Vincent Perrone - Director of Corporate Communications Jeff Riley - CEO Steve Shallcross - CFO Joseph Sliman - CMO.

Keith Markey - Griffin Securities Katherine Xu - William Blair.

Good morning, and welcome to the Synthetic Biologics 2017 Second Quarter Investor Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded.

At this time, I would like to turn the call over to Vincent Perrone, Director of Corporate Communications at Synthetic Biologics.

Vincent?.

Thank you, Rocco, and good afternoon everyone. Welcome to Synthetic Biologics 2017 second quarter investor conference call. Today, I'm joined by our CEO, Jeff Riley and our CFO, Steve Shallcross.

Synthetic Biologics issued a press release this morning, which provided operational highlights and reported our financial results for the quarter ending June 30, 2017. The release can be found on the Investors Relations section of our website.

During our call today, Jeff will provide an operational update on our microbiome focused clinical programs and Steve will 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 www.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 Jeff.

Jeff?.

Thanks Vincent, good morning everyone and thanks for joining our 2017 second quarter investor call. It continued to be an exciting time for Synthetic Biologics as several important milestones during the second quarter continue to drive our progress and momentum in and out of the clinic.

A few years ago we began developing two discovery stage programs centered on ideas of what was then known about the human microbiome. In a short time we have been successful in taking both programs through proof-of-concept studies.

In the same period, Synthetic Biologics has undergone significant change evolving from an early stage company focused on clinical development to a leader in pioneering translatable microbiome focused research and clinical development. Despite the clinical success we’ve enjoyed, our goal remains unchanged.

To continue to develop novel, innovative and simple solutions to complex and unmet medical needs while building long-term value for our shareholders. In this pursuit we are more focussed than ever and continue to work tirelessly on the advancement of our GI microbiome focussed assets and portfolio pipeline programs.

We believe more than ever that our programs have the potential to significantly improve the health outcomes for millions of underserved patients all over the world.

During today’s call, we will provide a clinical update on ribaxamase, our oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract to protect and preserve the natural balance of the gut microbiome, from C. difficile infection, overgrowth of pathogenic organisms and the emergence of antimicrobial resistance.

In SYN-010, our compound design to reduce methane production in the gut to treat the underlying cause of the symptoms commonly associated with irritable bowel syndrome with constipation.

Before we dive into our clinical update, I’d like to turn the call over to Steve Shallcross, our CFO who will provide an update on our financial results for the year.

Steve?.

Thanks Jeff. During the second quarter of 2017 we’ve continued to efficiently utilize our cash as we continue to deploy our capitals in support of our two lead phase 3 ready clinical programs.

We remain confident in our ability to continue to manage overhead while focusing the majority of our financial and human resources on the continued advancement of ribaxamase and SYN-010. Synthetic Biologics 2017 second quarter financials were included in a press release, which was distributed over the Newswire earlier this morning.

The company's 10-Q for the quarter ended June 30, 2017 was also filed with the SEC earlier today. For the three months ended June 30, 2017 general administrative expenses decreased 23% to $1.6 million compared to $2.1 million for the same period in 2016.

This decrease is primarily the result of higher salary expense and related benefit costs incurred in 2016 in connection with the transition of the administrative and financial office for our Maryland headquarter along with reduced travel and legal expenses.

Included in these numbers were charges related to stock based compensation of $539,000 three months ended June 30, 2017 compared to $500,000 for the same period in 2016. Research and development expenses decreased 33% to $4.8 million for the three months ended June 30, 2017 compared to $7.2 million for the same period in 2016.

This decrease is primarily the result of lower ribaxamase program costs. In addition, there were reductions in our research and development activities including our SYN-010 program offset by indirect cost primarily for medical affairs.

Research and development expenses include a charge of $4331,000 related to stock-based compensation for the three months ended June 31, 2017 compared to $400,000 for the same period in 2016. Other income was $2.2 million for the three months ended June 30, 2017 compared to other expense of $3.5 million for the same period in 2016.

Other income for the second quarter of 2017 is due to a non-cash income of $2.2 million from the change in fair value of warrants that resulted from a decrease in our stock price from the prior quarter. Cash and cash equivalents as of June 30, 2017 remain relatively unchanged at $13.4 million, a small decrease from the prior quarter.

During the quarter, we raised approximately $5.6 million in net proceeds utilizing our at-the-market facility. Future use of the ATM will depend largely on market conditions and the potential outcome from ongoing partnering discussions.

Looking ahead, we anticipate cash utilization will remain relatively steady for the third quarter of 2017 due to diminished clinical cost and our ability to effectively manage our overhead expenses. At this time, I’ll turn the call back over to Jeff..

one, implying physical -- implying fiscal best practices, strengthening our clinical infrastructure, maintaining manoeuvrability in a rapidly shifting healthcare investment environment, and exploring and evaluating opportunities to move our lead programs forward in a manner that is consistent with the best interest of our shareholders.

At this time, I'll turn the call back over to Vincent..

Thank you, Jeff. Rocco, we'd like to open the phone line to questions.

Would you please describe the procedure to ask questions for our listeners?.

Absolutely. We will now begin the question-and-answer session.[Operator Instructions] Today's first question comes from Keith Markey of Griffin Securities. Please go ahead..

Good morning and congratulations on the breakthrough designation. Jeff, I was just wondering if you could -- given the number of benefits that usually come with breakthrough designation status, could you allude to what you consider to be the most important of the advantages of having that..

Good morning, Keith, thanks for the question. I think that the biggest advantage is we can have multiple conversations with the FDA in an expedited manner. And there's no preset formula, if you will to having those conversations.

So as we said earlier in the conference call script toward the end of this quarter, we are going to meet with the FDA for that Type B multidisciplinary meeting. We've created roughly a 35 page briefing document, which essentially has all the data that has been generated to date in that document.

We'll submit that to the FDA, we'll have -- we'll go and have that discussion with them and then we'll decide together what the next steps are at that point in time..

Fantastic. And then, I was just wondering, Steve can you tell us a little bit more explicitly what the cash burn rate would be for the third quarter? You had a few moving parts this time around..

In the last quarter call Keith, our fix burn was about $1.2 million a month..

Okay..

And we can continue to experience that. In this last quarter, we had some run out cost from the ribaxamase trial that won't occur again in the next quarter here. But I would use about $1.2 million a month, this guidance..

Okay, great. I’ll get back in the queue. Thank you..

And our next question comes Katherine Xu of William Blair. Please go ahead..

Yes, hi, good morning. I'm just wondering whether you could give us some color on the partnership discussions, in particular, I guess intent given that the FDA getting the green line on the Phase 2b/3 design back in January.

Just curious about how that process is going? Is this a good enough of an asset to be partnered? What additional data or other things that partners might want, just to the extent that you can chat about it'll be great to get some color?.

Thanks Katherine for the question. We don't want to put this in the script necessarily, but the reality is the industry as a whole has not -- there's not been a lot of deals done. So from a macro perspective, I would challenge you to find a lot of late stage deals being done, the classic licensing deals or co-development deals.

They just have not been deploying capital, they be in big pharmas and the big biotechs. We are talking everybody. We are in multiple discussions on SYN-010 and ribaxamase at this stage of the game, but until the pharmas decide to start deploying capital, I think, it's tough to get a deal across the line.

And to be honest, I'm not going to do a crappy deal given that we have spent a significant amount of capital to get these assets to where they are at this point in time. So I can't give you much more color on that. I can tell you that there are a lot of conversations on almost daily basis with the variety of pharmas.

The feedback I've received at the bio conference a couple of months ago from Who's Who and the big guys out there, is they basically have words not to do deals up until recently, until there is clarity on the repatriation of their capital and just generally more clarity on the healthcare side of the equation.

So until we have that I think we -- I don't think we you're going to see a lot of deals being done out there. SYN-010 itself is a fantastic asset. I don't know why we need to keep saying this but at the end of the day, the competitive assets are linaclotide, which is the Allergan product or LINZESS.

We have Synergy's new drug out there, Trulance, which is an analog, frankly, it's a me too version of LINZESS, it's really nothing special. The majority of GI docs that we speak with they like these drugs and these are the only drugs available to treat irritable bowel syndrome, the constipation form.

And our drug will be fantastic, because again, it is completely safe from what we can see. It's impacting only 1 microorganism in the gut. Lovastatin is safe, this can be. We're looking at EMA-related stuff now as well as well the FDA. It's a great product and whether it's used alone or in combination with the existing drugs, we don't know.

I think there is a combination therapy, potential there as well. So we're looking forward to it. From a cash perspective, I mean let's address the elephant in the room. We did use the ATM last quarter.

There is no better way for us to keep our cash in line to where we need it to be at a less expensive way to do it at this stage of the game given the markets. There's just no better way to do it. So we're not raising capital to be in crazy numbers.

And to be honest, we can't raise enough capital to take SYN-010 forward ourselves at this stage of the game. So we are looking specifically for our partner and we will find one when they open up their core strengths. We have several in the queue. And then we'll go forward from there.

But until that point in time, we're going to be very fiduciarily responsible, not raise a lot of money on the ATM stage, say, what I would consider within the navigational buoys and focus on ribaxamase because that is the product that we are focused on at the moment with respect to the FDA in moving that program forward..

Thank you..

[Operator Instructions].

Thanks, Rocco .The second quarter of the 2017 was one of tremendous progress for Synthetic Biologics. The granting of breakthrough therapy designation for ribaxamase for the prevention of C. difficile infection is a critical and important milestone for our company and, frankly, for public health as well.

We look forward to working with the FDA on the continued advancement of ribaxamase and to sharing the outcomes from the conclusion of our Type B meeting later this year. Before we close the call, I'd like to announce that Synthetic Biologics is headed to San Diego to participate in Infectious Disease Week 2017 from October 4 through the 8.

In addition, I am very proud to announce that 5 abstracts, 5, highlighting research for ribaxamase, SYN-005 and SYN-006 programs were submitting and accepted for presentation. Keep in mind that these programs are franchises or extensions of our existing ribaxamase program.

You can visit syntheticbiologics.com for the dates and times and locations for each event. Members of the team will also be available at booth number 509, which is located in the exhibitor’s hall if you like to come talk to us.

Again, with 2 phase 3 ready programs in clinical development, the Synthetic Biologics team is more determined than ever to continue our work of advancing our cutting edge microbiome therapies through late-stage development and towards commercialization. We're proud of the progress we've made and excited for what lies ahead.

Thanks again, for joining our call and have a great day..