Lucid Diagnostics Inc 8-K/A, filed Mar 29, 2022

Lucid Diagnostics Inc. (LUCD)

8-K/A 2022-03-29 For: 2022-03-28

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Added on April 08, 2026

About this 8-K/A

Lucid Diagnostics Inc filed this 8-K/A on March 29, 2022, reporting on events of March 28, 2022.

Items reported

Item 2.02: Financial results
Item 7.01: Regulation FD disclosure
Item 9.01: Financial statements and exhibits

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One Grand Central Place, Suite 4600, New York, New York		10165
(Address of Principal Executive Offices)		(Zip Code)

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Exhibit No.		Description

99.1		Press release.

104.1		Cover Page Interactive Data File (embedded within the Inline XBRL document).

	PAVMED INC.

	By:	/s/ Dennis M. McGrath
		Dennis M. McGrath
		Chief Financial Officer

●	LucidDx Labs, a wholly owned subsidiary of Lucid, acquired the assets to operate its own new CLIA-certified, CAP-accredited clinical laboratory where it is now performing all EsoGuard testing. LucidDx Labs has upgraded its revenue cycle management provider and will start submitting Medicare claims using the effective $1938 Medicare payment rate. It continues to wait for Medicare Administrative Contractor Palmetto GBA’s MolDx program to issue a draft local coverage determination (LCD). The laboratory has been submitting claims to private payors and has been receiving approximately $1,150 per test representing approximately 60% out-of-network coverage.

●	Veris is successfully advancing its software, device, and data programs with the help of world-class technology and medical advisory boards and working very closely with Microsoft, as a member of its Global Partner program, and its software development partner, Loka Inc. The software platform is on schedule to launch commercially in 2H2022. Veris is hiring a Chief Commercial Officer and building its own data & analytics team to advance its data monetization strategy.

●	Veris successfully completed feasibility animal testing of multiple prototypes of an implantable device as well as an FDA pre-submission meeting. Based on FDA feedback it has developed a three-phase pipeline strategy, an initial platform launch in 2H2022 with wearables and connected medical devices, a subsequent FDA 510(k) path clearance of separate implantable monitoring device to be implanted alongside a traditional port, and an FDA de novo and EU CE Mark path for a fully integrated intelligent vascular access port.

●	NextFlo product development is progressing well with FDA submission and commercial launch targeted for the second half of this year. PAVmed has hired a VP, Sales for NextFlo who is working closely with Deloitte to lay the foundation for commercial launch targeting inpatient, outpatient, and home infusions.

●	CarpX continues with its limited commercial release utilizing early adopter key opinion leaders to advance procedural and product improvements. Eight new surgeons have been trained and five more are scheduled for training. Seven CarpX cases were performed in the fourth quarter of 2021. Clinical cases were then held to implement the product improvements and will restart this coming quarter. Development of next generation CarpX device incorporating integrated ultrasound imaging is progressing well.

●	PortIO launched its first-in-human clinical study in Colombia, South America with three successful implants. Although the Company remains engaged with FDA regarding its requirements for an IDE study, it has expanded its strategy to pursue a European study to support EU CE Mark clearance and provide additional human data for U.S. approval.

●	In March 2022, both the PAVmed and Lucid board of directors approved entering into an intercompany license between PAVmed and Lucid such that Lucid will be granted the rights to commercialize EsoCure for the endoscopic treatment of late esophageal precancer (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.

●	In March 2022, both the PAVmed and Lucid board of directors approved entering into a purchase and sale of the CapNostics, LLC assets, including the EsophaCap^® non-endoscopic sponge-based esophageal cell collection device, from PAVmed to Lucid as well as transferring the consulting agreement with the principal owner of CapNostics, LLC prior to the purchase by PAVmed on October 5, 2021.

●	For the fourth quarter of 2021, EsoGuard related revenues were $0.3 million while for the year ended December 31, 2021, revenues were $0.5 million. Fourth-quarter and full-year 2021 operating expenses were approximately $19.5 million and $54.3 million, respectively, which include stock-based compensation expenses of $4.4 million and $15.0 million, respectively. GAAP net loss attributable to shareholders for the fourth quarter and full-year 2021 were approximately $17.3 million and $50.6 million, or $(0.20) and $(0.65) per common share.
●	As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the fourth quarter and year ended December 31, 2021, were approximately $12.7 million and $33.2 million or $(0.15) and $(0.43) per common share.
●	PAVmed had cash and cash equivalents of $77.3 million as of December 31, 2021, compared with $17.3 million as of December 31, 2020.
●	On March 28, 2022, PAVmed’s majority-owned subsidiary, Lucid Diagnostics, Inc. entered into a Common Stock Purchase Agreement (the “Purchase Agreement”) with CF Principal Investments LLC (“Cantor”), an affiliate of Cantor Fitzgerald, relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, Lucid has the right to sell to Cantor up to $50.0 million of its common shares (the “Shares”), subject to certain conditions and limitations set forth in the Purchase Agreement. While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows Lucid to raise primary equity capital on a periodic basis at a price related to the current market price.
●	Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, Lucid will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be 96% of the volume-weighted average price of the Shares on such trading day.

	For the three months ended December 31,						For the year ended December 31,
	2021			2020			2021			2020

Revenue	$	300		$	-		$	500		$	-
Gross profit		(229	)		-			(85	)		-
Operating expenses		19,538			7,556			54,308			23,351
Loss from operations		(19,767	)		(7,556	)		(54,393	)		(23,351	)
Net income (loss) per common share, basic and diluted	$	(0.20	)	$	(0.14	)	$	(0.65	)	$	(0.73	)
Net loss attributable to common stockholders		(17,285	)		(8,812	)		(50,630	)		(34,563	)
Preferred Stock dividends and deemed dividends		67			72			283			287
Net income (loss) as reported		(17,218	)		(8,740	)		(50,347	)		(34,276	)
Adjustments:
Depreciation and amortization expense¹		166			6			226			23
Interest expense, net²		-			-			-			53
EBITDA		(17,052	)		(8,734	)		(50,121	)		(34,200	)

Other non-cash or financing related expenses:
Stock-based compensation expense³		4,380			586			15,009			2,044
Debt extinguishment/debt forgiveness²		-			1,897			3,415			6,497
Acquisition related¹		-			-			133			-
Change in FV convertible debt²		-			(194	)		(1,682	)		5,327
Offering costs convertible debt²		-			-			-			660
Non-GAAP adjusted (loss)		(12,672	)		(6,445	)		(33,246	)		(19,672	)
Basic and Diluted shares outstanding		86,368			63,820			77,516			47,432
Non-GAAP adjusted (loss) income per share	$	(0.15	)	$	(0.10	)	$	(0.43	)	$	(0.41	)

(ooo's except per-share amounts)	For the three months ended December 31,						For the year ended December 31,
	2021			2020			2021			2020
Commercial operations expense total		3,103			1,257			8,895			2,789
Stock-based compensation expense		(337	)		(95	)		(1,177	)		(278	)
Net commercial operations expense excluding SBC		2,766			1,162			7,718			2,511

General and administrative expense total		9,466			2,657			25,566			9,599
Stock-based compensation expense		(3,737	)		(356	)		(12,799	)		(1,304	)
Net general and administrative expense excluding SBC 5,729					2,301			12,767			8,295

Research and development expense total		6,969			3,642			19,847			10,963
Stock-based compensation expense		(306	)		(135	)		(1,033	)		(462	)
Net research and development expense excluding SBC 6,663					3,507			18,814			10,501

Total operating expenses		19,538			7,556			54,308			23,351
Stock-based compensation expense		(4,380	)		(586	)		(15,009	)		(2,044	)
Net operating expenses excluding SBC		15,158			6,970			39,299			21,307

●	For the fourth quarter of 2021, EsoGuard related revenues were $0.3 million, while for the year ended December 31, 2021, revenues were $0.5 million. Fourth-quarter and full-year 2021 operating expenses were approximately $11.1 million and $27.3 million, respectively, which include stock-based compensation expenses of $3.2 million and $9.6 million, respectively. GAAP net loss attributable to common stockholders for the fourth quarter and full-year 2021 were approximately $11.3 million and $28.1 million, or $(0.32) and $(1.51) per common share.
●	As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the fourth quarter and year ended December 31, 2021, were approximately $7.7 million and $17.8 million or $(0.22) and $(0.96) per common share.
●	Lucid had cash and cash equivalents of $53.7 million as of December 31, 2021, compared to $0.1 million as of December 31, 2020.
●	On March 28, 2022, the Company entered into a Common Stock Purchase Agreement (the “Purchase Agreement”) with CF Principal Investments LLC (“Cantor”), an affiliate of Cantor Fitzgerald, relating to a committed equity facility (the “Facility”). Pursuant to the Purchase Agreement, the Company has the right to sell to Cantor up to $50.0 million of its common shares (the “Shares”), subject to certain conditions and limitations set forth in the Purchase Agreement. 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 a price related to the current market price.
●	Sales of the Shares to Cantor under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time at its sole discretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of the Shares and determinations by the Company regarding the use of proceeds of such Shares. Upon the satisfaction of the conditions to Cantor’s obligation to purchase Shares, the Company will have the right, from time to time during the 36-month period after the commencement of the Facility, to direct Cantor to purchase up to a maximum number of Shares on any trading day. The purchase price of the Shares will be 96% of the volume-weighted average price of the Shares on such trading day.
●	The unaudited financial results for the year ended December 31, 2021, will be filed with the SEC on Form 10-K in the coming days and will be available at www.luciddx.com or www.sec.gov.

●	To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.

●	Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.

●	Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.