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PAVmed(PAVM) - 2024 Q3 - Quarterly Report
2024-11-14 02:29
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].
PAVmed Subsidiary, Veris Health, Awarded $1.8 Million NIH Grant to Enhance Cancer Care
Prnewswire· 2024-10-10 11:51
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].
PAVmed Announces Efforts to Regain Compliance with Nasdaq Listing Requirements
Prnewswire· 2024-09-16 20:30
Efforts include appointment of seasoned biotech investor Sundeep Agrawal, M.D. to board to replace departing directors NEW YORK, Sept. 16, 2024 /PRNewswire/ -- PAVmed Inc. (Nasdaq: PAVM) ("PAVmed" or the "Company") a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today announced that, as part of its efforts to regain compliance with Nasdaq's listing requirements, Lucid Diagnostics (Nasdaq: LUCD) ("Lucid") will be deconsolida ...
PAVmed(PAVM) - 2024 Q2 - Earnings Call Transcript
2024-08-13 22:59
PAVmed Inc. (NASDAQ:PAVM) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET Company Participants Matt Riley - Director of IR Lishan Aklog - Chairman and CEO Dennis McGrath - CFO Conference Call Participants Matthew Park - Cantor Fitzgerald Anthony Vendetti - Maxim Group Ed Woo - Ascendiant Capitalized Operator Good morning and welcome to PAVmed's Second Quarter 2024 Business Update Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a que ...
PAVmed(PAVM) - 2024 Q2 - Quarterly Results
2024-08-13 12:18
Exhibit 99.1 PAVmed Provides Business Update and Second Quarter 2024 Financial Results Lucid reports record quarterly EsoGuardtest volume and held productive meeting with CMS Medicare Administrative Contractor (MAC) Palmetto GBA's MolDX Program Veris Health actively pursuing financing following launch of pilot program with The Ohio State's James Cancer Hospital Conference call and webcast to be held today, August 13 at 8:30 AM EDT NEW YORK, August 13, 2024 - PAVmed Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed" or th ...
PAVmed(PAVM) - 2024 Q2 - Quarterly Report
2024-08-12 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each Class Trading Symbol(s) Name of each Exchange on which Registered Common Stock, $0.001 par value per share PAVM The NASDAQ Stock Market LLC Series Z Warrants, each to purchase 1/15th of one share of Common Stock PAVMZ The NASDAQ Stock Market LLC 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 June 30, 2024 OR ☐ TRANSITION REPORT PUR ...
PAVmed to Hold a Business Update Conference Call and Webcast on August 13, 2024
Prnewswire· 2024-07-30 12:15
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 Subsidiary, Veris Health, Announces Launch of Pilot Program with The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Prnewswire· 2024-06-13 11:58
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(PAVM) - 2024 Q1 - Earnings Call Transcript
2024-05-14 15:59
PAVmed Inc. (NASDAQ:PAVM) Q1 2024 Results Conference Call May 14, 2024 8:30 AM ET Company Participants Matt Riley - Director of IR Lishan Aklog - Chairman and CEO Dennis McGrath - CFO Conference Call Participants Anthony Vendetti - Maxim Group Frank Takkinen - Lake Street Capital Markets Ed Woo - Ascendiant Capital Operator Good morning, ladies and gentlemen. And welcome to the PAVmed First Quarter 2024 Business Update Conference Call [Operator Instructions]. This call is being recorded on Tuesday, May 14, ...
PAVmed(PAVM) - 2024 Q1 - Quarterly Results
2024-05-14 14:38
Exhibit 99.1 PAVmed Provides Business Update and First Quarter 2024 Financial Results Lucid strengthens balance sheet and secures a July 17, 2024 MolDX pre-submission meeting date ● Yesterday, Lucid reported that 1Q24 EsoGuard revenue was $1.0 million, which was flat compared to 4Q23 and represents a 124 percent increase from 1Q23. ● Strengthened balance sheet by Lucid's completion of a $29.8 million Series B Preferred Stock Offering. Veris Health completes MOU with The Ohio State's James Cancer Hospital Co ...