Theriva Biologics Inc (TOVX) 2015 Q3 法說會逐字稿

Hello and welcome to the Synthetic Biologics third-quarter 2015 investor conference call.

(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. Ms. Maly, Please go ahead.

Thank you, Keith, and good afternoon everyone. Welcome to Synthetic Biologics third-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 afternoon reporting third-quarter 2015 financial results and providing an update on our recent operational highlights. The release can be found on the investor section of our website.

During our call today Jeff will provide an update on our pipeline 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. This 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'd like to turn the call over to Jeff.

Thanks, Kris, and good afternoon everyone. Thanks for spending some time with us here this afternoon.

I'd like to begin with a recap of the progress we've made through the third quarter and we've accomplished a lot. Here's a brief rundown of the very exciting achievements we've made at Synthetic Biologics. We continue to make great strides in the clinic.

Firstly, we initiated two SYN-010 Phase 2 clinical trials for the treatment of irritable bowel syndrome with constipation or IBSC. We completed patient enrollment in the first Phase 2 clinical trial for SYN-010 and continue to successfully roll patients from the first trial into the second Phase 2 clinical trial as we speak.

Secondly, we initiated three SYN-004 Phase 2 clinical trials for the prevention of C. difficile infection. A Phase 2b proof-of-concept trial is going on in up to 370 patients at up to 75 global clinical sites.

We also initiated two Phase 2a trials in ileostomized participants and that's ongoing to provide data which will help further the development of SYN-004. We reported results in line with our expectations from four participants from our first Phase 2a trial in July of this year. And we completed participant enrollment in the first Phase 2a trial.

We acquired an exciting novel biotherapeutic asset designed to treat PKU from Intrexon Corporation, expanding our portfolio of microbiome-focused products. Also, the Bill & Melinda Gates Foundation awarded a grant to UT Austin, our academic pertussis collaborator, to generate preclinical proof-of-concept data to test the hypothesis that administration of our antibody at birth may also have a role in the prevention of pertussis. And lastly we amended license in clinical trial agreements with UCLA to further strengthen our MS intellectual property claims and were informed that MRI data analysis are ongoing to evaluate changes in brain that correlate with improvement seen in the clinical outcomes in the relapsed remitting study.

Also, we expanded our leadership team as we move through late stage Phase 2 clinical trials and prepare for Phase 3s next year. Specifically, Steve Shallcross joined us as CFO and brings with him public company operational financial and international biotech experience. Maureen Early joined us as Vice President, Commercial and will lead all commercial and marketing efforts. Dr. Klaus Gottlieb joined us as Vice President, Clinical & Regulatory Affairs having served in senior management positions with both Quintiles and the FDA. And most recently Ray Stapleton joined as a Senior VP, Manufacturing and brings more than 15 years of pharma-related manufacturing and operations experience with Merck.

In July we strengthened our balance sheet by completing the public offering of 17.3 million shares for net proceeds of $42.6 million which provides us with the resources to move our lead drug candidates through Phase 2 clinical studies. Finally, our clinical and operational progress continues to gain attention in the financial community as evidenced by additional coverage from three new sell side analysts for a total of five covering analysts to date.

Now I'd like to provide an update on our two lead gut microbiome-focused clinical programs, both of which are in Phase 2 clinical trials: SYN-010, our IBS-C program, and SYN-004, Our C. diff prevention program. Let's start off with SYN-010.

The program is addressing IBS-C, a functional GI disorder characterized by gas, abdominal pain, bloating and constipation. While the illness affects both men and women, almost two-thirds of diagnosed sufferers are women. Current treatment options including FDA approved drugs and over-the-counter laxatives treat the symptoms of constipation and tend to cause an IBS-C patient to swing from suffering from constipation to suffering from diarrhea.

Synthetic Biologics is developing SYN-010, our proprietary modified release formulation of lovastatin lactone to target a major cause of IBS-C, the abdominal pain, bloating, and constipation, not just the symptoms. SYN-010's unique mechanism of action is intended to reduce methane production by certain microorganisms in the GI tract and restore normal bowel function to IBS-C patients without disturbing the balance of the patient's gut microbiome.

During the third quarter we completed patient enrollment in the first Phase 2 randomized double-blind placebo-controlled clinical trial which is evaluating the ability of two dose strengths of SYN-010 to reduce production of methane in the gut of breath methane positive IBS-C patients. Secondary endpoints include improvement in the number of bowel movements per week and improvement in the abdominal pain and bloating per the standard scales required per FDA guidance.

As a reminder, this clinical trial enrolled approximately 60 patients who are being randomly assigned to a 1 to 1 to 1 ratio to one of three groups including two different SYN-010 dose groups and a placebo group. Patients are scheduled to receive a single oral dose of SYN-010 or placebo each day for 28 days. Analysis of patient data is ongoing and we expect to report top-line data from this trial by the end of this quarter.

The second significant milestone for the SYN-010 program was the initiation of the second Phase 2 multicenter open label clinical trial. Patients who complete the first Phase 2 SYN-010 clinical trial are eligible to immediately roll over into the second Phase 2 clinical study. The open label eight-week extension study is evaluating the sustainability of the effect of the higher dose of SYN-010 on breath methane production in breath methane positive patients with IBS-C.

And we'll also evaluate key clinical outcomes including frequency of complete spontaneous bowel movements, abdominal pain and bloating. More than half of the patients who have completed the first Phase 2 trial of SYN-010 have already rolled over into the second Phase 2 trial. And we anticipate reporting top-line results from the second Phase 2 clinical trial during the first half of 2016.

Now let's turn our attention to SYN-004 and talk about our second gut microbiome-focused program for the prevention of C. difficile infection. Our product candidate SYN-004 is designed to protect the gut microbiome from the effects of certain commonly used IV beta-lactam antibiotics for the prevention of C. difficile, an antibiotic associated diarrhea. Again, rather than treating the patient who already has an established C. difficile infection we designed SYN-004 to be what we believe is the first point of care preventative therapy that is intended to prevent the onset of primary C. difficile infection in antibiotic associated diarrhea.

Our novel Phase 2a clinical trials of SYN-004 are evaluating the safety and the ability of SYN-004 to degrade IV ceftriaxone in the gut alone and in the presence of the proton pump inhibitors, esomeprazole. In participants with functioning ileostomy these healthy volunteers have had all or a part of their colon removed and are fitted with an external pouch system for waste, therefore enabling easier sample of intestinal chyme.

I would like to clarify the design of the two Phase 2a clinical trials and why recruitment has been slower than anticipated. The Phase 2a trials were not designed as a hurdle to move the clinical development of SYN-004 into a Phase 2b proof-of-concept trial. Rather they were designed to generate additional PK and PD data to support SYN-004 and in the case of the PPI study to analyze any potential drug-to-drug interactions.

When designing and conducting a clinical trial using a novel approach there are always unknowns. What we and our principal investigators underestimated was the challenge of recruiting healthy ileostomized patients who were willing to simultaneously take ceftriaxone, SYN-004 and in the case of the second Phase 2a trial a PPI. We are grateful to these at-risk participants for taking part in these studies that are intended to help further development of SYN-004.

During the third quarter we enrolled enough participants to complete the first Phase 2a trial analysis. We anticipate the results will be consistent with our expectations and the positive PK and safety results demonstrated in the SYN-004 Phase 1a and 1b studies previously reported in March 2015 in the first four participants in the first Phase 2a previously reported in July 2015.

Data from these first four participants demonstrated SYN-004 degraded IV ceftriaxone in the chyme without affecting the ceftriaxone in the bloodstream. We expect to report top-line data from the first Phase 2a clinical trial by the end of this quarter and from the second Phase 2a clinical trial during the first half of next year.

The most significant milestone for the SYN-004 program during the third quarter was the initiation of the Phase 2b parallel group double-blind placebo-controlled proof-of-concept clinical trial intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection, C. difficile associated diarrhea and antibiotic associated diarrhea in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone. Before initiating the SYN-004 Phase 2b clinical trial safety and tolerability were demonstrated in two Phase 1 studies, a single ascending dose study and a multiple ascending dose study. Full analysis of the Phase 1 studies were completed, instead reports were resubmitted to the FDA.

The trial is anticipated to enroll approximately 370 patients at up to 75 global sites. Many Phase 2b clinical sites are open for enrollment and actively screening for patients with additional sites expected to open as we approach the cold and flu season, the majority of which are anticipated to be up and running by year-end. It is difficult to predict a completion date for the Phase 2b proof-of-concept trial as it is dependent on incidences of respiratory tract infections such as pneumonia and bronchitis.

In addition to our two lead microbiome-focused drug candidates we have three additional programs we are putting our efforts into. First one: PKU. In August we were pleased to add an exciting new discovery program to our pipeline, a program for the development of novel biotherapeutics for the treatment of phenylketonuria also called PKU, a chronic disease that can lead to profound cognitive impairment and behavioral disorders.

The development of these biotherapeutics expands our pipeline of products targeted for release in the GI tract without adverse impact on the natural balance of the patient's gut microbiome. Through an exclusive channel collaboration with Intrexon Corporation we are utilizing Intrexon's ActoBiotics platform to provide a proprietary method of delivering therapeutic proteins and peptides to the GI tract through food grade microbes. We believe a biotherapeutics-based approach has great potential to provide relief for PKU patients managing this devastating disease, an opportunity to improve upon current therapies that rely on constant dietary monitoring and drugs to increase phenylalanine breakdown.

Our second program is in pertussis. Our monoclonal antibody program to target and destroy pertussis toxin which is responsible for pertussis or whooping cough is expanding to include the prevention of pertussis in newborns. In addition, the treatment of newborns and other at-risk groups with pertussis with up to 300,000 deaths reported annually, primarily among infants during the first four months of life in the developing world, the prevention and treatment of pertussis is a growing unmet medical need.

Along with our collaborator Intrexon and our academic research collaborator, University of Texas at Austin, we have had many discussions with international nonprofit health organizations to secure non-dilutive funding to advance our monoclonal antibody program for pertussis. These efforts were rewarded when we were able to announce that the Bill & Melinda Gates Foundation awarded a grant to UT Austin to generate preclinical proof-of-concept data to test the hypothesis that antibody administration at birth may also have a role in the prevention of pertussis.

Dr. Maynard, the principal investigator of the grant at UT Austin, will test this hypothesis by using our monoclonal antibody. The grant award will be used to evaluate the potential of our monoclonal to prevent pertussis in nonhuman primates and provide support to move the prophylaxis program into human clinical trials.

During the third quarter we amended our license and clinical trial agreements with UCLA and were informed by UCLA that MRI analysis were ongoing to evaluate changes in the brain that correlate with improvements seen in clinical outcomes of female relapsed and remitting MS patients in the UCLA-led Phase 2 clinical trial for multiple sclerosis. Upon receipt of the MRI data set as is typical with academic collaborations we intend to conduct a thorough third-party analysis in order to confirm UCLA's results for potential business development discussions.

We expect to report top-line MRI data 30 days following the receipt of the data and the related analysis from UCLA. In the interim we continue discussions with potential strategic partners regarding Trimesta. Pending MRI data from UCLA and subsequent third-party analysis we intend to advance our discussions with potential partners.

Now I'd like to turn the call over to our CFO Steve Shallcross. Steve?

Thanks, Jeff, and good afternoon everyone. During the third quarter of 2015 we continue to operate in an efficient matter and we remain well-positioned to continue to execute our strategy of funding both lead microbiome-focused drug candidates through Phase 2 clinical trials. G&A expenses for the quarter increased to $1.6 million compared to $1.2 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 $10 million compared to $3.7 million for the same period in 2014. The increase in R&D expenses reflects increased program costs associated with expanded clinical development manufacturing and research activities for our gut microbiome-focused pipeline. Cash and cash equivalents as of September 30, 2015 were $31.8 million.

We anticipate cash utilization in the fourth quarter to decrease due to cash prepayments made during the third quarter related to the ongoing Phase 2b clinical trial for SYN-004 and the Phase 2 trials for SYN-010. As Jeff stated earlier, we do expect to report top-line data from multiple Phase 2 clinical trials here in the fourth quarter this year which should illustrate the value and the potential of our microbiome-related programs.

Now I will turn the call back over to Jeff.

Thanks, Steve. As we continue to move through Phase 2 development and begin to plan for Phase 3 trials and commercial entry of our microbiome candidates we remain well-positioned with the financial resources necessary to proceed with our clinical trials and continue to reinforce our leadership team.

Let me summarize once again our progress this quarter. For our C. difficile prevention program one, we completed enrollment in the first Phase 2a clinical trial and anticipate reporting top-line data before the end of this year; secondly, we also initiated the second Phase 2a clinical trial and expect to report top-line data during the first half of next year; thirdly, we expect the top-line data from the two Phase 2a clinical trials which are open label to be in line with our expectations; and lastly, we are very excited to initiate our Phase 2b proof-of-concept clinical trial.

Switching gears to our IBS-C program, we completed enrollment for the first Phase 2 clinical trial and anticipate reporting top-line data for this trial by the end of this year. Also, we were pleased to initiate the second Phase 2 trial and anticipate reporting top-line data from this study during the first half of next year.

In addition to reporting progress from our gut microbiome-focused portfolio we look forward to reporting the continued development of our monoclonal antibody intended for the prevention and treatment of pertussis in newborns as well as our innovative biotherapeutic approach to address the largely unmet medical needs associated with PKU. While we do not have a definitive timeline we continue to work with UCLA to ensure the accurate and complete analysis of the MRI data from relapsed and remitting MS patients.

We will keep you updated as we can. Overall we are very optimistic about the potential of Synthetic Biologics to address large markets and meet unmet medical needs while generating significant returns for our shareholders.

At this time I'd like to turn it back over to Kris.

Thank you, Jeff. Keith, we'd like to open the phone lines to questions now. Would you please describe the procedures to ask questions for our listeners?

(Operator Instructions) Adnan Butt, RBC Capital.

Hi everyone. Thanks for taking the question.

So the first one I'll ask is on 010. For the Phase 2 trials that are ongoing is this -- this is the first time you will be correlating breath methane levels with activity correct? And then do you expect a certain methane level to be required for having proceeding activity?

That's the first part. Secondly, is this Phase 2 data that you see, will it be sufficient to decide on a go/no go for a pivotal? Thanks.

Thanks, Adnan. So this is the first formalized clinical study as correlating methane gas with symptoms and the reduction of symptoms if you knock the methane gas levels down. That being said, anecdotally Dr. Mark Pimentel at Cedars-Sinai has spent several years working on this hypothesis and working in his clinic with other compounds that do knockout methane gas.

They tend to be detrimental to the patient long term but they do work on reducing methane gas. And he did see a very strong correlation which is why we had licensed and have partnered with Cedars-Sinai for this product.

With respect to the level of methane gas the current study we're looking at patients with methane breath levels greater than 10 parts per million which essentially is one of the entry criteria outside of the normal IBS-C ailments that these folks have. We're looking at reducing it obviously from that level down to as low as we can go. The current diagnostic tests only are accurate down to about 3 parts per million and we're not sure what is happening between let's say zero parts per million and that 3 parts per million because we do not yet have the diagnostic test to detect that.

We are working hand-in-hand with one of Cedars-Sinai's prior collaborators, a lab called Commonwealth, which is working on making a more sensitive test at this time. Does that answer your question?

Jeff, thanks for the clarity. I just have a follow-up on the program. What decides from the patient perspective who goes into the extension phase or not?

Well, all the patients historically within the IBS-C related program, the biggest problem that other investigators have had is patients tend to self-medicate or they drop out because the drugs are not very effective. So if you look at some of the other drugs that have been for recent clinical studies they have between 20% and 22% efficacy in their patient populations which means basically one out of every five patients is getting relief. So they have to power those studies exceptionally high in order to get enough patients to create a p-value that is statistically significant.

We thought that 60 patients given what Dr. Pimentel had seen anecdotally was a good number. And one of the promises that we gave the patients was if you can survive the 30-day initial Phase 2 study you will have the opportunity to roll over into an open label study for an additional two months at the highest dose of SYN-010.

So the folks that are rolling over in the SYN-010, there is far more than half of the folks have already rolled over into the second Phase 2 study, are all on the highest dose of SYN-010 and not on placebo anymore. That's how we worked it in order to get patient compliance and hopefully to keep them from self-medicating with laxatives and whatnot.

Jeff, the final part was if data from these two Phase 2s would be sufficient potentially to decide on a pivotal study for this program.

That's a possible. We will have to have an end of Phase 2 discussion with the FDA to discuss that. Again nobody's ever looked at reducing methane gas as one of the primaries and we're also obviously looking at the number of bowel movements and the other typical criteria, bloating and pain, so we'll To have that discussion with them after the study.

If it works as well as we hope it does we may be able to move very rapidly into a Phase 3. We have staffed up in order to do so. If anybody read Dr. Ray Stapleton, our manufacturing guy's press release CV, he was responsible for Mevacor which is the Merck drug which is a form of lovastatin.

He's very familiar with that small molecule and the scale up of that molecule. And that's what we're heading for at this time. So we are anticipating given FDA approval starting a Phase 3 pivotal study or two of those next year.

Okay. I'll get back in line. Thank you.

Katherine Xu, William Blair.

Joe on for Katherine. So I have a question regarding the Phase 2b program for SYN-004.

So have any begun dosing patients yet and if so can you give some color on how recruit has been? And then also are you still planning on doing an interim analysis in that study? And then I have one more follow-up question.

Okay. The answer is we have been screening patients for the Phase 2b. We have not yet found anybody to begin dosing.

We have roughly I want to say between 10 and 12 sites already up and running in the US. There are several more sites coming on in Canada and another dozen or so in the US over the next few months. We're going to have probably over 40 sites coming online in December over in Central and Eastern Europe.

The reason we're using Central and Eastern Europe is because their dosing regimen of ceftriaxone for pneumonia, etc., is exactly the same as what we use here in the US. So that was one of the primary criteria. Again it's 100% dependent upon I hate to say it but the flu season.

If it's a bad season this year we could recruit very, very quickly. If it's not as bad a flu season it is going to take us a little bit longer which is why we're not giving strong guidance on when we think we're going to finish the study.

The interim look is really predicated on two things. This would be an independent external group that would look at this, both a clinician and a statistician. They would be looking at the stop point would be either when there are 10 cases of confirmed C. difficile in this patient population or if we've reached the halfway point which is about 135, 140 patients in this particular study.

Then we would stop it, we take a look at it or they would look at it. They would then provide guidance as to whether we need to keep going or to go higher if necessary. Depends upon what's going on.

We do have permission from the FDA to expand the study up to as many as 600 patients if necessary for this particular study in order to get the p-value. Again dependent upon the infection rates in these various hospitals which vary broadly.

All right, great, thanks. And then on the SYN-010 for the second portion of that study have any patients decided not to roll over and if so are you replacing those patients with new patients to get to that 60 total? And is there a threshold for breath methane at entry if so?

There's not a threshold and what we powered this for the second Phase 2 is between 42 and 45 patients. I can tell you that we are well over that at this point in time.

So the first Phase 2 is 60 patients-plus. The second Phase 2 we needed, we wanted to roll over minimally 42 to 45 patients for that study. And we are over that.

So I think we're good statistically. We just have to see what the efficacy patterns look like.

All right, great. Thank you.

Keith Markey, Griffin Securities.

Hi Jeff, hi Steve. Thanks for taking my questions. I had a couple of questions related to the pertussis experiment that's going to be performed.

I was just wondering how long do you think it's going to take or do you think your antibodies will last in an infant? And can you just simply describe the experiment? In other words, how many times will you challenge the animal and at what point after administration of the antibodies?

Hi Keith. I can talk very high level to that. The protocol has not been completely put to bed yet but I will tell you what we're thinking.

In our previous nonhuman primate studies which were in baby baboons we did see prophylaxis in those animals which was part of the overall package that was presented to the Gates Foundation vis-a-vis University of Texas Austin and what got them excited and interested and this would be a very interesting novel approach. So that was the genesis of the discussions about a year ago, give or take, and moving the project forward. So what we're going to do is basically just replicate what we did back then one more time to make sure that it is working the way that we want it to.

We are only using one antibody. We are using the antibody that binds to 1B7 which is one of the toxins. We do have twin antibodies that seem to confirm a potentially higher efficacy effect.

But we're going to use one because again if you think about what the Gates Foundation's mandate is they work in the developing world trying to cure illnesses, vaccinations, those kinds of things. So the idea for this antibody would be there is a newborn in developing country. They usually don't see the doctors very often.

When the mom comes in and gives birth they are going to get a little shot of our antibody which we hope can prophylax them for a significant amount of time to where they can then get a vaccination later when they get older and they can take the vaccination. That's the concept. As a Company we would maintain the therapeutic use for the developed world and developing world which would be more of a stockpiling type of marketing commercialization strategy but that's the general concept.

So timing wise it really depends on the number of newborn primates that are coming out. There is another group from the FDA doing some work that is sucking up some of the newborns. So we'll be sharing the number of newborns as we go forward.

We hope to have it done I would say sometime next year. I don't want to give a time because we're not -- as soon as we start we'll give more guidance on it. And then right after that obviously to get into the clinic is relatively very fast after that point in time.

Okay great. Thanks.

If you recall we have orphan drug status on that product that we received last year.

Very good. Thanks. Then I was wondering if you could give us a sense of the type of preclinical work that you and Intrexon have planned at this point so far for the PKU therapy?

We don't have any at the moment. We need to find the molecules that work first. We're using the ActoGeniX platform over in Belgium.

We're looking at the different vectors and picking the one that is going to be what we think is the most efficacious and then we'll jump right in at that stage of the game. We will likely be working with academic groups and their specific preclinical models to vet the program. It's a fairly well understood disease state and then again we'll move fairly rapidly I think at that stage of the game.

We do not yet have orphan drug status on this. We may go for that but it may be a much broader market than we suspect at the moment. So we're digging into that as we speak.

Great, thank you.

Adnan Butt, RBC Capital.

Thanks guys. So just one on 004. For the Phase 2b will the primary endpoint be CDI prevention?

And then in terms of the antibiotic associated diarrhea endpoint, do you think that's something the FDA has softened its stance towards that could be used as an approvable endpoint or is it exploratory? Last but not least the either AAD or CDI prevention, they will both be evaluated over the same time period? That's the last question, thanks.

Thanks. You're trying to bait me. The reality, I mean let's take a step back for the listeners.

In essence if you don't have antibiotic associated diarrhea, if you don't have diarrhea when you're in the hospital it's highly unlikely that you're going to have C. diff. It basically means that you've not disrupted your intestinal microbiome which means that it's generally intact and if it's intact you're not going to get diarrhea which means you're not going to set up an environment where the C. diff bacteria which may already reside inside of you, many of us already have them, we're colonized, can grow crazy and cause problems.

So AAD are antibiotic associated diarrhea is our secondary endpoint. I'm not aware of any other companies that have ever had that. The FDA did allow us to put that in there and that was actually a suggestion by the CDC in our case that that would be an endpoint that they would like to see.

So we are evaluating that. Clostridium difficile associated diarrhea or CDAD is a subset of AAD. So if we knock out AAD obviously we're going to knockout CDAD.

The bonus of that obviously is the number of patient enrollment going forward if we were able to show very strong correlation in that and we could make that a co-primary or we could have those discussions with the FDA to potentially move that up it would make the Phase 3 study significantly easier for us as far as numbers. Right now we're looking at reduction in C. diff infections in that population as a primary with the secondary being antibiotic associated diarrhea. We're also looking at deep sequencing of the microbiome before and after and those kind of things to look at the protection side of the equation as well going forward.

So we're hopeful that we can show a profound impact on AAD. Historically with the prior compound and with our compounds to date we have had nearly 100% efficacy in knocking out diarrhea in these patients. Again it's a really simplistic concept.

If you could protect the number of species and the sheer numbers of the bugs living in your intestinal tract you are going to protect the patient from getting diarrhea. And if the patient doesn't get diarrhea especially in a hospital setting life is much, much better not only for the nurses but the doctors and the patient's that are dealing with these nasty diseases.

And they can focus on the primary disease that the patient has versus secondary diseases caused by antibiotic usage. Does that answer your question, Adnan?

Yes, all set. Thank you.

This concludes our question-and-answer session. I would like to turn the call back over to Jeff Riley for any closing remarks.

Thanks, Keith. As more evidence is discovered regarding the importance of the human microbiome I would like to thank our new shareholders who share this vision. But I would also like to take a moment to personally thank our long-term shareholders for their continued support and our dedicated team members who are passionate about what they do.

In the short span of one year we have transformed from a preclinical stage Company into a clinical Company. And as we look ahead to the next year we look forward to morphing into a later stage clinical Company with our eye on commercialization in the next couple of years.

Every day Synthetic Biologics moves closer to the goal of offering novel microbiome-focused products to large markets with very clear unmet medical needs. With our two lead microbiome programs in Phase 2 development we are very excited about the progress we are making going forward.

We look forward to reporting on our continued progress, especially reporting top-line results from our Phase 2 trials for C. diff and IBS-C. We are positioned to create value for our shareholders at multiple points during the remainder of 2015. Thanks again everyone and have a wonderful rest of your evening.

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