Q1 2022 Synlogic Inc Earnings Call

May 12, 2022

[music].

Okay.

Good morning, and welcome to <unk> first quarter 2022 conference call.

At this time all participants are in a listen only mode.

There will be a question and answer session at the end of this call.

Please be advised this call is being recorded.

I would now like to turn the call over to Andrew Funderburg of Kendall Investor Relations. Please proceed.

Thank you operator good morning.

And thank you for joining us on today's conference call. This morning, we issued a press release, which outlines our first quarter 2022 financial results and additional business updates. The release is available on the investors section of our website at Www Dot <unk> dot com joining.

Joining me on this call are Dr. <unk>, Brennan, President and Chief Executive Officer, Molly Harper Chief Business Officer, Dave Palmer, Chief Scientific Officer, and Michael Johnson, Chief Financial Officer.

Other members of the management team will be available during the Q&A.

The call <unk> will provide a review of first quarter highlights and recent progress, including an update on our lead program in PKU and Molly will share her perspective on the PKU opportunity.

I will discuss our earlier stage programs and collaborations and Michael will provide a financial overview.

Following our prepared remarks, we will open the call for questions.

As we begin I'd like to remind everyone that comments today may include forward looking statements made under the private Securities Litigation Reform Act of 1095.

These forward looking statements are made as of the date hereof and are subject to numerous factors assumptions risks and uncertainties, which change over time actual results could differ materially from those contained in any forward looking statement as a result of various factors, including those described under the heading forward looking statements in <unk> press release from earlier today or.

Under the heading risk factors and so projects. Most recent Form 10-K or in later filings with the SEC <unk> cautions you not to place undue reliance on any forward looking statements now I'd like to turn the call over to Eva.

Thanks, and good morning, everyone and thank you for joining us.

I'm happy to share with you today update on our recent progress as well as our financial results from the first quarter of 2022.

We've had a busy first quarter with significant progress.

Michael Jensen joined Us as Chief Financial Officer, bringing an impressive financial and operational background, and Biopharma and health care company across therapeutic categories and to commercialization.

This quarter also included a return to in person presentation at scientific Congresses.

In the month of May Congress presentation, comfort preclinical and clinical program data.

Well as.

Analytics from our manufacturing team.

Highlighting some magic achievements across multiple domains.

Looking ahead, while our phase II program in PKU program.

We like others in the industry have been affected by persistence and broad based factors, most notably labor shortages impacting our clinical trial sites.

For us these challenges increased in parallel with implementation of the second of the Symphony steady couldnt be 1934.

Today's press release updated timeline for our PKU program with <unk>.

Two days now expected in the second half of this year and phase III initiation in the first half of 2023.

The milestones for HBU and enteric Hyperoxaluria program remain unchanged with expected proof of concept and enteric hyperoxaluria and healthy volunteer data in each bu in the second half of 2022.

Importantly, these PKU program updates do not reflect challenges with patient interest of trial competition. It has been the opposite the more we engage with kols and clinicians in the PKU patient community. The more excited about the importance of and demand for a new treatment option.

And what a potential product profile could mean.

As the disease PKU presents.

Kipp medical need for new treatment option, and a relatively derisked path from a regulatory and commercial perspective.

Despite the devastating disease with multiple FDA approved treatments, a large majority over 75% of patients with PKU today remain untreated or under treated due to limitations of current options both in safety and efficacy.

At the same time, having two FDA approved drugs provides us with regulatory preceded that are helpful and unusual and rare disease drug development.

These precedents into a path to full approval based on the biochemical primary endpoint plasma fee reduction.

They also provide precedence.

Approval based on one Registrational study and without an advisory Committee.

These approved drugs also provide examples of phase III study designs and related considerations FTA at PMA approval.

Our interim phase II proof of concept data last year showed a potential profile that is differentiated and well suited for the patient to meet a new option.

Potentially efficacious safe treatment that could be used as either monotherapy or as an adjunct to coupon or separate Karen.

We look forward to providing an update on our phase II results in the second half of this year as we advance this program forward towards phase III Ultimate state registration.

I'd like to now hand, the call over to Molly expands upon our path to bringing the PKU program through to patients.

Thank you Eva.

Building on <unk> description of the clinical and regulatory program PKU Ensign logics approach in particular presents several advantages for commercialization.

First for rare disease, just wanted a large population.

And just by two approved treatments a large majority of patients remain untreated due to the limitations of today's treatment options.

The large untreated patient population reflects kuban or safra, Karen non responders for whom the other approved therapy policy daily injection is not viable option.

The latter situation, it's usually due to safety concerns given the risk of anaphylaxis and allergic reactions.

For those who do respond sure and stay on to then their fee levels are often remain above targets presenting an opportunity for adjunctive treatment.

Sure the vast majority of people with PKU need new treatment approaches, whether as a monotherapy and adjunctive option.

And as <unk> noted, we are thrilled to be advancing development of a potentially effective.

<unk>.

Orally administered monotherapy and adjunctive treatment option for individuals with PKU, we designed our drug candidate to consume fee without risk of systemic absorption and associated first events seen in other bio therapeutic approaches.

This assay product presentation being studied unexpected for commercialization is an easily administered lyophilize powder taken with meals three times a day.

SaaS a format it's familiar to this patient population as the same as used for Kuban and often nutritional supplements.

With this expected product profile, we are advancing a new treatment option for PKU with the potential for two distinct segments.

The untreated monotherapy patients and also as an adjunct treatment to two that are sub pop Karen.

As laid out here you can see that focusing just on the initial launch population with the greatest pent up demand. These two segments provide an addressable patient population of more than 3500 patients in the United States.

With this clear clinical positioning the way PKU with managed in the United States and many other countries presents several advantages for commercialization.

First PKU patients are diagnosed and well connected starting first through newborn screening there is a very active advocacy organization. The prescribing clinicians are concentrated at well defined treatment centers.

There are strong precedents for coverage and reimbursement via the pharmacy benefit and prior authorization processes, and we will use the well established specialty pharmacy and distribution channel.

Lastly, some logical benefit from the streamlined and simplified patient support needs of an orally administered drug without the need to provide the support of injection training our infusion clinic setup, so often seen in other rare disease therapies.

With that I'd now like to hand, the call back to <unk> to discuss the PKU programs path forward to phase III.

Thank you Molly.

To review the ongoing phase III study of our PKU program and what we're looking for in our upcoming data.

First the drug candidate.

The diagram on this slide illustrates a closely related drugs.

B 16, 18, and <unk> 19.

$19 34.

We developed can be 1934, starting from can be 16, 18, and using directed evolution to increase the productivity of the Pal enzyme that metabolizes fee.

There are in fact, only five amino acid changes needed to achieve optimized activity and the strains are over 99% genetically identical.

You'll recall that in September we announced phase one results from a head to head study in healthy volunteers between <unk> 18, and <unk> 1934.

This is Scott safety bridge between the two and confirmed at 1934 is greater potency based on multiple biomarkers or feed consumption in healthy volunteers.

Based on that phase one we made the decision to add a second arm to our phase III Symphony, one steady to obtain data, which can be 1934 in PKU patients.

Meanwhile, at the same time, we announced our interim analysis of the phase <unk> study in patients with statistically significant and clinically meaningful reductions in plasma <unk> for <unk>.

The remaining data from the phase III study indicate effect in PKU patients for the first time for both drug candidates and Costco provide data regarding <unk> as both monotherapy and adjunctive treatment.

An important step as we proceed to phase III with the selected drug candidates.

We anticipate data from the Symphony one study a phase III study in patients with classic PKU for both drug candidates.

This population is fee levels above 600 micro most producer at screening and does not adequately served by available therapies.

Each patient functions as their own control.

Subjects are placed on a strict diet, but designed to match their usual protein and fee intake at.

That each patient has a guy running followed by baseline assessments.

We've included both patient currently untreated as well as those on tax with Taryn to effect, the drug candidate as monotherapy and as an adjunctive option.

Patients receive increasing doses of the drug over two week with repeat on treatment assessments, followed by a washout period.

The diet management is maintained throughout the trial out to day 29.

We measure Naples defied fee prior to dosing and at day 14.

As a reminder, because our approach because of our approach we can utilize its highly drug specific marker of activity that confirms our drug candidates are consuming fee in the Gi track independent of a placebo controlled arm.

Measures of fasting plasma fee are taken at baseline prior to dosing after the end of the dose ramp at day seven and after a week at the treatment dose on day 14.

We also collect data on safety and Tolerability throughout the trial.

Again, it was a positive interim analysis last fall, but it could be $60 18 accurate capturing the phase one safety bridge with both candidates in healthy volunteers and greater potency, which can be 19, Turkey four that we added a second arm study for <unk> 934, we.

We amended the inclusion criteria to enable evaluation of a jump to any potential by allowing enrollment of patients who are on treatment with <unk>, but still have uncontrolled blood fee levels.

This should allow us to review, both monotherapy and adjunctive data.

At this point, we've demonstrated proof of concept with Cindy 16, 18 in PKU patients.

<unk> 1934 have established the safety bridge to <unk>, AP and demonstrated greater potency and healthy volunteers.

In addition, since last September we've progressed, our work on process development and stability further derisking the path to commercialization from a manufacturing perspective.

Barring any inconsistency with the profile already observed for Cindy 16, 18, and Symphony and Couldnt be 1934 in healthy volunteers.

Defense <unk> 1934 to phase III.

Pending completion of Symphony, one will conduct to end of phase two meeting with the FDA, which will allow us to confirm specific steady plan, including timing and other considerations prior to initiating phase III.

In summary, we believe our path forward is clear as we advance our programs into Registrational studies and potentially towards commercialization.

I'll now turn it over to Dave to discuss our other promising clinical and preclinical pipeline programs.

Dave.

Thanks, Lisa I'd like to review the additional programs, we're advancing from a very active pipeline.

We expect that Cindy $13 53 will be entering the clinic this year and.

And we will share data from our phase one trial in healthy volunteers for almost a scenario in the second half of this year.

<unk> $13 53 is highly synergistic with the PKU program in both the scientific approach and the.

Hi overlap of treating clinicians.

Our program for Enteric Hyperoxaluria Cindy <unk> is on track for a proof of concept readout in 2022.

We presented data last year from healthy volunteers that we view as promising proof of mechanism.

The current portion of the ongoing study is in patients with Rune Y gastric bypass surgery, who.

Who have elevated absorption of oxalate.

To evaluate whether <unk> can lower urinary oxalate in those patients.

We've also added a second phase one study to the <unk> program to.

To continue to build our clinical data set in patients with rune y gastric bypass.

This study will be performed in an inpatient setting where we can collect data as well as high quality 24 hour urine and fecal samples.

And we expect to enroll 10 patients.

The new Phase one study will evaluate a version of the SMB area to strain modified to remove the genes for cologuard and synthesis.

This modified stream and study are within the same SMB added to R&D and.

And we believe can support the demonstration of proof of concept for student behavior there too.

2022.

We're leveraging our platform to advance preclinical programs for other metabolic diseases like gout and for immunological conditions, such as inflammatory bowel disease.

We look forward to sharing updates about these programs as they progress through development.

We also have an ongoing collaboration with Roche to develop products for inflammatory bowel disease around the single target.

In parallel to our in house efforts.

I'll now turn things over to Michael to review our financial results.

Thanks, Dave and good morning, everyone earlier. This morning, we released our financial results for the first quarter ending March 31, 2022, and I am pleased to review the highlights of those results with you now.

Revenue was <unk> 2 million for the first quarter of 2022, there was no revenue for the same period in 2021 rare.

Revenue for Q1 of 2022 was due to our collaboration with Roche with the discovery of a novel synthetic biotic for treatment of inflammatory bowel disease or IBD.

For the first quarter of 2022, the company reported a consolidated net loss of $15 7 million or <unk> 22 per share compared to a consolidated net loss of $15 million of <unk> 36 per share for the corresponding period in 2021.

Turning to the balance sheet. Some logic ended the first quarter of 2022 with a $125 million in cash cash equivalents and marketable securities.

<unk> to $136 6 million as of December 31, 2021.

Under our current operating plan, we expected our cash will take us into 2024 and enables and largely to advance our clinical programs through multiple important data readouts across the metabolic portfolio.

Thank you for your attention and we look forward to keeping you updated on future calls I will now turn the call back over to Eva to wrap things up.

Thank you Michael this is an exciting period for us in logic as we advance all of our clinical stage programs and look towards the series of data Readouts, including PKU Phase II results, followed by phase III initiations to that program.

Well positioned with strong balance sheet to advance these important programs.

In the fortunate position of having funds available to support us well into 2024.

I'm very pleased with all of our progress and the commitment of our entire team to advance promising therapies to patients in need of new treatment options.

We will now open the call for questions.

If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.

To withdraw your question press the pound key.

Again that is star then one if you'd like to ask a question.

Our first question comes from Joseph Schwartz with SBB Securities.

Hi, I'm doing dialing in for Joe. Thank you for taking our questions. First you mentioned in your prepared remarks that labor shortages have affected your phase III PK trial and based on the timelines. It seems like it's just affecting our PKU program. So I was just wondering if you could please provide additional detail then how this impacts your PT you pre.

Graham, but not your enteric hyperoxaluria or Homo assisting area program and I have a follow up thank you.

Yes, Thanks, Jeremy for the question and so I think it was we were very unfortunate in terms of timing and right around the December January February timeframe, we were implementing a major amendment to the study we had assumed that that would go smoothly and follow the usual timelines and what we found was that sites, we're having very difficult.

As all businesses were around that time dealing with omicron and individuals being being out of work and turnover. There. So it really hit us at a time when we were making a big change to the study to implement the amendment to add 19, Turkey forced to trial, which really had a knock on effect on all of the downstream.

Activities, we had hoped that we would be able to make up for some of those delays as we went into the year, but unfortunately have to make the decision that to.

We need to change our guidance within the last couple of weeks. So thats kind of I think it was a perfect storm. If you will the price at the time when the study was coming into an intense periods.

We're seeing the effects of Covid on the omicron variants that obviously, we didnt anticipate last September so I think that's why it had.

And the disproportionate impact on the PKU program and so the other studies that we're already up and running at that time does that makes sense.

Yes, that's helpful. Thank you and then.

I have two more questions could you provide additional color on the ordering or when we can expect the updates from your three programs in second half.

Yes so.

As you know most of our studies are short during 10 studies, but they are of short duration. So it's very difficult for us to tell when exactly on what the order of those studies is going to be as we go on in the year and we may be able to tighten up the guidance in <unk> and we remain confident that we have lead ads from all three clinical programs in 2000.

22, but in terms of which one is going to come for a second and third I really can't tell you at this point.

Okay, Great and then my final question is I guess, you've accumulated a fairly sizable amount of data so far with your platform, including data in PKU patients enter a hyper auxiliary Ah patients in healthy volunteers. So I'm wondering if you could speak to a possible intrinsic variability associated with.

Your technology is there do you think there is one and if so what do you think it is thank you so much.

Yes, So I think you make a very good point, we have dosed at last count I think over 350 humans across all of the studies comprised of healthy volunteers as well as patients with disease and I think what we see consistently across all of the studies that we've done is that the bacteria.

Perform as designed so we designed them not colonized state owned colonized we don't see any systemic toxicity across any program, we see consistently that the bacteria switch on the function that they have been engineered to perform in vivo in the human Gi tract in a way that's very predictable. So when you look back at some of our.

Our preclinical modeling.

I think we've gotten better and better at predicting what kind of efficacy we see on average in humans. So I think for me that's very gratifying mean to science is working in some of those translational questions that we had really early on as a company have really been de risked at this point. So I think that's wonderful I.

I think the intrinsic variability question Youre getting to is around the PKU program and some we saw some patients and the interim data SaaS, who had really remarkable response in terms of fee lowering and then other patients who had less and less impressive response. So there was some variability there we don't understand exactly.

But the driver of that variability is as we go forward and dose more patients. We may get additional insights my best guess at this point in time is that there are differences in all of us between our Gi physiology and as some of us have.

Lower ph and our stomach some of us have faster small intestinal transit times.

That variability results in the normal biological variability you see with any drug.

There are some patients who respond more optimally than others, but as we continue to learn from our in our studies in patients I think will get bachelorette and farming and predicting the nice thing across all of our programs is that we have these biochemical biomarkers that really give us a nice early readout. So we can really deter.

German which patient subset are going to do well based on the actual endpoint pretty early on to try and you don't have to follow the patient for two years to work out whether or not theyre going to respond.

That's an attribute that is very favorable based on the diseases of the indications. We've chosen that will certainly be taking advantage of as we move forward into late phase development across all of the trials.

That's very helpful. Thank you again.

Thanks Jerry.

Our next question comes from Kay Mackay with Jordan.

Thanks.

So when we get to the point, where youre going to decide which path.

<unk> candidate to take forward, how much better would.

With $19 34 needs to be for for that to be the one to take forward.

Yes, so thats a great question Kay so just to take a step back what we've already demonstrated with the PKU program is that $60 18 achieves our kind of go forward as a strained for phase III, we had certain pre specified some criteria that needed to be mentioned, what we've seen across the program is at $60 <unk>.

<unk> criteria.

Now is which strained do we take forward is at $6 18, or 1934 and across all of the studies that we've done to date BJ in vitro animal studies are healthy volunteer crossover study. We've seen at 1934 has consistently <unk> in terms of activity, particularly around some of the biomarker.

<unk> and the <unk> lowering that we've seen in plasma.

Our expectation is at 1934 will be the stream that we take forward into phase III. We're just looking for some confirmatory evidence in the second arm of Symphony that Theres, nothing unanticipated with regard to safety and that that kind of biomarker strain activity pulled through what we've seen up to this point.

So I think based on everything we know today the likelihood is at $19 34 will be the go forward strain.

Okay and then.

Sure.

Can you give us some more color on the process excuse me process development improvements you simple business.

Yes, Yes, I think Tony Hayward as I said on the call. He has been leading that effort here. So I'll pass you over to Tony to describe some of the work that his team have been doing to prepare for a phase III study initiation.

Yeah, great. Thanks, Steve.

It was mentioned earlier, we've made concrete progress is currently executing on our plans.

So much that goes into full swing.

But to highlight or call out a couple of critical paths are important past we.

We finalized our formulation, which is key and we finalize the presentation, which you heard about a little bit ago from commodities.

This presentation is very patient friendly.

To give an example, like taking vitamin C, which session, which everyone's familiar with pouring into glass and water mixing and drinking it so very easy to take borrowing.

Also optimize and scaled up our manufacturing process to allow for higher production yields and that's that's really the process that would go forward into phase III and commercial.

And in addition, we've completed renovation expansion of our GMP manufacture sweet portion of scaled up process from the production that we will we will need moving ahead.

And to tie it altogether.

The risk in the past we've had some very positive to support a CMC regulatory correspondence with the agency.

We're seeing eye to eye and.

We understand what they are requiring of us and we're happy with where we stand.

So pulling this altogether and knowing that our scale will meet the demands for phase III and commercialization, we really believe that we've derisked, the CMC driving well towards phase III initiation.

Does that answer your question yes.

Yes.

Just in terms of avoiding any possible.

Delays due to comparability you feel like your conversations with the FDA that still can be any kind of issue.

Yeah, absolutely I mean, so so to back up a little bit.

Our technology, we are very big on single use technologies. So nothing is really tied to the facility.

Scale up is going kind of X, which is very reasonable within the regulatory acceptance criteria.

Like I mentioned the feedback from the from the agency has been very positive.

We know the path ahead, we know what we need to do from comparably standpoint to move forward into this process that will take forward to phase III. So we feel very comfortable where we are.

Okay. Thank you and then just finally for <unk> two.

Can you talk about the.

The modifications.

In the stream.

Yes, sure I think David is on the line and Dave <unk>, Our Chief Scientific Officer, and I think probably best case to describe.

Some of the small tweaks, we've made to ACI so too.

Yes, sure I'm happy to do that so.

The change that we've made is to delete genes that synthesize protocol called <unk>.

So call it back in pre clinically in animals has been associated with.

So gino toxicity or risks for Dino toxicity.

Whether there is a long term risk to that in humans is really unknown. There is really not a lot of great data to support that so its somewhat controversial if it would be a concern.

But rather than try to prove a negative.

Given the fact that we're able to manipulate the strains pretty readily we decided just to remove it from our stream.

Take that risk off the table and to move forward with the stream it doesn't synthesize those teams so.

That's true for the Ada of two stream and Thats also true for other strange in development.

Okay, and then with respect to that in patients study that Youll do you talked about the advantages of getting.

Samples, but anything else about the patient population that would.

To help to make it more homogeneous in any way.

No. So I think the patient populations are patients withdrew on why the big piece by we can control a biologic variability by bringing people into unit, but what you can control is their diet and you can make sure that the 24 year end collections are complete.

Those are obviously potential sources of variability when youre looking at a urinary oxalate endpoint. So understanding those potential sources of variability I think its medium portal for us and particularly given how important urinary oxalate measurements are going to be for this program going forward. So we thought it was prudent to invest in that now.

Particularly given the strong data we've seen in healthy volunteers.

With the strain so we're really looking forward to seeing some data from that trial and if <unk> read that in Asia. This year.

Yes.

Okay very good thank you.

Sure.

Our next question comes from Mark Breidenbach with Oppenheimer.

Hey, good morning, and sorry to here, we'll have to wait a little bit longer for that Symphony one update.

Just a couple of questions for me.

First with respect to your respective modeling Pelham elevated reduction in PKU patients using the healthy volunteer data I'm, just wondering if baseline plasma fee factors into the predicted.

Phenylalanine lowering in other words do you think the magnitude of the treatment effect could potentially be skewed simply by selecting patients who start out with either very high or very low baseline serum fee.

And then a second question is just maybe on the regulatory front.

I'm wondering what your current plans are for engaging with the EMA with respect to regulatory path in Europe .

We could expect the planned phase III trial to include ex U S clinical sites.

Yes, yes.

Two great questions Mark on the biology, one first of all.

But we predict based on our modeling is that the fee the attitude fee lowering will be.

Naive to the baseline levels and certainly that's what we've seen to date in the small number of patients from the Symphony study that we've looked at we have to.

B infusion to study patients need to have a blood fee level of greater than 600 micro mill producer.

We have patients obviously, who are just above that cut point in EMEA of patients who are coming in well into the <unk> in terms of their baseline fee levels and we seem to see consistent results, regardless of where patients come in so to date, the clinical data and the modeling seem to be very consistent.

As we as we learn more obviously from Symphony will continue to look at that but to date. It seems like there is potential for the stream to be active and to deliver efficacy regardless of where patients are coming in in terms of baseline levels.

The second question PMA is a great one and Mali has done a lot of great work in the last couple of months to really understand for us to potential commercially outside of the U S for our product and we believe actually there is a significant commercial opportunity and a significant opportunity to bring a new treatment to patients with PKU around the world as you know there are about <unk>.

<unk> patients in the U S with PKU when you look at globally. The addressable population, we're talking about 55 pads in patients so engaging with regulators outside of the FDA in the U S is absolutely something that we're focused on we've already started that work.

And we'll understand what the regulatory requirements are but.

Assuming that it's not onerous and that it makes sense from a business and an investment perspective, I'm certainly very committed to advancing treatments for PKU patients globally, and I think we have something that could really bring a lot of value to patients outside of the U S. So we'll be looking to do that as quickly as possible as we think about our phase III plans.

Okay, but too early to say whether or not the phase III trial would include ex U S sites.

But as you know Mark you.

<unk> as you engage with the regulators to understand what the patch and what they are going to acquire we're obviously not going to waste.

The most important thing for us from a business perspective is to get the PKU product approved as quickly as possible. So until you understand a little bit more from regulators exactly what that path to opening sites outside the U S is it's very difficult to give a commitment that you're absolutely going to do it because it just may not make sense from a business and timeline perspective to do so.

But certainly as a company, we intend to do that and we want to do that and assuming that it doesn't mean that there are no big delays.

We would intend to enroll the phase III study as quickly as possible, which is definitely aided by having more sites outside of the U S. So that's certainly our intent until we have a clear regulatory path an agreement, it's very difficult to say for certain that that's going to happen.

Does that makes sense. Thank you so much.

Thank you.

As a reminder, if you'd like to ask a question at this time that is star then one.

Our next question comes from Ram <unk> with HC Wainwright.

Hi, This is Mitchell on for Rob. Thank you for taking our questions.

The first question I have is for the <unk>.

PKU readout could you just kind of elaborate on the breadth of data, we can expect to see and how much will the data go into both streams.

Yeah. So the Symphony study was designed initially to have 12 patients dosed with <unk>. These patients have to be Catholic PKU. They werent able to be we excluded patients who were on any currently available pharmacotherapy for PKU and we announced data last September from deferred eight page.

<unk> to complete the study it looks really promising and as we start to think about okay. Moving forward into phase III. We made the decision to make to amendment number one was to add an additional arm with 19, Turkey for up to 12 patients and number two was to allow patients who are on <unk>, but had a blood fee level.

Over 600 to participate so those are the two changes we made.

We anticipate that the next readout would include.

<unk> data from the first arm, we announced data from the first Asian September as well as data from the second time <unk> and <unk>.

Some small amount of data in the combo, setting, where we're administering and either strain on the background of our sapper taryn. So thats kind of the breadth of what to anticipate in the second half year, and we're certainly really looking forward to continuing to build that data SaaS and continued to build our understanding in PKU and sharing externally.

As soon as we can.

Okay.

What would constitute the key driver of our go no go decision for the eight 802 program enteric Hyperoxaluria.

So that program is being developed for.

Patients who have increased year on year increase dietary oxalate absorption, we're really compelled by the unmet need in this indication. We continue to hear that there are patients who have really severe recurrent stone disease, where theyre, having multiple episodes of kidney stones per year, and we just did some data and shared some days extra.

During the at kidney week last year showing that these patients also have a very significant risk of chronic renal failure. So it really is a big unmet need.

Based on our feedback, 20% urinary oxalate lowering would be significant and would result in a lowering of the incidence of stones in these patients. So that's really what we're looking for is it 20% urinary oxalate lowering to achieve proof of concept to give us confidence that we really do have a product that can address that.

Met medical need so thats kind of our go criteria from an efficacy perspective.

Great. Thank you very much for taking the questions.

I'm showing no further questions in queue at this time I'd like to turn the call back to Dr. Rizo Brennan for closing remarks.

Thanks, so much and thanks, so much everyone for joining us. This morning, we look forward to keeping everyone updated as we progress through this very exciting year for us in logic. Thanks, so much.

This concludes today's conference call.

Thank you for participating you may now disconnect.

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Yes.

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Yes.

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Yes.

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Sure.

Yes.

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Yes.

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Yeah.

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Yes.

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Yes.

Okay.

Yes.

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