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Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Report
2025-05-13 20:58
Financial Performance - Revenue for the three months ended March 31, 2025, was $0.8 million, a decrease of 20% compared to $1.0 million for the same period in 2024[141] - Cost of revenue for the three months ended March 31, 2025, was approximately $1.6 million, down from $1.7 million in the prior year, reflecting a decrease of about 5.88%[142] - Sales and marketing expenses for the three months ended March 31, 2025, were approximately $4.1 million, a slight decrease of 2.38% from $4.2 million in the same period last year[142] - General and administrative expenses increased to approximately $6.2 million for the three months ended March 31, 2025, compared to $4.1 million in the same period of the prior year, reflecting a net increase of $2.1 million[143] - Research and development costs decreased to approximately $1.4 million for the three months ended March 31, 2025, down from $1.5 million in the prior year, primarily due to a $0.3 million decrease in manufacturing costs related to EsoCheck devices[144] - The amortization of acquired intangible assets was approximately $0.1 million for the three months ended March 31, 2025, compared to $0.4 million in the prior year, a decrease of $0.3 million due to certain assets being fully amortized[146] - The company experienced a net loss of approximately $26.9 million and used approximately $12.5 million of cash in operations during the quarter ended March 31, 2025[152] - Cash on hand at the end of the quarter was $25.2 million as of March 31, 2025[152] Funding and Capital Raising - The Company closed on the sale of 14,375,000 shares at $1.20 per share in April 2025, resulting in net proceeds of approximately $16.1 million for working capital[122] - The company closed on the sale of 13,939,331 shares of common stock at $1.10 per share on March 5, 2025, resulting in net proceeds of approximately $14.9 million[156] - On April 11, 2025, the company sold 14,375,000 shares of common stock at $1.20 per share, generating net proceeds of approximately $16.1 million[157] - The company raised gross proceeds of $21.975 million from the sale of 12.0% Senior Secured Convertible Notes due 2029 on November 22, 2024, with net proceeds of $18.3 million after repaying the March 2023 Senior Convertible Note[160] - The company has entered into a committed equity facility allowing for the purchase of up to $50 million of common stock, with $1.8 million raised as of March 31, 2025[158] Product Development and Research - The EsoGuard Esophageal DNA Test has demonstrated a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99%[119] - The Company plans to incur research and development expenses for the foreseeable future to support the development of existing products and new innovations[136] - An $8 million NIH grant was awarded for a five-year clinical study evaluating EsoCheck and EsoGuard for esophageal precancer detection among at-risk individuals without GERD symptoms[128] - EsoCheck is an FDA 510(k) and CE Mark cleared device that allows for non-invasive sampling of surface esophageal cells in a less than five-minute office procedure[120] Regulatory and Coverage Updates - A recent update to the NCCN Clinical Practice Guidelines now includes a section on Barrett's Esophagus (BE) screening, recommending non-endoscopic biomarker testing like EsoGuard as an alternative to invasive procedures[125] - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York, covering patients meeting established criteria for esophageal precancer testing[127] Accounting and Compliance - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts[164] - There have been no material changes to the company's critical accounting estimates in the three months ended March 31, 2025[164] - As of March 31, 2025, the company had a payment obligation liability of $0.0 million, indicating no accrued obligations under the payroll and benefit expense reimbursement agreement or other operating expenses[163] Strategic Focus - The company is focused on the commercialization of EsoGuard and expanding insurance reimbursement coverage while developing additional products and services[150]
Will Lucid Diagnostics Inc. (LUCD) Report Negative Earnings Next Week? What You Should Know
ZACKS· 2025-05-07 15:05
Company Overview - Lucid Diagnostics Inc. (LUCD) is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year improvement of +57.1% [3] - Revenues for the upcoming quarter are anticipated to be $1.3 million, which is a 30% increase from the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 40% higher in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Lucid Diagnostics aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [10][11] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likelihood of actual earnings deviating from consensus estimates, with a strong predictive power for positive readings [7][8] - Lucid Diagnostics currently holds a Zacks Rank of 2 (Buy), but this combination does not strongly indicate an earnings beat [11] Historical Performance - In the last reported quarter, Lucid Diagnostics was expected to post a loss of $0.15 per share but actually reported a loss of $0.19, resulting in a surprise of -26.67% [12] - The company has not beaten consensus EPS estimates in any of the last four quarters [13] Market Context - The upcoming earnings report for Lucid Diagnostics is scheduled for May 14, and the stock's movement will depend on whether the actual results exceed or fall short of expectations [2] - Other factors beyond earnings results may also influence stock performance, as stocks can decline despite an earnings beat or rise despite a miss [14][16]
Lucid Diagnostics to Hold a Business Update Conference Call and Webcast on May 14, 2025
Prnewswire· 2025-04-30 12:31
Core Points - Lucid Diagnostics Inc. will host a business update conference call and webcast on May 14, 2025, at 8:30 AM ET to discuss company operations and growth strategy [1] - The call will feature Lishan Aklog, M.D., the CEO, and Dennis McGrath, the CFO, who will present the first quarter 2025 financial results [1] - The conference call can be accessed via telephone or through the company's investor relations website [2] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [4] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [4] - Lucid's EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device are the first commercially available tools aimed at early detection of esophageal precancer [4]
NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD
Prnewswire· 2025-04-24 12:01
Core Insights - Lucid Diagnostics Inc. announced positive data from a National Cancer Institute-sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer in at-risk patients without GERD symptoms, potentially expanding the target population and market opportunity [1][2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [4] Study Findings - The study enrolled patients without GERD symptoms who met AGA recommendations for Barrett's Esophagus (BE) screening, demonstrating a 100% negative predictive value for detecting esophageal precancer [2] - The prevalence of BE in the study was found to be 8.4%, comparable to rates in symptomatic GERD patients [2] Market Opportunity - If the ongoing multicenter NIH-sponsored study replicates the promising results, the market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70%, potentially reaching a total of approximately $60 billion [3]
NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD
Prnewswire· 2025-04-24 12:01
Core Insights - Lucid Diagnostics Inc. announced positive data from a National Cancer Institute-sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer in at-risk patients without GERD symptoms, potentially expanding its market opportunity [1][2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [4] Study Findings - The study enrolled patients without GERD symptoms who met AGA recommendations for Barrett's Esophagus (BE) screening, demonstrating a 100% negative predictive value (NPV) for detecting esophageal precancer [2] - The prevalence of Barrett's Esophagus in the study was found to be 8.4%, comparable to rates in symptomatic GERD patients [2] Market Opportunity - If the ongoing multicenter NIH-sponsored study replicates the promising results, the market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70%, potentially reaching a total of approximately $60 billion [3]
Lucid Diagnostics Announces Pricing of Public Offering of Common Stock
Prnewswire· 2025-04-09 23:24
Core Viewpoint - Lucid Diagnostics Inc. has announced a public offering of 12,500,000 shares at a price of $1.20 per share, aiming to raise approximately $15 million for working capital and general corporate purposes [1][2]. Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [6]. Offering Details - The offering includes a 45-day option for underwriters to purchase an additional 1,875,000 shares at the public offering price [1]. - The gross proceeds from the offering are expected to be around $15 million, excluding any proceeds from the underwriters' option [2]. - The offering is expected to close on or about April 11, 2025, subject to customary closing conditions [2]. Underwriters - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [3]. Regulatory Information - The offering is made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022 [4]. - A prospectus supplement will be filed with the SEC, and the securities may only be offered by means of a written prospectus [4].
Lucid Diagnostics Announces Proposed Public Offering of Common Stock
Prnewswire· 2025-04-09 20:01
Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Offering Details - Lucid Diagnostics announced its intention to offer shares of common stock through an underwritten public offering, with plans to grant underwriters a 45-day option to purchase additional shares. Proceeds from the offering are expected to support working capital and general corporate purposes [1]. - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [2]. Regulatory Information - The offering is being made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022. A prospectus supplement will be filed with the SEC [3].
Lucid Diagnostics to Participate in Fireside Chat at the 24th Annual Needham Virtual Healthcare Conference
Prnewswire· 2025-04-03 13:00
NEW YORK, April 3, 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 Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer, will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Thursday, April 10, 2025 at 11:00 AM EDT. The fireside chat will be webcast live and can be accessed by visitin ...
Lucid Diagnostics Launches "Embrace the Future" Campaign Showcasing EsoCheck's Groundbreaking Collect+Protect Esophageal Cell Collection Technology
Prnewswire· 2025-03-27 12:01
Core Insights - Lucid Diagnostics Inc. has launched a campaign titled "Embrace the Future" to promote its EsoCheck® Esophageal Cell Collection Device, coinciding with Esophageal Cancer Awareness Month and the upcoming Digestive Disease Week (DDW) Conference [1] - The EsoCheck device has demonstrated outstanding performance in nearly 30,000 patients, showcasing a pristine safety record and high patient satisfaction, with a procedure time of less than three minutes [2] - EsoCheck, when used with Lucid's EsoGuard® Esophageal DNA Test, has achieved an unprecedented negative predictive value (NPV) of approximately 99% in detecting esophageal precancer [2] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [4] - The company's EsoGuard® Esophageal DNA Test, performed on samples collected via the EsoCheck device, is the first and only commercially available tool aimed at preventing cancer through early detection of esophageal precancer in at-risk patients [4] Industry Context - Esophageal Cancer Awareness Month serves as a reminder of the approximately 16,000 annual deaths in the U.S. due to esophageal cancer, which is now considered preventable with modern technologies [3] - The traditional "sponge-on-a-string" (SOS) devices used for cell collection have been criticized for their poor performance and safety issues, leading to multiple FDA recalls, while EsoCheck offers a targeted and safe alternative [3]
Lucid Diagnostics(LUCD) - 2024 Q4 - Annual Results
2025-03-25 12:00
Financial Performance - Recognized EsoGuard revenue of $1.2 million in Q4 2024, compared to $1.04 million in Q4 2023, marking a 15% year-over-year growth[10] - Operating expenses for Q4 2024 were approximately $13.6 million, including stock-based compensation expenses of $1.2 million[5] - GAAP net loss attributable to common stockholders was approximately $11.5 million or $(0.20) per common share for Q4 2024[5] - Non-GAAP adjusted loss for Q4 2024 was approximately $10.9 million or $(0.19) per common share[8] - Pro forma cash, including the first quarter 2025 common stock financing, is approximately $36.9 million at the start of 2025[8] - 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[6] Product Performance and Development - Processed a record 4,042 EsoGuard tests in Q4 2024, representing a 45% sequential increase and an 84% annual increase[6] - EsoGuard is the first and only commercially available test for esophageal precancer screening, endorsed by updated clinical practice guidelines[15] - The EsoGuard assay demonstrated over 90% sensitivity and specificity in detecting esophageal precancer and cancer based on a study of 408 patients[16] - EsoCheck is a noninvasive device that collects esophageal cell samples in under three minutes, utilizing proprietary Collect+Protect™ technology[17] - Lucid Diagnostics targets millions of GERD patients at risk for esophageal precancer and cancer, aiming to prevent cancer deaths through early detection[18] - The EsoGuard test is based on Next Generation Sequencing (NGS) and quantifies methylation at 31 sites on two genes[16] Regulatory and Market Developments - Secured first positive commercial insurance coverage policy for EsoGuard from Highmark Blue Cross Blue Shield, establishing a precedent for additional coverage decisions[6] - Updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines now includes EsoGuard as an acceptable alternative for esophageal precancer screening[6] - Case Western Reserve University and University Hospitals received an $8 million NIH grant to study EsoGuard for expanded indications, potentially increasing the total addressable market beyond $60 billion[6] Company Overview and Strategy - The company is a subsidiary of PAVmed Inc., focusing on cancer prevention medical diagnostics[18] - Lucid Diagnostics emphasizes the importance of screening, as fewer than 10% of at-risk patients currently undergo traditional screening[14] - Lucid Diagnostics plans to continue advancing its products through regulatory submissions and market expansion efforts[20] Risks and Challenges - Lucid Diagnostics faces risks including stock price volatility, regulatory uncertainties, and market acceptance of its products[20] - The company has a CLIA-certified, CAP-accredited laboratory for conducting EsoGuard tests[17]