Q4 2022 Lexicon Pharmaceuticals Inc Earnings Call

Speaker 2: Good afternoon and welcome to the Lexicon Pharmaceuticals fourth quarter 2022 earnings conference call.

Speaker 2: 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.

Speaker 2: To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2.

Speaker 2: Please note, this event is being recorded. I would now like to turn the conference over to Kerry Siragusa. Please go ahead.

Speaker 3: Thank you, Gary. Good afternoon and welcome to the Lexicon Pharmaceuticals Fourth Quarter 2022 Financial Results Conference Call. Joining me today are Lynell Coates, Lexicon's Chief Executive Officer, Jeff Wade, Lexicon's President and Chief Financial Officer,why are you here?

Speaker 3: 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.lexforma.com and through our SEC filing.

Speaker 3: 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.

Speaker 3: 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 sotagliflozin, LX9211, and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of sotagliflozin.

Speaker 3: 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.

Speaker 3: These risks include uncertainties related to our NDA for sotagliflozin and 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.

Speaker 3: 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.

Speaker 3: 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 Lanell Coates. Thank you, Kerry. Good afternoon, everyone, and thank you for joining us on the call.

Speaker 4: The fourth quarter of 2022 was another active period for both our lead programs, Sotagliflozin, 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.

Speaker 4: Starting with our LX9211 program for neuropathic pain, in June of last year, we have previously announced positive top-line results from our Phase 2 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 , Dutchtli, outweighed anxiety among first-generation and ??????? percept- olivet- GPA coded to take place along? paper west of G Despiélles.

Speaker 4: We announced top-line results from a second Phase II proof of concept study of LX9211 and pulse rheumatic neuralgia. These results demonstrated clear evidence of effect, further supporting the advancement and another indication within neuropathic pain.

Speaker 4: 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 measure that week six. One of the more exciting aspects of these results is the remarkable consistency seen across both the primary and secondary results.

Speaker 4: provide a significant opportunity to improve the treatment landscape for the benefit of patients.

Speaker 4: to improve the treatment landscape for the benefit of patients. Now turning the

Speaker 4: I'm pleased to say we had a late cycle review meeting with FDA earlier this week for NDA for the treatment of heart failure.

Speaker 4: 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.

Speaker 4: We look forward to continuing to work with FDA throughout the remainder of the review period and are planning to commercially launch SOTOGF flows in the U.S. and the first half of this year. Preparations for which are already underway.

Speaker 4: We continue to believe the unique data from our solace-worsing heart failure trial and 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 solace-worsing heart failure trial

Speaker 4: were presented at the American Heart Association scientific sessions demonstrating sotica flows and significant effects on 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.

Speaker 4: physicians, hospitals, and payers, and help differentiate soda-golf-flosin with an occurrent heart failure treatment paradigm. I'm going to turn to call now over Jeff, who will review the soda-golf-flosin program and the status of our commercial launch preparations. Jeff?

Speaker 4: and help differentiate soda conflozin within the current heart failure treatment paradigm. I'm going to turn the call now over to Jeff, who will review the soda conflozin program and the status of our commercial launch preparations. Jeff? Thanks, Juanel.

Speaker 5: 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.

Speaker 5: 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.

Speaker 5: and about 65% within a year.

Speaker 5: Hospital readmissions are burdensome for both patients and the healthcare system.

Speaker 5: 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.

Speaker 5: to identify new approaches to reduce hospital readmissions.

Speaker 5: 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 suggest…

Speaker 5: 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 for

Speaker 5: Heart failure is a very large multi-billion dollar market that is poised for substantial growth, along with increasing disease prevalence.

Speaker 5: This anticipated growth has been driven by new guidelines recently issued by major cardiology societies in the United States and elsewhere recommending the use of S. Chalte inhibitors as an important element in the standard of care for treating heart failure.

Speaker 5: Currently, at those 1.3 million hospitalizations a year due to heart failure, data suggests that fewer than 10 percent of patients are discharged with a prescription for an SGLT inhibitor. This provides an exceptional opportunity for SOTICLE Pleasant given its unique data showing its significant impact.

Speaker 5: 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's scientific sessions, assessing sonnacle pleasant effects in reducing cardiovascular mortality and the risk of hospital re-admissions.

Speaker 5: events as Jeff has shown in the prior slides. As a reminder, the soloist worsening heart failure trial enrolled approximately 1200 patients with heart failure who are either hospitalized or recently hospitalized and were transitioning out of the hospital.

Speaker 5: Double-blind randomized treatment began either in the hospital or within three days following hospital discharge. They were approximately 50% of patients in each of those two categories.

Speaker 5: 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.

Speaker 5: with the need to treat only four patients for one year to avoid one endpoint event, a finding which is unsurpassed within the STLT in Hibber class.

Speaker 5: The objective of Dr. Pitt's post-hoc analysis was to evaluate the efficacy of sotobuposin versus placebo at reducing hospital readmissions and mortality within 30 and 90 days post-discharge from a heart failure hospitalization. Among those patients…

Speaker 5: 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.

Speaker 5: You can see the sotaglifosin arm in the blue color begins to separate from the placebo arm in red very early on and showed that treatment with sotaglifosin resulted in a significant relative risk reduction versus placebo of approximately 50% for readmission for non-fatal heart failure events.

Speaker 5: and for the composite of cardiovascular death and re-admission for heart failure at both 30 and 90 days following the hospital discharge. The authors concluded that total post and 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.

Speaker 5: prior to hospital discharge. The author states that these findings are unique and underscored the benefits of early initiation of evidence-based heart failure therapy. SOTABOPOSAN is the first compound to demonstrate a reduction on both mortality and heart failure events for a treatment initiated during a heart failure hospitalization.

Speaker 5: 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 so to go both and achieve regulatory approval. We also wanted to highlight four additional upcoming data releases.

Speaker 5: by Dr. Verma, which concluded dual inhibition of SGLT2 and SGLT1 with SOTAL-FOSEN leads to an early and sustained reduction in outcomes in patients of heart failure that is apparent by 27 days post-reanimization.

Speaker 5: which concluded dual inhibition of SGLT2 and SGLT1 with soda-glufosin 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...

Speaker 5: 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 posters presentations during the week-end at AACC, 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 preparations.

Speaker 6: Thank you, Craig. As Juan Elreference earlier today, our commercial launch preparations for Sudden Flos and have been well underway for the better part of 2022.

Speaker 6: The majority of the infrastructure to support a commercial launch in heart failure in the US, and the first half of 2023 is currently in place, including the full payer and medical teams who have been having appropriate pre-approval 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 bidup date and May. We feel confident that we will have the right talent and resources to be ready for a very successful commercial.

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, Alex 9211 was shown to be well tolerated with a pharmacokinetic profile supportive of one stalee dosing.

Lexcon has been granted fast track designation by the FDA for diabetic peripheral neuropathic paint.

From a market perspective, the Neuropathic Pain Market is expected to grow by more than 13 percent 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.

a statistically significant reduction in the average daily pain score or ADPS at week 6.

compared to placebo in the low-dose arm. 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 reported in the trial.

Now, turning to the results of our second Phase II Proof of Concept Study in Post-Purpathic Neralgia, 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 pains for of 2.42 points.

from baseline at week 6 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 further development of LX9211 in another neuropathic pain condition. As Lanelle mentioned, when reviewing the data of both the relief DPN1 and relief THN1 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 observed 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 II proof of concept studies of LX9211 that support AAK1 inhibition as a potential new mechanism of action.

In conclusion, we have now completed two Phase II proof of concept studies of LX9211 that support AAK1 inhibition as a potential new mechanism of action for treating neuropathic pain.

We believe that LH9211 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 3 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 cause. I'd like to now turn the call back to Jeff to take us through the financial results for the fourth quarter of 2022.

We are proceeding with our plans for further development without cause. 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.

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 10K 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 Alex 911 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.

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 and the market set of plans 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 SOTIC Flos and heart failure.

In total, net loss for the fourth quarter of 2022 was $30.5 million or 16 cents per share as compared to 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 the 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-cast stock base 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. We will now begin the question and answer session.

draw your question, please press star then two.

At this time, we will pause momentarily to assemble our roster. Our first question is from Yigal Nakamovitz with City. Please go ahead.

You call your line is open on our end, do you have it muted on yours? Moving on, we'll go to Yasmin Rahimi with Piper Sandler. Please go ahead.

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 was 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 and any color in both of the topics would be greatly appreciated.

Yes, thank you for both questions. Let me start with the FDA. We had our lay cycle meeting a couple of days ago. So I'm extremely pleased with those conversations. As I indicated, there are no issues with application. We're not going to advise a committee based on their feedback.

please with that conversation just happened a couple days ago.

As for LX9211, conversations with partners have been ongoing. 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 3. 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 Alex 9211 once we get the FDA feedback on the face three program and also make some determinations as we make advances in discussions with potential partners. Lionel, maybe two additional questions to the great comments you just made.

cycle review with the FDA, what are the possible label outcomes in your view? Just broad strokes in regards to that would be really appreciate. And I'll all jump back into the queue. All right, Yasmin, you know you caused 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 we change between here and there, but the initial conversation with the agency, I think we're going to have a very good label. Everything that we have laid out here today in terms of the position of SOTOGFLOSEN, I think the label should follow suit with that. And so I'm just going to call it those conversations. It's very robust and very pleasing thus far. As for...

Partnership, no. They're not waiting for FDA feedback, but 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. Some are where I'm saying time.

Thank you so much. The next question is from Yigal Nakamavits with City. Please go ahead. Hi, team. This is Carly on Furrya Galkan here. Yes, we can. Yes, we can. Okay. Awesome. Thank you. So for Alex 9211, in the plots you shared from Relief VPN1 and Relief PHN.

on. Great question, Carly. Let me turn it over to Craig. Thank you, Carly, for the question. The error bars are really a reflection of the variability of the data in 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.

forecast to achieve statistical significance. And as a reminder, the reduction was 0.8 points in the ADPS4, 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 the study's a neuropathic pain or 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. As for as you start thinking about phase three, we've learned quite a bit about how best to set up the phase three study as well as you want to talk a little bit about the parameters.

Yeah, thank you, Lynell. 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 0 to 9. So as you can imagine, it is a very qualitative endpoint. It's not a lab value, it's not a diagnostic test.

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. But we've learned a lot in our phase 2 program to be sure we're getting the right patient accurate reflection of their pain state.

Okay, great. That's really helpful. And then we just also had one question on soloist. We were wondering if the data looked essentially the same when you looked at the group that started sodo while they were still in the hospital versus patients who started sodo within three days of discharge. Curious if you presented some analysis. Yes, so Carly, I'll answer that one as well.

I think we shared at the last earnings call and Dr. Pitch shared at the American Heart Associates and 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 on scheduled hospital admission or emergency room visit are the same. The group that we showed the 30 and 90 day 50 percent reduction in re-admission 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 are left the hospital, but you're still looking at a 50% reduction in the hard clinical endpoint of hospital readmission by 30 days. Okay, perfect. Thanks for taking our questions.

You bet. The next question is from Joseph Stranger with Needham and Company. Please go ahead. Hi, thanks for maintaining our questions. The first one is on soda and HF. Just wanted to be a kid. Confirm that there were no additional requests for data from FDA sort of ending around the late cycle review meeting. And then the second one is...

on 9211. You mentioned you're in partnership discussion, 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 9211 and potentially a phase three program post interaction with FDA and without a partnership?

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 type of work that is, is it modeling or otherwise? Thanks for taking our questions. Yeah, Joy, I want 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 passed a LASCICER review meeting, your past LASCICER review meeting. So in terms of additional data, no, there's not been any requests and additional data from the FDA.

We're at the stage now where we should be entering into late-win negotiations and discussions. So we're late in the process, that's what I would say. As for Alex 9211 and moving into Phase 3, 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 as 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 SOTA in terms of where we are at the FDA and we're in a good position to keep advancing so to get flows in 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 into phase three. And my hope is if we get alignment, I will be able to do that in some type of broad framework partnership. I think those were the three.

All right, any other questions? This concludes our question and answer session. I would like to turn the conference back over to Lonell Coates for any closing remarks. Well, thank you, 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 the

As we said, two proof of concept studies in diabetic periphery for pathocaine and post-apocalyptic neuralgia, planning and preparations for a phase to redevelop program are underway, and we will be able to share more about these plans as the year progresses. Second, we have successfully completed a lace-like review meeting with FDA for a new drug application, four so-to-go flows in the heart failure, and remain on track for our Pradoopa due for date of May 27th. And we plan to launch so-to-go flows in the heart failure and the first half.

of 2023. Finally, importantly, Lexicon is in a strong position, cash position, with the ability to fund operations well past the initial launch of soda good flozen 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.

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

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