Q1 2020 Earnings Call
Welcome to send logics first quarter 2020 conference call and webcast.
This time, all participants are when they listen only mode there'll be a question and answer session. At the end of this call. Please be advised that this call is being recorded.
Like it turned up all over to Dr. Elizabeth fulfil head of Investor Relations and corporate Communications. Please proceed.
Thank you Carlos.
Good morning, and thanks for joining us on todays conference call. You did this morning, we issued a press release, which outlines our first quarter trends Twentytwenty financial results and several other topics we plan to discuss today.
Releases are available on the Investor section of our website www Dot and logics T X dot com.
Joining me on this call will accept boom and interest in logic senior management.
Including E for Brendan President and Chief Executive Officer, Greg below interim Chief Financial Officer, and Richard Me Chief Medical Officer.
After he says introductory remarks, Greco briefly summarize all financial results for the quarter, an equal outline our progress for the quarter, nor expect to that's too much into the rest speaking.
Following our prepared remarks, well open up the cool question.
As we begin I'd like to remind everyone. The comments today may include forward looking statements made under the private Securities Litigation Reform Act at 1995.
Forward looking statements include without limitation statements other than statements of historical facts regarding the potential looks in logic platform to develop several peach extreme dressed a wide range diseases, including counseling metabolic disease, and inflammatory and immune disorders the future development.
Synthetic biologic medicines and the approach in watching is taking to discover and develop novel therapies using all synthetic biology technology.
And the expected timing of synergies to the controls and if anything she can control Dayton.
Actual results could differ materially from those contained in any forward looking statements as a result of various factors, including those described under the heading forward looking statements. Subsequent earnings press release trouble here today, who are under the heading risk factors into logics. Most recent form 10-Q choosing systems today.
Logic function seem not to place undue reliance on any forward looking statement now I'd like to to the cooling for two weeks.
Thank you Dave Good morning, everyone and thank you for joining us on a quarterly update calls to discuss our financial results for the first quarter of Twentytwenty and provide an update on our programs and upcoming milestones.
We hope you in your families are healthy and coping with the unprecedented circumstances, we find ourselves and as we navigate a new ways of working in the face of the Coke 19 pandemic.
I think that it's fair to say that the recent weeks have challenged us all.
I can logic, we're working to continue to keep both employees and patients who are participating our clinical trials.
Well, we operate against our strategy and advance our programs.
These difficult circumstances have challenged the usual formats site visits outboards clinical trials and investor meetings.
If I think new ways to successfully conduct many of these activities virtually including our upcoming R&D event on May 27.
Which I would tell you more about nature in the call.
Under the heading but you don't know has strong you are until your Tech kids I believe as a company. We have responded by becoming more innovative and resilient.
Despite the restrict the destruction of co hedged we've made good progress in Twentytwenty as we continue to develop our synthetic biology platform and pipeline.
Innovation, it's part of our culture.
We're developing a novelists passive medicines based on engineered my Coke synthetic biologic medicines.
It has the potential to address unmet medical need in a variety of therapeutic areas.
In deciding our synthetic biologic medicines bes synthetic biology to engineer different elements into bacteria.
Even two factories that can provide therapeutic benefits as well as Alan said as Hans the safety of the medicine.
The beauty of this platform is that this allows us to use other use somewhat the same synthetic biology parts in different medicines.
Every drain me bills, we gain information that understanding of the utility of beach, we use the ball park and the potential of the platform.
Experience, we're gaining with these components different synthetic biologic medicines is enabling us to advance subsequent programs more efficiently.
As an illustration all the price competitive biotic medicines, thus far are based on the single strained our chassis and non pathogenic strains eco like called Eco like Nashville, which has a long history assays used as a profile sake.
Using the same chassis drain repeatedly means that we've become experts in its engineering and manufacturing.
Weird theaters and developing this new casket medicine and are building the capabilities and skills required to across all stages of development of these novel drugs.
In early March nature Communications published a perspective altered by several of our scientists.
That provides a great introduction to the design and development engineers microbes therapeutics.
You can access a copy of the published articles on the presentations and publications page of the investors and media section of our website.
Our current pipeline, it's focused on a couple of areas that exploited natural properties of bacteria.
E. coli <unk> are about the many types of bacteria are able to death function into human G. I tracked.
Our core focus is on metabolic diseases, including phenol Keaton urea PK, you and enteric Hyperoxaluria encourage metabolite that is present in the got can build up to toxic levels in the blood and other tissues.
We can engineer bacteria to enable them to consume the metabolite and they've got to put the potential to lower systemic levels.
These disorders have relatively simple them well understood biology.
And effect relatively small numbers of patients.
In addition, dietary intervention and be disorders provides support for a G.I. based approach.
In addition to our rare metabolic programs and important part of our strategy to explore the breadth of our platform and evaluate the potential of Kentucky biotic medicines in modulating the immune system.
We are currently focused on leveraging the ability of bacteria to interact with the immune system in two areas.
Oncology and inflammatory bowel disease.
We see these broader indication areas that could be developed with a partner collaborator.
We have an ongoing collaboration with Abbvie could develop synthetic biologic medicines for the potential treatment IBP.
These synthetic biologic medicines are engineered to produce affected that down regulate the disease associated immune response.
Bacteria can also stimulate the immune system in certain settings and were exploiting b properties in our immuno oncology program, which Cindy 18 91.
Shouldn't be 80, 91 isn't pettitte biotic medicine, we've engineered to express and Immunostimulatory effector causes Sting agonist that augment that natural properties of the bacteria.
I wouldn't be 18, 91 is administered directly into solid tumors to stimulate the immune system to fight and potentially cleared the cancer.
In addition, we believed that the Immunostimulatory properties of our engineered bacteria could also be used as a vaccine and have an early initiatives to evaluate this approach as a potential covert vaccine working with our collaborators at gingko.
Work with Gingko has moved into high gear with the initiation of step up other projects for strain improvement and optimization.
We will share more details of these promising uses of syntactic biotic <unk> R&D event on May 27.
Before I tell you more about what we planned for the event, let me hand over to Greg to covered the financials for the crusher Greg.
Thank you Lisa and good morning, everyone.
Earlier today, we filed a form 10-Q that describes our financial results for the first quarter 20 point and we issued a press release. It also summarizes that data.
I'm pleased to review now the highlights of those results with you.
Research and development expenses were 12.7 million for the three months ended March 31, 2020, compared to 10.4 million for the corresponding period in 2019.
This increase was primarily due to the use of synthetic biology services provided under some logic collaboration with Gingko and increased clinical study activities associated with her soon be 16, 18, bridging study and our Cindy 18, 91 phase one clinical study.
General and administrative expenses were $3.8 million in the first quarter 2020, compared to 3.7 million to this dollars for the same period in 2019.
For the first quarter of 2020, the company reported a consolidated net loss of $15.8 million or 46 cents per share compared to a net loss of $12.9 million or 51 cents per share for the corresponding period in 2019.
Revenues in the first quarter 20, $24.1 million as compared to <unk> point $3 million for the same period and 29 team.
Revenues associated with the services performed under some logic collaboration agreement with Abbvie to develop a synthetic biotic medicine for the treatment of IP.
Now turning to the balance sheets in logic ended the first quarter 2020 with $114.2 million in cash cash equivalents and other investments.
As we outlined in a press release at the end of March as a result of the code and data we have experienced some delays in recruitment of subjects into our Cindy 18, 91 clinical trial as well as a potential delay in the initiation of our phase two clinical trial of Cindy 16, 18 in PK you patients.
These delays are expected to push out some of our projected expenses.
We're currently evaluating the effect of these delays as part of our customary long range planning process.
Reiterate that under our current operating plan, we expect that our cash will take us into 2022 and enable us to advance our clinical programs two important data readouts over the next 12 to 24 months.
Now before I hand, the call back to YFA I want to introducing new member of the finance team, Dan Roseanne Who's joined Us as our VP of finance.
Dan brings broad expertise and strategy long range planning valuation corporate development.
Capital allocation and portfolio management.
He previously spent six years at five and roles of increasing responsibility in the finance and research and development departments.
Yeah, Dan joined Simadi, just before the stay at home order went into place here in Massachusetts and in the midst of a busy reporting season. He had a mere 48 hours in the office to meet the team. So it's been a baptism by fire, but he's done a great job so far.
Thank you for your attention and we look forward to keeping you updated on future calls I'll now turn the call back to evolve.
Thanks, Greg.
Greg mentioned at the time based home orders were puts and takes our immuno oncology phase one clinical trial of skin be 18, 91 with ongoing and we were screening and dosing patients who would advance tumors are lymphoma in.
Subsequent weeks patients who are already part of the tried continued to receive treatment on many of the sites have remained open enrollment has slowed that's probably have day supply. We will have data from the monotherapy arm with the study and Twentytwenty. It may not be as complete a robust as we had anticipated.
However, we are evaluating ways to increase the likelihood of patient participation at sites become safer for patients to visits and we will update you as to when we expect to have data to share.
Lets shouldn't be 16 18.
Bring study data in hand, bridging study data in hand, we will also planning to initiate a phase two study of the solid formulation SNB 16, 18 in PK you patients to evaluate potential to lower systemic level at the female I mean.
We've been advancing the paperwork necessary to initiate the trial.
We're also and then think I plan to into the flexibility regarding virtual visits to mitigate the risk of future disruption to clinical trials. Once this initial phase of the I'd break it over.
Moving to more home based trial, it's something we would be considering for all programs and it's enabled by a or platform and our successful formulation I shouldn't be 16 18 at the last like preparation.
We've made good progress on this time I look forward to providing more information as to the design I <unk> upcoming R&D event nature of this month and on future calls.
During the R&D event. In addition, outlining our clinical programs in immuno oncology and PK. You. We will also provide more insight into the engine. We developed the concept of we use the both parts that in April I think pet classic platform.
The temptation capabilities allow us to move more efficient need to develop additional programs, particularly in our metabolic disease pipeline to develop strain capable of consuming toxic metabolites in the G. I track.
Along those lines, we were presented preclinical data from our entire make Hyperoxaluria program.
We will be joining fight expert in this field Dr., David Goldfarb, who is professor of medicine and see the all that you technical chief of the deficient of Nephrology and why you school of medicine, as well as chief of Nephrology I could be a medical center.
Dr. Goldfarb presented over a few I can tell the types of urea and as someone who I've personally experience a kidney stones. He would also be able to provide a patient perspective.
We will host a virtual R&D event from 12 30 to 330 P. M E T on Wednesday May 27.
It will find more details the access to a registration page on the event calendar and the Investor and media section of our website.
We hope that you can join us.
The last several weeks has been a test took a nation and the new way of operating for all of us.
So all of this means endeavor to keep our employees safe.
Money could work from home, which as world finding is a challenge, but doable and this age of video conferencing.
However, as we have ongoing the bar to work Weve also needed to defy working schedule. So that these activities could carry on while ensuring social distancing.
I want to commend all my colleagues for their resilient and extraordinary dedication. During this time to keep our operations running smoothly. So that we can continue to execute on our strategy and our mission of developing syntactic biotic medicines to eight patients with unmet medical need.
Summing up we have a tear mission to develop synthetic biologic medicines to address unmet medical need for patients.
Our strategy to use that platform engine that we have built to develop an internal pipeline as metabolic programs in which our engineered bacteria are designed to consume metabolic at toxins from the G. I tracked.
And broader immunology indications that we expect to developed through collaborations and partnerships.
Importantly, we are well positioned to meet this challenge with a strong cash position that will carry us through key milestones for our platform.
I'd like to thank you all for joining US. This morning, we will now open the call for questions.
Thank you at this time I would like to inform everyone in order to ask your question you could simply press star one your telephone keypad begin at Starwood on your telephone keypad to Q4 a question.
Our first question is from Mark Brides, Mark Breidenbach of open Heimer go ahead. Your question. Please.
Hey, good morning, and thanks for taking your question you thought I was just wondering if you can give us the sent her where we are in the 80 91 dose escalation process.
And how many cohorts you would want to complete before feeling comfortable with presenting interim data from the trial.
Sure and so we we announced with our press release and around the beginning of the co but that we were dosing patients in the second cohort 10th of that dose escalation. The aim of that trial is to see target engagement at it relatively well tolerated dose its difficult right that project how much.
He cohorts that's going to be I'm, you know certainly we'd like to continue to escalate and so far the safety and Tolerability profile appears to be amenable to continue to escalate.
But as with every phase one study ever kind of feeling our way along with regard to kind of safety and Tolerability early on so it's really very difficult market to say you know why there will be keeping maximum tolerated dose at the fourth or fifth for the six cohort and right now just given where we are.
So I think it it's going to be when if these issues of kind of feeling our way through the dose escalation and looking at the Biomarkers as we go along and certainly if we feel that there's something meaningful to to discuss go do just that.
Okay that makes sense and a quick follow up I'm, just wondering if it would make sense to activate any neutral sites in the 16 18 study to you know maybe focusing geographies, but a relatively less affected by cobot.
Any any plans to expand the number of prostate cancer.
Yeah, it's difficult, where obviously watching very closely on the biggest lever for us in the PK you program is going to be bring to try to the patients homes. So that you're not going patients into a medical center, a technical cost center and we recently received some feedback from the patient advocacy organization.
Iran. You patients a PK you and their appetite for coming into a center a person is happening maybe study nurses visit them at home and I think the response to that she got survey being overwhelming but you know patients are very amenable to having to study come to them in their homes with maybe a single nurse visit Chinatown.
Kelly and Tele health visit from the at investigator to take any of the medical information on my personal belief is I think that's the way at tries are going anyway. So if we can get ahead of the curve and invest in some of those capabilities now I think donda in good stead for the long term.
We have Lux geographically and it's as you know a moving target you know early on it seems like or maybe you know going to regions that appear to have good control you know what and had seen in a very low numbers. So.
Cases might be a good way, but even there some of those region, but the world's have seen an uptick in cases that they started to loosen up an open up their economy. So it's difficult to predict where in the worlds and if you know a take can take about six months to open up that trial sites and some of these new beach and so it's almost like looking through your.
Your Crystal ball.
Six months into feature.
But I think you know diversification is definitely the name of the game flexibility and be agitated definitely the named the game and I think they said earlier, you know, allowing more things to occur virtually I think it's the way that kinda could try they're going to get done and over the next year or so so we've been moving in that direction.
Okay perfect. Thanks for taking the questions.
My pleasure.
Thank you. Our next question is from regardless overarching H.C. Wainwright go ahead. Your question. Please.
Hi, This is Blair Cowen on for Rob just a couple of questions for you.
How is the enrollment grew 80 91 can you give us a little bit more detailed there and when might that second arm of the trial began in two there's still happen where the ended the year.
So in terms of enrollment <unk>, we've seen in patients who are already on the study are able to come in and get dosing, but most of the academic medical centers, where we're conducting that study in the U.S. have slowed down to new patients and coming into two studies that are ongoing. So we have you seen a slowdown.
In enrollment there and having said that we think that over the summer last those studies and Centrus will open back up particularly for oncology trials, because I think theres a realization that.
These patients are going to continue towards on.
And that off and your participation and try this is really go any hope. So I think all of the studies. That's are impacted by cohort I think the oncology studies will potentially be the for kind of sad to get going again as soon as as it becomes states have patients in the units and.
In terms of the answer to your second question Blair Reaming depends on our studies assigned had been button you would achieve maximum tolerated dose in the monotherapy arm before opening up the combo therapy parts of the trials, which is the second part of the study and so it really depends on how many cohorts we need to dose to achieve the Max.
One tolerated dose and that's when it's business as I mentioned earlier in answering marks question. We're still very early in the study to be able to predict whether we will achieve maximum tolerated dose after the fourth cohort or the six cohorts.
So it's just because it's a moving target we're absolutely pushing head on all cylinders and are actively looking at ways that we can accelerate enrollment in the second half the year by opening up additional sites.
So you know will continue to keep you know the investment community updated as we go through the study into and learn more about kind of the safety and activity profile of the age and at the right now it's very difficult to predict.
Okay, perfect and last question for me.
50, after and it's a competitive threat PK you.
I'm not too many of whats the product that you're I'm speaking about.
The molecule molecule I maybe pronounced.
To be after him.
It's that's the M. product that's the analog of a coupon.
Yes, yes, okay, and so the issue with coupon is an analog of BH for could you. The co factor for the PHN time, that's the endogenous way that those of US who don't have PK you metabolites seen allow me to top tyrosine.
A small subset of patients with PK you respond.
Whether it cools on or a coupon like agents and the subsets of patients who actually respond to coupon is about 20% to 30%. So we see that you know certain patients are responding to coupon and doing well, they're not going to be a candidate for our product.
Theres still a large proportion of patients with PK, you, who either don't respond to coupon are cool like product or who have the suboptimally response, meaning they see some decrease and their blood fee levels, but they don't actually achieve the ads therapeutic targets.
So we were aware, it's a coupon been approved for for sometime now so.
Good kind of because a good idea up you know how many patients are candidates for that product and we don't see assets as a threat necessarily and we actually see that there could be some complementarity at some point down the road, if we can achieve blood feed lowering.
Perfect. Thank you very much.
Welcome.
Our next question is from Ted Ted off of Piper Sandler.
Hi, This open.
Good morning Happy Friday.
Ted how are you.
Good I'm glad to hear a room goodwill and that will come quicker or do they feel your kroger, but maybe the criminal Oscar quicker will better or worse prior rubble.
Wondering sort of where you are in terms of.
For the platform in general.
Excluding Europe potency or.
Primary.
Mechanism.
Also encouraged her work in Europe.
It is true secondary recovery.
Well you the charts Im willing just holistic at a high level, where this clinicals it'll start to show meaningful differentiation versus other modalities. Thanks, so much.
Great. Thanks, Thanks, Ted that's a great question I'm going to answers in two parts, which is kind of consistent with how we think about our strategy number one is the internal pipeline in Graham metabolic programs and then the kind of more medium to long term into kind of immuno oncology space and so in terms of her metabolic programs we believe.
With that success, there may be required us to.
Choose targets that are within what we know we can achieve based on our PK you learnings. So if you will choose targets, where he meant metabolite that needs to be consumed it's within range of what we know we can achieve based on our initial learnings in PK you.
It was what led us to the entire Ecotrac. So urea program, we believe that based on the imagine metabolite that needs to be consumers have a technical benefit there that that's kind of within range of what we can do today and I think Denver second component for success is to continue to increase the ceiling of metabolic activity. So that we can continue to improve.
<unk> and see in says we can reach for higher and higher metabolic load.
And there we've learned a tremendous amount in the last year and through partnerships with gingko and other technology groups, we're really starting to understand how you can optimize these bacterial strain to do specific things I think thats its impact across.
Many different biomedical applications for us we're using its too and you know increase the amount of metabolite that bacteria can consume a unique notions gingko working with others like the during a to help and optimization of some of the manufacturing steps for their vaccine program. So I think this idea of using some pattern.
Biology to continue to optimize activity be at keno production of of a something thats required.
Manufacturing or in vivo metabolic activity in Frac platform I think it's certainly an area factors investigation that very exciting space right now and so that's the internal pipeline answer on the external pipeline, we need being you know a lot of these diseases are complex diseases that require more than one.
Sector and I think the idea that you can combine within our platform was certainly one of the attributes that attracted abbvie for instance in the early days and all of the company to think about working with us and there'd been able to combine different factors that may be perform different functions in.
People might be very important and we've seen that was 18 91 for instance, we know based on our preclinical data that we can stimulate multiple pathways, though the company's immune response in parallel and that's very challenging to do with other modalities.
Based on the preclinical data is that we have seen with that molecule. We're able to do that and will you have to walk before you can run and they'll start to gets kinda to explore more if that space.
But you know for now is that kind of more for medium and long range opportunity for us I think but.
We're certainly you know very excited at that capabilities, and we're able to see spaces, where you know our platform could really be disruptive.
And I think that's that's being them temporary energizing thing for us over the past couple of months.
Sure, let Kurt good pro forma you can imagine that tinker coping out of those capabilities.
Great.
Thanks for works are looking Port authority there.
Good day.
Okay.
Thank you. Our next question is from the go much a little bit of city go ahead. Your line is open.
Hi. This is she mentioned on to resolve ensuring that she can your question.
I Wonder if you just tell us a little bit more about what further optimization needs to be done for that and then just maybe broader question General how do you know when you're optimization process is complete imagine you could continue to go through many iterations here just curious on your thought process there.
Yeah. So it's a it's a perennial issue in drug development quite as good good enough to move forward into the clinic and what we've been able to build builds based on R&D program is to be able to set to establish excessive kind of go no go criteria for a clinical candidate. So once we start on the program.
We'll be able to set assessment criteria around how does that program need to look before we move forward into the clinic. So I'll just give you kind of that and interested. If example, if you will and then Terry Hyperoxaluria, we know that we all eats about 150 to 200 milligrams to vaccinate and our diet every day.
We know that if patients with and Terry it's very very difficult to get rid of oxalate from your died because it's been vegetables, and fruits and lots of different things, but if you can you know and in Terry Hyperoxaluria that their urinary oxalate will go down.
So that gives us some you know benchmarks in terms of how potent astray needs to be to move forward into I'd, enabling studies.
So we'll use that you know that understanding of saying, okay. We need to engineer a bacteria that can consume 150 to 200 metal pounds of Oxley I should do based on what we've learned from peak K., you stopped well tolerated and that will be kind of had good manufacturing characteristics and we always want to have the ability to get this into.
No one cap so no one one pill.
So were able to make some calculation based on those learnings and then we're able to calculate back how much oxleas, the hence benign cells meat bips consumed per hour in order to be good enough to move forward and we continued to do our interactive optimization until we hit that target.
And so programs that hit that target get to move forward into the next year you get to take two step forward on your snake from that or game programs that don't reach that target continued to be optimized and programs that moved forward. It defacto, they've they've kind of achieved what we think we need from the potency perspective in the case of and Maple syrup.
If you're in disease, we have made tremendous progress with gingko, but it hasn't achieved the bar that you believe that needed from the potency perspective to meet our minimum product profile based on our calculations. So that when continues and optimization Paul we've made great progress.
You know there's still some things that we think could continue to improve that strain and test that that continues to be a work in progress others, where we've achieved that goal we're moving forward.
Into development. So that's kind of how we we think about our drug development framework and we're learning all the time and we're continuing to tweak those criteria all at the time, but the idea is that you know hopefully if we're doing a good job every program. We take forward has a higher probability of success based on learnings from programs that went.
For <unk>.
Process has been worked out for protein biologics for small molecules, we have to work as course untested biotic medicines and I think has made some good progress there and we'll continue to learn as we go alone.
Let me tell you that was yeah that was very helpful very thorough.
And I guess, just sticking with the and a high proxy Ria program.
Maybe you're going to talk about this I'm sure you're actually at the irony R&D Davis, you could give us a preview how it little bit about the mechanism of action how many synthetics.
Corporated and that's it and do they could do do they produce a biomarker similar to how to like 18 produces repair gases that can be measured or is that not even necessary for this particular disease and you can easily measure lastly level.
Yes, so that the biomarker there would be uribe oxalate lowering.
And certainly prior companies who've been working in this space have demonstrated that it's possible to increase here in the oxalate in healthy volunteers by putting them on a high actually diet and then that could be useful way to demonstrate that proof of mechanism in vivo and you know I can't so too.
Many beans, otherwise people won't come to our own de events, but with certainly show in that the full engineering and all the pre clinical data that we've you know that weve developed today and it and some more the work and and future plans at that event nature. This month.
Great looking forward to thanks very much for taking the question.
My pleasure nothing.
Thank you I would like to remind everyone to ask your question you could superstar wanted your telephone keypad begin that scar wondering or telephone keypad.
The next question is from Joe Schwartz of SBB Levering go ahead. Your question. Please.
Thank you good morning, I Hope you are faring well I.
I was wondering if you could give us some more insight into how you stand in terms of the rate limiting steps to starting the next role for 16 18, and what you see is the biggest challenges.
Environment for the next phase of clinical development.
It seems like we're tentatively entering a period of somewhat more relaxed public behavior.
But obviously you know, there's arby's that need to be.
Pain, perhaps amended.
Things like that so just wondering if you could give us a more and more insight into how you how will you feel like you're positioned with enough size.
Yeah, no given this environment and how intensive this trial needs to be.
Yeah, So again.
Show all the details in terms of the study design that's at the end the month, but.
We've been working in a one of the nice thing he hasn't seemed a lot of very challenging things about the covert pandemic. When if the may be positive things have been better lot of condition metabolic physicians, who are often kinda flying around really busy doing kennewick are now home and we've had a lot of interaction with our Cana wells.
And our potential sites and continue to do there actually more available to us for phone calls and virtual AD boards now.
They were six months ago. So it's really given it's a good opportunity to work with them and team here.
At each site wafted local situation is.
Some sites I or beef continued to be open there.
They're continuing to see protocols to meet virtually to provide feedback.
Their site.
They have prioritized you know emergency.
I NPD and other kind of work based on the kind of unique situations that each site. So similarly to get ahead different states. There are responding here in the U.S. and we see that there's lots of kind of different no cold and variation in terms of how how we size is working and it's like in every study you know you have to kind of spend time.
I understand what the challenges are each site and make sure that when you write a protocol that you can have one single protocols that.
Can be and can be implemented at every site with their kind of unique challenges and capabilities. So that's exactly how we're using this time I actually think in some ways that we've had has a silver lining and silver lining here between kind of Holmes our.
Our relationship with the advocacy organization and decide and also our.
Thinking around tied to execute in operationalize. These kinds of studies now that we're moving into a more as a whole base.
Slides for the PK program and future programs as well so I'm certainly our mantra has been not just to survive what's actually use the challenges away to try and and tries operationally and that's what we plan to do and you know we think that based on our current and kind of evaluation there's no.
We supply all of the visits for this next study couldn't occur virtually inpatient told but that was what we need to do and so we were at pursuing gas is kind of the home based virtual type of obsess up.
I think there's different logistics there you know that you have to worry about in terms of shipping drug to the patient not precise and but that's all doable their vendors that are available to do that so a lot of what we've been doing in the last couple of weeks is being.
Surveying those vendors getting all of the the logistics and pace. So that we have a lot maximum flexibility and I know Richard done on the call and he's been basically doing all of that work with his team and Richard is there anything that you'd like to add in terms of what I've said to for Joe.
You know not.
Covered it.
I mean.
We've taken me opportunity.
It's really reach all to investigators patients.
Home health care providers consumer planning on.
Next up is very clear of if you've got skin shorter to bomb Primark study in patients are interested in the prospective.
So everybody is sort of moving towards total medicine.
No hurry workover virtual or.
Vision.
For both clinical trials.
Hello.
Well critical things can remember children and we continue to push.
We.
Continue to push the paperwork.
Through.
We had a and opportunity either because Youre Association.
Reached out to us where the opportunity to actually.
To a patient survey for because you patients on you'll have a responding to close learners.
Chris.
It's pretty participation we from there.
Overwhelmingly.
Overwhelmingly.
Their patients are still interested you started participation.
86% as opposed to responded.
Would consider participation.
So when we virtual trials.
Or tool or consistent with what we said before and we have been reaching out to home health care providers.
I have the opportunity to be really flexible and starting to either.
Two.
Recall school come in the clinic story or to a review of home.
Including the tracer.
Slide either.
Common we do.
So.
I think we're going to repaired.
Moved as an extra.
Good day.
That's really helpful incrementally added information.
Thank you over the next question is from Julian Harrison of BTI EG.
Go ahead your question please.
Hi, Good morning. Thank you for taking my questions for unless you de and Turk hyper Oxtellar urea just wondering if you plan to start clinical development with the liquid formulation like you did for 16 18 or is the solid form from the beginning in the realm of possibilities here.
And on its her hyperoxaluria, specifically kidney function seems like a very important aspect that the natural history. Here. So just curious how you plan to consider the spectral CKD and future development. Thanks.
Yeah. So great question, Julien and certainly our preference would be to move forward with the lie Olsen from the get go and that's certainly what we're planning to do and to do right now.
So you know unless there's some reason not to do that and that's how we plan to proceed the nice thing about having our own manufacturing infrastructure means that we're kind of were not relying on supply chain or vendors that may be in parts of the world that or you know more or less affected by by co head. So.
As of now I don't see any reason why we wouldn't move forward with that with with Elias straight from the gecko.
Sometimes you know thing you know there's challenges things happen for you feel like Okay, maybe we should learn something with liquids rather than a way set for life show, but as of today, our plans or that we would start clinical development straight away with the lyall product based on what we've learned from some PK you in just implemented.
In terms the kidney function I might have vessel for to Richard He has a lot of experience and oxalate disorders from time to other line them and I think puppy best condition to answer that particular question.
Yeah, I think for initial studies will.
Yes.
For each one.
It also for Intercard brought to you.
Yes.
Proof of concept abrasions.
Without severe kidney disease.
No.
Urinary oxalate excretion models because.
Answer your question.
It does thank you very much.
Again, if you would like to ask a question you could seem people thus far warming. Your telephone keypad next one is from Chris Howerton of Jefferies. Go ahead. Your question. Please.
Great. Thank you good morning, everyone.
So for the I guess or two questions for the.
More virtual or home oriented clinical trials.
I guess from a high level I'm interested to understand what kind of capital expenditures youre deploying to kind of.
Creases capabilities and then I'd also be interested in hearing about what the implications are for the number of clinical trial sites that might be required for any individual trial.
And then just a final question would be.
You know have you considered moving away from you call I'd, just because there seems to be some tolerability issues with.
Probably the fact that Theres Lps in the patients.
So thank you.
Yeah.
So I take a stab at at both parts of your question, Chris and so the first one in terms of the capability to do virtual clinical trials have been around profile. Each component that's required to do a successful virtual trial that kind of being established and some of the challenging components are just setting us up I'm guessing it's going you know it.
We had life's kind of thing.
In terms of had that impacts the number of site generally what happens if business kind of central site. That's provides oversight of a number of kind of virtual.
Virtual groups and and Richard mentioned for our initial PK study, we're going to have a hybrid so that will be the protocol will be written flexibly such that patients can come to that have a traditional center. They can do some site visits as home or the entire study can be conducted virtually there were still that's kind of the.
Early days of working at what the implications of that are on the number of centers that we would have in the U.S. and we'll certainly learn as as we go here in garnered from others, who have kind of gone down this path.
As I kind of thinking and burn about what the feature of medicine is like I think doing more remotely if that's the way of future. So whatever time and effort. We invest now I think will pay off in terms of the capital expenditure.
You know some some cost increase obviously, but other cost decrease when you're doing these kinds of studies and certainly and you know our initial assessment is that the distribution of cost will change as we look at the study plan, but the overall ballpark of how much it will cost us to execute study will stay relatively flat.
And compare to attack traditional set up and so so that that one into the chassis or units at the chassis organisms that were engineering in and you know lessons with no perfect chassis rights.
There are certainly advantages of using eco line so.
And then there's the potential factset other chassis organisms may have and the lower Lps, then maybe have better tolerability and certainly for now we're committed to equal I know, we think that there may be tradeoff, where you know you moved to a different chassis, but you actually have to dose much higher because it's more vulnerable Ted.
I guess event signs and and no P H compared to equalize initial so I think there's there's constant me going to be at pros and cons and no matter what chassis organism you choose to base your engineering on until we know equalizes. So now we know and love it for all the false and we think that.
We have and a lot of experience engineering, yet we've established ways that we can manufacture and certainly if we go forward, we're constantly evaluating bringing a second chassis and onboard as I talk about the shelf lives we use a ballpark.
And once we get to a point, where we think that we know what we've gotten around surround engineering and manufacturing you call and if so we may add another chassis organism to that shelf of reusable part, but our assessment now is that that will be based on capabilities, maybe you know.
Happy that are better secretion chassis that are better colonization as opposed to something based on on top of the lessee. So and that's kind of how we think long term, but in the short term work were pretty committed to missile.
Okay, Great and maybe just another question if you don't mind with respect to the interior Hyperoxaluria program. So for the I just wanted to clarify first of all are you planning and going after patients with chronic kidney disease and what's your view on what the approvable endpoint.
In the city.
Yeah, and so as Richard mentioned earlier initially will be taking patients with good renal function. The reason for that if we kind of know will ask that you would react place as a biomarker and that's challenging to interpret into context patients who have very low kidney function and chronic kidney disease. So our initial population it is going to be base.
And those with with decent renal function, we actually do see a huge potential application and in patients with chronic kidney disease, there actually often patients who have yet to STEMI Castillo says because they entered this kind of vicious cycle, where they're not able to create escalate into your and so they get start to get to build up of obsolete in there.
Car in other tissues.
And can enter into a phase or kind of multi multi system oxen doses. So we actually see that this big unmet need in that population and but certainly that would kind of be a secondary population for us. After we demonstrated proof of concept in patients with sufficient renal function and as you know there's there's work to be done there.
In terms of what the approvable endpoint might be and you can think about you know echo around cardiac function you could think about past Oxley. There are number of different potential endpoint, but we're pretty early in terms of I think king and certainly has had no regulatory interactions around what the path forward would be and.
In that kind of.
Second Terry you know kind of second population and our second indication, but we do see based on the biology, we can see it has as a big potential you know he if you're not making your and your only weight excrete escalators in your face you tried so that's kind of our zone right. That's our neighborhood. So it'll be just on first principles, we see that.
Good luck opportunity.
That makes them, okay very good yes, definitely does okay, well. Thanks, so much for taking the questions and look forward to the event and I guess just a few weeks.
Great. Thanks, Chris Quilty thing.
Okay that concludes the kidney session I would now like to turn the call back to evolve Brennan.
Great well at thank you so much everyone for joining us today and we look for seeing many of you at the end just a month and that our R&D event and will be available later today, if there any follow up questions. Thank you operator.
This concludes today's webcast. Thank you all for sending you may now disconnect.
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