PAVmed(PAVM)
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PAVmed (PAVM) Upgraded to Strong Buy: Here's Why
ZACKS· 2025-10-10 17:01
Core Viewpoint - PAVmed Inc. (PAVM) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [3][5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, thus affecting stock prices [3]. Company Performance and Outlook - The upgrade for PAVmed reflects an improvement in the company's underlying business, suggesting that investor sentiment regarding this trend could drive the stock price higher [4]. - Over the past three months, the Zacks Consensus Estimate for PAVmed has increased by 41.1%, indicating a positive shift in earnings expectations [7]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [6]. - PAVmed's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting strong potential for market-beating returns in the near term [9].
PAVmed Subsidiary, Veris Health and The Ohio State University Comprehensive Cancer Center Launch Commercial Phase of Strategic Partnership Agreement
Prnewswire· 2025-10-07 12:01
Core Insights - PAVmed Inc. and its subsidiary Veris Health have entered the commercial phase of their partnership with The Ohio State University Comprehensive Cancer Center to enhance personalized cancer care through the Veris Cancer Care Platform [1][2] Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors [5] - Veris Health, a majority-owned subsidiary of PAVmed, focuses on digital health and has developed a digital cancer care platform aimed at improving personalized cancer care through remote patient monitoring [5] Partnership Details - The partnership with OSUCCC – James aims to expand the clinical deployment of the Veris platform, which includes launching a clinical registry for patients enrolled in the program [2] - The Veris Cancer Care Platform features remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration [2][3] Platform Features - Patients enrolled in the Veris platform receive a VerisBox™ containing connected health care devices that transmit physiological data to a cloud-based clinician portal [3] - A patient portal allows symptom reporting and health tracking via a smartphone app, which also enables family members to participate in the patient's care journey [3] Future Developments - Veris is developing an implantable physiological monitor to be used alongside a vascular access port, enhancing the platform's clinical and commercial value by providing remote data independent of patient compliance [3]
PAVmed Signs Letter of Intent to License Groundbreaking Endoscopic Esophageal Imaging Technology
Prnewswire· 2025-08-26 12:01
Core Viewpoint - PAVmed Inc. has formed a new subsidiary to license advanced endoscopic imaging technology from Duke University, aimed at improving the diagnosis and treatment of esophageal dysplasia, which is a precursor to esophageal cancer [1][8]. Group 1: Technology and Collaboration - The technology involves a multi-modality probe that combines angle-resolved low coherence interferometry (a/LCI) with optical coherence tomography (OCT), potentially offering a more efficient alternative to traditional biopsies [1]. - PAVmed will collaborate with Lucid Diagnostics as a strategic and equity partner in this initiative [1]. - The technology is expected to enable real-time detection and immediate treatment of dysplasia during endoscopic procedures, addressing the limitations of traditional biopsy methods [3][6]. Group 2: Clinical Implications - Dr. Nicholas Shaheen highlighted that this technology could transform the diagnosis and treatment of esophageal precancer, improving patient outcomes and healthcare resource utilization [2]. - Prior clinical research indicated that the a/LCI technology demonstrated 100% sensitivity and 88% overall accuracy in detecting precancerous changes during live examinations [6]. - The integrated a/LCI and OCT technology has shown comparable sensitivity and improved specificity for detecting dysplasia, with results pending peer-reviewed publication [6]. Group 3: Company Strategy and Market Potential - PAVmed's CEO, Dr. Lishan Aklog, expressed optimism about the commercialization of this technology, anticipating that widespread adoption will significantly increase the diagnosis of esophageal precancer [7]. - The venture aligns with PAVmed's structure of independently financeable subsidiaries and builds on successful partnerships with academic medical centers [8]. - The exclusive worldwide license agreement for the a/LCI + OCT technology is contingent upon the execution of a definitive license agreement [8].
PAVmed(PAVM) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
[Introduction](index=1&type=section&id=Introduction) This section introduces PAVmed Inc., its subsidiaries, and outlines the Q2 2025 conference call details [Company Overview](index=1&type=section&id=Company%20Overview) PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, with key subsidiaries Lucid Diagnostics Inc. and Veris Health Inc - PAVmed Inc. (NASDAQ: PAVM) is a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors[2](index=2&type=chunk) - Key subsidiaries include Lucid Diagnostics Inc. (NASDAQ: LUCD) and Veris Health Inc[2](index=2&type=chunk) [Conference Call and Webcast](index=1&type=section&id=Conference%20Call%20and%20Webcast) A conference call and webcast were held on August 14, 2025, at 8:30 AM EDT to discuss the business update and financial results. A replay will be available for 30 days on the company's investor relations website - Conference call and webcast held on Thursday, August 14, 2025, at 8:30 AM EDT[1](index=1&type=chunk)[3](index=3&type=chunk) - A replay will be available for 30 days on the investor relations section of the Company's website[4](index=4&type=chunk) [Business Update Highlights](index=1&type=section&id=Business%20Update%20Highlights) This section highlights PAVmed's corporate strategy and key updates for Lucid Diagnostics and Veris Health [PAVmed Corporate Strategy](index=1&type=section&id=PAVmed%20Corporate%20Strategy) PAVmed has stabilized its corporate structure, strengthened its balance sheet, and is positioned to advance as a diversified commercial life sciences company. It operates with multiple independently-financed subsidiaries under a shared services model and actively evaluates new opportunities to leverage its platform - PAVmed has **stabilized its corporate structure**, strengthened its balance sheet, and is positioned to advance its vision as a diversified commercial life sciences company[5](index=5&type=chunk) - Operates with multiple independently-financed subsidiaries under a shared services model[5](index=5&type=chunk) - Remains actively engaged in evaluating new opportunities to leverage its shared services model and further diversify its portfolio[5](index=5&type=chunk)[8](index=8&type=chunk) [Lucid Diagnostics Updates](index=2&type=section&id=Lucid%20Diagnostics%20Updates) Lucid Diagnostics processed 2,756 EsoGuard tests and recognized $1.2 million in revenue for Q2 2025. The company secured a Contractor Advisory Committee (CAC) meeting for Medicare LCD, strengthened its balance sheet with a $16.1 million public offering, initiated commercial insurance coverage, and partnered with Hoag for a comprehensive testing program Lucid Diagnostics Q2 2025 Key Metrics | Metric | Value | | :-------------------------------- | :---------- | | EsoGuard Tests Processed (2Q25) | 2,756 | | EsoGuard Esophageal DNA Test Revenue (2Q25) | $1.2 million | - MolDX-participating Medicare Administrative Contractors (MACs) to convene a Contractor Advisory Committee (CAC) meeting on September 4, 2025, regarding Medicare LCD for EsoGuard[8](index=8&type=chunk) - Strengthened balance sheet with an underwritten public offering of common stock, netting approximately **$16.1 million in proceeds**, extending runway into 2026[8](index=8&type=chunk) - Initiated patient testing and billing under the first positive commercial insurance coverage policy for EsoGuard from Highmark Blue Cross Blue Shield, effective May 26, 2025, and partnered with Hoag to launch a comprehensive EsoGuard esophageal precancer testing program[8](index=8&type=chunk) [Veris Health Updates](index=2&type=section&id=Veris%20Health%20Updates) Veris Health completed a $2.5 million direct equity financing, supplementing a previous $2.4 million financing, securing sufficient capital for its implantable physiological monitor's development through FDA clearance. It also established a long-term strategic partnership with The Ohio State's James Cancer Hospital, with EHR integration underway and plans for full commercial deployment and expansion into AI-enabled clinical decision support - Completed a **$2.5 million direct equity financing**, supplementing a previous $2.4 million financing, now sufficiently capitalized to fund development of its implantable physiological monitor through FDA clearance[8](index=8&type=chunk) - Completed a long-term strategic partnership with The Ohio State's James Cancer Hospital; integration with the hospital's electronic health record (EHR) system is in process, with full commercial deployment to commence thereafter[8](index=8&type=chunk) - Advancing long-term strategic plan, which includes refining its commercial strategy, expanding commercial operations following FDA clearance, and broadening its scope of offering to include AI-enabled clinical decision support[8](index=8&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) This section presents PAVmed's Q2 2025 GAAP and non-GAAP financial results, including statements and reconciliations [Summary of Q2 2025 Financials (GAAP)](index=2&type=section&id=Summary%20of%20Q2%202025%20Financials%20(GAAP)) For the three months ended June 30, 2025, PAVmed reported operating expenses of approximately $4.7 million, including $0.2 million in stock-based compensation, and a GAAP net loss attributable to common stockholders of approximately $13.3 million, or $(0.74) per diluted common share. Cash and cash equivalents significantly increased to $4.0 million as of June 30, 2025, from $1.2 million at December 31, 2024 PAVmed Q2 2025 GAAP Financial Summary | Metric | Value (approx.) | | :------------------------------------ | :-------------- | | Operating Expenses | $4.7 million | | Stock-based Compensation (included) | $0.2 million | | GAAP Net Loss Attributable to Common Stockholders | $13.3 million | | GAAP Net Loss Per Common Share (diluted) | $(0.74) | Cash and Cash Equivalents Trend | Date | Cash and Cash Equivalents | | :------------- | :------------------------ | | June 30, 2025 | $4.0 million | | December 31, 2024 | $1.2 million | - The unaudited financial results for the three and six months ended June 30, 2025, were filed with the SEC on Form 10-Q on August 14, 2025[10](index=10&type=chunk) [Non-GAAP Financial Measures Explanation](index=3&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) PAVmed provides non-GAAP financial measures, including EBITDA and non-GAAP adjusted loss, to offer greater transparency into its financial performance. These measures adjust GAAP results for non-cash items like stock-based compensation, fair value changes of convertible securities, and debt extinguishment, aiming to provide a clearer view of core operating results and enhance comparability - Non-GAAP financial measures (EBITDA and non-GAAP adjusted loss) are provided to supplement GAAP results and enhance transparency for financial performance analysis and operational decision-making[10](index=10&type=chunk) - These measures adjust for stock-based compensation expense, loss on issuance or modification of convertible securities, periodic change in fair value of convertible securities, and loss on debt extinguishment[10](index=10&type=chunk) - Non-GAAP measures are not recognized under U.S. GAAP and are not intended to be a substitute for, or superior to, GAAP financial measures[10](index=10&type=chunk) [Condensed Consolidated Statement of Operations (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20(Unaudited)) The unaudited condensed consolidated statement of operations shows a significant decrease in revenue and operating expenses for Q2 2025 compared to Q2 2024. The GAAP net loss per common share improved, and the non-GAAP adjusted loss also saw a substantial reduction Condensed Consolidated Statement of Operations (Unaudited) - Q2 2025 vs Q2 2024 | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :--------------------------------------------- | :------ | :------ | | Revenue | $6 | $979 | | Operating expenses | $4,721 | $14,663 | | Net income (loss) per common share, diluted | $(0.74) | $(1.19) | | Net income (loss) attributable to common stockholders | $(13,308) | $(10,908) | | Non-GAAP adjusted (loss) | $(845) | $(7,651) | | Non-GAAP adjusted (loss) income per share, basic and diluted | $(0.05) | $(0.84) | - Revenue decreased from **$979 thousand** in Q2 2024 to **$6 thousand** in Q2 2025[12](index=12&type=chunk) - Operating expenses decreased from **$14,663 thousand** in Q2 2024 to **$4,721 thousand** in Q2 2025[12](index=12&type=chunk) [Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses](index=5&type=section&id=Reconciliation%20of%20GAAP%20Operating%20Expenses%20to%20Non-GAAP%20Net%20Operating%20Expenses) The reconciliation details adjustments made to GAAP operating expenses to arrive at non-GAAP net operating expenses. For Q2 2025, total operating expenses were $4.721 million, which, after adjustments for depreciation, amortization, stock-based compensation, and stock-issued operating expenses, resulted in non-GAAP net operating expenses of $4.484 million Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :-------------------- | :------ | :------ | | Total operating expenses | $4,721 | $14,663 | | Depreciation and amortization expense | $(22) | $(305) | | Operating expenses issued in stock | $(53) | $(140) | | Stock-based compensation expense | $(162) | $(1,904) | | Net operating expenses | $4,484 | $12,314 | - Total operating expenses decreased from **$14,663 thousand** in Q2 2024 to **$4,721 thousand** in Q2 2025[14](index=14&type=chunk) - Stock-based compensation expense decreased from **$1,904 thousand** in Q2 2024 to **$162 thousand** in Q2 2025[14](index=14&type=chunk) [About PAVmed and its Subsidiaries](index=5&type=section&id=About%20PAVmed%20and%20its%20Subsidiaries) This section provides an overview of PAVmed Inc. and its key subsidiaries, Lucid Diagnostics and Veris Health [PAVmed Inc. Overview](index=5&type=section&id=PAVmed%20Inc.%20Overview) PAVmed Inc. is a diversified commercial-stage medical technology company engaged in the medical device, diagnostics, and digital health sectors - PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors[15](index=15&type=chunk) [Lucid Diagnostics Inc. Overview](index=5&type=section&id=Lucid%20Diagnostics%20Inc.%20Overview) Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company, offering the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device for widespread early detection of esophageal precancer - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company[15](index=15&type=chunk) - Markets the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer[15](index=15&type=chunk) [Veris Health Inc. Overview](index=5&type=section&id=Veris%20Health%20Inc.%20Overview) Veris Health Inc. is a digital health company focused on enhanced personalized cancer care through remote patient monitoring, utilizing implantable biologic sensors with wireless communication and developing an implantable physiological monitor - Veris Health Inc. is a digital health company focused on enhanced personalized cancer care through remote patient monitoring[15](index=15&type=chunk) - Utilizes implantable biologic sensors with wireless communication along with a custom suite of connected external devices[15](index=15&type=chunk) - Concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform[15](index=15&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements based on current beliefs and expectations, which are subject to various risks and uncertainties. These risks, detailed in the company's SEC filings, could cause actual results to differ materially from those projected. The company disclaims any obligation to publicly update or revise these statements - This press release includes forward-looking statements that involve risks and uncertainties, based upon the current beliefs and expectations of PAVmed's and Lucid's management[19](index=19&type=chunk) - Risks and uncertainties that may cause actual results to differ include volatility in stock price, general economic and market conditions, R&D uncertainties, regulatory clearances, market acceptance, funding needs, and other competitive developments[19](index=19&type=chunk) - PAVmed and Lucid disclaim any intention or obligation to publicly update or revise any forward-looking statement[19](index=19&type=chunk) [Investor and Media Contact](index=6&type=section&id=Investor%20and%20Media%20Contact) Contact information for investor and media inquiries is provided for Matt Riley, representing PAVmed and Lucid Diagnostics - Matt Riley is the Investor and Media Contact for PAVmed and Lucid Diagnostics[20](index=20&type=chunk) - Contact email: mjr@pavmed.com[20](index=20&type=chunk)
PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results
Prnewswire· 2025-08-14 12:00
Lucid processed 2,756 EsoGuard® 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2025 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diver ...
PAVmed(PAVM) - 2025 Q2 - Quarterly Report
2025-08-14 00:04
[Part I - Financial Information](index=2&type=section&id=Part%20I%20-%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements and notes for the periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a significant increase in total assets and a shift from a stockholders' deficit to positive equity Condensed Consolidated Balance Sheets (in thousands) | Asset/Liability Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets:** | | | | Cash | $4,004 | $1,185 | | Total current assets | $5,488 | $2,164 | | Equity method investment - at fair value | $35,998 | $25,637 | | Total assets | $43,893 | $30,660 | | **Liabilities, Mezzanine Equity and Stockholders' Equity (Deficit):** | | | | Senior Secured Convertible Notes - at fair value | $6,800 | $29,100 | | Total current liabilities | $10,506 | $35,446 | | Total liabilities | $12,474 | $37,693 | | Mezzanine Equity (Series C Convertible Preferred Stock) | $3,260 | — | | Total Stockholders' Equity (Deficit) | $28,159 | $(7,033) | | Total Liabilities, Mezzanine Equity and Stockholders' Equity (Deficit) | $43,893 | $30,660 | - Total assets increased by approximately **$13.2 million** from December 31, 2024, to June 30, 2025, primarily driven by a significant increase in the equity method investment and cash[8](index=8&type=chunk) - Total liabilities decreased substantially by approximately **$25.2 million**, mainly due to a reduction in Senior Secured Convertible Notes[8](index=8&type=chunk) - Stockholders' Equity (Deficit) shifted from a **deficit of $7.0 million to a positive equity of $28.2 million**, indicating a significant improvement in the company's financial position[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations reflect a significant revenue decrease but a shift to net income in H1 2025 due to deconsolidation effects Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $6 | $979 | $14 | $1,989 | | Total operating expenses | $4,721 | $14,663 | $10,174 | $29,711 | | Operating loss | $(4,715) | $(13,684) | $(10,160) | $(27,722) | | Management fee income | $3,150 | — | $6,300 | — | | Change in fair value - equity method investment | $(10,643) | — | $10,361 | — | | Net income (loss) attributable to PAVmed Inc | $(11,921) | $(10,827) | $7,047 | $(26,039) | | Net income (loss) attributable to PAVmed Inc common stockholders | $(13,308) | $(10,908) | $4,386 | $(33,696) | | Net income (loss) per share – basic | $(0.74) | $(1.19) | $0.27 | $(3.78) | | Net income (loss) per share – diluted | $(0.74) | $(1.19) | $0.13 | $(3.78) | - Revenue **significantly decreased** for both the three and six months ended June 30, 2025, compared to 2024, primarily due to the deconsolidation of Lucid Diagnostics' operating results[11](index=11&type=chunk)[208](index=208&type=chunk)[222](index=222&type=chunk) - Total operating expenses saw **substantial reductions** for both periods in 2025 compared to 2024, also largely attributable to the deconsolidation of Lucid Diagnostics[11](index=11&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - The company reported a **net income attributable to PAVmed Inc of $7.0 million** for the six months ended June 30, 2025, a significant improvement from a **$26.0 million loss** in the prior year, driven by management fee income and a gain from the change in fair value of equity method investment[11](index=11&type=chunk)[229](index=229&type=chunk)[233](index=233&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity improved significantly, moving from a deficit to a positive balance due to net income and stock issuances - PAVmed Inc's total stockholders' equity (deficit) improved from a **deficit of $(7,033) thousand** as of December 31, 2024, to a **positive $28,159 thousand** as of June 30, 2025[17](index=17&type=chunk)[18](index=18&type=chunk) - Key changes include the issuance of **Series C Convertible Preferred Stock** through debt exchange and unsecured debt cancellation, and an increase in additional paid-in capital[17](index=17&type=chunk)[18](index=18&type=chunk) - The company recognized **net income of $7,047 thousand** for the six months ended June 30, 2025, contributing to the equity improvement[17](index=17&type=chunk)[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows show significantly reduced cash use in operations and lower financing proceeds compared to the prior year Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net income (loss) - before noncontrolling interest ("NCI") | $6,300 | $(33,426) | | Net cash flows used in operating activities | $(2,759) | $(24,765) | | Net cash flows used in investing activities | $(14) | $(45) | | Net cash flows provided by financing activities | $5,592 | $30,670 | | Net increase in cash | $2,819 | $5,860 | | Cash, end of period | $4,004 | $25,499 | - Net cash used in operating activities **significantly decreased from $(24.8) million in 2024 to $(2.8) million in 2025**, indicating improved operational efficiency or reduced burn rate[27](index=27&type=chunk) - Cash provided by financing activities **decreased from $30.7 million in 2024 to $5.6 million in 2025**, reflecting different financing strategies or needs[27](index=27&type=chunk) - The company ended the six months with **$4.0 million in cash**, an increase from the beginning of the period, despite lower financing proceeds compared to the prior year[27](index=27&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations for the line items and policies presented in the financial statements [Note 1 — The Company](index=12&type=section&id=Note%201%20%E2%80%94%20The%20Company) Outlines the company's multi-product life sciences business model and current strategic focus areas - PAVmed Inc is a multi-product life sciences company focused on innovating, developing, acquiring, and commercializing novel healthcare technologies[29](index=29&type=chunk) - The company's current strategy involves establishing distinct subsidiaries for each financed asset, allowing for tailored financing directly into each subsidiary[29](index=29&type=chunk) - Current focus areas include supporting **EsoGuard's commercial expansion** through Lucid Diagnostics, expanding access to the **Veris Cancer Care Platform**, developing an implantable physiological monitor through Veris Health, and advancing other assets via an incubator-type platform (PMX)[30](index=30&type=chunk) [Note 2 — Liquidity and Going Concern](index=12&type=section&id=Note%202%20%E2%80%94%20Liquidity%20and%20Going%20Concern) Recurring losses and a working capital deficiency raise substantial doubt about the company's ability to continue as a going concern - The Company generated **less than $0.1 million in revenue** and experienced recurring losses and negative cash flows from operating activities for the three and six months ended June 30, 2025[32](index=32&type=chunk) - As of June 30, 2025, the Company had a **working capital deficiency of approximately $5.0 million**, including $6.8 million in Senior Secured Convertible Notes classified as current liabilities and $4.0 million in cash[33](index=33&type=chunk) - These factors raise **substantial doubt about the Company's ability to continue as a going concern** within one year, necessitating increased revenues, cost control, and additional capital raises[34](index=34&type=chunk) [Note 3 — Summary of Significant Accounting Policies](index=13&type=section&id=Note%203%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) Details the basis of presentation, consolidation principles, revenue recognition, and adoption of new accounting standards - The financial statements are prepared in accordance with **U.S. GAAP and SEC rules**, with all intercompany transactions eliminated in consolidation[37](index=37&type=chunk) - PAVmed has a controlling financial interest in Veris Health Inc, but **ceased to have a controlling interest in Lucid Diagnostics** as of September 10, 2024, now accounting for it using the equity method with the fair value option[37](index=37&type=chunk) - Revenue recognition follows **ASC 606**, with current revenue primarily from the Veris Cancer Care Platform, and previously from Lucid's EsoGuard tests[44](index=44&type=chunk) - The company adopted **ASU No 2023-09 (Income Taxes)** effective January 1, 2025, and is evaluating other ASUs for future impact[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) [Note 4 — Equity Method Investment](index=16&type=section&id=Note%204%20%E2%80%94%20Equity%20Method%20Investment) Explains the accounting for the Lucid Diagnostics investment and presents its summarized financial information - PAVmed accounts for its investment in Lucid Diagnostics as an **equity method investment with the fair value option** since September 10, 2024, due to loss of controlling interest but retention of significant influence[62](index=62&type=chunk) Lucid Diagnostics Summarized Financial Information (in thousands) | Metric | June 30, 2025 | | :--- | :--- | | Cash | $31,123 | | Total assets | $38,670 | | Total liabilities | $30,808 | | Shareholders' equity | $7,862 | | Revenue (Three Months Ended June 30, 2025) | $1,163 | | Net income (loss) attributable to common stockholders (Three Months Ended June 30, 2025) | $(7,888) | | Revenue (Six Months Ended June 30, 2025) | $1,991 | | Net income (loss) attributable to common stockholders (Six Months Ended June 30, 2025) | $(43,906) | - The fair value of PAVmed's investment in Lucid was **$36.0 million** at June 30, 2025, up from $25.6 million at December 31, 2024, resulting in an **unrealized gain of $10.4 million** for the six months ended June 30, 2025[64](index=64&type=chunk) - PAVmed recognized **$3.15 million and $6.3 million in management fee income** from Lucid for the three and six months ended June 30, 2025, respectively, following Lucid's deconsolidation[65](index=65&type=chunk) [Note 5 — Revenue from Contracts with Customers](index=17&type=section&id=Note%205%20%E2%80%94%20Revenue%20from%20Contracts%20with%20Customers) Revenue has decreased significantly following the deconsolidation of Lucid Diagnostics Revenue and Cost of Revenue (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $979 | < $0.1 | $1,989 | | Cost of Revenue | $41 | $1,666 | $78 | $3,411 | - Revenue for the three and six months ended June 30, 2025, was **less than $0.1 million**, primarily from Veris Health Cancer Care Platform subscription revenue, a significant decrease from 2024 due to Lucid's deconsolidation[67](index=67&type=chunk) - Cost of revenue for the three and six months ended June 30, 2025, was also **less than $0.1 million**, mainly from Veris subscription revenue, down from $1.7 million and $3.4 million in 2024, respectively, due to Lucid's deconsolidation[68](index=68&type=chunk)[69](index=69&type=chunk) [Note 6 — Prepaid Expenses, Deposits, and Other Current Assets](index=17&type=section&id=Note%206%20%E2%80%94%20Prepaid%20Expenses%2C%20Deposits%2C%20and%20Other%20Current%20Assets) Details the components of prepaid expenses, which increased primarily due to higher advance payments and insurance Prepaid Expenses, Deposits, and Other Current Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Advanced payments to service providers and suppliers | $320 | $115 | | Prepaid insurance | $528 | $233 | | Deposits | $373 | $347 | | Veris Box supplies | $260 | $266 | | Total prepaid expenses, deposits and other current assets | $1,481 | $961 | - Total prepaid expenses, deposits, and other current assets **increased by $520 thousand** from December 31, 2024, to June 30, 2025, primarily due to higher advanced payments to service providers and prepaid insurance[70](index=70&type=chunk) [Note 7 — Leases](index=18&type=section&id=Note%207%20%E2%80%94%20Leases) Summarizes the company's operating lease liabilities and future payment obligations Future Lease Payments (in thousands) | Year | Amount | | :--- | :--- | | 2025 (remainder of year) | $357 | | 2026 | $724 | | 2027 | $594 | | 2028 | $471 | | 2029 | $481 | | Thereafter | $367 | | Total lease payments | $2,994 | | Less: imputed interest | $(484) | | Present value of lease liabilities | $2,510 | - The present value of lease liabilities as of June 30, 2025, was **$2.51 million**, with a weighted-average remaining lease term of 4.61 years and a weighted-average discount rate of 7.875%[71](index=71&type=chunk) - Operating lease right-of-use assets **decreased from $2.50 million** at December 31, 2024, to **$2.26 million** at June 30, 2025[71](index=71&type=chunk) [Note 8 — Commitment and Contingencies](index=18&type=section&id=Note%208%20%E2%80%94%20Commitment%20and%20Contingencies) The company is not aware of any pending legal proceedings likely to have a material impact on its financials - The Company may be subject to legal actions and claims in the ordinary course of business, including product liability, consumer, commercial, tax, and governmental matters[72](index=72&type=chunk) - As of the reporting date, the Company is **not aware of any pending legal or other proceedings** reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[72](index=72&type=chunk) [Note 9 — Financial Instruments Fair Value Measurements](index=19&type=section&id=Note%209%20%E2%80%94%20Financial%20Instruments%20Fair%20Value%20Measurements) Presents the fair value hierarchy for assets and liabilities, including the Lucid investment and convertible notes Fair Value Measurement on a Recurring Basis (in thousands) | Category | June 30, 2025 (Total) | December 31, 2024 (Total) | | :--- | :--- | :--- | | **Assets:** | | | | Investment in Lucid Diagnostics, Inc common stock | $35,998 | $25,637 | | **Liabilities:** | | | | Senior Secured Convertible Note - September 2022 | $6,800 | $8,800 | | Senior Secured Convertible Note - April 2022 | — | $20,300 | | Total liabilities at fair value | $6,800 | $29,100 | - The investment in Lucid Diagnostics common stock is classified as **Level 1 fair value**, based on quoted market prices[73](index=73&type=chunk) - Senior Secured Convertible Notes are classified as **Level 3 liabilities**, with fair values determined using Monte Carlo simulations and other valuation models[76](index=76&type=chunk)[78](index=78&type=chunk) - The April 2022 Senior Convertible Note was **fully satisfied** by June 30, 2025, while the September 2022 Senior Convertible Note's fair value decreased from $8.8 million to $6.8 million[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 10 — Debt](index=21&type=section&id=Note%2010%20%E2%80%94%20Debt) Details the terms, covenants, and recent modifications of the company's outstanding senior convertible notes Senior Convertible Notes Outstanding (in thousands) | Note | Maturity Date | Stated Interest Rate | Conversion Price per Share | Principal Outstanding (June 30, 2025) | Fair Value (June 30, 2025) | | :--- | :--- | :--- | :--- | :--- | :--- | | September 2022 Senior Convertible Note | Dec 31, 2025 | 7.875% | $1.068 | $6,579 | $6,800 | - The April 2022 Senior Convertible Note was **fully satisfied in January 2025** through a debt exchange, and the September 2022 Senior Convertible Note's conversion price was reset to $1.068 and maturity extended to December 31, 2025[82](index=82&type=chunk)[87](index=87&type=chunk)[90](index=90&type=chunk) - The Company is subject to financial covenants, including **minimum cash of $8.0 million**, which were **waived through December 31, 2025**[84](index=84&type=chunk)[90](index=90&type=chunk) - Debt extinguishment losses were **less than $0.1 million** for the six months ended June 30, 2025, significantly lower than $1.1 million in the prior year[92](index=92&type=chunk)[231](index=231&type=chunk)[235](index=235&type=chunk) [Note 11 — Stock-Based Compensation](index=24&type=section&id=Note%2011%20%E2%80%94%20Stock-Based%20Compensation) Summarizes stock option activity and the significant decrease in stock-based compensation expense post-deconsolidation PAVmed Stock Options Summary | Metric | Number of Stock Options (June 30, 2025) | Weighted Average Exercise Price (June 30, 2025) | | :--- | :--- | :--- | | Outstanding stock options | 822,143 | $19.44 | | Vested and exercisable stock options | 596,926 | $25.96 | - PAVmed granted **255,000 stock options** in the six months ended June 30, 2025, and accepted voluntary forfeiture of approximately **494,202 options** with higher exercise prices in January 2025[97](index=97&type=chunk)[99](index=99&type=chunk) Consolidated Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Cost of revenue | $0 | $0 | | Sales and marketing expenses | $1 | $46 | | General and administrative expenses | $148 | $944 | | Research and development expenses | $13 | $102 | | Total stock-based compensation expense | $162 | $1,092 | - Total consolidated stock-based compensation expense **decreased significantly** from $1,904 thousand (3 months) and $3,786 thousand (6 months) in 2024 to $162 thousand and $1,092 thousand in 2025, respectively, primarily due to Lucid's deconsolidation[104](index=104&type=chunk) [Note 12 — Preferred Stock](index=27&type=section&id=Note%2012%20%E2%80%94%20Preferred%20Stock) Outlines the terms of Series B and Series C Preferred Stock, including recent issuances, conversions, and dividend accruals - As of June 30, 2025, there were **1,469,969 shares of PAVmed Series B Convertible Preferred Stock outstanding**, with dividends of $88 thousand and $175 thousand earned for the three and six months ended June 30, 2025, respectively[110](index=110&type=chunk)[113](index=113&type=chunk) - PAVmed **Series C Convertible Preferred Stock was issued** through a $22.3 million debt exchange and a $2.6 million unsecured debt cancellation in January 2025, with a stated value of $1,000 per share and a 7.875% annual dividend rate[86](index=86&type=chunk)[88](index=88&type=chunk)[118](index=118&type=chunk) - The Series C Preferred Stock conversion price was **temporarily reduced to $0.40 per share** through September 30, 2025, and the company recognized deemed dividend charges totaling $818 thousand in Q2 2025[129](index=129&type=chunk)[131](index=131&type=chunk)[136](index=136&type=chunk) - A portion of Series C Preferred Stock ($1.26 million) was **reclassified to mezzanine equity** due to a substantive redemption feature[132](index=132&type=chunk) [Note 13 — Common Stock and Common Stock Purchase Warrants](index=31&type=section&id=Note%2013%20%E2%80%94%20Common%20Stock%20and%20Common%20Stock%20Purchase%20Warrants) Describes recent common stock issuances, warrant activity, and the company's status with Nasdaq listing requirements - PAVmed **regained compliance with Nasdaq's $2.5 million stockholders' equity requirement** in February 2025 but received a notice for non-compliance with the $1 bid price rule in January 2025, with an extension until January 19, 2026[142](index=142&type=chunk)[143](index=143&type=chunk) - In the six months ended June 30, 2025, the company issued **401,303 common shares** for debt repayments, **1,216,565 shares** through its ATM facility for $0.8 million net proceeds, and **3,840,094 shares** from Series C Preferred Stock conversions[139](index=139&type=chunk)[144](index=144&type=chunk) - A February 2025 offering generated **$2.37 million gross proceeds** from selling 2,574,350 common shares and pre-funded warrants to purchase 756,734 shares[147](index=147&type=chunk)[149](index=149&type=chunk) - All **Series Z Warrants**, representing the right to purchase 795,830 shares, **expired on April 30, 2025**[150](index=150&type=chunk) [Note 14 — Noncontrolling Interest](index=33&type=section&id=Note%2014%20%E2%80%94%20Noncontrolling%20Interest) Explains the accounting for the noncontrolling interest in the consolidated subsidiary, Veris Health Noncontrolling Interest (NCI) Equity (in thousands) | Category | June 30, 2025 | | :--- | :--- | | NCI – equity - December 31, 2024 | $(4,538) | | Net loss attributable to NCI | $(747) | | Impact of subsidiary equity transactions | $(7,928) | | Veris Health issuance of common stock for settlement of vendor service agreement | $104 | | Veris Offerings | $3,438 | | Stock-based compensation expense - Veris Health 2021 Equity Plan | $300 | | NCI – equity – June 30, 2025 | $(9,371) | - PAVmed **lost controlling financial interest in Lucid Diagnostics** on September 10, 2024, reducing its voting interest to less than 50.0%, but retains significant influence[153](index=153&type=chunk) - Veris Health is a **consolidated majority-owned subsidiary**, with PAVmed holding a 59.49% majority-interest ownership (83.9% on an as-converted basis)[155](index=155&type=chunk) - Veris Health completed a June 2025 offering, selling 1,800,000 common shares and warrants for **$2.5 million gross proceeds**, to fund development of its implantable physiological monitor[156](index=156&type=chunk)[157](index=157&type=chunk) [Note 15 — Net Income (Loss) Per Share](index=34&type=section&id=Note%2015%20%E2%80%94%20Net%20Income%20(Loss)%20Per%20Share) Provides the calculation of basic and diluted net income (loss) per share, showing a shift from loss to profit Net Income (Loss) Per Share Attributable to PAVmed Inc Common Stockholders | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) per share – basic | $(0.74) | $(1.19) | $0.27 | $(3.78) | | Net income (loss) per share – diluted | $(0.74) | $(1.19) | $0.13 | $(3.78) | | Weighted average common shares outstanding, basic | 18,084,653 | 9,152,819 | 15,992,034 | 8,923,862 | | Weighted average common shares outstanding, diluted | 18,084,653 | 9,152,819 | 54,272,962 | 8,923,862 | - Basic and diluted EPS for the six months ended June 30, 2025, were **$0.27 and $0.13**, respectively, a significant improvement from losses of $(3.78) in the prior year[160](index=160&type=chunk) - For periods with net losses (Q2 2025, Q2 2024, H1 2024), common stock equivalents were **excluded from diluted EPS calculation** as their inclusion would be anti-dilutive[162](index=162&type=chunk) [Note 16 — Segment Information](index=35&type=section&id=Note%2016%20%E2%80%94%20Segment%20Information) The company operates as a single reportable segment with revenues concentrated in the United States - PAVmed operates as a **single operating segment**, with its Chief Executive Officer serving as the Chief Operating Decision Maker (CODM)[164](index=164&type=chunk)[165](index=165&type=chunk) - The company's business activities are managed on a consolidated basis, and revenues are concentrated in the **United States**[164](index=164&type=chunk)[166](index=166&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes financial condition and results of operations, focusing on Lucid's deconsolidation, recent developments, and liquidity [FORWARD-LOOKING STATEMENTS](index=36&type=section&id=FORWARD-LOOKING%20STATEMENTS) Warns that the report contains forward-looking statements subject to significant risks and uncertainties - The report contains **forward-looking statements** regarding future results, financial position, business strategy, and operational objectives, which involve substantial risks and uncertainties[171](index=171&type=chunk) - Key risk factors include limited operating history, ability to generate revenue, regulatory approval, market acceptance, and **additional financing needs**[174](index=174&type=chunk) [Overview](index=37&type=section&id=Overview) Reiterates the company's multi-product life sciences strategy and current areas of strategic focus - PAVmed is a multi-product life sciences company focused on innovative healthcare technologies, utilizing a corporate structure with **distinct subsidiaries for each financed asset**[175](index=175&type=chunk) - Current strategic focus includes supporting Lucid Diagnostics' **EsoGuard**, expanding Veris Health's **Cancer Care Platform**, and advancing other products through an incubator-type platform (PMX)[176](index=176&type=chunk) [Recent Developments](index=37&type=section&id=Recent%20Developments) Summarizes recent business and financing activities across the company and its key subsidiaries [Business](index=37&type=section&id=Business) Highlights recent clinical, regulatory, and commercial milestones for the Lucid Diagnostics' EsoGuard test - Lucid Diagnostics submitted a clinical evidence package to MolDx in November 2024 for **Medicare coverage reconsideration of EsoGuard**, with a CAC Meeting scheduled for September 4, 2025[177](index=177&type=chunk)[178](index=178&type=chunk) - Lucid was added to the **Russell 2000® and 3000® Indexes** on June 27, 2025, and launched a comprehensive esophageal precancer testing program with Hoag using EsoGuard[179](index=179&type=chunk)[181](index=181&type=chunk) - **NCCN Clinical Practice Guidelines** updated in March 2025 to reference non-endoscopic biomarker testing, such as EsoGuard, as an acceptable alternative for BE screening[182](index=182&type=chunk) - Lucid published its fifth peer-reviewed clinical utility manuscript showing a **2.4-fold increase in BE detection** with EsoGuard triage, and Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York[183](index=183&type=chunk)[185](index=185&type=chunk) - Lucid announced an **$8 million NIH R01 grant** in February 2025 for a five-year clinical study evaluating EsoCheck and EsoGuard[186](index=186&type=chunk) [Financing](index=39&type=section&id=Financing) Summarizes recent capital raising activities at the PAVmed, Veris Health, and Lucid Diagnostics levels - Veris Health completed a June 2025 offering, raising approximately **$2.5 million in gross proceeds** to fund development of its implantable physiological monitor[188](index=188&type=chunk) - PAVmed and Veris completed a February 2025 offering, generating **$2.37 million in gross proceeds** from the sale of PAVmed common stock and pre-funded warrants, and Veris common stock[190](index=190&type=chunk) - PAVmed entered into a new **At-The-Market (ATM) Sales Agreement** with Maxim Group LLC in April 2025, allowing for sales of up to $2.88 million in common stock[192](index=192&type=chunk)[193](index=193&type=chunk) - Lucid Diagnostics completed a CMPO in April 2025, raising approximately **$16.2 million net**, and an RDO in March 2025, raising approximately **$14.9 million net**[195](index=195&type=chunk)[196](index=196&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Provides a comparative analysis of operating results, detailing the impact of Lucid Diagnostics' deconsolidation [Overview](index=40&type=section&id=Overview) Explains the expected impact of Lucid's deconsolidation on revenue and operating expense line items - Revenue is now primarily from the **Veris Health Cancer Care Platform**, shifting from Lucid's EsoGuard tests after its deconsolidation on September 10, 2024[198](index=198&type=chunk) - **Operating expenses are expected to decrease** due to Lucid's deconsolidation, as its expenses are no longer consolidated[199](index=199&type=chunk)[201](index=201&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - Other income and expense, net, primarily includes **management fee income from Lucid** and changes in fair value of convertible notes[205](index=205&type=chunk) [The three months ended June 30, 2025 as compared to three months ended June 30, 2024](index=41&type=section&id=The%20three%20months%20ended%20June%2030%2C%202025%20as%20compared%20to%20three%20months%20ended%20June%2030%2C%202024) Compares Q2 2025 results to Q2 2024, showing decreased revenue and expenses due to Lucid's deconsolidation Key Financial Changes (Three Months Ended June 30, 2025 vs 2024) (in millions) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $1.0 | $(0.9) | | Cost of revenue | < $0.1 | $1.7 | $(1.6) | | Sales and marketing expenses | $0.2 | $4.2 | $(4.0) | | General and administrative expenses | $3.7 | $7.0 | $(3.3) | | Research and development expenses | $0.8 | $1.6 | $(0.8) | | Amortization of acquired intangible assets | $0 | $0.1 | $(0.1) | | Management fee income | $3.2 | $0 | $3.2 | | Change in fair value of convertible debt | $0.2 (expense) | $0.6 (expense) | $(0.4) | | Change in fair value of Equity Method Investment | $(10.6) (loss) | $0 | $(10.6) | | Loss on Debt Extinguishment | $0 | $0.8 | $(0.8) | - **Significant decreases in revenue and operating expenses** are primarily due to Lucid's deconsolidation from PAVmed's operating results[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk) - Management fee income increased by **$3.2 million** due to Lucid's deconsolidation, while a **$10.6 million unrealized loss** was recognized on the equity method investment in Lucid[215](index=215&type=chunk)[220](index=220&type=chunk) [The six months ended June 30, 2025 as compared to six months ended June 30, 2024](index=43&type=section&id=The%20six%20months%20ended%20June%2030%2C%202025%20as%20compared%20to%20six%20months%20ended%20June%2030%2C%202024) Compares H1 2025 results to H1 2024, highlighting a shift to net income driven by deconsolidation effects Key Financial Changes (Six Months Ended June 30, 2025 vs 2024) (in millions) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $2.0 | $(1.9) | | Cost of revenue | < $0.1 | $3.4 | $(3.3) | | Sales and marketing expenses | $0.5 | $8.6 | $(8.1) | | General and administrative expenses | $8.1 | $13.7 | $(5.6) | | Research and development expenses | $1.6 | $3.6 | $(2.0) | | Amortization of acquired intangible assets | $0 | $0.5 | $(0.5) | | Management fee income | $6.3 | $0 | $6.3 | | Change in fair value of convertible debt | $0.3 (expense) | $2.7 (expense) | $(2.4) | | Change in fair value of Equity Method Investment | $10.4 (gain) | $0 | $10.4 | | Loss on Debt Extinguishment | < $0.1 | $1.1 | $(1.0) | | Deemed Dividend on Lucid Series A and Series A-1 Convertible Preferred Stock Exchange Offer | $0 | $7.5 | $(7.5) | - Similar to the quarterly trend, the six-month period shows **substantial decreases in revenue and operating expenses** due to Lucid's deconsolidation[222](index=222&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - Management fee income increased by **$6.3 million**, and an **unrealized gain of $10.4 million** was recognized on the equity method investment in Lucid[229](index=229&type=chunk)[233](index=233&type=chunk) - Debt extinguishment losses **decreased significantly from $1.1 million in 2024 to less than $0.1 million in 2025**[231](index=231&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's financing strategy, cash position, and the going concern uncertainty due to recurring losses - The company's financing strategy focuses on obtaining capital directly into subsidiaries (Lucid, Veris) but retains flexibility to raise capital at the PAVmed level[236](index=236&type=chunk) - PAVmed experienced net income of $6.3 million before noncontrolling interests and used **$2.8 million cash in operations** for the six months ended June 30, 2025, ending with **$4.0 million cash on hand**[237](index=237&type=chunk) - The company expects continued recurring losses and negative cash flows, necessitating additional capital, which raises **substantial doubt about its going concern ability**[237](index=237&type=chunk) - Key financing activities in H1 2025 included issuing shares via ATM for **$0.8 million net proceeds** and a February offering for **$2.37 million gross proceeds**[240](index=240&type=chunk) - The September 2022 Senior Convertible Note's maturity was **extended to December 31, 2025**, and its financial covenants were waived until that date[239](index=239&type=chunk)[241](index=241&type=chunk) - Veris Health raised approximately **$2.5 million in gross proceeds** from a June 2025 offering of common stock and warrants to fund its implantable physiological monitor development[262](index=262&type=chunk) [Critical Accounting Estimates](index=49&type=section&id=Critical%20Accounting%20Estimates) Confirms no material changes to critical accounting estimates related to fair value, stock compensation, and taxes - The preparation of financial statements requires management to make estimates and assumptions, particularly regarding **fair value of debt obligations** and **stock-based equity awards**[43](index=43&type=chunk)[265](index=265&type=chunk) - There have been **no material changes** to the critical accounting estimates in the three months ended June 30, 2025, as disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[265](index=265&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of disclosure controls and procedures and changes to internal controls over financial reporting [Evaluation of Disclosure Controls and Procedures](index=49&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the end of the reporting period - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[266](index=266&type=chunk) - These controls provide **reasonable assurance** that required information is recorded, processed, summarized, and reported within SEC specified time periods[266](index=266&type=chunk) [Changes to Internal Controls Over Financial Reporting](index=49&type=section&id=Changes%20to%20Internal%20Controls%20Over%20Financial%20Reporting) Reports no material changes to internal control over financial reporting during the most recent fiscal quarter - There have been **no material changes** to internal control over financial reporting during the fiscal quarter ended June 30, 2025[267](index=267&type=chunk) [Part II - Other Information](index=50&type=section&id=Part%20II%20-%20Other%20Information) [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) Addresses potential legal actions and claims the company may face during the ordinary course of business - The Company may be subject to various legal actions and claims, including product liability, consumer, commercial, tax, and governmental matters[269](index=269&type=chunk) - As of the reporting date, the Company is **not aware of any pending legal or other proceedings** that are reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[269](index=269&type=chunk) [Item 5. Other Information](index=50&type=section&id=Item%205.%20Other%20Information) Confirms no directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a **"Rule 10b5-1 trading arrangement"** or "non-Rule 10b5-1 trading arrangement" during the fiscal quarter ended June 30, 2025[273](index=273&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed as part of the Quarterly Report on Form 10-Q - The Exhibit Index includes the Sales Agreement (ATM Facility), the Sixth Amended and Restated 2014 Long-Term Incentive Equity Plan, and various certifications (e g, Section 302 and 906 of Sarbanes-Oxley Act)[281](index=281&type=chunk)
PAVmed(PAVM) - 2025 Q2 - Earnings Call Transcript
2025-08-13 13:30
Financial Data and Key Metrics Changes - Revenue for the second quarter was $1,200,000, reflecting a 40% increase from the first quarter and matching the previous quarterly high [9][39] - The cash balance at the end of the second quarter was $31,100,000, with a quarterly burn rate of $10,300,000, slightly better than the average burn rate of the previous four quarters [39][40] - Non-GAAP net loss for the second quarter was $9,900,000, which is an improvement of $1,200,000 sequentially [45] Business Line Data and Key Metrics Changes - EtherCAT test volume for the second quarter was 2,756 tests, within the target range of 2,500 to 3,000 tests per quarter [7] - The company invoiced nearly $7,000,000 for 2,756 tests, with revenue recognized at approximately $1,200,000, indicating a 40% sequential revenue increase and a 19% year-over-year increase [42][47] Market Data and Key Metrics Changes - The company is targeting a Medicare population that constitutes approximately 40% to 50% of the 30 million patients recommended for screening under existing guidelines [57] - Currently, the Medicare portion of testing is running in the 10% to 15% range, primarily due to a lack of targeted efforts [58] Company Strategy and Development Direction - The company is focused on securing Medicare coverage, which is seen as a critical milestone for accelerating commercialization efforts [6][36] - A Multi X Contractor Advisory Committee (CAC) meeting is scheduled for September 4, which is viewed as a significant step towards achieving a positive Medicare coverage policy outcome [12][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming CAC meeting and the potential for a positive outcome regarding Medicare coverage [36][54] - The company is taking proactive steps to prepare for increased Medicare patient engagement once coverage is secured [36][59] Other Important Information - The company has strengthened its balance sheet with a public offering that netted $16,100,000 in proceeds, providing sufficient resources to ramp up commercial efforts after securing Medicare approval [15][39] - The publication of a pilot study in the American Journal of Gastroenterology highlighted the effectiveness of EsoGuard, which could expand the total addressable market significantly if similar results are replicated in ongoing studies [16][18] Q&A Session Summary Question: Insights on the multi-jurisdictional CAC meeting - Management indicated that the meeting is a positive sign of collaboration among Medicare contractors, suggesting they are in the late stages of the coverage determination process [52][53] Question: Percentage of business currently from Medicare - Currently, the Medicare portion of testing is around 10% to 15%, with plans to increase this significantly once Medicare coverage is secured [58][59] Question: Timing expectations post-CAC meeting - Management expects a draft LCD to be published relatively quickly after the CAC meeting, with a comment period following that [62][70]
PAVmed to Hold a Business Update Conference Call and Webcast on August 14, 2025
Prnewswire· 2025-07-31 12:01
Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors [4] - The company has two subsidiaries: Lucid Diagnostics, which focuses on cancer prevention diagnostics, and Veris Health, which enhances personalized cancer care through remote patient monitoring [4] Upcoming Conference Call - PAVmed will host a business update conference call and webcast on August 14, 2025, at 8:30 AM ET [1] - The call will feature Lishan Aklog, M.D., the Chairman and CEO, providing an overview of the company's operations and growth strategy, along with Dennis McGrath, the President and CFO, discussing the second quarter 2025 financial results [1] Access Information - The webcast will be available on the investor relations section of the company's website [2] - U.S.-based callers can join the conference call by dialing 1-800-836-8184, while international listeners should dial 1-646-357-8785 [2] Replay Availability - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3]
PAVmed Subsidiary Veris Health Completes $2.5 Million Direct Equity Financing
Prnewswire· 2025-06-24 12:01
Core Insights - PAVmed Inc. completed a private placement equity financing for its subsidiary Veris Health, raising $2.5 million at a pre-money valuation of approximately $35 million [1][2][3] Group 1: Financing Details - Veris Health sold shares at $1.40 per share, with proceeds aimed at advancing its implantable physiological monitor through FDA clearance expected in 2026 [2][3] - The financing follows a previous $2.4 million round completed earlier in the year, indicating ongoing investor interest and confidence in Veris Health's potential [1][2] Group 2: Product and Technology - Veris Health focuses on personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2][4] - The Veris Cancer Care Platform integrates remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration to enhance patient care [4][5] Group 3: Strategic Importance - The financing is seen as a significant milestone for both PAVmed and Veris, providing necessary capital to fund the development and commercialization of the implantable physiological monitor [3][4] - The monitor is expected to serve as a key differentiator in the market, enhancing personalized care in conjunction with the Veris Cancer Care Platform [3][5]
PAVmed Subsidiary, Veris Health, Enters into Strategic Partnership Agreement with The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Prnewswire· 2025-06-03 12:31
Core Insights - Veris Health Inc. has established a strategic partnership with The Ohio State University Comprehensive Cancer Center (OSUCCC – James) following a successful pilot program of the Veris Cancer Care Platform™ [1][4] - The partnership aims to enhance personalized cancer care through remote patient monitoring and the development of the Veris Cancer Care Platform [2][3] Group 1: Partnership Details - The agreement includes a long-term, multi-project collaboration to further develop and commercialize the Veris Cancer Care Platform and its implantable physiologic monitor [2][3] - Key components of the partnership involve expanding commercial utilization across cancer care service lines, full electronic health record (EHR) integration, and launching a large clinical registry and clinical trial [3][4] Group 2: Platform Features - The Veris Cancer Care Platform offers remote physiological data collection, symptom reporting, telehealth capabilities, and EHR integration, aiming to improve personalized cancer care [4][5] - Patients enrolled in the platform receive a VerisBox™ with connected health care devices that transmit data to a cloud-based clinician portal, along with a patient smartphone app for symptom reporting and health tracking [5] Group 3: Company Background - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors, with Veris Health as its majority-owned subsidiary [7] - Veris Health focuses on enhancing personalized cancer care through innovative technologies, including the development of an implantable physiological monitor [7]