Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to CorMedix First Quarter 2018 Results Conference Call. At this time, all participants are in a listen-only model. A question-and-answer session will follow the formal presentation. [Operator Instructions]. Please note this conference is being recorded. I would now like to turn the conference over to your host, Monique Kosse from LifeSci Advisors. Thank you. You may begin.

Thank you. Good afternoon, and welcome to the CorMedix first quarter 2018 investor conference call. On this call today, Khoso Baluch, Chief Executive Officer of CorMedix will provide an update on the company's clinical programs and other matters. Liz Masson, Executive VP and Head of Clinical Operations will provide an update with respect to the ongoing efforts to complete the LOCK-IT-100 interim analysis. We will then turn the call over to Bob Cook, Chief Financial Officer. After their remarks, we will then turn the call back over to the operator a Q&A session. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, management 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 potential 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, results, and interpretations thereof, projections as to the company’s future capital raising, and 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. 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 Web site 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, Monique. Good afternoon everyone and thank you for joining us on our call today where we would like to review our first quarter 2018 financial performance and provide you with an update of our activities. As in our previous calls, we will provide updates on key areas that are most critical of driving value for CorMedix, including our ongoing Phase 3 clinical trial for Neutrolin and the planned interim analysis, a brief update on the pipeline development specifically our taurolidine-infused medical devices and neuroblastoma program, status update on Neutrolin sales in Europe and the Middle East, and quarter one 2018 financial update and our plans. So let me begin on the ongoing Phase 3 LOCK-IT-100 clinical trial and the interim analysis for Neutrolin, which is our top priority. We are currently anticipating that the Data Safety Monitoring Board will review our interim analysis and make its recommendation in July 2018, assuming no further delays in obtaining the additional data needed to assess secondary endpoints and serious adverse events to complete the review process are encountered. We are continuing efforts to complete this interim analysis and study as efficiently and as quickly as possible. In order to provide you further color to the task we have at hand, I have asked Liz Masson who is Executive VP and Head of our Clinical Operations to join us this afternoon to provide insight and details on the clinical data review process. Although we have made meaningful progress since our last call, it has taken far longer than anyone had expected. While we continue to work cooperatively with our CRO, we are in negotiations with them regarding further remediation efforts and financial considerations based on the delay in preparation to perform the interim analysis. We plan to provide an update once we have clarity on the outcomes of our negotiations with our CRO, which is one of the largest and most highly regarded CROs in the world and whose business includes running multi-sites clinical trials around the world, including for nearly all of the top 50 pharmaceutical companies. I will now turn the call over to Liz to provide more details on the review process. Liz?

Thank you, Khoso. I’m delighted to join this call and be able to provide more details on what we’ve been doing. Our focus remains to ensure that all the required data for the interim analysis is correct and source-verified for the subjects in the study up to the time we reached the 28 CAC-confirmed CRBSI in early December. While 28 cases sounds like a small number, the volume of data that comprises these cases is significant. Further, the onus is on CorMedix to ensure that the 28 cases we submit are the first 28 cases that occurred as we agreed in the amended protocol permitting an interim analysis with the FDA. To ensure that we have done that, the study team needs to review over two years of data for nearly 700 subjects including an assessment of all secondary efficacy endpoints for catheter removal and loss of patency. Remember, hemodialysis patients are treated at least three times per week generating thousands of treatment records that require review. Further, we need to collect data relating not only to what happens while subjects are undergoing dialysis but also while they are off dialysis and may have sought medical attention at a hospital, emergency center or other acute care settings. The volume of data combined with the complex medical makeup of these subjects presents us with an extraordinary path. Now, some of you may be wondering how we could have not anticipated these issues prior to the transfer of the data to CorMedix in early February for the interim analysis. Let me help frame an answer for you. All studies go through the same process of cleaning the data as the study is in progress and then goes through a specific final cleaning and source verification when there is either an interim analysis…

Thank you, Liz. Moving on to our pipeline, both the taurolidine-based medical devices and our neuroblastoma program. I want to provide you a brief update, specifically the taurolidine-infused suture, mesh, and hydrogel. First, I’d like to point out that we have spent approximately $275,000 moving these medical device programs forward with just one employee who is not part of the LOCK-IT-100 effort. We completed early preclinical trials during the first quarter of 2018. The study showed faster wound healing in early days for the taurolidine hydrogels, the sutures were structurally intact with up to 7% weight [ph] taurolidine infusion, none of the taurolidine-infused devices used in the studies inhibited wound healing. At a macro level, these results were encouraging but they are preliminary. We would need to move to the next step in the development plan to differentiate the devices from today’s standard of care so we can interest a partner to bring them to market. In light of the feedback we received from the FDA that the 510(k) pathway was not an option at present and that the FDA would therefore regulate CorMedix’s medical devices as a Class 3 medical device which requires a Premarket Approval Application, PMA, for the drug-device combination. CorMedix intends to continue to discuss the regulatory pathway with the FDA if and when the new drug application for Neutrolin is approved. Although there will presumably still be no appropriate predicate device, the no Class 2 [ph] can be proposed at that time based on the risk assessment and a reasonable assurance of safety and effectiveness. To this end we have put most of the medical device development activity on hold pending FDA approval of Neutrolin. We have ceased partnership outreach but we are open to meet with interested parties that express interest. That being said,…

Thanks very much, Khoso. The company will file its report on Form 10-Q for the quarter ended March 31, 2018 before today’s close of business. I urge you to read the information contained in the report for a more complete explanation of our financial results and for an analysis of results compared with the comparable period in 2017. With respect to our first quarter 2018 financial results, our net loss was approximately $10.2 million or $0.14 per share compared with a net loss of a $7.6 million or $0.19 per share in the first quarter of 2017. Our net loss in the fourth quarter of 2017 was $10.3 million or $0.15 per share. During 2018’s first quarter, we experienced higher costs related to the ongoing LOCK-IT-100 clinical study compared with previous quarters while other expenses continued to decline or remain flat. Operating expenses in the first quarter of 2018 were roughly unchanged from the fourth quarter of 2017, declining to 10.2 million compared with 10.4 million in the previous period. R&D expense decreased approximately 2% to $8.3 million due to a 77% decrease in manufacturing expense and a 29% decline in other R&D, while clinical trial expense increased by 21%. Our expense related to the clinical study was approximately $7.3 million or 71% of total operating expense during the first quarter of 2018. The increase in clinical trial expense was seen primarily in payments to participating sites which increased 86% from last quarter and from a 36% increase in consulting fees primarily due to additional staff hired to takeover site monitoring from our CROs. The increase in investigator payment reflects higher enrollment and a net increase in study subjects during the quarter. SG&A expense declined 3% to $1.9 million with reductions in virtually all areas except for patent expense and…

Thank you, Bob. The critical task on hand is the LOCK-IT-100 study and most specifically the interim analysis. The team that we have assembled over the last few months is experienced and focused on delivering. Another benefit of the task that the team is doing now with this quality monitoring is that it will allow us to avoid unnecessary delays at the end of the trial whether it is at the interim analysis or upon reaching 56 events. With that, I would now like to open our call for questions. I will hand it back to the operator.

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions]. Our first question is from Alexis Woods with LifeSci Capital.

Hi. Thanks for taking my question. I just wanted to know if you could speak to the level of confidence that you have that you’ll hit July 2018 for the interim readout and why you’re more confident now that you’ll be able to meet that timeline as opposed to how confident you’ve been in the past.

Sure. Thanks, Alexis. We have undergone a rigorous planning process with a number of experts and built very strong teams dedicated to the integrity of the data and it’s a process that gets regularly reviewed. So with that and the team that we’ve put in place, I’m very confident in our timeline at this point.

Okay. Thank you. And then I just have one more question related to the taurolidine-infused devices. If you could speak to the next steps for those programs and if it’s going to be preclinical or clinical? And then if it’s going to be preclinical, what you would need to see in order to eventually move it into the clinic?

Thank you, Alexis. I will cover that question. As I indicated in the prepared statements, in light of the feedback we received from the FDA on the 510(k) pathway that we would have to go down the PMA pathway. At the moment what we’re going to do is put the effort on hold. There’s going to be some minor work done just to make sure we have a clear path forward as to what work we will do at the right time to differentiate our products from the standard of care in the marketplace. But we are not going to be doing any more studies right now until we have got Neutrolin approved or the situation changes for us and then we would be ready to invest in that segment.

Okay. Thank you.

[Operator Instructions]. Ladies and gentlemen, we have reached the end of the question-and-answer session. I would like to turn the call back to Khoso Baluch for closing remarks.

Thank you everyone for listening in today. I’d like to thank our employees, our full-time consultants for their hard work and dedication, our Board members for their guidance and our shareholders for their ongoing support. We look forward to providing further information as developments continue to capitalize and to updating you again on our next earnings call. Thank you very much and have a good evening.

Thank you. This concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time.