Renalytix plc American Depositary Shares - RNLX STOCK NEWS

Renalytix (NASDAQ: RNLX) has announced a private placement fundraising of approximately $20.3 million through the sale of 3,699,910 Ordinary Shares and 7,511,525 American Depositary Shares (ADS), priced at $2.17 per ADS and £0.90 per Ordinary Share. The fundraising, expected to close by February 9, 2023, aims to support sales, marketing, and clinical product development. The proceeds will be allocated as follows: $10.3 million for clinical development, $7.7 million for marketing, and $2.0 million for corporate costs. Approximately 20% of the company’s shares will be affected post-fundraise.

Renalytix plc (NASDAQ: RNLX) has announced the launch of PRIME-CKD, a consortium aimed at developing personalized drug response tests for chronic kidney disease (CKD). The project has a total budget of $10 million over five years, with 10% allocated for commercial activities by Renalytix. Funded by Horizon Europe, the initiative involves 11 academic institutions and aims to validate biomarkers that predict patient drug response. The project is expected to enhance clinical practices and secure qualifications from regulatory agencies like the FDA and EMA. This aligns with Renalytix's goal to expand its KidneyIntelX platform's capabilities.

Renalytix has entered a critical agreement with the U.S. Veterans Health Administration to integrate its KidneyIntelX solution into the VA Health System, enhancing early-stage risk assessments for chronic kidney disease among the 960,000 veterans diagnosed with CKD. The collaboration allows healthcare providers at 171 VA Medical Centers to seamlessly access test results, ensuring high security for patient data. This initiative aims to improve timely detection and management of CKD, potentially saving the VHA an estimated $19 billion annually in CKD-related costs.

Renalytix (NASDAQ: RNLX) announced encouraging results from its KidneyIntelX clinical utility study, showcasing enhanced clinical decision-making for chronic kidney disease (CKD) in diabetes patients. The study involved 1,686 patients and highlighted that 57% of high-risk patients received medical interventions within three months. Participants in the high-risk group saw a nearly 10% improvement in HbA1c levels. Addressing kidney disease early could significantly reduce healthcare costs, as Medicare spends approximately $85 billion annually on early-stage CKD. The results were published in the Journal of Primary Care and Community Health.

Renalytix plc (NASDAQ: RNLX) reported its fiscal Q1 2023 results, highlighting a record of over 1,200 KidneyIntelX tests performed and $1.0 million in revenue, up from $0.5 million in Q1 FY22. The company secured new coverage with major insurance providers, including a significant payer in Illinois. Operating expenses slightly decreased to $12.0 million, while the net loss expanded to $12.0 million from $10.1 million year-over-year. Cash reserves stood at $31.0 million as of September 30, 2022.

Renalytix (NASDAQ: RNLX) released a study indicating that its KidneyIntelX test significantly enhances clinical decision-making for patients with early-stage diabetic kidney disease (DKD). The study showcased a 4.5-fold increase in prescriptions of SGLT2 inhibitors for high-risk patients. Conducted within Mount Sinai Health System, the study involved 1,686 patients and demonstrated increased medication management, specialist referrals, and follow-up visits for high-risk individuals. The findings aim to address the growing public health issue of CKD, with over 50,000 individuals annually progressing to kidney failure.

Renalytix plc (NASDAQ: RNLX) will report its first quarter fiscal year 2023 financial results on November 30, 2022, before market opening. A conference call will follow at 8:30 a.m. ET to discuss the results, business strategy, regulatory processes, and partnerships. Renalytix is a leader in bioprognosis for kidney health, with its flagship product, KidneyIntelX™, receiving Breakthrough Designation from the FDA to improve kidney disease prognosis and management.

Renalytix plc (NASDAQ: RNLX) will participate in the Stifel Healthcare Conference on November 15-16, 2022, at the Lotte New York Palace Hotel. Attendees can access a live and archived webcast of the presentation on the Company’s website starting at 3:35 p.m. ET on November 16. Renalytix is a pioneer in bioprognosis for kidney health, with its leading product, KidneyIntelX™, holding Breakthrough Designation from the FDA. This innovative solution aims to transform kidney disease prognosis and management.

Renalytix plc (NASDAQ: RNLX) released its full-year results for FY 2022, ending June 30. The company reported significant advancements, including the execution of 28 private insurance contracts and Medicare coverage for KidneyIntelX at $950 per test. They achieved partnerships with healthcare systems to enhance kidney health management and published key data supporting test utility in clinical settings. Revenue grew, bolstered by a $30 million financing package, although cash on hand decreased to $41.3 million from $65.2 million. Ongoing clinical studies further validate KidneyIntelX's benefits for diabetic kidney disease.