Seres Therapeutics Inc (MCRB) 2015 Q3 法說會逐字稿

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  • Operator

  • Good morning ladies and gentlemen, welcome to the Seres Therapeutics 2015 financial earnings conference call.

  • (Operator Instructions)

  • As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Beth DelGiacco, Investor Relations.

  • - IR

  • Thank you and good morning. A press release for the Company's third-quarter 2015 financial results became available at 8 AM Eastern time today. It can be found on the Investors and Media section of the Company's website at IR.serestherapeutics.com.

  • Before we begin, I'd like to remind everyone that during today's call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about our future expectations, the sufficiency of our cash, cash equivalent, and investments to fund our operation, the potential impact of our microbiome therapeutics platform on disease, the progress and development of our product candidates, our position in the marketplace, the potential for rapid adoption and reimbursement of our products, and the timing of clinical trials and related data.

  • Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section in our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015, and other reports we filed with the SEC. Any forward-looking statements represent our views as of today only. We disclaim any obligation to update any forward-looking statements made on today's call.

  • I will now pass the call over to President, CEO, and Chairman, Dr. Roger Pomerantz.

  • - President, CEO & Chairman of the Board of Directors

  • Thank you all for joining us. I also have Eric Shaff, Chief Financial Officer, here with me today to walk through our financials at the end of the call.

  • We are very excited to be here hosting our first conference call as a public Company. It's remarkable how much we've accomplished since I added on the CEO role in mid-2014. At that point, we were a Company of about ten people, with early clinical results. Since then, we have made meaningful progress as a Company in addressing some of today's most urgent health needs and in establishing a totally new therapeutic paradigm, leveraging for the first time the human microbiome with the potential to transform the treatment of a wide range of diseases.

  • To recap our progress to date, we successfully completed a phase 1B2 study, SER-109, which we expect to be the first microbiome therapeutic in patients with recurrent C. diff and showed unprecedented results. Patients treated with SER-109 showed 97% clinical cure rates at eight weeks after treatment. Among those who did not recur at eight weeks and were able to be followed up, greater than 90% had a durable response at six months. In addition, we saw no significant safety adverse events. We advanced this candidate into phase 2 and expect to have data mid-next year.

  • We expanded our pipeline of drug candidates to address other critical patient needs, including what we expect to be the first design or synthetic microbiome drug SER-262, which we expect will be ready to enter clinical studies mid-next year in patients with primary C. diff. We have advanced SER-287, which we expect to be the first microbiome therapy for a chronic disease, through clinical development. We are on track to begin the clinical trial before the end of this year in patients with active, mild to moderate Ulcerative Colitis who have failed first-line therapy.

  • By successfully demonstrating the potential of our microbiome therapeutics to be truly disruptive to current medical paradigms, we have established Seres as the leading microbiome therapeutic company worldwide. We took Seres to the market, raising approximately $139 million in our successful June IPO. And we are just getting started.

  • As we continue to lead the growth of this totally new field in medicine, we are also pursuing promising applications for microbiome therapeutics in other inflammatory diseases, in the prevention of serious infections following high-dose chemotherapy, and in human stem cell transplant patients, and in the discovery of new drugs for metabolic diseases, including diabetes, obesity, and NASH. But this isn't simply a biotech R&D shop focused on discovery and development.

  • Critically, we are continuing to build a biopharma platform with capabilities to support these therapeutic efforts, including CMC and manufacturing. We believe these capabilities, which will be vital for the growth and expansion, contribute to the uniqueness of Seres, creating a competitive advantage versus others hoping to work in microbiome therapeutics. I'll expand on all of these exciting therapeutic areas in the Seres' story in a few minutes, but as this is our first call, we'd like to use the opportunity to reintroduce our microbiome platform and explore why we believe our clinically validated approach will truly transform modern medicine.

  • To start with the basics, what is the microbiome? We have ascertained that it is an ecosystem, such as a forest or a coral reef, comprised of trillions of microorganisms. There are more than 120 trillion bacteria on and in every human at any given time, mostly in your intestines comprising the colonic microbiome. While bacteria usually have a negative connotation, the colonic microbiome supports human health by providing several essential functions, including the ability to resist infection by pathogens, the maturation and regulation of the immune system, and essential elements of energy metabolism, including glucose control.

  • Because of this direct involvement in performing essential functions, we now understand that the microbiome is a true organ. Once we started looking at the colonic microbiome as an organ, we recognized that we can target therapies as we can for other organ systems. Importantly, we realized that we can modify this organ by providing normal bacteria to restore health in some disease states. The organ is the microbiome, the disease is dysbiosis, or an unhealthy state of the microbiome, and we look to resolve symptoms, including C. difficile infection in the microbiome by returning this organ back to the state of health and normal function.

  • And how do we do that? Well, we determined that C. difficile is an ideal place to show clinical proof of concept for our microbiome therapeutics platform. This was the initial low hanging fruit for microbiome therapeutics. C. diff is an urgent public health need. It is the most common hospital-acquired infection in the United States, affecting approximately 800,000 people, and causing more than 29,000 preventable deaths each year.

  • Using modern sequencing technology, we determined that patients with C. diff who recur repeatedly on broad-spectrum antibiotics have a remarkably dysbiotic microbiome and lack firm acutes, which are key anaerobic spore-forming bacteria required for the microbiome to perform its essential functions. With these data, we rapidly confirmed the safety and efficacy of SER-109 in animal studies and our CMC and formulation teams efficiently define the reproducible method to make and deliver SER-109 a first in-field microbiome therapeutic.

  • With SER-109 and with our entire ecobiotic platform, we are using bacteria themselves as a therapy. For over 100 years, if a patient had an infection, that patient was and is typically treated with an antibiotic. Seres is changing that worldview. We now know that there are certain diseases and medical conditions that should not be treated with an antibiotic, but should be treated with other bacteria. What could be more disruptive than that?

  • In a dysbiotic microbiome, there is a deficiency in the colonic bacterial ecology that allows pathogens such as C. diff, but not limited to C. diff, to take hold and cause infection. SER-109 is created out of the bacteria in spore form from organisms that have co-evolved with us for tens of millions of years. Following a highly efficient and cost-effective development path unique to this new therapeutic modality, we have shown in a paradigm shifting clinical study that this drug candidate works in a dose independent manner with no concerns for drug-drug interactions. It's simply four pills taken once.

  • This is the whole regimen, and as such SER-109 is patient-friendly and should be much easier for patient compliance than any other potential alternatives. The bacterial spores go to the colon, turn back into bacteria, and replicate, restoring bacterial diversity and function, and bringing the microbiome back to a state of health. Of note, we use the colon as a bioreactor and the drug has been demonstrated to be dose independent. That is why the FDA does not require us to do a formal dose-finding phase 2B trial.

  • Our phase 1B2 study has validated this hypothesis in what we do believe to be unprecedented clinical results. We treated 30 patients in the US who presented with multiply recurrent C. diff after broad-spectrum antibiotic treatment, patients who experienced three or more episodes of C. diff within the last year. We looked at the responses at eight weeks, but also looked at the durability of SER-109 at six months. The eight week endpoint is critical because the medical literature shows that if a patient is going to recur, the vast majority of patients with C. diff recur within this timeframe.

  • In our study, we found that after treatment with SER-109, 97% of patients, or 29 out of 30, achieved a clinical cure, which was defined as the absence of diarrhea requiring antibiotic treatment. We also demonstrated minimal clinical carriage of C. diff at eight weeks, and as we looked out to six months, we saw greater than 90% long-term efficacy. With these data, we went back to the FDA and got the go-ahead for a phase 2 study, and have since received both orphan drug status and breakthrough designation for the first microbiome therapeutic candidate.

  • We initiated our phase 2 study in May of this year and expect to have topline results by mid-next year. The phase 2 is expected to enroll 87 patients across approximately 36 sites in the US, and is a randomized, double-blinded, placebo-controlled study. Similar to the Phase 1B2, the endpoints are very tractable and will include the absence of recurrence of C. diff through eight weeks after treatment.

  • After our Phase 1B2 success and clinical momentum in recurrent C. diff, the obvious question is, why not seek to prevent initial recurrence of C. diff in the first place? With SER-262, we plan to do just that. SER-262, the first synthetic or designed ecobiotic, is expected to enter the clinic mid-next year for primary C. diff. SER-262 is intended for patients who have been diagnosed with C. diff, received standard of care antibiotics for C. diff, and are then dosed with SER-262 to prevent any recurrence. Of note, recurrence of C. diff after a primary episode occurs in 25% to 30% of patients.

  • We have used our proprietary library of now over 13,000 bacterial strains, all present in a healthy human microbiome, to rationally design this drug candidate in vitro, and then grow the strains in anaerobic fermenters. It's been tested in animal models and we saw a remarkable potency similar to SER-109, including protection against both mortality and weight loss due to infection. Of note, we believe our unique library of organisms allows us to rationally design synthetic microbiome drugs for a host of diseases with high unmet medical needs in many therapeutic areas.

  • SER-262 and SER-109 comprise our C. diff franchise. While we believe the market for recurrent C. diff in the US is up to 110,000 patients, the market for SER-262 for primary C. diff is significantly greater. We estimate 800,000 patients or more in the US alone. Seres' goal is to provide a solution for every C. diff patient in the US, and then around the world and eliminate recurrence of this disease.

  • Our unwavering goal is to eliminate this growing scourge from hospitals and in the community, while also creating a compelling pharmacoeconomic case in support of our therapy. Today, each recurrent episode of C. diff costs $18,000, or even greater, to manage, a total cost burden of billions to the US healthcare system. We believe that the potential combination of a high clinical cure rate and a clean safety profile will strongly positioned our C. diff products for rapid adoption and reimbursement. From a pharmacoeconomic standpoint, we intend to provide real and immediate value to the healthcare system by sharply reducing the costs of managing C. diff for payers and for hospitals.

  • Our C. diff franchise is just the beginning of how we intend to use microbiome therapeutics to treat disease. We've taken a rigorous systematic and strategic approach to mapping out our pipeline, and as we learn more with each study and each indication, we will use this growing knowledge to rapidly develop the next generation of microbiome drug candidates, which we believe increases our probabilities of success in each of our chosen therapeutic areas and franchises. Building on the clinical results observed in C. diff, we now are looking beyond this to chronic disease indications where a change in the functional diversity of the microbiome can potentially impact these multi-factorial and difficult to treat disease states.

  • Like in C. diff, we began our initial development work for SER-287 with the advantage of knowing that fecal microbiota experiments conducted the US and in Europe provided support for the idea that directly addressing the microbiome could make a meaningful clinical difference in the treatment of active ulcerative colitis. Building on these insights, we formulated SER-287 as our first microbiome therapeutic candidate for a chronic disease. In several complementary, preclinical animal colitis models we have now demonstrated that SER-287 can reduce colitis signs and symptoms, as well as improve major histopathological measures. We are preparing to launch an initial Phase 1B study in patients with active, mild to moderate, ulcerative colitis.

  • The study is expected to be randomized, placebo-controlled, multiple dose study to evaluate safety and tolerability, changes in the microbiome, and the clinical response to SER-287 versus placebo, when added to a failing standard of care treatment regimen for ulcerative colitis. And similar to the C. diff franchise, we plan to start with SER-287, a biologically sourced product, but then expect to move towards a synthetic approach drug candidate SER-301. Of note, this is a clear example of how Seres and our fully integrated discovery to manufacturing platform can move with alacrity, and in a cost and time efficient manner to design and test drug candidates in the new microbiome space.

  • I think we are only beginning to see the power impossibility our technology and our differentiated approach to attacking disease. For example, in our SER-109 study, we observed and isolated an abundance of potential human pathogens and drug-resistant microbes present in a dysbiotic colonic microbiome of our patients. Interestingly, once treated with SER-109, not only did these patients tend not to have a recurrence of C. diff, these resistant organisms were dramatically reduced or fully eliminated.

  • A clear medical need for elimination of gut pathogens exists in a hematopoetics stem cell transfer patients, where deaths and illnesses from bacterial infections and graft versus host disease, correlate with increased gut dysbiosis. And so with an eye towards developing better drugs for patients in need, we have started work on SER-155 for these new indications. We don't have guidance yet on when this will be entering the clinic, but stay tuned.

  • We are also optimistic about the application of the microbiome for certain rare genetic diseases and for enhancing the safety of immunooncology drugs. In the setting of rare diseases, we believe we can engineer or establish specific consortia of microbiota that provide needed functional pathways to treat certain rare, genetic diseases.

  • In the setting of immunooncology, it is becoming increasingly clear that the composition of the gut microbiome plays a major role in determining the activation state of the immune system, which can play an important role in the safety profile of drugs that act via an immune mechanism. Immunooncology therapeutics have been shown to induce an inflammatory colitis, which we believe may be amenable to a microbiome solution. All of this is driven by our appreciation that the gut is the largest reservoir of immune cells in the body and is actually the largest immunological organ. We expect to have more to say about our efforts in rare genetic diseases and immunooncology in the future.

  • On top of all of these exciting developments within our pipeline, we have also been working behind the scenes in expanding our excellent Board with industry veterans with deep clinical and commercial expertise to help guide our rapid development. In June, we announced the appointment of Dr. Dennis Ausiello. Denny was the Chief of Medicine at Mass. General Hospital of the Harvard Medical School for 18 years, and continues to serve on the board of companies such as Pfizer and Alnylam. We believe he adds significant clinical leadership experience with a strong understanding of clinical trial design.

  • We also announced more recently the appointment of Kurt Graves to the Board. Kurt is the Chairman & CEO of Intarcia and has successfully built blockbuster drug franchises over the last 20 years. As we look towards commercialization of our products, Kurt will be an invaluable source of counsel and experience.

  • I also want to mention that we continue to build out our patent estate. We have another new allowed patent bringing our total to four US patents that have been allowed or issued, covering composition of matter and method of use for 109 for the entire C. diff franchise, and also ulcerative colitis and Crohn's disease. We expect to have more approvals soon, including patents on SER-155.

  • I'd now like to ask our CFO Eric Shaff to walk you through our recent financial performance.

  • - CFO

  • Thank you, Roger, and good morning, everyone. Today I'll be reviewing the results of the third quarter. I will provide an overview of some of the key components of our operating expenses, and I'll also provide an update on our balance sheet.

  • We reported a net loss in the quarter of $14.6 million, as compared to a loss of $4.6 million for the third quarter of 2014. The increase in net loss is driven by our continued growth in headcount, clinical and development spend related to SER-109, and the ongoing development of our microbiome therapeutics platform, as well as increased facilities costs in connection with the leases we entered into during 2015. The third-quarter net loss included stock-based compensation of $2.5 million, as compared to $0.6 million in the same period of the prior year.

  • Research and development expenses for the third quarter were $9.9 million, as compared to $2.5 million for the same period in the prior year. The increase in R&D expense was primarily due to expenditures in connection with our microbiome therapeutics platform, and clinical development of SER-109. R&D expenses for the third quarter included stock-based compensation expense of $1.3 million, as compared to $0.3 million for the same period in the prior year.

  • General and administrative expenses for the third quarter were $4.7 million, as compared to $1.1 million for the same period in the prior year. The increase in G&A expense was due primarily to our continued investment in business personnel and facility expansion to support overall growth, as well as increased professional fees and other costs associated with operating as a public Company. G&A expenses for the third quarter included stock-based compensation expense of $1.2 million, as compared to $0.3 million for the same period in the prior year.

  • Moving on to the balance sheet. We ended the prior quarter with $91.8 million in cash, cash equivalents, and investments, and ended the current quarter with $219.3 million in cash, cash equivalents, and investments. The increase in cash was due to the receipt of net proceeds of approximately $139 million, received upon the closing of our IPO earlier in the quarter. Cash burn during the third quarter included $1.5 million in capital expenditures to support increased lab activities and expansion of our internal manufacturing capabilities.

  • In addition, during the third quarter, we elected to retire our outstanding term loan debt and made a payment of $1.8 million to settle all outstanding principal amounts, final payment fees, and accrued interest. As of September 30, 2015, we had no outstanding debt on our balance sheet.

  • Finally, I'd like to reiterate our prior guidance as it relates to cash, cash equivalents, and investments. We believe that based on our current operating plan, we expect that our existing cash resources, as of September 30, 2015, will enable us to fund operating expenses and capital expenditure requirements, excluding cash inflows or outflows from business development activities, through at least the first half of 2017. We are pleased with our financial condition and our activities remain on target.

  • Now, I'll turn the call back over to Roger.

  • - President, CEO & Chairman of the Board of Directors

  • Thanks, Eric. Before we take your questions, I would like to say how pleased we have been with the growth of Seres to date and with the ongoing support from our shareholders and analysts. In addition, we expect the fourth quarter and 2016 to bring even more progress.

  • I'd like to quickly highlight the milestones we expect in the next nine to 12 months across our programs. For SER-109, our phase 2 study is underway and we expect to report topline data in the middle of next year. At that point, we will work with the FDA to finalize the clinical development and regulatory plan to get this breakthrough and orphan drug candidate to patients as rapidly, but as safely, as possible.

  • We also intend to move with what we expect to be the first synthetic microbiome drug targeting primary C. diff, drug candidate SER-262, into the clinic by the middle of next year. In our other programs, we expect to have the first microbiome therapeutic candidate for chronic disease, SER-287, into clinical development in patients with active, mild to moderate ulcerative colitis, by the end of this year. And we will continue our work on SER-155 to protect against both resistant bacterial infections and graft versus host disease, GVHD, following allogeneic stem cell transplants and will update you as we move this exciting new drug candidate forward.

  • I have said before that at Seres we are building a Company as a chimera. We combine the best of biotech with the best of biopharma. Our discovery efforts are cutting edge and we strive to be nimble and dynamic, evidenced by the speed in which we have been able to pivot around our SER-287 program and move it from inception to clinical trials, with remarkable speed and agility.

  • But at the same time, we have built solid capabilities and hired deeply experienced professionals in critical areas, such as CMC, folks who have track records of success and accomplishments in actually manufacturing drugs, which are approved by the FDA, an area where young companies typically face challenges. Unlike many biotech companies, we do not only do paradigm shifting science and biomedicine, but also, due to our seasoned CMC teams and their accumulating trade secrets, we can put a pill, in essence a true medicine, on the table very early in the process and in a highly cost-efficient manner.

  • Seres is now organized in three overarching therapeutic areas, with expertise from discovery to translational medicine, and then to clinical. These areas are infectious diseases, inflammatory diseases, and metabolic diseases. We are building an enterprise, careful not to move too quickly or spread ourselves too thin, but at the same time working with urgency to bring medicine to patients who need them most. It is truly an entirely new field in biomedicine and patient care.

  • We are sincerely thankful for the strong support we've experienced from our stockholders, through our IPO, and all of subsequent interactions. We look forward to working closely with you and keeping you up-to-date on the progress we are making across all of our programs and all of our therapeutic areas. Thank you very much for your time today and now we'll open the call for your questions.

  • Operator

  • (Operator Instructions)

  • Joseph Schwartz, Leerink Partners

  • - Analyst

  • Congratulations on all the progress. I was wondering if you could talk a little bit more about the phase two trial design and goals for SER-109, and how does that extend from the experience that you generated in phase 1B2?

  • - President, CEO & Chairman of the Board of Directors

  • Sure, I would love to answer that. So we first of all are pleased with where we are with the phase two trial, it's enrollment moving forward and 36 approximate centers across the United States and remain on track as I said, for the read out in mid-2016.

  • When we think about a further phase three, we will have more guidance on the start and potential design of the phase three, after we analyze the phase two data of course. But it's important to say that the phase two trial that's going on is highly similar to what we've showed in the unprecedented data in phase 1B2, the same group of patients, the main difference is that it's spread throughout the United States in both community and large centers, really as part of not only doing the trial as broad as possible, but also getting the word out of what a microbiome drug will look like.

  • We think this accomplishes both and again, we expect to read out in mid-2016.

  • - Analyst

  • For ulcerative colitis, can you talk a little bit about your strategy there relative to the data that has been generated for FMT? How do you anticipate that you'll be able to re-capitulate that or maybe even expand upon what has been generated there. Are there any technical challenges to administering SER-287 orally versus doing FMT from the other direction?

  • - President, CEO & Chairman of the Board of Directors

  • That's a great question, Joe. Just to talk a little bit about SER-287, again we are on track to initiate the study this year, still ironing out the final details with the FDA. We expect this to be chronic dosing.

  • To your point, one of the things that made us pivot and move here with alacrity, and now with animal model data in our own shop to show that SER-287 has a meaningful effect, at least in these animal models, was the fecal transplant data where, through colonoscopy, fecal transplants given once a week for two months, not a great regimen to commercialize, but a great proof of concept that the microbiome can work, where there were lots of changes in the Mayo Clinic scores of those patients, both in the two centers in the US and in Europe, and then what we're seeing was really remarkable, about 25% complete remission, very similar to what you see with monoclonal antibodies.

  • When we saw this, we said "aha," it was the same phenotype clinically as what we saw with C. dif. We pivot around SER-287, we have animal model data now, and we have this really strong proof of concept that chronic fecal transplants do help these patients. These are patients again who are failing firstline therapy, five ASA, and plus minus steroids, before monoclonals and immunosuppressants.

  • Our goal is to hit the population. It's the highest medical need for patients and it obviously is a great pharmaco economic space for a drug. When we look at the data, both in animals and in fecal transplants, we remain optimistic that a drug, not given once, but given chronically in different arms of this trial, will have a meaningful impact on not only the microbiome, but safety and efficacy in this portion of the disease.

  • Does that help?

  • - Analyst

  • Yes, very helpful.

  • Operator

  • (Operator Instructions)

  • Terence Flynn, Goldman Sachs

  • - Analyst

  • First, on SER-109, was just wondering what the latest thoughts are on XUS development plans. I know you guys have been talking to XUS regulators. And the second, I heard you say in your prepared remarks about a new allowed patent for SER-109. Just wondering if you can give us any more details there with respect to exactly what that covers and how it differs from your previously allowed patents.

  • - President, CEO & Chairman of the Board of Directors

  • Sure. Those are both great questions. As I've said, we believe SER-109 is not only a great drug candidate for recurrent C. dif in the US, but in Europe and around the world. When we think about how we will commercialize this, we intend to do SER-109 in the US ourselves, tractable call points, 100,000 to 110,000 orphan patients, key call points with G.I. and I.D. physicians. I've done this before in other lifetimes and that we think we can do quite well.

  • In Europe, we would be looking quite clearly for some partnering, but in Europe again, we might look at an alternative, a joint commercialization effort. But I'm not crazy, this is a worldwide drug and for brick, brick plus countries that have much of this epidemic where antibiotics are used quite frequently, we'll look to partner for the rest of world.

  • We, as you've mentioned, have spent the summer in Europe a lot with the team, not only at places such as Nice, but at various countries around Europe, their regulatory agencies, as well as the central regulators at AMEA. We have a real good idea what both the US and the European regulators need and want, and as I said we'll do it ourselves in the United States. We'll look for probably a joint commercialization effort in Europe.

  • Then your second question was on patents. And so yes, we did receive another patent for covering composition of matter method of use in the C. dif franchise. We don't really talk about the details of it, but I can tell you that we are very comfortable with our patent estate, both over all of C. dif, the entire C. dif franchise, SER-109 and SER-262, and also in IVD, and I'm not limited it to UC because we do have patent coverage for Crohn's.

  • Operator

  • John Newman, Canaccord CNET

  • - Analyst

  • I had a follow-up question on SER-287. What are some of the things that you are looking for as an early indication that SER-287 will be active in ulcerative colitis? I know that there has been some work done with fecal transplant there. That's very interesting, but what are some of the things that you're looking for both from the in vitro site and obviously in patients?

  • In patients, we know what the endpoints are, but what are some of the other things that you're looking for as an indication that the approach is going to be active?

  • - President, CEO & Chairman of the Board of Directors

  • That's another great question. As you explore a chronic disease that's multifactorial, it becomes somewhat more complex compared to, in a relative term, simple ID indications that are curable with an alien pathogen. When you look at SER-287 the fecal transplant was actually very important to us.

  • As you know, we like to go from the bedside to the bench back to the bedside in translational medicine. But we do have and have developed, a really great animal modeling preclinical translational group. So with the data that we have from fecal transplants in humans, the data we now have in the animal models, we have in our own hands and we are, as I said, cautiously optimistic.

  • Now to your point, in the trial, we are going to look very broadly because this is the first microbiome trial where true molecular and microbiologic meta-genomic analyses are used. So we will do a few things. We will chronically treat these patients.

  • We will look up front and at the end of the trial using flexible endoscopy about mucosal healing, which has become sine qua non of a really strong agent. We will do a lot of microbiome work looking at biomarkers, but also look at inflammatory biomarkers. We think that biomarkers are going to be key in deciding which patients get a microbiome therapy in IBD in general and in UC in particular.

  • So when you look at this trial, we are clearly looking for a changes in clinical endpoints, both the Mayo Clinic scale, remission, as well as, a mucosal healing. But we also want to use it as an exploratory approach, which we think is really will be trendsetting in determining biomarkers, which help segregate, what is really, I call a 19th century syndrome, inflammatory bowel disease, into modern molecular meta-genomic modern diseases.

  • Operator

  • (Operator Instructions)

  • I am not showing any further questions at this time. I would like to turn the call back over to Roger.

  • - President, CEO & Chairman of the Board of Directors

  • That's great. Thank you for coming to our first call. It was quite exciting, and I enjoyed letting you all know the Seres story and where we are. I look forward to talking to you all moving forward, both on these calls and informally as well. Thanks again.

  • Operator

  • Ladies and gentlemen, that does conclude today's presentation. You may now disconnect. Have a wonderful day.