Good afternoon, and welcome to the Synthetic Biologics' 2020 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 call over to Vincent Perrone, Director, Corporate Communication at Synthetic Biologics. Vincent?

Thanks, Grant and good afternoon, everyone. Welcome to Synthetic Biologics 2020 third quarter investor conference call. Today, I'm joined remotely by Steven Shallcross, Chief Executive and Financial Officer; Dr. Michael Kaleko, Senior Vice President 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 30, 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 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 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 statement 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 third quarter investor conference call. I hope everyone is safe and in good health. I'm excited to be with you this afternoon to share our third quarter operational highlights and financial results. It's been a busy quarter and a busy year for Synthetic Biologics. Clearly, this was a challenging quarter given the disappointing results of SYN-010 as well as the ongoing impact of the COVID-19 pandemic, which continues to test the global community and our healthcare system. Nevertheless, we've made substantial progress on both SYN-004 as well as SYN-020, and we're as excited as ever about the outlook for the business. We believe our ability to successfully navigate these challenging times is a testament to the diversity of our platform as well as the strength and resilience of our team and our clinical development partners. Earlier this year, we implemented a set of initiatives focused on prudent cash management and financial stewardship. This has allowed the company to aggressively conserve capital and extend out our runway. And as we anticipate clinical activities to return to normal, we remain focused on executing our strategy to advance our portfolio of GI-focused clinical development programs. We believe both SYN-004 and SYN-010 address very sizable and underserved markets. Moreover, the mechanisms of action are unrelated -- that are unrelated to SYN-010 and as such we remain highly encouraged by the clinical outlook for these two programs. With that backdrop, I'd like to provide an update on developments during the third quarter beginning with the SYN-010 Phase 2b investigator sponsored clinical trial in IBS-C patients. Last year, we began enrollment in a Phase 2b investigator sponsored clinical trial of SYN-010 in collaboration with our research partner Cedars-Sinai Medical Center. This trial was intended…

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

We will now begin the question-and-answer session [Operator Instructions] Our first question comes from Jason McCarthy with Maxim Group. Please go ahead.

Hey, guys. This is Michael Okunewitch on for Jason.

Hey, Michael.

How is it going? So on the peak, one of the things that you've repeatedly highlighted is dramatic cost reduction, which is made possible through your production process, down to I think you say 100 per gram from 10,000 per gram. So my first question is how many gram would someone generally use for a therapeutic application?

So let me bring Mike Kaleko in and let him answer that question. Mike. go ahead.

Well, the decision on dosing is usually made in Phase II clinical trials. So we don't know the exact numbers yet, but we believe it will be in the range of 5 to 30 milligrams per day per patient.

All right. Thank you. That certainly is pretty significant on a yearly basis. I also have another question on SYN-020 actually. I'd like to see if you could kind of lay out a bit of a road map for development. Because I know you've discussed that radiation enteropathy is probably the quickest way to registration. And then you're potentially moving into other indications like celiac or even potentially metabolic disease. So let's see if you could lay out how you're planning to approach this. Would you be going straight for radiation enteropathy? And then after that's done and approved moving into other indications? Would you look at doing things in parallel or potentially bringing partners on board to explore some of these other indications?

So, I'll take a shot at that first. So, obviously, we got to get through the safety studies, which we don't anticipate there being any difficulties given how clean the tox studies were in the animal models that we conducted. You raised an interesting strategy and we're evaluating all of the above. We have the ability assuming sufficient funding to run one or more of these programs to Phase 2s together or to do one of them or at least one leg of one of the two Phase 2 studies and then layering in in parallel the remainder assuming that we may have to do more than one. We also could possibly partner at that point in time and share some of that clinical burden with a partner. We have fielded some inbound calls with folks that have interest in this program. So that is totally within the realm of possibilities.

All right. Thank you very much. Also just one more if you don't mind, it might be early to say. Obviously, you haven't started anything, but could you give us a rough approximation on how long you're expecting this Phase 1 to last so we could start to see data from that?

Why don't you go, ahead Mike?

Of the Phase 1, the very first study is a single-ascending dose study. It should last a couple of months, I would imagine. And actually that includes data analysis. That would be followed by a multiple-ascending dose study. We don't have the details worked out with the FDA yet, so I can't really comment on it. But we anticipate -- well, let me not comment on it, but it would be relatively short-term cohorts maybe six months for that. And then we would at that point move on to the patients. Does that help answer your question? I'm sorry I don't have more details for you.

Right. No problem. Surely that definitely very helpful. Thanks. I appreciate it.

[Operator Instructions] There being no further questions, this will conclude our question-and-answer session. I would like to turn the conference back over to Steve Shallcross for any closing remarks.

Thanks again everyone for joining us this afternoon. And we thank you for your continued support, and we look forward to further updating you on our progress. Have a great evening and we'll talk to you next time. Thank you.

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