PAVmed Inc. Q2 FY2026 earnings call

Lucid Diagnostics (Strategic Investment)

• Continues advancing key reimbursement and commercialization initiatives; PAVMED is the largest shareholder, positioned to benefit from future value creation
• Near-term top priority is securing positive Medicare draft coverage; management remains confident in an ultimate positive outcome
• Expanded commercial coverage via a new positive policy from Laboratory Benefit Manager Concert, with multiple Concert health plans already adopting the policy
• VA commercialization progress is on track, with further success expected as the new federal budget cycle progresses

Verus

• Commercial phase of the Ohio State University (OSU) James Cancer Hospital strategic engagement is accelerating, with steadily increasing patient onboarding
• Secured a large purchase order to support ongoing commercial patient onboarding for the remainder of 2026; approximately two-thirds of planned departments have been onboarded, with the rest in implementation
• Current focus is reducing workflow friction and driving adoption within participating departments; the partnership target is enrolling 1,000 commercial patients in the registry within 12 months of EHR integration completion (achieved in spring 2026), which management confirms remains attainable
• Implantable physiologic monitor development is on track: design enhancements have extended battery life beyond the 2-year target, design freeze is targeted for Q3 2026, long lead-time biocompatibility testing is underway, the new contract manufacturer completed a successful trial build, and first-phase animal testing was successful; FDA 510(k) submission is targeted for early 2027

Relaunched Medical Device Portfolio

• Port IO: Implantable intraosseous vascular access port; positive First-in-Human study results (100% device patency, 90% of patients completing full intended implant duration, no device-related adverse events) were published in the Journal of Vascular Access
  • PAVMED owns full global intellectual property rights to Port IO; planning to submit an FDA pre-submission meeting request in Q4 2026
  • Previously expected to require the longer, more capital-intensive de novo regulatory pathway, but published First-in-Human data opens a potential opportunity for a faster, lower-cost 510(k) pathway, which management will pursue with FDA
• Octerus (Arcturus): Multimodal endoscopic imaging platform for identifying esophageal dysplasia, licensed from Duke University with full global rights
  • Probe refinement is ongoing, with substantial improvements to processing speeds to enable real-time procedural imaging and analysis
  • IRB approval for clinical validation work at UNC is expected in October 2026; initial FDA pre-submission draft is complete, with preparations ongoing for submission
  • Clinical validation will confirm probe performance, size, and ergonomics for clinical use, and is a key step toward probe design freeze; the project remains several years away from commercialization

Financing and Balance Sheet Updates

• Completed $30 million Series D preferred stock offering in February 2026 and issued a $15 million senior secured note to an existing investor; proceeds were used to redeem all outstanding Series C convertible preferred stock and retire prior existing convertible debt
• Series D preferred stock was converted to common stock after shareholder approval in March 2026; $30 million in warrants were issued, callable by PAVMED upon publication of a positive Medicare LCD for Lucid
• Cash balance as of June 30, 2026 was $3.8 million, not including potential $30 million from warrant exercises post-positive LCD and $2.5 million from outstanding Verus-related warrants callable after FDA clearance of the Verus implantable device

PAVMED does not break out detailed financial performance by individual product/segment in this call. Aggregate financial results are reported at the company level: Q2 2026 GAAP net loss before non-controlling interest and preferred dividends was $6.6 million, compared to a $12.3 million loss in the year-ago quarter. The reduction in net loss stems from smaller non-cash fair value charges on Lucid shares and convertible debt ($3.1 million in Q2 2026 vs. $10.8 million in Q2 2025). Non-GAAP R&D expenses increased $1.3 million year-over-year and $650,000 sequentially, driven primarily by development of the Verus implantable device. Non-GAAP operating expenses totaled $6.1 million in Q2 2026, $200,000 higher than the prior quarter and $400,000 above the 4-quarter average, reflecting incremental Verus R&D spending. Combined illustrative pro forma revenue from Verus and the Lucid management service agreement exceeds $3 million per quarter. As of June 30, 2026, PAVMED holds 15% of outstanding common shares (25% voting interest) in Lucid Diagnostics, valued at a $33 million equity method investment balance marked to market at $1.07 per share.

No explicit overall financial guidance for fiscal 2026 was provided in this call. Key project-specific forward-looking milestones are:

• Port IO FDA pre-submission meeting request targeted for Q4 2026, with the meeting potentially shifting to early 2027
• Verus implantable physiologic monitor design freeze targeted for Q3 2026, with FDA 510(k) submission targeted for early 2027
• Octerus IRB approval for clinical validation at UNC expected in October 2026
• The 1,000-patient enrollment target for the OSU Verus registry remains on track to be met within the first year of launch
• Future operating expense increases are expected to be tied primarily to R&D work to advance the Verus implantable device to FDA submission and clearance

• All forward-looking statements are inherently uncertain, and actual results may differ materially from expectations due to known and unknown risks, which are detailed in PAVMED's SEC filings (Form 10-K, 10-Q, 8-K)
• There is no guarantee that Port IO will qualify for the 510(k) regulatory pathway; if the de novo pathway is required, development timelines and capital requirements will be longer and higher
• Regulatory approval for all pipeline products is not guaranteed, and timelines may shift from current targets
• The company's current cash balance ($3.8 million as of Q2 end) is limited, and future progress of pipeline projects (including parallel console development for Octerus) is dependent on access to sufficient capital
• Medicare coverage approval for Lucid is a key near-term milestone, with no certainty of a positive outcome in the near term

Q: Analyst Ed Wu asked for clarity on the Port IO FDA timeline and regulatory pathway for 2027, and confirmed if PAVMED holds global rights for both Port IO and Octerus. / A: The pre-submission meeting request will be submitted in Q4 2026, but the actual meeting may slip to early 2027. While Port IO was previously expected to follow the longer, costlier de novo pathway, published First-in-Human data may qualify it for a faster 510(k) pathway, which management will pursue with FDA. PAVMED owns full global rights to Port IO (internal IP) and holds worldwide licensing rights for Octerus from Duke. (347 characters)

Q: Analyst Jeremy Pearlman asked for patient onboarding metrics and key milestones to track commercial traction for the Verus platform at OSU. / A: PAVMED is not disclosing hard patient numbers at this time, but provided qualitative context: EHR integration completed in spring 2026, two-thirds of planned departments are now onboarded, and enrollment has accelerated in recent months. The joint target of 1,000 enrolled patients within the first year remains attainable for both PAVMED and OSU. (336 characters)

Q: Jeremy Pearlman asked what the Octerus clinical validation study will demonstrate, and what the timeline is from validation to FDA submission. / A: Prior clinical work on the prototype already confirmed the technology's core ability to detect precancerous esophageal dysplasia. Current work focuses on refining the probe for size, ergonomics, and processing speed, and clinical validation will confirm these improvements as a step toward final probe design freeze. The overall project remains several years away from FDA submission and commercialization. (374 characters)

Q: Jeremy Pearlman asked if PAVMED has a commercialization plan in place for Port IO in the event the 510(k) pathway is approved. / A: PAVMED already has a clear commercial plan outlined. The target customer base is well-defined: primarily vascular surgeons and interventional radiologists who already implant vascular access devices. Preparatory work on pricing and coding is complete, and PAVMED has multiple flexible options for launch, including building a small internal sales team or partnering with existing distributors active in the vascular access space. (366 characters)