CorMedix, Inc. (CRMD) CEO Khoso Baluch on Q1 2019 Results - Earnings Call Transcript

About: CorMedix, Inc. (CRMD)
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Earning Call Audio

CorMedix, Inc. (NYSEMKT:CRMD) Q1 2019 Results Earnings Conference Call May 13, 2019 4:30 PM ET

Company Participants

Dan Ferry - IR-LifeSci Advisors

Khoso Baluch - CEO

Bob Cook - CFO

Phoebe Mounts - EVP and General Counsel

Paul Chew - Chief Medical Officer

Conference Call Participants


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.

Dan Ferry

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, 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 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.

Khoso Baluch

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 for streamlined development and regulatory flexibility regarding the evidence required to support drug approval for patient populations with serious disease and limited or no treatment options, while still meeting appropriate standards for safety and effectiveness including fewer or shorter clinical trials.

As I previously stated, the information submitted for the initial meeting with the FDA this year included data from 653 subjects at the time of the interim analysis for LOCK-IT-100 including the first 28 cases of the catheter-related bloodstream infection CRBSI. Because the study continued enrolling and treating subject until the study terminated in August 2018, the full efficacy data set is based on a total of 795 subjects and 41 CRBSI events as determined by the clinical adjudication committee.

During this meeting, we also shared with the FDA the preliminary topline results from the full data set since the unblinded data had just become available to us. The FDA requested us to provide it with full detail analysis of the primary endpoints for the newly available full data set as well as the secondary endpoints which are loss of patency and catheter removal and safety data.

The CorMedix team has completed its analysis of the data from LOCK-IT-100 that was requested by the FDA. You will soon be hearing from Phoebe details of where we are in this effort and what lies ahead.

On the medical front, I am pleased to say that Paul and his team have been busy. We have made good progress in getting the message about Neutrolin and our pipeline. Paul will be sharing with you during this call and presentation that was made last Friday at the National Kidney Foundation Spring meeting which the NKF approved as an oral presentation during the late-breaking presentations.

We were pleased to collaborate with the NKF to bring the outcome of the LOCK-IT-100 study tremendous results to the scientific community. Please ensure you are logged into earnings call website to follow the slide presentation that will be shown.

On our financial position, we continue to remain strong. We've had two press releases during the last two months in this area, the first occurred on April 11 where we announced that on April 5 a Friday 2019, the New York Stock Exchange America notified CorMedix that the company had regained compliance with the New York Stock Exchange America listing requirements. The second press release was on April 17 where we announced the closing of the sale of the 5.4 million of NOL tax benefits to two unrelated profitable New Jersey Corporation's through the New Jersey Economic Development Authority Business Tax Certificate Transfer Program.

As a result, the company has received approximately 5.1 million in cash from the sale of these NOL tax benefit. Bob would be covering further details of these items and CorMedix final financial position later on the call.

Now let's hear from Phoebe who will be sharing more with you on the first topic namely the regulatory update. Phoebe?

Phoebe Mounts

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 Solution as a single study in the limited population of hemodialysis patients.

In addition to the applicability of LPAD, the information discussed at the meeting with the FDA was based on the interim analysis and preliminary analyses of topline efficacy and safety data for the full data set. FDA requested additional information and analyses which we have planned to prepare as part of the clinical information required for the clinical study report.

It has been noted, there is a considerable amount of data generated from 806 subjects to a randomized LOCK-IT-100. The large number of subjects is a strength of the study because data on patient exposure to the investigational product Neutrolin is required for the FDA to assess the safety of the product before it is approved for commercial use.

We have been compiling the data on serious adverse events as well as adverse events generated over the three years of the study in the approximately 797 subjects and performing the statistical analyses to compare the safety profile of patients randomized to the Neutrolin environmental study with patients randomized to the heparin control arm.

As you can imagine with the large data base, it is been necessary to ensure that all of the information entered into the data phase are clear and being accurately interpreted. The statistical analyses have been completed and our internal review of the full adverse events data sets provides evidence to support that Neutrolin can be used safely as a catheter LOCK Solution in hemodialysis patients.

We also have been compiling additional data and information requested by FDA for the primary and secondary efficacy endpoints. As would be expected, FDA has requested information on the procedures and assessments conducted by the Clinical Adjudication Committee for confirmation of catheter-related bloodstream infection for the primary endpoint analyses.

More detailed analyses which had been planned were also requested for secondary endpoint. These analysis have been completed and support the strong topline results previously announced. These safety and efficacy analyses will be discussed in a few minutes by Paul, when he shows the slides presented at the National Kidney Foundation Spring Meeting on Friday, May 10.

We have requested another face-to-face meeting with the FDA to continue our dialogue on the data from LOCK-IT-100 and its support for the new drug application us providing substantial evidence of safety and effectiveness of Neutrolin as a catheter LOCK Solution in hemodialysis patients.

We are very happy to report that the FDA has granted our meeting requests. As you know, review meetings with the FDA are discretionary, so we very grateful to the FDA for continuing to work with us and recognize the potential of Neutrolin in addressing in unmet medical need of reducing catheter-related bloodstream infection as evidenced by the FDAs award of Fast Track status and Qualified Infectious Disease Product designation which we have previously secured for the use of Neutrolin in hemodialysis patients.

Now that the FDA has granted our meeting request, we are in the process of preparing the meeting materials for submission to the FDA. The procedures for the FDA's Center for Drug Evaluation and Research or CDER required - when the request for meeting has been granted. A background package of all of the material for discussion with the FDA be prepared and submitted. We're in the process of assembling the background package based on the analyses that are being conducted since the data and the LOCK database became available in our interpretation of those results.

Meeting material must be submitted to the agency as defined by the FDAs requirement. What are the topics for discussion with the FDA is the assessment of LOCK-IT-100 is providing substantial evidence of safety and effectiveness to support submission of the new drug application or NDA.

But it is important to note that in addition to the clinical evidence, the FDA requires extensive manufacturing information, pre-clinical data and other information relevant to commercial distribution in the United States. We are working to ensure that all of the components of the NDA are ready. Thus the FDA agreed that CorMedix can file an NDA based on our single clinical trial.

So we anticipate continuing our dialogue with the FDA and working towards having everything required for submission of the NDA as planned. I am excited and confident that internally we now have the team and capabilities to be successful.

With that I would like to turn to Paul, who will provide you on an update of the clinical affairs activity. Paul?

Paul Chew

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 is a major nephrology meeting, the results of the LOCK-IT-100 study. For those of you on your computer you'll see a slide deck that I’ll be presenting. The nine page slide will be posted on the CorMedix website.

At CorMedix,we are very proud that the results for LOCK-IT-100 were presented scientific session of the NKF in Boston last Friday by Dr. Anil Agarwal, from the Ohio State University unnoted interventional nephrologist and an investigator in this trial.

This trial is the largest and most rigorously designed study to answer very important question. Can Neutrolin reduce catheter-related bloodstream infections effectively and safely in hemodialysis patients to rely on central venous catheters for their vascular access?

Our collaborators, our national opinion leaders in nephrology who have been involved in CRBSI research for a very long time. The learning objectives for this audience in the room for Dr. Agarwal's presentation was that this was a landmark trial that showed Neutrolin markedly reduced CRBSI in subjects with catheter-based hemodialysis.

Infections in hemodialysis patients are a major cause of death, second only to cardiovascular disease because of frequent vascular access for hemodialysis usually three times per week and because of their immune compromised status, these patients are at risk for bloodstream infection and particular for the patients who require catheter-based hemodialysis, that's particularly true.

Although their account are less than 20% of hemodialysis patients, they account for nearly 17% of access related bloodstream infection. These patients are frequently hospitalized for these infections which aggravate other condition, such as diabetes and heart disease.

Neutrolin is a proprietary taurolidine based catheter LOCK Solution which has a secret buffer as well as heparin 1000 units per mill. Its already approved in the EU as a Class 3 medical device for reducing CRBSI and maintaining catheter patency and three populations requiring tunnels costs catheter.

Hemodialysis oncology total parenteral nutrition and the fourth one ICU, Intensive Care Unit. What’s the mechanism of action? Taurolidineis an antimicrobial product more as n antiseptic rather than an antibiotic. It access the catheter lumen and not in the body and the natures of unfold surface bacterial proteins and chemically disrupts membrane lipid killing microbes including bacteria and yeast. Due to its direct mechanism of action it has broad-spectrum activity that does not lend itself to microbial resistance.

In fact antimicrobial resistance has not been identified in vitro or in clinical use making it an attractive agent for preventing catheter infection. For the money administration after a patient complete a hemodialysis session Neutrolin is instilled into each of the two catheter lumens up to the fill volume of the lumen which is typically displayed on the plant which you see in the picture.

Neutrolin resides in the catheter until the next dialysis session before that next session Neutrolin is removed from the catheter with a syringe it's not intended for systemic administration. Previous clinical studies have been done Neutrolin and other taurolidine, citrate solution have been evaluated in Europe. [Reidenberg MARI and Solomon] study consistently showed an open label retrospective design that these catheter LOCK Solution reduce catheter -related bacteremia compared to historical control. And the references are provided at the end of the presentation.

Neutrolin in the U.S. although approved for use as a medical device in Europe Neutrolin is an investigational drug product in the U.S. for end stage renal disease patients requiring hemodialysis through a central venous catheter. Recognizing the potential value of Neutrolin FDA awarded the product both fast-track and qualified infectious disease product designation. Programs designed to incent the development of innovative products for serious and unmet medical needs.

The primary objective of LOCK-IT-100 the primary objective was to determine the efficacy and safety of Neutrolin compared to heparin 1000 units per ml to reduce CRBSI [indiscernible]. Heparin is the only approved catheter LOCK solution in the U.S. The primary endpoint was the time to CRBSI and the study was powered at 80% to show a 55% reduction in CRBSI at the 5% alpha level.

Secondary endpoint, secondary endpoints were related to catheter removal and lots of catheter patency as defined in that slide. So we are going to slow a little bit to make sure the slides are catching up because they're very slow. The secondary endpoints were catheter removal for any reason not needed because of maturity vascular due the catheter malfunction lots of catheter patency defined as DPA administration or catheter removal due to malfunction. And the definition of CRBSI is shown on the next slide.

CRBSI’s definition required either a fever above 37.8 degree Centigrade or chills or rigors documented by medical professional. And not only did you have to have fever and rigors, you also have to have significant changes in your vital sign heart rate, breathing and low blood pressure as shown in this slide.

So this was a calm deposit definition of signs and symptom and you also needed one positive blood culture other than for coagulated negative staphylococcus from either a peripheral venipuncture, dialysis ports or a bloodline.

Other sources of bloodstream infection needed to be excluded. Now all of the evaluations of these catheter-related bloodstream infections was done by a blinded external and independent Clinical Adjudication Committee. Now how did patients complete the study the definition of study completion all assessments had to be made through the study closure, if a subject has CRBSI meeting the study definition, catheter removal for any reason if the patient dies or is transferred to a non-study site or the termination of dialysis which is shown in this slide.

Now what were key inclusion criteria they'll be just coming up. We wanted a representative patient population and the key inclusion criteria were typical for hemodialysis study. And the subject had to have hemodialysis at least twice per week they had that the catheter flow of at least 250 mL per minute. The internal jugular or subclavian site had to have a tip appropriately placed in the RA-SVC junction. And that they had to have life expectancy of at least 180 days and the other measures you can see on this slide.

What were the key exclusion criteria, the key exclusion criteria were the subject could not be enrolled there was a recent antibiotic use or infection or other antimicrobial or catheter use. If they were bleeding or they had bleeding tendency or other immuno-compromised status such as cancer.

Those patients were excluded, but we have is the baseline demographics which will be coming up and let me say right here while we’re waiting for the slide that this patient population was very representative of the U.S. hemodialysis population and that both arms were well-balanced, with good representation across age, race and gender. So that this population of LOCK-IT-100 can be applicable to a broad range of hemodialysis patients and what you see here are the age breakdown, the female breakdown as well as race.

And on the next slide which will be coming up shortly is that the races were balanced, the ethnicity was also balanced with Hispanic or Latino ethnicity present and balanced. Diabetes which is a common cause of kidney disease was present among almost 70% of subject. Now in LOCK-IT-100 the study there were two-thirds of patients who were on dialysis for one year or less as you can see on this slide. One year or less the internal jugular was most common site for placement of the catheter which is the usual practice.

The study was an event driven study as we’ve said was a planned approval of 56 events, 56 CRBSI a pre-specified interim analysis was planned when 28 CRBSIs half the total had been accumulated. Now at the time of the interim analysis there was an independent and external data and safety monitoring board to review the CRBSI data including serious adverse eventually.

And after reviewing the data on 28 events the DSMB recommended that the study be terminated because of a 72% reduction in the risk of CRBSI by Neutrolin compared to heparin. Early stopping for success in the trial is not very common, but the results were convincing enough for the DSMB to make this recommendation.

And what will show you on the next slide is what did the DSMB see? There was a highly significant split in the number of infections as you can see here with 22 occurring in the heparin arm and only six in the Neutrolin arm resulting in a highly significant 72% reduction by Neutrolin with the P-value of .0034 which says that the likelihood of this being a chance event a flu is about three in 1000.

Now when all of the catheter infections were evaluated we looked at all the cases including the first 28 that had come in and we had a total of 41 cases at the time of study closure. Now with these additional events, you'll see on this slide there was a 71% reduction virtually identical which was even more significant with 32 infections in the heparin arm and only nine in the Neutrolin arm. Now the p-value was even more significant as 0.0006, 6 in 10,000 of being a chance outcome. So both analyses were very consistent.

And what we have now is the secondary endpoints, which were as you remember, catheter removal for any reason and catheter removal for positive reason. On the cath removal for any reason was a secondary endpoint, the results for both arms were similar. There was no significant difference as you can see there with the virtually identical hazard ratio here of 1.08.

The next endpoint, secondary endpoint now is to look at the reasons, positive reasons or negative reasons for removing a catheter. We can see that a positive reason for removing a catheter is because the subject doesn't need it anymore, the fistula or graft is mature and a catheter is no longer needed.

As you saw in the demographics, two thirds of subjects had dialysis only for one year or less. By one year most subjects should've advanced AV fistulas or graft. This slide show that although a post op analysis they were numerically more catheter removal for good reason on the Neutrolin side.

For a negative reason, heparin had more catheter removals for negative reasons due to CRBSI 29 versus eight. So with regards to catheter removal for any reason, there’s no significant difference of sub analyses suggest a tendency for more positive reasons of Neutrolin and more negative reasons for heparin.

Now let's look at catheter patency, the loss of catheter patency. Acquiring catheter for the secondary endpoint in this study was defined as investigator determined use of tPA for loss of patency or catheter removal for the loss of patency with the trend towards a more use of tPA at comparable levels of catheter removal for loss of patency.

And what you will see on the next side is the safety. The safety profile in the study of patients with end-stage renal disease is typical for this population. The serious adverse events were infrequent and similar. Shown are events occurring that are with 2% or more incident in either arm.

So in summary, what we wanted to show here is the primary outcome displays graphically.LOCK-IT-100 was a landmark study evaluating Neutrolin in the serious medical condition. It showed impressive and consistent reduction in CRBSI compared to heparin at both the interim and final analyses. The 71% to 72% reduction in CRBSIs is clinically and statistically significant.

LOCK-IT-100landmark study show that in ESRD, End-Stage Renal Disease patients with hemodialysis via a central venous catheter, Neutrolin catheter LOCK Solution provided a significantly reduced catheter-related bloodstream infection rates, a leading cause of mortality in hemodialysis.

Compared to heparin, there was no significant difference in either catheter removal for any reason or loss of catheter patency. Treatment emergent serious adverse events were infrequent and similar between Neutrolin and heparin arm.

LOCK-IT-100 is a special trial and being to show so convincingly, clinical benefit in one trial with a balanced and acceptable safety profile in a very sick population. I agree with what Dr. Agarwal said at the conclusion of his presentation that if Neutrolin is approved, it will be a significant new tool in the [indiscernible] catheter -related infections.

I’ll now turn the call back over to Khoso.

Khoso Baluch

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.

Bob Cook

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 reduction in accounts payable and accrued expenses, primarily related to CRO and other clinical trial-related payments.

While during the first quarter of 2018, accounts payable and accrued expense both increased due to the higher clinical trial activity. The impact of our CRO settlement continued during the first quarter of 2019 as we made further installments in accordance with the settlement agreement, primarily related to third-party investigator fees. A final payment will be made to our CRO for the balance of investigator fees and third-party costs once the paperwork due from the sites is collected, reviewed and stored in the study database.

We had anticipated this work to be completed during the second quarter of 2019 and while that timeframe is still possible, it is becoming more likely that the final payment will be made early in the third quarter. Our recorded point - we recorded $0.5 million in expense in the first quarter related to the new work order we signed last year with our CRO related to study closure and data transfer activities.

As I reported in March, we were able to take advantage of our ATM facility during the first quarter of 2019 raising $15.2 million at an average price of $8.90 per share. We have not used the ATM facility since before our last conference call.

In addition, we announced in April that we completed the previously disclosed sale of $5.4 million of NOL tax benefit to two unrelated profitable New Jersey Corporation's through the New Jersey economic development authorities business tax certificate transfer program. As a result, the company received approximately $5.1 million in cash from the sale of these NOL tax benefits.

Based on our existing cash and short-term investments at March 31, 2019 of $26.4 million and $5.1 million in proceeds we received from the sale of our NOLs, we believe we have the resources to fund the company's operating expenses into the third quarter of 2020.The extent of our 2020 financing needs will become clearer once we have confidence with respect to the FDA's requirements to file the Neutrolin NDA based on the LOCK-IT-100 study results.

Until then we may consider opportunistic transactions in order to strengthen our financial position and thereby improve our ability to negotiate with potential strategic partners and/or build our infrastructure in preparation for commercialization of Neutrolin for hemodialysis in the U.S. market.

As always any action we take will be done only if we believe it is in the best interest of our shareholders this may require additional capital. Given that we currently have only 4.6 million available under our ATM program we may allocate a portion of our existing S3 shelf registration to the ATM program.

With that I will now hand the call back to Khoso for his closing remarks. Khoso?

Khoso Baluch

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.

Question-and-Answer Session

A - Dan Ferry

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.

Khoso Baluch

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

Phoebe Mounts

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.

Dan Ferry

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?

Khoso Baluch

Good question, Dan. Phoebe?

Phoebe Mounts

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.

Khoso Baluch

Back to you, Dan.

Dan Ferry

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?

Khoso Baluch


Paul Chew

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.

Khoso Baluch

Dan, back to you.

Dan Ferry

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?

Khoso Baluch

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.

Dan Ferry

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?

Paul Chew

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.

Dan Ferry

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?

Khoso Baluch

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

Phoebe Mounts

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.

Khoso Baluch

Back to you, Dan.

Dan Ferry

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

Khoso Baluch

Let me ask Bob to answer that.

Bob Cook

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.