Study supports expanded indication and market opportunity for EsoGuard esophageal precancer testing NEW YORK, April 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), today announced positive data from a National Cancer Institute (NCI)-sponsored study demonstrating that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer (Barrett's ...

Core Insights - Bluejay Diagnostics, Inc. announced the acceptance of an abstract for the Symphony IL-6 Test at the SAEM Annual Meeting, highlighting its potential in sepsis management [1][2] - The SYMON-I study results will be presented, focusing on IL-6 as a prognostic biomarker for mortality in sepsis patients [1][4] Company Overview - Bluejay Diagnostics is focused on developing rapid and accessible biomarker testing, with its lead product being the Symphony IL-6 Test for sepsis triage [5] - The Symphony IL-6 Test aims to provide results in approximately 20 minutes, assisting healthcare professionals in making timely treatment decisions [5] Clinical Study Details - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I being a pilot study assessing IL-6 levels related to various mortality endpoints [4] - SYMON-II is a pivotal study intended to validate SYMON-I outcomes and support a 510(k) application to the FDA [4] Presentation Information - The presentation titled "Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)" will take place on May 14, 2025, by presenters John H. Lee, M.D., Ph.D. and Nathan Shapiro, M.D. [3]

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].

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].

Financial Data and Key Metrics Changes - In Q4, the company reported pharma services revenue of $1.5 million with a gross margin of 40%, exceeding expectations [27][28] - The outgoing cash flow in Q4 was $5.6 million, favorable to the targeted spend of $6 million, finishing the year with $10 million in cash [33][34] - The company successfully raised an additional $29 million in February, with significant participation from its largest shareholders, including Bio-Rad [35][36] Business Line Data and Key Metrics Changes - The company launched GraftAssure, a kidney transplant test, which has been utilized at leading transplant centers, providing valuable feedback for product development [5][8] - The company expects to have 20 transplant centers signed up by the end of 2025, translating to approximately $20 million in future annual recurring revenue [21] Market Data and Key Metrics Changes - The company achieved Medicare claims expansion to monitor high-risk transplant patients, potentially expanding the total addressable market by up to 20% [10] - The rollout of iota this summer is expected to increase the use of more marginal organs, contributing to market expansion over the next five years [11] Company Strategy and Development Direction - The company is focused on finalizing assay design, launching clinical trials, and submitting data packages to the FDA, with a projected timeline for market approval by mid-2026 [18] - The company aims to deepen relationships with potential strategic partners through its pharma services business, which provides non-dilutive capital [28][30] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about 2025, emphasizing the importance of finalizing the assay design and launching clinical trials [18] - The company is monitoring macro uncertainties around federal government funding that could affect timelines but remains optimistic about the FDA review process [15][17] Other Important Information - The company is committed to disciplined cash management, targeting about $6 million per quarter in cash burn for 2025 [39] - The company is focused on operational efficiency, which has allowed it to maintain a strong cash position while advancing its clinical assay development [34][38] Q&A Session Summary Question: Regulatory pathway and timing for FDA approval - The company is budgeting seven months for the de novo pathway, which is preferred due to the lack of a predicate device for donor-derived cell-free DNA [44] Question: Number of centers required for FDA package - A minimum of three sites is required for reproducibility work, with expectations to double that in the US and include centers in Europe [46][49] Question: Timing of FDA submission - The company is cautiously optimistic about enrolling 150 patients quickly, but is being conservative due to uncertainties in the regulatory environment [52] Question: Revenue from GraftAssure kits before FDA clearance - The company does not project material revenue from the RUO product this year, with significant revenue expected post-FDA clearance [57] Question: Bio-Rad's support for clinical trials - The company expects Bio-Rad to provide support for instruments and consumables, which will offset a significant portion of trial expenses [60] Question: Clinical evidence priorities post-FDA approval - The company plans to invest in heart, liver, and lung assays after establishing its kidney transplant assay [66] Question: Integration of the assay into existing workflows - The assay is designed to be easy to integrate into existing workflows, requiring minimal additional education for labs already performing HLA testing [75] Question: Competition response to market entry - The company anticipates competitors will highlight their experience and patient sample volume, but believes its FDA study will demonstrate the assay's clinical utility [81]

Financial Data and Key Metrics Changes - The company generated $1,200,000 in revenue for the fourth quarter, reflecting a 15% increase compared to the same quarter last year [27][28] - Test volume exceeded 4,000 tests in the fourth quarter, representing a record quarterly test volume [7][28] - The quarterly burn rate was $10,100,000, lower than the average burn rate of $11,000,000 for the preceding four quarters [25] Business Line Data and Key Metrics Changes - The EsoGuard sales channels have seen significant advancements, with a focus on expanding coverage and reimbursement [6][9] - The concierge medicine cash pay program has signed 20 contracts within a few weeks of launch, indicating strong initial traction [8][20] Market Data and Key Metrics Changes - The company has submitted claims to 400 payers, with ongoing conversations with numerous commercial payers [94] - The NCCN guidelines now include a section on screening for esophageal precancer, which is expected to influence positive policy coverage decisions from commercial payers [10][70] Company Strategy and Development Direction - The company is focused on driving revenue through expanded sales channels, including direct contracting with employers and concierge medicine [14][19] - The recent positive insurance coverage policy from Highmark Blue Cross Blue Shield is seen as a precedent for future engagements with commercial payers [9][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for significant growth in test volume and revenue in the second half of the year, particularly with the expected Medicare coverage [22][60] - The company is confident in its ability to scale operations and target the Medicare population effectively once coverage is secured [59][61] Other Important Information - The company secured an $8,000,000 NIH grant to study EsoGuard for expanded indications, which could significantly increase the total addressable market [12][48] - The balance sheet was strengthened through long-term debt refinancing and a registered direct common stock offering, extending the runway well past key reimbursement milestones [11][24] Q&A Session Summary Question: How should we think about the volume metric going forward? - Management advised to remain conservative on test volume expectations, focusing more on revenue rather than just volume [36][37] Question: Why was the effective ASP lower than expected? - The lower ASP was attributed to the timing of payments rather than a direct reflection of payment rates [42][44] Question: Can you size the opportunity from the $8,000,000 NIH grant? - The opportunity is significant, potentially adding 20 million patients to the screening recommendations [48][50] Question: What happens if Medicare coverage is secured? - The company plans to aggressively target the Medicare population and expects to submit a backlog of claims [60][86] Question: How will NCCN inclusion help the company? - Inclusion in NCCN guidelines is expected to serve as a powerful tool in discussions with commercial payers [70][72]

Sera Prognostics Inc (NASDAQ:SERA) Q4 2024 Earnings Conference Call March 19, 2025 5:00 PM ET Company Participants Peter DeNardo - IR, CapComm Partners Evguenia Lindgardt - President, CEO & Director Austin Aerts - CFO Conference Call Participants Dan Brennan - TD Cowen Margarate Boeye - William Blair Operator Good afternoon, and welcome to the Sera Prognostics Conference Call to review Fourth Quarter Fiscal Year 2024 Results. At this time, all participants are in listen-only mode. We will be facilitating a ...

Financial Data and Key Metrics Changes - Total revenue for 2024 reached a record $55.6 million, marking a 6% increase from 2023, primarily driven by ASP expansion [31][32] - Adjusted EBITDA loss narrowed to approximately $10 million, showcasing a 40% improvement over 2023 [39] - Gross margin expanded to just under 60% in 2024 compared to 56% in 2023, with Q4 gross margin at about 62% [35][36] Business Line Data and Key Metrics Changes - The average selling price (ASP) for AVISE CTD increased to $411, up $75 from 2023 and $126 since 2022 [32][8] - Testing volume for 2024 was 123,000 AVISE CTD units, down 11% relative to 2023 [136] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in rheumatoid arthritis (RA), estimating an annual rate of connective tissue disease evaluations at around 2.5 million tests, with a conservative penetration estimate of about 5% [104] Company Strategy and Development Direction - The company is focused on enhancing its value proposition in the RA market with the launch of new biomarkers, which are expected to broaden the utility for clinicians [79][81] - Plans to expand sales territories from 40 to potentially mid-40s during 2025 to drive profitable growth [127] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, expecting strong revenue growth driven by both ASP expansion and volume [24] - The company aims to achieve positive adjusted EBITDA by Q4 2025, marking a key milestone in its turnaround strategy [40] Other Important Information - The company has made significant investments in capacity and technology to meet expected demand, including a $1.2 million investment in flow cytometry equipment [70] - The launch of new biomarkers is seen as a catalyst for both patient care and competitive differentiation in the market [20][22] Q&A Session Summary Question: Can you help us think about modeling for ASP going forward based on the new markers? - Management indicated that while they cannot provide precise guidance for 2025, the $90 incremental revenue from new markers is a reasonable approximation, with potential for ASP to trend upwards [48][49] Question: What is the adjusted EBITDA profitability target for Q4? - Management confirmed that adjusted EBITDA is a good proxy for free cash flow, with expectations for positive adjusted EBITDA in Q4 2025 [54] Question: What is the sensitivity improvement from the RA33 launch? - The new T cell biomarkers improve sensitivity for lupus diagnosis, capturing roughly 51% of previously undiagnosed patients, while RA markers are expected to capture 15-16% of seronegative patients [65][68] Question: How does the company plan to recover lost volume from physicians? - Management believes the business is recoverable and is focused on optimizing processes to facilitate smoother interactions with physicians [94] Question: What is the opportunity for the test to penetrate the RA market? - The company estimates the RA market opportunity at around 2.5 million tests annually, with a conservative penetration estimate of about 5% [104] Question: How will the company balance volume growth with profitability? - Management expects to see volume growth improve in 2025, with plans for sales expansion and a focus on enhancing the quality of the sales team [111][113]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [5] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Recent Offering - Lucid Diagnostics announced subscription agreements to sell 13,939,331 shares of common stock at a price of $1.10 per share, expecting gross proceeds of approximately $15.3 million [1]. - The offering is being managed by Canaccord Genuity as the sole placement agent, with the closing expected around March 5, 2025, subject to customary conditions [2]. Use of Proceeds - The net proceeds from the offering will be used for working capital and other general corporate purposes [2]. Regulatory Information - The securities are being offered under a registration statement on Form S-3, which was declared effective by the SEC on December 6, 2022 [3]. - A prospectus supplement will be filed with the SEC regarding the securities being offered [3]. Product Information - Lucid's EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients, utilizing a noninvasive office procedure with the EsoCheck® Esophageal Cell Collection Device [5].

Financial Data and Key Metrics Changes - In Q4 2024, revenue totaled $119 million, representing a 21% year-over-year growth, while full-year revenue reached $446 million, reflecting a robust 23% year-over-year growth [9][32] - Testing revenue, which constitutes nearly 95% of the business, grew by 28% year-over-year [9] - The adjusted EBITDA margin for the full year was 20.6%, with cash generation exceeding $70 million [10][38] Business Line Data and Key Metrics Changes - Decipher testing revenue grew 44% year-over-year in Q4, with volume growth of 36% for the full year [10][33] - Afirma testing revenue increased by 4% year-over-year in Q4, with volume growth of 8% [16][33] - Prosigna revenue decreased by 18% year-over-year due to supply and manufacturing challenges [34] Market Data and Key Metrics Changes - The prostate cancer market is estimated to be approximately 40% penetrated, with the company holding over 65% market share, which increased by more than 500 basis points in 2024 [13] - The endocrinology market is about 65% penetrated, with growth projected in the low-single-digits [19] Company Strategy and Development Direction - The company aims for at least 80% market penetration across all indications, with Decipher being the only gene expression test recommended by the NCCN for personalized treatment decisions in prostate cancer [14] - The company is focusing on international expansion and launching tests as IVDs to meet patient needs outside the U.S. [25] - The NIGHTINGALE study for nasal swab testing has enrolled over 85% of the targeted 2,400 patients, with plans to demonstrate clinical utility [21][98] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of Decipher and Afirma, emphasizing the strong market opportunities and the importance of clinical evidence [55][92] - The company is navigating challenges related to its French subsidiary, which may impact timelines and operations [26][27] - Guidance for 2025 includes testing revenue of $470 million to $480 million, reflecting 12% to 15% year-over-year growth [42] Other Important Information - The company recorded a GAAP net income of $5.1 million in Q4 2024, with a significant tax benefit resulting in a negative effective tax rate [37][39] - The company is considering ceasing funding for its French operations, which may lead to bankruptcy proceedings if a buyer is not found [26][27] Q&A Session Summary Question: How does the company balance investment and margin improvement? - Management highlighted the importance of focusing on core products and long-term growth drivers while managing costs effectively [49][55] Question: What is the expected contribution of Afirma revenue growth? - The guidance for Afirma includes high-single-digit growth, primarily driven by volume rather than pricing [50][59] Question: Can you provide insights on metastatic revenue guidance? - Management indicated that the metastatic indication will have a more significant impact in the second half of the year, with a focus on proper launch and customer education [62][65] Question: What factors are contributing to Decipher's volume growth? - The NCCN guidelines and strong clinical evidence are key contributors to Decipher's growth, with ongoing efforts to generate more evidence [74][80] Question: What is the status of Prosigna and biopharma products? - Management clarified that Prosigna will continue, but its future is dependent on the outcome of the French entity's situation [83][86] Question: What are the potential upside levers for Decipher in 2025? - The company sees significant market opportunity with 60% of the market still unpenetrated, aiming for increased utilization and expansion into new accounts [91][92]