Financial Performance - Lucid reported record EsoGuard revenue of $1.2 million in Q3 2024, a 20% increase sequentially from Q2 2024[5] - GAAP net income attributable to common stockholders was approximately $64.3 million, or $1.44 per diluted share[9] - PAVmed's non-GAAP adjusted loss for Q3 2024 was approximately $5.4 million, or $(0.54) per common share[10] - For the three months ended September 2024, total operating expenses were $12,574, a decrease of 22.4% compared to $16,319 in the same period of 2023[15] - Net operating expenses for the nine months ended September 2024 were $34,992, down 14.9% from $41,099 in the same period of 2023[15] - Sales and marketing expenses for the three months ended September 2024 were $2,920, a decrease of 27.3% from $4,016 in the same period of 2023[15] - Research and development expenses for the three months ended September 2024 were $1,542, a decrease of 51.2% compared to $3,161 in the same period of 2023[15] Operational Highlights - A total of 2,787 commercial EsoGuard tests were performed in Q3 2024, with over 1,400 tests conducted in October alone, marking the largest three-month total in the company's history[5] - Lucid's ESOGUARD BE-1 clinical validation study has been accepted for peer-reviewed publication, completing the clinical evidence package for Medicare coverage submission[6] - PAVmed completed the deconsolidation of Lucid from its balance sheet on September 10, 2024, as part of efforts to regain compliance with Nasdaq listing standards[8] - PAVmed has until January 31, 2025, to regain compliance with Nasdaq listing standards through a proposed exchange of $25 million of convertible debt into preferred equity[8] Research and Development - Veris Health received a $1.8 million NIH grant to optimize its Cancer Care Platform in partnership with an academic cancer center[7] - The company operates in the medical device, diagnostics, and digital health sectors, with subsidiaries focused on cancer prevention and personalized cancer care[16] - Lucid Diagnostics markets the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device, the first tools for early detection of esophageal precancer[16] - Veris Health is developing an implantable physiological monitor to enhance personalized cancer care through remote patient monitoring[16] Risk Management - The company faces risks related to stock price volatility, regulatory approvals, and market acceptance of its products[18] - PAVmed and its subsidiaries are committed to advancing their products through research and development despite inherent uncertainties[18] - The company has a proactive approach to managing risks and uncertainties that may affect future operations[18]

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 ...

[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: ...

PAVmed Inc. (NASDAQ:PAVM) Q4 2023 Earnings Conference Call March 27, 2024 8:30 AM ET Company Participants Dennis McGrath - Executive Vice President & Chief Financial Officer Lishan Aklog - Chairman & Chief Executive Officer Conference Call Participants Nelson Cox - Lake Street Capital Markets, LLC. Ross Osborn - Cantor Fitzgerald Ed Woo - Ascendiant Capital Nick Sherwood - Maxim Group Operator Good morning and welcome to PAVmed's Fourth Quarter and Full Year 2023 Business Update Conference Call. [Operator I ...