Item 2. Management’s Discussion and Analysis
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
The following discussion and analysis
of our unaudited condensed consolidated financial condition and results of operations should be read together with our Annual Report on
Form 10-K for the year ended December 31, 2024 (the “Form 10-K”), as filed with the Securities and Exchange Commission (the
“SEC”).
Unless the context otherwise requires,
(i) “we”, “us”, and “our”, and the “Company” and “PAVmed” refer to PAVmed
Inc. and its subsidiaries, including its subsidiary Lucid Diagnostics Inc. (“Lucid Diagnostics” or “Lucid”) and
its majority-owned subsidiary Veris Health Inc. (“Veris Health” or “Veris”), (ii) “FDA” refers to
the Food and Drug Administration, (iii) “510(k)” refers to a premarket notification, submitted to the FDA by a manufacturer
pursuant to § 510(k) of the Food, Drug and Cosmetic Act and 21 CFR § 807 subpart E, (iv) “CLIA” refers to the Clinical
Laboratory Improvement Amendments of 1988 and associated regulations set forth in 42 CFR § 493, and (v) “LDT” refers
to a diagnostic test, defined by the FDA as “an IVD that is intended for clinical use and designed, manufactured and used within
a single laboratory,” which is generally subject only to self-certification of analytical validity under the CMS CLIA program.
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q
(this “Form 10-Q”), including the discussion and analysis of our unaudited condensed consolidated financial condition and
results of operations, contains forward-looking statements that involve substantial risks and
uncertainties. All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding
our future results of operations and financial position, business strategy and plans and objectives of management for future operations,
are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results
may differ significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences
include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important factors that may affect our actual results
include:
●
our limited operating history;
●
our financial performance, including our ability to generate revenue;
●
our ability to obtain regulatory approval for the commercialization of our products;
●
the risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like EsoGuard;
●
the ability of our products to achieve market acceptance;
●
our success in retaining or recruiting, or changes required in, our officers, key employees or directors;
●
our potential ability to obtain additional financing when and if needed;
●
our ability to protect our intellectual property;
●
our ability to complete strategic acquisitions;
●
our ability to manage growth and integrate acquired operations;
●
the potential liquidity and trading of our securities;
●
our regulatory and operational risks;
●
cybersecurity risks;
●
risks related to the COVID-19 pandemic and other health-related emergencies; and
●
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
In addition, our forward-looking
statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions, joint ventures or investments
we may make.
We may not actually
achieve the results, plans, and/or objectives disclosed in our forward-looking statements, and the intended or expected developments
and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place undue
reliance on our forward-looking statements. You should read this Quarterly Report on Form 10-Q and the documents we have filed as
exhibits to this Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially
different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by applicable law.
30
Overview
PAVmed is a multi-product life sciences
company organized to advance a pipeline of innovative healthcare technologies. Led by a team of highly skilled personnel with a track
record of bringing innovative products to market, PAVmed is focused on innovating, developing, acquiring, and commercializing novel products
that target unmet needs with large addressable market opportunities. Leveraging our corporate structure—a parent company that will
establish distinct subsidiaries for each financed asset—we have the flexibility to raise capital at the PAVmed level to fund product
development, or to structure financing directly into each subsidiary in a manner tailored to the applicable product, the latter of which
is our current strategy given prevailing market conditions.
Our current focus is multi-fold.
We continue to support commercial expansion and execution of EsoGuard, which is the flagship product of our subsidiary, Lucid Diagnostics,
of which we remain the shareholder with the largest voting interest. In addition, through a separate majority-owned subsidiary, Veris
Health, we offer the Veris Cancer Care Platform. We are focused in the immediate term on entering into strategic partnership opportunities
with leading academic oncology systems to expand access to the Veris Cancer Care Platform, while concurrently developing an implantable
physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform.
In terms of other existing products and technologies, we have adopted an incubator-type platform where we are looking to obtain financing
on a product-by-product basis as necessary to advance each asset to a meaningful inflection point along its path to commercialization.
Finally, as resources permit, we will continue to explore external innovations that fulfill our project selection criteria without limiting
ourselves to any target sector, specialty or condition.
Recent Developments
Business
EsoGuard Medicare Coverage
In November 2024, Lucid submitted
to MolDx its complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to
secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical
validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation
study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology (ACG) guidelines for
esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD
to secure Medicare coverage for EsoGuard.
NCCN Clinical Practice Guidelines Update
In March 2025, Lucid announced that
a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has added a new section on BE screening. The NCCN Guidelines®
now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which
recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative
to invasive upper endoscopy to detect esophageal precancer.
31
Recent Developments - continued
Business - continued
Clinical Study Publications
On March 18, 2025, Lucid announced
that its ENVET-BE clinical utility study has been accepted for publication in Gastroenterology & Hepatology—the fifth peer-reviewed
publication of clinical utility data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to present findings from a real-world
screening population. The manuscript, entitled “Enhancing the Diagnostic Yield of EGD for Diagnosis of Barrett’s Esophagus
Through Methylated DNA Biomarker Triage,” demonstrates that confirmatory upper endoscopy (EGD) performed in EsoGuard-positive patients
had a substantially higher diagnostic yield for detecting esophageal precancer (Barrett’s Esophagus or BE) than the expected yield
of screening EGD alone in at-risk patients. The ENVET-BE study reviewed real-world data from a cohort of 199 EsoGuard-positive patients
who completed confirmatory EGD. The overall positive diagnostic yield for BE was 2.4-fold higher than the expected yield of screening
EGD alone, based on disease prevalence within an at-risk population. The yield was nearly three-fold higher in patients meeting American
College of Gastroenterology (ACG) screening criteria.
Highmark Reimbursement Approval
On March 13, 2025, Lucid announced that Highmark Blue
Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive
screening of esophageal precancer and cancer in New York state. The new policy will cover EsoGuard in patients who meet established criteria
for esophageal precancer testing consistent with professional society guidelines.
CWRU NIH Grant Related to EsoGuard and EsoCheck
On February 27, 2025, Lucid announced that principal
investigators from CWRU and University Hospitals (“UH”), were awarded an $8 million National Institutes of Health (NIH) R01
grant to conduct a five-year clinical study designed to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk
individuals without symptoms of chronic gastroesophageal reflux disease (“GERD”). The study, “A Clinical Trial of Cancer
Prevention by Biomarker Based Detections of Barrett’s Esophagus and Its Progression,” aims to evaluate the effectiveness of
EsoCheck and EsoGuard in detecting esophageal precancer (Barrett’s Esophagus or BE) to prevent esophageal cancer (EAC) within a
non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association’s
(AGA) risk criteria for screening will be recruited across five participating research centers: University Hospitals, University of Colorado,
Johns Hopkins University, University of North Carolina, and Cleveland Clinic.
Financing
PAVmed ATM
On April 17, 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Maxim Group
LLC, as sales agent (“Maxim”), pursuant to which the Company may offer and sell, from time to time through or to Maxim, shares
of its common stock. Under the Sales Agreement, the Company may not
issue or sell through Maxim a dollar amount of shares that would exceed $2,880,000 of shares. The Company will pay Maxim a commission
of 3.0% of the aggregate gross sales prices of the shares. The Company intends to use the net proceeds from any such sales for working
capital and general corporate purposes.
This facility replaces the “at the market”
facility PAVmed previously maintained with Cantor (which facility was on substantially similar terms).
PAVmed/Veris Common Stock Offering
On February 18, 2025, the Company
and Veris entered into subscription agreements (each, a “Subscription Agreement”) with certain accredited investors (collectively,
the “Investors”), pursuant to which the Company agreed to sell and the Investors agreed to purchase (the “Offering”)
2,574,350 shares of the Company’s common stock and pre-funded warrants to purchase 756,734 shares of the Company’s common
stock (the “Pre-Funded Warrants”), at a purchase price of $0.7115 per share or warrant share (as applicable). In addition,
Veris agreed to issue to each Investor approximately 0.2033 shares of Veris’ common stock for each share or warrant share (as applicable)
purchased by such Investor, for an aggregate of 677,143 shares of Veris’ common stock. On February 21, 2025, the Company consummated
the Offering, generating gross proceeds to the Company of $2.37 million. The proceeds of the offering will be used to resume development
activities related to Veris’ implantable physiological monitor and for general working capital purposes.
32
Recent Developments - continued
Financing - continued
Lucid Diagnostics — Confidentially Marketed
Public Offering
On April 11, 2025, Lucid closed on the sale of 14,375,000
shares of its common stock, pursuant to its previously announced offering of shares of common stock at a price of $1.20 per share (the
“Lucid CMPO”)
The net proceeds from the Lucid CMPO, after deducting
the underwriting discount and other expenses of the Lucid CMPO, were approximately $16.1 million. Lucid intends to use the net proceeds
from the Lucid CMPO for working capital and general corporate purposes.
Lucid Diagnostics — Registered Direct Offering
On March 5, 2025, Lucid closed on
the sale of 13,939,331 shares of its common stock, pursuant to its previously announced offering of shares of common stock at a price
of $1.10 per share (the “Lucid RDO”).
The net proceeds of the Lucid RDO,
after deducting the estimated placement agent’s fees and other expenses of the Lucid RDO, were approximately $14.9 million.
Lucid intends to use the net proceeds from the Lucid RDO for working capital and other general corporate purposes.
In connection with the Lucid RDO,
Lucid suspended its “at the market offering” program. In November 2022, Lucid entered into a Controlled Equity Offering℠
Sales Agreement (the “Lucid Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”). Pursuant to the Sales
Agreement, from time to time, Lucid may offer and sell shares of its common stock to or through Cantor, acting as sales agent or principal.
Sales of Lucid’s common stock by Cantor, if any, under the Sales Agreement may be made by any method permitted by law and deemed
to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act (the “Lucid ATM
Offering”). Lucid filed a prospectus supplement dated December 6, 2022 (the “Lucid ATM Prospectus Supplement”), for
the offer and sale of shares of its common stock having an aggregate offering price of up to $6.5 million in the Lucid ATM Offering. Effective
as of March 4, 2025, Lucid terminated the Lucid ATM Prospectus Supplement. Lucid will not make any sales of common stock in the Lucid
ATM Offering unless and until a new prospectus or prospectus supplement is filed. Other than the termination of the Lucid ATM Prospectus
Supplement, the Lucid Sales Agreement remains in full force and effect.
Lucid Diagnostics — Debt Refinancing
On November 22, 2024,
Lucid closed on the sale of $21.975 million in principal amount of 12.0% Senior Secured Convertible Notes due 2029 (collectively,
the “Lucid 2024 Convertible Notes”), in a private placement, to certain accredited investors. Lucid realized gross
proceeds of $21.95 million and, after giving effect to the repayment in full of the Lucid March 2023 Senior Convertible Note, net proceeds of $18.3 million from the sale of the Lucid 2024 Convertible Notes.
33
Results of Operations
Overview
Revenue
The Company recognized revenue from subscription revenue derived from its Veris Health Cancer Care Platform. Until
September 10, 2024, the date of deconsolidation of Lucid Diagnostics from PAVmed’s consolidated results ,
t he Company recognized revenue primarily
resulting from the delivery of patient EsoGuard test results when the Company considered the collection of such consideration to be probable
to the extent that it is unconstrained.
Cost of revenue
Until September 10, 2024, the date of deconsolidation of Lucid Diagnostics from PAVmed’s consolidated results,
the cost of revenues recognized primarily
from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of test collection kits,
royalties and the cost of services to process tests and provide results to physicians. We have incurred expenses for tests in the period
in which the activities occur, therefore, gross margin as a percentage of revenue has varied from quarter to quarter due to costs being
incurred in one period that relate to revenues recognized in a later period.
We expect that gross margin for
our services will fluctuate based on the commercialization efforts of our subsidiaries.
Sales and marketing expenses
Sales and marketing
expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities, as
well as advertising and promotion expenses. We anticipate our sales and marketing expenses to decrease in the future compared to
historical periods due to the deconsolidation of Lucid, as going forward, the expenses associated with the sales and marketing
operations for the Lucid EsoGuard test will no longer be recorded within the Company’s operating results.
General and administrative expenses
General and administrative expenses
consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs, professional fees for accounting,
tax, audit and legal services, salaries and related costs for employees involved in third-party payor reimbursement contract negotiations
and consulting fees and other expenses associated with obtaining and maintaining patents within our intellectual property portfolio.
We anticipate our general
and administrative expenses will decrease in the future compared to historical periods due to the deconsolidation of Lucid, as going
forward, the general and administrative expenses, including third-party payor reimbursement costs, incurred by Lucid will no longer
be recorded within the Company’s operating results. 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 services,
insurance premiums and investor relations costs associated with maintaining compliance as a public company for PAVmed and its
majority-owned subsidiaries.
Research and development expenses
Research and development expenses
are recognized in the period they are incurred and consist principally of internal and external expenses incurred for the development
of our products, including:
●
consulting costs for engineering design and development;
●
salary and benefit costs associated with our medical research personnel and engineering personnel;
●
costs associated with submission of regulatory filings;
●
cost of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes; and
●
product design engineering studies.
The reported research and
development activities, including our clinical trials, were focused principally on the acceleration of EsoGuard and Veris Cancer
Care Platform commercialization. Due to the deconsolidation of Lucid, going forward, the expenses in respect of the Company’s
research and development activities will include those associated with research and development activities related to the Veris Cancer Care Platform, the PMX incubator program and other products in
our pipeline as well as applicable new technologies, as resources permit.
Other Income and Expense, net
Other income and expense, net, consists
principally of changes in fair value of our convertible notes and losses on extinguishment of debt upon repayment of such convertible
notes.
Presentation of Dollar Amounts
All dollar amounts in this Management’s
Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for share and per
share amounts.
34
Results of Operations - continued
The three months ended March 31, 2025 as compared
to three months ended March 31, 2024
Revenue
In the three months ended March
31, 2025, revenue was less than $0.1 million as compared to $1.0 million for the corresponding period in the prior year. The $1.0 million
decrease principally relates to the revenue from Lucid’s EsoGuard Esophageal DNA Tests not being included in our operating results
for the three months ended March 31, 2025 as compared to the prior year, during which all three months of Lucid’s operating results
were so included.
Cost of revenue
In the three months ended March
31, 2025, cost of revenue was less than $0.1 million as compared $1.7 million for the corresponding period in the prior year. The net
decrease of $1.7 million was principally related to Lucid’s results not being included in our operating results for the three months
ended March 31, 2025 as compared to the prior year, during which all three months of Lucid’s operating results were so included.
Sales and marketing expenses
In the three months ended March
31, 2025, sales and marketing costs were approximately $0.2 million as compared to $4.3 million for the corresponding period in the prior
year. The net decrease of $4.1 million was principally related to Lucid’s results not being included in our operating results for
the three months ended March 31, 2025 as compared to the prior year, during which all three months of Lucid’s operating results
were so included.
General and administrative expenses
In the three months ended March
31, 2025, general and administrative costs were approximately $4.4 million as compared to $6.7 million for the corresponding period in
the prior year. The net decrease of $2.3 million was principally related to Lucid’s results not being included in our operating
results for the three months ended March 31, 2025 as compared to the prior year, during which all three months of Lucid’s operating
results were so included.
Research and development expenses
In the three months ended March
31, 2025, research and development costs were approximately $0.8 million as compared to $1.9 million for the corresponding period in the
prior year. The net decrease of $1.1 million was principally related to Lucid’s results not being included in our operating results
for the three months ended March 31, 2025 as compared to the prior year, during which all three months of Lucid’s operating results
were so included.
Amortization of Acquired Intangible Assets
The amortization of acquired intangible
assets was zero in the three months ended March 31, 2025, as compared to $0.4 million for the corresponding period in the prior year.
The decrease of $0.4 million in the current period was due to certain acquired intangible assets being fully amortized in February 2024.
Other Income and Expense
Change in fair value of convertible debt
In the three months ended
March 31, 2025 and March 31, 2024, the change in the fair value of our convertible notes was less than $0.1 million and $2.2 million
of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and (for
the three months ended March 31, 2024 only) the Lucid March 2023 Senior Convertible Note. The April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note were initially measured at their
issue-date estimated fair value and subsequently remeasured at estimated fair value as of each applicable reporting period date. The
Company initially recognized an aggregate of $4.3 million of fair value non-cash expense on the issue dates.
35
Results of Operations - continued
The three months ended March 31, 2025 as compared
to three months ended March 31, 2024 - continued
Other Income and Expense - continued
Loss on Debt Extinguishment
In the three months ended March
31, 2025, a debt extinguishment loss in the aggregate of less than $0.1 million was recognized in connection with our April 2022 Senior
Convertible Note and September 2022 Senior Convertible Note as discussed below.
●
In the three months ended March 31, 2025, approximately $0.2 million of principal repayments along with less than $0.1 million of interest expense thereon, were settled through the issuance of 401,303 shares of common stock of the Company, with such shares having a fair value of approximately $0.3 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). The conversions resulted in a debt extinguishment loss of less than $0.1 million in the three months ended March 31, 2025.
In comparison, in the three months
ended March 31, 2024, a debt extinguishment loss in the aggregate of approximately $0.4 million was recognized in connection with our
April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note as discussed below.
●
In the three months ended March 31, 2024, approximately $0.3 million of principal repayments along with less than $0.1 million of interest expense thereon, were settled through the issuance of 112,461 shares of common stock of the Company, with such shares having a fair value of approximately $0.3 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). In addition, the Company agreed to pay $0.2 million in cash related to acceleration floor payments on these notes related to the conversion price being below the conversion floor price specified in the notes, recorded as debt extinguishment loss. The conversions and cash paid resulted in a debt extinguishment loss of $0.2 million in the three months ended March 31, 2024.
See Note 10 , 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.
Change in fair value of Equity Method Investment
At March 31, 2025, the
fair value of the Company’s investment in Lucid was $46.6 million, with the company recognizing an unrealized gain on its
investment in Lucid of $21.0 million in the accompanying unaudited condensed consolidated statements of operations for the three
months ended March 31, 2025. The fair value of common shares of Lucid held by the Company was determined using the closing price of
Lucid’s common stock per share on March 31, 2025 of $1.49.
Deemed Dividend on Lucid Series A and
Series A-1 Convertible Preferred Stock Exchange Offer
The 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 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 to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included
as a component of net loss attributable to common stockholders, summarized as follows:
Lucid Series B Convertible Preferred Stock Issuance and Lucid Series A/A-1 Exchange Offer
March 13, 2024
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
$ 31,790
Less: Carrying value related to Lucid Series A and Series A-1 Preferred Stock
Exchanged for Lucid Series B Preferred Stock (of 24,295 shares)
(24,294 )
Deemed Dividend Charged to Accumulated Deficit
$ 7,496
36
Liquidity and Capital Resources
Our current financing strategy is
to obtain capital directly into Lucid, Veris and other subsidiaries to fund any product development or 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 for the short-term or long-term commercialization and development of our products and services.
We have financed our operations
principally through the public and private issuances of our common stock, preferred stock, common stock 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 medical device companies that devote substantially all of their efforts to the commercialization
of their initial product and services and ongoing R&D and clinical trials. We experienced net income before noncontrolling interests
of approximately $18.6 million and used approximately $1.6 million of cash in operations for the three months ended March 31, 2025. Financing
activities provided $3.1 million of cash during the three months ended March 31, 2025. We ended the quarter with cash on-hand of $2.7 million
as of March 31, 2025. We expect to continue to experience recurring losses and negative cash flows from operations, and will continue
to fund our operations with debt and/or equity financing transactions. The Company’s ability to continue operations 12 months beyond the issuance of the financial statements,
will depend upon its ability to control its operating costs within the limits of the amounts collected from its management service contracts
with its non-consolidated subsidiaries, to substantially increase its revenues from the Veris Cancer Care platform, and to raise additional
capital through various potential sources including equity or debt financings or refinancing or restructuring existing debt obligations.
These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date
the accompanying unaudited condensed consolidated financial statements are issued.
Issue of Shares of Our Common Stock
During the three months ended March 31, 2025
●
We issued 1,216,565 shares
of our common stock for net proceeds of approximately $0.8 million, after payment of 3% commissions, through our at-the-market
equity facility with Cantor. (which has since been replaced by a similar facility with Maxim Group LLC). See below for more
information.
●
We issued 401,303 shares of our common stock in satisfaction of approximately $0.2 million of principal repayments along with less than $0.1 million of interest expense thereon under the September 2022 Senior Convertible Note.
●
We issued 1,300,000 shares
of our common stock as a result of conversions of $0.5 million of shares of our Series C Preferred Stock.
●
We issued 2,574,350 shares of our common stock and pre-funded warrants to purchase 756,734 shares of our common stock, in combination with the issuance of 677,143 shares of Veris, for gross proceeds of approximately $2.37 million.
●
We issued 77,408 shares of our common stock to vendors in exchange for less than $0.1 million of agreed upon services, which is included in general and administrative operating expenses on the Company’s unaudited condensed consolidated statement of operations.
Senior Convertible Notes
Effective as of March 31,
2022, we entered into a Securities Purchase Agreement (the “SPA”) with an accredited investor, pursuant to which we agreed
to sell, and the investor agreed to purchase an aggregate of $50.0 million face value principal of Senior Secured Convertible Notes.
On April 4, 2022, we completed an initial closing under the SPA, in which we sold to the investor a Senior Secured Convertible Note with
a face value principal of $27.5 million (the “April 2022 Senior Convertible Note”). The April 2022 Senior Secured Convertible
Note had an initial contractual maturity date of April 4, 2024, which maturity date the investor agreed to extend by one year, to April
4, 2025. The April 2022 Senior Convertible Note was satisfied in full in connection with the Exchange.
On September 8, 2022, we completed
an additional closing under the SPA, in which we sold to the investor an additional Senior Secured Convertible Note with a face value
principal of $11.25 million (the “September 2022 Senior Convertible Note”). The September 2022 Senior Secured Convertible
Note had an initial contractual maturity date of September 6, 2024, which maturity date has been now extended to December 31, 2025. The
September 2022 Senior Convertible Note may be converted into or otherwise paid in shares of our common stock as described in Note 10,
Debt .
37
Liquidity and Capital Resources - continued
Under the April 2022
Senior Convertible Note (until it was satisfied in full on January 17, 2025 upon consummation of the Exchange), the September 2022
Senior Convertible Note and the SPA, we are subject to certain customary affirmative and negative covenants regarding the incurrence
of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect
of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with
affiliates, among other customary matters. We also are subject to financial covenants requiring that (i) the amount of our available
cash equal or exceed $8.0 million at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the
SPA, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior
ten trading days, not exceed 30% (the “Debt to Market Cap Ratio Test”), and (iii) that our market capitalization shall
at no time be less than $75 million (the “Market Cap Test” and, together with the Debt to Market Cap Ratio Test, the
“Financial Tests”). The holder of the September 2022 Senior Convertible Note agreed, effective as of the consummation of
the Exchange, to waive any non-compliance with the Financial Tests through December 31, 2025. Based on that separate waiver, as of March 31,
2025, the Company was in compliance with the Financial Tests.
See Note 10 , Debt , to
the Financial Statements for additional information about the SPA, the April 2022 Senior Convertible Note, and the September 2022 Senior
Convertible Note. See also Note 4, Equity Method Investment , to the Financial Statements for additional information about the
September 2022 Senior Convertible Note as it relates to the MSA.
PAVmed Inc. ATM Facility
In the three months ended March 31, 2025, the Company sold 1,216,565 shares through its at-the-market
equity facility for net proceeds of approximately $0.8 million, after payment of 3% commissions.
On April 17, 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Maxim Group
LLC, as sales agent (“Maxim”), pursuant to which the Company may offer and sell, from time to time through or to Maxim, shares
of its common stock. Under the Sales Agreement, the Company may not
issue or sell through Maxim a dollar amount of shares that would exceed $2,880,000 of shares. The Company will pay Maxim a commission
of 3.0% of the aggregate gross sales prices of the shares. The Company intends to use the net proceeds from any such sales for working
capital and general corporate purposes.
This facility replaces the “at the market”
facility PAVmed previously maintained with Cantor (which facility was on substantially similar terms).
Series C Convertible Preferred Stock
On November 15, 2024, the Company
entered into an Exchange Agreement (the “Debt Exchange Agreement”) with the holder (the “Holder”) of the April
2022 Senior Convertible Note and the September 2022 Senior Convertible Note. The Debt Exchange Agreement provided for the exchange (the
“Exchange”) of $22.3 million in principal amount of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible
Note and interest thereon for 22,347 shares of Series C Preferred Stock. On January 17, 2025, after satisfaction of all conditions to
closing, the parties consummated the Exchange.
On November 20, 2024, the Company
entered into a Securities Purchase Agreement (the “Series C Securities Purchase Agreement”) with the Holder. The Series C
Securities Purchase Agreement provided for the purchase of 2,653 shares of Series C Preferred Stock at a price of $1,000 per share, with
the purchase price to be satisfied through the cancellation of $2.6 million of certain unsecured debt obligations owed by the Company
to the Holder (the “Purchase”). On January 24, 2025, after satisfaction of all conditions to closing, the parties consummated
the Purchase.
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Liquidity and Capital Resources - continued
The Series C Preferred Stock was
issued pursuant to the PAVmed Inc. Certificate of Designation of Preferences, Rights, and Limitations of Series C Convertible Preferred
Stock (“Series C Convertible Preferred Stock Certificate of Designation”) and has a par value of $0.001 per share. Each share
of Series C Preferred Stock has a stated value of $1,000 (plus the amount of any dividends thereon that are capitalized), and entitles
the holder thereof to a preferred dividend at a rate of 7.875% per annum, payable quarterly in arrears. The Series C Preferred Stock is
entitled to vote with the holders of shares of Common Stock, voting together as one class, on all matters in which the holders of the
preferred shares are permitted to vote with the class of shares of Common Stock pursuant to applicable law, on an as-converted basis (subject
to certain limitations, including the beneficial ownership limitation described below).
The Series C Preferred Stock is
pari passu with the Series B Convertible Preferred Stock, and is senior to all of the Company’s other equity securities. Upon liquidation,
a holder of Series C Preferred Stock will be entitled to receive in cash out of the assets of the Company, before any amount would be
paid to the holders of any of shares of the Company’s common stock, but pari passu with the holders of any Series B Preferred Stock
then outstanding, an amount per share equal to the greater of (A) the sum of (i) 110% of the stated value (plus any accrued and unpaid
dividends or other amounts then payable thereon) of such share of Series C Preferred Stock then outstanding and (ii) a ratable portion
of 100% of the stated value (plus any accrued and unpaid dividends or other amounts then payable thereon) of the Series B Preferred Stock
then outstanding and (B) the amount per share such holder would receive if such holder converted such share of Series C Preferred Stock
into the Company’s common stock immediately prior to the date of such payment.
Each share of Series C Preferred
Stock, plus accrued and unpaid dividends thereon, is convertible at any time, in whole or in part, at the holder’s option, into
shares of the Company’s common stock at an initial fixed conversion price of $1.068 per share, subject to certain adjustments. On
February 18, 2025, the Company agreed to reduce temporarily, and the holder of the Series C Preferred Stock consented to reducing temporarily,
the contractual conversion price under the Series C Preferred Stock to $0.40, during the period through March 31, 2025; provided that
the aggregate amount of conversions under the Series C Preferred Stock at such conversion price during such period does not exceed 1 million
shares. Such reduction was agreed to in connection with certain waivers granted by the holder of the Series C Preferred Stock, including
waivers necessary to permit the Company and Veris to consummate the Offering (as described in Note 13, Common Stock and Common Stock
Purchase Warrants ).
At any time following the
occurrence of a Triggering Event (as defined below), a holder of shares of the Series C Preferred Stock has the right to elect to
convert shares of Series C Preferred Stock into the Company’s common stock at an alternate conversion price equal to the lower
of: (i) the fixed conversion price then in effect, and (ii) the lowest of (A) 80% of the VWAP of the Company’s common stock as
of the trading day immediately preceding the delivery or deemed delivery of the applicable notice of conversion, (B) 80% of the VWAP
of the Company’s common stock as of the trading day of the delivery or deemed delivery of the applicable notice of conversion,
and (C) 80% of the average VWAP of the Company’s common stock for each of the two trading days with the lowest VWAP of the
Company’s common stock during the ten consecutive trading day period ending and including the trading day immediately prior to
the delivery or deemed delivery of the applicable notice of conversion, but in the case of clause (ii), not less than $0.2136 (as
adjusted for stock splits, stock dividends, stock combinations, recapitalizations and similar events) (such price, the
“Alternate Conversion Price”). The term “Triggering Event” includes events that would constitute an event of default under
the September 2022 Senior Convertible Note, in addition to the failure of the Company to complete a Qualified Company Optional
Redemption (as defined below) by March 31, 2025 (the “QCOR Triggering Event”). The principal consequence of a Triggering
Event (other than a bankruptcy-related Triggering Event) is to give the holder the right to elect an alternate conversion as
described above. In addition, the occurrence of a Triggering Event (other than a QCOR Triggering Event) will result in an increase
to the dividend rate and limit the Company’s right to redeem the Series C Preferred Stock. A Triggering Event (other than a
bankruptcy-related Triggering Event) will not otherwise accelerate any financial or other obligation on the part of the Company in
respect of the Series C Preferred Stock.
If the Company grants, issues or
sells (or enters into any agreement to grant, issue or sell) or is deemed to have granted, issued or sold, any shares of common stock,
for consideration per share less than the fixed conversion price then in effect, then immediately after such issuance, the fixed conversion
price shall be reduced to an amount equal to such lower price.
The Company has the right to redeem
all, but not less than all, of the shares of Series C Preferred Stock at a redemption price equal to 132.5% of the aggregate stated value
of the Series C Preferred Stock plus all accrued and unpaid dividends and other amounts then payable thereon. The Company also has an
additional one-time right to redeem a portion of the shares of Series C Preferred Stock with an aggregate stated value of at least $5
million at the same redemption price (a “Qualified Company Optional Redemption”).
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Liquidity and Capital Resources - continued
Upon a Change of Control (as defined
in the Series C Convertible Preferred Stock Certificate of Designation), a holder of the Series C Preferred Stock has the right to require
the Company to redeem all, or any portion, of the holder’s shares of Series C Preferred Stock at a price equal to 132.5% of the
stated value of the Series C Preferred Stock (plus any accrued and unpaid dividends or other amounts then payable thereon) or, if greater,
an amount determined pursuant to the Series C Convertible Preferred Stock Certificate of Designation based on the then-current market
price or the consideration payable in the Change of Control transaction, whichever is higher.
A holder may not convert any of
the shares of Series C Preferred Stock, to the extent that, after giving effect to such conversion, such holder (together with certain
of its affiliates and other related parties) would beneficially own in excess of 9.99% of the shares of the Company’s common stock
outstanding immediately after giving effect to such conversion (the “Maximum Percentage”). The Holder may from time to time
increase or decrease the Maximum Percentage; provided that in no event could the Maximum Percentage exceed 9.99%, provided, further, that
any such increase would not be effective until the 61st day after delivery of a notice to the Company of such increase.
The Company and its subsidiaries (other than Lucid) are subject to certain customary affirmative and negative covenants
regarding the rank of the Series C Preferred Stock, the incurrence of indebtedness, the existence of liens, the repayment of indebtedness
and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the
maturity of other indebtedness, transactions with affiliates and the ability to complete stock splits, among other customary matters.
The Company also is subject to a financial covenant requiring that it maintain its cash flow on a break-even basis.
See Note 12, Preferred Stock ,
to the Financial Statements for additional information about the Series C Preferred Stock.
PAVmed/Veris Common Stock Offering
On February 18, 2025, the Company
and Veris, entered into subscription agreements (each, a “Subscription Agreement”) with certain accredited investors (collectively,
the “Investors”), pursuant to which the Company agreed to sell and the Investors agreed to purchase (the “Offering”)
2,574,350 shares of the Company’s common stock and pre-funded warrants to purchase 756,734 shares of the Company’s common
stock (the “Pre-Funded Warrants”), at a purchase price of $0.7115 per share or warrant share (as applicable). In addition,
Veris agreed to issue to each Investor approximately 0.2033 shares of Veris’ common stock for each share or warrant share (as applicable)
purchased by such Investor, for an aggregate of 677,143 shares of Veris’ common stock. On February 21, 2025, the Company consummated
the Offering, generating gross proceeds to the Company of $2.37 million. The proceeds of the offering will be used to resume development
activities related to Veris’ implantable physiological monitor and for general working capital purposes.
The Subscription Agreement contains
customary representations, warranties, covenants and indemnities of the Company and the Investors, as well as a covenant by the Company
to provide the Investors with protection against subsequent equity raises by the Company or Veris at a lower purchase price (solely to
the extent the Investors continue to hold the shares issued in the Offering), with such protection to be effected through the issuance
of additional shares of Veris’ common stock. In addition, the Company (i) agreed to solicit the affirmative vote of its stockholders
by no later than its next meeting of stockholders, which will be held no later than June 30, 2025, for approval, for the purposes of the
rules of The Nasdaq Stock Market LLC, of the issuance of all of the shares underlying the Pre-Funded Warrants, and to hold additional
meetings quarterly thereafter to the extent such approval is not obtained, (ii) granted the Investors a 100% participation right in future
offerings of equity securities of the Company or its majority-owned subsidiaries, subject to existing participation rights of the Company’s
debt holder, and (iii) agreed not to incur, and not to permit its majority-owned subsidiaries to incur, any indebtedness until August
18, 2026, subject to certain exceptions. In accordance with the Subscription Agreement, the Company also entered into a registration rights
agreement (the “Registration Rights Agreement”) with the Investors, pursuant to which the Company agreed to file a registration
statement covering the resale of the shares of the Company’s common stock issued in the Offering, including the shares underlying
the Pre-Funded Warrants.
The Pre-Funded Warrants
become exercisable upon the receipt of the stockholder approval described above, expire on February 18, 2030, and have an exercise
price of $0.001 per share, subject to adjustment as described below. The Pre-Funded Warrants may be exercised for cash, or on a
cashless basis. In the event the Pre-Funded Warrants are exercised on a cashless basis, the holder will be entitled to receive a
number of shares of the Company’s common stock equal to (x) the excess of the market value of a share of the Company’s
common stock over the exercise price, multiplied by (y) the number of shares as to which the Pre-Funded Warrant is being exercised,
divided by (z) the market value of a share of the Company’s common stock. The exercise price and number and type of securities
or other property issuable on exercise of the Pre-Funded Warrants may be adjusted in certain circumstances, including in the event
of a stock split or combination, stock dividend, or a recapitalization, reorganization, merger or similar transaction. In addition,
a holder of the Pre-Funded Warrants will be entitled to participate in rights offerings or pro rata distributions by the Company.
However, there will be no adjustment for issuances of shares of common stock at a price below the exercise price.
40
Critical Accounting Estimates
The discussion and analysis of our
financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared
in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation
of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the amounts reporting
in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and
judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on various other factors that are believed
to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Our
critical accounting estimates are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 as
filed with the SEC on March 24, 2025. There have been no material changes to our critical accounting estimates in the three
months ended March 31, 2025.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.