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 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
results, 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.
31
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,
PMX, 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 our complete clinical evidence package in support of a request for reconsideration of the non-coverage
language in the local coverage determination, or “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, or “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.
As
part of the LCD reconsideration process, MolDx-participating Medicare Administrative Contractors convened a
Contractor Advisory Committee, or “CAC,” Meeting regarding the LCD on September 4, 2025. At the meeting, eleven experts, including physicians across multiple specialties (GI, primary care, pathology), major
society guideline co-authors (ACG, AGA (as defined below)) and industry leaders (American Foregut Society, American Society for Gastrointestinal
Endoscopy), participated in this extensive discussion of the unmet clinical need with respect to early detection of esophageal precancer
and the strength of the EsoGuard clinical validity and clinical utility data.
Russell
2000® and 3000® Indexes
On
June 27, 2025, Lucid was added to the Russell 2000® Index and the Russell 3000® Index, following the 2025 annual reconstitution
by FTSE Russell.
Hoag
Comprehensive Esophageal Precancer Testing Program Using EsoGuard
On
June 18, 2025, Lucid announced that Hoag, a nationally recognized regional healthcare delivery network, launched a comprehensive, integrated
esophageal precancer testing program using Lucid’s EsoGuard® Esophageal DNA Test. Lucid will partner with Hoag to offer EsoGuard
testing across its digestive health, primary care, and concierge medicine programs.
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.
32
Recent
Developments - continued
Business
- continued
Clinical
Study Publications
In
April 2025, Lucid’s fifth peer-reviewed clinical utility manuscript, “ Enhancing the Diagnostic Yield of EGD for Diagnosis
of Barrett’s Esophagus Through Methylated DNA Biomarker Triage ,” was published in Gastroenterology & Hepatology .
This manuscript presents clinical utility data from the ENVET-BE study, which is the second to assess the clinical utility of EsoGuard
in a real-world screening population. The ENVET-BE study analyzed 209 EsoGuard-positive patients who underwent biomarker triage and confirmatory
EGD in the 2023 calendar year, to test the hypothesis that EGDs performed on patients who first triage positive on EsoGuard have higher
diagnostic yield than screening EGDs alone. The yield of screening EGDs was estimated by literature-established disease prevalence (10.6%).
A 2.4-fold increase in BE detection compared with the performance goal was observed for the full study population. In the cohort meeting
American College of Gastroenterology (ACG) criteria for BE screening, the diagnostic yield was increased by 2.7-fold.
On
August 1, 2025, the American Journal of Gastroenterology e-published (ahead of printing) the manuscript “Nonendoscopic
Detection of Barrett’s Esophagus in Patients Without GERD Symptoms.” This investigator-initiated pilot study evaluated
EsoGuard in 120 patients without GERD symptoms, but meeting American Gastroenterological Association (AGA) BE screening criteria. Of
34 EsoGuard-positive patients, 27 underwent EGD, confirming BE in 9 cases (PPV: 33%). Of 86 EsoGuard-negative patients, 22 volunteered
for EGD, with zero BE cases (NPV: 100%). This is the first study to assess EsoGuard in this expanded risk group and informed the design
of a larger, ongoing NIH R01-funded study.
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,
which became effective as of May 26, 2025, 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.
Veris
Health and The Ohio State University Comprehensive Cancer Center Strategic Partnership
On
October 7, 2025, we announced the launch of the commercial phase of Veris’ strategic partnership with The Ohio State University
Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (“OSUCCC – James”).
Under the partnership, the Veris Cancer Care Platform is being deployed to enhance personalized cancer care for patients undergoing systemic
cancer therapy across OSUCCC – James.
Endoscopic
Esophageal Imaging Technology Letter of Intent with Duke University
On
August 26, 2025, PAVmed announced that it had executed a non-binding letter of intent with Duke University to license (on an exclusive, worldwide basis), through a
newly formed subsidiary, endoscopic imaging technology designed to identify and facilitate treatment of esophageal precancer
(dysplasia) during upper endoscopy. The multi-modality probe combines angle-resolved low coherence interferometry (a/LCI) with
optical coherence tomography (OCT) and is intended to enable real-time detection and potential immediate treatment of dysplasia
during the same endoscopic procedure.
Financing
Veris
Financing (June 2025)
On
June 23, 2025, Veris entered into subscription agreements (each, a “Veris June 2025 Subscription Agreement”) with certain
accredited investors (collectively, the “June 2025 Investors”), pursuant to which Veris agreed to sell and the June 2025
Investors agreed to purchase (the “June 2025 Offering”) 1,800,000 shares of common stock, par value $0.001 per share, of
Veris (“Veris Common Stock”) and warrants to purchase 1,800,000 shares of Veris Common Stock (“Veris Warrants”),
at a purchase price of $1.40 per share of Veris Common Stock. On the same day, Veris consummated the June 2025 Offering, generating gross
proceeds to Veris of approximately $2.5 million. The proceeds of the offering will be used to continue development activities related
to Veris’ implantable physiological monitor and for general working capital purposes.
The
Veris Warrants become exercisable six months after issuance and expire on the earlier of (i) the five-year anniversary of the initial
exercise date and (ii) the 60th day following receipt by Veris of FDA approval of its implantable physiological monitor. The Veris Warrants
have an exercise price of $1.40 per share, subject to adjustment under certain circumstances.
33
Recent
Developments - continued
Financing
- continued
PAVmed/Veris
Financing (February 2025)
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
Pre-Funded Warrants were exercised
as of June 19, 2025.
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 $2.88 million 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).
Lucid
Diagnostics — September 2025 Confidentially Marketed Public Offering
On
September 11, 2025, Lucid closed on the sale of 28,750,000 shares of its common stock, pursuant to its previously announced offering
of shares of common stock at a price of $1.00 per share (the “Lucid September CMPO”). The net proceeds from the Lucid September
CMPO, after deducting the underwriting discount and other expenses of the Lucid September CMPO, were approximately $27.0 million. Lucid
intends to use the net proceeds from the Lucid September CMPO for working capital and general corporate purposes.
Lucid
ATM Facility
On May 30, 2025, Lucid entered into a Controlled Equity Offering Agreement (also “ATM” or at-the-market”
offering) between Lucid and Maxim Group LLC for up to $25 million
of its common stock that may be offered and sold from time to time.
Lucid
Diagnostics — April 2025 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 April CMPO”). The net proceeds from the Lucid April CMPO, after
deducting the underwriting discount and other expenses of the Lucid April CMPO, were approximately $16.2 million. Lucid intends to use
the net proceeds from the Lucid April CMPO for working capital and general corporate purposes.
Lucid
Diagnostics — Registered Direct Offering
On
March 5, 2025, Lucid closed on the sale of 13,939,330 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.
34
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
The
Company’s cost of revenue from subscription revenue was derived from its Veris Health Cancer Care Platform. Until September 10,
2024, the date of deconsolidation of Lucid Diagnostics from PAVmed’s consolidated results, the cost of revenues recognized was
primarily from the delivery of patient EsoGuard test results and included 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 ending on or prior to September 30, 2024 due to the deconsolidation of Lucid as of September 10, 2024, 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 ending on or prior to September
30, 2024 due to the deconsolidation of Lucid as of September 10, 2024, 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
expenses of our research and development activities, including our clinical trials, for historical periods ending on or prior to September
30, 2024 were principally related to EsoGuard and the Veris Cancer Care Platform. Due to the deconsolidation of Lucid on September 10,
2024, the expenses in respect of the Company’s research and development activities for subsequent historical periods and future
periods 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 management fee income received from Lucid, 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 per share amounts.
35
The
three months ended September 30, 2025 as compared to three months ended September 30, 2024
Revenue
In
the three months ended September 30, 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 September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
Cost
of revenue
In
the three months ended September 30, 2025, cost of revenue costs were approximately $0.1 million, as compared to $1.4 million for the
corresponding period in the prior year. The net decrease of $1.3 million principally related to Lucid’s results not being included
in our operating results for the three months ended September 30, 2025 as compared to the prior year, during which Lucid’s operating
results were included through September 10, 2024.
Sales
and marketing expenses
In
the three months ended September 30, 2025, sales and marketing costs were approximately $0.2 million as compared to $2.9 million for
the corresponding period in the prior year. The net decrease of $2.7 million principally related to Lucid’s results not being included
in our operating results for the three months ended September 30, 2025 as compared to the prior year, during which Lucid’s operating
results were included through September 10, 2024.
General
and administrative expenses
In
the three months ended September 30, 2025, general and administrative costs were approximately $3.5 million as compared to $6.6 million
for the corresponding period in the prior year. The net decrease of $3.1 million principally related to Lucid’s results not being
included in our operating results for the three months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
Research
and development expenses
In
the three months ended September 30, 2025, research and development costs were approximately $1.1 million as compared to $1.5 million
for the corresponding period in the prior year. The net decrease of $0.4 million principally related to Lucid’s results not being
included in our operating results for the three months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was zero in the three months ended September 30, 2025, as compared to $0.1 million for the
corresponding period in the prior year. The decrease of $0.1 million in the current period was principally related to Lucid’s results not
being included in our operating results for the three months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended September 30, 2025 and 2024, the change in the fair value of our convertible notes was approximately $0.1 million
of expense and $0.2 million of income, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible
Note, and (for the period of July 1, 2024 through September 10, 2025, the date of the deconsolidation of Lucid) 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 reporting period date.
Change
in management fee income
In
the three months ended September 30, 2025, management fee income was approximately $3.2 million as compared to $0.7 million for the
corresponding period in the prior year. The reported increase of $2.5 million principally related to the fact that all of the fees
payable by Lucid under its management services agreement with the Company during the three months ended September 30, 2025 are
included in the results for such period, whereas only the portion of such fees paid in respect of the period following the September
10, 2024 deconsolidation of Lucid were included in the Company’s results for the three month period ended September
30, 2024.
36
Results
of Operations - continued
The
three months ended September 30, 2025 as compared to the three months ended September 30, 2024 - continued
Other
Income and Expense - continued
Loss
on Debt Extinguishment
The
Company did not incur debt extinguishment loss in the three months ended September 30, 2025.
In
the three months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.4 million was recognized in
connection with our April 2022 Senior Convertible Note, September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible
Note as discussed below.
● In
the three months ended September 30, 2024, approximately $0.5 million of principal repayments,
along with less than $0.1 million of interest expense thereon, were settled through the issuance
of 509,942 shares of common stock of the Company, with such shares having a fair value of
approximately $0.9 million (with such fair value measured as the respective conversion date
quoted closing price of the common stock of the Company). In addition, the Company agreed
to pay $0.7 million in cash related to acceleration floor payments on these notes related
to the conversion price being below the floor, recorded as debt extinguishment loss. The
conversions and floor acceleration payments resulted in a debt extinguishment loss of $1.1
million in the three months ended September 30, 2024.
● During
the period of July 1, 2024 through September 10, 2024, the date of the deconsolidation of Lucid, approximately $0.8 million of
principal repayments along with approximately $0.1 million of interest expense thereon, related to the Lucid March 2023 Senior
Convertible Note were settled through the issuance of 1,510,821 shares of Lucid common stock, with such shares having a fair value
of approximately $1.3 million (with such fair value measured as the quoted closing price of the common stock of Lucid on the
respective conversion date). The conversions resulted in a debt extinguishment loss of $0.3 million in the period July 1, 2024
through September 10, 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
September 30, 2025, the fair value of the Company’s investment in Lucid was $31.6 million, with the company recognizing an unrealized
loss on its investment in Lucid of $4.4 million in the accompanying unaudited condensed consolidated statements of operations for the
three months ended September 30, 2025. The fair value of common shares of Lucid held by the Company was determined using the $1.01 closing
price per share of Lucid’s common stock as of September 30, 2025, as compared to Lucid’s common stock price per share of $1.15
at June 30, 2025.
Results
of Operations - continued
The
nine months ended September 30, 2025 as compared to nine months ended September 30, 2024
Revenue
In
the nine months ended September 30, 2025, revenue was less than $0.1 million as compared to $3.0 million for the corresponding period
in the prior year. The $3.0 million decrease was principally related to the revenue from Lucid’s EsoGuard Esophageal DNA Tests
not being included in our operating results for the nine months ended September 30, 2025 as compared to the prior year, during which
Lucid’s operating results were included through September 10, 2024.
Cost
of revenue
In
the nine months ended September 30, 2025, cost of revenue was approximately $0.1 million as compared $4.8 million for the corresponding
period in the prior year. The net decrease of $4.7 million was principally related to Lucid’s results not being included in our
operating results for the nine months ended September 30, 2025 as compared to the prior year, during which Lucid’s operating results
were included through September 10, 2024.
Sales
and marketing expenses
In
the nine months ended September 30, 2025, sales and marketing costs were approximately $0.7 million as compared to $11.5 million for
the corresponding period in the prior year. The net decrease of $10.8 million was principally related to Lucid’s results not being
included in our operating results for the nine months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
General
and administrative expenses
In
the nine months ended September 30, 2025, general and administrative costs were approximately $11.6 million as compared to $20.3 million
for the corresponding period in the prior year. The net decrease of $8.7 million was principally related to Lucid’s results not
being included in our operating results for the nine months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
37
Results
of Operations - continued
The
nine months ended September 30, 2025 as compared to nine months ended September 30, 2024 - continued
Research
and development expenses
In
the nine months ended September 30, 2025, research and development costs were approximately $2.7 million as compared to $5.1 million
for the corresponding period in the prior year. The net decrease of $2.4 million was principally related to Lucid’s results not
being included in our operating results for the nine months ended September 30, 2025 as compared to the prior year, during which Lucid’s
operating results were included through September 10, 2024.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was zero in the nine months ended September 30, 2025, as compared to $0.6 million for the
corresponding period in the prior year. The decrease of $0.6 million in the current period was principally related to Lucid’s results
not being included in our operating results for the nine months ended September 30, 2025 as compared to the prior year, during which
Lucid’s operating results were included through September 10, 2024.
Other
Income and Expense
Change
in fair value of convertible debt
In
the nine months ended September 30, 2025 and September 30, 2024, the change in the fair value of our convertible notes was approximately
$0.4 million and $2.5 million of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior
Convertible Note, and (for the period of January 1, 2024 through September 10, 2025, the date of the deconsolidation of Lucid) 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.
Change
in management fee income
In
the nine months ended September 30, 2025, management fee income was approximately $9.5 million as compared to $0.7 million for the corresponding
period in the prior year. The increase of $8.8 million principally related the fact that all of the fees payable by Lucid under its management services agreement with the Company during the
nine months ended September 30, 2025 are included in the results for such period, whereas only the portion of such fees paid in respect
of the period following the September 10, 2024 deconsolidation of Lucid were included in the Company’s results for the nine month
period ended September 30, 2024.
Loss
on Debt Extinguishment
In
the nine months ended September 30, 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 nine months ended September 30, 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 nine months ended September
30, 2025.
In
comparison, in the nine months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $2.5 million was
recognized in connection with our April 2022 Senior Convertible Note, September 2022 Senior Convertible Note and the Lucid March 2023
Senior Convertible Note as discussed below.
● In
the nine months ended September 30, 2024, approximately $1.4 million of principal repayments
along with $0.1 million of interest expense thereon, were settled through the issuance of
1,084,366 shares of common stock of the Company, with such shares having a fair value of
approximately $2.0 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 $1.1 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 $1.5 million in the nine months ended September 30, 2024.
● During
the period of January 1, 2024 through September 10, 2024, the date of the deconsolidation of Lucid, approximately $2.0 million of
principal repayments along with approximately $0.8 million of interest expense thereon, related to the Lucid March 2023 Senior
Convertible Note were settled through the issuance 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 measured as the quoted closing price of the common stock of Lucid on the
respective conversion date). The conversions resulted in a debt extinguishment loss of $1.0 million in the period of January 1, 2024
through September 10, 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.
38
Results
of Operations - continued
The
nine months ended September 30, 2025 as compared to nine months ended September 30, 2024 - continued
Change
in fair value of Equity Method Investment
At
September 30, 2025, the fair value of the Company’s investment in Lucid was $31.6 million, with the company recognizing an unrealized
gain on its investment in Lucid of $6.0 million in the accompanying unaudited condensed consolidated statements of operations for the
nine months ended September 30, 2025. The fair value of common shares of Lucid held by the Company was determined using the $1.01 closing
price per share of Lucid’s common stock as of September 30, 2025, as compared to Lucid’s common stock price per share of
$0.819 at December 31, 2024.
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 $7.5 million
recognized as a deemed dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024,
with such deemed dividend included as a component of net loss attributable to common stockholders, summarized as follows:
Lucid Series B Convertible Preferred Stock Issuance and Lucid Series A/A-1 Exchange Offer ($ in thousands)
Nine Months Ended
September 30, 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
39
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 and Veris, at the subsidiary level, as well as through
management fees under our management service contract with Lucid. 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 products and services and ongoing R&D and clinical trials. We experienced net income before noncontrolling interests
of approximately $0.3 million and used approximately $3.7 million of cash in operations for the nine months ended September 30, 2025.
Financing activities provided $5.6 million of cash during the nine months ended September 30, 2025. We ended the quarter with cash on-hand
of $3.1 million as of September 30, 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 nine months ended September 30, 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 6,491,519 shares of our common stock as a result of conversions of $2.6 million 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 (which shares have been subsequently issued upon exercise of such warrants), in combination with the issuance of 677,143 shares of Veris, for gross
proceeds of approximately $2.37 million.
● We
issued 152,408 shares of our common stock to vendors in exchange for approximately $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
On
April 4, 2022 we sold to an 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 sold to the same 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. A portion of
the September 2022 Senior Convertible Note was satisfied in connection with the Exchange. The September 2022 Senior Convertible Note
is more fully described in Note 10, Debt .
40
Liquidity
and Capital Resources - continued
Under
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 to waive any non-compliance with the Financial Tests through
December 31, 2025.
See
Note 10 , Debt , to the Financial Statements for additional information about 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 nine months ended September 30, 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 $2.88
million 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.
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.
41
Liquidity
and Capital Resources - continued
The
stated value of 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. From time to time since February 18, 2025, the Company has agreed to reduce
temporarily, and the holder of the Series C Preferred Stock has consented to reducing temporarily, the contractual conversion price
under the Series C Preferred Stock to $0.40, subject to certain limitations on the number of shares of our common stock that may be
issued at such reduced conversion price. Such reductions were 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 (the foregoing temporary conversion price reductions (all of which were done as expressly permitted by the terms of
the Series C Preferred Stock) and related conversions of the Series C Preferred Stock being more fully described in Note 12, Preferred
Stock , and 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”).
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. As of September 30, 2025, the Company is in compliance with all such covenants.
See
Note 12, Preferred Stock , to the Financial Statements for additional information about the Series C Preferred Stock.
42
Liquidity
and Capital Resources - continued
PAVmed/Veris
Financing (February 2025)
On February 21, 2025, the Company and Veris, pursuant to subscription agreements,
dated as of February 18, 2025 (each, a “Subscription Agreement”) they entered into with certain accredited investors (collectively,
the “Investors”), consummated an offering (the “Offering”) of 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 issued 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. The Offering generated gross proceeds to the Company of $2.37 million. The Pre-Funded Warrants were classified
(through their date of exercise, on June 19, 2025) as equity as they were indexed to the Company’s own stock and met the criteria
for equity classification. The proceeds received were recorded in additional paid-in capital with no subsequent remeasurement.
Each 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) 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 (ii) 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. This registration statement was filed and became effective as of April 15, 2025.
Veris
Financing (June 2025)
On
June 23, 2025, Veris entered into subscription agreements (each, a “Veris June 2025 Subscription Agreement”) with certain
accredited investors (collectively, the “June 2025 Investors”), pursuant to which Veris agreed to sell and the June 2025
Investors agreed to purchase (the “June 2025 Offering”) 1,800,000 shares of common stock, par value $0.001 per share, of
Veris (“Veris Common Stock”) and warrants to purchase 1,800,000 shares of Veris Common Stock (“Veris Warrants”),
at a purchase price of $1.40 per share of Veris Common Stock. On the same day, Veris consummated the June 2025 Offering, generating gross
proceeds to Veris of approximately $2.5 million. The proceeds of the offering will be used to continue development activities related
to Veris’ implantable physiological monitor and for general working capital purposes.
The
Veris June 2025 Subscription Agreements contain customary representations, warranties, covenants and indemnities of Veris and the June
2025 Investors, as well as a covenant by Veris to provide the June 2025 Investors with protection against subsequent equity raises by
Veris at a lower valuation (solely to the extent the June 2025 Investors continue to hold the shares issued in the June 2025 Offering),
with such protection to be effected through the issuance of additional shares of Veris Common Stock. In addition, Veris granted certain
of the June 2025 Investors a 100% participation right in future offerings of equity securities by Veris, subject to existing participation
rights of the Company’s debt holder, and agreed not to incur any indebtedness until December 23, 2026, subject to certain exceptions.
In accordance with the Veris June 2025 Subscription Agreement, Veris also entered into a registration rights agreement (the “Registration
Rights Agreement”) with the June 2025 Investors, pursuant to which Veris granted the June 2025 Investors customary demand and piggyback
registration rights. The June 2025 Investors may exercise the demand registration rights only if Veris consummates a going public transaction.
The
Veris Warrants become exercisable six months after issuance and expire on the earlier of (i) the five-year anniversary of the initial
exercise date and (ii) the 60th day following receipt by Veris of FDA approval of its implantable physiological monitor. The Veris Warrants
have an exercise price of $1.40 per share, subject to adjustment as described below. The Veris Warrants may be exercised only for cash.
The exercise price and number and type of securities or other property issuable on exercise of the Veris 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, if Veris completes a subsequent equity raise at a lower valuation, the exercise price of
the Veris Warrants will be reduced to such lower valuation and the number of shares issuable on exercise of the Veris Warrants will be
increased so that the aggregate exercise price remains the same. In addition, a holder of the Veris Warrants will be entitled to participate
in rights offerings or pro rata distributions by Veris.
43
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 judgments. 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 September 30, 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.