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or otherwise, except as required by applicable law.
−Removed: is structured to be a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies.
+Added: is a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies.
by a team of highly skilled personnel with a track record of bringing innovative products to market, PAVmed is focused on innovating,
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current focus is multi-fold.
−Removed: We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of our
−Removed: subsidiary, Lucid Diagnostics (Nasdaq:
−Removed: In addition, through a separate
−Removed: majority-owned subsidiary, Veris Health, we are focused on entering into strategic
−Removed: partnership opportunities with leading academic oncology systems to expand access to the Veris Platform.
−Removed: In terms of other existing products
−Removed: and technologies, we have created an incubator-type platform where we are looking to obtain financing on a product-by-product basis as
−Removed: necessary to advance each asset to a meaningful inflection point along its path to commercialization.
−Removed: Finally, as resources permit, we
−Removed: will continue to explore external innovations that fulfill our project selection criteria without limiting ourselves to any target sector,
−Removed: specialty or condition.
+Added: We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of
+Added: our of our subsidiaries, Lucid Diagnostics (Nasdaq:
+Added: We also are continuing to advance the commercialization of the Veris
+Added: Cancer Care Platform, which is the lead product of another of our subsidiaries, Veris Health.
+Added: We are focused in the immediate term
+Added: on entering into strategic partnership opportunities with leading academic oncology systems to expand access to the Veris Platform, while concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy
+Added: port, which will interface with the Veris Platform.
+Added: In terms of other existing products and technologies, we have created an incubator-type platform where we are looking to obtain
+Added: financing on a product-by-product basis as necessary to advance each asset to a meaningful inflection point along its path to
+Added: commercialization.
+Added: Finally, as resources permit, we will continue to explore external innovations that fulfill our project selection
+Added: criteria without limiting ourselves to any target sector, specialty or condition.
Part I, Item 1, “Business”, in the Form 10-K for a more detailed summary of the medical device, diagnostics, and digital
health sectors and our key products, including in particular EsoGuard and the Veris Platform, which are currently our two leading products.
+Added: Changes to PAVmed Board Composition
+Added: Effective as of September 10, 2024,
+Added: Cox, M.D., and Joan B.
+Added: Harvey resigned from the Company’s board of directors.
+Added: Cox’s nor Ms.
+Added: resignation was due to any disagreement with the Company on any matter relating to its operations, policies or practices.
+Added: Also effective as of September 10,
+Added: 2024, the Company’s board of directors appointed Sundeep Agrawal, M.D.
+Added: as a Class B director.
+Added: Prior to being appointed to the Company’s
+Added: board of directors, Dr.
+Added: Agrawal had entered into a strategic advisory agreement with the Company to provide certain M&A advisory services.
+Added: Such agreement will remain in effect upon Dr.
+Added: Agrawal joining the board.
+Added: Pursuant to the agreement, Dr.
+Added: Agrawal will receive a monthly
+Added: consulting fee of $3,333.
+Added: The agreement is terminable by the Company on 10 days’ written notice.
+Added: Except for the foregoing, Dr.
+Added: has not engaged in any transactions with the Company that are required to be reported pursuant to Item 404(a) of Regulation S-K.
+Added: Lucid American Journal of Gastroenterology Publication
+Added: On November 7, 2024, Lucid announced
+Added: that its manuscript for its multi-center ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology,
+Added: the official journal of the American College of Gastroenterology (ACG).
+Added: This is the fourth publication presenting clinical validation
+Added: data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to demonstrate its performance in an intended-use screening population.
+Added: Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value in detecting esophageal precancer (Barrett’s
+Added: Esophagus or BE).
+Added: With the acceptance for publication of Lucid believes it now has a complete clinical evidence package to submit its
+Added: data to the MolDX program and formally seek Medicare coverage.
+Added: The prospective, multi-center study
+Added: presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic
+Added: EsoGuard testing followed by traditional upper endoscopy.
+Added: EsoGuard sensitivity and negative predictive value for detecting BE were approximately
+Added: 88% and 99%, respectively.
+Added: Specificity and positive predictive value were approximately 81% and 30%, respectively.
+Added: No serious adverse
+Added: events were reported.
+Added: Lucid IP Matters
+Added: On October 15, 2024, the Company
+Added: announced that Lucid received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application
+Added: covering its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to help detect esophageal precancer and cancer, a key
+Added: component of its EsoGuard® Esophageal DNA Test.
+Added: EsoGuard utilizes next-generation
+Added: sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1).
+Added: Such methylation has been shown
+Added: to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett’s Esophagus
+Added: or BE), to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma).
+Added: Although VIM methylation had been previously associated
+Added: with gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific.
+Added: Veris NIH Grant
+Added: On October 10, 2024, the Company
+Added: announced that Veris had been awarded a $1.8 million grant from the National Institute on Minority Health and Health Disparities (NIMHD),
+Added: an institute of the National Institutes of Health (NIH).
+Added: The two-year grant will fund research to optimize and validate the Veris Cancer
+Added: Care Platform for the needs of medically underserved cancer patients, in partnership with an academic cancer center.
+Added: The research project,
+Added: “Bridging the Gap:
+Added: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform,” will focus
+Added: on patients facing language barriers, limited access to technology, and socioeconomic disparities.
+Added: Veris Cancer Care Platform
+Added: On June 13, 2024, we announced that Veris and a National Cancer Institute-Designated
+Added: Comprehensive Cancer Center launched a pilot program and has enrolled the first patients from such center in such program on the Veris
+Added: Cancer Care Platform.
Distribution of Lucid Diagnostics Common Stock to Shareholders
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Services Agreement/Payroll Benefits and Expense Reimbursement Agreement with Lucid Diagnostics
−Removed: August 6, 2024, Lucid and the Company entered into a ninth amendment to the management services agreement between Lucid and PAVmed
−Removed: (“MSA”) to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July
+Added: August 6, 2024, PAVmed and Lucid entered into a ninth amendment to the management services agreement between PAVmed and Lucid (“MSA”)
+Added: to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July 1, 2024.
March 22, 2024, PAVmed and Lucid entered into an eighth amendment to MSA to increase the monthly fee thereunder from $0.75 million per
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the issuance of 3,331,771 shares of Lucid’s common stock.
−Removed: March 7, 2024, the Company received a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive
−Removed: business days (through March 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below
−Removed: the minimum of $35 million required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).
−Removed: The notification
−Removed: letter stated that the Company would be afforded 180 calendar days (until September 3, 2024) to regain compliance.
−Removed: In order to regain
−Removed: compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days.
−Removed: The notification
−Removed: letter also states that in the event the Company does not regain compliance prior to the expiration of the 180-day period, the Company
−Removed: will receive written notification that its securities are subject to delisting.
−Removed: The Nasdaq notification has no effect at this time on
−Removed: the listing of the Company’s common stock or Series Z warrants, and the stock and warrants will continue to trade uninterrupted
−Removed: under the symbol “PAVM” and “PAVMZ”, respectively.
−Removed: Moreover, the Company is actively pursuing strategies that
−Removed: it believes will allow it to regain compliance with the listing requirements, although there can be no assurance that those strategies
−Removed: will be successful.
March 21, 2024, the Company announced that it has launched a wholly owned incubator, PMX, to complete development and commercialization
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subsequently, seek to engage a strategic partner to acquire, license or distribute the commercial product.
−Removed: Cancer Care Platform
−Removed: June 13, 2024, we announced that Veris and a National Cancer Institute-Designated Comprehensive Cancer Center launched a pilot program
−Removed: and has enrolled the first patients from such center in such program on the Veris Cancer Care Platform.
+Added: The Company has an agreed upon term sheet for PortIO with a network of angel investors that is based on a pre-money
+Added: valuation of PortIO of $42 million, and due diligence by the investors is ongoing, although there can be no assurance that such transaction
+Added: will be consummated.
Enforcement Discretion
−Removed: April 2024, FDA published the final rule under which FDA intends to phase out its general enforcement discretion approach for LDTs so
−Removed: that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs (the proposed rule was
−Removed: published in October 2023).
−Removed: In the final rule, FDA has expanded the categories of LDTs that will be eligible for continued enforcement
−Removed: discretion, which include LDTs first marketed prior to May 6, 2024 and LDTs approved by New York State’s Clinical Laboratory Evaluation
−Removed: Program (NYS CLEP).
−Removed: As EsoGuard was marketed prior to the May 6, 2024, and is also NYS CLEP-approved, EsoGuard remains under continued
−Removed: enforcement discretion from FDA’s premarket review requirements and quality systems requirements (except for record-keeping).
−Removed: such, there is no immediate impact from the final rule on EsoGuard’s regulatory strategy.
+Added: April 2024, FDA published the final rule under which FDA intends to phase out its general enforcement discretion approach for LDTs
+Added: so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs (the proposed rule
+Added: was published in October 2023).
+Added: In the final rule, FDA has expanded the categories of LDTs that will be eligible for continued
+Added: enforcement discretion, which include LDTs first marketed prior to May 6, 2024 and LDTs approved by New York State’s Clinical
+Added: Laboratory Evaluation Program (NYS CLEP).
+Added: As EsoGuard was marketed prior to the May 6, 2024, and is also NYS CLEP-approved, EsoGuard
+Added: remains under continued enforcement discretion from FDA’s premarket review requirements and quality systems requirements
+Added: (except for record-keeping).
+Added: As such, there is no immediate impact from the final rule on EsoGuard’s regulatory
+Added: Extension to Regain Compliance with Nasdaq Listing
+Added: Rules to January 31, 2025
+Added: On November 8, 2024, a Nasdaq Hearings Panel (the “Panel”) granted the Company an extension, until January 31, 2025, to regain
+Added: compliance with the Nasdaq continued listing standards.
+Added: As previously disclosed, on March
+Added: 7, 2024, the Company received a notice from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) stating
+Added: that, for the prior 30 consecutive business days (through March 6, 2024), the market value of the Company’s listed securities had
+Added: been below the minimum of $35 million required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).
+Added: The Company was provided 180 calendar days, or until September 3, 2024, to regain compliance with the rule.
+Added: The Company did not regain
+Added: compliance with the rule during the allotted time period.
+Added: Accordingly, on September 10, 2024, the Company received a staff determination
+Added: letter from the Nasdaq Listing Qualifications Department, stating that unless the Company timely requested a hearing before the
+Added: Panel to appeal the staff determination, the Company’s securities would be subject to suspension and delisting.
+Added: The Company timely requested a hearing before the Panel, which was held on October 29, 2024.
+Added: During the extension granted by the Panel, the Company’s common stock
+Added: and Series Z warrants will continue to trade uninterrupted under the symbol “PAVM” and “PAVMZ”, respectively.
of Senior Convertible Notes;
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charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed 30%, and that the
−Removed: Company’s market capitalization not be less than $75 million.
−Removed: In consideration of the Note Amendment and Waiver, the Company
−Removed: agreed to pay the holder of the notes $2.0 million in cash (or in such other form as may be mutually agreed in writing), which
−Removed: currently is included in accrued expenses and other current liabilities on the Company’s unaudited condensed consolidated
−Removed: balance sheets as of June 30, 2024.
+Added: Company’s market capitalization not be less than $75 million (the “Financial Tests”).
+Added: In consideration of the Note
+Added: Amendment and Waiver, the Company agreed to pay the holder of the notes $2.0 million in cash (or in such other form as may be
+Added: mutually agreed in writing), which currently is included in accrued expenses and other current liabilities on the Company’s
+Added: unaudited condensed consolidated balance sheets as of September 30, 2024.
+Added: In addition, from time to time
+Added: from and after September 1, 2024 through November 11, 2024, the Company was not in compliance with the Financial Tests.
+Added: As of November
+Added: 11, 2024, the Investor agreed to waive any such non-compliance during such time period and thereafter through December 31, 2024.
our accompanying unaudited condensed consolidated financial statements Note 11, Debt , for further discussion of the senior convertible
+Added: Lucid March 2023 Senior Convertible Note Refinancing
+Added: On November 8, 2024, Lucid gave
+Added: notice to the holder of the Lucid March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem
+Added: the same for the redemption price specified in such note (the “Optional Redemption Price”).
+Added: Pursuant to the terms of the Lucid
+Added: March 2023 Senior Convertible Note, Lucid has not less than ten business days, and not more than twenty business days, from the date of
+Added: the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.
+Added: To finance the payment of the Optional
+Added: Redemption Price, Lucid has entered into a securities purchase agreement with certain accredited investors (the “Lucid 2024 Note Investors”).
+Added: Under the agreement, subject to customary closing conditions, Lucid has agreed to issue, and each 2024 Note Investor has agreed to purchase,
+Added: 12.0% senior secured convertible notes due 2029 (collectively, the “Lucid November 2024 Senior Convertible Notes”).
+Added: the date hereof, the aggregate commitments of the Lucid 2024 Note Investors exceed the Optional Redemption Price.
+Added: In connection with the purchase
+Added: and sale of the Lucid 2024 Convertible Notes, Lucid will agree not to sell, transfer or dispose of, directly or indirectly, any
+Added: shares of Lucid common stock for six months from the consummation of the offering, subject to certain limited exceptions, including in
+Added: the event of a fundamental transaction involving Lucid.
+Added: Lucid expects to complete the issuance
+Added: of the Lucid November 2024 Senior Convertible Notes and the redemption of the Lucid March 2023 Senior Convertible Note on or prior to
+Added: the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed
+Added: during such period, if at all.
Diagnostics - Preferred Stock Offerings
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public float, in May 2023, we amended our “at-the-market offering” to cover up to $18 million of our common stock.
−Removed: six month period ended June 30, 2024, the Company sold 333,299 shares through its at-the-market equity facility for net proceeds of approximately
−Removed: $0.7 million, after payment of 3% commissions.
−Removed: As of June 30, 2024, the Company had approximately $15.3 million remaining under the PAVmed
−Removed: ATM Facility.
−Removed: Subsequent to June 30, 2024, as of August 8, 2024, the Company sold 288,067 shares through their at-market equity
−Removed: facility for net proceeds of approximately $0.3 million after payment of 3% commissions.
−Removed: Diagnostics - Committed Equity Facility and ATM Facility
−Removed: March 2022, Lucid Diagnostics entered into a committed equity facility with a Cantor affiliate.
−Removed: Under the terms of the committed equity
−Removed: facility, the Cantor affiliate has committed to purchase up to $50 million of Lucid Diagnostics’ common stock from time to time
−Removed: at Lucid Diagnostics’ request.
−Removed: While there are distinct differences, the committed equity facility is structured similarly to a
−Removed: traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics to raise primary equity capital on a periodic basis
−Removed: at prices based on the existing market price.
−Removed: Cumulatively, a total of 680,263 shares of Lucid Diagnostics’ common stock were issued
−Removed: for net proceeds of approximately $1.8 million, after a 4% discount, as of June 30, 2024.
−Removed: November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock
−Removed: that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor.
−Removed: Cumulatively, a total
−Removed: of 230,068 shares of Lucid Diagnostics’ common stock were issued through its at-the-market equity facility for net proceeds of
−Removed: approximately $0.3 million, after payment of 3% commissions, as of June 30, 2024.
+Added: nine month period ended September 30, 2024, the Company sold 627,302 shares through its at-the-market equity facility for net proceeds
+Added: of approximately $1.0 million, after payment of 3% commissions.
+Added: As of September 30, 2024, the Company had approximately $15.1 million
+Added: remaining under the PAVmed ATM Facility.
of Operations
−Removed: Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
−Removed: such consideration to be probable to the extent that it is unconstrained.
−Removed: of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
−Removed: test collection kits, royalties and the cost of services to process tests and provide results to physicians.
−Removed: We incur expenses for tests
−Removed: in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
−Removed: to costs being incurred in one period that relate to revenues recognized in a later period.
−Removed: expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
−Removed: patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
+Added: Company recognized revenue primarily resulting from the delivery of patient EsoGuard test results when the Company considered the
+Added: collection of such consideration to be probable to the extent that it is unconstrained.
+Added: of revenues recognized primarily from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage,
+Added: shipment of test collection kits, royalties and the cost of services to process tests and provide results to physicians.
+Added: We have incurred
+Added: expenses for tests in the period in which the activities occur, therefore, gross margin as a percentage of revenue has varied from
+Added: quarter to quarter due to costs being incurred in one period that relate to revenues recognized in a later period.
+Added: expect that gross margin for our services will fluctuate based on the commercialization efforts of our majority-owned subsidiaries.
and marketing expenses
−Removed: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities,
−Removed: as well as advertising and promotion expenses.
−Removed: We anticipate our sales and marketing expenses will increase in the future, to the extent
−Removed: we expand our commercial sales and marketing operations as resources permit and insurance reimbursement coverage for our EsoGuard test
+Added: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing
+Added: activities, as well as advertising and promotion expenses.
+Added: We anticipate our sales and marketing expenses to decrease in the future
+Added: compared to historical periods due to the deconsolidation of Lucid, as the sales and marketing operations for the Lucid EsoGuard test is no longer recorded within the Company’s operating results.
and administrative expenses
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property portfolio.
−Removed: anticipate our general and administrative expenses will increase in the future to the extent our business operations grow.
−Removed: we anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related
−Removed: services, insurance premiums and investor relations costs associated with maintaining compliance as a public company.
+Added: anticipate our general and administrative expenses will decrease in the future compared to historical periods due to the deconsolidation of Lucid as the general and administrative
+Added: expenses, including third-party payor reimbursement costs, incurred by Lucid will no longer be recorded within the Company’s operating
+Added: In the future, general and administrative expenses will include those expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related
+Added: services, insurance premiums and investor relations costs associated with maintaining compliance as a public company for PAVmed and its majority-owned subsidiaries.
and development expenses
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for facilities maintained solely for research and development purposes.
−Removed: current research and development activities, including our clinical trials, are focused principally on the acceleration of EsoGuard and
+Added: The reported research and development activities, including our clinical trials, were focused principally on the acceleration of EsoGuard and
Veris Cancer Care Platform commercialization.
−Removed: We will resume research and development activities with respect to other products in our
+Added: In the future, the research and development activities will focus on the Veris Cancer Care Platform, the PMX incubator program and other products in our
pipeline as well as applicable new technologies, as resources permit.
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in millions, except for share and per share amounts.
−Removed: three months ended June 30, 2024 as compared to three months ended June 30, 2023
−Removed: 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: three months ended September 30, 2024 as compared to three months ended September 30, 2023
+Added: the three months ended September 30, 2024, revenue was $1.0 million as compared to $0.8 million for the corresponding period in the prior
The $0.2 million increase principally relates to the increase in volume of our EsoGuard Esophageal DNA Tests performed in our own
CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
−Removed: the three months ended June 30, 2024, cost of revenue remained relatively level, at approximately $1.7 million, as compared to the corresponding
−Removed: period in the prior year.
+Added: the three months ended September 30, 2024, cost of revenue costs were approximately $1.4 million, as compared to $1.8 million for the
+Added: corresponding period in the prior year.
+Added: The net decrease of $0.4 million was primarily related to:
+Added: approximately
+Added: $0.4 million decrease in manufacturing costs associated with the EsoCheck devices and EsoGuard Esophageal DNA Tests.
and marketing expenses
−Removed: the three months ended June 30, 2024, sales and marketing costs were approximately $4.2 million as compared to $4.3 million for the corresponding
−Removed: period in the prior year.
+Added: the three months ended September 30, 2024, sales and marketing costs were approximately $2.9 million as compared to $4.0 million for
+Added: the corresponding period in the prior year.
The net decrease of $1.1 million was principally related to:
approximately
−Removed: $0.1 million decrease in third-party consulting services at Lucid.
+Added: $1.0 million decrease in compensation related costs;
+Added: approximately
+Added: $0.1 million decrease in stock based compensation costs.
and administrative expenses
−Removed: the three months ended June 30, 2024, general and administrative costs were approximately $7.0 million as compared to $6.7 million for
−Removed: the corresponding period in the prior year.
−Removed: The net increase of $0.3 million was principally related to:
+Added: the three months ended September 30, 2024, general and administrative costs were approximately $6.6 million as compared to $6.9 million
+Added: for the corresponding period in the prior year.
+Added: The net decrease of $0.3 million was principally related to:
approximately
−Removed: $0.8 million increase in third-party professional fees and expenses related to investor relations and legal services;
+Added: $0.2 million decrease in third-party professional fees and legal expenses;
approximately
−Removed: $0.5 million decrease in stock based compensation from RSA and stock option grants to Lucid and PAVmed employees.
+Added: $0.1 million decrease in stock based compensation costs.
and development expenses
−Removed: the three months ended June 30, 2024, research and development costs were approximately $1.6 million as compared to $3.5 million for
−Removed: the corresponding period in the prior year.
+Added: the three months ended September 30, 2024, research and development costs were approximately $1.5 million as compared to $3.2 million
+Added: for the corresponding period in the prior year.
The net decrease of $1.7 million was principally related to:
2 unchanged sentences
approximately
−Removed: $0.4 million decrease in compensation and stock based compensation from RSA and stock option grants to Lucid and PAVmed employees and
−Removed: non-employees.
+Added: $0.3 million decrease in compensation and stock based compensation from RSA and stock option grants to Lucid and PAVmed employees
+Added: and non-employees;
+Added: approximately
+Added: $0.2 million decrease in third party consulting costs related to research and development activities;
+Added: approximately
+Added: $0.1 million decrease in developmental milestones paid to third parties.
of Acquired Intangible Assets
−Removed: amortization of acquired intangible assets was approximately $0.1 million in the three months ended June 30, 2024, as compared to $0.5
+Added: amortization of acquired intangible assets was approximately $0.1 million in the three months ended September 30, 2024, as compared to
$0.5 million for the corresponding period in the prior year.
1 unchanged sentence
intangible assets being fully amortized in February 2024.
+Added: Other Income and Expense
of Operations - continued
−Removed: three months ended June 30, 2024 as compared to the three months ended June 30, 2023 - continued
+Added: three months ended September 30, 2024 as compared to the three months ended September 30, 2023 - continued
Income and Expense
in fair value of convertible debt
−Removed: the three months ended June 30, 2024, the change in the fair value of our convertible notes was approximately $0.6 million of
−Removed: expense, related to the April 2022 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ”
−Removed: below), the September 2022 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ” below), and
−Removed: the Lucid March 2023 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ” below).
−Removed: 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note were
−Removed: initially measured at their issue-date estimated fair value and subsequently remeasured at estimated fair value as of each reporting
−Removed: The Company initially recognized an aggregate of $4.3 million of fair value non-cash expense on the issue
+Added: the three months ended September 30, 2024, the change in the fair value of our convertible notes was approximately $0.2 million of income,
+Added: related to the April 2022 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ” below), the September
+Added: 2022 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ” below), and the Lucid March 2023 Senior
+Added: Convertible Note (as defined in “ Liquidity and Capital Resources ” below).
+Added: The April 2022 Senior Convertible Note,
+Added: the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note were initially measured at their issue-date
+Added: estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date.
+Added: The Company initially recognized
+Added: an aggregate of $4.3 million of fair value non-cash expense on the issue dates.
on Debt Extinguishment
−Removed: the three months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.8 million was recognized in connection
−Removed: with our April 2022 Senior Convertible Note, September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note
−Removed: as discussed below.
−Removed: the three months ended June 30, 2024, approximately $0.7 million of principal repayments, along with less than $0.1 million of interest
−Removed: expense thereon, were settled through the issuance of 461,963 shares of common stock of the Company, with such shares having a fair
−Removed: value of approximately $0.8 million (with such fair value measured as the respective conversion date quoted closing price of the common
−Removed: stock of the Company).
−Removed: In addition, the Company paid $0.2 million in cash related to acceleration floor payments on these notes related
−Removed: to the conversion price being below the floor, recorded as debt extinguishment loss.
−Removed: The conversions and cash paid resulted in a debt
−Removed: extinguishment loss of $0.3 million in the three months ended June 30, 2024.
−Removed: the three months ended June 30, 2024, approximately $1.1 million of principal repayments along with approximately $0.2 million of interest
−Removed: expense thereon, were settled through the issuance of 2,117,883 shares of Lucid common stock, with such shares having a fair value
−Removed: of approximately $1.9 million (with such fair value measured as the quoted closing price of the common stock of Lucid on the respective
−Removed: conversion date).
−Removed: The conversions resulted in a debt extinguishment loss of $0.5 million in the three months ended June 30, 2024.
−Removed: comparison, in the three months ended June 30, 2023, a debt extinguishment loss in the aggregate of approximately $0.7 million was recognized
−Removed: in connection with our April 2022 Senior Convertible Note as discussed below.
−Removed: the three months ended June 30, 2023, approximately $1.7 million of principal repayments, along with less than $0.1 million of interest
−Removed: expense thereon, were settled through the issuance of 346,190 shares of common stock of the Company, with such shares having a fair
−Removed: value of approximately $2.4 million (with such fair value measured as the respective conversion date quoted closing price of the common
−Removed: stock of the Company).
−Removed: The conversions resulted in a debt extinguishment loss of $0.7 million in the three months ended June 30, 2023.
+Added: the three months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.4 million was recognized in
+Added: connection with our April 2022 Senior Convertible Note, September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible
+Added: Note as discussed below.
+Added: the three months ended September 30, 2024, approximately $0.5 million of principal repayments, along with less than $0.1 million
+Added: of interest expense thereon, were settled through the issuance of 509,942 shares of common stock of the Company, with such shares
+Added: having a fair value of approximately $0.9 million (with such fair value measured as the respective conversion date quoted closing
+Added: price of the common stock of the Company).
+Added: In addition, the Company agreed to pay $0.7 million in cash related to acceleration floor
+Added: payments on these notes related to the conversion price being below the floor, recorded as debt extinguishment loss.
+Added: The conversions
+Added: and floor acceleration payments resulted in a debt extinguishment loss of $1.1 million in the three months ended September 30, 2024.
+Added: the period of July 1, 2024 through September 10, 2024, the date of PAVmed’s deconsolidation, approximately $0.8 million of
+Added: principal repayments along with approximately $0.1 million of interest expense thereon, were settled through the issuance of 1,510,821
+Added: shares of Lucid common stock, with such shares having a fair value of approximately $1.3 million (with such fair value measured as
+Added: the quoted closing price of the common stock of Lucid on the respective conversion date).
+Added: The conversions resulted in a debt extinguishment
+Added: loss of $0.3 million in the period July 1, 2024 through September 10, 2024.
+Added: comparison, in the three months ended September 30, 2023, a debt extinguishment loss in the aggregate of approximately $1.8 million was
+Added: recognized in connection with our April 2022 Senior Convertible Note as discussed below.
+Added: the three months ended September 30, 2023, approximately $2.2 million of principal repayments, along with less than $0.1 million
+Added: of interest expense thereon, were settled through the issuance of 723,998 shares of common stock of the Company, with such shares
+Added: having a fair value of approximately $4.0 million (with such fair value measured as the respective conversion date quoted closing
+Added: price of the common stock of the Company).
+Added: The conversions resulted in a debt extinguishment loss of $1.8 million in the three months
+Added: ended September 30, 2023.
Note 11 , Debt , to the Financial Statements, for additional information with respect to the April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note.
+Added: on Deconsolidation of Lucid
+Added: of September 30, 2024, there were 51,597,718 shares of common stock of Lucid Diagnostics issued and outstanding, of which, the
+Added: Company held 31,302,444 shares.
+Added: On September 10, 2024, as a result of certain changes in the composition of the Company’s
+Added: board of directors as described above, in combination with the Company ceasing to have control over a majority of the voting power
+Added: of Lucid, the Company was considered to cease to have control over Lucid for the purposes of U.S.
+Added: GAAP, even though it continues to
+Added: own, and has not disposed any of its, 31,302,444 shares of common stock of Lucid.
+Added: However, PAVmed retained the ability to exercise
+Added: significant influence over Lucid.
+Added: Upon deconsolidation, the Company’s ownership of 31,302,444 shares of Lucid Diagnostics, Inc
+Added: common stock was valued at $25.1 million, which resulted in a gain on deconsolidation of $72.3 million in the accompanying unaudited
+Added: condensed consolidated statements of operations for the three months ended September 30, 2024.
+Added: in fair value of Equity Method Investment
+Added: At September 10, 2024 and September
+Added: 30, 2024, the fair value of the Company’s investment in Lucid was $25.1 million and $25.5 million, respectively, with the company
+Added: recognizing an unrealized gain on its investment in Lucid of $0.4 million in the accompanying condensed consolidated statements of operations
+Added: for three month period ended September 30, 2024.
+Added: The fair value of common shares held by the Company was determined using the closing
+Added: price of Lucid’s common stock per share on September 10, 2024 and September 30, 2024 of $0.802 and $0.815, respectively.
of Operations - continued
−Removed: six months ended June 30, 2024 as compared to six months ended June 30, 2023
−Removed: 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.
+Added: nine months ended September 30, 2024 as compared to nine months ended September 30, 2023
+Added: the nine months ended September 30, 2024, revenue was $3.0 million as compared to $1.4 million for the corresponding period in the prior
The $1.6 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory
for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
−Removed: the six months ended June 30, 2024, cost of revenue was approximately $3.4 million as compared to $3.0 million for the corresponding
−Removed: period in the prior year.
−Removed: The $0.4 million increase was principally related to:
−Removed: approximately
−Removed: $0.2 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal DNA tests and royalty costs;
−Removed: approximately
−Removed: $0.2 million increase in compensation related costs, including stock-based compensation.
+Added: the nine months ended September 30, 2024, cost of revenue remained relatively level, at approximately $4.8 million, as compared to the
+Added: corresponding period in the prior year.
and marketing expenses
−Removed: the six months ended June 30, 2024, sales and marketing costs were approximately $8.6 million as compared to $8.9 million for the corresponding
−Removed: period in the prior year.
+Added: the nine months ended September 30, 2024, sales and marketing costs were approximately $11.5 million as compared to $12.9 million for
+Added: the corresponding period in the prior year.
The net decrease of $1.4 million was principally related to:
4 unchanged sentences
and administrative expenses
−Removed: the six months ended June 30, 2024, general and administrative costs were approximately $13.7 million as compared to $17.1 million for
−Removed: the corresponding period in the prior year.
+Added: the nine months ended September 30, 2024, general and administrative costs were approximately $20.3 million as compared to $23.9 million
+Added: for the corresponding period in the prior year.
The net decrease of $3.6 million was principally related to:
2 unchanged sentences
approximately
−Removed: $0.5 million decrease in third-party professional fees and expenses related to related to the termination of the MSA-RDx, finance and
+Added: $0.5 million decrease in third-party professional fees, expenses related to related to the termination of the management services agreement with our former laboratory provider, and expenses for finance and
legal services.
−Removed: approximately
−Removed: $0.1 million increase in compensation related costs.
and development expenses
−Removed: the six months ended June 30, 2024, research and development costs were approximately $3.6 million as compared to $7.5 million for the
−Removed: corresponding period in the prior year.
+Added: the nine months ended September 30, 2024, research and development costs were approximately $5.1 million as compared to $10.7 million
+Added: for the corresponding period in the prior year.
The net decrease of $5.6 million was principally related to:
2 unchanged sentences
approximately
−Removed: $0.9 million decrease in compensation related costs and stock-based compensation, related to employees at PAVmed and Lucid.
+Added: $1.2 million decrease in compensation related costs and stock-based compensation.
of Acquired Intangible Assets
−Removed: amortization of acquired intangible assets was approximately $0.5 million in the six months ended June 30, 2024, as compared to $1.0
+Added: amortization of acquired intangible assets was approximately $0.6 million in the nine months ended September 30, 2024, as compared to
$1.5 million for the corresponding period in the prior year.
1 unchanged sentence
intangible assets being fully amortized in February 2024.
−Removed: of Operations - continued
−Removed: 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 six months ended June 30, 2024 and June 30, 2023, the change in the fair value of our convertible notes was approximately $2.7 million
−Removed: and $1.4 million of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note,
−Removed: and the Lucid March 2023 Senior Convertible Note.
−Removed: The April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note,
−Removed: and the Lucid March 2023 Senior Convertible Note were initially measured at their issue-date estimated fair value and subsequently remeasured
−Removed: at estimated fair value as of each reporting period date.
−Removed: The Company initially recognized an aggregate of $4.3 million of fair value
−Removed: non-cash expense on the issue dates.
+Added: the nine months ended September 30, 2024 and September 30, 2023, the change in the fair value of our convertible notes was approximately
+Added: $2.5 million and $5.8 million of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior
+Added: Convertible Note, and the Lucid March 2023 Senior Convertible Note.
+Added: The April 2022 Senior Convertible Note, the September 2022 Senior
+Added: Convertible Note, and the Lucid March 2023 Senior Convertible Note were initially measured at their issue-date estimated fair value and
+Added: subsequently remeasured at estimated fair value as of each reporting period date.
+Added: The Company initially recognized an aggregate of $4.3
+Added: million of fair value non-cash expense on the issue dates.
on Issue and Offering Costs - Senior Secured Convertible Note
−Removed: the six months ended June 30, 2023, in connection with the issue of the Lucid March 2023 Senior Convertible Note, we recognized a total
−Removed: of approximately $1.2 million of lender fees and offering costs.
−Removed: The Company did not incur lender fees and offering costs in the six
−Removed: months ended June 30, 2024.
+Added: the nine months ended September 30, 2023, in connection with the issue of the Lucid March 2023 Senior Convertible Note, we recognized
+Added: a total of approximately $1.2 million of lender fees and offering costs.
+Added: The Company did not incur lender fees and offering costs in
+Added: the nine months ended September 30, 2024.
+Added: of Operations - continued
+Added: nine months ended September 30, 2024 as compared to nine months ended September 30, 2023 - continued
+Added: Income and Expense - continued
on Debt Extinguishment
−Removed: the six months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.1 million was recognized in connection
−Removed: with our April 2022 Senior Convertible Note and September 2022 Senior Convertible Note as discussed below.
−Removed: the six months ended June 30, 2024, approximately $1.0 million of principal repayments along with less than $0.1 million of interest
−Removed: expense thereon, were settled through the issuance of 574,424 shares of common stock of the Company, with such shares having a fair
−Removed: value of approximately $1.1 million (with such fair value measured as the quoted closing price of the common stock of the Company on
−Removed: the respective conversion date).
−Removed: In addition, the Company paid $0.4 million in cash related to acceleration floor payments on these
−Removed: notes related to the conversion price being below the floor, recorded as debt extinguishment loss.
−Removed: The conversions and cash paid resulted
−Removed: in a debt extinguishment loss of $0.5 million in the six months ended June 30, 2024.
−Removed: the six months ended June 30, 2024, approximately $1.2 million of principal repayments along with approximately $0.7 million of interest
−Removed: expense thereon, were settled through the issuance of 2,661,181 shares of Lucid common stock, with such shares having a fair value
−Removed: of approximately $2.5 million (with such fair value measured as the quoted closing price of the common stock of Lucid on the respective
−Removed: conversion date).
−Removed: The conversions resulted in a debt extinguishment loss of $0.7 million in the six months ended June 30, 2024.
−Removed: comparison, in the six months ended June 30, 2023, a debt extinguishment loss in the aggregate of approximately $1.3 million was recognized
−Removed: in connection with our April 2022 Senior Convertible Note as discussed below.
−Removed: the six months ended June 30, 2023, approximately $3.2 million of principal repayments along with less than $0.1 million of interest
−Removed: expense thereon, were settled through the issuance of 634,899 shares of common stock of the Company, with such shares having a fair
−Removed: value of approximately $4.4 million (with such fair value measured as the quoted closing price of the common stock of the Company on
−Removed: the respective conversion date).
−Removed: The conversions resulted in a debt extinguishment loss of $1.3 million in the six months ended June
+Added: the nine months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $2.5 million was recognized in
+Added: connection with our April 2022 Senior Convertible Note and September 2022 Senior Convertible Note as discussed below.
+Added: the nine months ended September 30, 2024, approximately $1.4 million of principal repayments along with $0.1 million of interest
+Added: expense thereon, were settled through the issuance of 1,084,366 shares of common stock of the Company, with such shares having a
+Added: fair value of approximately $2.0 million (with such fair value measured as the quoted closing price of the common stock of the Company
+Added: on the respective conversion date).
+Added: In addition, the Company agreed to pay $1.1 million in cash related to acceleration floor payments
+Added: on these notes related to the conversion price being below the floor, recorded as debt extinguishment loss.
+Added: The conversions and cash
+Added: paid resulted in a debt extinguishment loss of $1.5 million in the nine months ended September 30, 2024.
+Added: the period of January 1, 2024 through September 10, 2024, the date of PAVmed’s deconsolidation of Lucid, approximately $2.0
+Added: million of principal repayments along with approximately $0.8 million of interest expense thereon, were settled through the issuance
+Added: of 4,172,002 shares of Lucid common stock, with such shares having a fair value of approximately $3.8 million (with such fair value
+Added: measured as the quoted closing price of the common stock of Lucid on the respective conversion date).
+Added: The conversions resulted in
+Added: a debt extinguishment loss of $1.0 million in the period of January 1, 2024 through September 10, 2024.
+Added: comparison, in the nine months ended September 30, 2023, a debt extinguishment loss in the aggregate of approximately $3.0 million was
+Added: recognized in connection with our April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note as discussed below.
+Added: the nine months ended September 30, 2023, approximately $5.1 million of principal repayments along with $0.3 million of interest
+Added: expense thereon, were settled through the issuance of 1,358,896 shares of common stock of the Company, with such shares having a
+Added: fair value of approximately $8.4 million (with such fair value measured as the quoted closing price of the common stock of the Company
+Added: on the respective conversion date).
+Added: The conversions resulted in a debt extinguishment loss of $3.0 million in the nine months ended
+Added: September 30, 2023.
Note 11 , Debt , to the Financial Statements, for additional information with respect to the April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note.
+Added: on Deconsolidation of Lucid
+Added: of September 30, 2024, there were 51,597,718 shares of common stock of Lucid Diagnostics issued and outstanding, of which, the
+Added: Company held 31,302,444 shares.
+Added: On September 10, 2024, as a result of changes in the composition of the Company’s board of
+Added: directors described above, in combination with the Company ceasing to have control over a majority of the voting power of Lucid, the
+Added: Company was considered to cease to have control over Lucid for the purposes of U.S.
+Added: GAAP, even though it continues to own, and has
+Added: not disposed any of its, 31,302,444 shares of common stock of Lucid .
+Added: However, PAVmed retained the ability to exercise significant influence over Lucid.
+Added: As a result, the Company deconsolidated Lucid.
+Added: Upon deconsolidation, the Company’s ownership of 31,302,444 shares of Lucid Diagnostics common stock was valued at $25.1
+Added: million, which resulted in a gain on deconsolidation of $72.3 million in the accompanying unaudited condensed consolidated
+Added: statements of operations for the nine months ended September 30, 2024.
+Added: in fair value of Equity Method Investment
+Added: September 10, 2024 and September 30, 2024, the fair value of the Company’s investment in Lucid was $25.1 million and $25.5 million,
+Added: respectively, with the company recognizing an unrealized gain on its investment in Lucid of $0.4 million in the accompanying condensed
+Added: consolidated statements of operations for nine month period ended September 30, 2024.
+Added: The fair value of common shares held by the Company
+Added: was determined using the closing price of Lucid’s common stock per share on September 10, 2024 and September 30, 2024 of $0.802
+Added: and $0.815, respectively.
Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
fair value of the consideration given in the form of the issue of 31,790 shares of Lucid Series B Preferred Stock, with such fair value
−Removed: recognized as the carrying value of such issued shares of Lucid Series B Preferred Stock, as compared to both the newly issued Lucid
−Removed: Series B Preferred Stock (fair value of $12.5 million) and the carrying value of the extinguished Lucid Series A and Series A-1 Preferred
+Added: recognized as the carrying value of such issued shares of Lucid Series B Preferred Stock, as compared to the carrying value of the extinguished Lucid Series A and Series A-1 Preferred
Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged
1 unchanged sentence
a component of net loss attributable to common stockholders, summarized as follows:
−Removed: B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
−Removed: Value - 44,285 shares of Series B Preferred Stock issued
−Removed: Fair value related to newly issued Series B Preferred Stock (of 12,495 shares)
+Added: Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
+Added: March 13, 2024
+Added: Fair Value - 31,790 shares of Lucid Series B Preferred Stock issued in exchange for Lucid Series A and Lucid Series A-1 Preferred Stock
Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)
−Removed: Dividend Charged to Accumulated Deficit
+Added: Deemed Dividend Charged to Accumulated Deficit
and Capital Resources
current financing strategy is to obtain capital directly into Lucid, Veris and other subsidiaries to fund any product development or
−Removed: other related activities.
+Added: other related activities, although we retain the flexibility to raise capital at the PAVmed level.
There are no assurances, however, we will be able to obtain an adequate level of financial resources required
1 unchanged sentence
have financed our operations principally through the public and private issuances of our common stock, preferred stock, common stock
−Removed: purchase warrants, and debt.
+Added: purchase warrants, and debt, both at the PAVmed level and, in the case of Lucid, at the subsidiary level.
We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and
1 unchanged sentence
and ongoing R&D and clinical trials.
−Removed: We experienced a net loss before noncontrolling interests of approximately $33.4 million and
−Removed: used approximately $24.8 million of cash in operations for the six months ended June 30, 2024.
−Removed: Financing activities provided $30.7 million
−Removed: of cash during the six months ended June 30, 2024.
−Removed: We ended the quarter with cash on-hand of $25.5 million as of June 30, 2024.
−Removed: to continue to experience recurring losses and negative cash flows from operations, and will continue to fund our operations with debt
−Removed: and/or equity financing transactions, including current obligations on the Company’s existing convertible debt which in accordance
−Removed: with management’s plans may include conversions to equity and refinancing our existing debt obligations to extend the maturity
−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 Test
−Removed: from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers,
−Removed: and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing
−Removed: existing debt obligations.
−Removed: These factors raise substantial doubt about the Company’s ability to continue as a going concern within
−Removed: one year after the date the accompanying unaudited condensed consolidated financial statements are issued.
+Added: We experienced net income before noncontrolling interests of approximately $27.3 million and
+Added: used approximately $33.6 million of cash in operations for the nine months ended September 30, 2024.
+Added: Financing activities provided $31.0
+Added: million of cash during the nine months ended September 30, 2024.
+Added: We ended the quarter with cash on-hand of $0.8 million as of September
+Added: We expect to continue to experience recurring losses and negative cash flows from operations, and will continue to fund our
+Added: operations with debt and/or equity financing transactions, including current obligations on the Company’s existing convertible
+Added: debt which in accordance with management’s plans may include conversions to equity and refinancing our existing debt obligations
+Added: to extend the maturity date.
+Added: The Company’s ability to continue operations 12 months beyond the issuance of the financial statements
+Added: will depend upon generating substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its
+Added: EsoGuard Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly
+Added: with self-insured employers, and on its ability to raise additional capital through various potential sources including equity and/or
+Added: debt financings or refinancing existing debt obligations.
+Added: These factors raise substantial doubt about the Company’s ability to
+Added: continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are
of Shares of Our Common Stock
−Removed: the six months ended June 30, 2024
−Removed: issued 34,332 shares of our common stock for proceeds of approximately $0.1 million under the PAVmed Employee Stock Purchase Plan (“ESPP”),
−Removed: as such plan is discussed in Note 11, Stock-Based Compensation, to the Financial Statements.
−Removed: issued 333,299 shares of our common stock for net proceeds of approximately $0.7 million, after payment of 3% commissions, from the
−Removed: sale of shares through PAVmed’s at-the-market equity facility through Cantor.
+Added: the nine months ended September 30, 2024
+Added: issued 34,332 shares of our common stock for proceeds of approximately $0.1 million under the PAVmed Employee Stock Purchase Plan
+Added: For more information about the ESPP, see Note 12, Stock-Based Compensation, to the Financial Statements.
+Added: issued 627,302 shares of our common stock for net proceeds of approximately $1.0 million, after payment of 3% commissions, through our at-the-market equity facility with Cantor.
See below for more information.
−Removed: issued 574,424 shares of our common stock in satisfaction of approximately $1.0 million of principal repayments along with less than
+Added: issued 1,084,366 shares of our common stock in satisfaction of approximately $1.4 million of principal repayments along with $0.1
million of interest expense thereon under the April 2022 Senior Convertible Note and September 2022 Senior Convertible Note.
Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022
−Removed: as of March 31, 2022, we entered into a Securities Purchase Agreement (referred to as the “SPA”) with an accredited investor, pursuant to which we agreed to sell, and the investor agreed
−Removed: to purchase an aggregate of $50.0 million face value principal of Senior Secured Convertible Notes.
−Removed: The SPA provided for the sale of
−Removed: the initial Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (referred to
−Removed: as the “April 2022 Senior Convertible Note”).
−Removed: The April 2022 Senior Secured Convertible Note had an initial contractual maturity
−Removed: date of April 4, 2024, which maturity date the investor agreed to extend by one year, to April 4, 2025.
−Removed: The April 2022 Senior Convertible
−Removed: Note may be converted into or otherwise paid in shares of our common stock as described in Note 10, Debt .
+Added: as of March 31, 2022, we entered into a Securities Purchase Agreement (the “SPA”) with an accredited investor, pursuant
+Added: to which we agreed to sell, and the investor agreed to purchase an aggregate of $50.0 million face value principal of Senior Secured
+Added: Convertible Notes.
+Added: On April 4, 2022, we completed an initial closing under the SPA, in which we sold to the investor a Senior
+Added: Secured Convertible Note with a face value principal of $27.5 million (the “April 2022 Senior Convertible Note”).
+Added: April 2022 Senior Secured Convertible Note had an initial contractual maturity date of April 4, 2024, which maturity date the
+Added: investor agreed to extend by one year, to April 4, 2025.
+Added: The April 2022 Senior Convertible Note may be converted into or otherwise
+Added: paid in shares of our common stock as described in Note 11, Debt .
September 8, 2022, we completed an additional closing under the SPA, in which we sold to the investor an additional Senior Secured Convertible
−Removed: Note with a face value principal of $11.25 million (referred to as the “September 2022 Senior Convertible Note”).
+Added: Note with a face value principal of $11.25 million (the “September 2022 Senior Convertible Note”).
The September
13 unchanged sentences
Cap Ratio Test, the “Financial Tests”).
−Removed: From time to time from and after December 1, 2023 through March 12, 2024, the Company
+Added: From time to time from and after September 1, 2024 through November 11, 2024, the Company
was not in compliance with the Financial Tests.
−Removed: As of March 12, 2024, the investor agreed to waive any such non-compliance during such
−Removed: time period and thereafter through August 31, 2024.
−Removed: Based on the waiver, as of June 30, 2024, the Company was in compliance with the
−Removed: Financial Tests.
+Added: As of November 11, 2024, the investor agreed to waive any such non-compliance during such
+Added: time period and thereafter through December 31, 2024.
+Added: Based on the waiver, as of September 30, 2024, the Company was in compliance with
+Added: the Financial Tests.
In addition, based on the waiver, the Company presently is in compliance with the Financial Tests.
and Capital Resources - continued
−Removed: consideration of the covenant waiver and maturity extensions discussed above, the Company agreed to pay the holder of the notes $2.0
−Removed: million in cash (or in such other form as may be mutually agreed in writing).
Note 11 , Debt , to the Financial Statements for additional information about the SPA, the April 2022 Senior Convertible Note, and
32 unchanged sentences
Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023
−Removed: as of March 13, 2023, Lucid Diagnostics entered into a Securities Purchase Agreement (referred to as the “Lucid SPA”)
−Removed: with an accredited institutional investor, pursuant to which Lucid Diagnostics agreed to sell, and the investor agreed to purchase a
−Removed: Senior Convertible Note (referred to as the “Lucid March 2023 Senior Convertible Note”) with a face value principal of $11.1 million.
+Added: as of March 13, 2023, Lucid Diagnostics entered into a Securities Purchase Agreement (the “Lucid SPA”) with
+Added: an accredited institutional investor, pursuant to which Lucid Diagnostics agreed to sell, and the investor agreed to purchase a Senior
+Added: Convertible Note (the “Lucid March 2023 Senior Convertible Note”) with a face value principal of $11.1 million.
Lucid Diagnostics issued the Lucid March 2023 Senior Convertible Note on March 21, 2023 pursuant to the Lucid SPA.
9 unchanged sentences
than $30 million (the “Lucid Financial Tests”).
−Removed: As of June 30, 2024, Lucid Diagnostics was in compliance with the Lucid Financial
+Added: As of September 30, 2024, Lucid Diagnostics was in compliance with the Lucid
+Added: Financial Tests.
In addition, Lucid Diagnostics presently is in compliance with the Lucid Financial Tests.
+Added: Liquidity and Capital Resources - continued
+Added: November 8, 2024, Lucid gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right
+Added: pursuant to such note to redeem the same for the Optional Redemption Price specified in such note.
+Added: To finance the payment of the
+Added: Optional Redemption Price, Lucid has entered into a securities purchase agreement with the 2024 Note Investors.
+Added: agreement, subject to customary closing conditions, Lucid has agreed to issue, and each 2024 Note Investor has agreed to purchase he
+Added: November 2024 Senior Convertible Notes, which are 12.0% senior secured convertible notes due 2029.
+Added: As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Lucid
+Added: Optional Redemption Price.
December 2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered
and sold under a Controlled Equity Offering Agreement between us and Cantor.
−Removed: In the six months ended June 30, 2024, the Company sold
−Removed: 333,299 shares through its at-the-market equity facility for net proceeds of approximately $0.7 million, after payment of 3% commissions.
−Removed: Subsequent to June 30, 2024, as of August 8, 2024, the Company sold 288,067 shares through their at-market equity facility
−Removed: for net proceeds of approximately $0.3 million after payment of 3% commissions.
+Added: In the nine months ended September 30, 2024, the Company
+Added: sold 627,302 shares through its at-the-market equity facility for net proceeds of approximately $1.0 million, after payment of 3% commissions.
and Capital Resources - continued
3 unchanged sentences
Cumulatively, a total of 680,263 shares
−Removed: of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of June
+Added: of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of September
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock
2 unchanged sentences
of 230,068 shares of Lucid Diagnostics’ common stock were issued through its at-the-market equity facility for net proceeds of
−Removed: approximately $0.3 million, after payment of 3% commissions, as of June 30, 2024.
+Added: approximately $0.3 million, after payment of 3% commissions, as of September 30, 2024.
Accounting Estimates
13 unchanged sentences
There have been no material changes to our critical accounting
−Removed: policies and estimates in the six months ended June 30, 2024.
+Added: policies and estimates in the nine months ended September 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.