Afternoon and welcome to Synthetic Biologics' 2019 Second Quarter Investor Conference Call. All participants will be in a 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, Denise and good afternoon everyone. Welcome to Synthetic Biologics' 2019 second quarter investor conference call. Today, I am joined by our Chief Executive and Financial Officer, Steven Shallcross; Dr. Michael Kaleko, Senior Vice President 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 quarter ending June 30th, 2019. The release can be found on the Investor Relations section of our website. During our call today, we'll provide an operational update on our GI and microbiome-focused clinical programs and summarize our financial results. We'll take questions after our prepared remarks. In addition to the phone line, this call is being streamed live via webcast, which will be archived on our website, 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, and 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 Steve. Steve?

Thanks, Vincent. Good afternoon, everyone, and thank you for joining our 2019 second quarter investor conference call. The last several months have been a period of careful planning and execution for Synthetic Biologics as we continue to strategically position and advance our portfolio of clinical programs targeting critical and unmet needs in the prevention of life-threatening GI and microbiome related disorders. Of particular note, this afternoon, we're delighted to announce a clinical trial collaboration with the Washington University School of Medicine to conduct the Phase 1b/2a clinical trial of SYN-004 or ribaxamase in up to 36 adults Allogeneic Hematopoietic Cell Transplant Recipients. Enrollment remains ongoing in our Phase 2b investigator-sponsored clinical trial, SYN-010 which is being conducted by Cedars-Sinai Medical Center, the study's sponsor. And we completed a very productive pre-IND meeting with the FDA for SYB-020 where we clarified the parameters for an IND-enabled toxicology studies and manufacturing requirement. Importantly, these initiatives and other activities were conducted under our continued sharp focus on prudent cash management and financial stewardship, which has enabled us to further extend our cash runway through at least the third quarter of 2020. With that backdrop, I'd like to share more detailed updates on our product portfolio starting with our SYN-004 or ribaxamase program. SYN-004 our first class therapeutic intervention designed to protect the gut microbiome from antibiotic mediated dysbiosis. Ribaxamase is designed to be taken in conjunction with certain IV beta-lactam antibiotics. It's novel mechanism of action involves degrading residual antibiotic excreted into the GI tract before it can disrupt the natural balance of the gut microbiome. It has been well established that the prolonged use of antibiotics significantly increases the risk of developing gastrointestinal infections like CDI as well as the emergence and spread of antimicrobial-resistant genes. We previously outlined potential approaches for…

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

We will now begin the question-and-answer session. [Operator Instructions] We have a question from Jim Molloy from Alliance Global Partners. Please go ahead sir.

Hi, guys. Thanks for taking my question. I had a question on the SYN-004 for the Washington University starting in first quarter 2020. And I apologize if I missed this on the call. I got a couple of calls I'm bouncing back and forth between. When does this be getting top line data from that trial?

So I'll start out here and then maybe Vince Wacher can give you a little bit more color. The only thing that we currently announced as we planned to start this, we haven't given any guidance yet on how long this trial is going to take. This is a very specialized patient population and we're going to have to see how the first cohort enrolls and the amount of time that takes. And then, obviously, that's going to depend on the subsequent cohorts and ultimately the timing of the complete trial. So I think as we get started with the first cohort and we start to get some idea of the timing around how long it's going to take to enroll, we'll be able to give clear guidance. I don't know, Vince, do you want to give any other color on that.

No. I think that that's a good description. The study, we reiterate, we need to go back and have another discussion with the FDA to ensure that they're comfortable with that it's pending on out there approval. So we can't be too clinical about the overall details. But as Steve indicated, there's three cohorts there. There is an opportunity of a data readouts between each of those, based around safety and pharmacokinetics. And we look forward to initiating that in the first part of next year.

All right. Great. Thank you for the color. And then on the 010 for IBS-C. Obviously, I guess, I just point out that there was an issue with the recruitment. Have they cleared it up and gotten squared away on the recruitment? And when do you -- just, how -- did they just pushed us back, data on this. I guess, you're saying, into the first quarter 2020, do you think there's room for that to move in the mid 2020? Or do you think they've sort of got the issue well in hand at this point?

You want to take that Vince again?

Yeah. So, I think, the recruitment challenge that's been predominantly around the screen-fail and it is a challenging IBS-C study because you need to run people in for two weeks to make sure that you get the appropriate baseline symptoms. The population is very well-diagnosed. IBS-C population with a long history of the disease, which means they have a long history of managing their disease. So I think the challenge is being to encourage people to change some of these long-term behaviors as they enter the study. I think the issue is being well-recognized now by the [indiscernible]. They are doing a lot of education and a lot of interacting with the patients to make sure that they can get pass this. And I think moving forward the screen-fail rate will go down significantly. But we don’t have a handle on that yet because this is a comparatively recent development as far as understanding what's being going on with the enrollment

Understood. Yes, the Cedars-Sinai are certainly top in the field sure get under control. All right. I appreciate you guys taking the questions.

Thanks, Jim.

And at this time, I would like to turn the conference call back over to Steven Shallcross for any closing remarks.

Thank you. I'd just like to make a few final comments before we conclude the call. I guess first and foremost, we really have a great company here with three outstanding assets that that really address three distinct therapeutic areas; GI and -- with that area, obviously, SYN-10 where we have an opportunity to make a huge difference in IBS-C and CIC. Second cancer treatment complications as we categorize it with SYN-004 we have the opportunity to address acute graft-versus-host disease and VRE. And with SYN-020, a product that could really I think provide a decent solution for cancer patients that are being treated with radiation. And then finally, infectious disease, where again we have the ability to move SYN-004 forward in the prevention of C. difficile infection and antimicrobial-resistant. Each of our assets have the potential to really, really help large numbers of patients and achieve sizable market share. And because we have multiple products in development, we have many opportunities to succeed sort of the multiple shots on goal opportunities that I've talked about in the past. Second, we're really a new company with a new focus. Following our restructuring last year, we really been able to sit down and come up with what I think is a very clear clinical and regulatory strategy. And with the strategy, we've really developed a real keen understanding of the market potential for all of our product. And once we've really had that understanding under our belt, we've put together a clinical strategy that I think finally and maybe for the first time, we're really targeting the right indications for each of these product. You coupled that with the fact that we've got a great manufacturing team. So we've been able to leverage that expertise and we've been able to produce…

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.