Hello and welcome to the Synthetic Biologics’ Third Quarter 2015 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 Kris Maly, Vice President, Corporate Communications at Synthetic Biologics. Ms. Maly please go ahead.

Thank you Steve and good afternoon everyone. Welcome to Synthetic Biologics’ third quarter 2015 financial results conference call. Today, I’m joined by our CEO, Jeff Riley; and our CFO, Steve Shallcross. Synthetic Biologics issued a press release this afternoon reporting its third quarter 2015 financial results and an update on our recent operational highlights. The release can be found on the Investors section of our Web site. During our call today, Jeff, will provide an update on our pipeline of programs and Steve will summarize our financial highlights. We will 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 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 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 the 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.

Thanks, Kris, and good afternoon everyone thanks for spending some time here with us this afternoon. I would like to begin with a recap of the progress we have made through the third quarter and we accomplished a lot. Here is a brief rundown of the very exciting achievements we have made at Synthetic Biologics'. We continue to make great strides in the clinic. Firstly, we initiated two SYN-010 Phase 2 clinical trials for the treatment of Irritable Bowel Syndrome with Constipation or IBS-C. We completed patient enrollment in the first Phase 2 clinical trial for SYN-010 and continued to successfully roll patients from the first trial into the second Phase 2 clinical trials as we speak. Secondly, we initiated three SYN-004 Phase 2 clinical trials for the prevention of C. difficile Infection. A Phase 2b proof-of-concept clinical trial is going on in up to 370 patients at up to 75 global clinical sites. We also two Phase 2a trials in ileostomies participants and that’s ongoing to provide data which will help further to development of SYN-004. We reported results in line with our expectations from four participants from our first Phase 2a trials in July of this year and we completed participant enrollment in the first Phase 2a trial. We acquired an exciting novel biotherapeutics, designed to treat PKU from Intrexon Corporation expanding our portfolio of microbiome-focused products. Also The Bill & Melinda Gates Foundation awarded a grant to UT Austin or academic Pertussis collaborator to generate preclinical proof-of-concept data to test the hypothesis that administration of our antibody at birth may also have a role in the prevention of Pertussis. And lastly, we amended license in clinical trial agreements with UCLA to further strengthen our MS intellectual property claims and we’re informed that MRI data analysis are ongoing…

Thanks, Jeff and good afternoon everyone. During the third quarter of 2015 we continued to operate in an efficient manner and we remain well positioned to continue to execute our strategy of funding both lead microbiome focused drug candidates through Phase 2 clinical trials. G&A expenses for the quarter increased to $1.6 million compared to $1.2 million for the same period in 2014, reflecting the investment we continue to make in our administrative resources. R&D expenses for the quarter increased to $10 million compared to $3.7 million for the same period in 2014. The increase in R&D expenses reflects increased program costs associated with expanded clinical development, manufacturing and research activities for our gut microbiome focus pipeline. Cash and cash equivalents as of September 30, 2015 were $31.8 million. We anticipate cash utilization in the fourth quarter to decrease due to cash prepayments made during the third quarter related to the ongoing Phase 2b clinical trial for SYN-004 and the Phase 2 trials for SYN-010. As Jeff stated earlier, we do expect to report top line data from multiple Phase 2 clinical trials during fourth quarter of this year which should illustrate the value and the potential of our microbiome related programs. Now I’ll turn the call back over to Jeff.

Thanks, Steve. As we continue to move through Phase 2 development and begin to plan for Phase 3 trials and commercial entry of our microbiome candidates, we remain well positioned with the financial resources necessary to proceed with our clinical trials and continue to reinforce our leadership team. Let me summarize once again our progress this quarter. For our C difficile prevention program; one, we completed enrollment in the first Phase 2a clinical trial and anticipate reporting top line data before the end of this year; secondly, we also initiated the second Phase 2a clinical trial and expect to report top line data during the first half of next year; thirdly, we expect the top line data from the two Phase 2a clinical trials, which are open label, to be in line with our expectations; and lastly, we are very excited to initiate our Phase 2b proof-of-concept clinical trial. Switching gears to our IBS-C program, we completed enrollment for the first Phase 2 clinical trial and anticipate reporting top line data from this trial by the end of this year. Also, we were pleased to initiate the second Phase 2 trial and anticipate reporting top line data from this study during the first half of next year. In addition to reporting progress from our gut microbiome focus portfolio, we looked forward to reporting the continued development of our monoclonal antibody intended for the prevention and treatment of pertussis in newborns, as well as our innovative biotherapeutic approach to address the largely unmet medical needs associated with PKU. While we do not have a definite timeline we continue to work with UCLA to ensure the accurate and complete analysis of the MRI data from relapse and remitting MS patients. We will keep you updated as we can. Overall, we are very optimistic about the potential of Synthetic Biologics to address large markets and meet unmet medical needs while generating significant returns for our shareholders. At this time, I’d like to turn it back over to Kris.

Thank you, Jeff. Keith we’d like to open the phone lines to questions now. Would you please describe the procedures to ask question to our listeners?

Yes. At this time, we will begin the question-and-answer session [Operator Instructions]. And the first question comes from Adnan Butt from RBC Capital.

First one, I’ll ask is on 010. For the Phase 2 trials that are ongoing, is this the first time you will be correlating methane levels with activity correct and then do you expect a certain methane level to be required for having for foreseen activity, that’s the first part. And secondly is just Phase 2 data that you see, will it be sufficient to decide on a go-no-go for a pivotal? Thanks.

Thanks Adnan. So this is the first formalized clinical study that’s correlating methane gas with symptoms and the reduction in those symptoms if you knock the methane gas levels down. That being said anecdotally Dr. Mark Pimentel's Cedars Sinai has been several years working on this hypothecs and working in his clinic with other compounds that do knock out methane gas, they tend to be detrimental to the patient long term, but they do work on reducing methane gas. And he did see a very strong co-relation which is why we are licensed in that partner with Cedars Sinai for this product. With respect to the level of methane gas, the current study we are looking at patients with methane breath levels greater than 10 parts per million which essentially is one of the entry criteria outside of normal IBS-C ailments that this folks have. We are looking at reducing it obviously from that level down to as low as we can go. The current diagnostic test only are accurate down to about 3 parts per million and we are not sure what is happening between the let's say zero parts per million and that 3 parts per million because we do not yet have the diagnostic test to detect that. We are working hand in hand with one of Cedars Sinai prior collaborate, a lab call Commonwealth which is working on making a sensitive test at this time. Is that answer your question Adnan?

Jeff thanks for the clarity. I just have the follow up on the program, what decided from the patient perspective for goes into the exception phase or not?

Well, all the patients historically with any IBS-C related program, the biggest problem that other investigators have had is the patients tend to self-medicate or they drop out because the drugs are not being or not very affective. So if you look at some of the other drugs that have been for recent clinical studies, may have between 20% and 22% efficacy in their patient population which means basically one out of every five patients is getting relief. So they have to power those studies exceptionally high in order to get an update just to create a key value that it's statistically significant. Now we thought that 60 patients given what Dr. Pimentel has seen anecdotally was a good number and one of the promises that we gave the patients was, if you can survive the 30 day initial Phase 2 study, you will have the opportunity to roll over into an open-label study for an additional two months at the highest dose of our SYN-010. So the folks are rolling over the SYN-010 and there is formula than half of the folks have already rolled over into the second Phase 2 study are all on the highest dose of SYN-010 and not on placebo anymore. That’s how we worked it in order to get patients complains and hopefully to keep them from self-medicating with laxatives and what not.

And then just the final part was -- is, data from these cities tour would be sufficient potentially to decide on a pivotal study for this program?

That is possible, will have to have end of Phase 2 discussion with the FDA to discuss that, again nobody has ever looked at reducing methane gas as one of the primaries and we are also obviously looking at the number bowel movements and other typical criteria, bloating and pain, so we’ll have to have that discussion with them after the study if it works as well as we hope it does. We may be able to move very rapidly into a Phase 3, we have staffed up in order to do so. If anybody read Dr. Ray Stapleton, our manufacturing guys, press release CV, I mean, he was responsible for MetaCore which is the Merck drug, which is form of lovastatin, he is very familiar with that small molecule and the scale up of that molecule and that’s what we are heading for. So we are anticipating given FDA approval, starting a Phase 3, pivotal study or two of those next year.

Okay I’ll get back in line, thank you.

Thank you and the next question comes from Katherine Xu with William Blair.

Joe on for Katherine, sort of a question regarding the Phase 2b program for SYN-004, so have any of those begun dosing patients yet and I was hoping you can give some color on how recruitment has been, and also are you still planning on doing that interim analysis in that study? And I have one more follow up question.

Okay. The answer is, we have been screening patients for the Phase 2b. We have not yet found anybody to begin dosing. We have roughly I want to say between 10 and 12 sites already up and running in the U.S. there are several more sites coming on in Canada and another dozen or so in the U.S. over the next few months. We are going to have probably over 40 sites coming online in December over in Central and Eastern Europe. The reason we are using Central and Eastern Europe is because they are dosing regimen of Zithromax [ph] for pneumonia, et cetera. is exactly the same as what we use here in U.S. So that was one of the primary criteria. Again it's a 100% dependent upon the flu season. If it's a bad season this year we could recruit very, very quickly. If it's not as bad as flu season it's going to take us a little bit longer which is why we are not giving strong guidance on when we think we are going to finish the study. The interim look is really predicated on two things. This would be an independent external group that would look at this both a clinician and a statistician. They would be looking at -- the start point would be either when there are 10 cases of confirmed C. difficile in the patient population or if we reach the half-way point which is about a 135-140 patients in this particular study. Then we will stop and we take a look at it or they would look at it, they would then provide guidance as to whether we need to keep going or to go higher if necessary depends upon what's going on. We do have permission from the FDA to expand the study up to as many as 600 patients if necessary for this particular study in order to get P value, again dependent upon the infection rates in these various hospitals, which vary broadly.

Alright guys, thanks. And then to [indiscernible] for the second portion of that study. Have any patients decided not to roll over and if so, are you replacing those patients with new patients, to get through to that 60 total and is there a threshold for breadth methane in that entry if so?

There is not a threshold, what we power this for the second Phase 2 to as between 42 and 45 patients. I can tell you that we are well over that at this point in time. So the first Phase 2 is 60 patients plus the second Phase 2, we wanted to roll over minimally 42 to 45 patients for that study and we are over that. So I think we’re good statistically, we just have to see what the efficacy patterns are like.

Thank you. And the next question comes from Keith Markey with Griffin Securities.

I had a couple of question related to [indiscernible] experiments that’s going to be performed. I was just wondering how long do you think it's going to take or do you think your antibodies were left [ph] were in an instant and can you just simply describe the experiment. In other words, how many times will you challenge the animals and at what point after administration of the antibodies?

Hi Keith. I can talk very high level to that, the protocol has not been completely put to bed yet, but I will tell you what we’re thinking. In our prior -- previous non-human primate studies which were in baby baboons, we did see peripheral access in those animals, which was part of the overall package that was presented to the Gates foundation vis-à-vis University of Texas, Austin and we got them excited and interested and this could be a very interesting novel approach. So that was the genesis of the discussions about a year ago, give or take, and then moving the project forward. So what we’re going to do is basically just replicate what we did back then one more time to make sure that it is working the way that we want it to. We are only using one antibodies, we are using the antibody that binds to 1B-7 which is one of the toxins. We do have twin antibodies that assume confirmed potentially higher efficacy effect, but we’re going to use one, because again if you think about what the Gates foundation’s mandated is, they work in a developing world, trying to cure illnesses, vaccinations those kind of things. So the idea for this antibody would be, there is a new born and in the developing country they usually don’t see the doctors very often when the mom comes in and gives birth, they’re going to get a little short of our antibody which we hope can propylam [ph] them for a significant amount of time, to where they can then get a vaccinations later, when they get older and they can take the vaccination. That's the concept. As a company we would maintain the therapeutic use for the developed world and developing world which would be more of a stock piling type of marketing commercialization strategy, but that's the general concept. So timing wise it really depends on the number of new born primates that are coming up, there is another group from the FDA doing some work that is sucking up some of that newborns, so we will be sharing the newborns as we go forward. We hope to have it done I would say sometime next year, I don’t want to give a time because we are not -- as soon as we start we’ll give more guidance on it and then right after that obviously, to get into the clinic is relatively very fast after that point in time. And if you recall we have [multiple speakers] drug status on that we’ve received last year.

Okay, great. Thanks. Very good thanks. And then I was wondering if you could give us the sense of this type of preclinical work that you and Intrexon has planned at this point, so far for the PKU therapy?

We don’t have any at the moment. We need to find the molecules that work first, we’re using the ActoGeniX plaftform over in Belgium. We’re looking at the different vectors and picking the one that is going to be what we think is the most efficacious, and then we’ll jump right in at that stage of the game, we will likely be working with academic groups and they’re specific preclinical models. To vet the program, it's a fairly well understood disease state and then we’ll move again -- will move fairly rapidly, I think at that stage of the game. We do not yet have orphan drugs status on this, we may go for that. But it may be a much broader market than what were we suspect at the moment. So we’re looking at that as we speak.

Great. Thank you.

And we have a follow up question from Adnan Butt with RBC capital.

Hey, thanks guys. So were just one on the 004, for the Phase 2b will the primary end point be CDI prevention and then in terms of the antibody associated diarrhea endpoint. Do you think that’s something the FDA has softened its stance towards, it could be used as an approvable endpoint or is it exploratory? And last but not least, either AAD or CDI prevention they’ll both be evaluated over the same time period? That’s the last question, thanks.

Thanks. You’re trying to bait me. The reality -- let’s take a step back for the listeners. In essence if you don’t have antibiotic associated diarrhea, if you don’t have diarrhea when you’re in the hospital, it’s highly unlikely that you’re going to have C. diff. It basically means that you’ve not disrupted your intestinal microbiome which means that it’s generally intact and if it’s intact you’re not going to get diarrhea, which means you’re not going to set up an environment where the C. diff bacteria which may already reside inside of you, many of us already have them -- we’ve colonized, can grow crazy and cause problems. So AAD or Antibiotic Associated Diarrhea is our secondary endpoint. I am not aware of any other companies that have ever had that, the FDA did allow us to put that in there, and that was actually a suggestion by the CDC in our case that that would be an endpoint that they would like to see. So we are evaluating that, cluster and difficile [ph] associated diarrhea receive that, is a subset of AAD. So if we knock out AAD, obviously we’re going to knock out C. deff. The bonus of that obviously is the number of patient enrollment going forward, if we are able to show very strong correlation in that and we could make that a co-primer or we could have those discussions with the FDA to potentially move that up, it would make the Phase 3 study significantly easier for us as far as numbers. Right now we’re looking at reduction in C. diff infections in that population as a primary with the secondary been Antibiotic Associated Diarrhea. We’re also looking at deep sequencing of the microbiome before and after and those kind of things to look at the protection side of the equation as well going forward. So we’re hopeful that we can show a profound impact on AAD. Historically, with a prior compound and there are compounds to-date, we have had nearly 100% efficacy in knocking out diarrhea in these patients. Again, it’s a really simplistic concept if you could protect the number of species and just the sheer numbers of the bugs living in your intestinal track, you’re going to protect the patient from getting diarrhea and if the patient doesn’t get diarrhea, especially in the hospital setting, life is much-much better not only for the nurses, but the doctors and the patients that are dealing with these nasty diseases and they can focus on the primary disease that the patient has versus secondary diseases caused by antibiotic usage. Does that answer your question Adnan?

Yes, all of them. Thank you.

Thank you. And that concludes our question-and-answer session. I would like to turn the call back over to Jeff Riley for any closing remarks.

Thanks Keith. As more evidence is discovered regarding the importance of the human microbiome, I’d like to thank our new shareholders who share this vision. But I would also like to take a moment to personally thank our long term shareholders for their continued support and our dedicated team members who are passionate about what they do. In a short span of one year, we have transformed from a preclinical stage company into a clinical company. And as we look ahead to the next year, we look forward to morphing into a later stage clinical company with our eye on commercialization in the next couple of years. Everyday Synthetic Biologics moves closer to the goal of offering novel microbiome focused products to large markets with very clear unmet medical needs. With our two lead microbiome programs in Phase 2 development we are very excited about the progress we are making going forward. We look forward to reporting on our continued progress, especially reporting top line results from our Phase 2 trials for C. diff and IBSC. We are positioned to create value for our shareholders at multiple points during the remainder of 2015. Thanks again everyone and have a wonderful rest of your evening.

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