CorMedix Inc. (CRMD) Q1 2017 Earnings Call Transcript
Published at 2017-05-10 20:25:06
Joshua Drumm - Investor Relations Khoso Baluch - Chief Executive Officer Bob Cook - Chief Financial Officer Judith Abrams - Chief Medical Officer Tony Pfaffle - Chief Scientific Officer
Raghuram Selvaraju - Rodman and Renshaw Ed White - FBR and Company
Greetings and welcome to the CorMedix First Quarter 2017 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] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Joshua Drumm, Investor Relations for CorMedix. Please go ahead.
Thanks, Kevin. Good morning and welcome to the CorMedix first quarter 2017 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we 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 United States and other product candidates, future financial position, future revenue and projected costs, and 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 and results thereof, projections as to the company’s future capital raising, 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. Our 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.
Thanks, Josh. Good afternoon, everyone, and thank you for joining us on our call today. During this call, the team and I will lay out the progress we have made over the last several months across multiple fronts against a backdrop of changing market conditions including updates on our current Phase 3 study and ongoing communications with the FDA. The four areas we will cover are the following: our recent financing and update on the ongoing LOCK-IT 100 clinical trial of Neutrolin in patients with end-stage renal disease receiving hemodialysis through central venous catheters; the advancement in our taurolidine-based development pipeline; and progress in our European commercialization of Neutrolin under our CE mark. As you know, we are focused on bringing Neutrolin, our broad-spectrum, non-antibiotic anti-infective solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters to the U.S. market. To that end, we recently completed a public offering of shares and warrants with gross proceeding totaling U.S. $14 million. That will be used to continue the development of Neutrolin in the ongoing, LOCK-IT 100, and the second and final LOCK-IT 200 Phase 3 clinical studies. Our Chief Medical Officer, Dr. Judith Abrams, will provide an update to our U.S. clinical program for Neutrolin in just a few minutes. For now, I will say that our patient enrollment rates remained strong. And as we stated in our recent trial update, we anticipate exceeding our original enrollment target of 632 patients by the fourth quarter of 2017. As we await clarity from the ongoing discussions with the FDA regarding possible prospective change to the LOCK-IT 100 trial protocol related, [indiscernible] to the apparent overall lower baseline rate of catheter related blood stream infection events, I am pleased that our continued surveillance and strategic activation of new clinical trial sites have kept our enrollment on track. An independent Data and Safety Monitoring Board recently completed a planned safety review of LOCK-IT 100 clinical trials and unanimously concluded that safe to continue the trial as designed. These results are consistent with our safety experience with Neutrolin in Europe. We are pleased that the results of this safety review are in line with Neutrolin’s anticipated product profile as a well tolerated and have the potential to reintroduce catheter related infections. With a planned interim data safety monitor board review behind us, efficient enrollment of hemodialysis patients remain our top focus. We are making every effort to facilitate a potential interim analysis of the LOCK-IT 100 data by the end of the year, which is dependent upon a payment of a pre-requisite number of blood stream infections in the study. We are hopeful that we can reach this important milestone as planned for the end of 2017 calendar year which will give us our first look in the U.S. at Neutrolin’s potential ability to reduce catheter related blood stream infections in patient with end-stage renal disease receiving hemodialysis to a central venous catheters. In addition to enhancing Neutrolin in the U.S. last month, we announced exciting news that we had secured our first European commercial collaboration with Hemotech, a French company based in Toulouse to launch and market Neutrolin throughout France and French overseas territories. I will elaborate on this shortly but first I’d like to turn the call over to Bob Cook, our Chief Financial Officer, for the financial update. Bob?
Thanks very much, Khoso. The company will shortly be filing its 10-Q for the quarter ended March 31, 2017. My financial report today largely compares our results for the first quarter 2017 versus the fourth quarter 2016 except where comparisons with the first quarter 2016 are necessary are useful standard financial metrics. I urge you to read the information contained in the 10-Q report for a more complete explanation of our financial results. With respect to our first quarter 2017 financial results, our net loss was approximately $7.6 million or $0.19 per share, compared with a net loss of $4.1 million or $0.11 per share for the first quarter 2016. Our net loss in the fourth quarter 2016 was $6.4 million or $0.16 per share. Operating expenses in the first quarter 2017 were $7.6 million compared with $6.5 million in the fourth quarter of 2016. The increase in operating expenses compared with the previous quarter was due to a $0.9 million or 22% increase in R&D expense and $0.2 million or 8% increase in G&A expense. The growth in R&D expense in the first quarter was led by a $0.5 million or 21% increase in clinical trial expense and a $0.3 million or $20% increase in other R&D expense primarily manufacturing and employee costs. During the quarter, we continue to increase our patient enrollment rates in the LOCK-IT 100 clinical trial, intensified our Neutrolin CMC efforts, hired our new Chief Medical Officer and additional clinical staff, and converted some of our consultants to employee status. We expect R&D expense to continue to increase from present levels over the next several quarters due to the pace of enrollment in the LOCK-IT 100 trial and through certain other CMC activities. G&A expense growth from the fourth quarter of 2016 was led by a $0.1 million increase in stock-based compensation plus smaller increases in consulting and accounting fees and employee costs. Our cash used in operations in the first quarter 2017 was $6.8 million compared with $6.5 million in the fourth quarter 2016. Cash was used primarily to conduct our Phase 3 study of Neutrolin, other R&D and related G&A activities. Our operating cash burn was funded primarily via drawdown of our cash on hand. Approximately $0.3 million was provided by the use of our ATM during the month of January 2017. As Khoso mentioned, we recently completed a public offering of common stock and warrants resulting in gross proceeds of approximately $14 million before deducting underwriting discounts and commissions and estimated offering expenses. The offering included the full exercise of H.C. Wainwright and Co.’s option to purchase additional shares of common stock and warrants from CorMedix. This offering closed last week on May 03. As of March 31, the company had cash and short-term investments of approximately $13.8 million. Based on our first quarter 2017 cash burn, this amount of cash would have been sufficient to fund the company’s operations for approximately six months which we judge an uncomfortably short and risky time period. Further, as we expect our cash burn to increase significantly over the balance of the year primarily as a result of the pace of enrollment in the LOCK-IT 100 trial, required CMC expenses and the planned commencement of the LOCK-IT 200 trial, we concluded that without timely access to additional funding, we might be forced to quartile patient enrollment and hence jeopardize the timing of our anticipated milestones. In addition to potentially increasing the duration of the clinical trial and possibly delaying the NDA filing, any enrollment related delay would certainly increase the cost of the clinical trial over and above any resulting from our proposed protocol changes. We surveyed the market during the first quarter seeking indications of interest and a financing of a size that would enable us to avoid returning for additional funding for at least several months. We then paused our financing efforts temporarily when we concluded that we would advise the market of the apparent overall lower rate of blood stream infections that was observed in the trial as well as our ongoing discussions with FDA concerning potential protocol changes to address this and other issues. This work took several weeks to complete ultimately resulting in our April 20 trial update press release. Once back on track, we confronted a market that had softened due to a high level of issuance. We were disappointed by the terms of the offering and then by the stocks post the transaction performance, but we closed the transaction nevertheless because we judged that forgoing the additional cash would impact our ability to raise cash in the future and would slow the momentum we had gained in the clinical trial. We believe that with the milestones upcoming over the next several months, there will be opportunities for the stock to regain ground lost over the last few weeks. Given the significant cost of the current LOCK-IT clinical trial and the anticipated start of our LOCK-IT 200 trial by year end, our cash and short term investments at March 31 and the net proceeds from the recent financing are unlikely to be sufficient to fund our operations for the next 12 months. However, as a result of the financing, we have lengthened our cash runway and assuming the one year warrant issued as part of the financing are exercised prior to the respiration, we will obtain additional cash that can be used to partially fund our cash requirements in 2018. Once we gain clarity with respect to the adoption of the proposed protocol amendments, we will be able to adjust our forecast and determine with a higher degree of confidence on future cash requirements. It’s now my pleasure to introduce our Chief Medical Officer, Dr. Judith Abrams, who is joining our call for the first time to give you a more detailed update on our LOCK-IT 100 trial currently underway. Judith?
Thank you, Bob. It is my pleasure to participate on today’s call and provide an update on Neutrolin’s U.S. clinical program. As Khoso mentioned, the independent data safety and monitoring board unanimously concluded that it was safe to continue the LOCK-IT 100 clinical trial as designed. This recommendation was based upon the valuation of data from the first 279 patients randomized into this event driven clinical trial. We recently announced that CorMedix is engaged in discussions with the FDA regarding possible perspective changes to the LOCK-IT 100 protocol in part to account for an apparent overall lower baseline rate of catheter-related blood stream infection events. As these discussions remain ongoing, we will provide further detail on the possible protocol amendments following conclusion of a discussion with the FDA. As we stated in our most recent trial update, we currently anticipate patient enrollment to exceed the originally targeted total of 632 patients and patient enrollment may continue into the second quarter of 2018 to enable us obtain a final planned number of requisite catheter-related blood stream infection events. If the requisite number of catheter-related blood stream infection events are obtained within this protected timeframe, top line results from the LOCK-IT 100 clinical trial would be anticipated around year end 2018 following the conclusion of the patient safety observation period. As Khoso mentioned, we are making every effort to enroll additional patients as efficiently as possible to meet these milestones. In parallel, we are pleased that the FDA accepted our proposal to include one or more interim efficacy analyses for the LOCK-IT 100 clinical trial as ongoing. The original trial protocol did not include any such analyses. These planned interim efficacy analyses should allow us to obtain our first look in the U.S. at Neutrolin’s potential ability to reduce catheter-related blood stream infections in patients with end-stage renal disease receiving hemodialysis through a central venous catheter. The timing of the interim analyses is also event driven but we currently anticipate that the first interim analysis may occur as early as the fourth quarter of 2017 pending attainment of the number of catheter-related blood stream infection event. We look forward to providing timely update on the status of the LOCK-IT 100 trial as well as a timing of potential interim analyses. We remain entirely focused on the successful completion of the Neutrolin registration program and agreeing Neutrolin to market in the U.S. Our goal and the goal of health organizations around the world is to eliminate costly and potentially deadly catheter-related blood stream infections altogether. We believe based on its broad spectrum antimicrobial activity that Neutrolin can help achieve this goal upon potential improvement. With that, I’d like to hand the call back to Khoso for a discussion of our development pipeline based on taurolidine the active component of Neutrolin. Khoso?
Thank you, Judith. While our main focus remains on gaining U.S. approval of Neutrolin, we are continuing to take advantage of additional opportunities to generate value for CorMedix based on quality. We’ve discussed our preliminary efforts in the medical device space where taurolidine maybe incorporated into various medical and surgical materials to confirm antimicrobial and anti-inflammatory properties. We’ve also discussed our ongoing work with POETIC consortium to combine taurolidine with other chemotherapies targeting cancer. On the medical device front, based on initial feasibility work in a number of different areas, we have made the strategic decision to focus our effort on investigating the incorporation of taurolidine into surgical measures, suture materials and hydrogels. We view this opportunity as the low-hanging fruits in an attractive market where we believe taurolidine infused products could have significant impact. I won’t go into details on this call as we plan to schedule a more robust R&D day event to discuss our taurolidine based pipeline within the coming months, but we currently expect to pursue the development of antimicrobial sutures for use following surgery and wound care, nanofiber mesh to provide antimicrobial structure support for burns and hernia repair, and antimicrobial hydrogels to prevent infections and promote healing of burns and diabetic foot ulcers. Once we’ve demonstrated proof of concept in vitro and in animal models, we will look to establish strategic partnerships to take these programs to the next stage along the 510(k) pathway. We will look to leverage the relatively shorter development pathway for medical devices to bring near term value to CorMedix. As I mentioned, we are preparing to discuss our current and planned pipeline activities in greater detail at an upcoming live meeting. We expect this event to take place in New York but will be webcast and archived on our website for all to listen. We will advise you on when that meeting will be taking place as soon as it is scheduled. Before I discuss our progress in commercializing Neutrolin in Europe, I like to hand the call to Tony Pfaffle, the Chief Scientific Officer, to talk about our recent work exploring the use of taurolidine to combat an emerging fungal pathogen that is concern in hospitals across the globe. Tony?
Thanks, Khoso. Candida auris or C. auris is a fungus, a species of pathogenic yeast that has emerged over the past few years as a serious global health threat according to the Centers for Disease Control. It is responsible for severe illness as well as life threatening blood stream and wound infections and hospitalized patients worldwide. Certain strains are resistant to all nature classes of antifungal drugs, something that has not been seen before and other species of candida. C. auris has been shown to inhabit and persist on surfaces in healthcare environments in the form of resistant biofilm and can readily spread between patients making it even more difficult to control. Of greatest relevance to CorMedix is that the CDC has reported that patients with central venous catheters are among those at greatest risk of infection with C. auris which can enter the blood stream and spread throughout the body causing serious invasive infections. As you know, taurolidine is the active antimicrobial component of our catheter lock solution, Neutrolin, which is specifically designed to prevent this kind of blood stream infection caused by an infected central venous catheter. Based on the mechanism of action of taurolidine and the fact that it has been shown to be effective against a broad spectrum of bacteria and fungi including multidrug resistant strains, we set out to test taurolidine against candida auris to see if it could have a beneficial impact on the significant threat to global hospitals. We partnered with the premier microbiology and antimicrobial surveillance laboratory, JMI Labs to conduct the sensitivity testing. They found that candida auris strains including clinical isolates provided by the CDC were 100% inhibited by taurolidine in vitro as the concentration currently contained in Neutrolin which has been shown to be safe in all clinical studies to date. While preliminary, these results are very encouraging because taurolidine’s potential efficacy against this deadly pathogen could add value across our entire pipeline. Sensitivity of C. auris to be taurolidine contained in Neutrolin may effectively reduce or prevent catheter related blood stream infections caused by this important pathogen with potentially positive implications for Europe where Neutrolin is a CE mark product as well as in the U.S. upon potential approval by the Food and Drug Administration. Beyond Neutrolin however if we can demonstrate that the taurolidine contains in our sutures, meshes and hydrogels currently in development is also effective against C. auris we may be able to prevent or treat C. auris infections following surgery in burns and in diabetic foot ulcers. We look forward to determining a path to work with global regulatory agencies to leverage the benefits of taurolidine and to help prevent resistant microbial infections. With that, I’ll hand the call back to Khoso to discuss our commercial efforts for Neutrolin in Europe. Thank you.
Thanks, Tony. As I mentioned, CorMedix secured our first European commercial collaboration with Hemotech to launch and market Neutrolin throughout France and French overseas territories. This landmark European agreement enables CorMedix to leverage Hemotech nearly 30 years of experience delivering high quality products to the hemodialysis community. Hemotech is the perfect partner to offer an innovative product like Neutrolin in these territories based on a significant presence across multiple clinic settings. It’s reach includes 92% of all French dialysis organizations as well at major hospitals where Neutrolin’s CE mark allows it to be marketed as a catheter lock solution for oncology and ICU patients with central venous catheters. We expect this initial commercial collaboration to enable CorMedix to begin augmenting our commercial presence in Europe. We intend to pursue additional partnerships that design to further expand ex U.S. sales of Neutrolin with the expectation that we will begin to generate initial sales revenues in the quarters to come, which may overtime partially offset our operational and clinical development cost in the U.S. We look forward to providing updates as we form commercial partnerships in additional ex U.S. territories. In conclusion, CorMedix remained focus on the success of our Phase 3 clinical program to secure FDA approval of Neutrolin in the U.S. In the phase of mounting anti-biotic resistant bacterial infections, the development and approval of a novel anti-microbial is important now more than ever. This is why we are dedicated to bringing Neutrolin to the market to help prevent potentially deadly catheter related blood stream infections in already vulnerable patient population. Let me say that I too, I’m disappointed with our current stock price. However, our recent financing add fuel to continue our pivotal clinical program, which will benefit from both FDA Fast Track providing the potential for priority review of our marketing application and the QIDP designation which secures up to 10 years of market exclusivity upon potential approval. In parallel, we are advancing our pipeline beyond Neutrolin to include multiple medical device opportunities as well as therapeutic use of taurolidine in often oncology indications. In short, we are moving along various pathways to increase value for CorMedix and its shareholders, and we look forward to providing the next update. With that, we can now move to the Q&A portion of the call. Thank you.
Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question today is coming from Ram Selvaraju from Rodman and Renshaw. Please proceed with your question.
Hi, I have one detailed question and two very minor ones. The detailed question pertains to the potential format of the proposed interim analyses in the LOCK-IT 100 study. Could you give us a sense of how these analyses might compare to the final top line data with respect to the types of endpoints you expect to use? Is there going to be no difference and is it simply just question of the number of events that are going to be the subject of the interim analyses? Or are there nuances that we should be aware of? And then with respect to the recent disclosure that taurolidine has been shown to be active against Candida auris, can you give us some additional background on this multidrug resistant organism? Have there been any cases of C. auris reported in the hospital setting in the United States as of yet? When was the first case reported in Europe? I believe it was in London in late 2016 but correct me if I’m wrong and what do you anticipate being the relative incidents in prevalence of this organism in the context of blood stream infection specifically? And then, Bob, I just had one clarificatory question for you. In the SG&A line item for this quarter, could you give us a breakdown of how much of that number was directly related to selling as opposed to G&A? Thank you.
Hey, Raj, thanks very much for your question. So what I would do is, for first question I’m going to ask Judith to help on so related to the interim question. The second of C. auris I’m going to ask Tony to elaborate and then as you’ve already decided it’s going to be Bob, so Bob will do the third one. So let’s first begin with Judith. Judith?
Hi, Raj. I understand your question you asked about the format of the interim analysis and in particular how it compares to the final top line that it provides to the analyses plan. So the interim analysis is going to be on a portion of the study population and it will look at the primary study endpoint as well as the safety, and will give us the DSMB will be doing this on our behalf and we’ll give us an indication as to how to proceed with the study.
Yes. So, you’re correct. In Europe, the UK in 2016 reported a significant number of cases. Since then the U.S. CDC has reported cases with highest prevalence in New York, New Jersey, Illinois and Indiana with a significant number of cases in New York. So the Department of Health, New York State Department of Health is targeted as a major pathogen to be dealt with. The first reported case was in Japan in 1996 and since then it’s been reported in nine countries over four continents. It’s more concerning because it’s resistant to flu console [ph] and most all isolates, 50% resistance to [indiscernible] and about 33% resistance to amphotericin B. So it’s MDR multidrug-resistant pathogen and that’s why both CDC and the State Health Departments are laser focused on addressing this concern. And one of the major issues is catheter related blood stream infection. So that’s why we are looking forward to helping address this issue.
Thank you, Tony. Bob, is it third question?
Yes. Raj, thanks very much for giving me the easiest one. Your question I think related to what number or how much within the total SG&A expense line related to selling expenses? And the answer is the number is very small, it’s between $100,000 and $200,000. So it’s pretty much as meaningless which is generally why in my comments I forget to mention the selling part and just stop it by G&A.
Okay, thank you. I’ll jump back in the queue. Thank you.
Thank you. Our next question is coming from Ed White from FBR and Company. Please proceed with your question.
Hi, yes, it’s FBR and company. So just a few questions. First, as far as the marketing agreement in Europe and in France, when will you see the first impact to your sales number? Is it this quarter, next quarter, is it late 2017? Then the next question is just you had mentioned the LOCK-IT 200 and I’m just curious if you can pin down more of a date of when that will start and what the study will look like? Thirdly, you did mention and I’m glad to see it the other potential products in surgical measures in management et cetera, when will you start – I know you certainly are going to go over to the R&D there so maybe you don’t want to answer it but just when can we see some preclinical data and do you expect to partner right after that before first inhuman? And the lastly, if I can just question, for Bob, regarding the diluted share count now after the deal, what that level is now and also when you’re talking about the cash run away, did I hear you right to say that even with the race you’re not going to make it through 2018, so we should expect another race between now and then. Thanks for the question.
Okay. So let me begin with taking the first three questions that you posed, Ed. So the marketing agreement in France, basically they have started the launch of it the tail end of April. So we should begin to see sales during this quarter and so that will now begin to come, again it will start slow and it will pick up as we go quarter-by-quarter going forward. Your second question about LOCK 200, with the recent activities we have had with LOCK 100 and our refinancing, at the moment we still have work to do on LOCK 200. So at the moment I’m seeing it for us to start something by the tail end of this year. We will be able to provide more update once we have finalized our ongoing discussions with the FDA on LOCK 100. The third question as you talked about the pipeline, the R&D data we will have which I expect will be happening over the next few months and I’m talking off potentially two or three months, you’re going to see the feasibility work that we have already done with the sutures, the hydrogels, the meshes. So you’re going to see that work. In parallel, we are doing further improving the efficiency of the technology that we’ve got there plus completing the animal models. And our goal will be that when we do have the R&D date, we will share more details about when to expect each of these different data points to be coming but all of them should take place during 2017. For your fourth question, I’m going to hand it over to Bob about the diluted share.
Yes. So, Ed, before the offering, we had – there was about 40.8 million shares outstanding and we issued in the offering another 18.6 million. So the diluted count following the offering that would put us at according to my numbers here my math 59.4 million.
And when that was fully diluted, that includes warrants?
No, it doesn’t. We haven’t done that. I haven’t done more calculation because we technically haven’t issued those warrants yet. So I have to go back and look at that, but I don’t have that number of the top of my head.
Okay. Thank you. That was the number that I was looking for. Okay. Thank you.
Okay. We can get that to you. The other thing with respect to the cash, the simple answer is no. The existing cash does not get us to the end of 2018. If you look at the amount of cash that we spent in the first quarter, it was $6.8 million, right. And on a pro forma basis, our existing cash at March 31 was $13.8 million and another $13 million from the offering so that’s $26 million. So that indicates that we have about four quarters of cash if our burn rate was to continue at the same level as the first quarter. So that by itself does not get us to the end of 2018. And then on top of that, we are expecting the burn to increase as the costs for the clinical trial increase but I don’t have good numbers on that because we are still working that out based on what the patient levels are going to look like. So that’s the best we can do for the moment and I think we need to look – we need to consider based on the current burn and what the current cash is to give us a sense really of what the needs are. And whether that’s true, another race or some other opportunity remains to be seen. I mean there is certainly no rush at this point to go and do anything new. So we’ll just be assessing the options that we have and we do have the preclinical stuff that Khoso has been talking about. There could be things that happen there. So there is a lot of opportunities that could happen between now and the time that it would be necessary to look at having more cash in the bank.
Okay, great. Thanks. And then just a last question, when will you know what the final enrollment or what you believe will be the final enrollment numbers for LOCK-IT 100?
Well, we are in active dialogue with the FDA and we should know by the third quarter of this year all the final details regarding the protocol and the size.
Okay, great. Thanks for taking my questions.
Thank you. Our next question today is coming from Gail Collins [ph], a private investor. Please proceed with your question.
Yes. Thanks for taking my question. I’d like to know why the infection rate is so low?
So the infection rate is actually consistent with what we see in the published literature and it’s with a very broad range and the infection rate is changing overtime as more rigorous management of these patients is brought to bear and also in the clinical trial setting that may have had an impact. But what look like we are observing a presence as well within the range of what’s reported in the population.
Thank you. Our next question today is coming from Evan Fraser [ph], a private investor. Please proceed with your question.
Hi, thank you. I would like to know how many infections have occurred in the study so far.
Yes. These kinds of details we don’t discuss because of the potential for introducing bias in an ongoing clinical trial. It’s a great question and we look forward to sharing all those data with you as the trial comes to conclusion.
Thank you. Our next question today is coming from Larry Stammen [ph], a private investor. Please proceed with your question.
Yes. Hi, thanks. I wanted to know if you have enough cash to finish the Phase 3 trials and if not how much more cash and time will be required until you get the FDA approval.
I mean again the answer is that, at this point, it’s safe to say that we do not have enough cash to finish the Phase 3 programs. With edges to few minutes ago, we walked through how far the current cash is going to take us. The current plan at this point would be to start a second Phase 3 trial at the end of this year which would go into I think early 2019, although that still remains to be seen. And the fact at this point, we don’t have a hard and fast number for what the total cost of the Phase 3 development program is going to be because we haven’t caused about – we still have a lot of work to do with respect to the LOCK-IT 200 trial. And although we have given estimates for the LOCK-IT 100 between the $26 million to $30 million range with the anticipated changes in the trial that we are in the process of making, that estimate is likely to change as well and certainly it’s going to be the $30 million level whereabouts rather than the $26 million. So I think we’ll have some clarity on this over the next several months but at the current time, I just don’t have a number that I can put out with any confidence that could be correct.
Thank you. We have reached the end of our question-and-answer session. I’d like to turn the floor back over to management for any further or closing comments.
Thank you very much. Thanks everyone for joining this call this afternoon, very much looking forward to hearing and seeing many of you during our R&D day that we will cover our pipeline. I think you will be intrigued by the information we will be sharing with you during the R&D day. So thank you once again for joining us and have a good evening. Bye-bye.
Thank you. That does conclude today’s teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.