PAVM 10-K & 10-Q changes, risk factors and insider trading
PAVmed Inc. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1624326 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “The accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note, could have a material effect on our reported financial results.”
Removed heading “We may not obtain the expected benefits of the incubator financing structure and may incur additional costs.”
Removed heading “FDA has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured at a laboratory would generally fall under the same enforcement approach as other IVDs. While we are confident that the proposed policy will not have a material impact on our business, there can be no assurance that will be the case.”
Removed heading “Our management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.”
Largest changes
“FDA has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured at a laboratory would generally fall under the same enforcement approach as other IVDs. While we are confident that the proposed policy will not have a material impact on our business, there can be no assurance that will be the case.”see in full comparison
“Most recently, on January 23, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until July 22, 2025) to regain compliance. …”see in full comparison
“The accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note, could have a material effect on our reported financial results.”see in full comparison
“In any event, if we fail to remain in compliance with the minimum bid price or any other Nasdaq listing requirement in the future, there can be no assurance that we will be able to regain compliance within the applicable grace period, in which case we could be delisted. Moreover, Nasdaq, in light of our history of noncompliance, may not allow us to leverage tools we have used in the past, such as a reverse stock split, to regain compliance.”see in full comparison
“Our management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.”see in full comparison
“We may not obtain the expected benefits of the incubator financing structure and may incur additional costs.”see in full comparison
Full comparison: every changed paragraph (52)
In our December 31, 20242025 consolidated financial statements, we have concluded and stated that our recurring losses
from operations, recurring cash flows used in operations and the requirement that we will need to raise additional capital in order to
fund our ongoing operations beyond March 2026 raise substantial doubt regarding our ability to continue as a going concern. Additionally,
our independent registered public accounting firm’s report on our consolidated financial statements includes an explanatory paragraph
expressing substantial doubt about our ability to continue as a going concern. Our plans to address this going concern risk include pursuing
further financings at PAVmed inor additionour to the recently completed Series C Preferred Stock Debt Exchange and the PAVmed and Veris Common
Stock Offering (we recently raised over $2.4 million in such offering)subsidiaries, and pursuing additional offerings of debt and/or equity securities.
The consolidated financial statements do not include any adjustments that might result from our inability to consummate such offerings
or our ability to continue as a going concern. Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient
proceeds in such offerings to pay our financial obligations as they become due. These factors raise substantial doubt about our ability
to continue as a going concern.
We
and our subsidiaries have faced significant challenges raising capital under the current market conditions, and therefore are highly dependent on the ability
of each of our subsidiaries to raise capital to fund its own and our operations.conditions.
Due
to challenging market conditions, we have found it difficult to raise capital directly into PAVmed (notwithstandingor our recent $2.37
million capital raise at PAVmed). As a result, we have become highly dependent on the ability of eachany of our subsidiaries to raise capital
to fund their own operations.subsidiaries. There is no assurance that we or our subsidiaries will be able to raise capital as needed to fund itsour or their future operations,
or that any of us or them will be able to do so on commercially reasonable terms. Accordingly, the failure of us or any of our subsidiaries to raise
the capital we or it needs to fund its operations, could have a material adverse effect on us and/or the portion of our business related to such subsidiary.
In our recent offering of Series D Preferred Stock, we issued warrants exercisable for an aggregate purchase price of $30 million. There can be no assurance that all or any of such warrants will be exercised. To the extent the warrants are not exercised, we will need to find alternate sources of capital, which may not be available on commercially reasonable terms.
In
addition, because of the challenges PAVmed has faced in terms of raising capital, we are highly dependent on our subsidiaries, including
Lucid Diagnostics, as resources for funding our operations (notably, PAVmed mayhas electrecently elected that Lucid Diagnostics satisfy its obligations
under our management services agreement through cash payment and, under the terms of our outstanding convertible debt, we are required
to elect to receive such payments in cash). In addition, under the terms of our outstanding convertible debt, if the price per share
of our common stock is less than the $1.068 conversion price of our Series C Preferred Stock, we are required to reserve 50% of all management
services agreement fees we receive, unless the holder of our debt waives such requirement (which it has through March 31, 2025). If Lucid
Diagnostics is unable to continue to make any such cash payments we elect to receive, or if we are so required to reserve 50% of the
management services agreement fees we receive, or if Lucid Diagnostics determines to terminate the management services agreement (i.e.,
because it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself, it may
not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.
If
we are successful in raising capital directly or through our subsidiaries, such transaction would dilute our shareholders' interests in PAVmed, and/or PAVmed’s (and accordingly, our shareholders’)
interest in such subsidiaries, which in turn could reduce the proceeds available to PAVmed (and its shareholders) upon any disposition
or liquidation of PAVmed or any such subsidiaries. In addition, the terms of any such investment into our subsidiaries could contain covenants and
other restrictions that impair PAVmed’s control over such subsidiaries or the manner in which such subsidiaries operate.
On January 21, 2026, the Company received a notification letter from the Listing Qualifications department of Nasdaq stating that the Company had regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market. As previously reported, on January 23, 2025, the Company had received a notification letter from the Listing Qualifications department stating that, for the prior 30 consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). Subsequently, Nasdaq determined that, from January 2, 2026 to January 19, 2026, the closing bid price of the Company’s common stock had been at $1 per share or greater. Accordingly, the Company had regained compliance with Nasdaq Listing Rule 5550(a)(2).
In any event, if we fail to remain in compliance with the minimum bid price or any other Nasdaq listing requirement in the future, there can be no assurance that we will be able to regain compliance within the applicable grace period, in which case we could be delisted. Moreover, Nasdaq, in light of our history of noncompliance, may not allow us to leverage tools we have used in the past, such as a reverse stock split, to regain compliance.
The
Company currently is (and from time to time in the recent past, the Company has been) out of compliance with the standards and requirements
for continued listing on Nasdaq.
Most recently,
on January 23, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30
consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum
of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter
stated that the Company would be afforded 180 calendar days (until July 22, 2025) to regain compliance. In order to regain compliance,
the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days. The notification
letter also stated that, in the event the Company does not regain compliance within the initial 180-day period, the Company may be eligible
for an additional 180-day period. If the Company is not eligible for the additional 180-day period, or if it appears to the Nasdaq staff
that the Company will not be able to cure the deficiency, the Nasdaq Listing Qualifications Department will provide notice after the
end of the initial 180-day period that the Company’s securities will be subject to delisting. In any event, there can be no assurance
that the Company will be able to regain compliance by the current or any extended deadline, in which case, the Company’s stock
would be delisted.
Our subsidiary Lucid may issue shares of its common and/or preferred stock
in the future, and the holder of our convertible debt may exchange such debt for our shares of Lucid common stock.future. These events could
reduce the percentage equity interest of PAVmed in Lucid.Lucid, and thereby reduce its influence over matters subject to a shareholder vote
and otherwise adversely affect your investment in PAVmed.
As
PAVmed beneficially owned approximately 27.5% as of theDecember date31, hereof,2025 ifand the27.1% maximum amountas of March 23, 2026 of our outstanding common stock (with such percentage inclusive of shares of our common stock underlying Lucid’sgranted outstandingbut convertibleunvested securitiesrestricted werestock issued
(includingawards and shares ofover Lucidwhich commonPAVmed stockotherwise issuedhas asbeen agranted dividendvoting thereon),control by the percentageholder of shares of Lucid common stock held by PAVmed
would be reduced from approximately 34% to approximately 18%.thereof). This reduced percentage would be further diluted in the
event of future convertible debt or stock issuances by Lucid or by issuances under Lucid’s long-term incentive plan and
employee stock purchase plan. While PAVmed may still hashave a significant ownership interest in Lucid in such event, the more its interest
in Lucid is diluted, the less influence it will have on matters requiring shareholder approval, including the election of
Lucid’s board of directors.
In addition, so long as any shares
of our Series C Preferred Stock remain outstanding, the holder of the September 2022 Senior Convertible Note may elect to exchange any
or all of such debt for the shares of Lucid Diagnostics we own at an exchange price of $0.85 per share, as of the date hereof, which would further reduce our ownership from the 18% to 13% (and as of March 20, 2025, the
closing bid price of a share of Lucid Diagnostics’ common stock was $1.57).
If PAVmed’s ownership interest (in terms of voting power) in Lucid declines, depending on the extent of such decline, PAVmed may no longer be deemed to primarily control Lucid for the purposes of the Investment Company Act of 1940, as amended (the “Investment Company Act”). In such event, the securities of Lucid held by PAVmed would no longer be excluded under certain tests used to determine whether PAVmed is deemed to be an investment company under the Investment Company Act. PAVmed still could claim that it otherwise does not meet the definition of an investment company, or that it qualifies for an exemption therefrom, but there can be no assurance that any such claim would be tenable or any such exemption would be available.
If PAVmed was deemed to be an investment company, it could seek to rely on the temporary exemption for transient
investment companies. If it was not able to rely on such exemption, or the period for relief under such exemption expired and PAVmed was
still deemed to be an investment company, PAVmed could be forced to register as an investment company and comply with substantive requirements
under the Investment Company Act, including limitations on its ability to borrow, limitations on its capital structure, restrictions on
acquisitions of interests in associated companies, prohibitions on transactions with affiliates, restrictions on specific investments,
and compliance with reporting, record keeping, voting, proxy disclosure and other rules and regulations. If PAVmed were forced to comply
with the Investment Company Act, its operations would significantly change, and it would be prevented from successfully executing its
business strategy. If PAVmed was forced to sell assetsor distribute to its shareholders its interest in Lucid to avoid regulation under the Investment Company Act, it also could be prevented
from successfully executing its business strategy.
We
and our subsidiaries may be required to repay or redeem, or to pay interest on, the September 2022 Senior Convertible2026 Note or any future
permitted indebtedness incurred by us or our subsidiaries, in cash. DespiteFor ourexample, right to pay the interest and principal balance of the
September 2022 Senior Convertible Note by issuing shares of our common stock, we may be required to repay such indebtedness in cash,
ifwhile we do not meethave certainto customarymake equityany conditionsprincipal (includinginstallment payments on under the 2026 Note prior to maturity in 2029, under the terms of such debt, we will owe annual cash interest payments of approximately $2.25 million, and are required to maintain a minimum pricecash andbalance volumeof thresholds)$5 ormillion, inwhich certainminimum otherbalance circumstances.
Forincreases example,to $8 million as of July 1, 2026. Moreover, we may be required to repay the outstanding principal balance and accrued but unpaid interest, along with a premium, upon
the occurrence of certain changes of control or an event of default.
Our
ability to make payments of the principal of, to pay interest on, or to redeem our indebtedness in cash, and to meet our minimum cash balance obligations, depends on our future performance,
which is subject to economic, financial, competitive and other factors beyond our control. We have not generated material revenue from
operations to date, and our business may not generate cash flow from operations in the future sufficient to service our indebtedness
and make necessary capital expenditures. In addition, the September 2022 Senior Convertible2026 Note contains, and any future indebtedness
may contain, restrictive covenants, including financial covenants. These payment obligations and covenants could have important consequences
on our business. In particular, they could:
The
debt service requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants
contained in the governing documents for any such indebtedness, could intensify these risks. For example, fromwe timemay tofall time since
the dateout of issuancecompliance such restrictive covenants. There is no assurance that the holder of the September2026 2022 Convertible Note, the Company was not in compliance with certain financial covenants
thereunder. The holders of such notes agreed to waive any such non-compliance through December 31, 2025. There is also no assurance
that the holdersNote will be willing to waive any future non-compliance with this or any other provision under the September 2022 Senior
Convertible Note,non-compliance, or if they are willing to do so, if the terms on which they are so willing will be acceptable to us.
If
we are unable to make the required cash payments, there could be a default under one or more of the instruments governing our indebtedness.
Any such default or acceleration may further result in an event of default and acceleration of our other indebtedness. In such event,
or if a default otherwise occurs under our indebtedness, including as a result of our failure to comply with the financial or other covenants
contained therein, the holders of our indebtedness could require us to immediately repay the outstanding principal and interest on such
indebtedness in cash, in some cases subject to a premium. Furthermore, the holdersholder of our secured indebtedness could foreclose on their
its security interestsinterest in our assets.
The
terms of our Series C Preferred Stock also include covenants substantially similar to those in the documentation that governs our
outstanding indebtedness, and accordingly, those covenants (and our failure to be in compliance with the same) could have the same
important consequences on our business.
The
accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note, could
have a material effect on our reported financial results.
In
May 2008, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position No. APB 14-1, Accounting for Convertible
Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial Cash Settlement), which has subsequently been codified
as Accounting Standards Codification 470-20, Debt with Conversion and Other Options, or “ASC 470-20.” Under ASC 470-20, an
entity must separately account for the liability and equity components of the convertible debt instruments (such as the September 2022
Senior Convertible Note) that may be settled entirely or partially in cash in a manner that reflects the issuer’s economic interest
cost. The effect of ASC 470-20 on the accounting for the September 2022 Senior Convertible Note is that the equity component is required
to be included in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheet and the value
of the equity component would be treated as original issue discount for purposes of accounting for the debt component of the September
2022 Senior Convertible Note. As a result, we will be required to record a greater amount of non-cash interest expense in current periods
presented as a result of the amortization of the discounted carrying value of the September 2022 Senior Convertible Note to their face
amount over the term of the September 2022 Senior Convertible Note. We will report lower net income in our financial results because
ASC 470-20 will require interest to include both the current period’s amortization of the debt discount and the instrument’s
coupon interest, which could adversely affect our reported or future financial results, and the market price of our common stock.
In
addition, under certain circumstances, convertible debt instruments (such as the September 2022 Senior Convertible Note) that may be
settled entirely or partially in cash are currently accounted for utilizing the treasury stock method, the effect of which is that the
shares issuable upon conversion of the September 2022 Senior Convertible Note are not included in the calculation of diluted earnings
per share except to the extent that the conversion value of the September 2022 Senior Convertible Note exceeds their principal amount.
Under the treasury stock method, for diluted earnings per share purposes, the transaction is accounted for as if the number of shares
of our common stock that would be necessary to settle such excess, if we elected to settle such excess in shares, are issued. We cannot
be sure that the accounting standards in the future will continue to permit the use of the treasury stock method. If we are unable to
use the treasury stock method in accounting for the shares issuable upon conversion of the September 2022 Senior Convertible Note, then
our diluted earnings per share would be adversely affected.
Notwithstanding
that we were recently able to raise capital directly into PAVmed and that we believe we have sufficient access to capital (including
under our management services agreement with Lucid Diagnostics) to maintain our current level of business activity, we intend to raise
additional capital, likelydirectly or through each of our subsidiaries, to support any business growth.growth and our long term business operations. Because we have not in the near term generated substantial
revenue or cash flow to date, unless we are able to generate substantial revenue in the near-term (which we do not anticipate being able
to do), we will require additional funds to:
If we do not have, or are not able to obtain, sufficient funds, we may have to delay product acquisition or development initiatives or license to third parties the rights to commercialize products or technologies we would otherwise seek to market. We also may have to reduce marketing, customer support or other resources devoted to our products.
To grow our business as planned, we must expand our acquisition, research and development sales, marketing and customer support capabilities, which will involve developing and administering our commercial infrastructure and/or collaborative commercial arrangements and partnerships. We must also maintain satisfactory arrangements for the manufacture and distribution of our tests and other products.
Initially,
Currently, we willdo not directly manufacture our products and will rely on third parties to do so for us. If our manufacturing and distribution agreements
are not satisfactory, we may not be able to develop or commercialize products as planned. In addition, we may not be able to contract
with third parties to manufacture our products in an economical manner. Furthermore, third-party manufacturers may not adequately perform
their obligations, may delay clinical development or submission of products for regulatory approval or otherwise may impair our competitive
position. We may not be able to enter into or maintain relationships with manufacturers that comply with good manufacturing practices.
If a product manufacturer fails to comply with good manufacturing practices, we could experience significant time delays or we may be
unable to commercialize or continue to market the products. Changes in our manufacturers could require costly new product testing and
facility compliance inspections. In the United States, failure to comply with good manufacturing practices or other applicable legal
requirements can lead to federal seizure of violative products, injunctive actions brought by the federal government, and potential criminal
and civil liability on the part of a company and its officers and employees. Because of these and other factors, we may not be able to
replace our manufacturing capacity quickly or efficiently in the event that our manufacturers are unable to manufacture our products
at one or more of their facilities. As a result, the sales and marketing of our products could be delayed or we could be forced to develop
our own manufacturing capacity, which could require substantial additional funds and personnel and compliance with extensive regulations.
We may expend considerable funds and other resources on the development of new and existing products without any guarantee these products will be successful. For example, we recently hired a Chief Business Officer of Medical Devices and we expect to make meaningful investments in the technologies that comprise the business segment he will oversee (e.g., PortIO, and the technology we license from Duke University that is comprised of a multi-modality probe combining a/LCI with OCT). If we are not successful in bringing one or more of these or any other products to market, whether because we fail to address marketplace demand, fail to develop viable technologies or otherwise, we may not generate any revenues and our results of operations could be seriously harmed.
We
may not obtain the expected benefits of the incubator financing structure and may incur additional costs.
We
believe that the incubator financing structure will provide us with future benefits. These expected benefits are not guaranteed and may
not be obtained if market conditions or other circumstances prevent us from taking advantage of the investment, financing and structuring
flexibility we expect to gain as a result of the incubator financing structure (to date, we have been unsuccessful in our efforts to
raise capital through this structure). If we fail to achieve some or all of the expected benefits of our incubator financing structure,
it could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows.
The implementation of our incubator financing structure also may result in substantial direct costs, which are expected to consist primarily
of attorneys’ fees and accountants’ fees, as well as loss of certain efficiencies. Moreover, the incubator financing structure
may not fully insulate the liabilities of our subsidiaries from each other or from PAVmed, especially if we do not observe the requisite
corporate formalities or adequately capitalize PAVmed or its subsidiaries.
EsoGuard’s
PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with
Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs
technical assessment of molecular diagnostic tests on behalf of itself and other MACs. Although CMS granted EsoGuard final Medicare payment
determination of $1,938.01, effective January 1, 2021, we have not received a final Medicare local coverage determination from MolDx.
Most recently, in May 2023, a final Local Coverage Determination (“LCD”) L39256, entitled “Molecular Testing for
Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” became effective on the CMS website by MAC Palmetto
GBA. (A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our
CLIA laboratory in Lake Forest, CA.CA). The LCD outlines criteria for future coverage that MolDX expects upper gastrointestinal precancer
and cancer molecular diagnostic tests to meet. These criteria include active GERD with at least two risk factors, as well as evidence
of analytic validity, clinical validity, and clinical utility. Although the LCD indicated that it found that no currently existing test
has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based on the
pertinent literature and society recommendations.” In November 2024, we announced that we submitted to MolDx our 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. However, there can be no assurance that MolDx will determine that EsoGuard meets the criteria for coverage as specified in
the LCD. If Lucid is not granted coverage, or if a determination is substantially delayed, that could have a material adverse effect
on Lucid’s ability to commercialize EsoGuard.
In November 2024, we announced that we submitted to MolDx our 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. As part of the LCD reconsideration process, MolDx-participating Medicare Administrative Contractors convened a 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) 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. However, there can be no assurance that MolDx will determine that we meet the criteria for coverage as specified in the LCD. If we are not granted coverage, or if a determination is substantially delayed, that could have a material adverse effect on our ability to commercialize EsoGuard.
If
we are unable to obtain favorable decisions from third-party payors, including CMS and managed care organizations, approving reimbursement
at adequate levels for our EsoGuard test and EsoCheck device, and any other product or service we may develop, or if coverage is later
revoked or reimbursement levels are reduced, our commercial success will be compromised, our ability to raise capital may be restricted
and our revenues would be significantly limited. Healthcare providers may be reluctant to prescribe our products if they believe that
reimbursement for the test will not be available for a significant number of their patients.
FDA
has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured at
a laboratory would generally fall under the same enforcement approach as other IVDs. While we are confident that the proposed policy
will not have a material impact on our business, there can be no assurance that will be the case.
On
May 6, 2024, the FDA issued a final rule aimed at helping to ensure the safety and effectiveness of LDTs. The rule amends the FDA’s
regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer
of the IVD is a laboratory. Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight
of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as
well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
The
phaseout policy contains the following five stages:
The
FDA also intends to exercise enforcement discretion and generally not enforce some or all applicable requirements for certain categories
of IVDs manufactured by a laboratory. The categories of enforcement discretion that are applicable to EsoGuard are summarized in the
table below.
As
EsoGuard was marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for
compliance with Stages 4 and 5. We will be implementing compliance with MDR requirements, correction and removal reporting
requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6,
2025. Gap analysis has been completed and we are expecting our compliance activities to be completed for Stages 2 and 3 before the FDA’s expected timeframes in 2026 and 2027, respectively. We are
confident that the proposed final rule will not have a commercial impact as the Company already has a robust QS management platform
for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by
the FDA. However, there can be no assurance that Lucid will be able to successfully transition the platform to fulfill the QS
requirements, as required by FDA, and its failure to do so could have a material impact on Lucid’s ability to commercialize
EsoGuard and on our business as a whole.
Our
principal ongoing clinical trials are those that relate to EsoGuard. For a summary of the status and certain information concerning the
results of those trials, please see above under “Background and Overview—EsoGuard and EsoCheck—Clinical Utility
and Clinical Trials”.
Once
regulatory approval has been obtained, the approved product and its manufacturer are subject to continual review by the FDA or non-U.S.
regulatory authorities. Our regulatory approval for any products we may develop may be subject to limitations on the indicated uses for
which the product may be marketed. Future approvals may contain requirements for potentially costly post-marketing follow-up studies
to monitor the safety and efficacy of the approved product. In addition, we are subject to extensive and ongoing regulatory requirements
by the FDA and other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion
and recordkeeping for our products. In addition, we are required to comply with cGMP regulations regarding the manufacture of any products
we may develop, which include requirements related to quality control and quality assurance as well as the corresponding maintenance
of records and documentation. Further, regulatory authorities must approve these manufacturing facilities before they can be used to
manufacture drug products, and these facilities are subject to continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with cGMP regulations. If we or a third party discover previously unknown problems with a product, such as
adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory
authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market
or suspension of manufacturing.
We may issue shares of our common and /or preferred stock in the future (including shares of our common stock upon exercise of the outstanding Series D warrants) which could reduce the equity interest of our stockholders and might cause a change in control of our ownership.
The
holder of our convertible debt and the holder of our Seriesdebt C Preferred Stock havehas certain rights with respect to the shares in Lucid
Diagnostics that we own, which may have a material impact on the return on any investment in shares of our common stock.
Under
the terms of the September2026 2022 Senior Convertible Note andNote, the Series C Preferred Stock, the holdersholder thereof havehas certain rights that
may impact the extent to which our shareholders would participate in any disposition of our shares of Lucid Diagnostics. For example,
any change of control of Lucid Diagnostics or any other disposition by us of our shares of Lucid Diagnostics requires the consent of
such holders. In addition, so long as any shares of our Series C Preferred Stock remain outstanding, the holder of the September 2022
Senior Convertible Note may elect to exchange any or all of such debt for the shares of Lucid Diagnostics we own at an exchange price
of $0.85 per share (and as of March 20, 2025, the closing bid price of a share of Lucid Diagnostics’ common stock was $1.57).
Further, upon any change of control of Lucid Diagnostics (so long as our shares of Lucid Diagnostics represent all or anysubstantially other transaction involving the dispositionall of our sharesassets) inrequires the consent of such holder. Further, upon any such change of control of Lucid Diagnostics,
we are obligated to use the proceeds thereof to redeem the September 2022 Senior Convertible2026 Note (for a redemption price equal to the outstanding principal balance of the Note plus any interest that would accrue thereon through maturity)
at a(not premiumto exceed two years of 132.5%,interest). and,Such moreover,redemption we may elect to use a portion of the proceeds of such transaction to redeem our outstanding Series
C Preferred Stock (i.e., in lieu of allowing such holder to exchange the debt for our Lucid shares or to convert the Series C Preferred
Stock into shares of our common stock, in each case at a more favorable price), whichpayment in turn would substantially reduce the proceeds
available to holders of our common stock as a result of such transaction. Any or all of these events could have a material impact on
the return on any investment in shares of our common stock.
Our
management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.
As
of December 31, 2024, our management and their affiliates collectively owned approximately 8% of our issued and outstanding shares
of common stock. Accordingly, these individuals would have considerable influence regarding the outcome of any transaction that requires
stockholder approval. Furthermore, our Board of Directors is and will be divided into three classes, each of which will generally serve
for a term of three years with only one class of directors being elected in each year. As a consequence of our “staggered”
Board of Directors, only a minority of the Board of Directors will be considered for election in any given year and our initial stockholders,
because of their ownership position, will have considerable influence regarding the outcome.
As
of DecemberMarch 31,27, 2024,2026, there were 11,198,9776,383,089 shares of our common stock issued and outstanding, and, as of such date, we also had issued
and outstanding:
(i) stock
options to purchase 1,065,31984,315 shares of our common stock at a weighted average exercise price of $25.50$197.02 per share, with such total number
inclusive of both stock options granted under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan (“PAVmed 2014 Equity Plan”);
247,109 1,500,879 shares of our common stock reserved for issuance, but not subject to outstanding stock-based equity awards under the PAVmed 2014
Equity Plan; and 139,86315,774 shares of our common stock reserved for issuance under the PAVmed Inc. Employee Stock Purchase Plan (“PAVmed
ESPP”) (ii) 11,937,450
Series Z Warrants, representing the right to purchase 795,830 shares of the Company’s common stock at an exercise price of $23.48
per whole share; and (iii) 1,412,865
shares of Series B Convertible Preferred Stock, convertible into 94,191 shares of our common stock.
(ivii) 25,000
1,559,991 shares of Series CB Convertible Preferred Stock, convertible into 23,408,2403,467 shares of our common stock; and (assumingiii) 30,000 Series D Preferred Warrants, representing the right to purchase 4,615,393 shares of Seriesthe CCompany’s Preferredcommon Stock
were converted in full on such datestock at thean fixed conversionexercise price of $1.068$6.50 per share).whole share.
In
addition, the September 2022 Senior Convertible Note has an outstanding principal amount, as of March 20, 2025, of $6.6 million,
which is convertible into 6,160,664 shares of our common stock (assuming the September 2022 Senior Convertible Note was
converted in full on such date at the fixed conversion price of $1.068 per share). The number of shares of common stock to be issued
under the September 2022 Senior Convertible Note may be substantially greater than the estimate set forth in this paragraph, if we
pay the interest and the installments of principal in shares of our common stock, because in such cases (and in certain other cases
as described elsewhere in this Annual Report on Form 10-K) the number of shares issued will be determined based on the then current
market price (but in any event not more than fixed conversion price per share or less than a floor price specified in the notes), or
if we agree to voluntarily reduce the conversion price under the note (for example, in consideration of any waiver or consent we
might need). We cannot predict the market price of our common stock at any future date, and therefore, we are unable to accurately
forecast or predict the total amount of shares that ultimately may be issued under these notes. In addition, the number of shares
issued under this note may be substantially greater if we voluntarily lower the conversion price, which we are permitted to do
pursuant to the terms thereof.
Similarly,
the number of shares of common stock to be issued upon conversion of the shares of Series C Preferred Stock may be substantially
greater than the estimate set forth in clause (iv) above, if a “triggering event” occurs, because in such event, the
number of shares issued will be determined based on the then current market price (but in any event not more than the fixed
conversion price per share or less than a floor price specified in the certificate of designations for the Series C Preferred
Stock), or if we agree to voluntarily reduce the conversion price for the Series C Preferred Stock (for example, in consideration of
any waiver or consent we might need).
On
February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common
stock held by the Company. On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock dividend of
approximately 38 shares of Lucid common stock for approximately every 1003 shares of PAVmed common stock they held as of such date. However, our Board
of Directors has no intention to make any further distributions of shares of Lucid common stock or other assets at this time.
Provisions
in our corporate charter and our bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that
stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.
These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby
depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders
to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors.
Because our Board of Directors is responsible for appointing the members of our management team, these provisions could in turn affect
any attempt by our stockholders to replace current members of our management team. Among others, these provisions include the following.
Management's Discussion & Analysis (MD&A)
New heading “Medical Device Developments”
New heading “Endoscopic Imaging Technology”
New heading “Department of Veteran Affairs (Lucid)”
New heading “Real-World Experience Data (Lucid)”
New heading “Strategic Commercial Partnership (Veris)”
New heading “Russell 2000® and 3000® Indexes (Lucid)”
New heading “NCCN Clinical Practice Guidelines Update (Lucid)”
New heading “Series D Offering and Recapitalization; Series D Conversion”
New heading “Reverse Stock Split; Reduction in Authorized Shares”
New heading “NASDAQ Compliance”
New heading “Veris Financing (June 2025)”
New heading “PAVmed/Veris Financing (February 2025)”
New heading “The year ended December 31, 2025 as compared to year ended December 31, 2024”
New heading “The year ended December 31, 2025 as compared to year ended December 31, 2024 - continued”
New heading “PAVmed/Veris Financing (February 2025)”
New heading “Veris Financing (June 2025)”
New heading “Recent Accounting Standards”
Removed heading “NCCN Clinical Practice Guidelines Update”
Removed heading “CWRU NIH Grant Related to EsoGuard and EsoCheck”
Removed heading “Veris NIH Grant”
Removed heading “Changes to Board Composition”
Removed heading “Intercompany Agreements with Lucid”
Removed heading “Veris Cancer Care Platform”
Removed heading “PAVmed/Veris Common Stock Offering”
Removed heading “Nasdaq Compliance with Stockholders’ Equity Continued Listing Standard”
Removed heading “Nasdaq Notice of Noncompliance with the Minimum Bid Price Requirement”
Removed heading “2014 Long-Term Incentive Plan”
Removed heading “Authorized Share Increase”
Removed heading “Lucid Diagnostics — Debt Refinancing”
Removed heading “Cost of revenue”
Removed heading “Cost of revenue”
Removed heading “The year ended December 31, 2024 as compared to year ended December 31, 2023 - continued”
Removed heading “Other Income and Expense - continued”
Removed heading “Loss on Issue and Offering Costs - Senior Secured Convertible Note”
Removed heading “The year ended December 31, 2024 as compared to year ended December 31, 2023 - continued”
Removed heading “Securities Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022”
Removed heading “Lucid Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023”
Removed heading “Lucid Diagnostics Inc. - Committed Equity Facility and ATM Facility”
Largest changes
“Under the Debt Exchange Agreement discussed above, effective as of consummation on the Exchange as of January 17, 2025, the Company also agreed to certain amendments and modifications to the September 2022 Convertible Note, including, without limitation, that the conversion price thereunder was reset to $1.068; that the maturity date was extended to December 31, 2025; that any change of control or disposition by the Company of its shares of Lucid common stock would require the prior written consent of the Required Holders (as defined in the September 2022 Convertible Note); …”see in full comparison
“On January 23, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until July 22, 2025) to regain compliance. …”see in full comparison
“Securities Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022”see in full comparison
“Lucid Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023”see in full comparison
“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. …”see in full comparison
“The year ended December 31, 2024 as compared to year ended December 31, 2023 - continued”see in full comparison
Full comparison: every changed paragraph (172)
PAVmed is a diversified commercial-stage life sciences company operating in the medical device, diagnostics, and digital health sectors. It operates through multiple independently financed subsidiaries under a shared services model. The Company’s strategy is to advance and commercialize innovative healthcare technologies through its subsidiaries while maintaining flexibility to structure financing at either the PAVmed level or within its subsidiaries.
The Company’s subsidiaries include Lucid Diagnostics, a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, of which the Company is the largest voting stockholder, and Veris Health, a majority-owned digital health company focused on improving personalized cancer care during treatment and throughout survivorship through digital health tools and the development of an implantable physiological monitor designed to interface with the Veris Cancer Care Platform.
PAVmed continues to support the commercial expansion of EsoGuard through Lucid Diagnostics and to pursue strategic partnerships to expand adoption of the Veris Cancer Care Platform. In addition, PAVmed is developing a medical device portfolio, including its PortIO implantable intraosseous vascular access device and recently licensed endoscopic imaging technology from Duke University. The Company continues to evaluate opportunities to expand its portfolio through internal development and external licensing.
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.
EsoGuard
Medicare Coverage (Lucid)
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.
As part of the LCD reconsideration process, MolDx-participating Medicare Administrative Contractors convened a 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) 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.
Medical Device Developments
In March 2026, PAVmed hired industry-veteran Joseph Virgilio to serve as PAVmed's Chief Business Officer for Medical Devices. Prior to joining PAVmed, Mr. Virgilio held leadership roles at a diverse group of medical device companies over the course of his 25-year career.
In this capacity, Mr. Virgilio will oversee the development and commercialization of PAVmed's current and future medical device portfolio. Such portfolio includes at this time the Company's PortIO implantable intraosseous vascular access device, which is being developed as a means for infusing fluids, medications and other substances directly into the bone marrow cavity and from there into the central venous circulation. The portfolio also includes technology licensed by PAVmed from Duke University that involves a multi-modality probe combining ("a/LCI") with optical coherence tomography ("OCT"), as more fully described below.
Endoscopic Imaging Technology
In February 2026, PAVmed entered into a definitive license agreement with Duke University, through a newly formed subsidiary, for the exclusive worldwide rights to technology involving a multi-modality probe combining angle-resolved low coherence interferometry (“a/LCI”) with optical coherence tomography (“OCT”). This technology may be used to identify and facilitate treatment of advanced esophageal precancer (“dysplasia”) during upper endoscopy. The platform is designed to integrate with standard endoscopic procedures and may enable real-time assessment of esophageal tissue to guide clinical decision-making during the procedure. Additionally, as the diagnosis of dysplasia currently relies on biopsy-based approaches, which require tissue sampling and subsequent pathological review, this technology may provide a complementary approach to streamline the evaluation and treatment process.
Department of Veteran Affairs (Lucid)
In January 2026, Lucid announced that it has been awarded a contract by the U.S. Department of Veterans Affairs for EsoGuard expanding access to esophageal precancer testing across the nation's largest integrated healthcare system, which serves more than nine million enrolled veterans annually. The contract is issued under the VA Federal Supply Schedule and includes pre-negotiated pricing for EsoGuard that matches the established Medicare payment rate determined by the Centers for Medicare & Medicaid Services (CMS), enabling VA hospitals and healthcare facilities nationwide to access EsoGuard through a single, national VA procurement framework.
Real-World Experience Data (Lucid)
In December 2025, Lucid announced results from an 18-month real-world experience evaluating EsoGuard and EsoCheck in approximately 12,000 patients. The analysis demonstrated high technical success rates, rapid procedure times, and appropriate physician utilization in routine clinical practice, consistent with previously reported clinical studies. The data are currently under peer review for publication.
Strategic Commercial Partnership (Veris)
In October 2025, we announced that Veris and The Ohio State University Comprehensive Cancer Center - The James Cancer Hospital and Solove Research Institute ("OSUCCC – The James"), a National Cancer Institute-Designated Comprehensive Cancer Center, launched the commercial phase of their long-term strategic partnership agreement. This transition to a commercial phase follows successful completion of a pilot program conducted at the OSUCCC -- The James.
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.
Clinical Study Publications (Lucid)
In September 2025, a case series published in Gastroenterology & Hepatology highlighted four real-world cases in which EsoGuard facilitated the timely detection of either high-grade dysplasia ("HGD") or intramucosal carcinoma ("IMC"; T1a esophageal adenocarcinoma). In all four cases, the patients had no prior history of EGD, including one individual who had previously declined multiple EGD referrals. Following positive in-office EsoGuard results, each patient proceeded with endoscopic evaluation, which led to successful identification and eradication of disease in all cases. This case series underscores both the clinical utility of EsoGuard in detecting early-stage neoplasia and the ease with which the test can be integrated into standard office workflows to enhance screening uptake and early disease detection.
Russell 2000® and 3000® Indexes (Lucid)
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.
NCCN Clinical Practice Guidelines Update (Lucid)
In March 2025, Lucid announced that a recent update to the 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.
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.
On November 7, 2024, Lucid announced that its manuscript for its multi-center ESOGUARD BE-1 study has been accepted
for publication in The American Journal of Gastroenterology, the official journal of the American College of Gastroenterology (ACG). This
is the fourth publication presenting clinical validation data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to demonstrate
its performance in an intended-use screening population. Consistent with previous studies, EsoGuard showed high sensitivity and negative
predictive value in detecting esophageal precancer (Barrett’s Esophagus or BE). The prospective, multi-center study presented data from
a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed
by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively.
Specificity and positive predictive value were approximately 81% and 30%, respectively. No serious adverse events were reported.
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.
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, covers EsoGuard in patients who meet established criteria for esophageal precancer testing consistent with professional society guidelines.
Veris
NIH Grant
On
October 10, 2024, PAVmed announced that Veris has been awarded a $1.8 million grant from the National Institute on Minority Health and
Health Disparities (NIMHD), an institute of the National Institutes of Health (NIH). The two-year grant will fund research to optimize
and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients, in partnership with an academic cancer
center. The research project, “Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer
Care Platform,” will focus on patients facing language barriers, limited access to technology, and socioeconomic disparities.
Changes
to Board Composition
Effective
as of September 10, 2024, James L. Cox, M.D., and Joan B. Harvey resigned from the Company’s board of directors. Neither Dr. Cox’s
nor Ms. Harvey’s resignation was due to any disagreement with the Company on any matter relating to its operations, policies or
practices.
Also
effective as of September 10, 2024, the Company’s board of directors appointed Sundeep Agrawal, M.D. as a Class B director. Prior
to being appointed to the Company’s board of directors, Dr. Agrawal had entered into a strategic advisory agreement with the Company
to provide certain M&A advisory services. Such agreement will remains in effect. Pursuant to the
agreement, Dr. Agrawal will receive a monthly consulting fee of $3 thousand. The agreement is terminable by the Company on 10 days’
written notice. Except for the foregoing, Dr. Agrawal has not engaged in any transactions with the Company that are required to be reported
pursuant to Item 404(a) of Regulation S-K.
Intercompany
Agreements with Lucid
On
August 6, 2024, the Company and Lucid entered into a ninth amendment to the management services agreement between them (“MSA”)
to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July 1, 2024. In addition,
under the terms of our convertible debt (as amended as of January 17, 2025), we are required to elect that these payments be made in cash.
Veris
Cancer Care Platform
On
June 13, 2024, we announced that Veris and a National Cancer Institute-Designated Comprehensive Cancer Center launched a pilot program
and has enrolled the first patients from such center in such program on the Veris Cancer Care Platform.
Series D Offering and Recapitalization; Series D Conversion
On February 3, 2026, PAVmed entered into subscription agreements with certain accredited investors and, pursuant to and concurrently with the execution of the Subscription Agreements, sold to the Investors, for an aggregate purchase price of $30.0 million, (i) 30,000 shares of the Company’s newly designated Series D Preferred Stock, and (ii) warrants (the “Series D Preferred Stock Warrant”) to purchase an additional 30,000 shares of Series D Preferred Stock, with each investor receiving 100 shares of Series D Preferred Stock and a warrant to purchase 100 shares of Series D Preferred Stock for each $100 thousand of its investment (the “Offering”). The initial conversion price of the Series D Preferred Stock is $6.50 per share, subject to adjustment in the event of stock splits, stock dividends, and similar transactions.
Concurrently with the Offering, the Company redeemed all 16,962 shares of Series C Preferred Stock outstanding and refinanced all $8.4 million in principal and interest of its 2022 Note, in consideration of a cash payment to the holder thereof (the “Holder”) of approximately $22.3 million (which was made using proceeds from the sale of the Series D Preferred Stock), and the issuance to the Holder of an amended and restated 2022 Note (the “2026 Note”) with a principal amount of $15.0 million.
The net proceeds of the Offering, taking into account the cash payments made in respect of the redemption of the Series C Preferred Stock and the 2022 Note, were approximately $7.6 million.
On March 27, 2026, PAVmed's shareholders approved the conversion of the Series D Preferred Stock into shares of our common stock. Promptly following such approval, 100% of the Series D Preferred Stock was converted in full into 4,615,393 shares of our common stock.
Notwithstanding the conversion of the Series D Preferred Stock into shares of our common stock, the Series D Preferred Stock Warrants remain outstanding. Upon the publication by Molecular Diagnostic Services Program (MolDx) of a draft local coverage determination that EsoGuard will be covered by Medicare, the Series D Preferred Stock Warrant will be callable by the Company at a price of $0.001 per warrant share. The Company may send written notice to the holders after such condition has been satisfied and, after receipt of such notice, the holders will have 30 days to exercise the warrants. If such warrants are exercised in full, the Company will receive an additional $30 million in cash proceeds in consideration for the issuance of an additional 4,615,393 shares of our common stock.
Reverse Stock Split; Reduction in Authorized Shares
At a special meeting of the Company’s stockholders held on December 5, 2025, the Company’s stockholders approved a Reverse Split at a specific ratio, ranging from 1-for-10 to 1-for-30, to be determined by the Board in its sole discretion, as well as the Reduction in Authorized Common Stock from 250,000,000 shares to 25,000,000 shares.
Following the special meeting, the Board approved a ratio of 1-for-30 for the Reverse Split. On December 30, 2025, in order to effect the Reverse Split and the Reduction in Authorized Common Stock, the Company filed a certificate of amendment to its certificate of incorporation, as amended, pursuant to which the Reverse Split and the Reduction in Authorized Common Stock became effective on Friday, January 2, 2026.
The purpose of the Reverse Split was to help the Company regain compliance with the $1 minimum bid requirement for continued listing on the Capital Market of the Nasdaq, which it did, as discussed below. All shares and per share amounts set forth herein give effect to the reverse stock split.
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 (“Nasdaq”), 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 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 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.
NASDAQ Compliance
The
lead investor in the Offering also agreed with the Company that it would, with respect to the election of the Company’s directors, vote
its shares of the Company’s common stock (including those exercisable in respect of their Pre-Funded Warrants) in accordance with
the Company’s board’s recommendations.
Nasdaq Compliance with Stockholders’
Equity Continued Listing Standard
What changed in the latest 10-Q
Risk Factors
We could not find a separate Risk Factors item in the latest 10-Q. Some companies leave it out of quarterly reports; see the annual 10-K risk factors and the original filing. Open the filing on SEC.gov.
Management's Discussion & Analysis (MD&A)
New heading “Change in fair value of Equity Method Investment”
New heading “The six months ended June 30, 2026 as compared to six months ended June 30, 2025”
New heading “The six months ended June 30, 2026 as compared to the six months ended June 30, 2025 - continued”
New heading “Other Income and Expense”
New heading “Change in fair value of convertible debt”
New heading “Change in management fee income”
Removed heading “Real-World Experience Data (Lucid)”
Removed heading “Reverse Stock Split; Reduction in Authorized Shares”
Removed heading “NASDAQ Compliance”
Removed heading “Cost of revenue”
Removed heading “Sales and marketing expenses”
Removed heading “General and administrative expenses”
Removed heading “Research and development expenses”
Removed heading “Cost of revenue”
Removed heading “Sales and marketing expenses”
Removed heading “General and administrative expenses”
Removed heading “Research and development expenses”
Largest changes
On February 3, 2026, we consummated a series of financing-related transactions (the “February 2026 Financing”), in connection with which we refinanced the September 2022 Senior Secured Convertible Note by issuing to the holder thereof an amended and restated September 2022 Senior Secured Convertible Note with a face value principal of $15.0 million (the “2026 Note”). The 2026 Note has an initial contractual maturity date of February 3, 2029. Effective as of June 30, 2026, the Company and the Holder agreed to amend the Minimum Cash Covenant (as defined above) under the 2026 Note to provide that the amount of the Company’s available cash will equal or exceed $2.5 million as of each Measurement Date (as defined above) (or, for any Measurement Date on or after September 15, 2026, $8.0 million), provided that the amendment will be deemed null and void unless by August 25, 2026, the Company is able to deposit $5 million in a blocked account formed for the benefit of the Holder. Accordingly, the Company was in compliance with all covenants under the 2026 Note as of June 30, 2026.see in full comparison
“The six months ended June 30, 2026 as compared to the six months ended June 30, 2025 - continued”see in full comparison
“The six months ended June 30, 2026 as compared to six months ended June 30, 2025”see in full comparison
Full comparison: every changed paragraph (63)
The Company’s subsidiaries include Lucid Diagnostics, which is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, and of which the Company is the largest voting stockholder,stockholder at approximately 25%, and Veris Health, which is a majority-owned digital health company focused on improving personalized cancer care during treatment and throughout survivorship through digital health tools and the development of an implantable physiological monitor designed to interface with the Veris Cancer Care Platform.
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,determination or (“LCD,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,Gastroenterology or (“ACG,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,Committee or (“CAC,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, AGAAmerican (asGastroenterological defined belowAssociation)) 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.
Real-World Experience Data (Lucid)
In December 2025, Lucid announced results from an 18-month real-world experience evaluating EsoGuard and EsoCheck in approximately 12,000 patients. The analysis demonstrated high technical success rates, rapid procedure times, and appropriate physician utilization in routine clinical practice, consistent with previously reported clinical studies. The data are currently under peer review for publication.
Reverse Stock Split; Reduction in Authorized Shares
At a special meeting of the Company’s stockholders held on December 5, 2025, the Company’s stockholders approved a reverse stock split of the Company’s outstanding shares of common stock (the “Reverse Split”) at a specific ratio, ranging from 1-for-10 to 1-for-30, to be determined by the Company’s board of directors (the “Board”) in its sole discretion, as well as an associated reduction in the number of shares of common stock the Company is authorized to issue (the “Reduction in Authorized Common Stock”) from 250,000,000 shares to 25,000,000 shares.
Following the special meeting, the Board approved a ratio of 1-for-30 for the Reverse Split. On December 30, 2025, in order to effect the Reverse Split and the Reduction in Authorized Common Stock, the Company filed a certificate of amendment to its certificate of incorporation, as amended, pursuant to which the Reverse Split and the Reduction in Authorized Common Stock became effective on Friday, January 2, 2026.
The purpose of the Reverse Split was to help the Company regain compliance with the $1 minimum bid requirement for continued listing on the Capital Market of the Nasdaq Stock Market LLC ("Nasdaq"), which it did, as discussed below. All shares and per share amounts set forth herein give effect to the reverse stock split.
NASDAQ Compliance
On January 21, 2026, the Company received a notification letter from the Nasdaq Listing Qualifications department stating that the Company had regained compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market.
As previously reported, on January 23, 2025, the Company had received a notification letter from the Listing Qualifications department stating that, for the prior 30 consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). Subsequently, Nasdaq determined that, from January 2, 2026 to January 19, 2026, the closing bid price of the Company’s common stock had been at $1 per share or greater. Accordingly, the Company had regained compliance with Nasdaq Listing Rule 5550(a)(2).
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 in an “at the market" facility. 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. Subsequent to June 30, 2026, through August 13, 2026, the Company sold 675,679 shares through the ATM equity facility for net proceeds of approximately $2.8 million, after payment of 3% commissions, or approximately $0.1 million. Following these sales, the Company has fully utilized the capacity available under the ATM equity facility, and no additional shares remain available for issuance thereunder.
On May 30, 2025, Lucid entered into an “at-the-market offering” (“Lucid ATM”) for up to $25.0 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Maxim Group LLC. In the threesix months ended MarchJune 31,30, 2026, Lucid sold 4,161,747 shares through the Lucid ATM equity facility for net proceeds of approximately $5.3 million, after payment of 3% commissions, ofor approximately $0.2 million.
Cost of revenue
The Company’s cost of revenue from subscription revenue was derived from its Veris Health Cancer Care Platform. We have incurred expenses associated with the platform 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.occur.
We expect that our gross margin for our services willmay fluctuate based on the commercialization efforts of our subsidiaries.
Sales and marketing expenses
General and administrative expenses
General and administrative expenses includesinclude 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.company.
Research and development expenses
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.
The three months ended MarchJune 31,30, 2026 as compared to three months ended MarchJune 31,30, 2025
In the three months ended MarchJune 31,30, 2026, revenue was relatively flat, at less than $0.1 million, as compared to the corresponding period in the prior year.
Cost of revenue
In the three months ended MarchJune 31,30, 2026, the cost of revenue costs werewas approximately $0.1 million, as compared to less than $0.1 million for the corresponding period in the prior year. The net increase of $0.1 million principally related to the compensation costs resulting from Veris' commercialization efforts.
Sales and marketing expenses
In the three months ended MarchJune 31,30, 2026, sales and marketing costs remained relatively flat, at approximately $0.2 million, as compared to the corresponding period in the prior year.
General and administrative expenses
In the three months ended MarchJune 31,30, 2026, general and administrative costs were approximately $6.4$4.7 millionmillion, as compared to $4.4$3.7 million for the corresponding period in the prior year. The net increase of $2.0$1.0 million principally related to:
Research and development expenses
In the three months ended MarchJune 31,30, 2026, research and development costs were approximately $1.4$2.1 millionmillion, as compared to $0.8 million for the corresponding period in the prior year. The net increase of $0.6$1.3 million principally related to the research and development costs incurred at Veris for the implantable physiological monitor.
The three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 - continued
In the three months ended MarchJune 31,30, 2026 and 2025, the change in the fair value of our convertible notes was approximately $3.4$0.6 million of income and $0.1$0.2 million of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note,Note and the 2026 Note.Note (as defined in Note 9, Debt, to the Financial Statements). The April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the 2026 Note,Note were initially measured at their issue-date estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date.
In the three months ended MarchJune 31,30, 2026, management fee income remained flat at $3.2 millionmillion, as compared to the corresponding period in the prior year.
Change in fair value of Equity Method Investment
At June 30, 2026, the fair value of the Company’s investment in Lucid was $33.5 million, with the Company recognizing an unrealized loss on its investment in Lucid of $2.5 million in the accompanying unaudited condensed consolidated statements of operations for the three months ended June 30, 2026. The fair value of common shares of Lucid held by the Company was determined using the $1.07 closing price per share of Lucid’s common stock as of June 30, 2026, as compared to Lucid’s common stock price per share of $1.15 at March 31, 2026.
At June 30, 2025, the fair value of the Company’s investment in Lucid was $36.0 million, with the Company recognizing an unrealized loss on its investment in Lucid of $10.6 million in the accompanying unaudited condensed consolidated statements of operations for the three months ended June 30, 2025. The fair value of common shares of Lucid held by the Company was determined using the $1.15 closing price per share of Lucid’s common stock as of June 30, 2025, as compared to Lucid’s common stock price per share of $1.49 at March 31, 2025.
The six months ended June 30, 2026 as compared to six months ended June 30, 2025
In the six months ended June 30, 2026, revenue was relatively flat, at less than $0.1 million, as compared to the corresponding period in the prior year.
In the six months ended June 30, 2026, the cost of revenue was approximately $0.2 million, as compared to $0.1 million for the corresponding period in the prior year. The net increase of $0.1 million principally related to the compensation costs resulting from Veris' commercialization efforts.
In the six months ended June 30, 2026, sales and marketing costs were approximately $0.4 million, as compared to $0.5 million for the corresponding period in the prior year. The net decrease of $0.1 million principally related to a decrease in third-party consulting costs.
In the six months ended June 30, 2026, general and administrative costs were approximately $11.0 million, as compared to $8.1 million for the corresponding period in the prior year. The net increase of $2.9 million principally related to:
In the six months ended June 30, 2026, research and development costs were approximately $3.5 million, as compared to $1.6 million for the corresponding period in the prior year. The net increase of $1.9 million principally related to:
Results of Operations - continued
The six months ended June 30, 2026 as compared to the six months ended June 30, 2025 - continued
Other Income and Expense
Change in fair value of convertible debt
In the six months ended June 30, 2026 and 2025, the change in the fair value of our convertible notes was approximately $2.8 million of income and $0.2 million of expense, respectively, related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the 2026 Note (as defined in Note 9, Debt, to the Financial Statements). The April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and 2026 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 six months ended June 30, 2026, management fee income remained flat at $6.3 million, as compared to the corresponding period in the prior year.
In the threesix months ended MarchJune 31,30, 2026, a debt extinguishment loss in the aggregate of approximately $3.4 million was recognized in connection with the redemption of the September 2022 Senior Convertible Note, as discussed below.
In the threesix months ended MarchJune 31,30, 2025, a debt extinguishment loss in the aggregate of approximately $0.1 million was recognized in connection with our April 2022 Senior Convertible Note and September 2022 Senior Convertible Note, as discussed below.
At MarchJune 31,30, 2026, the fair value of the Company’s investment in Lucid was $36.0$33.5 million, with the companyCompany recognizing an unrealized gainloss on its investment in Lucid of $1.9$0.6 million in the accompanying unaudited condensed consolidated statements of operations for the threesix months ended MarchJune 31,30, 2026. The fair value of common shares of Lucid held by the Company was determined using the $1.15$1.07 closing price per share of Lucid’s common stock as of MarchJune 31,30, 2026, as compared to Lucid’s common stock price per share of $1.09 at December 31, 2025.
At June 30, 2025, the fair value of the Company’s investment in Lucid was $36.0 million, with the Company recognizing an unrealized gain on its investment in Lucid of $10.4 million in the accompanying unaudited condensed consolidated statements of operations for the six months ended June 30, 2025. The fair value of common shares of Lucid held by the Company was determined using the $1.15 closing price per share of Lucid’s common stock as of June 30, 2025, as compared to Lucid’s common stock price per share of $0.819 at December 31, 2024.
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 loss before noncontrolling interests of approximately $1.1$7.7 million and used approximately $2.6$5.3 million of cash in operations for the threesix months ended MarchJune 31,30, 2026. Financing activities provided $7.6 million of cash during the threesix months ended MarchJune 31,30, 2026. We ended the quarter with cash on-hand of $6.5$3.8 million as of MarchJune 31,30, 2026. 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.
During the threesix months ended MarchJune 31,30, 2026
On September 8, 20222022, 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 was extended to December 31, 2026. A portion of the September 2022 Senior Convertible Note was satisfied in connection with the Exchange, and subsequently was satisfied in fullrefinanced in connection with the February 2026 Financing (as defined below).
On February 3, 2026, we consummated a series of financing-related transactions (the “February 2026 Financing”), in connection with which we refinanced the September 2022 Senior Secured Convertible Note by issuing to the holder thereof an amended and restated September 2022 Senior Secured Convertible Note with a face value principal of $15.0 million (the “2026 Note”). The 2026 Note has an initial contractual maturity date of February 3, 2029. Effective as of June 30, 2026, the Company and the Holder agreed to amend the Minimum Cash Covenant (as defined above) under the 2026 Note to provide that the amount of the Company’s available cash will equal or exceed $2.5 million as of each Measurement Date (as defined above) (or, for any Measurement Date on or after September 15, 2026, $8.0 million), provided that the amendment will be deemed null and void unless by August 25, 2026, the Company is able to deposit $5 million in a blocked account formed for the benefit of the Holder. Accordingly, the Company was in compliance with all covenants under the 2026 Note as of June 30, 2026.
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 in an “at the market" facility. 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. Subsequent to June 30, 2026, through August 13, 2026, the Company sold 675,679 shares through the ATM equity facility for net proceeds of approximately $2.8 million, after payment of 3% commissions, or approximately $0.1 million. Following these sales, the Company has fully utilized the capacity available under the ATM equity facility, and no additional shares remain available for issuance thereunder.
PAVM insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-04-02 | Lee Victoria Tou-Ho |
Grant/award | 70,000 | — | — |
Well-known investors holding PAVM (13F)
None of the 59 investors we track reported a position in their latest 13F.