Vincent Perrone - Manager of Corporate Communications Jeffery Riley - CEO and President Steven Shallcross - CFO, Treasurer and Secretary.

Tim Chiang - BTIG Patrick Lin - Primarius Capital.

Good evening and welcome to Synthetic Biologics First Quarter 2016 Operational Highlights and Financial Results Investor Conference Call. During the presentation 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. As this, I would now like to turn the call over to Vincent Perrone, Manager of Corporate Communications at Synthetic Biologics. Vincent, please go ahead..

Thank you, Denise and good evening, everyone. Welcome to Synthetic Biologics first quarter 2016 operational highlights and financial results 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 financial results for the quarter ending March 31, 2016. The release can be found in the Investors section of our website.

During our call today, Jeff, will provide an update on our 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 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. 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 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..

Thanks, Vincent, and thank you all for joining today. We are on a good course for this year as we continue to pivot from an early stage development company to a late stage clinical development company, focused on bringing our two lead GI microbiome-focused candidates closer to the market.

We are proud of the progress we've made and are excited for the milestone that lie ahead of us in 2016. Before we dive-in I'd like to provide a brief recap of the operational and clinical achievements Synthertic Biologics has made since the beginning of this year.

First of all, I'd like to recap our SYN-010 irritable bowel syndrome constipation programs. If you recall, it has a very unique mechanism of action of methane gas reduction which improves GI mortality, which is the underlying cause in some irritable bowel syndrome patients.

In addition, we have a very solid safety profile, observe the clinical studies versus other existing drugs on the market or currently in development. We also have positive top line data that was presented earlier this year from both of our two Phase 2 studies. We remained well positioned to initiate Phase 3 clinical trials for SYN-010.

During the second half of 2016 after the following steps. One, we have a DDW poster digestive disease. We post the presentation by Dr. Mark Pimentel on both phase 2 studies on May 22. SYN intends to have a a public Webex on Monday May 23 at 8:30 am East Coast time, where in Dr. Pimentel will present the detailed data from the two phase 2.

So we are going to go to a little bit more detail during that 90 minute Webex call. In addition, SYN will hold an ad board during the DDW conference to discuss SYN-010 Phase 3 design et cetera with the industry leaders. Then we intend to request an end of Phase 2 discussion with the FDA later this summer.

And then the Phase 3 of course we hope to commence later this year. Also we continue to hold partnering discussions with both the U.S. and non-U.S. Companies, keeping in mind that we have two unencumbered Phase 2 novel assets each with the $1 billion plus potential. Now I'd like to switch to our SYN-004 program for the prevention of C.

difficile infection, antibiotic-associated diarrhea and the emergence of antibiotic-resistant organisms. In the ongoing Phase 2b study as well as in the prior successful European Phase 2 study conducted by Ipsat which was a company that was spin out of the University of Helsinki. An exploratory endpoint is dysbiosis.

We believe SYN-004 has the ability to prevent the spread and occurrence of antibiotic resistance in the microorganisms present in the gut. Continued exposure, overuse and misuse of antibiotics cause microorganism to develop resistance to antimicrobial agents.

Research shows that resistance strength of microorganisms maybe capable of transferring resistant genes with other species contributing to the spread of antibiotic resistance. A very simplistic way of looking at this is that, the strong survive and the weak die when you put an antibiotic in somebody's GI track.

Our Phase 2b double blinded, proof-of-concept trail is ongoing. To date we have enrolled approximately 185 patients in the study. We anticipate completing this efficacy study later this year.

Also we completed enrollment for the second of two Phase 2a studies designed to evaluate the IV antibiotic-degrading effects and safety of SYN-004 in the presence of a proton pump inhibitor. In participants with the functioning ileostomies and anticipate reporting top line results in the next two weeks.

Given the study is open labeled we anticipate results from the second Phase 2a study to be consistent with our findings from our first Phase 2a study. Also more complete data set will be presented in the mid-June timeframe at the ASM Microbe Conference. As a result of our clinical progress in our SYN-004 program.

We've remained positioned to initiate a Phase 3 trial or trails during the first half of next year which will be proceeded by and the phase 2 discussion with the FDA. We intend to CDC and got our input from them on SYN-004 Phase 2b results as well as on Phase 3 trial design followed by an ad board comprised of industry experts later this year.

Our balance sheet remains well capitalized and we continue to operate in an efficient manner in the first quarter. As of March 31, we reported $15.1 million in cash and cash equivalents which provides us with the necessary resources to continue to move both our lead microbiome-focused drug candidates through Phase 2 clinical trials.

We have approximately 29 FTEs in total those are full time equivalent employees and roughly 80% of our burn rate on a monthly basis goes to research and development since we starting the clinical development process.

With the expected initiation of the Phase 3 trial for SYN-010 later this year and SYN-004 in the first half of next year, we will need to further strengthen our balance sheet and continue to evaluate capital raising strategies which will allow us to benefit from the clinical momentum we experienced in the first quarter of 2016.

Partnering discussions are ongoing for both GI microbiome-focused programs with the aim of potentially raising non-delivered capital for one or both programs.

Now, I'd like to turn the call to over to our CFO, Steve Shallcross, Steve?.

Thanks Jeff. And thank you all for joining us this evening. Before I discuss our financial results, I want to take a moment to reflect my time to Synthetic Biologics. I joined the company nearly one year ago and I continue to feel the same excitement today that I had when I started on day one.

My enthusiasm for our 2GI microbiome-focused programs is further encouraged by a sense of pride and motivation that I see in my colleagues each and every day. As a team we're more motivated than ever to continue to develop SYN-004 and SYN-010 with the aiming providing solutions that largely unmet and challenging medical needs.

I can assure that our team comes to work every day with the great sense of pride and purpose which strengthens our results as we continue to make progress in the clinic. I'll now take you through our financial results for the quarter ended March 31, 2016.

During the first quarter 2016, 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 GI microbiome-focused candidates as well as preparing to initiate our Phase 3 clinical trial for our IBS-C program before the end of this year.

Synthetic Biologics first quarter 2016 financials were included in the press release which was distributed over the Newswire earlier this afternoon. The company's 10-Q the quarter ended March 31, 2016 will be filed with the SEC later this evening.

For the quarter ended March 31, 2016 our general and administrative expenses were $2.4 million compared to $1.7 million in the same period last year.

This increase was primarily the result of increased employee cost associated with the transition of the administrative and financial office to our Maryland headquarters and increased legal fees and stock-based compensation expense.

Non-cash charges related stock-based compensation to $643,000 for the quarter ended March 31, 2016 compared to $582,000 for the same period last year. Research and development expenses increased to $8.2 million for the quarter ended March 31, 2016 compared to $6.5 million for the same period last year.

The increase is primarily the result of Phase 2 program cost associated with expanded clinical development, manufacturing and research and development activities with a microbiome-focused pipeline. Non-cash charges related stock-based compensation were $409,000 for the quarter ended March 31, 2016 compared to $246,000 for the same period last year.

Cash and cash equivalents as of March 31, 2016 were $15.1 million compared to $20.1 million at December 31, 2015. Our positive cash position reflects the partial utilization of our prepaid expense balance for our ongoing Phase 2 clinical programs and our ability to manage our overhead expenses as we continue to grow.

We anticipate cash utilization to remain steady in the second quarter of 2016 as cash prepayments made during 2015 will continue to be used to offset a portion of the cost associated with the ongoing Phase 2b clinical trial for SYN-004 and the completion of our Phase 2 trials for SYN-010. Now I’ll turn the call back over to Jeff..

Thanks, Steve. We’re going to keep the call pretty short and sweet today. And I look forward to our next earnings call in August. Vincent will outline the Q&A procedure.

Vincent?.

Thank you, Jeff. Denise, we would like to open the phone line to questions.

Would you please describe the procedure to ask questions for our listeners?.

[Operator Instructions] Your first question will come from Katherine Xu of William Blair. Please go ahead..

Yeah. Hi, guys. This is Joe on for Katherine. So for the Phase 2b of SYN-004 that in some announcements triggered with a 120 patients enrolled in 10 cases CDI.

But now it’s 185 patients enrolled and the interim now expect until summer, should we read into that - there have been fewer cases of CDI than had been expected and are you still projecting general total of 370 patient from the trial?.

Well, I got to be more precise with bad definitions. The 120 patients and 10 cases of C. difficile end in there. The other thing is there is a six week evaluation period after these patients are treated.

So we’ve treated - it rolled a 180 plus patients give or take, but what we've only seen is roughly 50 to 60 patients when we've had the full six week complete analysis of these patients. So we haven’t guide up to those numbers quite yet. But we anticipate be in there in the not too distant future..

Okay, great. Thanks.

And then quickly for the second Phase 2a of SYN-004 that's completed enrollment, how many patients were enrolled in total?.

20..

20..

Okay great thanks guys..

You bet. Thanks, Joe..

The next question will come from Adnan Butt of RBC Capital Markets. Please go ahead..

Hi guys, good afternoon. This is Arshad around for Adnan. Thank you for the question. I think you touched upon it briefly. But can you please just describe again what the DDW presentation will focus on? Just to start..

You bet, there is actually two posters. One is Dr. Mark Pimentel poster, where he will be basically doing a deeper dive under the two Phase 2 studies that we did. We did top line data earlier this year back in January, but he's going to go into the details. So that's what the poster is about.

And then second poster is on the second day, I believe it's Monday. And that is from Dr. Scott Lee [ph] who's one of our clinicians here inhouse. And he'll be talking about the specific mechanism of action and basically how we came to what that is with respect to the methane production [ph] itself.

The WebEx that we're having it on Monday is basically a recap of what Dr. Pimentel presents in his poster at DDW. Obviously DDW is a fairly focused audience. And we just wanted to make sure that analysts, investors and potential partners were able to look at all the data sort of at the same time on Monday..

Sure. Great, thank you.

And then can you - I guess characterize for us again the differentiation - the differentiating characteristics between SYN-010 and versus other IBS-C drugs out there?.

I think the primary differentiators including the underlying cause in this particular set of patients, which is methane production. And our drug is very, very safe, we didn't see anything any serious adverse events. It does not cause diarrhea like the other drugs that are either in development or in the market at this time.

Those are the two primary differentiators I think for this particular compound..

Okay fantastic thank you.

And then finally for, can you give us some idea of how much you estimate a Phase 3 program for SYN-010 will run?.

At the moment our best estimate is around $50 million give or take..

Okay..

And it will be depend heavily on the powering of that particular study. The ad board that we are having is designed to talk through a lot of those questions, also coming up in a couple of weeks. And then obviously we have to present this to the FDA at the end of Phase 2 discussion and get their input.

Obviously they really look and see what we need to do. The regulatory guidelines are very, very clear. [indiscernible] has already gone through the process as has [indiscernible] which is the synergy drug. So there is a well-trodden pathway that we probably need to go down and be very specific with.

Our drug is also a 505(b)(2) probably which is a little bit of a different pathway. We have a very good safety record with respect to lovastatin lactone. And so we're hopeful been that we can go up and potentially not have to dose as many patients as the prior studies and we can move on forward from there..

Great thank you so much..

You bet thank you..

The next question will come from Tim Chiang of BTIG. Please go ahead..

Hi, Jeff. I assume I believe in anything that changed since the beginning of the year in terms how you guys think about the Phase 3 plan for SYN-010. And how you're going to approach the FDA in setting up the trial design. I mean is it basically one study that you want to run.

And I think the last time you guys discussed the trial, you really wanted to be an all comers trial.

Is that still the case heading to this FDA meeting later this summer?.

In a nutshell, yes. Absolutely nothing is changed. I mean once we got the datasets earlier this year. That's we're still on that same course. Again there is a very well trodden path to getting an NDA for this particular this indication. It's highly highly likely that we will go after all comers in this particular study.

Again just to recap on the methane gas, the way that our study was powered right as we looked at all patients that has IBS-C that we have the clear diagnosis plus they had-to-have methane gas, 10 parts per million or higher diagnostically to get into the study. That was the baseline.

The existing diagnostic test are only accurate down the 3 parts per million. But we try to have to window of opportunity - a larger window there to make absolutely sure that we were testing the hypothesis which was if you reduce methane gas you've increase GI motility. That was the question, that was that we asked.

And the answer we got was absolutely and it does appear that way. what we don't know is what patients are below that three parts per million down zero. So there if here from Dr. Mark Pimentel obviously. He has his own opinions on that he' talk about that there in the WebEx coming up on 23.

Our opinion is it's probably a much broader chunk of that population and what we know of at this point in time..

And maybe just one follow up, Jeff, I mean when you got to the FDA are you pretty comfortable that the FDA will allow you to utilize all the safety data that’s available for lowest patent. I mean it’s certainly been a very well prescribed product for collect lipid lowering.

I'm just wondering if they would still require you to run additional sizable safety trials..

Tim you never know what the FDA is going to say I mean they will give us their feedback, but again at the end of the day Dr. Pimentel and I’ve been showing a variety of dog slides up until this point K-9 related PKPD slides which shows that very little of this, of our formulation gets absorbed systemically and what Dr.

Pimentel will show in several weeks is the exact numbers PKPD why that’s actually been absorbed and I don’t want to steal his thunder. But we feel pretty confident given what we have today that we’ll be able to present a convincing picture to the FDA as to what the safety profile of our drug is..

Okay, good. I’ll see you at DDW..

Alright. Thanks, Tim..

Our next question will be from Patrick Lin of Primarius Capital. Please go ahead..

Hi guys, thanks for taking my call. Just a couple of quick questions. Jeff, we’re looking at a market cap for SYN right now about $200 million in for generalist out there, perhaps you can give a little background on what you see as the addressable market size for the SYN-010 and SYN-004 please..

Yeah. Our market cap hasn't done so well as of today. The markets are not happy to us or anybody else it appears. SYN-010 by itself is probably a $1 dollar plus market. Keep in mind that the IBS-C market in general is smaller than at this point in time.

But there is a variety of problems with the way that we address the market today and again Mark Pimentel will address what he thinks we're going to have there’s a specific section where he’s going to present our data versus [indiscernible] type versus [indiscernible] type and how we would use these drugs potentially together and individually.

They are not necessarily mutually exclusive from a GI doctor perspective. That’s number one, number two, also keep in mind that historically what Dr. Pimentel land his own study to see SYN. There was significant impact on circulating glucose levels in these patients and there was impact on their BMI their body how much they weight.

So there is a variety of morbidly obese patients in a lot of studies he did and they had significant reduction in BMI plus the circulating glucose levels and those papers that you can get out there and Google out and find the papers and studies associated with those.

We feel again that our drug where the initial regulatory pathway is the cleanest and that’s irritable bowel syndrome with constipation again that’s a well-defined pathway forward.

But eventually whoever partners the drug going forward I think there are product extension opportunities in these other potential disease states that are far too large for us to do as a small company.

But somebody else I think will definitely engage in looking at whether or those metabolic diseases or something that would be where they could extend this drug into those particular spaces. That’s SYN-010, SYN-004 is a gigantic market. Essentially the slides that I tend to show and you can look at those in prior 8-Ks.

If you look at the number of doses of just beta-lactam antibiotics in the United States couple of years ago and you price our drug at a very reasonable $100 a day. You're still you're looking at a $12 billion plus market. It’s a gigantic market, even if you access 10% of that market it's still $1.2 billion it's a gigantic market.

Again what are doing with that drug. One would knocking down C. diff, it’s a preventive to keep C. diff infection from happening.

It eliminates antibody associated diarrhea, doesn't sound really sexy, but you know what it is a mass of problem in a variety of hospitals from just LPNR end perspective and third probably most important from a public health perspective is the antibody resistance.

So if our drug can protect the gut from setting up the directed evolutionary system or ecosystem or the strong survive and the weak die and they are swapping DNA. We can knock out our severely limit antibody resistance forming in these individuals; and as we know it all the latest papers from the microbiome reports.

Is there are a platter of diseases that are associated their genesis is in the destruction of the diversity of that microbiome when they're young and they take antibiotics. And a lot of that diversity of those weaker species never ever come back. There is a variety of papers looking at that as well.

So we feel pretty strongly that SYN-004 if properly the right trials are done and we're doing a Phase 2b is designed as a pivotal study. We power this very high to make that we can look at all the data appropriately. We feel pretty confident that it will become a main stay for hospital use.

Hopefully on their formularies where if you go into the hospital you gain IV beta-lactam antibiotic you're going to get our drug concurrent with that. So, two very large markets. Again Patrick, these are unencumbered assets. I can't stress that enough as an X business development guy from the former world variety of biotechs.

I can't tell you the number of biotechs after that haven't unencumbered $1 billion plus potential drug that's been through Phase 2 successfully. We have two of those in house. And so again from a partnering perspective, we're going to be looking monetizing one of those assets.

Probably not both and moving that forward on somebody else's dollar and with somebody else expertise while we move the other drug forward on our own. Sorry for the lengthy answer, sorry about that..

And I wasn't trying to highlight the market cap as negative as much as I've never seen a company with the multiple Phase 2 completed with multi-billion market opportunities distributing at such a low market cap. So that's the reason why I was kind of puzzle. On a separate note, maybe again for Jeff Riley here, can you give a little background Dr.

Pimentel in terms of his experience and maybe if the drugs and the revenues that he's dealt with and why you're excited that he's involved with the Synthetic here, because again the many of the generalist may or may not be aware of his background..

Yeah, you bet. I think you need to understand the background the irritable bowel syndrome as well. I just spent a couple of weeks in China as an example.

And over in China, they don't even recognize irritable bowel syndrome at disease state because they've not have the time to really understand the mechanism and understand what was happening with that particular patient population. Here in the United States and in Europe, it is well recognized as a disease.

It used to be thought it was a neurological disorder. And Dr. Pimentel has spent 25 years at Cedar Sinai and other institutions. Really basically busting them with open and saying it is not a neurological problem it is a microbiome oriented problem.

So his research basically ended up focusing on gas creation within the gut, both upper GI and lower GI track. And his first drug or his first idea was to use [0:27:36.8] which is an antibiotic that is delivered to the lower intestinal track to knock out a set of bacteria and basically make hydrogen gas.

And if you knock those out they noticed that irritable bowel syndrome diarrhea was a result fairly efficiently. That drug was Salex [ph] which was a multi-billion dollar drug company. They were about our size when they were in phase 2 and then they rocked it towards where they were thereafter.

They were about our size when they were in Phase 2 and then rocked toward thereafter. They were acquired by Valeant, couple of years ago for several billion dollars. And then after that of course Valeant has had their set of issues.

But their revenue has been very, very good coming out of that well over $500 million and projected to be well over $1 billion eventually. Dr. Pimentel, the other side of his research look at irritable bowel syndrome constipation which is the other side of the coin the same coin.

But the other side of the coin is there is organisms making methane gas and it was able to measure the methane gas and figure out that if you're knocked out the methane gas mechanism. These patients have irritable bowel syndrome constipation also resolve their issues.

The question is what drug or what chemical what compound do you use to do that safe and efficacious and does the job. And what he came up with was the [indiscernible] in Lactones specifically. And what we are able to do as a company as we were able to help him do that from the formulation perspective and just from a clinical development perspective.

But through that process we also discovered that these organisms live in the small intestinal track in very specific places that up until fairly recently most folks think that the small intestine is sterile environment, it is not. These bugs reside in these areas.

And so we were able to come up with a formulation and knock some out and as release the entire length of the digestive track to knock out that methane gas. So Mark been just a fabulous KOL or fabulous key opinion leader that we've been working with. We were very fortunate I think to be get him to do a deal with us.

I know Salex at the time was negotiating hard for the rights to this drug. Fortunately, they were in the middle of M&A discussion as well so we are able to get it.

They were distracted, but at the end of the day he's been fantastic and again I think if people listen into the WebEx Monday 23, they're going to hear the full story, not the company story entirely. It's going to be the Mark Story.

And exactly what he saw in these clinical studies as well as prior studies and where he thinks the drug need to go in the future..

Got it. Thank you. That was very helpful..

And ladies and gentlemen at this time, we will conclude the question-and-answer session. I would like to turn the conference back over to Jeff Riley for his closing remarks..

Thanks Dennis. With more and more intention focused on the microbiome research continues to shed light on its importance to overall human health. And our goal at Synthetic Biologics is simple, we want to build a strong portfolio of GI microbiome-focused products to meet the large and growing unmet medical need, while creating shareholder value.

As Patrick pointed out our market cap is relatively low and it's in incredibly deal at the stage of the game for investors. We feel a great sense of purpose and pride in continuing to develop our two lead multi-billion dollars programs that are designed to prevent a variety of problems.

We will continue to march toward Phase 3 clinical trials and we hope that in the future our shareholder value will continue to increase. I'm proud of our progress in the first quarter of 2016 and are enthusiastic for what lies ahead for during the remainder of the year.

There are variety of milestones that we've outlined prior and we look forward to hitting those milestones. Thanks again everyone for joining our call and have a happy [indiscernible]..

Ladies and gentlemen the conference has concluded. Thank you for attending today's presentation you may now disconnect your lines..