Good morning. And welcome to the Synthetic Biologics’ Second Quarter 2015 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. I would now like to turn the conference over to Kris Maly, Vice President, Corporate Communications at Synthetic Biologics. Please go ahead.

Thank you, Emily, and good morning, everyone. Welcome to Synthetic Biologics’ second quarter 2015 financial results conference call. Today, I’m joined by our CEO, Jeff Riley; and our CFO, Steve Shallcross. Synthetic Biologics issued a press release this morning reporting its second quarter 2015 financials results and an update on our recent operational highlights. The release can be found on the Investors section of our website. During our call today, Jeff, will provide an update on our pipeline of programs and Steve will summarize our financial highlights. We will take questions after our prepared remarks. In addition to the phone line, this call is being streamed live over the internet today and the webcast replay will be archived on our website 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 on 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 the conference call on account of new information, future events or otherwise, except as required by law. With that, I’ll turn the call over to Jeff. Jeff?

Thanks, Kris, and thanks everybody for joining us this morning. We’ve had a very busy quarter and we will try and share everything we can about it. During the second quarter and the first half of 2015, we’ve achieved significant clinical milestones with the initiation of Phase 2 clinical trials for both our C. difficile program and our irritable bowel syndrome program with constipation or IBS, and we expect to have Phase 2 data from both programs focusing on protecting the microbiome by the end of this year. As we move through Phase 2 development and begin to plan for Phase 3 trials and commercial entry of our microbiome candidates, it’s critical we have the financial resources and the team in place that can support these efforts. While there is likely less time spent in the clinical with the microbiome programs and the typical drug development program, these programs still require significant resources to complete clinical studies. To provide some of these resources we recently complete a public offering for net proceeds of approximately $42.6 million. Our continued progress combined with investor interest related to the microbiome enabled us to strengthen our balance sheet and provide resources to fund our current clinical development programs. We also expanded our leadership team during the second quarter, with the appointment of industry veterans of proven track records. Steve Shallcross, joined us as CFO and brings operational, financial and international biotech industry experience, as well as an established career leading the financial development and strategy for several publicly-traded biotech companies, including Vanda Pharmaceuticals. Maureen Early joined us in the newly created position of VP, Commercial to lead all commercial and marketing efforts. And Klaus Gottlieb, MD, joined us as President of Clinical and Regulatory Affairs, having served as Senior Medical Director, Therapeutic Strategy Lead,…

Thanks, Jeff. And good morning, everyone. As Jeff mentioned earlier, we recently completed a public offering of 15.3 million shares, including the fully exercised over-allotment option by the underwriters covering 2 million shares for net proceeds of approximately $42.6 million. The completion of this offering further strengthens our balance sheet and provides the financial resources for us to complete the ongoing Phase 2 programs for our two lead product candidates. During the second quarter of 2015, we continue to operate in an efficient manner. G&A expenses for the quarter increased to $2.2 million, compared to $1.8 million for the same period in 2014, reflecting the investment we continue to make in our administrative resources. R&D expenses for the quarter increased to $7.5 million, compared to $2.8 million for the same period in 2014. The increase in R&D expenses of approximately 165% is primarily the result of increased program cost associated with expanded clinical development, manufacturing, and research activities for our microbiome-focused pipeline, including company’s C. difficile and IBS-C programs. In addition to accommodate our expanded team, we will be moving into our new corporate offices in Rockville, Maryland on the Johns Hopkins NCI campus later this month. We anticipate cash utilization to continue to increase in the second half of this year due to expenses related to the initiation of a Phase 2b clinical trial for SYN-004 and of a second Phase 2 trial for SYN-010. We expect to report topline data from multiphase Phase 2 clinical trials during the second half of this year, which illustrate the value and potential of our microbiome-related programs. In addition to our second quarter 10-Q, we will be filing three other documents with the SEC today. First, to ensure the company flexibility, we are filing a Form S-3 to register in sale of $200 million worth of securities under shelf registration. We do not have immediate plans for using this vehicle but want to maintain maximum flexibility as the company moves forward. We are also filing a Form S-8, which registers the additional 2 million shares of common stock in the company’s 2010 stock incentive plan that were approved by our shareholders at the annual meeting in May. And finally, we will file a Form S-3 to supersede the current Form S-3, under which forms from the October 2014 financing are registered to ensure there is not a lapse in timing of an effective registration statement for these particular warrants. Now I will turn the call back over to Jeff.

Thanks, Steve. In summary, we demonstrated significant process during the second quarter and the initiatives to expand our management team and strength our balance sheet position as per further success. Synthetic Biologics is a leader in the microbiome space, the two Phase 2 drugs in the clinic which protect the microbiome while targeting specific pathogens. For our C. difficile program, we look forward to reporting topline data from our two Phase 2a trials and to the interim analysis of blinded data from our Phase 2b study later this year. For our IBS-C program, we look forward to completing both of the Phase 2 clinical studies and reporting topline data from our first Phase 2 trial later this year. We are also on look out for additional development stage microbiome folks programs that could position our team to build additional shareholder value over the long term. We believe we have a rich asset in our Trimesta MS program, which we intend to move forward during the remainder of 2015 potentially with the partner, and our monoclonal antibody candidate to treat whooping cough has demonstrated strong preclinical data that supports preparing for clinical development. Overall, we are very optimistic about the potential of Synthetic Biologics to address large markets and to meet unmet medical needs while generating significant returns for our shareholders. At this time, I will turn this back over to Kris.

Thanks, Jeff. Emily, we would like to open the phone line to questions now. Would you please describe the procedure to ask questions for our listeners?

[Operator Instructions] Our first question is from Katherine Xu of William Blair. Please go ahead.

Hi. Good morning. I do have a few questions. First, on the SYN-004 program, how many patients do you expect to report data on in the Phase 2a later this quarter? And then on the SYN-010 program, you have a secondary endpoint of, of course, the complete spontaneous bowel movements, abdominal pain, and bloating, do you plan to report that with the one week methane data as well, or is that three months endpoint? And on the PKU side, can you just compare some class, your program candidates with the BioMarin products? And lastly, on Trimesta, the UCLA last Phase 2 study in cognition, who is funding that study? Thank you.

Hi, Katherine. Good morning. Thanks for all the questions. The SYN-004 study, we’re looking at -- I’d say, I totally forgot what you just said. Let me go to the IBS space, so the IBS space, the both those Phase 2s, we are looking at all the tertiary endpoints of constipation, bloating, and pain, post 7 days and 28 days, so we are measuring that both in the first study as well as for the full three-month period in the second study. The MS drug cognition that current phase, that’s ongoing, is funded by both UCLA and Synthetic Biologics. And we’re looking forward to moving that thing forward. I mean at the end of the day, we did issue some data here a few weeks ago that we did talk to UCLA and basically renegotiated set of terms that were more beneficial to both parties. We got some intellectual property, they got better economics and that has given us the ability to move the MRI program and the data forward. Keep in mind that both the MRI data as well as the relapse remitting data will also be analyzed by the independent third party, I mean, that’s typical in the industry. And it’s really important to note that because it does take time for us to have a third party, look at the data, provide their analysis back for potential partnering with various folks out there. With respect to PKU, the commercial capability, this drug is quite large, it is an orphan drug. At first blush, we look at the market as being fairly robust, probably $500 million give or take total, and that is worldwide, worldwide being Europe and United States, Japan in this case. We feel that our product is significantly different from the other products out there as we’ll be delivering this using a lactase platform, which is part of the ActoGeniX, Intrexon collaboration. And could you repeat the SYN-004 question Katherine one more time for me? I apologies.

No problem. So the Phase 2a, you’re looking at eligibly it was developed for 20 patients, because you have some difficulty recruiting patients earlier in the times, just wondering we report a final data in this quarter, is it going to be 20 patients?

No. Likely be 12 patients in both those studies and we go up to 20, that was if we’re going to have some data that was the little less clear than what we get at -- we’re getting at the moment. But it appears that in the first set of patients that we’ve looked at for the Phase 2a PK/PD study that ceftriaxone SYN-004 behaving exactly the way that we expected them too and we expect the same thing with the PPI study. So my guess is we will have under 20 patients, but probably more than 12, 12 or more in each of those two Phase 2a studies.

Thank you.

Our next question is from Daryl Weber at Wells Fargo. Please go ahead.

Good morning, gentlemen. So with these two products, can you just give us a little more color as to the clinical pathway into humans, I mean, I know you got orphan drug and all. But maybe if you can us little more detail when we could be in humans and so the details to have a trials on all of it? Secondly, has the work progressed with Intrexon with respect to the specific gene for this therapy?

So some of this information we’ve released some of it we have not. I will speak with what we have talked about in the press release. PKU is an area that obviously is a genetic defect in these folks that have it or a missing gene in this case and as we all know UltraVector and the capability that Intrexon has internally is second to not in our particular space of identifying that. What Intrexon Belgium brings to the table is the delivery of that particular enzyme to the right spot. So given our technology, our ability to deliver things to the GI and have them released in a particular way throughout the GI tract and the L. lactis vector that they’re going to be using, we should be to deliver that particular enzyme replacement very efficiently to the gut of these particular patients. Well, looking at this is a discovery stage program that there already has been a fair amount of work done on it. We’re probably looking at between 12 and 18 months of as far as the discovery program to get a viable vector to move forward with this particular project.

Okay. Now last thing is can you tell us -- share with some of the economics of this deal with Intrexon? I mean, I know you guys announced it, but there were no details as what wasn’t accomplished?

What we did announced Dale, we are going to be paying an upfront fee for technology access fee to the product that’s being moved along in access to particular platform. We’ll also be paying on a monthly basis or quarterly basis for R&D support as we don't have true R&D or labs inside of our company. We’ll be utilizing Intrexon’s Belgium and U.S.-based labs for that. So there will be a monthly fee in addition to an upfront equity-based fee.

Thank you.

[Operator Instructions] Our next question is from Keith Markey of Griffin Securities. Please go ahead.

Hi. Thanks. Good morning. This is Zack Ajzenman in for Keith. Our first question and I’m sorry, if I missed in the prepared remarks but one more data from the cognition study of Trimesta be available?

The current status that’s ongoing is still recruiting, so what we’re looking at probably 18 months to two years at this stage.

Okay. And the number of shares outstanding as of today?

About 90 million give or take.

Great. Thanks a lot.

That concludes our question-and-answer session. I’d like to turn the conference back over to Jeff Riley for any closing remarks.

Thanks, Emily. I like to thank our new shareholders for joining us today. I also like to thank all of our long-term shareholders for their continued support. Everyday Synthetic Biologics moves closer to the goal of offering novel microbiome focused products to large markets with clear unmet medical needs. With our two lead microbiome programs in Phase 2 development, we are very excited about the progress we're making. We look forward to reporting our continued progress, especially reporting topline results from our multiple Phase 2 studies in C. diff and IBS by the end of this year. We are positioned to create value for shareholders at multiple inflection points through the remainder of 2015 and well into 2016 as well. Thanks again everybody and have a great day.

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