UroGen Pharma Ltd.

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the EuroGen Pharma Second Quarter 2021 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Sarah Sherman, Head of Investor Relations for EuroGen Pharma. Please go ahead.

Thank you, Operator, and welcome everyone to Eurogen Pharma's second quarter 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 30th, 2021. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Jeff Bova, Chief Commercial Officer, Dr. 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 gel mito, 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 risk can be found in our earnings press release and latest SEC disclosure documents. Your caution not to place undue reliance on these forward-looking statements and your urgent disclaims and the 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 2021, one of our key priorities remains the increased adoption of Gemido, the first approved therapy from a novel reverse thermal hydrogel technology platform. As we announced in July, we recorded $13 million in Gelmido net product sales for the second quarter of 2021 and $20.5 million for the first half of 2021. We believe this early success with Gelmido provides proof of concept for the broader platform, both in low-grade disease with UGN-102, as well as our expansion into high-grade disease and other tumor types. We are focused on changing the way urothelial cancers are treated, an area where there have been no significant advances in recent years. And we see gel mito 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 gel mito and expand with our second uro-oncology investigational product candidate, UGN-102, which is being studied in low-grade, intermediate-risk, non-muscle-invasive bladder cancer, a large patient population where there are no non-surgical primary treatment options. Our RT-GEL 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 102 Phase III Atlas study, but we are pleased with the progress and interest to date from centers around the world. While we focus on expanding our pipeline, we have also made progress in our commitment to expand Gelmido's geographic presence. We announced our first collaboration, which involves a license and supply agreement with Neoform to pursue regulatory approval and commercialization for Gelmido 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 two 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 Gemida regulatory and reimbursement pathways, and look forward to providing more detail on our XUS 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 two lead products set a strong foundation for our company. And assuming regulatory approval of UGM-102, our goal is to deliver peak revenues of over $1 billion by the end of 2027. Given the total market size of low-grade UTUC is over $700 million, and low-grade intermediate-risk non-muscle-invasive bladder cancer over $3 billion, we believe this goal is attainable and positions Urogen as a leader in uro-oncology. Beyond Gelmido and UGM-102, we continue to expand and progress our early-stage pipeline, both internally as well as with academic collaborations, 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 treatments 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 Gelmito. During the second quarter, we saw some return to a sense of normalcy with respect to the commercialization of gel mito 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 10th through the 13th 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 gel mito. 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 Dr. Katie Murray focused on how gel mito 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 Joe Mito 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 1st, we have increased the number of activated sites to 407, up from 316 as of May 1st. 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've increased the number of repeat accounts to 63 as of August 1st, up from 40 as of May 1st. 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 URGEN staff and nurse educators along the treatment continuum is critical to seamless integration of gel mito in their practices, and that practices are receiving timely and accurate reimbursement across Medicare and commercial covered lives. We consistently watch this number to ensure that physicians are identifying additional patients and gaining more and more comfort using our therapies. Reflecting on our strong second quarter, we do believe that there was some impact from patients who decided to wait for their vaccinations in the first quarter, who were then treated in the second quarter. And we're pleased that patients are returning to their positions 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 gel mito, 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 102 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 102 plus or minus TURBT compared to TURBT alone. As an event-driven phase three trial, we expect it will take approximately one year to enroll and an additional two 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 2b Optima 2 study to help inform the design and assumptions for the trial. We anticipate presenting the final Optima 2 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 non-surgical options in non-muscle invasive bladder cancer and the natural treated history of non-muscle invasive bladder cancer in the 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're also on track to begin our home installation feasibility study in the second half of this year. The trial will be a small, ten-patient study with the goal to demonstrate that UGN-102 can be safely administered by a healthcare professional in the home setting. We expect to enroll at approximately five 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 UGN301, our CTLA-4 antibody, and UGN201, our TLR7 agonist. We see UGN301 as a foundational checkpoint inhibitor and intend to study this agent as monotherapy and in combination therapy, including in combination with UGN201, as well as other agents. We refer to the combination of UGN201 and UGN301 as UGN302 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 UGN301, which is on the critical path as we move towards submitting an IMD for this asset. We expect to have the results of the toxicity study by the end of the year, and assuming an acceptable toxicity profile, We'll submit an IND for UGM301 in the first half of 2022. We are actively working with MD Anderson to further progress our understanding of the synergy between UGM201 and UGM301 and are on track to start a study in humans later this year with UGM201 to assess the immune modulatory activity in the bladder. We expect to see additional non-clinical 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 mirroring work at Johns Hopkins and are exploring the possibility to expand to 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 Jomaita for the second quarter of 2021 of approximately $13 million and $20.5 million for the first half of 2021. Cost of revenues for the second quarter of 2021 were approximately $1.4 million, resulting in a gross margin of 89.1%. As we mentioned on previous calls, in periods prior to receiving FDA approval for Gemido, we recognized inventory and related to costs associated with the manufacture of Gemido as research and development expense. We expect this to continue to impact cost of revenues through the second quarter 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% versus the 89.1%. for the three months ended June 30, 2021, if we had not sold DOMIDO units that were expensed prior to regulatory approval. Research and development expense for the second quarter ended June 30, 2021, for $12.1 million, compared to $8.1 million in the same period of 2020. Research and development expense also includes $1 million in non-cash share-based compensation expense for the second quarter ended June 30, 2021, as compared to $1.6 million for the same period in 2020. The overall increase in R&D expense relates to the initiation of our Phase III Atlas study for UGN 102 at the end of 2020. Selling general and administrative expenses for the second quarter ended June 30, 2021, were $22.3 million as compared to $24 million in the same period in 2020. The decrease in the annual selling general administrative expenses resulted primarily from the higher brand marketing expense in the second quarter of 2020 in preparation for the launch of Delmido, as well as a decrease in share-based compensation expense. Selling general and administrative expenses included $5 million in non-cash share-based compensation expense for the second quarter ended June 30, 2021, as compared to $5.5 million for the same period in 2020. For the second quarter ended June 30, 2021, we reported financing expense related to the prepaid forward obligation to RTW investments of $3.1 million. As previously reported, in accordance with U.S. generally accepted accounting principles, we expect to accrue approximately $12 to $15 million 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 Jomito sales recognized subsequent to the May 2021 closing. For the second quarter ended June 30, 2021, we reported a loss of $26.2 million or $1.17 per share. This compares to a net loss of approximately $31.3 million or $1.44 per share for the same period in 2020. The net loss for the second quarter ended June 30, 2021 includes $6 million in non-cash share-based compensation expense. For this first six months of 2021, net loss was $52.2 million as compared to $69.1 million for the same period in the prior year. This improvement in operating loss over the period was driven by our JOMIDA revenue of $20.5 million as compared to $0.4 million in the prior year. Total operating expense decreased slightly to $67.1 million as compared to $70.7 million in the prior year. Our guidance for 2021 operating expense remains unchanged and is in the range of $155 to $165 million. This includes estimated non-cash share-based compensation expense of $24 to $28 million, subject to market conditions. Lastly, we closed the second quarter with $129.3 million in cash, cash equivalents, and marketable securities. This includes the $75 million 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. Ladies and gentlemen, if you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key. Our first question comes from the line of Leland Gershaw 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 Gelmido, you mentioned that you're seeing increased repeat rates at an increasing number of centers. Maybe I wanted to see if you could share more color on kind of what's – you know, sort of the kinds of feedback you're getting from the physicians at those centers in terms of their interest in using gel mito, again, and the types of patients in which they may be using gel mito with respect to, you know, degree of pathology and location of the tumors and so forth. And have a follow-up. Thank you.

Hi. 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 Leland's follow-up suggests.

Sure, thanks. And as far as the number of accounts that are treating more than one patient, it's a couple things. You know, you've obviously got peer-to-peer influence within that practice, so physicians will ask their peers, you know, how did it go on a certain patient. Clinically, you know, 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 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 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. I'll say it's been across the indication. We've had recurrent patients that have been treated. 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 pool, and it will evolve into probably a 50-50 half coming from the recurrent pool, half coming from the newly diagnosed.

Thank you. That's very helpful. And then a question for Mark. In terms of these collaborations, obviously MD Anderson and then Johns Hopkins and 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 of the RT-Gel platform. Thanks.

Thanks, Leland. A great question. 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.

Yeah, my only comment is that is, you know, correct. We do see a lot of interest with different academic centers and using it. And so any time we get an inbound, you know, interest, we absolutely, 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 continuously look 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 usage of our, you know, very, very unique technology in the RTHL. So thanks, Leland.

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. You know, first, I guess, Jeff, I just wanted to ask – you know, what is the current status of utilization of gel mito in the different center types? You know, I think that there was some discussion of trends that you were seeing of additional equipment that physicians could augment their, you know, 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 you know, 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, you know, 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, Russ. Yeah, so some of the trends that we're seeing recently is, as you know, physicians can give this in an outpatient hospital, an ASC, a surgery center, or they, as you said, they make arrangements to give it in the clinic either via a 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 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, it's 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're hoping to collect a lot of data when we start the registry. So that was your first. The second, the patient builder. Yeah, 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. you know, the representatives able to build a patient, whether that's a newly diagnosed, whether that's recurrent, you know, number of tumors, size of tumors. And then what it does, it extrapolates out what the data tells us in Olympus. And so it allows the field to really talk to the entire indication to make sure that every one of those 6,000 to 7,000 patients that we see every year, gel mito is considered. We'll expand upon that. We're excited for a live AUA. But yeah, the reps have that patient builder 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 that we're going to be very busy. 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, and 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 into the queue.

Great. Thanks, Chris.

Thank you. Our next question comes from the line of Ram Salvaraju from AT Wainwright. Your question, please.

Yes. If you could, first of all, maybe give us some background on the relationship with NeoFarm and what might be some perspectives regarding the local Israeli market and NeoFarm's capabilities in that region.

Sure, Hiram. 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 Neoform has the capabilities, they already have the infrastructure to And it fit very nicely into what they're already doing. So we worked very closely with them, you know, for Israel. And, look, we've, you know, it's not a huge market, right? Let's be, you know, 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 Neoform, you know, we looked, like I said, at all of the different options. and felt like both from a financial and a capability standpoint, it made the most sense to do a partnership. And Neofarm 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, you know, as we expand globally. you know, you want partners that if we're not going to do it ourselves, that can bring that added extra capability. And we believe that NeoFarm does that in Israel.

Has NeoFarm expressed any interest in commercializing the product in countries outside of Israel? Or would you need to seek partners distinct from NeoFarm for those territories? And if so, 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 and 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 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, and 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-US 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'd 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 engaged experts in this area. You know, I obviously have run global businesses. We have other people in the company that have a lot of experience in areas. Our chief business officer, you know, 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, you know, two months on exactly what that looks like. Like, you know, what is it going to take? And I've said this before. In Japan, you always have to do a bridging study. They want to see the medicine in Japan. And 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, Rampa.

Now, 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 gel Mito 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, you know, they have their perspective on what, you know, what that would look like. And you want somebody who has that capability. In Europe, that's probably the number one capability you need. is market access. Can they get in there? Can they negotiate a good deal with the government? So we'll be looking for that capability. But I think we're in a position now where we have enough information and 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 activities and or clinical site recruiting activities, that either the continued rollout of gel mito 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, you know, I would be remiss if I said it would have no impact. I mean, I think that we've seen just, you know, things change the last couple of weeks. They're changing daily. You know, Jeff can comment. But, you know, accounts that maybe were going to open access are now shutting down access. I had my own personal experience with the health care system where, you know, a family member couldn't even 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 still see restrictions, right? And so 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, and 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, you know, we've got almost a hundred sites activated. So, you know, 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, you know, 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 need to, and I think patients are more comfortable now, especially those that have been vaccinated, you know, are more comfortable going out there. And, you know, 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 actually provide a timeline for completion of the non-human primate study with UGM-301? I'm 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 time.

Yeah, 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 Q&A is.

Yeah, probably by next year.

Yeah. Great. Thank you.

Thanks, Ram.

Thank you. And as a reminder, ladies and gentlemen, if you have a question at this time, please press star then 1. Our next question comes from the line, Matt Catlin from Lederberg Thalman. Your question, please.

Hey, guys. Congrats on the good quarter. Just wanted to follow up in terms of digging a little bit more to the prior question in terms of how have, I guess, third quarter sales and new starts been shaping up versus second quarter, and have you been able to maintain the momentum that you saw in the second quarter? In the third quarter, given the the changing dynamics here now with the Delta variant. And, uh, and, and then another question with respect to the nephrostatic tube, uh, study data, um, I guess maybe more for Mark, how will this, do you think impact use and uptake of gel Mito kind of going forward and not only in the context of the pandemic, but also kind of further out after we're kind of out of that, that range?

Yeah, Matt, Liz, we're not really providing month-over-month or month-to-month 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 time. you know, over the next few months and, you know, and beyond. So, you know, we remain bullish about that. But, Jeff, maybe you can just comment on what you're seeing out in the field around positions and around the reps and 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.

So, Jeff. Yep, thanks. You know, exactly what you said. So, you know, reps are going deeper into accounts. We're continuing to see growth and we'll continue to see that. And so, you know, as I said earlier, they've got a tool now to help even expand the, you know, to the full indication. Excited to have that. And, you know, I think AUA will be good timing to finish the year strong as well for a slide meeting. So, Mark?

Yeah, 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 a nephrostomy tube, which as many know is a tube placed directly through the skin of the back end of 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 the patient perspective. I think there was initial worry that the nephrostomy 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 acceptability.

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've provided the physician offices. So other than a couple of clinical nurse educators who need to be there the first 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 organizations practitioners in the community, or is this more reflective of Jeff and team beginning their sort of next wave of, you know, tiering and target account penetration here?

Jeff? Yep. So I would say it's the next wave. I think you're starting to see communities, you know, 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. And to your point, we expected out of the gates to be in the hospital and As we grow, we're going to continue to grow. We'll continue to grow in the hospital, but you're going to start to see more of that into the community.

Okay. Thanks for that caller. Then one on the pipeline side for us, just with regard to 301, I know you mentioned to an earlier question that the non-human primate work would be completed around year-end or so, but your comment 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.

Yeah, 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 investigators that are interested in potentially seeing it used in certain ways, and we would do that. And we also, you know, when we see other 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 in the continuum of different areas, but we don't have anything specific yet. This is just as we started to work with and the feedback that we're getting so far with 301, you know, anti-CTLA-4 is well known, you know, the efficacy is well known. So our ability to deliver it locally we believe has advantages both from an efficacy 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. As 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, you know, we still feel very positive and optimistic about patients' ability to come in and get our medicines delivered. So it remains fluid. We can't predict the impact, but we consistently, like I said, work. And we know now that 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 gel miters. So, again, thanks for your interest 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.