Good afternoon and welcome to the Synthetic Biologics 2018 Third Quarter Investor Conference Call. 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. At this time, I would like to turn the conference over to Vincent Perrone, Director of Corporate Communications at Synthetic Biologics. Vincent?

Thank you, Keith, and good afternoon everyone. Welcome to Synthetic Biologics 2018 third quarter investor conference call. Today, I'm joined by our Acting CEO and CFO, Steve Shallcross; Dr. Michael Kaleko, Senior Vice President, Research and Development; and Dr. Vince Wacher, Product Development and Partnering. Synthetic Biologics issued a press release this afternoon which provided operational highlights and reported our financial results for the period ending September 30, 2018. The release can be found on the Investors Relations section of our website. During our call today, we will provide an operational update on our microbiome-focused clinical programs and summarize our financial results. We'll take questions after our prepared remarks. In addition to the phone lines, this call is being streamed live via webcast which will be archived on our website synthethicbiologics.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 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 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 and thank you for joining us today. I'll be spending most of today's call providing important and exciting updates on our planned advancement of our late-stage and emerging clinical programs. But I want to begin by discussing the recent steps we have taken to further fortify our organizations financial footing and why we chose to undertake them. As you know, last month we announced the closing of our underwritten public offering of over $18 million, which will be used in part to fund the advancement of our late-stage clinical assets. Beginning in the third quarter, we were also able to utilize our at-the-market or ATM facility to raise an additional $11.8 million in net proceeds. With these proceeds, we have cash on hand of approximately $32 million which has substantially strengthened our financial position and provides us with runway to continue our operations into 2020. I have clearly heard and truly appreciate the concerns raised by some of our long-term investors about our decision to undertake this financing and the impact that has had on them. So let me assure you, it was an essential step in ensuring that we can bring the promise of these assets to reality. Quite frankly, it was also critical in ensuring the long-term sustainability and survivability of our organization. Our recent offering goes a long way and removing the significant financing overhang that has been ripping our stock. At the same time, it has enabled us to bring on board well known fundamental investors who believe in our programs and who may help to reduce volatility with experience with our stock during the last two years. Having said that, we are still very much to believe that there remain a serious disconnect between perceived value of the Company and the…

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

Yes, thank you. [Operator Instructions] And the first question comes from Katherine Xu with William Blair.

Steve, I’m just wondering with regards to the sort of new direction to take SYN-004, the allogeneic transplant markets. And can you just talk a little bit more about the size of the market? And how many patients are actually taking the IV beta-lactam antibiotics? And also from a pricing perspective, this could be a premium pricing market versus the broader indication and that could be much lower in pricing. So just curious about the thought there and also for the China partnership, can you just give some update on that?

So, you've raised a really good point on pricing power in this more narrowed indication. As a matter of fact, we think we also have the opportunity to possibly apply for orphan status. So along with that obvious would come significant pricing power. Let me let Vince Wacher talk a little bit about the market and then I could follow up with what we’re seeing in our China discussions?

Thanks Steve. The overall number of allogeneic transplants in the U.S. is significantly lower than CDI cases as you could imagine, there is about I think 10,000 per year so far. In the U.S. allogeneic HCT procedures and all prior to that Steve indicated before, there will be very few people that did not get the IV beta-lactams. It's a standard therapy to treat people for febrile neutropenia or months in the allogeneic HCT population. So 80% to 90% of those people would be eligible to receive that drug in the U.S. The numbers will be similar in Europe and somewhat lower in China. But as pointed out, the potential pricing power is significant and that’s because of the outcomes because the GVHD is so prevalent because the primary therapy for GVHD which is steroids filed more than 50% of the time. Prevention is everything in that indication. There no excuse to not trying for AGVHD. So, the smaller numbers have balanced out with higher processing power. And then moving forward into the broader indication leveraging the data from that study, we could then post-market on the HCT side have off label use Phase 2 studies by before expanded Phase 4 studies on putting the broader CDI population and look to leverage the higher price from the bone marrow transplant to get an increase in either the diagnosis-related group payments for the CDI or maybe a new technology add-on payment for the ribaxamase in the CDI populations. There are opportunities to really fix the appropriate payment for the product in the bigger indication at the higher price. But, again that’s all right now hypothetical was about to get to our clinical trials first.

So, then Katherine to answer your question about China, our discussions continue. We have a number of parties that remain engaged and interested. We continue to have various degrees of diligence, and we are having discussions with folks about how to possibly proceed into the clinic. I'll be honest though and I could tell you that, we've also experienced that since the Chinese market, particularly the biotech market there since it's taken hit in some of the value and these companies that are public have seen the value eroded that it is put some of them on their heels. We don't think overtime this is going to be an issue as we continue to try to move the ball forward, but it is an issue. And again, as I said before, I'm not going to talk any further about where we stand in terms of status and when we have something more definitive to talk about obviously we will make the disclosure at that time.

[Operator Instructions] And the next question comes from Jim Molloy with AGP.

I had a quick question on the HCT indication of the [skin end] to the wedge to sort of get some data rather have to pay for the much larger study. How much would data from that study inform any potential FDA approvals for the largest study? Should you get a partnership and get that up and running? Is that something that can be used adjunctively with the largest study to sort of order sort of show hey, we can get this to the FDA look at the small phase kind of work in and make sure to have a largest study?

Vince, why don’t you go ahead?

So, I think inform is the right word. I think it informs on a number of levels we can use safety data. We would definitely anticipate using pharmacokinetic data from that study. One of the things about the bone marrow transparent population is that they have a somewhat flammable intestine and so, if we demonstrate that our drug is not absorbed in that population and it doesn’t alter the pharmacokinetic of the intravenous antibiotics then that data will be extremely beneficial since that sort of question comes up with the FDA that can we be sure that the drug has not absorbed in a sick population. If we see an effect on the VRE, if you see an effect on the CDI in our studies, that is all submissible to the FDA as part of our overall data package to show hence of efficacy and also safety. So, I think it contributes to that, but it wouldn’t necessarily be considered the subgroup that would we could discount the largest study based on that. It may up rise our dosing, but we couldn’t say, hey, we have done 200 patients here and we have to do 200 less in the big indication.

And then, could you talk a little bit about the timing of the HCT study? I know there is a lot work that’s we've done, but second half of next year seems like, is that allowing too much time and proceed put there for a reason, but can you talk a little bit why it's going to be second half next year?

Go ahead Vince.

So, this population as you can imagine is quite sensitive. They're quite ill -- these are people that are going to be treated with chemotherapy to wipeout their immune systems before they get the bone morrow transplant and before they get the antibiotics. So, we have to move with a great degree of caution in this population and that's reflected in the different institutions. And some of our earlier conversations have highlighted that there are a number of levels of approval within any given institution as many as five and some of them. So, we have to move to some degree of caution with this. We also have to have our sourced discussions with the FDA about this indication. We have not approached the FDA and all devising a protocol organizing a pre-IND making those key near term elements that have their own timelines. As you know, the FDA has a certain set of timing to accept date meetings up, but beyond that I think really the length of time will be driven more by the institutions and then need to be sure that they are taking appropriate care with their patients.

My last question is on the 020 Dr. Pimentel study, in his lab study, that’s pretty good turnaround from starting it to getting the data by the second half next year. Obviously, Dr. Pimentel's lab done a quite a bit, if you talk little bit about the sort of excitement level on this compound and getting this trial up and running?

So, this is SYN-010, our lovastatin program. You're quite right. There is a great deal of excitement and a lot of this is to do with the fact that Cedars-Sinai has such a comprehensive GI presence but also has specializing functional gastrointestinal disorders like IBS. And so, Mark and the Cedars-Sinai team, he's the person that will actually get executing the study. Ruchi Mathur who is the Head of the MAST Program and Ali Rezaie who is also well known probably for the breath gas analysis. This is a team that sees a lot of patients. They have advised them that the patients are well educated about gas about methane, and they have been pumping the amino -- they have been saying, once we get studies, would you be available, are you interested. And so, people know that SYN-010 is in the works. And now, they have something concrete to hold on to. So they projected that they can enroll the kind of patients in the time of timeframe that we've anticipated and we look forward to saying that those results happened ideally in the timeframe that we've discussed.

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

Great, thanks, Keith. Well, before we end today’s call, I just want to make a couple of final comments here. First and foremost, thank you again for your support and believing in the assets that we currently have underdevelopment. These assets are great and more importantly as we move them back into the clinic, something that often gets left on the sideline when you think about biotechs is that we have, what I will refer to as multiple shots on goal that significantly reduce the risks as we move back to the clinic to develop these programs that we outlined for you today. The other point I hope we made clear to you is that, we're taken a very strategic and thoughtful approach toward unlocking the value of the assets that we own. And we believe that not only have we taken this approach that makes most sense for a company our size, we've taken steps to make sure we can maximize our ROI with the appropriate degree of clinical development risk that one would expect with the investment that we are trying to make. Finally, I just want to highlight once again the serious disconnect that we believe that exist between the perceived value of the Company and the potential value that we can unlock through our product portfolio. We again are trading significantly below cash and we are going to do everything we can to continue to reach out to new and existing investors so that we could fix this. We laid out a number of short-term and long-term milestones so that we can identify the key inflection and value creating point over the next 12 to 18 months that each of our investor should be able to benefit from, but more importantly, we have the cash to support these programs into 2020. And finally, you have the commitment from me and our team that we will do whatever it takes and we will remain focused on execution and ultimately delivering results. Thanks again and we look forward to keeping you updated on our progress as we move our lead programs back into the clinic and move our SYN-020 program further down the path toward an IND. Thanks again and have a great weekend.

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