Lucid Diagnostics - Lucid Diagnostics的EsoGuard在2024年第四季度的收入为120万美元[12]，测试量为4042，环比增长45%[12] - Highmark Blue Cross Blue Shield in New York 建立了EsoGuard的积极商业保险覆盖政策[12] - NCCN临床实践指南更新，包括食管癌前病变筛查，与ACG等专业协会指南保持一致[12] Veris Health - 完成了一项私募融资，总收益约为240万美元[16]，Veris普通股的定价为3500万美元的税前估值[16] - 与俄亥俄州立大学詹姆斯癌症医院的试点项目延长至2025年4月[16] Financial Performance - 截至2024年第四季度末，公司持有的现金为118.5万美元[21]，高于第三季度的76.5万美元[21]，增加了42万美元[21] - 2024年第四季度的收入为1万美元[23]，低于2023年第四季度的104.9万美元[23]，减少了103.9万美元[23] - 2024年第四季度的运营费用为519.8万美元[23]，低于2023年第四季度的1743.3万美元[23]，减少了1223.5万美元[23] - 2024年第四季度的净利润为114.2万美元[23]，而2023年第四季度的净亏损为1740.8万美元[23]，增加了1855万美元[23]

Financial Performance - Lucid Diagnostics recognized $1.2 million in EsoGuard Esophageal DNA Test revenue for Q4 2024, with a record of 4,042 tests processed, representing a 45% sequential increase and 84% annual increase [6]. - PAVmed's management service income from Lucid Diagnostics amounted to $3.2 million post-deconsolidation, reflected in Other Income [10]. - PAVmed's operating expenses for Q4 2024 were approximately $5.2 million, including stock-based compensation expenses of $0.7 million [10]. - GAAP net income attributable to common stockholders for Q4 2024 was approximately $1.3 million, or approximately $0.12 per common share on a diluted basis [10]. - Non-GAAP adjusted loss for Q4 2024 was approximately $0.7 million, or $(0.06) per common share [10]. - PAVmed's cash and cash equivalents as of December 31, 2024, were $1.2 million, projected to be approximately $3.6 million post-private placement [10]. Market Position and Product Development - The updated NCCN Clinical Practice Guidelines now include a section on esophageal precancer screening, enhancing EsoGuard's market position [6]. - An $8 million NIH grant was awarded to study EsoGuard for expanded indications, potentially increasing the total addressable market opportunity beyond $60 billion [6]. - Lucid Diagnostics markets the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device, the first tools for early detection of esophageal precancer [14]. - Veris Health secured approximately $2.4 million in private placement financing to advance the implantable physiological monitor through FDA clearance and commercial launch [6]. - Veris Health is developing an implantable physiological monitor to enhance personalized cancer care through remote patient monitoring [14]. Compliance and Regulatory Matters - PAVmed regained compliance with Nasdaq minimum bid price requirement, adding approximately $25 million to equity in Q1 2025 through debt restructuring [7]. - The company emphasizes the importance of regulatory authorities' satisfaction with clinical study designs and results for product clearance [18]. Risks and Challenges - PAVmed's future operations are subject to risks including stock price volatility, regulatory approval uncertainties, and market acceptance of its products [18]. - The company may face challenges in raising additional funding as needed for product development and commercialization [18]. - PAVmed and Lucid's management holds forward-looking statements that may differ from actual results due to various uncertainties [18]. - PAVmed and Lucid disclaim any obligation to publicly update or revise forward-looking statements based on changing expectations [18]. Contact Information - For more information, investors and media can contact Matt Riley at PAVmed and Lucid Diagnostics [19].

Core Viewpoint - PAVmed Inc. has made significant strides in stabilizing its corporate structure and balance sheet, positioning itself as a diversified commercial life sciences company with independently financed subsidiaries, particularly highlighting the achievements of Lucid Diagnostics and Veris Health [4]. Financial Results - For Q4 2024, PAVmed reported revenues of approximately $10,000, a decrease from $1,049,000 in Q4 2023. The total revenue for the year ended December 31, 2024, was $2,995,000, compared to $2,452,000 in 2023 [6]. - Operating expenses for Q4 2024 were approximately $5.2 million, down from $17.4 million in Q4 2023. For the full year, operating expenses were $47.5 million, compared to $71.2 million in 2023 [6]. - The GAAP net income attributable to common stockholders for Q4 2024 was approximately $1.3 million, or $0.12 per diluted share, compared to a loss of $1.98 per share in Q4 2023 [6]. - As of December 31, 2024, PAVmed had cash and cash equivalents of $1.2 million, which is projected to increase to approximately $3.6 million after a private placement in Q1 2025 [5]. Subsidiary Performance - Lucid Diagnostics has seen rapid uptake in concierge medicine contracts and has secured its first commercial insurance coverage policies, which are expected to drive future revenue growth [1]. - Veris Health has secured financing to advance its implantable physiological monitor through FDA clearance and commercial launch, indicating progress in its product development [1]. - The performance of Lucid, particularly with its EsoGuard product, is viewed as a key driver for PAVmed's long-term success and sustainability [4]. Corporate Developments - PAVmed completed a debt restructuring and deconsolidation of Lucid to regain Nasdaq compliance and strengthen its balance sheet [1]. - The company is set to hold a conference call and webcast to discuss its business updates and financial results, indicating a commitment to transparency with investors [2][3].

Clinical Evidence and Research - EsoGuard submitted a complete clinical evidence package to secure Medicare coverage, including six new peer-reviewed publications[348]. - EsoGuard demonstrated a 2.4-fold higher diagnostic yield for Barrett's Esophagus (BE) compared to expected yield from screening EGD alone, based on a cohort of 199 EsoGuard-positive patients[350]. - EsoGuard's sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively[352]. - Lucid received an $8 million NIH grant for a five-year clinical study evaluating EsoCheck and EsoGuard among at-risk individuals without GERD symptoms[354]. - Veris was awarded a $1.8 million NIH grant to optimize the Veris Cancer Care Platform for underserved cancer patients[356]. - EsoGuard is now referenced in the NCCN Guidelines as an acceptable alternative to invasive upper endoscopy for detecting esophageal precancer[349]. - A pilot program for the Veris Cancer Care Platform has been launched in collaboration with a National Cancer Institute-Designated Comprehensive Cancer Center[360]. - Research and development efforts will focus on the Veris Cancer Care Platform and other products in the pipeline as resources permit[394]. Financial Performance - Revenue for the year ended December 31, 2024, was $3.0 million, an increase of 20% compared to $2.5 million in the prior year, primarily driven by the EsoGuard Esophageal DNA Test[399]. - Cost of revenue decreased to $4.8 million in 2024 from $6.4 million in 2023, a reduction of 25% attributed to the limited inclusion of Lucid's results post-deconsolidation[400]. - The Company experienced net income before noncontrolling interests of approximately $28.4 million in 2024, while using approximately $33.6 million of cash in operations[414]. - Financing activities provided $31.3 million of cash during the year ended December 31, 2024[414]. - The Company ended the year with cash on-hand of $1.2 million as of December 31, 2024[414]. Stock and Shareholder Activities - The Company generated gross proceeds of $2.37 million from the sale of 2,574,350 shares of common stock and pre-funded warrants[361]. - The Company received shareholder approval to increase the total number of authorized shares from 50 million to 250 million on January 15, 2025[379]. - Lucid closed on the sale of 13,939,331 shares at $1.10 per share, generating net proceeds of approximately $14.5 million for working capital[380][381]. - The company raised a total of $18.16 million from the sale of 12,495 shares of Lucid Series B Preferred Stock at $1,000 per share and the exchange of existing preferred shares[422]. - The company issued approximately 11,634 shares of Lucid Series B-1 Preferred Stock, generating gross proceeds of $11.6 million, with a conversion price of $0.7228[424]. - The company realized gross proceeds of $21.95 million from the issuance of November 2024 Senior Convertible Notes, which were used to fully repay the Lucid March 2023 Senior Convertible Note[428]. - In the year ended December 31, 2024, the company sold 1,032,298 shares through its at-the-market equity facility for net proceeds of approximately $1.3 million[429]. - Cumulatively, the company issued 680,263 shares of common stock for net proceeds of approximately $1.8 million under a committed equity facility as of December 31, 2024[430]. - The company entered into an "at-the-market offering" for up to $6.5 million of its common stock, resulting in net proceeds of approximately $0.3 million from 230,068 shares sold as of December 31, 2024[431]. - The company issued 1,084,366 shares of common stock in satisfaction of approximately $1.4 million of principal repayments and $0.1 million of interest expense in 2024[415]. Compliance and Regulatory Matters - The Company regained compliance with Nasdaq's continued listing standard, maintaining at least $2.5 million in stockholders' equity[366]. - The Company achieved compliance through the exchange of $22.3 million in secured convertible notes for Series C Preferred Stock and a reduction in operating expenses due to the deconsolidation of Lucid[368]. - As of December 31, 2024, the company was in compliance with the Financial Tests, which require available cash to equal or exceed $8.0 million and market capitalization to be no less than $75 million[420]. - The company is subject to financial covenants under the Lucid March 2023 Senior Convertible Note, requiring available cash to equal or exceed $5.0 million and market capitalization to be no less than $30 million[427]. - The company has a Debt to Market Cap Ratio Test that should not exceed 30% based on the outstanding principal amount of notes and average market capitalization[420]. Expenses and Cost Management - The Company increased the monthly management services fee to Lucid from $0.83 million to $1.05 million[359]. - The Company anticipates a decrease in sales and marketing expenses due to the deconsolidation of Lucid, which will no longer be included in its operating results[391]. - Sales and marketing expenses decreased to approximately $11.6 million in 2024 from $17.6 million in 2023, a reduction of $6.0 million[401]. - General and administrative expenses were approximately $24.5 million in 2024, down from $30.9 million in 2023, reflecting a decrease of $6.4 million[401]. - Research and development costs fell to approximately $5.9 million in 2024 compared to $14.3 million in 2023, a decrease of $8.4 million[402]. Changes in Accounting Standards - The company adopted ASU No. 2023-07 for segment reporting, effective January 1, 2024, which did not materially impact its segment-related disclosures[441]. - The FASB issued ASU No. 2023-09 in December 2023, aimed at enhancing income tax disclosures, effective for annual periods beginning after December 15, 2024[443]. - ASU 2023-09 includes changes to rate reconciliation and income taxes paid information, but the company does not expect a significant impact on its consolidated financial statements[443]. - In October 2023, the FASB issued ASU No. 2023-06, which modifies disclosure requirements in response to the SEC's Disclosure Update and Simplification Initiative[444]. - The effective date for ASU 2023-06 amendments will align with the SEC's removal of related disclosures, with a potential removal of amendments if not enacted by June 30, 2027[444]. - The company is currently evaluating the potential impact of ASU 2023-06 on its consolidated financial statements[444]. Miscellaneous - The change in fair value of convertible debt resulted in approximately $0.5 million of income in 2024, compared to $6.0 million of expense in 2023[403]. - A gain on deconsolidation of Lucid Diagnostics was recognized at $72.3 million in 2024, with the value of the Company's shares in Lucid at $25.1 million[408]. - The outstanding principal balance of the September 2022 Senior Convertible Note was approximately $6.6 million after the exchange agreement[371]. - The conversion price for the September 2022 Convertible Note was reset to $1.068, with the maturity date extended to December 31, 2025[372]. - A deemed dividend of $7.5 million was recognized on the exchange of Lucid Series A and Series A-1 Convertible Preferred Stock for Series B Preferred Stock on March 13, 2024[412]. - The company does not have any off-balance sheet arrangements[446]. - There are no applicable quantitative and qualitative disclosures about market risk[447].

Core Insights - The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include non-endoscopic biomarker testing, such as Lucid's EsoGuard Esophageal DNA Test, as an acceptable alternative to invasive endoscopy for detecting esophageal precancer [1][2] Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company focused on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [3] - The EsoGuard Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients and is performed using the EsoCheck Esophageal Cell Collection Device, which allows for a noninvasive office procedure [3] Industry Impact - The alignment of NCCN Guidelines with multiple gastroenterology society guidelines on Barrett's Esophagus (BE) screening is expected to positively influence commercial insurance policy coverage decisions, thereby expanding access to EsoGuard testing [2]

Core Viewpoint - PAVmed Inc. is set to host a business update conference call on March 25, 2025, where the CEO will discuss the company's operations and growth strategy, alongside the CFO presenting the fourth quarter 2024 financial results [1]. 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 through the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, aimed at early detection of esophageal precancer [4]. - Veris Health Inc., which enhances personalized cancer care through remote patient monitoring and is developing an implantable physiological monitor to work with the Veris Cancer Care Platform [4]. Conference Call Details - The conference call will take place at 8:30 AM ET and will be accessible via a webcast on the company's investor relations website [2]. - U.S. callers can join by dialing 1-800-836-8184, while international listeners can call 1-646-357-8785, using the conference call name "PAVmed Business Update" [2]. - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3].

Core Insights - PAVmed Inc. and its subsidiary Veris Health Inc. completed a private placement financing of approximately $2.37 million, with Veris valued at around $35 million pre-money [1][2] - The financing will support the development of Veris' implantable physiological monitor, which aims to enhance personalized cancer care through early detection and reduced hospitalizations [2][4] Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors [6] - Veris Health Inc. focuses on personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2][3] Product and Technology - Veris Health's lead product, the Veris Cancer Care Platform, integrates remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration [3] - The platform includes a VerisBox™ for cancer patients, which transmits physiological data to a clinician portal and allows patients to report symptoms via a smartphone app [4] Strategic Importance - The financing is seen as a significant milestone for Veris Health, enabling advancement in its commercial strategy, including regulatory clearance and product launch [2] - The implantable physiological monitor is expected to enhance the clinical and commercial value of the Veris platform by providing remote data independent of patient compliance [4]

Core Points - PAVmed Inc. has regained compliance with Nasdaq's Continued Listing Standards for Primary Equity Securities, allowing its securities to continue trading on the Nasdaq Capital Market [1][2] - The company achieved compliance by increasing its stockholders' equity to over $2,500,000 through strategic initiatives, including the deconsolidation of its subsidiary Lucid Diagnostics and restructuring of its convertible debt [2] - PAVmed will be under a mandatory panel monitor for one year to ensure continued compliance with the stockholders' equity requirement [3] Company Overview - PAVmed Inc. operates in the medical device, diagnostics, and digital health sectors, with subsidiaries including Lucid Diagnostics and Veris Health [4] - Lucid Diagnostics focuses on cancer prevention through its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, which are designed for early detection of esophageal precancer [4] - Veris Health is developing a digital health platform for personalized cancer care, utilizing remote patient monitoring and implantable biologic sensors [4]

Nasdaq: PAVM, PAVMZ Q3 2024 Business Update November 14, 2024 LISHAN AKLOG, MD Chairman & CEO DENNIS MCGRATH President & CFO Disclaimer ▪ This presentation may contain certain forward-looking statements related to PAVmed Inc. or Lucid Diagnostics Inc. (the "Companies") that involve risks and uncertainties. ▪ Actual results and events may differ significantly from results and events discussed in forwardlooking statements. ▪ Factors that might cause or contribute to such differences include, but are not limit ...

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]