Q1 2021 Axcella Health Inc Earnings Call

May 6, 2021

Yeah.

[music].

And that'll be and and listen only mode until the question and answer session.

After today's presentation, there will be an opportunity to ask questions to ask a question you May press Star and then one on your Touchtone phone too.

To withdraw your question. Please press star and then too.

And now for opening remarks, I would not like to hand, the call over to Jason for debt, Vice President of Investor Relations and corporate Communications and Axilla. Please go ahead Sir.

Thank you very much operator, and good morning, everyone. We would like to advise that certain remarks, we will make on today's conference call such as those relating to our clinical trials for access 16, 65, and 11 25 include forward looking statements that are subject to various risks and uncertainties. These risks and uncertainties are detailed and our most recent form 10-Q.

And our other SEC filings, which can be accessed on our website X L. A health dot com or on the <unk> web site I'll forward looking statements represent our views as of today and the sixth 2021 and should not be relied upon as representing our views as of any subsequent date, we undertake no obligation to update these forward looking statements.

And.

Please also note that all of the clinical investigations, we have completed to date have been non investigational new drug or non INV clinical studies that were designed to evaluate product candidates for safety tolerability and effects on normal biological structures and function.

Are clinical trials of <unk> and 25, and 16 65 are being conducted under Imd's with the aim of treating patients with Nash and patience with a history of alert hepatic encephalopathy or ohh, respectively.

And now let me turn the call over to our President and CEO Bill Hinshaw to begin the discussion bill.

Thank you Jason and good morning, everyone. We appreciate you joining us for today's update it's a pleasure to report back to you on all the progress we've made since the start of 2021 frankly in many respects. This has been the busiest and most successful period and the company's history, we achieved key milestones that validated.

And replicated the strength speed and efficiency of our development approach.

Before we get into the details I'd first like to take this opportunity to express my gratitude to the entire excel at team for the thoughtful planning strong execution tireless efforts. Their work is provided us with an opportunity to demonstrate on a global scale that we can better the lives of patients with complex diseases using per per.

Prior Terry compositions of endogenous metabolic modulators or am's.

And we have two E. M. M compositions that have progressed into phase two development within just four years cutting the standard drug development timeline roughly in half and.

And this was a credit to the efficient work of our research and design team or modality that leverages amino acids and derivatives with well established safety and.

Interest and engagement from some of the world's leading Herpetologist and Gastroenterologist.

Naturally this is because of the day to we've generated it's also due to the fact that we're generating this data using amino acids with well established safety and Tolerability.

And January <unk> first I and the application was cleared by the FDA for 16 65. This candidates multi targeted approach distinguishes it from today's standards of care, Lachelier, and Rifaximin, which strictly focus on lowering ammonia.

And our prior clinical studies of 16, 65, we observed positive trends and ammonia handling improved amino acid balance and improve muscle function.

Even more importantly, given the regulatory path for O H E, where the narrow cognitive findings.

Positive dose dependent improvements were seen and all three neurocognitive measures that were included and our most recent study.

And a statistically significant change was seen and phs the gold standard for diagnosing H E.

And we are now gearing up for a randomized double blind phase two trial of 16 65, and this trial access 16, 65 will be compared to placebo over a 24 week period and a design that's highly streamlined with just one active arm.

Approximately 150 patients will be enrolled across 70, plus sites globally, virtually all of which have already been selected and engaged.

In fact, I'm pleased to report that we recently activated our initial sites.

We are enriching the population with a patients who are most likely to have OAG recurrence by including only patients who have experienced and <unk> event within six months of screening and who have narrow cognitive dysfunction at the time of screaming.

Primary and point is based on the proportion of patients who achieve at least two point improvement and Phs from base line to week 24.

Key secondary and points include the number of OAG events and time to OAG events, including hospitalization.

Based on COVID-19 and other relevant factors. Our initial estimate is that will be in a position to report top line data.

From the trial and the first quarter of 2023.

That said, we will closely monitored enrollment dynamics and provide updates as appropriate.

And the meantime, we look forward to having Dr. Rune-stone y'all, given and oral presentation about our access 16 65 clinical data at D. D. W. 2021 later this month.

We're at a very similar stage and accident 11, 25 development Ah candidate the targets multiple key pathways involved and the pathogenesis of Nash from metabolism inflammation to fibrosis.

And Nash Tag 2021, and March we had the opportunity to share next level insights about its mechanism of action as well as data from our most recent clinical study.

And just a few weeks ago or indie application for 11 25 was cleared by the FDA.

We're now finalizing preparations for a phase to be trial that will enroll approximately 270 patients with biopsy confirmed F. Two F. Three Nash.

This global randomized double blind trial will include too active arms, one anchor dose equivalent to the one we've used and our most recent study and a higher dose patient.

Patients will be randomized evenly across these and a placebo arm over a 48 week dosing period.

Similar to our 16 65 trial enrollment will be conducted across more than 70 global sites all of which have been selected and engaged and in recent days, we have activated the first clinical sites.

As you May recall and our most recent study that enrolled subjects with presume Nash, we saw meaningful improvements and the 11 25 arm versus placebo and virtually all measures with even greater effect seen and subjects, who also have type two diabetes.

And we will investigate this further and our phase to be by stratify and patients on their diabetic status.

We're using standard histological measures is and points with the proportion of patients achieving at least a two point improvement and the NASS score as the primary endpoint.

Secondaries focus on the achievement of biopsy confirmed resolution of Nash without worsening of fibrosis and the achievement of at least a one stage improvement and fibrosis without worsening of Nash.

Additionally, we will use a range of standard and state of the art noninvasive measures for additional and points, including MRI PDF F Allt and fiber scam.

Keith while axilla maintains its financial discipline and strength.

So lets briefly review the numbers for the quarters, starting with the balance sheet.

Thanks to our prudent cash management, we ended the first quarter of 2021 with $93 million in cash and marketable securities, which compared to $107 million as of December 31 2020.

We expect that this cash balance will enable us to expand our pipeline achieve additional key milestones and be sufficient to meet our operating needs into the third quarter of 2022.

Turning to the income statement, our research and development expenses for the first quarter of 2021 were $10 $2 million, which is roughly flat with $10 3 million for the first quarter of 2020.

We expect R&D cost to begin increasing and the quarters ahead.

And we begin to ramp and enrollment in our two new clinical trials.

G&A expenses were also roughly flat year over year coming in at $4 3 million for the for this quarters and at March 31, 2021 versus four one me and at all for the first quarter of 2020.

We expect G&A costs to remain at the same general level in the quarters ahead, as we continue to invest in our portfolio and platform.

And net loss for the first quarter of 2021 was $15 $2 million or <unk> 40 per share.

This includes approximately one 4 million at all and the noncash stock based compensation expense.

Net loss for the three months ended March 31, 'twenty, and 'twenty was $15 million or 65 cents per share.

So in summary, we are off to a strong start for 2020, one and we're looking forward to reporting back on our continued progress.

Now operator would you. Please open the line for questions.

Yeah.

Thank you and you will now begin the question and answer session.

Ask a question you May press Star then one on your telephone keypad.

And the speakerphone, please pick up your handset before pressing the keys.

To withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

And the first question will come from Yasmin Rahimi with Piper Sandler. Please go ahead.

Hey, Lisa.

And I'm sorry, yeah. Thank you so much I think your question.

And that's just what they eat and provide more color on the interim analysis and the Nash study in terms and design and buy them.

Thank you.

Sure So and good morning, Alicia Thanks for the question Yeah. So the interim analysis. So that we're planning a roughly mid next year will include the key elements that you're used to seeing in terms of MRI P. D. F F. A L T and fiber scan our planned measurements, we're looking and planning to do it.

94 week analysis that will provide progressive and additive information to our prior 12 and 16 week studies.

Data that we've already generated and a population with biopsy proven Nash and the setting and we look forward to updating you as we continue to progress our enrollment appropriately.

Reinforced that this data will be useful for us in terms of looking and considering or planning for a registration trial. The information we see on the type two diabetics as well as combinations and other opportunities that we see there. So thank you for your question and hopefully that answered it.

Thank you.

Yeah.

And the next question will come from Andrea <unk> with Wedbush Securities. Please go ahead.

Thank you operator.

Hi, This is Andreas Entre Liana.

Those.

And with the I N G and hand to initiate the phase II adult Nash study what additional information do you guys need to provide the SBA for them to consider expansion into pediatrics and.

And when do you anticipate clarity from the FDA.

Good morning, Andreas Thanks for the important question because as you know, there's a lot of intense and needed activity and adult while there is limited activity and the pediatric population and we believe that our modality. Our safety profile allows us to pursue that faster than most opportunities. So our plan right now is to focus.

<unk> on the adult program and get that going and then Reengage with the agency at the appropriate time to then design what would be the most efficient and I'll say informative fastest way to move forward and the pediatric population. So right now we'll come back to you and give you and appropriate update on <unk>.

And time.

We are focused right now and the adult population and then moving swiftly as makes sense into the pediatric population.

Okay. Thanks, I'll hop back into the queue. Thanks, guys.

Thanks.

And again and if you'd like to ask a question. Please press Star then one and.

Next question is from Michael Morabito with shutdown and capital markets. Please go ahead.

Hey team thanks for taking the questions and congrats on the progress so far this year.

And I, just wanted to try and get a little bit of additional color and the 11 and 25 study.

And if you've determined yet and what percentage of the patients will be type two diabetic and if you've said.

Publicly if.

Diabetes will be part of the randomization protocol and that's it.

And make sure that even though the balance that you're looking for.

And then I just was hoping to get.

A little bit of color on the.

And the cash runway what are some of the assumptions that go into that estimates and if you could.

Shed any any big details on how much expected ramp and R&D, we should expect as these two trials and they get to enroll or.

What day, what the shape of that group might look like.

Okay great.

Start and then turn it over to that latter question to Laurent Michael Good morning, Thanks for the comments on the progress and.

Overall for everybody here and we look forward to updating you on the very very near term on additional progress. So stay tuned for that in terms of the question around the 11 25, and the study and the approach towards type two diabetics. So there we are looking at generally as you know the pop.

<unk> is at least around 40% and were stratified for this and we have I'll say engaged the sites and the networks to make sure that we have the appropriate distribution that will allow us to have a good balance of all comers as well as type two diabetics and so we have taken all the appropriate.

And measures, while still ensuring the randomization and integrity of the study and are very confident of our ability to pull that through which will then help inform us because as you are familiar with Michael Our original study had all type two diabetics. The second study was stratified for type two diabetics and we look forward.

To continuing to demonstrate hopefully that differential advantage that could be very important for these difficult to treat patients.

So I'll turn it over to Leroy for your cash question.

Thank you bill thanks.

Thanks for the question.

The first quarter and.

And last quarter fourth quarter and first quarter of this year, we were in preparation mode.

For the upcoming trials. So we were winding down the studies following guidance. So we are going and we expect to see the R&D expenses to ramp up going forward as we get our trial underway.

And obviously all of that is dependent on the speed of enrollment of the day trial.

The cash runway, we have cash well into the third quarter of 2022, which would get us beyond additional key milestones, including the extension of our pipeline and we'll do what's appropriate to keep the company well funded while minimizing dilution.

Okay, great. Thanks for the year.

Permission.

The next question will come from Jessica Fye with Jpmorgan. Please go ahead.

Hi.

And my non for Jessica Fye.

Thanks for taking our question.

Given that the phase <unk> Nash is enrolling biopsies from patients how close to guidance.

Fishing, and Glen and Glenda them IFC sampling.

Can you use and final tissue.

I'm, sorry, we had some background noise.

And do you mind repeating the last part of your question I apologize.

Yeah.

Yes.

Go ahead, and start activation and going blind to biopsy sampling, our Kenya, and I like to share that.

Oh. So this study is a biopsy confirmed study so there will be a screening period and we.

Which they will have a biopsy and.

And in the period, so Allison and why don't you comment on the the lead in terms of the timeframe for that.

Yes. Thank you for your question so.

There is and <unk>.

Good amount of clinical and regulatory guidance and these types of biopsy trials and.

Additionally, clinical sites are very adept at using noninvasive markers and publish the algorithm and algorithms for screening and using biopsies to select the right kind of patients.

And so that we avoid F one and for Nash patients and finally, it is worth noting that we are using Dr. Harrison and some network.

And the best.

Cash trial and that work.

And the U S and say.

I've noted which and.

And selecting to be able to select the optimal patience and us.

And the screen failure rates.

And so it's a combination of using the appropriate noninvasive to then set up for the biopsy and make sure. We have the right patients hopefully that answered your question because unfortunately your phone was breaking up on us a little bit. So we're trying to make sure we address it properly so apologies for that.

Yeah. Thank you that ensign.

When modeling.

Do you expect the sites and the Nash traveling.

And to activate on a rolling basis.

And the Mega and anything out of the selling piece and east.

And starting to activate and the same day.

Yeah. So I think I picked that up. This is this is Jason so it will be on a rolling basis, we'll have a good number of sites up and running we already have several sites up and running.

And it'll be a progressive rolling.

Startup period.

Yes, we're covering 70 sites globally across multiple countries. So as you're probably familiar there are different processes and stages for each of those individual institutions. We do also have central IRB work here. So there will be to Jason's point progressive role with some nice.

Jumps periodically.

And the next question will come from Yaron <unk> with B Riley Securities. Please go ahead.

Hi, Good morning. This is all for my and thank you for the kidney and our affections. Congratulations on day two IMT assurance.

Couple of questions first can you provide additional color on the trial design, especially as you're talking about the restrictions and the <unk> for Nash and second can you provide some details on the upcoming TD tabular presentation. Thank you.

Okay.

Thank you I appreciate the question so in terms of the trial for $11 25.

And this is again, we're looking for biopsy confirmed phase F. Two F. Three.

We will be using the typical diet and management and guidance during the trial that you see in this field.

And we will be looking with the other standard markers about a certain level of MRI PDF, a certain level of inflammation.

Inflammation et cetera to establish the baseline to again getting biopsy confirmed F. Two F. Three Nash.

In terms of the DW presentation, and the Doctor Sanya all will be doing we're very excited about this this is our zero zero to acts of $16 65 data and there is additional depth and richness on some of the key markers that we've discussed with you. All previously so I would encourage you to take.

Look because I think it provides additional understanding of the nature of the impact of our active arms. So and as you can respect there is a appropriate embargo and and things of that nature. So I can't give you additional death right now, but it is worth looking into.

Yes, and Thats Super helpful. Thank you.

Thank you.

And once again, if you would like to ask a question. Please press Star then one.

The next question will come from Paul Choi with Goldman Sachs. Please go ahead.

Hi, Thank you and good morning, Bill and team at and let me add my congrats on the IMD clearances as well two from me. Please first on the on the Nash trial for 11 and 25 can you maybe just remind us what your line in terms of.

Diabetic therapies, particularly with <unk>, given the potentially confounding effects from weight loss from that class of drugs.

And then I had a follow up after that.

Okay. Thanks, Paul.

The comments on the congratulations and this important question. So we are not allowing GOP ones and <unk> because of the potential impact consistent with the previous studies that we executed.

However people can be on stable other diabetic medications as consistent with practice and the sphere.

Okay. Thank you for that and then on the <unk>.

165 can you maybe just update us on any potential <unk>.

Changes, our thoughts with regards to sort of background event rates for the placebo arm, particularly with regard to and the use of standard of care there or is the right way to think about it that.

And right there or breakthrough right it would largely be consistent with what's on label for <unk> net and other drugs and thank you.

Yeah no. Thanks, Paul very insightful question. So let me just.

Remind everybody that this population will be enriched they must've had one <unk> event and they must have a phe.

And so greater than minus four meaning less and minus four so they are and rich for that now based on the best study and the.

More recent data and this field what you typically see is a roughly a 22% breakthrough right in that timeframe on the combination of <unk> and Rifaximin and Youll see up to a $46 50 type range for patients who are just on the <unk> now that of course is and a clinical study setting.

And we are enriching these patients. So we do anticipate we will be reaching at least those levels.

For the background and we have factored in placebo effect as well into our study design.

Great. Thanks Bill.

Thank you Paul.

Ladies and gentlemen, this concludes our question and answer session I would like to turn the conference back over to Bill and Shaw for any closing remarks.

Okay, great. So thank you Chad and thank you everybody for tuning and this morning, we're very excited about our continued progress and as I alluded to earlier.

We're very much looking forward to updating you and the very very near term about continued progress on these important trials. We're also excited for the day Tw 2021 presentation and a few weeks and.

We ask you to remain safe remain engaged and thank you for your time and attention today. Operator. This concludes our call. This morning.

And thank you Sir.

<unk> has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

Okay.

[music].

Yeah.

[music].

Good morning, ladies and gentlemen, and welcome to accelerate first quarter 2021 conference call. Please be advised that today's call is being recorded and that all participants will be and they listen only mode until the question and answer session.

After today's presentation, there will be an opportunity to ask questions to ask a question you may price store and then one on your touch telecom.

To withdraw your question please price start and then too.

And now for opening remarks, I would not like to hand, the call over to Jason per day, Vice President of Investor Relations and corporate Communications and Axilla. Please go ahead Sir.

Our other SEC filings, which can be accessed on our website X L. A health dot com or on the <unk> web site I'll forward looking statements represent our views as of today and the 620 21 and should not be relied upon as representing our views as at any subsequent day, we undertake no obligation to update these forward looking statements.

Please also note that all of the clinical investigations, we have completed to date have been non investigational new drug or non I N. D. Clinical studies that were designed to evaluate product candidates for safety tolerability and effects on normal biological structure and function.

Are clinical trials and <unk> 11, 25, and 16 65 are being conducted under I N D. With the aim of treating patients with Nash and patients with a history of alert hepatic encephalopathy or O H, respectively.

And now let me turn the call over to our President and CEO Bill Hinshaw to begin the discussion bill.

Thank you Jason and good morning, everyone. We appreciate you joining us for today's update.

It's a pleasure to report back to you on all the progress we've made since the start of 2021 frankly in many respects. This has been the busiest and most successful period and the company's history, we achieved key milestones that validated and replicated the strength speed and efficiency of our develop and approach.

Prior Terry compositions of endogenous metabolic modulators or am's.

And we have two E. M. M compositions that have progressed into phase two development within just four years cutting the standard drug development timeline roughly in half.

And this was a credit to the efficient work of our research and design team or modality that leverages amino acids and derivatives with well established safety.

And the initial clinical development approach, we took to evaluate our candidates.

As Jason mentioned, our initial studies were conducted and a non IMD setting. This enabled us to quickly gauge our candidates safety and tolerability profile as well as their effects on various biology's, we're targeting to you using a range of noninvasive biomarkers.

At the end of the day, while there are notable benefits from our development speed and efficiency. We believe the most important and impactful advantage is the robust amount of data, we already have generated and more than 200 subjects with a paddock and sufficiency or presume Nash, we've done a significant amount of dose ranging.

While also demonstrating clear trophic activity across are targeted biology's.

This and turn has informed streamlined and we believe derisked the larger IMD enabled trials that are now getting underway.

But first of our candidates is ask 16, 65 Ah multi targeted oral agent for the reduction and the risk of recurrent Oh H E L.

<unk> is a severe narrow cognitive impairment that results from cirrhosis and the second is actually 11 25 are multi targeted oral candidate for the treatment of Nash.

This is a severe form of fatty liver disease that affects up to 40 million people and the U S alone.

Both 16, 65, and 11 25 are generating inbound interest and engagement from some of the world's leading herpetologist and gastroenterologist.

Naturally this is because of the day to we generated it's also due to the fact that we're generating this day to using amino acids with well established safety and Tolerability.

And January <unk> first I and the application was cleared by the F. D. A for 16 65. This candidates multi targeted approach distinguishes it from today's standards of care latch, a list and rifaximin, which strictly focus on lowering ammonia.

And our prior clinical studies of 16, 65, we observed positive trends and ammonia handling improved amino acid balance and improved muscle function.

Even more importantly, given the regulatory path for O H E, where the narrow cognitive findings per.

Positive dose dependent improvements were seen and all three narrow cognitive measures that were included and our most recent study.

And a statistically significant change was seen and ph, yes, the gold standard for diagnosing H E.

Approximately 150 patients will be enrolled across 70, plus sites globally virtually all of which have already been selected and engaged in fact I'm pleased to report that we recently activated our initial sites.

We are enriching the population with a patients who are most likely to have OAG recurrence by including only patients who have experienced and O. H event within six months of screening and who have narrow cognitive dysfunction at the time of screaming.

Primary and point is based on the proportion of patients who achieve at least at two point improvement and Phs from base line to week 24.

<unk> secondary and points include the number of O H events and time to OAG events, including hospitalization.

Based on COVID-19 and other relevant factors. Our initial estimate is that will be in a position to report top line data.

From the trial and the first quarter of 2023.

That said, we will closely monitored enrollment dynamics and provide updates as appropriate.

And the meantime, we look forward to having Dr ruins, Sonya all given and oral presentation about our access 16 65 clinical data at D. D. W. 2021 later this month.

We're at a very similar stage and actually 11 25 development Ah candidate the targets multiple key pathways involved and the pathogenesis of Nash from metabolism inflammation to fibrosis.

At Nash Tag 2021, and March we had the opportunity to share next level insights about its mechanism of action as well as data from our most recent clinical study.

And just a few weeks ago R. I N D application for 11 25 was cleared by the FDA.

We're now finalizing preparations for a phase to be trial that will enroll approximately 270 patients with biopsy confirmed F. Two to F. Three Nash.

This global randomized double blind trial will include too active arms, one anchor dose equivalent to the one we've used and our most recent study and a higher dose patient.

Patients will be randomized evenly across these and a placebo arm over a 48 week dosing period.

Similar to our 16 65 trial enrollment will be conducted across more than 70 global sites, all of which had been selected and engaged and in recent days, we have activated the first clinical sites.

As you May recall and our most recent study that enrolled subjects with presume Nash, we saw a meaningful improvements and the 11 25 arm versus placebo and virtually all measures with even greater effect seen and subjects, who also have type two diabetes.

And we'll investigate this further and our phase to be by stratify and patients on their diabetic status.

We're using standard histological measures is and points with the proportion of patients achieving at least at two point improvement and the NASS score as the primary endpoint.

Secondary is focused on the achievement of biopsy confirmed resolution of Nash without worsening of fibrosis and the achievement of at least a one stage improvement and fibrosis without worsening of Nash.

Additionally, we will use a range of standard and state of the art noninvasive measures for additional and points, including MRI P. D F F Allt and fiber scan.

These noninvasive markers will be the focus for an interim analysis and the trial.

At this stage, we expect to be and a physician to report interim data and mid 2022, when and meaningful segment of the enrolled population has reached 24 weeks of treatment.

In terms of the time and at the top line data. We are initially aiming for the second half of 2023, factoring and COVID-19 among other considerations.

In summary, we see great opportunities ahead for our lead candidates. We believe access 16 65 holds the potential to improve and eventually become the standard of care for O H E.

Meanwhile, accent 11, 25 is increasingly being viewed by physicians and key opinion leaders as a compelling first line candidate for adult and pediatric Nash with a potential to have an enhanced effect.

For the many Nash patients who also have type two diabetes we've.

And we look forward to updating you on these programs and the very near term.

And we see potential to extend the reach of AMM compositions well beyond these first indications a research team is hard at work on several potential opportunities to expand Accentless pipeline and we'll look forward to sharing some insights about their work as the year progresses.

So with that let me now turn the call over to our CFO Lamont Chardonnay to provide a brief financial update moron.

Thank you Bill and good morning, everyone.

We're off to a great starting 2021 with occurrence affects the first two I and these and.

And we're looking forward to start over Nick's Charles Itchy and Nash. These.

These milestones and I'll being achieved while axilla maintains its financial disappeared on strength.

So let's received reviewed the numbers for the quarters, starting with a batch.

Thanks, I'll put and cash management, we ended the first quarter of 2021 with 90 premium and I'm all in cash and marketable securities.

Which compared to 170 and along as of December 31st 2020.

We expect that is cash balance would enable us to explain a pipeline and.

<unk> that you shall key milestones and be sufficient to me got operating into the third quarter of 2022.

Turning to income statement Ah research and broke my expenses for the first quarter of 2021.

At $10.2 million, which is roughly flat with 10.3 me and then I'll ask for the first quarter of 2020.

We expect our and your cost to begin increasing and the quarters ahead and.

And we begin to ramp and one meant emailed to new clinical trials.

DNA expenses were also roughly flat yoga, you're coming in at four three me and the laws put it for these quarters and and March 31st 2021 vs. Four and one me and and all for the first quarter of 2020.

We expect you any costs to remain the same general level and the quarters ahead, as we continue to invest portfolio and platform.

And could I net loss for the first quarter of 2021.

$15 to me and the walls of 40 cents per share.

This includes approximately one point for me and at all and the non-cash dog based compensation expense.

And neck loss for three months and in March 31st 2021, 15, and all or 65 cents per share.

So in summary, we are off to a strong start for 2021, and we are looking for to reporting back on and continue programs.

Now operator will get peace upon the line for questions.

<unk>.

Thank you you will now begin the question and answer session to ask a question and repressed started and one and your telephone keypad and.

And the speaker phone please pick up your hand, and said before person and the keys too.

To withdraw your question. Please press Star then too and.

At this time, we will pause momentarily to assemble low roster.

And the first question will come from <unk> for him with Piper Sandler. Please go ahead.

Hey at three o'clock and on for Awhile and thank you so much for taking my question.

And I was just hoping you just by by Tomorrow color and the interior of Alaska and one last.

Okay, and and design and fine <unk>.

Sure. So good morning, elation and thanks for the question Yeah. So the interim analysis. So that we're planning roughly mid next year will include the key elements that you're used to seeing in terms of MRI P. D. F F. A L T and fiber scan are planned measurements.

Looking and planning to do a 24 week analysis that will provide progressive and additive information to our prior 12 and 16 weeks studies data that we've already generated and a population with biopsy proven Nash and the setting and we look forward to update and you as we continue to progress are and.

<unk> appropriately.

Reinforced with this data will be useful for us in terms of looking and considering or planning for a registration trial the information and we see on the type two diabetics as well as combinations and other opportunities that we see there. So thank you for your question and hopefully that answered it.

Okay.

And the next question will come from Andreas <unk> with Wedbush Securities. Please go ahead.

Thank you operator and good morning. This is Andreas Entre liana besides those.

With a V I N G and hand to initiate the fish too adult Nash study what did <unk> additional information do you guys need to provide bsba for them to consider expansion into pediatrics and when do you anticipate clarity and you have to.

Good morning, Andreas Thanks for the important question because there's you know, there's a lot of and tense and needed activity and adult while there's limited activity and the pediatric population and we believe that our modality. Our safety profile allows us to pursue that faster than most opportunities. So our plan right now is.

To focus on the adult program get that going and then re engage with the agency at the appropriate time to them design, what would be the most efficient and I'll say informative fastest way to move forward and the pediatric population. So right now will come back to you and giving you an appropriate update on.

And steps and time, but we are focused right now and the adult population and then moving swiftly as makes sense into the pediatric population.

Okay. Thanks, I'll hop back into the queue. Thanks. Thanks.

Thanks.

And again and if you'd like to ask a question please price scarred and one.

And next question is from Michael Moore beat out with Charlotte and capital markets. Please go ahead.

18 and.

Thanks for taking the questions and congrats on the progress so far this year I just wanted to try and get a little bit of additional color and the 11 25 study is if you've determined yet what percentage of the patients will be type two diabetic and if you'd said.

Publicly it's.

Diabetes will be part of the randomization for the call.

And make sure that you will the balance that you're looking for and then I just was hoping to get.

A little bit of color.

Color and the cash runway what are some of the assumptions I go into that estimates and if you did the shed any any day details on how much expected ramp and iron D. We should expect disease to child, they get to a rock or you know what the what the shape of that group might look like.

Okay, Great I'll start and then turn it over to that latter question to <unk> Michael Good morning. Thanks for the comments on the progress and overall for everybody here, we look forward to update and you on the very very near term an additional progress so stay tuned for that in terms of the question around the 11 and two.

Five and the study and the approach towards type two diabetics. So there we are looking at generally as you know the population is at least around 40 per cent and we are stratified and for this and we have I'll say engaged the sites and the networks to make sure that we have the appropriate distribution.

That will allow us to have a good balance of all comers as well as type two diabetics and so we have taken all the appropriate measures, while still ensuring the randomization and integrity of the study and are very confident of our ability to pull that through which will then help inform us because as you're familiar with Michael or.

Original study had all type two diabetics the second study with stratified per type two diabetics and we look forward to.

Continuing to demonstrate hopefully that differential advantage that could be very important for the difficult to treat patients.

So I'll turn it over to <unk> for your cash question.

Yes. Thank you Bill yeah. Thanks for the question both of the first quarter and last quarter of fourth quarter and first quarter of this year, we went and preparation mode.

For the upcoming Charles So we were winding down the studies.

And diabetes. So we are going to expect to see beyond the expenses too and I'm going Fort as we get our trial and <unk>.

I'll I'll I'll get you out of debt is dependent on the speed of and we'll and then I'll go with the call.

Called a cash flow and we we have cash well into the third quarter of 2022, which would get us beyond and chunky milestone, including the extension of Hall pipeline and we'll do what's appropriate to keep the company will send a lot and <unk>.

Okay, Great day, Thanks for me Yeah.

Information.

The next question will confirm Jessica fine with J P. Morgan. Please go ahead.

Hi, This is Jessica.

Jessica site.

And that question.

Given that the face to retire and Nash is annoying Leipzig authentication, how close to guidance dark occupation, and Glen and Glenda and a biopsy sampling 20th and final tissue.

I'm sorry, we had some background noise do you mind repeating the last part of your question I apologize.

Yeah.

And.

Can I, just start isolation, Glen and Glenda little lights, and sampling can you use and I'd like to share day.

Oh. So this this study is a biopsy confirmed studies, so there will be a screening period and which they will have a biopsy and.

And the and the period, so Alice and why don't you comment on the the lead in terms of the timeframe for that.

Yeah. Thank you for your question so there is and.

Good amount of clinical and regular Xray guidance Chinese tight supply Apsey trials and.

Additionally, clinical sites are very adapted using non invasive markers and publish the algorithm and algorithms for screening and you can biopsy to select the right kind of patients.

So that we avoid F. One at four Nash patients finally, and it's worth noting that way and using Doctor Harrison Some network.

And then the best and Nash trial network and.

And the U S as I've noted, which and uhm selecting and be able to select the optimal patience and us reduce screen Sally right.

Yeah. Thank you that and said just <unk> and <unk>.

Do you expect the site and and Nash Charlotte.

To activate on a rolling basis for them and get anything out of the seventies.

And he's getting to escalate at the same day.

Yeah. So I think I pick that up. This is this is Jason so it will be on a rolling basis will have a good number of sites up and running we already have several seconds up and running and it'll be a progressive rolling.

Startup period.

Yeah, we're we're covering the 70 sites globally across multiple countries. So as you are probably familiar there are different processes and stages for each of those individual institutions. We do also have central IRB work here. So there will be day, Jason's point progressive roll with some nice.

Jumps periodically yes.

And the next question will come from <unk> Z with the O'reilly Security. Please go ahead.

Good morning. This is you know fall and my aunt. Thank you, so, let's kidney and our affections, congratulations sounded too I and the insurance I have a couple of questions. First can you provide additional color on the child's designer and special as your thyroid restrictions and the <unk> and the second and can you provide some detail.

And all of the upcoming Tv's Avenue presentation. Thank you.

Okay. Thank.

Thank you I appreciate the question. So in terms of the trial for 11 25 and this this is again, we're looking for biopsy confirmed face F. Two F. Three we.

We will be using the typical diet management and guidance during the trial that you see in this field and we will be looking with the other standard markers about a certain level of MRI PDF F. A certain level of allt inflammation et cetera to establish the baseline to again.

And biopsy confirmed F. Two F three Nash.

In terms of the day D. W. A presentation and the Doctor son, Y'all will be doing we're very excited about this this is R. Zero zero to access 16, 65 data and there is additional depth and richness on some of the key markers that we've discussed with y'all previously so I would encourage you to.

Take a look because I think it provides additional understanding of the nature of the impact of our active arms. So yeah. As you can respect there's a appropriate embargo in and and things of that nature. So I can't give you additional desk right now, but it is worth looking into.

Yeah, and that's Super helpful. Thank you.

Thank you.

And once again and if you would like to ask a question. Please press star than one.

The next question will come from Paul Choi with Goldman Sachs. Please go ahead.

Hi, Thank you and good morning balance him and let me and my Congrats on India clearinghouse as well to for me. Please uhm first on the on the Nash trial for 11 25 can you maybe just to remind us.

You are alive in terms of.

Diabetic and therapies particular G. L E Y given the potentially confounding effects from weight loss from that class a drugs.

And then I had a follow up after that.

Okay. Thanks, Paul and I appreciate the comments on the congratulations and this important questions. So we are not allowing G. O P ones are tcdd's because of the potential impact consistent with the previous studies that we executed.

However people can beyond stable other diabetic medications as consistent with practice and the sphere.

Okay. Thank you for that and then on the 11th 65 and can you may be just update us on any potential.

Changes our thoughts with regard to turn it back around event rates for the placebo arm, particularly with regard to us and you use a standard of care of their or is the right way to think about it that so the event right there or breakthrough rabies would largely be consistent with what kind of label for <unk> net and other drugs. Thank you.

Yeah, no. Thanks, Paul very insightful questions. So let me just remind everybody that this population will be enriched they must have had one O H yoga and and they must have a ph.

Phs, a greater than minus four meaning less and minus four so they are and rich for that now based on the bass study and the more recent data and this field, which you typically see as a roughly of 22 per cent breakthrough right and that timeframe on the combination of <unk> and Rifaximin.

You'll see up to a 46 50 type range for patients who are just unlatch, let us know that of course is and a clinical study setting.

And we are enriching these patients. So we do anticipate will be reaching at least those levels for.

For the background, and we have factored and placebo effect as well into our study design.

Great Thanks, Bill and.

And keep up.

Ladies and gentlemen, and this concludes our question and answer session I would like to turn the conference back up your Bill and shop for any closing remarks.

Okay, great. So thank you Chad and thank you everybody for tuning and this morning, we're very excited about our continued progress and as I alluded to earlier, we're very much looking forward to update and you and the very very near term about continued progress on these important trials. We're also excited for the D. D. W 2021 presentation and a few.

[noise] weeks and and we ask you to remain safe remain engaged and thank you for your time and attention today operated this concludes our call this morning and.

And thank you, Sir and kind of.

France has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

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