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    PAVM
    Earnings call· Jun 2026(Q2 FY26)

    PAVmed Q2 FY26 earnings call PAVM

    Aug 14, 2026 Source

    Executive summary

    PAVmed Q2 FY26 — Strategic Progress Across Core Businesses

    PAVmed reported tangible progress across its core businesses in Q2 FY26, with Lucid advancing reimbursement and Veris building commercial momentum while developing its implantable device. The relaunched medical device portfolio, including PortIO and Octaris, is also moving forward, with PortIO showing promising first-in-human results and exploring a faster regulatory pathway. The company remains committed to its diversified model, aiming to enhance shareholder value through multiple opportunities despite increased R&D spend and a modest cash balance.

    Highlights

    5
    • Lucid continues to advance reimbursement and commercialization initiatives, with new positive EsoGuard coverage policy from VN Concert and progressing VA commercialization.

    • Veris is building commercial momentum with accelerating patient onboarding at Ohio State University and a large purchase order secured for ongoing patient onboarding.

    • Veris implantable physiologic monitor development is progressing well, targeting early 2027 FDA 510(k) submission, with battery life exceeding 2-year target and successful first phase animal testing.

    • PortIO first-in-human study demonstrated 100% device patency and 90% patients completing full intended implant duration, with no device-related adverse events.

    • PAVmed's non-GAAP loss decreased to $1.7 million, or $0.27 per share, compared to a higher loss in the prior year.

    Concerns

    3
    • Cash balance at June 30, 2026, was $3.8 million, not inclusive of expected warrant exercises.

    • Equity method investment balance for Lucid shares decreased to $33 million, reflecting a closing price of $1.07 on June 30, down from $1.09 at year-end and $1.15 at March 31.

    • R&D expenses increased by approximately $650,000 sequentially and $1.3 million year-over-year, largely due to Veris implantable device development.

    Guidance & targets

    5
    CategoryTargetConfidence
    Veris implantable FDA 510(k) submission
    Early 2027
    high materiality
    High
    PortIO FDA pre-submission meeting request
    Fourth quarter
    medium materiality
    High
    Veris OSU strategic engagement patient onboarding
    1,000 patients
    medium materiality
    High
    Veris implantable design freeze
    This month
    medium materiality
    High
    Octaris IRB approval
    Expected in October
    medium materiality
    High

    Operational metrics

    24
    Series D preferred stock offering
    $30 million
    February 2026

    Completed in February 2026.

    Senior secured note issued
    $15 million
    February 2026

    Issued concurrently with Series D offering to an existing investor, with a February 2029 maturity date and interest-only quarterly payments.

    Cash payment for Series C redemption
    $22.3 million
    February 2026

    Used from financing proceeds to redeem outstanding Series C convertible preferred stock.

    Series D preferred shares conversion
    Converted to common stock
    March 27, 2026

    Mandatorily converted upon shareholder approval.

    Warrants issued (EsoGuard LCD callable)
    $30 million
    Q2 FY26

    Convertible into common stock, callable by the company upon publication of a positive EsoGuard LCD.

    Warrants issued (Veris implantable clearance callable)
    $2.5 million
    Last year

    From Veris, callable upon the Veris implantable device being cleared by the FDA.

    Cash balance
    $3.8 million
    June 30, 2026

    Not inclusive of expected warrant exercises.

    Equity method investment balance (Lucid shares)
    $33 millionDown from $1.09 at year-end and $1.15 at March 31
    June 30, 2026

    Reflects 31.3 million Lucid shares mark-to-market, indicative of a closing price of $1.07 on June 30.

    PAVmed ownership of Lucid common shares
    15%
    Q2 FY26

    PAVmed remains the single largest common shareholder of Lucid Diagnostics.

    PAVmed voting interest in Lucid
    25%
    Q2 FY26

    PAVmed, together with its board and management, still has significant influence over Lucid.

    Veris revenue and Lucid management fee (combined)
    >$3 million
    Per quarter

    Combined for illustrative purposes, recorded below the line for SEC reporting.

    GAAP net loss (before NCI and preferred dividends)
    $6.6 millionVersus $12.3 million prior year loss
    Q2 FY26

    Driving force of difference is change in fair value of Lucid shares and convertible debt.

    Change in fair value of Lucid shares and convertible debt
    $3.1 millionCompared to $10.8 million in prior year quarter
    Q2 FY26

    Non-cash charge.

    GAAP net loss attributable to PAVmed
    $5.5 million
    Q2 FY26

    As reflected in the 10-Q.

    Non-GAAP loss
    $1.7 million
    Q2 FY26

    On a non-GAAP basis.

    R&D expenses (non-GAAP)
    IncreasedApproximately $650,000 sequentially and $1.3 million year-over-year
    Q2 FY26

    Largely for the Veris implantable device.

    Non-GAAP OpEx
    $6.1 millionAbove previous quarter by about $200,000 and above average of last 4 quarters by about $400,000
    Q2 FY26

    Reflects incremental Veris R&D expenditures.

    Veris OSU patient onboarding target
    1,000 patients
    Over a year

    In a registry as part of the strategic partnership with OSU.

    Veris OSU departments onboarded
    Two-thirds
    Q2 FY26

    Of planned departments, continuing to move through implementation process.

    Veris implantable battery life
    Beyond 2-year target
    Q2 FY26

    Design enhancements increased project battery life.

    PortIO device patency
    100%
    First-in-human study

    In 10 patients across multiple clinical sites.

    PortIO patients completing intended implant duration
    90%
    First-in-human study

    No device-related adverse events reported.

    Shares outstanding (including unvested RSAs)
    7.3 million
    Today

    Includes unvested RSAs.

    GAAP quarter-end outstanding shares
    6.3 million
    Q2 FY26

    Does not reflect unvested RSA amounts.

    Industry KPIs

    1
    MetricValueDetails
    Pivotal trial clinical evidence milestonesPortIO first-in-human study results published

    Deals & partnerships

    1
    Ohio State University (OSU)Strategic engagement for Veris commercialization and patient onboarding.large purchase orderover a year

    Agreement involves a commitment for OSU to enroll 1,000 commercial patients in a registry over a year, with EHR integration completed in spring.

    Risks & headwinds

    3
    Cash balance not inclusive of expected warrant exercises.Current

    $3.8 million cash at June 30

    Mitigation: Expectation of $30 million from warrants upon positive EsoGuard LCD and $2.5 million from Veris warrants upon FDA clearance.

    Decline in Lucid share value impacting equity investment balance.Q2 FY26

    Equity method investment balance of $33 million reflects Lucid shares at $1.07 on June 30, down from $1.09 at year-end and $1.15 at March 31.

    Increased R&D expenses.Q2 FY26

    Non-GAAP R&D increased by approximately $650,000 sequentially and $1.3 million year-over-year.

    Mitigation: These increases are tied mostly to R&D efforts for the Veris implantable device, indicating strategic investment.

    What to watch in Q3 FY26

    5

    Lucid Medicare coverage decision

    Next quarter
    CurrentConfident in ultimately securing positive draft coverage
    TargetPositive draft coverage

    Why it matters

    Medicare coverage is Lucid's most important near-term milestone and critical for its commercialization and future growth, impacting PAVmed's investment.

    Of course, Medicare coverage remains Lucid's most important near-term milestone, and we're confident that we will ultimately secure positive draft coverage.

    Q&A highlights

    5

    What is the anticipated news flow after the Q4 FDA meeting request for PortIO, and what is the expected regulatory pathway for 2027?

    Management clarified that while the meeting request is in Q4, the actual meeting might be in early 2027. They are exploring a 510(k) pathway for PortIO, which would be shorter and less capital-intensive than the previously anticipated De Novo pathway, especially given the successful first-in-human study.

    it appears that we may, there's no certainty yet, but that we may be able to pursue a 510(k) pathway with existing short-term intraosseous devices as a predicate.

    asked by Edward Woo · answered by Lishan Aklog

    2 min read5 chapters

    Detailed Narrative

    01

    Lucid Diagnostics Progress

    Lucid is advancing key reimbursement and commercialization initiatives, with Medicare coverage being a critical near-term milestone. A new positive EsoGuard coverage policy from VN Concert has expanded commercial coverage, with multiple health plans adopting it. VA commercialization is progressing, and continued progress across health systems and health economics is strengthening future growth. PAVmed remains Lucid's largest shareholder with approximately 15% common shares and 25% voting interest.

    02

    Veris Commercialization and Development

    The commercial phase of the Ohio State University strategic engagement is accelerating, with patient onboarding steadily increasing since EHR integration went live. A large purchase order was secured to support ongoing commercial patient onboarding for the rest of the year, and two-thirds of planned departments have been onboarded. The implantable physiologic monitor development is targeting an early 2027 FDA 510(k) submission, with battery life now exceeding the 2-year target and design freeze targeted for August 2026. Biocompatibility testing has been initiated, and the first phase of animal testing was successful.

    03

    PortIO Medical Device Portfolio

    PortIO, an implantable intraosseous port for long-term vascular access, demonstrated positive first-in-human results published in the Journal of Vascular Access. The study showed 100% device patency and 90% patients completing the full intended implant duration, with no device-related adverse events. The company expects to submit an FDA pre-submission meeting request in Q4 2026 and is exploring a 510(k) pathway instead of the longer De Novo pathway, which would shorten timelines and reduce capital requirements.

    04

    Octaris Endoscopic Imaging Platform

    Octaris is developing a multimodal endoscopic imaging platform licensed from Duke University to identify esophageal dysplasia. Probe development work at Duke is ongoing, with improved processing speeds for real-time imaging. Clinical validation work is being prepared at USC, with IRB approval expected in October 2026. An initial FDA pre-submission draft is completed, and regulatory work is focused on preparing for submission.

    05

    Financial Restructuring and Capital

    In February, PAVmed completed a $30 million Series D preferred stock offering and issued a $15 million senior secured note, using proceeds to redeem Series C preferred stock and retire convertible debt. The Series D preferred shares converted to common stock in March. The company also issued $30 million in warrants callable upon positive EsoGuard LCD and $2.5 million from Veris warrants callable upon Veris implantable device clearance.

    AI-generated summary of the company’s earnings call. Not investment advice.