Q3 2021 Astria Therapeutics Inc Earnings Call
Good day and thank you for standing by welcome to the Q3 2021 Astraea Therapeutics earnings conference call.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to.
To ask a question during the session you will need to press star one on your telephone.
Or any further assistance please press star zero.
I'd now like to hand, the conference over to your Speaker today, Andrew <unk> Senior Vice President Corporate Affairs. Please go ahead.
Thank you Alyssa welcome to today's after Therapeutics conference call, where we will provide a corporate update and review our third quarter 2021 or something like that.
With me today are Jill Milne, Chief Executive Officer, Andy Nichols, Chief Scientific Officer, Andrew <unk>, Chief Commercial Officer, and Noah Clauser, Chief Financial Officer.
We issued a press release this morning, summarizing our corporate update and our Q3 2021 financial results, which we will reference on today's call and is available on our website.
We are also using slides during today's call that are available within the events and presentations section to the investor as part of our website.
I would like to note that during today's call as mentioned on slide two we will make statements related to our business based on current and future expectations that may be considered forward looking statements under applicable securities laws and regulations.
Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties, including those discussed in our most recent annual report on Form 10-K, as well as discussions of potential risks uncertainties and other important factors and the subsequent SEC filings, which are available on our website.
Such statements represent our judgment as of today, an ashtray undertakes no obligation to publicly update any forward looking statements, except as required by law.
Let me pass the call over to Charles who will provide our corporate update and you will share recent preclinical data I'll start to one five interim will provide an overview of the need for new treatments and no will follow with the financial update Jill will then wrap things up Joe.
Thank you Andrea good morning, everyone and thank you for joining us on today's call turning to slide three I'm excited to introduce Austria Therapeutics are our company name and bodies our commitment to put patients first in all that we do.
Austria comes from the Threep word for star, reflecting that patients are the stars the guide us and give us our purpose. Our mission is to bring hope would life changing therapies to patients and families that are affected by rare and niche allergic and immunological diseases on slide four you will see an overview of the Astra reinvestment.
<unk> our lead program start to one five is a monoclonal antibody inhibitor of plasma <unk> that we are developing to treat patients living with hereditary angioedema or a J E. We see start to one five as an exciting opportunity to develop a product with the potential to be the most patient friendly prevented.
Give therapy for a J.
For important upcoming milestones we are on track for an IND filing in mid 2022 and expect initial clinical trial results by year end 2022. This first clinical trial has the potential to demonstrate clinical proof of concept for the differentiated profile of star 215.
We're also evaluating opportunities to expand our pipeline with the broader goal of addressing the unmet needs of patients with rare and niche allergic and email logical diseases.
We have an experienced team and board of directors backed by leading life Sciences investors at.
At the close of Q3, we were in a strong position with cash cash equivalents of $131 $8 million or so hours, which is expected to find the current operating plan through 2023, we have $18 3 million common shares outstanding on an ads basis and we.
Under the symbol <unk> SaaS on NASDAQ.
Slide five provides an overview of today's astraea corporate updates and start to one five program highlights.
We are making very good progress with the program and are on track for initial phase one clinical results expected by year end 2022.
Our Chief Scientific Officer, Andy Nichols presented new preclinical data last week at the American College of allergy asthma, and immunology annual scientific meeting regarding start to one fives binding affinity potency binding site and use of Y T E modifications to enable a long.
<unk> of action and he will review these results shortly.
Next Andrew <unk>, our Chief commercial officer will highlight the potential market opportunity for star 215, and our findings on the burden of disease and treatment and H H E, which we presented at the National organization for rare disorders Summit last month supporting the substantial need.
Need to decrease patient disease and treatment burden.
Subsequently NOAA closer our Chief Financial Officer will give an update on our financials for those that may be less familiar with H H E. Slide six provides an introduction.
H AE is a rare debilitating and life changing disease. It is characterized by severe unpredictable painful and sometimes life threatening edema.
The edema can occur in the skin, the abdomen and airway and most patients it's caused by a deficiency in a protein called C. One inhibitor, which is an important component of the body's contact pathway.
There are approximately 8000 people affected in the United States.
Patients have a significant burden of disease and live with the fear of an attack.
He has treated with preventative therapies to reduce the frequency of attacks and on demand therapies when an attack occurs.
Unmet need exists for effective preventative treatments with lower treatment burdens the global market for <unk> treatments is large and estimated to grow from $2 billion in 2020 to more than $4 $5 billion by 2026.
Slide seven illustrates the differences between our healthy blood vessel and a blood vessel impacted by each AE and shows how start to one five aims to prevent attacks and H E by inhibiting plasma callicutt.
In a healthy individuals.
Journal triggers such as pressure from holding a tool tissue stress our damage results in the production of plasma <unk>. This system in healthy individuals is kept in check by a protein called C. One inhibitor, which blocks the function of plasma <unk>.
And most patients with H H E.
C. One inhibitor is either absent or defective and in Hae's patient without active C. One inhibitor. There is no break for plasma <unk> and what you get is a runaway contact pathway whereby plasma <unk> continues to produce Brady kinin, which leads to pathological swelling.
With star to one five our goal in HAE patients is for plasma <unk> to be inhibited even in the absence of C. One inhibitor, thereby reducing brady kind in production and preventing edema and pain.
Over the years the therapeutic landscape for a J E has evolved immensely on slide eight you will see that the recent that recently the landscape changed in a positive direction with the entrance of plasma <unk> inhibitors. However, there remains unmet need as more than 50% of patients on <unk>.
<unk> plasma <unk> inhibitor still experienced attacks, we've heard from both patients and physicians that there is high interest in an effective preventative treatment option with infrequent dosing, we are aiming to deliver that profile with star 215 on slide nine you will see an overview of our.
Our lead program.
Star 215 is a monoclonal antibody inhibitor of plasma <unk> that we are developing to treat patients living with H H E. We see start to one five as an exciting opportunity to develop what could be the most patient friendly preventative treatment option for <unk> based on our data generated to date and the <unk>.
Existing treatment landscape, we think of the efficacy and dosing frequency as the key aspects that determined in HIV patients experience with a treatment and start to one five was designed with a clear vision aimed at addressing the needs of a J E patients.
What's exciting is its potential to provide long acting effective protection from the painful recurrent and sometimes life threatening attacks that are caused by a G E.
Now I'll hand, it over to Andy to give a more in depth look at star to one 5% and present, our recent findings Andy.
Thanks Jill.
Last week at the American College of allergy asthma and <unk>.
<unk> annual scientific meeting in New Orleans, I presented some of the preclinical data that describe the pharmacology and pharmacokinetics of <unk>.
One five and the poster described is available on our website.
Turning to slide 10.
Plasma <unk> binding affinity and plasma half life have been shown to be key drivers of efficacy for the prevention of HIV attacks.
We showed the start Q1 five binds to <unk> in vitro with high affinity about tenfold more potently than Atlanta daily amount.
And competition binding experiments star two and five was shown to bind to a different site on plasma <unk> the Atlanta diluent.
To characterize the potency of the 215, we use a physiologically relevant in vitro functional assay the photos bradykinin release from high molecular weight kininogen as catalyzed by plasma <unk> in other words, the exact same biochemistry that drives an HEB attack.
Note that the concentration of the high molecular weight kininogen used in the assay is similar to the circulating level in humans and the concentration of plasma collar crime that we use is in the range of what has been estimated to be present in plasma during an attack.
Importantly, the high binding affinity of <unk> 205, plus plasma <unk> translates into high functional potency and this physiologically relevant assay.
We looked at the concentration of antibody the results in 90% inhibition of <unk> activity because that is believed to be the therapeutically relevant level of inhibition to prevent HIV attacks.
In this assay star two and five has been shown to have about a 10 fold improvement in potency overlap 1 billion lab to inhibit plasma Kelly crime by 90%.
The potency of blended daily map that we see Elisa is actually consistent with the plasma levels that have been.
Reported to be required for clinical efficacy.
Moving to slide 11.
I also presented information about the half life extension technology used to start to one five.
The introduction of <unk> modifications and start <unk> were designed to extend plasma half life and enable a long duration of action.
<unk> modifications have been shown to extend the half life of other monoclonal antibodies with the half life in non human primates being 20% to 40 days.
In addition, there have been several antibodies with YTD modifications that have been in the clinic and they have been reported to have half lives in humans of 70% to 120 days.
As shown last week enhanced ph dependent CRM binding enabled by the way to <unk> modifications translated to a more than threefold increase in plasma half life with up to one five compared to his parental antibody with <unk> modifications.
In non human primates start to one five given at the same doses.
As Len Adobe Matt.
As a more than threefold longer half life of about 34 days and the potential for a longer half life in humans as suggested by other antibodies with the white to modifications.
Together these results support the potential for infrequent dosing with 205, possibly every three months so longer.
On slide 12, we look at the data from both the in vitro functional assay and the pharmacokinetics in nonhuman primates.
And we can begin to understand the potential relative duration of efficacy for each of the antibodies when given at the same dose.
In the Middle panel to Atlanta failure mode, you can see that the plasma levels fall below the IC 90 by approximately <unk> <unk>.
This means that 10 days after the antibody is dosed the levels fall below the therapeutic threshold that we are targeting of 90% inhibition of plasma <unk>.
In contrast, you can see in the left panel that the plasma level stuff <unk> remained above the predicted minimum therapeutic concentration for more than 84 days, which was the full duration of the experiments.
Lastly in the right hand panel you can see a PK PD model that synthesizes the same data together, but in a different way.
What is positive is the percent of plasma <unk> inhibition expected that the concentration of antibody at each of the time points in the pharmacokinetic experiment.
You can see the out for 84 days following star 205 dosing plasma <unk> is expected to be for all intents and purposes fully inhibited.
In contrast, <unk> Italia map, the inhibition of plasma <unk> falls below that 90% inhibition level by data by day 20 is about 50%.
These preclinical data showed that for the same dose of antibody start to one five is predicted to have a significantly longer duration of action the Atlanta daily map and that stuff to one five has the potential to be a plasma <unk> antibody with an increased potency and extended duration of action.
The CMC and non clinical development of <unk> of the way.
Looking with a CMO that has significant experience in development and commercialization of biotherapeutics, we have identified a proprietary high producing cell line and an appropriate formulation and these will be enabled to supply a planned phase one studies.
GOP toxicology program is in progress and all relevant pharmacodynamic clinical assays under development.
Based on this we expect to file an IND for stop <unk> five mid next year and to initiate our clinical program. Shortly thereafter.
Slide 13 outlines our plans for the first phase one study design.
We see an opportunity to establish clinical proof of concept for the differentiated profile, we anticipate for <unk> hundred five in the first clinical trial in healthy volunteers.
We anticipate that this trial will be informative in terms of pharmacological activity of <unk> hundred five.
We will monitor safety determine pharmacokinetics and utilize a pharmacodynamic biomarker assay to assess plasma <unk> inhibition.
Our goals for this trial was thought to upsize to demonstrate safety.
<unk> the extended half life show prolonged plasma <unk> inhibitory activity and to refine the dose and dosing regimen for our next trial.
Initial pharmacokinetic and Pharmacodynamic data from the first cohorts from this trial.
Our expected by year end 2022.
Due to the expected long half life of 215, we will follow the treated subjects for an extended period of time before the full data will be available.
If positive we believe this trial will set the stage for the differentiated profile of <unk> 205.
In summary on slide 14 start 205 has the opportunity to be the most patient friendly preventative treatment option for <unk> patients.
Our first objective was to identify a high potency antibody that could inhibit plasma count crime to the same levels as land Italian mob, but with less antibody and this has been achieved pre clinically.
The second objective was to engineer, an antibody with a long plasma half life potentially allowing for less frequent dosing and preventing attacks for a long period of time.
This has also been achieved pre clinically.
The important next step is to demonstrate the differentiated profile of <unk> to one five in the clinic.
With this we are aiming to provide patients with a differentiated new therapy, using a trusted treatment modality to prevent attacks and HIV over an extended period of time.
I'll now hand, it over to Andrew to speak to the needs of the community.
True.
Thanks, Andy and good morning, everyone.
On slide 15, we highlight that the need for improved treatment options has been emphasized in recent publications from both HIV patients as well as physicians and.
Patients continue to have frequent attacks and experienced corresponding exactly in depression.
Physicians note that their patients are somewhat satisfied with existing treatment options and are interested in participating in future clinical trials.
On slide 16, I'd like to highlight recent findings that we presented at the Nord Conference last month, showing that there is a need to decrease both the burden of disease and.
Also the treatment burden.
Findings came from interviews from HIV patients using a structured interview guidance.
Patients were screened for inclusion based on self identify disease type HLA types, one and two disease severity moderate or severe when not on treatment.
And eligibility for preventative treatment.
The finding suggests that <unk> patients are seeking to reduce their treatment burden as a.
Disease burden and many are open to trying new therapies that could address these needs.
On average patients tried two to three preventative treatments, most often switching for more convenient administration.
Additionally, despite being on preventative treatment.
Half of the patients interviewed think about future attacks often or always.
All patient shared that they would be compelled to switch from their current therapy, if a new therapy offered similar efficacy with less frequent dosing.
I'll now turn it over to Noah to provide a financial update.
Thanks, Andrew and good morning, everyone turning to our financials on slide 17, I will provide a brief summary.
As of September 32021, we had $131 $8 million of cash and cash equivalents, we expect that we have sufficient capital to fund the current operating plan through 2023.
Our R&D expense was $3 $8 million in Q3, 2021 compared to $7 8 million in Q3 2020.
Our G&A expense was $4 1 million in the third quarter of 2021 compared to $3 1 million in the third quarter of 2020, our operating loss was $7 9 million in Q3, 2021 compared to $10 $9 million in Q3 2021.
Our net loss was $7 $9 or <unk> 61 per share in Q3.
As of September 32021, we had common shares outstanding of approximately $13 million and $18 three common shares outstanding on an as converted basis additional financial information will be available in our 10-Q, which will be filed with the SEC aftermarket today I will now pass the call back.
Over to Joe.
Slide 18 outlines the expected upcoming milestones as we envision the future for Australia, we had astraea listen to the voices of DHA patient community to better understand their unmet needs and this guide what we do we are charting a new path for HIV patients one that envisions an.
<unk> for a better quality of life with a long acting preventative therapy that has meaningful efficacy with infrequent dosing. We are not stopping there. We're also evaluating opportunities to expand our pipeline with the broader goal of addressing the unmet needs of patients. Our goal is to develop therapeutics that bring meaningful changes to pay.
<unk> lives by pushing the boundaries of what is currently perceived as the standard of care for rare and niche diseases in allergy and immunology with that I'll ask the operator to open the call for your questions. Operator can you. Please repeat the instructions and poll for questions. Thank you Sir.
Finally, as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound or husky.
Your first question comes from the line of Heartland Chang of Oppenheimer. Please go ahead.
Great. Thank you. Thank you for the great.
Nice presentation here Joe team.
Just a couple of quick questions. One is you indicated your phase one study youll be looking for Biomarkers.
I'm sort of antibody half life inhibition macalpine.
Could do sort of serve as the fees to slash three kind of markers for.
Sort of accelerated approval type study, so that's number one or what would you need.
I'm doing a full full.
<unk> phase two and phase III planning and then number two in terms of your market research showing that if you go up to about three months you could have quite a few patients.
Switchover.
Could you give a little bit more color on whats the balance between decreasing attacks versus increasing.
The time between dosing so I'm sure. There's some kind of a relationship there also in patients and physicians mind could you give some color in your findings around that meeting that you'd like to decrease taxes as much as possible versus increasing.
Between that between doses.
Yeah.
Great. Thanks <unk>.
Let me start and see if I can address that both areas of your questions.
Certainly have Andy.
Contribute if I've left anything out and Andrew contributed on the market research side as well if I left anything out so first.
You asked about the Biomarkers.
And the phase one design in general.
So youre absolutely right, we are incorporating pharmacodynamic markers in our phase one study to understand the level of inhibition of plasma <unk> and we do see that as important as helping US chart our path.
Into our phase <unk> slash two and beyond.
To understand the level of inhibition that we're achieving I think this is a J.
He is.
A good space to be in as rare diseases go in terms of a relatively.
Understood and known regulatory and clinical path.
Getting to registration and we certainly will be looking at what has been done previously and optimizing it based on our program and the data that we're generating in that phase one.
And so we'll certainly be providing additional updates on our regulatory and clinical strategy in the coming months.
In terms of your question about the market research and what we've learned from patients and physicians.
I think there is.
What we did learn and I think what's important here is that patients do want to decrease.
Disease burden as well as treatment burden and so we think it's important to both reduce the frequency of attacks and to do that for long durations of time supported by infrequent dosing, we think that could be really a game changer for patients with HLA E. We really with 215.
Hope to have.
Our product.
That could allow patients to live differently with HCA and really.
With this infrequent dosing, but.
Robust efficacy we hope.
To be able to achieve that and certainly we have a lot of work to do to get ourselves in the clinic and to establish that that profile clinically and I'll pause for a moment and see if Andy or Andrew I want to add anything to those comments.
Only to say that we will certainly be working with regulators to explore the most expeditious path to approval whether that could include an accelerated.
Our approval pathway is certainly not clear at the moment.
The only thing I'll add on the market researches and it was very clear that patients really want to make sure first and foremost at their controller.
Controlling their disease so.
Maintaining a high level of efficacy is very important.
And then from there if you can reduce that burden of treatment.
Up to three months, obviously, the further along you could go.
More convincing that is so I would just say that.
You need to make sure that you are providing both of those elements.
<unk> treatment going forward and Thats really what excited.
The physicians that we talk to about the possibility of one to one five providing both of those benefits.
Great. Thank you Youre preclinical profile suggests you've got some good Billy to balance there. So thank you for the questions.
Thank you Josh.
Your next.
Next question comes from the line of <unk> <unk> with Jefferies. Please go ahead.
Hi, good morning, and thanks for taking my question and congratulations on all the progress you guys made.
So I have couple of questions about that.
Say the clinical development timeline.
Or start to one five.
So you said that in the presentation.
<unk>.
The drug has longer half life, you are looking to follow the patients for a long period of time. So I was just wondering when you expect to have the full data from phase one and when you present the data interim data from phase one by end of next year what type of data.
Do you plan to present from how many patients.
I have follow up questions.
Great. Thank.
Thanks. This is Jim let me start with that and let Andy finish so just to reiterate our clinical development timeline. We are on track to file an IND in mid 2022 and initiate the phase one <unk> study. Soon thereafter, we will have initial results from that phase one.
<unk> in normal healthy volunteers by year end of next year. So year end 2022, you asked what data that initial data.
We hope will support the differentiated profile that we believe we have and start to one five in terms of the extended half life and also demonstrate inhibition of plasma <unk> would start to one five and Youre absolutely right that this is a very long half life antibody that we expect.
To see a very long half life in human and we will be following those patients from that initial normal healthy volunteer for a long period of time to collect the appropriate safety.
And pharmacokinetic data so we will be following those patients well into <unk>.
<unk> 2023 and with that.
I'll hand, it to Andy maybe to comment on that but that initial data will be at year end 2022 to establish we hope that differentiated profile, yes. So.
Our expectation is that we will have pharmacokinetic data from.
At least the first couple of cohorts.
And Pharmacodynamic data from the first couple of cohorts.
And as of yet.
To allow us to not necessarily definitively calculate.
Life.
But to be able to say that it is extended.
That it has.
Pharmacologically.
Pharmacological activity.
They are able to estimate what sort of doses could be pharmacologically effective.
Because of the extended half life.
In fact in that 70 to 120 day range.
We will have to close the patients.
For.
Up to a year.
In order to be able to.
Adequately.
First the safety profile during exposure of the product. So it will take an extended period of time before the full dataset is available.
From this initial study, but that does not stop us from actually looking and making decisions based on the earliest data.
We will be collecting.
And you asked about outpatient numbers, we hope to give an update in the coming months about the details around the phase one design and hopefully more details about the full clinical development program for start to one five.
So with that updated.
Some time early next year.
We believe in the coming months, where as you might imagine actively working on refining that plan and want to make it available.
Publicly to let folks know what to expect at year end next year and what to expect going forward with the program.
So how long do you say to have whitewash.
Well.
<unk> estimate is from other monoclonal antibodies that have the same half life extension technology, the <unk> modification.
They have demonstrated a place of the 70 to 120 day range in humans.
An average of 90 days three months.
And you actually have to follow.
People from multiple half life.
So the dosing so you could imagine if the half life is three months.
We would actually has the flow of patients.
The volunteers in the phase one initial phase one study.
Sure.
Probably at least nine months, possibly up to 12 months.
So is your plan to start phase one will be in 2023 still intact.
So our plan is still intact, obviously right now refining our clinical development plan and that will be a discussion with.
Regulators and also will be informed by the data going into that phase one and the initial data from that phase one.
And last question I have is.
When should we expect to hear updates on the business development activity.
Yes, so we are actively evaluating opportunities to expand our pipeline in the area of rare and niche allergic and immunological diseases. We hope in the coming months to be able to talk about other opportunities that we intend to explore.
Great that's really helpful. Thank you.
Your next question comes from Laura Chico of Wedbush Securities. Please go ahead.
Hey, good morning, guys. Thanks for taking the question I actually wanted to circle back on the patient burden survey that you mentioned.
You indicated or the data shows that when patients are on preventive therapy, they're still having concerns about effectiveness and I'm wondering if you could just elaborate a little bit more on why the concern is there just I'm trying to understand is this just general disease concern or is there something specific about.
Prophylactic therapy efficacy and if it is more of the latter then I'm just kind of curious how 215.
What attributes to <unk> five might have to demonstrate in clinical studies to kind of avoid those.
The same kind of issue so any any attributes standout is most important for clinical differentiation.
Let me start and then hand it to Andrew.
So that's a great point and I think these patients generally live with a high level of anxiety in.
Fear about the potential of an attack.
I think one thing that we hope for start to one five and the profile that we hope to be able to support clinically for these patients is that by having a potent inhibitor of plasma <unk>.
That retains potency through a longer duration of action so for up to three months between doses, we hope to maintain a level of inhibition of plasma <unk> that prevents attacks from occurring for longer periods of time, So our hope would be.
That this could be a real benefit for patients and help alleviate some of the anxiety and stress that they live with in their everyday lives and thinking about this disease.
But I'll hand, it over to Andrew to add any additional comments sure.
Thank you for the question, we're obviously learning a lot.
And speaking with both physicians as well as with patients but.
With the advent of preventative treatments.
The good news is that many of these treatments do reduce the frequency of attacks and I think thats encouraging for patients. The challenge here is that they do still experienced attacks and some of those attacks, especially laryngeal attacks can be life threatening.
So I think.
The goal here is to make sure that we can.
Prevent or reduce the frequency of attacks as effectively as we can would start 2015, but in combination with that reduced treatment burden by extending.
The frequency of administration.
By up to three months so.
I think it's just the anxiety that these patients.
<unk>.
Still being on preventative treatments knowing that.
They could still be facing attacks.
Okay. That's super helpful. Thank you and maybe just one quick follow up and I apologize. If this has been asked but there was some recent competitor since you did the meeting related to anti <unk> therapy.
And I think there's certainly been an evolution in the prophylactic space, where we now have antibodies in the oral agents, but I'm wondering if you can speak a little bit to what you view.
As probably what modalities are best suited for prophylaxis, and how do you envision the competitive landscape changing with kind of these different modalities advancing thank you.
You want me to take a go ahead Julie.
So I think youre absolutely right there are multiple different modalities right now in use and more coming so we have.
The monoclonal antibodies like start to one five you mentioned.
I think the antisense data that was presented at.
Last week.
Which is yet another different modality coming in and that showed.
Effective reduction in percent attacks with every four week dosing, what we hope with.
Start to one five is here we are using a very trusted modality in the form of a monoclonal antibody.
And that.
File that we've been able to demonstrate.
Demonstrate pre clinically at this point.
Just a profile thats very differentiated from what's currently on the market in terms of the different types of modalities for preventative.
Treatment and <unk> as well as what we see in the pipeline.
Candidates that are in development and so we think start to one five being a trusted.
Modality in the form of monoclonal antibody with a highly differentiated profile that we believe could support once every three months or longer dosing could really make a significant difference in the preventative therapy landscape.
Thanks, very much super helpful.
Great. Thanks, a lot.
Your next question comes from Joseph <unk> is H C. Wainwright. Please go ahead.
Jill I wanted to start on the back end of your prepared comments about the potential pipeline expansion opportunities.
If you were to take 215 forward on your own would you be looking at assets that could be marketed in the same sales bag are you more flexible with regard to the types of opportunities Youre looking at with regard to orphan and niche indications.
Yeah. Thanks for that question, yes, we certainly will be as we consider opportunities for the pipeline, we're going to be opportunistic we want to stay in a.
Somewhat related space for the reasons that you just suggest wed like to optimize the organization that we're building.
And so that certainly makes a lot of sense for us, but I will say if there is a great opportunity in the allergy and immunology space, where we think we could make a significant difference for patients.
We will probably work on that.
Makes sense, thanks for that and I guess.
Switching to 215, obviously.
You provided a long list of obviously all your IND, enabling.
Activities and I guess I would ask it this way what do you consider your rate limiting step at this point it seems like your CMO is onboard and having.
Drug ready to go.
But I guess are you experiencing any issues or things you've had to prepare for with regard to the global global supply chain constraints.
Yes, that's a great question so.
As with everyone. We are we are making sure that we are well ahead of any potential issues right now.
Working as efficiently as we can to get to that IND in mid 2022, we remain on track for that and that's in large part because of trying to.
Think well ahead and well in advance of any potential issues that could arise and so just like many other companies in our position in IND, enabling studies and preparing for the clinic as we are doing things very far in advance to try to.
Prevent any issues from cropping up between now and the time that we want to get into the clinic and get to that initial proof of concept data.
Got it got it and my last question. If you don't mind I guess is it's truly speculative at this point because you don't have human data in the experiment hasnt been done. So if you were to.
Assume that you were to go forward with once every three months dosing.
One would assume at least in the field with the current therapies. There are certain rates that you might be projecting for breakthrough attacks and do you anticipate that those breakthrough attacks rates would increase as you get closer to the next dose.
That's a good question and something that is certainly on our mind as we develop the target product profile and refine it for start to one five because what we want to be able to do is to support every three months dosing or longer but to base that dosing.
See on the ability to reduce.
The occurrence of attacks to the greatest level possible. So youre absolutely right. The this will be informed by the data in patients and so our hope is that we can optimize the dose and the dosing frequency to minimize the occurrence of breakthrough attacks and so thats something thats going to be.
Right out front as we design those clinical studies in patients and as we look at the data to design, what we think the go forward dosing frequency is but.
Thats spot on what we're going to be thinking about great.
Great. Thanks, a lot guys.
As there are no further questions at this time I would like to hand, the conference back to Joe for any closing remarks.
Great. Thank you. Thank you all for joining our call. This morning and for your continued support of Austria, We will keep you updated as we execute on our start to one five program and share other areas of progress of the company. We look forward to speaking with you again soon Andrea that concludes today todays call a webcast replay will be.
Available for 90 days via the Investor Relations page on our website at Www Dot <unk> Dot com. Thank you.
Okay.
Hi.
Okay.
Sure.
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