Protagonist Therapeutics, Inc. (PTGX) 2017 Q4 法說會逐字稿

Good day, and welcome to the Protagonist Year-end 2017 Update Call. Today's conference is being recorded.

At this time, I would like to turn the conference over to Tom O'Neill, Chief Financial Officer of Protagonist. Please go ahead.

Thank you, operator. Good afternoon, everyone, and welcome to Protagonist's First year-end update call. You can listen to a live webcast or a replay of today's call by going to the Investor section of our website at protoganist-inc.com.

Before we begin, I'd like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for the purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the risk factor section of our annual report on Form 10-K, which is on file with the SEC.

While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change.

With that, I will now turn the call over to Dr. Dinesh Patel, President and CEO.

Good afternoon, everyone, and thank you for joining us on the call today to review our fourth quarter and year-end financial results and to provide a corporate update.

This is Protagonist's first earnings call and we look forward to creating and continuing this tradition of conducting year-end calls in the future going forward.

On today's call, I would like to take the opportunity to talk about 3 specific topics: First, we would like to talk about what is unique about Protagonist as a company; second, we would like to reflect upon our key accomplishments for 2017 as outlined in our press release that was issued today after the market close; and third, we would like to highlight the key catalysts and milestones we anticipate going forward for the year 2018.

Following that coverage, Tom will review our financials and after that, we will open up the call to a Q&A session.

On the call today, we also have with us, besides me and Tom, Dr. David Lu, our Chief Scientific Officer and Head of R&D and Dr. Richard Shames, our Chief Medical Officer. And they will be available to address any questions you may have during the Q&A session.

Okay, so let's begin by first talking about Protagonist, the company and its distinctive features.

We stand here today as a company possessing what I consider to be 3 quite compelling attributes: Our platform, our products and our people.

So first, we have an innovative proprietary peptide technology platform that enables us to discover novel tech sites in a dido of fashion and that can match the potency and selectivity of Biologics, with the added option of engineering oral stability into this website, if we choose to do so.

Second, through the use of this technology platform now, we as of today have built a pipeline of 3 different clinical stage assets. These 3 assets, namely PTG-100, PTG-200 and PTG-300, have the potential to truly transform the existing treatment paradigms for patients with significant unmet medical needs in various disease areas, including the blockbuster category of inflammatory bowel disease or IBD as well as rare diseases such as beta-thalassemia and chronic arthritis.

The third attribute is the incredible team of people, we have a sample to help us bring innovative, differentiated, potentially safer and more convenient treatment options to patients.

I have always maintained that Protagonist is about great assets and a great team and I truly believe that 1 needs both in order to be successful in the long run.

We have grown from 45 outstanding employees in 2016 to now 55 outstanding employees at the end of 2007 (sic) [2017], and we are planning for similar additional growth in 2018 by continuing to attract very high caliber talent to Protagonist.

Besides the employee pool, we have also strengthened our board of directors’ team in 2017 by appointing 2 new members with significant biotech industry and drug development experience.

Dr. Rusty Williams, who is currently Executive Chairman and founder and former President and CEO of Five Prime Therapeutics, is 1 addition, and the more recent 1 is Dr. Sarah Noonberg, who was recently Chief Medical Officer of Prothena Corporation.

So that was the overview about Protagonist, the company. Innovative platform, transformative and paradigm-shifting products and highly talented and passionate group of people.

Now let's go on to the second part of my talk, which is a short review of the highlights of 2017.

It was truly a transformative year in the history of Protagonist, where we began the year with 1 asset in clinical development and aggressively advanced our product pipeline during the year with 3 different assets in clinical development by the end of the year.

Let me point out that we have 2 different types of assets. The first 2 oral peptides are targeted therapy for IBD. Let's refer to that as a blockbuster category. What is a third asset is an injectable peptide for treating rare blood diseases so that's the orphan drug or the rare disease category.

With the 2 oral peptides, PTG-100 and PTG-200 for IBD, a common theme is that these peptides target the same biological pathways that are already validated by FDA-approved injectable antibody drugs.

For PTG-100, we commenced a global Phase IIb trial in ulcerative colitis. It targets alpha-4-beta-7 integrin, the same target through which the antibody drug ENTYVIO works. This is a drug from Takeda Pharmaceuticals that has been approved for both UC and Crohn's disease.

For the other asset, PTG-200, this is the asset that is partnered with the Janssen Pharmaceuticals. We commenced a Phase I safety study in healthy volunteers towards the end of 2017.

PTG-200 targets the IL-23 receptor and you may recall that Janssen's antibody drug Stelara is also an IL-23 pathway blocker that has been approved to take for psoriasis and Crohn's disease. So that's about our blockbuster potential IBD drugs in the gastrointestinal disease area space.

Our third asset is PTG-300 and it is outside of the G.I. area. It is an injectable peptide and is in clinical development for the potential treatment of anemia and iron overload related to certain rare blood disorders.

In the last quarter of last year, we completed a Phase I study in healthy volunteers. In this study, PTG-300 was well tolerated, with no serious adverse events or dose limiting toxicities reported.

In addition, we were also able to establish pharmacodynamic based clinical proof of concept with PTG-300 based upon achieving those related reductions in serum ion levels in healthy volunteers.

So for now, let's move from product development to business development and financing activities of last year.

On the partnership front in 2017, we signed a global licensing deal with Janssen Pharmaceuticals for PTG-200 when it was a preclinical stage asset.

The deal terms included a $1.50 million upfront payment and up to an additional $940 million in potential development and sale milestones as well as double-digit deal royalties on net sales and up to 30% co-detailing rights in the U.S.

I do want to point out that these futuristic $940 million bio-dollars do include license option payments of $125 million at the Phase II interim analysis and an additional $200 million at Phase II completion if Janssen chooses to retain its option for the license at those specific time points.

Overall, with the $50 million upfront payment from Janssen in the third quarter, along with the completion of an equity financing in the last quarter of 2017 that made it $64.5 million, we believe that we have adequate financial resources to fund operations through 2019.

So now that we have gone through an overview of the company and summarized the key accomplishments of 2017, let's move to the third segment of today's presentation.

What holds for us in the future, as we progress into 2018?

To make it very clear and simple, the Protagonist team has identified 7 specific milestones for 2018, which we believe will be a reflection of the maturity of our innovative products pipeline, further validation of the platform and the steady growth of company as an organization.

So starting off with PTG-100, our G.I. restricted alpha-4-beta-7 integrin oil peptide antagonist, there were 3 events that we hope to unveil during the year. First, an interim futility analysis for the ongoing Phase IIb trial in moderate to severe ulcerative colitis is planned for later this month. And second, we anticipate reporting final top line results from this trial in the fourth quarter of this year.

As a refresher, the ongoing Phase IIb UC study is a 200-plus patient global placebo-controlled trial to assess the safety, efficacy and dose-response relationship of up to 3 different doses of PTG-100 against placebo.

The planned interim futility analysis will be conducted by an independent data monitoring committee or the DMC.

This will result in a recommendation for continuation of or termination of the trial, which we will then communicate accordingly in the form of a go-no go decision via our press release.

If the trial has not met futility criteria and will continue, the DMC will have identified the most informative dose arm or arms to take forward, which includes dropping 1 or maybe even up to 2 out of the 3 active dose arms.

As you well know, the management will remain totally blinded to all the interim data including the number of doses selected or dropped, or the specific nature of the dose levels selected or dropped, in order to preserve the integrity of the trial.

Our third anticipated milestone for PTG-100 is based on the optimistic assumption that if the interim analysis of the UC trial is not futile, we will [then] shift clinical development of 100 for a new indication and that is chronic arthritis.

Arthritis is a rare inflammatory disease in UC patients who have undergone a total proctocolectomy followed by the construction of an ileal anal pouch commonly referred to as a J pouch.

There are currently no approved treatment for pouchitis and this disease affects approximately 20,000 patients in the U.S. and about the same number of patients outside of the U.S.

Our rationale for moving into pouchitis is based upon the relevance of the biological target alpha-4-beta-7 integrin to this disease, coupled with reported case studies of ENTYVIO, the [upload] integrin antagonist antibody that have demonstrated potential clinical benefits of such an agent in the treatment of the disease.

We can also share that we recently had a positive dialogue with regulatory agencies, including both the U.S. FDA and the MHRA in Europe and anticipate initiating a Phase II/III pouchitis trial in the second half of 2018 assuming the interim is not futile.

So those are our 3 specific milestones, affiliated with PTG-100 Phase II interim UC trial outcome in Q1, top line results in Q4 and potential initiation of a pouchitis trial in the second half if the interim UC outcome is not futile.

Now let's touch upon PTG-200, our oral G.I. restricted IL-23 receptor antagonist peptide for the treatment of IBD that we are developing in collaboration with Janssen.

We expect to achieve 2 specific milestones with PTG-200 in the second half of 2018. The first is the completion of the ongoing Phase I study and the second is filing the U.S. IND and starting a global Phase II trial in Crohn's patients in collaboration with Janssen.

As you may recall, we initiated a Phase I [sat mat] study with 200 in normal healthy volunteers in November 2017.

In the second half of this year, we intend to finish the study and report the Phase I top line results including safety, tolerability and PK observations.

Assuming favorable outcome, Janssen will plan to file an IND with the U.S. FDA and we will collaboratively initiate a global Phase II trial by the end of the year.

So in summary, we anticipate 2 milestones with PTG-200: Phase I completions and Phase II initiation. Both expected to occur in the second half of 2018.

So now, so far, I have covered 5 milestones for 2018, 3 associated with 100 and 2 milestones with 200.

This brings us to our sixth milestone and that is affiliated with PTG-300, the subcutaneous hepcidin mimetic, which we are developing for the treatment, potential treatment of anemia and iron overload in various rare blood disorders and diseases.

We are glad to highlight that just yesterday, we announced that the U.S. FDA has granted orphan drug designation to PTG-300, specifically for the treatment of beta-thalassemia. We plan to initiate a global clinical trial in these patients in the second half of this year, following our discussions with the regulatory authorities in the U.S. and Europe.

So that was about our sixth anticipated milestone and now at last but not least, let's talk about the seventh potential milestone.

As you may recall, all of our 3 assets, PTG-100, PTG-200 and PTG-300, have spanned from our internal proprietary peptide technology platform. Over the years, we have continued to optimize and apply the platform to new areas of significant unmet needs.

In that context, we expect to announce our fourth peptide asset, PTG-400 and commence IND enabling studies in the second half of this year. PTG-400 is an oral peptide that we intend to develop for a G.I. condition other than IBD.

So that wraps up the 3 main topics I wanted to highlight today. One, that we are a unique company with great platform, great products and great people. Second, it summarizes our accomplishments in 2017, which was a very successful and transformative year in the history of Protagonist. And third, we described the 7 specific anticipated milestones for 2018, which we believe is a reflection of the steady growth of our transformative assets and maturation of Protagonist as an organization.

With that, now, I will turn the call over to Tom to review our fourth quarter and year-end financial results. Tom?

Thank you, Dinesh. As Dinesh pointed out, we accomplished a lot in 2017, and believe we are well-positioned for 2018.

We ended 2017 with $155.5 million of cash, cash equivalents and investments. This includes the $50 million upfront payment from Janssen in the third quarter and $64.5 million net from our follow-on financing in Q4.

We do expect 2018 expenses to increase compared to 2017 as we advance our programs. We anticipate having enough resources to fund our operations through 2019.

To briefly summarize the financials, net loss for 2017 was $37 million as compared to $37.2 million for the prior year. Increased expenses in 2017 were partially offset by the Janssen license and collaboration revenue recognized during the last half of 2017.

The increase in expenses was due to higher research and development activities related to PTG-100, PTG-200, and PTG-300 clinical trials and other preclinical product candidate studies, as well as higher general and administrative expenses for operations.

License and collaboration revenue was $20.1 million for the full year 2017, consisting of $19 million of the $15 million upfront payment recognized in 2017 and $1.1 million of other services revenue for activities performed under the Janssen agreement.

Protagonist did not recognize any license or collaboration revenue in the prior year.

Research and development expenses for the full year 2017 were $46.2 million compared to $25.7 million for the prior year.

Higher research and development expenses in 2017 reflect the fact that we now have 3 assets in the clinic and continue to make progress with preclinical development studies for our other product candidates.

General and administrative expenses for the full year 2017 were $11.8 million compared to $7 million for the prior year. The increase in G&A expense supports the growth of our headcount in operations.

As mentioned, we ended 2017 with $155.5 million in cash, cash equivalents and investments.

With that, I will now open the call for questions. Operator?

(Operator Instructions) Our first question comes from the line of Ian Somaiya of BMO Capital Markets.

I had 2 questions for you, 1 on PTG-100 and other one on PTG-200. So on 100, as we approach the interim futility analysis, I think it'd be helpful for you to remind us exactly what the DMC would be looking at in terms of the efficacy results. Will there be any limitation? Or will the focus be on the primary endpoint or just clinical remission? What assets of the endoscopy data will be evaluated? Just if you could review that. And then, I have 1 follow-up on the 200 program.

Sure. It's a very relevant question and I will have our CMO, Rich Shames, answer the question.

Thank you, Dinesh and thank you, Ian, for the question. So as you recall, this is a global trial in approximately 240 patients with moderate to severe ulcerative colitis. We are starting the trial with 4 arms, 3 active arms and 1 placebo. And the trial is fully statistically powered to the primary endpoint of clinical remission. This is a 2-stage adaptive design in the sense that after the first 60 to 80 patients have been enrolled, we will conduct an interim analysis, primarily focused on futility and assuming that we pass the futility bar, then dose optimization decision will be made by an independent data moderating committee so we will remain blind to these results. Now, the futility analysis is based primarily on a conditional power -- achieving a conditional power of at least 10%, which assumes that there is at least a 10% probability of success if we continue enrolling the trial. Now this is based primarily around the primary endpoint of clinical remission. However, the DMC will also ensure that there is consistency among the key secondary endpoints, which as you mentioned include endoscopy scores, clinical response, et cetera. So that will be necessary for a decision around futility. Now assuming again that the trial is able to continue, then the DMC will be able to look across these clinical endpoints and if necessary, some of the pharmacodynamic end points, to look for a dose response among the 3 active doses compared to placebo. And based on that and balancing safety and efficacy, the DMC will make the best decision about moving the optimal doses forward. Now this is all -- this guidance is all provided to the DMC in the charter and 1 important consideration is that the DMC has been instructed to -- if there is not a clear dose discrimination present between the active doses, to take the 2 highest doses forward to -- for the remaining part of the trial. And this, of course, would optimize the probability of success at the end of the trial.

Okay. That's very helpful. And on the PTG-200 program, my question again relates to the interim analysis and the trigger for the $125 million option payment. Can you just walk us through what you and Janssen, or in this case, I guess, Janssen more specifically, will be looking at in confirming trial continues but also the option payment is made to you? And similarly, the $200 million payment at the end of Phase II, I'm assuming there is set criteria that have been laid out? And I just wonder if those are part of the contract? Or TBD when the data becomes available?

Ian, this is Dinesh. I can answer that question. The short and dull answer is that at this stage, we are not in a position to reveal any details of the Phase II study. This is, as you know, a collaborative asset now with Janssen. So we may opt to disclose the right amount of information at the right time. I do want to, however, clarify that the potential interim payment and the end of Phase II payment are based more around the idea of letting Janssen retain that option for the license and not necessarily attached to any specific clinical milestones.

Our next question comes from the line of Joseph Schwartz of Leerink Partners.

This is [Dagon] dialing on for Joe. Just a couple from me. With regards to the 100 futility analysis that you were going to be conduct later this month, just wondering if you can provide a little more context around the timing of your Phase II/III initiation study in chronic pouchitis? Are you already engaging some sites to facilitate that launch as soon as you get the futility analysis? Or how long of a bridge would we expect before that trial gets underway?

So I can give a short answer and then Rich, you can opt to elaborate if necessary. But yes, the idea is like all the background work, preparation is in progress for the pouchitis, meaning -- I think as we mentioned, we have had our dialogue with the regulatory agencies and in terms of the timing of the sequence of events, if the Phase II interim is positive -- I mean, is not futile, then we will be initiating the pouchitis in the second half of 2018. And as you can anticipate, the first component will be like an open label component of the study.

Yes. Thank you, Dinesh. I would just emphasize, Joe (sic), that we did have very successful meetings with both FDA and European agency. We are moving forward with plans for a Phase II/III study. The initiation of the Phase II part of the study, which essentially will be a pilot and dose finding component, would be after we pass the futility analysis decision and then we would not initiate the Phase III part of the study until the readout from the Phase II UC results.

I see. And then with regards to your future with PTG-100, I know you can only disclose so much with regards to your 200 partnership with Janssen but just wondering, are you looking to partner up 100 and UC as you move forward and then maybe focusing more on the rare indications? Or are you planning on pursuing independently 100 in UC and other large prevalent markets?

No. I think that's a good question. And we will always be open to the idea of collaboration opportunities with the right partners at the right time. And we have been fortunate to kind of have numerous options for all of our assets at almost all times. But we'll be inclined to do only the right deal at the right time and with the right partner. And as you well know, with 100, we are choosing to conduct a Phase II UC trial on our own but as with 200, we interview even when it was a preclinical asset. Because in Janssen, we found the right strategic partner with mutually aligned interest and with the right kind of deal terms.

Great. And then last question from me. So at our recent conference, you talked about how the treatment paradigm in UC and possibly even Crohn's too, the physicians have been reluctant on the broad immunosuppressive agents, the injectables that are currently available. And so therefore, oral therapies that are more immunomodulatory, are more value add and more appealing for both patients and physicians. So I just wanted to get your take on this, Dinesh, as you advance your oral peptides, 100 and 200, as we look on the broader landscape of competitive agents that are coming through, like S1P modulators, how are you thinking about the competitive landscape? And trying to differentiate your oral peptides from other immunomodulators out there?

Sure. So if you look at the history of therapy in different disease areas, it's pretty clear that different drugs, working through different mechanisms, find their own sweet spot in the arena of combination therapy. Right? When ACE inhibitors came in the market for hypertension, we already had diuretics and beta-blockers but then the ACE inhibitors found their dominance. So we believe that whether it's JAK inhibitors, S1PR1 modulators, IS 23 receptor blocker, like 200 or our own PTG-100, the integral specific blocker, everything will have a place and especially because of the fact that the whole paradigm is -- treatment paradigm is shifting and gravitating towards oral targeted therapy. The thing that is unique about our approach and it is by design is that with our most targets, the mechanisms are already validated. So from that context, we feel safe about approaching those mechanisms but coming up with an oral version of hopefully a safer, better drug down the road. And then more specifically in the arena of combination therapy, people will typically opt for different types of complementary mechanisms and in that context, PTG-100, which is an alpha-4-beta-7 integrin blocker, that has a place of its own and a specificity of IBD of its own. And we believe that, that will be a very unique and dominant value proposition in the arena of combination therapy where ideally, or at least according to our viewpoint, that will be PTG-100 and there will be other things that it will be combined with.

Our next question comes from the line of Adam Walsh of Stifel.

So I just have a follow-up on the PTG-100 question in pouchitis. You mentioned that you were going to potentially launch a trial there in the second half of 2018. How long do you think a trial like that would take? When we see some data from the pouchitis trial? And then can you also walk us through your thoughts on the market opportunity in pouchitis? How you kind of think about going after a rare disease and a drug that you're also developing for UC?

Yes. No, that's a very good question and I will have Rich take a stab at it and David, you can also chime in as appropriate.

Sure. Thanks, Dinesh and thank you, Adam, for the question. So as I mentioned earlier, with regard to the timing of the pouchitis program, the initiation of the pouchitis, which we are planning for at this point, would be based on passing that futility analysis and then we would be able to initiate the Phase II portion of that Phase II/III study, which essentially would be a proof of concept as well as a dose finding for the Phase III part, which could be registrational. The Phase III part of the study, and it will be a seamless design, would not be initiated until after the readout from the Phase II UC study. And so we believe that we would initiate the Phase III portion of that trial shortly after that time. As far as thinking about the opportunity in pouchitis, this as you know is a rare disease opportunity, about 20,000 to 40,000 patients in the U.S. and Europe. There are no, currently no approved therapies for this disease entity. Many patients take some form of antibiotics initially, but many patients become refractory to that and the current treatments really do not work particularly well. So there is quite an opportunity in this area to really develop novel therapies and both the regulatory agencies are certainly akin to the unmet medical need here and have allowed us to take this kind of accelerated path forward.

So Adam, to be fair to your question, we -- I mean first and foremost, this is a rare indication, so we are obviously are not -- nobody is looking for the number of patients that 1 would enroll in something like a UC or Crohn's trial. Right? Having said that, at this stage, we cannot give very specific guidance as to, like, when we expect to finish the Phase II portion for pouchitis. But whoever we have talked to, the TOS on that, they are very encouraged about trying out this asset with a proven mechanism. So that works very nicely for us and plus it's an oral. And then the commercial assessment for this sort of thing is honestly a bit open-ended. But as Rich mentioned, there is nothing available for this. And this is not like an ultra-rare disease. I mean, we are talking about 20,000 patients in the U.S., another equal number of patients in Europe and then 100,000-plus in the rest of the world.

Our next question comes from the line of Tim Chang of BTIG.

Dinesh, I notice that you guys had some additional patents of your PTG-100 and 200. Could you just go over the IP one more time? How do these additional patents protect your pipeline, key pipeline assets at this point?

Yes. I think that's -- I mean obviously, IP is a very integral component of our overall strategy and we are of the mind of keeping our coverage very broad and versatile and dominant. But having said that, I will have David Liu, our CSO and head of our R&D, chime into this.

Tim, I think first and foremost, these are homegrown, so the patent life for all of these are very extensive out to 2034 or '35. So there is a great runway for our development and commercialization of our assets. The strategy is always to protect it from a composition of matter analysis both from a broad view, so that's why you see some of the applications have much broader claims and then to solidify it, we always try to narrow it down to specific examples to protect specific compounds. So let's say, the usual approach that the industry takes and we are no different.

So David, how many patents in total do you guys have now, protecting 100 and 200? Is there a figure you guys could disclose?

So it's basically 3 for 100 and 2 for 200. 1 for 300.

And if I recall correctly, the other thing we would like to point out is like the earliest expiration of these patents, I mean we are talking about 2034 and beyond. Right, David?

Yes. And beyond these that have issued, as you could imagine, there are a slew of others that are following up in terms of being prosecuted.

Okay. Maybe I just have 1 follow-up, Dinesh, for you. You highlighted the strategy of potentially looking at a pouchitis indication for the 100 asset. Will that be a different formulation than the formulation you're currently working on in UC?

It's a very good question, Tim. And whether it's a different formulation or a different dose, those are the things that one has to keep in mind. Having said that, at this stage, we are keeping things pretty simple and we're just looking for our clinical proof of concept and then as the data unfolds, we'll respect the data and the responses and then act accordingly. But for now, it's the same formulation. That's the short answer. And the reason for that is also is as we can understand, is that PTG-100 is a very stable drug. We recover appreciable amounts of it in the feces. Like in Phase I study in healthy volunteers, we had up to 15%, 17% of the drug intact. So we believe that with the same formulation and once daily kind of approach, the drug should find its way to all parts of the G.I. tract from beginning to end where it needs to exert its action.

Our next question comes from the line of Douglas Tsao of Barclay.

So just to clarify 1 thing, Dinesh, do you expect to start the Phase II/III in pouchitis before you get the readout on the PTG-100 Phase II study?

Yes. So in short, the timing will be as follows; if the Phase II interim readout of the UC trial is not futile and the guidance for that is like we will have that in this quarter, so basically in this month, then we will initiate the Phase II part of the pouchitis trial. And if the Phase II UC trial top line results for which our guidance is Q4 of this year, if that is positive, then that will encourage us to initiate the Phase III part of the pouchitis trial study in 2019.

Okay. Got it. That's very helpful. And so in terms of the dose selection for the Phase II in pouchitis?

I will have Rich answer that question.

Yes. So -- thank you, Doug. So following our discussions with the regulatory agencies, we have moved toward having 2 doses in the Phase II part of that study that we would be able to compare and then select a dose for the Phase III part of that study. Now, as Dinesh said, because we're not initiating the Phase III part of that study until we get the Phase II UC readout, we will also bring that dose information into the decision, so that we can optimally select the dose to go into the Phase III registrational part of that pouchitis trial.

Okay. And then just 1 final one. For the futility analysis, you were going to drop a couple of doses. So do those patients exit the trial just to confirm that? Or do they continue on the doses that are continued in the trial?

So let me clarify that. So all of the patients who have gotten to the interim analysis have completed the trial. So it's a 12-week induction trial as you may recall and those patients, when they get the interim analysis, will be -- have completed the trial. So in the stage two part, assuming the trail goes forward, these will be new patients to enroll in the trial at that point and they would enroll and be randomized across the remaining arms.

At this time, I'd like to turn the call over to Dr. Patel for any closing remarks. Sir?

Sure. So thanks, everybody, for being on the call and asking some great questions. We, the management, really love this dialogue. But to wrap it up then, last year we successfully advanced 3 products in different stages of clinical development, targeting both G.I, IBD and orphan indications outside of the G.I. area. And orphan indications in the G.I. area as well, including pouchitis. So we expect 2018 to be another very productive year for us and as we continue to build on our momentum and execute against the key milestones and events we outlined today. We look forward to continuing to update you on our 7 specific milestones through press releases and at various investment and medical conferences throughout the year. Thank you again for joining us today.

Thank you, sir. Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day.