63 unchanged sentences
in an effort to prevent progression to esophageal cancer.
−Removed: is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with
+Added: is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck.
It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1).
−Removed: Analytical validation tests of
−Removed: EsoGuard demonstrated approximately 97% analytical sensitivity, 95% analytical specificity, approximately 98% analytical accuracy,
−Removed: and 100% inter-assay and intra-assay precision.
−Removed: Two independent clinical validation case control studies funded by the National
−Removed: Institute of Health utilized were performed using upper endoscopy with biopsies as the diagnostic comparator and confirmed EsoGuard
−Removed: accurately identifies BE.
−Removed: A pooled analysis of both studies demonstrated 84% sensitivity (95% confidence interval (“CI”)
−Removed: 76-90%), for detection of BE, and 86% specificity (95% CI 81-91%).
−Removed: Positive predictive value (“PPV”) and negative
−Removed: predictive value (“NPV”) were calculated using a BE prevalence of 10.6% published in a meta-analysis of U.S patients
−Removed: with gastroesophageal reflux disease (“GERD”).
+Added: Analytical validation tests of EsoGuard demonstrated
+Added: approximately 97% analytical sensitivity, 95% analytical specificity, approximately 98% analytical accuracy, and 100% inter-assay and
+Added: intra-assay precision.
+Added: Two independent clinical validation case control studies funded by the National Institute of Health were
+Added: performed using upper endoscopy with biopsies as the diagnostic comparator and confirmed EsoGuard accurately identifies BE.
+Added: analysis of both studies demonstrated 84% sensitivity (95% confidence interval (“CI”) 76-90%), for detection of BE, and 86%
+Added: specificity (95% CI 81-91%).
+Added: Positive predictive value (“ PPV”) and negative predictive
+Added: value (“NPV”) were calculated using a BE prevalence of 10.6% published in a meta-analysis of U.S patients with gastroesophageal
+Added: reflux disease (“GERD”).
This resulted in a PPV of approximately 42% and NPV of around 98% .
10 unchanged sentences
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and BE, including
−Removed: dysplastic BE and related precursors to EAC in patients with GERD, commonly known as chronic heart burn, acid reflux, or just reflux.
+Added: dysplastic BE and related precursors to EAC in patients with GERD, commonly known as chronic heartburn, acid reflux, or just reflux.
Agreements with PAVmed
−Removed: March 22, 2024, PAVmed and the Company entered into an eighth amendment to the the management services agreement between PAVmed and
−Removed: Lucid (“MSA”) to increase the monthly fee thereunder from $0.75 million per month to $0.83 million per month, effective
−Removed: as of January 1, 2024.
−Removed: The amendment also reset the maximum number of shares issuable under the agreement to 19.99% of the shares
−Removed: outstanding as of the date of the amendment.
−Removed: January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid
−Removed: (“PBERA”), PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the
−Removed: MSA and the PBERA through the issuance of 3,331,771 shares of Lucid’s common stock.
+Added: August 6, 2024, PAVmed and the Company entered into a ninth amendment to the management services agreement between PAVmed and Lucid
+Added: (“MSA”) to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July
+Added: March 22, 2024, PAVmed and the Company entered into an eighth amendment to the MSA to increase the monthly fee thereunder from $0.75
+Added: million per month to $0.83 million per month, effective as of January 1, 2024.
+Added: The amendment also reset the maximum number of shares
+Added: issuable under the agreement to 19.99% of the shares outstanding as of the date of the amendment.
+Added: January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”),
+Added: PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through
+Added: the issuance of 3,331,771 shares of Lucid’s common stock.
Enforcement Discretion
9 unchanged sentences
of Dennis Matheis to Board of Directors
−Removed: May 6, 2024, the board of directors of the Company appointed Dennis Matheis as a Class A director of the Company.
−Removed: In connection with
−Removed: his appointment, the Company will be entering into its standard form of indemnification agreement with Mr.
+Added: May 6, 2024, the board of directors of the Company appointed Dennis Matheis as a Class C director of the Company (and he was subsequently
+Added: re-elected to the board, together with the incumbent Class C directors of the Company, at the Company’s annual shareholders meeting
+Added: held on July 23, 2024).
In connection with his joining the board, Mr.
−Removed: Matheis received a grant of an option to acquire 241,500 shares of
−Removed: the Company’s common stock pursuant to the Company’s Amended and Restated 2018 Long-Term Incentive Equity Plan in accordance with the Company’s
−Removed: existing compensation policy for non-employee directors.
+Added: Matheis received a grant of an option to acquire 241,500 shares
+Added: of the Company’s common stock pursuant to the Company’s Amended and Restated 2018 Long-Term Incentive Equity Plan in accordance
+Added: with the Company’s existing compensation policy for non-employee directors.
+Added: Developments - continued
+Added: June 21, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive
+Added: business days (through June 20, 2024), the closing bid price of the Company’s common stock had been below the minimum of $1 per
+Added: share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).
+Added: The notification letter stated
+Added: that the Company would be afforded 180 calendar days (until December 18, 2024) to regain compliance, and that the Company could be eligible
+Added: for additional time.
+Added: The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.
+Added: Shares Increase
+Added: July 23, 2024, the Company filed an amendment to its Certificate of Incorporation to effectuate an increase in its authorized shares
+Added: from 200,000,000 to 300,000,000, in accordance with the shareholder approval of the same.
+Added: Such approval was granted at the annual meeting
+Added: of the Company’s stockholders held the same day.
B and Series B-1 Preferred Stock Offerings
−Removed: March 13, 2024, we entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange
−Removed: agreements (each, a “Series B Exchange Agreement”) with certain accredited investors (collectively, the “Series B
−Removed: Investors”), which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated
−Removed: Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), at a purchase price
−Removed: of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of our Series A Convertible Preferred Stock,
−Removed: par value $0.001 per share (the “Series A Preferred Stock”), and 10,670 shares of our Series A-1 Convertible Preferred
−Removed: Stock, par value $0.001 per share (the “Series A-1 Preferred Stock”), held by them for 31,790 shares of Series B
−Removed: Preferred Stock (collectively, the “Series B Offering and Exchange”).
−Removed: Prior to the execution of the Series B
−Removed: Subscription Agreements and the Series B Exchange Agreements, we entered into subscription agreements with certain of the Series B
−Removed: Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of $1,000 per
−Removed: share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series B
−Removed: Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above).
−Removed: Each share of the Series
−Removed: B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444.
−Removed: The terms of the Series B Preferred Stock also
−Removed: include a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common
−Removed: stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance
−Removed: The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of
−Removed: common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends
−Removed: are paid on shares of the common stock.
+Added: March 13, 2024, we entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements
+Added: (each, a “Series B Exchange Agreement”) with certain accredited investors (collectively, the “Series B Investors”),
+Added: which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated Series B Convertible Preferred
+Added: Stock, par value $0.001 per share (the “Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the
+Added: exchange by the Series B Investors of 13,625 shares of our Series A Convertible Preferred Stock, par value $0.001 per share (the “Series
+Added: A Preferred Stock”), and 10,670 shares of our Series A-1 Convertible Preferred Stock, par value $0.001 per share (the “Series
+Added: A-1 Preferred Stock”), held by them for 31,790 shares of Series B Preferred Stock (collectively, the “Series B Offering and
+Added: Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, we entered into
+Added: subscription agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1
+Added: Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series
+Added: B Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set
+Added: forth above).
+Added: Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444.
+Added: the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to 20% of the
+Added: number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary
+Added: of the issuance date.
+Added: The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to
+Added: shares of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such
+Added: dividends are paid on shares of the common stock.
The Series B Preferred Stock is a voting security.
−Removed: The aggregate gross proceeds of these
−Removed: transactions were $18.16 million (inclusive of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred
+Added: The aggregate gross proceeds of
+Added: these transactions were $18.16 million (inclusive of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred
Stock that was immediately exchanged for Series B Preferred Stock in the transactions).
2 unchanged sentences
remain outstanding.
−Removed: to March 31, 2024, on May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1
−Removed: Convertible Preferred Stock (the “Series B-1 Preferred Stock”).
−Removed: The terms of the Series B-1 Preferred Stock are
−Removed: substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock has a conversion
−Removed: price of $0.7228.
−Removed: The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.
−Removed: The aggregate gross
−Removed: proceeds from the issuances of the Series B Preferred Stock and Series B-1 Preferred Stock were approximately $29.8 million.
−Removed: the Company has concluded its Board-approved offering of $30 million of preferred stock.
+Added: May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Convertible Preferred Stock (the “Series
+Added: B-1 Preferred Stock”).
+Added: The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred
+Added: Stock, except that the Series B-1 Preferred Stock has a conversion price of $0.7228.
+Added: The aggregate gross proceeds from the sale of shares
+Added: in such offering were $11.6 million.
+Added: aggregate gross proceeds from the issuances of the Series B Preferred Stock and Series B-1 Preferred Stock were approximately $29.8 million.
+Added: As a result, the Company has concluded its Board-approved offering of $30 million of preferred stock.
of Operations
9 unchanged sentences
and marketing expenses
−Removed: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing
−Removed: activities, as well as the portion of the MSA Fee (as defined in Note 5, Related Party Transactions , to our accompanying
−Removed: unaudited condensed consolidated financial statements) allocated to sales and marketing expenses, which are principally costs
−Removed: related to PAVmed employees who are performing services for the Company.
−Removed: We anticipate our sales and marketing expenses will
−Removed: increase in the future, to the extent we expand our commercial sales and marketing operations as resources permit and insurance
−Removed: reimbursement coverage for our EsoGuard test expands.
+Added: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities,
+Added: as well as the portion of the MSA Fee (as defined in Note 5, Related Party Transactions , to our accompanying unaudited condensed
+Added: consolidated financial statements) allocated to sales and marketing expenses, which are principally costs related to PAVmed employees
+Added: who are performing services for the Company.
+Added: We anticipate our sales and marketing expenses will increase in the future, to the extent
+Added: we expand our commercial sales and marketing operations as resources permit and insurance reimbursement coverage for our EsoGuard test
and administrative expenses
24 unchanged sentences
of Operations - continued
−Removed: three months ended March 31, 2024 as compared to three months ended March 31, 2023
−Removed: the three months ended March 31, 2024, revenue was $1.0 million as compared to $0.4 million for the corresponding period in the prior
+Added: three months ended June 30, 2024 as compared to three months ended June 30, 2023
+Added: the three months ended June 30, 2024, revenue was $1.0 million as compared to $0.2 million for the corresponding period in the prior
+Added: The $0.8 million increase principally relates to the increase in volume of our EsoGuard Esophageal DNA Tests performed in our own
+Added: CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
+Added: the three months ended June 30, 2024, cost of revenue were approximately $1.6 million as compared to $1.5 million for the corresponding
+Added: period in the prior year.
+Added: The net increase of $0.1 million was principally related to:
+Added: ● approximately
+Added: $0.1 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal
+Added: DNA tests and royalty costs.
+Added: and marketing expenses
+Added: the three months ended June 30, 2024, sales and marketing costs were approximately $4.2 million as compared to $4.0 million for the corresponding
+Added: period in the prior year.
+Added: The net increase of $0.2 million was principally related to:
+Added: ● approximately
+Added: $0.2 million increase in compensation related costs.
+Added: and administrative expenses
+Added: the three months ended June 30, 2024, general and administrative costs were approximately $4.9 million as compared to $3.8 million for
+Added: the corresponding period in the prior year.
+Added: The net increase of $1.1 million was principally related to:
+Added: ● approximately
+Added: $0.7 million increase in third-party professional services related to investor relations
+Added: and legal services;
+Added: ● approximately
+Added: $0.3 million increase related to the amended MSA with PAVmed due to the growth and expansion
+Added: of our business and the services incurred through PAVmed;
+Added: ● approximately
+Added: $0.3 million increase related to compensation related costs;
+Added: ● approximately
+Added: $0.2 million decrease in stock-based compensation from RSA and stock option grants to Lucid
+Added: employees and non-employees.
+Added: and development expenses
+Added: the three months ended June 30, 2024, research and development costs were approximately $1.4 million, compared to $1.8 million for the
+Added: corresponding period in the prior year.
+Added: The net decrease of $0.4 million was principally related to:
+Added: ● approximately
+Added: $0.4 million decrease in development costs, particularly in clinical trial activities and
+Added: outside professional and consulting fees.
+Added: of Acquired Intangible Assets
+Added: amortization of acquired intangible assets was approximately $0.1 million in the three months ended June 30, 2024, as compared to $0.5
+Added: million for the corresponding period in the prior year.
+Added: The decrease of $0.4 million in the current period was due to certain acquired
+Added: intangible assets being fully amortized in February 2024.
+Added: Income and Expense
+Added: in fair value of convertible debt
+Added: the three months ended June 30, 2024, the change in the fair value of our convertible note was approximately $0.6 million of income,
+Added: related to the March 2023 Senior Convertible Note (as defined in Note 10, Debt , to our accompanying unaudited condensed consolidated
+Added: financial statements).
+Added: The March 2023 Senior Convertible Note was initially measured at its issue-date estimated fair value and subsequently remeasured
+Added: at estimated fair value as of each reporting period date.
+Added: The Company initially recognized a $0.8 million fair value non-cash expense
+Added: on the issue date.
+Added: of Operations - continued
+Added: three months ended June 30, 2024 as compared to three months ended June 30, 2023 - continued
+Added: on Debt Extinguishment
+Added: the three months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.5 million was recognized in connection
+Added: with our March 2023 Senior Convertible Note as discussed below.
+Added: the three months ended June 30, 2024, approximately $1.1 million of principal repayments
+Added: along with approximately $0.2 million of interest expense thereon, were settled through the
+Added: issuance of 2,117,883 shares of common stock of the Company, with such shares having a fair
+Added: value of approximately $1.9 million (with such fair value measured as the quoted closing
+Added: price of the common stock of the Company on the respective conversion date).
+Added: The conversions
+Added: resulted in a debt extinguishment loss of $0.5 million in the three months ended June 30,
+Added: The Company did not incur debt extinguishment loss in the three months ended June 30,
+Added: Note 10 , Debt , to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
+Added: to the March 2023 Senior Convertible Note.
+Added: six months ended June 30, 2024 as compared to six months ended June 30, 2023
+Added: the six months ended June 30, 2024, revenue was $2.0 million as compared to $0.6 million for the corresponding period in the prior year.
The $1.4 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory
−Removed: the three months ended March 31, 2024, cost of revenue was approximately $1.7 million as compared to $1.3 million for the corresponding
+Added: for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Test.
+Added: the six months ended June 30, 2024, cost of revenue was approximately $3.3 million as compared to $2.9 million for the corresponding
period in the prior year.
1 unchanged sentence
● approximately
−Removed: $0.2 million increase in EsoCheck and EsoGuard supplies costs;
+Added: $0.2 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal
+Added: DNA tests and royalty costs;
● approximately
1 unchanged sentence
and marketing expenses
−Removed: the three months ended March 31, 2024, sales and marketing costs were approximately $4.2 million as compared to $4.1 million for the
−Removed: corresponding period in the prior year.
+Added: the six months ended June 30, 2024, sales and marketing costs were approximately $8.4 million as compared to $8.2 million for the corresponding
+Added: period in the prior year.
The net increase of $0.2 million was principally related to:
3 unchanged sentences
and administrative expenses
−Removed: the three months ended March 31, 2024, general and administrative costs were approximately $4.1 million as compared to $6.9 million for
+Added: the six months ended June 30, 2024, general and administrative costs were approximately $8.9 million as compared to $10.7 million for
the corresponding period in the prior year.
3 unchanged sentences
● approximately
−Removed: $0.9 million decrease in third-party professional fees and expenses related to legal services
−Removed: and consulting fees;
−Removed: ● approximately
$0.5 million increase related to the amended MSA with PAVmed due to the growth and expansion
1 unchanged sentence
● approximately
−Removed: $0.2 million increase in compensation related costs principally as a result of an increase
−Removed: in headcount.
+Added: $0.3 million increase in third-party professional fees and expenses related to investor relations
+Added: services and consulting fees.
and development expenses
−Removed: the three months ended March 31, 2024, research and development costs were approximately $1.5 million, compared to $1.9 million for the
+Added: the six months ended June 30, 2024, research and development costs were approximately $2.9 million, compared to $3.7 million for the
corresponding period in the prior year.
2 unchanged sentences
$0.9 million decrease in development costs, particularly in clinical trial activities and
−Removed: outside professional and consulting fees with respect to EsoCure.
+Added: outside professional and consulting fees;
+Added: ● approximately
+Added: $0.1 million increase in stock-based compensation.
of Acquired Intangible Assets
−Removed: amortization of acquired intangible assets was approximately $0.4 million in the three months ended March 31, 2024, as compared to $0.5
+Added: amortization of acquired intangible assets was approximately $0.5 million in the six months ended June 30, 2024, as compared to $1.0
million for the corresponding period in the prior year.
1 unchanged sentence
intangible assets being fully amortized in February 2024.
+Added: of Operations - continued
+Added: six months ended June 30, 2024 as compared to six months ended June 30, 2023 - continued
Income and Expense
in fair value of convertible debt
−Removed: the three months ended March 31, 2024, the change in the fair value of our convertible note was approximately $0.3 million of
−Removed: income, related to the March 2023 Senior Convertible Note (as defined in Note 10, Debt , to our accompanying unaudited
−Removed: condensed consolidated financial statements).
−Removed: The March 2023 Senior Convertible Note was initially measured at its issue date
−Removed: estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date.
−Removed: The Company initially
−Removed: recognized a $0.8 million fair value remeasurement as a non-cash expense on the issue date.
−Removed: of Operations - continued
−Removed: three months ended March 31, 2024 as compared to three months ended March 31, 2023 - continued
+Added: the six months ended June 30, 2024, the change in the fair value of our convertible note was approximately $0.9 million of income, related
+Added: to the March 2023 Senior Convertible Note (as defined in Note 10 , Debt , to our accompanying unaudited condensed consolidated financial
+Added: The March 2023 Senior Convertible Note was initially measured at its issue date estimated fair value and subsequently remeasured
+Added: at estimated fair value as of each reporting period date.
+Added: The Company initially recognized a $0.8 million fair value remeasurement as
+Added: a non-cash expense on the issue date.
on Issue and Offering Costs - Senior Secured Convertible Note
−Removed: the three months ended March 31, 2023, in connection with the issue of the March 2023 Senior Convertible Note, we recognized a total
−Removed: of approximately $1.2 million of lender fee and offering costs paid by us.
−Removed: The Company did not incur lender fees and offering costs in
−Removed: the three months ended March 31, 2024 .
+Added: the six months ended June 30, 2023, in connection with the issue of the March 2023 Senior Convertible Note, we recognized a total of
+Added: approximately $1.2 million of lender fee and offering costs paid by us.
+Added: The Company did not incur lender fees and offering costs in the
+Added: six months ended June 30, 2024 .
on Debt Extinguishment
−Removed: the three months ended March 31, 2024, a debt extinguishment loss in the aggregate of approximately $0.2 million was recognized in connection
+Added: the six months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.7 million was recognized in connection
with our March 2023 Senior Convertible Note as discussed below.
−Removed: the three months ended March 31, 2024, approximately $0.1 million of principal repayments along with approximately $0.4 million of
−Removed: interest expense thereon, were settled through the issuance of 543,298 shares of common stock of the Company, with such shares
−Removed: having a fair value of approximately $0.7 million (with such fair value measured as the quoted closing price of the common stock of
−Removed: the Company on the respective conversion date).
−Removed: The conversions resulted in a debt extinguishment loss of $0.2 million in the three months ended March 31, 2024.
−Removed: Company did not incur debt extinguishment loss in the three months ended March 31, 2023.
−Removed: Note 10 , Debt , to our accompanying unaudited condensed consolidated financial statements, for additional information with
−Removed: respect to the March 2023 Senior Convertible Note.
+Added: the six months ended June 30, 2024, approximately $1.2 million of principal repayments along
+Added: with approximately $0.7 million of interest expense thereon, were settled through the issuance
+Added: of 2,661,181 shares of common stock of the Company, with such shares having a fair value
+Added: of approximately $2.5 million (with such fair value measured as the quoted closing price
+Added: of the common stock of the Company on the respective conversion date).
+Added: The conversions resulted
+Added: in a debt extinguishment loss of $0.7 million in the six months ended June 30, 2024.
+Added: Company did not incur debt extinguishment loss in the six months ended June 30, 2023.
+Added: Note 10 , Debt , to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
+Added: to the March 2023 Senior Convertible Note.
Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
−Removed: fair value of the consideration given in the form of the issue of 44,285 shares of Series B Convertible Preferred Stock, with such
−Removed: fair value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to both the
−Removed: newly issued Series B Convertible Preferred Stock (fair value of $12.5 million) and the carrying value of the extinguished Series A
−Removed: and Series A-1 Convertible Preferred Stock (carrying value of $24.3 million) ,
−Removed: resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged to accumulated deficit in the unaudited
−Removed: condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as a component of net loss attributable
−Removed: to common stockholders, summarized as follows:
−Removed: Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
−Removed: March 13, 2024
−Removed: Fair Value - 44,285 shares of Series B Preferred Stock issued
+Added: fair value of the consideration given in the form of the issue of 44,285 shares of Series B Convertible Preferred Stock, with such fair
+Added: value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to both the newly issued
+Added: Series B Convertible Preferred Stock (fair value of $12.5 million) and the carrying value of the extinguished Series A and Series A-1
+Added: Convertible Preferred Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed
+Added: dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend
+Added: included as a component of net loss attributable to common stockholders, summarized as follows:
+Added: B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
+Added: Value - 44,285 shares of Series B Preferred Stock issued
Fair value related to newly issued Series B Preferred Stock (of 12,495 shares)
−Removed: Carrying value related to Series A and Series A-1 Preferred Stock
−Removed: Exchanged for Series B Preferred Stock (of 24,295 shares)
−Removed: Deemed Dividend Charged to Accumulated Deficit
+Added: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)
+Added: Dividend Charged to Accumulated Deficit
and Capital Resources
4 unchanged sentences
establishment of Lucid Test Centers for the collection of cell samples using EsoCheck;
−Removed: the launch of the mobile testing unit;
−Removed: #CheckYourFoodTube testing days;
+Added: use of our mobile testing unit;
+Added: ongoing #CheckYourFoodTube
+Added: testing days;
and our direct contracting strategic initiative.
−Removed: Additionally, we are developing expanded clinical evidence
−Removed: to support insurance reimbursement adoption by government and private insurers.
−Removed: Further, as resources permit, the Company also intends
−Removed: to pursue development of other products and services.
+Added: Additionally, we are developing expanded clinical evidence to support
+Added: insurance reimbursement adoption by government and private insurers.
+Added: Further, as resources permit, the Company also intends to pursue
+Added: development of other products and services.
ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, including significantly
3 unchanged sentences
for the long-term commercialization and development of our products and services.
−Removed: are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote
−Removed: substantially all of their efforts to the commercialization of their initial product and services and ongoing research and
−Removed: development activities and conducting clinical trials.
−Removed: We experienced a net loss of approximately $10.6 million and used
−Removed: approximately $12.6 million of cash in operations during the three month period ended March 31, 2024.
−Removed: Financing activities provided
−Removed: $18.5 million of cash during the three month period ended March 31, 2024.
−Removed: We ended the quarter with cash on-hand of $24.8 million as
−Removed: of March 31, 2024.
−Removed: We expect to continue to experience recurring losses and negative cash flow from operations, and will continue to
−Removed: fund our operations with debt and/or equity financing transactions, including current obligations on our existing convertible debt
−Removed: which in accordance with management’s plans may include conversions to equity and refinancing our existing debt obligations to
−Removed: extend the maturity date.
−Removed: The Company’s ability to continue operations 12 months beyond the issuance of the financial statements will depend upon generating
−Removed: substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA
−Removed: Test from both government and private health insurance providers, increasing revenue through contracting directly with self-insured
−Removed: employers, and on raising additional capital through various potential sources including equity and/or debt financings
−Removed: or refinancing existing debt obligations.
−Removed: These factors raise substantial doubt about the Company’s ability to continue as a
−Removed: going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are
−Removed: Liquidity and Capital Resources - continued
+Added: are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
+Added: all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
+Added: conducting clinical trials.
+Added: We experienced a net loss of approximately $21.6 million and used approximately $24.1 million of cash in
+Added: operations during the six month period ended June 30, 2024.
+Added: Financing activities provided $30.2 million of cash during the six month
+Added: period ended June 30, 2024.
+Added: We ended the quarter with cash on-hand of $24.9 million as of June 30, 2024.
+Added: We expect to continue to experience
+Added: recurring losses and negative cash flow from operations, and will continue to fund our operations with debt and/or equity financing transactions,
+Added: including current obligations on our existing convertible debt which in accordance with management’s plans may include conversions
+Added: to equity and refinancing our existing debt obligations to extend the maturity date.
+Added: The Company’s ability to continue operations
+Added: 12 months beyond the issuance of the financial statements will depend upon generating substantial revenue that is conditioned on obtaining
+Added: positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers,
+Added: increasing revenue through contracting directly with self-insured employers, and on raising additional capital through various potential
+Added: sources including equity and/or debt financings or refinancing existing debt obligations.
+Added: These factors raise substantial doubt about
+Added: the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated
+Added: financial statements are issued.
Stock Offerings
−Removed: March 13, 2024, we entered into the Series B Subscription Agreements and Series B Exchange Agreements with the Series B Investors,
−Removed: which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated Series B Preferred
−Removed: Stock, at a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of our Series A
−Removed: Preferred Stock and 10,670 shares of our Series A-1 Preferred Stock held by them for 31,790 shares of Series B Preferred Stock.
−Removed: Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, we entered into subscription
−Removed: agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred
−Removed: Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B
−Removed: Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock
−Removed: set forth above).
−Removed: Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444.
−Removed: terms of the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to
−Removed: 20% of the number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and
−Removed: two-year anniversary of the issuance date.
−Removed: The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares
−Removed: of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends
−Removed: are paid on shares of the common stock.
+Added: March 13, 2024, we entered into the Series B Subscription Agreements and Series B Exchange Agreements with the Series B Investors, which
+Added: agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated Series B Preferred Stock, at
+Added: a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of our Series A Preferred Stock
+Added: and 10,670 shares of our Series A-1 Preferred Stock held by them for 31,790 shares of Series B Preferred Stock.
+Added: Prior to the execution
+Added: of the Series B Subscription Agreements and the Series B Exchange Agreements, we entered into subscription agreements with certain of
+Added: the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of
+Added: $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series
+Added: B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above).
+Added: Each share of the Series
+Added: B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444.
+Added: The terms of the Series B Preferred Stock also include
+Added: a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common stock into
+Added: which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance date.
+Added: of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of common stock basis, to and
+Added: in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends are paid on shares of the common
The Series B Preferred Stock is a voting security.
−Removed: The aggregate gross proceeds of these
−Removed: transactions were $18.16 million (inclusive of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred
−Removed: Stock that was immediately exchanged for Series B Preferred Stock in the transactions).
+Added: The aggregate gross proceeds of these transactions were $18.16 million (inclusive
+Added: of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately exchanged for Series
+Added: B Preferred Stock in the transactions).
a result of 100% of the then-outstanding shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares
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remain outstanding.
−Removed: Subsequent to
−Removed: March 31, 2024, on May 6, 2024, the Company issued approximately 11,634 shares
−Removed: of newly designated Series B-1 Preferred Stock.
−Removed: The terms of the Series
−Removed: B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred
−Removed: Stock has a conversion price of $0.7228.
−Removed: The aggregate gross proceeds from the sale of shares in such offering were $11.6
+Added: May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Preferred Stock.
+Added: The terms of the Series B-1
+Added: Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock
+Added: has a conversion price of $0.7228.
+Added: The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.
Placement - Securities Purchase Agreement
−Removed: as of March 13, 2023, we entered into the SPA with an accredited institutional investor, pursuant to which we agreed to sell, and the
+Added: as of March 13, 2023, we entered into a Securities Purchase Agreement (the “SPA”) with an accredited institutional investor, pursuant to which we agreed to sell, and the
investor agreed to purchase the March 2023 Senior Convertible Note with a face value principal of $11.1 million.
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after deducting a $1.186 million lender fee and offering costs.
+Added: and Capital Resources - continued
March 2023 Senior Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the
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$30 million (the “Financial Tests”).
−Removed: As of March 31, 2024, the Company was in compliance, and as of the date hereof, the
−Removed: Company is in compliance, with the Financial Tests.
−Removed: the three month period ended March 31, 2024, approximately $0.1 million of principal repayments along with approximately $0.4 million
−Removed: of interest expense thereon, were settled through the issuance of 543,298 shares of common stock of the Company, with such shares having
+Added: As of June 30, 2024, the Company was in compliance, and as of the date hereof, the Company
+Added: is in compliance, with the Financial Tests.
+Added: the six month period ended June 30, 2024, approximately $1.2 million of principal repayments along with approximately $0.7 million of
+Added: interest expense thereon, were settled through the issuance of 2,661,181 shares of common stock of the Company, with such shares having
a fair value of approximately $2.5 million (with such fair value measured as the respective conversion date quoted closing price of the
common stock of the Company).
−Removed: and Capital Resources - continued
Equity Facility and ATM Facility
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Cumulatively, a total of 680,263
−Removed: shares of common stock of the Company were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of March 31,
+Added: shares of common stock of the Company were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of June 30,
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock
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of 230,068 shares of the Company were issued through our at-the-market equity facility for net proceeds of approximately $0.3 million,
−Removed: after payment of 3% commissions, as of March 31, 2024.
+Added: after payment of 3% commissions, as of June 30, 2024.
Agreements with PAVmed
−Removed: our inception in May 2018 through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances
+Added: our inception in May 2018 through our initial public offering in October 2021, our operations were funded by PAVmed providing working capital cash advances
and by PAVmed paying certain operating expenses on our behalf.
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price of $0.70 per share).
−Removed: However, in no event will PAVmed be entitled to receive under the MSA, as amended, from and after the date of the eighth amendment to the MSA, more than 9,644,135 shares of our common stock (representing 19.99% of our outstanding shares
−Removed: of common stock as of immediately prior to the execution of the eighth amendment).
−Removed: of March 31, 2024, we had a Due To:
+Added: However, in no event will PAVmed be entitled to receive under the MSA, as amended, from and after the date
+Added: of the eighth amendment to the MSA, more than 9,644,135 shares of our common stock (representing 19.99% of our outstanding shares of
+Added: common stock as of immediately prior to the execution of the eighth amendment).
+Added: to June 30, 2024, in August 2024, the respective companies’ boards of directors approved the Company to enter into a ninth amendment
+Added: Under this amendment, the monthly fee due from the Company to PAVmed was increased from $0.83 million to $1.05 million, effective July 1,
+Added: of June 30, 2024, we had a Due To:
payment obligation liability of approximately $0.3 million, which liability is primarily
−Removed: comprised of our obligations under a payroll and benefit expense reimbursement agreement (the “PBERA”) and the MSA, as well other operating expenses paid by PAVmed on our behalf.
−Removed: See our accompanying
−Removed: unaudited condensed consolidated financial statements Note 5 , Related Party Transactions.
−Removed: In accordance with the MSA and the PBERA,
−Removed: on January 26, 2024, PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA
−Removed: and the PBERA through the issuance of 3,331,771 shares of the Company’s common stock.
+Added: comprised of our obligations under a payroll and benefit expense reimbursement agreement (the “PBERA”) and the MSA, as well
+Added: other operating expenses paid by PAVmed on our behalf.
+Added: See our accompanying unaudited condensed consolidated financial statements Note
+Added: 5 , Related Party Transactions.
+Added: In accordance with the MSA and the PBERA, on January 26, 2024, PAVmed elected to receive payment
+Added: of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares
+Added: of the Company’s common stock.
Accounting Estimates
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There have been no material changes to our critical accounting
−Removed: policies and estimates in the three months ended March 31, 2024.
+Added: policies and estimates in the six months ended June 30, 2024.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.