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spk02: Good afternoon and welcome to the Lexicon Pharmaceuticals fourth quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Carrie Siragusa. Please go ahead.
spk09: Thank you, Gary. Good afternoon, and welcome to the Lexicon Pharmaceuticals Fourth Quarter 2022 Financial Results Conference Call. Joining me today are Lynelle Coates, Lexicon's Chief Executive Officer, Jeff Wade, Lexicon's President and Chief Financial Officer, and Dr. Craig Granowitz, Lexicon Senior Vice President and Chief Medical Officer. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the fourth quarter of 2022, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with a slide presentation, is 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, including statements relating to the safety, efficacy, regulatory status, and therapeutic and commercial potential of Sotocoflozin, LX9211, and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of Sotagliflozin, LX9211, and our other drug candidates, and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, launch and commercialization plans for any approved products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include uncertainties related to our NDA for Sotagliflozin in heart failure and our discussions with the FDA regarding Sotagliflozin relating to heart failure and type 1 diabetes, the success of our commercialization efforts with respect to any approved products, the timing and results of clinical trials and preclinical studies of Sotagliflozin, LX9211, and our other drug candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our planned research, development, and commercialization activities. For a list and a description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. I would now like to turn the call over to Lynell Coats.
spk00: Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. Fourth quarter 2022 was another active period for both our lead programs, Sotagiflozin, our dual SGLT1 and 2 inhibitor that we're developing for heart failure, and LX9211, our AAK1 inhibitor, that we're developing for neuropathic pain. Starting with our LX9211 program for neuropathic pain, in June of last year, we had previously announced positive top line results from our phase two proof of concept study in diabetic peripheral neuropathic pain. The final data demonstrated further significant benefits in both burning pain and on pain interference with sleep. In December, we announced top line results from a second phase two proof of concept study of LX9211 in post-herpetic neuralgia. These results demonstrated clear evidence of effect, further supporting the advancement and another indication within neuropathic pain. These results showed a consistent and statistically significant reduction in average daily pain score, or ADPS, compared to placebo throughout the dosing period, but as we have shared, not reaching statistical significance on the primary endpoint measured at week six. One of the more exciting aspects of these results is the remarkable consistency seen across both Phase II studies, and we will share more today about the development plans already underway to move LX9211 forward to late-stage development. We continue to believe LX9211 represents an innovative approach to treating neuropathic pain and, if approved, could provide a significant opportunity to improve the treatment landscape for the benefit of patients. Now, turning the soda to flozin. I'm pleased to say we had our late cycle review meeting with the FDA earlier this week for our NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues and again confirmed that it has no plans to hold an advisory committee meeting. Therefore, we believe everything remains on track for our PDUFA target date of May 27, 2023. We look forward to continue to work with the FDA throughout the remainder of the review period and are planning to commercially launch Sotocoflozin in the U.S. in the first half of this year, preparations for which are already underway. We continue to believe the unique data from our SOLUS worsening heart failure trial in patients recently hospitalized for heart failure may provide a point of clinical differentiation, enabling a strong entry into the heart failure market. As a reminder, this past November, new data from the Soloist Worsening Heart Failure Trial were presented at the American Heart Association Scientific Sessions, demonstrating Sotica flows and significant effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 and 90 days following discharge after an initial event. This was indeed a significant finding that we believe could provide tremendous benefits to patients, physicians, hospitals, and payers, and help differentiate Sotagiflozin within the current heart failure treatment paradigm. I'm going to turn the call now over to Jeff, who will review the Sotagiflozin program and the status of our commercial launch preparations.
spk03: Jeff? Thanks, Lionel. There are 6.7 million people in the United States living with heart failure, a number that is expected to increase to 8 million by 2030. Heart failure is the leading cause of hospitalizations for Americans over 65 with more than 1 million hospitalizations for heart failure annually. Patients who are hospitalized for heart failure are highly likely to return with about 25% of patients being readmitted to the hospital within 30 days of discharge and about 65% within a year. Hospital readmissions are burdensome for both patients and the healthcare system. Annual costs from heart failure are expected to increase to nearly $70 billion by 2030, with 80% of those costs due to hospitalizations. There is a substantial unmet need for better treatment options for patients, and as these data make clear, a strong incentive for providers, hospitals, and payers to identify new approaches to reduce hospital readmissions. Aligned with that incentive are data from the Journal of the American College of Cardiology revealing a compelling reason to prioritize when patients are started on therapy in order to increase the likelihood that patients receive appropriate treatment following a hospitalization for heart failure. In particular, the data suggests that starting patients on therapy at the time of hospital discharge results in a significantly higher percentage of patients receiving appropriate treatment at 60 to 90 days, and at 12 months follow-up. Heart failure is a very large multi-billion dollar market that is poised for substantial growth. Along with increasing disease prevalence, this anticipated growth is being driven by new guidelines recently issued by major cardiology societies in the United States and elsewhere recommending the use of SGLT inhibitors as an important element in the standard of care for treating heart failure. Currently, of those 1.3 million hospitalizations a year due to heart failure, data suggests that fewer than 10% of patients are discharged with a prescription for an SGLT inhibitor. This provides an exceptional opportunity for psoriasis given its unique data showing its significant impact on that transition of care patient population. I will now turn the call over to Craig to provide a reminder on the unique data presented in November by Dr. Bertram Pett at the American Heart Association Scientific Sessions, assessing sonocompliasin's effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 and 90 days following discharge from a heart failure hospitalization. Thank you, Jeff.
spk04: As you can see, the group of patients from the solo study, while improving in their clinical journey, remain at risk for future heart failure events. as Jeff has shown in the prior slides. As a reminder, the soloist worsening heart failure trial enrolled approximately 1,200 patients with heart failure who were either hospitalized or recently hospitalized and were transitioning out of the hospital. Double-blind randomized treatment began either in the hospital or within three days following hospital discharge. There were approximately 50% of patients in each of those two categories. The primary endpoint for the trial was achieved with a statistically significant and clinically meaningful production of 33% in the composite of total cardiovascular death, hospitalization for heart failure, and urgent heart failure visits, with the need to treat only four patients for one year to avoid one endpoint event, finding which is unsurpassed within the SGLT inhibitor class. The objective of Dr. Pitt's post-hoc analysis was to evaluate the efficacy of sortyloposin versus placebo at reducing hospital readmissions and mortality within 30 and 90 days post-discharge from a heart failure hospitalization among those patients who began treatment on or before the date of discharge. As a reminder, there were no differences between the two groups for baseline characteristics or the primary endpoint. Presented here are the results for cardiovascular death and heart failure related events for 30 and 90 days post-discharge. You can see the sodaglifosin arm in the blue color begins to separate from the placebo arm in red very early on and showed that treatment with sodaglifosin resulted in a significant relative risk reduction versus placebo of approximately 50% for readmission for non-fatal heart failure events and for the composite of cardiovascular death and readmission for heart failure at both 30 and 90 days following hospital discharge. The authors concluded that sotaglifosin significantly reduces the 30 and 90-day rates of cardiovascular mortality and heart failure-related events, as well as total mortality by 90 days post-discharge when administered prior to hospital discharge. The authors state that these findings are unique and underscore the benefits of early initiation of evidence-based heart failure therapy. Sotaproposin is the first compound to demonstrate a reduction on both mortality and heart failure events for a treatment initiated during a heart failure hospitalization. We certainly agree with the authors that these results have important implications for patient quality of life and healthcare costs. And as Jeff has already mentioned, expect these data to be key points of differentiation in the marketplace, should pseudogliposin achieve regulatory approval. We also wanted to highlight four additional upcoming data releases at the American College of Cardiology's 72nd annual scientific sessions being held this coming weekend in New Orleans. This includes an important paper on the time to clinical benefit of Sotaglifosin in heart failure patients transitioning out of the hospital in the Soloist Worsening Heart Failure Study by Dr. Verma, which concluded dual inhibition of SGLT2 and SGLT1 with Sotaglifosin leads to an early and sustained reduction in outcomes in patients with heart failure that is apparent by 27 days post-randomization. These data support and further extend the results of the AHA findings that we highlighted above for this high-cost and high-risk population. This is in addition to three additional poster presentations during the weekend at ACC, which you can see the dates and times for each in the slide. I'll now turn the call back over to Jeff to share more on our commercial launch preparation.
spk03: Thank you, Craig. As Lonnell referenced earlier today, our commercial launch preparations for Sotocliflozin have been well underway for the better part of 2022. The majority of the infrastructure to support a commercial launch in heart failure in the U.S. in the first half of 2023 is currently in place, including the full payer and medical teams who have been having appropriate preapproval information exchanges with key stakeholders since late last year. In addition, we brought on our sales leadership team towards the end of last year, and we are currently in the process of interviewing for the sales representative positions that we plan to bring on board closer to the anticipated PDUFA date in May. We feel confident that we will have the right talent and resources to be ready for a very successful commercial launch following regulatory approval. We will now turn briefly to our LX9211 programs. LX9211 is a potent, highly selective small molecule inhibitor of a novel target, adapter-associated kinase 1 or AAK1. In a number of relevant animal models of neuropathic pain, LX9211 demonstrated consistent, significant reductions in pain scores, even when compared to positive controls such as gabapentin. LX9211 achieves high levels of drug in the CNS, And importantly, the mechanism of action of LX9211 is independent of the opioid pathway. In phase one studies, LX9211 was shown to be well-tolerated with a pharmacokinetic profile supportive of once-daily dosing. Lexicon has been granted fast-track designation by the FDA for diabetic peripheral neuropathic pain. From a market perspective, the neuropathic pain market is expected to grow by more than 13% worldwide between on an annual basis between 2020 and 2026, and is projected to be worth more than $13.2 billion. Currently available therapies are limited by a lack of efficacy, side effects, and potential for abuse. As a result, there is a great opportunity for new and innovative treatments, such as LX9211, to enter this growing market with great unmet need. I will now turn the call back to Craig to briefly review the key results from our phase two studies in two distinct types of neuropathic pain that read out last year. Thank you, Jeff.
spk04: As we discussed during our last quarterly call, the primary endpoint of the relief DPN1 study was achieved with a statistically significant reduction in the average daily pain score, or ADPS, at week six compared to placebo in the low-dose arms. There was an absolute reduction in ADPS from baseline of 1.39 points with a p-value of 0.007 compared to placebo. The high-dose arm achieved a reduction from baseline of 1.27 points with a p-value of 0.03 compared to placebo, narrowly missing the significant threshold of 0.028, but showing consistent effects. As announced at the 16th Annual Pain Therapeutic Summit in Washington, D.C. this past November, not only did LX9211 achieve the primary objective of the study by reducing patients' average daily pain score, but the final data demonstrated significant positive effects of LX9211 on measures that are meaningful to patients suffering from diabetic peripheral neuropathic pain, including burning pain and sleep interference. which have a direct impact on patient quality of life, as is shown in the attached slides. We also noted during the blinded five-week placebo runoff period in the study, there was a gradual tapering of efficacy in both treatment arms with no evidence of rebound pain or withdrawal symptoms. There were no observed differences in treatment emergent adverse events between the treatment and placebo arms during the runoff period, and no drug-related serious adverse events or deaths were reported in the trial. Now, turning to the results of our second phase two proof of concept study in post-hepatic neuralgia, relief PHN1. As we announced in December during our call, reporting the top line results from the trial, LX9211 achieved a reduction in average daily pain score of 2.42 points from baseline at week six compared to a reduction of 1.62 points in the placebo arm with a placebo-adjusted difference of 0.8 points and a p-value of 0.12. Although these results did not achieve significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect and achieved our goal for this small 79-patient study that further support the further development of LX9211 in another neuropathic pain condition. As Lynelle mentioned, when reviewing the data of both the relief DPN1 and relief PHN1 studies, we noted a remarkable consistency across the study results. When placing the graphs from the two studies side by side, the separation from placebo and mean change from baseline create similarly shaped curves. In addition to the timing and the magnitude of clinical benefit, we observe an adverse event profile that was consistent across both trials. To summarize, treatment emergent adverse events were generally mild to moderate. There were no drug-related serious adverse events in either study. Finally, dizziness was the most commonly reported treatment emergent adverse event. What we did not observe in the safety profile of LX9211 were some of the limitations of current therapies for neuropathic pain, such as peripheral edema, increased appetite, blurred vision, or dry mouth. The adverse events tended to occur early in treatment, suggesting the possibility that might be associated with the loading dose. And given the rapid onset of effect on ADPS, offering potential for further optimizing dosing for both tolerability and efficacy, effects that we are currently exploring. In conclusion, we have now completed two phase two proof of concept studies of LX9211 that support AAK1 inhibition as a potential new mechanism of action for treating neuropathic pain. We believe that LX9211 has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from neuropathic pain on a daily basis. This is a large and growing market with high unmet medical need. As a result, we are pursuing the rapid advancement of LX9211 into phase three development for the treatment of neuropathic pain. We are continuing the work to identify and optimize the proper dosing regimens, and we are preparing to engage in a dialogue with the FDA in the first half of this year on how best to advance the program into phase three development as quickly and efficiently as possible. As we have shared previously, we believe this program would benefit from a partnership that offers the right strategic fit for our organization and stakeholders And we are engaged in discussions in this regard, which we believe will yield a positive outcome. In the meantime, we are proceeding with our plans for further development without pause. I'd like to now turn the call back to Jeff to take us through the financial results for the fourth quarter of 2022. Thank you, Craig.
spk03: I will provide some key aspects of our fourth quarter 2022 financial results. More financial details can be found in the press release that we issued earlier today and our Form 10-K that will be filed shortly with the SEC. We ended the year with $138.4 million in cash and investments. We believe that our existing capital resources provide us with the right level of funding to support continued commercial preparations, make appropriate investments in research and clinical development, and move towards a potential LX9211 partnership. Our loan facility with Oxford Finance, which provides up to $100 million in additional borrowing capacity, gives us substantial financial flexibility as we prepare to embark upon the expected launch of Sotagliflozin in the first half of this year. We anticipate that our existing cash and investments, together with capacity under the loan facility, will provide us with sufficient resources to manage our operations well into the anticipated launch of sodagliflozin into the market without taking into account any proceeds from or costs assumed by a partner in any partnership that we may establish for LX9211. Now, turning to our financial results for the fourth quarter. As indicated in our press release this afternoon, we had minimal revenues for the fourth quarters of both 2022 and 2021. Research and development expenses for the fourth quarter of 2022 decreased to $14 million from $16.5 million for the corresponding period in 2021, and for the full year decreased to $52.8 million from $55 million in 2021, primarily due to lower professional and consulting fees in 2022 related to preparation for submission of our application for regulatory approval to market set of flows and for heart failure. Selling general and administrative expenses for the fourth quarter of 2022 increased to $16.3 million from $8.8 million for the corresponding period in 2021, and for the full year increased to $48.1 million from $32.3 million in 2021, primarily due to increases in salaries and benefits, professional and consulting costs, and marketing costs, relating to preparations for the commercial launch of sodic flows in heart failure. In total, net loss for the fourth quarter of 2022 was $30.5 million, or 16 cents per share, as compared to a net loss of $25.6 million, or 17 cents per share, in the corresponding period of 2021. Our net loss for the fourth quarters of 2022 and 2021 included non-cash stock-based compensation expense, of $3.3 million and $2.2 million, respectively. Net loss for the full year, 2022, was $101.9 million, or 62 cents per share, as compared to net loss of $87.8 million, or 60 cents per share, in 2021. For the full years of 2022 and 2021, net loss included non-cash stock-based compensation expense of $11.5 million and $10.6 million, respectively. I would like to pause now and ask the operator to open up the call to take your questions.
spk02: 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. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster.
spk05: Our first question is from Yigal Nakamovitz with Citi. Please go ahead. Yigal, your line is open on our end. Do you have it muted on yours?
spk02: Moving on, we'll go to Yasmeen Rahimi with Piper Sandler. Please go ahead.
spk06: Good afternoon, team, and congratulations again on getting great presentation at the American Cardiology Conference this weekend. Team, I guess the question that I have for you first is, have you had any additional interactions with the FDA since In the last few months, is there additional meetings that's on the schedule between now and May 27th? That would be great. And then in terms of timing and next plans for LX9211, just some strokes in terms of timing, which indication, in terms of diabetic neuropathy pain. in terms of the size of the study and duration of the trial. So, I appreciate you taking the questions in any color in both of the topics would be greatly appreciated.
spk00: Yes, thank you for both questions. Let me start with the FDA. We had our late cycle meeting a couple days ago. So, I'm extremely pleased with those conversations. As I indicated, there are no issues with application. We're not going to an advisory committee based on their feedback to us. We have literally moved into, at this point in time, the next stage is into a label negotiation. So we're very pleased about that. So we are well on target at this point to advance soda flows and forward market and approval. So couldn't be more pleased with that conversation that just happened a couple of days ago. As for LX9211, Conversations with partners have been ongoing. It was a robust, it's been a robust process with very high interest, and we're narrowing it down. And I think the next stage for us is to move forward with our conversation with FDA on how best we advance the program to phase three. Depending on, you know, should we pull the trigger on the partnership here sooner or later, That'll depend on certainly how we approach the FDA when that meeting is granted. So I think we're in very good shape to advance LX9211 once we get the FDA feedback on the phase three program and also make some determinations as we make advances on and discussions with potential partners.
spk06: Lionel, maybe two additional questions to the great comments you just made. Sure. One is, is there interest to do the partners wanted potential partner discussions would like to see FDA feedback or is it really not necessary to have that in place? And then in regards to the great cycle review with the FDA, what are the possible label outcomes, in your view, just broad strokes in regards to that would be really appreciated. And I'll jump back into the queue.
spk00: All right, Yasmin, you know you're causing trouble for me. We've entered into label negotiations, so I don't want to do that publicly. But I will say we're very pleased with the initial conversations. I think we are going to have a strong label. Anything can change between here and there. But the initial conversation with the agency, I think we're going to have a very good label. Everything we've laid out here today in terms of the I think the label should follow suit with that. And so I'm just going to color those conversations as very robust and very pleasing thus far. As for partnership, no. You know, they're not waiting for FDA feedback. But, you know, there's a chance that we may want to wait for that so that we know exactly how we want to go in to make sure we can determine the best value for the asset. But more importantly, I think there's an eagerness on all sides to try to keep advancing things appropriately. And my hope is that we can reach agreements both with the agency in a timely manner and potential partner somewhere around the same time.
spk07: Thank you so much.
spk02: The next question is from Yigal Nakamovitz with Citi. Please go ahead.
spk08: Hi, team. This is Carly on for you. Can you hear me okay?
spk02: Yes, we can. Yes, we can.
spk08: Okay, awesome. Thank you. So for LX9211, in the plots you shared from relief DPN1 and relief PHN1, we just wanted to kind of get your perspective on the overlapping error bars between drug and placebo. Obviously, you hit STATSIG, but there seems to be a fair amount of overlap in the error bars. So Just curious your thoughts on that, and as you think about the design for a phase three, are there any additional steps you can take to minimize a placebo response?
spk00: Great question. Carly, let me turn it over to Craig. Thank you, Carly, for the question.
spk04: The error bars are really a reflection of the variability of the data and the size of the study, and that's why we did not achieve significance, for example, in the THN1 study, because while the magnitude of the effect size was even larger than we had forecasted to achieve statistical significance, and as a reminder, the reduction was 0.8 points in the ADPS score, which was greater than we had powered the study, the variability was also somewhat larger than we had anticipated. We took a number of steps in the trial to minimize some of the variability, and one of the reasons why these studies in neuropathic pain are so difficult is patient variability. And we actually received quite a bit of positive feedback in the medical and scientific community for the design of the trial with pre-qualifying the patients with the run-in period, which as we've shared with this group before, actually undercuts the overall efficacy because by reducing variability, you are starting the patients already on placebo. which actually lowers their pain score because there is a strong placebo effect. So again, for full transparency and integrity of the data, we're showing the error bars, but the data are statistically significant. And I think it is a reflection of the population that is being studied that there is that degree of variability.
spk00: As for, as you start thinking about phase three, we've learned quite a bit about how best to to set up the phase three study, as well as you want to talk a little bit about the parameters.
spk04: Yeah, thank you, Linnell. So again, what we believe is that we're going to be having a program, not just a single study for phase three, which is very consistent with other clinical trials. The feedback we've had is some of the questions that have been asked. The 12-week study is probably the duration of the trials. And to continue to look at these run-in periods, to further refine the patient population and minimize those patients that have significant day-to-day variability in their pain score and to better harmonize the ability of patients to accurately complete these forms. As a reminder, the primary endpoint is what's called a visual analog scale. You are asking the patient to remember back during the course of that day what is their average pain score measured on a scale of zero to nine. So as you can imagine, it is a very qualitative endpoint. It's not a lab value. It's not a diagnostic test. It's a very subjective endpoint. So we want to make sure that we have patients that are having consistent pain, significant of moderate to severe pain, and a minimum of variability on day-to-day pain, as well as consistent ability to effectively comprehend and complete the forms. So we've learned a lot in our phase two program to be sure we're getting the right patient population that can give a consistent, accurate reflection of their pain state.
spk07: Okay, great. That's really helpful.
spk08: And then we just also had one question on soloists. We were wondering if the data looked essentially the same when you looked at the group that started Soto while they were still in the hospital versus patients who started Soto within three days of discharge. Curious if you presented that analysis.
spk04: Yeah. So, Carly, I'll answer that one as well. I think we shared at the last earnings call and Dr. Pitt shared at the American Heart Association, it's a terrific question. And what you see is that there is no difference in the primary endpoint between those two groups of patients. So whether you start the patient before they leave the hospital or on the day they leave the hospital, which is about half or 600 of those patients, or you start the patients within three days after leaving the hospital, The primary endpoint of cardiovascular death, emergency unscheduled hospital readmission, or emergency room visit are the same. The group that we showed the 30 and 90-day 50% reduction in readmission is, again, are the patients coming back to the hospital? So by definition, that is patients that have not yet left the hospital and are coming back to the hospital. And I think you asked the right question because what we've shown is that overall those patients are the same whether in the primary endpoint, whether they are leaving the hospital or have left the hospital. But you're still looking at a 50% reduction in the hard clinical endpoint of hospital readmission by 30 days.
spk07: Okay, perfect. Thanks for taking our questions.
spk02: You bet. The next question is from Joseph Stringer with Needham & Company. Please go ahead.
spk01: Hi, thanks for answering our questions. The first one is on SOTA and HF. Just wondering if you could confirm that there were no additional requests for data from FDA sort of in and around the late cycle review meeting. And then the second one is on 9211. You mentioned you're in partnership discretion, but a lot will depend on your upcoming meeting with FDA. So I guess, does this mean that you are in a position to initiate additional clinical trials of 9-2-1-1 and potentially a phase three program, you know, post interaction with FDA and without a partnership? And then I think in some of the prepared marks, you mentioned that you're doing some work to optimize the proper dosing regimens. Can you just characterize what, What type of work that is, is it modeling or otherwise? Thanks for taking our questions.
spk00: Yeah, Joy, I'm going to try my best to remember all your questions, but I appreciate all three. The first one in terms of the additional data, you know, when you get past a late cycle review meeting, you're past a late cycle review meeting. So in terms of additional data, no, there's not been any requests for additional data from the FDA. Okay. We're at the stage now where we should be entering into labor negotiations and discussions. So we're late in the process, that's what I would say. As for LX9211 and moving into phase three, we wouldn't want to do that until we have our FDA meeting, which we've requested. And as we know more about that, we'll certainly keep everybody informed of that. I would just characterize overall partnership conversations Good overall conversations, good progress with parties. It's always a challenge to make sure you're lying around value and lying around timing of how value gets created. And my view of the world is we understand the value of our asset, and we won't do anything less than achieving that value. So I think we're in a good position both with soda in terms of where we are at the FDA, and we're in a good position to keep advancing soda flows and forward. That's what the FDA meeting is about. And I think once we conclude that, we should be in a position to advance it into phase three. And my hope is if we get alignment, we'll be able to do that in some type of broad framework partnership.
spk05: I think those were the three. All right. Any other questions?
spk02: This concludes our question and answer session. I would like to turn the conference back over to Delano Coates for any closing remarks.
spk00: Well, thank you to everyone for joining us on today's call and for your continued support of Lexicon. I would like to close out by summarizing a couple of key milestones and events. First, for LX9211, based on the completion of As we've said, two proof-of-concept studies in diabetic peripheral neuropathic pain and post-hepatic neuralgia, planning and preparations for a Phase III development program are underway, and we will be able to share more about these plans as the year progresses. Second, we have successfully completed a late cycle review meeting with FDA for our new drug application for psoriasis and heart failure and remain on track for our PDUFA data May 27th. and we plan to launch soda-giflozin and heart failure in the first half of 2023. Finally, importantly, Lexicon is in a strong position, cash position, with the ability to fund operations well past initial launch of soda-giflozin and heart failure if approved. This has been a tremendous quarter for the company and for our stakeholders, and we expect these milestones to only increase value for all of our stakeholders in 2023. Look forward to continuing to communicate events out to you as they occur. Thank you very much for joining us.
spk02: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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