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Renalytix AI Shares Climb 30% on Q1 Earnings and EUA for JV's SARS-CoV-2 IgG Antibody Test Kit

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Shares of Renalytix AI Plc. traded 30% higher after the company reported Q1/21 financial results and that its joint venture with Mt. Sinai Health System was granted Emergency Use Authorization by the FDA for its SARS-CoV-2 IgG antibody test kit.

Artificial intelligence-enabled in vitro diagnostics company Renalytix AI Plc (RNLX:NASDAQ), which focuses on optimizing clinical kidney disease care, today announced operating and financial results for its first quarter 2021 ended September 30, 2020.

The company highlighted that in Q1/21 it launched KidneyIntelX within the Mount Sinai Health System and submitted a final package requesting U.S. Food and Drug Administration (FDA) clearance for KidneyIntelX. The firm noted that it also announced a collaboration partnership with AstraZeneca that is focused on developing and launching precision medicine strategies for cardiovascular, metabolic and renal diseases. The company also said that it has completed the spin-out of Verici Dx (previously FractalDx) and that Verici Dx completed its IPO on AIM on November 3, 2020.

The company reported that total operating expenses in Q1/21 were $5.4 million, compared to $2.0 million in Q1/20. The firm also indicated that research and development expenses in Q1/21 increased by $0.5 million to $1.7 million, up from $1.2 million in Q1/20. During the same time period, general and administrative expenses increased by $3.3 million to $4.1 million. compared to $0.8 million in the prior year's quarter.

The firm reported a net loss attributable to ordinary shareholders in Q1/21 of $7.2 million, compared to a net loss of $1.5 million in Q1/20.

Renalytix AI stated that it held cash and cash equivalents of $82.3 million on its balance sheet as September 30, 2020, which included $76.1 million generated from net proceeds received from the company's initial public offering on the Nasdaq Global Market.

The company explained that kidney disease is one of the most common and costly global chronic medical conditions. The firm stated that kidney disease is considered as a public health epidemic as it now affects more than 850 million people worldwide. The company advised that according to the Centers for Disease Control and Prevention (CDC) about 37 million people in the U.S. currently have chronic kidney disease (CKD) and reportedly 9 out of 10 adults with CKD do not even know they have the disease as it often has no symptoms and can go undetected until a very advanced stage.

The company noted that in May 2020 it joined with the Icahn School of Medicine at Mount Sinai to establish a joint venture, Kantaro Biosciences LLC. The firm stated that Kantaro was formed to develop and commercialize laboratory tests for the detection of antibodies against SARS-CoV-2 that were originally developed by Mount Sinai.

In a related story today, Kantaro Biosciences announced that "it has received Emergency Use Authorization (EUA) from the FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit."

The company stated that "unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19." The firm reported that it has contracted with Bio-Techne Corp. (TECH:NASDAQ) to initially manufacture up to 10 million test kits per month and then scale up even higher.

Kantaro Biosciences stated that "COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain," and its test kit received CE mark in October 2020 and is presently available in Europe in nearly 30 countries.

Kantaro's Chief Commercial Officer Sara Barrington commented, "COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City...It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust."

Bio-Techne Corp.'s President and CEO Chuck Kummeth remarked, "Widespread testing is critical in the fight against COVID-19. With this EUA in hand, we are ready to immediately supply this best-in-class serologic assay to clinicians across the United States...Manufacturing will begin with a capacity of up to 10 million tests per month. We anticipate that COVID-SeroKlir will play an increasingly important role in the decision making of healthcare providers and policymakers and are prepared to scale up to meet additional demand."

Renalytix AI described its business as "a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally." The firm stated that it designs its products to deliver significant improvements in diagnosing kidney disease and advancing capabilities in clinical care, drug target discovery, transplant management and patient stratification for drug clinical trials.

Renalytix AI Plc. began the day with a market cap of around $385 million with approximately 36 million shares outstanding. RNLX ADR shares opened almost 26% higher today at $13.43 (+$2.74, +25.63%) over yesterday's $10.69 closing price. The stock has traded today between $13.16 and $14.63 per share and is currently trading at $14.00 (+$3.31, +30.96%).

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