Urogen Pharma Ltd. (URGN) Q1 2018 Earnings Conference Call Transcript

Urogen Pharma Ltd. (URGN -3.72%)
Q1 2018 Earnings Conference Call
May. 15, 2018 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

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 my pleasure to turn the call over to Kate Bechtold, director of corporate communications and investor relations for UroGen Pharma. Please go ahead.

Catherine Bechtold -- Director of Corporate Communications and Investor Relations

Thank you, operator. Good morning, everyone, and welcome to the 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 the 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 provision 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 inspectors 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 investtors.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 event or otherwise. I will now turn the call over to Ron.

Ron Bentsur -- Chief Executive Officer

Thank you, Kate, good morning everyone, and thank you for joining us on our conference call. The first few months of 2018 has been exciting for UroGen. We continue to make strong progress toward our goal of becoming a leader in the field of uro-oncology and urology. 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 3 OLYMPUS trial of UGN-101, also known as Mito Gel, in patients with low-grade upper tract urothelial carcinoma, or UTUC.

We're encouraged to complete response rate observed in the trial 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 2019, 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 UTC, which 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, or CR, assessed at approximately 10 weeks from the start of treatment, or approximately five weeks following the six weekly catheter 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 at 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 intent to treat cohort of 28 patients, we saw a complete response rate of 57%. Recall that in our Compassionate Use program, the CR rate on an attempt-to-treat basis was eight out of 18, or 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 he CR rate on a slightly larger cohort of patients as well updated durability information. At the AUA conference, we will also provide the partial response, or PR rate, 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 of that at the Western St Francis Hotel in San Francisco. We are preparing for 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 or 2019. While getting 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 is 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-202; Vesimune, now referred as UGN-201; and BotuGel continue to advance.

We remain on track to submit an investigational new drug or IND application to the MDA for UGN-102 for the treatment of low-grade non-muscle invasive bladder cancer, or NMBC, mid-year and commence a Phase 2b clinical trial shortly thereafter. UGN-201 or Vesimune, a novel imiquimod formulation for blatter installation is currently being evaluated in preclinical models with and without immune checkpoint inhibitors for the treatment of high-grade UTUC. Under our active IND for 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 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 to the royalties on potential net sales. From a corporate perspective, we are well-capitalized, especially following a strong start to the quarter, with 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 U.S. operations and leadership with key hires across regulatory, clinical, and commercial functions 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.

Mark P. Schoenberg -- Chief Medical Officer

Thanks, Ron. The last few months have certainly been exciting for UroGen. As a urologist, I am particularly encouraged by interim results of our Phase 3 OLYMPUS study that will be presented at the AUA meeting in San Francisco on Monday, May 21. 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 whom 28 were evaluated by uretoroscopy and WASH cytology, the standard microscopic test with cells obtained from the urine of the upper tract, four to six weeks after the completion of therapy. At the AUA, we will provide data on additional patients whose data has 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 practicing neurologists, and we will provide insight into the PR rate 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 has been generally as expected, predominantly mild to moderate and has included urinary tract infection, slight pain, and transient creatinine 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 of patients with low-grade UTUC, who currently have limited therapeutic options.

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. I would be remiss in not to draw parallels between the data obtained from the UGN-101 Compassionate Use program and the results to date from the OLYMPUS trial. The Compassionate Use program enrolled 18 patients with confirmed 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 were candidates for kidney removal.

We observed a 44% CR rate in the ITT cohort and a 12-month median durability of 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 achieved CR status at the primary disease valuation. 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 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 could potentially benefit from our innovative RTGel platform. Like 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 inception of the bladder tumor or TURBT, followed by adjuvant chemo or immunotherapy. TURBT is performed under anesthesia and is associated with the standard risk of anesthesia in surgery such as injury to the bladder and postoperative bleeding. No drugs have been approved by the FDA as first-line treatment for and NMIBC and only three drugs have been approved by the FDA as adjuvant therapies. Based on strong Phase 2a data from the study of primary chemoablation in low-grade noninvasive disease using UGN-102, in which we observed an 85% CR rate, we plan to submit an IND for UGN-102 in the coming months and to start a 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 for RTGel in combination with BOTOX for the treatment of overactive bladder. The trail is anticipated to enroll up to 350 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 candidate UGN-201 or Vesimune. We continue to evaluate this novel imiquimod formulation for bladder installation as a single agent and in combination immune checkpoints 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 Ib 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.

Gary Titus -- Chief Financial Officer

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. 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 noncash share-based compensation expense. Research and development expenses for the quarter ended March 31, 2018, were $7.6 million, compared to $2.7 million for the quarter ended March 31, 2017, and includes $2.5 million in noncash share-based compensation expenses. The increase from 2017 to 2018 reflects an increase in direct costs associated with the UGN-101 Phase 3 OLYMPUS trial, an 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 noncash share-based compensation expenses.

As of March 31, 2018, we had approximately 15.5 million ordinary shares outstanding. With that, operator, I would now like to turn the call over for questions.

Questions and Answers:

Operator

Thank you. We will now begin the question-and-answer session. [Operator instructions] Our first question come from Matthew Andrews from Jefferies.

Matthew Andrews -- Jefferies -- Analyst

Hey, good morning. Couple for me on MitoGel. Ron, Mark, can you update us on enrollment timelines for OLYMPUS. Two, can you talk about where you are on CMC 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? Hello? Did we get disconnected? Huh?

Operator

Please hold.

Matthew Andrews -- Jefferies -- Analyst

Yup. Thank you.

Ron Bentsur -- Chief Executive Officer

Matt, can you hear us?

Matthew Andrews -- Jefferies -- Analyst

Yes. Now I can. Sorry did the questions come through?

Ron Bentsur -- Chief Executive Officer

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?

Matthew Andrews -- Jefferies -- Analyst

Yes. Right. CMC. Just where are you on CMC matters will factor with the filing -- that you tentatively plan to file in Q1.

So where are you with that?

Ron Bentsur -- Chief Executive Officer

Right. So in terms of 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 and obviously per all the agreements with the FDA, we do everything right. Everything is done meticulously and so on.

This study, I can assure you, it's moving along very well in terms of conduct and in terms of the -- you always strive for an impeccable type of a nature for this type of a steady. And we very much remain on track for NDA filing in the first quarter of 2019. One of the most important thing perhaps is the fact that, given everything that we've seen to date, 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 that 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 CMO's for the manufacture of the gel as well as the manufacture of mitomycin. All of that is coming together, converging very nicely along the timelines that we are projecting for NDA filing. Keep in mind one additional things that we have, which is the potential ability to buy mitomycin off the shelf as 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 is the data going to be published, so that manuscript is finished.

It's going to be submitted very soon. Hopefully, within the next, call it several months, this manuscript can be published and can be made publicly available. And finally, as 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. Given the nature of Compassionate Use program, it wasn't our 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.

Matthew Andrews -- Jefferies -- Analyst

Got it. Thank you.

Ron Bentsur -- Chief Executive Officer

Thanks.

Operator

Our next question comes Ren Benjamin from Raymond James.

Bin Lu -- Raymond James -- Analyst

Good morning, guys. This is Bin Lu on for Ren Benjamin. Can you hear me OK? First congrats on the progress made in the past quarter. I have some quick questions 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 the data disclosed in the abstract? Or the data that you've seen to date from the entire OLYMPUS study, because given that is open-label study.

And I have a couple of follow-ups.

Ron Bentsur -- Chief Executive Officer

Yes. I'll say a couple of sentences, 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 referred to as 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 standpoints, 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.

Mark P. Schoenberg -- Chief Medical Officer

I mean, I think the thing to the take away from this is 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 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 within the realm of expected urologic practice, and our investigators are carefully following these patients. And happily, so far, we're getting good results with what are considered to be minimal problems for the patients. So hopefully that trend will continue.

But so far, looks very favorable.

Bin Lu -- Raymond James -- Analyst

Got it. That's very helpful. And my second question is on the AUA presentation. So you mentioned that we'd see data from additional patients, is it fair to assume that is going to be the additional five patients out of the 33 patients? Or it would be more than 33?

Ron Bentsur -- Chief Executive Officer

It will 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 point for durability, there's going to be a fair amount of incremental information, again relative to having only an end of six. So on the 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.

Bin Lu -- Raymond James -- Analyst

Got it. That's helpful. I have one 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 product in development? And then secondly, beyond what you have right now in the pipeline, is it possible, or are you considering to develop other products for other indications even beyond bladder cancer? Especially in indications where we have existing drugs but the drugs are not working well because of a lack of -- or short do well time?

Ron Bentsur -- Chief Executive Officer

Mark, do you want to take the question?

Mark P. Schoenberg -- Chief Medical Officer

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 and our 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 can imagine, organ systems where this platform would be very useful. So without belaboring and I would say we are actively involved in that, and we are optimistic we'll find other opportunities to deploy the platform in the near future.

Bin Lu -- Raymond James -- Analyst

Great. Thanks. Good luck on your [Inaudible].

Mark P. Schoenberg -- Chief Medical Officer

Thank you.

Ron Bentsur -- Chief Executive Officer

Thank you very much

Operator

Our following question comes from Boris Peaker from Cowen.

Boris Peaker -- Cowen & Company -- Analyst

Great, good morning, guys.

Ron Bentsur -- Chief Executive Officer

Good morning.

Boris Peaker -- Cowen & Company -- Analyst

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?

Ron Bentsur -- Chief Executive Officer

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 initial six weekly installations. That is part of the protocol. So that, we believe, is going to be part, certainly, of 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 additional -- 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 is a good chance that 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 to, ultimately, be a 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.

Boris Peaker -- Cowen & Company -- Analyst

And in your discussions with the FDA regarding this strategy, did the agency asked, "We want to see a minimum of x number of patients at a certain number of months, in order to kind of consider this in a label"? Or was this not kind of officially discussed?

Ron Bentsur -- Chief Executive Officer

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 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 urological practices. So these things are not going to be unusual to the practicing community, and we're just introducing something and essentially the same format that they're already very well versed that. So the FDA is very aware of all of these -- this situation adn all these adjuvant therapies that are going on in urology, particularly in the bladder.

And now we, obviously, want to attribute 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.

Boris Peaker -- Cowen & Company -- Analyst

Great. And my last question on BotuGel, just curious what's the timeline for the Phase 2 study? And looking beyond that, what would be required to get it approved? I mean, would it require two randomized Phase 3 trials or can this be done on kind of a simpler regulatory path?

Ron Bentsur -- Chief Executive Officer

So we believe that the timing for the data from that Phase 2 study 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 two adequate and well-controlled studies, or is it one, because Botox is already approved in the indication and this is essentially a reformulation and all of 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 the Phase 2. But if that Phase 2 is successful -- and from our perspective there's no reason 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 uro-oncology. So we're very much looking forward to other results from that study.

And keep in mind that once they start a Phase 3, which is going to be -- if the Phase 2's successful, that Phase 3 will start very shortly thereafter. That also triggers a milestone payment to us of $20 million, which would be nice to receive as well. 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 the technology beyond what we're doing today.

Boris Peaker -- Cowen & Company -- Analyst

Perfect. Thank you very much for the detailed answer. Thanks for taking my question.

Ron Bentsur -- Chief Executive Officer

Thank you.

Operator

The following question comes from Leland Gershell from Oppenheimer.

Leland Gershell -- Oppenheimer & Company -- Analyst

Hey, good morning. Thanks for taking my question. Switching gears to the 201 program, wanted to ask if you could share any more color on the preclinical work that you're doing with that models, any further observations, even if just qualitative? And then relate to that, any further details you can provide on your thoughts with regard to upcoming clinical work, particularly with regard to the combination of checkpoint inhibitors?

Mark P. Schoenberg -- Chief Medical Officer

Sure. This is a very interesting program for us, because as I bet you're aware, we have predicate data from the Ib experiment in patients with high-grade noninvasive bladder cancer called carcinoma in situ who have failed BCG therapy, in which we saw that this novel formulation of 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, when in the context of where 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 an imiquimod 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 our 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 immuno-oncology. And in a setting where there is no topical therapy very, analogous to what we're doing low-grade 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.

Leland Gershell -- Oppenheimer & Company -- Analyst

And then just one financial question for Gary. Just with regard to the G&A coming in about $6 million for the quarter. Just wondering how we should regard that as perhaps a run rate or numbers for the rest of the year?

Gary Titus -- Chief Financial Officer

Thanks, Leland. Yes, I think you should consider that to be more of a current public run rate for us. Obviously, looking back at a year as 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 the not distant future.

Leland Gershell -- Oppenheimer & Company -- Analyst

All right. Great. Look forward to next week. Thanks for taking my question.

Gary Titus -- Chief Financial Officer

You're welcome.

Leland Gershell -- Oppenheimer & Company -- Analyst

Thank you.

Operator

Our following question comes from Matt Kaplan with Ladenburg Thalmann.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Hi, good morning, guys. So I guess first question for Mark, help us understand, in terms of the hurdle, in terms of overall response rate, more importantly, I guess complete response rate, that you're looking for in the OLYMPUS trial, given the unmet need space? And then also talk about the durability hurdle as well?

Mark P. Schoenberg -- Chief Medical Officer

Great questions and thank you. As I think we've discussed before, when we talk 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 practicing community urologist, a clinically meaningful outcome. And given the fact that there are no currently available medications used to treat this disease, we really have a -- 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 they're -- surgical therapies come in two flavors, it's endoscopic or kidney removal.

And we honestly are very dedicated to the idea that our platform and this therapy can save kidneys and also decrease the amount of recurrent surgery that many of these patients have to undergo in order to control this disease. Remember that with surgical monotherapy, the 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 that we have from our interim analysis, we are well above that.

So we believe we already have a very clinical meaningful CR rate based on our conversations with the FDA. And with respect to your second question, which was about durability, 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, 12 months' durability data, will, I think, be very interesting, not only to the FDA but also to the urologic community, which struggles to take care of these patients currently.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

OK. That's very helpful. I guess for Ron, beyond the completion of OLYMPUS study, what are the other hurdles to filing -- to prepare us for filing the NDA in the first quarter for MitoGel?

Ron Bentsur -- Chief Executive Officer

So in terms of the undertakings that need to get done for the filing, as you know, there are various modules that are involved in the NDA filings. The Phase 3, upon its completion, that will essentially complete the clinical obligations that we have for submissions that pull weeds need, obviously, the computer 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 505(b)(2) 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, and all things like that. All those things we're going to get waivers for because mitomycin has been approved for a number of years and all of 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 formulate 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, the preclinical and on the summary report and all that, there's a lot that's being started already. There's no reason to believe why we should not make that timeline in the first quarter and FDA filing and that's the overriding overarching milestone for the company. That is the most important milestone we are all very focused on right now.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

OK. Very good. And then, look, it seems like things are going to accelerate pretty quickly here, given the filing expected in the first quarter and then potential for accelerated review with the FDA. Can you talk about where to your commercial preparations are?

Ron Bentsur -- Chief Executive Officer

Yes. So Gary started to touch on it a little bit, but we're 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. For example, the VP of Commercial was hired several months ago, as you'll probably remember.

Director of Marketing, payer access. Director of Sales, a 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 on being MSL, Medical Science Liaison, that's going to come next.

So we're starting to produce pieces in place. So I think we've hired some tremendous talent on that front and we're really looking forward to it. I think we're going to have a very strong team. But again is 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 filings.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Great. Thanks a lot, Ron, and Mark, and the rest of the other.

Ron Bentsur -- Chief Executive Officer

Thanks a lot, Matt.

Mark P. Schoenberg -- Chief Medical Officer

Thank you, Matt.

Operator

Our following question comes from Jonathan Aschoff from National Securities.

Jonathan Aschoff -- National Securities -- Analyst

Hi, guys. Not much left to ask, but are you expecting a Phase 3 -- I hear what you're saying about Phase 3 enrollment and in hearing to the protocol but by saying 2H for the data, you're now saying that date in the third quarter is quite the unlikely stretch, correct?

Gary Titus -- Chief Financial Officer

Actually, what we're saying is that we're very much on track to file the NDA in Q1 of '19, which is what we've been saying all along. We develop the portable of the FDA that we're strictly adhering to. It's got very specific criteria, which were designed explicitly so we can provide the agency with a clear understanding of how this drug works and of efficacy. And that is what we're doing and we continue to enroll patients in the trial, and we believe this approach is going to be the best way to get us over the finish line.

So that's what we're doing.

Jonathan Aschoff -- National Securities -- Analyst

OK. And I was just curious, is there anything inherent about the Vesimune that makes it more likely to work in UTUC versus other cancers? Or is that your direction because of the company's uro-oncology focus?

Ron Bentsur -- Chief Executive Officer

So I'll start, and then maybe Mark can add as well. We believe that Vesimune, given the preliminary data that we saw on 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 we have 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 a single agent? Is it maybe with a gel, without the gel? These are all things that we're testing preclinical right now to try to come up with the best set of information that we can -- that can help us tease out the clinical path forward. But we definitely believe that there is potential there and we really -- a small company, we like that indication for all the obvious reasons, orphan indication, 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's going to be relatively low and these are all things that we're interested in pursuing.

And Mark, maybe you want to?

Mark P. Schoenberg -- Chief Medical Officer

No. I think that's a very great and complete answer. The only thing I would ask that is the intriguing data emerging in urothelial cancer, combining TLRs with checkpoints. And I think we are poised to be able to take advantage of that.

So there's an interesting and intriguing specific biology that we're going to explore and it looks very promising.

Jonathan Aschoff -- National Securities -- Analyst

OK. Thank you, guys.

Mark P. Schoenberg -- Chief Medical Officer

Thanks a lot, Jonathan.

Operator

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.

Ron Bentsur -- Chief Executive Officer

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 uro-oncology and urology.

On behalf of the UroGen team, thank you for your support. Operator, you may now disconnect.

Operator

[Operator signoff]

Duration: 51 minutes

Call Participants:

Catherine Bechtold -- Director of Corporate Communications and Investor Relations

Ron Bentsur -- Chief Executive Officer

Mark P. Schoenberg -- Chief Medical Officer

Gary Titus -- Chief Financial Officer

Matthew Andrews -- Jefferies -- Analyst

Bin Lu -- Raymond James -- Analyst

Boris Peaker -- Cowen & Company -- Analyst

Leland Gershell -- Oppenheimer & Company -- Analyst

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Jonathan Aschoff -- National Securities -- Analyst

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