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Renalytix plc (NASDAQ: RNLX) is a pioneering company focused on the development of artificial intelligence (AI)-enabled clinical diagnostic solutions for kidney disease, one of the most widespread and costly chronic medical conditions worldwide. The company's flagship product, KidneyIntelX™, is designed to improve the diagnosis, prognosis, and clinical management of kidney diseases, particularly in patients with type II diabetes and those of African ancestry who are at risk of fast-progressing kidney disease. By leveraging advanced AI algorithms, KidneyIntelX aims to enhance patient stratification for drug clinical trials, facilitate drug target discovery, and ultimately reduce the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.
Renalytix plc has achieved significant milestones, including the commercial launch of KidneyIntelX as a laboratory-developed test in its CLIA-certified laboratory facilities. The company's diagnostic solutions are designed to be integrated into health systems and utilized by drug developers for better patient outcomes. Recently, KidneyIntelX received FDA De Novo authorization, marking a significant step towards widespread clinical adoption.
Recent Achievements:
- Inclusion of KidneyIntelX in clinical guidelines
- Issuance of a Medicare coverage draft
- Launch of a direct-to-physician sales force
- Release of new real-world outcomes evidence
- Significant year-over-year expense reductions
- Completion of equity financing
- Initiation of a strategic sale process
Renalytix plc has also formed strategic partnerships with prominent research institutions such as Mount Sinai, Wake Forest, and Joslin, to advance its research and development efforts. The company's financial strategy includes a plan to further reduce payroll expenses and total general and administrative costs while preserving its sales capacity.
With an unwavering commitment to innovation and patient care, Renalytix plc continues to lead the way in transforming kidney disease diagnosis and treatment, thereby creating substantial value for patients, healthcare providers, and investors alike.
Renalytix Plc (NASDAQ: RNLX) announced the issuance of 22,814 new ordinary shares under its Employee Share Purchase Plan (ESPP) to settle the purchase of 11,407 American Depositary Shares. These shares were issued at a price of $7.8795 per ADS (£3.00 per Ordinary Share). Following this issuance, the total number of Ordinary Shares will rise to 74,760,432, each granting one vote. The new shares will be admitted to trading on AIM around April 12, 2022.
Renalytix plc (NASDAQ: RNLX) has completed an $8.8 million equity subscription and $21.2 million in convertible bonds, totaling $26.8 million in gross proceeds. The equity fundraise involved 2,221,794 new ordinary shares and 103,447 ADSs priced at $7.25 per ADS. Directors and management participated, raising $2.55 million. The proceeds will support general working capital and company growth. The completion of these fundraising efforts indicates strong confidence from management and may enhance shareholder value.
Renalytix Plc (NASDAQ: RNLX) announced a $30 million financing package, including an $8.8 million equity subscription at $7.25 per ADS and $21.2 million in convertible bonds. The financing will generate gross proceeds of $26.8 million for working capital and support company growth, providing a cash runway for at least 24 months. The convertible bonds feature a 5.5% coupon and are convertible at $8.70 per ADS. The transactions are expected to close around April 6, 2022. Issued shares represent about 3.4% of the company's capital post-fundraise.
Renalytix plc (NASDAQ: RNLX) reported Q2 FY22 financial results, achieving $0.8 million in revenue, up from $0.4 million in the prior year. Active physicians ordering KidneyIntelX and testing volume saw quarter-over-quarter growth. The company expanded insurance coverage, now with 22 private and 31 Medicaid contracts. Despite revenue growth, operating expenses rose to $14.1 million, leading to a net loss of $15.3 million. Cash and cash equivalents were $39.9 million as of December 31, 2021. Renalytix plans to improve kidney health through various partnerships and community programs.
Renalytix Plc (NASDAQ: RNLX) has appointed Timothy Scannell as an independent Non-Executive Director, enhancing its board with over 30 years of healthcare innovation experience. Previously President and COO of Stryker, Scannell currently leads Insulet Corporation and serves on several boards, including Novocure and Collagen Matrix. His expertise is expected to contribute significantly to Renalytix’s strategic direction, particularly in advancing its innovative KidneyIntelX product aimed at early-stage chronic kidney disease risk assessment.
Renalytix plc (NASDAQ: RNLX) announced its KidneyIntelX RAPID biobank program is on track to exceed 30,000 unique patient biospecimens by 2024. The program aims to enhance real-world evidence for improving kidney disease management and treatment precision through a growing dataset of over 4,000 unique samples in 2022. With a participation rate of over 95%, this biorepository is set to bolster regulatory and reimbursement initiatives, improving patient outcomes for chronic kidney disease and diabetes.
Renalytix (NASDAQ: RNLX) announced the release of its second quarter and first half fiscal year 2022 financial results on March 31, 2022, prior to market opening. The company will also host a conference call at 8:30 a.m. ET to discuss the results, business strategy, partnerships, and regulatory processes. The call can be accessed through specific dial-in numbers provided for the US, Canada, and the UK. Renalytix is recognized for its innovative solution, KidneyIntelX, aimed at improving kidney disease prognosis, which has received Breakthrough Designation from the FDA.
Renalytix announced the launch of myIntelX, an online access portal for physicians to order KidneyIntelX bioprognostic testing, aimed at enhancing early identification of patients at risk for kidney disease progression in type 2 diabetes. The portal will be available nationally and supports current testing locations like CDPHP health plans and Veterans Health Administration sites. KidneyIntelX is recognized for its innovative approach, being the only such platform with FDA Breakthrough Device Designation. The initiative hopes to improve patient care for chronic kidney disease, a growing public health concern.
Renalytix plc (NASDAQ: RNLX) recently presented new clinical data for its KidneyIntelX bioprognostic testing at the World Congress of Nephrology. The data emphasizes KidneyIntelX's efficacy in predicting kidney function decline in patients with early-stage diabetic kidney disease, outperforming traditional diagnostic methods such as UACR and eGFR. The tool aids primary care physicians in risk assessment and treatment decisions, potentially reducing hospital visits and improving patient quality of life. KidneyIntelX is the only early-stage solution for kidney health recognized with FDA Breakthrough Device Designation.
Renalytix plc (NASDAQ: RNLX) announced their participation in the Cowen 42nd Annual Health Care Conference, set for March 9, 2022, at 10:30 a.m. EST. The event will feature a fireside chat with the company's management and will be accessible via a live and archived webcast on their investors' website. Renalytix specializes in bioprognosis for kidney health, with their leading product, KidneyIntelX, receiving Breakthrough Designation from the U.S. FDA to enhance diagnosis and management of kidney disease.
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