ENDRA Life Sciences Inc (NASDAQ:NDRA) stock rose 3.18% (As on May 13, 11:39:43 AM UTC-4, Source: Google Finance) though the company in the first quarter of FY 22 has reported the net loss of $2.9 million, or $0.07 per share, compared with a net loss of $2.3 million, or $0.06 per share, in the first quarter of 2021. Cash and cash equivalents were $7.1 million as of March 31, 2022; $7.8 million was raised subsequent to the close of the first quarter through the company’s ATM facility. Operating expenses increased to $2.9 million in the first quarter of 2022 from $2.6 million in the same period in 2021. The increase was primarily due to increased spending for commercialization of TAEUS and ongoing product development.
Meanwhile, the company has raised a total of $8.7 million in gross proceeds year-to-date from the sale of common stock through its at-the-market (ATM) equity facility, of which $7.8 million was raised subsequent to the close of the first quarter. With this bolstered cash position, management believes ENDRA is capitalized to fund operations through several important milestones, including ramping-up commercial activities in Europe and advancing the TAEUS system through the regulatory process in the U.S.
Moreover, after extensive and productive dialogue with the U.S. Food and Drug Administration (FDA), ENDRA is pursuing the De Novo pathway for its TAEUS Liver System, which is intended to characterize fatty liver tissue as a non-invasive means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). The De Novo pathway will build upon ENDRA’s completed 510(k) application and provides ENDRA with the opportunity to set the bar for an entirely new product classification, which should yield important and sustainable commercial advantages for the novel TAEUS platform. Under the De Novo process, the company intends to provide smaller-scale TAEUS human study data, which will come from ENDRA’s existing clinical study sites and is not expected to add material expenses to ENDRA.
Further, ENDRA’s latest research partnership, with China’s renowned Shanghai General Hospital (Shanghai First People’s Hospital Affiliated with Shanghai Jiao Tong University), further validates interest in ENDRA’s technology and provides a strategic entry point into China’s healthcare market, which seeks to deliver cost-effective services to 1.4 billion citizens including an estimated 350 million people with NAFLD and Non-Alcoholic Steatohepatitis (NASH). The company was issued five U.S. patents, two European patents and four Chinese patents that further protect its optimized hybrid ultrasound and thermoacoustic imaging systems for a wide range of applications.