Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the UroGen Pharma Second Quarter 20 21 Financial Sarah Sherman, Head of Investor Relations for UroGen Pharma.
Please go ahead.
Thank you, Thank you, operator, and welcome everyone to UroGen Pharma's Q2 2021 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended June 30, 2021. The press release can be accessed on the Investors portion of our website at investors. Urogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer Jeff Bova, Chief Commercial Officer Doctor.
Mark Schoenberg, Chief Medical Officer and Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations, so we appreciate your patience and understanding should we have any technical difficulties. During today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing commercialization of JALMIDO, planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, 2021 financial guidance among other things. These forward looking statements are based on current information, assumptions and expectations that are subject to change.
A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward looking statements and UroGen disclaims any obligation to update these statements. I will now turn the call over to Liz.
Thank you, Sarah, and thank you all for joining us today as we provide an update on our progress and recent corporate development. At UroGen, we believe patients deserve better options and we're steadfast in our approach to fundamentally change the way uro oncology is treated today. As we move into the second half of twenty twenty one, one of our key priorities remains of JALMIDO, the first approved therapy from a novel reverse thermal hydrogel technology platform. As we announced in July, we recorded $13,000,000 in Gelmido net product sales for the Q2 of 2021 and $20,500,000 for the first half of twenty twenty one. We believe this early success with Yamido provides proof of concept for the broader platform both in low grade disease with UGN-one hundred and two as well as our expansion into high grade advances in recent years.
And we see JALMIDO as our first opportunity to make a positive impact for patients. It's critical for patients to have alternatives to invasive and or repetitive surgeries, which have a well defined associated morbidity, including negative outcomes from the use of general anesthesia. Our novel technology has enabled us to deliver non muscle invasive bladder cancer, a large patient population where there are no non surgical primary treatment options. Our RTGel platform enables us to develop these novel therapeutic approaches and we are enthusiastic about their potential. Mark will provide a more detailed update on the UGN-one hundred and two Phase 3 ATLAS study, but we are pleased with the progress and interest to date centers around
the world.
While we focus on expanding our pipeline, we have also made progress in our commitment to expand JALMIDO's geographic presence. We announced our first collaboration, which involves a license and supply agreement with NeoPharm to pursue regulatory approval and commercialization for JALMIDO in Israel. UroGen was founded in Israel and they played a key role in our pivotal trial. We look forward to the possibility of patients in Israel having access to this innovative treatment as quickly as possible. The 2 other priority regions for near term expansion are Japan and Europe.
Based on the work we have done to date, we believe we have a plan for Jomita regulatory and reimbursement pathways and look forward to providing more detail on our ex U. S. Strategy in the coming months. As we have communicated, our goal remains to establish our first two medicines as standard of care, changing the way these patients with low grade disease are treated. We believe by doing so, these 2 lead products set a strong foundation for our company.
And assuming regulatory approval of UGM-one hundred and two, our goal is to deliver peak revenues of over $1,000,000,000 by the end of 2027. Given the total market size of low grade UTUC is over $700,000,000 and low grade intermediate risk non muscle invasive bladder cancer over $3,000,000,000 we believe this goal is attainable and positions UroGen as a leader in uro oncology. Beyond JALMIDO and UGN-one hundred and two, we continue to expand and progress our early stage pipeline, both internally as well as with academic collaboration, and Mark will talk more about these programs. We are actively seeking opportunities to expand our portfolio with innovative medicines in areas for which there are no adequate treatment and where new technologies and innovation can make a difference for patients and we will share updates as available. And with that, I'd like to turn the call over to Jeff to provide a commercial update.
Jeff?
Thank you, Liz. I'm pleased to provide you with an update on our commercial launch of gel myto. During the Q2, we saw some return to a sense of normalcy with respect to the commercialization of gelmido and access to physicians, and they've been able to benefit from a higher level of in person physician interaction. Challenges do remain with 30% to 40% of the offices closed to representatives as we monitor the evolving COVID situation and the potential further impacts the pandemic may have on business, physicians and patients. As we enter the fall conference season, we look forward to having a major presence at the key urology conferences, including the American Urological Association, or AUA, which will be held from September 10 through 13 in Las Vegas and is the largest medical conference in the urology space.
AUA will be a hybrid virtual and in person meeting this year and will allow UroGen the opportunity to meet with physicians and provide education on JALMIDO. We will have both a virtual and in person booth, including an interactive patient builder and demonstrations on how our innovative hydrogel technology makes chemoablation possible. We'll also have a product theater with Doctor. Katie Murray focused on how GelMido is transforming the treatment paradigm in low grade UTUC, moving away from previous surgical treatments to the first drug therapy of its kind. Since launch, physician response to ZOMYTO has been positive, and we've been able to leverage the growing enthusiasm to increase the number of sites treating patients as well as the number of patients treated in each site.
We expect this growth to continue alongside the total number of active sites as we expand field engagement. As of August 1, we have increased the number of activated sites to 407, up from 316 as of May 1. These are sites that have either treated patients or have completed all of the internal processes required to allow them to treat patients. For repeat accounts, we have increased the number of repeat accounts to 63 as of August 1, up from 40 as of May 1. This suggests that physicians are seeing clinical efficacy of the therapy and benefit to patients, that reimbursement is working and all the components of the process are running smoothly.
We also hear from physicians that the education and support received from UroGen staff and nurse educators along the treatment continuum is critical to seamless integration of We consistently watch this number to ensure that physicians are identifying additional patients and gaining more and more comfort using our therapy. Reflecting on our strong Q2, we do believe that there was some impact from patients who decided to wait for their vaccinations in the Q1, who were then treated in the Q2. And we're pleased that patients are returning to their physicians and seeking treatment. In person engagement with the physician and office is critical given the administration of the therapy as well as the orphan drug nature of the disease, and this remains an important focus for our field team. As we look to the second half of the year, we see the importance of depth in each account.
We will focus on expanding the physicians and patients in our current accounts and leveraging the positive experience peers have with our treatment to increase the number of physicians utilizing our therapy. With that, I'll turn the call over to Mark to discuss our recent clinical updates. Mark?
Thank you, Jeff. I'll now touch upon the progress we have made on our clinical and non clinical programs this quarter. Starting with Gelmido, we are paving the way to do something different in neuro oncology. As we explore ways to optimize the treatment and think through lifecycle management, It is incumbent on us to ensure physicians and patients are utilizing gel Mito in the most optimal and appropriate manner for patient success. And we are committed to generating the data to support our key stakeholders.
We plan to start a registry and are also working with clinicians to better understand the use of administering gel MITO via nephrostomy tube in clinical practice. We expect to see data from nephrostomy tube use in the community starting later this year. As Liz mentioned, our leading late stage clinical program is UGN-one hundred and two for the treatment of low grade intermediate risk non muscle invasive bladder cancer. And we are actively enrolling patients in the ongoing ATLAS trial studying UGN-one hundred and two plus or minus to URBT compared to TURBT alone. As an event driven Phase III trial, we expect it will take approximately 1 year to enroll and an additional 2 years to complete, targeting an approval potentially by the end of 2024.
This is a very important patient population where the current standard of care is repeated surgery. And we are seeing that there is significant demand with nearly 100 sites activated in the U. S, Europe and Israel and the momentum enrollment is picking up. We look forward to providing updates for Atlas later this year. We've talked about the trial design for this study and how we relied on our Phase IIb OPTIMA II study to help inform the design and assumptions for the trial.
We anticipate presenting the final OPTIMA II data at a medical meeting this year as well as publishing the results in a peer reviewed journal. In addition to the OPTIMA 2 publication, we have sponsored research in a variety of areas of special relevance to our programs, including work on patient preference for nonsurgical options in non muscle invasive bladder cancer and the natural treated history of non muscle invasive bladder cancer in a U. S. HMO population. We have worked with our colleagues in academia to examine the financial impacts and medical complication rates associated with current standards of care for NMIBC in the U.
S. And we expect data from these studies to be presented at a medical meeting later this year. In parallel to the ATLAS trial, we are also on track to begin our home installation feasibility study in the second half of this year. The trial will be a small pen patient study with a goal to demonstrate that UGN-one hundred and two can be safely administered by a healthcare professional in the home setting. We expect to enroll at approximately 5 centers in the U.
S. I'd like to touch upon the progress we've made in our early stage immuno oncology pipeline, namely with UGN-three zero one, our CTLA-four antibody and UGN-two zero one, our TLR7 agonist. We see UGN-three zero one as a foundational checkpoint inhibitor and intend to study this agent as monotherapy and in combination therapy, including in combination with UGN-two zero one as well as other agents. We refer to the combination of UGN-two zero one and UGN-three zero one as UGN-three zero two and are initially studying this combination in patients with high grade non muscle invasive bladder cancer. In June, we started a non human primate toxicity study for UGN-three zero one, which is on the critical path as we move towards submitting an IND for this asset.
We expect to have the results of the toxicity study by the end of the year and assuming acceptable toxicity profile, we'll submit an IND for UGM-three zero one in the first half of twenty twenty two. We are actively working with MD Anderson to further progress our understanding of the synergy between UGN-two zero one and UGN-three zero one and are on track to start a study in humans later this year with UGN-two zero one to assess the immune modulatory activity in the bladder. We expect to see additional nonclinical data throughout 2022 from both monotherapy and combination therapy. Last quarter, we announced a sponsored research agreement with the Johns Hopkins University aiming to understand how local administration of checkpoint inhibition may be useful in the treatment of glioblastoma. We continue nearing work at Johns Hopkins and are exploring the possibility to expand other molecules and other tumor types.
Our team is also actively working both in our own labs and with other academic centers to explore our pipeline in other solid tumors. And with that, I'd like to turn the call over to Molly, who will discuss financials.
Thank you, Mark, and thank you to everyone for joining today's call. As mentioned by Liz and Jeff, we recorded net product sales of Jomita for the Q2 of 2021 of approximately $13,000,000 $20,500,000 for the first half of twenty twenty one. Cost of revenues for the Q2 of 2021 were approximately $1,400,000 resulting in a gross margin of 89.1%. As we mentioned on previous calls, in periods prior to receiving FDA approval for JYMIDO, we recognized inventory and related to costs associated with the manufacture of JYMIDO as research and development expense. We expect this to continue to impact cost of revenues through the Q2 of 2022 as we deplete inventories that we had expensed prior to receiving FDA approval.
As a result, our gross margin would have been approximately 87.7 percent versus the 89.1 percent for the 3 months ended June 30, 2021,
if we
had not sold ZOMITR units that were expensed prior to regulatory approval. Research and development expense for the Q2 ended June 30, 2021 were 12,100,000 dollars compared to $8,100,000 in the same period of 2020. Research and development expense also includes $1,000,000 in non cash share based compensation expense for the Q2 ended June 30, 2021, as compared to $1,600,000 for the same period in 2020. The overall increase in R and D expense relates to the initiation of our Phase 3 ATLAS study for UGN-one hundred and two at the end of 2020. Selling, general and administrative expenses for the Q2 ended June 30, 2021 were $22,300,000 as compared to $24,000,000 in the same period in 2020.
The decrease in annual selling, general and administrative expenses resulted primarily from the higher brand marketing expense in the Q2 of 2020 in preparation for the launch of JALMIDO as well as a decrease in share based compensation expense. Selling, general and administrative expenses included $5,000,000 in non cash share based compensation expense for the Q2 ended June 30, 2021, as compared to $5,500,000 for the same period in 2020. For the Q2 ended June 30, 2021, we reported financing expense related to the prepaid forward obligation to RTW Investments of $3,100,000 As previously reported, in accordance U. S. Generally accepted accounting principles, we expect to accrue approximately $12,000,000 to $15,000,000 in non operating financing expense related to the RTW transaction, which is reported below the operating income or loss line.
Cash payments in 2021 will equal 9.5% of net Gemital sales recognized subsequent to the May 2021 closing. For the Q2 ended June 30, 2021, we reported a loss of 26 $200,000 or $1.17 per share. This compares to a net loss of approximately $31,300,000 or 1.44 dollars per share for the same period in 2020. The net loss for the Q2 ended June 30, 2021 includes $6,000,000 in non cash share based compensation expense. For the 1st 6 months of 2021, net loss was $52,200,000 as compared to $69,100,000 for the same period in the prior year.
This improvement in operating loss over the period was driven by our JALMIDO revenue of $20,500,000 as compared to $400,000 in the prior year. Total operating expense decreased slightly to $67,100,000 as compared to $70,700,000 in the prior year. Our guidance for 2021 operating expense remains unchanged and is in the range of $155,000,000 to 165,000,000 dollars This includes estimated non cash share based compensation expense of $24,000,000 to $28,000,000 subject to market conditions. Lastly, we closed the 2nd quarter with $129,300,000 in cash, cash equivalents and marketable securities. This includes the $75,000,000 in funding from RTW, which we announced early in the year and which closed in May.
Based on our current operating plan and cash position, we believe we will have sufficient capital to fund operations into 2023. As a biotech company and as Mark indicated, we are always evaluating opportunities to expand the use of our platform technology. As such, we will continue to evaluate our cash needs to ensure we are investing in our future. With that operator, I would like to turn the call over for questions.
Certainly. You. Our first question comes from the line of Leland Gershell from Oppenheimer. Your question please.
Hi, good morning. Thank you for taking my question and congratulations on the nice commercial performance. A couple of questions. First on JALMAYDO, you had mentioned that you're seeing increased repeat rates at an increasing number of centers. Maybe wanted to see if you could share more color on kind of what's sort of what were the kinds of feedback you're getting from the physicians at those centers in terms of their interest in using JELMIDO again and the types of patients in which they may be using JELMIDO with respect to degree of pathology and location of the tumors and so forth?
And I have a follow-up. Thank you.
Thanks, Leland. Jeff, why don't you take that and Mark if you have any additional comments once Jeff is done and then we'll see what's Leland's follow-up. So Jeff?
Sure. Thanks. And as far as the number of accounts that are treating more than one patient, it's a couple of things. You've obviously got peer to peer influence within that practice. So physicians will ask their peers how did it go on a certain patient.
Clinically, obviously, what we hear are positives from a field perspective and they're sharing that with their colleagues. Obviously, as we said earlier, representatives are really motivated to go in and expand the depth in that account. So the reps between the representatives doing a good job expanding the depth and physicians talking to physicians, that's really why we've seen an increase in the number of accounts treating multiple patients. We have to continue that. There's still a lot of potential within given accounts, given the some of these accounts are 10, 15, 20 plus urologists in the account.
So we'll continue to do that. As far as the patients treated, because we have so many that have been treated, it has I'll say, it's been across the indication. We've had recurrent patients that have been treated. You're seeing more I'm seeing more newly diagnosed or hearing more newly diagnosed that maybe the resection is going to be challenging. And as I expected at launch, I expected to get more of the recurrent pull and it will evolve into probably a fifty-fifty half coming from the recurrent pull, half coming from the newly diagnosed.
Got you. Thank you. That's very helpful. And then a question for Mark. In terms of these collaborations, obviously MD Anderson and then Johns Hopkins in glioblastoma, Maybe if
you could just give us
a sense of how much further we should see additional potential academic type collaborations materialize as we go forward with the potential application of the RTG platform? Thanks.
Thanks, Leland. A great question. And as I think you've heard from Liz and from Molly, we are very interested in exploring other opportunities for the platform. And we know that the gel we're using can deliver a lot of different types of molecules to a lot of different types of venues within the body. So the answer is, I think you would expect to see more in time.
We're very actively pursuing this. And Liz may want to comment further, but I think there is more on the horizon.
Yes. My only comment is that is correct. We do see a lot of interest in with different academic centers and using it. And so anytime we get an inbound interest, we absolutely follow-up on that. And we've got a couple in the works right now that hopefully we can talk about in the next few months.
In addition to that, we haven't actively gone out to other companies. And we will we continuously look to say to think about whether we believe there's opportunity and then we'll proactively pursue those as well. So definitely, we believe that we have an opportunity to continue to expand the use of Thanks very much. I'll hop back in the queue.
Great. Thanks very much. I'll hop back in
the queue.
Great. Thank you. Our next question comes from the line of Chris Howerton from Jefferies. Your question please.
Fantastic. Good morning and thanks for taking the questions. First, I guess, Jeff, I just wanted to ask, what is the current status of utilization of GelMido in the different center types? I think that there was some discussion of trends that you were seeing of additional equipment that physicians could augment their offices with to be able to instill gel Mito in their locations as opposed to going to an ambulatory surgical center. So just kind of touching bases with the trends that you're seeing there in terms of the different types of centers.
And then the second question that I had is, frankly, I'm just intrigued with the mention that you had at the AUA of the interactive patient builder for UTUC. And I guess I was just kind of curious what were the important kind of variables or features that you found important or most intriguing or most educational to physicians heading into that experience? And then the third question I had was, if I may, is for Mark. I didn't hear any mention of any presentations at AUA this time. So just kind of wanted to see if there was still any kind of presence from either the clinical or preclinical work that you had been describing?
Thank you.
So Jeff, why don't you take the first two and Mark can definitely share with you what he can around AUA. We won't be able to share specifics, but we definitely have a lot happening at AUA. So Jeff?
Sure. Thanks, Chris. Yes, so some of the trends that we're seeing recently is, as you know, physicians can give this in outpatient hospital, an ASC, a surgery center or they as you said, they make arrangements to give it in the clinic either via nephrostomy tube or they bring fluoro into the clinic. As expected, we still have most of our administrations taking place in the hospital. What I've seen a good trend in is that we're starting to get diagnosis more in the community setting.
So that's starting to balance out. You're starting to see a diagnosis in the community setting. You're starting to see more administrations in their surgery center, which they may own or they have a strong affiliation with. And so that those are some of the trends we've seen and I expected to see. Obviously, if it's diagnosed in the community and they go to the hospital to administer it, that's fine as well.
But I do think you're starting to see an uptake both in diagnosis and administration in the community. And whether they do it in their surgery center or the clinic, entirely obviously up to them. It's still a very small portion of administration via nephrostomy tube, but it is growing. We get a lot of questions around it, and we are hoping to collect a lot of data when we start the registry. So that was your first.
The second, the patient builder. Yes. So we're excited for this. The field actually has this right now. The patient builder is designed to capture, as I was talking to Leland, the entire indication.
So the representative is able to build a patient, whether that's a newly diagnosed, whether that's recurrent, number of tumors, size of tumors. And then what it does, it extrapolates out what the data tells us in OLYNVUS. And so it allows the field to really talk to the entire indication to make sure that every one of those 6000 to 7000 patients that we see every year, gel Mito is considered. So we'll expand upon that. We're excited for a live AUA.
But yes, the reps have that patient builder as right now.
Chris, thanks for asking about the AUA. The organization has very specific rules about embargo related to accepted research that will be presented during the meeting. And as Liz alluded to, we have a bunch of things coming up for presentation at the meeting this year, but unfortunately, the embargo has not been formally lifted. So all I can tell you at this point is we're going to be very busy and we have a lot of exciting stuff to present and we can't talk about it yet, although we expect that the embargo will be lifted in the next couple of days. Then hopefully at that point, we'll be able to be more transparent about the specific research.
Okay. All right. Well, that's very clear. Thank you very much for taking the questions. And I'll hop back in the queue.
Great. Thanks, Chris.
Thank you. Our next question comes from the line of Ram Selvaraju from H. C. Wainwright. Your question please.
Yes. If you could first of all maybe give us some background on the relationship with NeoPharm and what might be some perspectives regarding the local Israeli market and NeoPharm's capabilities in that region?
Sure. Hi, Ram. They are one of the top, I don't want to say distributors, but commercial partners for many companies in Israel. So they have a very I mean, we as you can imagine, there was a lot of interest from multiple companies in Israel to be our commercial arm. We actually also considered do we do it ourselves.
But we felt like NeoPharm has the capabilities. They already have the infrastructure and it fit very nicely into what they're already doing. So we worked very closely with them for Israel. And look, we've it's not a huge market, right? Let's be realistic about that.
But it's very prideful for us, right? As we are an Israeli company, we started in Israel. They were a big part of what we've done. But NeoPharm, we looked, like I said, at all of the different options and felt like both from a financial and capability standpoint, it made the most sense to do a partnership. And the Affirm of all the companies rose to the top because of their capabilities.
And they've been really great to work with. So we feel very good about that decision. And we'll be looking for similar type of partners, frankly, as we expand globally. You want partners that if we're not going to do it ourselves, that can bring that added extra capability and we believe that NeoPharm does that in Israel.
Has NeoPharm expressed any interest in commercializing the product in countries outside of Israel? Or would you need to seek partners distinct from NeoPharm for those territories? And if so, can you give us an update on how the discussions are progressing?
Sure. They were interested in other countries. But as we've talked about before, we think it's really important for us to be very thoughtful about who we partner with in which geographies, right? We want to make sure that the partners we have are the top partners in those geographies. And I think what we also want to make sure we don't do is have so many partners that, one, it dilutes the effort, both our internal resources, but also the potential to have a bigger partner worldwide.
So we have not started even though we have had inbound interest in different regions. I would say pretty much every region in the world, we've had inbound interest. But we want to be careful that we don't just again have 10 different partners in 10 different regions around the world, but be a little bit more thoughtful. So what we've actually been focused on is let us develop, let us really understand what does it take to get approval and reimbursement in Europe? What does it take to get approval and reimbursement in Japan?
And we are very close to having a full plan set in place. And we've started to have conversations with those companies that have expressed interest. And then at the time where we feel like we have the knowledge and the path forward laid out, then we will also make some proactive contacts with companies in those regions. So I'll just say we are looking at potentially a company that has both Europe and Japan and China. So one ex U.
S. Partner outside of Israel, obviously. So that would be ideal, I think, in a lot of ways, but we want to make sure that it's a partner that will be successful in those markets. If that doesn't work out, then we probably look at potentially Europe, Japan and maybe China because obviously China is very unique. And again, while we have had some preliminary conversations, we just are finishing up exactly what will it take to be successful in those markets.
We can't negotiate the best deal for our company and for our shareholders with other partners until we know exactly what it would take. And that's kind of what we've been focused on. So, we've had we've engaged experts in this area. I obviously have run global businesses. We have other people in the company and have a lot of experience in areas.
Our Chief Business Officer lived in China for several years, so she has personal relationships. So we've really leveraged the knowledge and the know how that we have to make sure that when we do start to have those conversations, that we're putting ourselves in the best situation possible. So those will start in the fall. And I think that we'll be able to give an update over the next, I would say, 2 months on exactly what that looks like, like what is it going to take. And I've said this before, Japan, you always have to do a bridging study.
They want to see the medicine in their patients. It's more of a safety than an efficacy, but we know that we can get reimbursement there. Europe, it was about understanding what are the possibilities of us getting a decent reimbursement and not being compared to generic mitomycin and we think we have a path forward there. So now that we feel like we have more of an understanding of exactly what it takes, we'll start those conversations. So sorry, that was a long winded answer to your question, Ram.
So, just as a follow on to that, are you seeing any evidence that specifically within the context of Europe, potential partners to assist with the commercialization of Jelmydo want to actually see not only regulatory approval but also reimbursement discussions completed before they would be interested in getting involved? Or do you think that potential partnership could be consummated before all of that is set in stone?
Well, what we've been doing over the last few months is actually having those conversations with some of the payers. So we have some experts that we've been working with. So that was our decision that we felt like we wanted to understand, right? So some of the partners have said they have their perspective on what that would look like. And you want somebody who has that capability in Europe, that's we'll be looking for that capability.
But I that's what we'll be looking for that capability. But I think we're in a position now where we have enough information, enough knowledge that we'll be able to start those discussions.
Okay. And then just very quickly, given the rise of the Delta variant, are you seeing any evidence that if further restrictions or new restrictions are placed on face to face promotional activity and or clinical site recruiting activity that either the continued rollout of gel myto or enrollment in the ATLAS trial would be affected? And if so, in what way? Or do you think that this is something that you feel confident you can manage through on both of those fronts?
Well, I would be remiss if I said it would have no impact. I mean, I think that we've seen just the things change the last couple of weeks. They're changing daily. Jeff can comment, but accounts that maybe were going to open access are now shutting down access. I had my own personal experience with the healthcare system where a family member couldn't even get a couldn't get a hospital bed, because of COVID.
And so to say that it won't have any impact, we don't know that, right? We continue to see good access. We do see we still see restrictions, right? And so we it's a day by day, week by week thing. As far as Atlas is concerned, we feel like because we have a lot of sites up and running in different areas around the world that if we need to pivot and get more patients in one area versus others that we can actually do that, which is one of the reasons that we actually wanted to have more sites.
And as you heard, we've got almost 100 sites activated. So to be in that position, I think, will help us from an Atlas standpoint. I don't think that the Delta variant or COVID at this point would shut down our business, if that makes sense. So I don't think we're in a position where we're not going to be able to continue to be successful. So it might impact the ramp, but I don't think it's going to impact Some patients are still going to be need to.
And I think patients are more comfortable now, especially those who have been vaccinated, are more comfortable going out there. And Jeff talked about the nephrostomy tube. I personally am very excited about that administration and think that if things continue to shut down and the hospitals aren't able to do elective surgeries or elective procedures, then you may see an increase in nephrostomy tube. And we'll make sure that we are in a position to be able to support physician offices to be able to do that route of administration.
Okay. And then lastly, did you provide a timeline for completion of the non human primate study with UGN-three zero one? Not sure if I missed that.
Mark. No, that's okay. Mark, do you just want to comment on that? I don't remember if we said anything about timing.
Yes. We actually haven't. We're moving along. We're expecting data at the end of the year. So I suspect that we'll decide to talk about that after
the end
of the year. So I guess that's probably what we'll do.
Yes, I might have next year.
Yes, yes. Great. Thank you.
Thanks, Ram.
Thank you. Our next question comes from the line of Matt Kaplan from Ladenburg Thalmann. Your question please.
Hey guys, congrats on the good quarter. Just wanted to follow-up in terms of and dig in a little bit more to the prior question in terms of how have, I guess, 3rd quarter sales and new starts been shaping up versus 2nd quarter? And have you been able to maintain the momentum that you saw in the Q2, in the Q3, given the changing dynamics here now with the Delta variant? And then another question with respect to the nephropathy tube study data. I guess maybe more for Mark, how will this do you think impact use and uptake of JELMIDO kind of going forward, not only in the context of the pandemic, but also kind of further out after we're kind of out of that range?
Yes, Matt, Liz, we're not really providing month over month or month to month or data around patients. I would say we continue to see patient enrollment forms come in. We continue to see new patients being dosed. So we continue to see growth in the numbers that Jeff talked about. So we expect that we will continue to see adoption increase over the next few months and beyond.
So we remain bullish about that. But Jeff, maybe you can just comment on what you're seeing out in the field around physicians and around the reps, the representatives and what they're able to do. I think that would be very helpful for how things are going. And then turn over to Mark to answer the question on the study. Yes.
Thanks. Exactly what you said. So reps are going deeper into accounts. We're continuing to see growth and we'll continue to see that. And so as I said earlier, they've got a tool now to help even expand the to the full indication.
Excited to have that and I think KUA will be good timing to finish the year strong as well for a slide meeting. So, Mark?
Yes. Matt, just to make sure I'm answering the right question. The nephrostomy tube issue, I think, is what you're asking about. And it's a very interesting byproduct of the launch, because as you and others know, the pivotal study was done entirely in a retrograde manner, meaning that the drug was instilled into the kidney through a catheter placed through the urethra into the bladder and then up into the kidney. Practitioners have started placing an nephrostomy tube, which as many know is a tube placed directly through the skin of the back into the kidney, which provides direct access without the need for lower urinary tract instrumentation in order to deliver gel Mito.
And what we're hearing anecdotally is that it is a very acceptable method for delivering the drug, both from a practitioner and also from practitioner and also from the patient perspective. I think there was initial worry that the neproximate tube would be viewed by patients as an encumbrance and an inconvenience. As it turns out, it actually is both convenient, well tolerated and very significantly simplifies the office workflow. Imagine a patient coming into the office, pulling up their shirt, exposing the port effectively, the tube access into the kidney. The practitioner instills the drug and the patient goes home.
So we're hearing anecdotally that there are a lot of advantages, both from a patient acceptance as well as a workflow perspective using nephrostomy tubes. We know that there are investigators in the field now studying this, and we are expecting actually to see some presentations and papers in the coming year about this. So I expect that if what we're hearing anecdotally continues that there will be a significant uptake of this mode of delivery because it has a lot of advantages both in terms of again in office workflow as well as patient accessibility.
Okay. That's very helpful. Thanks for the added detail. And one last question, I guess given the success that you've been having, any plans to change your commercial footprint at this point?
No, not really. We're adding a couple of clinical nurse educators because we want to make sure that we one of the things that's been very helpful is the success and the support that we provided at the physician offices. So other than a couple of clinical nurse educators who need to be there the 1st or second time they do the installation, the footprint should stay the same.
Okay, very good. Thanks for taking the questions.
Thank you.
Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question please.
Hi, thank you. Good morning everyone and congrats Liz and team on the strong quarter. Just a couple from us, maybe starting with your comments on the community setting. Could you maybe just elaborate a little more if this is just more sort of early trialing by practitioners in the community? Or is this more reflective of Jeff and team beginning their sort of next wave of tiering and target account penetration here?
Jeff?
Yes. So I would say it's the next wave. I think you're starting to see communities. They're obviously looking to bring back revenue. There's been a big push to bring back revenue in the surgery center.
And so you're starting to see and as I've said you know as well, they like the J code. They like having the permanent code. And there's just a little more level of comfort. And so those doctors that were diagnosing in the community and going to the hospital are now saying, okay, I'm going to diagnose in the community and do this in my surgery center. So and to your point, we expected out of the gate to be in the hospital.
And as we grow, we're to continue to grow in the hospital, but you're going to start to see more of that into the community.
Okay. Then one on the pipeline side for us just with regard to 301. I know you mentioned that the earlier that to an earlier question that the non human primate work would be completed around year end or so. But your comment on your that you see it as a combinatorial asset for additional solid tumor types. Have you identified, I guess, at this point based on sort of analogs in the market where directionally you would go?
And then would you pursue this additional combination development as either investigator sponsored trials or would these be primarily company directed company sponsored, excuse me?
Yes, great question. I think that we are just starting to look to see other areas. And I think it would be both, right? We have assets out in the marketplace that are being studied where we think, oh, wow, that might be a good opportunity for us to do a combination, then we may do some
partnerships with other companies. So I
think we're looking at it, anything specific yet. This is just as we started to work with and the feedback that we're getting so far with 301, anti CTLA-four is well known, the efficacy is well known. So our ability to deliver it locally, we believe has advantages both from and safety standpoint. And so if we're able to do that in combination, we think there's a lot of opportunity there.
Okay. Thank you very much, Liz. I'll hop back in queue.
Thanks. Great. Thank you.
Thank you. And this does conclude the question and answer session of today's program. I'd like to hand the program back to Liz Barrett for any further remarks.
Great. Thank you, operator, and thanks to everybody for joining us today. We look forward to the remainder of the year, we're really poised to continue to advance our efforts, both our commercial efforts and our pipeline priorities. We'll continue to provide updates as we always do, as we leverage the proprietary technology we have, deliver on our promise to bring patients these novel therapies in areas where there really has been little innovation. So while we do recognize the COVID landscape, as I mentioned before, is evolving daily, we keep a close eye on it and the potential impact that it has to both patients and the healthcare system, we still feel very positive and optimistic about patients' ability to come in and get our medicines.
So it remains fluid. We can't predict the impact, but we consistently, like I said, work. And we know now that we can we have the flexibility and the adaptability to adapt to whatever situation there is because we are committed to ensuring that patients have access to Jomita. So again, thanks for your interest in the in our company. We look forward to more dialogue.
And operator, you can now disconnect.
Thank you. And thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.