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Urovant Sciences Ltd (UROV)
Q1Â 2019 Earnings Call
Aug 13, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by. Welcome to the Urovant Sciences Fiscal 2019 First Quarter Financial Results Conference Call. [Operator Instructions] Following management's prepared remarks, we will hold a question-and-answer session. [Operator Instructions]
I'd now like to turn the call over to Christine Ocampo, Chief Accounting Officer. Please go ahead. Ms. Ocampo.
Christine G. Ocampo -- Chief Accounting Officer
Thank you. It is my pleasure to welcome you to our conference call to discuss our financial and operating results for the fiscal 2019 first quarter. I'm joined today by two members of our leadership team, Keith Katkin, our Chief Executive Officer; and Dr. Cornelia Haag-Molkenteller, our Chief Medical Officer.
After the close of market today, Urovant issued a press release containing detailed information on results. You may access the release on our Company website, urovant.com. Today's remarks contain forward-looking statements, including statements regarding our plans and strategies for the clinical development of vibegron and other treatments for urologic diseases. I direct your attention to the forward-looking statements disclosure in today's press release and the Risk Factor section of the Form 10-K, which was filed in June 2019, as well as the Form 10-Q, which will be filed this week for a review of the various risks and uncertainties that could cause actual results to differ materially from projections.
With that said, I'll turn the call over to our CEO, Keith Katkin.
Keith A. Katkin -- Chief Executive Officer
Thank you, Christine, and my thanks to all of you for joining us today. Over the past three months, we've made significant progress across all of our programs, including the preparation of our NDA filing of vibegron. Importantly, today we announced that our ambulatory blood pressure study was successful and achieved its primary endpoint measure, which Cornelia will discuss in more detail later in this call. These results further support the safety and tolerability of vibegron and will be an important part of the vibegron NDA. We also had a very productive pre-NDA meeting with the FDA and continue to make excellent progress with the goal of filing the NDA by early 2020.
Other important business highlights include, in May, we presented the positive top line results from the pivotal Phase 3 EMPOWUR study of vibegron in patient's overactive bladder at the annual AUA meeting. We are now looking forward to presenting vibegron's positive clinical outcomes in more detail at the International Continence Society meeting in Sweden in September. Regarding the future commercialization of vibegron, we are pleased to see that the beta-3 agonist market share continues to increase with a 19% growth in the first half of 2019 compared with the same period in 2018. In addition, the overall OAB market is growing at approximately 2% year-over-year. We believe that the continued adoption of the beta-3 agonist mechanism of action is a strong benefit for vibegron commercialization given that there is no need to educate on a new class of therapy.
Regarding other clinical programs, we completed enrollment in part one of the Phase 3 study of vibegron in men with OAB and BPH. Assuming an acceptable safety profile, we will then move into part two of the study in the fourth quarter of this year, an important milestone given there is currently no approved treatment for concomitant OAB and BPH. Additionally, the Phase 2a trial for a vibegron for IBS-related abdominal pain continues to roll on schedule with results expected in 2020. And lastly, we've finalized the Phase 2a protocol for our novel gene therapy product for OAB, URO-902 and are preparing to start enrollment for that study by the end of the fourth quarter of this year.
With that, I'll now turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller, who will provide more detail to our clinical programs.
Cornelia Haag-Molkenteller -- Chief Medical Officer
Thank you, Keith. As mentioned, we continue to make excellent progress across all four of our clinical development programs. First, I will talk about the OAB program for vibegron. We continue to make great progress on the vibegron NDA filing. Following the positive top line results from the Phase 3 EMPOWUR study of certain malignant vibegron for overactive bladder, we're now pleased to report that we've achieved the primary endpoint for the ambulatory blood pressure study. The purpose of the study was to rule out an effective vibegron relative to placebo on daytime systolic blood pressure. The primary endpoint there was the change from baseline to day 28 in mean daytime ambulatory systolic blood pressure. The protocol was reviewed by the FDA in the fall of 2018.
The protocol predefined that for an affected vibegron, I mean, ambulatory systolic blood pressure to be ruled out the upper limit of the 90% confidence interval had to be less than 3.5 millimeter mercury for the daytime ambulatory systolic blood pressure for vibegron compared to placebo. The study enrolls 214 subjects across ten US sites. In accordance with FDA guidance, the study population has similar characteristics as the drug target population. Men and women aged 40 years to 75 years with OAB, this was a controlled study of 75 milligram versus placebo in a one-to-one randomization. The study was based on the 75 milligram vibegron dose plan of registration with the FDA. The duration of the study was four weeks and ambulatory 24-hour blood pressure, post measure that baseline [Indecipherable] 2 and 4.
Secondary endpoints with the change from baseline in mean daytime diastolic blood pressure heart rate and the full 24 hours change in systolic and diastolic pressure and heart rates as well as the maximum changes 30 minutes to 6.5 hours post dosing. A total of 108 subjects were involved into the placebo group, 106 subjects into the vibegron treatment group. 76 of the subjects were female and the main age was 59 years. 97% of the subject completed study. The results of the ambulatory blood pressure study are as follows. The primary study endpoint was achieved for vibegron. The vibegron minus placebo leads for, I mean, a change for the daytime ambulatory blood pressure from baseline to day 28 was 0.81 millimeter mercury with a 90% confident interval of minus 0.88 to plus 2.49. Therefore, the vibegron treatment group never crossed the upper bound of the pre-defined confidence interval of 3.5 millimeter mercury in this successful study as we ruled out a clinically relevant increase in systolic blood pressure of 3.5 millimeter mercury as agreed with the FDA. The confidence interval includes zero, which indicates that the mean change from the baseline data ambulatory blood pressure is not statistically different from placebo.
For the full 24 hour ambulatory systolic blood pressure, the treatment differences from baseline to day 28 for vibegron over placebo were plus 0.57 millimeter mercury, for diastolic blood pressure minus 0.19 millimeter mercury, and for the heart rates, plus 0.96 beats per minute. There was no statistically significant difference for vibegron compared to placebo in any of these endpoints or the primary endpoints.
Regarding the categorical changes from baseline, systolic blood pressure with in-clinic visit, vital signs they were small, not clinically relevant increases in the percentage of patients having a 10 millimeter or 15 millimeter mercury increase in systolic blood pressure compared to placebo. This resident [Phonetic] profile was consistent with the EMPOWUR Phase 3 study with the most common adverse events being headache, diarrhea, upper respiratory tract infection and urinary tract infections at rates below 5%. Regarding the adverse event of hypertension, the performance in the placebo group and five in the vibegron group. Therefore, there was one event more in the vibegron group compared to placebo. Of note, one subject that the vibegron group was taking a weight loss medication, which is known to increase blood pressure. We have discussed these results with leading cardiology experts and they agreed that these study results represent a very favorable outcome for vibegron.
In sum, this study further confirms the overall favorable safety profile observed in the EMPOWUR Phase 3 study, and we look forward to discussing the results with the FDA. To build on this momentum, we are preparing the manuscript of the Phase 3 EMPOWUR study results for publications and further results of the EMPOWUR study will presented globally at the International Continence Society meeting at Gothenburg, Sweden, in September. In the meantime, the long-term extension portion of the Phase 3 EMPOWUR study continues to progress well with data expected by the end of this quarter. We're continuing with our new drug application preparation by OAB indication. Earlier this year, we had productive pre-NDA meeting with the FDA. We're on track to submit the NDA in early 2020. Of note, the team is continuing to make every effort to accelerate the filing into the fourth quarter of this year.
Regarding our supplemental development program for vibregon in men with OAB, Benign Prostatic Hyperplasia or BPH, we have completed enrollment in the initial Part 1 safety assessment in 80 patients, where the assessment of recommendation from the Data Safety Monitoring Board is expected in the fourth quarter. Part 2 of the trial to assess safety and efficacy patients will start and there is important milestone as there's currently no FDA approved products specifically indicated for overactive bladder in men with BPH. The co-primary endpoints will be reduction micturition frequency and urgency episodes for 24 hours. Key secondary endpoints are reduction in nocturia episodes, which is the awakening at night devoid, prostate symptom scores and safety.
A clinical program for IBS-associated abdominal pain continues to enroll patients with a plan to enroll 200 females with IBS-associated pain due to IBS with diarrhea or mixed IBS, will be randomized to either 75 milligram of vibegron or placebo. The primary endpoint is a 30% reduction in abdominal pain intensity on an 11-point rating scale, which goes from zero to 10 at week 12 for IBS-D. The responder is defined as a subject with at least 30% decrease in worst abdominal pain compared to the weekly baseline average. Secondary endpoints include the global rating scale and safety in particular the lack of negative effects on the stool frequency or consistency. We expect to report top line data in 2020.
Finally, regarding our novel injectable gene therapy for OAB, URO-902, we're pleased to announce that the Phase 2a protocol has been finalized and we're preparing to start patient enrollment by the end of the fourth quarter in 2019.
Now I'll pass on to Christine for financial update.
Christine G. Ocampo -- Chief Accounting Officer
Thank you, Cornelia. In addition to the financial results summarized in the press release, you can find additional information at our upcoming Form 10-Q, which will be filed this week.
Research and development expenses were $22 million for the first quarter of 2019 compared with $28 million for the same period in the prior year. In the first quarter of 2019, research and development costs continue to be primarily attributed to our Phase 3 EMPOWUR trial. The decrease in R&D expenses in first quarter of 2019 compared to first quarter of 2018 is primarily attributed to a decrease in steady cost, due to the completion of the double blind portion of the Phase 3 EMPOWUR trial.
General and administrative expenses were $5.5 million for the first quarter of 2019 compared with $3.5 million for the same period in the prior year. The increase in G&A expenses is primarily attributed to personnel costs, including share based compensation, professional fees, such as legal and accounting, and general overhead and corporate operations expenses.
Total operating expenses for the first quarter of 2019 were $27.5 million compared with $31.5 million for the same period in fiscal 2018. Cash used in operations decreased by $1.5 million to $22.5 million for the quarter ended June 30, 2019, as compared to the previous quarter that ended March 31, 2019. Our net loss for the fiscal first quarter of 2019 were $28.5 million or $0.94 per share compared with a net loss of $31.3 million or $1.56 per share for the same period in fiscal 2018. As of June 30, 2019, our total cash and cash equivalents balance was $62.4 million or $92.4 million with the $30 million available to be drawn from Hercules Capital by September 30, 2019.
Now looking ahead to the second fiscal quarter of 2019. We currently expect our total operating expenses to be in the range of $30 million to $32 million as we closed out the open-label extension portion of our Phase 3 trial and continue our Phase 2 trial for the treatment of abdominal pain due to IBS and Part 1 of the Phase 3 trial for the treatment of OAB in men with BPH. And for the remainder of fiscal 2019, we expect our cash used in operations to be approximately $24 million to $26 million per quarter excluding anticipated milestone payment of $12.5 million that are due to Merck and Kyorin upon NDA filing.
And with that summary of our financial results, I'll turn the call back over to Keith for closing remarks.
Keith A. Katkin -- Chief Executive Officer
Thanks, Christine. In summary, there are a number of milestones planned for the remainder of fiscal year 2019 that will continue to drive us toward the goal of developing Urovant into a leading specialty urology company.
To recap our recent highlights and near-term goals, first, the positive Phase 3 EMPOWUR results for vibegron will continue to be shared in more detail through publication and Congress presentations, which will further support our belief that vibegron has the potential to be a best-in-class OAB therapy, if approved by the FDA. The additional safety study of vibegron in men with OAB and BPH via an Independent Data Safety Monitoring board is on target to be completed by the fourth quarter of 2019, and we plan to move quickly into Part 2 of the pivotal trial for the significant unmet needs. Also with the Phase 2A protocol finalized for our novel gene therapy product for OAB, we plan to start enrollment by the end of the fourth quarter of 2019, and most importantly, we continue to make great progress on our NDA with the goal of filing by early 2020.
With that, I would now like to open the line for questions. Operator?
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question comes from the line of Ritu Baral of Cowen. Your line is open.
Ritu Baral -- Cowen & Company -- Analyst
Good afternoon, everyone. Thanks for taking the question. Keith, can you remind us what's left before you can file the NDA application, now that the ambulatory blood pressure data is all in. Do you have any outstanding safety experience left to collect, anything left on CMC? And then I've got a follow-up.
Keith A. Katkin -- Chief Executive Officer
Sure. Thanks, Ritu. So as it relates to what we need for the NDA filing, we have mostly everything we need. Importantly, we still need the double blind extension study results. So that was a 40-week double blind extension of the original Phase 3 EMPOWUR. We expect that we'll have those results available in September. And then the only other component we need is, we just need our 12-month stability data for the program and that data is expected in December. Thus, we'll work once we get that data to file the NDA as quickly as possible post receipt of the disability data.
Ritu Baral -- Cowen & Company -- Analyst
Got it. And the 40-week extension with the efficacy component of that going to be supportive of the efficacy package or is that safety alone? And how do you plan on releasing that?
Keith A. Katkin -- Chief Executive Officer
Yeah. So certainly we'll release that either like we did with the ambulatory blood pressure study as part of an earnings call or separately. For the study, obviously, the safety is of paramount importance just to be able to demonstrate the continued safety over a full 52-week treatment period. We do have efficacy measures in the study as well. However, there is no placebo as a reminder, the extension study is just vibegron and tolterodine so any comparisons that we'll be looking at will just be numeric comparisons from an efficacy perspective.
Ritu Baral -- Cowen & Company -- Analyst
So the key there, as you just look at durability and effect on OAB measures?
Keith A. Katkin -- Chief Executive Officer
Exactly. I mean, ideally we'd want to see results similar to what we saw in the Merck Phase 2 long-term extension study in which efficacy was maintained over the entire time period or even slightly improved with a performance that is numerically better than tolterodine.
Ritu Baral -- Cowen & Company -- Analyst
Got it. And my follow-up is on, basically what we're seeing out there about potentially increased awareness, the increased focus on the dementia risk associated with anticholinergic medication. Can you talk about whether that's shown up on your most recent market research and if you've done any work on the awareness of that in the urologists community?
Keith A. Katkin -- Chief Executive Officer
So, yes, we have done work. The work that we have done perceived all of the recent news pickups. You may have seen it on CBS News, USA Today, we've got a late journal article coming out. But what I can tell you is that prior research that we did earlier this year, there is very low awareness from particularly patients that obviously -- almost no awareness. And from the clinician perspective, small percentage of doctors have heard something, but they didn't know exactly what the data looked like. So we obviously view this is a very significant opportunity as we get closer and closer to launch to appropriately educate the doctors on this risk and also to appropriately educate patients on this risk. But to doctors and patients that we have exposed to the information, and the patients, almost all of them want to switch off of an anticholinergics therapy immediately upon learning this information. And then for clinicians, they may want more information, they really want to understand the risks so they can make the appropriate trade-offs with their patients.
Ritu Baral -- Cowen & Company -- Analyst
Great. Thanks for taking the questions.
Keith A. Katkin -- Chief Executive Officer
Thanks, Ritu.
Operator
Thank you. Our next question comes from Joon Lee of SunTrust Robinson. Your line is open.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Hi. Thanks for the question and congrats on all your progress. One of the things I was surprised to learn is that, in your presentation you mention about 2.4 million patients or about 70% of patients on drug discontinued. Can you discuss some of the main reasons for discontinuation and whether the efficacy demonstrated by your -- by vibegron in Phase 3 EMPOWUR study is adequate to address those deficiencies in order to be commercially successful? And I have a follow-up. Thank you.
Keith A. Katkin -- Chief Executive Officer
Great. Thanks, Joon. So the -- I think what you're referring to is we believe that about 3.3 million patients start oral therapy every year. Over 70% of them discontinued within that first year or so, there's about 2.4 million patients that are back in the pool looking for a new treatment option every year which is likely why most all products that have been launched for OAB have been quite successful with most of them achieving blockbuster status. We think that the reason for the high drop out rate is really two-fold. If you're talking about the anticholinergics, which is a majority of the prescriptions. Anticholinergics, if you look at the package inserts, you can see that many of them are associated with very high rates of constipation, very high rates of dry mouth and some have even had a new label update, talking about cognitive concern and ability to cause agitation.
So what we believe is that as the patients are dealing with all of those side effects, they're looking at that relative to the relief that they're getting after their OAB and they just are coming to the conclusion that it's not worth it. And then therefore, go back into the treatment pool, which is why we believe Myrbetriq has been so successful since being launched in 2012.
Changing gears to Myrbetriq though, and looking at that information. We believe that a high percentage of patients using Myrbetriq early in the product -- early with the products use, because many patients, our data shows about 50% of patients are on the 25 milligram dose, and due to that starting dose, patients aren't getting the full adequate relief that they could get if they dose titrated, but these patients, well, it's got a great safety profile, these patients are not thrilled with the efficacy that they're getting at th starting 25 milligram dose. And therefore, our research suggests that's why they're dropping off, which is why we think having a one single convenient dose that delivers efficacious therapy at the starting dose is something that the market will accept and really adopt quite quickly.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
And so just following up on that response. I believe in your subset analysis, you had included those who were previously treated with mirabegron, who -- I don't know if they responded, but who responded well to vibegron. Were those patients mirabegron failures, and if so, why do you think they are responding to vibegron given similar mechanism of action?
Keith A. Katkin -- Chief Executive Officer
Yeah, all we know is that the patients in the study stopped taking mirabegron for whatever reason. We don't know, if we can technically call them a failure, but obviously for whatever reason they started on Myrbetriq and then stopped it at some point in time. That said, we obviously were quite pleased with the subset analysis where we saw a really robust treatment effect in those patients that had previously been on mirabegron when they were given vibegron. So we think that, again, just speaks to our enthusiasm for getting vibegron, FDA approved and getting out there for patients, because we think it's going to be an excellent choice for patients and hopefully we'll be able to bring relief to the millions of OAB patients that are out there suffering with OAB.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Great. And my last question is, I do appreciate your experiences that your previous payer firm where you successfully launched the drug in the long-term care centers. What can you tell us about your experiences there and the insights you gained that could be applied to the launch of vibegron? Thank you.
Keith A. Katkin -- Chief Executive Officer
Yeah, absolutely, and the long-term care setting is one that is not very straightforward. It's more of a essentially a facility approach to treating the patients. So there's a number of different stakeholders which have an interest in the appropriate treatment of the patients. So we feel very fortunate that we've got a team that's got a tremendous experience within this area, knows who all the stakeholders are, knows how to bring them together appropriately in order to have the dialog and help them with patient identification and then ultimately be able to bring -- hopefully bring relief to these patients suffering from OAB.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Thank you.
Keith A. Katkin -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Eric Joseph of JP Morgan. Your question please.
Eric Joseph -- JP Morgan -- Analyst
Hey, guys. Thanks for taking the question. I guess with -- first with the BPH studies successfully completed. Maybe you could sort of just discuss possibly [Phonetic] how we should be thinking about what the implications are for potential label in contrast to Myrbetriq. Curious to know to what extent the warnings and adverse reaction language for Myrbetriq currently give dark spots and also whether there are any beta-3 class effects that we should be thinking about here with implications to safety language in the label? Thanks.
Keith A. Katkin -- Chief Executive Officer
Yeah, thanks. I appreciate the question. So obviously whatever we do will be a discussion with the FDA in terms of what the ultimate label looks like. Certainly, we're -- we think we've got a very strong profile with vibegron. We would expect all of the information from the ambulatory blood pressure study, from our thorough QT study, from our Phase 3 study, all to go within the pharmacodynamic section of the package inserted in Section 12.2. So that's certainly going to be our baseline starting discussions with the FDA. It is entirely possible that the FDA will say beta-3s have a class effect on blood pressure and therefore we will get the same warning and precaution that mirabegron has for blood pressure within our label as well. That said, we're going to do everything that we can in our discussions with the FDA to convince them that that is not something that should be incorporated or a label given the extensive data that we have generated on the impact of that vibegron on blood pressure.
Eric Joseph -- JP Morgan -- Analyst
Great. Maybe just a commercial follow-up, if I could. Picking up on some of your earlier comments about script growth with Myrbetriq. It's demand continues on a solid quarterly growth trend kind of approaching like -- something like 25% year-over-year, but recent quarter sales things have flattened somewhat with pricing some sort of net pricing pressure. I'm just curious to get a sense of what your latest market research is with respect to anticipated pricing for vibegron relative to Myrbetriq or other comps in the segment?
Keith A. Katkin -- Chief Executive Officer
Yeah, I appreciate that, and we have noticed that there seems to have been a small drop off in the gross to net for mirabegron as well. We are very pleased to see that there is that robust volume growth within the -- for the -- beta-3 for vibegron, which I think speaks to the advantages of beta-3s and that people are certainly looking for relief outside of the anticholinergics.
In terms of our pricing, we know, obviously, we continue to watch mirabegron what they do from a pricing perspective. They have taken a pretty regular price increases. So we estimate that by the time we launched, their net price or their gross WAC price will be somewhere between $450 and $500. So we would see pricing within a band of wherever -- they're at of somewhere around plus or minus 20%.
Eric Joseph -- JP Morgan -- Analyst
Great. Thanks for taking my questions.
Keith A. Katkin -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from the line of Raghuram Selvaraju of HC Wainwright. Your question please.
Edward White -- HC Wainwright -- Analyst
Good afternoon. This is Edward on for Ram, I appreciate you guys taking the questions. Firstly, do you have any indication that vibegron might have applicability in some of the pain related indications beyond IBS-D, and just if so, what might these indications be and how vibegron's mechanism of action maybe be applicable in some of these arenas?
Cornelia Haag-Molkenteller -- Chief Medical Officer
Yeah. So this is Cornelia. You need to have at least beta-3 receptors or organs which are beta-3 receptors responsible for the pain. That's where the idea of the IBS comes from, because we have beta-3 receptors in our bladder and the guts. So that would be the only indication as of now. It is not probably to be seen as a systemic pain medication as opiates or things like that. You need beta-3 receptors for the drug to act. And there's potential also, there's painful bladder conditions that could be possible, which has to do with bladder contractility but that would be speculation as of now. Definitely it needs to be into the pharmacology and the presence of beta-3 receptors.
Edward White -- HC Wainwright -- Analyst
I see. And then moving on to BPH. I'm just wondering, if physicians are indicating to you that data from COURAGE will significantly sway the prescribing dispositions with respect to the usage of vibegron and how likely might it be for the vibegron usage to occur in patients with BPH who present with urgency prior to the formal extension of the label in this population?
Keith A. Katkin -- Chief Executive Officer
Yeah. So honestly, I can't comment about maybe you know how doctors may view the study and then how they may incorporate into their practice patterns. Well, we can say is that we are really excited about the potential for this indication. And as we've discussed before, the FDA has said specifically that they believe that is a separate and distinct indication for the treatment of OAB in men have BPH. And so, therefore, companies that just have an OAB indication, the FDA does not consider that appropriate for being used in these men.
If you look at the market opportunity, there's really two ways to win within this market. We estimated about 2 million men in the US that suffer from concomitant OAB and BPH. Our data suggests that only about 25% of them are treated and those that are treated are mostly treated with anticholinergics. And given anticholinergics associated with increased risk of urinary retention, something that's very bad for this population, we think we can come in and really focus on those 25% of men that are being treated and make a very strong case to move them over to vibegron once we have this -- assuming the study is successful and we get this indication with the FDA. But the real opportunity is in that 75% of men that go untreated. They go untreated primarily because there has not been a huge dialogue between the doctors and the patients about their OAB. And so we believe that by bringing this data to the forefront, we can have those conversations with doctors, we will be able to have those conversations with patients and really be able to explore helping these patients and these men that are suffering from both OAB and BPH. And when you consider of those 2 million men, every 100,000 that we can put on therapy represents about a $300 million revenue opportunity. It's easy to see how these indications to become quite meaningful, quite quickly, as we will be the only FDA product approved for the treatment of men that have OAB and BPH.
Edward White -- HC Wainwright -- Analyst
Yeah, absolutely. And then finally from me, just on the gene therapy. I'm wondering if you've received any feedback from physicians regarding URO-902 and the mechanism of action. And just if so, what kind of feedback have you been receiving so far?
Cornelia Haag-Molkenteller -- Chief Medical Officer
Well, we do have experts who -- with whom we consulted on the protocol, that's the main feedback. And they're very much looking forward to it because, again, we believe it may have and we have to emphasize may have a longer duration of actions and based on the current data and the amount of tumor [Phonetic] in our retention and that's because it's a different mechanism of action is not a neurotoxin. So -- and of course we need to see the study results. So the physicians we've talked to are predominantly the experts who are consulting with us on the study protocol.
Edward White -- HC Wainwright -- Analyst
Got it. Well, that's all for me. I appreciate you guys taking the questions.
Keith A. Katkin -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from the line of Biren Amin of Jefferies. Your line is open.
Biren Amin -- Jefferies -- Analyst
Yeah. Hi, guys. Thanks for taking my questions. Keith, I guess, on vibegron, the pre-NDA meeting with FDA, did the agency have any additional follow up request that they ask of you?
Cornelia Haag-Molkenteller -- Chief Medical Officer
No, I mean, the main meeting -- reason for pre-NDA meeting is to discuss the structure of the file, to discuss the structure of statistical tables, additional requirements. At the meeting, there were no surprises, no additional requirements that the FDA brought up. They know what our package will be and we've discussed with them and that was basically the result of the meeting. It was a productive meeting. It was not a very long meeting and was productive.
Biren Amin -- Jefferies -- Analyst
And given you're filing the NDA in early 2020 and you're likely going to have probably launch prep during the course of 2020, how are you thinking about your cash runway given, you know with, I guess, the Hercules Capital debt facility, so you have $30 million, if we count that, you have about 4.5 quarters of cash currently.
Keith A. Katkin -- Chief Executive Officer
Yeah, so obviously from a cash perspective, we continue to be unhappy with our stock price. We don't think it's really reflective of a company that's got great Phase 3 data launching into a market that has created blockbuster after blockbuster. So we continue to be patient. Again, we're fortunate that we've got a strong financial backer with Roivant as our parent company. And so as we move forward, we'll continue to really look at the markets, look at the different ways of financing the company, but at the current time, not in a huge rush particular at these -- at this stock price to do something.
Biren Amin -- Jefferies -- Analyst
Got it. And then, I guess, just on the additional indications for vibegron. Can you talk about the IBS pain indication, where that trial is currently in terms of enrollment? So I just wanted to ask on that indication. Thanks.
Keith A. Katkin -- Chief Executive Officer
Yeah, absolutely. So the study continues to enroll. And as we've said, expect to have top line data in 2020 as we get closer to the end of the year and closer to end of enrollment and it could be able to refine that timeline. But we still have a little ways to go with that study, but certainly expect that it's going to be a data read out in 2020 and we're going to push to make it as early in 2020 as we can.
Biren Amin -- Jefferies -- Analyst
Okay. And then I guess just on a 902 Phase 2a trial protocol. Are you dosing patients with a 24,000 microgram dose? And then, I think, you previously mentioned that you would dose on a single administration to assess for durability. I just want to get your thoughts on how long you'll follow these patients in the 2a trial and whether these patients coming into this study will have failed on Botox and/or neuromodulation?
Cornelia Haag-Molkenteller -- Chief Medical Officer
Okay, to answer your first question after consulting with the experts, they advised against taking Botox. So listen to the Phase 3 study, because there is no reason to know why there is Botox failures. So definitely we will have patients who are -- who are non-Botox failures for the bladder. And then the first, as you -- as you noticed the 24,000 microgram was the highest dose in the Phase 1b and that was effective for them to start with this. And then we're going to have a data monitoring safety board review well in a dose, one higher dose and we're going to follow in total for 48 weeks.
Biren Amin -- Jefferies -- Analyst
Great. Thank you.
Keith A. Katkin -- Chief Executive Officer
Thank you.
Operator
Thank you. At this time, I'd like to turn the call back over to Keith Katkin for any closing remarks. Sir?
Keith A. Katkin -- Chief Executive Officer
Thank you very much. I appreciate everybody's time this afternoon and look forward to keeping everyone uprise of our progress through the remainder of the year. Have a great afternoon and great evening.
Operator
[Operator Closing Remarks]
Duration: 40 minutes
Call participants:
Christine G. Ocampo -- Chief Accounting Officer
Keith A. Katkin -- Chief Executive Officer
Cornelia Haag-Molkenteller -- Chief Medical Officer
Ritu Baral -- Cowen & Company -- Analyst
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Eric Joseph -- JP Morgan -- Analyst
Edward White -- HC Wainwright -- Analyst
Biren Amin -- Jefferies -- Analyst
