Greetings. Welcome to CorMedix's First Quarter 2019 Earnings Conference Call. [Operator Instructions] Please note this conference is being recorded. I would now like to turn the conference over to your host Mr. Dan Ferry. Thank you, sir. You may begin.

Good afternoon. And welcome to the CorMedix first quarter 2019 investor conference call. Leading the call today is, Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Bob Cook, Chief Financial Officer of CorMedix; Phoebe Mounts, Executive Vice President and General Counsel; and Paul Chew, Chief Medical Officer. Please note that during this presentation, we will be displaying certain slides. So please log on to the link on our website so that you can see the slides. We will let you know when we will start to project certain slides. Before we begin, I would like to remind everyone that 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 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. In order to utilize our time on the call effectively please forward to me any questions you may wish to ask management at the conclusion of the call to my email address at daniel@lifesciadvisors.com. You may send them at any time during today's presentation. I will collate and read the questions at the conclusion of management's presentation within the time allowed. 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, Dan. Good afternoon, everyone, and thank you for joining us on our call. My comments today during this earnings call will be brief as most of the time will be spent by the experts who will be updating you on the three areas most critical to drive value for CorMedix. Before we get into the three area, I like to formally welcome Phoebe Mounts who recently joined CorMedix as Executive Vice President and General Counsel for legal, regulatory and compliance. We now have internally a very strong legal and regulatory team with Phoebe and her colleague who have joined CorMedix. I am very pleased that CorMedix continues to build the leadership team and for those of you who participated or heard the last earnings call I did mention that we will continue to evolve by expanding our team over the coming year. Now let’s get into the three areas. First, we will give you an update on the regulatory pathway for Neutrolin in particular the progress we've made with the FDA on moving the discussions forward since our last earnings call on March 14. Second, we’ll update you on the activities from our medical affairs group over the last few months, and third an update on the company's financial position and strategy. Before we get into details let me cover a couple of highlights. First as you know from the last meeting with the FDA, the FDA agreed that the company could request consideration of Neutrolin for approval under the LPAD pathway. For those of you who are not familiar with LPAD it stands Limited Population Pathway for Antibacterial and Antifungal Drugs. We're very pleased about this outcome what this means for Neutrolin is that if the FDA agrees to grant LPAD status, the FDA will have approaches…

Thank you, Khoso. Let me start by saying how pleased I am to join the CorMedix team and to be able to focus full time on continuing the great progress we have made on the regulatory pathway towards securing marketing authorization for Neutrolin in the United States. I am also very pleased have joining me on the legal and regulatory team at CorMedix are Jessica Vaughn and [indiscernible] who I can assure you have great enthusiasm and dedication for the work ahead and to continue our success. They have been part of the team with me that has been responsible for developing regulatory strategy for CorMedix and filings with the FDA over the past several years. We now have these talents and resources available to CorMedix full-time. As Khoso said, we were pleased with the outcome of the last meeting with the FDA and we look forward to continuing our discussions with the agency on the data from LOCK-IT-100. Our meeting focused on the regulatory pathway for Neutrolin in light of the extraordinarily positive results that we obtained from the study and the availability of LPAD as an option for filing the NDA as described by Khoso. The recent availability of LPAD provides the FDA with a new regulatory pathway for ensuring the development of anti-infective product that's facilitated to address the need for novel antimicrobial in the face of increasing antibiotic resistant. We are encouraged that the FDA has agreed that we can request marketing approval pursuant to LPAD which means that the statutory requirement for substantial evidence of safety and effectiveness based on clinical trials emphasis on the thorough of clinical trials is not absolute and the FDA has some flexibility to accept the data in LOCK-IT-100 for approval of a new drug application for a catheter LOCK…

Thank you, Phoebe. We've been making progress on several front. First, the American Society of Clinical Oncology will release an important abstract online on May 15, 2019, presenting the results of our CorMedix sponsored study for ASCO. The annual ASCO meeting is a major meeting – is a major educational and scientific event in oncology is in Chicago, Illinois on May 31 to June 4, 2019. The abstract entitled, effective targeted antitumor activity of the antimicrobial agent taurolidine against relapsed refractory neuroblastoma, cytotoxicity, target modulation and tumors xenograft study. This describe the antineoplastic activity of taurolidine in the preclinical study in the mouse model of neuroblastoma led by Dr. Aru Narendran, Professor of Pediatrics, Oncology, Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary. Next, multidrug-resistant Candida auris is an emerging fungal infection causing serious illness in humans at CDC and cited as a serious global health threat. Candida auris is associated with life-threatening bloodstream and wound infections causing recent hospital outbreaks here in the U.S. and globally with mortality up to 35%.It’s also able to form biofilm that enhances its pathogenicity and persistence in the hospital setting from ceiling tiles to floor tiles and even telephone. In vitro study show that taurolidine inhibits replication of this deadly pathogen and laboratory studies. The broad-spectrum activity of taurolidine underscores the potential utility of taurolidine for development not only of the active ingredient in Neutrolin but for all the therapeutic uses, such as sutures, hydrogels and surgical measures. We have submitted for publication at three clinical study describing taurolidine against Candida auris. These presentations and publications reflect CorMedix’ commitment to advancing the science and disseminating the ongoing research we’re performing to the broader scientific and medical community. And finally, last Friday we presented at the National Kidney Foundation, NKF, which…

Thank you, Paul and thank you, Phoebe for describing clearly important work for CorMedix as we continue to move forward. Thanks also appropriate to the investigators and the hemodialysis patients who contributed to the study success. Now let me ask Bob to cover quarter one financial results and the CorMedix's overall finances. Bob.

Thank you very much, Khoso. The company has filed its report on form 10-Q for the quarter ended March 31, 2019.Please read the information contained in this report for a more complete discussion of our financial results for the period. We are very pleased with our financial results for the three months ended March 31, 2019.Highlights for the quarter include the following. We recorded a net loss from operations of $5.2 million or $0.22 per share compared with a net loss of $10.2 million or $0.68 per share in the first quarter of 2018, a 49% improvement. The significant decline in net loss versus the first quarter of 2018 was due to a 65% decline in research and development expenses. R&D expense during the first quarter 2019 amounted to $2.9 million compared with $8.3 million during the first quarter 2018,a $5.4 million decline. This reduction occurred as a result of the winding down of the LOCK-IT-100 trial as our clinical trial expense dropped from $7.3 million in the first quarter of last year to $1.6 million in the latest quarter. Expense incurred from our CRO declined by more than 90% to 0.5 million during the recent quarter. SG&A A expense of $2 million in the first quarter 2019 was 4% higher than the first quarter of 2018.Higher stock compensation, staffing and compliance expenses as well as expenses related to preparation for Neutrolin's anticipated commercialization in the U.S. were offset by reductions in legal and patent expenses and accounting fees. Cash used in operations in the first quarter 2019 was approximately $7.4 million compared with the use of $7 million in the first quarter of 2018.Cash used in operations increased 6% despite a $5 million lower net loss during the first quarter of 2019 as a result of a $3.4 million…

Thank you, Bob. What Phoebe, Paul and Bob covered with you hopefully provides you insight into the important events on which we are focused that have occurred over these last two months. I'm pleased about the progress we're making. I'd like to reemphasize first as Phoebe elaborated our current discussions with the FDA are moving along and we look forward to completing the clinical study report and finalizing the clinical data required to demonstrate the safety and efficacy of Neutrolin as a catheter LOCK solution for hemodialysis patients. The team continues in power to prepare the components required for an NDA filing. Paul covered the recent NKF presentation and the upcoming ASCO abstract. We will be posting the slides from the NKF presentation on our corporate website tonight. Paul provided our current balance sheet and cash flow. We believe we have cash on hand sufficient for us to complete the regulatory discussions with the FDA and file an NDA. If the FDA agrees with our request to file based on a single study. If approved we believe Neutrolin will become the standard of care for preventing catheter-related bloodstream infection and taurolidine will have significant other applications against inflammation and infections. I'm very pleased with the strength of our management team adding Liz and Paul last year and now Phoebe and her team provides us the capabilities to complete the NDA filing as planned. We will continue to evolve by augmenting our team over the coming years. I'm also confident that the strategy we embarked on in early 2017 will continue to move steady fast forward at an ever-increasing pace. I look forward to providing you with material development update via CorMedix website press releases and conference call. Thank you for your continued support of CorMedix. This concludes management presentation. So Dan I’m going to hand back the call to you to read the first question that you have received.

Thank you, Khoso. So can you please clarify where we stand with the FDA and then behind that why the change versus submitting just the information the FDA requested? Thank you.

Thanks Dan. We have the benefit of having Phoebe here so I am going to ask Phoebe if you can respond to that?

Absolutely. I think we actually stand in a very good positions with FDA. My philosophy has always been its in response to the best interest to develop a good working relationship with FDA. And as we demonstrated in this call and throughout our relationship with CorMedix, we've been able to gain access to FDA in meetings to obtain guidance from them on issues that are important for the regulatory pathway. We have as we’ve talked about in the past had meeting with FDA to talk about the results from LOCK-IT-100. And there were question as you would expect in discussing the data with FDA. We are analyzing the data going forward to create the clinical study report and to respond to the questions that FDA had on the data and ask for additional analysis. We have asked for a follow-up meeting to continue the dialogue with FDA and to discuss those results. As I said a few minutes ago the meeting has been granted and we intend to go forward with that meeting as it continues the dialogue. There hasn’t really been a change as part of the process FDA requires that you request the meeting as I said it discretionary. We’re fortunate that the request was granted when the meeting request has been granted by the Center for Drug CEDR then respond to submit to background package, so with the process that we’re working through and we intend to go forward with the dialogue with FDA. Thank you.

Okay. Thanks, Phoebe. And so Khoso as a follow up to that do we have visibility into an end of Phase 3 meeting and - which may lead to a potential pre-NDA meeting?

Good question, Dan. Phoebe?

Absolutely. The process that I just described a few minutes ago is intended to get visibility into whether or not we are at an end of Phase 3.As everyone knows Phase 3 is when a sponsor conducts the pivotal trial to generate substantial evidence of safety and effectiveness. We’re helpful that the robust finding from LOCK-IT-100provide that substantial evidence, especially if we can take advantage of the LPAD regulatory pathway. If FDA agrees then we will be at the end of Phase 3, no additional Phase 3 study will need to be conducted. When we reach that point, we will be then in a position to go forward with pre-NDA discussions with FDA to start getting guidance from them on the other components that are required for filing the NDA.

Back to you, Dan.

Thanks, Khoso. Thanks, Phoebe. So what was the new information released at the NKF meeting and the follow-up there is how did the KOL community respond to that presentation?

Paul?

Thanks Dan. The NKF as you all know is the National Kidney Foundation, there are preclinical meeting is a very important and very clinically relevant. We’re pleased to collaborate with them to have an oral presentation of the late-breaking session where we thought over that in some detail. We present that study there and we believe it was better today to hear those point verbally before those slides go on the website. The result finding are very striking, six in 10,000 a chance that they are becoming being a chance event. As our surprise to see that there have been some misleading reports about what was presented are showing absolutely no difference in outcome and I don't even know those before meeting. Clearly the opinion leaders, we've been dealing with them some of them in the disclosures but there are many others who feel that this is a major breakthrough in the treatment of a very serious problem, highly positive. So we’re delighted to be able to present that at the NKF.

Dan, back to you.

Great. Thanks, Paul. So Khoso, how was the hiring or Phoebe Mounts being helpful and has she bit involved in any of the FDA discussions?

So for those of you who are not familiar, Phoebe has been involved with CorMedix going back to 2013.She spearheaded to basically the regulatory strategy for Neutrolin with the FDA, which got us the Fast Track QIDP designation and more recently she's also been involved when we be looking at our pipeline with the orphan drug designation. Phoebe is well after learning curve. Knows CorMedix, knows the Neutrolin in the regulatory pathway very well. The benefit of hiring her and her team with us is now they are full time focus on the priorities for CorMedix and obviously gives us as I mentioned in the pre-prepared remarks, the capabilities and bandwidth to get the NDA filing should the FDA agree with us. So it's been tremendous for CorMedix.

So the ASCO abstract will be on the few days. I believe its May 15th and given that the neuroblastoma program has been more or less on hold over these past several months, what is the current development plan to further this preclinical asset into the clinic?

Dan, first of all we’re delighted that this abstract has been accepted by us. So because I think it’s a very important state showing both the biomarker of improvement to reduction in tumor size and improve survival which we’ve disclosed in the previous meetings but you will get more details on abstract. We’re looking forward to moving the program forward, but at this stage our hands around that for driving Neutrolin across the finish line, hemodialysis that’s our respond early. Once we completed the heavy lifting, the Neutrolin will pick up on that other very important opportunity. Thanks, Dan.

Okay. Thanks, Paul. Khoso, why is the FDA taking so long to decide if CorMedix can move forward for an NDA filing based on one study?

Good question, Dan. I guess I can turn to Phoebe again.

Thank you for the question, Dan but I think I would argue that its not taking FDA so long. There is a process that I described that a sponsor must go through and in this case there is a very large database generated from LOCK-IT-100and its very important that we cover all of that data to establish the financial evidence of safety and effectiveness. We are asking FDA to do something that is not the normal pathway as I said the statutory requirements under the Federal Food Drug And Cosmetic Actis that there's substantial evidence of safety and effectiveness from clinical trials and that's been traditionally interpreted by FDA as we acquiring two well-controlled Phase 3 study. As we've been talking, we are asking FDA to find substantial evidence in a single trial LOCK-IT-100. So I think it is a process. We understand everyone’s enthusiasm for having this process move forward as fast as possible. We embrace that. We recognize the unmet medical need and I can assure you we are working as fast as we can FDA to take this to market.

Back to you, Dan.

Okay. Thanks, Phoebe, thanks Khoso. I know its almost 5:30 here. Khoso, have we got any institutional investors trying to CorMedix?

Let me ask Bob to answer that.

Thanks, Khoso and Dan. It's always difficult to be able to say with any level of certainty whether there are new or in fact who may be investing or buying the company's stock. I tend to judge based on the number of inbound calls that we get on the number of people who call and ask questions, the number of people with whom we meet and the types of questions and the number of questions that we get from them. And since we put out the results of the trial I guess particularly, since the earlier this year, I would say that there has been a very noticeable uptick in the level of interest that we have gotten from institutions, the number of meetings that we've had in not us pushing ourselves on them but meetings based on their request has increased significantly. The level of interest that we get from sell side analyst has increased significantly and so based on that anecdotal information I would say that there has been an increase in the level of - certainly the level of interest and I suspect also the level of investment from institutional investors.

Ladies and gentlemen, at this time there are no further questions out in queue. This does conclude today’s teleconference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.