Catherine Bechtold - Director, Corporate Communications and IR Ron Bentsur - CEO & Director Mark Schoenberg - Chief Medical Officer Gary Titus - CFO & Principal Accounting Officer.

Matthew Andrews - Jefferies Boris Peaker - Cowen and Company Leland Gershell - Oppenheimer Matt Kaplan - Ladenburg Thalmann Jonathan Aschoff - National Securities Corporation.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma First Quarter 2018 Financial Results and Business Update Conference Call. [Operator Instructions] 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's First 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 March 31, 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 Gary Titus, Chief Financial Officer.

Ron will provide a brief summary of our recent Corporate Development, and Mark will share clinical development and regulatory updates. Gary will then provide an overview of our financial highlights for the first 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 and 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, Cathe. Good morning, everyone and thank you for joining us on our conference call. The first few months of 2018 have been exciting for UroGen. We continue to make strong progress towards our goal of becoming a leader in the field of your oncology and neurology.

Most notably, we look forward to the upcoming late-breaking presentation next week at the American Urological Association or AUA annual meeting on the interim analysis of our pivotal Phase three Olympus trial of UGN-101 also known as MitoGel in patients with low grade upper tract urothelial carcinoma or UTUC.

We are encouraged by the complete response rate observed in the trial to date and plan to share top-line data from the trial in the second half of this year.

Our team remains intensely focused on our most important milestone submitting a new drug application or NDA to the FDA in the first quarter of with a potential for UGN-101 to become the first ever approved treatment for low-grade UTUC.

As a brief reminder, the Olympus trial is our open label single arm pivotal safety and efficacy trial of UGN-101 for the treatment of low-grade UTUC which is being conducted at clinical sites across the United States in Israel.

Patients in the trial undergo six weekly catheter installation treatments of UGN-101, the primary efficacy endpoint is complete response or CR assessed at approximately 10 weeks from the start of treatment or approximately five weeks following the six weekly installation of drug.

Patients who achieve a complete response are then followed up for durability of disease control for up to one year and are eligible to be treated monthly for up to 12 additional monthly maintenance therapies of UGN-101. Abstracts for the AUA meeting were made publicly available by the conference last month.

At the time of our abstract publication submission 28 patients enrolled in the study were a valuable for primary disease evaluation or complete response assessment. In this on an intent treat cohort of 28 patients, we saw a complete response rate of 57%.

Recall that in our compassionate use program the CR Aid on an intent to treat basis was 8 out of 18or 44%. Consequently we are certainly encouraged by the results from the interim analysis of the Olympus trial, which appear robust.

Mark will expand upon these initial interim results detailed in the abstract in a moment, however, I will note that UTUC is an indication with no FDA-approved drugs and is characterized by the need for repeated endoscopic procedures and the risk of kidney removal.

And we believe UGN-101 has the potential to be a paradigm shifting treatment for this patient population. We believe that this is a promising preliminary result and look forward to sharing additional details with the data presentation next week including the CRA on a slightly larger cohort of patients, as well as updated durability information.

At the AOA Conference, we will also provide the partial response or PRA achieved to date, although PRS are not part of the review for regulatory purposes, we do know that they may play an important role in the real-world setting. Following the Olympus data presentation we will host an investor event at the Westin St. Francis hotel in San Francisco.

We are preparing for a potential approval and launch of UGN-101 in the second half of 2019 following our planned submission of an NDA to the FDA in the first quarter of 2019, while gaining the first-ever approved treatment for low-grade UTUC is a top priority, we believe that it is merely the beginning of what we know it's possible when considering the full potential of the RTGEL, our proprietary sustained-release technology platform.

Other pipeline programs demonstrating only some of the potential of the platform including VesiGel which we now refer to as UGN-102, VesiMune immune now referred to UGN-201 and BotuGel continue to advance.

We remain on track to submit an investigational new drug or IND application to the FDA for UGN-102 for the treatment of low-grade non-muscle invasive bladder cancer or NMIBC mid-year and commence a Phase 2b clinical trial shortly thereafter.

UGN-201 or VesiMune a novel imiquimod formulation for bladder installation is currently being evaluated in preclinical models with and without immune checkpoint inhibitors for the treatment of high-grade UTUC.

Under our actives IND for UGN-201, we believe that we're on track to commence a clinical trial of UGN-201 in the first half of 2019 as either a single agent or in combination with another immunology agent.

Finally, our partner Allergen continues to enroll patients in the Phase 2 clinical trial of our RTGEL in combination with Botox collectively a drug candidate that we internally refer to as BotuGel for the treatment of overactive bladder.

Our partnership with Allergan provides proof of concept for the broader applicability of our RTGEL technology platform and we hope this becomes just one of many.

This partnership has brought us $25 million of non-dilutive cash to date and we're eligible to receive up to $200 million in additional cash payments from Allergan related to the achievement of certain development regulatory and commercial milestones in addition the royalties on potential net sales.

From a corporate perspective, we are well capitalized especially following a strong start to the quarter the completion of a follow-on public offering in January raising approximately $64.2 million in net proceeds with total cash at the end of the first quarter of $127.5 million. As we prepare for the next stage of our company's evolution.

The first quarter marked a period of continued growth and expansion of our US operations and leadership with key hires across regulatory, clinical and commercial functions to support this goal.

I will now hand it over to Mark who will provide more granularities around the preliminary findings from the Phase 3 Olympus study of UGN-101 in low-grade UTUC and expand on what's next in the pipeline. Mark, please go ahead..

Thanks, Ron. The last few months have certainly been exciting for UroGen as urologists I am particularly encouraged by the interim results of our Phase 3 Olympus study. It will be presented at the AUA meeting in San Francisco on Monday May 21st. Additional details can be found on the AUA's website.

Our abstract made public last month describes 33 patients enrolled in the Olympus trial of which 28 were evaluated by ureteroscopy and wash cytology, the standard microscopic tests of cells obtained from the urine of the upper track for the six weeks after the completion of therapy.

At the AUA, we will provide data on additional patients whose data have matured sufficiently to be informative. As Ron mentioned, we have observed a complete response rate of 57% in the ITT cohort to date.

It's important to mention that while only the CR rate will be considered for regulatory purposes in evaluating the Olympus trial, partial response rates will be meaningful to practice in neurologists, and we will provide insight into the PRA during the AUA presentation.

Our abstract also reported preliminary durability data for six patients all of whom remain disease-free, three months following completion of therapy. We will provide a fair amount of additional durability data at the AUA.

Treatment emergent adverse events associated with the use of UGN-101 have been generally as expected predominantly mild to moderate and have included urinary tract infection, flank pain and transient cracking elevation.

In aggregate, we view these efficacy and safety data to date as encouraging and supportive of a potentially paradigm-shifting approach to the treatment patients with low-grade UTUC who currently have limited therapeutic options.

UGN-101 maybe a particularly useful for those patients with rapidly and chronically recurrent cancer, and for those whose disease cannot be visualized or a second using contemporary endoscopic technology.

I would be remiss in not drawing parallels between the data obtained from UGN-101 compassion use program and the results to date from the Olympus trial. The compassion use program enrolled 18 patients would confirm low grade UTUC all of whom had tumors that were extensive and hard to resect.

Of note, a number of the patients in the program had only one kidney and all the candidates for kidney removal. We observed that 44% CR rate and ITT cohort and a 12-month median durability response with three patients disease-free more than 18 months after the completion of treatment. These results were achieved without additional maintenance therapy.

We do offer monthly maintenance therapy for up to 12 months for all patients in the Olympus trial, who achieve CR status at the primary disease evaluation.

This aspect of the Olympus trial design could possibly enhance long-term disease control and reflects what we believe will be the real-world use of UGN-101 once this product is available to practicing physicians and their patients.

We are looking forward to the presentation of the AUA next week and ultimately to potentially filing the NDA for UGN-101 in the first quarter of 2019.

In addition to the investor event Ron mentioned and in collaboration with Stat news I will be moderating an educational panel discussion at the a AUA with key opinion leaders on the urgent need to reshape the treatment paradigm across a number of uro oncologic conditions including low-grade UTUC and bladder cancers.

Our pipeline continues to advance as we look to other indications that can potentially benefit from our innovative RTGel platform, light low-grade UTUC and NMIBC or non-muscle invasive bladder cancer represents an important area of unmet need.

The standard of care for treating NMIBC is transurethral resection of bladder tumor or TURBT followed by adjuvant chemo or immunotherapy. TURBT is for organ or anesthesia and is associated with a standard risk of anesthesia and surgery such as injury to the bladder and post-operative bleeding.

No drugs have been approved by the FDA as first-line treatment for NMIBC and only three drugs have been approved by the FDA as adjutant therapy.

Based on strong Phase 2A data from a study of primary chemo ablation and low non-invasive disease using UGN-102 in which we observe an 85% CR rate, we plan to submit an IND for UGN-102 in the coming months and to start Phase 2b single arm open label trial in tough to treat low grade disease patients shortly thereafter.

Beyond UGN-101 and UGN-102, our partner Allergan continues to enroll patients in a Phase 2 clinical trial RTGel in combination with Botox for the treatment of overactive bladder.

The trial is anticipated to enroll up to 300 patients with overactive bladder with urge urinary incontinence who have had an inadequate response to, or are intolerant of traditional pharmacotherapy. Finally, we are also advancing our immuno oncology product candid UGN-201 for VesiMune.

We continue to evaluate this novel imiquimod formulation for bladder installation as a single agent and in combination immune checkpoint inhibitors for the treatment of high-grade UTUC in preclinical models.

A clinical trial conducted under the UGN-201 IND demonstrated preliminary single agent activity in a Phase 1b study for the treatment of carcinoma in situ. Further clinical development of UGN-201 in combination with our proprietary gel is planned for the first half of 2019. And we look forward to sharing updates of this program in the coming months.

With that I would now like to turn the call over to Gary to briefly review our financials..

Thank you, Mark and get 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 US approval of UGN-101 in 2019. As Ron mentioned, we closed the first quarter of 2018 with $127.5 million in cash and cash equivalents.

This includes the approximately $64.2 million in net proceeds from a public offering of our shares of common stock completed in January 2018. We believe our quarter end cash position will be sufficient to fund planned operations for well beyond the next 12 months.

For the first quarter of 2018, we reported a net loss of $13.4 million, or $0.88 per share. This compares to a net loss of approximately $3.4 million or a loss of $1.74 per share for the first quarter of 2017. This net loss includes $4.6 million in non-cash share based compensation expense.

Research and development expenses for the quarter ended March 31st, 2018 were $7.6 million compared to $2.7 million for the quarter ended March 31st, 2017. And includes $2.5 million in non-cash share based compensation expenses.

The increase from 2017 to 2018 reflects an increase in direct cost associated with the UGN-101 Phase 3 Olympus trial, and increase in personnel costs and an increase in share based compensation. General and administrative expenses were $6.1 million for the first quarter of 2018 as compared to $900,000 for the same period in 2017.

And includes $2.1 million in non-cash share based compensation expenses. As of March 31st, 2018, we had approximately $15.5 million ordinary shares outstanding. With that, operator, I would now like to turn the call over for questions..

[Operator Instructions] And the first question comes from Matthew Andrews from Jefferies..

Hey, good morning. A couple for me on MitoGel.

Ron and Mark can you update us on enrollment timelines for Olympus? Two; can you talk about where you are on CMC commercial area, commercial scale for MitoGel? And then lastly on MitoGel can you talk about when you may publish the compassionate use data? And any update since the Q4 call for long-term follow-up on those patients in the CUP..

Matt, can you hear us?.

Yes. Now I can.

Sorry did the questions come through?.

They did. I just want to make sure I heard all of them. So the first one was MitoGel enrollment.

The second one that was a commercial and the third one was CUP and the follow-up, right?.

Yes. Right CMC, where you on CMC with MitoGel considering the factor you tentatively plan to file in Q1.

So where are you with that?.

Right. So in terms of an enrollment into the MitoGel study. So we're making great progress, what's important for us is to adhere to the protocol and make sure that in obviously per all the agreements with the FDA, we do everything right, everything is done meticulously and so on.

The study I can assure you are moving along very well in terms of conduct, and in terms of you always strive for an impeccable type of a nature for this type of a study.

And we very much remain on track for NDA filing in the first quarter of 2019, and the most important thing perhaps is the fact that given everything that we've seen today including the data so far, and the conduct of the study, we are very confident that MitoGel can really make a difference in this indication, and can really change treatment paradigms for the way these patients are treated for low-grade UTUC.

Regarding CMC, we continue to make very good progress with CMC, obviously, we use outside CMOS for the manufacture of the gel, as well as the manufacture of mitomycin, all that is coming together converging very nicely along the timelines that we're projecting for NDA filing.

Keep in mind one additional thing that we have which is the potential ability to buy mitomycin off the shelf if we have to because it is a generic drug. It is being sold. Right now, we're opting to manufacture it ourselves through a third party because we think it's going to be more cost effective for us down the road.

But obviously there's always the degree of freedom I'll call it that to go to a third party - to go to one of the existing manufacturers and marketers of mitomycin and just buy it off the shelf if we have to. So I think we've got a little bit of flexibility there, but overall we're making very good progress on the CMC.

Regarding the compassionate use program, the manuscript that you asked about when the data is going to be published. So that manuscript is finished. It's going to be submitted very soon. So hopefully within the next call it several months this manuscript can be published and can be made publicly available.

And finally there's a follow-up on the patients from the compassionate use program as Mark alluded to we have three patients out of the eight complete responders that are way out there 18 plus months. One is out I think north of 24 months. So we're continuing to follow up on these patients.

Hopefully, we're going to be able to continue to do that as given the nature of a compassionate use program, it wasn't power protocol per se. So a lot of it depends on the goodwill of the sites and the patients and willing to share information.

But so far we have been able to retrieve that information and obviously we're keen to see how far these patients can continue to stay in remission. But overall we're very pleased by the results that we've seen so far with the median hovering a little bit north of 12 months with again three that are way out there.

Again the picture looks pretty favorable from our perspective..

Our next question comes from Reni Benjamin from Raymond James..

Good morning, guys. This is [Bindu] on for Benjamin. Hi, guys. Hear me okay? And so first congrats on the progress met in the past quarter. So just quick question for you and Mark, so when you and Mark made the commentary that you're pleased with the safety and efficacy data seen today with MitoGel.

So I was wondering if that comment was made based on data disclosed in the abstract or the data you've seen to date from the entire Olympus study because given that is an open label study. Then I'll have couple of follow ups..

Yes. I'll say a couple sentences and then I'll ask Mark to - because Mark after all is the urologist and he can provide his physician perspective. But the data that we refer to is the data to date based on the information that we get as a management team.

And obviously that includes a little bit more in terms of the patient number than what you saw in the abstract for the primary endpoint. And the safety is for all the patients that are in the study right now at various time points obviously. So it is more than what's just in the abstract and I can say from my vantage point I couldn't be more pleased.

It's all trending very favorably but go ahead Mark..

Yes. I mean I think the thing to take away from this is that what we're seeing - what you're seeing and what we're watching unfold in the trial is completely consistent with the type of therapy that we're delivering consistent with the types of things you'd see with the administration of mitomycin.

And we're not seeing morbidities or toxicities that are unusual. And so this is all well within the realm of expected neurologic practice and our investigators are carefully following these patients. And happily so far we're getting good results with what are considered to be very minimal problems for the patient.

So hopefully that trend will continue, but so far it looks very favorable..

Got it. That's very helpful and then my second question is on the AUA presentation. So you mentioned that we see data from additional patients.

Is it fair to assume that it's going to be the additional five patients out of the 33 patients or it would be more than 33?.

It'll be - I don't remember the exact number. It's around five more maybe six more. And also importantly there's going to be relative to what we had in the abstract, which I think was six out of six at the three month time points for durability. There's going to be a fair amount of incremental information, again relative to having only an N of six.

So on a durability front there will be a fair amount of additional information that's going to be included in the presentation versus what there was in the abstract itself..

Got it. That's was helpful. I've one last question if I may it's on the RTGel platform.

So just given the positive preliminary data we've seen so far with the MitoGel product, I was wondering if there's any reach through that we can have for other products in development? And then secondly beyond what we have right now in the pipeline is it possible that are you considering to develop other products for other indications even beyond bladder cancer especially indications where we have existing drugs, but the drugs are not working well because of a lack of or short dwell well time.

Thanks..

Mark you want to take the question..

Sure.

It's a great question and you can be quite certain that we are very interested in exploring additional opportunities because as I think you've heard us say this before, we think the platform is broadly applicable to all kinds of surface diseases that affect epithelium, which is of course what the UTUC program or a bladder program are great examples of.

So we are actively exploring that. We have a robust R&D group that is looking into various applications and you could imagine organ systems where this platform would be very useful. So without belaboring and I would say that we are actively involved in that.

And we are optimistic we'll find other opportunities to deploy the platform in the near future..

Our following question comes from Boris Peaker from Cowen..

Great, good morning, guys. So you mentioned some patients are getting long-term maintenance of the drug.

I'm just curious what would it take to actually get long-term maintenance into the label?.

So I think that given the fact that it's part of the protocol, so basically patients who achieve a complete response are entitled to receive up to 12 monthly maintenance, additional maintenance therapies above and beyond the initial six weekly installations.

That is part of the protocol so that we believe is going to be part certainly at the clinical trial section. And may even be part of the administration instructions in the label itself basically that they'll say that if a patient has achieved a complete response that patient should receive 12 monthly installations of the drug to support durability.

So again if it's part of the protocol and this was all obviously agreed to before the study started. There's a good chance that will go into the protocol certainly that was part of the intent going into the study. On one hand obviously we wanted to improve the durability by doing so but we also wanted it ultimately to be part of the label itself.

So that's kind of the rationale that went into the thinking behind the 12 monthly additional therapies for durability..

And in your discussion with the FDA regarding this strategy.

Did the agency asked we want to see a minimum of X number of patients out a certain number of months in order to kind of consider this in the label or was that not really a kind of officially discussed?.

No. That was not officially discussed. These are all secondary endpoints and exploratory endpoints and things like that, but we believe that anything above six months and in this kind of an indication is going to be perceived as very robust. And obviously anything north of that the more the merrier, but nothing, no specific numbers were discussed.

And keep in mind that maintenance therapy for example adjuvant therapy right is part of standard urological practices. So these things are not going to be unusual to the practicing community and we're just introducing something in essentially the same format that they're already very well-versed at.

So the FDA is very aware of all these situations and all these adjuvant therapies that are going on in urology particularly in the bladder. And now we obviously want to introduce that same concept into the upper tract. And again if everything goes well there's no reason to believe as to why this should not be part of the label..

Great. And my last question on VesiGel.

Just curious what's the time line for the Phase 2 clinical study and looking beyond that what would be required to get it approved? I mean would it require like two randomized Phase 3 trials or can this be done on to kind of a simpler regulatory path?.

So we believe that the timing for data from that Phase 2 study is in the first half of 2019 that Phase 2 is ongoing as you know it started about six or seven months ago. And it's enrolling cohorts as we speak. They've already moved up to the third cohort I believe. So it is moving forward very nicely.

So based on our internal projections we should see data from that study in the first half of 2019. And then they will start a Phase 3 program.

Now regarding the second part of your question what does that Phase 3 need to look like? Is it too adequate and well controlled studies? Or is it one because Botox has already approved in the indication and this is essentially a reformulation and all that. We don't have the answer to that question.

And Allergan, I can't speak on their behalf but they may not have it yet either. I think some of it obviously will be dependent on the strength of the data that's going to be seen in a Phase 2, but if that Phase 2 is successful and from our perspective there's no reason to believe why it shouldn't be.

But it is still a clinical trial and that's why they're running it to see if it works. But if it works for us I think it'll provide immediate validation above and beyond what we have today for the potential use of the RTGel outside of your oncology. So we're very much looking forward to the results from that study.

And keep in mind that once they start a Phase 3 which is going to be if the Phase 2 successful that Phase 3 will start very shortly thereafter that also triggers a milestone payment to us $20 million, which would be nice to receive as well. So it's nice to have this type of a product in the hands of the folks who know it best.

And really are the world leaders in dealing with this type of a compound. And it's really a validation story for us. If this thing succeeds I think it bodes very well for what we can do with this compound with other technology beyond what we're doing today..

Following question comes from Leland Gershell from Oppenheimer..

Hey, good morning. Thanks for taking my question. Switching gears to the 201 program I want to ask if you can share any more color on the preclinical work that you're doing with that. And models any further observations even if just qualitative.

And then related to that any further details you can provide on your thoughts with regard to upcoming clinical work particularly with regard to combination with checkpoint inhibitors?.

Sure. This is a very interesting program for us because as I bet you're aware we have predicate data from 1b experiment in patients with high grade non-invasive bladder cancer called carcinoma in situ, who had failed BCG therapy in which we saw that this novel formulation of the imiquimod did in fact have activity in this high grade disease.

So for us this is a very intriguing piece of information because not only is it interesting to have an agent that is active against high grade disease, but obviously within the context of what we are now beginning to appreciate about immune regulation and immuno oncology.

We know that this approach is active against urothelial cancer, and we would very much like to deploy active agents against high grade disease using our platform. So to that end we have been working in a urine model looking at the activity of the imiquimod formulation with and without checkpoint inhibitors.

And we are beginning to get what we believe are encouraging single data from those experiments that would lead us to develop a combination of the imiquimod formulation with gel that would make it possible for example to contemplate a protocol to treat high-grade upper tract disease, which would be a very novel application of immuno oncology surface and immuno oncology and in a setting where there is no topical therapy very analogous to what we're doing in low grades UTUC.

So I think you get the idea that we do have very interesting preclinical data. And we're now going to start to develop a clinical program to explore that possibility using the gel platform..

Thank you for that. And then just one financial question for Gary just with regard to the G&A coming in about $6 million for the quarter.

I just wanted to even comment on how we should regard that as a perhaps run rate or numbers actually the rest of this year?.

Thanks, Leland. Yes. I think you should consider that to be more of a current public company run rate for us. And obviously looking back at a year it's a private company so not really so comparative.

Additionally, keep in mind that we are doing a ramp up for the commercial operations that will continue that ramp up is a key focus for us as we continue to look forward to launching potentially MitoGel in not distant future..

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

Hi, good morning, guys.

So I guess first a question for Mark, help us understand in terms of the hurdle in terms of overall response rates /a more importantly I guess complete response rate that you're looking for in the Olympus trial given the unmet need of space and then also talked about the durability hurdle as well?.

Great questions and thank you. So as I think we've discussed before when we talked to the FDA about the design of this trial what we were advised by the agency was to come to them with what would be considered by the practicing community of urologist a clinically meaningful outcome.

And given the fact that there are no currently available medications used to treat this disease, we really have what we consider to be a pretty green pasture and a pretty low bar because the only therapy available for patients with this disease is surgical therapy and their surgical therapy as you know comes in two flavors, its endoscopic or kidney removal, and we obviously are very dedicated to the idea that our platform and this therapy can save kidneys and also decrease the amount of recurrence surgery that many of these patients have to undergo in order to control this disease.

Remember, that with surgical mono therapy recurrence rates for endoscopic control this disease are anywhere from 50% to 90% of a year. So we're currently targeting a 20% hurdle for success and as you can see we're based on the preliminary data we have from our interim analysis, we're well above that.

So we believe we already have a very clinically meaningful CR rate based on our conversations with the FDA.

And with respect to your second question which is about durability, and we have very intriguing data from the compassionate use program suggesting that even with just induction therapy one dose per week for six weeks, we can get very long term disease control, but certainly six, nine, twelve month durability data will I think be very interesting not only to the FDA but also to the to the urologic community, which struggles to take care of these patients currently..

That's very helpful, thank you.

And I guess for Ron beyond the completion of the Olympus study what are the other hurdles to filing - to prepare for filing the NDA in the first quarter module?.

So in terms of the undertakings that need to get done for the filing as you know there various modules that are involved in the NDA filing.

The Phase 3 upon its completion that will essentially complete the clinical obligations that we have for submissions that we would need obviously to complete a clinical study report and do all the integrated safety and efficacy reports that will go into the clinical section.

Keep in mind that because this is a 505B2 regulatory pathway, we are going to get some discounts in terms of the various experiments that otherwise we would need to conduct.

For example genotoxicity and carcinogenicity now things like that all those things were going to get waivers for because mitomycin is has been approved for a number of years, and all that. So I think it's really all about just having everything converge on the CMC side.

And writing up all the packages, making sure it's done right as you know these things take a little bit of time, you can't do it in a week.

These things require a fair amount of effort and you also need vendors that help you do that, but once the clinical trial is done and we kind of finalize that clinical study report then it's really all engines on go to try to finalize everything else. And have it all converge into this electronic package that you need to submit.

But given what we're seeing right now and as you can imagine there's a lot going on in parallel already on the CMC side, on the preclinical and on the summary reports and all that. There's a lot that's being started already.

There's no reason to believe why we should not meet that timeline of a first quarter NDA filing, and that's really the overriding, overarching milestone for the company. That is the most important milestone that we're all very focused on right now..

Okay, very good.

And then look it seems like things are going to accelerate pretty quickly here and given the filing expect in the first quarter and then potential for accelerated review with FDA can talk a little bit about where your commercial preparations are?.

Yes. So Gary started to touch on it a little bit but we were starting to plant some very important seeds for commercialization obviously without overextending because you want to do things in a modular fashion, and you want to time it right. But in terms of key hires, we're starting to put a lot of pieces in place.

So for example, the VP of commercial was hired several months ago as you probably remember. Director of Marketing, payer access, director of sales hire that is pending. So we've already hired really I would say four out of the five key positions that you need to start managing a commercial organization.

The fifth one being MSL, Medical Science Liaison that's going to come next. So we're starting to put all those pieces in place. I think we've hired some tremendous talent on those fronts. And we're really looking forward to it.

I think we're going to have a very strong team, but again it's going to be done slowly, gradually without jumping ahead of ourselves here. And it's all going to kind of coincide with the timelines of the clinical trials. And the NDA filing..

Our following question comes from Jonathan Aschoff from National Securities..

Hi, guys.

Not much left to ask but I hear what you just saying about Phase 3 enrollment and adhering to the protocol but by saying 2h for the data you're now saying that data in the third quarter is quite the unlikely stretch correct?.

Actually what we're saying is that we're very much on track to filing NDA in Q1 of 2019 which is what we've been saying all along. We developed a protocol with the FDA that we are strictly adhering to.

It's got very specific criteria which were designed explicitly so that we could ride the agency with a clear understanding on how this drug works and of efficacy. And that is what we were doing and we continue to enroll patients from the trial. And we believe that this approach is going to be the best way to get us over the finish line.

So that's what we're doing..

Okay and I was just curious is there anything inherent about VesiMune that makes it more likely to work in UTUC versus other cancers or is that your direction because of the company? You are oncology focus..

So I'll start then maybe Mark can add as well. We believe that VesiMune given the preliminary data that we saw in carcinoma in situ, so clearly we believe that in the right setting it can also work in that indication.

And that is considered an aggressive form of high-grade bladder cancer, but with respect to UTUC that is an area that we have obviously very keen interest in given the experience that we've had in low-grade UTUC and the familiarity that obviously we've developed over time in this indication.

And we also I think understand the landscape of high-grade UTUC very well and what goes on with the patient treatment and basically the sequela of what happens to all these patients in that setting. And we do believe that VesiMune can actually work in that indication.

It's just a matter of finding really the right format to give it the best chance for success. So for example is it in combination with some other immunotherapy or is it as a single agent.

Is it maybe with the gel without the gel, these are all things that we are testing pre-clinically right now to try to come up with the best set of information that we can - that can help us ease out the clinical path forward.

But we definitely believe that there's potential there and we really as a small company we like that indication for all the obvious reasons, orphan indication, and unmet medical need. We believe that the bar given the prognosis and the sequela and kidneys getting taken out left right and center.

We believe that the bar is going to be relatively low and these are all things that we are interested in pursuing. And Mark maybe you want -.

No. I think that's a very, very comprehensive answer. The only thing I would add is there's this very intriguing data emerging in urothelial cancer combining TLRS with checkpoints. And I think we're poised to be able to take advantage of that. So there's an interesting and intriguing specific biology that we are going to explore.

And it looks very promising..

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 everyone for taking the time to join us on the call today. We look forward to seeing many of you at the AUA annual meeting in San Francisco next week. And hope you'll be able to join us for our investor event following the Olympus data presentation.

We believe that we're on a dynamic trajectory to becoming a leader in the field of your uro oncology and urology. On behalf of the UroGen team, thank you for your support. Operator, you may now disconnect..

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