Theriva Biologics, Inc. (TOVX) Q4 2016 Earnings Report, Transcript and Summary

Good afternoon, and welcome to the Synthetic Biologics 2016 Year End Investor Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please also note that this event is being recorded. At this time, I would like to turn the conference over to Mr. Vincent Perrone, Director-Corporate Communications at Synthetic Biologics. Sir, please go ahead.

Thank you, Jamie, and good afternoon everyone. Welcome to Synthetic Biologics 2016 year end investor conference call. Today, I'm joined by our CEO, Jeff Riley; our CFO, Steve Shallcross and our CMO, Dr. Joseph Sliman Synthetic Biologics issued a press release this afternoon, which provided operational highlights and reported our 2016 yearend financial results. This release can be found in the Investors section of our website. During our call today, Jeff will provide an update on our late-stage micro-biome focus programs and Steve will summarize our financial highlights. We'll take questions after our prepared remarks. In addition to the phone lines, this call is being streamed live over the Internet today and the webcast replay will be archived on our website for 90 days. During this call, we will be making forward-looking statements regarding Synthetic Biologics' current expectations and projections about future events. Generally, the 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 upon current beliefs, expectations and assumptions, and are subject to a number of risks and uncertainties, including those set forth at 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 as 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?

Thanks Vincent. Good evening everyone and thanks for joining our call today. 2016 was a transformative and momentum building year for Synthetic Biologics. We are proud of the progress we have made in the clinic and are excited for the opportunities that lie ahead in 2017. We are in the middle of a very busy time for Synthetic Biologics. In 2016, we shared proof-of-concept clinical results for our two lead microbiome-focused clinical programs representing substantial milestones for our company. All of us are very excited and continue to work diligently towards advancing our cutting edge, microbiome based therapies through late stage development. Our goal remains to deliver a best in class in paradigm shifting drugs designed to improve the quality of life for millions of patients in greatly underserved markets for building shareholder value. During today’s call, I’ll provide a clinical update on ribaxamase, our oral enzyme designed to degrade certain IV beta-lactam antibiotics within a GI tract to protect and preserve the natural balance of the gut microbiome, from C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance and SYN-010 our proprietary modified release formulation of lovastatin lactone designed to reduce methane production of the gut to treat the underlying cause of the symptoms commonly associated with irritable bowel syndrome with constipation. Before we dive into the clinical update, I’d like to turn the call over to Steven Shallcross our CFO who will provide an update on our financial results for the year. Steve?

Thanks, Jeff. During the fourth quarter of 2016, we continue to effectively utilise our cash as we booked higher capital in support of our two lead clinical programs. We remain confident in our ability to continue to manage overhead while focusing the majority of our financial and human resources on the continued development of our two late state Phase 3 clinical programs. Synthetic Biologics' year end 2016 financials were included in the press release which was distributed over the news wire earlier this afternoon. The Company’s 10-K for the year ended December 31, 2016 will be filed at the SEC later this evening. For the year ended December 31, 2016 our general and administrative expenses were $10.1 million compared to $8.1 million in the same period last year. This increase of 20% is primarily the result of bank and legal fees related to the November 2016 financing associated with the liability, with the warrant liability, increased employee costs, costs associated with the transition of the administrative and financial office to our Maryland headquarters, an increase in stock based compensation. Included in these numbers were non-cash charges related to stock-based compensation of $2.4 million for the year ended December 31, 2016, compared to $2.1 million for the year ended December 31, 2015. Research and development expenses decreased to $29.1 million for the year ended December 31, 2016, from $32.9 million for the same period in 2015. This decrease is primarily the result of decreased program costs associated with clinical development programs and research activities within our microbiome-focused pipeline, including our IBS-C and Pertussis programs offset by an increase in C. difficile program costs and an increase in manufacturing costs. In 2015, we entered into an ECC with Intrexon Corporation for the development of a treatment for patients with PKU. Pursuant to the ECC, we issued 937,500 shares of our common stock in August of 2015 to Intrexon as payment of the technology access fee that resulted in a non-cash charge of about $3.0 million. Research and development expenses for 2015 also include a $1 million non-cash expense for achieving the third milestone as set forth in the Asset Purchase Agreement with Prev ABR dated November 28, 2012. Prev ABR exercised its option to receive the milestone payment in shares of our common stock that were issued in April 2015. Non-cash charges related to stock based compensation were $1.6 million for the year ended December 31, 2016, compared to $1.1 million for the same period of 2015. Cash and cash equivalents on December 31, 2016 were $19.1 million, compared to $20.8 million at December 31, 2015. Our current cash balance reflects the net proceeds from our November 2016 second year offering of $23.3 million. Now I’ll turn the call back over to Jeff.

Thanks Steve. At this time, I like to provide a clinical update for our two lead microbial focused [Indiscernible] programs. 2016 proved to be a transformative year clinically for our company highlighted by the announcement of clinically significant Phase 2 trial results for ribaxamase and SYN-010. As a result of this momentum, Synthetic Biologics is uniquely positioned amongst our clinically focused microbiome peers with two late stage unencumbered and potentially best-in-class Phase III Ready Assets targeted at addressing largely unmet medical needs. I’d like to start with an update on ribaxamase our first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics excreted into the GI tract to protect and preserve the naturally occurring dead microbiome for the prevention of CDI, AAD and the emergence of anti-microbial resistance. We are very excited about the potential for ribaxamase as a first line of defense against the unintended and damaging effects of antibiotic therapies to the gut microbiome. A healthy, diverse and balanced microbiome is associated with better overall health whereas an imbalanced microbiome also known as dysbiosis may contribute to the diseases ranging from infections in central nervous system disorders to various metabolic illnesses and perhaps even some cancers. The presence of a healthy, robust and well balanced gut microbiome can protect against the threat of infection by blocking colonization, by opportunistic and pathogenic microbes. This is because the diversity of microbes present in a healthy gut microbiome as a system or checks imbalances allowing the ecosystem of microorganisms to remain relatively steady. While species of microorganisms are limited or sharply reduced in the gut, this ecosystem is disrupted and may allow overpopulation by opportunistic, pathotgenic bacteria such as C. difficile. IV antibiotics are administered systemically to fight primary bacterial infections like pneumonia. The body disposes of residual IV antibiotics by carrying them through the liver for transport in the bile. Eventually the body excretes this still functional antibiotics via the large intestine. But this may unintentionally upset the natural balance of microbes in the GI tract by killing off good bacteria. Ribaxamase is designed as a first line of defence against this disruption and is specifically formulated to bypass the stomach avoiding systemic absorption and does not interfere with the ability of IV beta-lactam antibiotics to fight against primary infections. By protecting the patients native gut microbiome ribaxamase prevents the overgrowth of pathogenic organisms responsible for the development of CDI and other pathogenic organisms that may emerge as a result of antibiotic use. Earlier this year, we announced positive topline results from our global Phase 2b randomized placebo controlled proof of concept clinical trial for ribaxamase which consisted of 412 patients. We were very excited to report that ribaxamase achieved its primary endpoint from a statistically significant reduction in the incidence of CDI when compared to placebo. Preliminary topline analysis of the data indicated seven confirmed cases of CDI in the placebo group versus two cases in the ribaxamase treatment group, representing the relative risk reduction of 71.4%. Simply put, patients on a Phase 2b clinical trial who were administered ribaxamase in conjunction with IV ceftriaxone were 71.4% less likely to develop a C. difficile infection compared to patients receiving IV ceftriaxone and placebo. Interestingly, both cases of CDI occurring in the treatment group, occurred in patients who were administered ceftriaxone prior to their first dose of ribaxamase which was permitted under the protocol. It is also interesting to note that the patients newly colonized with C. diff to receive ribaxamase were less likely to progress to CDI than the patients treated with placebo who became newly colonized with C. diff. Both of these findings further reinforced the concept that the prevention of dysbiosis is the key to prevention of CDI. Preliminary results from this trial also demonstrated that while not reaching statistical significance as defined by the protocol secondary endpoint a clear and positive trend in the reduction of antibiotic-associated diarrhea from all causes for the most part to the reduction of CDI was observed in the ribaxasame treatment group as compared to the placebo group. When we initiated the ribaxasame program we believe ribaxasame had the potential to prevent the development and proliferation of anti microbial resistance in the gut microbiome. This thinking was predicated on prior Phase 2 results from a European study. Protecting against disruption of the gut microbiome may prevent environmental conditions in the GI tract that are conducive to the development of antimicrobial resistance. In designing our Phase 2b potentially pivotal study we incorporated exploratory endpoints designed to evaluate ribaxasame’s ability to protect the gut microbiome from colonization by opportunistic and resistant pathogens. One such pathogen is vancomycin-resistant enterococci or VRE. VRE can live in the human intestines and remain passive, kept in check by a healthy and robust microbial community, however if present in a Dysbiotic gut microbiome, VRE can aggressively proliferate in develop into a serious infection which may not be treatable by available antibiotic therapies. Preliminary analysis of our Phase 2b data demonstrate a statistically significant reduction, a P value of 0.0002 in new colonization by VRE for patients receiving ribaxamase as compared to placebo. A particular relevance as it relates to these data is to remember that patients enrolled in this trial were not treated with vancomycin and they came at the development of new colonization by VRE and other resistant pathogenic micro organisms is not limited to antibiotic mediation of the guy microbiome but instead may force and transfer the month’s patients in hospital settings. We are currently in the process of analyzing additional data from these exploratory endpoints designed to evaluate ribaxasame’s ability to protect the guy microbiome from opportunistic bacteria such as VRE. This includes analysis through funding awards to synthetic biologics from the centers for disease control and prevention the CDC to support research from our Phase 2b trial. Following the completion of analysis from these antibiotic microbial resistance focus exploratory endpoints we plan to meet with the CDC to share our findings and subsequently anticipate requesting end of Phase 2 meeting with the FDA later this year. Our goal is to work with the FDA to determine the appropriate regulatory pathway for Phase 3 development of ribaxamase with input from the CDC. We expect to initiate our first pivotal trial for ribaxamase during the first half of next year. The results from our Phase 2b study are consistent with the ribaxamase’s mechanism of action and provide a compelling demonstration of the potential of ribaxamase to help address the serious health and economic impacts associated with CDI, AAD and AMR resulting from antibiotic mediated dysbiosis of the guy microbiome. Ribaxamase represents a new, disruptive and simple approach to its rolling complex problem and may directly lead to more effective and efficient use of antibiotics. We seldom talk about our additional early stage programs which we view as [Indiscernible] extensions of ribaxamase. Utilizing our expertise and knowledge in the microbiome arena we are currently developing pre-clinical stage programs which harnest the same formulation expertise currently utilised for ribaxamase. The first is known as SYN-006. It is an enzyme comparable to ribaxamase and is designed to degrade residual IV carbapenem antibiotics in a similar fashion. Carbapenems are exceptional powerful antibiotics which are typically used as a drug of last resort. As noted earlier, antimicrobial resistance and the emergence of superbugs is making this class of compounds less effective. Synthetic biologics is developing a program to remediate this situation. In addition, our second extension of ribaxamase is called SYN-007. SYN-007 is a special formulation of ribaxamase designed to be co-administered with oral beta-lactam antibiotics such as [Indiscernible]. Again, the quest is to reduce the destruction of the microbiome and minimize the emergence of superbugs. The market for oral beta-lactam antibiotics is significantly larger than the market for IV beta-lactam antibiotics which is also quite large. We view ribaxamase in a sister compounds and formulations as a franchise not a single compound with the potential to have a significant lasting benefit for the way we administer antibiotics for many years to come. We view this program as a cradle to grave concepts were and we will continually be able to protect the gut microbiome from the time you're born until the time you die, thus preventing many diseases downstream. I like to switch gears SYN-010 now, our program designed to target and treat an underlying cause of irritable bowel syndrome with constipation. Currently marketing development stage therapies for IBS-C are designed as Me-Too or Me-Better drugs. They have been shown to treat the symptom of constipation associated with IBS-C but do little to address the abdominal pain and bloating. These therapies provide temporary relief to a long-term and often lifestyle altering and recurrent problem, and usually have serious side effects most commonly diary. In previously reported studies methane production in the gut was shown to be the primary causative factor of the symptoms associated with IBS-C. If follows then that by reducing methane production in the gut we can treat the cause of the symptoms associated with IBS-C potentially providing sustainable relief to the millions of people suffering from this disease around the world. This is our goal and our microbiome focus solution is what makes Synthetic Biologics, SYN-010 an outlier in the current landscape of IBS-C focused therapies. It is a game changer. Our gut microbiomes are comprised of thousands of species which represent trillions of cells existing symbiotically within the G.I. tract. One species in particular M. smithii, he is responsible for the vast majority of methane production in the gut. In previous Phase 2 trials we show that by interrupting the methane cycle of this specific microbial are proprietary formulation of SYN-010 we influence positive therapeutic outcomes in IBS-C patients with minimal impact to their naturally occurring gut microbiome with almost a zero occurrence of diarrhea. During the second quarter 2016 we announced positive results from these Phase II clinical trials which demonstrate that patients in the SYN-010 treatment groups experienced clinically significant improvements in bowel movements, abdominal pain and bloating compared to the placebo group. Following this announcement we held collaborative discussions with the FDA to determine the optimal regulatory pathway to advance SYN-010 into Phase 3 development. During the fourth quarter of 2016 we announced that Phase 2b/3 adaptive pivotal trial designed to further evaluate the efficacy and safety of SYN-010. Key components of our first pivotal trial for SYN-010 include a 12-week multi-center double-blinded placebo-controlled adaptive design, a study population of approximately 840 adult subjects, evaluation of efficacy and safety of two doses of SYN-010 21 mgs and 42 mgs compared to placebo, conducted approximately 150 clinical sites in North America, study subjects will be randomized in a 1:1:1 ratio receiving either 21 mgs, 42 mgs or placebo. Enrolment is open to all IBS-C patients. Breath methane will be measured at baseline to ensure comparable ratio high to low breath methane IBS-C patients at each treatment arm. An interim futility analysis may also be conducted with approximately 50% of patients in each dosing arm have completed treatment. Clinical Research conducted in Dr. Mark Pimentel's lab at Cedars-Sinai Medical Center suggest that M. smithii is a common inhabitant in most of our gut microbiomes and is not exclusive to IBS-C patients. You may recall Dr. Pimentel spent years researching bowel syndrome and was responsible for discovering the billion dollar plus drug rifaximin commercially known as Xifaxan for IBS diarrhea. This scientific and clinical insight enable him to identify M. smithii as a causative factor of IBS-C. Since an individual's microbial balances play a key role in determining the level of methane production in the gut there is no ubiquitous standard for what constitutes healthy or unhealthy methane production, in other words a one-size-fits-all approach to measuring therapeutic outcomes based on methane production alone would be inappropriate. We believe SYN-010 may provide a therapeutic benefit for all IBS-C patients. Unlike previous clinical trials for SYN-010 which measure breath methane is criteria for enrolment, our Phase 2b/3 clinical trial will be open to all adult IBS-C patients, breath-methane will be measured at baseline to ensure comparable ratio of methane IBS-C patients in each arm. Consistent with FDA written guidance, the primary objective for the studies to determine the efficacy of SYN-010 measured as an improvement from baseline in the percentage of overall weekly responders during the 12-week treatment for SYN-010 21 milligrams and 42 milligram daily doses compared to placebo. Secondary efficacy endpoints for both those strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, bowel movement frequency and stool consistency. With a clear path forward for SYN-010’s clinical development we are one step closer to achieving the goal of providing millions by IBS-C patients with a novel potentially best-in-class therapy that directly targets a root cause of IBS-C. We have reflected upon the importance of initiating our Phase 2b/3 pivotal study for SYN-010 with full confidence that we have the clinical and financial infrastructure necessary for its full, timely and successful completion thus once these components are solidified we intend to start the study later this year. To that end, we continue to evaluate and engage in ongoing discussions with several potential U.S.-based pharmaceutical partners as well as interested parties in Europe, China and Japan. In 2017 we’ll look to build upon the clinical successes of the last year as we continue to more primitive discovery early-stage Platform Company to a late-stage development company with an eye towards commercialization. At this time, I'll turn back over to Vincent.

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

Ladies and gentlemen, at this time will be a question-and-answer session. [Operator Instructions] And our first question today comes from Keith Markey from Griffin Securities. Please go ahead with your question.

Hi, Jeff. Thank you for taking the question. I was just wondering is VRE found in virtually all of the human guts and/or is it just how widely is it I found in the general population. And then I was wondering, do you believe that the decline in VRE associated with the revaccinated treatment is simply due to the protective effect of it on the gut microbiota?

Thanks for the question, Keith and happy to have you here on afternoon. I’m going to let our Chief Medical Officer Dr. Joe Sliman going to answer the question, if that's okay.

Sure.

Hi, Keith. So, to answer your question in two parts; VRE is found -- you can think of it similarly to CDAD [ph], it’s found out there in the environment, it is a rogue pathogen that doesn't grow too well, its hardy tough survivor but it's not that easy to proliferate easily crowded out like CDAD and it is an opportunistic infection. And the second part of your question would be about what allows it to overgrow? It is at least in theory, the growth or overgrowth in the human intestine is mediated by the dysbiotic component. So you see this most commonly in patients with sepsis patients with bone marrow transplants, the post transplant have no ability, then their gut microbiota wiped out. They have multiple antibiotics on board. They have no ability to fight off an infection and a multi-drug-resistant organism like VRE is one of the few things that can survive in that environment [Indiscernible]. And so it’s the dysbiotic component of the – but sort of side-effect I guess the best way to put antibiotic use more damage to the gut that allows VRE to show up and colonize.

Great. Thank you very much.

Sure.

Our next question comes from Ed White from FBR & Company. Please go ahead with your question.

Hi, guys. Thanks for taking my question. So the first one is for Steve, I’m just wondering if you can give us any kind of guidance on cash burn. I mean obviously it depends on when you start the you know for 2017, it depends on when you start the SYN-010 trial, but assuming maybe can give us a run rate without the trial starting and then a runway great with it? And then I have a follow-up question?

Right. So what I would build into models is that are fixed burn is running between 1.2 million to 1.5 million half a month and that’s been pretty consistent over the last several quarters. And then what we’ve talked about previously is that the cost of the SYN-010 trial would be somewhere around 25 to 30. So once we initiate the trial then you could start to build that additional variable cost into your models.

Great. Thanks Steve. And then the other question is just on the earlier stage product for the SYN-006 and SYN-007, do you have a timing of when you think they're going to reach human trials?

At this stage we’re just going to bring him up to the doorstep of an IND. We’re not going to -- there is no reason to drag them forward at this stage. Obviously the goal for that drug is also find a partner of some sort. But again we’re looking at is more of a franchise if write back some of this continues to show that it is work exceptionally well. We know that SYN-006, it is also worth of protein and enzyme. It’s relatively easy to manufacture. We’re working on that today. We’ve been able to scale it up. It will work exactly the same way and obviously the formulation expertise that we have, it will be released same exact way that will be used for carbapenem primarily instead of your beta-lactam's. So, I don't think there's a really any reason for us to drag that into the clinic unless we’re significantly larger or we had the capital or a partner wants to help us do that. The other drug is, we’re also doing the same thing. So the oral-oral formulation is really being pushed by that we want to get into more of the pediatric populations. Again there’s a lot of papers out there that show that even taking a single dose of antibiotics when you are three or four years old as your microbiome diversity never returns to baseline five and 10 years after the fact, there’s some great papers to show that and we don't know what that actually does to these patients long-term. There's a lot of diseases, 600 plus diseases that are now associated with disrupting that microbiome in some way shape or form. Keeping in mind that for example 90% of serotonin levels or serotonin created in the gut you know which manage your brain, happiness levels of you will. So SSRIs and all those -- all these things have a profound impact. So again the oral-oral formulation is to work for kids primarily pediatric populations and people are taking over-the-counter antibiotics around the world. And again the goal is to take it up to the doorstep of an IND. We’re using Peg [ph] models. We have a Peg microbial model that we use in-house that basically that has a very – it’s very similar to a human microbiome. Does that okay?

It does.

Thank you. Ed, we don’t want to spend the money at this stage of the meeting.

I totally understand. That’s great. And then just last question for you on the partners. Is there any of timing we should be looking for here, are you really trying to focusing on getting something on the books for 2017 so that you can advance SYN-010 in 2017and then ribaxamase in the first half of 2018?

We’re pushing as hard as we can and to be honest, I mean, the guidance I’ve given historically it takes 9 to 12 months from the time you have Phase 2 data to get a deal done. We got the data last -- the end of May of last year and we’re roughly nine months into the process and to be honest as you're going through diligence rooms and you're looking at the data rooms. The parties want to partner something really have to go through a variety of checkboxes and we just checked off sort of the last box here few weeks ago which was the FDA given us the green light on the Phase 2b/3 protocol. So once we had that in writing that sort of the last box for several groups looking at the data rooms and we’ll have to see whether or not that will convert to a term sheet which we hope it would. We’re not looking in the U.S. We’re not looking necessarily for US only partner so, if you look over in Europe as an example, our leading competitor linaclotide, LINZESS, really isn’t sold very much over there. It’s called CONSTELLA, for many years it was sold by company called Amarok which the Spanish based pharmaceutical company, but the EMA really doesn't like that drug. They didn't approve it. They had to go country-by-country, most countries don't sell it because again the Europeans have a very different perspective on side effect profiles and such. So the folks have you spoken was pretty excited frankly to have a drug that is benign is ours from a side-effect perspective. There are no real side-effects and something to that could potentially be used in the pediatric population once we get through these studies we’d obviously do a Phase 4 and pediatric plan we've already written that and we’re working to move forward with that. So again from a partnering you know the best I can give you is we just got the data from ribaxamase again nine to 12 months we got that out in January, you can kind of guesstimate what is going to take for that. And again that drug is unusual. So we’re not sure we’re talking to folks, but I don’t know if that’s to be partner within any effective base company or company that has a hospital-based sales force. There’s is a variety of permutations there. IBS-C much more straightforward, that’s something with the G.I. franchise typically and that's more of a G.I. specific salesforce kind of concept.

Okay. Great. Thanks Jeff, that’s all I have.

Our next question comes from Katherine Xu from William Blair. Please go ahead with your question.

Thank you and good afternoon. I’m just wondering with regard to our SYN-010 Phase 3 start. I think previously you were guiding first half of 2017 now is kind of full year 2017. Is that contingent on a partnership deal?

It’s not contingent, Katherine, I mean, as we stated earlier we’re looking at. There are two pieces of the equation. One is our clinical infrastructure, I’m choosing the right zero and we are with auditing sites, we’re going out, we’re building all that today. We’re doing electronic journal et cetera so, we’re building that as we go forward and the other component is to be honest I don't want to start a study unless we have the financial wherewithal to make that happen. And that could be through a partner or it could be your other mechanisms. We’re not looking at diluting the company further if we can avoid it, and we’re going to just basically press, pause on this until such time as we have those piece -- both those pieces in place. So it could start as soon as the end of the summer, they maybe a little later but somewhere in that timeframe I would guess.

And therefore ribaxamase, what are the key issues or key step they have to take basically one after another to get you the Phase 3 start from this current point?

So, right back, if you recall the Phase 2b study that we just reported on was design as a pivotal study. Now whether the FDA allows us to use that, we don’t know yet, but we’re very hopeful that they may. The next step how we’re getting the jean sequencing data, the 16 S sequencing data which is what the CDC pay for, we’ll have that in hand probably buy or at least the portion of it by the end of this month. We’re going to be down to the CDC probably in a April-ish. We’re trying to get down the calendar at the moment and that going to take a fair amount of time. We have to go through the data sets with them. The AMR data is likely going to be pretty spectacular if we go back and look at what happened in the European studies, which means we don't know what the endpoints are going to be necessarily for the next Phase 3 study. It could be -- we could run it exactly the way we just ran it which is probably the safest because we know that works and powered up a little bit higher or we may change the secondary out for AMR or another endpoint to pain upon what the CDC sort of guides us toward. So that's in the next couple of months when that after the CDC's input obviously we will get together with KOLs and really look at what would that Phase 3 look like with the CDC feedback and then hopefully the CDC will interact with her sister agency and they will go to the FDA that takes a couple months right to get on their calendar and then talk to them about what we’re thinking as far as what that protocol should look like. So, we’re looking at probably toward the latter part of this year before all these things kind of come to fruition. We intend to release the data on the sequencing here as soon as we have it though. And then there’s going to be a deeper dive frankly into that data as well. So there’s going to be a lot of papers coming out that DDW[ph] and the other conferences associated with that antibiotic -- antimicrobial resistance stuff if you will plus to just the normal data that we've already generated. So I would suppose that probably towards the end of the year we should have everything locked and loaded, ready to go will. Well we have a partner? Maybe, to be honest this drug fairly unique from a mechanistic perspective, so there is not a clear-cut, should Mark partner this drug to go with their anti-infective franchise, should Roche look at it. Possibly, we use their drugs substract sort in their last study, but it's not clear right now which one is – which big pharma is probably the right pharma. I would guess is some may probably with a hospital-based sales force, they are probably the best one. So maybe at J&J would actually probably be a good one as well, so we’re not sure exactly who, but the goal again is to try and get that loaded. Once we have the capital to do that whether that’s through a partnership or some other mechanism, we have to start the manufacturing and the manufacturing takes nine to 12 months, it’s a protein, Dr. Stapleton in our organization as a skillet sucker up, it’s going to take a bit of time to get cGMP material and then obviously we start the study at that stage of the game. Sorry for the long answer.

No. That was very good. Thank you very much. And then lastly for Joe, the two patients in Phase 2 [Indiscernible ] study, who had PDi but were given highly before ribaxamase, how long was the idea given before the ribaxamase, I’m just curious?

Yes. We haven’t put that up probably, yes, I can’t talk about it right now, but that will come out whenever we published a data. But I can just reiterate what Jeff said which is that the timing of dosing matters because it's the display assistant mediates on the process here. And it will become clear and it will be more clear when it put in context with the rest of the EMR data and sequencing data.

And then what did the protocol say. What did the protocol say in the light until how late can you…?

The protocol say 30 minuets. The protocol say, the window is – the dosing window was 30 minutes, yes.

Okay. Thank you.

Our next question comes from Adnan Butt from RBC Capital Markets. Please go ahead with your questions.

Thanks. Folks first on ribaxamase, are there other organisms similar to the VRE or CD I whose colonization you are looking for or is important as well. And then second on SYN-010 what’s the interim that you touched on, sorry if I missed it instead, an efficacy safety or is that [Indiscernible] sizing hurdle? Thanks.

Sure. So, to answer your first question, yes, there are other specific organisms multi-drug resistance organism we’re looking at and as soon as we have that data available to release we will put it out, but yes, did look at some specifically VRE was in top of the list along to see if though not only because it’s always prominent so to speak in healthcare right now, but because we were asked specifically to look at that one, so we prioritize that one. But yes, we are looking at other ones. The other question was involves the interim analysis for Phase 2b. The part that’s come in between the 2b and three parts of first pivotal study for SYN-010, that is a blinded utility analysis, so we’re going to look at each does which is independently powered. Against placebo we won’t look at it, we’ll have an independent data monitoring community to look at it. And the only question will be is do we have efficacy or indication of efficacy in either dose or both doses and so they’ll tell us to either go or stop. That’s it.

Thanks.

And to just clarify on that, so if they say go where we feel fairly confidence it’s working, right. So we’ll continue into the Phase 3 with all three placebo in both doses or one dose, if they see one dose is not working. If its not working we’ll stop the study and this is a beautiful part of the adaptive design at the FDA help us create which is we then can go back and look at all the patients. And keep in mind we take methane samples at the beginning, so we had a good baseline. We know the patients that had three parts per million or five parts per million and higher and then we will stratified. We’ll look at those patients specifically stratifying and go back and begin enrol patients with obviously a narrower label, but still – we’re not death in the water, we get to move forward with the methane positive patients per that baseline for breath testing.

Thanks.

It’s kind of two shot simple.

And our next question comes from Tim Chiang from BTIG.

Hi, Jeff you mentioned DDW [ph] I mean what sort of presence are you guys going to have there, you know how many data presentations do you plan on having at that conference this year?

We’ve applied for several Tim but they haven’t really told us yet exactly how many we have two of them; we’ve applied for other late breakers. I can’t tell you we’ll likely have a boost there, we’ve never had a boost, but we are going to have more of a presence than we typically do, just because we have two drugs sort of in the Phase 3 and DDWs typically a GI conference, right but GI dots were getting more into the C. diff side of things, so we are getting into the microbiome so we are going to be presenting both drugs at that conference.

And just a quick follow up, I guess will you be able to show more of the details from this ribaxamase trial at [Indiscernible] done.

And absolutely, again we have to go to – we have to take the sequencing data, we have to go to the CDC first. We are not going to release until we get their input on it. So after the CDC you know then we’ll roll that out, we’ll probably do that in the scientific forums and not necessarily in the press release or anything like that.

Okay. Great. Thanks.

And ladies and gentlemen, at this time we’ve reached the end of today’s question and answer session. I’d like to turn the conference call back over to management for any closing remarks.

Thanks Jamie. We feel a great sense of purpose and pride and continuing to develop ribaxamase and SYN-010. We are seeing more and more attention and focus being placed on developing interkit and [Indiscernible] microbiome based therapeutics our goal remains to build innovative, novel and simple approaches to complex and largely unmet medical needs. Our approach to clinical development of microbiome therapeutics is unique in that it leverages existing and well defined guidance from the FDA while applying cutting edge microbiome science to effectively deliver therapeutic outcomes. We are proud of the progress we made in 2016 and we look forward to what lies ahead in 2017. I’d like to thank the staff at Synthetic Biologics for kicking butt. They have moved these two products from point A to point B in under three years. This is unheard of from bench to Phase 3, extremely dedicated group of folks so I have to say thank you to them and for the investors that have stuck with us and we look forward to moving forward in 2017 and into 2018 as we aim for a potential commercial launch in 2020, 2021. Thanks again for everybody. Have a good day.

Ladies and gentlemen, that does conclude today’s conference call.We thank you for attending. You may now disconnect your lines.