Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors [4] - The company has two subsidiaries: Lucid Diagnostics, which focuses on cancer prevention diagnostics, and Veris Health, which enhances personalized cancer care through remote patient monitoring [4] Upcoming Conference Call - PAVmed will host a business update conference call and webcast on May 15, 2025, at 8:30 AM ET [1] - The call will feature Lishan Aklog, M.D., providing an overview of the company's operations and growth strategy, and Dennis McGrath discussing the first quarter 2025 financial results [1] Access Information - The webcast will be available on the investor relations section of the company's website [2] - U.S.-based callers can join the conference call by dialing 1-800-836-8184, while international listeners should dial 1-646-357-8785 [2] Replay Availability - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3]

Company Overview - Microbix Biosystems Inc. is a life sciences innovator, manufacturer, and exporter, focusing on proprietary biological products for human health [4] - The company has over 120 skilled employees and aims for revenues of C$ 2.0 million or more per month [4] - Microbix specializes in critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [4][5] Product and Service Offerings - Microbix's antigens support antibody tests for approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs [4] - The company also develops proprietary products such as Kinlytic, a biologic thrombolytic drug for treating blood clots, and reagents for molecular diagnostic testing [5] Conference Participation - Microbix will attend and present at the 2025 Bloom Burton & Co. Healthcare Investor Conference on May 5 & 6, 2025 [1][2] - CEO Cameron Groome will present to investors on May 6 at 2:30 p.m. Eastern Time, and senior management will engage in one-on-one meetings with investors [2] Industry Context - The Bloom Burton & Co. Conference aims to connect investors with developments in the Canadian healthcare and life sciences sector [2][3] - Bloom Burton & Co. provides capital raising, M&A advisory, equity research, and strategic advisory services to accelerate returns in the healthcare sector [3]

Financial Data and Key Metrics Changes - The company reported a net loss of $67.6 million or $0.10 per share for Q1 2025, compared to a net loss of $81.8 million or $0.12 per share for the same period in 2024 [24] - Total revenue for Q1 2025 was $149.9 million, a decrease from $173.7 million in Q1 2024, primarily due to the sale of assets to LabCorp [18][20] - Operating loss for Q1 2025 was $58.7 million, compared to an operating loss of $62.1 million in Q1 2024 [24] Business Line Data and Key Metrics Changes - Diagnostics segment revenue was $102.8 million for Q1 2025, down from $126.9 million in Q1 2024, largely due to the LabCorp transaction [18][20] - The Pharmaceutical segment revenue increased slightly to $47.1 million in Q1 2025 from $46.8 million in Q1 2024, with product revenue including international sales at $34.8 million [20] - The 4Kscore test in the Diagnostics segment reported a 14.5% year-over-year growth [10] Market Data and Key Metrics Changes - The company anticipates total revenues for 2025 to be between $675 million and $685 million, with service revenue projected between $400 million and $425 million [29] - Revenue from products is expected to be between $165 million and $175 million, while other revenue, including Pfizer gross profit share, is estimated between $30 million and $40 million [29] Company Strategy and Development Direction - The company is focused on advancing its strategic initiatives, including the sale of BioReference's oncology business to LabCorp, which is expected to enhance profitability [5][9] - A $100 million increase in the common stock repurchase program was approved, bringing the total to $200 million, indicating confidence in the company's undervalued shares [7] - The company aims to reach profitability within the year and is executing a multi-year program to improve operational efficiencies in the Diagnostics segment [12][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive value for shareholders despite challenges in the commercial environment affecting product sales [5][20] - The company expects to incur additional non-recurring costs of $5 million in Q2 2025, primarily related to severance [28] - Management remains optimistic about the progress of its pharmaceutical programs and the potential for profitability in the Diagnostics segment post-LabCorp transaction [18][28] Other Important Information - The company ended Q1 2025 with approximately $450 million in cash and equivalents, having exited its position in GNDX, adding $51 million to its cash balance [25] - The company completed a convertible debt exchange, eliminating $159.2 million of outstanding convertible notes [25] Q&A Session Summary Question: What are some possible explanations for the negative dynamics for ENGENLA? - Management indicated that the growth rates for prescriptions continue, suggesting the issue is likely related to the commercial environment rather than competition [33] Question: Could you comment on why Pfizer withdrew their EU application for the adult setting? - Management noted that Pfizer is focusing on pediatric indications due to the larger market size, which influenced their decision [34] Question: Could you provide a rough timeline about the development program of the GLP-oneglucagon tablet candidate? - The IND is expected to be filed by the end of this year or early next year, with Phase one trial results anticipated by the end of 2026 [37][38] Question: Can you give us a sense of the Diagnostic business and BioReference? - Management confirmed that the remaining business is expected to generate between $310 million and $320 million on an annualized basis [45] Question: What are the next steps for the subcutaneous obesity program and NASH program? - Both programs are in the pre-IND phase, with plans to enter Phase I trials soon, focusing on safety and pharmacological behavior [56][57]

Core Insights - OPKO Health, Inc. reported a consolidated total revenue of $149.9 million for Q1 2025, a decrease from $173.7 million in Q1 2024, with an operating loss of $67.2 million compared to $71.5 million in the previous year [2][3][14] - The company signed a definitive agreement with Labcorp to sell oncology and related clinical testing assets for up to $225 million, expected to close in the second half of 2025 [2] - OPKO entered into a collaboration agreement with Entera Bio to develop an oral GLP-1/glucagon tablet candidate for obesity and metabolic disorders, with OPKO holding a 60% ownership interest [2] - The company authorized an additional $100 million for its common stock repurchase program, increasing the total capacity to $200 million [2] Financial Performance - Total revenues for Q1 2025 were $149.9 million, down from $173.7 million in Q1 2024, with revenues from services at $102.8 million compared to $126.9 million in the prior year [14] - Revenue from products was $34.8 million, a decrease from $38.1 million in Q1 2024, primarily due to unfavorable foreign currency exchange rates and a decline in Rayaldee sales [3][14] - The net loss for Q1 2025 was $67.6 million, or $0.10 per share, compared to a net loss of $81.8 million, or $0.12 per share, in Q1 2024 [14] Operational Highlights - The company is advancing its immuno-oncology and immunology portfolio, with multiple clinical candidates in development, including MDX2001, MDX2003, and MDX2004 [2] - Enrollment and dosing for a Phase 1 Epstein-Barr virus vaccine trial, developed in collaboration with Merck, have commenced [2] - OPKO's cash, cash equivalents, and restricted cash totaled $449.7 million as of March 31, 2025, following the sale of GeneDx shares [8] Strategic Initiatives - The sale of BioReference's oncology assets is part of OPKO's strategy to streamline operations while maintaining core clinical testing services, which generated approximately $300 million in revenue for 2024 [2] - The collaboration with Entera Bio aims to leverage OPKO's proprietary technology to address obesity and metabolic disorders, indicating a focus on innovative therapeutic solutions [2] - The company continues to pursue share repurchase programs as part of its capital allocation strategy, reflecting confidence in its long-term value [2]

Company Announcement - MDxHealth SA will release its financial results for the first quarter ended March 31, 2025, after market close on May 14, 2025 [1] - A conference call will be held on the same day at 4:30pm ET / 22:30 CET, featuring CEO Michael K. McGarrity and CFO Ron Kalfus [2] Company Overview - MDxHealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment [3] - The company's tests utilize proprietary genomic, epigenetic (methylation), and other molecular technologies to assist in the diagnosis and prognosis of urologic cancers and diseases [3] - MDxHealth's U.S. headquarters and laboratory operations are located in Irvine, California, with additional operations in Plano, Texas, and European headquarters in Herstal, Belgium [3]

Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].

Core Viewpoint - Oncocyte Corp. has published new data on its blood-based transplant rejection assay, indicating significant advancements in understanding organ rejection and potential market expansion opportunities for monitoring high-risk patients [1][4]. Scientific Significance - The study demonstrates a correlation between microvascular and vascular inflammation and elevated donor-derived cell-free DNA (dd-cfDNA) levels in blood plasma, enhancing the understanding of organ rejection biology [2]. - Two novel observations were made: T-cell mediated rejection (TCMR) is linked to high dd-cfDNA levels in the presence of vascular inflammation, while calcineurin inhibitor toxicity does not elevate dd-cfDNA levels [7][8]. Strategic Significance - The research supports the long-term management of high-risk transplant patients using Oncocyte's proprietary test, which is positioned to disrupt the market with more affordable and faster testing options [4][5]. - The study's findings validate the clinical utility of dd-cfDNA testing over a decade post-transplant, indicating its relevance in ongoing patient management [5]. - A significant portion of patients with organ rejection also exhibited de novo donor-specific antibodies, aligning with Oncocyte's previous clinical trial findings that led to expanded Medicare reimbursement [6]. Market Expansion - Oncocyte is developing a kitted version of its assay for local lab use, aiming to enhance accessibility and affordability of transplant monitoring tests [3]. - The collaboration with Charité University in Berlin has been instrumental in advancing scientific knowledge in transplantation, further solidifying Oncocyte's position in the market [4].

SALT LAKE CITY, April 29, 2025 (GLOBE NEWSWIRE) -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today it will release its first quarter 2025 financial results on Thursday, May 8, 2025, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss its financial results with analysts. Management on the call will include Dwight Egan, ...

Core Insights - Mainz Biomed N.V. is focused on molecular genetics diagnostics for early cancer detection and is progressing towards FDA premarket approval for its products [1][4] Company Developments - The company reported significant progress in Q1 2025, driven by strong clinical results from three studies published in 2024 [1] - The eAArly DETECT 2 study has commenced, evaluating a next-generation colorectal cancer test with results expected by the end of 2025 [4] - Mainz Biomed has signed a license agreement with Liquid Biosciences to access novel mRNA biomarkers for early pancreatic cancer detection, achieving 95% sensitivity and 98% specificity in independent validation [4] - A strategic partnership with labor team w ag has been established to introduce the ColoAlert CRC screening test to the Swiss market, addressing the urgent need for early detection in Switzerland [4] - The enhanced ColoAlert CRC screening test has been launched in Germany, coinciding with Colorectal Cancer Awareness Month in March 2025 [4] Regulatory Compliance - Mainz Biomed has regained compliance with Nasdaq's minimum stockholders' equity requirement and the minimum bid price requirement, ensuring full compliance with all Nasdaq continued listing requirements [4]

Core Insights - AccuStem Sciences, Inc. and EmeritusDX are expanding their strategic partnership to commercialize the MSC test for lung cancer screening, aiming to improve accuracy in lung nodule stratification and reduce healthcare costs [1][3] - The MSC test analyzes 24 microRNAs to differentiate between high- and low-risk lung nodules, facilitating earlier patient care and potentially minimizing unnecessary procedures [2] - The operational deployment of the MSC test is planned for launch in US clinics in 2026, with both companies pursuing reimbursement strategies to enhance access for the 1.6 million patients diagnosed annually with lung nodules in the US [3] Company Overview - AccuStem is focused on optimizing outcomes and quality of life for cancer patients through proprietary molecular testing that addresses unmet clinical needs from screening to treatment [5] - EmeritusDX specializes in delivering actionable clinical information and operates a world-class laboratory that supports cancer diagnosis and treatment [7] Leadership Statements - Wendy Blosser, CEO of AccuStem, emphasized the significance of the MSC test in lung cancer screening technology and the potential for impactful diagnostic solutions [4] - Robert Embree, CEO of EmeritusDX, expressed excitement about the collaboration and the commitment to expanding access to innovative diagnostics for cancer patients [4]