Good afternoon and welcome to Synthetic Biologics' 2019 Year End Investor Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. At this time, I would like to turn the call over to Vincent Perrone, Director, Corporate Communications at Synthetic Biologics. Vincent?

Thank you, Carrie and good afternoon everyone. Welcome to Synthetic Biologics' 2019 year end investor conference call. Today, I am joined by our Chief Executive and Financial Officer, Steven Shallcross; Dr. Michael Kaleko, SVP of Research and Development; and Dr. Vince Wacher, Head of Product and Corporate Development. Synthetic Biologics issued a press release this afternoon, which provided operational highlights and reported our financial results for the year ending December 31, 2019. The release can be found in the Investor section of our website. During our call today, we'll provide an operational update on our GI and microbiome-focused clinical programs and will summarize our financial results. We'll take questions after prepared our remarks. In addition to the phone line, this call is being streamed live via webcast, which will be archived on our website, www.syntheticbiologics.com 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 terminologies 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 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 said, I'd like to turn the call over to Steve. Steve?

Thanks, Vincent. Good afternoon, everyone and thank you for joining our 2019 year end investor conference call. I'm happy to be with you all this evening and look forward to sharing important and exciting updates on our strategy and progress for advancing our late stage and emerging clinical programs during today's call. 2019 was a year of considerable progress for the company marked by several key advancements for our portfolio GI and microbiome focused clinical programs targeting critical unmet needs in the prevention of life threatening gut microbiome infections and GI disorders. As a matter of fact, I can't remember anytime, but I've been more excited about our company, especially when thinking about what potentially lays ahead for us in 2020. Our hard work and determination in and out of the clinic are beginning to align with the tangible results and goals we set out to achieve just over 18 months ago. Of particular note, we continue to make advancements in our ongoing Phase IIb clinical trial of SYN-010, which is being conducted as an investigator sponsored clinical trial out of Cedars-Sinai Medical Center. We announced the clinical trial agreement with Washington University and subsequently held the Type C meeting with the FDA to solidify the clinical program parameters for Phase Ib/IIa clinical trial of SYN-004 in allogeneic hematopoietic transplant patients, which is expected to begin in the second quarter. We advanced product manufacturing completed toxicology work and held successful pre-IND meeting with the FDA in December for our SYN-020 program in advance of our planned IND submission in early April. And we're also very active in securing additional protections to further bolster the intellectual property state for our lead programs, which we believe are instrumental components and our discussions with prospective partners including several important patents and claims related…

Thank you, Steve. Carrie, we'd like to open the phone line to questions. Would you please describe the procedure to ask questions for our listeners?

At this time, we will begin the question-and-answer session. [Operator Instructions] The first question will come from Jason McCarthy of Maxim Group.

Hey guys, this is Michael Okunewitch on the line for Jason.

Hey, Mike, how are you doing?

Doing good. So the Phase IIb data readout coming up SYN-010, I'd like to see if you could help us frame the possible results? Like what sort of rates would you consider to make 10 a competitive entry in the IBS space considering that from the other drugs out there, we've seen pivotal overall response rates of around 30%.

I'll let Vince Wacher take that question. And I think there's two parts. The initial answer for your question and I think there's some ideas that we may have on how we may approach our discussions with the FDA as we think about a Phase III clinical design program. Vince you want to take that?

Yeah, I think the short answer is that on average is about – as you indicated about a 30% response rate across the board in the general IBS population. We are still working on how to effectively evaluate their response rate because our data and further we go mechanistically with our program indicates that we should be considering methane positive patients as our population. So not everybody necessarily in the entire IBS or CIC landscape, but based on mechanism of action, we should be focusing on methane positive patients. We know from our Phase IIa studies that we can knock down methane. What we don't know in a large clinical trial is the overall effect of knocking methane down in a broader population of patients. And that's something we will need to look forward to as we really see the results from this study and evaluate how to move forward into Phase III. So I realize that's kind of nebulous, but I mean, as a baseline 30% is the industry standard, but we would look to be better in patients that had a methane problem that was causative of their constipation.

Thank you. Actually, I wanted to talk about the mechanism of action a little bit considering how unique SYN-010s mechanism is, and especially given the really impressive loading reduction rate. 70%. I want to see, is there an opportunity to use this as a combination therapy in those groups where they're responding on one of the particular metrics, but maybe not an overall responder?

You're quite right. I mean, we are certainly not bloody minded about – you must use our drug versus the other drug base. I think there's room for combination therapy in this space and any IBS or CIC patient gestures a lot some of their disease has used combinations of things that are over the counter. It would certainly make sense that if there's something additional or different like SYN-010, to go with something like a nucleotide or any of the other agents to draw water into the intestine, there is an opportunity potentially to use them either in sequence or in combination to optimize therapy. So yes, we do think that that's a possibility in the population.

Alright, thank you. And then I'd – the last one, I like to switch gears a bit over to graft versus host disease actually. So I'd like to see if you could give us a bit more color on the addressable market for a vaccination of GVHD? How many of these patients are actually receiving beta-lactam's, excluding carbapenems? And then how would moving into GVHD position you to expand into the broader organ transplant infection control markets?

The first answer is 80% to 90% of patients will end up developing a favor and they'll get an IV beta-lactam antibiotic at some stage. So a very large portion of the patients would end up potentially being candidates for SYN-004 and as a preventative they don't even have to have signs of developing GVHD, we want to prevent all of that. So anybody, any patient that got an IV beta-lactam antibiotic is a candidate for our drug. So it's not a fraction of 80% to 90% or 80% to 95% of those patients. It's potentially all of them. And then the mechanism of action is the same for multiple indications for preventing GVHD, preventing clostridium difficile infection preventing opportunistic infection by vancomycin-resistant Enterococci. They are all a function of protecting the microbiome from the antibiotic damage and that's something we need to emphasize. We don't have a biological target in the patient. Our target is the quote unquote, toxin, which is the antibiotic that takes greater than the intestine. So by doing that, by protecting the microbiome, the microbiome prevents the VRE, the microbiome prevents the clostridium difficile infection. And so by pursuing these endpoints in a study, around allogeneic HCT patients, we have an opportunity to see multiple potential effects in aGVHD preventing CDI and the CDI rates in that population is as high as 30% and VRE colonization and infection. Those outcomes, even if they are secondary endpoints in a clinical trial are things that could help guide the utility and expanded evaluation post market and to expand into other broader indications. Clearly that will take more clinical experience. They'll take additional clinical trials or clinical use, but that could be investigated driven, that could be done at the hospital level once the product is available through its initial approval.

Alright, thank you guys for taking the question and congratulations on the progress. Looking forward to future releases.

Thanks Mike.

Thank you. I would now like to turn the conference back over to Steve Shallcross for any closing remarks.

Thank you. Just a couple comments here, in closing. As I stated at the beginning of our call today, we really believe we're very, very close to realizing the benefits from over 18 months of some really, really hard work. More specifically, we've developed what I think is an exciting path forward for ribaxamase, that is not only realistic from a funding perspective, but clinically relevant in terms of addressing a significant unmet need in the marketplace. More importantly, our strategy is simple and that we're initially targeting a small segment of the market, namely the acute graft versus host disease and bone marrow transplant patient markets, where the incident rate of VRE colonization, bacteremia and CDI are just incredibly high. So for successful, we plan to expand that label as we just talked and today, potentially lucrative market which would include solid organ transplants, and ultimately, we believe we can end up in the broader indication for the prevention of C. difficile infection and now microbial resistance. Our key achievements for a vaccination, just in this last 12 to 18 months include our collaboration with Washington University, who by the way, is a leading bone marrow transplant centre in the world, agreement with the FDA on a path forward with a Phase Ib/IIa clinical trial design, and very shortly we'll be in a position where we initiate that trial. Second, we strengthen our partnership with Cedars-Sinai and initiated a Phase IIb investigator sponsored study that is primarily funded by the Cedars team and as its ongoing and being conducted by their highly acclaimed MAST organization. When this study is finished, we really believe we'll have identified the ideal dose to advance this program into Phase III clinical trials, ultimately with the goal of generating the efficacy and safety data…

Thank you. The conference is now concluded. Thank you all for attending today's presentation. You may now disconnect your lines. Have a great day.