Q2 2024 Lexicon Pharmaceuticals Inc Earnings Call

Good day and welcome the lexicon Pharmaceuticals second quarter 'twenty 'twenty four financial results conference call.

Operator: Good day, and welcome to the Lexicon Pharmaceuticals second quarter 2024 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a call from the specialists by pressing the star key followed by zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note, this event is being recorded. I would now like to turn the conference over to Lisa DeFrancesco, Head of Investor Relations and Corporate Strategy. Please go ahead.

Speaker Change: All participants will be in a listen only mode.

Speaker Change: Do you need a system like signal a conference specialist by pressing the star key followed by zero on your telephone keypad.

After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad.

I would draw your question. Please press Star then two.

Please note this event is being recorded.

I would now like to turn the conference over to Lisa Defrancesco.

Lisa DeFrancesco: Head of Investor Relations and corporate strategy. Please go ahead.

Lisa DeFrancesco: Thank you Betsy and good afternoon, and welcome to the Lexicon Pharmaceuticals second quarter 2022, 24 financial results Conference call. Joining me today are Dr. Mike I've been Lucky cause new Chief Executive Officer, and director, that's weighed President and Chief Operating Officer, Tom Garner Senior Vice President and Chief.

Lisa DeFrancesco: Thank you, Betsy. Good afternoon, and welcome to the Lexicon Pharmaceuticals second quarter 2022-24 Financial Results Conference Call. Joining me today are Dr. Mike Exton, Lexicon's new Chief Executive Officer and Director, Jeff Wade, President and Chief Operating Officer, Tom Garner, Senior Vice President and Chief Commercial Officer, Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer, and Dr. Alan Main, Executive Vice President, Innovation and Chemical Sciences. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the second quarter of 2024, which is available on our website at www.lexpharma.com and through our SEC filing.

Officer, Dr. Craig Randomize, Senior Vice President and Chief Medical Officer, and Dr. Alan Main executive Vice President of innovation and chemical Sciences.

Speaker Change: Earlier this afternoon lexicon issued a press release announcing our financial results for the second quarter of 2024, which is available on our website at www dot like pharma dot com and through our SEC filings a webcast of this call along with a slide presentation is also available on our website. During this call. We will review the information provided in the release.

Lisa DeFrancesco: A webcast of this call, along with a slide presentation, is also available on our website. During this call, we will review the information provided in the release, provide a corporate update, and then use the remainder of our time to answer your questions. Before we begin, let me remind you that we will be making forward-looking statements relating to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of Inpepa, Synquista, LX9211, LX9851, and our other drug programs, as well as our business generally.

Lisa DeFrancesco: Provide a corporate update and then use the remainder of our time to answer your question.

Lisa DeFrancesco: Before we begin let me remind you that we will be making forward looking statements.

Lisa DeFrancesco: Relating to the safety efficacy clinical development regulatory status and therapeutic and commercial potential of been pepper sequester, Alex 91, one Alex 9851, and our other drug programs as well as our business generally.

Lisa DeFrancesco: These statements may include characterizations and projections relating to our commercial launch of Inpepa and heart failure, as well as the clinical development, regulatory status, and market opportunity for all of our drug programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, strategic alliances, and intellectual property, as well as other matters that are not historical facts or information. Various risks that may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We would refer you to our most recent annual report on Form 10-K and other SEC filings for detailed information describing such risks. I would now like to turn the call over to Mike Exson.

These statements may include characterizations and projections relating to our commercial launch them Perpend heart failure as well as the clinical development regulatory status and market opportunity for all of our drug program.

Lisa DeFrancesco: Our call May also contain forward looking statements relating to our growth and future operating results discovery and development of our drug candidates strategic alliances and intellectual property as well as other matters that are not historical facts or information.

Various risks that may cause our actual results to differ materially from those expressed or implied in such forward looking statements. Let me refer you to our most recent annual report on Form 10-K, and other SEC filings for detailed information describing such risks.

Lisa DeFrancesco: I would now like to turn the call over to Mike Jackson.

Mike Exton: Thanks, Lisa, and good day, everyone. Thanks for joining us on the call. Before we begin our discussion on Lexicon's results for the second quarter of 2024, let me start by saying that even in my first few weeks here as CEO, I can already see what a tremendous opportunity we have to bring innovative new therapies to patients, transform the treatment landscape of multiple therapeutic areas, and indeed transform Lexicon as a company. Now, moving on to our accomplishments for the year, which are indeed incredibly significant. First of all, our in-pepper business continued to grow modestly.

Mike Jackson: Thanks, Lisa and good day, everyone. Thanks for joining us on the call.

Mike Exton: We saw progress across all areas of focus in this highly competitive market. Importantly, we also resubmitted our NDA FERS inquiry and have received the PDUFA goal date of December 20, 2024, setting us up for a potential commercial launch in this untapped market in early 2025. Furthermore, our Phase 3 study for sotogliflozin in hypertrophic cardiomyopathy, or HCM, is underway, with sites already open and beginning to enroll patients. In addition, our Phase 2B study for LX9211 in Diabetic Peripheral Neuropathic Pain, or DPNP, is on track to meet its timelines and its objectives, with top-line data anticipated in the second quarter of 2025.

Mike Jackson: Before we begin our discussion on lexicons results for the second quarter of 2024, let me start by saying that even in my first few weeks here as they are.

Mike Exton: And finally, our exciting novel drug candidate, LX9851, an oral therapy for obesity and weight management, which we believe has the potential to become an innovative next-gen treatment in this large market, is progressing into preclinical development. These are all really solid opportunities for Lexicon, not only for next year but well beyond.

Speaker Change: So you've got a tremendous opportunity we have to bring innovative new therapies to patients transform the treatment landscape of multiple therapeutic areas and indeed transform lexicon as a company.

Mike Jackson: Now moving on to our accomplishments for the year, which are indeed incredibly significant.

Speaker Change: First of all our paper business continued to grow modestly and we saw progress across all areas of focus in this highly competitive market.

Lisa DeFrancesco: Importantly, we also have resubmitted, our NDA for <unk> and have received a particular goal date of December 22020 for setting us up for a potential commercial launch in this untapped market in early 2025.

Mike Jackson: Furthermore, our phase three study facade explosion in hypertrophic cardiomyopathy or H C. M is underway with sites already open and beginning to enroll patients.

Mike Jackson: In addition, now phase II B study for <unk> nine to one one in diabetic peripheral neuropathic pain or D. P and pay is on track to meet its timelines and its objectives with top line data anticipated second quarter of 2025.

Mike Jackson: And finally, our exciting novel drug candidates <unk> 905, one and oral therapy.

Mike Jackson: And White management, which we believe has the potential to become an innovative next gen treatment in this large market is progressing into preclinical development.

Mike Jackson: These are all really solid opportunities for lexicon not only for next year.

Mike Jackson: But well beyond.

Mike Jackson: So let's take a look inside of the flows and in particular we.

Mike Exton: But let's take a look at sotogliflozin in particular. We see a significant opportunity for value and growth with this compound across additional indications where sotogliflozin's unique mechanism of action has potential for beneficial effects. Lexicon has taken a purposeful approach to each one of the areas that we're exploring. As a result, we're now preparing for the next near-term opportunity to commercially launch Zinquista for glycemic control in adults with type 1 diabetes and chronic kidney disease, while working towards a longer-term goal of expanding sodagliflozin into HCM. Now, in both of these areas, there are no SDLT therapies indicated.

Mike Jackson: We see a significant opportunity for value and great with this compound.

Mike Jackson: Additional indications, where <unk> unique mechanism of action has potential for beneficial effect lexicon has taken a purposeful approach in each one of the areas that we're exploring and as a result, we're now preparing for the next near term opportunity to commercially launch the twister, but glycemic control.

Mike Jackson: So in adults with type, one diabetes and chronic kidney disease.

Speaker Change: Working towards our longer term goal of expanding started good flows in into how you see them.

Speaker Change: Now in both of these areas there were no S. G O T therapies indicated and we believe that the dual inhibition of S. D O T. One and two offers unique advantages.

Mike Exton: And we believe that the dual inhibition of SDLT 1 and 2 offers a unique advantage. These areas of unmet need are also highly concentrated in terms of the treatment landscape, and they're very different from the competitive environment we're experiencing in heart failure, which is currently dominated by two larger players within a complex treatment and reimbursement environment. These are really very exciting near and long-term opportunities for Lexicon. And as we advance this pipeline of current and potential indications for sotogliflozin, we'll continue to weigh and consider where this unique innovation can have the most impact for patients.

Speaker Change: These areas of abandonment NATO also highly concentrated in terms of treatment landscape and they're very different from the competitive environment. We're experiencing in heart failure, which currently is dominated by two larger players within a complex treatment and reimbursement environment.

Speaker Change: These are really very exciting near and long term opportunities for lexicon as we advance this pipeline of current and potential indications outside of the flows and will continue to weigh and consider where this unique innovation can have the most impact for patients.

Speaker Change: Now as we then go and look Holistically at our pipeline, we see similar pipeline in appeal opportunities for other candidates as well we have the ability to potentially address unmet medical needs within large market with development opportunities beyond their initial indications whether pursued by lexicon malaria.

Mike Exton: Now, as we then go and look holistically at our pipeline, we see similar pipeline and appeal opportunities for our other candidates as well. We have the ability to potentially address unmet medical needs within large markets with development opportunities beyond their initial indications, whether pursued by Lexicon alone or with a strategic partner. And so I'm truly thrilled to have joined Lexicon at this pivotal time, when we can focus on unlocking the significant value that these opportunities represent. With that overview, I'd now like to turn it over to Jeff Wade, President and COO, to discuss in detail the business and financial results. It's over to you, Jeff.

Speaker Change: With a strategic partner and so I am truly thrilled to have joined lexicon at this pivotal time, when we can focus on unlocking the significant value that these opportunities represent.

Speaker Change: With that overview I'd like to now turn it over to Jeff Wade President and say go away to discuss in detail the business and financial results over to you Jay Thank.

Jeff Wade: Thank you, Mike. I'd like to begin with our MPEFA results. Net sales for the second quarter of 2024 were $1.6 million, and $2.7 million for the first half of 2020.

Jeff Wade: Thank you Mike I'd like to begin with are in Peppa result, net.

Jeff Wade: Net sales for the second quarter of 2024 were $1 $6 million and $2 $7 million for the first half of 2024.

Jeff Wade: We saw improvements in build TRX and the number of new prescribers, a modest expansion in access, and greater pull. This progress is due to the strong efforts of the team assembled by and aligned under Tom Garner since he joined the company last. Achieving better market access remains the key to more significant growth for MPEPA in heart failure. Our goal has been and remains to achieve formulary access that is favorable for patients and equitable in light of MPEPPA's values, and we are continuing to have discussions with payers driven by MPEPA's values and differentiating data.

Speaker Change: We saw improvements in build T Rx and number of new prescribers, a modest expansion in access and greater pull through.

Speaker Change: This progress is due to the strong efforts of the team assembled by and aligned under Tom Garner since he joined the company last year.

Speaker Change: Achieving better market access remains the key to more significant growth for Peppa and heart failure.

Speaker Change: Our goal has been and remains to achieve formulary access that is favorable for patients and equitable and light up in pepsico's value and we're continuing to have discussions with payers driven by pet those value and differentiating data.

Jeff Wade: Payer coverage improved slightly in the second quarter to 48%, although most of this coverage still requires step-through of competing therapies, an obstacle that we're focused on eliminating. Some payers have been taking longer to make coverage decisions due to uncertainties associated with the IRA, particularly around the prices to be announced by CMS on September 1st for the first group of products selected for negotiation, a group that includes three major heart failure medications.

Speaker Change: Payer coverage improved slightly in the second quarter to 48%. Although most of this coverage still require a step through of competing therapies and obstacles that were focused on eliminating.

Speaker Change: Some payers have been taking longer to make coverage decisions due to uncertainties associated with the I R. A particularly around the prices to be announced by CMS on September 1st for the first group of products selected for negotiation a group that includes three major heart failure medications.

Jeff Wade: We expect improvements in coverage as these uncertainties are resolved and as we continue to demonstrate the value of MPEFA for patients, providers, and payers. However, it's important to note that SHLT use remains highly underpenetrated in heart failure with significant room for growth despite strong recommendations within the ACC treatment guidelines and consensus statements for both HFRAF and HFPAF. Recommendations that are based in substantial part on MPAPA data, especially as it relates to initiation of therapy after hospitalization.

Speaker Change: We expect improvements in coverage as these uncertainties are resolved and as we continue to demonstrate the value of the peso for patients providers and payers.

Speaker Change: It is important to note that S shall T use remains highly underpenetrated in heart failure with significant room for growth. Despite strong recommendations within the ACC treatment guidelines and consensus statements for both <unk> and half past recommendations.

Speaker Change: Recommendations that are based in substantial part unimpaired data, especially as it relates to initiation of therapy after a hospitalization.

Speaker Change: I'd now like to move to sequester, which has the opportunity to be the first ever oral adjunct to insulin therapy indicated to improve glycemic control in adults with type one diabetes.

Jeff Wade: I'd now like to move on to Zinquista, which has the opportunity to be the first ever oral adjunct to insulin therapy indicated to improve glycemic control in adults with type 1 diabetes. Our approach with Senquista is part of our overall strategy to expand the use of sotagloplasin beyond the competitive heart failure market into high-value opportunities where other SGLT inhibitors are not indicated and in which we believe sotagloplasin's unique SGLT1 mechanism offers advantages. We've made a lot of progress this past quarter and in the time since.

Speaker Change: Our approach with sequester as part of our overall strategy to expand the use of solar the pleasant beyond the competitive heart failure market into high value opportunities, where other STL T inhibitors are not indicated and which we believe set a good pleasant unique agile T. One mechanism offers advantages.

Speaker Change: We've made a lot of progress this past quarter and in the time since.

Jeff Wade: We resubmitted our NDA for sequesta in June as an adjunct to insulin in adults with type 1 diabetes and CKD. The FDA notified us in July that they considered our resubmission to be a complete response to their 2019 Action Letter, and they gave us a PDUFA goal date of December 20, 2024. Based on our recent communications with FDA, it is likely we will have the opportunity for an advisory. We look forward to the chance to present and discuss with the committee and key stakeholders, including, importantly, the patient community. The opportunity for Zinquista to address the significant unmet need for adjunctive glycemic control in this population.

Speaker Change: We resubmitted our NDA for sequester in June as an adjunct to insulin <unk> in adults with type one diabetes and CK D.

Speaker Change: The FDA notified us in July that they considered our resubmission to be a complete response to their 2019 action letter and they gave US a <unk> goal date of December 20-F 2024.

Speaker Change: Based on our recent communications with FDA. It is likely we will have the opportunity for an advisory Committee meeting.

Speaker Change: We look forward to the chance to present and discuss with the committee and key stakeholders, including importantly, the patient community the opportunity for sequester to address the significant unmet need for adjunctive glycemic control in this population.

Speaker Change: From our preliminary market research, we expect more than 400000 adults in the U S with type one diabetes and chronic kidney disease could be eligible for treatment.

Jeff Wade: From our preliminary market research, we expect more than 400,000 adults in the U.S. with type 1 diabetes and chronic kidney disease could be eligible for treatment. We've seen strong enthusiasm for an approved adjunct to insulin among the concentrated group of endocrinologists who manage treatment decisions in type 1 diabetes. From our payer research, we expect the market access environment to be considerably more favorable in type 1 diabetes than in heart failure. Our opportunity to be the first adjunct to insulin therapy in a market in which patients are highly engaged and an indication that is not subject to extensive management are all important factors for achieving favorable and timely market access.

Speaker Change: And we have seen strong enthusiasm for an approved adjunct to insulin.

Speaker Change: The concentrated group of endocrinologists, you manage treatment decisions and type one diabetes.

Speaker Change: From our payer research, we expect the market access environment to be considerably more favorable in type one diabetes and heart failure.

Speaker Change: Our opportunity to be the first adjunct to insulin therapy in a.

Speaker Change: A market in which patients are highly engaged in an indication that is not subject to extensive management are all important factors for achieving favorable and timely market access.

Jeff Wade: We believe that soda collision's unique dual SGLT1 and SGLT2 mechanism offers advantages in addressing the challenges in people who have type 1 diabetes and chronic kidney disease. Both are relevant to type 1 diabetes, but the inhibition of SGLT1, the primary transporter for glucose uptake from the GI tract, offers particular benefits. SGLT1 inhibition slows the uptake of glucose from meals, blunting postprandial glucose peaks, and reduces glycemic variability.

Speaker Change: We believe that showed it wasn't unique dual astral two one in Nashville to two mechanism offers advantages and addressing the challenges and people who have type one diabetes and chronic kidney disease.

Speaker Change: Both are relevant to type one diabetes, but the inhibition of <unk> one the primary transporter for glucose uptake from the GI tract offers particular benefits <unk>, one inhibition slows the uptake of glucose for meals blunting, postprandial glucose peaks and reducing waste by semic varied.

Speaker Change: Ability and unlike as Joel T. Two inhibition the effects of the <unk>, one inhibition do not decline with the reduced renal function that characterizes chronic kidney disease.

Jeff Wade: And unlike SGLT-2 inhibition, the effects of SGLT-1 inhibition do not decline with the reduced renal function that characterizes chronic kidney disease. The focus of our NDA resubmission on people with type 1 diabetes and chronic kidney disease aligns then both with a population in which better glycemic control is more important and also with cytoplasm's unique mechanism of action. We believe that the greater benefit in this population weighs favorably against the increased risk of diabetic ketoacidosis, or DKA, that has been observed in clinical studies of all SGLT inhibitors, including psilocybin and type 1 diabetes, and that drove the complete response letter that our resubmission addressed.

Speaker Change: The focus of our NDA resubmission on people with type one diabetes and chronic kidney disease aligns then both with a population in which a better glycemic control is more important and also was set as opposed to a unique mechanism of action.

Speaker Change: We believe that the greater benefit in this population weighs favorably against the increased risk of diabetic ketoacidosis or D. K that has been observed in clinical studies, Oh, she'll T inhibitors, including surgical pleasant and type one diabetes and that drove the complete response letter that our resubmission addresses.

Speaker Change: We are pleased to say that we have initiated our pivotal phase three so not a trial for H C M with the opportunity to transform the standard of care in this area of high unmet need.

Jeff Wade: We are pleased to say that we have initiated our Pivotal Phase 3 Sonata trial for HCM with the opportunity to transform the standard of care in this area of high unmet need. We are leveraging outcomes data from our SCORE trial in heart failure, KCCQ data from Soloist, and other evidence providing a strong scientific rationale for the potential of psotagliposin in this indication. This slide shows the design of Sonata H

Speaker Change: We are leveraging outcomes data from our score trial in heart failure, Casey CQ data from silhouettes and other evidence providing a strong scientific rationale for the potential upside of a pleasant and the syndication.

Speaker Change: This slide shows the design of Sonata H C. M. A pivotal phase III placebo controlled study with a target enrollment of 500 patients with obstructive or non obstructive HCM we.

Jeff Wade: Pivotal Phase III placebo-controlled study with a targeted enrollment of 500 patients with obstructive or non-obstructive HCM. We have sites up and running, and we have commenced patient recruitment in the study. The primary endpoint of the study is change from baseline and the KCCQ score, an endpoint that has been accepted by the FDA as the primary endpoint in this and other label-enabling HCM trials and with which we have previously achieved success in our soloist heart failure trial.

Speaker Change: We have sites up and running and have commenced patient recruitment in the study.

Speaker Change: The primary endpoint of the study is changed from baseline in K C. C. Q score an endpoint that has been accepted by the FDA as the primary end point in this and other label, enabling HCM trials and with which we have previously achieved success in our soloist heart failure trial.

Jeff Wade: Importantly, Sonata HCM is studying a broader patient population than that studied in other ongoing trials in HCM, as we are allowing patients to be on cardiac myosin inhibitors as well as allowing the use of beta blockers and calcium channel blockers. We are also enrolling patients with an injection fraction down to 50%, which is lower than the studies of cardiac myosin inhibitors for which heart failure is a risk. And, of course, sodium plosin is already indicated, as in PEPA, to reduce heart failure, which is the major risk for these patients.

Speaker Change: Importantly, sonata HCM is studying a broader patient population that's studied and other ongoing trials in HCM.

Speaker Change: As we are allowing patients to be on cardiac myosin inhibitors, as well as allowing the use of beta blockers and calcium channel blockers.

Speaker Change: We are also enrolling patients with an ejection fraction down to 50%, which is lower than the studies of cardiac myosin inhibitors for which heart failure as a risk.

Speaker Change: And of course, certain pleasant as already indicated as an pepper to reduce heart failure, which is the major risk for these patients.

Speaker Change: We have obtained feedback from FDA that success in this single study could support a broad label for sudden pleasant and H C M.

Jeff Wade: We have obtained feedback from FDA that success in this single study could support a broad label for psilocybin and HCM. Once again, an indication in an important area of unmet need that would be unique to sodagluposin among SGLTN. Current estimates suggest that around 1 million patients in the United States today have HCM. Many are not diagnosed, in part because of the nonspecific nature of HCM symptoms, but diagnostic rates have been rising rapidly, a trend which is expected to continue over the next decade with increased focus on the disease.

Speaker Change: Once again, and then vacation and an important area of unmet need that would be unique to show to the pleasant among S gel T inhibitors.

Speaker Change: Yeah.

Speaker Change: Estimates suggest that around 1 million patients in the United States today have HCM. Many are not diagnosed in part because of the nonspecific nature of HCM symptoms. The diagnostic rates have been rising rapidly a trend which is expected to continue over the next decade with increased focus on the disease.

Speaker Change: Looking further into our pipeline, we have and Alex 9211, another opportunity to redefine the standard of care in an important area of need in this case in neuropathic pain.

Jeff Wade: Looking further into our pipeline, we have in LX9211 another opportunity to redefine the standard of care in an important area of need, in this case, neuropathic pain. LX9211 has the potential to be the first new non-opioid treatment for neuropathic pain in over two decades. Our progress phase 2b dose optimization study began enrolling towards the end of 2023 and is well on track for top line data in the first half of 2025.

Speaker Change: Alex 9211 has the potential to be the first new non opioid treatment for neuropathic pain in over two decades.

Speaker Change: Our progress phase <unk> dose optimization study began enrolling towards the end of 2023 and is well on track for topline data in the first half of 2025.

Jeff Wade: It is important to note that this study, like our proof-of-concept studies, is placebo-controlled and allows patients to remain on stable-dose, standard-of-care therapy rather than remove all pain medications, consistent with how DPNP drugs are likely to be used in real world practice. We learned a great deal in our Phase 2 relief DPN study, which we are applying to this Phase 2B progress study, with a key hypothesis being that we can improve tolerability by eliminating the 10X first day loading dose in the prior study.

Speaker Change: It is important to note that this study like our proof of concept studies is placebo controlled and allows patients to remain on stable dose standard of care therapy, rather than removing all pain medications consistent with how D. P. M. P drugs are likely to be used in real world practice.

Speaker Change: We learned a great deal in our phase two relief D. P. M study, which we're applying to this phase to be progress study with a key hypothesis being that we can improve tolerability by eliminating the tenex burst de loading dose and the prior study at this point, we feel quite confident about where we are.

Jeff Wade: At this point, we feel quite confident about where we are in this study and are very much looking forward to the results next year. Approximately 20 million patients in the United States are suffering with some type of neuropathic pain, of which about 5 million have DPNP, with significant growth predicted in the future.

Speaker Change: In this study and are very much looking forward to the results next year.

Speaker Change: Approximately 20 million patients in the United States are suffering with some type of neuropathic pain of which about 5 million have D. P. M P with significant growth predicted in the future.

Jeff Wade: We believe LX9211 could offer a real benefit to patients and to the clinical community who are looking for better options to improve outcomes for patients with these conditions. Our newest drug candidate to emerge from our Genome 5000 platform is LX9851 in the exciting area of obesity and weight management. We believe that LX9851 has the potential, like our other assets, to be developed for additional indications and to be used as a combination therapy as well.

Speaker Change: We believe Alex 91, one could offer a real benefit to patients into the clinical community, who are looking for better options to improve outcomes for patients with deep yet.

Speaker Change: Our newest drug candidate to emerge from our genome 5000 platform is Alex 90, 851 in the exciting area of obesity and weight management.

Speaker Change: We believe that <unk> 95, one has the potential like our other assets to be developed in additional indications and to be used as it come as a combination therapy as well.

Jeff Wade: LX9851 is a small molecule inhibitor of the target acyl-CoA synthetase 5, or ACSL5, that we believe could be given orally for chronic weight management with a target product profile that reduces body fat, spares lean body mass, and favorably affects overall metabolic profile. In preclinical studies, it has reduced cholesterol and triglycerides, improved insulin sensitivity, and demonstrated potential in additional related The obesity and weight management space is an area of tremendous interest, and we're very excited about the potential for an oral, once-daily therapy with these mechanisms that complement and enhance current therapy.

Speaker Change: 95, one is a small molecule inhibitor of the target.

Speaker Change: <unk>, Kuwait synthetase, five or a C. S. L. Five that we believe could be given orally for chronic weight management with the target product profile that reduces body fat.

Speaker Change: Bears lean body mass and favorably affects overall metabolic profile.

Speaker Change: In preclinical studies, it has reduced cholesterol and triglycerides improved insulin sensitivity and demonstrated potential in additional related indications such as metabolic syndrome and mash.

Speaker Change: The obesity and weight management space is an area of tremendous interest.

Speaker Change: Very excited about the potential for an oral once daily therapy with these mechanisms that complement and enhance current therapies. We've moved into IND, enabling studies and we are very focused on submitting data to upcoming medical meetings.

Jeff Wade: We've moved into IND-enabling studies, and we are very focused on submitting data to upcoming medical journals. Now we will review some of the key elements of our second quarter 2024 financial results. You can find more financial details in the press release that we issued earlier today and in our 10-Q that will be filed shortly with the SEC. We ended the quarter with $310 million in cash and investments. As indicated in our press release this afternoon, we had $1.6 million in revenues in the second quarter of 2024, almost all from net sales of MPEPA, and had minimal revenues for the same period in 2023.

Speaker Change: Now we will review some of the key elements of our second quarter of 2024 financial results you can find more financial details in the press release that we issued earlier today and in our 10-Q that will be filed shortly with the SEC.

Jeff Wade: R&D expenses for the second quarter of 2024 increased to $17.6 million from $14.5 million for the corresponding period in 2023, primarily due to higher external R&D expenses as our development programs progress. SG&A expenses for the second quarter of 2024 increased to $39.2 million from $30 million for the corresponding period in 2023, reflecting the investment in the commercial launch of MPEPA. In total, the net loss for the second quarter of 2024 was $53.4 million, or 17 cents per share, as compared to a net loss of $44.9 million, or 22 cents per share, in the corresponding period of 2023. For the second quarters of 2024 and 2023, the net loss included non-cash stock-based compensation expense of $4.9 million and $3.8 million, respectively. Now I'll turn it back over to Mike for some closing remarks. Yeah, thanks.

Speaker Change: We ended the quarter with $310 million in cash and investments.

Speaker Change: As indicated in our press release. This afternoon, we had $1.6 million in revenues in the second quarter of 2024, almost all from net sales of them Pepper and had minimal revenues for the same period in 2023.

Speaker Change: R&D expenses for the second quarter of 2024 increased to $17 6 million from $14 $5 million for the corresponding period in 2023, primarily due to higher external R&D expenses as our development programs progress.

Speaker Change: SG&A expenses for the second quarter of 2024 increased to $39 $2 million from $30 million for the corresponding period in 2023, reflecting the investment in the commercial launch of the pepper.

Speaker Change: And total net loss for the second quarter of 2024 was $53 $4 million or <unk> 17 per share as compared to a net loss of $44 $9 million or 22 cents per share in the corresponding period in 2023.

Speaker Change: For the second quarters of 2024 in 2023 net loss included noncash stock based compensation expense of $4 $9 million and $348 million respectively.

Speaker Change: Now I'll turn it back over to Mike for some closing remarks.

Mike Exton: Yeah, thanks, Jeff. Look, in summary, the next 18 months for Lexicon includes several important planned catalysts. First of all, we've got the potential to launch Zinquista in the early part of next year, which for us is an exclusive opportunity and importantly, a much-needed additional treatment option for the type 1 diabetes community. Secondly, we've initiated our Sonata Phase III study of soda glosin in HCM, and that presents a new and promising area of focus.

Mike Jackson: Yeah. Thanks, Jeff look in summary, the next 18 months for lexicon includes several important planned catalysts.

Mike Exton: Thirdly, our progress in the Phase 2B study of LX9211 in DPNP is on track, with top-line data in Q2 of next year. And then finally, we've commenced IND-enabling studies of LX9851 in the rapidly evolving area of obesity and weight management, where current treatments are primed for next-gen and combination therapy. So each of these opportunities has a lot in common. They're all in a large

Mike Jackson: First of all we've got the potential to launch <unk> in the early part of next year, which for US is an exclusive opportunity and importantly, a much needed additional treatment option for the type one diabetes community.

Speaker Change: Secondly, we've initiated out to not a phase III study of started closing in H C M and that presents a new and promising area of focus.

Speaker Change: Thirdly, our progress phase two based study of <unk> nine to one one in D. P. N P is on track.

Speaker Change: Top line data in Q2 of next year.

Speaker Change: And then finally, we've commenced our NDA, enabling studies of Alex 9851 in the rapidly evolving area of obesity and weight management with current treatments are prime for Nexgen and combination therapies.

Speaker Change: Each of these opportunities have a lot in common.

Speaker Change: All in large markets.

Mike Exton: There are significant areas of unmet need where there is white space, with the true need for new, innovative therapy. And within each of these areas, we have the potential to be the first or only truly exclusive in our approach, unlike what we're experiencing in heart failure currently. And each of these opportunities is supported by thoughtful clinical development that is informed by discussions with the FDA and designed to incorporate real-world elements of how the drug would actually be used in the market.

Speaker Change: There are significant areas of unmet need where there is white space.

Speaker Change: A true need for new innovative therapies and within each of these areas. We have the potential to be the first or only truly exclusive now approach. Unlike what we're experiencing in heart failure currently.

Speaker Change: And each of these opportunities are supported by thoughtful clinical development that is informed by discussions with the FDA and designed to incorporate real world elements of how the drug would actually be used in the market.

Mike Exton: So as we enter the back half of the year, we're currently evaluating our strategy and our resourcing in order to ensure that we are optimized for success across these programs. We believe that we'll have the opportunity over the next 18 months to significantly improve treatment paradigms. Transform Lexicon as a company and create significant value for all of our stakeholders, most importantly, including the patients that we serve. So with that, I'd like to turn it back to the operator to open up the Q&A.

Speaker Change: So as we entered the back half of the year. We're currently evaluating our strategy and our Resourcing in order to ensure that we are optimized for success across these programs. We believe that will have the opportunity over the next 18 months to significantly improved treatment paradigms.

Speaker Change: <unk> form lexicon as a company and create significant value for all of our stakeholders. Most importantly, including the patients that we serve so with that I'd like to turn it back to the operator to open up the Q&A.

Speaker Change: We will now begin the question and answer session.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Yasmeen Rahimi, with Piper Sandler. Please go ahead.

Speaker Change: To ask a question you May press Star then one on your telephone keypad.

Speaker Change: If you think that's speakerphone, please pick up your handset before pressing the keys.

Speaker Change: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

Speaker Change: At this time I will pause momentarily to assemble our roster.

Speaker Change: Yeah.

Speaker Change: Sure.

Speaker Change: Yeah.

Speaker Change: The first question today comes from <unk> Rahimi with.

Speaker Change: Piper Sandler. Please go ahead.

Yasmeen Rahimi: Great. Thank you so much, team, for all the updates.

Rahimi: Great. Thank you so much team for all that ethane Hum type question.

Speaker Change: Second question did you mention I think it sounded like in the PEC Omar Saad Congrats for preparing for an op comm I guess.

Yasmeen Rahimi: A few questions on Synquesta. Did you mention? I think it sounded like in the prepared remarks that you guys were preparing for an outcome. I guess you could maybe talk about whether an outcome is expected, when it could occur, and what possible topics might be. That's sort of like big bucket number one. And then bucket two is if you could talk about commercially how you're thinking about, sort of, do you need to add more salespeople?

Speaker Change: Maybe talk about whether an outcome is expected when it could occur what could be possible topic.

Speaker Change: So that's sort of like big bucket, one and bucket. Two is if you could talk about commercially how you were thinking about sort of do you need to add more sales people.

Yasmeen Rahimi: Is there any, you know, as you will be focused on patients that are under the care of endocrinologists? What would the launch trajectory look like in a more endocrinology-focused setting versus a cardiovascular focus? We'd appreciate any color around that as well. And I'll jump back into the queue for any other questions.

Speaker Change: Is there any.

Speaker Change: He will be focused on patients that are under the care of endocrinologists are well what the launch trajectory look like in a more endocrinology focus setting busted that.

Speaker Change: Cardiovascular Okay, what does it mean.

Speaker Change: Any color around that as well and I'll jump back into the key for any other questions.

Speaker Change: Okay.

Mike Exton: Thanks a lot, Yasmeen. I heard two big buckets, not sure if you had a third, but let me pass the first one to Craig for the adcom and what we're thinking of timing and expectations, etc.

Speaker Change: Thanks, a lot guys may not I had two big buckets not sure. If you had a third but let me let me pass the first wanted to Craig for the Yadkin Com and what we're thinking of timing and expectations et cetera. Yeah. Thank you for the question Yeah. As you know at this point, we expect that we will get an AD com from.

Craig Granowitz: My question, Yas, and, you know, at this point, we expect that we will get an outcome from the FDA, and it will really focus on the risk-benefit of treatment, as I think we've shared at prior calls and at other meetings and communications that, you know, we've really worked hard to find a population where the risk-benefit is more favorable. We are currently committed, and the FDA has been committed to our target action date of December 20th of this year.

Speaker Change: The F D a.

Speaker Change: And it really would focus on the risk benefit of treatment and I think we've shared in prior calls and at other meetings and communications that we've really worked hard to find a population where the risk benefit is more favorable but we currently are committed and the FDA has been committed to our target action date of December <unk>.

Speaker Change: Of this year.

Craig Granowitz: I think I'll just take a moment on the risk-benefit in that, you know, we believe that this group of patients with chronic kidney disease are at a much higher rate of disease progression to end-stage disease across a range of underlying diseases, such as end-stage kidney disease, heart failure, stroke, myocardial infarction, severe retinopathy, and other diseases. So glycemia is actually a marker for that, and the indication we're seeking, as a reminder, is a glycemia control indication in that group of patients with underlying chronic kidney disease.

Speaker Change: I'll just take a moment on the risk benefit.

Speaker Change: And that we believe that this group of patients with chronic kidney disease are at much higher rate of disease progression to end stage disease across a range of underlying diseases, such as end stage kidney disease heart failure stroke myocardial infarction.

Speaker Change: <unk> retinopathy in other diseases, so glycemia.

Speaker Change: <unk> a marker for that and the indication we're seeking as a reminder is quite see me a control indication with that group of patients with underlying chronic kidney disease. So we're not seeking an indication right now for preventing this early progression of the chronic kidney disease with that as a marker of patients that are going to have much more raw.

Craig Granowitz: So we're not necessarily seeking an indication right now for preventing progression of chronic kidney disease, but that is a marker of patients that are going to have much more rapidly progressive disease across a range of complications of type 1 diabetes. So I think in that regard, you know, we've gotten great feedback from the patient and physician community on the need for this therapy. I think in prior communications from FDA, some of which were published, that they acknowledged that insulin alone is not enough in type 1 diabetes patients.

Speaker Change: Lee.

Speaker Change: Progressive disease across a range of complications of type one diabetes.

Speaker Change: So I think in that regard, we've gotten great feedback from the patient and physician community.

Speaker Change: And then on the need for this therapy I think in prior communications from F. D. A somewhat publicly that they acknowledged that insulin alone is not enough and type one diabetes patients. They have acknowledged that those that don't have tight glycemic control are at risk of progression to more rapidly progressive disease. So you know we look forward to the.

Craig Granowitz: They've acknowledged that those that don't have tight glycemic control are at risk of progression of more rapidly progressive disease. So, you know, we look forward to the opportunity, if there is an ADCOMM, to share all of this with both the FDA and the medical community.

Speaker Change: Opportunity. If there is an AD com that we will be able to share all of this with both the FDA and the medical community.

Mike Exton: Yeah, great. Thanks, Craig. We feel very confident going into that adcom and look forward to presenting all of our and independent data at that time. So I'll throw the second question, the second big bucket, to Tom, the Chief Commercial Officer, which is really focusing on the commercial footprint for Zinquista and particularly around Field Force. Tom, if you could take that question. Absolutely. Yeah, thanks.

Speaker Change: Yeah, great. Thanks, Greg, we feel very confident going into that ad com.

Speaker Change: And look forward to presenting all of al and independent data at that time, so I'll throw at a the second question and the second big bucket to Tom the Chief commercial officer, which really focusing on the commercial footprint offers and questar and particularly around field force Tom If you.

Tom Garner: Could take that question absolutely.

Mike Exton: Thanks, Mike. And thanks for the question, Yasmeen.

Tom Garner: Yeah, Thanks, Mike and thanks for the question, Yeah, So I think as you're well aware.

Tom Garner: So I think, as you are aware, we've spent significant amounts of time and effort really building a highly capable commercial infrastructure that covers field sales and access. I'm going as deep as kind of patient support programs as well. I've taken some time since I joined the company as well just to make sure that we're focusing all of our efforts in the right place with eyes on PEPFAR, but kind of with knowing that Zinguista is probably going to be coming down the track at some point in the future as well.

Speaker Change:

Tom Garner: At this time, and that's where it really building a highly capable commercial infrastructure and that crosses field sales access.

Tom Garner: And going as deep as kind of a patient scope.

Speaker Change: Programs as well.

Speaker Change: I've taken some time since I joined the company and so I guess to make sure that we're focusing all of our efforts in the right place with Orange soda in peso, but kind of with with knowing the sequester is probably going to be coming down the truck at some point in the future as well.

Tom Garner: I think, as you're very well aware, and Jeff mentioned this, you know, this is going to be a somewhat more concentrated marketplace than what we see for heart failure. So we estimate that there's going to be between 3,000 to 4,000 endocrinologists who treat the lion's share of these patients. So given that existing infrastructure that we have in terms of commercial, and as you know, we have around 150 representatives in PEPFAR at the moment, our plan is that we're going to try and leverage that team as far as possible to make sure that we can kind of really deliver on the value that we know we can unlock with Zinguista very quickly, given the unmet needs that I think are very clear here, while at the same time making sure that, you know, for in PEPFAR as well, we continue to support where needed as well.

Speaker Change: I think as you're very well aware and Jeff mentioned. This this is gonna be a somewhat more concentrated market place than what we see for Australia. So we estimate that that's going to be between three to 4000, endocrinologists, who treat the lion's share of these patients so given the existing infrastructure that we have in terms of commercial.

Speaker Change: We have around 150 representatives, who in Petro at the moment. Our plan is that we're going to try and leverage that team as far as possible.

Tom Garner: To make sure that we can really deliver on the value that we know we can unlock with zinc with still very quickly just given the unmet needs that I think are very clear here, while at the same time, making sure that if we're in pet foods, where we contribute to school when needed as well.

Speaker Change: Thanks, Tom Thank you so much.

Tom Garner: Thanks, Tom. Thank you so much.

Speaker Change: Thanks.

Speaker Change: The next question comes from Andrew Tsai with Jefferies. Please go ahead.

Operator: The next question comes from Andrew Tsai with Jeffrey. Please go ahead.

Andrew Tsai: And secondly, do you think, based on the comments so far today, that Zinquisto's launch could be stronger than what you're seeing with Empetha right now?

Andrew Tsai: Hey, thanks.

Andrew Tsai: Thank you taking my questions, maybe just on the AD com actually going back to the outcome would it be safe to presume that you're preparing for hypothetical voting decisions or questions around the risk benefit.

Speaker Change: And as well as a risk mitigation strategy.

Speaker Change: Mr or is there anything else, you're specifically preparing for and then secondly, do you think then based on the comments so.

Speaker Change: So far today that then classes as a launch could be stronger than what youre seeing with in peso right now thanks.

Andrew Tsai: Alright.

Andrew Tsai: Great. Same order. I'll throw them to you first with Craig, then Tom.

Tom Garner: Same order I'll throw to you first would probably been Tom great. Thank you Andrew again, we really feel strongly that based on all of the discussions that we've had with the FDA over this past number of months.

Craig Granowitz: Thank you, Andrew. Again, we really feel strongly that based on all of the discussions that we've had with the FDA over this past number of months, they are really going to focus on the risk-benefit. You know, what we've talked about is that in this subgroup, which has a much higher risk of progression to the complications of diabetes, that tight glycemic control is even more important. And the data have shown convincingly, both overall and the entire in tandem program, nearly 3000 patients, but also in that renal subgroup, that you have similar and highly significant control of glycemia, whether on baseline insulin or optimized insulin therapy.

Speaker Change: They really are going to focus on on the risk benefit you know I think what we've talked about is that in this subgroup, which has much higher risk of progression to the complications of diabetes that tight glycemic control was even more important and the data has shown convincingly both overall in the entire in tandem program.

Speaker Change: Nearly 3000 patients, but also in that renal subgroup.

Andrew Tsai: Have similar and highly significant control a glycemia weather on baseline insulin or optimized insulin therapy and that that Tycho ive seen the control will be associated with less progressive disease.

Craig Granowitz: And that tight glycemic control will be associated with less progressive disease. And we've also shown and published that the risk of diabetic ketoacidosis seems to be similar in that subgroup of patients with underlying CKD than in the overall population. So we feel quite strongly that the primary questions that FDA will ask are about overall risk and benefit.

Speaker Change: And we've also shown and published that the risk of diabetic ketoacidosis seems to be similar in that subgroup of patients with underlying CK D than in the overall population. So we feel quite strongly that the primary questions that FDA will ask us about overall risk benefit.

Tom Garner: Thanks, Craig. And Tom, to you.

Craig Randomize: Thanks, Craig and Hum.

Speaker Change: See you.

Tom Garner: Absolutely. Thanks for the question, Andrew. So, as we think about Inquista for T1D versus MPEFFA for heart failure, the first thing I would say is that this is going to be a very, very different space to what we encountered with heart failure. You know, as Mike mentioned during his remarks, this is going to be a space that's going to be basically untapped. We know there is some small amount of off-label usage of SDLTs at the moment, but largely speaking, this is not a market that has really been brought to the fore.

Speaker Change: Absolutely.

Speaker Change: A question on <unk>. So as we think about Sunquest 41 visit versus in Perth, Australia. I mean, the first thing I would say is that this is going to be a very very different space to what we encountered with heart failure.

Andrew Tsai: As Mike mentioned during his remarks this is going to be a space. That's that's basically untapped. We noted there is some.

Speaker Change: Small amount of off label usage bestial Ts at the moment, but largely speaking this is not a market that has really been approached before so we believe that given the unmet need given the fact that we know we have a group of endocrinologists, who have been kind of at the starting line being wanting to be able to use these products for quite some.

Tom Garner: So we believe that given the unmet need, given the fact that we know we have a group of endocrinologists who have been kind of at the starting line of wanting to be able to use these products for quite some time, there is clearly untapped potential there that we think we're going to be able to capture very quickly. The other thing that I would point out to you that is going to be markedly different from heart failure is just the pair dynamics.

Speaker Change: Sometime there is clearly untapped potential.

Andrew Tsai: Potential that we think we're gonna be able to capture very quickly. The other thing that I would point out to you today is gonna be markedly different from how it was just the payer dynamics.

Speaker Change: The challenge that we that we faced within Peppa is the thought that heart failure is a tightly managed category.

Tom Garner: The challenge that we face within Pepper is the fact that heart failure is a tightly managed category, and we are up against some very big competitors who have some very significant rebate dollars that they're paying. We're continuing to push very hard, but as we've started the same dialogue with those pairs as it relates to Zinqvista, I can tell you that the feedback they're already getting on the profile, on the potential utilization management, and how they view just the general management of this category, in particular for T1D patients, is going to look and feel very, very different from what we faced with heart failure. So I think yes is the answer to your question. We do see that this will potentially be a space where we can make a very meaningful impact pretty quickly, just given the concentrated market.

Speaker Change: We have record again.

Speaker Change: Very big competitors, who have some very significant rebate dollars that they pay.

Andrew Tsai: Wake up when you're continuing to push very hard but as we've started the same dialogue with those payers as it relates to things Christa I can tell you that the feedback that we're already getting on the profile on the potential utilization management and how they view just the general management of this category in particular T. One patient who's going to.

Speaker Change: And feel very very different to what we say to the telephone so.

Speaker Change: Yes is the answer to your question, we do see that this will potentially be a space, where we can make a very meaningful impact.

Speaker Change: Switching quickly just given the concentrated.

Speaker Change: But we're going into.

Tom Garner: Thanks. Thanks.

Speaker Change: Makes sense. Thank you Amanda.

Mike Exton: Okay, just if you'd allow me, Andrew, to just add to that that, in fact, that's how we see the rest of the pipeline. I think you know, as we go through this strategic review, I think we see that each of our assets offers this opportunity for a pipeline in a pill, which is multiple indications, and those indications are in spaces where Lifers Inquisitor will be the first and only player either as an adjunct or standalone therapy, and as you're aware, that provides, as Tom explained, very different payer dynamics, and very different dynamics at the provider interaction, and So, thank you. Right? Congratulations on

Speaker Change: Okay, and just if you'll allow me Andrew too.

Andrew Tsai: Add to that is that in fact, that's how we see the rest of the pipeline.

Speaker Change: Thank you know as we go through this strategic review I think we see that a H a val assets offers this opportunity for a pipeline in a pill, which has multiple indications in those indications are in spaces, where like losing cuesta, who will be the first and only player either as an adjunct to standard.

Speaker Change: <unk> therapy.

Tom Garner: As you're aware that provides as Tom explained very different payer dynamics very different dynamics at the at the provider.

Speaker Change: Interaction and so we feel very very.

Speaker Change: Confident that <unk> has the opportunity to be a very significant make a.

Speaker Change: Medicine for lexicon.

Speaker Change: Thank you.

Mike Exton: Right. Congratulations on executing on that front as well as everything else.

Speaker Change: Alright, congratulations on executing on that front is as long as everything else.

Speaker Change: Thanks, so much.

Speaker Change: As a reminder, if you have a question. Please press star one to enter the question queue.

Operator: As a reminder, if you have a question, please press star and 1 to enter the question queue. The next question comes from Joe Pantinis with H.P. Wainwright. Please go ahead.

Speaker Change: The next question comes from Joe Fenech with.

Joe Fenech: H C. Wainwright. Please go ahead.

Joe Fenech: Hey, everybody. Good afternoon. Thanks for taking the question first I wanted to focus on the HCM program. It's good the program is up and running and I wanted to sort of talk about your views about the evolution of the space. So when you recently had your R&D day.

Joe Pantinis: Everybody, good afternoon. Thanks for taking the time to answer the question. First, I wanted to focus on the HCM program. It's good that the program is up and running. And I wanted to sort of talk about your views on the evolution of the space. So when you recently had your R&D day, you positioned soda glufosin sort of in between, you know, the beta blockers, et cetera, on the front end and the CMIs on the back end. And your current study, you're also going to be including the CMIs. But I guess, how do you envision soda glufosin fitting in as of this point, since you can also include the CMI population?

Speaker Change: Your position soda good flows in a sort of in between the beta blockers et cetera on the front end and the CMI is on the back and and your current study you're gonna be I'm also including for the Cmi's, but I guess, how do you envision sort of go flows and fitting in as at this point since you can also.

Joe Fenech: Include the CMI population.

Joe Fenech: Yeah, Great question Ivy queue again, Greg.

Craig Granowitz: Yeah, great question. Over to you again, Craig.

Craig Granowitz: Yeah, so, you know, again, I think they have different mechanisms of action that are complementary. And since we are enrolling patients that are symptomatic, they're symptomatic regardless of their underlying therapy. So whether they're on nothing or a beta block or a calcium channel blocker or a CMI or all combinations thereof, the inclusion criteria are those with a KCCQ score of less than 80. So we think that it provides the maximum flexibility to providers to manage the symptomatic relief in these patients, which is the key reason why patients with HCM present in general and why they require treatment and the goal of treatment. And as a reminder, the other agents that are in development right now, particularly in non-obstructive disease, FDA has also allowed KCCQ as the primary endpoint, just like the primary endpoint of the SONATA HCM trial.

Speaker Change: Yeah. So you know.

Speaker Change: I think they have different mechanisms of action that are complementary.

Speaker Change: And since we are enrolling patients that are symptomatic or symptomatic regardless of their underlying therapy.

Joe Fenech: So whether there are nothing or a beta blocker calcium channel blocker for CMI or or combinations thereof.

Joe Fenech: Inclusion criteria is those with a case you see Q score of less than 80.

Joe Fenech: But we think that it provides the maximum flexibility to providers too.

Joe Fenech: To manage the symptomatic relief in these patients which is the key reason why patients with HCM present in general and why they require treatment and the goal of treatment and as a reminder, the other agents that are in development right now, particularly in non obstructive disease FDA has also allowed.

Joe Fenech: So you see Q as the primary endpoint just like the endpoint primary endpoint of the Sonata HCM trial.

Speaker Change: That's very helpful. And then sorry, and then I'm just curious.

Craig Granowitz: That's very helpful. Thank you.

Speaker Change: About the potential timelines I don't know if you're ready to think about that now since its just started and disclosure and the second question maybe for Mike you mentioned in the prepared comments and in the press release and in one of your answers you know talking about strategy and resources and strategic review, obviously youre not prepared now.

Mike Exton: And then just curious about the potential timelines. I don't know if, you know, you're ready to think about that now since it's just started and disclosure. And the second question, maybe for Mike, you mentioned in the prepared comments and in the press release and in one of your answers that you talked about strategy and resources and strategic review. Obviously, you're not prepared now to show your hand, but I wanted to sort of get a sense of what potential outcomes or, you know, goals are you looking for as part of that.

Speaker Change: To show your hand, but wanted to sort of get a sense of you know what potential outcomes or goals or are you looking for as part of that.

Craig Granowitz: Yep, fantastic. Craig, firstly, on the timeline of HCM.

Mike Jackson: Yes, not fantastic crank up firstly for the timeline of HCM I think we've shared in general some of the timelines previously.

Craig Granowitz: Yeah, I think we've shared in general some of the timelines previously, and again, as a reminder, we got this study up and running extraordinarily quickly, and we're really looking at having final data towards the end of 2026, early 2027. So I think that's the timeline that we're looking at, and as Jeff Wade showed in his slides, we really have a treatment duration that's quite a bit shorter because the drug has already been proven in a number of heart failure-related indications. So we're looking at a 26-week treatment duration, not a 52-week treatment duration, which will accelerate timelines quite a bit.

Speaker Change: Again as a reminder, we got this study up and running extraordinarily quickly and we're really looking at having a final data towards the end of 2026 early 2027, So I think that the timeline that we're looking at as a reminder.

Jeff Wade: Jeff Wade showed in his slides, we really have a treatment duration, that's quite quite a bit shorter because the drug has already been proven in a number of heart failure related indications, where we're looking at a 26 week treatment duration, not a 52 week treatment duration, which will accelerate timelines quite a bit.

Speaker Change: Right.

Mike Exton: And maybe, Joe, if you could just pile on a little on to the first question, because, yes, while we foresee sodaglufosin potentially being an adjunct to all indicated therapies for HCM, clearly, there's a huge timeline gap between initiation of base therapies, CCBs or beta blockers, through to CMIs, just because of the complexity and the logistics that the centers face in initiating those later therapies. And where we have a demonstrated safety profile, an easy oral therapy, we see that it can form a place within that position in the treatment paradigm, as the team has explained previously, but not exclusively so.

Joe Fenech: And maybe Joe if you allow me just to pile on a little longer for the first question.

Speaker Change: Because yes, while we pursue he started the flows and potentially being a adjunct to all indicated therapies for H C. M. Clearly, there's a huge timeline gap between initiation of basal therapies cc basal four beta blockers are through to semis just because of.

Speaker Change: The the complexity and the logistics that.

Joe Fenech: The center's facing initiating by just light of therapies.

Speaker Change: And where we have a demonstrated safety profile, an easy oral therapy, we see that it can be a form of place within that our position in the treatment paradigm as the team as we explained previously but not exclusively so I think that.

Mike Exton: And I think that gives us a unique position, actually, across the HCM. Now, I appreciate the question on the strategic review. We're well into it. I started that with my team pretty much immediately when I started, and we're getting great insights as a part of that. What are we looking to achieve? It's overall a very simple equation, and that is, we have a lot of opportunities, actually, more than what a company our size probably deserves or has, and yet we need to be very thoughtful at how we deploy our resources across those opportunities to maximize them all, because they're all fantastic medicines and unique indications.

Speaker Change: Gives us a unique position actually across the hype Sam now I. Appreciate the question on the strategic review, we're well into it Oh I've started that with my team pretty much immediately when I started and and we're getting great insights as a as a part of that.

Speaker Change: What what are we looking to achieve it's overall, a very simple equation and that is we have a lot of opportunities actually.

Speaker Change: [laughter] more than what a company our size, probably deserves or or has and yet we need to be very thoughtful in how we deploy our resources across those opportunities to maximize the mole because theyre all fantastic medicines and unique indications.

Speaker Change: And so that's really the answer the way of searching for us across the sort of current therapy.

Mike Exton: And so that's really the answer that we're searching for, across the sort of current therapies, across our pipeline therapies, you know, where do we place our resources and effort to maximize the return for the organization? And that's where we are. And you're right, I'm not going to reveal my hand quite yet. Absolutely. Thank you very much for all the details. No, I appreciate it. Thanks.

Speaker Change: Therapies across our pipeline therapies, where do we place our resources and efforts to maximize the return.

Speaker Change: For the organization and that's way way, where we're at and you're right I'm not going to do on my hand quite yet.

Speaker Change: Absolutely no.

Speaker Change: You very much for all the details.

Speaker Change: No I appreciate it thanks.

Speaker Change: The next question comes from Rolling over that with Leerink partners. Please go ahead.

Operator: The next question comes from Roanna Ruiz with Lee Ring Partner. Please go ahead.

Speaker Change: Great afternoon, everyone.

Roanna Ruiz: Great afternoon, everyone. So maybe I'd like to continue with questions about the phase three Sonata trial in HCM. I was curious, what has the feedback been from trial sites and investigators so far as you're kicking it off? And could you remind us about what standards you plan to use to ensure tight execution of that trial as well?

Speaker Change: So maybe continuing with questions about the phase III is to not a trial in HCM I was just curious what is the feedback then from trial sites and investigators so far as youre kicking it off and could you remind us about what standards you plan to use to ensure tight execution of that trial as well.

Speaker Change: Right. Another one for you Greg.

Craig Granowitz: Right, another one for you, Craig.

Craig Granowitz: Yeah, Roanna, it's a great question and, you know, the feedback has been really positive. We've identified all of the sites that we need for the trial in a number of countries around the world. I think you've seen or can see on clintrials.gov that the trial started around the end of June and that we're operating in a large number of countries, but the single largest contributor of sites will be the United States, and we really have a top-notch group of HCM centers around the country that are participating.

Greg: Euro and it's a great question and you know.

Greg: The feedback I have to say has been really positive we've identified all of the sites that we need for the trial.

Greg: In a number of countries around the world I think you've seen or can see on calling trials dot gov that the trial activated around the end of June and that we're operating in a in a large number of countries, but the single largest contributor of sites will be the United States.

Speaker Change: And we really have a top notch group of HCM centers around the country that are participating in I think the things I really like about the trial or any of the topics that Jeff already covered is that if a therapy that is has very little friction to get patients on can be used either alone or on top of.

Craig Granowitz: And I think the things I really like about the trial are many of the topics that Jeff already covered, such as that it's a therapy that has very little friction to get patients on, can be used either alone or on top of existing therapies, and it's oral once daily and has an ejection fraction down to 50%. You don't require all the echoes. It has a pragmatic, straightforward, and relatively easy to administer endpoint of a KCCQ. You don't have all the CPET and all the other things.

Speaker Change: Of existing therapies into oral once daily.

Speaker Change: As an ejection fraction down to 50% you don't require all the echoes it.

Speaker Change: Has a pragmatic and straightforward and relatively easy to administer and point of a case you see Q you don't have all the C pet and all the other things. So the feedback on trial execution from a study size standpoint has been very positive because it's a whole lot easier to to include patients on <unk>.

Craig Granowitz: So the feedback on trial execution from a study site standpoint has been very positive because it's a whole lot easier to include patients. I think there's also a general expectation that there's this sort of understanding that, yeah, I think the stroke's gonna work. I mean, the most common thing I hear from investigators is, yeah, it makes sense, it's gonna work, especially because many of them in obstructive disease where they said, well, gee, you know, if you remove the obstruction, does that solve the problem?

Speaker Change: Theres also a general expectation that that there's this sort of understanding that yeah. I think the stroke is going to work I mean, the most common thing I hear from investigators yeah. It makes sense, it's going to work in.

Greg: Especially because many of them in obstructive disease, where they said well Gee you know if you remove the obstruction that solve the problem, but when they think about it many of those patients within a few years back with symptomatic disease again, and that's why we included both obstructive and non obstructive as the underlying genetic default and Pat.

Craig Granowitz: But when they think about it, many of those patients in a few years are back with symptomatic disease again. And that's why we included both obstructive and non-obstructive obstructive pulmonary disease because the underlying genetic default in pathophysiology between the two is far more similar than dissimilar. So that's really where including both obstructive and non-obstructive agents on top of or instead of other therapies with an EF down to 50, the KCCQ score as the primary endpoint, a relatively shorter duration of therapy with an agent and class that they're familiar with, I think really all stack up in a very favorable way.

Greg: So if the geology between the two is far more similar than dissimilar.

Speaker Change: So, that's really where including both obstructive and non obstructive on top of or instead of other therapies with an E. F down to 50 casing CQ score as the primary endpoint are relatively shorter duration of therapy with an agent in class that theyre familiar I think really all.

Speaker Change: Stack up in a very favorable way.

Mike Exton: Roanna, you know, you talked about what controls or mechanisms we have to see that it gets executed appropriately. I think, in fact, Craig and his team have shown their execution excellence in clinical trials with 9211 and have really been able to demonstrate in a study that obviously was coming from another study that had some issues, but here we're on track with recruitment, and, you know, that's powering along, and the timeline that Craig and his team met to get Sonata up and running was incredibly tight, and so the ability to recruit the number of sites that So we are running with this very, very fast and look forward to updating you on progress in the near future.

Ron: Ron Ron.

Craig Randomize: I know you talked about what controls mechanisms do we have to say that it gets executed appropriately I think in fact, Craig and his team schein they execution excellence in clinical trials with 9211, and really being able to demonstrate in a in a study that.

Ron: Obviously, it was coming from another study that had some issues.

Ron: But he we're on track with our with recruitment and you know that's powering along and the timeline that Craig and his team met to get to not up and running was incredibly tight.

Ron: And so the ability to recruit the number of sites that they have.

Ron: Ever since the protocol was finalized is pretty amazing. So we are running with this very very fast and look forward to updating on progress in the near future.

Ron: Yeah.

Speaker Change: Got it and then a quick follow up for me I wanted to ask about the obesity program as well could you just elaborate a bit more what excites you about Alex 90, 851, and how this product profile could layer into the treatment paradigm in the future assuming that there could be more products approved by then more combo regimens.

Roanna Ruiz: Got it. And a quick follow-up for me. I wanted to ask about the obesity program as well. Could you just elaborate a bit more? What excites you about LX9851 and how this product profile could layer into the treatment paradigm in the future, assuming that there could be more products approved by them and more combo regimens?

Speaker Change: Yeah, absolutely so.

Mike Exton: Yeah, absolutely. So I'll turn it over to Alan in the first instance to give a little bit of background on his baby. I mean, 9851. And so Alan, why don't you take us through it, and then a couple of others may give some other opinions on top.

Alan Main: I'll turn it over to Alan in the first instance to give it a little bit of background on his baby I mean 951, and so Alan why don't you take us through and then a couple of others. My my life's a mother of opinions on top.

Alan Main: Yeah, absolutely, absolutely. You know, obviously, the weight management field is incredibly exciting. Treatment is evolving, but despite the success of the GLIP-1 agonists, I think there are still some important questions, cost and ease of use, reduction of lean body mass, and tolerability, and you know, with LX9851, we think we're addressing all of those issues. You know, it's a small molecule, relatively easy to manufacture, and it's an oral product. In our preclinical studies, in our knockout studies, we've seen a very nice reduction in fat only with no change in lean body mass and tolerability.

Alan Main: Yeah, absolutely absolutely.

Alan Main: Obviously, the weight management field is incredibly exciting treatment is evolving.

Alan Main: But despite the success of the blip one agonist.

Speaker Change: I think theres still some important questions.

Speaker Change: Cost and ease of use.

Speaker Change: Reduction of lean body mass and Tolerability and.

Speaker Change: With Alex 90, 851, we think we're addressing all of those issues.

Speaker Change: Small molecule.

Speaker Change: Relatively easy to manufacture its oral product.

Speaker Change: In our preclinical studies now knockout studies, we've seen a very nice reduction in fat only with no change in lean body mass.

Speaker Change: And Tolerability.

Alan Main: In our preclinical studies, so far, we've never seen any evidence of diarrhea, and that includes our knockout mice. And if you think about it, the enzyme is inhibited 100 percent for their entire lives, and we haven't seen any diarrhea or anything like that in mice or any of the other preclinical species we've looked at. So we're very excited about this agent. It's a totally new mechanism that was discovered by our gene knockout work. To our knowledge, nobody else is working on this, and we think it really addresses a lot of the current issues in terms of treatment for weight management.

Speaker Change: Preclinical studies, so far we've never seen any evidence of diarrhea and that includes our knockout mice and if you think about it the enzyme is inhibited 100% for their entire lives and we haven't seen any diarrhea or anything like that in mysore or any of the other preclinical species.

Speaker Change: Looked at so we're very excited about this agents, it's a totally new mechanism that was discovered by our gene knockout work.

Speaker Change: To our knowledge nobody else is working on this and we think it really addresses.

Speaker Change: A lot of the current issues in terms of.

Speaker Change: Treatment of weight management.

Craig Randomize: Maybe I'll ask Craig to just charging some comments from them from a clinical perspective, what are your views on that pipeline.

Craig Granowitz: Maybe I'll ask Craig to just throw some comments from a clinical perspective on what he sees within Dynate 5.1.

Craig Granowitz: I think the other important point, and Alan touched on it, but just to put a finer point on it, this enzyme is expressed really in only two tissues. It's in the apical part of the GI tract, particularly the ileum, and in the liver. And I think all the effects that we're seeing are really related to weight management and this ileal break concept, which is really driven by the gut. And then also some of the data that Alan has previously shared, looking at favorable effects on lipid profile and progression of plaque in the coronary arteries of susceptible animals and also in liver fat overall, are indicative and reflective of the narrow distribution of the expression of this enzyme. So we're excited that it is a unique mechanism but also one that's really tailored to the tissues where a lot of these disease processes are taking place.

Craig Randomize: I think the other important point and Alan touched on it but just to put a finer point on it.

Craig Randomize: This enzyme is express really only two tissues.

Alan Main: It's in the apical part of the Gi tract, particularly the OEM and in the liver.

Speaker Change: I think all the effects that we're seeing is really related to the weight management and it's illegal break concept, which is really driven by the gut.

Speaker Change: And then also some of the data that Alan as previously shared with me a favorable effects on lipid profile and.

Alan Main: Progression of plaque in the coronary arteries of susceptible animals.

Speaker Change: And also in liver fat overall, I think are indicative and reflective of the narrow distribution of the expression of this enzyme. So we're excited that it has a unique mechanism, but also one that is really tailored in the tissues, where a lot of these disease processes are taking place.

Speaker Change: Well I know you can you can tell we're excited by this asset because we don't want to have the site, including myself just commercial commercially of course, we don't know where the basically white management.

Roanna Ruiz: Roanna, you can tell that we're excited by this asset because we all want to have a say, including myself. Just commercially, of course, we don't know where the obesity weight management space will be in the years to come. However, I think it's reasonably easy to predict that there will be combination therapies beyond the incretins. And as you know, a lot of the new medicines that are being developed are incretin based, different formulations, etc.

Speaker Change: Space will be in use to come however, I think it's reasonably easy to predict there'll be combination therapies beyond the <unk> and as you know a lot of the new medicines that are being developed developed during Clinton based.

Speaker Change: <unk> formulations et cetera.

Roanna Ruiz: And other somewhat similar metabolic conditions have shown us that new mechanisms of action are always appreciated as combination therapies, diabetes being an obvious choice here. So we're pretty, pretty excited about it. And we're going to learn a lot more about the clinical development, a lot more about the biology over the coming years. And I look forward to continuing to update you all.

Speaker Change: And other somewhat similar metabolic conditions of shyness that new mechanisms of action are always appreciated as combination therapies diabetes paying an obvious.

Speaker Change: These choices, so we're pretty pretty excited by it and we're going to learn a lot more about the clinical development and a lot more about the biology over the coming years and.

Speaker Change: Look forward to continuing to update you all.

Speaker Change: Yep sounds good looking forward to more updates thanks.

Operator: Sounds good. Looking forward to more updates. Thanks.

Speaker Change: Thanks.

Speaker Change: Yeah.

Speaker Change: The next question comes from Michael some of it with Citi. Please go ahead.

Yigal Nochomovitz: The next question comes from Yigal Nochomovitz with Citi. Please go ahead.

Speaker Change: Hi, guys. This is Oscar Mubarak al. Thanks for taking my question. So I just wanted to ask a follow up on on the last question was related.

Ashim Mubarak: Hi guys, this is Ashim Mubarak on Yigal. Thanks for taking my questions. I just wanted to ask a follow-up on the last questions related to the obesity program. It sounds like on the safety front, you believe that this program might be differentiated on diarrhea, but I'm curious if you have any sense of what maybe the nausea profile might look like. And to the similar question on safety, you know, I think one of the things we're wondering about is that these obesity drugs seem to be, may be necessary to dose very chronically for long periods of time. So I'm curious how long in terms of duration of therapy you've explored in your preclinical models, especially on the safety side.

Speaker Change: So the obesity program it sounds like on the safety front and who you believe that this program might be differentiated on diarrhea, but I'm curious if you have any sense of what maybe the nausea profile might look like.

Speaker Change: Hum.

Speaker Change: So a similar question on on safety.

Speaker Change: I think one of the things we were wondering about is the obesity drugs seem to be.

Speaker Change: And maybe that sort of dose very chronically for long periods of time, So I'm curious how how long in terms of duration of therapy explored and you're in these sort of preclinical models, especially on the safety side.

Alan Main: Great, yeah, thanks very much. So Alan, over to you for the question on nausea and then duration of therapy, particularly from a safety perspective.

Speaker Change: Right Yeah. Thanks, Thanks, very much so Alan over to you for the question on nausea.

Speaker Change: And then duration of therapy, particularly from a safety perspective.

Alan Main: Sure. Thank you.

Alan Main: Sure, thank you. So nausea, as you probably know, that's rather difficult to look at in preclinical studies. But what I would say is, you know, it's important to note that the inhibition of this enzyme doesn't completely reduce the absorption of free fatty acids. What it does is it delays absorption so that it can go further down, the fatty acids can reach what Craig mentioned, the ileal break mechanism.

Alan Main: So no I mean as you probably know that's rather difficult to look at and in preclinical studies.

Speaker Change: And but what I would say is it's important to note that the inhibition of this enzyme doesn't completely reduce the absorption of free fatty acids. What it does is it delays the absorption.

Speaker Change: So that it can go further down the fatty acids can go further down in the GI and then trigger you know what.

Speaker Change: What Craig mentioned the illegal break mechanism.

Alan Main: So, you know, obviously, to really look at nausea, you would have to do, you know, we have to look at the studies in phase one. So far, I think most of our studies have been only about one-month duration, and we'll be doing the IND-enabling tox studies, which will also be one-month duration in two species. But we do have plans on the preclinical side, exactly as suggested, to do studies of much longer duration, for three and six months.

Speaker Change: So.

Craig Randomize: Sleep to really look at nausea, you would have to do we have to look through the studies in phase one.

Speaker Change: So far I think most of our studies have been only about one month duration and we will be doing the IND, enabling tox studies, which will also be one month duration in two species.

Speaker Change: But we do have plans in the on the preclinical side exactly as you suggested.

Speaker Change: <unk> studies of a much longer duration for three and six months.

Speaker Change: Got it.

Speaker Change: <unk>.

Alan Main: Got it. Thank you. Now, if you'd also allow us, Yigal, to elaborate a little bit more, there's also some evidence beyond our group that might suggest that nausea is not an issue. Craig, maybe you want to talk a little bit about that. Yeah.

Speaker Change: No.

Craig Randomize: If you allow US also you got to to elaborate a little bit more. There's also some evidence beyond al group that might suggest that a nausea is not an issue Craig maybe you wanted to talk a little bit about that yeah. It's a great question and the beautiful thing is we have to knock out mouse models and.

Craig Granowitz: Yeah, it's a great question, and the beautiful thing is we have the knockout mouse models and the tolerability and safety of those over the life of both the mice. But also, there is more recently some limited human genetic data of knockdown and knockout variants of ACSL-5, and those individuals seem to live a full and normal life without any issues. The only issues you see are very early in life; there is a modification of diet that is needed for the first couple weeks, but after that, these children seem to grow on and develop normally into normal adults.

Craig Randomize: The Tolerability and safety of those over the life of both the mice, but also there is more recently some limited human genetic data of knockdown in knockout variance.

Craig Randomize: CSL five and in those.

Speaker Change: Individuals' seem to live a full in normal life without any issues.

Speaker Change: The only issue you see it's very early in life.

Speaker Change: There is a modification of diet that is needed for the first couple of weeks, but after that these children seem to grow on and develop normally into normal adult. So I think we feel that both from the knock outside on with the animals.

Craig Granowitz: So, you know, I think we feel that both from the knockout side with the animals and some of the human genetics that have been identified, we have something that is probably going to be able to be dosed for very, very long periods of time comfortably. And again, as Alan said, we need to do all the long-term toxicity tests on animals, and then the actual human clinical program with this particular inhibitor will need to be done. But I think we have a high degree of confidence, based on what we know, that they can be dosed safely for long periods of time.

Speaker Change: And some of the human genetics that have been identified.

Alan Main: We have something that is probably going to be able to be dosed for very very long periods of time comfortably and again as Alan said, we need to do all the long term tox in the animals and then the actual human clinical program with this particular inhibitor or will need to be done, but I think we have high degree of car.

Alan Main: And just based on what we know is that they can be dosed safely for long periods of time.

Craig Granowitz: That's super helpful. If I could ask one more quick question on the same topic, I'm just sort of thinking about how this mechanism, if this mechanism has applicability in areas outside of diabetes, but maybe in related areas. We know that GLIPP1s are involved in diabetes as well, but I think more recently, some of the larger players have even talked about heart failure. I'm just wondering if this mechanism has any relevance there as well, for maybe obvious reasons. Next slide. Yeah, the answer is yes. And

Speaker Change: Got it that's super helpful and if I could ask one more quick one on the on the same topic I'm also we're thinking about.

Speaker Change: How this mechanism if this mechanism has applicability in areas.

Speaker Change: Areas outside of diabetes, but maybe in related areas.

Speaker Change: Once theyre in diabetes, as well, but I think more recently some some of the larger players have even talked about heart failure.

Speaker Change: I'm just wondering if that's mechanism has any relevance there as well for maybe obvious reasons.

Alan Main: Yeah. The answer is yes, and Oh could I could turn to Alan where we've actually shown data in a number of metabolic conditions that you would assume.

Mike Exton: Yeah, the answer is yes. And I could turn to Alan, where we've actually shown data in a number of metabolic conditions, as you would assume, from reducing body weight and obesity. Some of it is incredibly exciting, and we're looking to present that data at medical conferences in the near future. So the short answer is yes, there's opportunity within lipidology, opportunity within other metabolic conditions as well. So looking at a very, very interesting

Alan Main: Reducing body weight in obesity.

Speaker Change: Some of it is incredibly exciting way, we're looking to present that data at medical conferences in the near future. So the short answer is yes, there's there's opportunity within our lipid allergy opportunity within other metabolic conditions as well so booking looking very very.

Alan Main: Interesting mechanism here.

Speaker Change: Got it thank you very much.

Speaker Change: Thanks, a lot.

Speaker Change: This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks.

Operator: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.

Speaker Change: So I'd just like to thank you all for attending todays Q2.

Mike Exton: I'd just like to thank you all for attending today's Q2 Earnings Call. We're incredibly pleased with the progress that has been made today. We've got a busy back half of the year and into 2025, but that provides us with many, many opportunities that we're really looking forward to. So we look forward to continued dialogue, and we'll speak to you all soon.

Speaker Change: Earnings call.

Speaker Change: We're incredibly pleased with the progress that is being made.

Speaker Change: Today, we've got a busy back half of the year end and into 2025, but that provides us. Many many opportunities that we're really looking forward to so look forward to continued dialogue and we'll speak to you all soon.

Speaker Change: Yeah.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].