Q2 2022 Lexicon Pharmaceuticals Inc Earnings Call
[music].
Good afternoon, ladies and gentlemen, and welcome to the Lexicon Pharmaceuticals, Inc. Second quarter 2022 earnings Conference call.
At this time all lines are in a listen only mode.
Following the presentation, we will conduct a question and answer session if.
If at any time during this call you require immediate assistance. Please press star Zero 40, operator.
Today's call is being recorded Tuesday August 2nd 2022, and I would now like to turn the conference over to Mr. Mike Kelly. Please go ahead Sir.
Thank you Michelle good afternoon, and welcome to the Lexicon Pharmaceuticals second quarter 2022 financial results Conference call.
Joining me today are what L coats lexicons, Chief Executive Officer.
Jeff Wade Lexicons, President and Chief Financial Officer and.
And Dr. Craig granted lexicon, senior Vice President and Chief Medical Officer.
Earlier this afternoon lexicon issued a press release announcing our financial results for the second quarter of 2022, which is available on our website at www Dot <unk> Dot com.
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 then release provided a corporate update and then use the remainder of our time.
To answer your questions.
Before we begin let me remind you that we'll be making forward looking statements including statements relating.
Two the safety efficacy and therapeutic and commercial potential of started disclosing Alex 91, one and other drug candidates each.
These statements May include characterizations of the expected timing and results of clinical trials instead of the closing.
Alex 91, one and our other drug candidates and the regulatory status and market opportunity for those programs.
This call May also contain forward looking statements.
Waiting to our growth and future operating results 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 soda floods in heart failure.
Our discussions with the FDA regarding Cedric of closing relating to heart failure in type one diabetes.
Access of our commercialization efforts with respect to any approved products the <unk>.
<unk> and results of clinical trials and preclinical studies of <unk> <unk> nine to one one and our other drug candidates.
Tenants 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 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 Enel coats.
You, Mike and good afternoon, everyone for joining the call.
So we go to the next slide.
As expected the second quarter of 2022 was a pivotal time for lexicon with major milestones achieved for both our due <unk> one and two inhibitor soda good flows for heart failure, and our 8-K, one inhibitor Alex 91, one for neuropathic pain.
We resubmitted, our new drug application for soda got flows them for the treatment of heart failure in May and as we announced last week. The filing was accepted by the FDA with a standard review and an anticipated <unk>.
Target date in May 2023.
Our regulatory interactions have given us confidence and seeking a broad label in heart failure, including patients with and without type two diabetes expanding on the potential opportunity of a soda good flows.
Importantly, we believe the unique data from our soloist WH F trial, and recent and worsening heart failure may provide a point of differentiation and strong entry into the heart failure market if approved.
The overall heart failure market is already a very large multibillion dollar market and is anticipated to further grow at nearly 20% per year for.
For the most of this decade.
Driven primarily by the <unk> inhibitor class and newly adopted guidelines for heart failure in the U S.
We believe that our unique mechanism of action clinical data in a growing market offers an opportunity for soda Cup flows in to achieve blockbuster potential.
We look forward to continuing to work with FDA throughout the review period, and if approved for marketing we're planning to launch soda good flows and in the U S. In the first half of next year.
I'm pleased to speak about another major achievement this quarter.
We announced positive topline results for our phase II proof of concept study of Alex nine to one one in painful diabetic neuropathy.
By achieving the primary endpoint of this study we accomplished our ambitions our ambitious goal of translating a new mechanism of action for the treatment of neuropathic pain from research and discovery to human clinical results.
This represents the culmination of over 15 years of biological research medicinal chemistry, and clinical science on a novel target that we through our proprietary discovery platform were the first to identify as a potential target for neuropathic pain.
We have a second proof of concept study for Alex not to one one in parcel post herpetic neuralgia with top line results anticipated to read out before the end of this year.
The large multibillion dollar neuropathic pain market remains largely unsatisfied unsatisfied with today's treatments and.
<unk> innovative approach with a novel compounds such as Alex 9211.
Could provide a significant opportunity to change of neuropathic pain treatment landscape for.
For the benefit.
Millions of patients.
I will now turn the call over to Jeff to discuss our opportunity and strategy for soda got flows in heart failure Jeff.
Thank you Lyle.
Art failure is a condition characterized by chronic decline overtime actuated by acute de compensated heart failure events that often require hospitalization.
R squared trial address patients experiencing this chronic decline showing a benefit on heart failure endpoints that were consistent across the patient population that included patients with and without heart failure at baseline.
Our soloist Debbie HFF study address patients who are hospitalized with a worsening heart failure event initiating therapy in the hospital prior to discharge or promptly following discharge.
Both studies achieved success on a common primary endpoint a reduction of the risk of cardiovascular death hospitalization for heart failure or urgent heart failure visits.
We believe that the results of soloist Debbie HFF.
With its unique data supporting initiation of therapy at a critical point in patient care will be an important element distinguishing our proposed label.
As long as Al mentioned the market for heart failure medications is expected to grow rapidly over coming years as a result of newly adopted guidelines recommending STL T inhibitors as an element of the standard of care across a broad range of heart failure patients.
The guidelines recently adopted by three major cardiology societies in the United States.
<unk> Heart Association, the American College of Cardiology, and the heart failure Society of America adopt <unk> two inhibitors as standard of care for heart failure with reduced ejection fraction with our recommendation at the highest level of competence.
Provide a similar recommendation, notably with a higher level of confidence than for any other class of therapy for heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction, which collectively represent 60% of all heart failure patients.
Importantly, the guidelines highlight the need to optimize medical therapies during heart failure, hospitalizations, and specifically cite the <unk> study.
Based on the results of our soloist Debbie HFF and scored phase III outcome studies, we are seeking a label that encompasses indications for reducing the risk of cardiovascular death hospitalization for heart failure and urgent heart failure visits in adults with heart failure.
With and without type two diabetes, including those with acute or worsening heart failure.
And reducing the risk of cardiovascular death hospitalization for heart failure and urgent heart failure visit.
Non fatal myocardial infarction and non fatal stroke in adults with type one type two diabetes chronic kidney disease and other cardiovascular risk factors.
As previously indicated we haven't anticipated <unk> target action date in May 2023, and expect to be in a position to launch promptly following anticipated approval in the first half of next year.
Unlike other diseases within cardiovascular medicine heart failure is very much a symptomatic disease in which patients endure a tremendous burden impacting daily lives.
When patients experience, a worsening heart failure that they're compelled to seek medical attention because they feel fatigued unable to conduct their normal daily activities and experienced significant shortness of breath even at rest.
Worsening heart failure episodes, often lead to hospitalizations, which are burdensome not only to the patient, but also to the health care system.
This is another area in which heart failure differs from many other cardiovascular diseases. There is an alignment among the interest of patient provider and payer.
The patient is highly motivated to seek better treatment to improve their symptoms and avoid a return visits to the hospital.
Providers have an economic incentive to do the same driven not only by a desire to deliver good patient care, but also by quality care metrics and penalties.
And payers face similar incentives with the desire to avoid that very expensive hospitalizations that are the biggest driver of heart failure costs.
The transition of care following a heart failure that is important in another key respect.
When these patients are initiated on new therapy within the hospital setting or at discharge.
Far more likely to receive and remain compliant with therapy as seen with both the 60 to 90 day in 12 month follow up statistics.
In this slide it.
It is exactly at this point the transition of care from hospitals to outpatient setting that we intend to target our efforts with surgical pleasant and leverage the uniqueness of our data from the soloist W. H F trial in this patient population.
Finally, we believe that with our unique soloist Debbie HFF data.
Strategy that is focused on heart failure, and even more specifically on the transition of care for patients hospitalized for heart failure, and the specialized and concentrated prescriber base that treats these patients we can be highly competitive in our target market with a modestly sized field force of around 100 reps.
I will now turn the call over to Craig to discuss our second significant milestone this quarter achievement of proof of concept for Alex 91, one and our phase two relief Dps one proof of concept study in painful diabetic neuropathy.
Thank you Jeff.
Alex 91, one is a potent highly selective small molecule inhibitor of a novel target adaptor associated kinase, one or a 8-K y.
This program and the steady results, we will discuss are backed by many years of scientific rigor and dedication from both lexicon and Bristol Myers Squibb, with whom we are in in neuroscience drug Discovery Alliance witness neuropathic pain target was uncovered leveraging lexicon Jean technique.
<unk> technology.
Lexicon with since April to reclaim the rights of 8-K, one target and associated development candidate from the alliance and.
We hold exclusive development and commercialization rights with modest milestone and royalty financial obligations owed to BMS.
And a number of clinically relevant animal models of neuropathic pain, Alex 90, 111 demonstrated consistent significant reductions in pain scores.
Even when compared to positive controls such as gabapentin.
Alex 91, one achieved high levels of drug in the CNS and importantly, the mechanism of action of Alex 91, one is independent of the opiate pathway.
In phase one studies, Alex 91, warehouses 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.
As a reminder, the relief VPN one study was a randomized double blind placebo controlled parallel group multicenter phase II study.
There were a total of three arms in the trial randomized on a one to one to one basis, including a placebo group.
Two active groups each consisting of a loading dose on day, one only of 10 times the maintenance dose and then once daily dosing for a total of six weeks.
The 102 hundred milligram loading doses were selected to achieve.
<unk> state blood levels on day, one of dosing in order to maximize the probability of achieving an early efficacy signal.
A concept study.
Primary endpoint of the study was changed from baseline to week, six and the average daily pain score or a D.
And the study was conducted at approximately 40 clinical sites in the United States.
A total of 319 patients was equally distributed amongst the three treatment arms.
Mean age at baseline was 62 years with agenda distribution of approximately 60% male and 40% female.
And a mean BMI of 32.
The median baseline pain score was approximately 6.6 on a scale of zero to 10.
Approximately 45% of all patients were on one background medication for their painful diabetic neuropathy with the vast majority of these being on gabapentin.
The primary endpoint of the study was achieved with a statistically significant reduction in ADP as at week six compared to placebo in the low dose arm.
It was an absolute reduction in <unk> from baseline of 1.39 points.
With a P value of 0.007 compared with placebo.
The high dose arm achieved the reduction from baseline of 1.27 points with.
With a P value of 0.03, compared with placebo, which narrowly missed significant stress hold of 0.0 to eight but showing consistent effects.
Interestingly the use of a rescue medication acetaminophen was highest in the placebo arm and lower in the two dose groups.
The therapeutic effect were seen early bearing treatment with separation from placebo being evident and statistically significant by week one.
In both dose arms and remaining throughout the treatment period.
Importantly, the drug effect was remarkably consistent across a number of factors, including age sex background, <unk> medication and baseline pain score.
Equally important the <unk>.
Patient reported outcomes, which are a measure of the patients overall, well being or experienced during the study showed greater improvement in those treated with Alex 91, one compared with placebo.
Adverse events were more frequent in the <unk> 91, one treatment arms and particularly at the higher dose as expected.
Just on our experience in phase one.
The most common events observed were dizziness, headache and nausea.
With nearly all reported as mild or moderate in nature.
What we did not observe in the safety profile of Alex 91, one or some of the liabilities of current therapies for painful diabetic neuropathy, such as peripheral edema.
Increased appetite blurred vision or dry mouth.
The adverse events tend to occur early in treatment, suggesting the possibility that they may be associated with a loading dose and given the rapid onset of effect on ADP S offering potential for further optimizing dosing for both Tolerability and efficacy.
To summarize we believe the results of the relief TPN. One study support a 8-K, one inhibition as a potential new mechanism of action for neuropathic pain and for further advancing <unk> 90 to one one in the development for the treatment of diabetic.
Neuropathic pain.
We believe that Alex 91 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.
We are proceeding with our work to identify and optimize the proper dosing regimen to take into phase III studies, and we are committed to doing that work in a thoughtful but expeditious manner.
As you might imagine this program has garnered a tremendous amount of external interest, particularly now that we have crossed that proof of concept threshold, where most others have failed.
For a variety of reasons not the least of which is the potential size of this opportunity. We believe that this program would benefit from a partnership that offers the right strategic fit for our organization and stakeholders.
Lastly, let.
Let me highlight that we will be outlining a series of publications and presentations throughout the remainder of this year to the <unk> 91, one program.
We have already received acceptances at medical meetings upcoming this fall for the design of the released the Pn study in September and a podium presentation for the full study results in November .
With that I would like to turn the call back to Jeff to take us through the financial results for the second quarter of 2022.
Thank you Craig.
I will provide some key aspects of our second quarter 2022 financial results more financial details can be found in the press release that we issued earlier today and our upcoming 10-Q SEC filings.
We ended the quarter with $62 million in cash and investments.
This amount does not take into account, the recently announced $85 million public offering and concurrent private placement of our common stock, which closed yesterday and from which we received approximate net proceeds of $82 2 million that will bolster our cash runway moving forward.
Together with our existing capital resources. The proceeds from this recent round of financing provide us with funding to support continued commercial preparations and the potential launch of set a pleasant and heart failure.
Our loan facility with Oxford, Finance, which provides up to $125 million and additional borrowing capacity gives us substantial financial flexibility as we proceed with preparations for the launch of sudden flows and make appropriate investments in research and clinical development and move towards a potential <unk> nine to one one partner.
Sure.
As a result, we expect that we will have sufficient resources to manage our operations through at least one year past the anticipated launch of surgical pleasant into the market without taking into account any proceeds or cost assumed by a partner in any partnership that we may establish for Alex 91, one.
Now turning to our financial results for the second quarter.
As indicated in our press release. This afternoon, we had minimal revenues for the second quarters of both 2022 and 2021.
Research and development expenses for the second quarter of 2022 increased to $13 4 million from $10 $3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits and higher professional and consulting costs related to this resubmission of our new drug application for.
Plus.
Selling general and administrative expenses for the second quarter of 2022 increased to $10 7 million from $7 9 million for the same period in 2021, primarily due to increases in personnel and external expenses relating to preparations for the commercial launch aesthetic pleasure.
And total net loss for the second quarter of 2022 was $24 6 million or <unk> 16 per share as compared to a net loss of $18 $1 million or <unk> 13 per share in the corresponding period of 2021.
Our net loss for the second quarters of 2022, and 2021 included noncash stock based compensation expense of $2 $8 million for both quarters.
I would like to pause now and ask the operator to open up the call to take your questions.
Thank you Sir.
Ladies and gentlemen, we will now begin the question and answer session.
If you would like to ask a question. Please press star followed by the number one on your telephone keypad.
If you would like to withdraw your question. Please press star followed by number two.
One moment. Please for your first question.
Your first question comes from Yigal <unk> of Citigroup. Please go ahead.
Hi, guys. Thanks, very much for taking my questions. So I had one on Alex 91, one so as you know in the approval trials for Lyrica Cymbalta. They showed a placebo corrected etfs from a range of <unk> eight to one two but there was no background gabapentin that was permitted in those studies you guys.
Showed a <unk> 67, placebo corrected eight etfs, but 45% of the patients were on the background pain medications. So getting to my question do you think that in a future phase III youre going to need to be in that eight to one.
Placebo corrected range to be competitive or given that the expectation will be that youre going to have patients that are already on background pain meds that are lower <unk>.
Seven Super correct to ADP as would be still very competitive commercially.
Okay.
You got it this is a lot of excuse me. That's a very good question my sense says and I'll, let Craig answer the question more thoroughly my senses.
What do we do in phase III, we're probably going to have to have a background use of other payments I think that's the best way to do it because it really shows the innovation above and beyond whats already out in the market and that's what we've done in phase two and so we would probably expect the same as a result, you cannot expect the same delta that you would if you had placebo.
Well basically being something less than the innovation in markets such as the Gaba pin noise and other other compounds that are currently treating so.
That's my sense, but I'll turn it over to Craig for any further thoughts from him.
Thank you Yigal, Thank you lanell.
<unk> got a great question and that's one we've been thinking about quite a bit.
I think mechanistically.
There is every reason to believe that.
Looking at a different mechanism of action than the gap of pensions that we could get additive activity.
And I think we've been able to have a strong hint of that even though the study was not designed or powered to look at that.
That is.
Good.
Staying hypothesis. So that is something that we are further going to explore for sure in phase III I think just to reiterate your question about the magnitude of the effect I just wanted to stress and remind us all of a few points.
First it was an intent to treat analysis of all treated patients.
The second is that as you know looking at the approved label of any of the other drugs doses and responses are all over the place and they vary quite a bit in terms of reduction from baseline ADP.
The third is as you know that there was a run in period in this study, which also in a sense artificially elevates. The response in all of the arms, including the placebo. So everybody was starting at a higher baseline point.
So we think for all of those reasons as well as the fact that the patients in terms of their patient reported outcomes also responded in general feeling better on.
I would now like 91, one and placebo that we have a clinically meaningful and important clinical effect.
Okay.
Okay, Great that's Super Super helpful. And then switching gears to heart failure, so well now.
You guys have done a very nice job in my opinion in making the case for differentiation versus the competing STL. Since he is in heart failure and just to summarize the evidence for the benefit of everyone. Listening you showed a 37% relative risk reduction in total CV death, HHS American heart failure, and scored and soloist versus the much lower 21%.
And that composite endpoint and the Emperor preserve trial and then you further demonstrated the benefit in patients hospitalized for acute Decompensate heart failure those were excluded from Emperor preserve and finally, the demonstrated benefits on MRI and stroke and scored much lower hazard ratios and we are seeing with the selected <unk> as.
You know in the canvas declare an empiric trials. So those are very compelling arguments from versus your peers in SDLP too. So but my question is I'm curious about entresto and what your claim for differentiation of <unk> versus Entresto given that I assume that you also want to take share from Entresto. In addition.
To taking share from <unk>. Thank you.
Yeah.
Jeff is itching to give a point of view on this so I'm going to let Jeff give his thoughts on it.
So.
I wouldn't necessarily view and trust as a competitor for us.
Entresto is is a.
That is in a different class of therapy, it's basically in a same classes therapy with ace inhibitors and arbs.
And as recommended in that class of therapy.
For for treatment of heart failure. So we don't really need to take share from entresto to be successful we are adding a separate classes therapy that has shown compelling results that is rated equally with entresto.
And about 40% of the market and the head of Entresto and about 60% of the market in terms of in terms of the.
Nine recommendations, so I think that will be in a strong position.
<unk> can be used with entresto, we can be used with the naas inhibitor or an arb.
We should have.
Really we haven't really compelling results and I think we can be differentiated from.
From others within this class and really capitalize on the.
The guidelines that are really evidence driven.
As to the benefit of <unk> inhibitors, including cynical pleasant.
Yes, you've got I think all I would add is that the.
One of our resuscitation you just made about our data the soloist data, so remarkable and that over 90%.
I believe the patients in that in that study were on standard of care, whether it was a it was the army or an arb or ace inhibitor. They were already on supportive care and then when you add it soda good flows into that mix you saw that big Delta. If you will that 37% so you're seeing the significant.
Adding soda into the mix on the current standard of care of care, which is what Geoff is talking about we don't have to take anything from them, but soda flows or needs to be part of the mix. If you want to get the overall benefit that we reported out in a soloist trial.
Got it and then just one small question.
I think in the press release, the other day on the acceptance of the NDA. It didn't see anything about FDA wanting a panel for soda in heart failure is that correct or is that still open for discussion.
Well, we'll never speak for the FDA on an advisory panel.
But I would say that.
Yeah.
There is there is nothing here in my opinion.
That should initiate an advisory panel given that.
What we've seen with other reviews of other compounds within the class.
The data is fairly straightforward.
You don't have any safety issues in this program.
The data is consistent across the patient groups. So my sense is if.
It's highly unlikely we will have a panel, but I would never say never.
Okay got it thank you.
Yes.
Your next question comes from Joseph Stringer of Needham and company. Please go ahead.
Hi, Thanks for taking our questions can you remind us again, just the next steps for the pivotal program here.
Is it additional phase II dose ranging trial.
Is that something that you had planned to do to sort of.
For now the right dose.
Perhaps go lower dose than.
The previous phase, two and maybe optimize the loading dose or where do you go straight into <unk>.
Sort of a phase three program here and then more just on strategy around partnering Alex 91, one would you would you look to secure a partner or when would you look to secure a partner.
And when you need one to advance this program forward.
Okay.
Great question, Joe one is that no we don't need a partner to advance the program for it we'd always planned to do additional work because we were pushing dose.
We're trying to learn because it was a proof of concept study and we are learning we're learning the impact of what the loading dose may have done both in supporting the efficacy of the program as well as what it may have done certainly to create some degree of.
The aes that we saw and so as we're going through now and analyzing that data. It will help inform us of what we're going to do in the next program that will allow us to accelerate our findings. So we can accelerate in the phase III, but it was always part of the planning to.
To do more around dosing as we learn more so I would say stay tuned on that but I'll, let Craig comment any further on the plant for for the next stage.
Yeah. Thank you.
I would now and Joseph.
I think.
So when we look at it.
Just on the results achieved in this pilot you could make a strong argument.
That the dose, even though not optimized at all with the loading dose you could take that into clinical trials on the basis of the fact that we had a significant magnitude of effect.
With a P value of 0.007.
The rapidity of the effect with the benefit seen in the first week that was maintained.
The concurrence of the patient reported outcomes.
Two the benefit in the 110 dose and the fact that there were fewer rescue meds required in that dose and the hydro's arm compared to placebo, but to the point that <unk> was making we think we can do better.
We think that our fee.
As to Tolerability optimization study that could result in better compliance and potentially lead to better efficacy.
Could give us even better results and better patient.
Experienced during treatment and that really is the next study that we're planning and we're really working hard now getting the last of the PK results in some other.
Smaller bits of data from the VPN study to make a final determination of what kind of design, we'd like to do going forward.
Yes, the only thing I would add Joey on the partnership side.
The to your question, we don't need to.
Two wafer partner to do that work, we're doing it now, but what I would say is because the interest is fairly high.
Those conversations are starting underway as we speak.
Okay.
Great and just a follow up on.
The post.
Neurology.
Trial readout, how would those results influence how you how you move forward with 91 one.
Jeff you want to take.
We basically have already established the key point, which was to establish the translation of this target and the proof of concept in.
In humans and that was that was the important element. This is really going to add some additional information.
It potentially adds another indication within neuropathic pain that we can pursue.
Be supportive information, it's a lot smaller study.
So that's.
It's going to be its got a lot less.
Less powered given that this study size, but we think that it's going to be complementary information that will allow that will help inform further development, but the key study that we wanted to get results key outcome that we wanted to get was to establish proof of concept mechanism.
And that's already been achieved.
Yes, I think what the PHN to Jeff's point could help you with if you want to go for a broad.
Neuropathic pain.
View, then you want to show signals in multiple areas, including.
The first one which is VPN.
But if you want the biggest market you've already achieved that signal if you want a bigger opportunity to expand it out then you want to get a signal and some other areas like PHN.
And by itself is a relatively small market, but you would like to get a good signal there that allows you to pursue a bigger broader.
Opportunity relative to neuropathic pain, and thats the value of it.
Thanks, that's very helpful and thanks for taking my questions.
Oh you bet.
Ladies and gentlemen, once again, if you would like to ask a question. Please press star one now.
There are no further questions from the phone lines I will turn the conference back to Mr. Coats for closing remarks.
Well, let me firstly, thanks, Charlie for joining us on the call and the support that you show for lexicon.
I'll close out by summarizing our key milestones and events first we now have an.
Accepted new drug application for soda good flows in heart failure with and without diabetes with a <unk> date in May 2023, and we plan to launch soda. Good flows in heart failure, if approved in the first half of 2023.
Secondly, we achieved positive top line results for the relief TPN. One study in June with full data to be presented at a medical conference. This year. This is very important to US we worked very hard for this and we will be providing full data at.
At a conference where the data has now been accepted in November so stay tuned for that you'll get to see the full dataset.
We anticipate top line results from our relief PHN one study before the end of this year.
Lastly, and importantly, we have recently closed a round of financing that puts us in a very strong position and extends our ability to fund our operations well past initial launch of soda flows them and heart failure. If it's approved so we're in a very good position to execute was what's near term for us and create value and benefit for our stakeholders.
So it has been a tremendous quarter.
There'll be many other siding developments on the horizon, and we look forward to continuing to update you and share our progress as we make it.
Thank you very much for joining us.
Ladies and gentlemen. This concludes your conference call for this afternoon, we would like to thank everyone for participating and ask that you. Please disconnect your lines.
Okay.
[music].
Sure.