Welcome to our dedicated page for Renalytix plc American Depositary Shares news (Ticker: RNLX), a resource for investors and traders seeking the latest updates and insights on Renalytix plc American Depositary Shares stock.
Renalytix plc (RNLX) delivers AI-driven diagnostic solutions transforming kidney disease management through advanced clinical analytics. This dedicated news hub provides investors and healthcare professionals with essential updates on regulatory milestones, clinical validations, and strategic partnerships shaping the future of precision diagnostics.
Access real-time updates on FDA clearances, peer-reviewed study publications, and health system collaborations. Our curated news collection enables informed tracking of RNLX's progress in developing AI-powered tools for early kidney disease detection and risk stratification in high-risk populations.
Key updates include earnings reports, technology licensing agreements, clinical trial outcomes, and reimbursement developments. All content is verified through primary sources to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to RNLX's latest advancements in merging artificial intelligence with renal healthcare solutions. Regularly updated to serve as your definitive source for tracking innovations in AI-driven clinical diagnostics.
Renalytix plc (LSE: RENX) (OTCQB: RNLXY), an AI-enabled in vitro diagnostics company focused on kidney disease management, has announced the commencement of trading of its American Depository Shares (ADSs) on the OTCQB Venture Market under the symbol 'RNLXY' effective October 8, 2024. This move follows the company's decision to downlist from Nasdaq to reduce costs and redirect capital towards commercialization efforts.
CEO James McCullough stated that recent steps to improve the balance sheet through financing and restructuring have positioned the company to pursue strategic goals towards improved profitability. The transition to OTCQB, along with continued listing on the London Stock Exchange, is expected to significantly decrease general and administrative costs, allowing Renalytix to focus on growing sales of kidneyintelX and delivering shareholder value.
Renalytix has announced a collaboration with the Steno Diabetes Center Copenhagen to implement its KidneyIntelX platform in Europe, marking the first expansion outside the US. This partnership aims to enhance the clinical management of diabetes and chronic kidney disease (DKD) through precision medicine. Initial steps involve integrating KidneyIntelX into Steno's laboratory workflows, educating clinicians and patients, and leveraging electronic health records for risk-based care management. The collaboration will also focus on CE marking requirements, clinical utility data, and cost-effectiveness analysis, thus paving the way for future product developments.
Renalytix has submitted a hearing request to the Nasdaq Hearings Panel to address a staff delisting determination. This action temporarily halts the suspension of Renalytix's American Depositary Shares (ADSs) on the Nasdaq Global Market under the symbol 'RNLX'. The company plans to present a strategy to regain compliance with Nasdaq's listing requirements, but there is no guarantee the plan will be accepted or that compliance will be restored.
The delisting risk arises from Renalytix's failure to meet Nasdaq's minimum closing bid price and market value of listed securities requirements. Delisting could severely impact the ease of trading Renalytix's ADSs, their market price, and the company's ability to raise capital. The Panel may grant an extension of up to 180 days from the delisting notice date to resolve these issues.
Renalytix announced that on June 13, 2024, Medicare issued a final Local Coverage Determination (LCD) for its kidneyintelX.dkd test, effective from August 1, 2024. The Medicare price for the test is set at $950 per test, and specific CPT codes have been established. The LCD covers tests for patients with Type 2 diabetes and Stage 1-3b Chronic Kidney Disease, aligning with the FDA label. This LCD comes after key milestones such as FDA authorization, clinical outcomes data, and inclusion in clinical guidelines, positioning kidneyintelX.dkd as a preventative standard for 14 million Americans. The company expects this Medicare coverage to drive further adoption and coverage decisions, leading to incremental sales growth in targeted US regions with lower operational costs.
Renalytix (NASDAQ: RNLX) reported its financial results for the third quarter of fiscal year 2024, ending March 31, 2024. Key highlights include the inclusion of KidneyIntelX in international clinical guidelines and the issuance of a Medicare coverage draft. The company launched a direct-to-physician sales force and their FDA-authorized KidneyIntelX.dkd in April. Significant expense reductions were achieved, with a 50% decrease in headcount and a 40% reduction in total operating costs year-over-year. Despite these efforts, revenue for the quarter was $0.5 million, down from $0.7 million year-over-year, with a net loss of $7.7 million compared to $12.1 million in the prior period. The company completed equity financings raising $13.5 million and has $4.7 million in cash and cash equivalents. Operating expenses were reduced by 41%, primarily due to cuts in compensation and external R&D projects. The company is also in a strategic sale process, engaging multiple potential acquirers.
Renalytix plc (NASDAQ: RNLX) will report its third quarter fiscal year 2024 financial results on May 15, 2024. The Company will discuss key topics like business strategy, partnerships, and regulatory processes. Conference call and webcast details are provided for interested parties.
