Q3 2020 Lexicon Pharmaceuticals Inc Earnings Call
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Oh Good morning, My name is Jody and ill be your conference operator today at this time I would like to welcome everyone to the lexicon Pharmaceuticals third quarter 2020 financial results call. All lines have been placed on mute to prevent any background noise.
After the speakers remarks, there will be a question and answer session.
I would like to ask a question. During this time CP Press Star then the number one your telephone.
If you went back to John's question breast about.
I would now like Kinda conference over to your first speaker today, Josh Josh Schultz you may begin.
Thank you Julien good morning, and welcome to the Lexicon Pharmaceuticals third quarter 2020 financial result, and clinical update conference call.
Joining me today are Lynn L. coats, lexicons, President and Chief Executive Officer, Dr. Evergreen title Lexicons Executive Vice President of research and development.
Jeff Wade Lexicons executive Vice President of corporate and administrative affairs, and Chief Financial Officer.
Earlier today lexicon issued a press release announcing our financial results for the third quarter 2020, which is available on our website at www Dot flex pharma dotcom and through our SBC 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 that really provide an update on our clinical programs and then use the remainder of our call of our time to answer your questions.
Before we begin let me remind you that we will be making forward looking statements, including the statements relating to the safety efficacy and the therapeutic and commercial potential I like nine to one one sort of good flows then and other potential drug candidate.
These statements May include characterizations other expected timing and results of clinical trials of the L. <unk> nine to one one so to close them and other drug candidates and their 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 candidate.
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 risks include uncertainties related to the timing and results of clinical trials and preclinical studies about like nine to one one so to close them 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.
It's imposed by patents owned or controlled by third parties and the requirements of substantial funding to conduct our research and development activity.
For a list and a description of the risk and uncertainties that we face. Please see the reports we have filed with the Securities and Exchange Commission.
I will now turn the call over to Lynn LCOS. Thank.
Thank you Chad good morning, everyone and thank you for joining us on the call.
We welcome the opportunity to discuss a pivotal quarter for lexicon, and which we shifted our focus to Alex nine to one one and our other scientific assets and research and development.
During the third quarter, we completed the seller was a mellow and related assets to to Sarah Therapeutics. This sale allowed us to strengthen our balance sheet by repaying our 150 million our term loan in full we also exchanged $75.8 million in principal amount of our convertible notes for cash in common stock.
Okay and have retired more than 90% of our outstanding debt in total.
We are in a very good position to focus our time and effort on the advancement of Alex nine to one one which is a program. We have been excited about for a number of years previous will share more about this program and the potential we see for it to become a new treatment option the millions of people suffering from neuropathic pain.
Starting in the fourth quarter lexicon will be operating as a much more streamlined and focused company. We expect our cash burn to be dramatically lower moving forward into 2021, and we will be laser focused on advancing Alex non 211 through to phase two clinical trials in diabetic peripheral neuropathy pain.
In post Herpetic neuralgia, Jeff will delve into the financials more deeply including our outlook on expect to spend moving forward.
I feel confident that with the delevering of our balance sheet in a substantial reduction in our expected spend we're in a much better position to advance our science and increase the opportunity for values to flow through to our stakeholders.
On slide four I'd like to take a quick moment and remind everyone that soda the flows and remains an important asset in our science and development pipeline. This is a drug that we wholly own and continues to bleed has the potential to become a very important new treatment, but in many people living with type one diabetes.
One of the flows and has shown in a phase three program involving approximately 3000 patients to be effective as an adjunct to insulin and reducing a one c. and achieving other secondary efficacy endpoints, which led to an approval in Europe for type one diabetes last year, we continue to believe that the diabetic ketoacidosis risk.
Observed in the Phase three program is manageable and we will continue to seek approval in the United States.
At this point, we feel there is an opportunity to initiate the next phase of our strategy and we engage with the FDA. It is important that we we gain alignment with the agency on a clear pathway forward and type one diabetes and we plan to start that work. This quarter, we will be providing updates to you in the coming months as we make progress.
Yes toward this outcome.
We're also completing their early close out of scored and soloists two outcome studies have shown good flows in with primary endpoints evaluating a composite of total cardiovascular death.
Hospitalizations for heart failure, and urgent visits for heart failure. The outcome. The outcomes of those trials will be presented as part of a late breaker session titled late breaking science at the upcoming American Heart Association scientific session on November 16th at eight P.M. Eastern time, so centric.
Lenders.
With that I would like to invite previously to update you on our important pipeline asset non 211 dot style.
Thank you Linda.
It looks like the one one is it open only delivered selective small molecule inhibitor of it'd be too associated kind is which I live in preference as AK, one which is a pathway. We believe may have utility in reducing neuropathic pain, while avoiding the addictive downside of the opioid pathways.
Alex nine to one one was discovered by scientists working within our drug Discovery Alliance with Bristol Myers Squibb and be now wholly owned all rights to our next nine to one one as well as any additional compounds acting to NK one pathway that we may develop.
As you can see on this chart, we have already initiated a phase two proof of concept study in diabetic, but from neuropathic pain and we plan to initiate an additional phase two proof of concept study in post herpetic neuralgia by the end of this year.
We expect that both of these phase two studies will read out by the end of next year.
Neuropathic pain affects a large portion of the population within a worldwide market of approximately $6.4 billion and estimated sales expected for 220. The worldwide market is expected to grow at over 13% a year to $13.2 billion by 2000.
26.
That is estimated to be a prevalence of approximately 12 million people worldwide suffering from BNP and 600000 people suffering from PHN and 226.
Despite neuropathic pain affecting millions of people there remains a high level of unmet need for those suffering from the condition.
The current doping tied up these are limited by a lack of efficacy compounded by disruptive side effects.
Yes. It is not too many people are doing to opioids to experience. Some love an overly pitch of course, coty did own risk potential abuse and addiction.
We feel that Alex nine to one one towards inhibition, okay. One independent from the opioid pathway has the potential to overcome many of the shortcomings of cut incentive fees and could become a welcome new innovation for those suffering from neuropathic pain on it it would be seen basis.
So let's talk a little bit about why we are so interested in AK, one as an innovative pathways, putting neuropathic pain.
The discovery, Okay, one as a potential target for neuropathic pain occurred in the course of our multi year discovery and research program, we conducted about a decade ago called the genome 5000 project.
In that initiative, we started the phenotypes of approximately 5000 different knockout mouse line and identified the AK when mom knock out mice as exhibiting the most compelling phenotype when neuropathy been among all the genes. We studied here at lexicon.
Our preclinical data for Alex nine to one one has demonstrated excellent central nervous system penetration and.
And reductions in fan behavior in animal models of neuropathic pain.
Take you through some of our preclinical findings for Alex tied to one one in these animal models shortly.
But what is very important is that we have conducted several preclinical data to confirm Alex nine to one one independence from the opioid pathway and so far we have Paul no concerns at all under addictive potential with Alex nine to one one.
We have conducted single and multiple ascending dose phase one clinical studies in healthy volunteers to study the safety Tolerability and pharmacokinetics of I'd like nine to one one.
These studies support the preclinical profile, we had obtained in automotive trees.
Alex nine to one one was voted on record with dose proportional pharmacokinetics that was supportive of once daily dosing.
There were no drug related serious adverse events and the most common adverse events were transient headaches and dizziness.
Overall, we feel Ilecs nine to one one represents an innovative potential approach to accrete neuropathic pain without the addictive potential of many of the current therapies and treatments.
Let me show you some of the preclinical data supporting our view that Alex nine to one one may be beneficial for people suffering from diabetic peripheral neuropathy fan and post herpetic neuralgia.
But diabetics Bennett from neuropathic pain people living with diabetes, often develop nerve damage, which caused painful de heavy locating symptoms most often in their legs and feet. It has estimated that 60% to 70% of people with diabetes.
Developed but not for a new profit neuropathy at some point in their life.
On this slide you will see the effect of FX nine to one one in the gold standard diabetic peripheral neuropathy band Marty in rack also card SPC module.
In this model stuff goes or both him STC is used to induce diabetes in rack and then test that's performed to evaluate the rights sensitivity to mechanical Albania, which is a condition associated with diabetes, we had even slight touch can cause a painful sensation.
Despite the brown.
And portal lines the prone line to present the right in his diabetes was induced while the third quarter liner it presents the controlled racks without diabetes and with normal sensitivity to touch.
The rack along the Brown line of feeling the full effect of neuropathic pain from their diabetes and that feels band with any type of touch as shown by zero percent inhibition of mechanical allodynia.
That's correct along the purple line are not feeling any effects of neuropathic pain or sensitivity to touch as shown by 100% inhibition of mechanical allodynia.
The lines in between these two extremes show the effect of Alex nine to one one on the diabetic correct as.
As you can see that as a clear dose response to Alex nine to one one.
That enables these diabetic racks to experience its statistically higher degree of touch without span at the one milligram and three milligram per kilogram levels.
By the EPS comparison in the same experiment gabapentin, what business was adamant stood at 100 milligram per kilogram and resulted in a similar response as the one milligram and three milligram per kilogram levels of Halex nine to one one.
So we were able to achieve a similar level of efficacy at a much lower doors with Alex nine to one one.
More importantly at this level of dosing, we saw no motor impairment to direct and no impairment of performance and at cognition model, which are the two significant side effects of Gaba painted.
Viewer advanced Alex nine to one one into a phase two proof of concept trial and BNP. This trial is a double blind placebo controlled pattern group study that is expected to enroll approximately 300 patients from Cody us sites.
Patients will be randomized to one of the three arms placebo.
100 milligram initial dose followed by 10 milligram maintenance dose and 200 milligram initial dose followed by 20 milligram maintenance dose of I like nine to one one with a one to one to one randomization.
The primary endpoint is changed from baseline to week, six and average daily pain score a very standard symptom measurement tool used in most of the neuropathic pain trials.
The first patient was dosed during the third quarter of this year and we expect results in the fourth quarter of 2021.
We have taken steps to mitigate the strong placebo effect that is characteristic of studies in diabetic peripheral neuropathy pain, including studying a large number of patients over a long treatment theater conducting the trial exclusively in the United States and otherwise designing that trial with the potential placebo effect in mind.
Now, let's turn our attention to the second indication post herpetic neuralgia post.
Post herpetic neuralgia is the most common complication of shingles.
And due June two contract shingles will often be left with no damage that causes blooming sharp pain long after the rash and blisters of shingles disappear people off on an order rates and people with greater acute pain, greater rash CBS city auto and immunosuppressive therapies are.
More likely to develop PHN.
This condition can last months two years.
On this slide you will see the effect of Alex nine to one one in post herpetic neuralgia modeling racks.
This model, where sellers oyster, which has the widest that causes shingles is introduced to that.
Sorry, no terminal by nature and prefer to stay in the dark usually only entering belied then under duress and this model we looked at that time. The fact spend in dark horse has been looked after placing the right in the test chamber. The exact was still related on the phase.
The filament every 15 seconds.
We measure to time direct spend in the dark over five minute intervals, but 300 seconds.
Extra presented by the White circle dotted line have not been administered divide us and therefore act normally.
As you can see in both graphs they spend nearly all their time.
In the dark the racks that are presented by Blue circles dotted line had been then mr. delight us and therefore are in pain from shingles and spend large amounts of time in the light.
On the left graph, we tested the effect on the racks of a single dose of our drug like nine to 117 days post virus infection as.
As you can see that racks, which were treated with our drug will expand to one one acting acted similarly to the prospect for not infected.
On the right graph, we tested effect on drugs of seven daily doses of Alex nine to one 114 days post wireless infection.
In this case the rack switch were treated with our drug Alex nine to one one active nearly identical to that aspect were not infected and you can see grid separation from the untreated rats.
By way of comparison, we ran the same past head to head with gabapentin at 100 milligram per kilogram. Once again, we have the single doses of Alex nine to one one and gabapentin on the left and multiple doses of Alex nine to one one and gabapentin on the right.
The Cadone hundred single those resulted in a similar response as a single dose of 30 milligram per kilogram of pellets nine to one one.
Both drugs provided a statistically significant improvement in time in the dark as compared to the untreated eye drops.
In the multiple dose administration involving seven doses of.
Our drug I like nine to one month and gabapentin, we saw further separation when comparing gabapentin treated Rex to Alex nine to one one treated rack. The fan response was significantly better in our Alex nine to one one treated right.
Alex nine to one one we've been able to achieve a similar all potentially superior level of efficacy at both single and multiple dose and using a much lower doses than double Brendan.
We are very encouraged by the preclinical data and we will be initiating additional phase two clinical study of I'd like nine to one one in post herpetic neuralgia.
In general appear Chen has a lower placebo effect, an outcome, but more straightforward. The PHN trial will be a small pilot study with two arms only placebo versus 200 milligram initial dose followed by 20 milligram maintenance dose daily.
We plan to enroll approximately 74 patients in approximately 30 sites globally.
The primary endpoint is also a change from baseline to week six average daily pain score and we expect the first patient to be dosed later this year.
Overall, we feel that our drug Alex nine to one one has the potential to show a significant benefits for people suffering from DPM B and PHN and we look forward to completing and reporting results from both of these studies towards the end of next year.
With that I would like to turn the call over to Jeff Wade to discuss our financial results Jeff.
Thank you Bobby.
To begin I will discuss key aspects of our third quarter financials more.
More financial details can be found in the press release that we issued earlier today and in our upcoming 10-Q SEC filings.
As indicated in our press release, we had net product revenues of $6.5 million for the third quarter.
Reflecting product sales prior to the completion of the sale answer mellow and related assets to sure Sarah Therapeutics on September eight 2020.
This compares to net product revenues of $8.4 million from the prior year quarter, which represented a full three months of product sales.
The prior year quarter also reflected collaborative revenues of $260 million from the termination of the alliance with CNTV and recognition of that remaining amount at $23.5 million allocated to performance obligations from the initial agreement with Sanofi.
Research and development expenses for the third quarter increased to $40.1 million from $26.7 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to certain closing subsequent to the termination of the Santa PEO clients.
Selling general and administrative expenses for the third quarter decreased to $12 million from $13.9 million for the same period in 2019.
Our R&D and Gionee expenses for the quarter included severance expenses associated with personnel changes relating to the sale of your mellow and refocusing of our operations around our research and development stage assets.
Finally, we recognized a gain of $132.8 million during the quarter from the sale EPS or mellow and related assets future Sarah.
In total we had net income for the third quarter at $82.6 million or 71 cents per diluted share as compared to a net income of $226.1 million or $1.95 cents per diluted share in the corresponding period in 2019.
Our net income for the third quarter of 2020 and 2019.
Elected noncash stock based compensation expense of $1.9 million and $3.6 million respectively.
We ended the third quarter of 2020 with $111.4 million in cash and short term investments as compared to $271.7 million as of December 31, 2019.
We eliminated most of our debt during the third quarter, reducing our overall indebtedness from $245.3 million at June Thirtyth.
$20.3 million at September Thirtyth.
And we eliminated an additional $8.8 million in convertible debt in early October.
During the third quarter, we realigned the company to focus our efforts moving forward on Elyse nine to one one and other research activities.
This resulted in our headcount and operating expenses being reduced moving forward.
We now expect our total full year operating expenses for 2020 to be $225 million to $231 million down from $230 million to $250 million.
We expect fourth quarter R&D expenses to be in the range of $22 million to $27 million, which would put our full year 2020, R&D expenses in a range of $175 million to $180 million with the top end of the range down from the $185 million reflected in our prior guide.
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Notably our anticipated fourth quarter, R&D expenses will be substantially less than the $40.1 million. We recorded in the third quarter results of our continued wind down of the surgical gloves and type two diabetes program and outcome studies, which will be substantially complete in the fourth quarter.
We expect fourth quarter SGN, a expenses to be in the range of $6 million to $7 million, which would put our full year 2020, SGN expenses in a range of $47 million to $48 million down from our prior guidance of $55 million to $65 million.
We expect non cash expenses to be approximately $20 million of our total operating expenses.
Overall, we expect that our cash will be sufficient to fund our operations for at least the next 12 months.
I will now turn the call back to tell on that.
Thank you, Jeff So let me summarize.
I think for us as a company were pre.
Pretty excited about Alex not to one one it's been a compounded I've been excited about from the time I started here and we.
We negotiated to the wholly owned rights from our alliance with BMS, Our discovery Alliance with BMS.
To have this compound we have now cleared away to focus on this compound and accelerated through development I truly believe it will be a game changer for us should we be successful and therefore, we have now put ourselves in a position to focus on it but.
For the remainder of 2020, we expect to initiate the phase two study is studies in post herpetic neuralgia as well as the Pnp and as noted before we expect to report the phase two study results with both.
Of these studies by the end of next year.
And then once again I will remind everybody on November 16th at eight P.M. Eastern time, we expect the presentation of the data from a soda flows and soloists and scored phase three studies at the American Heart Association scientific session.
With that I will stop there and turn the call over to the operator for today.
Thank you ladies and gentlemen, we will now begin the question and answer session.
I remind you wish to ask a question. Please press star one telephone.
For me the Alpha Bob can you just back on your question. Please press <unk>. Once again, please press star one question.
Your first question comes from the line of Yigal Nochomovitz from Citigroup. Your line is open. Please ask your question.
Hi, great. Thanks, very much for taking the question.
Hi, Jane you mentioned, the placebo effect with some of them. They are Patrick pain trial I'm wondering if you could just talk a little bit more detail. Please in terms of the specific steps you're taking both for the.
The diabetic peripheral neuropathy neuropathic pain study as well as the post herpetic Neuralgia study. Thanks.
Thanks steps, you're taking in order to to mitigate the placebo response in both those studies.
Thanks, you called for your question.
But a lot of relevant question actually we took a little bit of time in order to figure out how we wondered are designed this protocol in order to mitigate this placebo effect.
When we looked at the other studies, which have been done in the area provide their fans and all that so what we are basically we have done is we have mitigated by making sure that we are having a large number of patients in each of the randomization.
Cohorts. So if you have a one to one to one randomization and like I mentioned for DPM PV have 300 patients. So we will have approximately 100 patients per arm.
We also have a very good.
Good amount of efficacy Peter So most of those other studies have fared because they have not studied the efficacy.
For up to six weeks and we are going to study for six weeks with that placebo effect in mind. We have also trend our investigators to look for this placebo effect and we are making sure that these patients will be enrolled automated.
Filling out their diary on a daily basis to ensure compliance and if they have a high placebo effect, we are evaluating whether.
They should be in the study or not in this study. So we are basically taking care of placebo.
Placebo effect on multiple levels.
For.
And that is all for diabetic peripheral neuropathy spanier gold poured PHN, it's a more homogeneous disease and the practice of treating PHN is widely accepted worldwide. So we had a little less concerned about the placebo effect of Phs.
Okay got it thank you.
And then just one question for Jeff.
You you extinguished almost all of the data over 90%.
Any particular reason you just didn't go unnoticed extinguished all of it you have a small amount left on the balance sheet.
Yes, well in that as of early October we have less than $12 million outstanding.
So it is a it's an agreed upon exchange so we had to get get chewed agreements and we we did what we thought was optimal our goal is to reduce the debt. So that wouldnt be an obstacle going forward and we think that at the level that it is now we've achieved that objective.
Okay, great. Thanks.
And then just one one more question on sort of a frozen.
Can you spend a little more time, just talking about some of the details in terms of the plan to seek approval in the U.S. fourth.
Are you going to conducting these studies.
And there are other analyses of the existing studies that you can do to help the sta better understand that.
Dk risking perspective.
And what is the what is the strategy now in terms of trying to seek approval in the us for type one diabetes.
You got it. Thank you for the question I think we watch very carefully what the other players were going to do.
So in this space and I think as we can clearly see.
Particularly given the COVID-19 struck most have moved away from type one and have chosen not to go forward for us we feel very.
Hi, Thanks for taking the questions me to piggyback on that last one and talked about how some of the competitors have moved away from the type one indication yet they're still out there there on the mark with type two and there's obviously a lot of experience out there with their drugs. He concerned at all that that if you.
If you do the work to get the F. D. A aligned on a pathway to type one. The basically you guys are going to be doing the leg work for the entire class and there's still an opportunity. Once you guys put in the work for others to just kind of quickly piggyback off your pathway and quickly bring their products to market as well based on the data.
They have.
Yeah, that's a great question and certainly it's a it's a possibility, but I think the way we have one trying to appropriately kindness and too we are in a unique position where we we we have done most of the work and we have created I think the.
The greatest amount of data to be able to have an approved indication versus when I say the others have not move forward in the absence of an approved indication it'll be very difficult, particularly given you'll be managing a safety risk. So I think if we would be successful and we move in this direction and we do get into the.
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We would have done the work that would be necessary to have an approved product where you have clear mandates around how to manage that product and a safeway.
Unless the other companies choose to pivot at this point and do the same work.
I do not see them coming on the same pathway is we are so I do think it's a unique opportunity for us given our position versus theirs. So.
I will leave it at that.
Alright, great.
Far as.
Discovery pipeline, you guys have obviously shifted being being more of a discovery company at this point should we expect to see any potential new compounds move into the clinic.
Or an indie stage in 2021 or should we really be thinking about 2021, being just 9211, and maybe any movement on type one and for surgical frozen.
Yeah. That's a great question I think we have an opportunity to move another asset into.
Enabling studies in 2021 so.
So I would say stay tuned to that work is being done, but 2021 really will be about.
Two compounds for us one soda the flolan.
I think you will clearly see we're not banding that I think it's an opportunity to accelerate worked with doing there, but as a low cost effort at this time and secondly, and most importantly is really to spend as much as of our time as we can to accelerate 9211, because as I've said I've always believed that has the greatest potential to transform the company and we need.
No that sooner than later, so that's where most of our efforts will we be placed in 2021, but we will continue to to advance would discovery engine and look at ways in which we can put products until the clinic beyond 2021, particularly going into 2022.
Great and what makes me as one last one and Jeff.
Jeff you gave us.
Some color on how to think about queue for spending.
Should we think of those as baseline levels to work with going into 2021 any there's still.
Obviously, you guys are going to be ramping up to phase two studies, but other than that are there other moving parts within the Q4 numbers.
We should think about when we start looking into 2021.
I would just say that the 2021 fourthquarter R&D spend is still going to be higher than it will be in and be sorry to 2024th quarter R&D spend you'll still be higher than it will be.
In 2021, because we are still winding down some of the activities and the sort of a pleasant type two diabetes and outcome studies and this and this quarter.
And that will be largely almost entirely complete by the end of this quarter. So we will have that some some lower R&d's then next year compared to this year.
Great. Thanks.
Thank you again in order to ask questions. The first star on number one telephone.
Next question from Stephen the money from detail your line is open.
Good morning, guys. Thanks for taking the question.
Was maybe just wondering if you could speak a little bit too.
The amount of wiggle room that you've kind of provided into the year and 21 phase two data guidance for both of the face twos with respect to just a piece of patient enrollment.
I know that this was a trial I think the D. P. On trial was was it was kind of slowed a little bit due to covid and I would imagine that's in it.
Those are both indications, which are probably a bit more sensitive to patient visits and perhaps some others. So.
Maybe just talk a little bit about your confidence in the guidelines you you provided with respect to anticipated piece of.
Patient enrollment and how do you think that maybe impact just over the coming months.
Steve I appreciate the question.
Yeah, I think we made it clear that we did slowdown on enrollment in our efforts when COVID-19 hidden March.
Otherwise the program I think we'll be much further along.
And we are having to think through what that's going to look like should we have another challenge around COVID-19, So there's a little bit of wiggle room in there, but not a whole lot.
Our objective is to put all of our resources and efforts into getting this enrollment.
Up to speed and in a position, where we can overcome any challenge or risks to COVID-19. So that's kind of built in at this point with that being said, it's anybody's game [laughter], we COVID-19, and what may happen in the near term future.
Understood and I know that these are blind to trials, but.
Would there be an opportunity for you guys to maybe structure and some kind of an terminalis. This is it for whatever reason where Ah.
Approaching the end of next year and.
You don't get half that amount of patient data to to formerly close trial.
Say that we're giving thoughts to all of the ways in which we can provide information around this program as.
As we're confident about it.
Earlier than than later, so I would I would categorize it that way.
Okay. Thanks for taking the question.
Yeah.
Thank you again harder to ask a question please press, Taiwan and your telephone.
[noise].
[noise] there are no further question at this time please thinking.
Well, let me thank everyone for joining us this morning.
I think it's been a remarkable third quarter, where we have <unk>.
Moved back to our roots have been a very strong scientific company and discovery as well as development.
And it's important to note that we still have a streaming high confidence soda flolan.
Particularly for type one diabetes more news will come forward on a soloist and scored program on November 16th at eight PM at the American Heart Association I would encourage you to to chime into that program to hear those data would be called out.
For Alex 9211, our confidence is very high around this program I thought Dr. Talented a very good job of outlining wire confidence is high and what we've seen preclinical and what's been supported in phase one trials. The way we've designed the phase two trials I think give.
Gives us every shot of being successful and not 211, because this is a remarkably unmet need area.
Will continue to push forward.
With the FDA strategically and I think become very transparent, how we intend to do that as a quarter progressive and we go into the new year to ensure that patients have an opportunity to soda go clothes and for type one diabetes with that being said I appreciate everyone dialing in.
Joining us thank you.
That does conclude hour. Thank thank <unk>. Thank you for participating in the office.
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