Q1 2024 UroGen Pharma Ltd Earnings Call

Okay.

Operator: Good morning, ladies and gentlemen. Thank you for standing by.

Operator: Welcome to the Urogen Pharma First Quarter 2024 Earnings Call. 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. You may begin.

Good morning, ladies and gentlemen, thank you for standing by welcome to the urgent pharma first quarter 2024 earnings call. Please be advised that today's conference is being recorded and now like to hand, the conference over to your first speaker today, Mr. Perone head of Investor Relations you may begin.

Vincent I. Perrone: Thank you, operator. Good morning, everyone.

Perone: Thank you operator, good morning, everyone and welcome to European Pharma first quarter 2024 financial results and business update conference call.

Perone: Earlier. This morning, we issued a press release, providing an overview of our corporate highlights and financial results for the quarter ended March 31 2020.

Perone: The press release can be accessed on the investors portion of our website.

Vincent I. Perrone: And welcome to Urogen Pharma's first quarter 2024 financial results and business update conference. Earlier this morning, we issued a press release providing an overview of our corporate highlights and financial results for the quarter ended March 31, 2020. The press release can be accessed on the investors portion of our website. Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Bova, Chief Commercial Officer, and Dong Kim, Chief Financial Officer.

Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff BOVA, Chief Commercial Officer, and Dan <unk>, Chief Financial Officer.

Vincent I. 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 expectations, as well as potential future commercialization activities for UGN 102, if approved. Anticipated data, including envisioned durability data, regulatory filings, and decisions, including UGN 102 potentially receiving priority review, UGN 102 being the primary growth driver for Urogen if approved, future R&D efforts, our corporate goals, and 2024 financial guidance, among others.

Perone: During today's call, we will be making certain forward looking statements.

Perone: These may include statements regarding our ongoing commercialization activities related to our ongoing.

Perone: Boeing 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 <unk>, one or two.

Perone: Anticipated data, including envisioned durability data regulatory filings and decisions, including <unk>, one or two potentially receiving priority review UGG, having one or two being the primary growth driver for European approved future R&D efforts, our corporate goals in 2024 financial guidance among other things.

Vincent I. 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 secdisclosure.com. You are cautioned not to place undue reliance on these forward-looking statements, and your agenda disclaims any obligations to update them. With that, I'll turn the call over to Liz.

Perone: These forward looking statements are based on current information assumptions and expectations that are subject to change a description of potential risks can be found in our earnings press release and latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements and European disclaims any obligations to update these statements.

Perone: Yes.

Perone: With that I'll turn the call over to Liz.

Elizabeth A. Barrett: Thank you, Vincent, and thank you, everyone, for joining us this morning. As we look ahead to 2024, we have several near-term catalysts, including the planned release of the 12-month duration of response data from the ENVISION study in June, and our expected NDA submission this year. We have assembled a strong body of data that demonstrates a compelling clinical profile for UGM-102. The ATLAS and ENVISION trials both met their primary endpoint, and if approved, we believe UGM-102 will advance the standard of care in low-grade, intermediate-risk, non-muscle-invasive bladder cancer from repetitive surgery to a minimally-invasive, routine, non-surgical option.

Thank you Vincent and thank you everyone for joining us. This morning as we look ahead to 2024, we have several near term catalysts, including the planned release at the 12 month duration of response data from the envision study in June with our expected NDA submission this year.

Liz: We have assembled a strong body of data that demonstrates a compelling clinical profile for UGI and minor to the Atlas and envision trials both met their primary endpoints and if approved we believe <unk> will advance the standard of care in low grade intermediate risk non muscle invasive bladder cancer from repetitive.

Liz: I'm, sorry, three to a minimally invasive routine nonsurgical option. Our research reflects overwhelming support from both urologists and patients with the intent to use by over 90% of surveyed neurologists and over 90% of surveyed patients and the ambition study preferred Eugene.

Elizabeth A. Barrett: Our research reflects overwhelming support from both urologists and patients, with the intent to use by over 90% of surveyed urologists, and over 90% of surveyed patients in the ENVISION study preferring UGM-102 to a TURBT. We are pleased to announce that we will host our virtual event to share the Envision durability data on June 13th. The database lock will occur later this week, and we are very much looking forward to sharing the final results from Envision at that time.

Liz: <unk>.

Liz: We are pleased to announce that we will host our virtual event to share the envisioned durability data on June 13.

Liz: The database lock while occurred later this week and we are very much looking forward to sharing the final results for envision at that time.

Elizabeth A. Barrett: Earlier this year, we announced the initiation of a rolling NDA submission, and we believe the upcoming envisioned data will support completion of the NDA in Q3 of this year. Assuming priority review, we could launch as early as Q1 of 2025. The commercial opportunity is significant. We estimate that the overall market is approximately 10 times the size of the urothelial carcinoma market that Jalmido currently addresses. We intend to seek a broad indication for UGM 102.

Liz: Earlier this year, we announced the initiation of a rolling NDA submission and we believe the upcoming envision data will support completion of the NDA in Q3 of this year.

Liz: Assuming priority review, we could launch as early as Q1 in 2025.

Liz: The commercial opportunity is significant we estimate that the overall market is approximately 10 times the size of the IOL failures carcinoma market that Yamato currently addresses.

Liz: We intend to seek a broad indication for Eugene window to conservatively, we estimate the size of the market opportunity to be over $3 billion. This represents a substantial market opportunity for our company and a chance to meaningfully impact the treatment paradigms and improve patient outcome.

Elizabeth A. Barrett: Conservatively, we estimate the size of the market opportunity to be over $3 billion. This represents a substantial market opportunity for our company and a chance to meaningfully impact the treatment paradigms and improve patient outcomes. Our ongoing commercialization plan will include an incremental sales force expansion. Pricing analysis and market resources are currently ongoing, but we expect pricing to be in the $16,000 to $19,000 range per dose.

Liz: Our ongoing commercialization plan will include an incremental sales force expansion pricing analysis and market research are currently ongoing but we expect pricing to be in the 16000 to $19000 range per dose.

Elizabeth A. Barrett: Given the response and feedback we have received, we believe patients will strongly welcome a minimally invasive, non-surgical alternative to TRBT. While we don't expect to replace T over T in all patients, UGM 102 will be the first and only medicine approved for patients with low-grade intermediate-risk non-muscle invasive bladder cancer, and we believe we'll offer an advance in treatment if approved. Jeff will provide more details on our commercial strategy in a few minutes.

Liz: Given the response and feedback we have received we believe patients will strongly welcome a minimally invasive non surgical alternative to tier I V T.

Liz: While we don't expect to replace T. Every T and our patients you Jan one or two will be the first and only medicine approved for patients with low grade intermediate risk non muscle invasive bladder cancer and we believe will offer an advance in treatment if approved Jeff will provide more details on our commercial strategy in a few minutes.

Elizabeth A. Barrett: In April, we announced FDA acceptance of the IND for UGN 103, an important next step in our lifecycle management strategy. UGN 103 is our next generation formulation of UGN 102, which combines our proprietary RT gel technology with MedX's proprietary formulation of mitomycin. A key aspect of this program is the potential for extended patent coverage for our next-generation urothelial cancer franchise. Medec has intellectual property protection into 2035, and Urgen's pending U.S. patent applications, if approved, could extend patent coverage until December of 2041.

Liz: In April we announced FDA acceptance of the I N D for Eugene one of three an important next step in our lifecycle management strategy one of three as our next generation formulation of <unk> in one or two which combines our proprietary Archie gel technology with <unk> proprietary formulation.

Speaker Change: Might have missed it.

Speaker Change: Key aspect that this program is a potential for extended patent coverage for our next generation neural failure cancer franchise.

Now that has intellectual property protection into 2035, and your origins pending U S patent applications if approved could extend patent coverage until December of 2041.

Elizabeth A. Barrett: We are preparing to initiate clinical endpoint studies to support NDAs for UGN 103 and UGN 104, the latter being our next generation formulation of gelmito. We anticipate dosing patients in the planned phase 3 trial of UGN 103 by the end of this year, and UGN 104 shortly thereafter. As reported, Jomita revenues were $18.8 million for the quarter, an approximate 10% increase over Q1 2023. More importantly, patient enrollment forms or PEFs in Q1 were the highest ever, indicating demand continues to grow. As we have experienced in the past, seasonality in Q1 results in a delay in patients being treated due to the resetting of insurance.

Speaker Change: We are preparing to initiate clinical endpoint studies to support NDA for <unk>, three and Eugene and warehouse for the latter being our next generation formulation of <unk>, we anticipate dosing patients in the planned phase III trial of <unk> in one of three by end of this year and <unk> four shortly.

Speaker Change: Thereafter.

Speaker Change: As reported <unk> revenues were $18 $8 million for the quarter, an approximate 10% increase over Q1 2023.

Speaker Change: More importantly patient enrollment forms are passed in Q1 were the highest ever indicating demand continues to grow as.

Speaker Change: As we have experienced in the past seasonality in Q1 resulted in a delay in patients being treated due to resetting of insurance.

Elizabeth A. Barrett: We have seen conversions accelerate in March and April, providing support for continued growth of Jelmito. We're very excited by a recent post hoc analysis from the Olympus trial that evaluated the long-term efficacy of Gemmido in patients who experienced a complete response. Mark will elaborate on this momentarily, but at a high level, findings suggest that Gelmido can offer extended disease-free periods, with some patients experiencing no recurrence for approximately 48 months.

Speaker Change: We have seen conversions accelerate in March and April providing support for continued growth at Yamato.

Speaker Change: We're very excited by our recent post hoc analysis from the Olympus trial that evaluated the long term efficacy of <unk> in patients who experienced a complete response.

Speaker Change: Mark will elaborate on this momentarily, but at a high level of finding suggests that <unk> can offer extended disease free periods with some patients experiencing no recurrence for approximately 48 months.

Elizabeth A. Barrett: We recently released this data to the field and are optimistic about its impact on urology. Lastly, our balance sheet remains a priority and our cash position is strong, with $164.5 million in cash, cash equivalents, and marketable securities as of March 31st. Our capital allocation strategy continues to prioritize the ramp-up of UGM-102 supply and its commercial launch, alongside bolstering Gelmito cells. Our latest financial projections, assumptions, and sales forecasts affirm our belief that our current balance sheet is robust enough to sustain our operations through anticipated breakthroughs.

Speaker Change: We recently released this data to the field and are optimistic about its impact with urologists.

Speaker Change: Lastly, our balance sheet remains a priority and our cash position is strong with $164 $5 million in cash cash equivalents and marketable securities as of March 31.

Speaker Change: Our capital allocation strategy continues to prioritize the ramp up of Eugene and one or two supply and its commercial launch alongside bolstering job might've cells.

Speaker Change: Our latest financial projections assumptions in sales forecast affirm our belief that our current balance sheet is robust enough to sustain our operations through anticipated breakeven.

Elizabeth A. Barrett: So we do not need to raise additional capital with our current plan. Having said that, there are a plethora of opportunities to further study our medicines across new patient populations and position our company for longer-term sustainable growth. We will remain diligent with capital deployment and opportunistically strengthen our balance sheet to accelerate and execute those potential growth opportunities. I will now turn the call over to Dr. Mark Schoenberg, our Chief Medical Officer, for a clinical update. Mark.

So we do not need to raise additional capital with our current plan.

Speaker Change: Having said that there is a plethora of opportunities to further study our medicines across new patient populations and position our company for longer term sustained growth.

Speaker Change: We will remain diligent with capita apply minutes opportunistically strengthen our balance sheet to accelerate and execute those potential growth opportunities.

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

Mark P. Schoenberg: Thank you, Liz. I'd like to start by previewing results from a not-yet-published post-hoc analysis from the OLYMPUS trial Liz mentioned earlier. The post-hoc analysis evaluated long-term outcomes of gelmito use for primary chemoablation in patients with low-grade UTUC based on results from the OLYMPUS trial and a subsequent long-term rollover trial. After receiving six weekly doses of gelmito, 41 of 71 patients in OLYMPUS achieved a complete response, and their health outcomes were tracked for up to 12 months.

Thank you Liz.

Mark P. Schoenberg: Let me start by previewing results from a not yet published post hoc analysis from the Olympus trial Louis mentioned earlier.

Post hoc analysis of value, we did long term outcomes of Joe might have use for primary chemo ablation in patients with low grade <unk> based on results from the Olympus trial and.

Mark P. Schoenberg: 20 of the patients remaining in complete response at 12 months enrolled in a five-year rollover trial. Results for all 41 patients who initially achieved complete response indicated a promising median duration of response of 47.8 months based on a median follow-up of 28.1 months. Among the 20 patients enrolled in the long-term rollover trial, the median duration of response was not estimable as 75% of these patients continued to show no signs of disease recurrence or progression by the data cutoff date.

Mark P. Schoenberg: Subsequent long term rollover trial after receiving six weekly doses of Joe made up 41 at 71 patients and Olympus achieved a complete response and their health outcomes were track for up to 12 months.

Mark P. Schoenberg: <unk> of the patients remaining in complete response at 12 months enrolled at five year rollover trials.

Mark P. Schoenberg: <unk> for all 41 patients who initially achieved complete response indicated a promising median duration of response of $47 eight months based on our median follow up of $28 one months among.

Among the 20 patients enrolled in the long term rollover trial. The median duration of response was not estimable as 75% of these patients continued to show no signs of disease recurrence or progression by the data cutoff date, we plan to submit these results for peer review and look forward to sharing additional updates when available.

Mark P. Schoenberg: We plan to submit these results for peer review and look forward to sharing additional updates when available. Urogen had a significant presence at the recent American Neurologic Association meeting, which took place in San Antonio, with a total of four abstracts presented.

Mark P. Schoenberg: <unk> had a significant presence at the recent American Urologic Association meeting, which took place in San Antonio with a total of four abstracts presented.

Mark P. Schoenberg: The first of these was a post-hoc analysis from the ATLAS trial of UGN-102, which was highlighted in a podium presentation by Dr. William Wang from NYU Langone. The analysis showed that UGN-102 used with or without TURBT improved disease-free survival and duration of response compared to TURBT alone. This analysis revealed that both new and recurrent low-grade intermediate-risk NMIBC patients who received UGN-102 achieved similar outcomes. Specifically, DFS rates were 77.4% for new patients and 63.2% for recurrent patients at 15 months, while durable complete response rates were 87.5% for new patients and 69.1% for recurrent patients at 12 months. Jelmito was featured in three presentations at the AUA.

Mark P. Schoenberg: The first of these was opposed to Hawk analysis from the Atlas trial of <unk> 102, which was highlighted in a podium presentation by Dr. William Huang.

Mark P. Schoenberg: And why are you letting go.

Mark P. Schoenberg: Analysis showed that Eugene and one or two used with or without <unk> improved disease free survival and duration of response compared to <unk> alone.

Analysis revealed that both new and recurrent low grade intermediate risk <unk> patients, who received <unk> in one or two achieved similar outcomes, specifically DFS rates were 77, 4% for new patients and 63, 2% for recurrent patients at 15 months, while durable complete.

Mark P. Schoenberg: Response rates were 87, 5% for new patients and 69, 1% for recurrent patients with 12 months.

Mark P. Schoenberg: Joe <unk> was featured in three presentations at the way. This product is approved for the chemo ablative use in low grade disease of the upper urinary tract independent long term real world analyses that were presented demonstrated 86% recurrence free survival of 24 months with the <unk> treatment for <unk>.

Mark P. Schoenberg: This product is approved for chemoablative use in low-grade disease of the upper urinary tract. Independent, long-term, real-world analyses that were presented demonstrated 86% recurrence-free survival at 24 months with the Jelmito treatment for patients who responded to initial induction, and there does not appear to be a difference in recurrence rates between antegrade and retrograde methods of administration, original tumor size, multif The long-term analysis also evaluated the value of maintenance use of Gel Mito.

Mark P. Schoenberg: So you responded to initial induction.

Mark P. Schoenberg: And there does not appear to be a difference in recurrence rates between integrate in retrograde methods of administration original tumor size multifocal <unk> or tumor location.

Mark P. Schoenberg: Long term analysis also evaluated the value of maintenance use of Joe made out although the analyses consisted of the 13 patient cohort 100% of these patients maintained a complete response at 24 months. The authors concluded that administration of maintenance appears to be associated with significantly better recurrence free survival.

Mark P. Schoenberg: Although the analyses consisted of a 13-patient cohort, 100% of these patients maintained a complete response at 24 months. The authors concluded that administration of maintenance therapy appears to be associated with significantly better recurrence-free survival. I would now like to spend a few moments talking about the progress made in UGN 102. As Liz mentioned, the next milestone for this program is the evaluation of the secondary endpoint of the ENVISION trial, duration of response at 12 months following a complete response. We intend to share these results at a company-sponsored virtual event on June 13. The database log is scheduled for later this week, and we look forward to sharing the results next month.

Mark P. Schoenberg: I would now like to spend a few moments talking about the progress made in the Eugene and one of the two program as Liz mentioned the next milestone for this program is the evaluation of the secondary endpoint of the envision trial duration of response at 12 months. Following a complete response, we intend to share. These results at a company sponsored virtual event on June 30.

Mark P. Schoenberg: Keith.

Mark P. Schoenberg: Database lock is scheduled for later this week and we look forward to sharing the results next month.

Mark P. Schoenberg: I'd like to summarize the value proposition for UGN 102 and the rationale supporting our belief in the strength of our regulatory application and, if approved, widespread adoption by urology. UGN-102 has demonstrated consistency in the three-month complete response rate across ATLAS and VISION, as well as our prior Phase IIb study, Optima II. Moreover, the ATLAS data suggests UGN-102 is superior in surgery once a complete response is achieved. In the ATLAS ITT population, 80% of patients who received UGN 102 plus or minus TURBT were still disease-free at 12 months following complete response, compared to only 50% of patients who had a TURBT alone.

Mark P. Schoenberg: I'd like to summarize the value proposition for UGI, and 102, and the rationale supporting our belief in the strength of our regulatory application and if approved widespread adoption by urologists UGI and one of the key was demonstrated consistency in the three month complete response rate across Atlas and vision as well as our prior phase.

Mark P. Schoenberg: <unk> study Optima two.

Mark P. Schoenberg: Moreover, the Atlas data suggests <unk> here in one or two is superior to surgery. Once a complete response is achieved in.

Mark P. Schoenberg: In the Atlas ITT population, 80% of patients, who achieve who received <unk> plus or minus tier RPT were still disease free at 12 months. Following complete response compared to only 50% of patients who had a <unk> alone.

Mark P. Schoenberg: A significant benefit of UGN-102 lies in its innovative RT gel delivery mechanism, which provides sustained release treatment directly to the bladder tissue for up to six hours. This extended dwell time enables treatment of both visible lesions and underlying abnormal cells that predispose to disease recurrence. This attribute is critically important because, despite their expertise, urologists may not be able to detect all such cells during surgical procedures.

Mark P. Schoenberg: A significant benefit of <unk> 102 lies in its innovative rte gel delivery mechanism, which provides sustained release treatment directly to the bladder tissue for up to six hours.

Mark P. Schoenberg: The extended dwell time facilitates treatment of both visible lesions and underlying abnormal cells that predispose to disease recurrence. This attribute is critically important because despite their expertise urologists may not be able to detect all such cells. During surgical procedures. We believe <unk> 102 offers a clinically.

Jeffrey Bova: We believe UGN-102 offers a clinically meaningful improvement over surgery in reducing recurrence risk and prolonging disease-free intervals for patients, while lowering the overall treatment burden on patients. As Liz mentioned, we are actively advancing the development of next-generation formulations of UGN-102 and Gelmite Up. The investigational new drug application for UGN-103 was accepted by the FDA, enabling us to proceed to clinical trials. We plan to initiate a Phase III trial of approximately 87 patients before year-end.

Mark P. Schoenberg: Meaningful improvement over surgery, and reducing recurrence risk and prolonged disease free intervals for patients while lowering the overall treatment burden on patients.

Mark P. Schoenberg: As Liz mentioned, we are actively advancing the development of next generation formulations of UGI, and one or two and Joe might have.

Mark P. Schoenberg: Investigational new drug application for <unk> in one of the three was accepted by the FDA, enabling us to proceed to clinical trials, we plan to initiate a phase III trial of approximately 87 patients before year end. Additionally.

Jeffrey Bova: Additionally, we are progressing with the development of UGN-104, a next-generation formulation of gelmito, to begin sometime thereafter. Additionally, beyond our LEAD programs, we continue to develop our immuno-oncology candidate, UGN-301. UGN-301 is comprised of an anti-CTLA-4 antibody delivered using our proprietary RTGL technology. We are conducting a Phase I clinical study to evaluate safety and to establish a recommended Phase II dose for UGN-301 as monotherapy as well as in combination therapy. We hope to report safety and tolerability data from the monotherapy arm by late 2024.

Mark P. Schoenberg: Additionally, we are progressing with the development of Eugene One O for a next generation formulation of <unk> to begin sometime thereafter.

Mark P. Schoenberg: And our lead programs, we continue to develop our immuno oncology candidate <unk> 301, and 301 is comprised of an anti <unk> four antibody delivered using our proprietary Archie Archie gel technology.

Mark P. Schoenberg: We are conducting a phase one clinical study to evaluate the safety Tolerability and establish a recommended phase two dose for <unk> 301, as mono as well as combination therapy.

Mark P. Schoenberg: We hope to report safety and Tolerability data from the monotherapy arm by late 2024, we.

Jeffrey Bova: We have also initiated combination therapy arms evaluating UGN-301 plus gemcitabine and UGN-301 plus UGN-201, our proprietary formulation of imiquimod, a TLR7 agonist, in high-grade NMIPC patients. We believe we have a unique approach in this area and look forward to providing updates as the program moves forward. Now, over to Jeff for a commercial update.

We have also initiated combination therapy arms evaluating <unk> 301, plus Gemcitabine and <unk> 301, plus <unk> 201, our proprietary formulation of <unk>, a <unk> seven agonist and high grade <unk> patients. We believe we have a unique approach in this area and look forward to providing updates as.

Mark P. Schoenberg: The program moves forward now over to Jeff for a commercial update.

Jeffrey Bova: Thank you, Mark. Gelmido net sales were $18.8 million in Q1. Seasonality trends in the first quarter, which are characterized by deductible resets in January and February, were magnified compared to prior years. As Liz mentioned, patient enrollment forms were the highest ever in Q1, indicating strong demand. We're seeing an improvement in the conversion trend in Q2 with a normalized path to new patient initiation, leading to a reduction in the gap between enrollments and units sold. The data from the current quarter is on track with expectations of continued growth for gelmido sales and remains aligned with full year revenue guidance. We anticipate typical seasonality dynamics throughout the rest of the year.

Thank you Mark Joe Midol net sales were $18 8 million in Q1 seasonality trends in the first quarter, which are characterized by deductible resets in January and February were magnified compared to prior years as Liz mentioned patient enrollment forms with the highest ever in Q1, indicating strong demand.

Mark P. Schoenberg: Seeing an improvement in the conversion trend in Q2 with a normalized path to new patient start leading to a reduction in the gap between enrollments and units sold.

The data from the current quarter is on track with expectations of continued growth for <unk> sales and remain aligned with full year revenue guidance, we anticipate typical seasonality dynamics throughout the rest of the year.

Jeffrey Bova: As Mark stated, AUA was very productive, meaning with multiple data readouts, reinforcing the value of gel mice. We have promptly integrated the post-hoc long-term follow-up data from the Olympus trial into our field operations to further enrich engagement with Urali. These data, which complement the already robust body of real-world outcomes data, will serve as a powerful evidence-based resource reinforcing discussions about gelmido's ability to deliver complete response rates and prolonged durable disease-free periods. For UGN 102, the pre-commercialization plan is well underway, targeting an early 2025 launch. As we get closer to the approval date, we will add a modest number of additional reps to our existing field sales force.

Mark P. Schoenberg: As Mark stated it was very productive meeting with multiple data readouts reinforcing the value of Joe might know we have promptly integrated the post hoc long term follow up data from the Olympus trial into our field operations to further enrich engagement with urologists.

Mark P. Schoenberg: These data, which complement the already robust body of real world outcomes data will serve as a powerful evidenced based resource reinforcing discussions about John <unk> ability to deliver complete response rates and prolonged durable disease free periods.

Mark P. Schoenberg: For UGI and wanted to the pre commercialization plan is well underway.

Mark P. Schoenberg: <unk> in early 2025 launch as.

Mark P. Schoenberg: As we get closer to the approval date, we will add a modest number of additional reps to our existing field sales force.

Jeffrey Bova: There's approximately a 95% prescriber overlap with Jelmido, and we plan on leveraging our commercial organization to execute extreme line loss. As mentioned earlier, there is a strongly recognized unmet need amongst both urologists and patients for a new treatment option that has the potential to reduce recurrence risk and prolong disease-free injury. Importantly, our research indicates a strong patient preference for non-surgical options that can reduce their overall treatment burden. Supported by a simple method of administration and robust clinical data, if approved, we are poised to transform the way patients with low-grade, intermediate-risk, non-muscle-invasive bladder cancer are treated.

Mark P. Schoenberg: There is approximately a 95% prescriber overlap with Joe and Idaho, and we plan on leveraging our commercial organization to execute extremely in March.

Mark P. Schoenberg: As mentioned earlier, we were strongly recognized unmet need amongst both urologists and patients for a new treatment option that has the potential reduced recurrence risk and prolong disease free intervals.

Mark P. Schoenberg: Importantly, our research indicates a strong patient preference for non surgical options. They can reduce their overall treatment burden.

Supported by a simple method of administration and robust clinical data. If approved we are poised to transform the way patients with low grade intermediate risk non muscle invasive bladder cancer are treated.

Jeffrey Bova: UGN-102 provides sustained chemoablation directly to the bladder tissue to treat both visible lesions and the underlying pathology, and the clinical data we have generated suggest that UGN-102 appears to be superior to the current surgical standard of care. We know that 70% of patients face multiple cycles of recurrence and surgical resection over time. Our market research reflects urologists' concern about high recurrence rates and a strong desire for new treatment options that may prolong disease-free intervals.

Mark P. Schoenberg: <unk> hundred to provide sustained chemo ablation directly to the bladder tissue to treat both visible lesions and the underlying pathology and the clinical data. We have generated suggest that <unk> 102 appears to be superior to the current surgical standard of care.

Mark P. Schoenberg: We know that 70% of patients face multiple cycles of recurrence and surgical resection overtime.

Mark P. Schoenberg: Our market research reflects urologists concerned about high recurrence rates and a strong desire for new treatment options that may prolong disease free intervals.

Jeffrey Bova: We also anticipate that economic factors will not hinder urologists' adoption of UGN-102 as the treatment will be delivered in the physician's office. Our launch preparations are sharply focused on removing any logistical, operational, and financial barriers to use so that urologists can use UGN-102 worry-free based on their conviction behind clinical merit alone. UGN 102 also has the advantage of being easy to administer, either by the doctor, nurse, or extender, offering a substantial benefit in terms of patient and doctor convenience.

We also anticipate that economic factors will not hinder urologist adoption of <unk> in one or two as the treatment will be delivered in the physician's office.

Mark P. Schoenberg: Our launch preparations are sharply focused on removing any logistical operational and financial barriers to use so that urologists can use 100 to worry free based on their conviction behind clinical merit alone.

Mark P. Schoenberg: UGI and wanted to also has the advantage of being easier easy to administer either by the doctor nurse or extender offering a substantial benefit in terms of patient and doctor convenience.

Jeffrey Bova: This streamlined approach enhances the experience for the patient and simplifies the treatment process considered. Based on market research, we believe the fastest adoption for UGN-102 will initially occur in three groups of patients. These are patients who have had multiple recurrences, those that would be considered surgical failure, patients with early recurrence, and patients who are ineligible or unwilling to undergo surgery.

Mark P. Schoenberg: This streamlined approach enhances the experience for the patient and simplified the treatment process considerably.

Mark P. Schoenberg: Based on market research, we believe the fastest adoption for UGI unwanted too will initially occur in three groups of patients.

Mark P. Schoenberg: These are patients who have had multiple recurrences those that would be considered surgical failures.

Mark P. Schoenberg: Patients with early recurrence and patients who are ineligible or unwilling to undergo surgery.

Dong Kim: Our goal for UGN 102, if approved, is to achieve broad adoption, and we are confident physicians will have a positive experience and broadly adopt it. We will keep you updated as we address key insights into our plans as we prepare. I will now turn the call over to Dong Kim to discuss our financial results.

Mark P. Schoenberg: Our goal for EOG on one or two if approved is to achieve broad adoption.

Mark P. Schoenberg: And we are confident physicians will have a positive experience and broadly adopt.

Mark P. Schoenberg: We will keep you updated as we address key insights into our plans as we prepare for launch.

Mark P. Schoenberg: I will now turn the call over to Don Kim to discuss our financial results.

Dong Kim: Thank you, Jeff. Revenue comprised of JEremitor sales for the three months ended March 31st, 2024 was $18.8 million, compared with $17.2 million in the comparable period in 2023. Cost of revenue was $1.7 million in the first quarter of 2024 compared with $2.3 million in the comparable period of 2023. The overall decrease of $0.6 million is primarily attributable to certain non-recurring payments made in connection with our supply arrangement in the prior year, decrease in mixing fees, and decrease in the gel micro per unit cost.

Dong Kim: Thank you Jeff revenue comprised arbitrary Mitra says for the three months ended March 31, 2024 was $18 8 million compared with $17 $2 million in the competitive appear in 2023.

Dong Kim: Cost of revenue was a one point to $7 million in the first quarter over 2024, compared with $2 $3 million in the comparable period of 2023.

Dong Kim: The overall decrease over $6 million is primarily attributable to certain nonrecurring payments made in connection with our supply arrangements in the prior year.

Dong Kim: In mixing fees and decrease in the gym, Mike of per unit cost.

Dong Kim: R&D expenses were $15.5 million and $12.5 million for the first quarters of 2024 and 2023, respectively. The year-over-year increase was primarily a result of regulatory-related expenses in connection with UGM-102, as well as R&D expenses in connection with the initiation of our Phase III study for UGM-103.

Dong Kim: R&D expenses were $15 5 million.

Dong Kim: And $12 5 million for the first quarters of 2024 and 2023, respectively.

Dong Kim: The year over year increase was primarily a result of regulatory related expenses in connection with the user on the tool as well as R&D expenses in connection with the initiation of our phase III study for <unk> 103.

Dong Kim: Selling general and administrative expenses for the first quarter of 2024 were $27.3 million, including non-cash share-based compensation expense of $2.2 million. This compares to $24.5 million, including non-cash share-based compensation expense of $1.8 million for the same period in 2023. The increased year-over-year was primarily attributable to UGN-102 brand marketing costs. Interest expense was $2.4 million and $3.6 million for the first quarters of 2024 and 2023, respectively. The decrease was primarily attributed to the decrease in the margin interest rate and the related impact on amortization of the discount on the Pharmacon loan as a result of the amended and restated loan agreement in March 2024.

Dong Kim: Okay.

Dong Kim: Selling general and administrative expenses for the first quarter over 2024, or 27 $3 million, including noncash share based compensation expense of $2 2 million.

This compares to 24 point to $5 million, including noncash share based compensation expense of $1 8 million for the same period in 2023.

Dong Kim: The increase year over year was primarily attributable to use gen, one or two brand marketing costs.

Interest expense was two point to $4 million and three points of $6 million for the first quarters of 2024 and 2023, respectively.

Dong Kim: The decrease was primarily attributed to the decrease in the margin interest rate and the related impact to amortization of the discount on the pharma upon alone as a result of the amended and restated the agreement in March 2024.

Operator: The net loss was $32.3 million, or $0.97 per share, and $30.2 million, or $1.30 per share, for the first quarters of 2024 and 2023, respectively. As of March 31st, 2024, we had $164.5 million in cash, cash equivalents, and marketable security. During the first quarter, we utilized our ATM facility for gross proceeds of approximately $56 million. Today, we are reiterating our full year 2024 Net Product Revenues guidance from GERMITAL to be in the range of $95 to $102 million.

Dong Kim: Net loss was $32 3 million.

Dong Kim: <unk> 97 per share.

Dong Kim: And $32 million or $1 <unk> per share for the first quarters of 2024 and 2023, respectively.

Dong Kim: As of March 31, 2024, we had 164 point to $5 million in cash cash equivalence and marketable securities.

Dong Kim: During the first quarter, we utilized our ATM facility for gross proceeds of approximately $56 million.

Dong Kim: Today, we are reiterating our full year 2024, net product revenues guidance from <unk> to be in the range of $95 million to $102 million.

Operator: We expect full year 2024 operating expenses in the range of $175 to $185 million, including non-cash share-based compensation expense of $6 to $11 million, subject to market conditions. The anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW investments is expected to be in the range of 21 to 26 million dollars; of this amount, approximately $12.4 to $13.3 million is expected to be in cash. For further details of our financials, please refer to our quarterly report on FOM10Q, which has been filed with the SEC. We are now ready to open the call to questions. Operator.

Dong Kim: We expect full year 2020 for operating expenses in the range of $175 million to $185 million.

Dong Kim: Including noncash share based compensation expense of $611 million.

Dong Kim: Subject to market conditions.

The anticipated full year 2024, non cash financing expense related to the prepaid obligation to RTW reinvest months.

Dong Kim: <unk> to be in the range of 21% to $26 million.

Dong Kim: Of this amount approximately 12 four to $13 $3 million is expected to be in cash.

Dong Kim: For further details of our financials. Please refer to our quarterly report on Form 10-Q, which has been filed with SEC.

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

Operator: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A list. Our first question comes from the line of Tara Bancroft of TD Cowen. Your line is now

Speaker Change: Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced towards higher question. Please press star one again, please standby, while we compile the Q&A roster.

Jeffrey Bova: Thank you. Jeff, why don't you take this?

Speaker Change: Our first question comes from the line of <unk> <unk> of Cowen. Your line is now open.

Cowen: Hi, good morning, So I am wondering if you could tell us approximately how many patients are included in each of the three buckets that you mentioned of initial adopters and which of those you think may be the most robust users and then.

Cowen: From there how do you imagine adoption to look over time, especially as you continue your education and awareness efforts.

Jeffrey Bova: Yeah, thanks, Tara. So the unwilling or unfit for surgery are around 10% of patients. We believe that's a conservative number because really, there are no other choices but to have to do surgery. But in a conservative number around 10%, 10 to 15% are unwilling or unfit for surgery. About 25%, 23% from Medicare data tells us that they have five or more recurrences. So you're a frequent recurrence. And then that same number is also an early recurrence.

Speaker Change: Thank you.

Speaker Change: Jeff why don't you take that yes, I think thanks.

Jeffrey Bova: Thanks Tara.

Jeffrey Bova: Unwilling or unfit for surgeries around 10% of patients. We believe that's a conservative number because really there are no other choices, but to have to do with surgery.

Jeffrey Bova: But in a conservative number around 10%, 10% to 15% are unwilling or unfit for surgery.

Jeffrey Bova: 25% 23 for Medicare data tells us that they have five or more recurrence.

Jeffrey Bova: Your frequent recurrence and then that same numbers also early returns so a quarter the patients will have.

Jeffrey Bova: So a quarter of the patients will have a recurrence within six to nine months. So a good number of patients that physicians have told us really will benefit from UGM 102. And then your second question was around adoption.

Recurrence within six to nine months. So a good number of patients that physicians have told us really Jan one or two will have a benefit for.

Jeffrey Bova: And then your second question was around adoption certainly I think those three areas will be where it's adopted.

Elizabeth A. Barrett: Certainly, I think those three areas will be where it's adopted the soonest. And then it's imperative that the commercial team drives that adoption to have one or two available to every patient, whether it's newly dead, depending on the label, whether it's newly diagnosed, or someone that's had a previous. Yeah, I guess the only thing I'll add to that is we do expect the adoption curve to be faster than what we've seen with Jelmido for a few reasons, mainly what Jeff has talked about in the sense of how much easier it is to give.

Jeffrey Bova: The soonest.

Jeffrey Bova: And then it is imperative that the commercial team drive that adoption.

Jeffrey Bova: To have one or two available to every patient whether its newly direct spending on the label whether its newly diagnosed or someone that's had a previous to your RBC.

Jeffrey Bova: Yes.

Speaker Change: The only thing I'll add to that is we do expect.

Speaker Change: Adoption curve to be faster than what we've seen with Yamato for IP reasons that immuno mainly with Jeff has talked about in the center.

Elizabeth A. Barrett: And, and, you know, that being the case, and the knowledge and experience that a lot of these physicians already have with our current medicine, so we expect that to be much quicker than it was for Jelmido. But even if it had the same adoption curve as Jelmido, again, being 10 times the size, you know, you can do the math, right? If you look at what we did last year, over $80 million in revenue for Jelmido, if you just said it was the same and, you know, third year on the market, what would it look like? It's something like that, so that would be a good analogy. Okay, thanks so much.

Speaker Change: Hum.

Speaker Change: How much easier it is to give.

Speaker Change: And that being the case and the knowledge and experience that a lot of these physicians already have with R.

Speaker Change: Our current medicines that we expect that to be much quicker than that than it was for <unk>, but even even if it were the same adoption curve for <unk> again beyond 10 times. The size you can do the math right.

If you look at what we did last year over $80 million in revenue far spreads Yamato. If you just said if it's sustained and in a third year on the market what would it look like it's something like that so that would be a good analogue.

Speaker Change: Okay. Thanks, so much.

Speaker Change: Thank you Mahmud for next question.

Operator: Thank you one moment for our next question. Our next question comes from the line of Raghuram Selvaraju of HC Wainwright & Co. Your line is now open.

Speaker Change: Our next question comes from the line of Robert <unk> of H C. Wainwright <unk> co. Your line is now open.

Unknown Attendee: Thanks very much for taking my questions. Just with respect to reimbursement for UGN-102, I was wondering if you could give us some granularity on the following. Firstly, do you think that there might be potential upside to your envisaged pricing range and what factors might influence that from a clinical data efficacy profile perspective? Secondly, maybe Jeff, you could explain a little bit about how a J-code might work in the case of UGN-102 or, if it's not applicable, why?

Robert: Thank you very much for taking my question just with respect to reimbursement for Upa in one or two I was wondering if you could give us some granularity on the following firstly do you think that there might be potential upside to your envisaged pricing range.

Robert: Factors might influence that from a clinical data efficacy profile perspective, secondly, maybe Jeff you could explain a little bit about how.

Robert: J code might work in the case of UPN, one or two or not applicable why it might not be applicable and then lastly.

Unknown Attendee: And then lastly, if you're talking about an incremental expansion of the salesforce, can you just remind us what the salesforce headcount is currently and how you expect that to change as and when UGN 102 is approved and launched? Thank you.

Robert: If you're talking about an incremental expansion of the sales force can you just remind us what the sales force head count is currently and how you expect that to change as and when you Jan one or two is approved and being launched.

Unknown Executive: Sure. Thanks, Ram.

Speaker Change: Sure. Thanks, Ron I'll take that first one on pricing and then turn it over to Jeff for the other two questions, but yes, we do see upside versus what we've communicated in the past.

It's going to be a real balance.

Elizabeth A. Barrett: I'll take this first one on pricing and then turn it over to Jeff for the other two questions. But yes, we do see upside versus what we've communicated in the past. I think it's going to be a real balance.

Speaker Change: Again this treatment is for low grade disease, so low grade disease versus high grade disease. So the pricing is different but we absolutely will.

Jeffrey Bova: I think the final data that's going to be shared in June. We will also have an impact on that so to your point what factors impacted obviously when our data came out last year, we had already done pricing research that gave us an opportunity to push the upper bounds of that and I think.

Elizabeth A. Barrett: Again, you know, this treatment is for low-grade disease, so low-grade disease versus high-grade disease, so the pricing is different. But we absolutely will, you know, and I think the final data that's going to be shared in June will also have an impact on that. So, to your point, what factors impacted, you know, obviously, when our data came out last year, we had already done pricing research. That gave us an opportunity to push the upper bounds of that.

Elizabeth A. Barrett: And I think, you know, given the data that we expect in June, may be the same thing. So, we will finalize the pricing, obviously, you know, before launch, but we haven't done so now. And I can tell you that we're looking at a higher range and even a little bit higher than what we've talked about. So, Jeff.

Jeffrey Bova: Given the data that we expect in June.

Jeffrey Bova: It may may be the same things that we will finalize the pricing obviously, we have before launch, but we havent now, but I can tell you that we're looking at a higher range and even a little bit higher than what we've talked about it in the past.

Jeffrey Bova: Yeah, and let me comment on the J code. So, yes, we will eventually have a permanent J code. Like all Part B drugs, though, we will have a miscellaneous code until CMS reviews it. The nice thing, as we saw with Gelmido, is that we were approved in the second quarter of 2020. You then apply for that permanent J code the following quarter. They take a quarter to review, and we had a permanent J code in January of 2021. So depending on our approval timing, that will be the process. But the nice thing is that they're reviewing these quarterly now versus annually.

Jeffrey Bova: Jeff.

Let me comment on the J code. So yes, we will eventually have a permanent J code like all part B drugs, though we will have a miscellaneous code until CMS reviews. The nice thing as we saw with <unk>. We were approved in the second quarter of 2020, you then apply for that permanent J code. The following.

Quarter, they take a quarter to review and we had a permanent J code January of 2021, so depending on our approval timing that will be the process.

Jeffrey Bova: But the nice thing is is that they are reviewing these quarterly now versus annually. So I expect that same process to take place for UGI and 102.

Jeffrey Bova: So I expect that same process to take place for UGN 102. At current headcount, we do have around seven regions and 45 territory business managers. Those are the reps supported by the reimbursement team, nurses, as well as key account directors and FRMs. We will expand one region; we will go from seven to eight. And we're kind of finalizing right now the number of representatives, but anywhere between, you know, 10 and 15 representatives as well, followed up by support functions as well. So hopefully

Jeffrey Bova: Current head count we do have around seven regions 45 territory business managers. Those are the reps supported by reimbursement team nurses as well as key account directors and fr rounds.

Jeffrey Bova: We'll expand one region, we will go from 7% to eight and we're kind of finalizing right now the number of representatives, but anywhere between 10 and 15 representatives.

Jeffrey Bova: As well followed up by those support functions as well so hopefully that helps.

Unknown Attendee: Very helpful. And just as a quick follow-up to that, I don't know whether Liz or Don would you like to comment on how you expect the GNA infrastructure of the company to change in the wake of UGN 102's approval, or if you don't really expect much change on that front. Thank you.

Speaker Change: Very helpful and just as a quick follow up to that.

Speaker Change: Don't know whether live or.

Speaker Change: Don you want to comment on how you expect the G&A infrastructure of the company to change in the wake of <unk> approval or if you don't really expect much change on that front. Thank you.

Dong Kim: Yeah, Don. Do you just want to comment on GNA? Absolutely.

Speaker Change: Yes, Don do you want to comment on G&A.

Dong Kim: So thanks, Ron. So basically, we don't see that much difference after this year. So this year, we are going to spend some money to build an inventory and build some sales force, but then it will be pretty consistent. Liz, do you want to add? Nope, I think that's correct.

Dong Kim: So no. Thanks, Rob So basically no we don't see accident multifunctional. After this year. So this year, we haven't spent some money to build of inventory and into some sales.

Dong Kim: Sales force, but then it will be pretty consistent.

Elizabeth A. Barrett: Nope, I think that's correct. Thank you.

Dong Kim: No I think Thats correct.

Speaker Change: Thank you.

Operator: Thank you one moment for our next question. Our next question comes from the line of Matt Kaplan of Leidenberg Daumen. Your line is now open.

Speaker Change: Thank you gentlemen for next question.

Speaker Change: Our next question comes from the line of Matt Kaplan of Ladenburg Thalmann. Your line is now open.

Unknown Attendee: Hey, good morning, guys. Just as we're nearing a month out, the envisioned study, 12 month durability data. Can you give us a little bit more detail in terms of what we should be looking for? And then Liz, you commented on, depending on that data, some pricing upside, and what would drive that in terms of the durability data?

Matthew Lee Kaplan: Hey, good morning, guys.

Matthew Lee Kaplan: Just as we know we are nearing months out the envision study 12 months durability data.

Matthew Lee Kaplan: Can you give us a little bit more detail in terms of what we should be looking for and then Linda you commented on depending on that data some pricing upside and what would drive that in terms of durability data as well.

Elizabeth A. Barrett: Yeah, so, um... I mean, I guess I'm not really sure if you're saying what we expect the number to be or what we expect to see just from a, you know, from a perspective of what you'll see. Obviously, we'll share the 12 month durability and any, you know, update on safety and, you know, and what our current expectations are even beyond. So we'll be estimating. So we'll be able to share sort of, you know, estimates of the kind of median where we expect the median to be.

Linda: Yes so.

Linda: I mean, I guess the crime not really sure if youre, saying what.

Linda: We expect the number to be or where do we expect to see just from me.

Linda: From a perspective of what Youll see obviously, well share that 12 month durability and any update on.

Linda: Safety.

And what our current expectations are even beyond that will be estimating so we'll be able to share sort of estimates of kind of media and where we expect the median to be and so a lot of great data and my point around pricing is obviously the better that data is.

Elizabeth A. Barrett: And so, you know, a lot of great data. And my point around pricing is obviously the better that data is, you know, the better value that we'll be giving patients and physicians and the practice and the health care system. And that will, you know, that's where we've been from a pricing standpoint. So that's our expectation for what would be, quote, unquote, a win. You know, I would say, without saying too much, we believe that if you look at the Atlas data and where we were on the 12 month data there, those patients were 69% for all recurrent patients, and the patients that had a prior TRBT were 66%. So, you know, anything in that area or above would definitely be a home run. So, you know, we're excited again to share that data in June. [inaudible]

Linda: The better value that will be giving patients and physicians in their practice and the health care system.

Linda: That well.

Linda: Where we've been from a pricing standpoint, so that's our expectation for what would be quite I'm quite a win.

Speaker Change: I would say with without saying too much.

Speaker Change: We believe that if you look at the Atlas data and where we borrow in the 12 month data there.

Speaker Change: And those patients are 69% for all recurrent patients and the patients that had had a priority RPT was 66%. So anything in that area are Bob we would definitely they will likely be a homerun. So we're excited again to share that data in June.

Unknown Attendee: Thanks, Elizabeth. That's really helpful. And then, in terms of maybe for Don, the impacts of the discounts associated with the Medicare refunds and for unused drugs and G40B purchases, what was the magnitude of that impact in the quarter? And then what should we expect kind of going forward throughout the year?

Speaker Change: Alright.

Speaker Change: Really helpful and then.

Speaker Change: In terms of maybe for Don the impacts of the discounts associated with the Medicare responds and con used drug and <unk> purchases.

What was what was the magnitude of that impact in the in the quarter and then what should we expect kind of going forward throughout the year.

Speaker Change: Yeah, So Don.

Dong Kim: Yeah, so for I think it's better in the chest to answer, but in general, we expect a similar number in terms of overall gross net, but with regard more specifically, like, you know, 340, 340 B, or the wastage provision, we expect it to be more favorable to Eurogen for one or two over Jeremiah, and Jeffrey, do you want to add anything?

Dong Kim: Yes, so Paul I think are better and the test.

Dong Kim: But in general we expect a similar.

Dong Kim: Number in terms of overall gross net but we've got more specifically like in the three body three fully be ore wastage provision, we expect more favorable to euros in.

Dong Kim: One or two or so.

Dong Kim: Michael and Jeff fleets at anything.

Jeffrey Bova: Yeah, I think the percentage for Gelmido will remain the same from the wastage provision. Obviously, the more we sell, that will be impacted. But I don't see 340B. It does vary quarter to quarter. But I just want to reiterate, Matt, that 102 should not have either of those impacts. The bladder can expand, and we can deliver all of 102, so we won't be impacted there as well as most of it will eventually be given in the clinic. So it is not as impacted from a 340B.

Dong Kim: Yes.

Speaker Change: I think the percentage for John <unk> will remain the same from the.

The wastage provision obviously the more we sell.

Speaker Change: It will be impacted but.

Speaker Change: I don't see 340 B.

Speaker Change: It does vary quarter to quarter, but just want to reiterate Matt that one or two should not have that either one of those impacts from the bladder can expand.

And we can deliver all of 102, so we won't be impacted there as well as most of this will eventually be given in the clinic, so not as impacted from a 340 bps standpoint.

Unknown Attendee: Okay, okay, that's good. And then, maybe from Mark, in terms of development pathways for next-gen products, 103 and 104. I guess, what will it take to get these products to market? Are you contemplating just single Phase III studies for each?

Matthew Lee Kaplan: Okay. Okay. That's good and then last question Mark in terms of development pathways for Nexgen products 103 and 104.

Speaker Change: Yes, what will it take to get these products and market are you contemplating just single phase III studies for each.

Unknown Attendee: Matt, thanks. So I think it's probably a little bit premature for us to say exactly how this is going to play out because we are, as you know, not only developing information about 301 for monotherapy, but the basis of this program is really a combination program using two drugs of different types. So it might be a combination immunotherapy with two different immunomodulators, immuno plus chemo. So we know we're going to have, as Liz has alluded to earlier, safety data, and a phase two recommended dose later this year, and we'll report on that for 301.

Matt. Thanks, So I think it's probably a little bit premature for us to say exactly how this is going to play out because we are as you know not only developing information about 301 are for monotherapy, but the basis of this program is really a combination program.

Matthew Lee Kaplan: Two drugs of different types. So it might be a combination of immunotherapy with two different immuno modulator immuno plus.

Matthew Lee Kaplan: Plus chemo. So we know we're going to have as was alluded to earlier.

Unknown Attendee: But as we collect more data on the combinations, we'll probably be able to talk a little bit more about what the development pathway looks like for the most promising of these combinations. It's probably as much as I should say, but Liz may want to comment as well.

Matthew Lee Kaplan: Safety data.

Speaker Change: In a phase two a recommended dose later this year and we'll report on that 301, but as we elaborate more data on the combinations will probably be able to talk a little bit more about what the development pathway looks like for the most promising of these combinations is probably as much as I should say, but let's maybe want to comment as well.

Elizabeth A. Barrett: No, nothing additional unless you Matt had any additional questions just making sure you were talking about 301 and

Speaker Change: No nothing additional unless you had any additional questions just making sure you were talking about 301 and not one of three and four.

Unknown Attendee: Yeah, I had kind of targeted 103, 104, but... Oh, I'm sorry. I misheard it. So... Yeah, no. I apologize. Yes, single Phase III studies smaller than what we required for our original approvals, smaller, for example, than envisioned, but we expect Phase III studies to be adequate to achieve approval for those new next-generation products for both gel Mito and for 102. Sorry, I misunderstood the question. Yeah, we all...

Speaker Change: Yeah.

Speaker Change: I had kind of targeted $1 314, but im sorry talent.

So yes.

Yes, I apologize yes.

Speaker Change: Single Phase III study is smaller than what we were required tomorrow for original approvals smaller for example than envisioned but we expect phase III studies to be adequate to achieve approval for those new next generation products for both <unk> and for one or two sorry, I misunderstood the question.

Elizabeth A. Barrett: Yeah, which is why we expect the approval to be obviously much quicker because, you know, we don't have to enroll as many patients and therefore, you know, our enrollment, you know, should, you know, we will finish our enrollment for 102 and 25 and, therefore, we will have follow-up and filing in 26 for UGM 103, which is the next generation for UGM 102. Thanks guys. Thanks guys. Thank you.

Speaker Change: Yes, which is why we expect the approval to be obviously much quicker because we don't have to enroll as many patients and therefore our enrollment.

Speaker Change: We'll finish our enrollment.

Speaker Change: For one or two in 'twenty five and therefore.

Speaker Change: You have follow up and filing in 2006 for you Jim.

Speaker Change: <unk>, which is the next generation for you Jan one or two.

Speaker Change: Got it thanks guys.

Operator: Thank you, one moment, for our next question. Our next question comes from the line of Leland Gershell of Oppenheimer. Your line is now open.

Thank you.

Speaker Change: Thank you next question.

Speaker Change: Our next question comes from the line of <unk> of Oppenheimer. Your line is now open.

Unknown Attendee: Hey, good morning. Thanks for taking our questions. A couple from us.

Oppenheimer: Hey, good morning, Thanks for taking our questions.

Oppenheimer: A couple from us.

Oppenheimer: The company in the past.

Oppenheimer: That said that there's sort of a 50% are with respect to this 12 months, but when you get the sense.

Unknown Attendee: The company in the past has said that there's sort of a 50% bar with respect to the 12-month durability data from Envision. I'm just wondering what that means when you say bar and how we should think about that number versus the higher numbers that you mentioned, 102. And then just another question for Mark. I wasn't sure if you would mention when we would see the data and if it's one of the data for 301.

Oppenheimer: Envisioned I'm just wondering how we should interpret what that means when you say.

Oppenheimer: And how we should think about.

Oppenheimer: That number versus the higher numbers that you mentioned can you clarify on this fall.

Oppenheimer: With respect to.

Oppenheimer: The level of enthusiasm for urologists to adapt.

Speaker Change: One or two.

Speaker Change: And then just another.

Speaker Change: Another question for Mark.

Mark P. Schoenberg: I wasn't sure if you mentioned when we would see the data and if the clinical data for 301.

Mark Schoenberg: Yes.

Speaker Change: I would like to know when we might see that thank you.

Mark P. Schoenberg: So Mark, do you want to talk about, you know, sort of the 50% that we've always talked about? Sure. That'd be great.

Speaker Change: So mark do you when I talk about sort of the 50% that we've always talked about sure.

Mark P. Schoenberg: Cases that would be.

Mark P. Schoenberg: And then yes, yes sure.

Mark P. Schoenberg: Sure, Yes, Leland thanks, so with respect to the bar.

Speaker Change: Maybe just to clarify.

Mark P. Schoenberg: on this call, I have heard Liz say publicly before that when we started the 102 program, the 50% number was a number we came up with as a projection of what we thought would be clinically meaningful. We know from conversations with urologists, and I can say independently, you know, from a clinical perspective, that a number lower than that would be clinically meaningful in terms of its practical utility in taking care of this chronically recurrent patient population.

Leland: I think many people on this call have heard Liz said publicly before that when we started the one or two program with 50% number was the number we came up with is a projection of what we thought would be clinically meaningful we know from conversations with urologists and I can see independently.

Leland: From a clinical perspective that a number lower than that would be clinically meaningful in terms of its practical utility and taking care of this chronically recurrent patient populations. Nonetheless, this 50% number was our projection now as you've noted the data we have.

Mark P. Schoenberg: Nonetheless, this 50% number was our projection. Now, as you noted, the data we've provided from our clinical trials are actually better than that 50% number. And as Liz was saying, remember also that Envision, unlike Atlas, is a pure recurrent population of patients. So when we look at the Atlas subgroup of recurrent patients, we know that for those who had a prior QRBT, and that is essentially the Envision population in microcosm, the durability data were 66% at that important 12-month follow-up time point.

Leland: We've provided from our clinical trials are actually better than that 50% number and as Luke was saying remember also that envision. Unlike Atlas edition is a pure recurrent population of patients. So when we look at the outwith subgroup of recurrent patients we know but for those who had a prior <unk> and that is essentially be envisioned.

Leland: Duration in microcosm, the durability data we're 66%.

Mark P. Schoenberg: So we think, as Liz said earlier, that something in the mid-60s is likely to be what we would be looking for and what we would consider to be very successful and consistent with our prior experience. So again, the 50% was a projection. The 66% is what we actually know empirically from our own clinical trials program. That's what we're projecting.

At the <unk>.

Leland: 12 months at that important 12 months of follow up time point. So we think as was said earlier.

Leland: Something in the mid sixties.

Leland: We would be what we would be looking for and what we would consider to be very successful and consistent with our prior <unk>.

Leland: <unk>.

Leland: So again, 50% was a projection to 66% is what we actually know empirically from our own clinical trials program. That's what we're projecting we'll see if something like that and envision and then just to answer the final question with respect to 301.

Mark P. Schoenberg: We'll see if something like that happens in Envision. And then just to answer the final question with respect to 301, later this year is what we said in terms of when we'll be able to provide safety data and a recommended phase two dose. When exactly is not clear, but certainly by the time we have the SEO meeting at the end of the year, which is where we would probably present those data. I hope that's it.

Leland: Later this year is what we've said in terms of when we'll be able to provide safety.

Leland: Data and a recommended phase two dose when exactly is not clear, but likely certainly by the time, we have the suo meeting at the end of year, which is where we would probably present those data.

Unknown Attendee: No, thank you. And then one more, if I may, you know, given other chemo agents, like the GEM, cytogene, dostexyl, regimen, and in BCG, now you've high grade shown to have benefits. I'm wondering if you're looking at other chemo agents as part of the gel formulation for greater dwell time and perhaps better results.

Speaker Change: I hope that's helpful.

Speaker Change: Thank you and then and then one more if I may given other chemo agents like the Gen <unk> regimen in <unk>.

Speaker Change: Hi, great.

Speaker Change: Sean to have Dennis I'm wondering if anything other chemo agents as part of the gel formulation compared to dwell time in federal mogul.

Mark P. Schoenberg: Liz, do you want to talk about that?

Speaker Change: Okay.

Speaker Change: Got it.

Unknown Attendee: Leland, if I understand you correctly, the question is, have we thought about putting gemcitabine in the gel? And the answer is, we've certainly talked about this.

Speaker Change: Unless you want to talk about that please.

Speaker Change: Please go ahead.

Speaker Change: So yes, so so leland if I understood. The question is have we thought about putting gemcitabine in the gel and the answer is we've certainly talked about this this may want to comment on some of the commercial and IP issues related to that but we know from a formulation perspective that our chemists are able to formulate a lot of <unk>.

Elizabeth A. Barrett: Liz may want to comment on some of the commercial NIP issues related to that, but we know from a formulation perspective that our chemists are able to formulate a lot of different drugs in the gel. And as we've said before, we can do combination therapy as well, where we can put more than one agent in the gel. So we certainly had that conversation, but again, I'm going to defer to Liz with regard to any future plans regarding the formulation of gem in the gel.

Speaker Change: Drugs in the gel as we've said before we know we can do combination therapy as well, where we can put more than one agents in the gel. So we certainly have that conversation, but again I'm going to defer to with regard to any future plans regarding the formulation of German Magellan.

Elizabeth A. Barrett: Yeah, so the comment I'll make on GEMS specifically, but then I'd like to, you know, just comment on kind of the broader utility in other ways. There wouldn't be any IP protection by the time we got to market.

Speaker Change: Yes, so the comment I'll make on Jim specifically, but then I'd like to just comment on kind of the broader utility in other ways as well.

Speaker Change: Won't be any IP protection by the time, we would get to market. So Jim side of being in our current Joe is not something that we would be moving forward with having said that we actually are in the process of looking at many other.

Elizabeth A. Barrett: So the GEMS side of being in our current gel is not something that we would be moving forward with. Having said that, we are actually in the process of looking at many other agents that are either in the market or in development in the market, frankly, at all stages and all types, whether it be chemotherapy or target agencies or viruses. We're doing a whole landscape about what would be our next product, but particularly as we move into high-grade gel.

Agents that are better in the either in the market or in development in the market frankly at all stages and all types, whether it be chemotherapy or target agencies, the pilot and we're doing it while landscape about.

That would be our next product, particularly as we move we move into to high grade disease, and the 301 program very important and high grade disease, because we do have long IP with the Cta for so anything in combination with that would allow us to have.

Elizabeth A. Barrett: And the 301 program, very important in high-grade disease because we do have, you know, long IP with CTLA-4. So anything in combination with that would allow us to have, you know, would allow us to have that, which is why you'll see that, and you'll see combinations with CTLA-4 that, you know, will give us some IP as we move into high-grade disease. So a lot of things that we're looking at, both for low-grade disease and for high-grade disease, many different things. I think the complexity of bladder cancer is not necessarily really understood and appreciated by everybody, but there are a lot of different patients.

Speaker Change: Would allow us to have that that's the case.

Speaker Change: That being the case, which is why you'll see that you'll see combinations with <unk> four that will give us some IP as we move into high grade disease.

Speaker Change: A lot of things that we're looking at both for low grade disease and for high grade disease in many different and I think the complexity of a bladder cancer is not necessarily really understood and appreciated by everybody, but there are a lot of different patients and as you start to look at the <unk>.

Elizabeth A. Barrett: And as you start to look at the TAR data, you start to look at the CG data, it really, really does show that, you know, it really does show that everything works in different patient populations in different ways. And so, you know, we will definitely be developing multiple products as we go forward, you know, across these many different patient types. But, you know, I'm looking forward to hopefully sharing more about that later in the year as we prioritize, you know, where we want to go next.

Speaker Change: Tara data you start to look at the safety data.

Speaker Change: Really really does show that.

Speaker Change: Yes, it really does show that.

Everything works in different patient populations in different ways, and so we will definitely be prosecuting multiple products as we go forward across these many different patient types, but looking forward as I hopefully sharing more more about that.

Speaker Change: Later in the year as we as we prioritize where we want to go next but and then also suffice it to say that given given what we expect with new GM one or two there is there is also opportunity to Gucci and one or two into high grade disease, but even within populations like unwilling and unable on the broader low rate low.

Elizabeth A. Barrett: And then also suffice it to say that given what we expect with UGM-102, there's also, you know, an opportunity to move UGM-102 into high-grade disease. But even within populations like unwilling and unable in the broader low-grade, low-risk patient population, there's opportunity in this space, and we expect to begin to prosecute against that with our priorities obviously being our next generation, which allows us, because extended IP allows us to do more with UGM-103 and UGM-104. So, hopefully, that's helpful. Thank you. Thank you one more time.

Grade low risk patient population.

Speaker Change: The date of this space and we expect to continue.

Speaker Change: To begin to prosecute against that with our priority is obviously being our next generation, which allows us that extended IP allows us to do more with your GM one of three in EG and went out for so hopefully that's helpful. Leland.

Speaker Change: Alright, thank you.

Operator: Thank you one moment for our next question. Our next question comes from the line of Paul Choi of Coleman Sachs. Your line is now open.

Speaker Change: Thank you Paul and one for next question.

Kyuwon Choi: Our next question comes from the line of par Choi of Goldman Sachs. Your line is now open.

Unknown Attendee: Hi, everyone. Thank you so much for taking our question. This is Khalil calling in for Paul.

Kyuwon Choi: Hi, everyone. Thank you so much for taking my question. This is <unk>, calling in for Paul I guess, a quick confirmatory question for US and then a quick follow up.

Choi: You mentioned that the potential commercial launch of GGP in one or two might be.

Choi: More rapid than you might've, just given the prescriber overlap and slightly higher sales force just wondering if you could.

Choi: Maybe add some granularity on that and maybe just confirm that's what we're that's what you're trying to say and then.

Choi: For 301, you mentioned that you might provide some safety data later this year.

Choi: That's for the monotherapy data any any granularity on the timing of when you might provide an update regarding the combinations and just maybe some more granularity on your general idea about expansion into higher risk populations or high grade disease. Thank you so much.

Unknown Attendee: I guess a quick confirmative question for us and then a quick follow-up. You mentioned that the potential commercial launch of UGN 102 might be more rapid than Gelmido, just given the prescriber overlap and the slightly higher Salesforce just wanted to see if you could maybe add some granularity to that and maybe just confirm that's what we're trying to say. And then for 301, you mentioned that you might provide some safety data later this year.

Choi: Sure.

Speaker Change: I would just.

Speaker Change: Ill turn it over to Mark to talk about.

Speaker Change: About 301 and sort of what our expectation is there and then and then Jeff can answer the first questions sorry going backwards, but go ahead, Mark yes, sure. Thanks list so.

You as Lisa said earlier in the call. The 301 program is targeting high grade disease, and as I'm sure. The audiences, where when you start looking at patients with high grade disease. The natural place to take this sort of a program would be into the BCG I'm responsible refractory population.

Unknown Attendee: That's for the monotherapy data, any granularity on the timing of when you might provide an update regarding the combinations, and just maybe some more granularity on your general idea about expansion into higher risk populations or high-grade disease. Thank you so much.

Speaker Change: With respect to timing of data on 301, again thats, probably the end of the year the combinations sometime in 'twenty five we haven't been more specific than that but we will provide whatever we have on those combinations with respect to any kind of efficacy signal in safety data.

That we would have.

Unknown Attendee: Sure. Yeah, I'll just, you know, turn it over to Mark to talk about, you know, 301 and sort of what our expectations are there, and then Jeff can answer the first question. So, sorry, going backwards, but go ahead, Mark.

Speaker Change: In 2005, and then in terms of the program My expectation. This may want to comment as well is that this would then rollout into initially BCG refractory population of patients with a variety of reasons, but that seems to me to be from a clinical perspective, most logical fit for a first.

Speaker Change: Our approach to that population of patients.

Speaker Change: Thanks, Mark and Jeff and I, just wanted to talk about the adoption of <unk>.

Speaker Change: Yes, I think the biggest the one thing we hear with regards to gel in Idaho is just the number of patients that are out there and physicians will tell us, particularly with this data that we saw from <unk>. They are very.

Speaker Change: Positive in and around the four year long term medium long term follow up but the biggest objection we get as I just I don't have a lot of these patients we won't have that with 102 and in fact, we've seen in market research instead of two to three patients a year with Joe might or they have two to three patients a month that fit the intermediate risk category.

Speaker Change: And so the comp most comment I wouldn't even call it objection, but yes it.

Speaker Change: It is as I like what I hear clinically about gel Murdo I just don't have many patients we won't hear that.

Speaker Change: And then the second as Liz alluded to earlier the operational lift so these accounts already.

Speaker Change: BCG days they'll have jem side are they.

Speaker Change: They have days, where they will bring in these patients the nurse or extender will give the dose and will fit right into that that sort of already established way operationally that they treat.

Speaker Change: And so a lot of this will be given in the clinic, we won't have as many hospital bureaucracy to get through formulary, obviously will support that if they want to give it in the hospital, we will we will support that and get it on formulary, but the operational lift is much different and then the objection of I don't have a lot of patients goes away.

Speaker Change: Got it that's helpful context. Thank you so much.

Mark P. Schoenberg: Yeah, sure. Thanks, Liz.

Thank you I'm showing no further questions at this time I would like to turn it back to Liz Barrett for closing remarks. Thank.

Mark P. Schoenberg: So, as Liz said earlier in the call, the 301 program is targeting high-grade disease. And as I'm sure the audience is aware, when you start looking at patients with high-grade disease, the natural place to take this sort of a program would be into the BCG unresponsive or refractory population. So, with respect to timing of data on 301, again, that's probably the end of the year, and the combinations sometime in 2025. We haven't been more specific than that, but we will provide whatever we have on those combinations with respect to any kind of efficacy signal and safety data that we would have in 2025.

Mark P. Schoenberg: And then, in terms of the program, my expectation, Liz may want to comment as well, is that this would then roll out initially to a BCG refractory population of patients for a variety of reasons. But that seems to me to be, from a clinical perspective, the most logical fit for a first approach to that population of patients.

Jeffrey Bova: Thanks, Mark and Jeff. You just want to talk about, you know, the adoption of UGM 102. Yeah, I think that

Elizabeth A. Barrett: Thank you. Thank you operator, thanks again for everybody joining us today I just want to reiterate how excited we are with the data that was just presented at <unk>. It was a great way for us.

Jeffrey Bova: Yeah, I think the biggest objection we get is that, you know, the one thing we hear with regard to gelmido is just the number of patients that are out there, and physicians will tell us, particularly with this data that we saw from AUA, they're very positive in and around, you know, the four-year long-term, medium long-term follow-up. But the biggest objection we get is that, I just, I don't have We won't have that with 102.

Jeffrey Bova: In fact, we've seen in market research, you know, instead of two to three patients a year with gelmido, they have two to three patients a month that fit the intermediate risk category. And so the most common objection, I don't even call it an objection, but it is, is that I like what I hear clinically about gelmido. I just don't have many patients. We won't hear that.

Jeffrey Bova: And then the second, as Liz alluded to earlier, the operational list. So these accounts already are, they'll have BCG days, they'll have gem sites, you know, they'll have days where they bring in these patients, the nurse or extender will give the dose, and it will fit right into that, that sort of already established way operationally that they treat. And so a lot of this will be given in the clinic. We won't have as many hospital bureaucracies to get through the formulary.

Jeffrey Bova: Obviously, we'll support that if they want to give it in the hospital, we will, we will support that and get it on the formulary. But the operational lift is much different. And then the objection of, "I don't have a lot of patients" goes away.

Unknown Attendee: Got it. That's a helpful context. Thank you so much.

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

Elizabeth A. Barrett: Thank you. Thank you, Operator.

Operator: Thanks again for everybody joining us today. I just want to reiterate how excited we are with the data that was just presented at AUA. It was a great AUA for us. And, very importantly, as I mentioned, and Mark as well, we're really looking forward to the data event on June 13th. So I hope to see all of you there, although virtually, but I hope to see you there. So have a great day. Operator, you can now disconnect.

Elizabeth A. Barrett: And very importantly, as I mentioned end markets, while we're really looking forward to the data <unk> been on June 13th I Hope to see here see all of you there, although very slowly, but I hope to see you. There so have a great day operator can now disconnect.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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

Speaker Change: Okay.

Speaker Change: [music].

Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].