Good afternoon ladies, and gentlemen and welcome to the Fourth Quarter of Fiscal Year 2018 Earnings Conference Call for Helius Medical Technologies. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the Company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management, including statements regarding the potential FDA clearance of the PoNS device, the future commercialization of the PoNS treatment, expected future clinical and regulatory timelines and projected financial results. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the Risk Factors sections of our most recent Annual Report on Form 10-K filed with the SEC. Such factors may be updated from time to time in our filings with the SEC, which are available on our website. All statements made during this call are as of March 14, 2019. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law. I would now like to turn the call over to Mr. Phil Deschamps, Helius Medical's Chief Executive Officer. Please go ahead, sir.

Thank you so much, operator. And welcome everyone for Helius Medical's fourth quarter and full year 2018 earnings conference call. I'm joined on the call today by Joyce LaViscount, our Chief Financial Officer and COO. Let me provide you with a quick agenda on the topics that we intend to cover today. I'm going to start with the brief recap of our financial results during the fourth quarter followed by a discussion of our recent operational progress in the two countries where we are primarily focused Canada and the U.S. This discussion will include an update on our recent progress in Canada where we have now begun to commercialize our PoNS treatment and an update on our progress with the U.S. FDA. Following these remarks, I'll turn the call over to Joyce who will discuss our financial results for the fourth quarter and full year ended December 31, 2018, in greater detail and review our guidance for 2019 which we introduced in our earnings press release this afternoon. I'll then share some additional thoughts on the key areas where Helius is focused in 2019 and the years to come before opening the call to questions. Beginning with a brief recap of our Q4 financial results, we are very pleased to report our first revenue-generating quarter in Helius's history. During the fourth quarter of 2018, we recognized $478,000 of license fee revenue related to the strategic alliance agreement we have with the Canadian company called HealthTech Connex and its operating entity Heuro Canada. Under this important agreement, Helius is entitled to receive license fee from HealthTech Connex for the rights we granted to Heuro Canada, which is responsible for the development of neuroplasticity clinics to treat patients and the creation of replicable model for future clinic expansion in Canada. We believe…

Thanks, Phil. We reported revenue of 478,000 for the fourth quarter of 2018 compared to no revenue in the prior year period. This revenue was license fee revenue related to the satisfaction of our performance obligation as part of the strategic alliance agreement with HealthTech Connex and Heuro Canada. Operating expenses for the fourth quarter 2018 decreased 129,000 or 2% year-over-year to 5.7 million. The change in operating expenses was driven by a $1.1 million or 34% decrease in research and development expenses, which was due to reduced product development cost. This was offset almost entirely by a 1 million or 38% year-over-year increase in general administrative expenses primarily due to increased expenses related to our commercial infrastructure build out. Loss from operations for the fourth quarter of 2018 was 5.3 million compared to a loss from operations of 5.9 million for the prior year period. Total other expense for the fourth quarter of 2018 decreased to 2 million or 93% year-over-year to a 147,000 compared to 2.1 million in the fourth quarter of 2017. The year-over-year decrease in total other expenses was driven primarily by the change in fair value of derivative financial instruments, which was a loss of $221,000 for the fourth quarter of 2018 compared to a gain of 2 million in the fourth quarter of 2017. The change in fair value of derivative financial instrument was primarily attributable to the change in our stock price, volatility and a number of derivative financial instruments being measured during the period. The net loss for the fourth quarter of 2018 was 5.1 million or $0.21 per basic share compared to a net loss of 3.7 million or $0.19 per basic share for the fourth quarter of 2017. Dilutive loss per share was $0.22 and $0.26 for the quarters ended…

Thank you, Joyce. Looking ahead to 2019, we will continue to focus on advancing our effective strategies in Canada and the U.S. In Canada, we are going to work to ensure the successful commercialization of our PoNS treatment as we progress through its initial stages. Specifically in 2019, we expect to engage three additional neuroplasticity clinics in Canada during the course of the year basically one in each of the last three quarters of the year and 2019 with a total of five clinics. In the U.S., we remained focused on obtaining de novo classification and 510(k) clearance for our PoNS device. We will continue to provide FDA with any information necessary to facilitate its review of our submission, so we can bring our innovative PoNS treatment to more than 1.5 million U.S. patients that we estimate are living with chronic balance deficit caused by mild-to-moderate TBI. With respect to U.S. clinical experience program, we expect to continue recruiting and enrolling patients at CEP sites throughout the year. We've established our own neurorehabilitation center known as Helius Neurorehab adjacent to our corporate headquarters in Newtown, PA, which will operate as a clinical research site and serve as our sixth and final CEP site. We believe that the experience gained through the commercialization efforts in Canada as well as our U.S., clinical experience program will help us to establish our commercial infrastructure and provide us with insight that informs our commercialization efforts in the U.S. post-FDA clearance. In addition to pursuing our respective strategies in the U.S. and Canada, we will continue to pursue regulatory clearance in other markets that represents additional opportunities for PoNS treatment. In Europe, we submitted an application for a CE Mark during the fourth quarter 2018 and in Australia we now expect to submit an application…

[Operator Instructions] And your first question comes from the line of Steven Lichtman from Oppenheimer. Your line is open.

So, you mentioned in Canada, you had a chance to meet with some of your current patients. I'm wondering what you are also hearing from prospective patients in terms of interest? And what the two centers are up and running? What they are hearing from prospective patients and interest?

Well, yes, I did get to meet them. It was quite a cool day. In Canada, there has been a lot of expectations for us to eventually clear our technology there. So, there has been a lot of people that have essentially been waiting for this day. The clinics are actually managed by the Heuro people, so we don't really get involved in the forecast of their own patients and their own sort of waiting list or schedules. We basically measure their performance and our performance based on their orders on a monthly basis.

And then in the U.S. based upon when you filed when you think we will hear next from FDA?

Your guess is as good as mine, Steve. From our perspective, what we felt really important about is as we believe that we've answered all of the questions that FDA requested from us. We know that once we now have submitted that the FDA will take up our file and there is no specific guidance as to when that -- when they are scheduled to get back to us. We do note that FDA is an organization that designed to approve products and they get bonus on improving products not so much on the other side. So, we will have to see and rely on their own pressure to see when they get back to us, but we have no specific idea.

[Operator Instructions] And your next question comes from the line Sean Lavin from the BTIG. Your line is open.

It's Marie. So I wanted to ask a question about the CEP program. I would love to hear a little bit of feedback of how those are enrolling -- how quickly those are enrolling? And any patients' feedback you are hearing I guess in the U.S. patient population?

Yes, so, this is what we did Marie. When our Canadian launch was accelerated and we changed our focus on what the CEPs were going to do since we are going to be able to gather health economics data from our Canadian launch in real life patients. We changed our protocols in Canada as I was discussing. For those of you who know clinical trial programs, when you change a protocol you have to get a whole new IRB approval, you have to go through the whole process again. So we did that at the end of the fourth quarter, and so now pretty much all of the IRBs have gotten back. So, we are essentially getting back into the recruiting of the trial. We also felt that we had the -- every issue has a silver lining. And with FDA asking us our AI, we figured we would have enough little bit of time to be able to change the protocol to gather more comprehensive data since we were going to get it on that side. So, we are just starting to recruit patients, we had a few patients that finished treatment already and a few randomized, but it's still in the single digits.

And I know that Steve asked a question about Canada, but I would love to hear if you can give [audio gap] also I know that you are planning [audio gap] online this year. Why don’t we see any revenue I guess from centers that you bring online in the second quarter given that you turned the first two round pretty quickly?

Sure, so let me answer your second question first. We fully expect that we would drive revenue in those clinics, but today those clinics are not set up. So, we are only forecasting revenue in terms of things that we absolutely have in hand. And right now, we have in hand two centers and we Joyce's guidance the $1.6 million to $2 million U.S. to be derived from those two clinics. And once the clinics come onboard, I will then be able to forecast their revenue. So, on a quarterly basis, as they come onboard, we will be able to change our guidance based on the knowledge of where those clinics are. So, we just want to be as responsible as we can and being able to project what we have in hand. With respect to waiting list, again, it's really, really important for us in a way that we have set up our Canadian system because the practice of medicine essentially is independent of us. We wanted to set ourselves up as a medical device manufacturer. So, we transfer our devices based on the demand of the clinics. What patients get treated in Canada? What diagnosis they have is really the jurisdiction of the clinics, and so we purposely do not get involved in understanding what waiting lists are, what the diagnosis are. All we do essentially make sure that we get our orders about three weeks before the month end and then we supply them with that treatment. So, that's the reality and it's really, really important for us to comply with all the regulatory rules that we are subjected to.

We are currently showing no additional participants in the queue. I will now turn the call back over to the speakers.

Okay, well, thank you very much everyone and heartfelt thank you for all of you who are on the phone that are our existing shareholders. It certainly is not lost on us that we live by the generosity of our shareholders, and we hope that you found through this very important milestone that we have reached the last quarter and over the first three months of -- the year are just so incredibly exciting for us. So, we look forward to giving you our quarterly reports as they come through. All the best to each and all of you.

Thank you.

That does conclude our conference call for today. Thank you for your participation.