Core Insights - PAVmed Inc. has reported significant progress in its business operations, particularly through its subsidiaries Lucid Diagnostics and Veris Health, while also addressing compliance with Nasdaq listing requirements [4][6]. Business Update Highlights - PAVmed has completed a deconsolidation and is finalizing a debt restructuring to regain Nasdaq compliance [4]. - Lucid Diagnostics is preparing to submit a clinical evidence package to seek Medicare coverage for its EsoGuard test, which has shown commercial and clinical success [4][5]. - Veris Health has completed a pilot program with The Ohio State's James Cancer Hospital and is pursuing financing for its implantable monitor development [5][12]. Financial Performance - For Q3 2024, EsoGuard revenues reached $1.2 million, marking a 20% increase from Q2 2024, with a total of 2,787 tests performed [5]. - PAVmed reported operating expenses of approximately $12.6 million for Q3 2024, with a GAAP net income of approximately $64.3 million [7][9]. - The company had cash and cash equivalents of $0.8 million as of September 30, 2024, down from $19.6 million at the end of 2023 [7]. Subsidiary Developments - Lucid Diagnostics is expanding its direct contracting initiatives and has achieved a record number of tests performed in October 2024 [5]. - Veris Health received a $1.8 million NIH grant to enhance its Cancer Care Platform and is in discussions for long-term partnerships [5][12]. Nasdaq Compliance Efforts - PAVmed has until January 31, 2025, to regain compliance with Nasdaq by increasing stockholders' equity through a proposed exchange of $25 million in convertible debt for preferred equity [6].

Product Performance - PAVmed's flagship product, EsoGuard, demonstrated a sensitivity of approximately 88% and a negative predictive value of 99% in detecting esophageal precancer in a recent study[161][162]. - Lucid received a Notice of Allowance for a patent application covering its method of using methylation of the cyclin-A1 gene for detecting esophageal precancer, a key component of EsoGuard[163]. Financial Performance - The Company recognized revenue of $1.0 million for the three months ended September 30, 2024, compared to $0.8 million for the same period in 2023, reflecting a $0.2 million increase due to higher volume of EsoGuard Esophageal DNA Tests performed[197]. - In the nine months ended September 30, 2024, revenue increased to $3.0 million from $1.4 million in the same period of the previous year, primarily driven by the EsoGuard Esophageal DNA Test[212]. - The company recognized a gain on deconsolidation of Lucid amounting to $72.3 million for the three months ended September 30, 2024, following the deconsolidation of its investment in Lucid Diagnostics[209]. Cost Management - Cost of revenue for the three months ended September 30, 2024, was approximately $1.4 million, down from $1.8 million in the prior year, primarily due to a $0.4 million decrease in manufacturing costs associated with EsoCheck devices and EsoGuard tests[198]. - Sales and marketing expenses decreased to approximately $2.9 million in the three months ended September 30, 2024, from $4.0 million in the prior year, a net decrease of $1.1 million mainly due to reduced compensation-related costs[199]. - General and administrative expenses were approximately $6.6 million for the three months ended September 30, 2024, compared to $6.9 million in the same period last year, reflecting a decrease of $0.3 million[200]. - Research and development expenses decreased to approximately $1.5 million for the three months ended September 30, 2024, from $3.2 million in the prior year, a net decrease of $1.7 million primarily due to reduced clinical trial activities[201]. Capital and Funding - The company received a $1.8 million grant from the National Institute on Minority Health and Health Disparities to optimize the Veris Cancer Care Platform for underserved cancer patients[165]. - The aggregate gross proceeds from the Lucid Series B Offering and Exchange amounted to $18.16 million, including $5.67 million from the sale of Series A-1 Preferred Stock exchanged for Series B Preferred Stock[184]. - The company issued 627,302 shares for net proceeds of approximately $1.0 million through its at-the-market equity facility with Cantor[241]. - The company entered into an "at-the-market offering" for up to $6.5 million, issuing 230,068 shares for net proceeds of approximately $0.3 million as of September 30, 2024[244]. Compliance and Regulatory - The FDA's final rule allows EsoGuard to remain under continued enforcement discretion, as it was marketed prior to May 6, 2024, and is NYS CLEP-approved[174]. - PAVmed was granted an extension until January 31, 2025, to regain compliance with Nasdaq listing standards after failing to meet the $35 million market value requirement[175][176]. - As of September 30, 2024, the company was in compliance with the financial covenants requiring available cash to equal or exceed $8.0 million and a market capitalization of no less than $75 million[234]. - As of September 30, 2024, Lucid Diagnostics was in compliance with its financial tests, including maintaining available cash of at least $5.0 million[239]. Debt Management - A debt extinguishment loss of approximately $1.4 million was recognized in connection with the April 2022, September 2022, and Lucid March 2023 Senior Convertible Notes for the three months ended September 30, 2024[205]. - The company experienced a debt extinguishment loss of approximately $2.5 million in the nine months ended September 30, 2024, related to its Senior Convertible Notes[220]. - The Company entered into a Note Amendment and Waiver, extending the maturity dates of certain Senior Convertible Notes to April 4, 2025, and September 8, 2025, and agreed to pay $2.0 million in cash to the note holder[178]. Strategic Initiatives - PAVmed launched a wholly owned incubator, PMX, to develop and commercialize existing portfolio technologies, starting with PortIO, which has a premoney valuation of $42 million[172][173]. - The company is focused on commercial expansion of the Veris Cancer Care Platform and is seeking strategic partnerships with academic oncology systems[157]. - PAVmed is exploring external innovations that meet its project selection criteria without limiting itself to any specific sector or condition[157].

Core Viewpoint - Veris Health Inc. has been awarded a $1.8 million grant from the National Institute on Minority Health and Health Disparities to optimize its Cancer Care Platform for medically underserved cancer patients [1][2]. Group 1: Grant and Research Focus - The two-year grant will fund research aimed at enhancing the Veris Cancer Care Platform to address the needs of cancer patients facing language barriers, limited access to technology, and socioeconomic disparities [1]. - The research project is titled "Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform" [1]. Group 2: Company and Technology Overview - Veris Health Inc. specializes in personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2]. - The Veris Cancer Care Platform includes features such as remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration [3]. Group 3: Strategic Implications - The NIH grant is considered important non-dilutive funding that supports Veris's commercial strategy, including regulatory clearance and the launch of its implantable physiological monitor [2]. - The grant aligns with PAVmed's long-term strategy to ensure that its subsidiaries, like Veris, are independently financeable while leveraging shared infrastructure [2].

Conference Call and Webcast at 8:30 AM Eastern Time Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. For more and for more information about PAVmed, please visit pavmed.com. For more information about Veris Health, please visit verishealth.com. The webcast will be available at the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by te ...

PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its majority-owned subsidiary, Veris Health Inc., is a digital health company whose lead product is a digital cancer care platform with physiologic data collection, symptom reporting and telehealth functions, designed to improve personalized cancer care through remote patient monitoring. Veris has also been developing an implantable physiological monitor, designe ...

Financial Data and Key Metrics Changes - The cash balance at the end of Q1 2024 was $25.5 million, with an additional $11.6 million added from Lucid financing, resulting in pro forma cash of $37.1 million [12] - The average quarterly burn rate for the trailing four quarters was $11.7 million [12] - Non-GAAP loss for Q1 2024 was $8.6 million, reflecting a $2 million sequential improvement compared to Q4 2023 and a $2.5 million improvement year-over-year [16] - Total non-GAAP operating expenses for Q1 2024 were $12.6 million, showing a $2.2 million sequential improvement and a $2.4 million improvement year-over-year [16] Business Line Data and Key Metrics Changes - Lucid's revenue for Q1 2024 was approximately $1 million, flat compared to Q4 2023 but more than double the revenue from Q1 2023 [15] - EsoGuard test volume grew by 10% quarter-on-quarter, with 2,420 tests conducted in Q1 2024 [15][7] - Veris Health is focusing on large academic cancer centers, with a memorandum of understanding signed with Ohio State University for a pilot program involving 100 patients [9][18] Market Data and Key Metrics Changes - The average allowed amount for out-of-network claims was approximately $1,800, with 75% of claims adjudicated and about 46% resulting in allowable amounts [16][8] - The total addressable market for PortIO is estimated to be upwards of $3 billion, targeting patients with poor veins and those in renal failure [11] Company Strategy and Development Direction - The company is pursuing a strategy to drive shareholder value through independently financed subsidiaries like Lucid, Veris, and PMX PortIO, leveraging shared infrastructure [4][6] - The PMX incubator was launched to raise capital for individual products, with PortIO as the first target [6][10] - The focus is on securing coverage from regional plans in biomarker legislation states to enhance market access for EsoGuard [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Lucid's progress and the upcoming MolDX presubmission meeting scheduled for July 17, 2024, to seek coverage for EsoGuard [4][8] - The company is actively seeking new independently financable technologies with large market opportunities [6] - Management highlighted the importance of capital raising efforts for advancing initiatives in Veris and the PMX incubator [12][31] Other Important Information - The company completed just under $30 million in a Series B preferred offering, strengthening its balance sheet [8] - The first-in-human study for PortIO showed excellent results with no complications [11] Q&A Session Summary Question: What are the milestones or expectations for the Ohio State MOU? - The pilot study aims to demonstrate feasibility with 100 patients, focusing on connecting patients to monitoring tools and providing data to physicians [19] Question: What does the total revenue opportunity look like for Ohio State? - The cancer center has 10,000 patients in infusion therapy, with potential recurring revenue of approximately $1,000 to $1,200 per patient per year [22] Question: How should we think about the opportunity of players like Ohio State? - There are several dozen centers on the target list, with about five in active engagement, including Ohio State [24] Question: How could strategic investments from venture arms be structured? - Investments from academic centers typically serve as a vote of confidence in the commercial potential of the partnership [25] Question: Can you discuss the fundraising environment for PortIO and PMX incubator initiatives? - The fundraising process is challenging but promising, with a focus on raising capital for PortIO first, followed by other projects like EsoCure and CarpX in parallel [31]

[PAVmed Q1 2024 Business Update and Financial Results](index=1&type=section&id=PAVmed%20Q1%202024%20Business%20Update%20and%20Financial%20Results) [Business Update](index=1&type=section&id=Business%20Update%20Highlights) PAVmed reported significant progress across its subsidiaries, focusing on driving value through Lucid, Veris, and the PMX Incubator - PAVmed's updated strategy is to drive shareholder value through its independently-financed subsidiaries (Lucid, Veris, and PMX Incubator) that utilize a shared infrastructure[4](index=4&type=chunk) [Lucid Diagnostics Highlights](index=1&type=section&id=Lucid%20Diagnostics%20Highlights) Lucid Diagnostics reported 124% YoY revenue growth, secured $29.8 million in financing, and advanced key clinical milestones | Metric | Value | Change (YoY) | | :--- | :--- | :--- | | Q1 2024 EsoGuard Revenue | $1.0 million | +124% vs Q1 2023 | - Strengthened its balance sheet by completing a **$29.8 million Series B Preferred Stock Offering**, providing runway through key reimbursement milestones[4](index=4&type=chunk)[5](index=5&type=chunk) - Secured a critical **MolDX pre-submission meeting for July 17, 2024**, to review data for technical assessment under its foundational LCD[8](index=8&type=chunk) - Published positive data from a landmark National Cancer Institute (NCI)-sponsored clinical validation study, strengthening clinical data for payor engagement[8](index=8&type=chunk) [Veris Health and PMX Incubator Highlights](index=2&type=section&id=Veris%20Health%20and%20PMX%20Incubator%20Highlights) Veris Health advanced its cancer care platform pilot while the PMX incubator actively seeks capital for its portfolio companies - Veris Health completed a Memorandum of Understanding (MOU) with The Ohio State's James Cancer Hospital to implement a pilot program for the Veris Cancer Care Platform[8](index=8&type=chunk) - Veris has a clear path to FDA clearance for its implantable monitor, which is **contingent on securing additional financing**[8](index=8&type=chunk) - The PMX incubator is **actively seeking to raise capital** for PortIO Corp. and other technologies including EsoCure and CarpX[8](index=8&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) The company reported $1.0 million in Q1 revenue, a GAAP net loss of $22.8 million, and an improved non-GAAP adjusted loss of $8.6 million [Q1 2024 Key Financial Metrics](index=2&type=section&id=Q1%202024%20Key%20Financial%20Metrics) Q1 revenue more than doubled to $1.01 million YoY, operating expenses decreased, and the cash position strengthened to $25.5 million | Financial Metric (in thousands, except per-share) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Revenue | $1,010 | $446 | | Operating Expenses | $15,046 | $20,847 | | Net Loss Attributable to Common Stockholders | $(22,788) | $(18,005) | | Net Loss per Common Share | $(2.62) | $(2.78) | | Balance Sheet Item | As of Mar 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $25.5 million | $19.6 million | [Non-GAAP Financial Measures](index=2&type=section&id=PAVmed%20Non-GAAP%20Measures) The company uses non-GAAP measures to provide transparency, reporting an improved adjusted loss of $8.6 million for Q1 2024 - Management uses non-GAAP financial measures like EBITDA and non-GAAP adjusted loss to provide greater transparency and analyze underlying operational performance by excluding certain non-cash and financing-related expenses[7](index=7&type=chunk)[8](index=8&type=chunk) | Non-GAAP Reconciliation (in thousands, except per-share) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss | $(18,512) | $(22,214) | | **Non-GAAP Adjusted (Loss)** | **$(8,638)** | **$(11,169)** | | **Non-GAAP Adjusted (Loss) per Share** | **$(0.99)** | **$(1.73)** | | Operating Expense Reconciliation (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Operating Expenses (GAAP) | $15,046 | $20,847 | | Stock-based compensation expense | $(1,882) | $(4,419) | | Depreciation and amortization expense | $(586) | $(727) | | **Net Operating Expenses (Non-GAAP)** | **$12,578** | **$14,988** | [About PAVmed and its Subsidiaries](index=5&type=section&id=About%20PAVmed%20and%20its%20Subsidiaries) PAVmed is a commercial-stage med-tech company with subsidiaries focused on esophageal cancer diagnostics and digital cancer care - PAVmed is a diversified commercial-stage medical technology company[12](index=12&type=chunk) - Its subsidiary, Lucid Diagnostics, markets the **EsoGuard Esophageal DNA Test** and **EsoCheck Esophageal Cell Collection Device** for early detection of esophageal precancer[12](index=12&type=chunk) - Its subsidiary, Veris Health, is a digital health company focused on personalized cancer care through **remote patient monitoring** with implantable sensors[12](index=12&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements subject to inherent risks and uncertainties that could affect actual results - The press release includes forward-looking statements that involve risks and uncertainties and are not historical facts[16](index=16&type=chunk) - Potential risks include **stock price volatility, economic conditions, R&D uncertainties, regulatory hurdles, and market acceptance** of products[16](index=16&type=chunk)

The webcast will take place on Tuesday, May 14, 2024, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ (Registrant's Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Exchange Act: Commission File Number: ...

Financial Data and Key Metrics Changes - Quarterly revenue increased by 33% compared to the prior quarter, indicating strong growth momentum [5][39] - Non-GAAP loss for the year was $42 million, with a quarterly average loss of $10.5 million, and the fourth quarter loss was $10.6 million, consistent with the annual average [46][44] - Cash balance at the end of the quarter was $19.6 million, reflecting a sequential burn of $11.8 million, with a 31% reduction in quarterly burn rate since the beginning of 2023 [44][38] Business Line Data and Key Metrics Changes - Lucid Diagnostics recognized revenue of $1,040,000 for the fourth quarter, representing a 33% increase over the third quarter, with test volume at 2,200 tests [39][10] - Veris Health is shifting its strategy to target large academic and regional cancer centers, which is expected to enhance its financeability [26][34] - The PMX incubator was launched to develop and commercialize existing medtech portfolio technologies, starting with PortIO, EsoCure, and CarpX [15][4] Market Data and Key Metrics Changes - The estimated market opportunity for the technologies being developed is approximately $500 million, excluding the dialysis population [16] - The reimbursement landscape is improving, with about 82% of claims adjudicated, and 46% of those resulting in an allowable amount by insurance companies [20][41] Company Strategy and Development Direction - The company is focusing on driving shareholder value through independently financed subsidiaries, similar to Lucid, leveraging shared infrastructure [24][27] - The strategy includes seeking groundbreaking independently financeable technologies with large market opportunities [28][4] - The company aims to replicate Lucid's success by engaging with large academic cancer centers and establishing long-term commercial partnerships [34][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for revenue growth through direct contracting and improved reimbursement processes [32][50] - The company is actively pursuing financing opportunities for its subsidiaries and believes it has a clear path to FDA clearance for its implantable monitor [6][35] - Management acknowledged the challenges in the reimbursement landscape but remains committed to enhancing long-term shareholder value [3][24] Other Important Information - The company has raised $18.1 million in preferred stock financing, strengthening Lucid's balance sheet [10] - The PMX incubator is a wholly owned subsidiary of PAVmed, aimed at securing financing for individual products [67][80] Q&A Session Summary Question: Can you provide additional commentary on the biomarker legislation? - Management noted that 15 states have some form of biomarker legislation, which varies by state, and they are starting to gain traction in this area [47][48] Question: How should we think about the potential revenue contribution from Veris in '24 and '25? - Management indicated that while there are longer lead times with large strategic accounts, the revenue opportunity is substantial due to the larger patient populations [58][60] Question: What is the status of the incubator and financial commitments? - The incubator is wholly owned by PAVmed, and the plan is to secure individual financing for each product without diluting PAVmed's majority stake [67][71]