Good afternoon, ladies and gentlemen and welcome to the ENDRA Life Sciences First Quarter 2021 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode and we will open the floor for your questions and comments after the presentation.

It is now my pleasure to turn the floor over to your host, Yvonne Briggs. Ma’am, the floor is yours..

Thank you, operator. This is Yvonne Briggs with LHA, ENDRA Life Sciences’ Investor Relations firm. Good afternoon and welcome to ENDRA’s first quarter 2021 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic.

And for those of you who don’t have a copy, you can access it in the Investors section of ENDRA’s website..

Thank you, Yvonne. Good afternoon, everyone. Thank you for joining us today to review ENDRA’s first quarter 2021 financial results and business update.

I am delighted that our business progress and investor outreach has attracted growing attention within the investment community and has positioned ENDRA solidly as we enter the second quarter with a record high level of cash. I am also pleased that ENDRA has accomplished several key milestones thus far in 2021, which we will review on today’s call.

We continue to advance our Thermo Acoustic-Enhanced Ultrasound Technology known as TAEUS on multiple fronts.

As you know, TAEUS is a simple to use proprietary technology platform, with the first application focused on measuring liver fat for the early assessment of non-alcoholic fatty liver disease known as NAFLD and its inflammatory stage known as non-alcoholic steatohepatitis, or NASH.

We believe there is a significant opportunity for TAEUS in this first indication, as NAFLD and NASH affect more than a billion people globally.

By enhancing existing ultrasound systems, which today cannot alone accurately measure liver fat for clinical staging of NAFLD/NASH, TAEUS allows clinicians to visualize tissues in ways similar to an MRI, but at the point of patient care and it’s 50x lower cost.

Last year, we received a CE Mark for the NAFLD/NASH application for TAEUS and we also submitted a 510k application with the U.S. FDA. As I mentioned on our last conference call, the TAEUS 510k submission continues to be in the normal process with the FDA. We have been supporting the process by responding to the FDA’s questions as they arise.

And these questions relate to information, for example, requesting additional information on how the TAEUS technology functions or how it relates on a number of levels to our chosen predicate. We consider this back and forth with the agency to be a standard part of the process for new technology like TAEUS.

And naturally, this Q&A with the FDA can extend historical review timeframes and the FDA doesn’t provide guidance in terms of timing. But I want to assure investors, we are in compliance with the process and we remain optimistic about securing FDA clearance in 2021..

Thank you, Francois and good afternoon everyone. As Francois mentioned, we are making good progress with our commercial initiatives for the TAEUS system. The environment in the U.S. continues to improve with the easing of restrictions as new case of COVID-19 decline and vaccines are being administered on a broad basis.

Europe on the other hand, as like with their distribution of vaccines and continues to implement restrictions, thereby hampering in-person interaction. Importantly, we are starting to see favorable trends regarding a lessening of new cases in Europe. And this will hopefully continue.

Nonetheless, we are taking the appropriate measured steps to position ENDRA for future growth. I would like to start by discussing the status of our 6 clinical evaluation partners.

As we have mentioned in the past, the studies are approved by each facility’s Institutional Review Board, allowing this research institution to use technology deemed low risk prior to FDA or other regulatory clearances.

Rocky Vista was our first partner to start scanning patients earlier this year and they are targeting a study of some 200 patients comparing their liver fat measurement on our TAEUS system, with a gold standard MRI-PDFF.

MRIs continue to have a significant backlog as elective procedures were postponed during the pandemic, but most centers are making good progress in working through that backlog and are returning to pre-pandemic operations.

As we continue to enhance our sales efforts as Francois mentioned, we added two more professionals to our commercial team in Europe and now have ENDRA representative in the UK, France and Germany. Initially due to the pandemic, we implemented a cautious strategy and failed our hiring plans given the restriction and lack of mobility.

However, that is beginning to change. We will monitor Europe closely and adjust our plans accordingly to maintain capital efficiency while being flexible to add resources when warranted. Currently, our commercial team’s priority is to drive local awareness and garner interest for the TAEUS system.

Further, our team will support our clinical evaluation partners when they commence their studies. In addition, we are creating awareness through various e-marketing and education campaigns for TAEUS.

We continue to produce educational videos, publish whitepapers, and leverage our website, which contains valuable information and data on the benefits of TAEUS. Industry tradeshows continue to be a great resource for industry contacts and for sales leads.

And Francois mentioned, we recently participated in AIUM and expect to participate in several more well-attended conferences later this year. Most of the conferences taking place after the summer will be in-person and we are looking forward to meet our customers once again..

Thank you, Renaud. Our financial results for the first quarter of 2021 are as follows. For the quarter ended March 31, 2021, our operating expenses decreased to $2.6 million, down from $3.1 million for the same period in 2020. The reduction was due to reduced spending for outsourced product development and investor relations and legal fees.

Our research and development spending decreased year-over-year by approximately $400,000 as we completed development of TAEUS and prepared our system for commercial launch.

In turn, our sales and marketing costs increased by approximately $50,000 for the quarter as we began to gear up our sales efforts now that COVID restrictions are starting to lift. General and administrative costs decreased by approximately $200,000 due to reduced spending for investor relations and legal fees.

Our net loss per share for the 2021 first quarter was $0.06 compared with $0.29 per share a year ago. Our cash balances as of March 31, 2021 were $16.8 million. This includes $2.8 million raised through the conversion of a majority of our remaining non-traded warrants and $9.8 million in proceeds from sales under our ATM facility.

We believe these funds will provide adequate capital to fund planned operations in ENDRA throughout the remainder of 2021 and into 2022. We continue to employ an asset-light model and we will implement a conservative approach to spending as we continue to advance our commercialization initiatives.

Given our solid balance sheet, we remain opportunistic regarding strategic investments that will leverage our operations and create shareholder value..

number one, securing 510(k) clearance for TAEUS in the U.S.; number two, expanding the dataset of clinical evidence through our strategically positioned study sites to support global commercialization efforts; number three, accelerating our commercial channel and marketing activities in line with the reopening of global markets with plans to generate revenue in both Europe and the U.S.

in 2021; fourth, expanding our pharmaceutical and other industry partnerships to facilitate adoption of TAEUS beyond the clinical end user market; and fifth, continuing to bolster our intellectual property portfolio to defend our technology and increase outlicensing opportunities.

So with that review of the business highlights and financial results, I’d now like to open the call for questions.

Operator?.

Operator:.

Okay. Operator, if there are no more questions, we can wrap up the call. I appreciate everyone’s time. Again, thank you everyone for joining us today. We look forward to keeping you updated on our progress and milestones and to speaking with you during conference calls to discuss important news and events and accomplishments.

I wish you all a good evening..

Thank you, ladies and gentlemen. This does conclude today’s conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation..