Q2 2022 Synlogic Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A.
Good morning, welcome to send logic second 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 that this call is being recorded I would now like to turn the call over to <unk>.
Andrew Thunderbird Kendall Investor Relations. Please proceed.
Thank you operator.
Morning, and thank you for joining us on today's conference call. This morning, we issued a press release, which outlines our second 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 me on this call are Dr. <unk>, Brennan, President and Chief Executive Officer, Molly Harker, Chief Business Officer, Dave Harbour, Chief Scientific Officer, and Michael Johnson, Chief Financial Officer.
Other members of the management team will be available during the Q&A.
During the call people will provide a review of this quarters highlights Molly will provide additional detail for the clinical programs, Dave will discuss our earlier stage programs and collaborations.
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 1995.
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.
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 as <unk> press release from earlier today or under the heading risk factors in <unk>. 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, Andrew Good morning, everyone and thank you for joining us.
I'm happy to share updates on our recent progress our financial results for the second quarter of 2022 and upcoming milestones.
This is an exciting time, Kristen logic and the synthetic biotic platform.
Our most advanced program in PKU in the second quarter, we announced that we received a positive opinion on orphan drug designation from the European Medicines agency or EMA for <unk> for the treatment of PKU.
This is an important step for our program at the EMA opinion reflect recognized need for new treatment of PKU.
In the remainder of 2022, we expect three clinical data readouts from three different programs.
These include for the PKU program, the phase III data Readouts and phase III candidate confirmation.
Brixton be hurricane 53, as synthetic biotic designed to consume the timing as a potential treatment for <unk>.
Thank you.
Findings from the recently initiated phase one healthy volunteer study.
And finally for Cindy a T cell to a potential treatment for enteric Hyperoxaluria. We also expect to share proof of concept data.
We recently recognized <unk>, Turkey 53 is our third program to enter the clinic in less than two years.
Reflecting the advantages of synthetic biotics.
Can be Turkey, 53, built on technical as well as regulatory synergies and the promise of this platform the biotherapeutics based on synthetic biology.
<unk> 13, 53 entered the clinic within just the year has been named as the Kennedy.
This was done for can be 82, and <unk> 94 P. S. T. A way for traditional preclinical toxicology package for <unk> 13, 53, recognizing the transferable findings of using the E coli Mitchell chassis.
Moving beyond the clinical pipeline I'm excited to announce the newest addition to the same logic pipeline.
<unk> 2081 for gout.
<unk> is a well known and often debilitating form of inflammatory arthritis caused the intense joint pain and limited range of motion due to excessive levels of uric acid.
Patients remain underserved, especially those who are intolerant of Earth refractory too.
Bailable therapies.
We are excited to advance <unk> B 21, our second synthetic biotic developed through our partnership with Ginkgo Bio works.
And finally, it was a pleasure to share earlier.
And Vincent Tobin.
<unk> General counsel and corporate Secretary.
As discussed on our last call trial readiness activities are underway for the start of our phase III study for the PKU program in the first half of 2023.
This builds on phase III interim analysis at proof of concept data shared last fall demonstrating in PKU patients can be 16, 18 drug activity and reduction in plasma.
<unk> asset PKU patients or in April from the capitalized and become your toxic at high levels.
In parallel with the proof of concept, we guys. We confirmed even greater potency with next generation can be 19, Turkey for divesting the safety bridge at a phase one head to head study.
Since then we've progressed can be 19, Turkey for such that now the presumed phase III candidates. However.
However that will be confirmed after assessing it shouldn't be 19, Turkey for experience in PKU patients from the phase III study could be shared later this year.
Looking ahead to phase two data, we have an opportunity to remind the audience of the endpoints, we use to confirm drug activity.
For all of our programs, we look for multiple end points that are specific to the synthetic biotic to assess if they are working as intended.
For PKU, our synthetic biotic is designed to metabolites in the Gi tract.
Conventional just expressed in a more precise and controlled way.
Provide labor C or D five feet apart.
Carr to protect meal at baseline and then again after treatment in the store.
Eddie.
This is the primary endpoint for the phase III Symphony trial there.
We are also assessing the impact of our synthetic biotic on fasting plasma <unk> levels as well as TCA in plasma and hey, Jay in urine to metabolic byproduct, which can only be produced if our stream effectively consuming fee.
We also look forward to sharing data from evaluation as a monotherapy, but also as an adjunct to start preparing a coupon.
With that I'll pass the call over to Marty to provide a bit more perspective on the significance of this positioning and our differentiation in PKU as well as some further color on our <unk> program.
Okay.
Thank you Ebrahim.
Eva has described how our phase two design reflects our positioning in PKU.
Targeting the more severe patients who in the case of PK. You are also a large majority of the patient population. This includes both monotherapy and adjunctive peso.
The more mild patients with PKU are often described in terms of ph for or cruzan responsiveness. However.
However, even in these patients in spite of responding to and benefiting from Couvade often have fee levels far above desired levels.
These patients present, an opportunity for adjunctive treatment.
The large majority of PKU patients in the U S and northern Europe are considered the hub classical PKU.
These are the patients with higher fee levels, who did not respond to susanne and for whom <unk> is not an option we find tremendous appreciation for the potential of an oral non systemic approach like some larger.
This is the currently untreated patient population, who presents an opportunity for our approach as monotherapy.
So <unk> program positioning would you see as shown here in the middle is for these more severe patients.
Who are currently untreated or in need of additional fee lowering as an adjunct.
Turning now to <unk> 53, which is even noted recently entered the clinic in healthy volunteers.
We've shared that this program builds on disease state synergies since as an inborn error of metabolism Theres, a direct overlap between <unk> and PKU in terms of Pis kols and connected patient community.
In terms of the current disease management patients with HCV. You also must live with restrictive diets that are considered even more onerous and challenging than those for PKU.
And to reduce the risk of impaired cognitive function or developmental disabilities.
In addition, however, elevated homocysteine levels in HCM presents significant risk of devastating and acute systemic complications including thrombus.
All of them in stroke skeletal weakness and associated fracture dislocation.
But like PKU, the current standard of care for Hcl Reis the need for new approach.
Approach that is orally administered without systemic absorption and associated risks and also conducive to both monotherapy and adjunctive or combination treatment approach.
Today's standard of care is the generic pain known as the brand name <unk>, which has been generic for decades does not alleviate dietary restrictions and often leaves further need for homeless athene reduction.
Current options in development are injectable enzyme replacement therapies from speaking with Kols clinicians and patients we have heard consistently the excitement for an oral option, particularly one with the profile of an engineered probiotic and we are excited about moving this program forward.
At this point I'd like to turn the discussion over to Dave to provide a bit more context regarding our upcoming data readouts as well as our newest drug candidates.
Thanks Molly.
It is a pleasure to review this exciting time for our pipeline as it both advances and has added a new drug candidate.
Mali and <unk> have both touched upon our upcoming data readouts in PKU and <unk>.
We are also looking forward to proof of concept data in support of <unk>.
Designed to consume oxalate in the Gi tract and reduce risk of recurrent kidney stones and related renal complications and patients with enteric hyperoxaluria.
Cindy <unk> is being evaluated in two studies.
One in patients with ruin Y gastric bypass surgery, who have elevated absorption of oxalate.
To evaluate whether <unk> can lower urinary oxalate in those patients.
There was a second ongoing phase one study.
<unk> 802 program to continue to build our clinical dataset and patients with rune Y gastric bypass.
This is an inpatient setting study.
Where are we can collect diet data as well as high quality 24 hour urine and fecal samples.
We believe that the combination of parameters assessed will support proof of concept for this patient population.
It is also my pleasure to share that we have made an additional program in our metabolic pipeline.
<unk> 2081.
Synthetic biotic designed to consume uric acid in the Gi tract.
With the goal of lowering systemic uric acid levels for the treatment of gout.
As Eva mentioned this is our second drug candidate through our partnership with Ginkgo Bio works.
We are tremendously excited about the opportunity to add another much needed option to the gout treatment repertoire.
Which remains quite limited today by current treatments.
Which are limited in terms of safety efficacy or the patient experience.
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 second quarter, ending June 32022, and I am pleased to review the highlights of those results with you now.
Revenue was <unk> 2 million for the second quarter of 2022.
With the same period in 2021.
Revenue was from our collaboration with Roche for the discovery.
Novel synthetic biotic for treatment of inflammatory bowel disease.
For the second quarter of 2022, the company reported a consolidated net loss of $15 7 million compared to a consolidated net loss of $15 million.
The corresponding period in 2021.
Turning to the balance sheet and logic in the second quarter of 2022.
With $106 8 million in cash cash equivalents and marketable securities compared to $125 million as of March 31 2022.
Under our current operating plan, we expect that our cash will take us into 2024, and then able to largely to advance our clinical programs with multiple important data readouts across our 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 Keith to wrap things up.
Thank you Michael.
It's an exciting period for <unk> logic as we advanced three anticipated data readouts in the coming months and the phase III initiation in the first half of 2023.
We are well positioned with a strong balance sheet to advance these important programs.
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.
Need of new treatment options.
We will now open the call for questions.
As a reminder to ask a question you will need to press star one one on your telephone please standby, while we compile the Q&A roster.
Our first question comes from the line of Joseph Schwartz from <unk> Securities.
Dialing in for Joe. Thank you for taking our question.
The first one is on your PKU franchise.
Another company recently lowered their sales guidance further PKU franchise, citing that PKU treatment centers have not bounce backs from the pandemic and I know you mentioned labor shortages on your earnings call last quarter. So I'm wondering if you're still detecting some challenges enrolling symphony and <unk>.
Internal expectation is on the market opportunity has been adjusted based on the recovery rate observed from the other company.
Thanks, Jerry this is Eva.
I can say that our guidance for the two data is unchanged. We plan to have data later this year regarding the market dynamics in PKU, maybe I'll pass the call over to Molly to make some comments, we've obviously been observing other products and learning from them and that she can provide you with a little bit more color there.
<unk>.
Hi, there thanks for the question so.
<unk> of the other products, what we've generally heard from the clinicians there is that.
The interest in new therapies, and alternative therapies that provide a different profile is extremely strong and in every single patient appointment, they're having they're talking about not just what's available but also options in development.
But meanwhile, clinician.
Clinicians across categories.
Treatment categories are seeing different pieces of return too.
Unquote normal, including seasonality consideration whats guiding.
<unk> and the opportunity that's the foundation of our program really Hasnt changed and if anything as we engage with the community is just alright getting.
Stronger and stronger.
Okay. That's helpful. Thank you and then maybe continuing on the enrolment theme I know, it's very early but are you anticipating major differences in your phase III enrollment versus phase two that could affect the enrollment rate.
I'm wondering if that just expecting it to be faster or slower or about the same based on your experience.
Yeah, Great question.
There are a couple of things that are going to be very different jewelry for the phase III program compete phase III program number one thing is that we have a lot more sites. So we anticipate going to multiple countries and regions and happening.
Our full difference in terms of the number of sites that we'll be using to enroll at the tribe will obviously be baker, but I think spreading a broader geographic mix will certainly help us in terms of achieving the required enrollment rates.
I think the second component is that theyre going to be big differences in terms of the study design.
So these patients with PKU.
Very interested in having access to Turkey beyond just two weeks of a phase <unk> study.
That's some of the feedback that we've received as you've been enrolling phase two is that if patients are interested.
May be phase III, where they have the opportunity.
In an open label extension study and have that opportunity if they benefit from treatment to be able to continue until the product is approved that's very similar to lots of rare diseases. That's always a key concern for patients and enrolling they don't want to have potential benefit and then have to discontinue.
Discontinue the product.
And I think the hurricane that's going to be very different.
Between the phase two into phase III, if the phase III will obviously be a lot less intensive in terms of.
The commitment and work required for patients and sites.
Phase III study is very data rich and theres lots of endpoints patients have multiple visits to the clinic for EMEA test and other things.
And that's obviously, a big burden for patients it pays off because you get these nice biomarker endpoint and cloud we're learning about the program that makes perfect sense, but if you move to phase III.
I think the burden for sites and for patients will be a lot lower because we'd really be focusing in on the past must be lowering as the primary endpoint with less frequent bad debt.
A much more or less intensive does that in terms of blood draws and other assessments.
Those are the kind of key factors.
And the good news is we have out there.
<unk> other phase III trial to base, our enrollment projections on so when we come to that point.
Providing guidance around phase III enrollment rates and things like that we have some precedent to go by.
For those kinds of data points.
Okay, Great. That's very helpful. And then maybe finally, if I could just squeeze one more and.
How should we think about <unk>, playing a role and see a reduction my.
My understanding is <unk> phase III trial included children and adults I'm on the other hand your phase II trial is enrolling on 18 and up and I know that the platforms are different.
But you know I.
I guess the question is are you anticipating or expecting other brands cielo offering based on H. Thank you very much yeah. So I think that that's a great question I think number one thing in terms of pediatric product development.
Was it your baseband outlier because it had been used clinically in Japan.
When Biomarin 50 initial R&D. So it did have some clinical data and safety.
<unk> and exposure, but in general the agency like you to demonstrate safety and some probability that patients will benefit before you start enrolling those who are less two or below the HFC essentially.
Our plan would be to continue to work with the FDA to be able to broaden that enrolled those younger patients in a stepwise manner.
Just on the data that we're gathering in the phase two study because we do recognize that the pediatric patients are key.
For us with big unmet need and obviously lifelong consequences, so we'll be moving as quickly and aggressively.
Aggressively as possible to get those patients on study.
In fact at the endpoint with pediatric patients. There's no reason from a biology perspective, why pediatric patients will respond differently to adults in terms of the lowering.
One thing that is different in the pediatric patients is may be the end point needs to be different often particularly the young kids to under very tight.
Parental control will often have baseline lower fee levels and in those patients may be the endpoint needs to be protein liberalization at the end of how much additional natural protein can be added to their diet, rather than just looking at lowering because.
Some of the parents with kids, who have peak.
Very obsessive moms.
Monitoring fee levels, very frequently and really keeping the diet very tightly controlled.
So there may be differences just in terms of.
The right endpoints into various populations as we March down to age group, but we're absolutely thinking about pediatric development as part of our overall clinical development plan and <unk> got tremendous opportunity in that particular segment for <unk>.
Our candidates.
Thank you. Our next question comes from the line of Mark Breidenbach from Oppenheimer.
And thanks for taking our questions just a few from us.
First of all when can we expect you to announce the finalized phase III protocol details or what you're going to have to kind of wait until next year for that and can we assume that trial is being designed with the intention to support registration in more than one geography, maybe both U S and Europe .
Second question on the PKU.
Whether or not youre going to be relying on your in house manufacturing capabilities.
The study and if you have clearly spelled out.
The list of CMC requirements from the FDA for.
Drug product, that's going to be used in phase III and beyond.
So those two questions on TK, you and then maybe one on the new program and I guess I'm just wondering if you would expect.
<unk> thousand 81 to have any impact on your gas production from endogenous sources.
Or maybe even on renal excretion of uric acid or with this product only reduced uric acid derived from from dietary sources. Thanks.
Thanks, so much for taking the questions.
Yes, thanks, so much mark for your questions and for.
For the first one in terms of the phase III design, we plan to have an end of phase two meeting with the FDA, where we'll get final assignment on the specific design before we disclose that externally I think that's the prudent thing to do.
So the manufacturing requirements, we've had a lot of good discussions with them, but we've been going through development around our CMC and particularly our analytics for our product and have been very good alignment Jenny good collaborate shows.
Discussion with them, we don't foresee any major showstoppers there based on the back and forth that we've had to date, but obviously the final agreement comes with the end of phase II meeting minutes and as soon as we have dosed in hand, we'll be sharing the overall study design as well as the overall feedback from FDA.
With the investment community.
The other components of your question is about global regulatory we do see a lot.
A lot of opportunity for this product.
55.
55 pads in patients with PKU globally about 17% of those are in the U S. So there is clearly a big unmet medical need a large PKU population and I think some interesting commercial opportunity ex U S and some of those geographies. So we are as you've seen with our announcement of our EMA orphan.
Designation, we're actively pursuing ex U S regulatory alignment.
Having said that the most important thing for us is speed to BLA in the U S. So we are engaging but also maintaining focus on initiating our phase III study as quickly as possible and don't want to compromise our speed our success with FDA.
Turning to get global alignment FERC for PKU.
And then on the final PK. Your question about manufacturing I think we have Tony on the line, maybe I'll ask him to explain in more detail what our plans are for manufacturing to phase III material.
The trial Tony Yes.
Yes. Thank you. So I know I think the first point you mentioned in terms of regulatory correspondence with the FDA. We've had positive supportive CMC regulatory correspondence, we constantly have gone back and forth and Thats on a good path to the question I think on manufacturing and supporting the phase III. We've made concrete progress next units plan. So.
We have product to supply for the phase III and that comes from what I'd describe as maybe three different pieces.
First piece as we optimize our process.
To allow for higher yields within that.
By improving our cell density, but we also have scaled up.
And the second piece is that we have complete expansion and renovation of the suite or our manufacturing facility to allow us to support this next level of scale up where the scaled up process.
And we've also completed a tech transfer into the suite and where we're really getting ready now for.
The future GMP activities to support the phase III.
The combination of the scale of the improved process cell densities that allows for high yield. The fact that we've expanded our suite. All these pieces coming together to allow us to support the phase III and we will provide material support production of materials for the phase III from a credit suite.
Does that answer your question.
It does thank you.
And then thanks again.
Hey, guys out Burger, yes, yes, yes, I wasn't I wasn't forgetting that Mark I think we have Gabe hover on the line. He can maybe explain some of the biology, we've done some really elegant work in research to at least to date the role of <unk> in <unk>.
And we look forward to sharing that at a future academic meeting, but maybe Dave can give you some of the high points today.
Yes, I'd be happy to do that.
For just said I think I understand the biology, and uric acid metabolism and distribution has been a big component of advancing this program forward.
I think for many of the metabolites were interested and there are multiple pools to draw on rate. Obviously diet component that is true for the new assets oxalate I think we think that's also true for uric acid.
There are also pools. Many of these metabolites that re circulate from the systemic compartment into the gut and then back out.
Circulation pathway than we did.
Scribe that for phenol allocated <unk> as a potential pool to also access.
We also think that happens with uric acid and so that comes from some some literature. Some older literature Thats really highlighted I've got component in the metabolism of just endogenous uric acid and clearance from that compartment and so we do think that there'll be the ability of the bug to access some of that pool as well.
And we have some of our own data.
In both rodents and nonhuman primates that support that so.
It's likely to be bolt compartments is kind of the short answer to your to your question.
Alright, thanks, so much for that clarification and good luck with everything.
Thanks.
Thank you as a reminder to ask a question you will need to press star one one on your telephone.
As a reminder, please hit star one one on your telephone.
Our next question comes from the line of Ryan Hill, ROM Silva Rajeev <unk> from H C. Wainwright.
Hi, everyone. This is mitchell on for Rob. Thank you for taking your questions.
Wanted to ask you were talking about on the enrollment rate for PKU phase III versus phase two it could be a little less intensive.
Because in phase II, you are collecting a lot of data that's going to be very data rich could you talk about any differences that you could expect anything you would.
Leave out on the phase III design versus phase III in terms of that data in terms of like biomarker collection and others.
What might we see more of in the phase II that we.
Potentially it wouldnt get to see in the phase III.
Yeah. So good question Mitchell.
This is Eva.
The phase two study, we really wanted to dig in most efficient design possible helped us understand whether this product could be effective in lowering fee in PKU patients.
Based on the data we announced last year that we were successful in that I think the data is very internally consistent we had multiple biomarkers all arrows pointing in the same way. So we know based on those days and are hoping to kind of further confirm that later this year.
Can work I think the phase III study is now going to evaluate and kind of sharpen up the clinical profile for this product and.
And theres going to be multiple learnings from the phase two that we'll take forward into phase III design. The two most important component I think from my perspective as a drug developer.
The proportion of patients who are going to respond the proportion of the PK patients who are going to have a response and then what's going to be the feed lowering.
And that responder population I think those are the real critical endpoint.
That's so much easier and pointed to a blood sample that can be taken every couple of weeks for plasma theres no need for neocart to overnight fasting intentions multiple time point data curves back we're doing in phase III.
I think the second component is just making sure that we optimize the tolerability profile of the product as you've mentioned before we have Gi aes, we've learnt a tremendous amount from all of our programs in terms of how to best manage and mitigate what we've seen is that those a either very individual and I think allowing people to <unk>.
Trade up to the right dose and find the right dose for Dan is going to be a really important component of our phase III study design. So I think.
<unk> efficacy components as well as Tolerability components, and I think overall, we see tremendous promise.
Based on the learnings from phase two that we can really optimize that phase III design to be as informative as possible and also have a good enrollment rate by having it.
Low burden for patients and for sites.
Yeah.
Thank you I would now like to turn the conference back to E mailed Brennan for closing remarks.
I'd just like to close by thanking everyone for joining us today for the call. We look forward to the second half of this year and thank you so much for your attention.
This concludes today's conference call. Thank you for participating you may now disconnect.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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