Good afternoon and welcome to the Synthetic Biologics' 2020 First Quarter Investor Conference Call. At this time, I would like to turn the call over to Vincent Perrone, Director, Corporate Communication at Synthetic Biologics. Please go ahead, Vincent.

Thank you, Taylor and good afternoon everyone. Welcome to Synthetic Biologics 2020 first quarter investor conference call. Today, I'm joined remotely 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 March 31, 2020. 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, 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 terminology such as may, should, expects, anticipates, intends, plans, believes and 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, everyone, and thank you for joining our 2020 first quarter investor conference call. On behalf of the team here at Synthetic Biologics, we hope you're safe and in good health. I'm glad to be with you all this afternoon and I look forward to sharing important updates on our strategy for advancing our portfolio of GI and microbiome-focused clinical programs during today's call. Today, I'll review our 2020 first quarter operational highlights and financial results and go over our updated clinical development strategy, which reflects the rise and impact of COVID-19 as well as the regional and national response to it. Our focus now and in the past is the safety and wellbeing of patients we aim to serve, our clinical and research and development partners and of course the dedicated team here at Synthetic Biologics. For the better part of the first quarter of 2020, we remain in line to deliver on the timelines and milestones we set out for our SYN-010 and SYN-004 clinical programs at the beginning of last year. As we disclosed in a press release earlier today, recommendations by local governments, hospitals and healthcare organizations to reallocate their resources towards battling COVID-19 pandemic are having a widespread material impact on ongoing and planned clinical trials. This includes our ongoing Phase 2b investigator-sponsored clinical trial of SYN-010, which is intended to treat irritable bowel syndrome with constipation and is being conducted out of Cedars-Sinai Medical Center in California. And our planned Phase 1b/2a clinical trial of SYN-004 in allogeneic hematopoietic cell transplant recipients, which will be conducted by the Washington University School of Medicine in St. Louis. We support governments and hospital policies and efforts to battle the spread of the novel coronavirus and recognize these policies will vary greatly by region…

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

Thank you. [Operator Instructions] Your first question comes from James Molloy from Alliance Global Partners. Please go ahead.

Hey guys, thanks for taking my question and certainly some unprecedented times and some real challenges for you guys going forward. I know that you've given sort of the best guidance and the hospitals giving you the best guidance that they can at this time. Given sort of how things have progressed and the way things are looking at least in the areas of the hospitals are and how realistic you think those guidelines are potential restarting knowing this virus seems to be impacting different parts of the country in different ways?

So, thanks for asking the question. Jim. I'll do the best to give you my opinion and maybe Vince has an opinion as well. So, you know, we have regular discussions with the team at Cedars and the team at WashU. And interestingly, although they're both in different locations there are also, sort of in large population centers. So you know as we watch this all unfold, every night on the various news networks, I think we're getting the best information that we can at this time on what's going on, sort of at a macro level. And then, the hospitals individually, they've taken their internal resources and they're focused on dealing with this matter at the micro level. So, unless we see some dramatic changes, my expectation is that, we won't see significant movement from the guidance that we've given. But if – on the other head of the coin, things change you know in a more positive light perhaps the guidance can be changed and we'll get back on track sooner than later.

I think maybe on the SYN-010, the interim look in the third quarter for the futility analysis third quarter 2020. How much should you – should turn out that you need to keep enrolling? What's the expectation for final data? Should that be the case?

Let me, I'll hand that off to Vince and let him take that one on.

So the short answer is that depends on the results of the analysis. So I think there's a case where we can say that we guarantee that the results would come out in this timeframe, that the interim analysis will do two things, whereas it'll tell us if the study looks like it's worth continuing. And then we have a discussion to be had with the study side and the sponsor Cedars-Sinai about the ability to go forward and the length of time that investigators feel comfortable advancing the study. We still don't know yet where Cedars-Sinai, the institution is in terms of their COVID-19 actions and recovery from the – having to deal with the kind of 2019 measures, sorry, I was actually on a web call this morning and one of the Directors from Cedars-Sinai, one of the operational Directors from Cedars-Sinai and I was asked a question about when they would get back to normal and they are working through all of the things I need to do and that's quite a list and so wasn't able to give any specific guidance on that. And so we don't know either when the study might kick off, if we decide to start it again.

Understood. Unprecedented times to be sure. Just a quick clarification, I think on the call you said you've cashed first quarter 20, I believe you didn’t say first quarter 2021, maybe misheard.

Right. To get us at least through the first quarter of 2021.

Perfect. Then have you guys applied for or received any, you have the small business loans or cash that the payroll protection things that have been enacted.

So we've taken a position in our company that since we're a public entity that these funds are better suited for folks that really need them. We haven't laid off any of our staff, we don't intend to. And there's a lot of other folks that I think need those types of funds more than we do.

Awesome. Thank you for taking the questions.

Thank you. Your next question comes from Jason McCarthy from Maxim Group. Please go ahead.

Hey guys, this is Michael Okunewitch on the line for Jason. Thank you for taking the question.

Hey, Mike.

The first one is a bit more high level, but with the ongoing pandemic, the anti-infective space overall seems like it might be getting more attention that we haven't seen in past years especially, you know, these patients are being heavily treated with antibiotics to rent secondary bacterial pneumonia, which is one of the major causes of death. So looking at that antimicrobial resistance could also be brought in to get greater focus. So my question is, as more patients receive antibiotics and AMR comes into greater focus, is there a possibility that right back to mace attracts a partner or get some – or development gets accelerated towards those larger indications?

I'll take a first stab at that and then maybe Vince can relay some of our discussion that we had with Dr. Dubberke. I think you're right, but it still doesn't change, the matter of having to conduct a pretty large clinical trial to get a program like this over the line and that would require us, ultimately recruiting dozens and dozens of sites around the world in order to accomplish that. That I think you're thinking about this is right on. And we'll see what happens. I know, Vince, you want to talk about some of the comments Erik had about the specific transplantations.

Yes, I think the opportunity to – the ribaxamase to be used in populations where antibiotic users going up is very encouraging, we like to see that. We don't – we can't make a prediction about partnering of course, because that whole area is still vague as far as people's interesting treatments versus preventatives versus focus on COVID-19. And I'm sure that your question is very astute, who else is thinking about other things and other than COVID-19. So I think there's an education curve around potential partnering that's required. But if you look at things like the GI symptoms that are associated with things like COVID and they're aggravated by antibiotics, that's the ribaxamase sweet spot is preventing that GI damage caused by antibiotics. So in hypothetically, that should encourage further interest in the product. And we hope that that holds true, not just for ribaxamase, but across interest in antibiotics and making antibiotics better and safer and prevention. Prevention is key, I think we're finding. So we have something that prevents that damage and could help, it's just a question of resources. And I think the overall partnering population coming to the realization that these are all part of the same antibiotic strategy to be able to deliver the best antibiotic care with the greatest safety and possible preventative outcomes, preventing secondary infections and other things like that.

All right. Yes. Thank you. Thank you. And then the next one is on SYN-010, you're expecting that futility analysis in the near future. So I like to see, I guess, a two parter. First, what sort of result would you figure that a prospective partner would need to see in order to consider the data compelling? And then could you give us an idea of how many patients have already been enrolled in the study and like the size of that futility analysis?

Why don't you go ahead, Vince?

So what a partner – what we hear from partners is that is they're looking for something differentiated and so we have to show that we are differentiated. Clearly people want to see efficacy out of the trial in terms of the symptoms – dose, we're looking to see if we can get a better dose response we didn't get in our first Phase 2 study. And so we would like to see efficacy and a dose response and ideally some other added benefits, something useful. For example, we – even in the study today, we've had no incidences of diarrhea. So that's potentially a benefit if it holds up in unblinded analysis. But those are the sorts of things that partners are looking for. The futility analysis, we have outpatients in SYN-010 to decide whether or not the study should keep going, whether or not we're actually seeing a meaningful signal. We will have to wait until an analysis is done before and calculate what length of time and number of patients we might be looking at to continue the study, if that's what is required. I mean, if the futility analysis somehow gives us some terrific outcome, that's a futility analysis. So it's very limited. We can evaluate that in the overall scope and the overall context of what's going on with the hospitals and clinical trials and clinical trial participation and determine how long we go and how many more patients are needed.

All right, thank you. And just – I’m sorry, are you going to continue?

No, go ahead. Go ahead. I'm sorry. Go ahead.

Just – so my last question is going to be on the GVHD trial. And so now that initiation is expected in first quarter 2021. I'd like to see obviously everything goes on track with COVID. Would it be reasonable to expect data from that trial emerging around year-end 2021.

If we were to engage in the first quarter of 2021, we could possibly have at least one of the three cohorts report out some data. And we'll see what happens. If things turn out to be better and now we start to get through this difficult period much more quickly, there's always a possibility of starting this trial before then. In the meantime, we're still doing work on the program. We're near completion on aligning with WashU and establishing the safety data monitoring committee, setting up all the necessary databases. We've submitted the final revisions of the protocol to the FDA and we're waiting for that, that period for the FDA to review that to pass. And once that happens, it will be handed off back to WashU for their IV to go through their file approval. So we are continuing to work on the program so whenever we get the green light, we'll be prepared to advance into the clinic.

All right. Thank you very much.

Thank you. There are no further questions at this time. I would now like to hand the conference back to Steve Shallcross for any closing remarks.

Thank you. And thank you, our shareholder base for the support that you continue to give us. We, I think are making tremendous progress across the board with all of our programs. We look forward to future news flow and updating you on our continued progress. Thanks again and stay safe.