UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-37685 (Registrant's Telephone Number, Including Area Code) Securities registered under Section 12(b) of the Exchange A ...

PAVmed Inc. (NASDAQ:PAVM) Q1 2023 Earnings Conference Call May 17, 2023 8:30 AM ET Company Participants Lishan Aklog - Chairman, Chief Executive Officer Dennis McGrath - Executive Vice President, Chief Financial Officer Michael Parks - Vice President, Investor Relations Conference Call Participants Ross Osborn - Cantor Fitzgerald Anthony Vendetti - Maxim Group Ed Woo - Ascendiant Capital Operator Welcome to the PAVmed business update and first quarter 2023 financial results conference call. At this time, a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-37685 PAVMED INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (IRS Employe ...

PAVmed Inc. (NASDAQ:PAVM) Q4 2022 Earnings Conference Call March 15, 2023 8:30 AM ET Company Participants Michael Parks – Vice President, Investor Relations Lishan Aklog – Chairman and CEO Dennis McGrath – Chief Financial Officer Conference Call Participants Ross Osborn – Cantor Fitzgerald Frank Takkinen – Lake Street Capital Anthony Vendetti – Maxim Group Ed Woo – Ascendiant Capital Operator Welcome to the PAVmed's Business Update and Fourth Quarter 2022 Financial Results Conference Call. At this time all ...

| --- | --- | --- | --- | |----------------------------------|-------|--------|--------| | Accounts Payable | 3,299 | 2,704 | 595 | | Senior Secured Convertible Notes | 0 | 33,650 | 33,650 | | Other Current Liabilities | 4,259 | 4,846 | 587 | | Long-Term Liabilities | 0 | 1,846 | 1,846 | | Shares Outstanding | 86.4M | 94.5M | 8.1M | Nasdaq: PAVM, PAVMZ Disclaimer § Actual results and events may differ significantly from results and events discussed in forwardlooking statements. /med § Adjustments in near-te ...

Part I [Business](index=5&type=section&id=Item%201.%20Business) PAVmed is a commercial-stage medical technology company focused on Diagnostics, Medical Devices, and Digital Health, prioritizing EsoGuard and Veris commercialization [Background and Overview](index=5&type=section&id=Item%201.%20Business-Overview) - PAVmed is a multi-product, commercial-stage medical technology company focused on capital efficiency and speed to market[17](index=17&type=chunk) - The company's current primary focus is on the commercial expansion of its leading products, EsoGuard and the Veris Cancer Care Platform[18](index=18&type=chunk) - PAVmed operates in three main business lines: Diagnostics, Medical Devices, and Digital Health[19](index=19&type=chunk) [EsoGuard and EsoCheck](index=5&type=section&id=Item%201.%20Business-EsoGuard%20and%20EsoCheck) EsoGuard is a diagnostic DNA test for early esophageal precancer detection, targeting a **$60 billion** U.S. market with a **$1,938.01** Medicare payment - EsoGuard is the first and only commercially available diagnostic test for widespread screening of esophageal precancer in at-risk GERD patients, using samples from the FDA-cleared EsoCheck device[20](index=20&type=chunk) - The target market for EsoGuard screening is estimated at **30 million** U.S. individuals, representing a total addressable market opportunity exceeding **$60 billion**[25](index=25&type=chunk)[26](index=26&type=chunk) - CMS granted EsoGuard a final Medicare payment determination of **$1,938.01**, effective January 1, 2021[37](index=37&type=chunk) - Commercialization efforts include a network of Lucid Test Centers, a satellite program for physician offices, community testing events, and a telemedicine program for self-referrals[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - The company has delayed its BE-1 and BE-2 clinical trials to prioritize studies that more efficiently generate clinical utility data to drive commercialization[42](index=42&type=chunk) [Veris Cancer Care Platform](index=13&type=section&id=Item%201.%20Business-Veris%20Cancer%20Care%20Platform) The Veris Cancer Care Platform is a digital health solution for remote patient monitoring in oncology, operating on a SaaS model with a U.S. market exceeding **$2 billion** - Veris Health is a majority-owned subsidiary focused on digital health, built upon the acquisition of Oncodisc's remote patient monitoring technology for cancer care[55](index=55&type=chunk) - The Veris Cancer Care Platform uses connected devices to collect physiologic data and patient-reported symptoms, integrating with Electronic Health Records (EHR) to help care teams detect complications early[57](index=57&type=chunk) - The business model is a B2B, software-as-a-service (SaaS) recurring-revenue model targeting oncology practices and hospitals[58](index=58&type=chunk) - The total addressable U.S. market opportunity is estimated to exceed **$2 billion**, with future expansion planned for cardiovascular diseases, renal disease, and COPD[61](index=61&type=chunk)[59](index=59&type=chunk) [Product Pipeline](index=15&type=section&id=Item%201.%20Business-Product%20Pipeline) PAVmed's product pipeline, including EsoCure, CarpX, and PortIO, is secondary to EsoGuard and Veris commercialization, with CarpX having FDA 510(k) clearance - The company is deprioritizing its development pipeline, including EsoCure, CarpX, and NextFlo, to focus resources on the commercialization of EsoGuard and the Veris Cancer Care Platform[69](index=69&type=chunk) - CarpX, a minimally invasive device for carpal tunnel syndrome, received **FDA 510(k) marketing clearance** in April 2020 and **European CE Mark Certification** in May 2021[72](index=72&type=chunk) [Recent Developments](index=17&type=section&id=Item%201.%20Business-Recent%20Developments) Recent developments include terminating the RDx agreement for **$2.7 million** savings, Veris Health signing first customers, securing **$34.4 million** from convertible notes, and addressing NASDAQ compliance - Lucid terminated its Management Services Agreement with RDx, bringing lab operations fully in-house, which is expected to improve efficiency and result in a net savings of **$2.725 million**[77](index=77&type=chunk)[78](index=78&type=chunk) - Veris Health signed its first customer, New Jersey Cancer Care, in December 2022 and has since signed two additional cancer centers[80](index=80&type=chunk) - The company received a NASDAQ notice on December 29, 2022, for its stock price being below the **$1.00** minimum. It is seeking shareholder approval for a reverse stock split to regain compliance[81](index=81&type=chunk) - PAVmed raised a total of **$34.4 million** in net proceeds from the sale of Senior Secured Convertible Notes in April and September 2022[84](index=84&type=chunk)[85](index=85&type=chunk) - Lucid Diagnostics raised **$13.625 million** in gross proceeds from a Series A Preferred Stock offering on March 7, 2023[89](index=89&type=chunk) [Intellectual Property](index=21&type=section&id=Item%201.%20Business-Intellectual%20Property) The company protects its proprietary technologies through patents, trademarks, and trade secrets, owning or licensing **55** domestic and foreign patents across **11** product families - The company owns or has rights to **55** domestic and foreign patents across **11** product families[95](index=95&type=chunk) Patent Expiration Timeline for Key Technologies | Technology | First Expiration Year | | :--- | :--- | | EsoCheck | May 2034 | | EsoGuard | August 2024 | | Veris Health | November 2038 | | EsoCure | March 2036 | | CarpX | November 2037 | | PortIO | November 2035 | [Government Regulation](index=24&type=section&id=Item%201.%20Business-Government%20Regulation) PAVmed's products are subject to extensive FDA regulation, including device classification, 510(k) or PMA clearance, post-market compliance, CLIA certification, and adherence to healthcare laws like HIPAA - Products are subject to extensive FDA regulation, with medical devices classified into three classes (I, II, III) requiring different levels of control, from general controls to pre-market notification (510(k)) or pre-market approval (PMA)[110](index=110&type=chunk)[111](index=111&type=chunk)[117](index=117&type=chunk) - EsoGuard received FDA "Breakthrough Device Designation" in February 2020, which may expedite its development, assessment, and review as an in-vitro diagnostic (IVD) device[47](index=47&type=chunk) - Lucid's clinical laboratory is subject to U.S. and state laws, including CLIA (Clinical Laboratory Improvement Amendments), which imposes certification and quality standards[123](index=123&type=chunk) - The company is subject to other key U.S. regulations including the Federal Anti-Kickback Statute, False Claims Act, Physician Payment Sunshine Act, and HIPAA for data privacy[127](index=127&type=chunk)[129](index=129&type=chunk)[131](index=131&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial risks including operating losses and funding needs, business risks like competition and market acceptance, regulatory hurdles, and stock-related risks such as potential NASDAQ delisting and dilution - The company has a history of operating losses and expects them to continue, requiring substantial additional funding to support business growth and commercialization[163](index=163&type=chunk)[164](index=164&type=chunk)[174](index=174&type=chunk) - Servicing debt requires significant cash, and restrictive covenants, including minimum cash and market capitalization requirements, could adversely affect operations. The company has previously been out of compliance with certain financial covenants[165](index=165&type=chunk)[167](index=167&type=chunk) - The company's products, particularly EsoGuard and Veris, face intense competition and may never achieve market acceptance, which is dependent on factors like regulatory approval, physician adoption, and third-party reimbursement[175](index=175&type=chunk)[183](index=183&type=chunk) - The company received a notice from Nasdaq on December 29, 2022, for its stock price falling below the **$1.00** minimum requirement, posing a risk of delisting if compliance is not regained[246](index=246&type=chunk) - Significant dilution risk exists due to a large number of outstanding warrants, stock options, and convertible securities, including Senior Convertible Notes that can be converted into a substantial number of shares[251](index=251&type=chunk)[252](index=252&type=chunk) [Property](index=63&type=section&id=Item%202.%20Properties) The company leases its corporate headquarters in New York, an R&D facility in Massachusetts, a CLIA lab in California, and multiple Lucid Test Centers across **11** states totaling **11,429 square feet** - The company's corporate headquarters are at 360 Madison Avenue, New York, NY, under a lease that commenced on February 1, 2023[268](index=268&type=chunk) - Key leased facilities include a **7,375 sq. ft.** R&D facility in Massachusetts, a **21,019 sq. ft.** CLIA laboratory in California, and approximately **11,429 sq. ft.** across various Lucid Test Centers in **11 states**[268](index=268&type=chunk) [Legal Proceedings](index=65&type=section&id=Item%203.%20Legal%20Proceedings) The company resolved two legal matters, settling a stockholder complaint for **$450,000** and a Benchmark Investments complaint for **$450,000** - A stockholder complaint in Delaware Court of Chancery regarding the 2020 Annual Meeting was settled, with a court-approved plaintiff's fee award of **$450,000** paid by the company in December 2022[272](index=272&type=chunk) - A complaint from Benchmark Investments, Inc. regarding alleged violations of an engagement letter was settled in February 2023 for a payment of **$450,000**[273](index=273&type=chunk) Part II [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=66&type=section&id=Item%205.%20Market%20for%20Registrant%E2%80%99s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) PAVmed's common stock and Series Z Warrants trade on Nasdaq, with the company addressing a **$1.00** minimum bid price notice, and no cash dividends paid on common stock - The company's common stock (PAVM) and Series Z Warrants (PAVMZ) are traded on the Nasdaq Capital Market[277](index=277&type=chunk) - On December 29, 2022, the company received a Nasdaq notice for its closing bid price being below the **$1.00** minimum for 30 consecutive business days and has until June 27, 2023, to regain compliance[277](index=277&type=chunk) - As of March 9, 2023, there were **98,419,795 shares** of common stock outstanding held by an estimated 214 holders of record[278](index=278&type=chunk) - The company has not paid cash dividends on common stock and does not intend to in the foreseeable future. Dividends on Series B Convertible Preferred Stock accrue at **8%** annually and are paid in-kind[279](index=279&type=chunk)[282](index=282&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=68&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) PAVmed's 2022 financial results show **$0.4 million** revenue and a widened net loss of **$89.0 million**, driven by increased operating expenses, with **$34.4 million** raised from convertible notes [Results of Operations](index=72&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) In 2022, revenue decreased to **$0.4 million**, while total operating expenses surged to **$91.3 million**, resulting in a net loss from operations of **$90.9 million** Comparison of Operations (in millions) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | $0.4 | $0.5 | | Cost of Revenue | $3.6 | $0.6 | | Sales and Marketing | $19.3 | $8.9 | | General and Administrative | $41.0 | $25.4 | | Research and Development | $25.5 | $19.8 | | **Total Operating Expenses** | **$91.3** | **$54.9** | | **Net Loss from Operations** | **($90.9)** | **($54.4)** | | **Net Loss Attributable to PAVmed Inc.** | **($89.0)** | **($50.3)** | - Sales and marketing expenses increased by **$10.4 million**, primarily due to a **$7.4 million** increase in compensation costs from higher headcount to support commercial activities[326](index=326&type=chunk) - General and administrative expenses rose by **$15.6 million**, driven by a **$9.2 million** increase in consulting services (patents, legal, regulatory) and a **$3.5 million** increase in compensation costs[326](index=326&type=chunk) - Research and development expenses grew by **$5.7 million**, mainly due to a **$3.2 million** increase in development and clinical trial costs for key products and a **$2.5 million** increase in compensation for clinical and engineering staff[327](index=327&type=chunk) [Liquidity and Capital Resources](index=77&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) The company finances operations through equity and debt, raising **$34.4 million** from convertible notes in 2022, and asserts sufficient liquidity for one year despite debt covenants and past non-compliance - The company believes its cash on-hand and committed debt and equity financing sources are sufficient to fund operations for one year from the date of the financial statements[336](index=336&type=chunk)[434](index=434&type=chunk) - In 2022, the company issued Senior Secured Convertible Notes with a total face value of **$38.75 million**, receiving net proceeds of **$34.4 million**[338](index=338&type=chunk)[339](index=339&type=chunk) - The convertible notes contain financial covenants requiring a minimum cash balance of **$8.0 million**, a maximum debt-to-market cap ratio, and a minimum market capitalization of **$75 million**. The company was not in compliance with certain tests at times, including as of December 31, 2022, but received a waiver from the investor[341](index=341&type=chunk)[547](index=547&type=chunk) - Subsidiary Lucid Diagnostics raised approximately **$1.8 million** through a committed equity facility in 2022 and an additional **$13.625 million** from a Series A Preferred Stock offering in March 2023[348](index=348&type=chunk)[343](index=343&type=chunk) [Controls and Procedures](index=84&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with no material changes in Q4 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[373](index=373&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[376](index=376&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=85&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information for Items 10-14, covering governance, compensation, and ownership, is incorporated by reference from the company's 2023 proxy statement, to be filed within 120 days - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees (Item 14) is incorporated by reference from the company's 2023 proxy statement[382](index=382&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=86&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section presents the consolidated financial statements for 2022 and 2021, including balance sheets and statements of operations, with the auditor's report highlighting convertible notes valuation as a critical audit matter Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash | $39,744 | $77,258 | | Total Current Assets | $43,926 | $82,637 | | **Total Assets** | **$53,980** | **$86,976** | | Senior Secured Convertible Notes - at fair value | $33,650 | $0 | | Total Current Liabilities | $41,200 | $7,558 | | **Total Liabilities** | **$43,046** | **$7,558** | | **Total Stockholders' Equity** | **$10,934** | **$79,418** | Consolidated Statement of Operations Data (in thousands, except per share data) | Account | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Revenue | $377 | $500 | | Total operating expenses | $91,304 | $54,893 | | Net loss from operations | ($90,927) | ($54,393) | | **Net loss attributable to PAVmed Inc.** | **($88,983)** | **($50,347)** | | **Net loss per share attributable to PAVmed Inc. - basic and diluted** | **($1.00)** | **($0.65)** | - The independent auditor, Marcum LLP, identified the valuation of the Senior Secured Convertible Notes as a critical audit matter due to the complex methodology and significant management assumptions involved, such as debt yield and implied volatility[407](index=407&type=chunk)[408](index=408&type=chunk)

PAVmed Inc. (NASDAQ:PAVM) Q3 2022 Earnings Conference Call November 15, 2022 4:30 PM ET Company Participants Adrian Miller - VP, IR Lishan Aklog - Chairman and CEO Dennis McGrath - President and CFO Conference Call Participants Charlie Montang - Lake Street Capital Markets Edward Woo - Ascending Capital Markets LLC Anthony Vendetti - Maxim Group Operator Ladies and gentlemen, greetings and welcome to the PAVmed Inc. Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen- ...

PAVmed Inc. (NASDAQ:PAVM) Q2 2022 Earnings Conference Call August 16, 2022 4:30 PM ET Company Participants Adrian Miller - VP, IR Lishan Aklog - Chairman and CEO Dennis McGrath - President and CFO Conference Call Participants Ross Osborn - Cantor Fitzgerald Frank Takkinen - Lake Street Capital Markets Edward Woo - Ascending Capital Anthony Vendetti - Maxim Group Operator Greeting. Welcome to the PAVmed Inc. Second Quarter 2022 Business Update Conference Call. At this time, all participants are in a listen-o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-37685 PAVMED INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 47-1214177 (State or Other Jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-37685 PAVMED INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 47-1214177 (State or Other Jurisdic ...