Catherine Bechtold - Director of Corporate Communications and IR Ron Bentsur - CEO Mark Schoenberg - Chief Medical Officer Stephen Mullennix - COO.

Boris Peaker - Cowen Matthew Andrews - Jefferies Leland Gershell - Oppenheimer Reni Benjamin - Raymond James Matt Kaplan - Ladenburg Thalmann.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Second Quarter 2018 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Cate Bechtold, Director of Corporate Communications and Investor Relations for Urogen Pharma. Please go ahead..

Thank you, operator. Good morning, everyone, and welcome to the UroGen Pharma second quarter 2018 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 June 30, 2018.

The press release can be accessed on the Investors portion of our website at investors.urogen.com. Joining me on the call today are Ron Bentsur, Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; and Stephen Mullennix, our Chief Operating Officer.

Ron will provide a brief summary of our recent Corporate Development, and Mark will share clinical development and regulatory updates. Stephen will then provide an overview of our financial highlights for the second quarter of 2018 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 this 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 annual report on Form 20-F filed with the SEC on March 15, 2018, and other filings that UroGen Pharma makes with the SEC from time to time.

We encourage all investors to read the company's annual report on Form 20-F 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 represents 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 Ron..

Thank you, Kate. Good morning, everyone, and thank you for joining us on our conference call today. The second quarter of 2018 was a period of dynamic clinical and operational execution for UroGen.

We continue to make progress towards our goal of establishing a leadership position in the field of uro-oncology as we advance our two lead programs, UGN-101 and UGN-102 that we believe have the potential to become the first front-line, nonsurgical therapies for patients in their respective indications.

The update on our lead product UGN-101 formerly referred to as MitoGel is no doubt of greatest interest. The ongoing Phase III is an open label, singlearm trial. In May, we presented positive findings from an interim analysis of 34 patients in the OLYMPUS Phase III trial at the American Urologic Association or AUA annual meeting.

The results were extremely encouraging with 59% achieving a complete response or CR. In addition, five of 34 patients or 15% achieved a partial response. At the time of the interim analysis, durability also appeared favorable. Of the 20 patients who achieved the CR, 13 patients had reached the three-month follow-up time point and all remained in CR.

Of those 13 patients, four had reached the six month follow-up time point and one had reached the nine month follow-up time point and all remained in CR. The data following the interim analysis reported three months ago at the AUA continues to be very compelling, and we look forward to presenting top line results from the study later this year.

Importantly, we recently received formal guidance from the FDA that the UGN-101 program is eligible for a rolling NDA submission and as such, we now plan to initiate a rolling NDA submission for UGN-101 in the fourth quarter of 2018. This is ahead of our initial submission projection of Q1 2019.

This will bring us one step closer to potentially having the first drug ever approved as a first-line chemoablation treatment in low-grade UTUC and potentially transforming the treatment paradigm. I will let Mark discuss our progress on the clinical front in more detail, but I will briefly review a few additional accomplishments from recent months.

While we continue to move forward with our lead program UGN-101, we're also happy to report significant progress with our other pipeline drug candidates.

At the end of the second quarter, we submitted an investigational new drug or IND application to the FDA for UGN-102, formerly referred to as VesiGel, Urogen's mitomycin gel for introvesical installation for the treatment of patients with low-grade non-muscle invasive bladder cancer or NMIBC.

UGN-102 represents the next big opportunity of our RTGel platform with a potential to address approximately 400,000 patients diagnosed with low-grade NMIBC.

I'm pleased to announce that following our IND submission at the end of June, we have now initiated our Phase IIb singlearm open label, multicenter trial to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with low-grade NMIBC who are at high risk for recurrence.

These patients are commonly referred to as the tough to treat patients. The design of the study should also allow us to provide data updates periodically and we anticipate that the first such update - is early as Q1 2019.

Over the last several months, we have been conducting extensive preclinical work for UGN-201, or Vesimune, our [indiscernible] receptor seven agonist immunotherapy based drug candidate to potentially address high-grade tumors, specifically, we have been testing Vesimune preclinically as a single agent and in combination with checkpoint inhibitors for the treatment of high-grade tumors.

Mark will elaborate further on this program. While our pipeline continues to advance, we believe that we're in the nascent stages of a true potential of our RTGel platform. We strongly believe that UTUC and bladder cancer could be just the beginning.

They demonstrate the opportunity to realize the full potential of proven therapies through longer dwell time in a body cavity. The first example beyond our uro-oncology pipeline is the agreement that we have with Allergan to advance their research, which combines BOTOX with our RTGel platform.

We believe other critical areas of exploration will likely be G.I. in women's health. In the immediate term, we continue to focus on assembling the best talent to lead our transition from clinical stage to commercialization. In July, we announced that Shawn Tomasello joined our Board of Directors.

Shawn was a renowned industry expert with a history of commercializing revolutionary multibillion-dollar products in hematology oncology.

Her expertise in successfully defining a market and launching disruptive and innovative therapies in areas of high unmet medical need has been clearly on display in her role at Pharma Cyclix with one of the most successful oncology drug launches in history with improvika [ph] and had her most recent role as Chief Commercial Officer of Kite Pharma now Kite, a Gilead company where she led the commercialization of Yescarta, the first ever approved CAR-T therapy.

We are thrilled that Shawn has joined our board as we prepare for the potential approval and commercialization of UGN-101. In addition, we couldn't be more pleased to announce last week that Peter Pfreundschuh will be joining UroGen as Chief Financial Officer effective August 20.

Peter brings more than two decades of executive leadership experience in life sciences most recently serving as CFO of Sick Campo pharmaceuticals where he played a critical role in its recent acquisition by Mallinckrodt for $1.2 billion.

Stephen Mullinax will continue in his role as Chief Operating Officer and we believe that his operational excellence combined with Peter's successful track record as CFO will create an excellent partnership. We look forward to formally introducing Peter to all of you over the next few weeks.

This quarter was marked by continued execution across multiple fronts and we're excited to build on that progress. I will now turn it over to Mark who will discuss our clinical programs in more detail. Mark, please go-ahead..

Thanks, Ron. As a practicing neurologist, I'd first like to say how proud I am from what our team has accomplished and what this could ultimately mean for patients. We are certainly excited about the date that we've seen to date from our UGN-101 trial.

To add to Ron's previous remarks, our OLYMPUS trial is being conducted at clinical sites across the United States and Israel. Patients in the trial undergo six weekly catheter installation treatments of UGN-101.

The primary efficacy endpoint is complete response in CR, assessed that approximately 10 weeks from the start of treatment or approximately four weeks following the sixth weekly installation of the therapy.

Patients who achieve a complete response at primary disease evaluation or PDE are then followed up with durability of disease control for up to one year, and are eligible to receive up to a year maintenance therapy of UGN-101.

PDE consists of [indiscernible] and wash psychology, a standard microscopic test of cells obtained from the urine of the upper tract board of six weeks after the completion of treatment.

The CR rate of 59% as we reported in our interim analysis three months ago at the AUA combined with the fact that UGN-101 was well tolerated is remarkably compelling. It is also important to mention that in the study, more than a one third of the patients presented with unrecitable tumors.

Such patients in a real-life setting would be candidates for kidney removal. Our optimism about the 59% CR rate from interim analysis is further fueled by comparison to the CR rate of 44% observed in the UGN-101 Compassionate Use program. As well as the 20% CR rate that has been deemed clinically meaningful by key opinion leaders in the field.

In addition to the 59% of the intent to treat population who achieved a CR at the time of the interim analysis, 15% or five of the 34 patients achieved a partial response.

While only the CR will be considered for regulatory purposes in evaluating the OLYMPUS trial, we believe that partial response rates will also be meaningful to practicing physicians in the real world. Let me put all of this in context with typical outcomes for these patients.

The thousands of patients currently living with UTUC do not have many therapeutic options to manage their disease. By potentially enabling the treatment of these tumors by nonsurgical means, we are sparing patients from the well-known risks and complications associated with repetitive surgical procedures and potential kidney removal.

We believe that UGN-101 may be particularly useful for those patients with rapidly and chronically recurrent cancer and for those whose disease cannot be visualized or resected using contemporary endoscopic technology, because surgical therapy has limitations [indiscernible] UTUC remains a chronic relapsing problem among elderly patients that have relatively few effective treatment options.

And those are the fortunate patients that present with receptible tumors. For those who present with armiceptible tumors unfortunately, the only current alternative is kidney removal.

In which clear consensus amongst an expert panel discussing the interim data of UGN-101 at an event during the 2018 AUA that UGN-101 offers an opportunity to avoid major quality of life altering surgery in associated complications.

Experts further noted that this may be a viable alternative for patients whose health may suffer as a result of major surgery while further renal function loss.

With the planned completion of the UGN-101 trial in the second half of this year and the initiation of the rolling submission of the UGN-101 NDA plan for the fourth quarter, we are getting closer to delivering a technology that has the potential to change the outlook for patients with low-grade UTUC.

We are now three months past the interim analysis presentation at the AUA and continue to be encouraged by the results observed in the trial. We look forward for leveraging the experience we've gained from the UGN-101 clinical studies as we embark on our next product candidate UGN-102.

This month, we initiated our Phase IIb singlearm, open label, multicenter trial designed to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with low-grade, non-muscle invasive bladder cancer or NMIBC who are at risk for recurrence.

Like UTUC, there are currently no drugs approved by the FDA as first-line treatment for NMIBC and only three drugs have been approved by the FDA all as Agyeman treatments following TUR BT or trailing vehicle reception in bladder tumor.

TUR BT is performed under anesthesia and is associated with the standard risk of anesthesia as well as injury to the bladder and postoperative bleeding. Relapse of diseases, common after TUR BT with approximately 40% of patients recuring at one year.

It is not unusual for patients to require multiple repetitive surgical procedures to control NMIBC making bladder cancer the costliest cancer to treat in the United States. The annual incidence of urothelial bladder cancer is approximately 80,000 in the United States with the prevalence of 700,000.

NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year. This means there is potentially a large patient population that may benefit from UGN-102.

The Phase IIb Optima II trial is an open label singlearm study and is anticipated to enroll approximately 60 patients primarily in clinical sites in the U.S. As we move forward with this study, we are encouraged by the results of our Phase IIa study of UGN-102 in which an 86% CR rate was achieved.

We look forward to initial data from the Optima II trial anticipated in early 2019. We look forward to initial data from the Optima II trial anticipated in early 2019.

We continue to advance research for UGN-201, known as Vesimune, our novel and implement population for bladder installation as a single agent and in combination with a new checkpoint inhibitors for the treatment of high-grade urothelial cancer.

Preclinical models have demonstrated antitumor effects of UGN-201 as a single agent as well as in combination with novel immunomodulatory molecules via intravesical installation in urothelial cancer. We are particularly encouraged by the single agent approach and look forward to updating you on these preclinical experiments later this year.

We are also working on formulating Vesimune with our RTGel because we believe the dwell time is a critical parameter for the ultimate use of this agent as well. We have made significant strides towards achieving this formulation, we look forward to updating you on the specifics of a clinical trial design for UGN-201 later this year.

With that, I would now like to turn the call over to Stephen to briefly review 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 and support our commercial planning efforts in preparation for potential U.S. approval of UGN-101 in 2019. We closed the second quarter of 2018 with $119.1 million in cash and cash equivalents.

We believe our quarter end cash position will be sufficient to fund planned operations for well beyond the next 12 months. For the second quarter and six months ended June 30, 2018, we reported a net loss of $18 million or $1.14 per share and $31.4 million or $2.02 per share respectively.

This compares to net losses of approximately $6.2 million or $0.70 per share and a $9.6 million or $1.81 per share for the same periods in 2017. The net losses for the second quarter and six months ended June 30, 2018 include $7.7 million and a $12.3 million respectively in non-cash, share-based compensation expense.

Research and development expenses for the second quarter and six months ended June 30, 2018, were $8.3 million and $15.9 million respectively, compared to $3.7 million and $6.3 million for the same periods ended June 30, 2017 and include $2.8 million and $5.3 million in non-cash, share-based compensation expenses respectively.

The increase from 2017 to 2018 reflects an increase in direct costs associated with our UGN-101 Phase III OLYMPUS trial, an increase in personnel costs and an increase in share-based compensation.

General and administrative expenses for the second quarter and six months ended June 30, 2018, were $10.2 million and $16.3 million respectively as compared to $2.3 million and $3.2 million for the same periods in 2017 and include $4.9 million and $7.0 million in non-cash share-based compensation expenses respectively.

As of June 30, 2018, we had approximately $15.9 million ordinary shares outstanding. With that, operator, I would now like to turn the call over for questions..

Thank you. [Operator Instructions] And our first question is from Boris Peaker from Cowen..

Good morning..

Good morning, Boris..

My first question maybe just on the definition of disease.

Could you just elaborate on what's the difference between low-grade non-muscle invasive bladder cancer with or without a high risk of returns? And what fraction of low-grade patients fall within the low-grade - low risk versus high risk of returns?.

Hey, Boris, it's Mark. Great question, an important one for this trial. Low-grade non-muscle invasive bladder cancer is actually the big group in non-muscle invasive blood cancer, somewhere around 60% of patients who have non-muscle disease fall into this group.

The high recurring fraction in this population, which is a problem for urologists because these are people who effectively fail surgical therapy and recur multiple times both within the year and also throughout life are tough to treat and are defined both by us and in our conversations with the agencies tough to treat.

So this group probably represents we estimate somewhere between 10% and 15%, excuse me, of the total population, but we're choosing to focus on them because they represent a real unmet need in our conversation with physicians and frankly, across the spectrum of urologists with whom we've discussed this application.

And remember, the group of patients we're drawing this subset from is 400,000 prevalence in the United States. So this provides us with we think a window into a very big population of patients who would be served by a nonsurgical alternative, particularly for those who don't respond a surgical therapy by recuring multiple times during life..

Got you.

Mark, let me just clarify, when you said 10% to 15%, that's of the entire NMIBC or only of the low-grade NMIBC?.

That's of the low-grade group..

Got you.

And so my question for the second question is for UGN-102 Optima trial, you mentioned you're going to provide interim updates in the single arm study, I'm just curious how many updates are you anticipating, it's just a single update? Or do you think you could squeeze in multiple ones?.

Hi, Boris. It's Ron. Probably, multiple ones, every time, we'll have a critical mass of data accumulated, we'll look for an important venue to report the data whether it's a medical conference or something along those lines.

But we anticipate that over the course of the study, which will probably take roughly 15 to 18 months from start to finish, we will have several opportunities to report data..

Great. Thank you very much for taking my questions..

Thank you..

Our next question is from Matthew Andrews from Jefferies..

Hey, good morning.

Ron and Mark, just curious what changed relative to MitoGel and the timing and how did this meeting come about with the agency? Have you shared data with them on the OLYMPUS study at this point in time? Just curious how that all came about?.

Are you referring to the rolling submission or?.

Yes. That's correct. I apologize.

You moved it up a quarter so just curious was there something in the data that you shared with them that they felt warranted giving you this guidance to accelerate the timing a little bit?.

Keep in mind that when we presented the data at the AUA, before we did that, we reached out to the agency to basically ask for permission to do that because we felt that the AUA is a very important venue to get the word out and to obviously, increase the awareness because of the size and the attendance of a venue such as the AUA.

So in doing so, we shared the data with them, it was roughly the same data set that was presented at the AUA and there was a little bit of follow up dialogue after that and we received formal guidance from them that we are eligible for a rolling submission about a month or one and a half months ago, something like that and we kind of conquest internally to figure out what - how we want to approach that and how quickly we can get that started and we came to the conclusion internally that we in fact could be in a position or should be in a position to start the rolling submission in the fourth quarter as opposed to the first quarter of 2019.

So that puts us slightly ahead of schedule. So obviously, that's very good news.

First of all, the fact that the FDA has given us this ability in a formal fashion, they basically are allowing for a rolling submission and as you know, rolling submission does give you an opportunity to expedite things because modules that don't necessarily have to wait for final data can get prepared and can get submitted and that also helps out the review process overall so that's really the intent of the whole thing.

So we're very pleased by that obviously and I can't speak on behalf of the FDA but obviously, one would want to believe or one would expect that a lot of it was driven by the strength of the data that was presented to them when we reached out to them to ask for the AUA presentation..

Got you.

And then excuse me, presumably, you would need data in all set roughly 74 to include into the clinical section when you file? Or do you believe you just have to be close to that 74-ish to submit the package?.

Yes. So we would need the top line data. So in order to finish the clinical module, keep in mind that the clinical module is just one of five modules, there are other modules that we can start working on and we believe we can complete by the fourth quarter's so we could start that submission.

And also keep in mind at the time of the submission of the clinical module, we will not have all the durability information yet because we'll still have patients that need to be followed up for that 12 month period. The FDA is fully aware of that. That's been agreed to.

So during the review process, we will provide them with durability and safety updates from the patients that are being followed up..

And then just a follow-up on Boris's question, from a clinical or regulatory standpoint, is there any sort of controversy in and around the finding this patient population that's at risk for recurrence with the low-grade non-muscle? Do you have agreement with the FDA for this study, what the exact population is that you're going to study?.

Matt, so I'll answer top level and then I'll ask Mark to provide a little bit more detail. But we have discussed this population preliminarily with the FDA. We believe that the FDA understands that a population like that does exist, these are patients that are essentially surgery failures.

They just recur very frequently, which in essence means that the surgery doesn't do a very good job on these patients and it could be for a variety of reasons.

And we believe that there is a meeting of the minds in so far as the fact that a subpopulation of that clearly exists and it just becomes futile to essentially take these patients and put them into this vicious cycle over and over and over again very frequently.

Now obviously, this is a Phase IIb study, this is not a pivotal study so at the end of the day, the data is going to determine what the next undertaking is going to be.

Whether this study could potentially qualify or whether this study enhanced meaning more patients could become a pivotal study or possibly, another Phase III study would be needed, again, it's a little premature to be able to ascertain that but I think that there's clearly an understanding from the FDA that a population like this does exist.

But again, just to be cautious, this is a Phase IIb study, this is not a pivotal study. Go ahead, Mark..

Just to add on to that Matt, there is a very clear message from urologic community that this population is a problem.

And anybody in practice who takes care of these patients knows that there is a segment of the population of patients with low-grade disease who recur so often that they cannot be considered anything other than essentially not responsive to contemporary therapy. So here's an unmet need.

And we believe that by focusing on that group, we're really addressing a tangible verifiable medical problem and we have collaboration from our KOLs and from discussion with urologists in the community. So we feel confident that we can identify this group..

Okay, great. Thank you..

Thank you..

Our next question is from Leland Gershell from Oppenheimer..

Hey, good morning..

Good morning.].

Morning, On the UGN-102 Optima trial, the design of the trial should be the same effectively as it is for OLYMPUS in terms of weekly infusion six weekly? And then will patients be eligible who better response for immunotherapy? How should we think about the design?.

Yeah, so.

Leland, it's Mark, exactly the same type of design in a sense that patients will have [indiscernible] disease, they'll receive six weeks of weekly installations of 102 and then after a resting period, which is traditional in neurology of four to six weeks, a primary disease evaluation completely in analogist what seen in the 101 trial and then these patients will be followed.

At this point, we are not planning on providing maintenance therapy for these patients but that's the current design..

Okay. Great.

And then as we look toward the final data from OLYMPUS later this year, will we be also be seeing data from the maintenance heading also conspicuous in terms of longer-term therapy with UGN-101?.

So hopefully, we continue to follow these patients out and keep in mind that we're seeing some very extended durabilities from the Compassionate Use program.

In fact, one patient is out two years and we know of another patient that's out north of one of a half years, well north of one of a half years so we know that we're seeing some very nice robust durability results from the study. So obviously, we're very keen to continue to follow these patients out.

Sometimes it's - sometimes it's difficult because it's three years from the start of treatment.

So some patients move and some patients get lost to follow-up and so on but the bottom line is that overall, when you look at the durability picture that has emerged from the Compassionate Use program, we're very encouraged by that, the median durability is north of 12 months.

And again, it's a small end, it's only eight patients that were followed out but if it's any indication of what's to come from the OLYMPUS study then obviously, we've got very good reason to be optimistic..

Okay. Great. And then my last question is on the financial side. As we look at the R&D and SG&A, which are bumping up a little bit.

How should we think about those expenses through the rest of this year as the Optima trial gets going and precommercial plans are made for UGN-101 with the rolling [indiscernible] also going on?.

This is Stephen. The levels that you're seeing through the last quarter will be what we predict through the bulk of the end of the year. There may be a slight uptick as we bring on sites and patients into the 102 study but I don't expect a dramatic increase there..

Okay, great. That's very helpful. Thanks so much..

Thank you..

Our next question is from Reni Benjamin of Raymond James..

Hey, good morning, guys, Thanks for taking the question. I guess just to start off, you guys mentioned the five of 34 patients who achieved a partial response.

Do these patients with PRs, do they anything convert to a CR later treatment or maintenance treatment? And how in the landscape or with physicians right now, how are PR's typically viewed for an indication like this?.

Hi, Ren, it's Mark. So a great question. In the trial, once you have not had a CR, you are considered a non-responder so for the purposes of the regulatory submission, they don't count.

However, importantly, if you talk to doctors in the real world, partial response is also very meaningful because what this means is the patients who had potentially disease that could not be managed endoscopically, patients that would end up having to have your kidneys removed to now be converted to patients who can have a minor surgical procedure and be rendered disease free.

So we saw this in the Compassionate Use program where several patients had the disease that was considerably downsized from what would have viewed unacceptable to manageable.

So we know as a practical matter that this will very likely be used in the real world of 101 once - hopefully when it's available for the treatment in patients in general practice..

And Reni, in fact, we had one patient in the Compassionate Use who was a partial responder and then that patient was actually retreated with UGN-101 and achieved a complete response. So that may happen in the real world as well, re-treatment to try to achieve a complete response..

Got it.

And then how many patients are - do you have a sense of how many patients are opting to continue to take the monthly and I call it a booster but treatment after the initial six weeks of infusions?.

Yes. So only the patients who achieve a complete response obviously are eligible to receive the monthly maintenance. And right now, about two third of the patients are opting to do that. And quite frankly, the other one third that's not doing it is opting out mostly due to convenience reasons. Keep in mind this is an elderly patient population.

It's not easy for them to comment and drive into a clinic monthly. So they do it for the initial treatment because it's very important but sometimes it's just too taxing on them just from a logistical perspective. But still, the lion share of the patients are opting into the maintenance program..

Got it.

And then I know the topline results are expected at the end of this year, is it fair to assume that the top line results will be press released and then more detailed results at a conference next year? Or is there a conference this year that I'm forgetting about?.

We don't know yet. We don't know. We'll obviously - once we confine to in the resolution, we'll provide updates on that..

Okay. Can you okay. Go ahead..

No. No. Obviously, we're on track to reporting top line by - in the second half. I don't know exactly what the conference venue is going to be where we'll provide the full detail..

Got it. And can you talk a little bit about your ex U.S.

Military strategy and how that might unfold?.

Yes. So we plan to have a formal meeting with the EMA this year. And obviously, it's too early to tell but we're certainly hopeful that they will recognize the program that is being undertaken here in the U.S. as a program that will be sufficient for approval in Europe for upper tract.

That's certainly the goal and we'll find out within a few months and look worse case, if they demand another study, we'll probably end up running another study to get that European approval but we're certainly hoping and we'll certainly try to negotiate hard to get this current program to qualify as the approval study or the OLYMPUS study to qualify as the pivotal study for Europe as well..

Got it. Thanks for taking the questions and congrats on the progress..

Thank you very much..

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

Hi, good morning, guys..

Morning..

I guess a question from Mark. Just wanted to follow-up and get a little bit more details on the UGN-102.

What should we do looking for and a phase IIb study given the patient population you're unrolling the? And the context of the prior results from Phase II that we saw a very high CR rate?.

Yes. So this population I think it probably obviously what we've been talking about. This population is even more adversely affected population that was studied in the Optima 1 program. So if you remember the Optima 1 program had an 86% complete response and very encouraging durability.

So now, we're moving to an even more adversely affected group of people who have even higher rates of recurrence and the reason we're doing that is because we think there is an unmet medical need that we're pretty clear on based on our conversations with our doctors.

And also sort of falls in line with the data that we have available from Optima 1 showing that the approach works better in people with multifocal tumors, with larger tumors, that's the target we're after.

We're trying to look at people who would otherwise have to have surgery, we're spearing them the risk of anesthesia et cetera as opposed to people who could taking care in the office who have tiny tumors that could be for generated. So what we're looking for is a CR rate in this adversely affected population as well as durability.

But obviously, it's a worse group. So the numbers we're looking at would be probably lower than what we saw in Optima 1 remained to be seen in the trial..

Great, that's helpful. And then for 101 as you're nearing the start of your rolling submission of the NDA.

Is there a potential for a priority review status there?.

Yes. There certainly is potential for priority review. We believe that we should be eligible and hopefully, we'll hear soon. But again, until we have it in writing and confirmed, we just need to wait and to see if we get it.

Obviously, we're very keen on getting it because it will mean an expedited review of typically six months as opposed to 10 or 12 months. So obviously, that would be very beneficial and given the fact that we have fast-track and orphan drug designations, particularly fast track, we should be eligible. But again, we need formal certification for that..

Okay. And then just shifting gears, you mentioned the kind of air base technology, the gel technology and potentially applications outside of your urology and G.I. implement cell.

When should we expect to hear some of the details around what you're going to pursue their from a pipeline review?.

Yes. We're starting to look into that. The R&D group is putting pen to paper to start working on those two potential avenues. So over the next few months, we will be probably elucidating path forward, including the possibility of already generating some preclinical data in those areas.

So definitely, people should be on the lookout for at least some preclinical data within the next call it six to nine months for those two potential avenues..

Congrats on the progress, guys. And thanks for taking the questions..

Thanks..

I am showing no further questions at this time. I will now turn the call back over to UroGen's CEO, Ron Bentsur for closing remarks..

Thank you, operator. I want to thank you all for your time today. We remain very pleased with the progress we've made this quarter and look forward to updating you on key milestones in the months ahead. Operator, you may now disconnect..

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