Q1 2021 Synlogic Inc Earnings Call
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Good morning, and welcome to city logic first quarter 2021 conference call. At this time all participants are in a listen only mode there'll be a question and answer session. At the end of this call. Please be advised that this call is being recorded I would now like to turn the call over to Daniel will then.
Head of finance and Investor Relations. Please proceed.
Thank you operator, good morning, and thanks for joining us on today's conference call.
This morning, we issued a press release, which outlines our first quarter 2021 financial results and additional business updates. The release is available on the investors section of our web site Hudson logic, TX Dot com.
Joining me on this call our Doctor equal Brennan, President and Chief Executive Officer, and Dr. Richard Reese Chief Medical Officer.
Other members of the management team, including interim CFO Gregg Beloff on the full team will be available during the Q&A.
During the call if it will provide a review of first quarter highlights and recent progress Richard will provide an update on our metabolic portfolio and our lead programs in phenylketonuria in enteric Hyperoxaluria.
And I will summarize our financial results for the quarter.
Following our prepared remarks, we will open the call for your 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 statements as a result of various factors, including those described under the forward looking statements <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.
So on logic cautions you not to place undue reliance on any forward looking statements.
Now I'd like to turn the call over to your phone.
Thanks, Dan Good morning, everyone and thank you for joining us I'm thrilled to share with you today, our financial results from the first quarter of 2021 as well as recent execution and progress across our portfolio.
We are executing on our plan to demonstrate the clinical potential of price synthetic biotic platform in 2021.
Proof of mechanism established in our two lead Massa biotic programs and a strengthened balance sheet, we are well positioned to deliver proof of concept readouts for both shouldn't be 16 18 in PKU and then be a keto too in enteric hyperoxaluria nature of this year.
Since we started the year, we continue to maintain a rapid pace, but you were developing synthetic biotic medicines with the goal of providing meaningful treatments for patients with serious diseases.
We are rapidly progressing on metabolic disease pipeline, which leverages the ability of our platform to engineer, a synthetic biotic medicine and deliver them safely into the human Gi tract to consume a toxic metabolites.
We believe that there are a wide variety of disease day, but this approach could transform patients' lives.
I see planned for late stage clinical development of our coli metabolic programs.
<unk> made the decision to expand our manufacturing footprint by more than 50 per cent to build expanded from in patient on nationalization capacity.
This build out which will be completed in the second half of the year will enable clinical supply to support the potential late stage development on.
Shouldn't be 16, 18 and shouldn't be a P. Two two.
By building, a fully integrated internal process development and manufacturing infrastructure.
Logic will be able to respond quickly to the needs of our clinical programs and ensure the rapid progress of our pipeline.
Completion of the build out this year sets us up for a rapid transition to late stage development for our metabolic portfolio after potential proof of concept readouts in the second half of 2021.
Since our announcement that shouldn't be a day. So too has achieved proof of mechanism in human with dietary hydroxyurea.
We now have two metabolic programs.
Can be 16, 18, and PKU and shouldn't be a peso to inventory kyprolis or your yet that have demonstrated the ability to consume a toxic metabolized within the human gastrointestinal tract.
Both programs have done so at levels that have the potential to be clinically meaningful in patients with disease.
And in both cases, we have clinical trials ongoing in patients to demonstrate impact on critical endpoint with Readouts expected later this year.
With our candidates in PKU, we have previously demonstrated without lyophilize formulation of shouldn't be 16, 18 was able to consume phenylalanine in the Gi tract of healthy volunteers.
We are currently evaluating day strained and adult PKU patients in an ongoing phase two study we called Didnt anyone.
This trial continues to enroll well and we're delighted to see my so much patient and investigator interest.
We continue to hear from patients and caregivers, that's a safe oral therapy, which reduces plasma fee levels I consuming fee in the Gi tract would be a welcome addition to the market.
So I shouldn't be 16, 18 has been progressing in the clinic soon be 19, Turkey for its also moving true I N T enabling activities.
Shouldn't be 1934, which was developed using a novel directed evolution approach from can be 16, 18 has demonstrated enhanced activity compared to can be 16, 18, and preclinical models of food consumption.
We will provide additional updates at this strain progressing towards the check.
Send me a keto too is that others need metabolic program.
It's designed to consume the toxic metabolite oxalate in the Gi tract in patients with enteric Hyperoxaluria and leidy causes oxalate nephropathy, and recurrent kidney stones for which there are no approved therapies.
We placed healthy volunteers on a high oxalate diet and increase the urinary oxalate levels, thereby increasing dietary hyperoxaluria.
And demonstrated robust and dose response of urinary oxalate reduction relative to placebo.
In only 15 months after we nominated it shouldn't be a T cell to these data demonstrate the speed and part of the synthetic biotic platform.
We're moving rapidly towards clinical proof of concept in patients with enteric hyperoxaluria.
B of the Phase one study is enrolling well.
This study gives us an opportunity this year to demonstrate what very well may be the most clinically attractive profile for patients suffering from enteric hyperoxaluria.
We're taking the learnings from our co lead metabolic programs and applying them to novel approaches to address other inherited and acquired metabolic disorders.
Together with our partners at Pico by at work, we're advancing our synthetic biotic platform across multiple metabolic disorders and inflammatory condition pictures IBD.
We continue to make good progress on this exploratory in preclinical work and we'll share additional updates over the course of the year.
Our immuno oncology portfolio also continues to advance.
We shared an update on our syn be 18 91 program in immune oncology at the recent American Association for cancer Research annual meeting and continue to enroll both monotherapy and combination therapy arms of the phase one study.
Data from both arms will continue to be reported over the course of 2021.
Our team has done a tremendous job executing across multiple programs.
This resilience and teamwork has allowed us to set the stage from multiple meaningful readout in 2021.
Thanks to our careful capital stewardship on recent financing event catalyzed by a high quality syndicate of institutional investors.
All milestones occur well within our cash window.
In summary, 2021 has already been an incredibly exciting year for the company.
We now have demonstrated proof of mechanism in humans from both of our lead metabolic programs PKU and Terry Kyprolis of urea and.
And the opportunity to demonstrate proof of concept in both programs is makes it this year.
Now, let me turn the call over to Richard to share progress on the metabolic programs.
Richard.
Thank you Paul.
I would like to now walk you through the progress across our metabolic portfolio.
Well if people said, we now have demonstrated proof of mechanism in humans from both on lead metabolic programs PKU, it didn't kill or perhaps a year ago.
Our studies are executing well.
Both programs have the potential to demonstrate proof of concept in 2021.
Let me begin with PKU.
Yeah.
PKU is an inherited metabolic disease in which children are born without the ability to metabolize phenylalanine well see.
Despite the availability of dietary management and approved treatment a large proportion of patients struggle to maintain plug fee levels in the target range required to avoid neurocognitive deficits and irreversible neurological damage.
Through our conversations with patients caregivers and advocates within the PKU community.
So it is increasingly clear off of both current and emerging treatment options continue to leave too many patients behind.
It's safe.
Tolerable reversible and oral therapy would be welcome.
So on logic approach to pizza, you, a simple and intuitive.
It is well understood reducing the dietary consumption or you don't.
Colony reduces plasma fee levels in patients with class called PKU.
Our approach its appeal to build on my biology to introduce a synthetic biotic medicine into the Gi tract.
Which is specifically designed to consume fees.
And produced a measurable biomarkers TCA and interest.
Sending 16 18 has shown promising activity.
We have demonstrated the ability to see in the Gi tract.
Most recently in our solid on bridging study in healthy volunteers.
Which we shared an update on the American College of medical genetics and you're on me.
The next step is to understand how the consumption of the wood yard truck in PKU patients will impact plasma free levels.
Yeah.
Do I answer that question, we have initiated a phase two symphony one study had multiple sites across the U S.
All sorts of active and are currently enrolling well.
Patient interest is robust with the option for at home virtual or in clinic from petrol station.
So going on for somebody one phase two proof of concept study altra demonstrate the potential of Cindy 16, 18 to lower blood fee and adult PKU patients and validate our Pharmacodynamic model.
Better understand the relationship between the production of strained biomarkers and plasma steel or for Cindy 16 18.
Remember if a patient from symphony have no therapeutic options.
Yeah in eligible and appropriate for or unresponsive to Kuban will put value.
These patients on a lot behind by current therapies.
The study is powered to detect 20 per cent reductions on feet.
PKU patients and investigators tell us that 20% fee reductions and an oral Paul and reversible therapeutics, which is on foster for coupon non responders would.
It would be a welcome treatment option.
Following up on the success of <unk> 16, 18, we continue with the development of Symbian 1934.
And evolved synthetic biotic medicine in the PKU portfolio.
Cindy 1934 is progressing through R&D, enabling studies.
And it has a potential to strengthen our PKU fridge on Brian.
Higher levels of fee consumption low.
We're dosing or both.
The willingness of advocates caregivers and patients to engage with us and other sponsors that's critical to advancing new treatment options for this devastating disease.
We would like to thank them for their participation.
Let me now provide an update on our phase one study of 78, eight or two for the treatment of enteric hyperoxaluria.
Which continues to advance in part B of the study.
Patients falling promising results in healthy volunteers.
Until a couple of artful urea is a devastating condition with no treatment options and which dangerously high levels of urinary oxalate lead to progressive kidney damage in oxalate in the property.
It also on occurs as a result, our primary insult to the bowl.
Such as inflammatory bowel disease shortfalls syndrome, or as a result of surgical procedures, such as root and why.
Weight loss surgery.
If left untreated the dangerously high levels of urinary oxalate calls recurrent kidney stone formation, therefore, calcinosis in progressive damage, resulting in chronic kidney disease.
Since oxalate is present in many healthy Foods, Inc.
Total couple of OXXO urea is almost impossible to control with diet.
That means these patients are at risk for serious kidney complications.
As you know we have demonstrated syn b aviator true proof of mechanism in a dietary Hyperoxaluria study.
We are now moving to part B of that study and where Cindy in their day to will be evaluated for the potential to lower urinary oxalate and enteric hyperoxaluria patients.
Let me walk you through both parts of this thing.
Yes.
So primary outcome of part a of the phase one study was safety and Tolerability with results used to select the dose for further study and in patients with a total carper auxiliary.
Part B of the trial.
We completed dosing of five cohorts and per day of this study.
And the efficacy analysis.
Clinically meaningful per cent change from baseline urinary oxalate was 28, 6% lower compared to placebo.
311 lifestyle dose.
This dose was well tolerated and will be used in part b of the study.
Similar to our other programs, we did not observe any systemic toxicity thermo assays are serious adverse event.
Dose.
Adverse events were generally mild to moderate Gi related and transient.
We saw that a dose ramp where patients take a single dose on the first day.
Two doses on the second day and three doses on the third day significantly improve the tolerability profile.
Cindy a day or two because of non colonising non reproducing strength and clearance from subjects after the cessation of dosing.
Yes.
We examine the ability of Cindy it at her two to lower urinary oxalate levels and this solitary hyperoxaluria model in healthy volunteers.
Let me spend a moment on this slide because it is an important one.
Here, we present the change in urinary oxalate from LIFO.
Relative to placebo within each dosing cohort.
Across both price every regimen.
The 600 milligram dietary oxalate regimen is on the low.
And one in which subjects consumed 400 milligrams of dietary actually is on the right.
In both cases subjects were treated with multiple ascending doses of syn be it on too.
We were thrilled to see substantial urinary oxalate Laurie.
At multiple dose levels under both dietary regimen.
And across multiple dosing cohorts.
This consistent result, and it goes to book responsive manner is very encouraging.
The lower bond on the 90% confidence interval did not cross-sterile from.
One of your 11, 311 and 611 total.
These day to indicate to us are robust and reproducible results.
I am now going to focus on the dose level, we have chosen to move forward to part B of this study.
Patients with enteric Hyperoxaluria.
Due to ruin Y gastric bypass surgery.
These patients will have dangerously high levels of urinary oxalate due to their underlying gastrointestinal conditions.
We have chosen a dose of three here love on lifestyles for biopsy of the trial.
We believe this dose could provide a clinically meaningful reduction in these dangerously high urinary oxalate levels.
For this population.
Yeah.
But the 311 dose.
We observed the tolerability profile similar to the equal on missile program.
But always transient Gi side effects.
This dose resulted in a 28.6 reduction in urinary oxalate relative to the placebo group.
At the end of the dosing period so.
You're right actually level and the placebo group was $58 one milligram.
Compared to 41 milligram in the treated group.
If we assume based on existing literature.
Proximately 10 per cent of the dietary oxalate is absorbed systemically and excrete it in the urine.
These data suggest that healthy volunteers treated with syndicated or to hedge.
Had urinary oxalate levels equivalent to only 400 milligrams a day.
Despite being on a stable 600 milligram died.
The clinical implications of this finding are very exciting.
As we move into patients.
No.
Let me turn to what we'll learn from part B of this study.
Which we are now executing on and have multiple sites enrolling as we speak.
We will assess the urinary oxalate lowering potential Cindy Edo too.
V. A crossover design in patients with enteric Hyperoxaluria area following ruined Y gastric bypass surgery.
We believe that this patient population is an attractive one to conduct a clinical study.
Because it is relative relatively homogeneous and easy to identify.
You had also translational irrelevant.
Well the other sponsors demonstrating relatively consistent results between ROE and ROI patients with enteric hyperoxaluria.
And patients with other underlying.
Yes.
The regulatory and clinical path and this indication is relatively straightforward.
With significant precedents by sponsors and related diseases, such as primary hyperoxaluria.
For the importance of urinary oxalate.
Cause one critical on point.
We will continue to work closely with regulatory authorities.
We develop our clinical strategy.
Our initial efficacy assessments will evaluate clinically relevant reduction in urinary oxalate levels.
And feedback from our key investigators suggest greater than 20 per cent lowering in patients.
Would be meaningful.
Lowering dangerously high levels of urinary oxalate is the only way to reduce the risk of disease progression and reduce or eliminate oxalate nephropathy.
We are pleased that shouldn't be a delta two has demonstrated the potential to lower urinary oxalate levels in healthy volunteers with induced dietary hyper actual uri.
We are looking forward to advancing the program rapidly into patients and providing additional data this year.
As we move forward with both of our lead programs and PKU and enteric Hyperoxaluria area.
I will come back to you with more information.
As the studies unfold.
Now, let me hand, the call over to Dan to briefly run through our financial results Dan.
Thank you Richard and good morning, everyone.
This morning, we released our financial results for the first quarter ended March 31 2021.
And I'd like to review the highlights of those results with you now.
First on.
I'm pleased to say, we strike send our balance sheet subsequent to the end of the first quarter with the completion of a public offering of 11 5 million shares.
Net proceeds from the offering were $32 6 million, bringing the company's cash balance to an approximate $127 million.
Now to the quarterly results.
Research and development expenses were $11 2 million for the three months ended March 31 2021.
Compared to $12 7 million for the corresponding period in 2020.
R&D expense for the three months ended March 31, 2020. One consisted primarily of costs related to our collaboration with Ginkgo bio works for the optimization of synthetic biotic medicines.
Well its clinical study activities associated with <unk>, 16, 18, and should be 80, though too as well as the ongoing Senvy 18, 91 phase one study.
General and administrative expenses were $3 9 million for the first quarter of 2021 compared to $3 8 million for the same period in 2020.
For the first quarter of 2021, the company reported a consolidated net loss of 15 million or <unk> 36 per share compared to a net loss of $15 8 million or <unk> 46 cents per share for the corresponding period in 2020.
We had no revenues in the first quarter of 2021 compared to <unk> 1 million for the same period in 2020.
Revenue was associated with services performed under some largest collaboration with Abbvie to develop synthetic biotic medicines for the treatment of inflammatory bowel disease and agreement, which has since been terminated.
Now turning to the balance sheet.
So on logic ended the first quarter of 2021 with $94 4 million in cash cash equivalents and short term investments.
Under our current operating plan taking into account both these quarterly results as well as our subsequent financing we expect our cash on cash equivalents to be sufficient to fund the company through the second half of 2023.
This will enable some logic to advance clinical programs through important data readouts over the coming months.
Thank you for your attention we look forward to keeping you updated on future calls.
I will now turn it over to equal to wrap up.
Thank you Dan.
Our team has made tremendous progress across all of our programs both in and outside the clinic, we're executing effectively and with a sense of urgency we've demonstrated proof of mechanism in humans from both of our lead metabolic programs PKU unimpaired cutbacks on urea.
And we look forward to the opportunity to demonstrate proof of concept in both program later this year.
We will now open the call for questions.
If you'd like to ask a question. Please press Star then one if your question has been answered and you'd like to remove yourself from the queue. You May press the pound key.
Our first question comes from Joseph Schwartz with SBB Leerink. Your line is open.
Hi, I'm Jerry dialing in for Joe. Thank you for taking our questions on.
My first one is on can be a eight O. Two I was wondering if you could describe the phase wouldn't be here ordinary oxalate pattern in healthy volunteers that you observed over the course of the study I believe that the data release, we're in a particular time points and specifically I'm interested in knowing no one.
Could you describe how the treatment and placebo arm looked over time and two what's the delta there franchise. The difference between the two arms plateauing or still separating towards the end of the trial.
Great. Thanks, Jerry This is Easter here on I think that's a great question for.
Richard to answer so Richard do you want to take your first question on we can come back to a subsequent questions after that.
Sure.
The data will be presented in an upcoming meetings.
And we look forward to that just a little preview on this.
It is a great question and what we found in terms of the 600 milligram group, which is low.
Data, we presented here was that the placebo group kept increase from their urinary oxalate excretion up until treatment day too so.
There was a little tail yeah, even after the.
Run in period, where.
The placebo group.
Continued to increase after that it appeared depressed plateau and both in terms of the placebo excretions accretion on 24 hours from Richard.
Are you on your actually as well as the treatment difference between placebo and the EBITDA of two treatment groups.
And we showed the data.
Somewhere about.
To get moving.
Wow.
20 milligram difference and that was put on by the end of the treatment period.
Okay. Thank you for your question Jerry.
Yep Yep, Thank you and then.
I guess for Cindy 16, 18, and eight eight O. Two we're expecting data you know both in second half and I was just wondering if you could just help us see how what the potential order in which they could see the data.
Yeah. Unfortunately, we don't yet have full line of sight, there really neck and neck in terms of the execution and we've guided to second half on this year for both studies and as we can kind of progressed through the year.
Our next question comes from Lina Kaminski with Jones trading your line is open.
Thank you hi, good morning, So I guess my first question is on a day. Those two can you talk a little bit more on kind of your consideration for dose selection for the phase one B study.
You know in terms of your expectations on different kinds of urinary oxalate lowering in patients.
On the 28, 6% you saw him you know considering the baseline in both parts of the study.
Then I have a follow up.
Okay.
Richard do you want to take that question.
Yeah.
So if I was just making sure you were back because we lost you for just a moment, but it sounds like you are so we're good to go.
Hi, Thanks, Richard would you like to handle that question.
Sure here of course, we're very interested in how the healthy volunteer data will translate into patients with health accounts here and we're also optimistic.
Oh for a couple of different <unk>.
First of all there is precedent as probably another sponsor.
True that they have to go on to your data translated.
In terms of treatment to patients with integrity, so urea and secondly, and most importantly for us, which we believe has potential differentiating on track.
On a lot of the oxalate in patients with into income per ounce cocky here. It is.
So on and the colon and the transit time to the colon is much much longer than the transit time in the upper Gi system.
No in healthy volunteers most of the oxalate is absorbed.
In the upper Gi So our Australia and gets you know whenever I noticed for six hours or six hours to consume oxalate before it's absorbed well.
As an intern paper on so urea patients where a lot as I said before there were a lot of the.
Akshay is taken up by the colon and there isn't a long trend of time in the colon.
Yeah, the strain will have a much longer time to consume oxalate in patients.
Before it is absorbed and the learning the short of it is our expert team expectation is that we will meet you know 28, 6% treatment difference between.
As a day or two in Seattle and patients with enteric hyperoxaluria or in the optimistic viewpoint, we may.
Do even better.
Having said that we need to do the experiment on in.
And you were in process of doing the experiment right now and we're quite pleased with our with our enrollment.
Got it thank you and I guess the other question is on <unk>.
So how should we be thinking of 1930 or are.
Should we be thinking on it but it essentially cannibalizing 16, 18 team or is that going to be a separate assets that should or it may expand the market opportunity and I guess in terms of maybe you can help us elaborate on timing when can we anticipate to see filing or even.
It ended up going on.
Yeah.
Yeah. Thanks, <unk>, so just furniture business background.
The company took 16 18 and try to make we chose a person of Paul that was described in the literature. So that's the enzyme that converts phenylalanine into TCA in the bacteria, but we weren't sure that that was the best possible enzyme to choose so around the time that we initiated the clinical development of 16.
The team we also undertook a kind of a technology landscaping to see what technologies were available out there that would allow us to determine whether we could optimize or do better based on the pal enzyme activity that is demonstrating that <unk> taken forward. So 1934 is the result of work that started to.
Some time ago, and we've been really pleased both in terms of how we've been able to assess the various technologies that are available on to optimize drilling activity as well as had the team had been able to kind of make a very nice decision charts. If you will about music 19, Turkey for us as the best.
On a bleed if you will of all of those strains that factory is about two backups forward and we have started to guide the enabling work will certainly provide additional updates as that program moving forward and we would expect it to move very rapidly and to potentially be able to dovetail into the development program at the right.
Time, it seemed like the right decision, but you know the day.
It would be very much based on the data from those 16 18 as well as how rapidly 19, Turkey for progressive and frontier.
In the clinic I'm you know on we'll make the right decision for the program and once we have all of the data in hand, and so hopefully that makes sense.
Yeah that that is thank you so much and again congrats on the quarter and thank you for taking my question.
Penn cleanup.
Our next question comes from ROM Silverado with H C. Wainwright Your line is open.
Hi, This is Mike on for Ram Silverado true. Thanks for taking my question. So I was just wondering regarding the ginkgo bio works IPO, what implications my kinko's going public have for its relationship with simple logic and its ability to that.
Dedicate more resources to the partnership.
Yeah. So obviously, it's a great congrats there on an order for our partners Ginkgo. Our collaboration continues to be very strong we work with them very actively and as they develop their platform will be absolutely looking for ways to apply back to our preclinical programs I'm sorry.
That's a very exciting I think advancement in terms of taking care of business, Dave Inc. The Chief Scientific officer here he'd be most closely involved with the ginkgo collaboration so maybe I'll ask Jane to provide some color in terms of how we currently work with ginkgo on some of the additional preclinical metabolic programs that were.
Bringing Paul Rankin development, Dave do you want to comment on that.
Yeah sure I'd be happy to.
Oh, yeah definitely congratulations so they can go to.
<unk> been great partners up until this point and we're looking forward to continuing to work with them.
We work with them really closely on advancing the platform and really contributing to the early stages of our development programs.
Helping us in optimizing candidates.
Bringing some resources and capability that we don't.
Have or need to build in house and so it really allows us to focus the team on a one on the go to mid mid to later stage development candidates and really focus on kind of a clinical opportunities and by working with Ginkgo. We're we think we're really able to feed the pipeline.
Kind of help build that next stage of assets. So we're looking forward to continuing that and and maybe some additional opportunities that will come.
With their success so.
But it really should remain status quo on and really help impact on pipeline going forward.
Great color, thanks, very much for taking my question.
Thanks Mark.
Our next question comes from Ryan Mills with Jefferies. Your line is open.
Hi, everyone. Thanks for taking our questions. So I just.
Wondering what sort of capex.
Capex is going to be required for the CMC expansion and if it has any implications for your R&D spend moving forward.
Yeah. That's a great question, maybe I'll ask a diner on attorney to come on come back obviously, you know usually exciting advancement from having access to <unk>.
Higher scale from Mentation on last night vision capabilities. So that we can move into the late stages of development, which I think is is critical as our programs advance and I'll ask John maybe to comment on the Capex implications of bathroom, then Tony to provide any additional color at required channel.
Moving to you.
Yes. Thank you Lisa so to remind folks we have a very capital efficient approach to our manufacturing capability in which we partner with an on demand clean room provider. So so we feel very comfortable that we can make this investment off the strength of the balance sheet.
I do think that our burn going forward in 2022, you know will presumably be incrementally higher due to the cost of late stage development, both clinical trial costs and drug substance on and material, but this scale up will be done in a very capital efficient way, we're not providing.
Our guidance, but we're talking low single digit millions not mid or high it's very much absorbable for Ah Ah Ah Ah balance sheet on the P&L of our size and I would welcome Tony sharing a little bit more about the capabilities that this would enable because we see this as a core differentiator investment for our company.
No. Thank you Dan Yeah, that's that's correct I can add.
A little bit on the capital.
Just as background as you may have heard previously we use single use technologies. The single use technologies allows efficient scale up and efficient cost. So for that reason as Jim mentioned I do agree it shouldnt be that high.
The ability to scale up allows us to support the late stage and maybe even beyond and at this point in time, we're evaluating those capabilities and the ability to.
Support the clinical stage downstream.
Great. Thank you.
Thanks, Brian for the question.
There are no further questions I'd like to turn the call back over to you from Brennan for any concluding remarks.
So I'd just like to finally, thank everybody for joining us on today's call birthday on the Bellatrix day for any follow up questions and hope everyone has a great day. Thank you.
Ladies and gentlemen, this does conclude the program and you may now disconnect have a great day.
Uh huh.
Yeah.
Yes.
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Yeah.
Okay.
Yeah.