Good afternoon and welcome to Synthetic Biologics' 2019 Third Quarter 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. Please go ahead, Vincent.

Thanks Amy and good afternoon everyone. Welcome to Synthetic Biologics' 2019 third quarter 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 quarter ending September 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 prepared 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 third quarter investor conference call. Today I'll be providing a brief update on our portfolio of GI and microbiome-focused clinical programs which leverage the gut microbiome to improve patient incomes, and then I'll share our financial results for the period ending September 30, 2019. During the third quarter, we continue to focus on the execution of our strategic initiatives, as we advance our portfolio of clinical programs targeting critical and unmet needs in the prevention of life threatening GI and microbiome related disorders. A particular note, first we announced a clinical trial collaboration with the Washington University School of Medicine to conduct a Phase I/II clinical trial SYN-004 or ribaxamase in up to 36 allogeneic hematopoietic cell transplant recipients. Second, the enrollment remains ongoing and our Phase IIb investigator sponsored clinical trial SYN-010 which is being conducted by the medically associated Science and Technology Program at Cedars-Sinai Medical Center, the study's sponsor. And finally, we continue our work on pre-IND enabling toxicology and manufacturing studies in order to support an IND submission during the first quarter of 2020 for our SYN-020 program. 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 end of next year, that's December 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 is our first-in-class therapeutic intervention designed to protect the gut microbiome from antibiotic-mediated dysbiosis. It is designed to be taken in conjunction with certain IV beta-lactam antibiotics, and its novel mechanism of action is designed to degrade residual antibiotic excreted into the GI…

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

Certainly. At this time, we will begin the question-and-answer session. [Operator Instructions] Our first question comes from Jim Molloy at Alliance Global Partners.

Hey guys, thanks for taking my question. I had a question on the Type C meeting with the FDA. So can you be little bit more -- or how specific can you get on what exactly you hope to get out of that meeting and just say up for going forward in the Phase Ib/IIA for?

Hey Jim, how are you doing? This is Steve. I'll start out and then if Vince Wacher has anything further to add, he could contribute as well. So the purpose of this meeting is to review the protocol that has been put together by our team at Wash U and our folks internally. It's kind of a novel approach to demonstrate that our product is in fact safe in this fragile patient population. But more importantly, I think a lot of focus and attention will be paid on the trial design and the design’s ability to demonstrate that ribaxamase is not systemically absorbed and that it does not interfere with antibiotic use in these patients. We do not believe based on previous trials that we have conducted that this is going to be an issue, but nonetheless, the patient populations are bit different. So we've designed this trial to once and for all demonstrate in fact that that ribaxamase will be safe for this group of patients. The protocol is a little unique in its design, it's going to sort of evaluate three antibiotics in three cohorts in increasing strength and after each of those cohorts, we'll have a data readout. So there'll be milestones that we will be talking to the market about as we progress further along in this trial. I don’t know Vince do you have anything further to add?

No, I think that’s covered. This is a new population for us. And we are addressing questions that the FDA has asked us before by running this trial, and we want them to agree that this is the right way to go. That this is -- that this will address their queries and that they are comfortable with the design of the trial, but also our safety oversight to make sure we protect the patients.

Excellent, thank you. And then I know last call the SYN-010, there's been there's some challenges on the screening period of the baseline measurements by the Pimentel Lab. And I know that anticipation would be that will quickly be resolved. That got resolved, and is all squared -- everything squared away on enrollment with Pimentel Lab?

Yes, I think we've made a lot of progress there. We meet frequently with their team Vince, do you want to briefly update there?

Yes, we have worked on a couple of different things to try and boost the enrollment into the study. And we’ve actually just initiated a program with a more comprehensive outreach to bolster what the activities that have been done inside the Cedars-Sinai Medical Center program, they have reached out themselves to nearly 1,000 patients. But we have initiated a program now through another vendor that could triple that outreach and expand the area of the outreach so that we can get more patients in from more distal sites and reimburse them for travel, so by doing that we have to rapidly accelerate the enrollment but also diversify the population beyond just the area around Greater Los Angeles.

All right, great. And the last question on my end, the -- you made comments on the runway going out to the Q4 and the good fiscal discipline but certainly the number of operating expense went up pretty sharply in this quarter. Is that a one-time number, should things return back to the $3 million, $4 million range because it would seem that these levels with 2018 in the back, it wouldn't seem like you could get to the fourth quarter of next year?

It will. That's a great observation. We continue to spend a lot of time on looking at areas where we can significantly reduce our burn. And a lot of our savings have resulted in reductions in G&A, we saw a bit of a bump this quarter. And that was due primarily to a lot of the costs associated with the manufacturing activities for our SYN-020 product and the ongoing toxicology studies. All those expenses were planned. They're coming in, and they're pretty much in line with where we expected them to be. But your observation is correct. We'll start to see the larger sort of non-fixed expenses diminish and you'll see more of a steady burn. I'll point out that, Jesus, well over sort of a year and a half ago, our monthly fixed burn was somewhere in the neighborhood of $1 million to a month. We have brought that down to under $400,000 a month right now. So we've done a great job internally with our team to really get our arms around our costs.

Excellent. Thank you for taking the questions.

This concludes our question-and-answer session. I would like to turn the conference back over to Steve Shallcross for closing remarks.

Thanks, thanks, Amy. I'd like to close on a comment that I made a few minutes ago before the Q&A. And that is that I really believe the capital markets are totally ignoring the underlying value of our asset. So, what are we doing about that? And I guess the best way to frame this is to look at the facts. First of all, during the last several years, we've completed multiple Phase II clinical studies which has demonstrated proof-of-concept for our two lead programs that we spent so much time talking about and not only that, they've also garnered the necessary KOL support that we think is incredibly important and needed to further advance these programs. Perhaps the previous clinical strategies were a bit shortsighted but ultimately the bottom line is that we've been successful with generating compelling clinical data to further support the advancements of these really exciting and potentially viable products for markets, which still to be quite frank have significant unmet needs. So the bottom line is we've learned from the past, and we use that knowledge and experience to pivot towards a solid, clinical path that we believe will ultimately unlock that value. So let me reiterate, it really makes no sense that we are currently trading at a market cap that is a fraction of our historical path, while during that same time frame, the clinical development risk of all of our programs has been further reduced. Second, we're working with some of the best and globally recognized experts and institutions in the world namely, leading experts from Cedars-Sinai Medical Center on our SYN-010 program, the Washington University School of Medicine in St. Louis on our SYN-004 program, in Massachusetts General Hospital on our SYN-020 program. Clearly, our portfolio products harness the interest and support of these world renowned clinicians who've been instrumental in working with us as we plan for the advancement of these very important compounds. Finally, we thoroughly understand that data and deals matter. During the past 12 months, we've been working feverishly to develop an Institute high quality and cost-effective clinical programs that are well designed, focus on the optimal clinical indications and offer the greatest opportunity for success. When the data is ultimately reported from our current clinical activities, I'm confident that I and we will spark the necessary interest from potential partners around the world. I can assure you that we continue to remain engaged with multiple interested parties for all of our programs in order to ensure that once the data is in hand, we can act quickly. Thank you again for your support and we look forward to keeping you informed on our progress. Have a good evening.

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