Synthetic Biologics, Inc.
Q4 2015 Earnings Call Transcript

Published: 11 Mar 2016

[Operator:]

Good afternoon and welcome to Synthetic Biologics’ 2015 Year End Investor Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Ms. Kris Maly, Vice President of Corporate Communications at Synthetic Biologics. Kris?

[Kris Maly:]

Thank you, Diane and good afternoon, everyone. Welcome to Synthetic Biologics 2015 year-end investor conference call. Today, I’m joined by our CEO, Jeff Riley; and our CFO, Steve Shallcross. Synthetic Biologics issued a press release this afternoon which provided operational highlights and recorded 2015 year-end financial results. The release can be found in the Investors section of our website. During our call today, Jeff, will provide an update on our microbiome-focused pipeline programs and Steve will summarize our financial highlights. We’ll take questions after our prepared remarks. In addition to the phone line, this call is being streamed live over the internet today and the webcast replay will be archived on our website for 60 days. During this call, we will be making forward-looking statements regarding Synthetic Biologics current expectations and projections about future events. Generally, forward-looking statements can be identified by terminology such as may, should, expects, anticipates, intends, plans, believes, estimates and similar expressions. These statements are based on current beliefs, expectations and assumptions, and are subject to a number of risks and uncertainties, including those set forth in Synthetic Biologics filings with the SEC, many of which are difficult to predict. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information on this call is provided only as of the date of this call and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. With that, I’d like to turn the call over to Jeff.

[Jeff Riley:]

Thanks, Kris, and thanks everybody for joining the call today. 2015 was an exceptional year for Synthetic Biologics. We are very proud of the progress we’ve made and are exciting for the milestones that lie ahead. Before we dive in, I’d like to provide a brief recap of the clinical achievements Synthetic Biologics has made since the beginning of the fourth quarter of last year. As a result of clinical progress in our SYN-010 program for the treatment of irritable bowel syndrome with constipation or IBS-C. We expect to initiate Phase 3 clinical trials for SYN-010 during the second half of 2016. And we anticipate requesting an end of Phase 2 discussion meeting with the FDA during the summer of 2016. In the clinic, we reported positive top-line data from our first Phase 2 acute study, which show that SYN-010 met its primary endpoint of lowering breath methane compared to baseline. We also reported solid top-line data from our second Phase 2 extension study, has clearly demonstrated a statistically significant decrease in methane production. As statistically significant reduction in the mean IBS symptom severity score or IBS-SSS which includes abdominal pain, bloating, stool frequency and quality of life scores for all patients from Study 1 baseline to the end of the second Phase 2 study. Also an increase in the percentage of patients identified as monthly responders, an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements and abdominal pain. Also there were no serious adverse events to include diarrhea that were observed during both of these trials. We reported additional progress from our three Phase 2 trials for SYN-004, for the prevention of C. difficile infection, antibiotic-associated diarrhea and the emergence of antibiotic-resistant organisms. As a result of our clinical progress in our SYN-004 program, which I’ll outline in a moment. We are planning to initiate a Phase 3 trial or trials in the second half of this year as well. Our Phase 2b proof-of-concept trial is ongoing, and as of today we have enrolled 98 patients into the Phase 2b study. For the first 2a clinical trial we reported positive top-line data showing SYN-004 successfully degraded residual IV ceftriaxone in patients without affecting the intended level of ceftriaxone in the bloodstream. We anticipate reporting top-line results in the first half of 2016, for our second Phase 2a study designed to evaluate IV antibiotic-degrading effects, and the safety of SYN-004 in the presence of the proton pump inhibitor in participants with functioning ileostomies. We initiate a pre-clinical study with our collaborator to generate pre-clinical proof-of-concept data to evaluate the potential of SYN-005, our monoclonal antibody with orphan drug designation to prevent Pertussis or whooping cough. This study has been funded by a grant awarded from the Bill & Melinda Gates Foundation to the University of Texas. Also we are collaborating on a novel biotherapeutic asset designed to treat PKU with ActoGeniX, a Belgium subsidiary of Intrexon Corporation, expanding our portfolio of microbiome-focused products. Our balance sheet remains well capitalized, and we have the resources to continue to move both of our lead microbiome-focused drug candidates through Phase 2 clinical trials. As we look ahead to the initiation of Phase 3 trials for SYN-010 and SYN-004 later this year. We will need to further strengthen our balance sheet. We are currently evaluating several capital raising strategies, which allow us to continue the progress we made during 2015. We continue to engage in partnering discussions for both microbiome-focused programs, with the aim of potentially raising non-dilutive capital for one or both of our lead drug candidates. Now I'd like to provide an update on our two lead gut microbiome-focused clinical programs in a little bit more detail. We'll start off with SYN-010. Our SYN-010 program is addressing irritable bowel syndrome constipation. Current treatment options including FDA approved drugs and over-the-counter laxatives treat the symptoms associated with IBS-C, but do little to treat the underlying cause of the disease. SYN-010 is intended to reduce methane production by certain microorganisms, mainly M. smithii in the gut while minimizing disruption to the microbiome to treat the underlying cause of IBS-C and not just the symptoms. Since the beginning of the fourth quarter, we made tremendous clinical progress in our IBS-C program and achieve two significant Phase 2 milestones. First, we completed the first Phase 2 four week acute study of SYN-010 in this Phase 2 study, 63 patients with IBS-C in a breath methane value greater than 10 parts per million at screening, were randomly assigned to receive either placebo, 21 milligram dose of SYN-010 or a 42 milligrams dose of SYN-010 orally, once-daily for 28 days. Breath methane was measured at 7 and 28 days as compared to baseline. In December, we were pleased to report positive top-line results from this trial, which clearly demonstrated that SYN-010 lowered breath methane and improved stool frequency within dose groups at 7 or 28 days of treatment. Patients who completed the first Phase 2 trial were eligible to complete, immediately rollover into the second Phase 2 study. This open label, eight week extension study is designed to evaluate the sustainability effect of the higher dose strength of SYN-010 on breath methane production, as well as evaluate key clinical outcomes to include complete spontaneous bowel movements, abdominal pain, and bloating. Of the 63 patients who completed the first Phase 2 trial, 54 elected to rollover into the extension study. All patients in the second Phase 2 trial were given a once-daily oral 42 milligram dose of SYN-010 for eight weeks. In January, we achieved a second clinical milestone for our IBS-C program, when we announced outstanding top-line results from this study. Specifically, top-line data from all patients who completed the second Phase 2 clinical trial of SYN-010, showed a statically significant P value of 0.002. For a decrease of methane production from the beginning of the first Phase 2 study or day one to the end of the second Phase 2 study day 84. Most importantly, top-line data from the second Phase 2 study also showed improvements in secondary efficacy endpoints including a P value of less than 0.0001 for reduction in the mean IBS symptom severity score, which includes abdominal pain, bloating, stool frequency, and quality of life scores for all patients from study one baseline to the end of second Phase 2 study and an increase in the percentage of patients identified as monthly responders. Again, this is an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements and abdominal pain. I’d like to mention that the design of the secondary clinical outcomes measured in our two Phase 2 studies were based on FDA clinical guidelines of the Phase 3 regulatory approval pathway for previously approved IBS-C treatments. Following the announcement of positive top-line data from both SYN-010 Phase 2 trials Synthetic Biologics plans to submit an end of Phase 2 meeting requests with the FDA. We anticipate meeting with the FDA this summer and initiating Phase 3 trials in the second half of this year. Now I'm going to switch gears to SYN-004 and talk about our second gut microbiome-focused program for the prevention of C. difficile infection. Our product candidates SYN-004 is an oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract to preserve the natural balance of the gut microbiome for the prevention of CDI, antibiotic-associated diarrhea and the emergence of antibiotic-resistant organisms. During the fourth quarter, we made significant progress on all three Phase 2 clinical trials for SYN-004. I'd like to start with an update of our Phase 2b proof-of-concept clinical trial, intended to evaluate the ability of SYN-004 to prevent C. difficile infection. C. difficile associated diarrhea and antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection like pneumonia and receiving at least five days of IV ceftriaxone antibiotic. We design this trial anticipating to enroll approximately 370 patients and up to 75 global sites, and are pleased to report that at this time, enrollment is ongoing and remains on schedule. As of today, we have enrolled approximately 98 patients into the Phase 2b study. Once we have enrolled either 120 patients and confirmed 10 cases of C. difficile infection, a blinded interim analysis will be conducted by an independent monitor committee to evaluate the baseline rate of CDI in the placebo group. We are on schedule to perform this analysis in the first half of 2016. At the same time, we will compare the rate of antibiotic-associated diarrhea in treatment in placebo arms in order to evaluate SYN-004s ability to prevent antibiotic-associated diarrhea in patients receiving SYN-004 and IV ceftriaxone versus patients receiving placebo in IV ceftriaxone. In the ongoing Phase 2b study an exploratory endpoint is dysbiosis. We believe SYN-004 may have the ability to prevent spread of antibiotic-resistant in the microorganisms present in the gut. Continued exposure, overuse and misuse of antibiotics causes microorganisms to develop resistance to antimicrobial agents. Now I’d like to provide an update on our novel – our two novel Phase 2a study designed to evaluate the safety and ability of SYN-004 to degrade IV ceftriaxone in the gut alone and in the presence of the proton pump inhibitor in participants with functioning ileostomies. These healthy volunteers have had all or part of their colon removed and are fitted with an external pouch system for waste. Therefore enabling easier sampling of intestinal kind. In the fourth quarter, we announced top-line results that demonstrated SYN-004 successfully degraded residual ceftriaxone in the GI tract of 10 healthy participants. Evaluation of the kind from these participants demonstrated that both the 75 milligram and 150 milligram dosage strength of SYN-004 degraded residual IV ceftriaxone without affecting the intended level of the antibiotic in the bloodstream. In addition, both dosage strength of SYN-004 appeared to be well-tolerated by the participants in the study. The second Phase 2a clinical trial for SYN-004 is currently ongoing, and is evaluating the GI antibiotic degrading effects of SYN-004 in the presence of a proton pump inhibitor. In healthy participants with functioning ileostomies. We anticipate reporting top-line results from this trial during the first half of this year, and expect results to be consistent with findings from our first 2a study. In addition to our two lead microbiome-focused drug candidates. I would like to briefly touch upon our growing pipeline of programs that we are also putting effort into Pertussis is our first program. It's a humanized monoclonal antibody program to target and destroy Pertussis toxin which is responsible for Pertussis or whooping cough and this continues to move forward. In 2015, the Bill & Melinda Gates Foundation awarded a grant to our academic collaborator, University of Texas at Austin to generate preclinical proof-of-concept data to test the hypothesis that antibody administration at birth may also have a role in the prevention of Pertussis. We anticipate having pre-clinical data by the end of this year. As a treatment, the therapeutic maybe tested in critically ill infants, with up to 300,000 babies dying annually worldwide. With Pertussis to potentially shorten disease course, mitigate complications and diminish mortality. As a prophylactic, the therapeutic has the potential to provide protection to at-risk newborns in the developing world to protect them from Pertussis for the first few months of life. The timeframe during which the infants are at greatest risk for severe disease but are too young to be immunized using a typical vaccine strategy. Our second earlier stage project is PKU and this is through our collaboration with Intrexon, we are pursuing a development and commercialized – commercialization of novel biotherapeutics for the treatment of patients with PKU. This is a chronic disease that can lead to profound cognitive impairment and behavioral disorders. We anticipate going into in vivo studies by the end of this year. Now I'd like to turn the call over to our Chief Financial Officer, Steve Shallcross. Steve?

[Steve Shallcross:]

Thanks, Jeff. During the fourth quarter of 2015, we continue to operate efficiently and remain well positioned to execute on our plan of completing our Phase 2 clinical trials for our two lead microbiome-focused candidates. Synthetic Biologics year-end 2015 financials were included in the press release, which was distributed over the newswire earlier this afternoon. The company's 10-K for the year ended December 31, 2015 will be filed with the SEC later this evening. For the year ended December 31, 2015, our general and administrative expenses were $8.1 million compared to $6 million in the same period last year. Included in these numbers were non-cash charges related to stock-based compensation of $2.1 million for the year ended December 31, 2015, compared to $ 1.6 million for the year ended December 31, 2014. Research and development expenses increased to $32.9 million for the year ended December 31, 2015. This increase of 127% was primarily the result of increased program costs associated with expanded clinical development, manufacturing and research activities within our microbiome-focused pipeline, including companies Phase 2 C. difficile and IBS-C clinical programs. Non-cash charges related stock-based compensation were $1.1 million for the year ended December 31, 2015 compared to $803,000 for the year ended December 31, 2014. Cash and cash equivalents at December 31, 2015 were $20.8 million compared to $17.5 million at December 31, 2014. We anticipate cash utilization in the first quarter of 2016 to decrease as cash prepayments made during 2015 are expected to be used to offset a large portion of the costs associated with these ongoing Phase 2b clinical trial for SYN-004 and the completion of our Phase 2 trials for SYN-010. In addition to previously disclosed positive top-line data we reported for both lead microbiome-focused programs, we expect to report top-line data in second Phase 2a clinical trial for SYN-004 in the first half of 2016. Furthermore, we expect to initiate two Phase 3 trials in the second half of the year, which we believe will further add shareholder value to our microbiome related programs. Now I’ll turn the call back over to Jeff.

[Jeff Riley:]

Thanks, Steve. As we continue to move our lead microbiome-focused candidates through Phase 2 development and begin to plan for Phase 3 trials and commercial entry. We should be well positioned with the financial resources necessary to maintain the momentum we experienced in 2015. Let me recap our progress from the beginning of the fourth quarter once more. For our IBS-C program, first we anticipate beginning Phase 3 clinical trials in the second half of this year. Two, we intend to submit a request for an end of Phase 2 meeting with the FDA during the summer of 2016 this year. Three, we completed the first Phase 2 clinical trial and announced top-line data demonstrating symptom met its primary endpoint. Four, we completed the second Phase 2 clinical trial, extension study and announced outstanding top-line results including data demonstrating that SYN-010 sustained a statistically significant reduction of breath methane and more importantly data demonstrating a statistically significant reduction in the mean IBS-SSS scores for all patients from Study 1. And there were no serious adverse events including diarrhea, during both of these studies. Turning your attention back to C. difficile and antibiotic-associated diarrhea prevention program. We also – we anticipate initiating a Phase 3 trial or trials in the second part of this year. Our Phase 2b proof-of-concept study is going very well and has enrolled 98 patients to-date. We announced top-line results from the first Phase 2a study, demonstrating SYN-004 successfully degraded residual IV ceftriaxone and we will announce top-line data from the second Phase 2a clinical trial, during the first half of this year. Overall 2015 was a year filled with clinical, positive clinical milestones and we are optimistic about the potential Synthetic Biologics to address large markets and meet unmet medical needs while generating significant returns for our shareholders. Looking forward to 2016, we believe this will be the year Synthetic Biologics completes the pivot from an early stage clinical development company to a late stage Phase 3 commercially focused company. At this time, I will turn it back over to Kris.

[Operator:]

Thank you, Jeff. Diane, we’d like to open the phone line back to questions now. Would you please describe the procedure to ask questions for our listeners?

[Operator:]

Certainly. We will now begin the question-and-answer session. [Operator Instructions] Our first question will come from Tim Chiang of BTIG. Please go ahead. Tim Chiang Hi, thanks, Jeff. When do you think we will be able to see some of the more detailed results from the second Phase 2 study for SYN-010. And would you be able to see some of that data at the upcoming DDW meeting? Jeff Riley Yes, absolutely. There are two posters that we will be representing there, our Dr. Pimentel will be presenting one of those and we’re modeled up until that point so that’s in May. We will be putting out a new presentation for the ROTH Conference for next week. There will be an 8-K filed on Monday and there is some new data and slides in that as well that may help. Tim Chiang And just one follow-up Jeff, you sort of highlighted that you may consider looking at non-dilutive players to get funding is there anything more specific you could talk about there I mean, it’s something that you are about to start from pretty sizable Phase 3 studies in the back half of this year for SYN-010 so if they need more funding? Jeff Riley Absolutely, I mean there is a classic evolution of a biotech company, right. I mean for the first two and a half, three years we were a discovery stage company. We bought programs, we build programs and we got them to a point, where we could put them in a clinic and last year was our year of the clinic. We started the Phase Is early last year and the burn rate obviously went up, because we were in Phase 1s and Phase 2s for both the programs. In this year, as you pointed out we will be in Phase 3s for the latter part of this year, likely for both programs. We are in multiple discussions with different pharma and large biotech partners, as you can imagine. We don’t want to partner everything that’s not the intention. The intention is to partner one of these drugs with a deal or co-development deal or something that makes sense for our shareholders, where we retain enough for the asset to make it worthwhile downstream. But we also are expecting to get enough capital that we can reapply that capital to the other drug that’s left. That we have in our pipeline. That being said, we are designing the Phase 3 programs for both. We will have the end of Phase 2 discussion here, later in this year, rather this summer for IBS specifically. And we are going to drive the programs forward if we have to raise capital we will. But the reality is we are hoping to get a deal done in a fairly timely manner that will help and leave some of the lead that we have for capital going forward. I pointed out in the prior call that we will need for both programs to get all the way through the Phase 3s entirely. We need roughly 150 million bucks. We anticipate that those numbers will be spread out over two to three year period of time two and a half year period of time. With launch dates for these drugs somewhere around 2018, 2019. Tim Chiang Okay, great that’s it, very good detail. Thanks Jeffrey. Jeff Riley Thanks Tim.

[Operator:]

Out next question will come from Katherine Xu of William Blair. Please go ahead. Katherine Xu Hi, good afternoon, can you hear me? Jeff Riley Hi, Katherine. Katherine Xu Hi, hi. So I’m just wondering, have you submitted the request to the FDA for the NSH [ph] meeting and if you haven’t what are needed? Jeff Riley We have not yet done that, we have done – our Chief Medical officer here that will address that Dr. Joe Sliman. Joe Sliman Hi, Katherine. We’ve submitted one Type C meeting request so far for manufacturing questions. We are planning on submitting a second Type C meeting request for a few of the pre-clinical questions. And as soon as we have confirmation on both of those, hopefully within a few weeks we are going to submit our end of Phase 2 meeting request. We are just waiting for free clarifications from the agency before submitting the full package. Katherine Xu Thank you, Joe. So basically I didn’t need to see the Phase 2 data before assessing the request? Joe Sliman That’s the second, no, I know they have. Jeff Riley Yes. Steve Shallcross Yes. Jeff Riley That’s not what it’s about, it’s simply we want to get clarification on a few things, having to do with the rest of the program, before we submit the full end of Phase 2 request. So that we can talk about… Katherine Xu I got it. Steve Shallcross And keep in mind. Katherine Xu I got it. Steve Shallcross 70 days, right. Regulatory wise the FDA has 70 days to respond to, our formal request for an end of Phase 2 discussion, shaking kind of back into the numbers, which is why we are saying late 2016 we have some more time. Katherine Xu Right, and what are the major points that you think that you want to go over in the end of Phase 2 meetings with intent? Jeff Riley Dose selection primarily, as well as the use of methane in the Phase 3 program. Katherine Xu Thank you. Jeff Riley Okay.

[Operator:]

Okay. Our next question comes from Adnan Butt of RBC Capital Markets. Please go ahead. Adnan Butt Thanks. And guys congrats on the progress to Phase 3 is potentially first on 010 for the Phase 3 and I think Joe you just touched on it. For the Phase 3 would the company like to use breath methane levels or would you like to go after all patients or is that after the FDA to start. Joe Sliman So we will prefer to not have to be required to use methane. The discussion with the agency will center around the best way to use the existing tests, there are uncertified out there. Adnan Butt Okay. And regardless of whether the test is used to enrich patients are not would you continue to evaluate breath methane levels and clinical outcomes? Joe Sliman Yes, I think we will continue to look at, not just in Phase 3 but in post-licensing as well. I think it would be only prudent to continue to export, but it’s more or less only for academic purposes. The most important thing is that we can hit the clinical endpoints. Jeff Riley I mean Adnan, this is Jeff. I mean for the audience out there, the reality is we did it, we measure breath methane in these Phase 2s specifically to try and confirm what the mechanism was, because up until those point, nobody had explored other than Dr. Mark Pimentel, Cedars Sinai exactly what you know a mechanism of nature number one, and two doesn’t have a profound impact on this particular disease. And we came out of the Phase 2 was the recognition that, absolutely it has a profound impact and if we can mitigate it in some way, in this case using our lovastatin lactone formulation, it works. So, going forward we’ll obviously continue to look at it. But our preference, and this is a preference and we have to have this conversation with the FDAs to have an all comers. We’ll look at both those levels and we'll pick the one that makes the most sense and it will be a robust study for sure. And we’ll be looking at the clinical endpoints and the encouraging part for us is this was powered for methane, that’s what we were looking at, that was methane, but what we found out was that we had statistical significance in the actual clinical endpoints as well. So very encouraging for us to have that conversation with the FDA and then drive toward Phase 3 the latter part of this year. Adnan Butt Okay. And then just one on 004. So on what basis can the company – would if the company have confidence that it could progress towards Phase 3 does that indicate that the company would have some kind of activity data from the Phase 2b that's ongoing? Jeff Riley Well, I think you and I discussed this offline. But in one of the last calls we had. The Phase 2b was designed to enroll between 370 and 600 patients, it was designed as a pivotal study, we’re well on track to get to that first level of patients, the interim analysis will keep – we're going to remain double-blinded. I want to be very clear we're not going to unblind the study have that interim analysis. There's a third-party that will look at us and give us the thumbs up or thumbs down as far as…. Steve Shallcross Futility Jeff Riley Futility right, enroll more patients are not. In-house that we’re having the discussions, as to whether or not, it makes sense if we have enough patients to stop at that time. And make this a Phase 2 instead of a Phase 2b. And the reasoning behind that is antibiotic-associated diarrhea which – our interim folks will also look at. And this is critical because – basically if the patients don't have diarrhea, they're not going to get C. diff, right, it means that the microbiome, the dysbiosis is not happening. And they’re maintaining the populations and the diversity that they need to have in their gut to protect themselves. So at antibiotic-associated diarrhea is actually, probably a much easier endpoint and obviously you don't have to power it as high. As you would for a true prophylactic C. difficile clinical study. So we're having that internal debate here, the way that we have a design today, we’ll just continue with the Phase 2b, we’ll get the data sometime later this year. We'll go to the FDA, have an end of Phase 2 discussion, and decide what we're going to do at that point or we may stop the study. But however many patients we have 200, 300 whatever the numbers are. Look and see what we have at that time, obviously we'll report that out to the public markets. But more importantly we’ll go have a discussion with the CDC and the FDA about what we see and whether or not it makes sense for us to reorder those endpoints. Including the exploratory endpoint of antibiotic resistance are diminishing, reducing the antibiotic-resistance in these patients, which were also measuring. I’m sorry for the long-winded answer, but I that – yes, again, as a decision tree for us. Adnan Butt Okay. And then the transition or what was the start of the Phase 3. Are they partner dependent or are your the company is going to return back to Phase 3 is regardless? Jeff Riley The IBS-C is not partner dependent. So that is actively in the majority of discussions that we’re having with the bigger guys out there. C. difficile I mean SYN-004 again as a small company, if we do not get partnership for that or we do not get the capital. We can very easily do other Phase 2s in smaller studies and keep learning more about the drug. But we probably will not be able to go into the Phase 3 right away. With unlimited capital, we can go into the Phase 3, the latter part with both of these probably this year for sure. Adnan Butt Okay. Thank you.

[Operator:]

Our next question comes from Ed White of FBR and Company. Please go ahead. Ed White Hi, thanks for taking my question. So just going back to the Phase 2b trial in 004. So you said the company is going to make the decision whether to remain on track with trial designed as it is or to stop it and then look at the AAD endpoint instead. So if the trial is blinded, I’m just curious as to how you are going to make that decision. You are obviously – it sounds like you have to unblind the data to make that decision. Am I correct in saying that? Jeff Riley We have an unblinded interim analysis unblinding committee and that committee is independent. They are contracted by our CRO. We don’t even know who they are technically. Only our CRO knows. And they will look at the number of cases that we have in both treatment and placebo groups. And they have a charge to look at only futility based upon – efficacy and based upon placebo rate. So they can tell us whether we have enough power to make a decision, as to whether we have efficacy or not. And if we do have enough power whether we have efficacy or not. Does that make sense? Ed White Yes, it does. Jeff Riley We’re not unblinded. Steve Shallcross We’ll know whether we can stop or not based upon that feedback from those folks without unblinding the study. And then we would unblind obviously if they said, you had your where you need to be. We talked about it earlier right, it’s – we have to have before they do the analysis, we have to have a minimum of 120 patients enrolled in the study, we’re almost there now. And 10 confirmed cases of C. diff, right. And I can tell you how many of those we have, but there are some. And once we hit those two endpoints, that’s when it goes to the committee they’ll look at it and they’ll provide feedback to us at that point in time. Ed White Okay. And is that feedback, are you going to make that available to the public? Steve Shallcross That’s under highly, likely we will. But at this – at the moment if we continue to go forward, it will just be a yes for going forward or no we’re not. If it’s a no we’re not, then we will release the data as to what we see at that point in time. Ed White Okay, great. Thank you. And then my next question is just on 005. Is there any, what’s the timeframe for getting the pre-clinical data from the University of Texas and then also, if this goes into the clinic is it and ended 2017, could it be something after that. And if it goes into the clinic, do you expect that the Gates Foundation will still be funding that or will you be funding that yourself at that point? Jeff Riley So this is the Pertussis project for everybody else out there, SYN-005 is the monoclonal antibody. The way it’s working today is that we are recruiting, we’re doing non-human primate studies. The number of baby, non-human primates is very difficult to get these guys, because we’re basically doing the study exactly as we would in humans, which is the newborn – it’s a newborn baby primate, we’re injecting them, we are measuring to see what’s happening, if we – whether we can invoke prophylaxis in these babies going forward, which is exactly what we would do in humans. We are looking – what we had seen previously is that, it didn’t confer some type of prophylaxis or preventative against these babies getting Pertussis. But what we haven’t done is doing the actual newborn [indiscernible] useful dose of antibody. Let’s see what happens and today we’re very encouraged as we look at this going forward. So the idea would be, if we have enough of an end, enough of these by year-end, we would probably stop the study, we take a look at it. If it’s statically significant we’ll drive forward. That will obviously have another discussion with the Bill & Melinda Gates folks. They can’t guarantee, they’re going to fund the clinical studies going forward. But it’s likely, if we get good data, but we don’t know. And if they don’t then we’ll probably drive that forward or partner that program as well. And there are – there have been active discussions with some of the folks that are vaccine manufacturers and distributors that this would fall into that category. Again the current deal we have or the current discussions with the Gates folks are they would get the prophylactic use. We would keep the therapeutic use. This is an orphan drug strategy, probably as stockpile type of therapeutic use strategy that we would pursue and we could do that very easily as a small company. So we would probably be in the clinic sometime in 2017 is our best guess. And what that study would look like, it would be that big. But then again the question really would be – what would be measuring likely white blood cell counts like we’re doing today in these non-human primates. Sorry, get for the long-winded answer, but that’s we haven’t talked too much about that program historically. Ed White Right. I understand. And then thanks for all the color on it. That’s all I have. Thank you.

[Operator:]

This concludes our question-and-answer session. I’d now like to turn the conference back to Jeff Riley for any closing remarks.

[Jeff Riley:]

Thanks, Diane. Again, everybody, thank you for joining us today. With more intensive placed on the microbiome research continues to shed light on all importance of microbiome place in human health. We feel a great sense of purpose and pride and continue to develop our two lead multibillion dollar programs. SYN-010, again to treat IBS-C and SYN-004 to treat CDI, CDAD, AAD in antibiotic resistance. As both programs continue to march toward Phase 3 clinical trials later this year. Synthetic Biologics move closer to our goal of offering novel microbiome-focused projects. We’re proud of the progress we’ve made in 2015 becoming a clinical development stage company and we’re very excited to move into a late stage clinical development company within a next two to three years to hopefully become commercial based company. Thanks again everybody for joining our call. Have a great evening.

[Operator:]

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.