Good morning, ladies and gentlemen. Thank you for standing by and welcome to UroGen Pharma's First Quarter 2019 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Kate Bechtold, Director of Corporate Communications and Investor Relations for UroGen Pharma. Please go ahead..

Thank you, operator. Good morning, everyone, and welcome to UroGen Pharma’s first quarter 2019 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended March 31, 2019.

The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Peter Pfreundschuh, Chief Financial Officer.

Joining us for the Q&A portion of this call will be Stephen Mullennix, Chief Operating Officer. Liz will provide a summary of our recent corporate developments and Mark will share clinical developments and regulatory updates.

Peter will then provide an overview of our financial highlights for the first quarter of 2019 before we open up the call for questions. As a reminder, during today's call, we will be making certain forward-looking statements.

Various remarks that we make during the call about the company's future expectations, plans, and prospects constitute forward looking statements for purposes of the 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 Factors section of UroGen Pharma's quarterly report on Form 10-Q to be filed with the SEC today and other filings that UroGen Pharma makes with the SEC from time to time.

We encourage all investors to read the company's quarterly report on Form 10-Q and the company's other SEC filings. These documents are available under the SEC Filings section of the Investors page of UroGen's website at investors.urogen.com.

In addition, all information we provide on this conference call regarding matters that are not historical facts are forward-looking statements and represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

While we may elect to update these forward-looking statements at some point in the future, we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events or otherwise. I will now turn the call over to Liz..

Thank you, Kate. Good morning, everyone and thank you for joining our call. May 4 marked UroGen's two-year anniversary as a publicly-traded company.

This gave me the opportunity to reflect on the important progress the company has made in a very short period of time and, in particular, how the past three months have set the stage for what we believe will be a pivotal year for the company.

Having just returned from the American Urological Association meeting in Chicago, we're excited to see a new analysis from the pivotal Phase III OLYMPUS trial of UGN-101, mitomycin gel for instillation, an investigational formulation for the primary non-surgical treatment of patients with low-grade upper tract urothelial cancer.

This analysis presented by Dr. Seth Lerner during the plenary session highlighted the unmet need in patients with new and recurrent low-grade UTUC and the potential of UGN-101 to treat these low-grade tumors, including those that are unresectable.

We were very pleased to report a consistent complete response rate of 59% and six-month durability remains strong with 89% of evaluable patients maintaining a complete response.

The meeting was a great opportunity for UroGen colleagues to meet with key stakeholders as we educate the community on our proprietary RTGel and shared data on the significant unmet need for these patients.

We are focused on ensuring we cross the finish line with our New Drug Application for UGN-101 in the second half of this year, with a planned launch for the first half of 2020, obviously, subject to receiving regulatory approval. If approved, UGN-101 will be the first drug approved for the non-surgical treatment of low-grade UTUC.

As each day moves us closer to a submission and approval, we continue to accelerate our prelaunch preparation activities and infrastructure build-out to position ourselves for a successful commercial launch.

Our commercial and medical plans incorporate a multifaceted approach with three major pillars involving data generation and publication, building awareness of our RTGel technology, and educating the market on the unmet need in UTUC. Awareness is a critical component of rapid adoption. And this is a key area of focus for our teams.

We've taken several steps to address this in recent months including the OLYMPUS data generation and publications, the launch of www.utuc.com, which is the first resource designed to address a void in the urology space by educating patients about UTUC and available treatment options and deployment of our team of seven medical science liaisons, or MSLs, to engage in scientific exchange.

AUA provided an ideal venue to engage KOLs with over 50 formal one-on-one meetings and many other interactions completed. This is a novel technology for which there is no precedent in UTUC and it as a priority to educate physicians on this new potential paradigm shifting approach.

In addition to education and awareness, the team is prioritizing development of support programs to ensure the seamless integration into the urology practice, following anticipated regulatory approval.

While we expect unique FDA labeling for UGN-101 and its administration, the procedures and protocols involved in UGN-101 instillation are all standard to the urologic community. UGN-101 was designed to provide physicians with a familiar organ-sparing approach that also aligns well with standard ambulatory practice.

Our plan is to focus on about a third of the urology accounts, which treat 90% of the patients with UTUC. Based on our analysis, we plan to hire a nimble sales force of approximately 50 highly experienced individuals who can swiftly and effectively navigate the unique needs of UGN-101.

We will have a multidisciplinary team that includes sales and account representatives, field reimbursement specialists to support the unique needs of billing and coding for our therapy, and certified nurse educators to provide technical training and support for product installation.

This multidisciplinary approach will ensure a reliable and efficient workflow to create a positive experience for both the patient and provider throughout the treatment. We expect our field-based team to be fully staffed, trained and ready to launch by the end of the year.

Our proactive market access strategy is designed to ensure that patients who need UGN-101 will be able to receive it and that physicians will be able to acquire UGN-101 when needed. Our teams are excited and preparing to bring UGN-101 to patients shortly following regulatory approval.

In addition to laying the foundation for successful launch of UGN-101, we are also developing the plan for UGN-102, our investigational program for low-grade non-muscle invasive bladder cancer.

Similar to UGN-101, UGN-102 has the potential to transform the treatment paradigm for these patients as there are currently no drugs approved in the US as first line treatment for this patient population.

There are approximately 80,000 patients for whom repetitive surgical resection via transurethral resection of bladder tumor, or TURBT, remains the standard of care. We look forward to presenting early complete response data on a cohort of patients in the second half of this year.

In addition to our late-stage programs, we're also focused on building a sustainable growth company through the advancement of our internal portfolio as well as assessing external opportunities.

Our primary focus as a company is on transformation in the treatment of urological cancers and we will opportunistically consider collaborations in both oncology and urology where we can leverage our expertise and uniquely deliver innovation to patients.

A few weeks ago, we announced an agreement with Janssen to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. Under the terms of the agreement, UroGen and Janssen will each conduct certain activities. This is an example of collaborations we will prioritize.

Lastly, Allergan continues to enroll patients in its Phase II trial of our customized RTGel formula in combination with Botox for the treatment of overactive bladder. Per clinicaltrials.gov, enrollment is expected to be complete in 2019, with data and next steps finalized in 2020.

I would now like to turn the call over to Mark to discuss in more detail our progress and clinical development programs.

Mark?.

Thank you, Liz. I view the recent progress as an important and exciting step in the field of uro-oncology and what this means for patients.

As a practicing urologist, I can speak to the technical challenge that low-grade UTUC presents to physicians, as the current standard of care requires surgical intervention, which puts patients at risk for complications associated with repetitive endoscopic surgical procedures and kidney removal.

In the current treatment paradigm for low-grade UTUC, approximately 80% of patients who present with the disease will undergo kidney removal at some point in their treatment, either in initial presentation or at the time that endoscopic surgery fails to control the disease.

These patients are generally elderly and are subject to the short-term risks associated with kidney removal surgery, such as bleeding, infection, injury to adjacent organs, against the backdrop of common comorbidities such as hypertension, diabetes, cardiac disease and obesity.

In addition, the patients are also at risk for complications associated with anesthesia and the downstream deleterious effects of chronic renal insufficiency. Renal preservation in this population would address a significant unmet medical need.

The feedback we received from urologists at the AUA meetings is that the current standard of care leads to undertreatment or overtreatment of this disease, with a patient ultimately losing the kidney.

There has been a drive in urology and oncology spaces toward organ preservation, and this aligns with the work we are doing at UroGen, and particularly, with UGN-101. As Liz mentioned, Dr. Seth Lerner presented an updated analysis from our Phase III OLYMPUS clinical trial during the plenary session at the AUA annual meeting this past weekend.

The presentation discussed the minimally-invasive chemoablation approach of UGN-101 to treat low-grade UTUC, including those that are unresectable. The totality of the data observed to date from the OLYMPUS trial makes us optimistic that, if approved, UGN-101 could change the treatment paradigm for low-grade UTUC.

To provide a brief recap of the results from the OLYMPUS trial, the analysis showed that in the intent to treat population, 71 patients had undergone primary endpoint evaluation at the time of the analysis and 42 of the 71 patients, 59%, achieved a complete response. 41 patients entered follow-up.

And of the evaluated complete responses to date, 27 patients have undergone a six-month evaluation and 24 of the 27 patients, 89%, have remained disease free at six months. Overall, 5 of 41 patients who achieved a complete response have relapsed at any time during the study.

Of these 71 patients, 34 were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline; and 20 of 34 of these patients, 59%, achieved an initial complete response. These are the patients who, under the current standard of care, would be immediate candidates for kidney removal.

The most common adverse events were urinary tract infection, ureteral narrowing and stricture formation. The safety profile of UGN-101 continues to be acceptable with most treatment emergent adverse events characterized as mild or moderate and transient.

The high response rates and durability observed today provide further evidence that the non-surgical treatment of low-grade UTUC with UGN-101 may result in clinically meaningful, recurrence-free survival. In addition to UGN-101, we are optimistic about our second pipeline program, UGN-102.

We continue to enroll patients in our OPTIMA II Phase IIb, single arm, open label, multicenter trial designed to assess the efficacy and safety of UGN-102 for intravesical instillation as a potential first line chemoablation agent in the treatment of patients with intermediate risk, low-grade, non-muscle invasive bladder cancer.

To provide a bit of background on low-grade, non-muscle invasive bladder cancer and the rationale behind our clinical development strategy, low grade NMIBC is a patient population whereby the current standard of care, transurethral resection of a bladder tumor, is used repeatedly to address recurrence of disease.

A substantial subset of NMIBC patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to manage chronic bladder cancer recurrences.

We have elected to study the intermediate risk population as we believe UGN-102 can have an immediate impact on this population and providing non-surgical alternative for the treatment of chronic relapse. We remain on track to complete enrollment for the OPTIMA II trial this year and expect to report initial data in the second half of 2019.

The initial data update will consist of complete response rate with durability information to be reported at a later time. Beyond UGN-101 and UGN-102, we continue to advance our earlier-stage immunotherapy program, UGN-201. UGN-201 is our TLR7/8 immunomodulatory agent for the treatment of high-grade bladder cancer.

We are currently finalizing our development pathway to advance this program and we'll provide an update for UGN-201 later this year. With that, I would like to turn the call over to Peter who will share our financials..

Thank you, Mark. And good morning to all of you on today's call. UroGen is well capitalized to further advance our clinical development programs as well as our commercial planning efforts in preparation for a potential US approval and launch of UGN-101 in 2020.

We closed the first quarter of 2019 with 246.7 million in cash and cash equivalents and short-term investments. And in January, we successfully completed a public offering of ordinary shares, resulting in net proceeds of approximately $161.4 million. For the first quarter of 2019, we reported a net loss of 21.4 million or $1.11 per share.

This compares to a net loss of approximately 13.4 million or $0.88 per share for the first quarter of 2018. This net loss includes a $7.4 million charge in non-cash stock-based compensation expense during the first quarter of 2019.

Research and development expenses for the quarter ended March 31, 2019 were 9.7 million as compared to 7.6 million for the quarter ended March 31, 2018, and included 2.3 million in non-cash stock-based compensation expense.

The increase from 2018 to 2019 was attributable mainly to costs associated with UGN-101 Phase III OLYMPUS trial, an increase in personnel costs to support our ongoing clinical and regulatory efforts, and an increase in share-based compensation expense.

General and administrative expenses for the quarter ended March 31, 2019 were 12.7 million as compared to 6.1 million for the quarter ended March 31, 2018, and included 5.1 million in non-cash stock-based compensation expense.

The increase from 2018 to 2019 was attributable mainly to an increase in personnel and related costs to support our growing business, an increase in commercialization, infrastructure and services, an increase in consultant and other outside fees, and an increase in share-based compensation expense.

As of March 31, 2019, we had approximately 20.8 million ordinary shares outstanding. The 2019 financial guidance as set forth earlier this year remains. And based upon our anticipated activities and business goals, we project our recurring cash balance to carry us for at least 24 months.

With that, operator, I would like to turn the call over for questions..

[Operator Instructions] And our first question comes from Derek Archila from Stifel..

Thanks for taking the questions and congrats on the progress. I just had one question here. Just wanted to get a sense if there's any color that you can provide as far as the proportion of patients actually receiving the monthly maintenance therapy in the follow-up phase in the OLYMPUS trial? Thanks..

Hi, Derek. It's Liz. I'll just make a comment and then turn it over to Mark and he can get into -- and he can tell you all those. He's probably going to say the same thing I am. It's been very inconsistent.

And so, I think that, as we start to think about the future of medicine, and I do want Mark to comment as a urologist, I think that that's probably how it will play out in real world.

So, our perspective on that is that the sixth instillation is really what we expect to be our duration of therapy with potentially some patients and physicians treating it at different intervals.

Mark, would you like to comment?.

Sure. As you pointed out Liz, I can't really improve on that answer. What we do notice in this study is that doctors have tended to utilize the maintenance protocol very specifically according to their own needs and not necessarily in a consistent manner. That also happens to comport with what we see in clinical practice.

Doctors tend to use maintenance therapies for this disease, including in the bladder in a rather specific way depending upon patient characteristics, et cetera.

So, I think it would be good to think as we are, and as Liz points out, about the induction course, the first six doses as being the mainstay of therapy and then we'll have to see how that plays out in practice with regard to maintenance..

Our next question comes from Ram Selvaraju from H.C. Wainwright..

Hi. Thanks very much for taking my questions. I'll try to zip through these as quickly as possible. Just wanted to get some additional clarity on the way in which data is likely to be reported from the UGN-102 Phase IIb trial.

If you anticipate there being multiple cohort data releases going into the final top line readouts or if there is just going to be one interim data release, then we should expect top line? And also, if you could maybe comment on the baseline characteristics of the patient population in this study, in particular the age range or at least a median or average age of patients who have been enrolled? And then, I had a couple of follow-ups regarding your external collaborations..

Thanks, Ram. I’ll comment on the data dissemination and then I'll turn it over to Mark who can give you more around the demographics or the patient population, probably less about demographics.

So, our intention is that, when we have a level of cohort of patients that we're confident, it's fairly representative and we had talked in the past around 25% to 30% of that patient population that we would do a disclosure and share some early CR data.

I don't call it an interim analysis, and the reason is because it won't have any durability data this year because these patients, obviously, have to be followed. And while the timing for the UTUC is six months, because that's the mean – the average time where a patient recurs, after the bladder, it's more like 12 months.

So, we will need to see 12-month durability. Our plan, at this point, is again to share some early CR data this year. We don't really have a very specific disclosure plan where we say, well, after this many patients, we'll give an update, and after this many patients, we'll give an update.

I think that what we'll do is see how the data is playing out and when it's most appropriate to share.

But I would say that we have been talking internally about doing an Investor Day in the fall where we would share more specific data, which is where we would probably share our first opportunity to look at 102, have even more data on 101 and then actually be able to share data on our 201 program as well.

So, I think the timing of that again is sort of in the fall time frame. And from that perspective, one thing to sort of to note. I think also our plan is -- and we've already started to think about what the next study for bladder would look like.

As we've said in the past, in our conversations with the FDA, once we get enough data where we feel like we can have a conversation with the FDA to design a study, my point of telling you that is that we won't wait until we get all of the CR and durability data on 102 to do our pivotal study.

So, we will want to move into a pivotal study as quickly as possible, but obviously want to do it when we have enough information that we can design the appropriate study and ensure approval as quickly as possible. So, with that, I'll turn it over to Mark and he can talk to you more about the patient population of 102..

Thanks, Liz. And I think many people on the call already know this, but bladder cancer tends to occur in people generally in their sort of sixth, seventh, eighth decades of life. We haven't done a specific analysis yet because the trial is actually enrolling and this is happening in real time.

So, I can't give you the numbers right now with respect to the average age of enrollment. But, typically, patients would be in their 60s and 70s.

These are obviously patients we've picked because they have characteristics of intermediate risk, non-muscle invasive bladder cancer and those characteristics are, for example, things like multi-focal tumors, low grade histology, they can have a history of prior tumors.

So, these are people who are likely to recur and we believe that's a population where there is a specific unmet medical need because these patients generally undergo repetitive transurethral resection for the management of the disease process.

And we've independently heard that, from physicians, these patients are considered those who are not well served by the contemporary standard of care, and so we're exploring what we believe is a promising alternative to the standard of care with the 102 program..

Okay. Thanks very much for that information. So, one other item that I was curious about was the optimal number of instillations. This is probably a question that's pertinent to both 101 and 102, and especially the question of the number of instillation as that pertains to usage, for example, of 101 in specifically re-treatment of recurrences.

So, I was wondering if you had any thoughts about that. In particular, I'd be interested to know whether you think that's -- in a real world context, there might actually be the possibility of conducting treatment with fewer instillations than were utilized in the OLYMPUS trial, for example..

Thanks. This is Liz and I'll make a comment. And, again, if Mark wants to add anything to that. I mean, at this point in time, we expect that the physicians will use the sixth instillation.

You are correct, in a sense of, we would really have to conduct a separate study that allowed for the optimal sort of optimizing dose, the number of instillations, and that was not done. And even with the maintenance question that came earlier, it was not -- the analysis was not in our study around optimal number of maintenance doses.

We expect -- and again, Mark can comment on this as well -- that physicians have already talked about potentially retreatment and what we have done is to launch -- and I say launch because we're in the process of finalizing the protocol for the retreatment study. So, we are going to do a retreatment study.

It is our belief that patients would be able to benefit from retreatment when they do recur. That study's timing will obviously depend on patients recurring. And the good news is, as you saw, our recurrence data with patients is very low. So, they are staying in the CR for a very long period of time. But we do want to do a retreatment study.

So, the question around optimal number of instillations, I don't think that physicians will have data to support doing fewer than the six instillations. And as Mark said and commented earlier, I think you'll see a very heterogeneous approach to how physicians may do maintenance.

But we do think that the optimal dose at this point is the sixth instillation and I would expect that the majority of the physicians will do that. Some may fewer, some may more. And, therefore, that's why we feel pretty confident in the six number.

Mark, do you want to add anything to that?.

Liz, I can't add much. That's the answer. Thank you..

Okay. And then, very quickly, on the external collaborations, I have two quick questions.

Firstly, with BotuGel, do you expect that Allergan would permit the dissemination of information pertaining to the enrollment status as and when that trial completes enrollment? And then, with respect to the Janssen collaboration that you guys announced a couple of months ago, can you give us any additional contextual information about that collaboration at this time? What general therapeutic area it's focusing on? What Janssen's domain of interest might be? And how this pertains to the unique properties of RTGel? Thank you..

Unfortunately, I'm sorry, but we cannot provide more information on our collaboration with Janssen than we already have. That's sort of our agreement with them. I think it's important to understand that what we're doing is an early feasibility study, right, with them. And so, it's been something that we've been talking to them for quite a while.

And we're interested in, and hopefully, we can do the experiment. And if everything goes well, we'll be able to talk more about that in a few months. On the Allergan, I think the best place to sort of follow what's happening with Allergan is on clinicaltrials.gov. We did have a really good meeting with them when we were out in Chicago for AUA.

They are enrolling in the Phase II. They call that their proof-of-concept study. They have confirmed that they expect completion of enrollment as it shows in clinicaltrials.gov in 2019 and they are already thinking about what the next step is.

And so, I think that once enrollment is -- it's obviously also an open label study, so they will have some data. As they start to get data in 2020, they'll make a decision. But I don't think – I would not expect that they will share anything, any data. I would expect that the -- again, the enrollment would follow along with clinicaltrials.gov.

I don't think they have any intentions of doing any public announcements around this study..

Our next question comes from Boris Peaker from Cowen..

Good morning. So, my first question is on UTUC.

I was wondering, is there any way to segment the patient population to identify potentially kind of early adopter subgroups to kind of the low-hanging fruit in the indication? Would it be maybe those with unresectable disease, the baseline or any other characteristics? And then, how big is that subgroup out of the entire population?.

Again. I'd just make a comment and turn it over to Mark. I think that -- we see all of the patients with low grade UTUC as being good candidates for this procedure, because for a couple of reasons. One, you're correct, and as was just presented at AUA around, there's a fairly large, almost 50% of patients that have unresectable tumors.

So, yes, you would argue, those might be the first ones. But then you also have these patients who have multiple endoscopic ablation surgery, which is also not a pleasant thing for patients. So, we believe that, overall, all of the candidates, both the new and recurrent candidates, patients, would be candidates for our therapy.

I don't know, Mark, if you want to sort of comment on that.

As a physician, would you look to one or the other as being more of an early adoption type of patient?.

No. I think those two groups are important to call out. I think the other issue is, remember, this is a completely novel way of approaching this disease and there isn't a lot of background with regard to the percentage of patients who have tumors amenable to conservative management, who actually aren't well managed by virtue of their unresectability.

So, to some extent, we're providing new information in this trial about the proportion of patients who would be ideal candidates. For example, for UGN-101, who heretofore have been treated somewhat anonymously using repetitive endoscopic technology. But I think Liz is right, both groups are good candidates for this therapy.

And we've already heard from physicians that there would be no need frankly to segment one population versus another and that whole variety of patients will be good candidates for initial treatment with this therapy..

Great. My second question is on 102. I'm just curious, you mentioned that you want to start a Phase III study before all the final results are in for the Phase II.

So, how are you thinking in terms of the primary endpoint? Specifically, are you thinking that the objective is to show non-inferiority or superiority to TURBT? And if so, in deciding that, what specific data will you look for in the Phase II?.

It's a good question. And we're still again working on exactly what that means. And a lot of it will depend on what the FDA has to say, right? So we, as a group, have sort of debated, would you really want to do a control, head to head study against TURB, which may be what the agency asked for.

Unfortunately, and again, if Mark wants to comment further, he can. This patient population, we specifically picked this patient population because this is a patient population where the surgery doesn't work.

And so, given that, I think, for the FDA and regulatory approval, non-inferiority might be okay, we have to really consider whether it makes sense for us to actually do a superiority study.

If you believe that by segmenting those patients in this intermediate risk patient population where a surgery is not working and we may be able to do a superiority study because, as you know, the number of patients and the time may be very different for a non-inferiority study versus the superiority study. So, I think we're still working on that.

I think what we'll want before we actually pull the trigger are a couple of things. One, a robust number of CR data that we've talked about. We will want some durability data.

So, we won't wait for all the patients to hit 12 months, but we're going to want to see a good amount of patients' durability at least over 6 months before we would pull the trigger on a Phase III study, pivotal study. And then, again, lastly, discussions with the FDA. So, Mark, I don't know if you want to add anything else to that..

The only thing to add is to emphasize something that Liz has pointed out already, which is that, one of the important metrics in this population is durability response.

So, I would think that that would be a very important endpoint for any future trial that we construct and, obviously, dependent upon what we see in the IIb trial that's running right now..

The only thing I will say is we had quite a few physician meetings when we were out in Chicago.

And I think that these physicians see these patients -- they were actually talking to us about having to do these types of procedures like 20 and 30 times on some of these really -- these patients who -- and I think physicians are looking for an alternative. And 102 would be a great alternative, assuming the data plays out.

So, excited about the opportunity..

Our next question comes from Matt Kaplan from Ladenburg Thalmann..

I wanted to dig in a little bit to the ongoing OLYMPUS study, given the results that you just presented at AUA. I guess, Mark, maybe a question for you.

What are the reactions from your colleagues in terms of the durability and safety data that they're seeing for 101 in this patient population?.

Matt, thank you. It's a good question. As I think we've previously discussed, the adverse event profile that we've discovered so far in the trial is consistent with manipulation of the upper urinary tract by a variety of means, including laser ablation of tumors and endoscopic removal of kidney stones.

So, when urologists look at the adverse event profile, their responses have so far been that looks consistent with the type of sort of morbidity profile that we'd expect, given what you're trying to achieve in this population.

I got an e-mail yesterday actually from one of our investigators asking when 101 would be available because he's already getting calls from his referring community physicians. This is a person at an academic center. They want to know when this is going to be available for general clinical use.

So, the word is beginning to get out about this product and about the results from the trial, presumably because of the recent disclosure at the AUA. And now, the community is becoming conscious of this alternative to laser ablation and repetitive endoscopic surgery for these patients.

So, I believe we are optimistic that, as people become educated about the results and become aware of the technology, there'll be some real enthusiasm for use in this particular patient population..

That's helpful.

And then, with respect to the question from your colleague, where are you in terms of completion of the NDA filing and, I guess, what is the rate limiting step there?.

Yeah. It's Liz. I'll just comment on that. The rate-limiting step, as we've said all along, is really just the durability data on those patients, right? So, waiting for that time to pass. So, the agency was very clear that they want a six-month durability data on the majority of patients, and so we want to ensure a robust submission to the FDA.

And so, we have said second half of this year. But it is expected to be toward the latter half of the second half, I would say, of the year because we simply want to make sure that we have a large majority of the patient population. It really needs to be 75-plus-percent of the patients at six months.

So, the only thing really holding us back is waiting for those patients and the timing of those patients. And so far, we expect that to happen this summer. And then, obviously, the team will have to do all of the database lock, the database cleaning and the work that goes along with the submission.

So, that's why we're sort of thinking about that timing..

Okay. That's helpful.

And given the near term of that filing and potential approval, can you talk a little bit about, I guess, your commercialization plans for 102 -- 101, sorry?.

Absolutely. We're very excited about it. We have a small team that's already in place. The commercial head is Jeff Bova. He was at Bayer. We actually have quite a few of his team members who [indiscernible] along with him when he came. And so, we have a group of people who know this market.

They know the uro, specifically urological oncology physicians in the marketplace and how things work. And so, they've been doing a lot of work in preparation. And we had, I would say, a very, very good presence at AUA. We had a ton of one-on-one meetings. We had a couple of ad boards. Our presence at the booth was very, very strong, the traffic.

And so, I think -- I was getting text messages from some of my friends, topping shows, taking pictures of the banners. So, I think we had a nice sort of kickoff at AUA.

And, really, we're starting to interview for our field management team and then the plan is to have about 50 reps along with this requisite field reimbursement managers and nurse educators. We already have 7 MSLs. Those MSLs have been out meeting physicians and having peer-to-peer discussions around UroGen and around our RTGel platform.

And so, we feel very good about the fact that we have a strong team. I think the other important thing, Mark sort of commented on earlier, but this is what I would call a previously-ignored sort of area, particularly as it is to education.

And Mark commented on the fact that, even the unresectable patient population, there's not a lot of data out there. So, we're actually the first company to be out there generating data on this patient population and the sequelae of their disease and the implications and supporting them. And we launched www.utuc.com.

Surprisingly enough, there have been no resources out there in this area for patients. And so, we think we have a real opportunity to fill a void both for healthcare professionals as well as patients. So, we're off running and have a lot of work to do, obviously, over the next few months, but we have a great team in place to do that..

Great. And thanks for the detail.

And just shifting to 102 and the OPTIMA study, I guess, given the expectation for an initial data later this year with respect to a complete response rate, I guess, for Mark, what would be kind of clinically meaningful CR rate that would get people excited?.

So, I'll speculate a little bit because, of course, this is an ongoing trial. But just to put it in context, we know that, if you look at the data for patients who undergo transurethral resection, which is the standard of care, and the recurrence rate at a year is somewhere between 30% and 40%, and that's all-comers.

That's not the adverse population we've chosen.

I think given the population we've chosen, which is a group we believe at much greater likelihood for recurrence after initial surgical therapy, an initial complete response rate at 50% with the durability of, I guess, recurrence-free survival at a year and half of that group, so 25% or 30%, I think would be clinically meaningful.

And, obviously, we need to see how the study plays out, but I think that gives you a sense of what we're looking for..

Our next question comes from Chris Howerton from Jefferies..

Great. Thanks for taking the questions. Honestly, I think most of them have been asked at this point. But I was thinking about for 102 in the NMIBC population.

In terms of the trial design, would there be any plans to think about 102 as an adjuvant to TURBT and how would that work within the commentary with respect to feasibility or superiority?.

Yeah. I think -- it's Liz. And again, I'll ask Mark if he wants to add anything. But we were discussing all of those, right? And I would say that there's not likely to be one, you will have one pivotal study, the most important study.

But you are correct, in the sense of, even when we were out in AUA, again, with all of our interactions with physicians, there's tons of ideas. So, we have no lack of ideas for generating data on 101 and 102.

So, we do want to very thoughtfully consider where we should go, which studies we should do, we will obviously support physicians who have ideas and want to work with us on our products.

So, I think we're in a really, really good place and I think we have an opportunity, to your point, in different areas of non-muscle invasive bladder cancer, low grade with 102 in reaching either -- it would be adjuvant therapy or current -- what we have currently. Mark, I don't know if you want to add anything else to that..

No. I think that's great, Liz. I think we want to see what the data looks like and then I think we'll be able to have more educated conversations both with our KOLs and physicians and collaborators, so that we can figure out what the right study is next, but I think it's premature to say..

Okay, great.

And then, for 201, when we think about the types of patient populations that could be served by that asset, could you provide any more color in terms of what you might be thinking with respect to the high grade population?.

Mark, do you want to talk specifically about the CIS and then we can talk about the potential to expand beyond that patient population?.

Sure.

Chris, as I'm sure you're aware, there's been pretty clear guidance from the agency regarding the management of and the study of patients who have carcinoma in situ, a form of high-grade non-muscle invasive disease that has historically been treated with BCG, when it fails and returns after BCG therapy, and that population of patients normally is treated by bladder removal surgery, radical cystectomy.

So, there is an urgent need to provide that group of patients with alternatives that don't require organ removal. And so, there's a lot of focus on that. And the FDA actually has provided guidance with single-arm small trials, open label are acceptable.

So, there are a lot of potential clinical trial design advantages for looking at that group and they represent a real unmet medical need. So, we would obviously be very interested in thinking creatively about how to treat individuals who have not responded or who have relapsed after BCG therapy, the relapsing population, so to speak.

And that would give us a platform to think then more broadly about other forms of high grade, non-muscle invasive disease. We do know that that disease is responsive to immunomodulation.

That's what BCG generically does, although the mechanism is not so clear as to how that's effected, but we know that the TLR7/8 agonist does invoke some of the mechanisms that are putatively important to BCG efficacy and we think it would be a productive way of exploring utility of that asset in the context of a known unmet need..

And, I guess, my only -- the only thing I'll add to that is that I think, but we also believe that 201 will have benefit beyond just the CIS patient population. So, we will be looking to -- at the broader low grade non-muscle invasive bladder cancer patient population. So, just wanted to add that in there..

I'm showing no further questions at this time. I will now turn the call back over to UroGen's President and CEO, Liz Barrett, for closing remarks..

Thank you, operator. As you've heard this morning, 2019 has been a really busy year and it's a pivotal year for UroGen with many key events, as we've discussed, in the second half of 2019. So, we appreciate you joining the call. We'd like to thank you for your continued support and interest in UroGen. And, operator, you may now disconnect. Thank you..

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating and you may now disconnect..