinical studies and engineering studies;design and development;
costs associated with regulatory filings;
patent license fees;
cost of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
product design engineering studies;
fees associated with conducting clinical trials for our EsoGuard diagnostic assay; and
MSA Fee allocated to research and development, as such MSA Fee are discussed below.

 

We plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as well as new innovations. Our research and development activities, including our clinical trials, are focused principally on obtaining FDA approvals, facilitating insurer reimbursement, encouraging physician adoption and developing product improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.

 

22

Results of Operations - continued

Overview - continued

Presentation of Dollar Amounts

All dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands of dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts.

27

 

Three Monthsmonths ended March 31,September 30, 2022 as compared to three months ended March 31,September 30, 2021

 

Revenue

In the three months ended March 31,September 30, 2022, revenue was $0.2$0.1 million as compared to no revenue$0.2 million in the corresponding period in the prior year. The $0.2$0.1 million increasedecrease principally relates to ourthe termination of the EsoGuard Commercialization Agreement dated August 1, 2021, which resulted in revenue recognition of $0.1 million per month beginning August 2021 - throughwith RDx, as the Company transitioned to its own laboratory operations effective February 25, 2022 termination date of such agreement.2022. The decrease was offset by revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory for the three months ended September 30, 2022.

 

Cost of revenue

In the three months ended March 31,September 30, 2022, cost of revenue was approximately $0.4$1.6 million as compared to no cost of revenue in$0.1 million for the corresponding period in the prior year. The $0.4$1.5 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement noted above.related to:

 

approximately $0.2 million increase in compensation related costs as a result of an increase in headcount;
approximately $0.4 million increase in EsoCheck and EsoGuard supplies usage costs; and
approximately $0.9 million increase in laboratory operations costs.

Sales and marketing expenses

 

In the three months ended March 31,September 30, 2022, sales and marketing costs were approximately $3.3$3.9 million, compared to $0.7$0.9 million for the corresponding period in the prior year. The net increase of $2.6$3.0 million was principally related to:

 

approximately $2.2$2.9 million increase in compensation related costs, including stock-based compensation of approximately $0.4 million in stock based compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”) to Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase in headcount; and
approximately $0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
approximately $0.1 million decreaseincrease in the MSA fee allocation from PAVmed related to the growthconsulting and expansion of Lucid’s business and theoutside professional services incurred through PAVmed.fees.

 

General and administrative expenses

 

In the three months ended March 31,September 30, 2022, general and administrative costs were approximately $5.7 million, compared to $1.2$3.5 million for the corresponding period in the prior year. The net increase of $4.5$2.2 million was principally related to:

 

approximately $1.6$0.7 million increase in compensation related costs, including stock-based compensation of approximately $1.4$0.2 million in stock based compensation with respect to RSA grants under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”) to Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase in headcount;
approximately $2.5$0.5 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of public relations and investor relations firms, and public company expenses; and
approximately $0.4$0.6 million increase in the MSA fees, afterfee allocation from PAVmed related to the growth and expansion of our business and the services incurred through PAVmed.PAVmed; and
approximately $0.4 million increase in general business expenses.

2823

Results of Operations - continued

 

Three Monthsmonths ended March 31,September 30, 2022 as compared to three months ended March 31,September 30, 2021 - continued

Research and development expenses

 

In the three months ended March 31,September 30, 2022, research and development costs were approximately $2.9$2.7 million, compared to $1.8$2.2 million for the corresponding period in the prior year. The net increase of $1.1$0.5 million was principally related to:

 

approximately $0.8$0.3 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees with respect to EsoCheck, EsoCure and EsoGuard;
approximately $0.1 million increase in compensation related costs and related to expanded clinical and engineering staff; and
approximately $0.2 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of Lucid’sour business and the services incurred through PAVmed.

 

See our accompanying unaudited condensed consolidated financial statements for each of: Note 54, Related Party Transactions,for a discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting agreements and stock options and restricted stock awards;awards and for a discussion of the MSA between Lucid Diagnostics and PAVmed; and Note 1110, Stock-Based Compensation, for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan.

Nine months ended September 30, 2022 as compared to nine months ended September 30, 2021

Revenue

In the nine months ended September 30, 2022, revenue was $0.3 million as compared to $0.2 million in the corresponding period in the prior year. The $0.1 million increase principally relates to revenue for laboratory services rendered for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory. The increase was partially offset by the termination of the EsoGuard Commercialization Agreement, with RDx as the Company transitioned to its own laboratory operations effective February 25, 2022.

Cost of revenue

In the nine months ended September 30, 2022, cost of revenue was approximately $2.0 million as compared to $0.1 million for the corresponding period in the prior year. The $1.9 million increase principally related to:

approximately $0.4 million increase in compensation related costs as a result of an increase in headcount;
approximately $0.6 million increase in EsoCheck and EsoGuard supplies usage costs; and
approximately $0.9 million increase in laboratory operations costs.

Sales and marketing expenses

In the nine months ended September 30, 2022, sales and marketing costs were approximately $11.1 million, compared to $2.6 million for the corresponding period in the prior year. The net increase of $8.5 million was principally related to:

approximately $7.7 million increase in compensation related costs, including stock-based compensation of approximately $1.2 million with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
approximately $1.0 million increase in consulting and outside professional services fees and for EsoCheck and EsoGuard; and
approximately $0.2 million decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred through PAVmed.

General and administrative expenses

In the nine months ended September 30, 2022, general and administrative costs were approximately $18.2 million, compared to $7.8 million for the corresponding period in the prior year. The net increase of $10.4 million was principally related to:

approximately $2.7 million increase in compensation related costs, including stock-based compensation of approximately $1.8 million with respect to RSA grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
approximately $4.8 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of public relations and investor relations firms, and public company expenses;
approximately $1.3 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred through PAVmed; and
approximately $1.6 million increase general business expenses.

2924

Results of Operations - continued

Nine months ended September 30, 2022 as compared to nine months ended September 30, 2021 - continued

Research and development expenses

In the nine months ended September 30, 2022, research and development costs were approximately $9.0 million, compared to $5.8 million for the corresponding period in the prior year. The net increase of $3.2 million was principally related to:

approximately $2.5 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees with respect to EsoCheck, EsoCure and EsoGuard;
approximately $0.2 million increase in compensation related costs and related to expanded clinical and engineering staff; and
approximately $0.5 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred through PAVmed.

See our accompanying unaudited condensed consolidated financial statements for each of: Note 4, Related Party Transactions, for a discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting agreements and stock options and restricted stock awards and for a discussion of the MSA between Lucid Diagnostics and PAVmed; and Note 10, Stock-Based Compensation, for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan.

 

Liquidity and Capital Resources

 

Our current operational activities are principally focused on the commercialization of EsoGuard. We have financedare expanding commercialization across multiple sales channels, including: the communication to and education of medical practitioners and clinicians regarding EsoGuard; and the establishment of Lucid Diagnostics Test Centers for the collection of cell samples using EsoCheck. Additionally, we are developing expanded clinical evidence to support insurance reimbursement adoption by government and private insurers. Further, the Company is also pursuing development of other products and services, including EsoCure, an Esophageal Ablation Device.

Our ability to generate revenue depends upon our operations principally through advances from PAVmedability to successfully advance the commercialization of EsoGuard, while also completing the clinical studies, product and throughservice development, and necessary regulatory approval thereof. There are no assurances, however, we will be able to obtain an adequate level of financial resources required for the issuancelong-term commercialization and development of common stock inour products and services.

Prior to our initial public offering (“IPO”). of our common stock in October 2021, our operations were funded by PAVmed, inclusive of providing working capital cash advances and the payment of certain operating expenses on our behalf. Additionally, certain of our operations continue to be managed by PAVmed personnel, for which we incur expense according to the provisions of a MSA between us and PAVmed. See Note 4, Related Party Transactions, for a discussion of the MSA.

We are 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 R&Dresearch and development activities and conducting clinical trials. We expect to continue to experience recurring losses from operations and will continue to fund our operations with debt and/orand equity financing transactions. Notwithstanding, however, with theour cash on-hand as of March 31, 2022, we expectthe date hereof and committed equity sources of financing, the Company expects to be able to fund our futureits operations and meet its financial obligations as they become due for the one year period from the date of the issue of ourthe Company’s unaudited condensed consolidated financial statements, as included herein in this Quarterly ReportForm 10-Q.

Committed Equity Facility - March 28, 2022

On March 28, 2022, we entered into a committed equity facility with Cantor. Under the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of our common stock from time to time at our request. While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows us to raise primary equity capital on Form 10-Qa periodic basis at prices based on the existing market price. As of September 30, 2022, under the committed equity facility, a total of 680,263 shares of common stock of the Company were issued for the period ended March 31, 2022.proceeds of approximately $1.8 million.

 

Due To: PAVmed Inc.

 

Since our inception in May 2018 through our IPO in October 2021, our operations were been funded by PAVmed providing working capital cash advances and the payment by PAVmed of certain operating expenses on-our-behalf.on our behalf. Additionally, our daily operations have been and continue to be principally managed by personnel employed by PAVmed, for which we incur a MSA Fee expense accordingexpense. The MSA Fee is charged on a monthly basis and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed Inc. personnel to the provisionsCompany, with any such change in the MSA Fee being subject to approval of the Lucid Diagnostics Inc. and PAVmed Inc. boards of directors. In this regard, in August 2022, the boards of directors of Lucid Diagnostics Inc. and PAVmed Inc. approved a sixth amendment to the MSA discussed above.to increase the MSA Fee to $550 per month from $390 per month, with such increase effective on a prospective basis commencing July 1, 2022. Pursuant to the sixth amendment, the parties agreed PAVmed Inc. may elect to receive payment of the monthly MSA Fee in cash or in shares of our common stock, with such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of the applicable month (subject to a floor price of $0.70 per share). However, in no event will PAVmed Inc. be entitled to receive under the MSA, as amended, more than 7,709,836 shares of our common stock (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the sixth amendment). The shares that may be issued under the MSA, as amended, are being offered and sold in transactions exempt from registration under the Securities Act of 1933, as amended, in reliance on the exemption afforded under Section 4(a)(2) thereof.

 

As of March 31,September 30, 2022, we had a Due To: PAVmed Inc. payment obligation liability of an aggregate of approximately $1.8$6.6 million payable to reimburse for the transfer of CapNostics, LLC, and for reimbursement of employee related costs and certain operating expenses paid by PAVmed Inc. on our behalf. See our accompanying unaudited condensed consolidated financial statements Note 6,5, Due To PAVmed Inc.

Lucid Diagnostics Inc. Committed Equity Facility

In March 2022, we entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the facility, Cantor has committed to purchase up to $50 million in our shares of our common stock from time to time at our request. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market price.

Upon the initial satisfaction of the conditions to Cantor’s obligation to purchase shares under the facility, including that a registration statement registering the resale by Cantor of the Shares under the Securities Act is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion until the first day of the month next following the expiration of the 36-month period after the effective date of the registration statement, to direct Cantor to purchase shares in accordance with the terms of the facility, by delivering written notice to Cantor prior to the commencement of trading on any trading day, subject to certain maximum amounts. The purchase price of the shares will be 96% of the volume weighted average price of the shares of common stock during the trading date on which we have timely delivered written notice to Cantor directing it to purchase shares under the facility.

We will not sell, and Cantor will not purchase, any shares pursuant to the facility, if the aggregate number of shares of common stock issued pursuant to the facility would exceed 7,482,763 shares of common stock, unless we obtain approval of our stockholders for the sale of shares in excess of such amount. In addition, we will not sell, and Cantor will not purchase, any shares pursuant to the facility, which, when aggregated with all other shares of common stock then beneficially owned by Cantor and its affiliates, would result in the beneficial ownership by Cantor and its affiliates of more than 4.99% of our outstanding voting power or shares of common stock.

In connection with the execution of the agreement for the facility, we agreed to pay Cantor $1.0 million as consideration for its irrevocable commitment to purchase the shares upon the terms and subject to the satisfaction of the conditions set forth in such agreement. In addition, pursuant to the agreement, e agreed to reimburse Cantor for certain of its expenses. We also entered into a registration rights agreement with Cantor. We have the right to terminate the agreement at any time after initial satisfaction of the conditions to Cantor’s obligation to purchase shares under the facility, at no cost or penalty, upon three trading days’ prior written notice.

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Critical Accounting Policies and Significant Judgments and Estimates

 

The discussion and analysis of our (unaudited) financial condition and consolidated results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along with the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the corresponding periods. In accordance with U.S. GAAP, we base our estimates on historical experience and on various other assumptions we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Please seeOur critical accounting policies are as disclosed in the Company’s annual report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates, of our unaudited condensed consolidated financial statements included herein in this Form 10-Q, for a summary of significant accounting policies.10-Q.

 

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Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31,September 30, 2022. Based on such evaluation, our principal executive officer and principal financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controlsforms and procedures include, without limitation, controls and procedures designed to ensure information required to be disclosed by us in the reports we file or submit under the Exchange Act is(ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

 

Changes to Internal Controls Over Financial Reporting

 

There has been no change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our fiscal quarter ended March 31,September 30, 2022 that has materially affected, or is reasonably likely to materially affect, our internals control over financial reporting.

 

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Part II - Other Information

Item 1. Legal Proceedings

 

In the ordinary course of our 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. Except as otherwise noted herein, the Company does not believe it is currently a party to any other 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.

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

See the disclosure in “Liquidity and Capital Resources - Committed Equity Facility - March 28, 2022” under Item 2 above and in the Current Report on Form 8-K filed by us with the SEC on April 1, 2022, each of which is incorporated herein by reference, for a description of the committed equity facility with Cantor and the shares issuable to Cantor thereunder.

In addition, effective as of August 25, 2022, we issued 82,618 shares of our common stock to an entity designated by RDx, in satisfaction of a $250,000 installment payment due under the asset purchase agreement dated February 25, 2022, between LucidDx Labs (our wholly-owned subsidiary) and RDx, and unrelated third-party. See the Current Report on Form 8-K filed by us with the SEC on March 3, 2022, which is incorporated herein by reference, for a fuller description of the asset purchase agreement with RDx and the installment payments thereunder.

On October 14, 2021, we completed our initial public offering (“IPO”) of our common stock under an effective registration statement on Form S-1 (SEC File No. 333-259721). As of September 30, 2022, of the net proceeds of $64.4 million, approximately $39.3 million has been used, in a manner consistent with the use of proceeds set forth in the prospectus for our IPO, as follows: approximately $5.3 million of net repayments due to PAVmed; approximately $4.7 million for the purchase of our laboratory equipment, software, and its operating expenses; and $29.3 million of working capital expenditures. None of the proceeds have been paid to any of our directors, officers, 10% stockholders, or affiliates, other than as described above.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “Exhibit Index” below.

 

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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.

 

 Lucid Diagnostics Inc.
   
May 16,November 14, 2022By:/s/ Dennis M McGrath
  Dennis M McGrath
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

 

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EXHIBIT INDEX

 

    Incorporation by Reference
Exhibit No. Description Form Exhibit No. Date
2.1‡ Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. ‡ 8-K 2.1 3/3/2022
10.1 Common Stock Purchase Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc. 8-K 10.1 4/1/2022
10.2 Registration Rights Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc. 8-K 10.2 4/1/2022
10.3 Management Services Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc. and ResearchDx, Inc. 8-K 10.1 3/3/2022
10.4 Employment Agreement, dated as of February 22, 2022, by and between Lishan Aklog, M.D. and Lucid Diagnostics Inc. 8-K 10.1 1/20/2022
10.5 Employment Agreement, dated as of February 22, 2022, by and between Dennis McGrath and Lucid Diagnostics Inc. 8-K 10.2 1/20/2022
10.6 Employment Agreement, dated as of February 22, 2022, by and between Shaun O’Neil and Lucid Diagnostics Inc. (incorporated by reference to Exhibit to the Current Report on Form filed by Lucid Diagnostics on). 8-K 10.1 3/23/2022
31.1 Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *    
31.2 Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *    
32.1 Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *    
32.2 Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *    
101.INS Inline XBRL Instance Document *    
101.CAL Inline XBRL Taxonomy Extension Schema *    
101.DEF Inline XBRL Taxonomy Extension Calculation Linkbase *    
101.LAB Inline XBRL Taxonomy Extension Label Linkbase *    
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase *    
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)      
Incorporation by Reference
Exhibit No.DescriptionFormExhibit No.Date
2.1‡Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. ‡8-K2.13/3/2022
10.1Amended and Restated 2018 Long-Term Incentive Equity Plan.DEF 14AAnnex A5/2/2022
10.2Employee Stock Purchase PlanDEF 14AAnnex B5/2/2022
31.1Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
31.2Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
32.1Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
32.2Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
101.INSInline XBRL Instance Document*
101.CALInline XBRL Taxonomy Extension Schema*
101.DEFInline XBRL Taxonomy Extension Calculation Linkbase*
101.LABInline XBRL Taxonomy Extension Label Linkbase*
101.PREInline XBRL Taxonomy Extension Presentation Linkbase*
104Cover Page Interactive Data File (embedded within the Inline XBRL document)*

 

* Filed herewith.

‡ Certain exhibits and schedules have been omitted pursuant to Item 601(b)(10) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the Securities and Exchange Commission.

 

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