Assembly Biosciences Inc Earnings Call
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Thank you for holding your conference will begin momentarily. Thank you for your patients. Once again, thank you for holding and your conference will begin momentarily. Thank you for your patience.
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Good afternoon, and welcome to Assembly Biosciences Conference call at this time, all participants are in a listen only mode. After their prepared remarks, we will conduct a question and answer session. As a reminder, this conference call is being recorded.
I'd like to turn the call over to Loren Glazer Senior Vice President of Investor Relations and corporate Affairs for Assembly.
Good afternoon, and thank you for joining us as we discuss the hepatitis D program updates that we announced today. This press release is available in the news and events section of our corporate website at Www Dot Assembly bio dotcom. Our corporate presentation is also available in the same section of our website as a reference, though we will not be referring to a specific.
On this call. Please note that a replay of today's call and audio webcast also will be available from our website.
In a moment I will turn the call over to our Chief Executive Officer, and President Dr. John Mccutcheon to provide opening remarks, and then we will host a Q&A session joining John for the Q&A portion of the call will be our Chief Medical Officer, Dr. Luisa Stamm, our Chief Scientific Officer, Dr. Bill Delaney, our Chief Financial Officer, Tom Russo and our chief legal and <unk>.
Isn't this officer, Jason Okazaki.
Before we begin I want to remind you that we will be making forward looking statements, including statements regarding our future research and development plans evaluation of interim data the timing of clinical trials trial result, and therapeutic potential of our research and development program. These statements are subject to the safe Harbor protections provided under the private Securities Litigation Reform Act of 1995.
They involve certain assumptions risks and uncertainties that are beyond our control and actual results may differ materially from those forward looking statements. A description of these risks can be found in our latest SEC disclosure documents and press releases Assembly does not undertake any obligation to update any forward looking statements made during this call I'll now hand, the call over to our CEO.
Dr. John Mccutcheon.
Yeah.
Thanks, Lauren and thank you to everyone for joining us today I thought I would share.
But he was since I joined the company in 2019, our vision and ultimate goal has been and continues to be doing patients with hepatitis C and frame them from the burden of a lifetime chronic treatment in order to advance and accelerate our progress towards that goal, we have decided going forward to focus our efforts.
Debbie cobia, sodium cyanide and curative combination for hepatitis C rather than continuing to pursue a chronic suppressive therapy indications in parallel.
This afternoon, we would like to provide more background on that decision as well as an update on our overall episodic sales strategy and our expanding research pipeline, which includes work on a fourth generation core and dividend.
Our work on safety DNA disruptive another price.
Clinical programs focused on novel Hepatitis C virus tug.
And of course, we're happy to answer any questions you may have as Lauren said.
The greatest unmet medical need for hepatitis b patients as a finite from curative therapy consulting so that has always been the ambition of this company from the same with you on the call today, I remember, saying to you when I joined Assembly about 18 months ago that I believe that I still do that we will view of this disease.
As we did hepatitis C.
Of the approximately 270 million hepatitis C patients worldwide.
5 million also currently being treated.
Treatments aside from those patients.
Also last long.
In order to truly change the outcomes for patients with hepatitis C infection and trades at a greater proportion of <unk> patients, it's clear that we need to more than just the coding viral suppression.
To therapy.
The final EIS in surety as combination therapy and based upon that work so well.
We are confident non I'm confident that COVID-19 dividends will be a central part of it.
As you know our pipeline includes the most advanced and potentially best in class codes.
And they've been developed.
In phase II trial, maybe call via plus nuc therapy demonstrates deeper viral suppression with a favorable safety profile, which was an important step for the hepatitis C sales the step that we plan to build upon true continued development of <unk> as well as the next generation well pattern.
Total inhibitor candidates, we believe the combination of these.
Direct antiviral mechanism that is cool plus nuc suppressed viral replication levels that could not be previously achieved will form the backbone for combination therapy to remain central to ASP on interiors.
In periods of strategies.
We know that's fine on Cherokee therapies is still a way off particularly in light of the study 211 results. We shared with you in the fall.
However, we have always viewed the pursuit of pure as a longer term endeavor and it was that and thought that drove us to evaluate in parallel near term opportunity to bring them more effective chronic suppressive therapy to patients who do not currently achieve adequate will complete suppression with a standard.
Better.
As you recall last year, we completed though interactions and received regulatory go ahead in China to commence to phase III Registrational study to evaluate very cool a bit as the chronic suppressive therapy and different populations.
China, obviously has a large hepatitis C prevalent.
Free agency that therefore egan.
Is it a new treatment option.
As we plan for those studies with our partner Beijing, we met with experts around the World and then also initiated discussions with the FDA with the intention of issuing.
Issuing a global chronic suppressive therapy program.
FDA feedback however has been different from that as the Chinese and MTA and we do not see a clear path forward in the U S. So this approach given fda's view that the vast majority of these patients are in loss costs.
While the current standard of care.
And discussions with hepatitis expert.
<unk> indicated that this type of approach or an add on suppressive therapy is less of a need and less value in terms of what trading physicians need or want to their price.
So after significant internal and external discussions and analyses, including discussions in agreement with our partners Beijing for the China territory, we have concluded that rather than proceeding with the phase III suppressive therapy studies, we should go all in.
And focus our efforts on finalizing curative therapies. We believe this represents the greatest unmet medical need for the hepatitis C patients that we serve.
The potential to create the greatest value.
The organization as well.
But the decision to not pursue chronic suppressive therapy, we can now concentrate our resources on finite therapies, including initiation of the planned triple combinations with February COVID-19 as well as additional potential combination studies and study arm.
Advancement of more potent next generation core inhibitors and expansion of the breadth and depth of our research and discovery program.
Redirecting the resources previously reserved for those Registrational studies and other related activities will allow us to advance all of these initiatives offset while simultaneously extending our cash runway into 2023.
I know I've already provided a lot of information and updates.
So in light of all this let me review for US the three key components of our hepatitis C strategy and how our current and future product line will drive our progress.
The first component of the standards on advancing our portfolio of leading core inhibitors to select the best molecule to bring forward as part of finite and curative combination strategy.
We have three potent <unk> inhibitors in the clinic and we are planning on selecting a fourth generation comes out in the first half of this year, which I will speak more about shortly and discussing our new research and discovery program.
All four core inhibitors have different scaffold and presented a unique opportunity to more deeply suppress viral replication and hence be an integral component of the drive towards finite intuitive.
The nation regimen.
We do not plan on bringing or inhibited forward and sequential and similar fashions, but rather we will execute.
On a consolidated driven development plans to select the optimal core inhibitor that low.
They enable to use and length of stay it's finite intuitive combination studies.
This leads me to the second component of our strategy advancing proof of concept triple a potentially quad combination studies with news and our core inhibitor.
Inhibits the initial step in this approach includes vertical via combined with the new moving as the antiviral backbone that these plants triple combination studies two of which we expect to initiate in the first half of this year.
Previously noted the combination of very cold beer on a nude as already demonstrated potent antiviral activity and a favorable safety profile in phase II studies.
Ideally situated now for those proof of concept studies as the other core inhibitors progressed and if they show a differentiated efficacy and safety profile, we will be able to bring them forward into this part of the strategy.
Sure.
Earlier today, we announced the initiation of a phase II trial evaluating <unk> in combination with interferon and treatment naive hepatitis C antigen positive subjects.
In addition to its anti viral affected as many players tried to give you the logical effect that are beneficial and augmenting both specific non specific hepatitis C.
Related immunity.
Notably this is a drug that has shown the highest rates are low.
<unk> in combination with a nuc and previous controlled studies.
The other combination trial with vertical we anticipate initiating shortly is being conducted in collaboration with our booth.
Combining the RNA therapeutic candidate AB 729, with vertical via in new and a phase two trial enrolling.
Enrolling biologically suppressed E antigen negative subjects RNA AI has been shown to inhibit viral antigen production and its effect on surface antigen also offer the potential to restore the immune response to hepatitis b.
And both Triple combination studies, we will be evaluating the safety and non treatment response of the three drug combination.
Each of the two drugs in combination with new.
If the data suggests in each of these trials.
Enhanced on treatment efficacy parameters. We then have the option to incorporate modified stopping criteria to assess off price response.
We also continue to explore additional combination studies to evaluate the core inhibitor and it goes a bit now and you expect together one of potentially two other mechanisms. So please stay tuned.
Here also.
In parallel with the Baby, Colombia combination studies I've. Just described we are actively advancing a pipeline of more potent next generation core inhibitor. The most advanced plenty of $1 58 has been shown to be 10 fold more potent than Debbie crosbie it against the formation of new CCC DNA.
In in vitro studies.
Phase one day $21 58 demonstrated potent antiviral activity.
Well safety profile when dosed once daily for 14 days.
Our phase II trial of $21 58 bonds with a new is ongoing in treatment naive E antigen positive subjects.
We'd hope to reported interim data later this year.
And Italy will be evaluated in the chain and DNA pre genomic RNA and other HPV related viral antigens and comparing that to our prior data in the same population that we treated with <unk>.
If these data suggest that the increased potency observed with $21 58 in the lab has translated to improved clinical efficacy on treatment.
We'll also be able to incorporate modified stopping criteria for the purpose of evaluating off trade response.
Additionally, we also have 370, <unk> III, which recently completed initial phase one evaluation in healthy subjects.
And as I mentioned earlier, we are very excited with our progress towards nomination the fourth core inhibitor candidate during the first half of this year.
Fourth generation core inhibitor, we are aiming for our compounds have the potential best in class profile.
This will include greater potency that is single digit nanomole, a potency against CCC DNA formation and also antiviral potency.
Of course, it will have pan genotypic hepatitis C activity.
Claim preclinical safety profile I saw your ability.
Once daily single pill dosing and the potential to be co formulated with other therapeutics in a fixed dose combination regimen.
Once we nominate a full generation core inhibitor. We will proceed as quickly as possible to develop both of these compounds and subscribed since day with a data driven approach to ultimately advance not only our most promising candidate into latter stages as I've outlined so again stay tuned please.
The fourth generation core inhibitor actually leads me into the third and final component of our strategy, which is expanding the breadth and depth of our research engine.
And the core inhibitor mechanism.
In 2020, we made significant strides in expanding our pipeline of research programs, both internally and externally.
As we announced also back in November we obtained option rights to core protein CCC DNA disruptions arising through our research collaboration with Tau Pharmaceuticals.
Those discovery platform targets different phases of the hip the virus replication cycle distinct.
From viral assembly, and then have the potential to interfere with viral nucleic acid, including CCC DNA transcription within the nucleus of the cell with the many trends.
Todd.
This could prove a strong complementary mechanism of action to a core inhibitor pipeline for over a decade, the Holy Grail of the hepatitis C. Cure field has been to develop therapies that target CCC DNA slides to grade disrupt prevent transcription of this reservoir.
So we're very excited about this novel small molecule approach.
At the same time now internal research team has worked very hard on unique hepatitis b targets that we believe are also differentiated in this space.
Has the potential to accelerate.
Progress towards those finite and curative therapies per head.
These research programs have coalesced from the decades of experience that our CFO Bill Delaney.
Dedicated to pioneering hepatitis C virus biology in virology as well as the contribution from this group of course.
Well it would be premature to disclose the specific targets. We can tell you that we have two novel differentiated projects underway and we will keep you apprised as this work as it progresses.
The emergence of our early stage pipeline is further evidenced that we now have precisely the right people in place to pursue our vision. Many of US spent a large part of our careers in virology and hepatitis B remains a critical and exciting field of research focusing.
Very pervasive difficult to cure viral disease.
Well cloud team has extensive hepatitis experience.
<unk> strong record strong track record executing in viral hepatitis and is committed to advancing the sales of HBV research towards this goal.
<unk> therapy patients with the disease.
We are all excited to develop a leading core inhibitor portfolio and accelerate our novel discovery programs to drive us closer to that finite from curative therapy approach for these patients.
With that we're now happy to take your questions. As a reminder, Luisa Bill Tom and Jason are all here with me. So operator would you open the question and answer session line. Please.
Thank you and we have a question. Please press Star then one on your Touchtone phone if you wish to be removed from the queue. Please press the pound sign or the hash key.
Youre using a speakerphone you may need to pick up the handset first before pressing the numbers. Once again if you have a question. Please press Star then one on your Touchtone phone.
And our first question comes from Salim Syed from Mizuho. Please go ahead.
Okay.
Selling you might be on mute.
Our next question comes from Brian <unk> from Baird. Please go ahead.
Hey, good afternoon, guys. Thanks for taking my question and thanks for the update.
I guess, maybe you can just dig a little bit deeper into kind of the thoughts on on not pursuing the chronic indication for <unk>.
You know really going full bore into targeting sort of acute therapy. I mean is there any new data that's been generated sort of a space that kind of gives you confidence in kind of pathway to achieve here, particularly with core inhibitors and then maybe the second question.
On the on the.
The core of your Percolator interferon phase two triple combo study.
Just thoughts on on.
Is this primarily just kind of a safety of a triple combination study.
Or do you think could be durability of treatment here.
Eventually maybe.
Some sort of stopping criteria as.
As well thanks.
Hey, Brian It's John Thanks for the question I'll start with the third.
And then I'll hand, it over to.
Bill.
In terms of.
That as well and then I'll ask Luis to comment on the Triple combination therapy initiation was interferon in terms of is it safety or efficacy and what the plan is.
So the answer to your question is a new data that gave us greater.
Confidence.
Core inhibitor based program is going to provide is curative regimens.
It is clear to all of US did you must did you give a little evidence of our reputation too.
Even before you consider anybody so I think thats, the premise and was saying.
Levels of viral suppression with a core inhibitor and use that haven't been seen with Duke Salon before without first generation compound and then we'll be looking at.
The more potent compounds, which have been designed to be more potent against CCC DNA. So we don't have new day during the planning today, but the premises day from a virological perspective build you want to add anything to that in terms of what Bryan asked here. He's asking really is there any new data that we have all the sales as it's ways to think that.
A strong anti viral backbone will get us towards a cure.
Yes.
John So just just to respond to that.
Thanks, Brian.
So I mean, I think greater greater potency, particularly against the second mechanism of <unk> inhibitors.
Really what we're driving after the ability to inhibit the formation of new CCC DNA. So while we don't have new data.
Just looking at the data that we have in terms of the potency of the molecule that we have the exposure that they achieved in the clinic.
We are confident we will reach a much higher.
Level of inhibition with that second mechanism with our second generation compounds.
We have a slide Brian and a new corporate slide deck, that's on our website that looks at the potency of the <unk>.
Compounds and what we're hoping to achieve with the fourth generation compound as well.
We've talked about this.
Hoping we'll be able to advance and nominate that candidate soon but that is a very attractive profile. So the weighted to the second part of Brian's question is this just a safety study with interferon or what is it.
Yes. So we are happy to start our first triple combination study with an RPI core inhibitor in any part of Derek and interferon just last week.
The primary objectives are safety and efficacy initially we will be looking at on treatment efficacy.
Looking at the different viral parameters DNA Pgi, RNA and again with the dual combination compared to the triple combination.
Based on what we see Derek.
We anticipate that will incorporate monetize stopping criteria and be able to evaluate after treatment efficacy what those modified shopping from here you are at this time, Inc.
I'm determined we continue to analyze the data from study 211.
After which we shared at a high level that.
And think about this question, we haven't reached the criteria there what were thinking and looking at the on treatment response, and anticipating incorporating modify stopping criteria.
I'll share more details about that when we have more information.
Great. Thank you very much.
And our next question comes from Rajiv Prasad from William Blair. Please go ahead.
Thanks for taking the question.
I wanted to kind of discuss a little bit about.
How we should be looking at the.
Potential interim data readout from the <unk> study in.
In the context of the Triple combo data as well as some of the stopping criteria comments you've made.
Are there any specific data points that you're looking at internally. There that gives you that will give you more confidence on our potential.
Maybe 12 week regimen with with the second Gen.
<unk> inhibitor.
Thanks, Raj I'll ask the weighted too.
So the question first and I might chime in a bit afterwards.
Thank you so as John mentioned, our current phase two study with 21 58 will be evaluating 21, 58, and then secondary treatment naive E antigen positive individual we chose this population because of the dynamic range of afford it and the ability to us.
That's the impact.
The second generation core inhibitor on CCC, DNA and compare it to the prior results with DVR Phase II study 202 in a similar population we are going to be doing cross study comparisons of the final parameters, including PD RNA E antigen and correlated antigen and share point, we started in channel discussions about.
Statistically and clinically would be meaningful and give us give us confidence that 2000 non ticket is better than DVR and as mentioned, we hope to have some interim data by the end of this year and that would be the earliest point at which we could be making this is that when we have more information about the flow share it when we can.
So thanks Louise It Raj look well look we can look at 12 weeks, we can look at 24 weeks.
The half life.
Lots been of CCC DNA.
We believe somewhere in that range.
This is more potent against the prevention of the formation of new CCC DNI will be hoping to look for those differences and we Havent study conducted for now.
In the same population as we did with <unk>, so that will be the.
Our price so again, it's going to be driven by the data we have to say the safety.
Patients in that study as it gives us a fairly good feeling we know.
Where we're going and then in terms of the Triple you touched a little bit about in terms of the triple net.
Litigated.
And we said we're going to initiate funds. The two of our first triple combination studies now so it wouldn't be getting data to compare.
Tandem with to compare this experiment with two drugs with $21 58 until.
The following year, so that would be another component here as well so.
We'll see how we can drive it down will say about multiplied stopping rules.
Compares with Debbie Crosbie will take a scientific approach and we'll work it out.
And then we have three demonstrates ray and hopefully we'll be able to accelerate our flow generation compound.
Well, so thats the approach on the cooler and dividends.
I do believe in.
And I think it just gets back to <unk> question as well.
You must inhibitor all evidence of viral replication and shut the spigot off and Thats what were trying to do as well as prevent the formation of UCC DNI.
So thank you Roger.
And our next question comes from Michael Yee from Jefferies. Please go ahead.
Hi, guys. Good afternoon, thanks for the call.
Two questions one it is.
In relation to the.
Congress impressive treatment strategy I'm not sure if I caught it but from what.
There any incremental information from FDA or even China, China FDA.
That kind of this is going to take too long or maybe it was just a market opportunity maybe just shed some more light on what happened there and what.
Jean says and then the second question is in regards to combination studies.
Your comments, how long the RNA I combo would be.
<unk>.
What kind of information you get out of that that would be good data.
And.
What other types of comverse could be possible PD, one PDL, one et cetera, CLR, maybe just pieces of it. Thank you.
Thanks, Mike.
Congratulations on the birth of your son.
I will ask Luis to talk first about the combination is what we're doing with DSI Rnas.
<unk> duration.
In terms of other triples, let me just say that checkpoint inhibitors would be one.
There are some other possible growth possibilities out there that we're considering and discussing as well we could also look at the quarter as well.
In future studies in other studies weighted Ed.
<unk> mechanism of action, but generation of <unk>.
The average is collaborations the laser.
Yes, so as John mentioned, we're going to be again looking at the triple combination compared to the two double combination and we are targeting initially evaluation of safety and efficacy and neurologic <unk> suppressed patients.
As I've mentioned, we're going to be starting the study in the first half of the share and we'll share more details about the dosing and the duration at that time.
Thanks, Louise Mike the first question a bit a bit delving into the chronic suppressive therapy why the.
What was the change in the strategy what transpired look the interactions with the Chinese regulatory body was.
Go ahead.
Populations.
Safety database et cetera. So.
That was that was tied down the FTAA doesn't see it the same way.
Sales in most of these patients.
Currently serves appropriately and adequately by standard of care, new therapy with a very very small niche population that are only constantly viral relatively suppressed.
So therefore, we're a global trial.
Trial in our global plans Wouldnt advantage logo.
We will try we will plan to total would've been in China.
<unk> territory plan. So we have these extensive discussions with Beijing and we came to the conclusions from that night you today that we're not going to move forward with chronic suppressive therapy.
Stephen one that space alone in China, and we should put those valuable results.
Into trying to cure patients, which is going to be more of a balanced approach and it's going to take longer we understand that.
It did become a discussion about well it's a much smaller population, it's a niche population, it's going to take longer.
Is that really what we should be doing so I think to summarize.
We listen to over a period of many many many months we listened to many constituencies and I think we made the right decision.
And we're doing what we should be doing what's best for the patients and certainly best Trust US company as shareholders that our collaborators that we focus on pure which is actually as I said why I came to the company anyway. So that's what transpired, Mike without getting into all the details.
I hope that makes sense that makes sense, thanks, John and my son from your exposure data.
Okay.
Good.
And our next question comes from Geoffrey Porges from SBB Leerink.
Thank you very much John.
I have a fairly fundamental question, which is.
Why did the book to Bill.
Have you.
<unk> achieved from.
Long undetectable virus.
The virus came back so what youll profiling explanation for why sales.
That youre trying to stick with more potency.
Gross.
Going down.
The side of a mountain foster.
Doesn't necessarily make a big difference.
So.
I mean, you can only get to wanted to taxable accounts you saw im trying to understand.
Failure mechanism a more potent core inhibitor is doing great.
Yes.
That's true of prevailing assumption, then why spend any more money onto the COVID-19.
Thank you, Jeff I think you've asked me this one before.
So I'll start again, and then I'll hand, it over to Bill.
The virologist as well.
And then I'll circle back on the wide spend more money on debit coal per year.
Uh huh.
So.
So.
<unk> had the discussion before.
And it's not just about inhibiting.
What we can detect it to that inhibiting <unk> CCC DNA formation, Bill, perhaps you could add on a little bit more would you mind.
Be happy to John.
Thanks, Jeff So.
So this comes back to and I think also touches on some of the earlier questions the differences in our compounds.
<unk>.
No.
Well, they're all potent anti virals and can interfere with the formation and the release of new virus. They don't all have similar activity against <unk>.
Formation of new CCC DNA.
Looking at the potency of Evercore veer from that second activity in plasma concentrations. It achieves in the protein binding for that compound it isn't where it needs to be to really address that mechanism.
And that's why having a compound with 10 more central more potent 21 58, we believe we'll be able to address that mechanism.
<unk>.
I think thats.
I believe we haven't hit the threshold, we need to hit in the clinic with several core beer. So that's part of our strategy is answering that question in the clinic and then.
I think the second part is as John talked about.
Secondly out of three is looking at combinations, which we've also discussed the.
The value of our core beer in pushing down anti viral replication further.
During the combinations so thats.
Thank you Bill so again, it's about the second mechanism not just the antiviral potency I think builds articulated that better than I can articulate it as it usually does in terms of formation of CCC DNA and then you know.
We're looking at other mechanisms as well which started out.
And we've talked about initiating our first two triples.
And as I've said to you today are quite eager to do more of that.
What sort of.
Positive towards that today, as well and it's not even involved an additional mechanism I've said stay tuned until <unk>.
Net today the second part of your question Jeff is.
Why spend more money on February COVID-19.
If I have a compound thats as size with some enhanced potency. According to our sales being able to xiaomi and the lead in the clinic, we can switch per vehicles via App and that is what I'm trying to say and directly today and we will do that by looking at a subsequent core inhibitors.
When we have enough safety data and we can assume that more potent against this mechanism. The CCC DNA formation, and I'd be very happy to do that and accelerate them and to switch them out into double combinations triple combinations.
All of those things that we need to do so that is the plan. So I hope that helps and addresses your question.
In the right direction, but thank you.
Thank you Jeff.
And our next question comes from Salim Sayed from Mizuho. Please go ahead.
Great. Thanks for the question guys.
So John just one from me maybe bill.
When I'm looking at slide 16 in the deck you guys have.
<unk>, one 5 billion.
DD&A Formation chart.
I'm, just curious where the 300 milligram sort of when do you think falls on this curve do you think that is.
You never got force.
<unk> inhibition with PBR right.
Even though even though it sounded like initially.
For some reason, we would we would be able to achieve finite therapy with <unk>. So I'm just curious here with the 300 milligram.
One 5 million.
Do you think youll be able to get CCC complete CCC DNA inhibition.
Does it fall on the bottom part of this curve.
Bill.
The curve here on slide 16, yeah.
Yeah. Thanks Sterling.
So so.
This will certainly give us.
If youre looking at slide 16, this gives us a twentyfold multiple above what we could achieve with <unk>, which we certainly believe it's worth exploring in.
This will this should be enough potency to start to inhibit that reservoir whether.
The kinetics of it we'll have to determine that in the clinic, but certainly believe that this is over and order of magnitude.
In terms of additional potency compared to <unk> and how that will play out over time.
We believe this is something that needs to be tested and we'll answer that question.
Also.
Why with our.
Third compounded in the fourth compound, while we're targeting an even greater level of potency. So that we can.
Inhibits maximize that inhibition on that second mechanism of action.
Okay.
Okay. Thanks, so much.
That helps Glenn.
Yeah, I think I think that helps thank you.
Our next question comes from Nicole <unk> from <unk>. Please go ahead.
Hi, Good evening, guys and thanks for taking my question.
So as you were seeing earlier, you're only non finite curative therapy.
What day to help you with this decision and with each one as well.
11 Q zone.
And can you elaborate a little bit more on the modified stopping criteria. After the results from 211.
Thanks, Nicole it's John I'll start.
We haven't talked about the modified stopping criteria, we have a scientific presentation coming up at amazing that we'll look at some of the analysis of that data, but for right now we haven't publicly talked about modified stuffing criteria.
Okay for now.
Study 211 did not play a part in the decision to not take food a chronic suppressive therapy, we had data and have an in house.
Now in hand from study 211 based upon DNA and RNA, but allowed us to have an approvable endpoint for a better chronic suppressive therapy. So it wasn't a failure.
Our first experimental our first trial to be able to cure any party.
Lead to an SVR upon cessation of therapy.
As I said and as I responded to others today.
We spend a lot of time as you always do when you.
You're gathering information from regulators you are gathering information from Kols, you're doing all of that work to try and determine what you should do as well as planning your clinical trial.
And we had a divergence of opinions between what we could do in China, and what we could do.
<unk>.
With the FDA that meant that we would have ended up with a regional China around lead flow suppressive is low.
Chronic suppressive therapy trial, which is not really what we had envisioned we would be doing.
And we had extensive discussions with with our partner Peking about what to do in China as well. So it was those.
Discussions, but it wasn't a failure to obtain an STR of a significant percentage.
In study 211, the change that decision, making process. So again I will just say.
Ah.
Yes.
The chronic suppressive therapy was al in parallel strategy, where we were trying to do the other things that have changed.
Because we come to a global trial and we don't want to do a regional trial with had extensive discussions it's a very small population and we think we should we are best off in our company has been small.
Patients the best off we put those resources.
Into.
Curative therapies net will also extend our runway. So that's what we've decided to do and I think that's the best thing. It's the smartest decision. This sign you gather data you go down one path you change your mind, that's what's happened here.
It's a smart decision, it's not necessarily anything other than that and that's what I would say to each day, Nicole I hope that answered both of your questions.
Yeah. That's helpful. Thank you so much.
We have no further questions at this time I will now turn the call back to Dr. John Mccutcheon from for closing remarks.
Yes.
Well, thank you Jenny.
We are excited about our singular focus on finite therapy and curative therapies moving forward. This is a longer term effort and progress will come incrementally over time as I've said today and in the past also but I believe it's the right thing to do scientifically and from the patients and we believe it has the potential.
To create the greatest value for all the constituents moving forward.
We are fortunate to have the program.
The name the resources and the collaborator is necessary to try and accomplish these goals. So with that we look forward to providing you updates in the future.
Clinical development and our research programs.
They mature so thank you all for joining US again today and this concludes our call.
Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.
Okay.
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