Greetings, and welcome to CorMedix Third Quarter 2018 Investor 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. It is now pleasure to introduce your host Dan Ferry, LifeSci Advisors. Please go ahead.

Thank you. Good afternoon. And welcome to the CorMedix third quarter 2018 investor conference call. Leading the call today is, Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Bob Cook, Chief Financial Officer; Liz Masson, Executive Vice President and Head of Clinical Operations; and Paul Chew, Chief Medical Officer. After the prepared remarks, we will open up the call for Q&A. 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, and 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. 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 today where we would like to review our third quarter 2018 financial performance and provide you with an update on our activities. Today’s call will focus on three areas most critical to driving value for CorMedix. Number one, our Phase 3 LOCK-IT-100 clinical trial for Neutrolin, in particular the progress we have made in closing the study and the upcoming meeting with the FDA. Number two, an update of medics development pipeline and specifically the final report of the animal study in neuroblastoma program with the POETIC Consortium. And number three, quarter three financial updates and our financial strategy for the next few months. This will include our recent competed settlement with our CRO. Before we get into the details, let me frame this call with a couple of highlights. As you know, our July 25 announcement, the independent Data Safety Monitoring Board reviewed the unblinded data for our Phase 3 LOCK-IT-100 clinical trial interim analysis and recommended the trial be halted for efficacy, as it had met the predefined criteria agreed with the FDA. No safety concerns were identified. It is important to remember that the company and its advisors still remain blinded until the database is locked, to avoid any introduction of bias into the study results. We anticipate this will occur at the end of the year 2018. To this end, we have work systematically to close the study, to protect the study subjects, clean and lock the database and prepare the clinical study report. The team has done an excellent job in our own schedule to complete this task as it was planned. You will hear more details about this aspect from Liz during this call. We've also stated in the…

Thank you, Khoso. I'm delighted to join this call and be able to provide more details on our activities over the last few months as they relate to the LOCK-IT-100 study. We have been focused on ensuring an orderly termination of the study for which we are working closely with our CRO and the investigator sites during this critical time. The effort began on July 26 when we notified the participating sites and Institutional Review Boards, IRBs of the positive interim analysis results in confirmation of the study ending. Shortly thereafter, our team implemented a plan to complete subject dosing and record all trial-related data. We are pleased that all subjects have now been given the last dose of study drug and are completely off the study, having completed their one month safety follow-up visit. The 69 participating sites have been tiered for closure by our internal team based on a number of factors including enrollment. And once the final data point is entered in the clinical database, the monitoring team will be able to complete the rigorous cleaning of the remaining data site by site. As of this past Friday, 52 of the sites have been closed and the remaining 17 will be closed by November 30. Once we've completed the cleaning process, and all the appropriate edit checks and data management processes have been run, the database will be locked and transferred to BCI, our independent biostatistical group. This effort has required that my entire team of approximately 30 full time senior CRAs visit all of the sites. Today we have cleaned close to 97% of all of the clinical data. In addition to the data cleaning and monitoring, there is a full reconciliation of investigational product underway. I am confident, as I indicated during last quarter's conference call that these activities that I just outlined are on track to be completed by the end of 2018. In addition, we are preparing in conjunction with our CRO all the essential documents so that they will be ready for FDA inspection, which is routine for studies. Additionally, the team has implemented robust quality assurance and quality control processes that are well underway. It is essential that all of the processes, procedures, and systems that were used in the study are thoroughly reviewed to ensure the highest integrity of study conduct. It should be noted that completion of all of this work is essential for our new drug applications, but not for the upcoming FDA meeting. I hope this helps clarify where we are in this important process. And I will now turn the call back over to you Khoso.

Thank you, Liz. Great effort from you and the team. No I’ll ask Paul to cover the two topics of the upcoming FDA meeting and the pipeline. Paul?

Thank you, Khoso. As you know Neutrolin is an investigational product in the U.S. and the ability to terminate LOCK-IT-100 early based on the demonstration of efficacy at the interim analysis moves us closer to realizing the value of Neutrolin as a major advance in the prevention of catheter-related infections, in hemodialysis patients. A significant cause of healthcare acquired infections which can lead to hospitalization and death are less than 25% of infections. We're continuing to progress the Neutrolin development program to bring this product to market as soon as possible. We believe that Neutrolin can fill a significant unmet medical need. As Khoso noted in his introductory comments, we believe that the robust results from the LOCK-IT-100 support consideration by FDA is substantial evidence of effectiveness and safety. The FDA previously guided CorMedix to focus on to Phase 3 studies to support the filing of the NDA for Neutrolin. The FDA's guidance allows for the two studies to be undertaken in different patient populations using central venous catheters. We focused significant effort and time in developing a submission to the FDA to request Neutrolin’s approval pursuant to a newly available program. Just this summer, FDA announced LPAD, Limited Population Pathway, for antibacterial and antifungal drugs. LPAD provides for FDA to streamline clinical development by relying on fewer or smaller clinical trials for a limited population. We’ve carefully crafted our arguments for our proposed approval pathway for Neutrolin limited to hemodialysis patients with central venous catheters based on a single study, namely LOCK-IT-100 using LPAD. This has required us to continue cleaning the database as discussed by Liz and carefully compile information for the safety database. As we announced in August, the interim analysis was based on the primary endpoints to assess effectiveness. The FDA has clear requirements in terms…

Thank you, Paul. Clearly a critical time for CorMedix with the FDA meeting. Now let me ask Bob to cover quarter three financial results and the CRO supplements. Bob?

Thank you very much, Khoso. The company will file its report on Form 10-Q for the quarter ended September 30, 2018 before today's close of business. I urge you to read the information contained in that report for a more complete discussion of our financial results. With respect to our third quarter 2018 financial results, our net loss was approximately $10.2 million or $0.11 a share compared with a net loss of $10 million or $0.17 a share in the third quarter of 2017. Our net loss in the second quarter of 2018 was $8.6 million or $0.10 a share. During 2018’s third quarter, the costs associated with our LOCK-IT-100 clinical study increased significantly compared with the second quarter as we prepared for and conducted the interim analysis and then commenced to wind down the study and close out the sites. Operating expenses in the third quarter of 2018 increased 20.5% over the second quarter of 2018 to $10.3 million compared with $8.5 million in the previous quarter. R&D expense increased approximately 25.6% to $8.3 million from $6.6 million, due to a 31.6% increase in clinical trial expense, while other R&D declined approximately 6%. Our expense, specifically related to the clinical study was approximately $7.6 million or 74% of total operating expense during the third quarter of this year. The increase in clinical trial expense was most particularly seen in investigator fees and site cost, which increased $2.1 million quarter-over-quarter, and were driven by the center's needs to complete patient dosing and the one-month safety follow up and record all trial related data as quickly as possible in order to permit timely site closure. Direct CRO expenses increased $0.3 million, reflecting preparations for the interim analysis followed by data collection and cleaning. Partially offsetting the increases in investigator payments and…

Thank you, Bob. What Liz, Paul and Bob covered with you, hopefully provides you some insight into the journey since our last earning call and also reaffirms our focus and priority during these coming months. I'd like to reemphasize. As Liz indicated, we're on track to lock the database by year end 2018 in preparation for closing the study and issuing the final clinical study report. As Paul indicated, we have focused significant effort and time in carefully preparing CorMedix’s arguments and rationale for defending new prunes NDA pathway with the FDA. In addition, after the database is locked, we will announce the results of the interim efficacy analysis expected in early 2019. As appropriate, we will share more details on CorMedix’s neuroblastoma program as it becomes available. And finally, we have also turned our attention to the building blocks required to commercialize Neutrolin in the U.S. We are pleased with the recent release from the center of Medicare and Medicaid services, CMS, in early November 2018 or the ESRD perspective payment system, PPS, final rule, which includes the proposed expansion of the transitional drug add-on payment adjustments that we have supported. This should help new innovations such as Neutrolin. While we make preparations on the most effective way to commercialize Neutrolin in U.S., we remained open to strategic and/or commercial partnership as long as it's in the best interest of our shareholders. After laboring for many years to get Neutrolin over the finish line, CorMedix is very near achieving a critical accomplishment. In my opinion, once approved Neutrolin will become the standard of care for preventing catheter -related bloodstream infections, and taurolidine will have significant other applications against inflammation and infections. I'm pleased with the leadership team at CorMedix, their breadth of knowledge and expertise has provided CorMedix the required bandwidth to ensure that both strategically and from an execution perspective, we can achieve our ultimate goals. This team coupled with the strategy we embarked on in early 2017, continues to move steady fast forward at an ever growing pace. I look forward to providing you updates both via CorMedix website and via conference call. Thank you for your support of CorMedix. Now let me hand the call back to Stacey [ph].

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Ram Selvaraju with H. C. Wainwright. Please go ahead.

Hi there, this is Julian on for Ram Selvaraju. Thanks for taking my questions. First, just to confirm, you plan on having a pre-NDA meeting with the FDA before the end of the year and you plan on reporting the outcome of that in the first quarter of next year. Did I hear that correctly?

Well, let me be a little more precise. A pre-NDA meeting presupposed with an NDA. And so we're even pre-pre NDA. We want to talk with the FDA about an NDA based on LOCK-IT-100 as a single determine trial.

Okay, got it. And the timing of that, that was correct?

Well, as we said, our hope is that we will get in 4Q.

Okay, got it. And for my last question, I was just curious if you have any early thoughts on label extension for catheter-related bloodstream infections beyond just those secondary to hemodialysis?

Well, as you know, in many presentations we've made, there were so many catheter-related infections related to cancer patients who need chemotherapy, critical care patients, even patients who get all of their nutrition from catheters. So all of that's going to be part of our plan going forward.

Thanks very much.

[Operator Instructions] There don't seem to be any further questions at this time. I would like to turn the floor over to Khoso Baluch. Please go ahead.