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…

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…

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.