Q2 2024 UroGen Pharma Ltd Earnings Call

August 13, 2024

Speaker Change: Good day, and thank you for standing by. Welcome to the 2024 Second Quarter Urgent Pharma Earnings Call. At this time, all participants are in listen-only mode.

Operator: At this time, all participants are in listen-only mode.

Operator: After this speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press Start 1-1 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press start 1-1 again.

Speaker Change: After this speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised.

Operator: Please provide that today's conference has been recorded.

Vincent Perrone: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to your first speaker today, Vincent Perrone, Head of Investment Relations. Please go ahead.

Vincent Perrone: I'll not like to hand the conference over to your first speaker today, Vincent Perrone, Head of Investor Relations. Peace call ahead.

Vincent Perrone: Thank you, operator.

Liz Barrett: Good morning, everyone, and welcome to Urogen Pharma's second quarter of 2024 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, 2024. The press release can be accessed on the investor's portion of our website at investors.urigen.com.

Vincent Perrone: Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's second quarter 2024 financial results and business update conference call.

Speaker Change: 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, 2024. The press release can be accessed on the Investors portion of our website at investors.eurogen.com.

Liz Barrett: Joining me today are Liz Barrett, President and Chief Executive Officer; Dr. Mark Schoenberg, Chief Medical Officer; David Lynn, Chief Commercial Officer; and Don Kim, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmino, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectation, as well as potential future commercialization activities for UGN 102 to improve. Anticipated data, regulatory filings, and decisions including UGN 102 potentially receiving priority review, UGN 102 being a primary growth driver for your agenda to improve, future research and development efforts, our corporate goals, and 2024 financial guidance, among other things.

Speaker Change: Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lin, Chief Commercial Officer, and Dong Kim, Chief Financial Officer.

Speaker Change: During today's call we will be making

Speaker Change: These may include statements regarding our ongoing commercialization activities related to gelmino.

Speaker Change: Our Ongoing and Planned Clinical Trials, Commercial and Clinical Milestones

Speaker Change: Market and Revenue Opportunities, our Commercialization Strategy and Expectation, as well as potential future commercialization activities for UGN 102, if approved.

Speaker Change: Anticipated data, regulatory filings, and decisions including UGN 102 potentially receiving priority review, UGN 102 being a primary growth driver for Eurogen if approved, future research and development efforts, our corporate goals, and 2024 financial guidance, among other things.

Liz Barrett: These forward-looking statements are based on current information, assumptions, and expectations that are subject to change.

Speaker Change: These forward-looking statements are based on current information, assumptions, and expectations that are subject to change.

Liz Barrett: A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. There are caution not to play undualizing some of these forward-looking statements, and your agenda explains any obligation to update these statements.

Speaker Change: A description of potential risks can be found in our earnings press release and latest SEC disclosure documents.

Speaker Change: There are caution not to place undue reliance on these forward-looking statements, and your agenda slams any obligation to update these statements.

Liz Barrett: I'll now turn the call over to Liz Barrett, President and CEO. Liz.

Speaker Change: I'll now turn the call over to Liz Barrett, President and CEO. Liz?

Liz Barrett: Thank you, Vincent, and thank you for everyone joining this morning. The clear highlight of the second quarter was from our lead product candidate, our announcement of positive 12-month duration of response data from the Invision Study, evaluating UGN 102 and patients with low-grade intermediate risk non-muslim-based bladder cancer. We previously announced a compelling, complete response rate of 79.6% at three months. The durability data showed that for those patients who had achieved a CR at three months, the duration of response was an unprecedented 82.3% at 12 months by Kaplan-Meier analysis. This is the highest duration of response ever reported in this patient population.

Liz Barrett: Thank you, Vincent, and thank you for everyone joining this morning.

Liz Barrett: The clear highlight of the second quarter was from our lead product candidate, our announcement of positive 12-month duration of response data from the ENVISION study, evaluating UGN-102 in patients with low-grade, intermediate-risk, non-muscle invasive bladder cancer.

Liz Barrett: We previously announced a compelling complete response rate of 79.6% at three months.

Liz Barrett: The durability data showed that for those patients who had achieved a CR at 3 months, the duration of response was an unprecedented 82.3% at 12 months by Kaplan-Meier analysis.

Liz Barrett: This is the highest duration of response ever reported in this patient population.

Liz Barrett: We presented these data during a virtual event on June 13th. The event included presentations by several key opinion leaders with expertise in urology. We also interviewed a patient who spoke about his experience in the Invision Trial and the challenges that come with a surgical standard of care. This was an excellent opportunity to hear the perspectives of both physicians and patients in the urology community. The replay is available on our website, and I would encourage those unable to join to listen to the replay. The body of clinical data that supports UGN-102 is very compelling, with consistent three-month complete response rates across Envision, Atlas, and the prior phase to Optimal Two studies.

Liz Barrett: We presented these data during a virtual event on June 13th. The event included presentations by several key opinion leaders with expertise in urology.

Operator: earnings call. At this time, all participants are in listen only mode. After this speaker's presentation, there will be a question and answer session.

Speaker Change: We also interviewed a patient who spoke about his experience in the ENVISION trial and the challenges that come with a surgical standard of care. This was an excellent opportunity to hear the perspectives of both physicians and patients in the urology community.

Operator: To ask a question during the session, you'll need to press start 1-1 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press start 1-1 again.

Speaker Change: The replay is available on our website and I would encourage those unable to join to listen to the replay.

Operator: Please provide that today's conference has been recorded.

Vincent Perrone: I'll not like to hand the conference over to your first speaker today, Vincent Perrone, head of investor relations. Peace call ahead. Thank you, operator.

Speaker Change: The body of clinical data that supports UGN-102 is very compelling, with consistent 3-month complete response rates across ENVISION, ATLAS, and the prior Phase II Optima II study.

Vincent Perrone: Good morning, everyone, and welcome to Urogen Pharma's second quarter of 2024 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, 2024. The press release can be accessed on the investor's portion of our website at investors.urigen.com. Joining me today on Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, David Lynn, Chief Commercial Officer, and Don Kim, Chief Financial Officer.

Liz Barrett: Duration of response across all trials was also impressive, giving us confidence in the ability of UGN-102 to improve patient outcomes and quality of life.

Speaker Change: Duration of response across all trials was also impressive giving us confidence in the ability of UGM 102 to improve patient outcomes and quality of life.

Liz Barrett: Our immediate priority is to complete our NDA submission for UGN-102 and low-grade intermediate risks on both invasive bladder cancer, which we expect in the very near term. The NDA is a rolling submission that was initiated earlier this year. Assuming priori review, we expect an approval decision as early as the first quarter of 2025. The estimated market opportunity for UGN-102 is over $5 billion, and it approved it would be the first FDA approved medicine for this patient population. We expect 1-0 UGN-102 will transform the treatment paradigm for this patient population as well as our company. There are an estimated 82,000 patients treated with low-grade intermediate risks on both invasive bladder cancer in the U.S.

Speaker Change: Our immediate priority is to complete our NDA submission for UGM-102 and low-grade intermediate-risk non-muscle invasive bladder cancer, which we expect in the very near term.

Speaker Change: The NDA is a rolling submission that was initiated earlier this year. Assuming priority review, we expect an approval decision as early as the first quarter of 2025.

Vincent Perrone: During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmino, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectation, as well as potential future commercialization activities for UGN 102 to improve. Anticipated data, regulatory filings, and decisions including UGN 102 potentially receiving priority review, UGN 102 being a primary growth driver for your agenda to improve, future research and development efforts, our corporate goals, and 2024 financial guidance among other things.

Speaker Change: The estimated market opportunity for UGM 102 is over $5 billion, and if approved, it would be the first FDA-approved medicine for this patient population.

Speaker Change: We expect UGM 102 will transform the treatment paradigm for this patient population as well as our company.

Speaker Change: There are an estimated 82,000 patients treated with low-grade, intermediate-risk, non-muscle-invasive bladder cancer in the U.S. each year. This is over 10 times the size of the gelmito market in upper tracheo-ophelial carcinoma, or UTUC.

Liz Barrett: each year. This is over 10 times the size of the Jolmito market, an up-retractual folio carcinoma, or UTUC. Unlike most rare diseases, which are constant and concentrated, UTUC is episodic, dispersed, and treated by a wide range of physicians, making patient distribution more challenging. In contrast, bladder cancer is prevalent and is regularly treated by nearly all urologists. UTN-102 is relatively easy for physicians and their staff to administer. Perhaps most importantly, we believe it can fit seamlessly into current practice based on physician feedback. This is critical as we expected would not disrupt a physician's practice. Instead, it could expand their practice by better utilizing staff, as they can easily be administered by a nurse or physician extender with minimal training and does not require special equipment.

Speaker Change: Unlike most rare diseases, which are constant and concentrated, UTUC is episodic, dispersed, and treated by a wide range of physicians, making patient distribution more challenging.

Vincent Perrone: 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. There are caution not to play undualizing some of these forward-looking statements and your agenda explains any obligation to update these statements.

Speaker Change: In contrast, bladder cancer is prevalent and is regularly treated by nearly all urologists.

Speaker Change: UTM-102 is relatively easy for physicians and their staff to administer.

Liz Barrett: I'll now turn the call over to Liz Barrett, President and CEO. Liz. Thank you, Vincent, and thank you for everyone joining this morning.

Speaker Change: Perhaps most importantly, we believe it can fit seamlessly into current practice based on physician feedback.

Speaker Change: This is critical as we expect it would not disrupt a physician's practice. Instead, it could expand their practice by better utilizing staff as they can easily be administered by a nurse or physician extender with minimal training and does not require special equipment.

Liz Barrett: The clear highlight of the second quarter was from our lead product candidate, our announcement of positive 12-month duration of response data from the Invision Study, evaluating UGN 102 and patients with low-grade intermediate risk non-muslim-based bladder cancer. We previously announced a compelling, complete response rate of 79.6% at three months. The durability data showed that for those patients who had achieved a CR at three months, the duration of response was an unprecedented 82.3% at 12 months by Kaplan Meyer analysis. This is the highest duration of response ever reported in this patient population.

Liz Barrett: We have learned from my experience of the past few years and have prepared to aggressively drive market penetration for UGN-102 if approved. David Lynn is recently appointed Chief Commercial Officer, so we'll provide more detail on our plans in a few minutes.

Speaker Change: We have learned from our experience over the past few years and are prepared to aggressively drive market penetration for UGM 102, if approved.

David Lin: David Lin, our recently appointed Chief Commercial Officer, will provide more details on our plans in a few minutes.

Liz Barrett: In April, we announced the FDA acceptance of the IND for UGN-103, marking a significant step in our life cycle management strategy. Developed with technology licensed from MedAC, UGN-103 is expected to offer manufacturing efficiencies and additional IP protection through June 2035, utilizing current MedAC-issued patents and potentially until December 2041 with our pending U.S. patents. We have activated our first site and expected to have our first patient dose in the very near. Future.

David Lin: In April, we announced the FDA acceptance of the IND for UGN 103, marking a significant step in our lifecycle management strategy.

David Lin: Developed with technology licensed from MEDAC, UGM-103 is expected to offer manufacturing efficiencies and additional IP protection through June 2035 utilizing current MEDAC issued patents.

Speaker Change: and potentially until December 2041 with our pending U.S. patents.

Speaker Change: We have activated our first sites and expect to have our first patient dose in the very near future.

Liz Barrett: As previously disclosed, assuming positive data and approval, we plan to launch the next generation product of UGM 102 in the first half of 2027. Domino-generated net product revenue of 21.8 million dollars in the second quarter. This represented approximately 16% growth sequentially versus the first quarter, and 3% growth over the same period in 2023. This is due in part to growing 340B and wasteage provisioned headwinds, as well as a contraction and pest conversions from the prior year. While the revenue results were below expectations, we remain optimistic on the continued growth of Jomino for patients with low-grade UTUC.

Speaker Change: As previously disclosed, assuming positive data and approval, we plan to launch the next generation product of UGM 102 in the first half of 2027.

Liz Barrett: The replay is available on our website and I would encourage those unable to join to listen to the replay. The body of clinical data that supports UGN-102 is very compelling, with consistent three-month complete response rates across envision, atlas, and the prior phase to optimal two studies. Duration of response across all trials was also impressive, giving us confidence in the ability of UGN-102 to improve patient outcomes and quality of life.

Speaker Change: Gelmido generated net product revenue of $21.8 million in the second quarter. This represented approximately 16% growth sequentially versus the first quarter and 3% growth over the same period in 2023.

Speaker Change: This is due in part to growing 340B and wastage provision headwinds.

Speaker Change: as well as a contraction and PEP conversions from the prior year.

Speaker Change: While the revenue results were below expectations, we remain optimistic on the continued growth of gelmito for patients with low-grade UTUC.

Liz Barrett: Notwithstanding the single digit Euro-year growth in net revenue, we saw 14% growth in patient enrollment forms in the first half of the year as compared to the same period in 2023. The lower conversion rate and higher discounts muted the actual patient demand.

Speaker Change: Notwithstanding the single-digit year-over-year growth in net revenue, we saw 14% growth in patient enrollment forms in the first half of the year as compared to the same period in 2023.

Liz Barrett: The estimated market opportunity for UGN-102 is over $5 billion and it approved it would be the first FDA approved medicine for this patient population. We expect 1-0 UGN-102 will transform the treatment paradigm for this patient population as well as our company. There are an estimated 82,000 patients treated with low-grade intermediate risks on both invasive bladder cancer in the U.S, each year. This is over 10 times the size of the Jolmito market, an up-retractual folio carcinoma, or UTUC.

Speaker Change: The lower conversion rate and higher discounts muted the actual patient demand.

Liz Barrett: Our capital resources continue to be a priority. In June, we took the opportunity to strengthen our balance sheets through a successful public offering. This raised net proceeds of approximately $116.2 million, which will support our launch of UGM 102. It also gives us the flexibility to evaluate business development opportunities to advance our leadership in urologic and specialty cancers. We expect to end the year with approximately $220 million on the balance sheet, which will support a strong launch of UGM 102. Assuming approval in the first quarter of 2025 and based on our latest projections and financial models, we estimate that we now have sufficient cash to support our business to and through profitability.

Speaker Change: Our capital resources continue to be a priority. In June, we took the opportunity to strengthen our balance sheet through a successful public offering.

Speaker Change: This raised net proceeds of approximately $116.2 million, which will support our launch of UGM 102. It also gives us the flexibility to evaluate business development opportunities to advance our leadership in urologic and specialty cancers.

Liz Barrett: Unlike most rare diseases, which are constant and concentrated, UTUC is episodic, dispersed, and treated by a wide range of physicians, making patient distribution more challenging. In contrast, bladder cancer is prevalent and is regularly treated by nearly all urologists. UTN-102 is relatively easy for physicians and their staff to administer. Perhaps most importantly, we believe it can fit seamlessly into current practice based on physician feedback. This is critical as we expected would not disrupt a physician's practice.

Speaker Change: We expect to end the year with approximately $220 million on the balance sheet.

Speaker Change: which will support a strong launch of UGM 102.

Speaker Change: Assuming approval in the first quarter of 2025 and based on our latest projections and financial models, we estimate that we now have sufficient cash to support our business to and through profitability.

Mark Schoenberg: I will now turn their call over to Dr. Mark Schoenberg, our Chief Medical Officer for clinical updates. Mark?

Speaker Change: I will now turn the call over to Dr. Mark Schoenberg, our Chief Medical Officer, for a clinical update. Mark?

Mark Schoenberg: Thank you, Liz. We discussed the latest Envision clinical results in detail during our virtual event in June. But let me spend a few minutes on the highlights.

Mark Schoenberg: Thank you, Liz.

Speaker Change: We discussed the latest InVision clinical results in detail during our virtual event in June, but let me spend a few minutes on the highlights. InVision was a phase 3 multinational single-arm pivotal study in patients with low-grade intermediate risk non-muscle invasive bladder cancer.

Mark Schoenberg: In Vision was a phase 3 multinational single-arm pivotal study in patients with low grade intermediate risk and earned muscle invasive bladder cancer. A total of 240 patients were enrolled; the median age was 70, and two-thirds of patients were ill. All patients enrolled had at least one T-R-B-T and experienced a recurrence of bladder cancer within the past year. Therefore, this patient population represents approximately 75 percent of the estimated annual cases in the U.S. of low grade intermediate risk non-musical invasive bladder cancer, equating to around 60,000 estimated cases annually. UGM 102 was administered once weekly via intravascular installation for six consecutive weeks.

Liz Barrett: Instead, it could expand their practice by better utilizing staff as they can easily be administered by a nurse or physician extender with minimal training and does not require special equipment. We have learned from my experience of the past few years and have prepared to aggressively drive market penetration for UGN-102 if approved.

Speaker Change: A total of 240 patients were enrolled. The median age was 70 and two-thirds of patients were male. All patients enrolled had at least one TURBT and experienced a recurrence of bladder cancer within the past year.

Liz Barrett: David Lynn are recently appointed Chief Commercial Officer, so we'll provide more detail on our plans in a few minutes.

Liz Barrett: In April, we announced the FDA acceptance of the IND for UGN-103, marking a significant step in our life cycle management strategy. Developed with technology licensed from MedAC, UGN-103 is expected to offer manufacturing efficiencies and additional IP protection through June 2035 utilizing current MedAC-issued patents and potentially until December 2041 with our pending U.S, patents.

Speaker Change: Therefore, this patient population represents approximately 75% of the estimated annual cases in the U.S. of low-grade intermediate-risk non-muscle invasive bladder cancer, equating to around 60,000 estimated cases annually.

Speaker Change: UGN 102 was administered once weekly.

Mark Schoenberg: Participants then returned approximately three months after the first installation for determination of response. Accepting a response was based on visual observation during systoscopy, forecast, biopsy, and urine psychology. The three-month complete response rate was 79.6 percent. Of those patients that were not complete responders, less than 3 percent progressed to high grade disease, which is lower than the published range for disease progression in patients with this disease treated by T-R-B-T. In June, we announced results from a key second-year endpoint of duration of response. Among patients who achieved the complete response of three months, the estimated duration of response of 12 months was an unprecedented 82.3 percent.

Speaker Change: via intravestigal installation for six consecutive weeks.

Speaker Change: Participants then returned approximately three months after the first installation for determination of response.

Liz Barrett: We have activated our first site and expected to have our first patient dose in the very near. Future.

Speaker Change: Assessing a response was based on visual observation during cystoscopy.

Liz Barrett: As previously disclosed, assuming positive data and approval, we plan to launch the next generation product of UGM 102 in the first half of 2027.

Speaker Change: for-cause biopsy and urine cytology. The three-month complete response rate was 79.6 percent.

Speaker Change: Of those patients that were not complete responders, less than 3% progressed to high-grade disease, which is lower than the published range for disease progression in patients with this disease treated by PURBT.

Liz Barrett: Domino-generated net product revenue of 21.8 million dollars in the second quarter. This represented approximately 16% growth sequentially versus the first quarter, and 3% growth over the same period in 2023.

Speaker Change: In June, we announced results from the key secondary endpoint of durational response.

Liz Barrett: This is due in part to growing 340B and wasteage provisioned headwinds, as well as a contraction and pest conversions from the prior year.

Speaker Change: Among patients who achieved a complete response at three months, the estimated duration of response at 12 months was an unprecedented 82.3 percent.

Mark Schoenberg: It's too early to estimate median duration of response, given that so few patients who achieved the complete response subsequently went on to have this in these recurrences. However, we can use secondary predictive models such as a weevil model, which estimates a median duration of response of 40 months for complete responders based on the data thus far. The side effect profile is consistent with previous clinical trials of the Gen 102. Adverse events were, in general, mild and moderate in severity. The vast majority were lower urinary tract symptoms, and these are symptoms that you're allowed to see commonly and typically can manage.

Liz Barrett: While the revenue results were below expectations, we remain optimistic on the continued growth of Jomino for patients with low-grade UTUC. Notwithstanding the single digit Euro-year growth in net revenue, we saw 14% growth in patient enrollment forms in the first half of the year as compared to the same period in 2023. The lower conversion rate and higher discounts muted the actual patient demand.

Speaker Change: It's too early to estimate median duration of response, given that so few patients who achieved a complete response

Speaker Change: subsequently went on to have disease recurrence. However, we can use secondary predictive models, such as a Weevil model, which estimates a median duration of response of 40 months for complete responders, based on the data thus far.

Speaker Change: The side effect profile is consistent with previous clinical trials of UGM-102. Adverse events were, in general, mild to moderate in severity. The vast majority were lower urinary tract symptoms, and these are symptoms that urologists see commonly and typically can manage.

Mark Schoenberg: These latest results demonstrated strong duration of response for UGN 102 across three clinical trials. In the Phase 2B Optometube study, the estimated nine-month duration of response was 69.9 percent. Ending atlas for those patients that received UGN 102 alone and demonstrated a complete response rate, the estimated 12-month duration of response in the CR population was 79.6 percent. The consistency of these data is obviously very encouraging. We believe the overall body of evidence for UGN 102 will help us to make a compelling case for FDA approval and support widespread use by urologists if approved.

Speaker Change: These latest results demonstrate a strong duration of response for UGA-102 across three clinical trials. In the Phase 2b Optima II study, the estimated nine-month duration response was 69.9 percent.

Speaker Change: And in ATLAS, for those patients that received UGM-102 alone and demonstrated a complete response rate, the estimated 12-month duration of response in the CR population was 79.6%.

Speaker Change: The consistency of these data is obviously very encouraging. We believe the overall body of evidence for UGM-102 will help us make a compelling case for FDA approval and support widespread use by urologists, if approved.

Mark Schoenberg: Low-grade IR NMIDC is characterized by a high recurrence rate of a low risk of progression. This condition is essentially chronic, necessitating long-term monitoring and management. The current standard of care for these patients is transient report resection. TRBT will typically require 70-10 days for initial recovery. Approximately one-third of patients who undergo this procedure will experience some form of post-operative complication, typically within three months of surgery. The average age for diagnosis and bladder cancer is in the mid-70s, so many of these patients are not great candidates for surgery. Repeated rounds of anesthesia pose a risk of cognitive decline in the elderly population, with the literature also indicating a potential more calorie risk.

Mark Schoenberg: I will now turn their call over to Dr. Mark Schoenberg, our chief medical officer for clinical updates. Mark? Thank you, Liz.

Speaker Change: Low-grade IR NMIB-C is characterized by a high recurrence rate but a low risk of progression. This condition is essentially chronic, necessitating long-term monitoring and management. The current standard of care for these patients is transurequal resection.

Mark Schoenberg: We discussed the latest envision clinical results in detail during our virtual event in June. But let me send a few minutes on the highlights.

Mark Schoenberg: In vision was a phase 3 multinational single-art pivotal study in patients with low grade intermediate risk and earned muscle invasive bladder cancer. A total of 240 patients were enrolled, the median age was 70, and two-thirds of patients were ill. All patients enrolled had at least one T-R-B-T and experienced a recurrence of bladder cancer within the past year. Therefore, this patient population represents approximately 75 percent of the estimated annual cases in the U.S, of low grade intermediate risk non-musical invasive bladder cancer, equating to around 60,000 estimated cases annually.

Speaker Change: TURBT will typically require 7 to 10 days for initial recovery.

Speaker Change: Approximately one-third of patients who undergo this procedure will experience some form of post-operative complication, typically within three months of surgery.

Speaker Change: The average age for diagnosis of bladder cancer is in the mid-70s, so many of these patients are not great candidates for surgery. Repeated rounds of anesthesia pose a risk of cognitive decline in the elderly population, with the literature also indicating a potential mortality risk.

Mark Schoenberg: Additionally, for younger patients, repeated TRBT can cause cumulative lighter damage and negatively impact quality of life. We believe that the ability of UGN 102 to achieve durable, complete responses non-surgically and to potentially reduce recurrence rates while extending these three intervals will provide advance in care of this patient population.

Speaker Change: Additionally, for younger patients, repeated TRBT can cause cumulative bladder damage and negatively impact quality of life.

Mark Schoenberg: UGM 102 was administered once weekly via intravascular installation for six consecutive weeks. Participants then returned approximately three months after the first installation for determination of response. Accepting a response was based on visual observation during systoscopy, forecast, biopsy, and urine psychology. The three month complete response rate was 79.6 percent. Of those patients that were not complete responders, less than 3 percent progressed to high grade disease, which is lower than the published range for disease progression, in patients with this disease treated by T-R-B-T.

Speaker Change: We believe that the ability of UGM-102 to achieve durable, complete responses non-surgically and to potentially reduce recurrence rates while extending disease-free intervals will provide an advance in the care of this patient population.

Mark Schoenberg: As Liz mentioned, the execution of a single RNC's three clinical trials for UGN 103, the next generation successor to UGN 102, are progressing well. We have onboarded three clinical sites in the U.S. and plan to enroll approximately 87 patients. We expected those the first patients in the next few weeks, in a full enrollment anticipated in the first half of 2025, with an NDA filing in the first half of 2026 and a potential approval in the first half of 2027.

Speaker Change: As Liz mentioned, the execution of the single arm phase 3 clinical trial for UGM

Liz Barrett: 103, the next generation successor to UGM 102, are progressing well. We have onboarded three clinical sites in the U.S. and plan to enroll approximately 87 patients.

Speaker Change: We expect to dose the first patients in the next few weeks and the full enrollment is anticipated in the first half of 2025 With an NDA filing in the first half of 2026 and a potential approval in the first half of 2027

Mark Schoenberg: In June, we announced results from a key second-year end point of duration of response. Among patients who achieved the complete response of three months, the estimated duration of response of 12 months was an unprecedented 82.3 percent. It's too early to estimate median duration of response given that so few patients who achieved the complete response subsequently went on to have this in these recurrence. However, we can use secondary predictive models such as a weevil model, which estimates a median duration of response of 40 months for complete responders based on the data thus far.

Mark Schoenberg: We foresee a similar development plan for UGN 104, our next generation formulation of Kelmaio, and expected to commence a single RNF-based research early next year. Turner.

Speaker Change: We foresee a similar development plan for UGM-104, our next generation formulation of gelmito, and expect to commence a single arm phase 3 study early next year.

Mark Schoenberg: Turning to our pipeline, we continue to develop our Inno entology candidate, EGM-311. EGM-311 is an anti-CTLA-4 antibody delivered using our proprietary RQGL technology. We are conducting a phase-1 clinical study to evaluate the safety, tolerability, and to establish a record of the phase-2 dose for EGM-211 as EGM-311 therapy, as well as combination therapy. We plan to report safety and tolerability data from the monotherapy arm in late 2024. We've also initiated combination therapy arms evaluating EGM-311 plus gem-sighting, and EGM-311 plus EGM-201 are proprietary formulation of the nickel mod of POR-7 Agnes, unhybrated NMIVC patients. We look forward to providing updates as the programming moves forward.

Speaker Change: Turning to our pipeline, we continue to develop our immunoontology candidate EGM-301.

Speaker Change: EGM-301 is an anti-CTLA-4 antibody delivered using our proprietary RQGL technology.

Speaker Change: We are conducting a Phase I clinical study to evaluate the safety, tolerability, and to establish a recommended Phase II dose for DGM-301 as immunotherapy, as well as combination therapy.

Mark Schoenberg: The side effect profile is consistent with previous clinical trials of the Gen 102 adverse events were in general, mild and moderate in severity. The vast majority were lower urinary tract symptoms, and these are symptoms that you're allowed to see commonly and typically can manage.

Speaker Change: We plan to report safety and tolerability data for the monotherapy arm in late 2024.

Speaker Change: We've also initiated combination therapy arms, evaluating UGM-301 plus gemcitabine and UGM-301 plus UGM-201, our proprietary formulation of the Niquimod, a TLR7 agonist in hybrid MMIVC patients.

Mark Schoenberg: These latest results demonstrated strong duration of response for UGN 102 across three clinical trials. In the Phase 2B Optometube study, the estimated nine month duration of response was 69.9 percent. Ending atlas for those patients that received UGN 102 alone and demonstrated a complete response rate, the estimated 12 month duration of response in the CR population was 79.6 percent. The consistency of these data is obviously very encouraging.

David Lynn: Now, over to David Lynn for commercial update. Thank you, Mark, and good morning, everyone. I am incredibly excited to take on the role of Chief Commercial Officer, a Urogen. The team has done a fantastic job revolutionizing patient care. With the potential commercialization of EGM-102, there is incredible opportunity for significant value creation. While we will continue to support adoption of gel mito to maximize the value of that product, my number one priority this year is to prepare for the commercial launch of EGM-102. We will apply all that we have learned with gel mito to the launch of EGM-102, different proofs.

Speaker Change: We look forward to providing updates as the programming moves forward. Now over to David Lynn for a commercial update.

David Lynn: Thank You Mark and good morning everyone. I'm incredibly excited to take on the role of Chief Commercial Officer at Urgent.

David Lynn: The team has done a fantastic job revolutionizing patient care.

Speaker Change: With the potential commercialization of UGN-102, there is incredible opportunity for significant value creation.

Mark Schoenberg: We believe the overall body of evidence for UGN 102 will help us to make a compelling case for FDA approval and support widespread use by urologists if approved.

David Lynn: While we will continue to support adoption of gelmido to maximize the value of that product, my number one priority this year is to prepare for the commercial launch of UGN 102.

David Lynn: We will apply all that we have learned with Jelmido to the launch of UGN-102. Different proofs.

David Lynn: EGM-102 commercialization planning is well underway, targeting an early 2025 launch, assuming priority review.

David Lynn: UGM 102 Commercialization Planning is well underway, targeting an early 2025 launch, assuming priority review.

David Lynn: I would like to highlight five key components of our commercialization plan with further details on our plans as the year progresses. Liz and Mark have already discussed the remarkable body of clinical evidence supporting EGM-102. We are already engaging with the medical community through various educational initiatives to broaden awareness of the needs in low grade intermediate risk, nonmuscle invasive bladder cancer, as well as our clinical data, so the value proposition of the product is well understood upon approval. Second, we want to make it easy for accounts to integrate UGM-102 into their treatment protocols upon approval. We can streamline this process by offering comprehensive support, including training for health care professionals and their office staff.

David Lynn: I would like to highlight five key components of our commercialization plan with further details on our plans as the year progresses.

David Lynn: Liz and Mark have already discussed the remarkable body of clinical evidence supporting UGN 102.

Mark Schoenberg: The average age for diagnosis and bladder cancer is in the mid-70s, so many of these patients are not great candidates for surgery. Repeated rounds of anesthesia pose a risk of cognitive decline in the elderly population with the literature also indicating a potential more calorie risk. Additionally, for younger patients, repeated TRBT can cause cumulative lighter damage and negatively impact quality of life. We believe that the ability of UGN 102 to achieve durable, complete responses non-surgically and to potentially reduce recurrence rates while extending these three intervals will provide advance in care of this patient population.

Speaker Change: We are already engaging with the medical community through various educational initiatives to broaden awareness of the needs in low-grade, intermediate risk, non-muscle-invasive bladder cancer.

Speaker Change: as well as our clinical data so the value proposition of the product is well understood upon approval.

Speaker Change: Second, we want to make it easy for accounts to integrate UGN-102 into their treatment protocols upon approval.

Speaker Change: We can streamline this process by offering comprehensive support, including training for health care professionals and their office staff.

David Lynn: Third, we will focus on informing and supporting confidence in access and reimbursement. We are currently planning engagement initiatives that will inform stakeholders about UGM-102's coverage options and reimbursement processes. Fourth, we believe that 102 will ultimately offer a better experience for patients, with a potential for both improved clinical outcomes, as well as a reduced burden from surgery. We want to drive a productive patient-position dialogue with the goal of fostering a collaborative decision-making process.

Speaker Change: Third, we will focus on informing and supporting confidence in access and reimbursement.

Mark Schoenberg: As Liz mentioned, the execution of a single RNC's three clinical trial for UGN 103, the next generation successor to UGN 102, are progressing well. We have onboarded three clinical sites in the U.S, and plan to enroll approximately 87 patients.

Speaker Change: We are currently planning engagement initiatives that will inform stakeholders about UGN 102's coverage options and reimbursement processes.

Speaker Change: Fourth, we believe that 102 will ultimately offer a better experience for patients with the potential for both improved clinical outcomes as well as a reduced burden from surgery.

Mark Schoenberg: We expected those the first patients in the next few weeks in a full enrollment anticipated in the first half of 2025 with an NDA filing in the first half of 2026 and a potential approval in the first half of 2027.

Speaker Change: We want to drive a productive patient-physician dialogue with the goal of fostering a collaborative decision-making process.

David Lynn: Finally, the planned launch of UGM-102 means that Eurogen will transition from a diffuse rare disease focus to selling a specialty product that has much broader potential. We will scale our commercial capabilities, notably patient support and distribution infrastructure, as well as an incremental increase in our sales force, noting that there is already significant prescriber overlap with Joe Mido. As we think about leveraging our experience with Joe Mido, we have learned that there are certain clinical practices that tend to respond better to increased contact with our sales and support personnel. Based on these findings, we are increasing the frequency of interaction with these accounts now with Joe Mido.

Mark Schoenberg: We foresee a similar development plan for UGN 104, our next generation formulation of Kelmaio, and expected to commence a single RNF-based research early next year. Turner.

Speaker Change: Finally, the planned launch of UGN 102 means that Urogen will transition from a diffuse rare disease focus to selling a specialty product that has much broader potential.

Speaker Change: We will scale our commercial capabilities, notably patient support and distribution infrastructure, as well as an incremental increase in our sales force.

Speaker Change: noting that there is already significant prescriber overlap with gel mito.

Speaker Change: As we think about leveraging our experience with gelmido, we have learned that there are certain clinical practices that tend to respond better to increased contact with our sales and support personnel.

Mark Schoenberg: We plan to report safety and tolerability data from the monotherapy arm in late 2024. We've also initiated combination therapy arms evaluating EGM-311 plus gem-sighting, and EGM-311 plus EGM-201 are proprietary formulation of the nickel mod of POR-7 Agnes, unhybrated NMIVC patients.

Speaker Change: Based on these findings, we are increasing the frequency of interaction with these accounts now with Jelmio.

David Lynn: Lastly, I'll note that together with our collaborators in academia, we continue to generate new real-world data for Joe Mido. This is a great opportunity to reinforce the value proposition with the urology community. Joe Mido was recently featured in three presentations at AUA. The data included independent long-term real-world analyses that demonstrated a very high recurrence-free survival of 86% at 24 months for patients who had responded to initial induction. There were also new data supporting the value of maintenance use of Joe Mido and how maintenance appears to be associated with significantly better recurrence-free survival. These studies generated a lot of interest at AUA, and our commercial and medical affairs teams are now incorporating them into their communications with clinicians.

Speaker Change: Lastly, I'll note that together with our collaborators in academia, we continue to generate new real-world data for gelmito.

Speaker Change: This is a great opportunity to reinforce its value proposition with the urology community.

Speaker Change: Joe Maida was recently featured in three presentations at AUA.

Mark Schoenberg: We look forward to providing updates as the programming moves forward.

David Lynn: Now, over to David Lynn for commercial update.

Speaker Change: The data included independent, long-term, real-world analyses that demonstrated a very high recurrence-free survival of 86% at 24 months for patients who had responded to initial induction.

David Lynn: Thank you, Mark, and good morning, everyone. I am incredibly excited to take on the role of Chief Commercial Officer, a Urogen. The team has done a fantastic job revolutionizing patient care. With the potential commercialization of EGM-102, there is incredible opportunity for significant value creation. While we will continue to support adoption of gel mito to maximize the value of that product, my number one priority this year is to prepare for the commercial launch of EGM-102. We will apply all that we have learned with gel mito to the launch of EGM-102, different proofs. EGM-102 commercialization planning is well underway, targeting an early 2025 launch, assuming priority review.

Speaker Change: There were also new data supporting the value of maintenance use of gelmino, and how maintenance appears to be associated with significantly better recurrence-free survival.

Speaker Change: These studies generated a lot of interest at AUA, and our commercial and medical affairs teams are now incorporating them into their communications with clinicians.

Don Kim: I will now turn the call over to Don Kim to discuss our financials. Thank you, David. For the second quarter of 2024, we report to Jerry Mayer by his own net product revenues of $21.8 million. Cost of revenue for the second quarter ended June 30, 2024, was $2.2 million compared with $2.4 million for the second quarter of 2023. The overall decrease year-over-year was primarily attributable to certain non-recording payments made in connection with our supply arrangement in the prior year. Research and development expenses in the second quarter were $15.4 million as compared to $11.6 million for the same period in 2023.

Speaker Change: I will now turn the call over to Dong Kim to discuss our financials.

Dong Kim: Thank you, David. For the second quarter of 2024, we report to the Jeremiah Vital Net Product Revenues of $21.8 million.

Dong Kim: Cost of revenue for the second quarter ended June 30, 2024 was $2.2 million, compared with $2.4 million for the second quarter of 2023.

Speaker Change: The overall decrease year-over-year was primarily attributable to certain non-recurring payments made in connection with our supply arrangement in the prior year.

Speaker Change: Research and development expenses in the second quarter were $15.4 million, as compared to $11.6 million for the same period in 2023.

Don Kim: The overall increase year-over-year was primarily due to higher costs related to manufacturing of Eugene 102, as well as R&D expenses in connection with our initiation of phase 3 study for Eugene 103, partially offset by lower Eugene 102 clinical trial costs. Selling and marketing expenses in the second quarter were $18.9 million compared with $13.9 million for the same period in 2023. The increase year-over-year was primarily attributable to Eugene 102 brand marketing costs, as well as an increase in overall commercial operation costs. General and administrative expenses were $11.2 million in the second quarter compared with $8.6 million for the second quarter ended 2023.

David Lynn: Second, we want to make it easy for accounts to integrate UGM-102 into their treatment protocols upon approval. We can streamline this process by offering comprehensive support, including training for health care professionals and their office staff. Third, we will focus on informing and supporting confidence in access and reimbursement. We are currently planning engagement initiatives that will inform stakeholders about UGM-102's coverage options and reimbursement processes. Fourth, we believe that 102 will ultimately offer a better experience for patients, with a potential for both improved clinical outcomes, as well as a reduced burden from surgery.

Speaker Change: The overall increased year-over-year was primarily due to higher costs related to manufacturing of UGN-102, as well as R&D expenses in connection with our initiation of a Phase III study for UGN-103.

Speaker Change: partially offset by lower UGN-102 clinical trial costs.

Speaker Change: Selling and marketing expenses in the second quarter were $18.9 million compared with $13.9 million for the same period in 2023.

Speaker Change: The increase year-over-year was primarily attributable to UGN 102 brand marketing costs as well as an increase in overall commercial operation costs.

David Lynn: We want to drive a productive patient-position dialogue with the goal of fostering a collaborative decision-making process. Finally, the planned launch of UGM-102 means that Eurogen will transition from a diffuse rare disease focus to selling a specialty product that has much broader potential. We will scale our commercial capabilities, notably patient support and distribution infrastructure, as well as an incremental increase in our sales force, noting that there is already significant prescriber overlap with Joe Mido.

Speaker Change: General and administrative expenses were $11.2 million in the second quarter, compared with $8.6 million for the second quarter ended 2023.

Don Kim: The increase was primarily attributable to legal and compliance activities, pre-commercial marketing communication expenses related to Eugene 102, third-party advisory services, and ongoing management services. Noon Cash, financing expense related to the prepaid for the obligation to RTW Investments was $5.8 million for the second quarter of 2024, compared with $5.3 million in the same period in 2023. The decrease was primarily attributed to the decrease in the margin interest rates and the related impacts to omartidation of the discount on the pharmacone loan as a result of the amended and restated loan agreement in March 2024. Net loss for the second quarter was $33.4 million, or 91 cents net loss per basic and diluted ordinary share, as compared to $24.1 million, or basic and diluted net loss per ordinary share of $1.3 for the same period in 2023.

Speaker Change: The increase was primarily attributable to legal and compliance activities, pre-commercial marketing communication expenses related to UGN-102, third-party advisory services, and ongoing managed services.

Speaker Change: Non-cash financing expense related to the prepaid forward obligation to RTW Investments was $5.8 million for the second quarter of 2024, compared with $5.3 million in the same period in 2023.

David Lynn: As we think about leveraging our experience with Joe Mido, we have learned that there are certain clinical practices that tend to respond better to increase contact with our sales and support personnel. Based on these findings, we are increasing the frequency of interaction with these accounts now with Joe Mido. Lastly, I'll note that together with our collaborators in academia, we continue to generate new real-world data for Joe Mido. This is a great opportunity to reinforce the value proposition with the urology community.

Speaker Change: [inaudible]

Speaker Change: Interest expense in the second quarter was $3.5 million compared with $3.8 million for the same period in 2023. The decrease was primarily attributed to the decrease in the margin interest rate and the related impact to amortization of the discount on the Pharmacon loan as a result of the amended and restated loan agreement in March 2024.

David Lynn: Joe Mido was recently featured in three presentations at AUA. The data included independent long-term real-world analyses that demonstrated a very high recurrence-free survival of 86% at 24 months for patients who had responded to initial induction. There were also new data supporting the value of maintenance use of Joe Mido and how maintenance appears to be associated with significantly better recurrence-free survival. These studies generated a lot of interest at AUA and our commercial and medical affairs teams are now incorporating them into their communications with clinicians.

Speaker Change: Net loss for the second quarter was $33.4 million or $0.91 billion.

Speaker Change: net loss per basic and diluted ordinary share, as compared to $24.1 million or basic and diluted net loss per ordinary share of $1.03 for the same period in 2023.

Don Kim: Cash equivalent and marketer with securities on June 30 were approximately $241.3 million. In June 2024, we completed an underwritten public offering of 5 million ordinary shares at a price of $17.50 per share, and two certain investors, in lieu of issuing ordinary shares, restored pre-funded warrants to purchase approximately $1.1 million ordinary shares at a purchase price of $17.499 per pre-funded warrants. Growth process from the offering before deducting underwriting discounts and commissions and estimated offering expenses were approximately $107.5 million. In July 2024, the underwriters exercised their option to purchase the full overlapment of approximately 921,000 additional shares.

Speaker Change: Cash, cash equivalents, and marketable securities on June 30 were approximately $241.3 million.

Don Kim: I will now turn the call over to Don Kim to discuss our financials. Thank you, David. For the second quarter of 2024, we report to Jerry Mayer by his own net product revenues of $21.8 million. Cost of revenue for the second quarter ended June 30, 2024 was $2.2 million compared with $2.4 million for the second quarter of 2023. The overall decrease year-over-year was primarily attributable to certain non-recording payments made in connection with our supply arrangement in the prior year.

Speaker Change: In June 2024,

Speaker Change: We completed an underwritten public offering of 5 million ordinary shares at a price of $17.50 per share.

Speaker Change: And to certain investors, in lieu of issuing ordinary shares, we sold

Speaker Change: pre-funded warrants to purchase approximately 1.1 million ordinary shares at a purchase price of $17.499 per pre-funded warrant.

Don Kim: Research and development expenses in the second quarter were $15.4 million as compared to $11.6 million for the same period in 2023. The overall increase year-over-year was primarily due to higher costs related to manufacturing of Eugene 102, as well as R&D expenses in connection with our initiation of phase 3 study for Eugene 103, partially offset by lower Eugene 102 clinical trial costs. Selling and marketing expenses in the second quarter were $18.9 million compared with $13.9 million for the same period in 2023.

Speaker Change: Growth proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $107.5 million.

Speaker Change: In July 2024, the underwriters exercised their option to purchase the full overalignment of approximately 921,000 additional shares.

Don Kim: This yielded further growth process to the company of $16.1 million before deducting underwriting discounts and commissions and estimated offering expenses. With respect to our previously provided Gel Mitre 2024 full year revenue guidance, we see a path towards the lower end of that range. With respect to our previously provided full year 2024 of tax guidance, we expect to be towards the higher end of this range. With revised non-cash share-based compensation expense of $9 to $13 million, subject to market conditions. Our anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW Investment is unchanged and expected to be in the range of $21 to $26 million.

Speaker Change: This yielded further growth prospects for the company of $16.1 million.

Speaker Change: before deducting underwriting discounts and commissions and estimated offering expenses.

Speaker Change: With respect to our previously provided GEL-MITO 2024 full-year revenue guidance, we see a path towards the lower end of that range.

Don Kim: The increase year-over-year was primarily attributable to Eugene 102 brand marketing costs as well as an increase in overall commercial operation costs. General and administrative expenses were $11.2 million in the second quarter compared with $8.6 million for the second quarter ended 2023. The increase was primarily attributable to legal and compliance activities, pre-commercial marketing communication expenses related to Eugene 102, third-party advisory services and ongoing management services. Noon Cash, financing expense related to the prepaid for the obligation to RTW investments was $5.8 million for the second quarter of 2024, compared with $5.3 million in the same period in 2023.

Speaker Change: With respect to our previously provided full year 2024 OPEX guidance, we expect to be towards the higher end of this range.

Speaker Change: with revised non-cash share-based compensation expense of 9 to 30 million dollars subject to market conditions.

Speaker Change: I would anticipate the full year 2024 non-cash financing expense related to the prepaid obligation to RTW investment is unchanged and expected to be in the range of 21 to 26 million dollars.

Don Kim: The rate for the cash component of RTW obligation will be 13% of global net product sales of Gel Mitre 2024.

Speaker Change: The rate for the cash component of RTW abrogation will be 13% of global net product sales of gel miso in 2024.

Don Kim: For further details on our financials, including results for the six months ended June 30, 2024, please report to our quarterly report on Form 10-Q, which has been filed with the FCC.

Speaker Change: For further details on our financials, including results for the six months ended June 30, 2024, please refer to our quarterly report on Form 10-Q, which has been filed with SEC.

Operator: We are now ready to open the core for questions.

Operator: Operator? Thank you.

Speaker Change: We are now ready to open the call for questions. Operator?

Operator: At this time, we'll conduct the question-and-answer session. If you're reminded to ask a question, you'll need to press star 1-100, telephone, and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster.

Don Kim: The decrease was primarily attributed to the decrease in the margin interest rates and the related impacts to omartidation of the discount on the pharmacone loan as a result of the amended and restated loan agreement in March 2024. Net loss for the second quarter was $33.4 million or 91 cents net loss per basic and diluted ordinary share as compared to $24.1 million or basic and diluted net loss per ordinary share of $1.3 for the same period in 2023.

Speaker Change: Thank you. At this time we will conduct a question and answer session. As a reminder to ask a question you need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 1 again. Please stand by while we compile the Q&A roster.

Tara Bancroft: Our first question comes from the line of Tara Bancroft of TD Cowan. Your line is now open.

Speaker Change: Our first question comes from the line of Tara Brancroft of TD Cowen. Your line is now open.

Tara Bancroft: Good morning. Thanks for taking a question. So I was wondering if you could give us some more detailed expectations for what Joe Mito revenue can look like by quarter for the rest of the year to result in your guidance, like such as whether it would mostly back end weighted or anything else. Thanks.

Tara Brancroft: Hi, good morning. Thanks for taking the questions. So I was wondering if you could give us some more detailed expectations for what gelmido revenue can look like by quarter for the rest of the year to result in your guidance, such as whether it would mostly be back-end weighted or anything else. Thanks.

Don Kim: Cash equivalent and marketer with securities on June 30 were approximately $241.3 million. In June 2024, we completed an underwritten public offering of 5 million ordinary shares at a price of $17.50 per share and two certain investors in lieu of issuing ordinary shares restored pre-funded warrants to purchase approximately $1.1 million ordinary shares at a purchase price of $17.499 per pre-funded warrants. Growth process from the offering before deducting underwriting discounts and commissions and estimated offering expenses were approximately $107.5 million.

Liz Barrett: Yeah. Hi, Tara. It's Liz. Appreciate the question, but we're not going to provide. We've never provided quarterly guidance, and we want to. So I think the important thing in what we said is that we're not going to give additional guidance for the year, given the variability that we've seen so far to date. Again, you know, this is the first time we've seen the conversion rate decline. We've seen increases in RG, you know, gross to net. And so, because of that, we feel like it's probably more prudent just to kind of leave things where they are.

Tara Brancroft: Yeah, hi Tara, it's Liz. Appreciate the question, but we're not going to provide, we've never provided quarterly guidance and we won't do so. I think the important thing of what we said is that

Tara Brancroft: We're not going to give additional guidance for the year, given the variability that we've seen so far to date.

Tara Brancroft: You know, this is the first time we've seen a

Tara Brancroft: We've seen the conversion rate decline. We've seen increases in ROG gross to net. And so because of that, we feel like it's probably more prudent just to kind of leave things where they are. And what we've said is that we do see a path to the low end of the guidance.

Liz Barrett: And what we've said is that we do see a path to the low end of the guidance, you know, if things go well for the next, you know, the next few months.

Liz Barrett: You know, interestingly, what we continue to learn is this being a very rare disease. If you look at the top 20 accounts from last year, they're not the top 20 accounts from this year. So I really do also want to just comment.

Tara Brancroft: if things go well for the next few months. Interestingly, what we continue to learn is this being a very rare disease.

Don Kim: In July 2024, the underwriters exercised their option to purchase the full overlapment of approximately 921,000 additional shares. This yielded further growth process to the company of $16.1 million before deducting underwriting discounts and commissions and estimated offering expenses. With respect to our previously provided gel mitre 2024 full year revenue guidance, we see a path towards the lower end of that range. With respect to our previously provided full year 2024 of tax guidance, we expect to be towards the higher end of this range.

Tara Brancroft: If you look at the top 20 accounts from last year, they're not the top 20 accounts from this year. So, I really do also want to just comment, I'm going to turn it over to David now, really love what David's doing, digging into what we need to do to ensure the high touch

David Lynn: I'm going to turn it over to David now. Really love what David's doing, digging into what we need to do to ensure the high touch support that we need to provide because these patients, you don't know where they are, right? One, you know, again, you know, one month or in one place or in a different place. So our ability to increase our region frequency and the high touch nature of it. So David, can you just sort of give some additional color on some of the things that you're doing and working on to ensure that the rest of the year, you know, we actually see that conversion go back up to our normal, normal rate?

Tara Brancroft: that we need to provide because these patients, you don't know where they are, right? Again, one month they're in one place, they're in a different place. So our ability to increase our reach and frequency and the high touch nature of it. So David, can you just sort of.

David: Give some additional color on some of the things that you're doing and working on to ensure that they the rest of the year You know, we actually see that conversion go back up to our normal normal rate

David Lynn: Yeah, thanks for the questions.

David Lynn: I'm really enthusiastic about what we're seeing with John Mito, particularly because the significant on my need is significant. And one of the things that the organization has learned over time is that the support that the origin provides to the physicians and their practices is really an important component to seeing that conversion through. From the time of patient enrollment, all the way through receiving the six doses of treatment. So we are doubling down in terms of higher touch with many of the accounts that are seeing more patient volume to make sure that we are supporting them appropriately, not only in the logistical components of administering John Mito, but also making sure that their confidence around access and reimbursement is at a very high level.

Don Kim: With revised non-cash share-based compensation expense of $9 to $13 million subject to market conditions. Our anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW investment is unchanged and expected to be in the range of $21 to $26 million. The rate for the cash component of RTW obligation will be 13% of global net product sales of gel mitre 2024.

David: Yeah, thanks for the questions. I'm really enthusiastic about what we're seeing with gelmido, particularly because the significant unmet need is significant. And one of the things that the organization has learned over time is that

Speaker Change: The support that URGEN provides to the physicians and their practices

Speaker Change: is really an important component to seeing that conversion through from the time of patient enrollment all the way through receiving the six doses of treatment. So we are doubling down in terms of higher touch with many of the accounts that are seeing more patient volume.

Don Kim: For further details on our financials, including results for the six months ended June 30, 2024, please report to our quarterly report on form 10Q, which has been filed with FCC.

Speaker Change: to make sure that we are supporting them appropriately, not only in the...

Speaker Change: The logistical components of administering dry model, but also making sure that their confidence around access and reimbursement

David Lynn: So the continued on that need is there, and we are very much looking forward to supporting our customer base and getting your patients to treat them.

Speaker Change: is at a very high level.

Operator: We are now ready to open the core for questions. Operator? Thank you.

Speaker Change: The continued unmet need is there and we are very

Speaker Change: much looking forward to supporting our customer base in getting their patients to treatment.

David Lynn: Okay, great.

Operator: At this time, we'll conduct the question answer session. If you're reminded to ask a question, you'll need to press star 1-100 telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster.

Tara Bancroft: Thanks so much for all that detail.

Speaker Change: Thank you.

Speaker Change: Okay, great. Yeah, thanks so much for all that detail.

Operator: We'll move in for our next question.

Raghuram Selvaraju: Our next question comes from Lina Raghuram Selvaraju of H.C. Winwright and Colt. Your line is now open. Thanks very much for taking my questions.

Speaker Change: Our next question comes from Raghuram Sararaju of H.C. Wainwright & Co. Your line is now open.

Raghuram Selvaraju: Can you hear me? Yes, Ramakhan. Thank you. So I just wanted to see if you could perhaps give us some more granularity as you look towards the potential commercial introduction of UGN 102. And, you know, again, speaking to what you were just saying before, is about the high touch approach that you want to take to continued commercialization of gel Mito. Maybe give us some both qualitative and quantitative metrics regarding how you intend to implement the sales and marketing infrastructure to support UGN 102. Ultimately, what you think the field sales force is going to look like both in terms of size as well as account targeting as and when UGN 102 gets to the market and how much of the existing infrastructure you expect to be able to place in the service of support of UGN 102 once that new product comes online.

Liz Barrett: Our first question comes from the line of Tara Bancroft of TD Cowan. Your line is now open. Good morning. Thanks for taking a question. So I was wondering if you could give us some more detailed expectations for what Joe Mito revenue can look like by quarter for the rest of the year to result in your guidance, like such as whether it would mostly back end weighted or anything else. Thanks. Yeah. Hi, Tara.

Raghuram Sararaju: Thanks very much for taking my questions. Can you hear me?

Speaker Change: Yes, Ram, I can. Thank you.

Raghuram Sararaju: So, I just wanted to see if you could perhaps give us some more granularity as you look towards the potential commercial introduction of UGN-102.

Raghuram Sararaju: And, you know, again, speaking to what you were just saying before, Liz, about the high-touch approach that you want to take.

Liz Barrett: It's Liz. Appreciate the question, but we're not going to provide. We've never provided quarterly guidance and we want to. So I think the important thing in what we said is that we're not going to give additional guidance for the year given the variability that we've seen so far to date. Again, you know, this is the first time we've seen the conversion rate decline. We've seen increases in RG, you know, gross to net.

Speaker Change: to continued commercialization of gelmido.

Speaker Change: Maybe give us some both qualitative and quantitative metrics regarding

Speaker Change: how you intend to implement the sales and marketing infrastructure to support UGN 102.

Speaker Change: ultimately what you think.

Speaker Change: The field sales force is going to look like both in terms of size as well as account targeting.

Speaker Change: as and when UGN-102 gets to the market and how much of the existing infrastructure you expect to be able to place in the service of support of UGN-102 once that new product comes online. Thanks.

Liz Barrett: And so because of that, we feel like it's probably more prudent just to kind of leave things where they are. And what we've said is that we do see a path to the low end of the guidance, you know, if things go well for the next, you know, the next few months. You know, interestingly, what we continue to learn is this being a very rare disease. If you look at the top 20 accounts from last year, they're not the top 20 accounts from this year. So I really do also want to just comment.

David Lynn: Thanks.

David Lynn: Sure. Thanks.

David Lynn: So David, why don't you start, and I'll add in any additional commentary. Thank you. Yeah, thanks very much for the question. As we've talked about, we think UGN 102 is a really transformative opportunity for patient care and low-grade intermediate-risk, non-muscle-invasive bladder cancer. So the things will take into account at the at this point in terms of commercialization. We know we've got to educate the physician base around the unmanied and also make sure that the remarkable data around UGN 102 is well understood. The second thing we'll do is ensure that we have comprehensive support around integrating UGN 102 into their workflows.

Speaker Change: Sure, thanks. So David, why don't you start and I'll add in any additional commentary. Thank you.

David: Yeah, thanks very much for the question. As we've talked about, we think UGN 102 is a

David: Really transformative opportunity for patient care and low-grade intermediate risk non-muscle invasive bladder cancer so the things we'll take into account at the

Speaker Change: At this point, in terms of commercialization, we know we've got to educate the physician base around the unmet need and also make sure that the remarkable data around UGN 102 is well understood.

Speaker Change: The second thing we'll do is ensure that we have comprehensive support around integrating UGM 102 into their workflows.

David Lynn: And then, importantly, we will also focus on driving confidence and access and reimbursement. How that translates into scaling up our organization that I think, as we've previously stated, we anticipate a modest increase in our sales force. We are contemplating somewhere between 10 and 15 sales reps, or we call them territory business managers. And then the important thing is the matrix team that surrounds that group, which handles nursing support as well as field reimbursement. We'll also be looking at how to scale that capability up to provide the appropriate level of support for a new medicine such as UGN 102.

Speaker Change: And then importantly, we will also focus on driving confidence and access and reimbursement.

Speaker Change: how that translates into...

Speaker Change: Scaling up our organization that I think as we've previously stated

Speaker Change: We anticipate a modest increase in our sales force.

David Lynn: Yeah, thanks for the questions. I'm really enthusiastic about what we're seeing with John Mito, particularly because the significant on my need is significant. And one of the things that the organization has learned over time is that the support that the origin provides to the physicians and their practices is really an important component to seeing that conversion through. From the time of patient enrollment, all the way through receiving the six doses of treatment.

Speaker Change: We are contemplating somewhere between 10 and 15 sales reps or we call them territory business managers and then the important thing is the matrix team that surrounds that group which handles nursing support as well as

Speaker Change: field reimbursement. We'll also be looking at how to scale that capability up to provide the appropriate level of support for a new medicine such as UGM-102. Most of the, actually all of the gelmido learnings

Liz Barrett: Most of the, actually all of the gel mido learnings have taught us that we can leverage pretty much everything that we're doing for gel mido and then supplementing it in specific instances. Because, as we've said, the patient population is slightly larger or considerably larger, and we will scale appropriately.

David Lynn: So we are doubling down in terms of higher touch with many of the accounts that are seeing more patient volume to make sure that we are supporting them appropriately, not only in the logistical components of administering John Mito, but also making sure that their confidence around access and reimbursement is at a very high level. So the continued on that need is there and we are very much looking forward to supporting our customer base and getting your patients to treat them.

Speaker Change: have taught us that we can leverage pretty much everything that we're doing for gelmito, and then supplementing it in specific instances. Because as we've said, the patient population is slightly larger, or considerably larger, and we will scale appropriately. So those final tweaks are being planned right now.

Liz Barrett: So those final tweaks are being planned right now. Yeah, and so I think the thing that David, you know, talked about here and what we, the difference and we've talked about this a lot, is a significant difference right when you think about the integration into the physician practice. So the most important thing for physicians, and look, this is, you know, experienced with oncologists, well, you have to make it seamless for their practice or they will not adopt the product regardless of how great the data is. And so that's been the number one thing that David's been focused on is how do we ensure the seamless integration and the differences we've talked about many times between UGN 102 and Gel Mido.

Unknown Attendee: Okay, great. Thanks so much for all that detail. Thank you.

Speaker Change: I think we're going to do this.

Speaker Change: Yeah and so I think the thing that David you know talked about here and what we the difference and we've talked about this a lot there's a significant difference right when you think about the integration the into the physician practice.

Operator: We'll move in for our next question.

David: So, the most important thing for physicians, and look, this is, you know, experiences with oncology as well, you have to make it seamless for their practice or they will not adopt the product regardless of how great the data is.

Raghuram Selvaraju: Our next question comes from Lina Raghuram Selvaraju of H.C. Winwright and Colt. Your line is now open. Thanks very much for taking my questions. Can you hear me? Yes, Ramakhan. Thank you.

David: And so that's been the number one thing that David's been focused on, is how do we ensure

David: the seamless integration. And the difference, as we've talked about many times between UGM-102 and GELMITO

Liz Barrett: So is gel mido hard? It's hard because you've got to have a foroscopy. So you have to; it has to be done by a physician. So you most of the time have to go to a surgery center or to the hospital. Very different UGM 102 can be done by an extender. It's very nice. They already have these quote-unquote IVT days and their practice. So it fits very nicely into that, but we will not sort of assume that to be the case, and to David's point, make sure that we do have the types of roles that we need to support that.

Liz Barrett: So I just wanted to see if you could perhaps give us some more granularity as you look towards the potential commercial introduction of UGN 102. And, you know, again, speaking to what you were just saying before is about the high touch approach that you want to take to continued commercialization of gel Mito. Maybe give us some both qualitative and quantitative metrics regarding how you intend to implement the sales and marketing infrastructure to support UGN 102.

David: It's hard because you've got to have a fluoroscopy, so it has to be done by a physician.

David: So you most of the time have to go to a surgery center or to the hospital.

David: very different. UGM 102 can be done by an extender. It fits very nicely. They already have these quote-unquote IVT days in their practice.

David: So it fits very nicely into that, but we will not sort of assume that to be the case, and to David's point, make sure that we do have

Liz Barrett: Ultimately, what you think the field sales force is going to look like both in terms of size as well as account targeting as and when UGN 102 gets to the market and how much of the existing infrastructure you expect to be able to place in the service of support of UGN 102 once that new product comes online. Thanks. Sure. Thanks. So David, why don't you start and I'll add in any additional commentary.

Liz Barrett: And, you know, we're, you know, David's already brought up, you know, things that, you know, in the current plan where he feels like we need to augment, and we're going to do that. We will make sure that the increase acceleration of adoption for UGN 102, and then we don't just do a plug and play with which amido, but we're really looking at it as a fresh new launch, although we are fortunate enough to have a nice overlap. So, you know, so you, you know, from the position standpoint, so relationships that we built and, and you know, those positions are excited about, that have used Jummite or excited about UGM 102, positions that have not used Jummite or excited about UGM 102.

David: David's already brought up things in the current plan where he feels like we need to augment and we're going to do that. We will ensure that the—

David: increase acceleration of adoption for UGN 102 and that we don't just do a plug-and-play.

David: with John Maito, but we're really looking at it as a fresh new launch, although we are

Liz Barrett: Thank you. Yeah, thanks very much for the question. As we've talked about, we think UGN 102 is a really transformative opportunity for patient care and low grade intermediate risk, non-muscle and basic bladder cancer. So the things will take into account at the at this point in terms of commercialization. We know we've got to educate the physician base around the unmanied and also make sure that the remarkable data around UGN 102 is well understood.

David: fortunate enough to have a nice overlap. So, you know, so you, you know, from the physician's standpoint, so relationships that we've built and

David: and those physicians that have used gelmite are excited about UGM-102, physicians that have not used gelmite are excited about UGM-102.

Liz Barrett: And so, again, you know, all of that is in the works that, you know, is what we're working on right now.

Liz Barrett: Ramram will continue to provide additional, additional color around that as we, you know, as we work it out in the next few minutes.

David: And so, again, all of that is in the works, as we're working on right now. And we'll continue to provide additional color around that as we work it out in the next few months.

Liz Barrett: The second thing we'll do is ensure that we have comprehensive support around integrating UGN 102 into their workflows. And then importantly, we will also focus on driving confidence and access and reimbursement. How that translates into scaling up our organization that I think as we've previously stated, we anticipate a modest increase in our sales force. We are contemplating somewhere between 10 and 15 sales reps or we call them territory business managers. And then the important thing is the matrix team that surrounds that group which handles nursing support as well as field reimbursement.

Liz Barrett: And do you think that the presence of UGN 102, just in and of itself, might actually provide a tailwind to Joe Mito sales as well? Yeah, that's been, you know, and I've said that before.

Speaker Change: And do you think that the presence of UGN-102, just in and of itself, might actually provide a tailwind to gelmido sales as well?

Liz Barrett: I actually do think it's a, you know, what I call a reverse halo because after physicians see the, you know, their experience with UGN 102, you know, they may be more willing to work a little bit harder for Joe Mito. I also believe that patients will become more engaged as well. It's very difficult to engage, you know, do anything, you know, dramatic with patients when there's only 6,000 of them annually. Very different when there's 80,000 of them and we can do more around, you know, educating and engaging the patient and ensuring that sort of patient position dialogue is productive and that they're shared sort of decision making between the two of them, but absolutely agree, Ron, that there's an opportunity for a reverse halo there.

Speaker Change: Yeah, that's been, you know, and I've said that before. I actually do think it's a what, you know, what I call a reverse halo.

Speaker Change: because after physicians see their experience with UGM-102, they may be more willing to work a little bit harder for gelmito. I also believe that patients will become more engaged as well. It's very difficult.

Liz Barrett: We'll also be looking at how to scale that capability up to provide the appropriate level of support for a new medicine such as UGN 102. Most of the, actually all of the gel mido learnings have taught us that we can leverage pretty much everything that we're doing for gel mido and then supplementing it in specific instances. Because as we've said, the patient population is slightly larger or considerably larger and we will scale appropriately.

Speaker Change: to engage, you know, do anything, you know, dramatic with patience.

Speaker Change: when there's only 6,000 of them annually, very different when there's 80,000 of them and we can do more around educating and engaging the patient and ensuring that sort of patient-physician dialogue.

Speaker Change: is productive and that there's shared sort of decision-making between the two of them. But absolutely agree, Ron, that there's an opportunity for a reverse halo there.

Liz Barrett: And very quickly on the pipeline, can you comment on any specific efforts you expect to be making to further accelerate the development of 103 and 104, which are central to your life cycle management strategy, as well as clarify that when you said earlier that you think the company may at this point be sustainably financed through to achievement of profitability, that this also includes the expected investments you plan to make, not just in 103 and 104, but in potentially 301, as well. Yeah, absolutely, great, great question. We do believe that we are financed through profitability, you know, and beyond, given including what you just talked about, including the, you know, where we need to be with 103 and 104. You know, one of the reasons that, you know, we took our expenses where we didn't take them up, obviously, they're still within range, but we guided to the higher end is because we've accelerated both 103 and 104, and so we want to make sure that we get those done as quickly as possible, and so we are financed that way.

Liz Barrett: So those final tweaks are being planned right now. Yeah, and so I think the thing that David, you know, talked about here and what we, the difference and we've talked about this a lot is a significant difference right when you think about the integration into the physician practice. So the most important thing for physicians and look, this is, you know, experienced with oncologist, well, you have to make it seamless for their practice or they will not adopt adopt the product regardless of how great the data is.

Speaker Change: And very quickly, on the pipeline, can you comment on any specific efforts?

Speaker Change: You expect to be making to further accelerate the development of 103 and 104, which are central to your lifecycle management strategy, as well as clarify that when you said earlier that you think the company may at this point be

Speaker Change: sustainably finance through to achievement of profitability, that this also includes the expected investments you plan to make not just in 103 and 104 but in potentially 301 as well?

Liz Barrett: And so that's been the number one thing that David's been focused on is how do we ensure the seamless integration and the differences we've talked about many times between UGN 102 and gel mido. So is gel mido hard? It's hard because you've got to have a foroscopy. So you have to, it has to be done by a physician. So you most of the time have to go to a surgery center or to the hospital.

Speaker Change: Yeah, absolutely. Great, great question. We do believe that we are financed through profitability, you know, and beyond given, including what you just talked about, including the, the,

Speaker Change: you know, where we need to be with 103 and 104. You know, one of the reasons that, you know, we took our expenses where we didn't take them up, obviously they're still within range, but we guided to the higher end is because we've accelerated both 103 and 104. And so we want to make sure that we get those done as quickly as possible.

Liz Barrett: Very different UGM 102 can be done by an extender. It's very nicely. They already have these quote-unquote IVT days and their practice. So it fits very nicely into that, but we will not sort of assume that to be the case and to David's point, make sure that we do have the types of roles that we need to support that. And, you know, we're, you know, David's already brought up, you know, things that, you know, in the current plan where he feels like we need to augment and we're going to do that.

Liz Barrett: And so to your point, life cycle management, you know, we're excited about that. We already started; we've already, you know, have sites that have started with 103. We anticipate first patient dose very shortly, and we'll obviously announce that as that comes out, and then again, as quickly as we can behind that start with UGM 104. The nice thing about those life cycle management clinical studies is they don't have to be as big, right? So they're small or now that there's experience in this patient population with our own medicine, with Joe Mito and Eugene 102, we were able to, you know, discuss with the FDA what we typically, what they would expect to see.

Speaker Change: and so we are financed that way. And so to your point, life cycle management.

Speaker Change: You know, we're excited about that. We already started. We've already, you know, have sites that have started with 103. We anticipate first patient dose very shortly. And we'll obviously announce that as that comes out. And then, and then again, as quick quickly as we can behind that start with UGM 104. The nice thing about those life cycle management clinical studies is they they they don't have to be as big, right? So they're smaller now that there's experience in this patient population with their own medicines with Jelmido and UGM 102.

Liz Barrett: We will make sure that the increase acceleration of adoption for UGN 102 and then we don't just do a plug and play with which amido, but we're really looking at it as a fresh new launch, although we are fortunate enough to have a nice overlap. So, you know, so you, you know, from the position standpoint, so relationships that we built and, and, you know, those positions are excited about, that have used Jummite or excited about UGM 102, positions that have not used Jummite or excited about UGM 102.

Speaker Change: were able to discuss with the FDA what they would typically expect to see. So as long as they deliver in that range, we should be able to go to them with fewer patients. So those should be accelerated. And that allows us to still have money to...

Liz Barrett: So long as those, they deliver in that range, we should be able to go to them with fewer, fewer patients, so those should be accelerated. And that allows us to still have met, you know, money to, you know, for their other areas.

Liz Barrett: And so, again, you know, all of that is in the works that, you know, is what we're working on right now. Ramram will continue to provide additional, additional color around that as we, you know, as we work it out in the next few minutes. And do you think that the presence of UGN 102, just in and of itself, might actually provide a tailwind to gel mitre sales as well? Yeah, that's been, you know, and I've said that before.

Liz Barrett: We've talked to other companies that are interested in putting their medicines in our jail, and we're going to be talking about a few of those over the next few months that we'll be announcing those. And we, our current financing allows us to continue to do some of those as well, collaborations. Now we can't go out into a massive, you know, acquisition, but we will be able to fund and finance collaborations as we go forward, taking our technology and adding potentially to our technology as well as going into, you know, using new medicines in this space.

Speaker Change: For their other areas, we've talked to other companies that are interested in putting their medicines in our gel, and we're going to be talking about a few of those over the next few months, and we'll be announcing those.

Speaker Change: and our current financing allows us to continue to do some of those as well, collaborations. Now, we can't go out and do a massive...

Speaker Change: acquisition, but we will be able to fund and finance collaborations as we go forward, taking our technology and adding potentially to our technology, as well as going into using new medicines in this space. So I hope that helps. If there's something I missed, please let me know.

Liz Barrett: I actually do think it's a what, you know, what I call a reverse halo because after physicians see the, you know, their experience with UGN 102, you know, they may be more willing to work a little bit harder[inaudible] No, thank you. That's very helpful. Thank you so much. Thank you.

Liz Barrett: So I hope that helps if there's something on this. Please let me know.

Raghuram Selvaraju: No, thank you. That's very helpful. Thank you so much. Thank you.

Speaker Change: Thank you. That's very helpful. Thank you so much. Thanks, Ron.

Leland Gershell: One moment for our next question. Our next question comes from a line of Leland Gershell of Oppenheimer.

Speaker Change: Thank you. One moment for our next question.

Leland Gershell: Your line is not open.

Speaker Change: [inaudible]

Speaker Change: Our next question comes from the line of Dylan Gorshaw of Oppenheimer. Your line is now open.

Leland Gershell: Good morning. Thanks for taking my questions.

Leland Gershell: One task with respect to, you know, to be a larger potential for the gel technology. Maybe in perhaps more advanced disease, wondering if you guys have contemplated the look at UGN 102 in high grade NMIBC, either on its own or perhaps paired with another agent, given that there has been data showing that, you know, there could be a role for my demise and in high grade NMIBC and perhaps the gel and hired well time, that could sort of, you know, turbo charge. You know, that's potential benefit.

Dylan Gorshaw: Good morning. Thanks for taking my questions. I wanted to ask with respect to, you know, could be a larger potential for the gel technology in perhaps more advanced disease. I'm wondering, Liz, if you guys have contemplated the look at

Eugene: Eugene 102 in high grade

Speaker Change: NMIBC either on its own or perhaps paired with another agent given that there has been data showing that you know there could be a role for mitomycin in high-grade NMIBC and perhaps a gel in higher dwell time that could sort of you know turbocharge

Liz Barrett: Absolutely. We definitely are; that's part of our life cycle planning. You know, we do believe, as you know, that combination therapies, as we get into high grade disease, will probably be more, more, more relevant. And so we all do it.

Speaker Change: You know, that potential benefit.

Speaker Change: Absolutely. We definitely are. That's part of our lifecycle planning. You know, we do believe, as you know, that combination therapies, as we get into high-grade disease,

Mark Schoenberg: Mark and his team are doing that work as we speak to, to come up with where, where will we go next, right? We, you know, we have a list of potential opportunities. But definitely be looking at UGN 102 in high-grade disease.

Mark Schoenberg: will probably be more relevant. And so we'll do it, Mark and his team are doing that work as we speak to come up with where will we go next, right? We have a list of potential opportunities, but definitely be looking at UGM-102 and high-grade disease.

Kelsey Goodwin: Thank you. One moment for next question. Our next question comes from a line of Kelsey Goodwin of Guglehem Security.

Mark Schoenberg: Thank you.

Speaker Change: Thank you, one moment, for our next question.

Kelsey Goodwin: Your line is now open. Oh, hey, thanks for taking our questions, and congrats on the progress this quarter. Two for us.

Speaker Change: Our next question comes from the line of Kelsey Goodwin of Guggenheim Security. Your line is now open.

Kelsey Goodwin: First, when we think about the gelmido headwinds that you face, maybe could you just remind us to what extent they're relevant or have read through to UGN 102.

Kelsey Goodwin: Oh hey, thanks for taking our questions and congrats on the progress this quarter. Two from us. First, when we think about the Joe Mido headwinds,

Speaker Change: that you face, maybe could you just remind us to what extent they're relevant or have reached through to UGN 102? And then separately, now that you have Envisioned Durability Data in hand, can you provide more color on what you've been hearing in recent weeks?

Kelsey Goodwin: And then separately, now that you have envisioned durability data in hand, can you provide more color on what you've been hearing in recent weeks from KOLs in the intermediate risk space? Thank you so much.

Liz Barrett: Sure. Thanks, Kelsey.

David Lynn: I'll turn the first question over to David and also ask from Mark to comment, you know, to David on both of those. And then, Mark, please add in any color as well. Yeah, thanks for the question. So, with regard to the question on Gelmido, as we discussed, a lot of the headwinds from our growth in that perspective were on 340B chargebacks and also Medicare refunds for discarded drug. We expect those to be significantly less exposure when we come to UGN 102, because UGN 102, when you think about where it would be administered, it will be more heavily focused in community practices.

Speaker Change: from KOL's In the Intermediate Risk Space. Thank you so much. Sure, thanks Kelsey. I'll turn the first question over to David and also ask for Mark to comment. Well, you know, so David on both of those and then Mark, please add in any color as well.

David: Yeah, thanks for the question. So with regard to the question on gelmido, as we discussed, a lot of the headwinds from a gross to net perspective were on 340B chargebacks and also Medicare refunds for discarded drug.

David: We expect those to be significantly less exposure when it comes to UGN-102 because UGN-102, when you think about where

David Lynn: And then, with regard to discarded drug provisions, we anticipate that to be considerably less and under the threshold. So, as we look forward, I think many of those headwinds will be less of an issue. Thank you.

David: It would be administered. It will be more heavily focused in community practices. And then with regard to discarded drug provisions, we anticipate that to be considerably less and under the threshold. So as we look forward, I think many of those headwinds will be less of an issue.

Matthew Kaplan: We'll move it for the next question. Our next question comes from the line of Matt Kaplan, of Leadingburg, Dolmond. Your line is now open.

Speaker Change: Thank you. One moment for our next question.

Operator: One moment for our next question.

Speaker Change: Our next question comes from the line of Matt Kaplan of Leidenberg-Dolman. Your line is now open.

Matthew Kaplan: Hey, good morning, guys.

Matthew Kaplan: Just first question, how should we think about the potential for our prior to review being granted for UGN 102 as you near the submission here? Yeah, look, it's a great question, Matt. You know, my regulatory guy, you know, has very, very high confidence. I'm just probably don't much better than I give a percentage, but it's, it's very, very likely. The reason is because of the things we've been talking about, right? The data is very compelling. There are no other drugs approved. Of course, there is, you know, surgical, but there's, if you look at the what the FDA publishes around priority review, you know, we fit into their guidelines, and so we believe that we should, you know, we should get priority review.

Matt Kaplan: Hey, good morning guys. Just our first question, how should we think about the potential for a priority review being granted for UGN 102-SU near the submission?

Leland Gershell: Our next question comes from a line of Leland Gershell of Openheimer.

Liz Barrett: Your line is not open. Good morning. Thanks for taking my questions. One task with respect to, you know, to be a larger potential for the gel technology. Maybe in perhaps more advanced disease, wondering if you guys have contemplated the look at UGN 102 in high grade NMIBC, either on its own or perhaps paired with another agent, given that there has been data showing that, you know, there could be a role for my demise and in high grade NMIBC and perhaps the gel and hired well time, that could sort of, you know, turbo charge. You know, that's potential benefit.

Matt Kaplan: here.

Speaker Change: Yeah, look, it's a great question Matt, you know, we my regulatory guy You know has very very high confidence. I'm just laughing because

Speaker Change: I tease him all the time because, you know, he thinks I probably don't wish better than I give a percentage, but it's very, very likely.

Speaker Change: The reason is because of the things we've been talking about, right? The data is very compelling, there are no other drugs approved, of course there is, you know, surgical.

Speaker Change: But if you look at what the FDA publishes around priority review, we fit into their guidelines, and so we believe that we should get priority review. Having just said that, we all know that there's no guarantees.

Liz Barrett: Absolutely. We definitely are, that's part of our life cycle planning. You know, we do believe as, as you know, that combination therapies, as we get into high grade disease, will probably be more, more, more relevant. And so we all do it. Mark and his team are doing that work as we speak to, to come up with where, where will we go next, right? We, you know, we have a list of potential opportunities. But definitely be looking at UGN 102 in high grade disease.

Liz Barrett: Having just said that, we all know that there's no guarantees, and so, you know, we will be sharing obviously as soon as we file, and then we get our acceptance, and when we get the acceptance, which is 60 days later, you know, that's when they'll tell us whether we have priority review. But we feel very confident that we'll get priority review, but obviously, you know, can't, you know, can't guarantee that to be the case, but we feel like we do definitely, you know, that we definitely fit nicely into that. Great, great. That's helpful, thank you.

Unknown Attendee: Thank you.

Operator: Thank you, one moment for next question.

Speaker Change: And so, you know, we will be sharing, obviously, as soon as we file, and then we get our acceptance. And when we get the acceptance, which is 60 days later,

Speaker Change: That's when they'll tell us whether we have priority review, but we feel very confident that we'll get priority review, but obviously can't guarantee that to be the case, but we feel like we definitely fit nicely into that.

Liz Barrett: And then, just shifting to your commercial product, you know, might as well talk a little bit about the performance during the second quarter and how, and the potential for improved growth going forward specifically. Can you address some of the headwinds that you're running into, the chargebacks, the unused drug, and just in terms of the transition of patients that are in the queue there, and to treat the patients as well going forward? Yeah, Matt, look, it's a great question.

Speaker Change: Great, great. That's helpful. Thanks, Liz.

Kelsey Goodwin: Our next question comes from a line of Kelsey Goodwin of Guglehem Security. Your line is now open. Oh, hey, thanks for taking our questions and congrats on the progress this quarter. Two for us. First, when we think about the gelmido headwinds that you face, maybe could you just remind us to what extent they're relevant or have read through to UGN 102. And then separately, now that you have envisioned durability data in hand, can you provide more color on what you've been hearing in recent weeks from KOLs in the intermediate risk space? Thank you so much. Sure. Thanks, Kelsey.

Speaker Change: and then just shifting to your commercial.

Speaker Change: Products you might know.

Speaker Change: Talk a little bit about the performance during the second quarter and the potential for improved growth going forward. Can you address some of the headwinds?

David Lynn: I'll turn the first question over to David and also ask from Mark to comment, you know, to David on both of those. And then, Mark, please add in any color as well. Yeah, thanks for the question. So with regard to the question on gelmido, as we discussed, a lot of the headwinds from our growth in that perspective were on 340B chargebacks and also Medicare refunds for discarded drug. We expect those to be significantly less exposure when we come to UGN 102, because UGN 102, when you think about where it would be administered, it will be more heavily focused in community practices.

Speaker Change: that you're running into, the chargebacks, the unused drug.

Speaker Change: and just in terms of the transition of patients that are that are in the queue there and to treated patients as well going forward.

Liz Barrett: I'll make a few comments, and then turn it over to David to add anything. Yes, I absolutely believe it. You know, I've been out myself obviously talking to, you know, to physicians who use Gelmido, those that are clinically convicted or clinically convicted. And what I mean by that is there are major institutions around the country, our top, top KOLs in this space, who use Gelmido in every single one of their patients. And, you know, I say every single one. Yeah, maybe, maybe there's a couple that they don't, but for the most part, they treat all of their patients.

Speaker Change: Yeah, Matt, look, it's a great question. I'll make a few comments and then turn it over to David to add anything. Yes, I absolutely believe it. You know, I've been out myself obviously talking to

Speaker Change: to physicians who use Jalmito, those that are clinically convicted are clinically convicted.

David Lynn: And then with regard to discarded drug provisions, we anticipate that to be considerably less and under the threshold. So as we look forward, I think many of those headwinds will be less of an issue. Thank you.

Speaker Change: And what I mean by that is there are major institutions around the country, our top KOLs in this space, who use Jelmite on every single one of their patients.

Operator: We'll move it for next question.

Speaker Change: and you know I say everything one yeah maybe maybe there's a couple that they don't but for the most part they they treat all of their patients that tells me

Liz Barrett: That tells me that there is clinical conviction, and that they believe in Gelmido. So a lot of it is around what David talked about earlier, and just, you know, what we really hear is the, and even Dr. Linahem, when we had the event for 102, she talked about the, you know, the logistics around gelmido, and that being the single largest barrier to, you know, to adoption. And I believe the set, the real, the biggest largest barrier is actually around patient identification. You've got 6,000 patients, you've got 10,000 urologists, you know, and so, as I mentioned earlier, you know, when we, you know, take a look at our top 20 accounts from in 24, there's difference in our top 20, you know, there's obviously some overlap, but more than half of the top 20 accounts in 24 and not the ones in 23.

Speaker Change: that there is clinical conviction and that they believe in Jelmido.

David: So a lot of it is around what David talked about earlier, and just, you know, what we really hear is the, and even Dr. Linehan, when we had the event for 102, she talked about the, you know, the logistics around Jomito, and that being the single largest barrier to, you know, to adoption.

Matt Kaplan: Our next question comes from the line of Matt Kaplan, of Leadingburg, Dolmond. Your line is now open. Hey, good morning, guys. Just first question, how should we think about the potential for our prior to review being granted for UGN 102 as you near the submission here? Yeah, look, it's a great question, Matt. You know, my my regulatory guy, you know, has very, very high confidence. I'm just probably don't much better than I give a percentage, but it's it's very, very likely.

Speaker Change: And I believe the biggest, largest barrier is actually around patient identification.

Matt Kaplan: The reason is because of the things we've been talking about, right? The data is very compelling. There are no other drugs approved. Of course, there is, you know, surgical, but there's, if you look at the what the FDA publishes around priority review, you know, we fit into their guidelines, and so we believe that we should, you know, we should get priority review. Having just said that, we all know that there's no guarantees, and so, you know, we will be sharing obviously as soon as we file, and then we get our acceptance, and when we get the acceptance, which is 60 days later, you know, that's when they'll tell us whether we have priority review.

Speaker Change: You've got 6,000 patients, you've got 10,000 urologists, you know, and so as I mentioned earlier, you know, you know, when, when we, you know, take a look at our top 20 accounts from

Speaker Change: and 24, they're different than our top 28. You know, there's obviously some overlap.

Speaker Change: but more than half of the top 20 accounts in 24 and not the ones in 23. And it's not a matter of that there is a negative experience and therefore they're not using it, it's just when the patient, you know, is there. And so I think that that is one of the things that we're really focused on and one of the things that David has implemented just over the last few weeks.

Liz Barrett: And it's not a matter of that there is a negative experience, and therefore they're not using; it's just when the patient, you know, is there. And so I think that that is one of the things that we're really focused on. One of the things that David has implemented just over the last few weeks is ensuring that we are increasing and improving our reach and frequency so that we are there to help identify those patients. To your point, the growth to net and the wastage, they are going to be what they are. Those are, in some, a lot of respects uncontrollables for us.

David: is ensuring that we are increasing and improving our reach and frequency so that we are there to help identify those patients.

David: To your point, the growth to net and the wastage, they are going to be what they are. Those are, in some, a lot of respects, uncontrollable for us. So what we have to do is we have to double down on patient identification and adoption. And that's what we're focused on.

David Lynn: So what we have to do is we have to double down on patient identification and adoption, and that's what we're focused on, and the conversion. There were a myriad of different reasons, nothing, no one thing, but, you know, you have to be there from the beginning. And when that patient was identified, if we had just translated the patient enrollment form growth in the first half, we would be well, you know, well within, we would have, we would have not had to miss this, you know, this quarter or last quarter. So, you know, that also tells me that the demand is there, and it's something else that's holding it up, and those are the things that we're working on.

David: and the conversion. There were a myriad of different reasons, nothing, no one thing, but you know, you have to be there from the beginning of when that patient was identified. If we had just translated the patient enrollment form growth

Matt Kaplan: But we feel very confident that we'll get priority review, but obviously, you know, can't, you know, can't guarantee that to be the case, but we feel like we do definitely, you know, that we definitely fit nicely into that. Great, great. That's helpful, thank you.

David: In the first half, we would have not had a miss this quarter or last quarter. So that also tells me that the demand is there, and something else is holding it up. And those are the things that we're working on. I don't know, David, if you want to add any additional color to that.

David Lynn: I don't know, David, if you want to, if you want to add any additional color to that. Thanks, Liz. No, the only thing I would add is, as we've talked about, the clinical conviction of the customers that we speak to is very high, and those particularly with experience, administering gel mito, as well as what their patients have told them, is that it's a positive experience. Our biggest challenge is being at the right place at the right time, as it is a very diffuse patient population. So when we are with a customer that has identified a patient, it is incumbent upon us to deliver the most seamless process we can in supporting them with training and scheduling.

David: Thanks Liz. Now the only thing I would add is as we've talked about the clinical conviction of the customers that we speak to is very high and those particularly with experience

David: administering gelmido as well as what their patients have told them is that it's a positive experience.

David: Our biggest challenge is being at the right place at the right time, as it is a very diffuse patient population.

Liz Barrett: Yeah, Matt, look, it's a great question. I'll make a few comments, and then turn it over to David to add anything. Yes, I absolutely believe it. You know, I've been out myself obviously talking to, you know, to physicians who use gelmido, those that are clinically convicted or clinically convicted. And what I mean by that is there are major institutions around the country, our top, top KOLs in this space, who use gelmido in every single one of their patients.

David: When we...

David: When we are with a customer that has identified a patient, it is incumbent upon us to deliver the most seamless process we can in supporting them.

Liz Barrett: And, you know, I say every single one. Yeah, maybe, maybe there's a couple that they don't, but for the most part, they treat all of their patients. That tells me that there is clinical conviction, and that they believe in gelmido. So a lot of it is around what David talked about earlier, and just, you know, what we really hear is the, and even Dr. Linahem, when we had the event for 102, she talked about the, you know, the logistics around gelmido, and that being the single largest barrier to, you know, to adoption.

David Lynn: So I think our fundamentals are very strong, and we are doubling down to make sure that we execute flawlessly when offices find or identify patients.

David: with training and scheduling. So I think our fundamentals are very strong and we are doubling down to make sure that we execute flawlessly when offices find or identify patients.

Matthew Kaplan: Thank you, guys.

Matthew Kaplan: Thanks, and thanks, Matt.

Matthew Kaplan: And I do want to go back to Kelsey. I'm sorry, we didn't answer your second question. I'm just going to ask Mark to comment. He recently got back from a bikini event, and obviously we've all had a lot of interaction with KOL. So Mark, maybe you can get some color on the recent event and your recent conversation with KOLs. Yeah, thank you. Thanks for the question. It's an exciting time in the community, as represented by the Bladder Cancer Advocacy Network, as this audience may know, is already very aware of the envisioned data as well as the predicate data from Atlas and Optum of the Phase 2 trial.

Speaker Change: Thank you guys.

Speaker Change: Thanks, Matt. And I do want to go back to Kelsey. I'm sorry, we didn't answer your second question. I'm just going to ask Mark to comment.

Mark Schoenberg: He recently got back from a Beacon event, and obviously we've all had a lot of interaction with KOLs.

Mark Schoenberg: So, Mark, maybe you can give some color on the recent event and your recent conversations with KOLs. Yeah, thanks, Liz. Just answer Kelsey's second question. Yeah, Kelsey, thanks for the question, and it's an exciting time in the community.

Speaker Change: as represented by the Bladder Cancer Advocacy Network, as this audience may know, is already very aware of the ENVISION data, as well as the PREDICATE data from ATLAS.

Mark Schoenberg: And there is growing excitement about the potential availability of this drug if approved, and I think people are really beginning to understand. I heard this in KOLs just this past week in San Diego at the meeting. A lot of exciting about the possibility that this is going to be available for patients that will make it possible in an office setting, in a manner that is much less technically complex than the delivery of gel mito to provide chemo-ablation for patients who here to for have really only had TRBT available as the option for treating this disease.

Speaker Change: and Optum at a phase two trial. And there is growing excitement about the potential availability of this drug if approved. And I think people are really beginning to understand. I heard this from KOLs just this past week in San Diego.

Liz Barrett: And I believe the set, the real, the biggest largest barrier is actually around patient identification. You've got 6,000 patients, you've got 10,000 urologists, you know, and so as I mentioned earlier, you know, when, when we, you know, take a look at our top 20 accounts from in 24, there's difference in our top 20, you know, there's obviously some overlap, but more than half of the top 20 accounts in 24 and not the ones in 23.

Speaker Change: at the meeting.

Speaker Change: A lot of excitement about the possibility that this is going to be available for patients, that it will make it possible in an office setting.

Speaker Change: in a manner that is much less technically complex than the delivery of gelmido.

Speaker Change: to provide chemoablation for patients who heretofore have really only had TURBT available as the option for treating this disease. So I would say in aggregate, both, and this is a mixed audience, this is both patients and docs and people from industry.

Liz Barrett: And it's not a matter of that there is a negative experience, and therefore they're not using, it's just when the patient, you know, is there. And so I think that, that is one of the things that we're really focused on, one of the things that David has implemented just over the last few weeks is ensuring that we are increasing and improving our reach and frequency so that we are there to help identify those patients.

Mark Schoenberg: So I would like to thank the Drs and people from industry. Patients and doctors are excited about the potential for the approval of Gigi and 102, as are we. So exciting times, I think, as reflected by that conversation.

Speaker Change: Patients and doctors are excited about the potential for the approval of UGN 102, as are we, so exciting times, I think, as reflected by that conversation.

Paul Joy: Operator, any additional questions? Yes, our next question is from Paul Joy of Common Sachs.

Liz Barrett: To your point, the growth to net and the wastage, they are going to be what they are. Those are, in some, a lot of respects uncontrollables for us. So what we have to do is we have to double down on patient identification and adoption, and that's what we're focused on, and the conversion. There were a myriad of different reasons, nothing, no one thing, but, you know, you have to be there from the beginning and when that patient was identified, if we had just translated the patient enrollment form growth in the first half, we would be well, you know, well within, we would have, we would have not had to miss this, you know, this quarter or last quarter.

Speaker Change: Operator, any additional questions?

Paul Joy: Your line is now open. Hi, good morning, everyone.

Speaker Change: Yes, our next question is from Paul Joy of Coleman Sachs. Your line is now open.

Paul Joy: Thank you for taking our questions. My first question is just to follow up on the 340B commentary. Can you elaborate on this and whether you think it's just more a seasonal one-timer impact in the quarter or do you anticipate this to be more the ongoing mix for gel mito?

Speaker Change: Good morning, everyone. Thank you for taking our question.

Speaker Change: My first question is just a follow-up on the 340B commentary. Can you elaborate on this and whether you think this is just more a seasonal one-timer impact in the quarter or do you sort of anticipate this to be more the ongoing mix for gel mito and then

Paul Joy: And then for 102, it's part of the offer here with regard to drug waste and so forth, having a pre-filled device and do exactly mitigated by that. And then my second question for Mark is with regards to 103 and 104. I appreciate the detailed timeline that you've laid out, Mark. Can you maybe elaborate whether you would potentially have any interim data updates for those programs in 25 or 26, or are you just planning to present top line results and proceed with the filing?

Speaker Change: for 102. Is part of the offset here with regard to drug waste and so forth having a prefilled device and do you expect that to be mitigated by that?

Liz Barrett: So, you know, that also tells me that the demand is there, and it's something else that's holding it up, and those are the things that we're working on. I don't know, David, if you want to, if you want to add any additional color to that. Thanks, Liz. No, the only thing I would add is, as we've talked about, the clinical conviction of the customers that we speak to is very high, and those particularly with experience, administering gel mito, as well as what their patients have told them is that it's a positive experience.

Speaker Change: And then my second question from Mark is with regards to 103 and 104. I appreciate the detailed timeline that you've laid out, Mark.

Mark Schoenberg: elaborate whether you would potentially have any interim data updates for those programs in 2025 or 2026, or are you just planning to present top-line results and proceed with the filing? Thanks for taking our questions.

Don Kim: Thanks for taking our question.

Don Kim: Yeah, and thanks, Paul. I've just come in on the gross to net, and I wish I had a crystal ball where that's concerned. We see quite a bit of variability quarter to quarter. So I do think I think we have hit, you know, a place where we're not going to go back to the higher, you know, to the lower discounts. You know, we'll continue to see that. So I think an aggregate over the years, so I think there continue to be variability quarter to quarter. Is that making it very difficult? And, but I think that we're going to continue to see that as a headwind.

Liz Barrett: Our biggest challenge is being at the right place at the right time as it is a very diffuse patient population. So when we are with a customer that has identified a patient, it is incumbent upon us to deliver the most seamless process we can in supporting them with training and scheduling. So I think our fundamentals are very strong, and we are doubling down to make sure that we execute flawlessly when offices find or identify patients.

Speaker Change: Yeah, and thanks Paul. I've just comment on the gross to net and and you know, I wish I had a crystal ball where that's concerned. We see quite a bit of variability quarter to quarter.

Speaker Change: So I do think, I think we have hit, you know, a place where we're not going to go back.

Speaker Change: to the higher, you know, to the lower discounts, you know, we'll continue to see that. So I think in aggregate over the year, so I think there continue to be variability quarter to quarter. So that making it very difficult and but I do, but I think that we're going to continue to see that as a headwind. I don't think it will increase much more than we've already seen this, you know, the variability now. Like I said, it's at a new low.

Liz Barrett: Thank you, guys. Thanks, and thanks, Matt. And I do want to go back to Kelsey. I'm sorry, we didn't answer your second question. I'm just going to ask Mark to comment. He recently got back from a bikini event, and obviously we've all had a lot of interaction with KOL. So Mark, maybe you can get some color on the recent event and your recent conversation with KOLs. Yeah, thank you. Thanks for the question.

Liz Barrett: I don't think it will increase much more than we've already seen this, you know, the variability now, like I said, is that a new low only because we don't see that obviously as much with, you know, with nephrostomy tube administration, you know, as you do, as you do with other, although, you know, I do think this is what the single biggest issue facing our industry today. You hear it from a lot of people around 340 B, I think we need to, we need to figure out a way to have that address because what you're seeing is, you know, institutions, they're, they buy, you know, by practices and, you know, they get the 340 B, you know, discount, even though, you know, it's delivered in, you know, into a account account.

Speaker Change: only because we don't see that obviously as much with

Speaker Change: with nephrostomy tube administration, as you do with other. Although, I do think this is the single biggest issue facing our industry today. You hear it from a lot of people around 340B. I think we need to figure out a way to have that addressed.

Liz Barrett: It's an exciting time in the community, as represented by the bladder cancer advocacy network, as this audience may know, is already very aware of the envisioned data as well as the predicate data from Atlas and Optum of the Phase 2 trial. And there is growing excitement about the potential availability of this drug if approved, and I think people are really beginning to understand. I heard this in KOLs just this past week in San Diego at the meeting.

Speaker Change: because what you're seeing is, you know, institutions, they buy, you know, buy practices and, you know, they get the 340B.

Liz Barrett: So I don't think that we'll see further erosion, but I don't think that we'll see further erosion.

Speaker Change: you know, discount, even though, you know, it's delivered in, you know, into an account. So I don't think that we'll see further erosion, but I think that what is here is going to be here to stay from a gross-to-net perspective.

Liz Barrett: But I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I don't think that we'll see further erosion, but I think that what is here is going to be here to stay from a growth to net perspective. So, again, as I mentioned before, even with the headlands of growth to net, and the, and the way such provision, I think we learn now pretty good at what we can anticipate.

Liz Barrett: A lot of exciting about the possibility that this is going to be available for patients that will make it possible in an office setting, in a manner that is much less technically complex than the delivery of gel mito to provide chemo-ablation for patients who here to for have really only had TRBT available as the option for treating this disease. So I would like to thank the Drs and people from industry patients and doctors are excited about the potential for the approval of Gigi and 102, as are we. So exciting times, I think, as reflected by that conversation.

Speaker Change: So, again, as I mentioned before, even with the headwinds of growth to net and the way this provision, I think we've learned now pretty good at what we can anticipate.

Liz Barrett: I think what, you know, it's incumbent upon us to, to drive adoption and drive the demand and ensure that that demand translates to an actual patient being treated. And that's something that, you know, that, again, David is really, really focused on. So I think that that's going to be the key identifying the patients and translating every patient to a, you know, to a dose. And again, we're seeing that a little bit better in, you know, third quarter so far, but I don't want to get ahead of ourselves. And that's what we saw in the first six months, which we had not seen before.

Speaker Change: I think what, you know, it's incumbent upon us to drive adoption and drive the demand and ensure that that demand translates to an actual patient being treated.

Operator: Operator, any additional questions?

Speaker Change: and that's something that you know that again David is really really focused on so I think that that's going to be the key identifying the patients and translating every patient

Speaker Change: to a, you know, to a dose. And again, we're seeing that a little bit better in, you know, the third quarter so far, but I don't want to get ahead of ourselves.

Paul Joy: Yes, our next question is from Paul Joy of Common Sachs. Your line is now open. Hi, good morning, everyone. Thank you for taking our questions. My first question is just to follow up on the 340B commentary. Can you elaborate on this and whether you think it's just more a seasonal one-timer impact in the quarter or do you anticipate this to be more the ongoing mix for gel mito? And then for for 102, it's part of the offer here with regard to drug waste and so forth, having a pre-filled device and do exactly mitigated by that.

Liz Barrett: And if we had simply done that, even with the headlands. You know, we would be where we needed to be. So, you know, feel good about our ability. And like I said, we believe there's a path to the lower end of the guidance. I feel really good about the stuff that David is implementing. And so I, you know, we'll continue to drive that.

Speaker Change: And that's what we saw in the first six months, which we had not seen before. And if we had simply done that, even with the headwinds.

Speaker Change: you know, we would be where we needed to be. So, you know, feel good about our ability, like I said, we believe there's a path to the lower end of the guidance.

David: I feel really good about the stuff that David is implementing, and so I, you know, will continue to drive that. But be assured, it's going to continue to be a slog, right, with John Maido. Very, very different than UGN 102.

Liz Barrett: But, but be assured, it's going to continue to be a slog, right, with which I might very, very different than in UGN 102, which we, we know will be not only the practice economics, but the ease of use. And the learning and ensuring that we have, you know, all the things that, you know, we underestimated with John Mayer, that we don't do that. We will not make that, you know, you know, we won't do that again where we underestimate the logistics. And so that's one of the things that David's really, really focused on.

David: which we know will be not only the practice economics but the ease of use.

David: and the learning and ensuring that we have you know all the things that you know we underestimated with John Maida that we don't do that and we will not make that

Paul Joy: And then my second question for Mark is with regards to 103 and 104, appreciate the detailed timeline that you've laid out Mark. Can you maybe elaborate whether you would potentially have any interim data updates for those programs in 25 or 26 or are you just planning to present top line results and proceed with the filing? Thanks for taking our question. Yeah, and thanks Paul, I've just come in on the gross to net and I wish I had a crystal ball where that's concerned.

David: We won't do that again where we underestimate the logistics, and so that's one of the things that David's really, really focused on.

Mark Schoenberg: So, with that, Mark, why don't you answer the question around UGM 103 and 104?

Mark Schoenberg: Yeah, Paul, thanks. So, as Liz said in her remarks, 103 is already rolling in because it is a smaller trial. We anticipate rapid, a cruel completing in sort of early to mid 25.

Mark Schoenberg: So with that, Mark, why don't you answer the question around UGM-103 and UGM-104? Yeah, Paul, thanks. So as Liz said in her remarks, 103 is already rolling in. Because it is a smaller trial, we anticipate rapid

Mark Schoenberg: accrual, completing.

Paul Joy: We see quite a bit of variability quarter to quarter. So I do think I think we have hit, you know, a place where we're not going to go back to the higher, you know, to the lower discounts, you know, we'll continue to see that. So I think an aggregate over the years so I think there continue to be variability quarter to quarter, so is that making it very difficult and but I do, but I think that we're going to continue to see that as a headwind.

Liz Barrett: Candidly, it's pretty mature to talk about the timeline on 104, but with respect to releasing interim data on either program and have to defer the Liz because they are going to be fast, a crewing trials with an approach to disease with which we are already familiar. I'm not certain that we would want to do that, but I, again, have to defer to Liz as to how she's going to approach the availability and release of interim data from those trials. Yeah, I think the one thing that we would consider is the CRA data, right? Being able to given that that is in and of itself, you know, we may be able to disclose and share that.

Speaker Change: in sort of early to mid-1980s.

Speaker Change: Candidly, it's premature to talk about the timeline on 1.0.4, but with respect to releasing interim data on either program, I'd have to defer to Liz because they are going to be fast accruing trials with...

Speaker Change: an approach to disease with which we are already familiar. I'm not certain that we would want to do that, but again, I have to defer to Liz as to how she's going to approach the availability and release of interim data from those trials.

Liz Barrett: Yeah, I think the one thing that we would consider is the CR data, right, being able to, given that that is a, in and of itself.

Paul Joy: I don't think it will increase much more than we've already seen this, you know, the variability now, like I said, is that a new low only because we don't see that obviously as much with, you know, with nephrostomy tube administration, you know, as you do, as you do with[inaudible] think that what is here is going to be here to stay from a growth to net perspective. So, again, as I mentioned before, even with the headlands of growth to net, and the, and the way such provision, I think we learn now pretty good at what we can anticipate.

Liz Barrett: The most important thing for us is we have been very, you know, you know, conservative in the sense of we don't want to jeopardize anything with the FDA. In example, you know, some of the other companies out there have been giving, you know, updating on all of their durability data on an ongoing basis. We chose not to do that because we did not want the FDA to have any, any reason to question our data and so the integrity of our data. So we would not share ongoing durability data, but I think what we could, we could be able to share is so the initial CR.

Liz Barrett: We may be able to disclose and share that. The most important thing for us is we have been very...

Liz Barrett: and many others who are conservative in the sense that we don't want to jeopardize anything with the FDA. An example, you know, some of the other...

Liz Barrett: companies out there have been giving, you know, updating on all of their

Liz Barrett: on an ongoing basis. We chose not to do that because we did not want the FDA to have any reason to do that.

Liz Barrett: to question our data, and so the integrity of our data. So we would not share ongoing durability data, but I think what we would be able to share is the initial CR. And I think that's something that we'll look at doing. But other than that, we would not share on the durability. I just don't think it's good practice.

Liz Barrett: And I think, you know, that that's something that we'll, you know, look at doing. But other than that, we would not share on the durability. I just don't think it's good practice.

Liz Barrett: And like I said, we don't want to, we don't want to do anything that could jeopardize, you know, our filings. That we will, we will continue to be very conservative from that perspective.

Liz Barrett: And like I said, we don't want to do anything that could jeopardize our filing, so we will continue to be very conservative from that perspective.

Paul Joy: I think what, you know, it's incumbent upon us to, to drive adoption and drive the, the demand and ensure that that demand translates to an actual patient being treated. And that's something that, you know, that, again, David is really, really focused on. So I think that that's going to be the key identifying the patients and translating every patient to a, you know, to a dose. And again, we're seeing, we're seeing that a little bit better in, you know, third quarter so far, but I don't want to get ahead of ourselves.

Paul Joy: Got it. I appreciate the color. Thank you.

Liz Barrett: I'm showing all further questions at this time. I'd like to turn it back to this very serial for close your remarks. Yeah.

Liz Barrett: Got it. I appreciate the call, Alec.

Liz Barrett: Thank you. I'm showing no further questions at this time and I'd like to turn it back to Liz Barrett, CAO, for closing remarks.

Liz Barrett: Thank you. And thanks, everybody, for joining us today. I think you heard from us today; our real shift and focus is toward UGM 102. You know, we will be, you know, finishing our filing, as we've talked about, very, you know, very shortly. And we'll share that with you. We'll anticipate, you know, the feedback from the FDA and, you know, in short order after that, and we'll keep you posted on things. I think the compelling nature of the data, the durability, the recurrence-free survival. Both, frankly, for UGM 102 and Yamato show that we have, and we, you know, have the ability and potential to transform the way that these patients were treated.

Liz Barrett: Thank you, and thanks everybody for joining us today. I think you heard from us today, our real shift in focus is toward UGM 102. We will be finishing our filing, as we've talked about, very shortly, and we'll share that with you. We'll anticipate feedback from the FDA.

Paul Joy: And that's what we saw in the first six months, which we had not seen before. And if we had simply done that, even with the headlands. You know, we would be where we needed to be. So, you know, feel good about our ability. And like I said, we believe there's a path to the lower end of the guidance. I feel really good about the stuff that David is implementing. And so I, you know, we'll continue to drive that.

Liz Barrett: and, you know, in short order, after that, and we'll keep you posted on things. I think the compelling nature of the data, the durability, the recurrence-free survival, both, frankly, for UGM-102 and jaumito,

Liz Barrett: show that we have, and we, you know, have the ability and potential to transform the way that these patients are treated, that's always been our mission and our vision for our company. So, not only will it transform that for patients, but also for our company. So, we'll keep you posted. Thanks for your questions and participation today, and we look forward to the ongoing dialogue. Operator, you can disconnect now.

Liz Barrett: That's always been our mission and our vision for our company. So that's not only will it transform that for patients, but also for our company. So we'll keep you posted. Thanks for your questions and participation today.

Paul Joy: But, but be assured, it's going to continue to be a slog, right, with which I might very, very different than in UGN 102, which we, we know will be not only the practice economics, but the ease of use. And the learning and ensuring that we have, you know, all the things that, you know, we underestimated with John Mayer, that we don't do that. We will not make that, you know, you know, we won't do that again where we underestimate the logistics.

Operator: And we look forward to the ongoing dialogue, operator.

Operator: You can just connect now. Thank you for your participation in today's conference.

Operator: This is a conclude program. You may now disconnect.

Speaker Change: Thank you for your participation in today's conference. This concludes the program. You may now disconnect.

Speaker Change: Thank you.

Paul Joy: And so that's one of the things that David's really, really focused on. So with that, Mark, why don't you answer the question around UGM 103 and 104? Yeah, Paul, thanks. So as Liz said in her remarks, 103 is already rolling in because it is a smaller trial. We anticipate rapid, a cruel completing in sort of early to mid 25. Candidly, it's pretty mature to talk about the timeline on 104, but with respect to releasing interim data on either program and have to defer the Liz because they are going to be fast, a crewing trials with an approach to disease with which we are already familiar.

Paul Joy: I'm not certain that we would want to do that, but I, again, I have to defer the Liz as to how she's going to approach the availability and release an interim data from those trials. Yeah, I think the one thing that we would consider is the CRA data, right? Being able to given that that is in and of itself, you know, we may be able to disclose and share that. The most important thing for us is we have been very, you know, you know, conservative in the sense of we don't want to jeopardize anything with the FDA.

Speaker Change: and many more. Thank you. Thank you. Thank you. Thank you. Thank you.

Paul Joy: In example, you know, some of the other companies out there have been giving, you know, updating on all of their durability data on an ongoing basis. We chose not to do that because we did not want the FDA to have any, any reason to question our data and so the integrity of our data. So we would not share ongoing durability data, but I think what we could, we could be able to share is so the initial CR.

Paul Joy: And I think, you know, that that's something that we'll, you know, we'll look at doing. But other than that, we would not share on the durability. I just don't think it's good practice. And like I said, we don't want to, we don't want to do anything that could jeopardize, you know, our filings that we will, we will continue to be very conservative from that perspective. Got it. I appreciate the color. Thank you. I'm showing all further questions at this time.

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Liz Barrett: I'd like to turn it back to this very serial for close your remarks. Yeah. Thank you. And thanks, everybody, for joining us today. I think you heard from from us today are our real shift and focus is toward UGM 102. You know, we, we will be, you know, finishing our filing as we've talked about very, you know, very shortly. And we'll share that with you. We'll anticipate, you know, the feedback from the FDA and, you know, in short order after that and we'll keep you posted on things.

Liz Barrett: I think the compelling nature of the data, the durability, the recurrence free survival. Both, frankly, for UGM 102 and Yamato show that we have, and we, you know, have the ability and potential to transform the way that these patients were treated. That's always been our mission and our vision for our company. So that's not only will it transform that for patients, but also for our company. So we'll keep you posted. Thanks for your questions and participation today.

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Liz Barrett: And we look forward to the ongoing dialogue operator. You can just connect now. Thank you for your participation in today's conference. This is a conclude program. You may now disconnect. [inaudible] John, John, John, John, John, John, John, John, John, John, John, John,[inaudible] John, John, John[inaudible][inaudible] Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul, Paul,[inaudible] Dr. Paret, Dr. Paret, Dr. Paret, Raghuram Selvaraju, Dr. Paret, Raghuram Selvaraju[inaudible] Dr. Paret, Dr. Paret, Dr. Paret, Dr. Paret,[inaudible]

Speaker Change: Music Music Music Music Music Music Music Music Music Music

Speaker Change: Who is Jeffrey Barrett?

Speaker Change: Music Music Music Music Music Music Music Music Music

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Speaker Change: and many more. Thank you. Thank you. Thank you. Thank you. Thank you.

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