Greetings and welcome to the CorMedix Fourth Quarter 2016 Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. And it is now my pleasure to introduce your host, Mr. Joshua Drumm, Investor Relations for CorMedix. Thank you. You may begin.

Thank you, Michele. Good morning and welcome to the CorMedix fourth quarter and year-end 2016 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following. Any statements other than statements of historical fact regarding management’s expectations, beliefs, goals and plans about the company’s prospects, including its clinical development program for Neutrolin in the U.S. and other product candidates, future financial position, future revenues and projected costs, and market acceptance of Neutrolin and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, costs and results thereof, projections as to the company’s future capital raising, spending and cash position, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our product candidates, and expectations as to manufacturing and product component costs. Our actual results may differ materially from these projections or estimates due to a variety of important factors including, but not limited to, uncertainties related to clinical development, regulatory approvals, and commercialization. These risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov, or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that CorMedix does not intend to update these forward-looking statements, except as required by law. At this time, it is now my pleasure to turn the call over to Mr. Khoso Baluch, Chief Executive Officer of CorMedix. Khoso, please go ahead.

Thank you, Josh. Good morning, everyone, and thanks for joining us. On the call today, we will review a number of key advancements at CorMedix that we believe positioned the company for success. On our November conference call, we provided a comprehensive update on our lead Phase 3 program for Neutrolin, including sharing with some issues we discover that were impacting the trial enrollment rate. Since identifying these issues and instituting various strategies to overcome them. I’m pleased to say that we are on track to complete the study as outlined, on which I will go into further details in a few minutes. We continue to maintain our primary focus on enrolling the Phase 3 study for Neutrolin as effectively as possible. In addition to diligent trial execution, we’ve made significant effort to optimize our infrastructure to support significant future growth, both for Neutrolin and beyond. This includes a significant expansion of our senior leadership team two of whom are joining me on the call this morning. We’re excited to enhance the senior management team with these experienced leaders, which we believe will enable CorMedix to execute effectively across multiple fronts. So to start the call, I would like to introduce a new member of our leadership team, Chief Financial Officer, Bob Cook, who joins CorMedix with 25 years of experience in senior financial leadership positions across the healthcare industry and will takeover our financial forecasting, compliance, and reporting responsibilities, as well as business development for CorMedix. Bob will provide an update on our financial results for the fourth quarter and full-year later on this call. Next, I’m pleased to welcome Jack Armstrong as Executive Vice President for Technical Operations and Head of HR. Jack has been with CorMedix for sometime in this role as a consultant, and we are…

Thank you very much, Khoso. I’m delighted to join the CorMedix team at this exciting time in the company’s history, and to report today our financial results for the fourth quarter and full-year 2016. The company filed its 10-K for the year ended December 31, 2016 yesterday. My comments today are a partial summary of the information contained in that report, which I very much urge you to read. With respect to our fourth quarter 2016 results, our net loss was $6.4 million, or $0.16 per share, compared with a loss – a net loss of $9.1 million, or $0.23 per share in the third quarter 2016, and a net loss of $3.9 million, or a $0.11 per share for the fourth quarter 2015. Operating expenses in the fourth quarter 2016 were $6.5 million compared with $9.2 million in the third quarter. The decrease in operating expenses compared with the previous quarter was due to a 41% decline in R&D expense, partially offset by a 5% increase in G&A expense. R&D expense in the third quarter was at its high for the year due to significant Neutrolin, CMC-related development expenses, and new product development initiatives in addition to the ongoing ramp up of clinical trial expenses. R&D expense over the next several quarters is expected to significantly increase over the fourth quarter as a result of the continuing enrollment into the LOCK IT 100 trial and the ongoing preparations to commence the LOCK-IT 200 trial towards year-end. Cash used in operations in the fourth quarter 2016 was $6.5 million. Cash was used primarily after our Phase 3 study of Neutrolin and related G&A activities. Our operating cash burn was funded primarily be a drawdown of our cash on hand. For the full-year 2016, the company recorded a net loss of…

Thank you, Bob. In conclusion, CorMedix is and will remain focused on securing approval of Neutrolin to prevent catheter-related bloodstream infections by successfully completing our Phase 3 clinical program. These infections remain a significant threat to the health of all patients in the U.S. with central venous catheters and with an ever-increasing threat of bacterial resistance blooming right on the horizon. And following physicians and patients with new antimicrobial is more important than ever. CorMedix is probably stepping up to the World Health Organization mandate for novel anti-infectives that combat resistance. Increased awareness and attention on the hospital-based microbial infection and overly aided our development and future commercial efforts by increasing the need for a product like Neutrolin. This is exemplified by Neutrolin receiving both FDA Fast Track and QIDP designation, significantly hesiting Neutrolin FDA review process, while securing potential market exclusivity for up to 10 years. We are committed to unlocking significant long-term value for our shareholders by launching this much needed product into a very broad and sizable U.S. market upon potential approval. And we look forward to providing future updates as we work diligently to complete the Phase 3 program. With that, we can now move on to the Q&A portions of this call.

Thank you. We’ll now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Ram Selvaraju with Rodman & Renshaw. Please proceed with your question. Mr. Selvaraju, your line is now open. So you can proceed with your question please. Perhaps your line is on mute.

Good morning, Rob. We’re not hearing you.

Okay. [Operator Instructions] Our next question comes from the line of Ben Reed with Maxim Group. Please proceed with your question.

Hi, guys. I was wondering, we passed the halfway point in enrollment. When can we expect interim data?

Hi, Ben, thanks for your question. Hence I covered it also in the previous call what we’re going to be doing is a safety check as we pass the midpoint. But it’s not an efficacy check. And so the Data Safety Monitor Board has been informed that we have passed the midpoint. So they will be doing a review over the coming weeks on the safety aspect of our Neutrolin product versus the control law. So I should be seeing that take place over the coming weeks. And that should be the only time you should hear from us in case we do find that there is an issue, or should I say, the Data Safety Monitor Board finds, there’s an issue. But as I indicated also on the previous call, I expect that to be very unlikely knowing that this part is already available in Europe on the market.

So would we get a press release on, if they say anything, or if they just say continue, everything looks good, anything like that at all?

If you don’t hear from me then that is good meals. So I do not expect to make any press release on the outcome. Now, if there are, obviously, we have any, or should I say the Data Safety Monitor Board has any concerns, at that point, I would obviously then put out a press release.

And there’s a chance they could say everything looks amazing and get early approval to write, although it’s small?

No, that is not possible, as they will not be looking at the efficacy part, it – they will not be able to say everything looks great from an efficacy perspective, if that’s what your question is. So they would be looking at the safety and be able to give us the green light to continue the study as we’re doing it, or if they see an issue, then we will obviously have to explore it.

All right. Thank you.

Welcome.

Thank you. Our next question comes from the line of Ram Selvaraju with Rodman & Renshaw. Please proceed with your question.

Hi, Khoso, can you hear me now?

Now I hear you, Ram. Good morning.

Good morning. I apologize, but anyway. So I have three quick questions. Firstly, could you walk us through what you anticipate to be the spending requirements through the course of 2017, as you approach fully enrolling the LOCK-IT 100 study? Secondly, could you perhaps give us some color on when you anticipate being able to start any other clinical development activities with Neutrolin like, for example, on the POETIC front, whether we might expect to see any of this move forward in clinical development over the course of 2017, or whether those activities might be pushed out further? And then finally, whether you see any additional potential impetus for Neutrolin as a product outside of the United States, and potentially whether there might be additional momentum in sales coming from outside of the U.S. over the course of 2017? Thank you.

Thanks, Ram. So, let’s begin the three questions you asked. So first and obviously, we don’t share what our projections are and our spend for 2017. But I think if you look historically what our spend rate has been for year, particularly 2016, you should – that should give you a gauge of roughly where our spend would be. In terms of our assets we employed, right now it would be feasibility work that we’re doing to better characterize the mechanism of action. So it won’t be, both cell line and animal model work that we will be doing and it will be all preclinical. I do not expect to get into clinical in 2017. As to your third question related to Neutrolin sales OUS, and I know, we covered it quite in depth last quarter call. As I indicated, we are ensuring that we focus all our resources here in the U.S, because the greatest inflection point for CorMedix will be to get Neutrolin completed their Phase 3 studies and approved in the U.S. and launch in the U.S. market. And, however, having said that, there’s always a time and place to look at Neutrolin for the other markets, where we already have the product approved under the CE Mark, which is like the 510(k) pathway in the U.S. And so, there will be a right time and place for Neutrolin in those other markets. And I would provide updates related to the steps we will take there at the right time. But at the moment, our focus is very much to make sure the first Phase 3 study is on track, and make sure, we get the second study up and running as soon as possible.

Okay, thank you. And then just a housekeeping question for Bob, if I may. What do you anticipate in terms of stock-based compensation expense for 2017 in terms of how that compares to 2016?

Ram, we’re working through the numbers right now and we’ll have more to say when we report the first quarter results. I think of the – just based on what I’ve seen so far I was expected to be roughly in the same ballpark. But again, I think we’ll have more details on that one when we show the first quarter numbers.

Thank you.

You’re welcome.

Thank you. There are no further questions at this time. I’d like to turn the floor back over to Mr. Baluch for closing comments.

Well, thank you very much for those of you that took the time to get up early morning to be on this call. I very much appreciate it. It’s an exciting time for CorMedix. We’ve got the Phase 3 – the first Phase 3 study now moving in terms of the enrollment in the right direction. Our projected timeline to close the study would be Q4 of 2017. I’m confident with the addition of the senior leadership that – team that we’ve got together. We now have the bandwidth to execute on a variety of different fronts. I’m also excited on looking and moving forward. Although, we’re still in preclinical work, but our pipeline, which should add a lot of additional value to our shareholders. So, thank you very much and have a good day, and happy St. Patrick’s Day for those of you who are celebrating it. Thank you. Bye-bye.

Thank you. This conclude today’s teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.