Renalytix plc American Depositary Shares - RNLX STOCK NEWS

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.

Renalytix plc (NASDAQ: RNLX) announces a registered direct offering of ordinary shares to DB Capital Partners Healthcare, L.P. at $0.75 per NASDAQ ADS, with potential total financing of up to $4 million. The net proceeds will support commercial sales activity during the ongoing Formal Sale Process.

Renalytix plc (RNLX) announces the inclusion of KidneyIntelX in the 2024 KDIGO Clinical Practice Guideline for CKD management. The guideline emphasizes risk prediction for disease progression and personalized treatment. Renalytix received FDA de-novo marketing authorization for KidneyIntelX in June 2023, with positive outcomes data supporting its use.

Renalytix plc reported financial results for the fiscal second quarter ended December 31, 2023, showcasing revenue growth, reimbursement coverage, and cost management improvements. KidneyIntelX saw increased sales and FDA approval, with real-world evidence supporting its efficacy. Operating cost reductions were significant, leading to a reduced cash burn rate. Despite a decrease in revenue compared to the previous year, the company has taken steps to lower expenses and preserve revenue generating activities.

Renalytix plc (RNLX) to participate in BTIG MedTech Conference in Snowbird, Utah without a formal presentation.