Paul Arndt – Managing Director, LifeSci Advisors Khoso Baluch – Chief Executive Officer Liz Masson – Executive Vice President and Head of Clinical Operations Paul Chew – Chief Medical Officer Bob Cook – Chief Financial Officer

Ram Selvaraju – H.C. Wainwright Alexis Woods – LifeSci Capital

Greetings, and welcome to CorMedix Second Quarter Corporate Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] I would now like to turn the conference over to your host Mr. Paul Arndt, Managing Director of LifeSci Advisors. Thank you, Mr. Arndt. You may begin.

Thank you, operator, and good afternoon, everyone. And welcome to the CorMedix second 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, Paul. Good afternoon, everyone, and thank you for joining us on our call today where we would like to review our second quarter 2018 financial performance and provide you with an update on our activities. The call will focus on two areas most critical to driving value for CorMedix. Number one, our Phase 3 LOCK-IT-100 clinical trial for Neutrolin in particular the successful outcomes of the recently completed interim analysis and the activities to wind down the study as we prepared to request the meeting with the FDA to agree on the next steps to ultimately bring Neutrolin to the market in the U.S. Number two, our quarter two 2018 financial update and our financial strategy for the rest of the year. So let me begin with the first point. As you know from previous calls, we had scheduled the meeting of the Data Safety Monitoring Board, DSMB to review the results of the interim analysis in July 2018 and to make its recommendations about the trial. I’m pleased to report that we met the timeline. The LOCK-IT-100 study is a Phase 3 multicenter, double-blind, randomized active control study using today standard of care heparin to demonstrate the safety and effectiveness of Neutrolin in presenting catheter-related blood stream infection called CRBSI as the primary endpoint in subjects receiving hemodialysis therapy as treatment for end stage renal disease. As previously discussed with FDA, the interim analysis was designed to take place when 28 CRBSI events occurred in the study. Allow me to remind you of the three possible interim analysis outcomes. First, we could stop the study due to demonstration of efficacy, because the study met the predefined requirements for the primary efficacy endpoints. Number two, continue the study as designed until 56 CRBSI events occurred. And number three, stop the study due to futility, because its unlikely that statistical significant results can be obtained. As you know from our announcement from July 25, the independent DSMB reviewed and the unblinded data for our Phase 3 LOCK-IT-100 clinical trial interim analysis based on the 28 CRBSI cases and recommended the trial be halted for efficacy as it had met the pre-defined criteria for stopping and no safety concerns were identified. We were thrilled at this outcome, which was the best case scenario for the Neutrolin study and it is an uncommon occurrence in Phase 3 development. While we were optimistic that a positive interim analysis might occur given the available body of data for taurolidine Neutrolin, we believe this outcome is a remarkable achievement. In light of this achievement, we plan to seek the FDA agreement that we file an NDA based on a single clinical trial specifically LOCK-IT-100. Based on the DSMB’s recommendation, we have stopped enrollment activity for the trial and began the process of terminating the study in accordance with good clinical practice. The company has remained blinded to the specific results of the interim analysis to ensure that no bias is introduced while the trial is being terminated. In order to provide you with some color to the task at hand, I’ve asked Liz Masson, CorMedix’s Executive Vice President and Head of Clinical Operations to join us this afternoon to provide insight and details on the steps currently being taken. I will now turn the call over to Liz.

Thank you, Khoso. I’m happy to join this call and be able to provide more details on the activities required to close the LOCK-IT-100 study. We are now focused on ensuring an orderly termination of the study, which requires that we work closely with the sites during this critical time. The effort we’ve had on July 26, when we notified the participating sites an institutional review boards, IRBs of the positive interim analysis result. Certainly thereafter our team formulated a plan for the study subject to be notified and to administer the last dose of study drug by August 4. For the study protocol all subject will return for a safety follow visit approximately one month after exposure to the last dose of study drug. The study participants were given an IRB approved letter announcing the positive results of the interim analysis that support early termination of the study and thanking them for their voluntary participation in this pivotal trial. The 67 currently participating sites have been tiered for closure by our internal team, they’ve done a number of factors including enrollment numbers. And once the final data point is entered into the clinical data base, the monitoring team will be able to complete the rigorous cleaning of the remaining data site by site. As we prepared for the interim analysis, our team cleaned a large volume of data with a heavy emphasis on the primary and secondary endpoint in subject safety. For those subjects enrolled through early December 2017. There remains a great deal with data for those subjects plus all of the data for the subject that enrolled after early December through late July. Additionally, their regulatory investigational product and administrative test that need to be performed for all of the sites in parallel as cleaning the data. 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 in transferred to BCI our independent bio statistical group. We anticipate these activities that I just outlined will take the remainder of 2018 to complete, but we continue to look for efficiencies in these processes. I hope this helps to better understand the critical path we are performing. At this point, I’ll turn the call back over to Khoso.

Thank you, Liz. What you’ve heard from Liz are the operational aspects of winding down the involvement of the site and the subjects currently enrolled in the study. And the required steps to complete the study termination. Our CRO is working cooperately with us while we continue our negotiation regarding certain financial considerations related to the activities completed to perform the interim analysis. I would now like to introduce you to Paul Chew, the Chief Medical Officer for CorMedix who will walk you through the next stage of Neutrolin development program. Paul?

Thank you, Khoso. I’ll provide more details on the drug development activities going forward. Neutrolin as an investigational product in U.S. and the recommendation of the DSMB moves us closer in U.S. to realizing the potential of Neutrolin as a major advancement prevention of catheter-related infections in hemodialysis patients. A significant cause of healthcare required infections which can lead to hospitalizations and sometimes even death. Based on the positive interim analysis, we’re continuing to progress the Neutrolin development programs to bring this product as soon as possible to patients. We believe that Neutrolin can sell a significant unmet medical needs. Based on the DSMB recommendation enrollment has stopped and the orderly closed out of the trial was underway as Liz was just outlined. This remaining information must be included in a new drug application. Now many of you may be wondering what happened now, what happened next. We’re planning to discuss these results of the interim analysis of FDA, which means that a package is being prepared that will be submitted as the meeting request at FDA to determine the path forward in the development program and we expect this meeting will occur in quarter four of 2018. The previous guidance from the FDA on Neutrolin’s development focused on two Phase 3 studies to support the filing of the NDA for Neutrolin. Discussions involved having two studies in different patient populations using central venous catheters. The FDA has clear requirements in terms of what is expected to substantiate the evidence required for a new product in terms of efficacy and safety. As a result of the DSMB recommendation to stop LOCK-IT-100 early for efficacy and we’re now safety concerns were identified, we’re looking forward to engaging with FDA on the next steps. Now should FDA agree with CorMedix is assertion of LOCK-IT-100 shows that Neutrolin provide substantial evidence of safety and effectiveness and the catheter loss solution for using hemodialysis patients. We expect them to move forward with an NDA for Neutrolin for use in hemodialysis patients to prevent CRBSI. Now an NDA is a big undertaking with many volumes and thousands of pages, which will require significant work and coordination. And NDA consist of 19 sections encompassing many different subjects at which clinical and manufacturing of [indiscernible] of this include chemistry, stability, preclinical data and labeling claims and more. We’ll share more specific information and timelines once we’ve met with FDA and agreed on a course of action. We expect to have results of the FDA meeting during the fourth quarter of 2018. I’ll turn back the call now to Khoso Baluch.

Thank you, Paul. What Liz and Paul have covered with you is exciting and provides you an insight into the direction towards which we at CorMedix are pushing with respect to the final development for Neutrolin. I’d like to reemphasize a couple of points. Number one, we are winding down the study, no more subjects are being enrolled in the study, we expect most of the common subjects to be up investigational drug by now and for the final safety with it’s to be completed by September. Therefore, CorMedix clinical trial expenses are expected to decrease as we enter quarter four 2018. Number two, as Liz was stated, we will continue the process to collect, clean and prepare, all of the remaining data so that LOCK-IT-100 study is properly closed and the data is available for the new drug application. Number three, as Paul indicated, we are in the process of preparing a meeting request with the FDA to discuss the next steps in the development plan. Based on the outcome of the discussions with the FDA, we will be providing further updates that will cover the Neutrolin development plan. Let me remind you that Neutrolin has both fast track and QIDP status. In recognition that there is a significant unmet medical need to prevent infections in hemodialysis patient with central venous catheters. Before I turn the call over to Bob to review the financials, I want to reiterate our strategy at CorMedix. We are a development company with 17 employees and many full time clinical consultants focus on the products for the prevention and treatment of infections and inflammatory disease. We have an exciting near-term potential opportunity with our Phase 3 asset in Neutrolin and look forward to the FDA meeting in quarter four 2018. With that, I will now turn the call over Bob. Bob?

Thank you, Khoso. The company will file its report on Form 10-Q for the quarter ended June 30, 2018 before today’s close of business. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our second quarter 2018 financial results, our net loss was approximately $8.6 million, or $0.10 per share, compared with a net loss of $5.1 million, or $0.10 per share, in the second quarter of 2017. Our net loss in the first quarter of 2018 was in comparison $10.2 million or $0.14 per share. During 2018’s second quarter, the costs associated with our LOCK-IT-100 clinical study declined compared with the first quarter, as we focused our attention away from enrollment and towards the interim efficacy analysis that occurred in July. Operating expenses in the second quarter of 2018 declined 16% from the first quarter of 2018 to $8.5 million, compared with $10.2 million in the previous period. R&D expense declined approximately 20% to $6.6 million from $8.3 million, due to a 21% decrease in clinical trial expense, while other R&D declined 16%. Our expense related to the clinical study was approximately $5.8 million or 67% of our total operating expense during the second quarter of this year. The decrease in clinical trial expense was broadly felt in expenses incurred by our CRO, the third-party positive expenses and investigator fees, which together declined 44% from the last quarter to $3.3 million. While the expenses of our in-house clinical operations team increased 71% to $2.5 million, and partially offset the overall reduction in R&D. The increase in clinical operations expense was primarily due to additional staff hired to assume site monitoring and SAV reviewing activities from our CRO. SG&A expense increased 5% to $2 million compared with $1.9 million in the first quarter of this year. Higher legal fees and a small increase in employee expenses offset a reduction in sales and marketing and accounting expense during the quarter. Cash used in operations in the second quarter 2018 was approximately $4.3 million compared with a use of $7.1 million in the first quarter of 2018. The significant reduction in cash used in operations during the quarter was due to an increase in accounts payable related to the LOCK-IT-100 trial reflecting our suspension of payments to our CRO, while negotiations are ongoing regarding certain financial considerations for the delay and additional costs that we incurred in performing the interim efficacy analysis of the study. I will comment further on this a little later in my presentation. With respect to our financial results for the six months ended June 30, our net loss was approximately $18.7 million or $0.24 per share, compared with a net loss of $12.7 million or $0.27 per share for the six months ended June 30, 2017. Operating expenses during the first half of 2018 amounted to $18.7 million compared with $18.4 million in the second half of 2017, an increase of only $0.3 million or 1.6%. Operating expenses in the first half of 2017 amounted to $14.7 million. The sequential increases in operating expenses are due primarily to expenses related to the LOCK-IT-100 study. Cash used in operations during the first half of this year was approximately $11.4 million compared with cash used to $14.5 million in the first half of last year. The reduction in cash used in operations occurred despite a higher net loss in 2018 as a result of a significant build up in accounts payable during the second quarter of this year. Our balance sheet at June 30, 2018 contains a total of approximately $12.4 million combined in accounts payable and accrued expenses compared with $8.7 million at March 31. During the second quarter, accounts payable essentially doubled, while accrued expense declined about 4%. As I mentioned earlier in my presentation, this significant change occurred due to our ongoing negotiations with our CRO regarding the delay in our interim efficacy analysis for the LOCK-IT-100 study. Approximately $8.7 million of the outstanding accrued expense and accounts payable at June 30 are payable to our CRO. The final disposition of which will be determined through our negotiations. We have suspended payments while negotiations are continuing. We are pleased that despite our disagreement, our CRO continues to work closely with us as we wind down the trial and complete collecting and analyzing the balance of the clinical data that will be a part of our future regulatory submission. During the second quarter of 2018, we utilized our aftermarket facility raising $0.9 million. We raised a further $6.9 million after commissions through the ATM after June 30, taking advantage a very large daily trading volumes and significantly higher stock prices resulting from the market’s reaction to the DSMB recommendation. Based on our existing cash at June 30 of $4.7 million, the additional cash we have realized today through our ATM program and our ongoing negotiations with our CRO, we believe we have the resources to fund the significant cost of winding down the LOCK-IT-100 study and to prepare for and hold our planned meeting with the FDA with respect to Neutrolin proposed development plan without additional financing. The extents of our future financing needs will become clearer, once we reach agreement with the FDA regarding the final development path to Neutrolin. But depending upon the ultimate disposition of the negotiations with our CRO, we maybe able to continue operations to year-end or beyond without the need to raise additional funds. We will consider opportunistic financing earlier to ensure sufficient funds for our planned operations. Yes, we believe such a transaction would be in our shareholders best interest. We will provide an update on our CRO negotiations as soon as possible. And with that, I will now hand the call back to Khoso for his closing remarks.

Thank you, Bob. I’m delighted that the LOCK-IT-100 study came to a positive conclusion at the interim analysis. The strategy we’ve been bucked on in early 2017 paid off. I want to thank everyone who has been involved with the study employees and directors, past and present and the consultants for the efforts and commitments. CorMedix as a company has evolved over the last 24 months, becoming a company with robust processes and practice led by solid leadership team capable of developing taurolidine franchise better than ever before. We’re called CorMedix with the collaboration of a handful of strategic consultants look forward to engaging with the FDA to take Neutrolin across the finish line. I look forward to providing you with update both via our CorMedix website and via conference call. Thank you for your support of CorMedix. And I will now pass it back to the moderator for the Q&A

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Ram Selvaraju of H.C. Wainwright. Please proceed with your question.

Hi, thanks very much for taking my question. I just had three relatively quick ones. Firstly, Khoso I wanted to see if it would be possible for you to provide us with the p-value from the interim analysis of the LOCK-IT-100 study at this time. Do you have that information?

Thanks, Ram, for your question. It’s a very interesting question. I’m going to cover at a macro level and then I’m pleased to add a little bit. First, we remain blinded as a team. And however the study as I mentioned met the pre-defined target for statistical significance with respect to the primary endpoint, which resulted in DSMB recommending that the study be stopped. So we don’t have visibility to the p-value.

Okay.

Next question Ram.

Yes. Do you have a sense at this juncture of what kind of commercial infrastructure you believe it would take to launch Neutrolin assuming that there would be a reasonably timeframe pathway to approval based on the LOCK-IT-100 results, and specifically for the indication that is covered by the design of the LOCK-IT-100 study.

Thanks, Ram, for your question. Yes, we do have a draft plan of what a commercial organization would look like, but I also fully understand the challenges and risk for a small company faces to build a commercial market access infrastructure here in the U.S., particularly when you only have one product in the bag. Therefore, in parallel we will be very open and in some cases be very proactive in identifying strategic partnerships, as long as it’s in the best interest of our shareholders.

Okay. And then just very quickly one question for Bob, if I may. Bob, can you give us a sense of what the base of R&D quarterly spent is likely to be for the company going forward. If you dial out all the costs associated with winding down LOCK-IT-100. In other words, once you’re done with LOCK-IT-100 not including what expenses would be associated with the assembly of that FDA that you might classify as R&D spend. What’s the Basel quarterly R&D spends?

You see from the second quarter numbers, I think we said that our cash spend was about $4.3 million, as you could see where most of the R&D that the trial expense was about 67% of the total. So if we just strip out the clinical study and just look at the operating on going costs. Then you’re looking at a burn roughly of about $1.5 million per month. And at this point, it’s hard to see what increase if any there might be in that, you’re might not might not be any at all, there might be a slight decline, but for the time being for the next several months I think we’re looking at that base level of expense for the company.

And that’s $1.5 million per month or per quarter.

Per month.

Per month, okay. Thank you.

Okay.

Thanks, Ram.

Our next question comes from the line of Alexis Woods of LifeSci Capital. Please proceed with your question.

Hi, congrats again on a success for interim analysis. I just wanted to – if you can speak to, if the FDA does not agree that LOCK-IT-100 trial was sufficient for an NDA filing. What indication you would be exploring in the next study and kind of what your timelines would be for making those announcements and how long that study might take.

Thanks, Alexis for your question. I’ll pass it on to Paul, who is here Chief Medical Officer. Paul?

Hi, Alexis, thanks for the question. Well, I think as far as to read the mind of the FDA and [indiscernible] short to speculate on what we will do. But as I said earlier, the original plan was to do two studies in a Phase 3 program. And so we are going to a few indications, if still early on what we would do for another CVC, central venous catheter program and that would shape the shape obviously Alexis, after discussion with the FDA.

Okay, got it. Thank you.

I would now like to turn the conference back over to Khoso for closing remarks.

Thank you very much. Well, I just want to thank everybody for joining us on this call. Clearly, it is a critical moment in the company’s history and we look forward to having our meeting with the FDA and then being able to provide an update to everyone, like I said either through our website or on a conference call. So thank you very much and have a great evening.