Q2 2020 Synlogic Inc Earnings Call
Good morning, welcome to send logic second quarter 2020 conference call. At this time I'll bet you shut ins I know listen only mode it'll be question and answer session at the.
End of this call.
She advised that this call is being recorded.
I'd now like to tend to call over to Daniel Roseanne head of corporate Finance and Investor Relations. Please proceed.
Thank you operator, good morning, Thanks for joining us on today's conference call. This morning, we issued a press release, which outlines our second quarter 2020 financial results.
Several other topics that we plan to discuss today.
The releases available on the Investor section of our website.
Www dot in logic.
Tom.
Joining me. This morning are you for Brian President and Chief Executive Officer, Greg The law interim Chief Financial Officer, and Richard Reid, Chief Medical Officer.
Also joining us today for questions is told me why our newly appointed Chief operating officer Congratulations.
During the call either will provide a brief outline second quarter highlights and recent progress.
I will summarize our financial results for the quarter and Richard will provide an overview and update on our entire Hyperoxaluria fulghum.
Following our prepared remarks, well open the call for your question.
As we begin I'd like to remind everyone that Thomas today May include forward looking statements made under the private Securities Litigation Reform Act as much of that.
These forward looking statements are made as up to date hereof and are subject to numerous doctors assumptions risks and uncertainties, which change overtime actual results could differ materially from those contain any forward looking statements as result of various factors, including those described under the heading forward looking statement instant budgets press released earlier today.
Or under the heading this crashes instant budgets most recent form 10-K or in later filings with the FCC.
Logic cautions you not to place undue reliance on any problem.
And now I'd like to turn call over.
Thanks, Dan Good morning, everyone and thank you for joining us on our call to discuss our second quarter Twentytwenty financial results.
We can properly and upcoming milestones.
I think we should be recalled during our R&D day it depends for years since I first heard rights in logic and the concept of using synthetic biology to engineer bacterial cells to create a new task of therapeutic.
The idea that we could treat disease. It in a fundamentally new way captured my attention. Both in terms just a challenge of working at Hal.
More importantly, the potential I thought to offer hope to patient devastating diseases.
I'm pleased to report that the underlying concept of our company Excites me just as much today I think did on my first state can magic.
We have made great progress in bringing the promise of synthetic biology to try to 2000 and are building premier content biology platform engineer bacteria can catch a classic medicines that benefit patients in new ways.
Hi momentum is accelerating and I know, we have the team technology and portfolio to succeed.
Okay, coupled with a strong cash position ensures that we have to resources to capitalize on our strong foundation and drive our cap on development and clinical stage assets forward in the near term.
One key element kept the differentiating capabilities being built into logic is our internal and and manufacturing capability, which can take syndicated biotic medicine from the lab, the bad site at pace and with high quality.
Over the past two years, Tony a lot has led the way in helping us build capital efficient Bastian chats and resilient manufacturing operations group.
It gives me great pleasure to congratulate Tony today on his promotion to Chief operating officer.
This expanded through both recognition, okay impact on the logic and the confidence in our manufacturing capabilities necessary to achieve success.
Tony would you like to see if you worried.
Thanks, Lisa let me just say briefly how grateful and to a team at some logic for the trust. The partnership we have built over the past few years.
For our manufacturing a laboratory teams covert has been a real mental and physical test.
So impressed took away the team has risen to the challenge and continues to execute at high level. So we can deliver for patients while maintaining a high standards of safety and quality.
I'm looking forward to seeing our portfolio advance and continuing to lead such a great organization.
Thanks, Tony.
Now, let me turn now to an update on our business in portfolio progress over the past for sure.
We are rapidly progressing our internal metabolic disease pipeline, which leverages the ability of our platform to safely deliver its intended biotic medicine into the human G. I track to consume toxic substances.
The metabolic pipeline is entering it can actually exciting time with the phase two study, which we called Symphony expected to begin in day Twentytwenty in PK you.
Our new with metabolic program shouldn't be 82, two and inherit hyperoxaluria expected to enter the clinic early next year.
Richard will provide more detail in his remarks, but we're encouraged with the preclinical activity of CNB T. Two two and the candidates currently I in D., enabling studies.
We are enthusiastic about attention at this program to help patients with dangerously high urinary oxalate levels.
[laughter] oxalate is present in many healthy food incoming hyperoxaluria, it's almost impossible to control with ice alone.
This means these patients at risk for serious kidney complications natural casino says Jones and chronic kidney disease.
There are currently no available treatments and so we are moving on this with a sense of urgency.
Our Immunomodulation portfolio also continues to advance in both immuno oncology and immunology.
We have recently gained a rights to get that content, but Arctic medicines for all the factors targeting IBT.
Which one and I want to fully leverage our cats I'm trying to fund our G.I. based program portfolio.
More on that work to come at the programs mature.
Let me update you know on our most advanced program can be 60 18 for the treatment you PK you.
PK you has become a hotbed of innovation for drug developers advancing new modalities.
It's a credit to the efforts and bravery of patients investigators and parents in the PK you community.
But I see token patients and caregivers, it's clear to us that both current and emerging treatment options, we'll continue to be too many patients behind.
On a safe tolerable reversible and oral therapy would be welcomed.
Our initial program in PK, you has shown promising activity.
We have demonstrated the ability to consume fee in the G. I track most recently in our solid oral bridging study in healthy volunteers.
The next step is to understand had the consumption to see into G. I tracked in PK, you patients would impact plasma see vessels.
To answer that question, we expect to initiate a phase two symphony study later this year.
The goal is that the phase two study or to demonstrate potential FNB 16, 18 to lower blood fee and agile PK you patients.
Validate our PD model in order to understand the relationship between the production of strain Biomarkers and feed Loring for Syn be 16 18.
To ensure we can effectively cardiac tissue study in the midst of to cope with 19 pandemic, we're using a flexible design in which patients can participate in clinic or in their homes.
I designed directly informed by patients and investigator feedback.
Looking forward to execute executing this study and sharing results in the middle of 2021.
A key advantage at the synthetic biology platform is the ability to rapidly injury and improved the activity of our strain.
To that and we're making investments in our PK you strain to further optimize activity and coking C.
This man hours to target higher Napa fee. During can we have modeled for syn be 16 18.
We continued to be active in the lab with multiple collaborators collaborators imputing gingko on next generation streams, and we'll be updating you as we move forward.
We also continue to build our immunomodulation portfolio, which leverages, our syntactic biotic platform.
Exploit the interaction between bacteria and the immune system in more complex diseases, imputing immunology and oncology.
We're advancing our phase one clinical trial, a soon be 18 ninetyone.
In solid tumors.
Despite the Coke 19 pandemic enrollment in this study continues to track well the monotherapy arm of soon be 18, 91 study is intended to demonstrate feasibility safety and identify a maximum tolerated dose.
Shouldn't be 18, 91 was designed to take advantage of the Immunostimulatory properties of our back to you know chassis and we've also programmed 18 91 to produce Sting agonist cyclical <unk> and T.
By delivering a sting agonist directly into antigen presenting cells and the tumor we hope to avoid the T cell apoptosis, which reduced the efficacy of traditional small molecules targeting sting pathway.
We highlighted initial data at our recent R&D day in May and we continue to see data, which supports that injection a CNB 18, 91, it's feasible under strain generally well tolerated.
To date, there are no dose limiting toxicities are infection seen within be 60, Cindy 18 91 administration.
We will share a fuller read out of the Cindy 18, 91 monotherapy data closer to the end fear.
In summary, we feel that we have great potential to bring in new therapeutic approach to patients have made exciting progress in our pipeline entering a solid position to execute on our upcoming milestones.
As you can see across our programs, we're executing effectively to accelerate the generation of clinical data. This includes significant cashless and PK you inherit hypoxia urea and immuno oncology over the next six to 12 months.
Now, let me turn the call over to Greg to briefly run through the financials and our updated guidance.
Greg Thanks, if any and good afternoon everyone.
This morning, we released our financial results for the second quarter ended June 30, 2020, and I'm pleased to review those highlights with you now.
Research and development expenses were 12.9 million for three months ended June 30, 2020, compared to 9.7 million for the corresponding period in 2019.
This increase was primarily due to the use of synthetic biology services provided under send largest can elaborate collaboration with gingko, an increased clinical study activities associated with our soon be 16, 18, bridging study and our CNB 18, 91 phase one study.
Turning to general and administrative expenses those expenses were 3.5 million in the second quarter of 2020 as compared to 3.7 million for the same period in 2019.
For the second quarter of 2020, the company reported a consolidated net loss, a $15.5 million or 44 cents per share.
Paired to a net loss of 12.3 million or 45 cents per share for the corresponding period in 2019.
Revenues in the first quarter of 2020 were 445000 as compared to 350000 for the same period in 2019.
Revenue is associated with the services performed under some logics collaboration agreement with Abbvie to develop a synthetic biotic medicine for the treatment of IBT.
This agreement has now been terminated and we do not anticipate any further revenue from Abbvie.
Now turning to the balance sheet. Some logic ended the quarter second quarter of 2020 with 109 million in cash cash equivalents and other investments.
Under our current operating plan, we expect that this cash will take us into 2022 and enable us to advance our clinical programs two very important data readouts over the next six to 18 months.
Thank you for your attention and we look forward to keeping you updated on future calls I will now turn the call back to Eva.
Thanks, Greg switching gears I'd like to turn over the called for Chief Medical Officer, Dr., Richard We who will provide an overview of our new it or the metabolic program for inherent hypoxia urea.
Richard.
[noise] salespeople.
Hi, I'm going to provide an overview of our mirror those coral notable core.
Which has the potential to address a serious unmet need for patients suffering from inter hyperoxaluria.
Cindy and NATO too is an orally administered synthetic biology.
Husband designed to consume Oxley geometry.
To reduce carport absorption.
And lower oxalate levels in the here.
Which has a drug and preventative impact on kidney so information.
Hey, Hallmark this disease.
This program Leverages, our platform for Billy go live or an engineered bar bacteria into the human geometry.
Consumer toxic substrate.
In this case Oxley.
Okay, that's problem and many of the healthy foods, we enjoy and are supposed to enjoy.
That's all reducing your oxalate dietary intervention, just if not feasible for most patients.
[noise] oxalate, it'll put byproduct of normal cellular metabolism.
And is absorbed into geometry.
I'm sorry.
He always come out by just oxalate and rely on renal excretion to eliminated from the body.
If artfully present in the kidneys and excess.
No to guards damage in a condition called Hyperoxaluria.
[noise] Hyperoxaluria, often are companies and underlying growth all disease or consultant.
Pick gastric bypass surgery.
Commodore involved disease short bowel syndrome or other causes.
Stubbornly high your oxalate levels and port patients kidney help at risk.
Leading to know for Gulf witnesses, so formation and increasing dramatically the risk of chronic kidney disease.
[noise] Harbor OXXO here, we are presenting to probably reformed primary or hereditary.
And then Turk can acquire for.
[noise] primary Arbor, all told here is a versarpps serious in rare form of the disease footprint, you usually presents to the pediatric population.
It's causing for genetic defect, resulting overproduction of awfully bunker liver.
Investigational treatment targeting the underlying genetic defect have shown encouraging results in this population.
But fluff treatment whatever no impact on Intercard Bronxville Europe.
Which is pathogenic hyper absorption of dietary honestly.
From a geometry.
[noise] real for focus on secondary hyperoxaluria or in Turkey.
And acquired medical condition, which affects over 212 adult in New York alone.
First critical sort of until a couple actually Oreo golf in the development of kidney stones.
Painful and sort of consequence of the disease, which can cause great suffering and require significant ongoing interventional care for patients.
That's risk of can be solved kidney damage increases with growth we all that.
Your honor and levels Helocs what excretion.
And there's currently no approved treatment for to recover all clearer.
And prevention for call. It can you still information in this disease.
[noise] dietary sources of off what are difficult to avoid.
Putting patients with pre existing ball because these risks.
Pork kidney.
[noise] Cindy it'll too.
I'm, sorry, Bob medication engineered to consume our toys electronics.
Isn't the same Chelsea organism PK you strike.
So they don't to engineered to convert artfully performance.
Well florange yards or from approximately and levels of oxalate in Europe.
We believe this is a differentiated profile because I'm like other attempts to reduce urinary oxalate.
I couldn't be it later to act through all did you you're on track.
It is important to note the former isn't up onto an product normal microbiome activity.
And is not quite affordable MRO marker for Arkalyk consumption.
The format is rapidly Mattel watch when the body what's in the body.
Therefore, urinary oxalate will be a pottery barn marker showing africa's evidence of efficacy.
[noise] dividing syndicated are too.
We're taking advantage of silver comp on it but we have successfully used before do you.
Including the E. coli missile Dr. Charles.
He opened or promoter to control expression to remanufacturing and in the GR truck.
And the Simon Oxytrol.
Sure it replication industry.
[noise] leveraging these reasonable parts for our platform.
A lot of to move quickly through preclinical development.
The regulatory clinical pathway. This indication is relatively straightforward.
With significant positive profit it like other sponsors.
What are your portions of your order cancellations one critical.
We will continue to work closely with regulatory authorities as we develop our clinical strategy.
Our initial efficacy assessment as.
Well evaluate clinically relevant reductions and urinary oxalate levels.
And our goal is to reduce these levels like 20% to 50%.
In terms of safety, we expect to demonstrate safety and Tolerability had an efficacious dose.
Oh clinical development plan will give us the opportunity for a relatively rapid proof of concept readout by focusing after initial healthy volunteer mouse study.
Patients what a tariff hyperoxaluria after wouldn't want gastric bypass surgery.
Because the underlying ball disease for hyperoxaluria patients can be quite heterogeneous.
The post gastric bypass population provide operable cohort cleanly, so the ability of Cindy it it or to.
The lower urinary oxalate.
In conclusion.
Hi Tech Harbor also urea fits once in logic stretch.
It is a relatively well understood biology put a hobby on Monday.
Consumption of our toy within the geography has been shown to directly more urinary oxylate.
Prototype strings demonstrate our fleet Laurie.
Drill handy.
Local study.
And modeling, which translates out activity to the human geometry.
So just the potential to result in clinically relevant reductions in your in Iraq.
Oh next steps are to fall, we always viewed our drug candidate syndicated are too.
Confirm safety and Tolerability in healthy volunteers.
And then move to potentially demonstrate urinary oxalate, Laurie and a focus gap.
Population.
I look forward to providing more detail in the future.
But now.
Let me hand to hand, you back to you referenced.
Before.
Thank you Richard as I said, it's wonderful to see our tenneco portfolio, expanding and I believe in terracotta crux of urea is an excellent indication for our platform.
I want to N. by once again tanking distant logic team employees and their families pretty fantastic work and dedication during cautious being difficult few months for everyone.
It's energizing to be part of such a dedicated team.
We will now open the call for questions.
Ladies and gentlemen to ask a question no need to press Star then one and your telephone to withdraw your question press the pound.
Please standby why we've compiled the Q and a roster.
Our first question comes from global LEMS, though of Jarden. Your line is open.
Hi, good morning, and thanks for taking my call. Congrats on the progress I just came over from another call. So I apologize. If this was covered but can you talk a little bit more about the.
The the prevalence of and territory, perhaps filler.
And prevalence incidents whatever you think is relevant food market potential and directionally to the extent you do get it into the clinic exterior or where where do you feel this sets in terms of the importance of it as the value driver for its and logic as a company.
Yeah, well, it's all about your other programs.
Yes, yes, yes, 10, so much to your question, they're two part question Cogs pass over to return to address the first part which is around the epidemiology of entire type crops are urea and then I'll take the ball back for the second part to recognize the importance of I guess as the program. So I'm Richard do you want to buy.
Some color around the epidemiology.
Sure. Thank you Jennifer Yeah, you're all unlike primary hyperoxaluria, which is a.
Pretty rare on slide 8000, you ask loan we believe that into her auxel urea.
As much more calm and we're looking at.
[noise] <unk> approval, it's about 202 hundred 50000 patients for year you in the U.S., So it's quite a bit.
More prevalent no you know what if we just girls in R&D day.
Or kind of patient profile be targeting patients with Cara Hyperoxaluria, who also oh.
A record kidney stones, and when you take that into account the Cardinal health care and becomes a bit more focused somewhere of about 80000, no patient to here with interim abroad to Europe.
And recurrent kidney stones.
Assisted with our plan TPP at this point.
Got to answer your question.
Yes indeed.
Great and I think bullet in terms of see kind of general importance of the program. You know we think that we have three really important programs that are either in Atlantic or a moving rapidly to be in mechanic and and for us at the company I think the most important thing is to demonstrate that.
You know, we can make a real impact for patients I crossed and one of those indications I think each one has as an opportunity to demonstrate that within that kind of current cash window for the company I think the nice thing about eight k. So two program that we have this nice you and me biomass.
Occur of or would you during the oxalate levels and our current plan as as Richard can kinda provide more color to either today or later into initially look at page healthy volunteers, who were on a high Oh, we pay from on a high out to me diet, but then in that kind of an expansion cohorts to.
Going to patients who have been Terry hyperoxaluria I'd be able to measure and impact on their your oneoks, ignoring and there's a really great relationship between urinary oxalate levels ones and that risk for kidney stones and a kidney damage. So we think that just isn't a nice development path there with a nice me true to that.
Funny thing biomarker and nature kind of clinical endpoint. So yeah, we think but this is a really compelling opportunity for us and there's also night.
From the program perspective, our bacteria have the opportunity to work on obsolete throughout the G. I tracked a which is I think can take advantage of this program and our approach in particular and then finally, we think that the levels of oxalate that need to be consumed by the bacteria if within range of what we can achieve so.
I think there were certain very price and by the program and looking forward to getting into the clinic in generating some data.
Great. Thank you and richer.
Thanks Paula.
Our next question comes from Ted Tenthoff of Piper Sandler Your line is open.
Great. Thank you very much good morning, everyone.
Let's turn the on the you know.
The immuno oncology program.
I'm wondering sort of how that's progressing and whether you would consider partnering data at some point it [laughter]. Thanks.
Yes, so on the yeah, It's Richard mentioned his remarks, and we weren't sure. It earlier in the European Cofunds, Hey, How's that would impact these each kind of up our ongoing clinical programs and what we've seen so far away. The 18 91 programs and stuff the cancer centers have been pace.
Joe getting cancer want to enroll in some of these early stage oncology studies. So I think have been relatively less impacted and those kinds of setting compared to some maybe more chronic disease settings, and so as we said to study is enrolling well and we're on track to share some data from monotherapy later this year.
You know that person dies in terms of senior center unimportant partnership opportunity for us while we focus on our metabolic programs is kinda back internal pipeline.
What we really need to deal with generate some days had to demonstrates that this approach is viable that were not setting up you know that there's regulatory path forward, obviously, which I think we've demonstrated by can get Gadea I'd open any Atlantic.
Patients right Todd wait they were not having sections with said the engineered bacteria, which I think it has been a draw back for prior similar kind of bacterial approaches and then I think find me that the bacteria are behaving as designed into human body and I think those are all questions that we'll be able to answer.
With that with the monotherapy on so I think as we continue to accrue days had mechanic well continue to learn and they'll continue to have conversations and to us to keep options open around the program. So am I think that so that kind of the current plan and we're making good progress against us.
Does that answer your question Ted.
Thank you for looking forward to two data later this year.
Yes.
Our next question comes from ROM Silverado of into C. Wainwright. Your line is open.
Hi, This is Blair Cowen on for Rob I'm, just a couple of questions for me.
The agreement with Abbvie is terminated when you look for another partner for the IB program.
Yeah, I think I'd be D. is a really interesting application for our cat one than our technology, but it's a challenging one for us take on clinically and commercially just because it's such a competitive space and so I think that's you know firmly parsed impart what we call or expand portfolio, which are areas, where baby, we'll do so.
I must be early work some of the preclinical work, but then certainly look to partner if some of the early days as exciting. So that's very much the plan Blair. There and then that will will then you know generate 10 days on some of the programs and shared those at the appropriate time.
Okay and for 16 18 can you talk little bit more about how you adapted the trial design for the phase two to accommodate for coated.
Yeah. That's a great point taught me behind that went over to maturity being the and leading the charge their clinical perspective. So Richard do you want to expand into bets on and I reparation tons for the at study.
Yeah, absolutely I mean, I think we've.
One thing that's very helpful, but everybody is our ability to adapt.
The.
Phase two study for.
For the ongoing covert top 10, Duncan and what where they've been able to students is forced on in my career as we've been able to really design the operational aspects of the phase two is pretty study in peak PK, you, allowing for Bob home based and and office Thanksgiving and we're going to able to.
Got to protocol to operational while there is.
Yeah.
All the site and so put the patients will some patient yeah. We had the we actually got great. There earlier in the year or when you go over what you're starting to national T.K.U.S. illustration came to us that yeah, we really interested in [noise].
Making sure the patients vaccines to clinical trials, even during the cold with gross margin.
Oh, we're able to get X nail studio and because your association for a survey directly to patients and understand their need their desires and things of that nature for clinical trials in overwhelmingly.
Well the patients were for participating clinical trials and keeping them going well, it's always nice split motivation preferred to do the clinical drug at home.
As opposed to.
Going into the clinic, but they were amenable to our going into the clinic. So we've received a lot of really good feedback albums design that somebody phase two trial and now we have a troll where patients can either go into the office if not for performance patients and the slight conductive into care. We also have the ability to conduct.
So it's completely at home Oh, we have trained up home health care nurses, which are trained to clinical pharmacology to do all the assumption, Oklahoma when things are really I'm excited about it was our ability to adapt quickly.
And you know because.
Oh available to them.
Brought us continued to patients out there who want to participate in continue moving moving this project forward.
Okay, Great and then just one more on 18 91.
Where are you in the dose escalation process and can you talk a little bit about how the first arm of the trial, it's going to inform the second or are the true.
Yeah sure Richard you want to continue with that one.
[laughter] sure right here right now is because we know the said on R&D day.
Couple of months ago now than we had we're enrolling a core its wanting to continue to enroll cohorts in the monotherapy arm of the trial. So from what we're looking for in terms of monotherapy and specifically how it will to address the combo therapy as we're looking obviously the primary importance.
Safety.
And you know, it's because if it said we've had no dose limiting toxicities.
At this point.
We were well continue to move forward on that.
And what we're looking for Oh, he's a monotherapy arm yes.
Go also target engagement, which we are continuing to evaluate.
In terms of our gauging this thing kind of Oh effectively.
In the.
I mean, the jackup lesions and any other clinical yeah, we are well early clinical.
Importantly, recently announced Irish her work that got we're all looking for these are exploratory endpoints and were primarily looking for all those endpoints in [noise].
Monotherapy arm in any injected, leaving and then when we.
Do you.
And I think most will directly foremost oh Wow, we expect both safety in these patients when we use a combination arm.
It does show efficacy markers entry.
Moving into the come more from the study.
Yeah, so blurred, but they'll be providing a more thorough update later this year as as we guided to with all of the with all if the data. So a you'll have to a cold your horses until then for a more fulsome updates.
Alright. Thank you appreciate it.
Our next question comes from Mark breeding back of Oppenheimer. Your line is open.
Hi, guys. This is Matt on for Mark Thanks for taking your questions. Two part question on 16 18. The first what do you see as kind of minimum clinically meaningful reductions here see.
Obviously, you know that 360, micromill or benchmark is kind of the gold standard, but if you weren't to reduce said as you know under that benchmark. What do you kind of said at least a minimum clinically meaningful amount.
In the second part of my question is if you're also considering measuring protein liberalization in the trial and how might you go about measuring that thanks.
Yeah, Great I'm, not I'm happy to the first one and and maybe mass handoff to it to return for the second going around how were looking at protein and so what I would say if they sent them at the same SH two studies. So what we're really and once you seem to studies that we can move C and that's a modeling is put.
Active of what we're seeing a PK patients from a product profile perspective, I think and see loring programs really depends on where you're starting so there's a broad kinda pheno type of patient terms afraid they come in at their baseline fee levels and so what weve discussed previously, but we want to see if it hurt.
2% lowering from baseline for that to be something that would we think would achieve our our product profile, obviously, we'd love to get grace or a nice to see reduction and but you know that said, Turkey presented is what we're aiming for minimally for 16 18, and obviously quite did that gets you into the current target.
For you know that gets her piecyk guidance as you rightly pointed out was it that's 360 that maybe depends on where patients dark and whether they're already on some kind of protein restricted dyess, if you're starting off at 500 or 600, you don't make it you close.
And you may need to continue to take some to limit your protein intake. In addition, and so that kind of how we've been seeing things in terms of at the primary endpoint for a subsequent at Lake Phase study, but obviously the proportion of patients achieving target blood female books would also be an additional endpoint that we wouldn't.
Measure in that nature study and but for now where we just focused on looking at in the Symphony trial I to actually see lowering in patients with PK, you and you're right. You know diet is gonna be really important component to control Richard on maybe crossover team to talk about how are we seeing.
Thinking if I thought in terms of this study design for now at last me being just.
Aiming to maintain consistent protein intake to add to study and then into subsequent study could look at the impact of 16, 18, and the ability to liberalized the diet.
But in this Symphony study, we're going to try and isolate the effective 16 18, if you will by maintaining at the backend protein consumption pretty consistent.
Richard do you want to discuss briefly how we've been thinking about doing that.
Sure you know one important aspects when you're looking at pod.
Levels and where it right now is to maintain a diet.
Well drilling through the Scott again, and we have very strict controls and we think the stricter and most rigorous tight controls for phase two study or proof of concepts.
It has been.
Provided in in patients with PK you [laughter] during the screening period patient record your guide for at least five days using a daily to didn't take log.
On the Dietitian, Oh will interviewed all the patients for the result, and create a customized cycle menu for listing food answering choices for me Oh for meals throughout the trial.
Minions will be doing wanting to maintain can always protein entry into it.
And then the patients will have always menus and record the doctor intake throughout the a phase two trial as well its safety as well as a follow up period.
And so in terms of our phase two trial, where we're looking at rigorous.
Dietary.
Matching earned take up you know, we work really hard to do that.
Good good proof of concept.
The other you point you brought up which is very interesting too often something we're looking.
For future studies is.
Idling increase protein intake.
I'm really hard it's cumbersome, it's hard for the patients hard for the families.
And we're talking with extra extra real experts as well with patient and family themselves. We believe that there would be great value.
Liberalizing this protein.
Consumption limit up to 10 to 15 additional grams of fee per day in in the patient can families with <unk>.
Real.
Fine that's valuable and our future research options as we you know like you know.
<unk>.
Get proof of concept is to look into the S. N design studies, specifically looking at protein liberalization Bolton adult and you know maybe even more importantly in the pediatric population liberalizing protein from Tampa up to 25 grams per day for these patient <unk> onions.
Strict diet.
Understood. Thanks, guys here that's on the progress.
Oh, Thanks Man.
Next question comes from you call milk, a moment of city Elon that's open.
Good morning. This is currently on for you a doll. Thanks very much for taking a question just first I'm 16, 18, what are they getting factor, it's very initiating involvement M. S. H.
Yes, that's right. Thanks for that Sad question Carly we we're very fortunate let them. You know 16 18, we were just at the point of getting to study up and running winter Cove pandemic broke can be really had an opportunity to.
Kind of redesign the study realizing that covered with not going to be a one or two months.
The likelihood was that this is something that was going to continue to circulate in the community for a period of time in and I think that approach in retrospect would probably be the right right approach to take because we decided to pause initiation of the study and really take time to me design and which has outlined didn't respond to an error in your question really.
Think about our operational strategy based on an assumption that you know there was going to be ongoing and you know circulation of of this virus until it at a vaccine with fans. So we have gotten to get a week, we tell us looked at it from all different angles, we've gotten to plan and in line, we have all of the vendor.
Up and running and so we're now and that kind of set up phase all of the study and are are on track as as the previous get Guy did to add any shakes in the study in the second half of this year. So you know in retrospect I think we've been for a place that we took that time, because there's nothing worse than you know and open study that that <unk>.
Continental so I can for very comfortable with where we've landed in terms of the operational pen and they're looking forward to a data from pique your patient next year.
Okay, Great. That's helpful. And then just one on 18 91, you've got it for initiating the <unk>.
Combo arm with pickle isn't that in early 2021, just wondering if it's still your understanding that you'll have reached the M. T D. In Atlanta therapy arm by that point in time and and if you haven't is there a possibility or would you consider you know opening a combo cohort and continuing dose escalation and mano.
Therapy and parallel.
Yeah. So we're constantly evaluation that as we see days that emerge from the the study you know right now that remains the plan M. But you know so far is Richard mentioned, we haven't seen N D. L. Ts Monday monotherapy arm continues to go L. S O as we continue to evaluate will absolutely.
Keep you another infestors in the loop regarding our plan, but as of today and <unk> guidance stand.
Okay, great. Thanks for taking the question.
Thanks currently.
Next question comes from Chris How're some of Jeffrey you one is open.
[noise] hi, good morning, Thanks for taking the questions. So I guess, maybe it's just a couple of for me I was intrigued by the commentary around further 16 18 optimization. So you know just just curious how you would consider any of those optimizations moving forward.
And how you'd be able to bridge that to the curved formulation. If you saw any of those attractive.
Secondarily, you know four eight 802, you mentioned one of the advantages Richard was the connect throughout the G. I tract and just wondering if you could put a specific point on the biogeography that you think is most relevant particularly in gastric bypass spacious six.
Alright, so I'm going to pick the PKU with we call. It an attorney P. K U two point, though.
You know, we've really realized over the past two years back Uhm, you know learning from mechanic, but also continuing to optimize is a really important component of our platform you know, what's a week foundational component of synthetic biology.
Design test bills kind of cycles back to add that go through so we've been working on you know working at whether the we can do that should've been 16 18 F for some time and I have made some interesting progress with a number of external partners, which has allowed us to kind of a value eight o'clock technologies can really have.
An impact when it comes to up to my patient of some of our strange. But then also can provide us with a more potent strained potentially compared to 16 18. So I think for me, there's gonna be two components around making the kind of decision, which I think it is and you're getting at Chris number one is going to be your card there.
Ah modeling is predictive see loring M. In the Turner can I think for learn that from the Symphony style.
<unk> you know we've discussed previously and important component of our pet for them as being able to predict T. S. A K C that we're like hate to see in patient and and I think we've done some interesting metabolic modeling work and now at the rubbers meeting the road with with a faith to simply study and looking at how well that predicts the amount to feed.
<unk> that C N N pique your patients. So I think that's gonna be the first kind of important information point I think the next important important information point is how much pressure, we can do with some of these optimization technology. We shared some data Orange D day to show that we've made interesting progress based on on one of our learning.
And I think looking at both of those both the <unk> you said that we see relation to you know what we predicted as well as looking at has some of those next generation strange are performing in our modeling will help us determine kind of the best of breed. If you will to take into <unk> development and I know the the follow up question that's alright.
D. On your mind is like you know how it regulation is going to think about that in terms of you know it was at one development program person starting again at the beginning so we haven't had any regulatory interactions around that yet, but as soon as we do and we understand it isn't that more about exactly what backpack when it looked like M. We'd be delighted to.
To share and you know what that strategy S. M does that make sense to you yeah, yeah totally.
Great. So would you like do you want to address the a T. S O two issue and that kind of where they got me think is important for the various etiologies of entire <unk>. So you are you.
Sure you know like I can O N D day redo.
So four burgers or really an expert and a Dr pepper to Europe.
Really pointed out you and help you volunteers.
Important Oh wait absorption thrilled did you have a drink <unk>.
Including the stomach a small intestine and <unk>.
Yeah until we wanted to sort of create an ideal product or a product would consume actually through you know of components of G. R. A truck and N. As you pointed out this may depend somewhat the in N out of me and the underlying issue weird.
Pepper actually you're a patient for example.
<unk> my password.
<unk> <unk>, while I have a much smaller stomach opponent the normal and.
Sure. Unfortunately absorption is likely G O E lower down on a junior drive two cream [noise] small intestine, and particularly colon for the for these patients.
In particular.
And what we've gone to sort of answer this question <unk> prior to clinic you use our.
In vivo system, where we've created.
So in order to God, Florida, and in vitro model Vanilla is both stomach ache stomach and kalana components.
And this was again part of our presentation, <unk> stomach and corn component [laughter] and actually absorption with.
[noise] with our with only strain would you like which is almost identical to shouldn't be today or two and we're show there were able to consume much weight and both of them like department stores stomach a colon would you like like was very important.
Florida.
We have a big also able to show that would've been able to.
Get viable.
Send hawksworth or you know smells horrible smells recovered and feces and nonhuman primates and that's just on the menu alright.
Human primate.
After administration of.
It shouldn't be entre not even primary ketchup, we did we have some pretty good evidence that we do maintain activity and violent extra vulnerability throughout did you want to drink.
Okay I will very good.
Yeah, I I I think Oh save any other questions for for the time. Thank you so much.
Alright, Thanks correct.
[noise] there are no further questions. Please proceed with the closing remarks.
Great. Thanks, so much Michelle I'm, so I'd like just like everyone for joining us today, it's been a great call and I look forward to keep you updated that'd be your progresses.
Thank you.
Ladies and gentlemen. This concludes today's conference call. Thank you for participating you may know disconnect everyone have a great day.
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