Latest news with #EsoGuard
New York Post
22-05-2025
- Health
- New York Post
Firefighter battling Stage 4 cancer had 'very benign' symptom
Baltimore firefighter Steve Dorsey had the worst Valentine's Day — but he's feeling the love now. Dorsey, 56, was diagnosed on Feb. 14 with Stage 4 esophageal cancer that spread to his lymph nodes and liver. 9 Baltimore firefighter Steve Dorsey, 56, was diagnosed on Valentine's Day with Stage 4 esophageal cancer that spread to his lymph nodes and liver. Courtesy of Baltimore firefighter Steve Dorsey The 21-year department veteran is on medical leave, undergoing chemotherapy in the hopes of shrinking his tumors, as his colleagues rally around him. 'My co-workers in the Baltimore City Fire Department have been nothing but just outstanding and supportive,' Dorsey told The Post. 'The love that I've gotten out of them has been amazing.' Esophageal cancer is an aggressive, deadly cancer often caught in advanced stages. The five-year survival rate is low — especially for Stage 4 patients. Dorsey is sharing his story to encourage first responders to be proactive about their health. The father of four is also trying to get fire departments nationwide to offer Lucid Diagnostics' EsoGuard DNA test to detect abnormal esophageal cells before they progress to cancer. 'My mission is to bring awareness to esophageal cancer [since firefighters have a] 63% higher [risk] than the general population. It's right there with testicular cancer and mesothelioma,' Dorsey said. 'And also bring awareness, too, that there is testing available.' 9 Esophageal cancer is an aggressive, deadly cancer often caught in advanced stages. The five-year survival rate is low — especially for Stage 4 patients. Courtesy of Baltimore firefighter Steve Dorsey Dorsey said he underwent routine check-ups every six months, with high blood pressure his only concern. Everything was fine until January, when he started to have trouble swallowing. The difficulties were 'very benign' at first — sometimes he'd have to drink some fluids to wash the food down. 'It progressively just started getting worse, where it was very difficult to eat anything, basically, without regurgitating it back up,' Dorsey recalled. 9 Dorsey joined the fire department in 2004, becoming a pump operator assigned to Engine 57 in Curtis Bay. Courtesy of Baltimore firefighter Steve Dorsey A series of tests revealed masses in his lower esophagus, lymph nodes and liver. Chemotherapy began in March and is expected to last into June. 'I will have a follow-up CT scan done to see what the tumors look like,' Dorsey shared. 'We're hopeful that they've shrunk down, and if the chemotherapy and immunotherapies are successful in that, then we'll just keep moving forward with that.' 9 Though he's on medical leave, Dorsey often returns to the firehouse to visit with his colleagues. Courtesy of Baltimore firefighter Steve Dorsey In the meantime, Dorsey has been making regular trips to the firehouse to see his pals. The longtime pump operator, assigned to Engine 57 in Curtis Bay, misses the camaraderie. In one recent visit, he was the first to back a new firetruck into the firehouse, a symbolic tradition in the fire service. 'Firefighting is one of those jobs where you absolutely love the job,' Dorsey said. 'I like to say being a firefighter in Baltimore city is the best job in the world and probably one of the worst places you can do it.' 9 'It's been a great ride,' Dorsey said while reflecting on his 21-year career. Courtesy of Baltimore firefighter Steve Dorsey Dorsey is a third-generation Baltimore firefighter. He had long dreamed of being on the front lines and decided to go for it at 35 as his oldest son graduated from high school. While he knew about the physical dangers, he wished there was a better understanding of the long-term health risks when he joined the department in 2004. Firefighters endure toxic chemicals, smoke, extreme heat and loud noise while saving lives, raising their risk of post-traumatic stress disorder, heart disease, respiratory illnesses and certain types of cancer. 9 Dorsey is a third-generation Baltimore firefighter. He had long dreamed of being on the front lines and decided to go for it at 35 as his oldest son graduated from high school. Courtesy of Baltimore firefighter Steve Dorsey Beyond battling blazes, Dorsey said he was constantly exposed to diesel exhaust at the firehouse due to inadequate ventilation. Even his protective gear exacerbated the problem. 'When I came to the fire department in 2004, firefighters were only issued one set of turnout gear,' he said, noting that dirty gear used to be a badge of honor. 'Changes have been made over the years. We've been issued a second set of turnout gear — the coat and the pants — and so after a fire, we actually send those in and they get laundered, and we switch into our second set of gear.' 9 Dorsey's turnout gear used to be a badge of honor, but it likely exacerbated his cancer risk. Courtesy of Baltimore firefighter Steve Dorsey A spokesperson for the Baltimore fire department did not return a Post request for comment. Dorsey said the city recently agreed that his cancer is a line-of-duty illness. Esophageal cancer is a relatively rare cancer, accounting for only 1% of all cancer cases in the US. The Firefighter Cancer Support Network reports that firefighters have a 39% increased risk of dying from esophageal cancer. 9 Dorsey is a father of four and grandfather of five (pictured here). Courtesy of Baltimore firefighter Steve Dorsey Lucid Diagnostics, headquartered in Manhattan, hopes to catch the cancer before it develops. EsoGuard is a non-invasive test that uses a swallowable capsule to collect cells from the lower esophagus for analysis. The test, which launched commercially in 2019, looks for genetic markers associated with Barrett's esophagus (esophageal precancer) and esophageal adenocarcinoma (cancer). 'A lot of fire departments across the country are partnering with EsoGuard to offer this testing to their members. Baltimore city was not one,' Dorsey said. 9 Dorsey is trying to get fire departments nationwide to offer Lucid Diagnostics' EsoGuard DNA test to detect abnormal esophageal cells before they progress to cancer. Lucid said it has screened over 10,000 firefighters. In New York, it's held small events with the FDNY. 'We have been engaging with the 9/11 WTC foundation to add this as a covered benefit, but do not currently have an active policy,' Lucid told The Post. 'We remain optimistic that the clinicians see the value for this high-risk group and we'll be able to fully implement it at the NYC WTC in the coming months.' As he spreads awareness about the importance of cancer screenings, Dorsey is being celebrated by his community for his impact and resilience. Two fundraisers have been set for the summer to help pay Dorsey's medical expenses. Over $9,700 has been raised via GoFundMe. Eventually, his sick leave will turn into medical retirement. The grandfather of five had planned to retire in six or seven years — not like this. 'I didn't expect it to happen this early or happen this way,' Dorsey said. But as he reflected on his career, he noted that, 'It's been a great ride.'
Yahoo
14-05-2025
- Business
- Yahoo
Lucid Diagnostics Provides Business Update and Reports First Quarter 2025 Financial Results
Processed 3,034 EsoGuard® tests and recognized revenue of $0.8 million in 1Q25 Secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Conference call and webcast to be held today, May 14th, at 8:30 AM EDT NEW YORK, May 14, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM) ("PAVmed"), today provided a business update for the Company and reported financial results for the three months ended March 31, 2025. Conference Call and Webcast The webcast will take place on Wednesday, May 14, 2025, at 8:30 AM and will be accessible in the investor relations section of the Company's website at Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. 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 Business Highlights "We are now better positioned than ever to capitalize on EsoGuard's significant clinical and commercial opportunity," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We continue to make strong progress on multiple fronts – expanding our cash-pay and contracted programs targeting concierge medicine practices and self-insured employers, while also gaining traction with regional commercial insurers for EsoGuard coverage. With additional capital secured, we have extended our operational runway well beyond key upcoming reimbursement milestones, including Medicare. This positions us to accelerate commercialization efforts once these milestones are achieved." Processed 3,034 EsoGuard® Esophageal DNA Tests in 1Q25, Recognized $0.8 million in EsoGuard revenue for 1Q25. Strengthened balance sheet with two common stock offerings with strategic long-term investors, netting approximately $30.6 million in proceeds; ended 1Q25 with over $40 million in proforma cash and extended runway well into 2026 and past key milestones. Launched "Embrace the Future" campaign, showcasing the EsoCheck® Cell Collection Device's groundbreaking Collect+Protect™ Technology relative to antiquated sponge-on-a-string devices. Partnered with a major health system to launch a comprehensive EsoGuard esophageal precancer testing program, expanding access to at-risk patients across the health system's digestive health, primary care, and concierge medicine programs. Continued to gain traction in cash-pay concierge medicine and employer markets sales channels, both of which are expected to begin driving contractually-guaranteed revenue in 2H25. NCI-sponsored study demonstrated EsoGuard effectively detects esophageal precancer in at-risk patients without GERD, supporting expanded indication and may increase market opportunity by as much as 70%. Granted a U.S. patent for key technology underlying EsoGuard, adding to an already robust intellectual property portfolio. The patent covers proprietary methods using methylation of the SqBE18 (CCNA1) gene to detect esophageal precancer and cancer Financial Results For the three months ended March 31, 2025, EsoGuard related revenues were $0.8 million. Operating expenses were approximately $13.3 million, which included stock-based compensation expenses of $1.0 million. GAAP net loss attributable to common stockholders was approximately $36.0 million or $(0.52) per common share. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted loss for the three months ended March 31, 2025, was approximately $11.2 million or $(0.16) per common share. Lucid had cash and cash equivalents of $25.2 million as of March 31, 2025, compared to $22.4 million as of December 31, 2024. Subsequent to March 31, 2025, the Company completed an underwritten public offering of its common stock for net proceeds of $16.1 million. The unaudited financial results for the three months ended March 31, 2025, were filed with the SEC on Form 10-Q on May 13, 2025, and available at or Lucid Non-GAAP Measures To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three months ended March 31, 2025, and 2024 are as follows: Condensed consolidated statements of operations (unaudited) (in thousands except per-share amounts)For the three months ended March 31, 20252024Revenue$ 828$ 1,001Operating expenses13,31511,793 Other (Income) expense14,421(180) Net Loss(26,908)(10,612) Net income (loss) per common share, basic and diluted$ (0.52)$ (0.40) Net loss attributable to common stockholders(36,018)(18,108) Preferred Stock dividends and deemed dividends9,1107,496 Net income (loss) as reported(26,908)(10,612) Adjustments: Depreciation and amortization expense1221501 Interest expense, net2(57)(56) EBITDA(26,744)(10,167)Other non-cash or financing related expenses: Stock-based compensation expense31,030933 Operating expenses issued in stock17423 Change in FV convertible debt214,478(291) Debt extinguishments loss - Senior Secured Convertible Note2—167 Non-GAAP adjusted (loss)$ (11,162)$ (9,335) Basic and Diluted shares outstanding68,79645,014 Non-GAAP adjusted (loss) income per share$(0.16)$(0.21)1 Included in general and administrative expenses in the financial statements.2 Included in other income and expenses.3 Stock-based compensation ("SBC") expense included in operating expenses is detailed as follows in the table below by category within operating expenses for the non-GAAP Net operating expenses: Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses (in thousands except per-share amounts)For the three months ended March 31, 20252024 Cost of revenues$ 1,551$ 1,656 Stock-based compensation expense3(71)(36) Net cost of revenues1,4801,620Amortization of intangible assets105372Sales and marketing4,0694,194 Stock-based compensation expense3(239)(350) Net sales and marketing3,8303,844General and administrative6,1624,070 Depreciation expense(116)(129) Operating expenses issued in stock(74)(23) Stock-based compensation expense3(601)(330) Net general and administrative5,3713,588Research and development1,4281,501 Stock-based compensation expense3(119)(217) Net research and development1,3091,284Total operating expenses13,31511,793 Depreciation and amortization expense(221)(501) Operating expenses issued in stock(74)(23) Stock-based compensation expense3(1,030)(933) Net operating expenses$ 11,990$ 10,336About Lucid DiagnosticsLucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with GERD, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information, please visit and for more information about its parent company PAVmed, please visit Forward-Looking StatementsThis press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics' management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. View original content to download multimedia: SOURCE Lucid Diagnostics
Yahoo
26-03-2025
- Business
- Yahoo
PAVmed Inc (PAVM) Q4 2024 Earnings Call Highlights: Strategic Growth and Financial Stability
Lucid Diagnostics Revenue: $1.2 million in the fourth quarter. EsoGuard Test Volume: 4,042 tests, representing a 45% growth quarter-on-quarter. Veris Health Financing: $2.4 million private placement at a $35 million pre-money valuation. NIH Grant for Veris: $1.8 million, payable over two years. Cash Flow: Operating at cash flow breakeven with incremental expenses offset by dedicated funding. Non-GAAP Loss: $688,000 for the fourth quarter, offset by NIH grant proceeds of $900,000. Management Service Income: $3.2 million from Lucid Diagnostics for the quarter. Operating Expenses: Approximately $5.2 million, including $700,000 in stock-based compensation. GAAP Net Income: $1.3 million or $0.12 per common share on a diluted basis for the quarter. Non-GAAP Operating Expenses: $4.2 million for the fourth quarter. Warning! GuruFocus has detected 3 Warning Signs with PAVM. Release Date: March 25, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PAVmed Inc (NASDAQ:PAVM) successfully completed a strategic transformation to stabilize its corporate structure and balance sheet, positioning the company for sustainable growth. Lucid Diagnostics, a subsidiary of PAVmed Inc (NASDAQ:PAVM), achieved a 45% growth in test volume quarter-on-quarter, generating $1.2 million in revenue. The company secured its first positive commercial insurance coverage policy for EsoGuard with Highmark Blue Cross Blue Shield in New York. PAVmed Inc (NASDAQ:PAVM) strengthened its balance sheet through long-term debt refinancing and a registered direct common stock offering, extending its cash runway. Veris Health, another subsidiary, completed a private placement financing with gross proceeds of $2.4 million, reflecting strong investor confidence in its long-term commercial potential. PAVmed Inc (NASDAQ:PAVM) faces uncertainties related to forward-looking statements, which are subject to known and unknown risks that could affect actual results. The company is still awaiting a response from the MolDX Group regarding Medicare coverage for EsoGuard, which introduces uncertainty in reimbursement timelines. PAVmed Inc (NASDAQ:PAVM) has ongoing discussions with financial and strategic investors for direct investment in PortIO Corp, indicating a need for additional funding. The deconsolidation of Lucid Diagnostics from PAVmed Inc (NASDAQ:PAVM)'s financial statements has led to complexities in financial reporting and understanding historical data. The company is dependent on securing funding for Veris Health and PortIO to cover incremental development costs, which could impact future operations if not obtained. Q: Can you provide details on the Veris Health Care Cancer platform's pilot program with Ohio State and the nature of the contract? A: Lishan Aklog, Chairman and CEO, explained that the engagement with Ohio State is both a commercial and strategic partnership. The contract will involve Ohio State enrolling a substantial number of patients in a registry, which will help in data collection for ongoing improvements and AI development. Ohio State will also be the first site for the initial implantation of the device once FDA cleared. Q: What is the timeline for the implantable device's FDA approval now that funding is secured? A: Lishan Aklog stated that the manufacturing process is being rebooted, and they expect to be ready for submission by the end of this year or early 2026. The FDA has been engaged in pre-submission meetings, and it appears a full-blown clinical trial may not be necessary, which could expedite the process. Q: Are there any competing products for Veris as you engage with other cancer centers? A: Lishan Aklog noted that while there are generic remote patient monitoring tools, Veris is unique as it is specifically designed for cancer patients undergoing systemic therapy. The implantable device is a proprietary technology that will serve as a significant differentiator and barrier to entry for competitors. Q: What is the path to FDA approval for PortIO, and are additional studies required? A: Lishan Aklog explained that PortIO is a new category of device using the intraosseous site for long-term vascular access. The pathway involves a de novo submission, and they plan to launch an IDE study with 50-80 patients, aiming for FDA clearance within two years of the study's start. Q: Can you provide insights into discussions with other institutions for Veris pilot launches and learnings from OSU? A: Lishan Aklog mentioned that they have had meaningful conversations with about a dozen cancer centers and more advanced discussions with four or five. The focus is currently on advancing the implantable device, and they plan to expand pilot sites after its clearance, leveraging data from the OSU engagement. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
24-03-2025
- Business
- Yahoo
Lucid Diagnostics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Processed a record 4,042 EsoGuard tests in 4Q24, a 45% sequential and 84% annual increase Recognized EsoGuard revenue of $1.2 million in 4Q24 New sales channel generated over 20 new cash-pay concierge medicine contracts Secured first agreement to pay for EsoGuard under state biomarker legislation Conference call and webcast to be held today, March 24th at 8:30 AM EDT NEW YORK, March 24, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), today provided a business update for the Company and reported financial results for the fourth quarter and full year ended December 31, 2024. Conference Call and Webcast The webcast will take place on Monday, March 24, 2024, at 8:30 AM and will be accessible in the investor relations section of the Company's website at Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. 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 Business Highlights "The Lucid team finished 2024 on a strong note and 2025—which promises to be a pivotal year—is off to an exceptional start marked by significant advancements in EsoGuard's commercial coverage, sales channels, and clinical evidence base," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We believe we are on the cusp of achieving broader payor coverage for EsoGuard and expect our focus on new contractually-guaranteed revenue sales channels, including concierge medicine, to drive revenue growth in the second half of 2025. We are now well positioned to capitalize on EsoGuard's very large clinical and market opportunity." Recognized $1.2 million in EsoGuard revenue for 4Q24. Processed a single-quarter record of 4,042 EsoGuard tests in 4Q24, a 45% sequential increase and 84% annual increase. Executed over 20 cash-pay concierge medicine contracts in the first few weeks following the launch of new sales channels targeting contractually-guaranteed revenue. Secured first positive commercial insurance coverage policy for EsoGuard from Highmark Blue Cross Blue Shield, establishing a strong precedent to drive additional positive policy coverage decisions. Secured first agreement to pay for EsoGuard under state biomarker legislation with Blue Cross Blue Shield of Rhode Island. Submitted EsoGuard clinical evidence package to MolDX in support of a request for reconsideration of existing Medicare Local Coverage Determination (LCD). Updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines now includes a section on esophageal precancer screening which references existing professional society guidelines recommending non-endoscopic biomarker testing, such as EsoGuard, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer. CLUE and ENVET-BE clinical utility studies accepted for peer-reviewed publication, further strengthening EsoGuard's already robust clinical evidence package. CLUE, now published, demonstrated high patient compliance with referral to endoscopy following a positive EsoGuard result. ENVET-BE demonstrated a nearly three-fold increase in the positive diagnostic yield of invasive endoscopy in at-risk patients recommended for precancer testing by ACG guidelines, further solidifying EsoGuard's role as a non-invasive triage tool. Case Western Reserve University and University Hospitals investigators awarded $8 million NIH grant to study EsoGuard for expanded indication in patients without GERD, potentially increasing the total addressable market opportunity beyond the current ~$60 billion based on an estimated 30 million at-risk patients with chronic GERD. Completed a $22 million convertible debt refinancing and a $15.3 million common stock financing, yielding a total of $32.8 million in net proceeds which extended cash runway beyond key reimbursement milestones. Eliminated "baby shelf" restrictions, providing greater flexibility for future financings. Regained compliance with Nasdaq minimum bid price requirement for continued listing on the Nasdaq Capital Market. Financial Results For the three months ended December 31, 2024, EsoGuard related revenues were $1.2 million. Operating expenses were approximately $13.6 million, which included stock-based compensation expenses of $1.2 million. GAAP net loss attributable to common stockholders was approximately $11.5 million or $(0.20) per common share. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted loss for the three months ended December 31, 2024, was approximately $10.9 million or $(0.19) per common share. Lucid had cash and cash equivalents of $22.4 million as of December 31, 2024. Pro forma cash, including the first quarter 2025 common stock financing, is approximately $36.9 million at the start of 2025. The audited financial results for the year ended December 31, 2024, were filed with the SEC on Form 10-K on March 24, 2025, and available at or Lucid Non-GAAP Measures To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three months and years ended December 31, 2024, and 2023 are as follows: Condensed consolidated statements of operations (unaudited) (in thousands except per-share amounts)For the three months ended December 31,For the year ended December 31, 2024202320242023Revenue$ 1,197$ 1,040$ 4,346$ 2,428Operating expenses13,57112,49450,39850,910 Other (Income) expense(833)(625)(523)4,184 Net Loss(11,541)(10,829)(45,529)(52,666) Net income (loss) per common share, basic and diluted$ (0.20)$ (0.26)$ (1.05)$ (1.26) Net loss attributable to common stockholders(11,541)(10,829)(53,025)(52,666) Preferred Stock dividends and deemed dividends——7,496— Net income (loss) as reported(11,541)(10,829)(45,529)(52,666) Adjustments: Depreciation and amortization expense12226291,1672,499 Interest expense, net2(58)(85)(296)(8) EBITDA(11,377)(10,285)(44,658)(50,175)Other non-cash or financing related expenses: Stock-based compensation expense31,1729654,5346,822 ResearchDx acquisition paid in stock1———713 Operating expenses issued in stock198—34623 Change in FV convertible debt2(4,825)(540)(5,394)2,980 Offering costs convertible debt2———1,186 Debt extinguishments loss - Senior Secured Convertible Note24,050—5,16726 Non-GAAP adjusted (loss)$ (10,882)$ (9,860)$ (40,005)$ (38,425) Basic and Diluted shares outstanding58,37842,33050,51641,756 Non-GAAP adjusted (loss) income per share$(0.19)$(0.23)$(0.79)$(0.92)1 Included in general and administrative expenses in the financial statements. 2 Included in other income and expenses. 3 Stock-based compensation ("SBC") expense included in operating expenses is detailed as follows in the table below by category within operating expenses for the non-GAAP Net operating expenses: Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses (in thousands except per-share amounts)For the three months ended December 31,For the year ended December 31, 2024202320242023 Cost of revenues$ 2,145$ 1,458$ 7,099$ 5,979 Stock-based compensation expense3(42)(30)(164)(100) Net cost of revenues2,1031,4286,9355,879Amortization of intangible assets1055056862,021Sales and marketing4,0034,40816,46316,404 Stock-based compensation expense3(300)(356)(1,365)(1,411) Net sales and marketing3,7034,05215,09814,993General and administrative5,8654,20520,15819,254 Depreciation expense(117)(124)(481)(478) RDx Settlement in Stock———(713) Operating expenses issued in stock(98)—(346)(23) Stock-based compensation expense3(691)(390)(2,330)(4,628) Net general and administrative4,9593,69117,00113,412Research and development1,4531,9185,9927,252 Stock-based compensation expense3(139)(189)(675)(683) Net research and development1,3141,7295,3176,569Total operating expenses13,57112,49450,39850,910 Depreciation and amortization expense(222)(629)(1,167)(2,499) RDx Settlement in Stock———(713) Operating expenses issued in stock(98)—(346)(23) Stock-based compensation expense3(1,172)(965)(4,534)(6,822) Net operating expenses$ 12,079$ 10,900$ 44,351$ 40,853 About EsoGuard and EsoCheck Millions of patients with gastroesophageal reflux disease (GERD) are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80 percent of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500 percent over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5 percent to 15 percent of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer. Esophageal precancer screening is already recommended by clinical practice guidelines for the millions of GERD patients with multiple risk factors, including age over 50 years, male sex, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10 percent of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that death could likely have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment at the precancer stage. The only missing element for a viable esophageal cancer prevention program has been the lack of an easily-accessible, in-office screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected non-endoscopically with EsoCheck, is the missing element – the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of Gastroenterology (ACG) clinical practice guideline and an American Gastroenterological Association (AGA) clinical practice update both endorse non-endoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States. EsoGuard is a Next Generation Sequencing (NGS) based DNA methylation assay performed on surface esophageal cells collected with EsoCheck, which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was initially evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90 percent sensitivity and specificity at detecting esophageal precancer and cancer. EsoCheck is a CE Marked and FDA 510(k) cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than three-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid's CLIA-certified, CAP-accredited, NYS CLEP approved laboratory, LucidDx Labs, for EsoGuard testing. About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with GERD, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information, please visit and for more information about its parent company PAVmed, please visit Forward-Looking Statements This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics' management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. View original content to download multimedia: SOURCE Lucid Diagnostics Sign in to access your portfolio
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27-02-2025
- Health
- Yahoo
Renowned Investigators Awarded $8 Million NIH Grant to Study Lucid Diagnostics' EsoGuard® in At-Risk Patients without Symptomatic GERD
Lucid to support study of this expanded indication for esophageal precancer testing in partnership with NIH investigators NEW YORK, Feb. 27, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that a consortium of prestigious academic medical centers, led by principal investigators from Case Western Reserve University (CWRU) and University Hospitals (UH), has been awarded an $8 million National Institutes of Health (NIH) R01 grant to conduct a five-year clinical study designed to evaluate esophageal precancer detection using Lucid's EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test among at-risk individuals without symptoms of chronic gastroesophageal reflux disease (GERD). The study, "A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett's Esophagus and Its Progression," aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett's Esophagus or BE) to prevent esophageal cancer (EAC) within a non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association's (AGA) risk criteria for screening will be recruited across five participating research centers: University Hospitals, University of Colorado, Johns Hopkins University, University of North Carolina, and Cleveland Clinic. "Patients without GERD symptoms account for nearly half of prevalent esophageal cancer cases," said Amitabh Chak, M.D., Professor of Medicine and Oncology at CWRU, gastroenterologist at UH, and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center. "However, these individuals would be excluded from screening based on the American College of Gastroenterology (ACG) guidelines where chronic GERD is a mandatory prerequisite. We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened, and to do so in a manner that does not over-tax limited endoscopy resources. Given the dismal 20% five-year survival associated with esophageal cancer, increased detection and treatment of BE is the best strategy to meaningfully impact esophageal cancer-related mortality." "We are excited to support this landmark study, continuing our longstanding collaboration with Drs. Amitabh Chak, Sanford Markowitz, and Joseph Willis, principal investigators on the NIH grant, and are gratified that the NIH has committed substantial resources focused on our technology," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "This study has the potential to significantly expand the target population for EsoGuard esophageal precancer testing." The technology behind EsoGuard and EsoCheck was developed at CWRU and UH by faculty members Sanford Markowitz, M.D., Ph.D., Amitabh Chak, M.D., Joseph Willis, M.D., and Helen Moinova, Ph.D. They have collaborated closely with the Lucid team since Lucid licensed the technologies on an exclusive basis from CWRU in 2018. About Lucid DiagnosticsLucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information about Lucid, please visit and for more information about its parent company PAVmed, please visit View original content to download multimedia: SOURCE Lucid Diagnostics Sign in to access your portfolio
